How can current oncological datasets be adjusted to support the automated patient recruitment in clinical trials?

OBJECTIVES: This study aims to identify necessary adjustments required in existing oncological datasets to effectively support automated patient recruitment. METHODS: We extracted and categorized the inclusion and exclusion criteria from 115 oncological trials registered on ClinicalTrials.gov in 2022. These criteria were then compared with the content of the oBDS (Oncological Base Dataset version 3.0), Germany's legally mandated oncological data standard. RESULTS: The analysis revealed that 42.9% of generalized inclusion and exclusion criteria are typically present as data fields in the oBDS. On average, 54.6% of all criteria per trial were covered. Notably, certain criteria such as comorbidities, pregnancy status, and laboratory values frequently appeared in trial protocols but were absent in the oBDS. CONCLUSION: The omission of criteria, notably comorbidities, within the oBDS restricts its functionality to support trial recruitment. Addressing this limitation would enhance its overall effectiveness. Furthermore, the implications of these findings extend beyond Germany, suggesting potential relevance and applicability to oncological datasets globally.

Hydroa Vacciniforme-Like T-Cell Lymphoma: A Further Brazilian Case.

Hydroa vacciniforme (HV)-like lymphoma is a rare, usually fatal Epstein-Barr virus-driven lymphoproliferative disease affecting children from Asia, Mexico, and South America. Cutaneous manifestations imitate HV, a benign photodermatosis in which systemic symptoms are not observed, and spontaneous regression occurs later in adolescence or young adulthood. We report a case of HV-like lymphoma in a 12-year-old girl, descendent from an ancient Amazon indigenous tribe that, as far as we know, represents the second Brazilian case ever reported in the medical literature.

Associação de vitiligo com autoanticorpos tireoidianos / Vitiligo and its association with thyroid autoantibodies

Objetivo: Analisar a presença de autoanticorpos antitireoidianos (anti-TPO) no soro de pessoas acometidas por vitiligo. Métodos: Estudo do tipo caso-controle retrospectivo realizado em serviço de dermatologia de referência na Amazônia, com amostra constituída por dois grupos: Grupo Vitiligo (n=56), com diagnóstico clínico de vitiligo, e Grupo Controle (n=30), que se declarou sadio, não portador de vitiligo, de outra dermatose e/ou doença autoimune diagnosticada. O registro dos dados foi feito pelo preenchimento de protocolo específico usado em entrevista para ambos os grupos, além de coleta de sangue para dosagem de autoanticorpos anti-TPO para os dois grupos. O teste qui quadrado e a odds ratio (OR) foram utilizados para variáveis qualitativas; para as quantitativas, foi utilizado o teste t de Student, e o nível de significância foi de p≤5%. Resultados: A história pessoal de doença autoimune esteve presente em 7,14% dos portadores versus 0% dos controles. Não houve diferenças estatisticamente relevantes com relação aos antecedentes familiares entre os grupos (OR: 0,5704; p=0,4146). Quanto à positividade para os autoanticorpos anti-TPO (níveis superiores ao ponto de corte), não houve relevância estatística (qui quadrado 2,844; p=0,229). Entretanto, na comparação dos níveis séricos absolutos de autoanticorpos anti-TPO entre os grupos, foram obtidos 129,49±323,88 para o portador da doença e 35,85±13,16 para o controle, com t=2,1602 e p=0,0351. Conclusão: Embora não tenha sido relevante a diferença entre os Grupo Vitiligo e Controle quanto à positividade para o autoanticorpos anti-TPO, ao se considerar a comparação com os valores séricos absolutos do Grupo Vitiligo, estes foram maiores que os apresentados pelos controles, sendo esta diferença estatisticamente relevante.(AU)

Objective: To analyze the presence of antithyroid autoantibodies (anti-TPO) in the serum of people affected by vitiligo. Methods: This is a study of retrospective casecontrol, performed in a reference dermatological center in Amazonia, with a sample consisting of two groups: Vitiligo group (n=56), with clinical diagnosis of vitiligo, and the Control Group (n=30), who was self-declared as healthy, nonvitiligo carrier, with no other dermatosis and/or diagnosed autoimmune disease. The data recording was made with specific protocol completion in an interview for both groups, and blood collection for antithyroid autoantibodies dosage for both groups. Chi-square and odds ratio (OR) tests were used for qualitative variables; for the quantitative ones, t-Student test, and significance level of p≤5%. Results: The personal history of autoimmune disease was present in 7.14% of patients compared to 0% of controls. There were no statistically significant differences in relation to family history between the groups (odds ratio: 0.5704; p=0.4146). As for the positivity for antithyroid autoantibodies (levels above the cutoff point), there was no statistical significance (chi-square=2.844, p=0.229). However, when comparing the absolute serum levels of antithyroid autoantibodies between the groups, 129.49±323.88 was obtained for the carrier of the disease, and 35.85±13:16 to controls, with t=2.1602, and p=0.0351. Conclusion: Although the difference between vitiligo and control groups were not significant regarding positivity for antithyroid autoantibodies, when the comparison with the absolute serum levels of the group with vitiligo was considered, they were higher than those presented by the controls, with this difference being statistically significant.(AU)

[The PRRSV-serumneutralization test detects gaps in herd immunity]. / Der PRRSV-Serumneutralisationstest detektiert Lücken in der Herdenimmunität.

Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) appears in two genotypes (EU and US), for both genotypes attenuated live-vaccines are available. A cross-sectional study in 38 Bavarian sow herds was performed to assess the level of neutralizing antibodies. Per herd 38 blood samples were collected (10 weaned piglets, 10 gilts and 6 sows of 1./2., 3J4. and 5/6. parity, respectively). Sera were tested by ELISA, serumneutralization test (SNT) against EU- and US-vaccine virus, and pooled sera were tested by real-time RT-PCR. Herds were classified by the last vaccination of sows as "Vacc EU" "Vacc US"and "nv (non-vaccinated) and by detection of PRRSV-US and vaccination of piglets were not included as variables. Sows of group (2) Vacc EU/EU- showed the highest EU-SNT-titers irrespective of parity. Groups (5) Vacc US/EU+ and (1) Vacc EU/EU+ followed in descending order. Significantly lower SNT-titers in (1) Vacc EU/EU+ were especially observed in sows of 1/2. Parity (Kruskal-Wallis, p < 0.05). Very low SNT-titers were observed in the three remaining groups (3) nv/EU+, (4) nv/EU- and (6) Vacc US/EU-. In US-vaccinated herds detection of PRRSV-EU coincided with strong ELISA-reactivity in all animal groups. In EU-vaccinated herds this was only observed for weaned piglets. Sows showed a strong ELISA-reactivity irrespective of detection of PRRSV-EU. The value of the ELISA is restricted to the certification of PRRSV-free herds. The EU-SNT reflects the level of herd immunity at least against vaccine virus; it indicates gaps in herd immunity.

Evaluation of cases of pemphigus vulgaris and pemphigus foliaceus from a reference service in Pará state, Brazil.

BACKGROUND: Pemphigusis a bullous, rare and chronic autoimmune disease. There are two major forms of pemphigus: vulgaris and foliaceus. Epidemiological data and clinical outcome in patients diagnosed in the Brazilian Amazon states are still rare. OBJECTIVES: To study the occurrence of the disease during the study period and analyze the epidemiological profile of patients, the most common subtype of pemphigus, and the clinical evolution of patients. METHODS: Retrospective analysis of medical records of hospitalized patients with pemphigus foliaceus and pemphigus vulgaris in the period from 2003 to 2010 in Dermatology Service of Hospital Fundação Santa Casa de Misericórdia do Pará, Belém, Northern Brazil. RESULTS: We found a total of 20 cases of pemphigus during the study period, 8 of which were of foliaceus pemphigus and 12 of vulgaris pemphigus. Pemphigus foliaceus had the predominance of male patients (75%), showed satisfactory clinical evolution, and was characterized by absence of pediatric cases. Pemphigus vulgaris affected more women (66.7%), showed mean hospital stay of 1 to 3 months (50%), and there were three cases of death (25%). The prescribed immunosuppressive drugs included prednisone with or without combination of azathioprine and/or dapsone. Sepsis was associated with 100% of the deaths. CONCLUSIONS: The occurrence of the disease is rare, there are no familiar/endemic outbreaks in the sample. Evolution is usually favorable, but secondary infection is associated with worse prognosis. The choice of best drugs to treat pemphigus remains controversial.

Evaluation of cases of pemphigus vulgaris and pemphigus foliaceus from a reference service in Pará state, Brazil

BACKGROUND: Pemphigusis a bullous, rare and chronic autoimmune disease. There are two major forms of pemphigus: vulgaris and foliaceus. Epidemiological data and clinical outcome in patients diagnosed in the Brazilian Amazon states are still rare. OBJECTIVES: To study the occurrence of the disease during the study period and analyze the epidemiological profile of patients, the most common subtype of pemphigus, and the clinical evolution of patients. METHODS: Retrospective analysis of medical records of hospitalized patients with pemphigus foliaceus and pemphigus vulgaris in the period from 2003 to 2010 in Dermatology Service of Hospital Fundação Santa Casa de Misericórdia do Pará, Belém, Northern Brazil. RESULTS: We found a total of 20 cases of pemphigus during the study period, 8 of which were of foliaceus pemphigus and 12 of vulgaris pemphigus. Pemphigus foliaceus had the predominance of male patients (75%), showed satisfactory clinical evolution, and was characterized by absence of pediatric cases. Pemphigus vulgaris affected more women (66.7%), showed mean hospital stay of 1 to 3 months (50%), and there were three cases of death (25%). The prescribed immunosuppressive drugs included prednisone with or without combination of azathioprine and/or dapsone. Sepsis was associated with 100% of the deaths. CONCLUSIONS: The occurrence of the disease is rare, there are no familiar/endemic outbreaks in the sample. Evolution is usually favorable, but secondary infection is associated with worse prognosis. The choice of best drugs to treat pemphigus remains controversial. .

Desenvolvimento de pó efervescente probiótico e simbiótico / Development of effervescent probiotic and symbiotic powder

Lactobacillus plantarum e Lactobacillus rhamnosus são micro-organismos probióticos eficazes na diminuição de risco de doenças coronarianas, redução do transpasse de enterobactérias fecais e redução dos sintomas da síndrome do intestino irritado, porém o comportamento desses micro-organismos em determinadas condições ainda necessita ser elucidado. O objetivo deste trabalho foi desenvolver um pó efervescente probiótico e simbiótico contendo Lactobacillus plantarum e Lactobacillus rhamnosus e testar o efeito da adição de inulina na formulação em função da viabilidade dos micro-organismos no produto nos tempos 0, 15, 30 e 45 dias de armazenamento e após digestão in vitro. Os caldos lactose, MRS e sacarose foram avaliados para a obtenção do Lactobacillus plantarum e Lactobacillus rhamnosus em pó nas temperaturas de desidratação em estufa: 40 °C, 45 °C, 50 °C, 55 °C, e a combinação caldo/temperatura de desidratação de maior viabilidade dos micro-organismos foi sacarose/40 °C. Foram testadas duas formulações: (F1) base efervescente, saborizante de laranja e lactose contendo Lactobacillus plantarum e Lactobacillus rhamnosus; (F2) formulação F1 adicionada de 1g de inulina. Na avaliação da estabilidade ao armazenamento até 45 dias, os micro-organismos se apresentaram viáveis em F1 (pH 5,65, umidade 1,8% e atividade de água 0,467) e F2 (pH 5,81, umidade 2,8% e atividade de água 0,402), acima do requerido para ter efeito probiótico (108 a 109 UFC). No teste de digestão in vitro, em contato com fluido gástrico simulado (FGS), a viabilidade do Lactobacillus plantarum e Lactobacillus rhamnosus decresceu, havendo recuperação parcial em contato com fluido intestinal simulado (FIS). Para as duas formulações, em ambos fluidos, a contagem dos Lactobacillus esteve no nível preconizado para apresentar efeito probiótico. A presença de inulina na formulação apresentou efeito significativo na manutenção da viabilidade celular.

Lactobacillus plantarum and Lactobacillus rhamnosus are probiotic microorganisms efficient in reducing risk of coronary heart disease, reducing the overlapping of fecal enterobacteria, and reducing the symptoms of irritable bowel syndrome, but the behavior of the microorganism under certain conditions need to be elucidated. The objective of this study was to develop an effervescent probiotic and symbiotic powder containing Lactobacillus plantarum and Lactobacillus rhamnosus and study the effect of inulin addition by evaluating of microorganisms viability in the product at 0, 15, 30 and 45 days and after digestion in vitro. The broths lactose, MRS and sucrose were evaluated for obtaining Lactobacillus plantarum and Lactobacillus rhamnosus powder at dehydration temperatures of 40 °C, 45 °C, 50 °C, and 55 °C. The combination broth/dehydration temperature that resulted in higher viability of the microorganisms was sucrose/40 °C. Two formulations were tested: (F1) effervescent base, orange flavor and lactose containing Lactobacillus plantarum and Lactobacillus rhamnosus; (F2) formulation F1 with 1g of inulin. Regarding the storage stability of the microorganisms, they were viable in F1 (pH 5.65, moisture 1.8% and water activity 0.467) and F2 (pH 5.81, moisture 2.8% and water activity 0.402), above the levels required to have probiotic effect (108 to 109 UFC). In in vitro digestion, the viability of Lactobacillus plantarum and Lactobacillus rhamnosus decreased in contact with simulated gastric fluid (SGF), with partial recovery in simulated intestinal fluid (SIF). For both formulations, at both simulated fluids the enumeration of Lactobacillus was within the limits recommended for presenting probiotic effects. The inulin significantly affected the cell viability.

Sarcoid-like paracoccidioidomycosis presenting with perineural granuloma / Paracoccidioidomicose sarcoidica com granuloma perineural

Paracoccidioidomycosis presenting as a sarcoid-like plaque may be misdiagnosed as leprosy, especially when shared endemic areas are concerned. We report the case of a Brazilian male patient presenting with an ulcerated plaque on his left ear and neighboring areas. The plaque simulated tuberculoid leprosy type 1 reaction, both clinically and histopathologically. A perineural granuloma with no organisms detected by routine and Fite-Faraco staining reinforced that diagnosis. Paracoccidioidomycosis was confirmed only after a second biopsy, taken from the ulcerated area.

Paracoccidioidomicose expressando-se como placa sarcoídica pode ser confundida com hanseníase, especialmente em zonas endêmicas comuns às duas condições. Apresentamos um paciente brasileiro, com placa ulcerada na orelha direita e em áreas vizinhas que simulava, clinica e histopatologicamente, hanseníase tuberculoide em reação tipo 1. O encontro de granuloma perineural, sem parasitas detectáveis às colorações de rotina e Fite-Faraco, reforçou a hipótese de hanseníase. Apenas com uma nova biópsia, desta vez da área ulcerada, a paracoccidioidomicose pôde ser confirmada.

Sarcoid-like paracoccidioidomycosis presenting with perineural granuloma.

Paracoccidioidomycosis presenting as a sarcoid-like plaque may be misdiagnosed as leprosy, especially when shared endemic areas are concerned. We report the case of a Brazilian male patient presenting with an ulcerated plaque on his left ear and neighboring areas. The plaque simulated tuberculoid leprosy type 1 reaction, both clinically and histopathologically. A perineural granuloma with no organisms detected by routine and Fite-Faraco staining reinforced that diagnosis. Paracoccidioidomycosis was confirmed only after a second biopsy, taken from the ulcerated area.

Revisão sobre a patogenia da leishmaniose tegumentar americana na Amazônia, com ênfase à doença causada por Leishmania (V. ) braziliensis e Leishmania (L. ) amazonensis / Revisiting the pathogenesis of the american tegumentary leishmaniasis in Amazonian, with emphasis to the disease due to Leishmania (V. ) braziliensis and Leishmania (L.) amazonensis

A patogenia da leishmaniose tegumentar americana (LTA) na Amazônia foi revisada à luz dos mais recentes aspectos associados ao espectro clínico, histopatológico e imunopatológico da doença causada por Leishmania (V.) braziliensis e Leishmania (L.) amazonensis. Esta revisão mostrou a existência de uma dicotomia entre as duas espécies de Leishmania e a resposta imune celular; enquanto a L. (V.) braziliensis mostra forte tendência em dirigir a infecção, a partir da forma central do espectro clínico-imunológico, a leishmaniose cutânea localizada (LCL), para o pólo imunológico hiperreativo, representado pela leishmaniose cutâneo-mucosa (LCM), com exacerbação da hipersensibilidade e perfil da resposta CD4 tipo-Thl, a L. (L.) amazonensis mostra o oposto, dirige a infecção para o pólo imunológico hiporreativo, representado pela leishmaniose cutânea anérgica difusa (LCAD), com forte inibição da hipersensibilidade e perfil da resposta CD4 tipo- Th2. Entre a forma central LCL e as formas polares LCM e LCAD a infecção passa por uma fase intermediária, a leishmaniose cutânea disseminada borderline (LCDB), com inibição parcial da hipersensibilidade e peifil da resposta CD4 Thl + Th2. Estes são, provavelmente, os principais mecanismos imunológicos que modulam a patogenia da LTA causada por L. (V.) braziliensis e L. (L.) amazonensis.

The pathogenesis of American tegumentary leishmaniasis (ATL) was reviewed ifl the light of more recent features of clinical, histopathological and immunopathological spectrum of disease caused by Leishmania (V.) braziliensis and Leishmania (L.) amazonensis. This review has shown a dichotomy in the interaction between these two species of Leishmania with the human .cellular immune response; while L. (V.) braziliensis shows a clear tendency to direct infection, from the localized cutaneous leishmaniasis (LCL) in the center of the clinical-immunological spectrum of disease, to the hyperactive immunologic pole represented by mucocutaneous leishmaniasis (MCL), which shows exacerbated hypersensitivity reaction and CD4 Thl-type immune response, L. (L.) amazonensis shows the opposite,. directing infection to the hypoactive immunologic pole consisted by anergic diffuse cutaneous leishmaniasis (ADCL), associated with a marked inhibition of hypersensitivity reaction and CD4 Th2type immune response. Between the central LCL and thetwo polar MCL and ADCL forms the infection may present an intermediary phase, borderline disseminated cutaneous leishmaniasis (BDCL), which shows partial inhibition of hypersensitivity reaction and a mixed CD4 Thl plus Th2 immune response. These are probably the main immunological mechanisms regarding the immune response dichotomy that modulates the pathogenesis of ATL caused by these Leishmania parasites.