cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.5128192
title: Supplementary Material for: Randomized, Double-Blind, Placebo-Controlled, Withdrawal Study of Colestilan after Dose Titration in Chronic Kidney Disease Dialysis Patients with Hyperphosphatemia

description: <b><i>Background/Aims:</i></b> Colestilan is a new non-calcium-based phosphate binder licensed in Europe for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis (CKD 5D). This study was conducted to evaluate efficacy in a North American patient population and also to examine secondary actions of colestilan on lipid profile and glycated hemoglobin (HbA1c). <b><i>Methods:</i></b> This was a multicenter, randomized, double-blind, placebo-controlled withdrawal study, after an initial open-label titration period. Patients (n = 245) with stable phosphate control received 6-15 g/day colestilan during a 12-week, flexible titration period after which 169 were randomized to continue the same dose (n = 85) or switch to placebo (n = 84) for 4 weeks. The primary endpoint was the change in serum phosphorus level during the placebo-controlled withdrawal period. <b><i>Results:</i></b> A significant difference of -1.01 mg/dl (-0.33 mmol/l) in mean change in serum phosphorus, favoring colestilan, was seen during the placebo-controlled withdrawal period (p &lt; 0.001). Colestilan reduced serum phosphorus significantly from baseline to week 12 (-1.54 mg/dl (-0.50 mmol/l); p &lt; 0.001). Serum calcium levels were not affected. Colestilan significantly reduced and maintained reductions in calcium × phosphorus ion product (Ca × P), parathyroid hormone, total cholesterol, low-density lipoprotein cholesterol, uric acid and also HbA1c in patients with elevated baseline HbA1c. Colestilan was generally well tolerated; most adverse events were gastrointestinal. <b><i>Conclusion:</i></b> In this first clinical trial with colestilan in a North American patient population, colestilan demonstrated significant efficacy in controlling serum phosphorus levels in CKD 5D patients with hyperphosphatemia, without increasing calcium levels.
DOI: 10.6084/m9.figshare.5128195.v1
title: Supplementary Material for: Internet-Based Self-Help for Trichotillomania: A Randomized Controlled Study Comparing Decoupling and Progressive Muscle Relaxation

description: <b><i>Background:</i></b> Trichotillomania (TTM) is characterized by recurrent hair-pulling that results in substantial hair loss. A previous pilot study demonstrated that the online self-help intervention ‘decoupling' (DC) might be effective at reducing hair-pulling symptoms, with a stronger effect than progressive muscle relaxation (PMR). We aimed to extend these findings using a more robust randomized clinical trial design, including diagnostic interviews by phone, a 6-month follow-up and e-mail support. <b><i>Methods:</i></b> One hundred five adults with TTM were recruited online and randomly allocated to either DC (n = 55) or PMR (n = 50). The intervention lasted 4 weeks, with severity of TTM assessed at 3 time points (before intervention, immediately after intervention and at the 6-month follow-up) using the Massachusetts General Hospital Hair-Pulling Scale (MGH-HPS). Both intention-to-treat and completer analyses were conducted. <b><i>Results:</i></b> Intention-to-treat analysis demonstrated highly significant and comparable symptom reductions (MGH-HPS) in both the DC and PMR groups (p &lt; 0.001, partial η<sup>2</sup> = 0.31) that persisted through 6 months of follow-up. Participants' subjective appraisals favoured DC in some areas (e.g. greater satisfaction with DC than PMR). Completer analyses demonstrated the same pattern as the intention-to-treat analyses. <b><i>Conclusions:</i></b> Despite subjective appraisals in favour of DC, symptom reduction was comparable in the two groups. While the results suggest that even short Internet-based interventions like DC and PMR potentially help individuals with TTM, a partial effect of unspecific factors, like regression towards the mean, cannot be ruled out. Therefore, longitudinal studies with non-treated controls are warranted.
DOI: 10.6084/m9.figshare.5128183
title: Supplementary Material for: Sarcomatous Carcinoma of the Orbit: A Case Report and Review of the Literature

description: Sarcomatous carcinomas (SCs) are rare tumours that contain malignant cells with epithelial and mesenchymal characteristics. SC rarely presents in the head and neck, and occurs even less often in the orbit. Only 8 cases of SCs located in the orbit or affecting the globe function have been described in the English literature. Here, we report a case of SC affecting the right orbit. SC is associated with a poor prognosis and advanced disease at presentation. Diagnosis is difficult, as histology often fails to definitively identify SC, necessitating a wide panel of molecular/immunological markers. Treatment options are generally aggressive but risky, and frequently yield poor results. Due to the rarity of SC, there has been little focus on the development of improved treatment options.
DOI: 10.6084/m9.figshare.5128186
title: Supplementary Material for: Analysis of the Risk Factors for Aerobic Vaginitis: A Case-Control Study

description: <b><i>Aims:</i></b> Aerobic vaginitis (AV) is a newly defined clinical entity which may interfere with women's reproductive health and have negative effects on pregnancy. This study was to identify the risk factors for AV. <b><i>Methods:</i></b> Participants in this case-control study included healthy women and women with AV. All participants completed a standardized questionnaire covering sociodemographic factors, sexual behaviors, personal hygiene habits and health behaviors. Uni- and multivariate logistic regression analyses were used for statistical evaluation. <b><i>Results:</i></b> A total of 290 women of reproductive age were enrolled. In the multivariate analysis, unmarried status (odds ratio [OR] 2.606, 95% confidence interval [CI] 1.257-5.402), use of an intrauterine device (OR 4.989, 95% CI 1.922-12.952), long-term use of antibiotics (OR 11.176, 95% CI 1.363-91.666) and frequent vaginal douching (OR 4.689, 95% CI 1.363-16.135) were independent risk factors for AV. On the contrary, consistent condom use (OR 0.546, 95% CI 0.301-0.991) and college-level education or above (OR 0.255, 95% CI 0.131-0.497) were independent protective factors. <b><i>Conclusion:</i></b> Measures that may be considered to prevent AV include enhancing education to improve women's knowledge related to reproductive health, especially unmarried women, encouraging them to consistently use condoms as a contraceptive method, to avoid long-term use of antibiotics and to stop frequent vaginal douching.
DOI: 10.6084/m9.figshare.5128189
title: Supplementary Material for: Proinflammatory Caspase A Activation and an Antiviral State Are Induced by a Zebrafish Perforin after Possible Cellular and Functional Diversification from a Myeloid Ancestor

description: In mammals, perforins play a central role in the granule-dependent cell death induced by natural killer T cells and cytotoxic T lymphocytes, and participate both in the defense against virus-infected and neoplastic cells and in the recognition of nonself molecules by the immune system. Little is known about fish perforin genes. We examined the zebrafish with the aim of increasing our knowledge about the role of perforins. We characterized 6 perforin genes in the zebrafish genome, and we studied them at the evolutionary level in combination with expression patterns in several tissues and cell populations, during both larval development and in the course of a viral infection. Our results suggest the specialization of different cell types in the production of perforins. Moreover, functional diversification during the evolution of these molecules could be inferred from this study. In particular, one of the genes, <i>prf19b</i>, which is mainly produced by myeloid cells, seemed to be involved in antiviral defense, conferring protection after an in vivo infection.
DOI: 10.6084/m9.figshare.5128192.v1
title: Supplementary Material for: Randomized, Double-Blind, Placebo-Controlled, Withdrawal Study of Colestilan after Dose Titration in Chronic Kidney Disease Dialysis Patients with Hyperphosphatemia

description: <b><i>Background/Aims:</i></b> Colestilan is a new non-calcium-based phosphate binder licensed in Europe for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis (CKD 5D). This study was conducted to evaluate efficacy in a North American patient population and also to examine secondary actions of colestilan on lipid profile and glycated hemoglobin (HbA1c). <b><i>Methods:</i></b> This was a multicenter, randomized, double-blind, placebo-controlled withdrawal study, after an initial open-label titration period. Patients (n = 245) with stable phosphate control received 6-15 g/day colestilan during a 12-week, flexible titration period after which 169 were randomized to continue the same dose (n = 85) or switch to placebo (n = 84) for 4 weeks. The primary endpoint was the change in serum phosphorus level during the placebo-controlled withdrawal period. <b><i>Results:</i></b> A significant difference of -1.01 mg/dl (-0.33 mmol/l) in mean change in serum phosphorus, favoring colestilan, was seen during the placebo-controlled withdrawal period (p &lt; 0.001). Colestilan reduced serum phosphorus significantly from baseline to week 12 (-1.54 mg/dl (-0.50 mmol/l); p &lt; 0.001). Serum calcium levels were not affected. Colestilan significantly reduced and maintained reductions in calcium × phosphorus ion product (Ca × P), parathyroid hormone, total cholesterol, low-density lipoprotein cholesterol, uric acid and also HbA1c in patients with elevated baseline HbA1c. Colestilan was generally well tolerated; most adverse events were gastrointestinal. <b><i>Conclusion:</i></b> In this first clinical trial with colestilan in a North American patient population, colestilan demonstrated significant efficacy in controlling serum phosphorus levels in CKD 5D patients with hyperphosphatemia, without increasing calcium levels.
DOI: 10.6084/m9.figshare.5128180
title: Supplementary Material for: Role of Psychosocial Variables on Chemotherapy-Induced Nausea and Vomiting and Health-Related Quality of Life among Cancer Patients: A European Study

description: <b><i>Background:</i></b> Chemotherapy-induced nausea and vomiting (CINV) continue to be a distressing problem still reported by cancer patients, with negative consequences on quality of life (QoL). <b><i>Aims:</i></b> To prospectively explore the association of psychosocial variables, including emotional distress, maladaptive coping styles and the doctor-patient relationship, with CINV and QoL among cancer outpatients. <b><i>Methods:</i></b> A prospective study was conducted on 302 consecutive cancer patients (response rate 80.9%) in Austria, Italy and Spain. The Distress Thermometer (DT), the Mini-Mental Adjustment to Cancer (Mini-MAC), and the Patient Satisfaction with Doctor Questionnaire (PSQ) were used to assess psychosocial variables before chemotherapy. In the 5 days after chemotherapy, CINV was examined by using a daily diary, and the Functional Living Index for Emesis (FLIE) was used to assess QoL. <b><i>Results:</i></b> More than half of the patients reported nausea (54%), and a small percentage reported vomiting (14%). CINV had a negative impact on QoL (FLIE caseness, p &lt; 0.01). Maladaptive coping (i.e. hopelessness-helplessness and anxious preoccupation) and emotional distress were associated with CINV (p &lt; 0.05) and poorer QoL (p &lt; 0.05). In logistic regression analysis, nausea was predicted by Mini-MAC/H (OR = 1.1, p = 0.03) and younger age (OR = 0.97, p = 0.04); negative impact on QoL was predicted by grade of chemotherapy emetogenesis (OR = 1.7, p &lt; 0.01) and Mini-MAC/H (OR = 1.2, p = 0.04). <b><i>Conclusions:</i></b> Screening and assessment of psychological variables, especially coping, could help in identifying cancer patients at risk for chemotherapy-induced nausea, in spite of the use of antiemetic treatment.
DOI: 10.6084/m9.figshare.5128186.v1
title: Supplementary Material for: Analysis of the Risk Factors for Aerobic Vaginitis: A Case-Control Study

description: <b><i>Aims:</i></b> Aerobic vaginitis (AV) is a newly defined clinical entity which may interfere with women's reproductive health and have negative effects on pregnancy. This study was to identify the risk factors for AV. <b><i>Methods:</i></b> Participants in this case-control study included healthy women and women with AV. All participants completed a standardized questionnaire covering sociodemographic factors, sexual behaviors, personal hygiene habits and health behaviors. Uni- and multivariate logistic regression analyses were used for statistical evaluation. <b><i>Results:</i></b> A total of 290 women of reproductive age were enrolled. In the multivariate analysis, unmarried status (odds ratio [OR] 2.606, 95% confidence interval [CI] 1.257-5.402), use of an intrauterine device (OR 4.989, 95% CI 1.922-12.952), long-term use of antibiotics (OR 11.176, 95% CI 1.363-91.666) and frequent vaginal douching (OR 4.689, 95% CI 1.363-16.135) were independent risk factors for AV. On the contrary, consistent condom use (OR 0.546, 95% CI 0.301-0.991) and college-level education or above (OR 0.255, 95% CI 0.131-0.497) were independent protective factors. <b><i>Conclusion:</i></b> Measures that may be considered to prevent AV include enhancing education to improve women's knowledge related to reproductive health, especially unmarried women, encouraging them to consistently use condoms as a contraceptive method, to avoid long-term use of antibiotics and to stop frequent vaginal douching.
DOI: 10.6084/m9.figshare.5128174
title: Supplementary Material for: AGO Recommendations for the Diagnosis and Treatment of Patients with Advanced and Metastatic Breast Cancer: Update 2015

description: Medicine
DOI: 10.6084/m9.figshare.5128180.v1
title: Supplementary Material for: Role of Psychosocial Variables on Chemotherapy-Induced Nausea and Vomiting and Health-Related Quality of Life among Cancer Patients: A European Study

description: <b><i>Background:</i></b> Chemotherapy-induced nausea and vomiting (CINV) continue to be a distressing problem still reported by cancer patients, with negative consequences on quality of life (QoL). <b><i>Aims:</i></b> To prospectively explore the association of psychosocial variables, including emotional distress, maladaptive coping styles and the doctor-patient relationship, with CINV and QoL among cancer outpatients. <b><i>Methods:</i></b> A prospective study was conducted on 302 consecutive cancer patients (response rate 80.9%) in Austria, Italy and Spain. The Distress Thermometer (DT), the Mini-Mental Adjustment to Cancer (Mini-MAC), and the Patient Satisfaction with Doctor Questionnaire (PSQ) were used to assess psychosocial variables before chemotherapy. In the 5 days after chemotherapy, CINV was examined by using a daily diary, and the Functional Living Index for Emesis (FLIE) was used to assess QoL. <b><i>Results:</i></b> More than half of the patients reported nausea (54%), and a small percentage reported vomiting (14%). CINV had a negative impact on QoL (FLIE caseness, p &lt; 0.01). Maladaptive coping (i.e. hopelessness-helplessness and anxious preoccupation) and emotional distress were associated with CINV (p &lt; 0.05) and poorer QoL (p &lt; 0.05). In logistic regression analysis, nausea was predicted by Mini-MAC/H (OR = 1.1, p = 0.03) and younger age (OR = 0.97, p = 0.04); negative impact on QoL was predicted by grade of chemotherapy emetogenesis (OR = 1.7, p &lt; 0.01) and Mini-MAC/H (OR = 1.2, p = 0.04). <b><i>Conclusions:</i></b> Screening and assessment of psychological variables, especially coping, could help in identifying cancer patients at risk for chemotherapy-induced nausea, in spite of the use of antiemetic treatment.
DOI: 10.6084/m9.figshare.5128183.v1
title: Supplementary Material for: Sarcomatous Carcinoma of the Orbit: A Case Report and Review of the Literature

description: Sarcomatous carcinomas (SCs) are rare tumours that contain malignant cells with epithelial and mesenchymal characteristics. SC rarely presents in the head and neck, and occurs even less often in the orbit. Only 8 cases of SCs located in the orbit or affecting the globe function have been described in the English literature. Here, we report a case of SC affecting the right orbit. SC is associated with a poor prognosis and advanced disease at presentation. Diagnosis is difficult, as histology often fails to definitively identify SC, necessitating a wide panel of molecular/immunological markers. Treatment options are generally aggressive but risky, and frequently yield poor results. Due to the rarity of SC, there has been little focus on the development of improved treatment options.
DOI: 10.6084/m9.figshare.5128171
title: Supplementary Material for: Gastrointestinal Immune Response to the Shrimp Allergen Tropomyosin: Histological and Immunological Analysis in an Animal Model of Shrimp Tropomyosin Hypersensitivity

description: <b><i>Background:</i></b> Shellfish hypersensitivity is among the most common food allergies. A murine model of IgE-mediated shrimp allergy has been established in our laboratory. The aim of this study is to determine the intestinal histological changes and cytokine expression profile of this model sensitized with the major shellfish allergen tropomyosin. <b><i>Methods:</i></b> Female Balb/c mice orally sensitized and challenged with recombinant tropomyosin were sacrificed. Continuous sections of duodenum, jejunum and ileum were prepared using the Swiss roll technique for histological and immunological analysis. Duodenal epithelial cell apoptosis and migration were examined. mRNA expression of IL-4, IL-6, IL-10, IL-13, IL-18 and IFN-γ in intestinal tissue was measured via RT-PCR. <b><i>Results:</i></b> In tropomyosin-sensitized and challenged mice, an increased number of eosinophils, mast cells and goblet cells was found 24 h after challenge. There were also increased mast cell and goblet cell numbers at 72 h after challenge, but the level of eosinophils decreased. Differences compared with control mice are most prominent at the duodenum compared to the distal regions. In addition, TUNEL assay indicates a significantly higher apoptosis rate in sensitized mice sacrificed 72 h after challenge, and mRNA expression showed a biased Th2/Th1 cytokine profile and a higher level of murine mast cell protease 1. <b><i>Conclusions:</i></b> This study documented a multitude of histological and immunological changes in the gut in a murine model of shrimp allergy. Even without repetitive intragastric challenge, shrimp tropomyosin induces an increase in the number of inflammatory cells to varying degrees within the small intestine. This model provides an important tool for testing new therapeutic interventions.
DOI: 10.6084/m9.figshare.5128177
title: Supplementary Material for: How Well Do Customers of Direct-to-Consumer Personal Genomic Testing Services Comprehend Genetic Test Results? Findings from the Impact of Personal Genomics Study

description: <b><i>Aim:</i></b> To assess customer comprehension of health-related personal genomic testing (PGT) results. <b><i>Methods:</i></b> We presented sample reports of genetic results and examined responses to comprehension questions in 1,030 PGT customers (mean age: 46.7 years; 59.9% female; 79.0% college graduates; 14.9% non-White; 4.7% of Hispanic/Latino ethnicity). Sample reports presented a genetic risk for Alzheimer's disease and type 2 diabetes, carrier screening summary results for &gt;30 conditions, results for phenylketonuria and cystic fibrosis, and drug response results for a statin drug. Logistic regression was used to identify correlates of participant comprehension. <b><i>Results:</i></b> Participants exhibited high overall comprehension (mean score: 79.1% correct). The highest comprehension (range: 81.1-97.4% correct) was observed in the statin drug response and carrier screening summary results, and lower comprehension (range: 63.6-74.8% correct) on specific carrier screening results. Higher levels of numeracy, genetic knowledge, and education were significantly associated with greater comprehension. Older age (≥60 years) was associated with lower comprehension scores. <b><i>Conclusions:</i></b> Most customers accurately interpreted the health implications of PGT results; however, comprehension varied by demographic characteristics, numeracy and genetic knowledge, and types and format of the genetic information presented. Results suggest a need to tailor the presentation of PGT results by test type and customer characteristics.
DOI: 10.6084/m9.figshare.5128165
title: Supplementary Material for: Extraordinary Diversity in the Origins of Sex Chromosomes in Anurans Inferred from Comparative Gene Mapping

description: Sex determination in frogs (anurans) is genetic and includes both male and female heterogamety. However, the origins of the sex chromosomes and their differentiation processes are poorly known. To investigate diversity in the origins of anuran sex chromosomes, we compared the chromosomal locations of sex-linked genes in 4 species: the African clawed frog<i> (Xenopus laevis)</i>, the Western clawed frog <i>(Silurana/X. tropicalis)</i>, the Japanese bell-ring frog <i>(Buergeria buergeri)</i>, and the Japanese wrinkled frog<i> (Rana rugosa)</i>. Comparative mapping data revealed that the sex chromosomes of <i>X. laevis</i>, <i>X. tropicalis</i> and <i>R. rugosa </i>are different chromosome pairs; however, the sex chromosomes of <i>X. tropicalis</i> and <i>B. buergeri</i> are homologous, although this may represent distinct evolutionary origins. We also examined the status of sex chromosomal differentiation in <i>B. buergeri</i>, which possesses heteromorphic ZW sex chromosomes, using comparative genomic hybridization and chromosome painting with DNA probes from the microdissected W chromosome. At least 3 rearrangement events have occurred in the proto-W chromosome: deletion of the nucleolus organizer region and a paracentric inversion followed by amplification of non-W-specific repetitive sequences.
DOI: 10.6084/m9.figshare.5128168
title: Supplementary Material for: Is Mechanical Bowel Preparation Necessary for Gynecologic Surgery? A Systematic Review and Meta-Analysis

description: <b><i>Objective:</i></b> To clarify the efficacy and side effects of mechanical bowel preparation (MBP) before gynecologic surgery. <b><i>Methods:</i></b> A systematic review was conducted. Embase, PubMed, the Cochrane Central Register of Controlled Trials in the Cochrane Library and China National Knowledge Infrastructure were searched. Randomized controlled trials on MBP prior to gynecologic surgery were included. The software package Revman 5.3 was used for statistical analysis. Odds ratio (OR) and standard mean deviation were calculated for dichotomous and continuous variable, respectively. <b><i>Results:</i></b> The quality of the included studies was moderate to good. MBP prior to laparoscopic gynecologic benign surgery or vaginal prolapse surgery has not been proven to be valuable for surgical performance, mainly involving visualization of the surgical field (OR 1.52, 95% confidence interval [CI] 1 to 2.32; Z = 1.95, p = 0.05), bowel handling (OR 2.21, 95% CI 0.83 to 5.84; Z = 1.59, p = 0.11), surgical complications (OR 1.3, 95% CI 0.46 to 3.67; Z = 0.5, p = 0.62) and bowel preparation. The discomfort due to oral catharsis is severer than no bowel preparation and enema, however without any difference between enema and no bowel preparation. <b><i>Conclusion:</i></b> The routine practice of MBP before gynecologic surgery needs to be reconsidered. This traditional clinical behavior has to be abandoned before benign laparoscopic surgery. Studies on the role of MBP for gynecologic laparotomy and gynecologic cancer are urgent.