Calella De La Costa, Spain
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.
Phase
N/ASpan
52 weeksSponsor
Universidad Complutense de MadridGetafe, Madrid
Recruiting
Healthy Volunteers
Development of a Molecular Diagnostic Tool for Endometrial Cancer.
Phase
N/ASpan
53 weeksSponsor
MiMARK Diagnostics, S.L.Getafe, Madrid
Recruiting
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.
Phase
N/ASpan
79 weeksSponsor
Hospital Clinic of BarcelonaGetafe, Madrid
Recruiting
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.
Phase
N/ASpan
244 weeksSponsor
Hospital Universitario GetafeGetafe, Madrid
Recruiting
Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
The aim of the present study is to prospectively evaluate the safety of Edoxaban in daily clinical practice in Spain in elderly patients with nonvalvular atrial fibrillation who meet the criteria for frailty and who have been prescribed the drug recently (<6 months prior to inclusion). The study will provide us with a clear and real-life picture of bleeding and ischemic complications and possible treatment interruptions with Edoxaban in real life and in a large subgroup, although underrepresented in the studies.
Phase
N/ASpan
100 weeksSponsor
Galaxia EmpíricaGetafe, Madrid
Recruiting
Global BurdEn of MechanIcal VeNtilatIon (GEMINI). VeNtilatIon (GEMINI Study) 2022 for VENTILAGROUP.
Patient Population and Participating Centers Research personnel prospectively will follow up all newly admitted adult patients admitted in the ICU who received ventilator support. A region will be defined as a country or collection of countries represented by a National Coordinator. We aimed to include a total amount of ICUs with similar characteristics (approximately 1525 ICUs) from each region accordingly to the global population of the participating country. Participating centers Recruitment for participation in GEMINI study will be by open invitation, through the Steering Committee. National Coordinators will be selected, and committed to enroll local ICUs for the inclusion of patients. Participation is entirely voluntary, with no financial incentive. Institutional review board/ Local Ethics committees approval will be obtained by the participating institutions in accordance with local ethical regulations.Currently, the study has been approved by the Ethics Committee of the Universitary Hospital of Getafe, Madrid, Spain as a coordinating center (CEIM 22/27). Study design This will be an observational, prospective, no interventional, international and multicenter study coordinated by Hospital universitarian from Getafe, Madrid, Spain in 52 countries (see appendix for participanting regions) and will have a inclusion period of 3 months recruitment window, and then to pick any consecutive 4 week period within that window. The recruitment framing will start October 1st 2022 until march 31th 2023. Then, a follow-up period at six months after hospital discharge. The project will be inscribed in a Web-based resource that will provide patients, their family members, health care professionals, researchers, and the public an easy access to information regarding the protocol (clinicaltrials.gov) before the starting of the study. Study outcomes, data collection, and statistical analyses will be established a priori and submitted for publication in a peer-review International Journal before data access. Study Population - Inclusion Criteria In order to include participants from different regions and countries and being comparable between them, the Steering Committee will create some clinical operative definitions for the selection of the participating ICUs from each region. This study will be conducted in Intensive Care Units ([medical ICU], coronary ICU, surgical ICU, neurocritical ICU) that meet the following criteria: 1. ICUs that have six or more beds and/or average (during prior 12 months) of more than 30% of the patients admitted requiring mechanical ventilation. 2. ICUs that have staff specialists in Intensive Care Medicine, or visiting physicians with intensive care training and/or physicians who have more than five years of intensive care experience. The INCLUSION CRITERIA FOR THE PATIENTS, as following: 1. All consecutive adult patients (≥ 18 years old) who are admitted to the ICU and require invasive mechanical ventilation (endotracheal tube or tracheostomy) longer than 12 hours. 2. Adult patients admitted to the ICU and require advanced respiratory support (high flow oxygen nasal cannula, or noninvasive ventilation including BIPAP or CPAP modalities with oronasal, nasal, helmet or facial mask) with acute respiratory failure defined as PaO2/ fraction of inspired oxygen (FiO2), [PaO2/FiO2] ratio <300, or the pulse oximetric saturation (SpO2/FiO2 ) ratio < 315 for more than 1 hour. 3. Adult patients in whom mechanical ventilation were started outside the study ICU at the same Institution and/or a different Institution, including Emergency Room, Operating Room (OR), /or were then transferred to the ICU at the participating center. ▪ Exclusion Criteria 1. The following ICUs will be excluded: a. Pediatric ICU. b. Post-Operators Anesthesia Recovery Room. 2. Patients less than 18 years old. 3. Patients admitted after elective surgery and who require mechanical ventilation for less than 12 hours (excepting patients who receive non-invasive ventilation). 4. Patients will be excluded if they were transferred to participating ICUs without a documented intubation time, or underwent a tracheotomy at prior to ICU admission. 5. Patients that were at participating ICUs for 24 hours or more, were readmitted during the study period. Study Protocol 1. Data from patients who meet the inclusion criteria and who are enrolled in the study will be collected according to the following situations, whichever occurs first: 1. DAILY WITHIN 7 DAYS after the beginning of mechanical ventilation for recording clinical variables, and then for alternative days up to day 28. 2. Until ICU discharge/or death after inclusion, whatever will come first for recording complications, events and clinical outcomes. 3. FOLLOW-UP OF SIX MONTHS AFTER ICU DISCHARGE for long term outcomes, ONLY in those participants requiring invasive mechanical ventilation for at least 3 or more consecutive days. 2. If the patient is discharged from the hospital and subsequently readmitted and requires mechanical ventilation, this patient WILL NOT BE considered a new patient. 3. If the patient is transferred out of the ICU and requires ventilation during the same hospital stay WILL NOT BE considered a new patient. 4. Data will be collected using an electronic case report forms, through a secure online connection (Appendix). 5. The Investigator or Local Research Collaborator in each ICU will collect the data. It is crucially important that only the Local Research Collaborator become thoroughly familiar with the study objectives and data collection in each ICU. Otherwise, there is a risk that the normal routine in an ICU will be disrupted, and data collected will no longer reflect usual activities. 6. The National Coordinator for each country must be consulted regarding any protocol related questions. ▪ Outcomes The main outcome will be ICU mortality. The secondary outcomes will include: frailty at 6 months from hospital discharge (only for those participants requiring invasive mechanical ventilation for at least 3 consecutive days), 28-day mortality, hospital and 6-months mortality, length of ICU and hospital stay, duration of ventilatory support, free-hospital days and free-ventilator days, failure of noninvasive respiratory support, reintubation rate, tracheotomy rate, decision for withdrawal or withholding vital support rate, and ICU readmission rate. Other intermediate outcomes will be as: rate of complications and organ failure during ICU stay (barotrauma, delirium, ICU-acquired weakness, acute renal failure or need of replacement renal therapy, shock). Data collection Data regarding written directives, demographic data, comorbidities, frailty scale (baseline health will be assessed and disability in the month before ICU admission retrospectively at six months), daily screening, preferred modalities of ventilator support, ventilatory approach for liberation from mechanical ventilation, and practices of sedation or neuromuscular blockers pertaining to invasive mechanical ventilation and discontinuation will be collected daily during the period of ventilatory support. Case report forms (CRFs; appendix) will be electronically provided by the investigators using a secured internet based website. Data collection on admission will included demographic data and comorbid diseases. Clinical and laboratory data for simplified acute physiology score (SAPS) 3 will be reported as the worst values within 24 h after admission. A daily assessment of organ function in accordance with the sequential organ failure assessment (SOFA) score5 will be done. ▪ Statistical analyses Randomization This is a prospective, observational, and no intervention study, and therefore, randomization is not applicable. Sample size calculation Despite of the characteristics of this observational study (an international and multicenter observational study) with multiple objectives to evaluate, we will decide to include patients according with the calculation of the sample size for the main objective (ICU mortality). In this way, we estimated that 9,092 patients would need to be enrolled for the study to have 90% power to detect a rate of ICU mortality of 25% versus 28% in the previous study, at an overall two-sided alpha level of 0.05. By assuming 20% of missing cases, a final 10,910 patient will be required for the study. In addition to the statistical criterion, a hierarchical criterion will be added regarding the minimum number of cases included depending on the demographics of the participating countries, in order to obtain information on representative clinical practice. Then, the study should reach 500 cases per country with <10 million inhabitants , 500-1000 cases for countries with 11-25 million, 1000-1500 cases for countries with 26-50 million and more than 1200 cases for countries with more than 50 million inhabitants. The secondary objectives will be tested using the same sample size. Statistical Methods The investigators will used descriptive statistics to summarize binary (number and percentage, and continuous (mean and standard deviations (SD) and median and interquartile range [IQR], when appropriate) variables. The Kolmogorov-Smirnov test will be used, and histograms and quantile-quantile plots will be examined to verify if there were significant deviations from the normality assumption of continuous variables Student's t or Mann Whitney U tests will be use to compare continuous variables and chi-squared tests will be used for categorical variables. The investigators will express differences in clinical outcomes using the absolute difference with 95% confidence intervals with Yates continuity correction for binary outcomes and median (IQR) with bootstrapped 95% for continuous outcomes. P values will be adjusted for clustering of ICUs within hospitals by using a mixed-model framework and will be corrected for multiple testing using the Holmes-Bonferroni method. Residuals will be assessed to ensure the normality assumption. A logistic model with a logit link function will be used to identify baseline characteristics and factors that developed between ICU admission and clinical outcomes and complications related to the use of specific ventilatory strategies and comorbidities and frailty. Clustering will be accounted for by including a random effect for hospital. To identify factors associated with ICU mortality, the researchers will construct two different approaches: a multilevel logistic model with a logit link including patient variables (age, basal frailty, IMV duration, modified Sequential Organ Failure Assessment [SOFA] respiratory score, , and primary diagnosis; model 1); patient and site variables (screening, hospital type, hospital profit status, and adjusting IMV support, and region; model 2); and patient, site, and practitioner variables (model 3). On the other hand, we will develop different models of machine learning to identify clinical subphenotypes to predict clinical outcomes as ICU mortality, 6-months mortality, successful extubation or prolonged ventilatory support as main secondary outcomes. Adjusted model will have the best balance of variables based on discrimination (C statistic) and calibration (calibration slope and calibration-in-the-large) after performing internal bootstrap validation and finally an external validation as sensitivity analysis by taking 30% of the global cohort of included patients. The investigators will assume that missing variables in regression analyses (eg, SAPS 3 score at ICU admission, SOFA score) will be missing at random. These variables will be imputed using multiple imputation by chained equations. A 2-sided P values <.05 will indicate statistical significance. The least significant difference testing procedure will be used for pairwise comparisons. In-hospital death will be analyzed using multilevel logistic regression with three levels: hospital, and country. The results of fixed effects (measures of association) will be given as odds ratios (OR) with their 95% CIs and the 80% interval OR. Random effects (measures of variation) measures included the variance and its SE, the proportional change in variance, and the median OR (MOR). Data will be processed and analyzed in the department of Statistics department of the Hospital Universitario Ramón y Cajal (Madrid, Spain), in collaboration with the department of intensive care of Getafe University Hospital (Madrid, Spain). Analyses will be performed using Stata Software 16.0 (StataCorp LP, College Station, Texas). This study follows multidisciplinary guidelines for reporting machine learning predictive models in biomedical research. A number of classification models will be used, including logistic regression, neural networks, and ensemble models such as random forest and decision trees. Data collection methods All data used in this study will be routinely collected from the clinical parameters obtained daily during the ICU admission. These data will be collected by each participating center led by a local coordinator and saved in an online database created ad hoc according with legislation and in adherence with safety and confidential international legal requirements and will have a personal access for National Coordinators and local collaborators under a personal profile with username and password. This online database will be designed in the Hospital universitarian from Getafe. Finally, the principal investigator will store the completed, anonymous and irreversible database with a limited access during 20 years. Detailed instructions explaining the aim of the study, instructions for data collection, and definitions were available through a secured website for all participants before starting data collection and throughout the study period. The coordinating Centre will answer any additional queries on a per case basis during data collection. Validity checks will be made concurrent with data entry on the electronic CRF including plausibility checks within each variable and between variables. Data will be further reviewed by the coordinating centre for plausibility and availability of outcome parameter (death in the ICU), and any doubts will be clarified with the centre in question. There will not be on-site monitoring. However, National Coordinators will send queries to local collaborators to fulfill outliers and main missing data. For the purposes of this study, the world was divided into nine geographical regions: North America, South America, Western Europe, Eastern Europe, Middle East, south Asia, east and southeast Asia, Oceania, and Africa. Individual countries will be also classified into three income groups in accordance with their 2020 gross national income (GNI) per person, using thresholds defined by the World Bank Atlas method: (World Bank. GNI per capita, Atlas method (current US$). http://data.worldbank.org/indicator/NY.GNP.PCAP. CD (accessed April 5, 2022); GNI less than US$8700 was defined as low and lowermiddle income, $8700-$19400 was defined as upper-middle income, and greater than $19400 was defined as high income). Detailed instructions explaining the aim of the study, instructions for data collection, and definitions will be available through a secured website for all participants before starting data collection and throughout the study period. Any additional queries will be answered on a percase basis by the coordinating centre during data collection. Validity checks will be made concurrent with data entry on the electronic CRF including plausibility checks within each variable and between variables. Data monitoring Committee (DMC) A committee of three main investigators will ensure the rights and safety of participants involved in the study are protected. Main missing variables will be detected and will sent to the National Coordinators to be completed. Quality Control Extensive efforts will be made to ensure the quality of the data collected throughout the study. At each site, the study physicians, including review of the chart, will review the data from a randomly chosen 5 percent of screened patients and from all patients about whom the screeners had questions. Data from a random sample of 7 percent of cases were abstracted and entered into the database twice, with an error rate of less than 0.25 percent. The charts will be reevaluated until the final notes, laboratory test results, and other results will be completed. Complete data will be necessary to include participants in the final analysis, and we will accept participants with no missing data for the main variables or participants with missing data less than 10% for secondary variables. All local regulations must be met and the necessary documentation submitted to the Study Coordinating Center. Physicians from each participating country as lead national coordinators will be recruited. Site investigators will be also responsible for ensuring safety, anonymous data integrity and validity. The Steering Committee and National Coordinators will have full access to all the data in the study and had final responsibility for the decision to submit for publication.
Phase
N/ASpan
105 weeksSponsor
Hospital Universitario GetafeGetafe, Madrid
Recruiting
Development of Continuous Assessment of Frailty and Muscle Quality in Older Subjects: ECOFRAIL Protocol
Background: Frailty derived from muscle quality loss can potentially be delayed through early detection and physical exercise interventions. There is a need for affordable tools for the objective evaluation of muscle quality, in both cross-sectional and longitudinal assessment. Literature suggests that quantitative analysis of ultrasound data captures morphometric, compositional and microstructural muscle properties, while biological essays derived from blood samples are associated with functional information. The aim of this study is to evaluate multi-parametric combinations of ultrasound and blood-based biomarkers to provide a cross-sectional evaluation of the patient frailty phenotype and to monitor muscle quality changes associated with supervised exercise programs. Methods: This is a prospective observational multi-center study including patients older than 70 years with ability to give informed consent. We will recruit 100 patients from hospital environments and 100 from primary care facilities. At least two exams per patient (baseline and follow-up), with a total of (with a minimum total of 400 exams) exams. In the hospital environments, 50 patients will be measured pre/post a 16-week individualized and supervised exercise programme, and 50 patients will be followed-up after the same period without intervention. The primary care patients will undergo a one-year follow-up evaluation. The primary goal is to compare cross-sectional evaluations of physical performance, functional capacity, body composition and derived scales of sarcopenia and frailty with biomarker combinations obtained from muscle ultrasound and blood-based essays. We will analyze ultrasound raw data obtained with a point-of-care device, and a set of biomarkers previously associated with frailty by quantitative Real time PCR (qRT-PCR) and enzyme-linked immunosorbent assay (ELISA). Secondly, we will analyze the sensitivity of these biomarkers to detect short-term muscle quality changes as well as functional improvement after a supervised exercise intervention with respect to usual care. Discussion: The presented study protocol will combine portable technologies based on quantitative muscle ultrasound and blood biomarkers for objective cross-sectional assessment of muscle quality in both hospital and primary care settings. It aims to provide data to investigate associations between biomarker combinations with cross-sectional clinical assessment of frailty and sarcopenia, as well as musculoskeletal changes after multicomponent physical exercise programs.
Phase
N/ASpan
122 weeksSponsor
University of DeustoGetafe
Recruiting
Healthy Volunteers
Analysis of the Evolution of Mortality in an Intensive Care Unit
Phase
N/ASpan
1853 weeksSponsor
Hospital Universitario GetafeGetafe, Madrid
Recruiting
Characterization of the Intestinal and Vaginal Microbiota in Long-term Survivors of Gynecological Cancer
The human epithelial surface is colonized by a community of microorganisms, the microbiota, which disruption (dysbiosis) can impact a variety of functions, leading to inflammation, altered immunity and numerous diseases, including cancer. Pelvic cancers are among the most frequently diagnosed cancers worldwide, and pelvic radiotherapy is often an essential part of multimodal therapeutic approaches but can lead to a wide range of complications for which there is currently no treatment. The gut microbiota is altered by radiotherapy, and a relationship between gut microbiota composition, health status, and pelvic radiotherapy has been suggested. In recent years, there has been growing evidence that radiotherapy also alters the vaginal microbiota. The study proposes the characterization of the intestinal and vaginal microbiota in long-term radiated cervical and endometrial cancer survivors to study its association with long-term radiotherapy side effects. For this purpose, a descriptive cross-sectional study will be carried out in patients affected by cervical or endometrial cancer, in early stages, with good vital prognosis who have received radiotherapy, using healthy postmenopausal women as a control group. If the microbiota is indeed associated with the side effects of radiotherapy, this would open the possibility of identifying predictive markers, using machine learning analysis of the patients' quality of life, and would help in the search for future therapies based on the restoration of the vaginal and intestinal microbiota. Through network analysis, it would be possible to find out which factors related to patients' diet and lifestyle could be related to dysbiosis and radiotherapy-induced adverse outcomes and poor quality of life.
Phase
N/ASpan
159 weeksSponsor
Maria Bailen AndrinoGetafe, Madrid
Recruiting
Healthy Volunteers
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
The study CLOU064C12301 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants. The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS). The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years. A second study of identical design (CLOU064C12302) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.
Phase
3Span
463 weeksSponsor
Novartis PharmaceuticalsGetafe, Madrid
Recruiting