Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological...
Hematologic DiseasesSecondary Immune DeficiencyThe purpose of this observational study is to compare the administration of standard of care Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion time and infusion related reactions. Patient satisfaction, number of actions taken by the nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in...
Partial Seizures (With or Without Secondary Generalized Seizures)Primary Generalized Tonic-clonic SeizuresThe objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: unknown adverse drug reactions (ADRs); occurrence of ADRs; factors that are likely to affect safety and efficacy; occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
Imaging Evaluation of the Therapeutic Response of Breast Cancer Bone Metastasis (EMOS)
Breast CancerBreast cancers are among the cancers that metastasize the most to the skeleton. The appearance of bone metastasis, whether they are initials or during a relapse, is a turning point of the disease, due to the additional morbidity they imply (pain, pathologic fractures, hypercalcaemia, neurological compression, etc.). A specific treatment of these metastasis is often undertaken, usually a chemotherapy or hormone therapy. It is important to evaluate the efficacy of this treatment in order to know whether to continue or change it depending on the response observed. But there is no consensus at this time on paraclinical examinations enabling this monitoring. Also, if some criteria for assessing bone metastasis in imaging and nuclear medicine (MDA, PERCIST, EORTC) have been published in the literature, none is formally validated and evaluation in routine practice remains subjective. The main objective of our study is to determine if the PET-CT and the whole-body MRI are in agreement on the status of bone metastasis (stability, progression, partial response, complete response).
Comparing of Modified Wet Suction Technique and Dry Suction Technique for EUS-FNA of Solid Occupying...
Pancreas NeoplasmsLymphatic Metastasis6 moreThe purpose of this study is to compare the diagnosis accuracy of modified wet suction technique and 5ml dry suction technique on solid occupying lesions.
Bone Pain Score Validation Initiative
Bone MetastasisTranslation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple SclerosisThe primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.
Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases...
Castration-Resistant Prostatic CancerThis observational prospective single arm cohort study is designed to assess pain and bone pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition, overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal event (SSE), course of blood counts, and safety will be assessed.
FSRT Combined With TMZ for Large BMs: a PSM Study
Brain MetastasesRadiotherapy1 moreA propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.
Study to Explore the Mechanism of Acquired Immune Escape In Participants With Metastatic Cancer...
NeoplasmsThe purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies.
Secondary Distribution of HIV Self-tests Through Antenatal Care Clinic Attendees and Index Clients...
HIV/AIDSHIV InfectionsA three arm cluster randomized trial randomizing government primary health clinics to a) standard of care (SOC) with clinic invitation only; b) standard of care (SOC) and one self-test kit to give to sexual partner (s); c) standard of care (SOC) and self-test kit and monetary incentive given to partner conditional on clinic attendance and completion of pre-set procedures to determine secondary accuracy. Trial to be conducted in four districts (Blantyre, Zomba, Machinga and Chikwawa) in Malawi in collaboration with the Ministry of Health. Two primary outcomes: proportion of male partners of antenatal care clinic attendees reported by the woman to have tested for human immunodeficiency virus (HIV) within 28 days of enrolling the woman Number of new HIV positives identified by providing trial services to newly tested HIV positive clients in routine HIV testing service within 28 days of enrolling the index client. Data analysed as intention to treat with all eligible antenatal care (ANC) attendees and index clients at each health facility as the denominator, with unpaired t-test used to compare each intervention arm to the standard of care (SOC).