Caen Cedex 4, France

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)

Precision Nutrition

1. Define plasma levels prediction formulas for each involved nutrient, based on relevant genotypes; 2. Characterize the roles that food intakes may have in the alteriations of such plasma levels, depending on genotype structure; 3. Based on clinical data, create predictive equations using dependent variables (genotypes) in order to define optima nutrient intakes; 4. (Secondary aim): compare the efficacy of a nutrigenetic-based intervention with a non-nutrigenetic intervention (classical approach). (Original text in Romanian language: 1. Definirea unor formule de predictie a nivelelor din sange, in functie de variatiile genetice; 2. Caracterizarea rolului pe care aportul alimentar de nutrienti il are in modularea acestor valori, in contextul variatiilor genetice. 3. Gasirea unor formule de predictie in care variabilele independente (variatii genetice si combinatii ale acestora) sa defineasca necesarul de nutrienti pentru a normaliza valorile sangvine ale acestor nutrienti. 4. (Obiectiv secundar): compararea eficacitatii unei interventii nutrigenetice fata de o interventie clasica nutritionala (non-nutrigenetica).)

A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors

Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer

Investigators hypothesize that malnutrition has an adverse impact on the clinical course of patients with advanced PDAC treated with chemotherapy. Aims: To investigate the association between the nutritional status and pancreatic exocrine function and the clinical outcomes of patients with advanced PDAC. Study design: The PAncreatic Cancer MAlnutrition and exocrine pancreatic INsufficiency in the course of chemotherapy in unresectable pancreatic cancer (PAC-MAIN) study is a non-profit, international, multicentre, prospective, observational, cohort study evaluating the effect of the nutritional status and pancreatic exocrine function on the main outcomes of patients with advanced PDAC. The study will be carried out in Russia, Turkey, Serbia, Romania, Italy, and Spain as a part of the Pancreas 2000 Educational Program. Pancreas 2000 is a post-graduate educational program that prepares young gastroenterologists, surgeons, radiologists, and other physicians for specialization in Pancreatology. Patient-related: - sex, race, age at diagnosis - Mini-Nutritional Assessment (MNA) score - sarcopenia (measured with computed tomography (CT) fat free mass is reduced; i.e. appendicular\L2 skeletal muscle mass index <7.2 kg/m2 (men) or <5.5 kg/m2 (women)); - cachexia (weight loss (WL)>5% in last 6 months, or WL>2% if body mass index (BMI) <20 kg/m² or sarcopenia); - 12-item functional assessment of anorexia/cachexia therapy anorexia/cachexia subscale (FAACT-A/CS-12) - a biliary stent - a duodenal stent - total and direct bilirubin - ECOG status - European Organization for Research and Treatment of Cancer (EORTC) QLQ-PAN26 scale - Date of diagnosis, visit 1, visit 2 (3 months), and death/loss from follow up - Check up on survival at 6m Tumor-related: - Tumor site documented by endoscopic ultrasound, CT, or magnetic resonance imaging (head, body, or tail) - Stage according to the TNM classification - Vessels involved - Presence and site of metastatic disease - Ascites - CA-19-9 - Response evaluation criteria in solid tumors (RECIST) (for visit 2) Nutritional parameters: - Leucocytes (lymphocytes, neutrophils), neutrophil to lymphocytes ratio, erythrocytes, hemoglobin, hematocrit, platelets - C-reactive protein, total protein, albumin, cholesterol, iron, transferrin, ferritin, magnesium, zinc - International normalized ratio, activated partial thromboplastin time - Blood fasting glucose, glycated hemoglobin Pancreatic function and treatment: - PEI, fecal elastase-1, pancreatic enzyme replacement therapy (PERT), date of starting PERT, the dosage of daily taken PERT - Diabetes mellitus (DM), date of DM diagnosis, DM type, DM treatment Treatment-related: - Planned chemotherapy protocol Dosages of chemotherapy planned (mg/m2) - Percent of standard chemotherapy dose delivered - Percent of planned chemotherapy delivered - Changes to the predefined schedule (dose reduction, schedule modifications, stop before planned) - Date of treatment start and end - Adverse events (National Cancer Institute toxicity scale for visit 2) Description of the intervention (schedule of visits): Visit 1 (screening, within 1 month from initial diagnosis). Patients will be informed about the study. Once patients agree with the inclusion in the study the investigators will evaluate the inclusion and exclusion criteria. Those patients who meet all the inclusion criteria and none of the exclusion criteria will be finally included in the study. In this visit, patients, tumor-related variables, and general patients' features will be recorded, and quality of life questionnaire will be administered. The researcher will record weight, height, body mass index (BMI), unplanned WL % for the last 6 months. Each patient's baseline nutrition status will be evaluated using the MNA scores prior to starting chemotherapy. Patients will be classified as in the group with no nutritional risk, at risk of malnutrition, or malnourished. Nutritional parameters and pancreatic function will be evaluated through blood tests and a fecal test. Visit 2 (3 months after the first dose of planned chemotherapy). The researcher will record in the case report form (CRF) the planned chemotherapy, schedule, doses, dose reduction, and any adverse event. The same variables recorded at Visit 1 will be checked again. Check up 3 (end of the study, 6 months). The researcher will record in the CRF the overall survival and time until progression. Medication of the study: The study is of observational nature, so a pre-planned treatment is not considered. However, the use of pancreatic enzyme replacement treatment will be recorded as well as data regarding the employed chemotherapy regimen. Power size calculation: The expected percent of chemotherapy delivered in well-nourished patients was based on a study that assessed the chemotherapy dose intensity in gastrointestinal malignancies included pancreaticobiliary disease during the firsts 8 weeks after the start of the chemotherapy23. Based on an expected percentage of chemotherapy delivered of 70% in well-nourished patients, with a type I error of 0.05 and a type II error of 0.20, a sample size of 93 patients per group will be required in case of a percentage difference of chemotherapy delivered of 20% between well-nourished and malnourished, 163 patients per group in case of a difference of 15% between both groups and 356 patients per group in case of 10% of difference. Discussion: Given the sparse overall scientific data on the subject, the investigators have designed a study that addresses the impact of patient's nutritional status and dietary intervention on the clinical course of patients with advanced PDAC treated with chemotherapy and is aimed at establishing whether it affects both tolerance and tumor response to medical therapy. PAC-MAIN will be the first study specifically investigating whether the nutritional status influences the possibility to complete planned chemotherapy in patients with advanced PDAC.

KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

This trial will evaluate the efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or ianalumab given every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous). using the 2003 International Society for Nephrology (ISN)/Renal Pathology Society (RPS) criteria).

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

Participants will undergo a screening assessment over a period of less than or equal to (<=) 28 days to determine eligibility. Eligible participants will be treated by the Investigator's choice of RT alone or RT in combination with cetuximab. Following the Investigator's choice, participants will be randomized in a 1:1 ratio: - Arm A: JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab - Arm B: Investigator's choice of RT alone or RT in combination with cetuximab All participants (Arm A and Arm B) will receive 70 Gy in 35 fractions over a 7 week period. An EOT visit will be performed 4 weeks after the completion of RT. Follow-up visits will start at 12 weeks post-RT completion, and will continue every 12 weeks for 2 years, and then every 24 weeks thereafter until death; the participant is determined to be lost to follow up; withdrawal of consent; or the end of the study, whichever occurs first. Participants who have received further anti-cancer therapy for the study disease and/or have had disease progression/recurrence will be followed only for survival information

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery