Feb 3rd, 2023 - There are 2 panels in this study. In Panel A, POS IV will be evaluated in ≥8 participants, including ≥5 who are <3 months of age and ≥3 who are 3 months to <2 years of age. In Panel B, both POS IV and POS PFS will be evaluated in ≥14 participants, including ≥3 who are <3 months of age and ≥5 who transition to the PFS formulation of POS.

Feb 3rd, 2023 - PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of nanoparticle albumin-bound rapamycin (ABI-009) administered as an intravenous infusion over 30 minutes on days 1 and 8 of a 21-day cycle, in combination with temozolomide and irinotecan hydrochloride (irinotecan) (administered on days 1-5) in pediatric patients with recurrent or refract...

Feb 3rd, 2023 - β-blockers have anti-ischemic, anti-arrhythmic, and anti-adrenergic properties. In order to reduce cardiovascular mortality and morbidity, current major guidelines recommend that oral treatment of β-blockers should be continued during and after hospitalization in patients with acute myocardial infarction (AMI) and without contraindications to β-blocker use. A clinically important but difficult ...

Feb 3rd, 2023 - The 60 volunteers participating in the study who meet the inclusion criteria, will be randomly divided into two groups: Control group (nutritional promotion): volunteers will be provided with basic nutritional recommendations based on a Mediterranean diet. Experimental group (Nutribiota): volunteers will be instructed to follow a dietary strategy similar to the control group, but including the ...

Feb 3rd, 2023 - A subset of participants have MDS characterized by an overexpression of the RARA gene. A blood test will be used to identify participants with RARA-positive MDS. Assessment of the RARA biomarker for study eligibility will be done by collection of blood samples from potential study participants at the pre-screening visit and testing at a central laboratory. Participants who meet eligibility requ...

Feb 3rd, 2023 - This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

Feb 3rd, 2023 - PRIMARY OBJECTIVES: I. To evaluate overall survival (OS) of adjuvant reirradiation plus concurrent pembrolizumab followed by pembrolizumab to complete 12 months total of pembrolizumab to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk head and neck squamous cell carcinoma (HNSCC) patients. II. To evaluate OS of adjuvant pembrolizumab for 12 months compared to adjuvant ...

Feb 3rd, 2023 - The purpose of this study is to determine the value of a detailed medical history, acquired by computer-directed, patient self-entry of data, for efficient disposition of patients presenting to the emergency department (ED) with chest pain and non-diagnostic first ECG and/or serum markers for acute coronary syndrome (ACS). The research questions posed are: will the added data and systems-based ...

Feb 3rd, 2023 - Patients admitted on this protocol will have, or be suspected of having, a Leishmania infection. The major objectives of the protocol are to diagnose and classify the Leishmania infection and to provide species-based therapy to study the natural history of the treated infection. As part of the standard evaluation of these patients, infecting parasite isolates will be obtained when possible and ...

Feb 3rd, 2023 - This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice

Feb 3rd, 2023 - The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive gebasaxturev (V937) in combination with pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of gebasaxturev...

Feb 3rd, 2023 - MRSA SSTIs have become endemic in congregate community settings where there is frequent close person-to-person contact, such as athletic teams, correctional facilities, and military training facilities. These infections interfere with the mission of training soldiers as they impair soldiers' ability to participate in required activities and successfully complete a training program. Hygiene-base...

Feb 3rd, 2023 - The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. Composition and diversity of the microbiome will be assessed by 16sRNA sequencing, skins swabs are screened for rifampicin-resistant staphylococci onto Mannitol-salt-agar plates...

Feb 3rd, 2023 - Adherence to antibiotic regimen for common childhood illnesses, such as otitis media and streptococcal pharyngitis, is related to a variety of outcomes such as illness' remission, prevention of recurrent infections, maintaining of cost-effectiveness, and prevention of the growth of antibiotic-resistance. A patient and family 's therapeutic education about the intake of an oral solution of antib...

Feb 3rd, 2023 - This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study of HBI-8000 or Placebo combined with nivolumab. Randomization of eligible patients will be stratified by PD-L1 expression (positive, ≥1% expression level versus negative, <1% expression level) and LDH (normal versus elevated) in the main study. Adults with new, progressive brain metastasis, or adolescents with or ...

Feb 3rd, 2023 - The acquisition of opportunistic infections has been causally linked to innate and acquired immunodeficiencies. We have recently identified a population of Asian women with autoantibodies to interferon gamma (IFN?), all of whom were diagnosed by virtue of nontuberculous mycobacterial infections. Similar patient populations have been reported from Thailand, and we have found similar autoantibodi...

Feb 3rd, 2023 - The perpuse of this study is to investigate the feasibility of the Philips interventional MRI suite "iSuite" to create an electroanatomical map of the heart based on which the real-time location of the catheters can be correctly and reliably visualized during CMR-guided electrophysiological procedure (CMR-EP).

Feb 3rd, 2023 - Study Description The purpose of this study is to analyze the data that have been collected as part of NIH-AARP study (OH95CN025), a historical cohort; in this study we seek to continue to conduct research, but no new study activities will be requested from the study participants. Objective To examine relationships between diet, lifestyle, and cancers by means of a prospective cohort design To ...

Feb 3rd, 2023 - Streptococcus pneumoniae (pneumococcus) is a bacterium that causes severe infections in children and adults such as meningitis, pneumonia, and blood stream infection. There are many types of these bacteria defined by the type of sugar coat that they have. These are classified as serotypes. There are common serotypes that cause severe disease and are preventable by vaccination of children. Other...

Feb 3rd, 2023 - Awareness, or explicit recall, under sedation is often intended and expected by anesthesiologists and is assumed that does not associate with any sequelae. Thus, awareness under sedation is a common event and is estimated to occur in around one-quarter of patients in our population. However, two recent registry studies suggested some patients with awareness under sedation have comparable psycho...