
Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocognitive Development and Behaviour...
Multiple SclerosisIntroduction: Fetal exposure to glucocorticoids (GCs) used to induce fetal lung maturation in women threatened by premature labour is known to induce aberrations in brain development and stress sensitivity, cognitive dysfunction and neuro-psychiatric disorders in later life which all predict early brain ageing. Another common source of fetal GC exposure is the treatment of relapses in multiple sclerosis (MS), the most common neurological disease in young women. Despite the lack of studies, the 300-fold higher dosage of GCs for MS relapse treatment compared to obstetric indications is considered harmless for the fetus . Objectives: To examine the effects of GCs for MS relapse treatment during pregnancy on offspring structural and functional brain development, stress sensitivity, and cognitive and behavioural performance. Methods: Epidemiological multi-centre cohort study in 80 children and adolescents aged 8 to 18 years whose mothers received GCs to treat a MS relapse during pregnancy compared to unexposed participants. Expected Impact: Creating a guideline-changing evidence-based risk-benefit assessment regarding benefits of the MS relapse therapy for the mother and potential harm to the child.

Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk...
Bladder CancerBladder Cancer Recurrent4 moreThe aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.

Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment...
Ovarian Clear Cell AdenocarcinomaPlatinum-Sensitive Ovarian Carcinoma13 moreThis phase II trial tests whether pembrolizumab combined with bevacizumab with or without agonist anti-CD40 CDX-1140 works to shrink tumors in patients with ovarian cancer that has come back (recurrent). Anti-CD40 CDX-1140 works by stimulating certain immune cells within the tumor and, when combined with other immunotherapy treatments, may increase antitumor antibody production. Immunotherapy with monoclonal antibodies, such as pembrolizumab and bevacizumab, may help the body's immune system, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and bevacizumab with anti-CD40 CDX-1140 may decrease symptoms, prolonged survival, and improve quality of life in patients with ovarian cancer.

HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy...
Breast CancerThe primary goals of this trial will be to determine the safety and immune activity of HER-2 pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease post neoadjuvant therapy. Investigators will also explore the possibility of determining whether circulating tumor cells can be used as surrogate to assess response to vaccination.

Type 1 Diabetes Recurrence in Pancreas Transplants
Diabetes MellitusType 1The hypothesis is that humoral and cellular islet-specific responses are an early risk factor for recurrence of autoimmunity and hyperglycemia in simultaneous pancreas-kidney (SPK) recipients independent of alloimmunity. This study will test the hypothesis and will assess their individual and combined predictive value.

Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients...
Colorectal NeoplasmsThe performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.

Chronic Recurrent Multifocal Osteomyelitis - a Bacterial Cause?
Chronic Recurrent Multifocal OsteomyelitisChronic recurrent multifocal osteomyelitis (CRMO) is an immune-mediated chronic inflammatory self- limiting disease with non-suppurative inflammation involving one or multiple bone foci. A bacterial etiology has not yet been proven, but the investigators hypothesize that CRMO is caused by chronic infection. Using existing knowledge of chronic infections combined with sensitive molecular techniques, the hope is to elucidate the cause of CRMO by proving or disproving bacteria as the underlying etiology. In addition, a novel method, 18F-NaF-PET/MRI, will be investigated as to which it can improve diagnosis of CRMO. The investigators hypothesize that 18F-NaF-PET/MRI will have higher diagnostic accuracy than 99m-diphosphonate planar bone scintigraphy and SPECT/CT.

Endocardial Vs Epicardial Ablation for Recurrent Paroxysmal AF
Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein IsolationThere is no current accepted and predictably effective ablative therapy for patients with recurrent paroxysmal atrial fibrillation after prior pulmonary vein isolation (PVI). This study will compare redo PVI with hybrid epicardial ablation incorporating posterior wall isolation and LAA clip, and redo PVI.

Iron Status in Female Infertility and Recurrent Miscarriage
Recurrent MiscarriageInfertility1 moreMultiple studies suggest a link between the iron status and the development of the endometrium. Therefore, a sufficient iron supply seems to relevant for female fertility and reproduction. To gain further insight on the effects of iron status on female fertility, a prospective study on infertile women und women with recurrent miscarriage will be conducted. In these, the iron status will be evaluated in detail. In addition, a control group of healthy women without infertility will be enrolled.

Preventing Inhibitor Recurrence Indefinitely
Hemophilia AImmune ToleranceThis study will enroll children who have hemophilia A with inhibitors who successfully completed immune tolerance induction per the ISTH criteria (negative inhibitor titer, recovery >66% of expected, and half-life of >6 hours with their current FVIII concentrate). Previous to emicizumab, there was only one option for these patients which was to continue FVIII therapy in a prophylaxis mode to prevent bleeding. There was a sense that the ongoing FVIII served to maintain tolerance however no evidence for this notion exists and in fact what limited data is available suggests that continuing FVIII may not be necessary simply to maintain tolerance. To figure out this question, this will be a randomized, controlled 2 arm study which will randomize patients post-successful ITI to emicizumab plus weekly FVIII (for maintenance of tolerance) versus emicizumab alone. Patients will be followed for up to 2 years. We aim to enroll 52 subjects. The FVIII weekly arm can use any factor VIII concentrate and emicizumab is standard of care for inhibitor and non-inhibitor patients.