Sioux Fallas, South Dakota

Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

There will be no screening period for this study as patients will transfer directly from parent studies. After providing informed consent, all eligible participants should start Crizanlizumab treatment at the earliest convenience following the treatment schedule of 28 days of the last dose in the parent study. Crizanlizumab will be administered at the same dose/schedule as in the parent study. Study participants will have a safety follow up visit conducted 105 days after last administration of study treatment. The safety follow up at 105 days is not applicable for those participants who continue to receive Crizanlizumab after end of treatment visit either commercially or through PSDS. The study is expected to remain open for 10 years from the first Patient's first visit (FPFV) in this clinical study or until study treatment becomes commercially available and is reimbursed in the respective indication or until such time that all enrolled patients no longer need treatment with Crizanlizumab, or a PSDS treatment plan is allowed and approved as per local laws and regulations, whichever comes first

A First-in-Human Open-label, Phase I/Ib Dose Escalation and Expansion Cohort Study of EOS006215 as Monotherapy and in Combination With Pembrolizumab or Other Anticancer Treatments in Participants With Advanced Solid Tumors

The study will be conducted in 2 parts: - Part 1 - Dose Escalation Phase I dose escalation cohorts for EOS006215 as monotherapy and in combination with anticancer treatments in participants with specific tumor types. - Part 2 - Dose Expansion Phase Ib dose expansion cohort(s) may be included to further evaluate the safety, tolerability, efficacy, PK and PD of EOS006215 as monotherapy or in combination with anticancer treatments in participants with specific tumor types.

Evaluation of New Device for Beta-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis

Cystic fibrosis (CF) is a rare genetic disease affecting 1 baby in 2,850 live births in Belgium and associated with high morbidity and mortality. CF is caused by CFTR mutations resulting in loss-of-function of the CFTR protein. It leads to dramatic abnormalities in transepithelial ion transport and the production of thick mucus obstructing airways and duct lumens of exocrine glands. The gold standard for CF diagnosis is an accurate Gibson and Cooke sweat test which is very sensitive to lost or abrogated CFTR function, but shows a logarithmic relationship between sweat Cl - content and CFTR function: e.g. a 5% residual CFTR function is associated with sweat Cl- concentrations found below the diagnostic threshold (<60 mmol/L). Consequently, diagnosing CF is challenging in borderline cases and/or in the presence of CFTR mutations not recognized as disease-causing (CFTR2 data base; https://cftr2.org/). Contrary to routine sweat test measuring the CFTR-mediated reabsorption of Cl- in the sweat duct, beta-adrenergic sweat secretion test (BAST) measures CFTR mediated secretion of Cl- in the secretory coil of the sweat gland . Sato and Sato discovered in the early 1980s that CFTR-mediated sweat secretion can be stimulated with β-adrenergic agonists if the thermoregulative cholinergic sweat secretion is simultaneously inhibited with atropine . β-adrenergic sweat secretion was absent in people with CF (pwCF) and half-maximal in healthy heterozygous carriers of CFTR mutation (HTZ). Therefore, BAST seems to be a highly sensitive CFTR bioassay suitable for screening of CFTR dysfunction, monitoring the efficacy of new therapeutic interventions and differential diagnosis of exocrine pancreatic sufficient-CF, CFTR-Related disease and cystic fibrosis screen positive and finallyinconclusive diagnosis. BAST detect the relative improvement due to a novel treatment, while at the same time show that the levels did not return to a normal range. The available measurement range can thus be used to assess the individual response to therapeutic interventions, but can also be used to stratify patients in the intermediate range of activity, which fall into a spectrum, ranging from a severe loss of function in classical cystic fibrosis to the cystic fibrosis related disease with a relatively lowered activity.

The Added-value of PSMA PET in Detecting Clinically Significant Prostate Cancer Lesions in Patients Undergoing MRI-targeted Biopsy. (PANDORA)

Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment

Testing and Evaluating a Psychoeducation Tool and Guidelines for Victims of Violence in Belgian Hospitals.

A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer

Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients

The Dragon PLC Trial (DRAGON-PLC)

Primary liver cancer (PLC) is the third most common cause of cancer death worldwide. Surgical resection is the mainstay for a curative approach as contemporary chemotherapy and immune-based therapies only lead to a median survival of 10-14 months. A complete surgical resection increases the median survival to 42 months (range 32-52 months). However, PLC is mainly diagnosed at an advanced stage and >70% of PLC patients are ineligible for an immediate surgical approach. There are different reasons that make a patient ineligible for surgery, one important reason is the risk of liver failure after the surgery due to a small remnant liver. This study aims to improve the oncological, radiological and surgical strategy to allow more patients to undergo liver resection safely, to improve quality of life and to extend overall survival at acceptable costs. Adequate function of the future liver remnant (FLR) is a prerequisite for surgical resectability. This is necessary in order to avoid liver failure after surgery, a major cause of morbidity (38%) and mortality (27%). To mitigate this risk, regenerative strategies based on preoperative calculation of the FLR volume and function are essential. Patients with technically resectable disease but predicted insufficient FLR volume or function are referred to as primarily unresectable or potentially resectable (PU/PR). These patients can undergo strategies that capitalize on the regenerative capacity of the liver which aim to preoperatively increase the FLR volume and function in order to allow surgery. Many of the patients that are primarily unresectable due to an insufficient FLR can become ultimately and safely resectable after the induction of adequate FLR-hypertrophy by the current standard, portal vein embolisation (PVE). However, 25% of patients do not show sufficient FLR growth after PVE and are unable to safely undergo resection. A new approach has been developed to improve this. Combined portal and hepatic vein embolisation (PVE/HVE) has great promise in terms of increasing FLR growth, resection rate (RR), safety and potentially, overall survival. Establishing PVE/HVE as the new standard could result in increased survival and a better quality of life (QoL) for patients.

Study of Lipid Mediators in Chronic Postoperative Pain - LICP