Don Benito-villanueva De La Serena, Spain

Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer

DEMETHER is an international, multicenter, open-label, single arm phase II clinical trial designed to evaluate the efficacy of a 6-cycle induction phase with T-DXd treatment followed by a maintenance phase with PHESGO treatment in patients with HER2-positive unresectable locally recurrent or MBC. Upon meeting all selection criteria, a total of 165 participants will be enrolled. Participants with no prior chemotherapy or HER2-targeted therapy for advanced or MBC (one prior line of endocrine therapy is allowed for MBC) will be eligible. Participants who have received neoadjuvant or adjuvant chemotherapy will be eligible, with a DFI from completion of systemic chemotherapy to advanced or metastatic diagnosis of > 12 months. Patients will continue study treatment until end of treatment (EoT) defined as the date of disease progression, death, discontinuation from the study treatment for any other reason, or up to 3 years (36 months) after T-DXd initiation, whichever occurs first. After discontinuation, all participants will undergo a safety visit at 28 (± 7 days) days after last treatment dose in order to follow up toxicities and changes in concomitant medication. Patients discontinuing the study treatment at any time will enter a post-treatment follow-up period during which survival and subsequent anticancer therapy information will be collected every 3 months (± 7 days) from the safety visit until death, lost to follow-up, elective withdrawal from the study, or the end of study (EoS), whichever occurs first. The main objectives of DEMETHER study are to determine the efficacy of induction treatment with T-DXd followed by PHESGO as maintenance therapy in terms of progression-free survival (PFS) rate at 1 year and overall survival (OS) rate at 3 years. End of study (EoS) is defined as the last data collection point at the last participant's safety visit and occur 36 months + 28 days (± 7 days) after the last patient included in the study initiates T-DXd treatment, unless premature termination of the study.

Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

Efferent Loop Stimulation Previous to Ileostomy Closure. Ileostim Trial.

The loop ileostomy is an effective method used to bypass faecal contents and reduce the sequelae of possible anastomotic leakage. I t is most often performed after a low anterior resection indicated for lower-middle rectal cancer. A second operation is required for closure, with a morbidity of about 25%. Bowel obstruction is the most common complication following this procedure, with an incidence of up to 29%. There is also a risk of anastomotic leakage, observed in 2% of patients, with a reintervention rate approaching 10%. A recent meta-analysis reported up to 2% mortality after stoma reversal. There are many structural changes in the mucosa of the small bowel after ileostomy formation, which may contribute to the observed morbidity. The distal end may be atrophied, with pathophysiological changes contributing to a reduction in absorptive function and motility. CONTROVERSY Many studies have been completed in order to detect possible risk factors - both patient-related and surgery-related - for complications in ileostomy closure surgery. Currently, there is a lack of research studies focused on the preoperative management of these patients. THE NEED FOR SUCH A STUDY There is a high risk of complications following ileostomy reversal (as high as 20%), including bowel dysfunction, anastomotic leakage, bowel perforation and postoperative ileus. This increases the length of hospital stay and healthcare costs. Our purpose is to reduce this complication rate by optimizing the preoperative status of the distal ileum and to analyze its impact on the reduction of postoperative ileus. MAIN PURPOSE (OBJECTIVE/GOAL/ SUBJET/PURPOSE) To assess whether efferent loop stimulation two weeks before ileostomy closure decreases the incidence of postoperative paralytic ileus. SECUNDARY/SIDE/MINOR To evaluate hospital stay and short- and long-term postoperative complications in both groups. To compare postoperative anal continence in both groups. INCLUSION CRITERIA Patients over 18 years of age who undergo a scheduled protective ileostomy closure surgery, performed in rectal cancer surgery. All patients will follow a homogeneous protocol for testing the rectal anastomosis prior to closure, based on an opaque enema to rule out the presence of anastomotic leakage. Entry into the study does not affect the other surgical indications, in terms of time to ileostomy closure, type of operation or anaesthesia, or request for additional tests. Elective surgery. Patients who sign the informed consent document. EXCLUSION CRITERIA Patients undergoing simultaneous abdominal procedures at the time of ileostomy closure. History of protective ileostomy for a pathology other than rectal cancer. History of surgery in the ileal region. BACKGROUND DATA Age, sex, body mass index (calculated as weight in kilograms divided by height in metres squared), American Society of Anesthesiologists (ASA) status and primary diagnosis. Neoadjuvant RT, neoadjuvant QT, time since end of adjuvant chemotherapy. Comorbidities (hypertension, DM, dyslipidaemia, respiratory pathology, others). Complications of the primary tumour surgery. Baseline analytical parameters: proteins, creatinine, ions, Hb and leukocytes. SURGICAL DATA Operative time (in minutes), presence of parasternal hernia, time from main surgery to ileostomy closure, mesh placement. EFFERENT LOOP STIMULATION TECHNIQUE: During the two weeks prior to the ileostomy closure procedure, daily stimulation of the efferent loop will be performed by irrigation with 500 ml of physiological saline or 500 ml of warm water, preferably bottled, associated with a nutritional thickener (Resource, Nestlé Health-science, 6.4g sachet). The patient will be instructed by a stomatotherapy nurse. Stimulation will be performed up to the day before the intervention. Kegel exercises will be suggested. SURGICAL TECHNIQUE Every surgeon will use his or her usual technique, with a choice between options A and B, using the same technique for all patients included in the study, regardless of the group assigned in the randomization. Option A. Mechanical closure: Peri-ileostomy incision. Ileostomy closure technique: anti-peristaltic L-L anastomosis by linear stapler with triple stapling, with endo-stapler closure of the enterotomy and similar loading. Invagination of the staple line. Option B. Manual closing Peri-ileostomy incision. Ileostomy closure technique: Manual closure of the enterotomy with monofilament or braided suture, using loose stitches or continuous suture, according to standard technique. All patients will receive the same antibiotic and antithrombotic prophylaxis. No antibiotic administration is expected during the postoperative period, following a Zero Surgical Infection (ZSI) protocol. PRIMARY OUTCOMES Presence of paralytic ileus (defined as intolerance to oral food on or after the third postoperative day, in the absence of clinical or radiological signs of obstruction, requiring placement of a nasogastric tube or associated with two of the following: nausea/vomiting, abdominal distention and the absence of flatus). ADDITIONAL, MINOR, SECONDARY OUTCOMES Secondary outcomes will include length of hospital stay, time to tolerate regular diet, time to first passage of flatus, time to first passage of stool, general morbidity [including anastomotic leak, surgical site infection (superficial, deep, organ space), other complications: urinary tract infection, pneumonia, postoperative acute kidney injury, deep vein thrombosis, pulmonary embolism, small bowel obstruction, myocardial infarction, stroke, reoperation and "other". Mortality and diarrhoea. The severity of surgical complications will be classified according to the Clavien-Dindo scale. Grade of postoperative continence and incidence of anterior resection syndrome. Hospital readmission rate. LONG-TERM OUTCOMES (6 MONTHS): Readmission rate. Surgical re-intervention. Eventration. THE STATISTICAL ANALYSIS A comparative analysis will be performed between the two groups according to prior stimulation of the efferent loop or not. Categorical samples will be analyzed by means of contingency tables and Chi-square. Continuous variables will be examined by comparing means using Student's t-test and medians with the Mann-Whitney U test. Values of p <0.05 will be considered statistically significant. The SPPS 15.0 Inc. Chicago IL. software was used for this purpose. Sample size estimation: Assuming an alpha risk of 0.05 and a beta risk of 0.2, in a two-tailed test, it is estimated that 68 patients need to be included in each group to find a statistically significant difference in proportions. A ratio of 0.29 in the control group and 0.1 in the intervention group is considered. A loss of patients of 5% is assumed. Randomization will be performed in a 1:1 ratio in each hospital using the Sealed Envelope simple randomization service program. The researcher will not know the assigned group at the time of offering the study to the patient. ETHICAL APPROVAL The study will be pre-approved by the local Research Ethics Committee (IRB). Patients will be informed of the possibility of participation in the study by signing the informed consent before being included. The patient will be able to withdraw his/her consent at any time without this affecting the medical care he/she will receive. The study will be performed in accordance with the Declaration of Helsinki. FINANCIAL REPORT No financial compensation for participation in the study is foreseen for either the patient or the research team. This study has not received any financial support.

A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years

Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml / day. allopurinol 300 mg / day. gastric protection (as center). daily monitoring of blood glucose daily monitoring of renal function. Intrathecal treatment (diagnosis and prophylactic / therapeutic) day -5: 12 mg were administered intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition of CNS involvement by LAL (and its therapeutic consequences) based on morphological observation of blasts in CSF cytocentrifuge. Remission induction : Tolerance prephase period can be used to establish the final indication of treatment (standard protocol or frail patients). Day 0 is free of treatment and is considered as +1 the first day of induction. Systemic treatment - Vincristine (VCR) 1 mg (absolute dose) EV 1, 8, 15 and 22. - Dexamethasone (DEX): 10 mg/m2 EV, IM or PO days 1-2, 8-9 days 15-16, 22-23. Intrathecal chemotherapy Triple therapy was administered with methotrexate (MTX), cytosine arabinoside (ARA-C) and hydrocortisone, days 1, 8, 15 and 22 (five doses total prophylactic between prephase and induction): MTX 12 mg ARA-C 40 mg Dexamethasone 4 mg If initial infiltration of the CNS is administered once every 72 hours until the disappearance of blast cell morphology CSF (cytocentrifugation) in at least two consecutive taps. Alternatively be administered liposomal cytarabine (DepoCyt) fortnightly if authorized by the center or in the context of a clinical trial Maintenance treatment of first year : Maintenance during the first year will start after full recovery after induction and after complete reassessment of the disease (including myelogram) and will last until one year from the time of documentation of complete remission. The basic treatment to include mercaptopurine 50 mg/m2 PO day and methotrexate 20 mg/m2 IM weekly. Once every 3 months will be added to maintenance treatment a "mini-reinduction" consisting - VCR: 1 mg (absolute dose), i.v., day 1. - Dexamethasone 40 mg / day, i.v. or p.o., days 1-2. - Not considered more doses of triple intrathecal therapy. Reinduction only be practiced during the first year after remission, so a total of 4 quarterly. Maintenance of the second year: After the first year of maintenance will perform a complete reassessment of the disease (including myelogram) and if the patient remains in complete remission maintenance will continue (without reinduction) until two years from the time of diagnosis. The initial dose of mercaptopurine and methotrexate will be identical to the first year. Must comply (by increases or decreases of 20% of the dose) to maintain the numbers of neutrophil counts between 1.5 and 3x109/l and platelets above 100x109 / L

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma