Getafe. Madrid, Spain

Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries

Prospective observational study in patients with Myocardial Infarction (MI) divided into two groups: MI with obstructive coronary arteries (MICAD) and MI with non-obstructive coronary arteries (MINOCA). Levels of interleukin-6, tumor necrosis factor-alpha, high-sensitivity C- reactive protein, and asymmetric dimethylarginine will be determined at three time points: within the 24 hours from the onset of pain, discharge, and two months after MI. The association of biomarkers, normalized by peak troponin value, with the risk of MINOCA will be evaluated using logistic regression.

Development of a Molecular Diagnostic Tool for Endometrial Cancer.

Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain.

With the present investigation it is wondered whether the choice of manual therapy techniques, specifically the pressure release of myofascial trigger points in the upper trapezius and sternocleidomastoid muscles, provide significant benefits in combination with therapeutic exercise and postural hygiene (treatment group), as opposed to the unique application of therapeutic exercise and postural hygiene (control group), thus constituting a treatment of choice in patients with mechanical neck pain. A treatment protocol of one session per week will be carried out, and a follow-up two weeks after the end of the treatment protocol. If, as postulated, pressure release is more effective than the treatment received by the control group, the choice of this type of technique for myofascial pain syndrome would benefit a high percentage of people who often come asking for treatment in pain treatment centers. Pressure release provides a painless manual stimulus, thus effectively resolving the symptomatology of myofascial trigger points without the need for invasive treatments or medication, which may have more contraindications.

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Risk Stratification Using MEESSI-AHF Scale in ED and Impact on AHF Outcomes

Study 1: A non-intervention study involving the consecutive inclusion of 3,200 patients with AHF in 16 Spanish EDs managed according to the usual practice. Individual risk will be retrospectively stratified according to the MEESSI-AHF scale, and we will analyze the distribution of the categories of risk in patients admitted and discharged and the prognosis of patients with low risk discharged from the ED and compare the events observed in this subgroup of patients with the recommended international standards. Study 2: This is a cuasiexperimental study in 8 EDs with consecutive inclusion of 1,600 patients with AHF managed according to the usual practice (without stratification of risk, pre-phase) and 1,600 patients managed after the implementation of the MEESSI-AHF scales for risk stratification before the final decision making in the ED (post-phase). If the patient has low risk the calculator will propose discharge; for the remaining categories of risk the calculator will propose patient admission. The final decision corresponds to the attending physician and if this decision differs from what was proposed, a reason will be given. Study 3: Open multicentre (8 EDs) randomized clinical trial (1:1) comparing the results obtained in the patients randomized to usual clinical practice (1,600 patients) with those obtained in the patients randomized to the use of the MEESSI-AHF scale for risk stratification (1,600 patients) prior to decision making. The dynamics of the decision proposed by the scale will be the same as that in Study 2. Main outcomes (Studies 1, 2, 3): Death (by any cause and cardiovascular cause) at 30 days and at 1 year; combined event (revisit to the ED or hospitalization for AHF or death) at 30 days post-discharge (global analysis of all the patients with AHF stratified by categories of risk); days alive and outside the hospital at 30 days after the index event (consultation to the ED); and proportion of patients managed without hospitalization.

Study of the Association Between Presbycusis With the Incidence of Frailty

Effects of Release and Ischemic Pressure of Trigger Points on Neck Pain. A Crossover, Controlled and Randomized Trial.

The present pilot study is proposed as a crossover, controlled and randomized clinical trial, with blinded evaluation of response variables. The aim of the study is to test whether the Pressure Release of Myofascial Trigger Points technique(PRM) is effective in treating Myofascial Trigger Points present in the upper trapezius muscle of patients with mechanical cervical pain. This will be compared mainly with another manual technique that presents more evidence such as Ischemic Pressure (IP), through the evaluation of the Visual Analogical Scale (VAS), the Threshold of Pain at Pressure (TPP) and the Northwick Park Questionnaire (NPC) of neck disability, Spanish version. The patients, with a minimum sample for the pilot study of 30 subjects, of working age (18-50 years) with mechanical neck pain for at least the last month, will be recruited from the clinic "Fisioterapia Los Molinos" in the town of Getafe, the same place where the treatment will be carried out. They will be randomly divided into three groups: one will be given Pressure Release of Myofascial Trigger Points technique (PRM), another Ischemic Pressure technique (IP), and a last one will be assigned as a control group. In compliance with the corresponding ethical criteria, the three groups will be subjected to random crossover so that no patient is left untreated. Visual Analogical Scale (VAS), Threshold of Pain at Pressure (TPP) and Northwick Park Questionnaire (NPC) of neck disability (spanish version), will be evaluated before and immediately after treatment. Statistical analysis will be performed by IBM SPSS v22.0 program or a later version, verifying that the sample meets the criteria of normality and homogeneity and comparing the results of the variables through an ANOVA Analysis of variance.

Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions

Acute hypoxemic respiratory failure (AHRF), and its more severe form termed the acute respiratory distress syndrome (ARDS), is a catastrophic illness of multifactorial etiology characterized by a severe inflammatory process of the lung leading to hypoxemic respiratory failure requiring mechanical ventilation (MV). Pulmonary infections are the leading causes of AHRF and ARDS. Translational research has established a strong association between dysregulated systemic and pulmonary inflammation and progression or delayed resolution of AHRF.2 Glucocorticoid receptor-mediated downregulation of systemic and pulmonary inflammation is essential to accelerate disease resolution and restore tissue homeostasis, and can be enhanced with glucocorticoid treatment. The COVID-19 pandemic is a critical moment for the world, in which even industrially advanced countries have rapidly reached intensive care units (ICUs) saturation, and intensivists are forced to make difficult ethical decisions that are uncommon outside war zones. As with other bacterial or viral infections, severe pneumonia is the main condition leading to AHRF and ARDS requiring weeks of MV with high mortality (35-55%) in critically ill patients. There has been great interest in the role of corticosteroids to attenuate the pulmonary and systemic damage in ARDS patients because of their potent anti-inflammatory and antifibrotic properties.3 Corticosteroids have been off patent for greater than 20 years, they are cheap, and globally equitable. However, the efficacy of corticosteroids in AHRF (including ARDS) caused by infections remains controversial. Only two large randomized clinical trials (RCT) have shown that the administration of dexamethasone is able to reduce mortality in patients with AHRF. Villar et al in Spain observed that moderate doses of dexamethasone (10-20 mg/d x 10 days) caused a 15% absolute reduction of 60-day mortality in patients with established moderate-to-severe ARDS from multiple etiologies. Horby et al in the RECOVERY trial in Great Britain reported that dexamethasone at low doses (6 mg/d x 10 days) reduced 28-day mortality in patients with AHRF caused by COVID-19. These findings confirmed that corticosteroid therapy is associated with a sizable reduction in duration of MV and hospital mortality. These two RCTs will change clinical practice for the management of AHRF and ARDS. However, there is a reasonable doubt whether dexamethasone at moderate doses (10-20 mg/d) would cause a greater reduction in mortality than 6 mg/d. Our goal in this study is to respond this question.

Treatment of Breakpoint Cluster Region-Abelson (BCR-ABL) Negative ALL in Adults

Patients will be uniformly treated with four drug-induction: vincristine (VCR), prednisone (PDN), pegylated asparaginase (PegASP), daunorubicin (DNR). Resistant patients will receive a second induction with fludarabine, Ara-C, G-Colony-Stimulating Factor (G-CSF) and idarubicin (FLAG-IDA). Patients with adequate MRD clearance after induction will receive 3 blocks of early consolidation. If adequate MRD clearance and good genetic background, the patients will proceed to delayed intensification, reinduction and maintenance. The remaining patients will receive early or delayed alloHSCT.

Impact of Intravenous Iron Treatment of Preoperative Anemia in Patients With LEAD (IRONPAD)

The IRONPAD Study is a phase IV randomised controlled trial with two branches of treatment on the efficacy of intravenous iron therapy for the optimisation of blood use and prognosis in the perioperative period of patients with anaemia undergoing revascularisation for chronic lower limb ischemia. Patients admitted to hospital with anaemia and indication of elective revascularisation surgery for chronic ischemia of the lower limbs will be eligible for screening. Anaemia in this study is established following the WHO criteria with haemoglobin (Hb) <130 g/L in men and <120 g/L in women 21. Patients will be selected according to the usual practice, without excluding patients because of comorbidity or other reasons that may affect results (selection bias). Prior to inclusion, freely given written informed consent will be obtained from all patients. Once included, each patient will be masked into a unique identity number (correlative according to inclusion), as a reference of patient ID in the registry. Each patient will be randomised to a line A or line B of treatment. - Line A: a single, ferric carboxymaltose (Ferinject®) 1000 mg IV iron dose administration. The infusion will be according to product specifications with an approximate duration of 15 minutes during hospitalisation and will not require an additional site visit or extended period of hospitalisation. - Line B: control. The control group will not receive specific treatment. In case of severe iron deficiency anaemia, oral iron supplements (iron sulphate dihydrate) will be given. Both lines may be followed in addition to taking vitamin B12 and folic acid, if indicated. The patient, once included in the study, may receive a blood transfusion if the following criteria are met: - Absolute indication: Hemodynamic instability Active bleeding Hb <7 g/dl - Relative indications: in case of Hb <8.5 g/dL or haematocrit <28% following the clinical criteria of the medical specialist. Interventions to be measured: The data collected at baseline will include patients' past medical history, medications, blood tests (including hemogram, iron tests and renal function), comorbidity index (Charlson Scale), lower limbs chronic ischemia category and the limb scheduled for revascularisation (including registry of any trophic lesions and if they have signs of active infection), height, weight and body-mass index of the patient. In addition, already validated quality of life questionnaire, the Short Form-36 Health Survey (SF-36) will be completed. Procedure data will record: date of IV iron treatment, if received, dose and any adverse events during or after administration; ASA (American Society of Anaesthesiologists) risk level; type of surgery performed for revascularisation of lower limbs, information on clinical success and complications of the intervention. Blood records will include haemoglobin before and first day after surgery and number of red blood cell units of or any other blood component transfused during the surgical procedure. If surgery does not finally take place, data from the 30 days after inclusion will be registered for analysis with intention to treat. The hospital discharge visit will record: date of discharge; last hemogram; number of blood transfusions from the postoperative period until discharge; days in intensive care; adverse events such as medical and surgical complications as well as mortality. The final follow-up visit will take place 30 days after the main surgery (with + 7 day window) it would be performed by telephone, in the outpatient consultation or in the hospital if the patient continues to be hospitalised; in that case, the discharge visit and final visit will be made simultaneously. It will record: blood tests (including hemogram, iron tests), clinical success, serious adverse events (SAE) and mortality, which may have occurred between hospital discharge and the visit in addition to Short Form-36 Health Survey (SF-36). See Fig. 1 for Assessment flow diagram.