Friol, Spain

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63)

Pain Neuroscience Education and Physical Exercise Program in Chronic Back Pain

Justification: Chronic musculoskeletal pain (CMP) affects more than 20% of the population, its prevalence is increasing, generating suffering and high health expenditure. The current knowledge of neurophysiology of pain shows that the painful experience in CMP is not necessarily associated with peripheral tissue damage and is due more to an alteration of central mechanisms of pain processing and to the dysfunction of endogenous pain inhibitory mechanisms. Physical exercise (PE) has been shown to be effective in CMP. Pain neuroscience education (PNE) improves the levels of pain catastrophism, Kinesiophobia, quality of life, disability and also modifies maladaptive cognitions that favour a painful response. Objectives: To evaluate the efficacy of a PNE and PE in patients with chronic back pain (CBP). Changes in pain intensity, pain thresholds, Catastrophism, kinesiophobia, disability, central sensitization and quality of are measured. Material and methods: Multicenter randomized clinical trial (RCT) with 170 patients. Intervention group receive 6 sessions of PNE and a 6 weeks PE program (18 sessions) aimed at improving functional capacity, neurogenesis and cerebral plasticity. Control group receive usual physiotherapy treatment (supported by the current protocols in Primary Care in the Health System of Castilla y León). The outcome variables are measured by Visual Analog Scale (EVA), Pressure Pain Threshold (PPT), Kinesiophobia Tampa Scale (TKS-11), Central Sensitization Questionnaire (CSC), Pain Catastrophism Questionnaire (CCD), disability (Roland-Morris), Quality of life (SF-36) and satisfaction (CSQ-8). An initial assessment, post-intervention (week 10), at six months and at year is performed. Patients Evaluator and Outcomes Assessor are masked. Applicability of results: The proposed intervention is simple and reproducible. It can be performed in the Primary Care Physiotherapy Units. It requires few resources, and it can produce changes in pain intensity, functionality and quality of life of patients with CBP

Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells

A Phase 2b, double-blind (neither the participant nor the investigator will know if active drug or placebo is assigned), placebo-controlled, randomized (assigned by chance), in which subjects with Lupus Nephritis (LN), who do not respond -or respond partially- to induction treatment, shall receive either MSCs (2 million cells/Kg) or placebo by intravenous injection. The administration of cells will be done only once.

Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis

Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage

1. Introduction Cholelithiasis occurs in 10-20% of the general population (1). Up to 18% of these subjects will present symptoms and, of these, 1.5% will present an episode of pancreatitis, cholecystitis or acute cholangitis (2). In this way, the pathology associated with biliary lithiasis is the first digestive cause of hospital admission (3). The treatment of the pathology associated with biliary lithiasis therefore deals with two problems, controlling the acute process and preventing new episodes. In general, laparoscopic cholecystectomy is the recommended method to reduce the risk of recurrence. 2. Hypothesis Conceptual hypothesis: In patients with symptomatic choledocholithiasis who are not candidates for surgery with indication for ERCP, transmural drainage of the gallbladder reduces the risk of recurrence. Operational hypothesis: In subjects> 75 years with symptomatic choledocholithiasis, performing an ERCP with sphincterotomy and transmural drainage of the gallbladder vs. ERCP with sphincterotomy reduces the risk of admission due to complications of cholelithiasis during a 1-year follow-up period. 3. Objectives. Primary objective: - To assess whether ERCP associated with transmural gallbladder drainage is able to reduce biliary disease income compared with ERCP in patients not candidates for surgery with symptomatic choledocholithiasis and cholelithiasis during one year of follow-up. Secondary objectives: - Describe the proportion of technical successes and complications associated with transmural biliary drainage, ERCP and those associated with admission. - Compare the proportion of income from non-biliary causes in both groups. - Compare mortality during admission and during follow-up in both groups. - To compare the incidence of biliary and non-biliary admissions during the follow-up year in both groups. - Compare the hospital costs of the index income and those generated in the 12 months of follow-up between the patients assigned to the control group and the experimental group. 4. Design Multicentric double-blind randomized trial 5. Methods Study population The study population includes all patients older than 75 years with symptomatic choledocholithiasis. This includes the pictures of acute cholangitis, obstructive jaundice or biliary colic secondary to choledocholithiasis. Participation in the study will be offered to all consecutive patients who meet inclusion criteria and do not present exclusion criteria diagnosed in the participating centers once the project is started until the estimated sample size is completed (see below). Given that in these patients the usual clinical practice is the realization of an ERCP, they will be identified from the ERCP requests received in the endoscopy units. Intervention Patients who meet the inclusion criteria and do not present any exclusion criteria will be invited to participate in the study. Between the formalization of the request and the endoscopic exploration the informed consent will be completed according to the law 41/2002 of autonomy of the patient without that for that reason the relationship with his doctor is altered or there is any prejudice in his treatment. 1. Endoscopic act It will be held at the Rio Hortega University Hospital, the University General Hospital of Alicante or the Ramón y Cajal University Hospital. First, ERCP will be performed. Subsequently, an endoscopic ultrasound will be performed to rule out local causes of exclusion. If there is no contraindication, randomization and placement of transmural vesicular drainage will be carried out if assigned to the intervention group: - Control group: An ERCP with biliary sphincterotomy will be performed. The performance of other techniques (balloon extraction, dilation, placement of biliary prosthesis ...) is at the expense of the endoscopist. The procedure will be performed under direct sedation with propofol controlled by the endoscopist team, and with CO2 (carbon dioxide) insufflation. - Intervention group: ERCP with biliary sphincterotomy will be performed. The performance of other techniques (balloon extraction, dilation, placement of biliary prosthesis ...) is at the expense of the endoscopist. After this, transmural drainage of the gallbladder will be performed by placing a LAMS (lumen apposing metal stent) Axios (Boston Scientific) usually 15x10 mm or 10x10 mm to allow direct cholecystoscopy with a conventional gastroscope or transnasal gastroscope. The placement of the drainage will be performed in the same endoscopic act, by means of an Olympus® sectorial echoendoscope, assisted with X-rays, which allows puncturing the vesicle from the gastric antrum or the duodenal bulb to generate a cholecysto-gastrostomy or cholecysto-duodenostomy respectively. After the puncture of the vesicle from the most optimal anatomical point, it will be tutored with guidance and a Hot Axios® LAMS will be placed on it to generate the anastomosis between the aforementioned structures. After the placement of the prosthesis, it will be subject to the decision of the endoscopist to perform cholescystoscopy to perform the maneuvers it deems appropriate (extraction of stones, taking biopsies, resection of polyps ...). The performance of both procedures will be performed under direct sedation with propofol controlled by the endoscopist team, and with CO2 insufflation, according to the usual practice of the HURH (Universitary Hospital Río Hortega) Endoscopy Unit. 2. Hospitalization: After the procedure, the hospital management is in the hands of its responsible physicians in plant at the requesting center. A report will be delivered that does not show if the patient has had the LAMS implanted or not. Therefore, physicians responsible for plant management will not receive information about the assigned group or whether transmural vesicular drainage has been performed. C.3) Follow-up: It will be held in each of the participating centers. It will consist of 4 face-to-face visits (after 1 day, 3 months, 6 months and 12 months after the procedure) and 2 phone calls (7 days after the procedure and 9 months). In the case of institutionalized patients or those with serious mobility problems, in-person visits may be made by telephone in an exceptional manner. The physician responsible for the follow-up will be blinded as to the procedure performed (it will not be specified if transmural drainage was performed in the endoscopic report, nor will images of the drainage be included in the discharge report available in the electronic medical record until after the completion of the study or if complications are suspected). During the follow-up visits, it will be confirmed that the prosthesis remains normalized by abdominal ultrasound. Sample size Assuming a proportion of readmissions of biliary cause of 25% in the control group and 7% in the experimental group, with an alpha risk of 5% and a power of 80% and using the arc transformation sine given the proportion of the experimental group, an estimated 60 subjects per group are needed. Given the age of the patients to be included and the mortality associated with the underlying disease, a proportion of losses of 20% is estimated, which would require 75 patients per group. The annual number of ERCP performed at the Río Hortega university hospital ranges from 1,000 to 1100. Assuming also a number of examinations to be carried out in the collaborating centers, with the inclusion and exclusion criteria exposed, a recruitment interval of 12-18 months is estimated. Randomization It will be done once the patient agrees to participate in the work and has verified the absence of exclusion criteria. To avoid imbalances between the groups, it will be stratified by baseline diagnosis (cholangitis vs others), given that the mortality during admission associated with acute cholangitis is significantly greater than in the rest of the included conditions. Within each stratum a pure randomization will be carried out by means of a sequence generated by computer where the probability of belonging to each group will be 0.5. For each stratum, there will be a total of n numbered closed opaque envelopes (where n = total sample size) that will be stored in the endoscopy unit and will be opened consecutively as participants are included. Adverse effects monitoring The adverse effects identified during the study will be classified according to the classification of ASGE (for adverse endoscopic effects) for those associated with hospitalization. According to the interval from the procedure they will be divided between postprocedure (in the first 7 days from the same) and late (after this time). Its relationship with the procedure will be classified as definitive, probable, possible or improbable. Data Collect The data collection will be done by the main researcher or collaborating researchers through a data collection notebook (CRD) anonymously and dissociated from the clinical information by means of a patient identification code. 6. Data management Data from the data collection notebooks will be merged by the main researcher or collaborating researchers anonymously, encrypted and decoupled from the clinical information by means of a patient identification code (ID), in a database made through the application RedCap available through the Spanish Association of Gastroenterology and the data will be downloaded in the form of an Excel file (Microsoft Corporation,USA). The responsible researcher will define an ID for each participant. The data entered in the database will be anonymous and the database will be protected with a password to which only the researchers will have access. The unified file will be kept in the Río Hortega University Hospital and will be maintained until the end of the study. Regarding the application of the Organic Law on Data Protection 15/1999 and Royal Decree 1720/2007 that develops it, it should be noted that the protocol defined in the project oriented to epidemiological analysis, determines that the files will record information completely anonymized. 7. Statistical analysis It will be done through the STATA program (StataCorp, 2013. Stata Statistical Software: Release 13. College Station, StataCorp LP). Descriptive analysis In the quantitative variables the arithmetic average and the standard deviation will be calculated (the variables that do not follow a normal distribution will be described with median, minimum, maximum and interquartile range), and the categorical ones will be expressed as percentages and their 95% confidence intervals . Hypothesis contrast The analysis of the primary objective, the hospital admission of biliary cause, will be carried out through the Z test of homogeneity without using the correction of Yates. The confidence interval of the difference between the two groups will also be estimated. An intention-to-treat analysis will be performed, regardless of the endoscopic treatment received after randomization.

International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

The trial LBL 2018 is a collaborative prospective, multi-national, multi-center, randomized clinical trial for the treatment of children and adolescents with newly diagnosed lymphoblastic lymphoma. The LBL 2018 trial will be open for the qualified centers of following participating study Groups (core study cohort): AIEOP (Italy), BFM (Austria, Czech Republic, Germany, Switzerland), BSPHO (Belgium), CoALL (Germany), DCOG (The Netherlands), NOPHO (Denmark, Finland, Norway, Sweden), PPLLSG (Poland), SEHOP (Spain) and SFCE (France). HKPHOSG (Hong Kong), HPOG (Hungary), ISPHO (Israel), NSPHO (Moscow), SHOP (Portugal) and SPS (Slovak Republic) start patient recruitment into the extended study cohort (without randomization). Over the trial period study groups may switch from the extended study cohort to the core study cohort. Primary objectives: - Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) - Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02) Patients are stratified into 3 different risk groups according to CNS status, immunophenotype, genetic markers and stage of disease at diagnosis: high risk group (HR), standard risk group I/II (SR I/II) and standard risk group (SR). Patients in the risk groups SR I/II and SR are randomized (R1) in two arms after a cytoreductive prephase with prednisone. Patients in standard arm receive the standard induction phase with prednisone. Patients in the experimental arm receive an induction phase with dexamethasone instead of prednisone. In SR group, induction phase is followed by the consolidation phase, the non-HR extra-compartment phase with HD-MTX (high-dose methotrexate), the reintensification phase and the maintenance therapy for the total therapy duration of 24 months. In SR I/II group, patients receive no reintensification phase. The Induction phase is followed by the consolidation phase, the non-HR extra-compartment phase and the maintenance therapy for the total therapy duration of 24 months. Patients in the HR group are eligible for randomization (R1) as outlined above. In addition high risk patients are eligible for second randomization (R2) at the end of induction phase. In the standard arm, HR-patients receive the consolidation phase and the non-HR extra-compartment phase. In the experimental arm, HR-patients receive a consolidation phase including two additional doses of PEG asparaginase and the HR-intensified extra-compartment phase consisting of two high risk courses alternating with two HD-MTX courses. Either phase is followed by the reintensification phase and the maintenance therapy for the total therapy duration of 24 months. Patients with involvement of the CNS (CNS positive) are stratified to the high risk group (HR) and are eligible for both randomizations (R1 and R2). Additionally, patients with CNS involvement (CNS positive) receive intensified intrathecal therapy. Intrathecal therapy consists of TIT (triple intrathecal therapy) after diagnosis of CNS involvement. TIT is administered twice weekly until clearance of blasts in the cerebrospinal fluid is achieved. Further intrathecal therapy is provided at the same points of time as for patients without CNS involvement, but TIT instead of MTX IT. In addition, patients receive four additional doses of TIT during maintenance. Cranial irradiation is omitted for patients with CNS involvement.

N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS

The investigators want to investigate whether the N680S polymorphism of the FSRH gene could affects ovarian response with different nature of the FSH used (human FSH and recombinant FSH) in patients undergoing two consecutive cycles of IVF/ICSI with controlled ovarian stimulation. All patients who agree to participate in the study will have a blood sample taken on the same day as a routine extraction performed for the 2nd cycle of the controlled ovarian stimulation in accordance with the standard clinical practice of each hospital. The sample will be sent to the central laboratory to determine the genotype of the afore mentioned polymorphism and correlate it with the clinical results obtained with the two cycles of controlled ovarian stimulation. In order to avoid any bias, the study population will follow a crossover design with respect to the type of FSH used in the first and second cycles of the COS (i.e., half of the recruited patients must have undergone a first cycle of COS with recombinant FSH and a second cycle with human FSH; and, conversely, the other half must have undergone a first cycle with human FSH and a second cycle with recombinant FSH). In order to avoid potential modifications to the inclusion criteria, the time elapsed between the two cycles should not exceed 6 months.

Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain

Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)

Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®

The study shall enrol subjects who were treated with the TricValve® Transcatheter Bicaval Valves System® in the Inferior Vena Cava and Superior vena cava. On compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study. The study duration for the individual subject will be up to 5 year follow up. The follow-up should be made through pre-established periodic clinical consultations at discharge, 1 month, 6 months, 1 year follow up to 5 years after the procedure. In the consultations, routine exams such as hemogram, renal function, electrocardiogram and echocardiography in order to ascertain the bioprosthesis functioning and its hemodynamic profile are documented as per clinical routine practise.