Can resistance prehabilitation training bring additional benefits in valvular cardiac surgery? protocol for a randomized controlled trial.

INTRODUCTION: Cardiovascular diseases (CVD) are a group of illnesses that include coronary heart disease, cerebrovascular disease, congenital heart disease and deep vein thrombosis. Major surgery is often chosen as the treatment of choice for CVD. The concept of fast-track rehabilitation after surgery appeared in the 1970s. Participation in these exercise-based prehabilitation programmes may decrease postoperative complications and length of hospital stay. The primary aim of the present study is to evaluate whether the implementation of an additional resistance training (RT) prehabilitation protocol within cardiac exercises based prehabilitation can reduce intensive care unit (ICU) length of stay, postoperative complications and hospital length of stay (LOS). METHODS: A protocol of a prospective, parallel, randomised clinical trial includes 96 adult patients diagnosed with valvular pathology and who have been scheduled for surgery. The participants will be randomly assigned to two groups of 48. Control group will be treated with ventilatory and strengthening of respiratory muscles, and aerobic exercise. Experimental group, in addition, will be treated with RT of peripheral muscles. Both hospital stay and ICU stay will be assessed as main variables. Other secondary variables such as exercise capacity, quality of life and respiratory values will also be assessed. Quantitative variables will be analysed with a T-Test or ANOVA, or Mann Witney if the distribution is non-parametric. RESULTS AND CONCLUSION: This will be the first controlled clinical study focused on adding strength exercise as an additional treatment during prehabilitation. The results of this study will focus on helping to improve rehabilitation and prehabilitation protocols, considering that it is essential to maintain pulmonary training, as well as the inclusion of peripheral exercises that help people with heart disease to be in a better physical condition in order to increase their participation and sense of quality of life.

Benefits of physical activity self-monitoring in patients with haemophilia: a prospective study with one-year follow-up.

INTRODUCTION: Activity wristbands have been shown to be effective in relation to self-monitoring activity levels and increasing exercise adherence. However, previous reports have been based on short-term follow-ups in people with haemophilia (PWH). AIM: (1) To evaluate compliance with physical activity (PA) recommendations in PWH during a 1-year follow-up period using activity wristbands to record daily steps and intensity; (2) To determine the effect of PA self-monitoring on clinical outcomes. METHODS: A prospective observational study was conducted in 27 adults with severe haemophilia undergoing prophylactic treatment. The Fitbit Charge HR was used to track daily PA for an entire year. The participants were encouraged to try to reach a goal of 10,000 steps/day and to track their progress. The pre- and post-evaluation included quality of life (A36 Hemophilia-QoL Questionnaire), joint health (Haemophilia Joint Health Score), functionality (Timed Up and Go test), and muscle strength. RESULTS: A total of 323.63 (95%CI: 194-364) valid days (i.e., > 2000 steps) were recorded. The annual average number of steps per day taken by participants was 10,379. Sixteen (59%) PWH reached 10,000 steps/day at baseline and 17 (63%) at 1 year follow-up, with no significant differences (x2 = .33; p = .56). A statistically significant improvement was observed in daily moderate activity time (p = .012) and in the 'physical health' quality of life subscale (mean difference: 2.15 points; 95%CI: .64-3.65; p = .007). CONCLUSION: Our results suggest that patients with severe haemophilia who self-managed their PA can improve their long-term quality of life in the domain of physical health and also the daily time spent in moderate-intensity PA.

Cross-cultural adaptation of the FRAIL scale for critically ill patients in Spain.

AIM: To translate and culturally adapt the FRAIL scale into Spanish and perform a preliminary test of diagnostic accuracy in patients admitted to intensive care units. DESIGN: Cross-sectional diagnostic study. METHODS: Five intensive care units (ICU) in Spain were participated. Stage 1: Three native Spanish-speaking bilingual translators familiar with the field of critical care translated the scale from English into Spanish. Stage 2: Three native English-speaking bilingual translators familiar with critical care medicine. Stage 3: Authors of the original scale compared the English original and back-translated versions of the scale. Stage 4: Five nurses with more than 5 years of ICU experience and five critical care physicians assessed the comprehension and relevance of each of the items of the Spanish version in 30 patients of 3 different age ranges (<50, 50-65 and >65 years). RESULTS: The FRAIL scale was translated and adapted cross-culturally for patients admitted to intensive care units in Spain. The process consisted of four stages: translation, back translation, comparison and pilot test. There was good correspondence between the original scale and the Spanish version in 100% of the items. The participating patients assessed the relevance (content validity) and comprehensibility (face validity) of each of the items of the first Spanish version. The relevance of some of the items scored low when the scale was used in patients younger than 65 years. CONCLUSIONS: We have cross-culturally adapted the FRAIL scale, originally in English, to Spanish for its use in the critical care medical setting in Spanish-speaking countries. IMPLICATIONS FOR PROFESSIONALS: Physicians and nurses can apply the new scale to all patients admitted to the intensive care units. Nursing care can be adapted according to frailty, trying to reduce the side effects of admission to these units for the most fragile patients. REPORTING METHOD: The manuscript's authors have adhered to the EQUATOR guidelines, using the COSMIN reporting guideline for studies on the measurement properties of patient-reported outcome measures. PATIENT OR PUBLIC CONTRIBUTION: In a pilot clinical study, we applied the first version of the FRAIL-Spain scale to intensive care unit (ICU) patients. Five nurses with more than 5 years of ICU experience and five critical care physicians assessed the relevance (content validity) and comprehensibility (face validity) of the five items of the first Spanish version. Relevance was assessed using a 4-point Likert scale ranging from 1 (no relevance) to 4 (high relevance), and comprehensibility was assessed as poor, acceptable or good. Each health professional applied the scale to three patients (total number of patients = 30) of three different age ranges (<50, 50-65 and >65 years) and recorded the time of application of the scale to each patient. Although the frailty scales were initially created by geriatricians to be applied to the elders, there is little experience with their application in critically ill patients of any age. Therefore, more information is needed to determine the relevance of using this scale in critical care patients. In this pilot study, we considered that nurses and critical care physicians should evaluate frailty using this adapted scale in adult patients admitted to the Intensive Care Units.

Effect of including a dietary supplement of raisins, a food rich in polyphenols, on cognitive function in healthy older adults; a study protocol for a randomized clinical trial.

BACKGROUND: Polyphenols have been shown to be effective against many chronic diseases, including neurodegenerative diseases. Specifically, the consumption of raisins, being a food rich in polyphenols, has been attributed with neuroprotective benefits. Therefore, our main objective is to evaluate the effect of including 50 g of raisins in the diet daily for 6 months, on the improvement of cognitive performance, cardiovascular risk factors and markers of inflammation in a population of older adults without cognitive impairment. METHODS: Design and intervention: This study will be a randomized controlled clinical trial of two parallel groups. Each subject included in the study will be randomly assigned to one of two study groups: control group (no supplement), intervention group (50 g of raisins daily during 6 months). STUDY POPULATION: The participants will be selected by consecutive sampling in the Primary Care consultations of urban health centers in Salamanca and Zamora (Spain), taking into account the selection criteria. STUDY VARIABLES: Two visits will be made, baseline and at 6 months. Cognitive performance will be evaluated (Mini-Mental State Examination test, Rey Auditory Verbal Learning Test, verbal fluency and montreal cognitive assessment (Moca)). It will also be analyzed the level of physical activity, quality of life, activities of daily living, energy and nutritional composition of the diet, body composition, blood pressure, heart rate, markers of inflammation and other laboratory tests of clinical relevance (glycaemia, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides). In addition, sociodemographic data, personal and family history, medication use and alcohol and tobacco consumption will be collected. DISCUSSION: In this project, it is intended to contribute to minimize the problems derived from cognitive deterioration in older people. TRIAL REGISTRATION: ClincalTrials.gov Identifier: NCT04966455 Registration date: July 1, 2021.

A 39-Year-Old Woman with Endometriosis Who Developed a Subcapsular Liver Hematoma Following Laparotomic Surgical Left Adnexectomy, Rectosigmoid Anastomosis, and Bilateral Ureteral Reimplantation.

BACKGROUND Endometriosis is a chronic inflammatory disease caused by endometrial tissue that grows outside the uterus. Deep endometriosis surgery is associated with considerable rates of complications, although such rates are lower in surgical procedures carried out by expert surgical teams. This report details a case of a rare but life-threatening complication in the postoperative period following 72 h of endometriosis surgery: a giant subcapsular hepatic hematoma, which was successfully managed conservatively. CASE REPORT Here we describe the case of a 39-year-old woman with deep endometriosis with ureteral, ovarian, and intestinal involvement requiring multidisciplinary surgery. She presented with severe anemia, respiratory distress, and oliguria 72 h postoperatively. A 3-phase computed tomography (CT) scan revealed a giant intrahepatic subcapsular hematoma (180×165×50 mm) lateral to the right hepatic lobe, which was managed conservatively. The patient evolved favorably and the hematoma was reduced (77×16 mm) in a follow-up CT scan performed 5 months later. CONCLUSIONS Giant liver hematoma is a rare, life-threatening complication. The current experience relating to its management remains largely limited owing to the rarity of the condition and paucity of published cases. Actually, we found no articles on hepatic hematoma in the context of endometriosis surgery. Early diagnosis and treatment are essential to reduce the patient's risk of death. Imaging diagnosis plays an essential role.

Use of Venetoclax in Patients with Relapsed or Refractory Acute Myeloid Leukemia: The PETHEMA Registry Experience.

The effectiveness of venetoclax (VEN) in relapsed or refractory acute myeloid leukemia (RR-AML) has not been well established. This retrospective, multicenter, observational database studied the effectiveness of VEN in a cohort of 51 RR-AML patients and evaluated for predictors of response and overall survival (OS). The median age was 68 years, most were at high risk, 61% received ≥2 therapies for AML, 49% had received hypomethylating agents, and ECOG was ≥2 in 52%. Complete remission (CR) rate, including CR with incomplete hematological recovery (CRi), was 12.4%. Additionally, 10.4% experienced partial response (PR). The CR/CRi was higher in combination with azacitidine (AZA; 17.9%) than with decitabine (DEC; 6.7%) and low-dose cytarabine (LDAC; 0%). Mutated NPM1 was associated with increased CR/CRi. Median OS was 104 days (95% CI: 56-151). For the combination with AZA, DEC, and LDAC, median OS was 120 days, 104 days, and 69 days, respectively; p = 0.875. Treatment response and ECOG 0 influenced OS in a multivariate model. A total of 28% of patients required interruption of VEN because of toxicity. Our real-life series describes a marginal probability of CR/CRi and poor OS after VEN-based salvage. Patients included had very poor-risk features and were heavily pretreated. The small percentage of responders did not reach the median OS.

Coping strategies used by health-care workers during the SARS-COV2 crisis. A real-world analysis.

The aim of this paper is to analyze the main coping strategies used by frontline teams during the first days of the COVID pandemic confinement in Spain. This information could be necessary in order to carry out training programs that allow a better handling of future emergency situations, as well as acting more effectively and with less negative emotional impact. A questionnaire was used to identify different psychological profiles for coping, and in turn, other relevant variables were analyzed. The most used strategies by health professionals were problem solving, desiderative thinking and social support. Emotional expression and social support were used more by women. Significantly different behaviors were found in desiderative thinking (lower in people of 35-50 years old, and social support, higher in people 35 years old). The symptoms most commonly experienced by medical personnel were: sleep disorders, anxiety, tension, depressive symptoms, gastrointestinal symptoms and general somatic muscular symptoms. A relationship could be determined between the age/gender of the workers and the participants' overall assessment of their ability to cope with the COVID-19 stress situation they had experienced (men 50 years old and women between 35 and 50 years old, who felt able or very able to cope with the stress caused by the health emergency. However, women <35 years old and >50 years old believed they were able to cope poorly with the circumstances. The advantage of specific training plans in order to help with some stress symptoms could be suggested, aimed at the acquisition of tools based on problem solving, and emotional management in stressful and emergency situations.

Frequency of Iatrogenic Sexual Dysfunction Associated with Antihypertensive Compounds.

Iatrogenic sexual dysfunction (SD) caused by antihypertensive (AH) compounds, provoking sexual desire, orgasm or arousal dysfunction, is a common clinical adverse event. Unfortunately, it is often underestimated and underreported by clinicians and prescribers in clinical practice, deteriorating the adherence and patient quality of life. The objective of this study was to investigate the frequency of SD in patients treated with different antihypertensive compounds; a real-life naturalistic and cross-sectional study in patients receiving AH treatment was carried out. Method: A total of 256 patients were included in the study (188 males and 68 females who met the inclusion and exclusion criteria). The validated Psychotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ-SALSEX) was transversally applied once at least every two months following the onset of the treatment in order to measure possible AH-related SD. Although the spontaneous reporting of SD was very low (6.81% females/24.8% males), 66.40% of the patients reported impaired sexual function through the SALSEX questionnaire after the treatment onset, as follows: decreased desire (55.8% females/54.2% males), delayed orgasm (42.6%/45.7%), anorgasmia (42.6%/43.6%) and arousal difficulties (53%/59.6%). The average frequency of moderate to severe iatrogenic SD was 66.4% with AH in monotherapy as follows: angiotensin II receptor antagonists (ARBs), 29.8%; calcium antagonists, 40%; diuretics, 42.9%; beta blockers, 43.8%; and angiotensin-converting enzyme (ACE) inhibitors, 77.8%. Combined treatments showed a higher percentage of main SD (70.3%): diuretic + ACE inhibitor, 42.3%; ARB + calcium antagonist, 55.6%; diuretic + calcium antagonist, 68.8%; and diuretic + ARB, 74.2%. The greatest risk factors associated with SD were poor general health, age over 60 with a comorbid coronary or musculoskeletal disease, mood disorder and diuretic +ARB combined therapy. Conclusion: SD is common in patients treated with antihypertensive drugs, and it is still underreported. The most harmful treatment deteriorating sexual function was the combination of diuretic +ARB, while the least harmful was monotherapy with ARBs. More research is needed on the clinical management of this problem to preserve the quality of life of patients and their partners.

Frequency, Clinical Characteristics and Outcome of Adults With Acute Lymphoblastic Leukemia and COVID 19 Infection in the First vs. Second Pandemic Wave in Spain.

BACKGROUND AND OBJECTIVE: SARS-CoV-2 infection has bimodal distribution in Europe with a first wave in March to June 2020 and a second in September 2020 to February 2021. We compared the frequency, clinical characteristics and outcomes of adults with acute lymphoblastic leukemia (ALL) and infection in the first vs. second pandemic waves in Spain. PATIENTS AND METHODS: In this prospective study the characteristics of ALL and COVID-19 infection, comorbidities, treatment and outcome in the two periods were compared. The study ended when vaccination against SARS-CoV-2 was implemented in Spain. RESULTS: Twenty eight patients were collected in the first wave and 24 in the second. The median age was 46.5 years (range 20-83). Patients from the first wave had a trend to more severe ALL (higher frequency of patients under induction or submitted to transplantation or under immunosuppressive therapy). No significant differences were observed in need for oxygen support, intensive care unit (ICU) requirement, days in ICU and time to COVID-19 infection recovery. Seventeen patients (33%) died, with death attributed to COVID infection in 15 (29%), without significant differences in the 100 day overall survival (OS) probabilities in the two waves (68% ± 17% vs. 56% ± 30%). The only prognostic factor for OS identified by was the presence of comorbidities at COVID-19 infection (HR: 5.358 [95% CI: 1.875- 15.313]). CONCLUSION: The frequency and mortality of COVID-19 infection were high in adults with ALL, without changes over time, providing evidence in favor of vaccination priority for these patients.

Outcomes and prognostic factors of adults with refractory or relapsed T-cell acute lymphoblastic leukemia included in measurable residual disease-oriented trials.

Despite high complete remission (CR) rates with frontline therapy, relapses are frequent in adults with T-cell acute lymphoblastic leukemia (T-ALL) with limited salvage options. We analyzed the outcomes and prognostic factors for CR to salvage therapy and overall survival (OS) of patients with R/R T-ALL included in two prospective measurable residual disease-oriented trials. Seventy-five patients (70 relapsed, 5 refractory) were identified. Relapses occurred in bone marrow, isolated or combined in 50 patients, and in the central nervous system (CNS; isolated or combined) in 20. Second CR was attained in 30/75 patients (40%). Treatment with FLAG-Ida and isolated CNS relapse were independently associated with a higher CR rate after first salvage therapy. The median OS was 6.2 (95% confidence interval [CI], 3.9-8.6) months, with a 4-year OS probability of 18% (95% CI, 9%-27%). No differences in survival were observed according to the treatment with hematopoietic stem cell transplantation in patients in CR after first salvage therapy. Multivariable analysis showed a ≥12-month interval between first CR and relapse, CR after first salvage therapy and isolated CNS relapse as favorable prognostic factors for OS with hazard ratios (HR) (95% CI) of 1.931 (1.109-3.362), 2.958 (1.640-5.334), and 2.976 (1.157-7.655), respectively. This study confirms the poor outcomes of adults with R/R T-ALL among whom FLAG-Ida was the best of the rescue therapies evaluated. Late relapse, CR after first rescue therapy and isolated CNS relapse showed prognostic impact on survival. More effective rescue therapies are needed in adults with R/R T-ALL.

Students' Perceptions of Instructional Rubrics in Neurological Physical Therapy and Their Effects on Students' Engagement and Course Satisfaction.

One of the main challenges faced by physical therapy (PT) students is to learn the practical skills involved in neurological physical therapy (PT). To help them to acquire these skills, a set of rubrics were designed for formative purposes. This paper presents the process followed in the creation of these rubrics and their application in the classroom, noting that students perceived them as valid, reliable, and highly useful for learning. The perception of the validity and usefulness of the rubrics has different closely related dimensions, showing homogeneous values across the students´ sociodemographic and educational variables, with the exception of dedication to studying, which showed a significant relationship with schoolwork engagement and course satisfaction. The adequacy of the hypothesized structural model of the relationships among the variables was confirmed. Direct effects of the perception of the rubrics' validity and engagement on course satisfaction were found, as well as direct effects of the assessment of the usefulness of the rubrics on schoolwork engagement and indirect effects on course satisfaction through this latter variable. The results are discussed taking into account the conclusions of previous research and different instructional implications.

Validity of the International Physical Activity Questionnaire Long Form for Assessing Physical Activity and Sedentary Behavior in Subjects with Chronic Stroke.

Validation studies of questionnaires used to assess physical activity (PA) and sedentary behavior (SB) in stroke survivors are scarce. This cross-sectional study aimed to examine the validity of the International Physical Activity Questionnaire long-form (IPAQ-LF) in community living adults with post-stroke sequelae (≥6 months) and preserved ambulation. Participants' functional mobility, lower limb strength, ambulatory level, stroke severity, and disability were assessed. An accelerometer (ActiGraph GT3X+) was worn for ≥7 consecutive days. Subsequently, the IPAQ-LF was interview-administered. Fifty-six participants (58.1 ± 11.1 years, 66.1% male) were included. A strong correlation between the two methods was found for total PA time (ρ = 0.55, p < 0.001). According to the Bland-Altman analyses, over-reporting moderate-to-vigorous PA and under-reporting total PA in the IPAQ-LF were found in those participants with higher PA levels. Both methods measured sedentary time similarly, though random error was observed between them. Moderate-strong correlations were found between the IPAQ-LF and physical function (ρ = 0.29-0.60, p < 0.05). In conclusion, in people with chronic stroke, the IPAQ-LF presented acceptable levels of validity for estimating total PA time in those who are insufficiently active. Therefore, it could be a useful tool to screen for inactive individuals with chronic stroke who can benefit from PA interventions addressed to implement healthier lifestyles.

Retirada accidental de sondas enterales en el paciente crítico / Accidental removal of feeding tubes in critical patients

Objetivo: evaluar el impacto de una sesión formativa en las tasas de retirada accidental (RA) [autorretirada y retirada por causa externa al paciente (CEP)] de la sonda enteral (SE) y en los niveles de analgosedación e identificación del delirio, en pacientes de un Servicio de Cuidados Intensivos y Grandes Quemados (UCI-UGQ).Método: estudio observacional prospectivo antes-después, realizado en una UCI-UGQ de 24 camas. Primer periodo: del 15-10-2018 al 15-01-2019, segundo periodo: del 15-07-2019 al 15-01-2020. Entre periodos se comunicaron los resultados y se hizo una sesión formativa (sujeción SE, valoración dolor, sedación y delirio). Incluidos todos los pacientes portadores de SE. Variables: demográficas, gravedad, motivo de retirada, evento adverso como consecuencia de la retirada o reinserción, dolor, sedación/agitación y delirio. Análisis: descriptivo y tasas de incidencia por 1.000 días dispositivo. Aprobado por CEIm.Resultados: ingresos en 2018 vs. 2019: 232 vs. 408 (1.586 vs. 3.149 días estancia); mujeres: 34% vs. 42%. SAPS III, Mediana (RIC): 57 (45-67) vs. 45 (33-54). Insertadas 156 vs. 295 SE. Tasas de RA por 1.000 días de dispositivo: global 56,68 vs. 45,87 (p= 0,42); autorretirada 48,13 vs. 37,72 (p= 0,36), CEP 8,56 vs. 8,15 (p= 0,90). No se registraron eventos adversos. En el momento de la autorretirada presentaban dolor (EVN/ESCID> 0) 26,6% vs. 19% pacientes; agitación (RASS> 0) 66,6% vs. 40,6% pacientes; delirio (CAM-ICU positivo) 33,3% vs. 20,3% pacientes.Conclusiones: tras la sesión formativa se observó una reducción no significativa en las tasas de RA. En las autorretiradas se comprobó un descenso significativo de la agitación y un descenso clínicamente relevante del dolor y presencia de delirio.(AU)

Objective: to assess the impact of a training session on accidental removal (AR) rates of the feeding tube (FT) [self-removal and removal due to a cause external to the patient (CEP] and on the levels of analgesia & sedation and delirium detection, in patients from an Intensive Care and Major Burns Unit (ICU-MBU).Method: an observational, before-and-after, prospective study, conducted in a 24-bed ICU-MBU- First period: October, 15th, 2018 to January, 15th, 2019: second period: July, 15th, 2019 to January, 15th, 2020. Results were reported between periods, and a training session was conducted (FT attachment, pain assessment, sedation, and delirium). All patients with FT were included. Variables: demographics, severity, reason for removal, adverse event as a consequence of removal or reinsertion, pain, sedation/agitation, and delirium. Analysis: descriptive, and incidence rates per 1,000 device days. Approved by the Drug Research Ethics Committee (CEIm).Results: hospitalizations in 2018 vs. 2019: 232 vs. 408 (1,586 vs. 3,149 hospitalization days); women: 34% vs. 42%. SAPS III, Median (IQR): 57 (45-67) vs. 45 (33-54). FTs inserted: 156 vs. 295. AR rates per 1,000 device days: overall 56.68 vs. 45.87 (p= 0.42); self-removal: 48.13 vs. 37.72 (p= 0.36), CEP 8.56 vs. 8.15 (p= 0.90). No adverse events were reported. At the time of self-removal, 26.6% vs. 19% patients presented pain (VAS/ESCID> 0); 66.6% vs. 40.6% patients presented agitation (RASS> 0, and 33.3% vs. 20.3% patients presented delirium (positive CAM-ICU).Conclusions: after the training session, a non-significant reduction in AR rates was observed. In cases of self-removal, a significant reduction in agitation was observed, as well as a clinically relevant reduction in pain and presence of delirium.(AU)

Chemotherapy or allogeneic transplantation in high-risk Philadelphia chromosome-negative adult lymphoblastic leukemia.

The need for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) with high-risk (HR) features and adequate measurable residual disease (MRD) clearance remains unclear. The aim of the ALL-HR-11 trial was to evaluate the outcomes of HR Ph- adult ALL patients following chemotherapy or allo-HSCT administered based on end-induction and consolidation MRD levels. Patients aged 15 to 60 years with HR-ALL in complete response (CR) and MRD levels (centrally assessed by 8-color flow cytometry) <0.1% after induction and <0.01% after early consolidation were assigned to receive delayed consolidation and maintenance therapy up to 2 years in CR. The remaining patients were allocated to allo-HSCT. CR was attained in 315/348 patients (91%), with MRD <0.1% after induction in 220/289 patients (76%). By intention-to-treat, 218 patients were assigned to chemotherapy and 106 to allo-HSCT. The 5-year (±95% confidence interval) cumulative incidence of relapse (CIR), overall survival (OS), and event-free survival probabilities for the whole series were 43% ± 7%, 49% ± 7%, and 40% ± 6%, respectively, with CIR and OS rates of 45% ± 8% and 59% ± 9% for patients assigned to chemotherapy and of 40% ± 12% and 38% ± 11% for those assigned to allo-HSCT, respectively. Our results show that avoiding allo-HSCT does not hamper the outcomes of HR Ph- adult ALL patients up to 60 years with adequate MRD response after induction and consolidation. Better postremission alternative therapies are especially needed for patients with poor MRD clearance. This trial was registered at www.clinicaltrials.gov as # NCT01540812.

Short and medium-term effects of a multicomponent physical exercise program with a Mediterranean diet on bone mineral density, gait, balance, and fall risk for patients with Alzheimer disease: Randomized controlled clinical trial study protocol.

INTRODUCTION: Reduced bone mineral density and increased risk of falls are related with Alzheimer disease, and these increase likelihood of bone osteoporotic fractures causing serious complications such as disability, fear of falling, loss autonomy, decreased quality of life, and anticipated mortality in elderly patients. Gait and balance disturb are 2 factors to favor falls in elderly, and in patients with cognitive impairment, the risk of falls increases to double. Exercise and Mediterranean diet produce beneficial effects for aging, cognitive decline, and are widely recommended to reduce the effects of osteoporosis, fall risk, and related fragility fractures. The primary objective of this study is to evaluate the short and medium-term effects during 6 months, of a multicomponent physical exercise program with a Mediterranean diet on bone mineral density, fall risk, balance, and gait by a controlled clinical trial in patients with Alzheimer disease. METHODS: The study is a 6-month, randomized controlled parallel-group, single-blinded clinical trial. Institutionalized patients with Alzheimer disease will be included. The intervention group will perform a multicomponent physical exercise program in reduced groups, with a frequency of 3 sessions per week, associated with a Mediterranean diet. This program includes strength, balance, and aerobic resistance exercises, and in the main part of the session, also ludic exercises to improve agility, coordination, and balance. The control group will receive usual care. The outcomes to assess are the change of physical functions, such as gait and balance, and the change of bone mineral density by calcaneal quantitative ultrasound, during the study follow-up at 1, 3, and 6 months. This clinical trial will generate more and new evidence on the effects of a multicomponent physical exercise program and Mediterranean diet in patients with Alzheimer disease on risk of falls and osteoporotic fractures, the relation of these with bone mineral density, gait and balance, and the correlations between them. ETHICS AND DISSEMINATION: This study protocol has been approved by the Ethics Committee of the University of Salamanca. The results will be published in peer-reviewed journals and disseminated in national and international conferences, to the participants and their families, and the general public through the associations of people with AD. TRIAL REGISTRATION ID: ClínicalTrials.gov ID: NCT04439097.

Mediterranean diet and health: A systematic review of epidemiological studies and intervention trials.

Diet is a crucial variable for a healthy life. A rapidly growing number of studies in recent years support the hypothesis that the Mediterranean diet (MedDiet) has a beneficial effect on certain body systems, but the highly varied objectives and quality of these publications warrants an updated assessment. In the present review we performed a comprehensive evaluation of current evidence on the impact of the MedDiet on human health, assessing its effect on the incidence or progression of the main non-communicable diseases and their intermediate outcomes and risk factors. We scrutinised the clinical evidence from observational studies and randomised controlled trials. Cardiovascular disease was the condition with most information. The MedDiet showed a general preventive effect, which was reproduced to varying degrees for certain intermediate cardiovascular outcomes such as blood pressure, lipids, obesity, metabolic syndrome and diabetes. Benefits were also found for several types of cancer, brain function (including cognition, mood and to a lesser extent Parkinson's disease) and mortality. The quality of the published evidence was, however, generally moderate or low. In conclusion, the MedDiet shows a favourable impact on health. General adoption of a MedDiet is concordant with current policies promoting healthy and sustainable nutrition worldwide. Nonetheless, more high-quality research is needed to improve the consistency of the findings.

A pediatric regimen for adolescents and young adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: Results of the ALLRE08 PETHEMA trial.

BACKGROUND: Pediatric-based or -inspired trials have improved the prognosis of adolescents and young adults (AYA) with Philadelphia chromosome-negative (Ph-neg) acute lymphoblastic leukemia (ALL). METHODS: This study reports the results of treatment of the ALLRE08 trial, a full pediatric trial for AYA aged 15-30 years with standard-risk (SR) ALL. RESULTS: From 2008 to 2018, 89 patients (38 adolescents [15-18 years] and 51 young adults [YA, 19-30 years], median age: 20 [15-29] years) were enrolled in the ALLRE08 trial. The complete response (CR) was 95%. Twenty-two patients were transferred to a high-risk (HR) protocol because of poor marrow response on day 14 (n = 20) or high-level of end-induction minimal residual response (MRD ≥ 0.25%, n = 2). Cumulative incidence of relapse (CIR) at 5 years was 35% (95%CI: 23%-47%), with significant differences between adolescents and YA: 13% (4%-28%) vs 52% (34%-67%), P = .012. No treatment-related mortality was observed in 66/66 patients following the ALLRE08 trial vs 3/23 patients moved to a HR trial. The estimated 5-year overall survival (OS) was 74% (95%CI: 63%-85%), with significantly higher rates for adolescents vs YA: 87% (95%CI: 74%-100%) vs 63% (46%-80%), P = .021. Although CIR or OS were lower in patients who were transferred to a HR trial, the differences were not statistically significant (CIR: 34% [21%-47%] vs 37% [14%-61%]; OS: 78% [66%-90%] vs 61% [31%;91%]). CONCLUSION: A full pediatric trial is feasible and effective for AYA with Ph-neg, SR-ALL, with better results for adolescents than for YA. Outcome of patients with poor early response rescued with a HR trial was not significantly inferior.

The Mediterranean diet: A historical perspective on food for health.

The Mediterranean diet (MedDiet) represents the crystallisation of the centuries-old cooking legacies of different civilisations. The association of the MedDiet with longevity and low cardiovascular risk prompted the Seven Countries Study, which provided epidemiological evidence on the health effects of diet. This led to further studies, both epidemiological and interventional. Scales to measure adherence as well as studies of food components have consolidated a body of knowledge that is of great interest to institutions and governmental agencies. The recognition of its benefits for health has made the widespread introduction of the MedDiet an urgent challenge. Parallel efforts are being made to extend research through experimental and clinical studies. The purpose of this review is to present the historical background of the MedDiet, the main steps leading to the recognition of its health benefits, and the current strategy to facilitate its global implementation.

Low Amyloid-PET Uptake in Iowa-Type Cerebral Amyloid Angiopathy with Cerebral Venous Thrombosis.

Hereditary cerebral amyloid angiopathies (CAA) are rare disorders of early onset and severe course. We describe a 47-year-old patient with Iowa-type amyloid precursor protein (APP) mutation-related hereditary CAA that manifested with concomitant lobar hemorrhage and venous sinus thrombosis. To analyze the cerebral amyloid-ß burden, an amyloid-PET was performed, demonstrating low cortical retention except for the calcarine cortex. High amyloid retention was also found in the thalamus and pallidum. The co-occurrence of CAA and venous thrombosis has not been previously reported in Iowa CAA and its mechanism is yet to be elucidated. Low cortical florbetapir-PET uptake does not rule out CAA in young patients, who may benefit from genetic testing to reach diagnosis when suspicion is strong.