The TEOGIC study project: a comprehensive characterization of early onset gastrointestinal cancer in the Northern area of Spain.

BACKGROUND: Gastrointestinal cancers represent one of the most prevalent diseases worldwide. Strikingly, the incidence of Early Onset Gastrointestinal Cancer (EOGIC) has been rising during the last decades and changes in lifestyle and environmental exposure seem to play a role. EOGIC has been defined as a different entity compared to on-average gastrointestinal cancer, with distinct clinical and molecular characteristics. Inherent to the particularities of younger age, there is an unmet need for a tailored approach for the management of these patients. The TEOGIC proposes a comprehensive study to characterize EOGIC patients in the northern of Spain. METHODS: Patients with histologically confirmed new diagnosis of colorectal, gastroesophageal and pancreatic adenocarcinoma will be considered for two cohorts: EOGIC (≤ 50 years old) and non-EOGIC (60-75 years old), with a ratio of 1:2. Two hundred and forty patients will be recruited in 4 Public Hospitals from northern Spain. After receiving unified informed consent, demographic and clinical data of the patients will be collected in a REDCap database. Lifestyle related data will be obtained in questionnaires assessing diet, physical activity and the general quality of life of the patients before diagnosis. Biological samples prior to any onco-specific treatment will be obtained for the analyses of circulating inflammatory proteins, gut microbiota, and the proteome of the tumor microenvironment. Histologic characteristics and routine biomarkers will be also collected. Thereafter, data will be integrated and analyzed to assess tumor specific, pan-tumor and sex-associated differential characteristics of EOGIC. DISCUSSION: The underlying risk factors and differential characteristics of EOGIC remain poorly studied, particularly in our geographical area. Although limited by the exploratory nature and the small sample size estimated to be recruited, TEOGIC represents the first attempt to comprehensively characterize these young patients, and thus attend to their special needs. Findings derived from this study could contribute to raise awareness and preventive behaviors in the population. In parallel, molecular studies could lead to the identification of potential novel non-invasive biomarkers and therapeutic targets that would help in the development of the tailored clinical management of these patients, focusing on screening programs for early diagnosis and precision medicine.

Monitoring endoscopic postoperative recurrence in Crohn's disease after an ileocecal resection. Does capsule endoscopy have a role in the short and long term?

Background: Small bowel capsule endoscopy (SBCE) is a noninvasive method to detect endoscopic postoperative recurrence (POR) after an ileocolonic resection in Crohn's Disease (CD). Few studies have evaluated the role of SBCE in the early POR (= 12 months). Data for detection of late POR (>12 months) and evaluation of treatment response in previous POR is scarce. We aimed to assess the SBCE performance in the three scenarios (early-POR, late-POR, and previous-POR). Methods: Retrospective 11-year cohort study of SBCE procedures performed on CD patients with ileocolonic resection. Disease activity by Rutgeerts score (RS), correlation with biomarkers, and therapeutic changes were recorded. Results: We included 113 SBCE procedures (34 early-POR, 44 late-POR, and 35 previous-POR). 105 procedures (92.9%) were complete and 97 SBCE (85.5%) were conclusive with no differences between groups. Relevant POR (RS ≥i2) was more frequent in the early-POR group compared to late-POR (58.8% vs 27.3%, p=0.02). In the previous-POR, RS improved in 43.5% of procedures, worsened in 26%, and remained unchanged in 30.5%. Fecal calprotectin (FCP) value of 100µg/g displayed the best accuracy: sensitivity 53.8%, specificity 78.8%, positive predictive value 66.7% and negative predictive value 68.4%. SBCE guided therapeutic changes in 43 patients (38%). No adverse events occurred in our cohort. Conclusion: SBCE is a safe and effective method to assess POR in the early and late setting in clinical practice, and for the evaluation of treatment response to previous POR. FCP is an accurate surrogate marker of POR and 100µg/g value had the best overall accuracy.

Representation of Racial and Ethnic Minority Populations in Dementia Prevention Trials: A Systematic Review.

Despite older racial and ethnic minorities (REMs) being more likely to develop dementia they are underrepresented in clinical trials focused on neurological disorders. Inclusion of REMs in dementia prevention studies is vital to reducing the impact of disparities in dementia risk. We conducted a systematic review to characterize the number of REM enrolled in brain health and prevention randomized controlled trials (RCTs). RTCs published from January 1, 2004 to April 21, 2020 were included. Participants were normal cognitive adults aged 45 years and older who participated in a Phase II or Phase III U.S. based preventative trial. Analyses were performed to examine differences in trial characteristics between RCTs that did and those that did not report race/ethnicity and to calculate the pooled proportion of each racial/ethnic group in randomized brain healthy prevention trials. A total of 42 studies consisting of 100,748 participants were included in the final analyses. A total of 26 (62%) reported some racial/ethnic identity data. The pooled proportion of REM participants was 0.256 (95% CI, 0.191, 0.326). There is a lack of racial/ethnic reporting of participants and REMs remain underrepresented in brain health prevention RCTs.

Treatment of chronic diabetic foot ulcers with bemiparin: a randomized, triple-blind, placebo-controlled, clinical trial.

AIMS: To assess the efficacy and safety of bemiparin in the treatment of chronic diabetic foot ulcers. METHODS: A triple-blind, parallel, randomized, placebo-controlled trial. Patients aged > 18 years, [corrected] with diabetes for at least 3 years, and with a foot ulcer persisting for > 3 months were selected from 39 Spanish centres. Bemiparin 3500 IU/day for 10 days, followed by 2500 IU/day for up to 3 months plus standard care for ulcers, was compared with placebo plus standard care for ulcers for 3 months. The primary efficacy end-point was ulcer improvement, defined as an objective decrease in ulcer area of >or= 50%, measured by digital photography and ImageJ software, and/or any decrease in Wagner's ulcer grade at 3 months. RESULTS: Ulcer improvement rates were 70.3% (26 of 37 patients) in the bemiparin group and 45.5% (15 of 33 patients) in the placebo group [absolute difference 24.8; 95% confidence interval (CI) 2.3, 47.3; P = 0.035] (number needed to treat 4; 95% CI 2, 43). Complete healing rates at 3 months were similar in both groups (35.1% vs. 33.3%; P = 0.874), as were the number of adverse events. CONCLUSIONS: Bemiparin is more effective than placebo in the management of diabetic foot ulcers and has few side-effects.

[Triple-blind clinical trial with placebo control to evaluate the efficacy of a heparin of low molecular weight (bemiparin) for treating slow-responding ulcers in diabetic foot in primary care]. / Ensayo clínico, controlado con placebo, triple ciego, para evaluar la eficacia de una heparina de bajo peso molecular (bemiparina) en el tratamiento de las úlceras tórpidas del pie diabético, en atención primaria.

OBJECTIVES: To establish the degree of efficacy of bemiparin treatment over 3 months in the improvement of slow-responding ulcers in diabetic foot. Also, to evaluate the safety of bemiparin and quality of life and to compare the evolution of retinopathy and nephropathy against placebo. DESIGN: Stage III clinical trial to evaluate efficacy and safety in a new indication of a medicine already on the market, parallel in two branches, randomised, triple-blind, and controlled with placebo. SETTING: Health care centres in Mallorca, Spain. PARTICIPANTS: 42 patients per branch, over 18, with type-1 or 2 DM of over 3 years evolution, and one or more first or second-degree ulcers on the Wagner scale, distal to the knee, that did not heal in three months of health care. Randomised allocation in blocks of four.Interventions. The experimental drug was bemiparin (heparin of low molecular weight), injected subcutaneously at 3500 IU/day for the first 10 days and 2500 IU/day up to 90 days. As control, physiological serum was injected sub-cutaneously in a similar volume for masking. MAIN MEASUREMENTS: An "effect"was defined as a reduction of at least 50% in its surface area and/or a favourable evolution in status to a degree between the control at the start of treatment and at three months. Other measurements included proteinuria, retinography and quality of life (SF-36). Analysis of efficacy through principle of intention to treat.

Ensayo clínico, controlado con placebo, triple ciego, para evaluar la eficacia de una heparina de bajo peso molecular (bemiparina) en el tratamiento de las úlceras tórpidas del pie diabético, en atención primaria / Triple-blind clinical trial with placebo control to evaluate the efficacy of a heparin of low molecular weight (bemiparin) for treating slow-responding ulcers in diabetic foot in primary care

Objetivos. Establecer el grado de eficacia del tratamiento con bemiparina durante 3 meses en la mejoría de las úlceras tórpidas del pie diabético. Secundariamente se evalúa la seguridad de la bemiparina, la calidad de vida y se compara la evolución de la retinopatía y nefropatía frente a placebo. Diseño. Ensayo clínico fase III de evaluación de eficacia y seguridad en una nueva indicación de un fármaco ya comercializado, paralelo de dos grupos, aleatorizado, triple ciego y controlado con placebo. Emplazamiento. Centros de atención primaria de Mallorca (España).Participantes. Un total de 42 pacientes por grupo, mayores de 18 años, con diabetes mellitus (DM) tipo 1 o 2, de más de 3 años de evolución, y una o más úlceras de grado 1 y 2 de la clasificación de Wagner, distal a la rodilla, que no ha curado en 3 meses de atención sanitaria. Asignación aleatoria por bloques de cuatro. Intervenciones. El fármaco experimental es la bemiparina (heparina de bajo peso molecular), en inyección subcutánea, 3.500 U/día los 10 primeros días y 2.500 U/día hasta los 90 días. Como fármaco de control se utilizó suero fisiológico en inyección subcutánea en volumen similar para su enmascaramiento. Mediciones principales. Se define como "efecto" una reducción en, al menos, un 50 por ciento en el área de su superficie y/o variación favorable del estadio en un grado entre el control al iniciar el tratamiento y a los 3 meses. Otras mediciones incluyen proteinuria, retinografías y calidad de vida (SF-36). Se llevó a cabo un análisis de eficacia por principio de intención de tratar (AU)

Bilateral idiopathic macular pucker: a case report.

BACKGROUND: Idiopathic epiretinal membrane or macular pucker is a common disorder which typically affects older individuals. Contraction of epiretinal tissue causes changes to occur in the underlying retina stimulating the appearance of a macular hole. This paper presents a case of bilateral macular pucker with accompanying pseudohole. The diagnosis, pathophysiology and management are discussed. METHODS: A 68-year-old male was examined for decreased vision in both eyes. Relevant ophthalmoscopic findings included macular changes compatible with surface wrinkling maculopathy. RESULTS: The patient was diagnosed with bilateral epiretinal membranes with accompanying pseudoholes. The diagnosis was confirmed by fluorescein angiography. Since the patient's vision loss was minimal, the need for surgery was precluded. The patient was to be monitored routinely. CONCLUSIONS: Macular pucker, the most common of acquired macular disorders, has become an important clinical entity. Recognizing distinguishing features, especially in cases associated with pseudohole, will allow more precise diagnostic and prognostic patient counseling. Regular follow-up examinations of patients with mild visual loss become important, because they permit optimal time for surgical intervention.