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 - The trajectory of the HIV epidemic in coming decades will be determined by the degree to which we can identify infected persons and engage them in care - a point implicit in the ambitious UNAIDS "90-90-90" target, which sets 90% goals for HIV diagnosis, linkage of infected persons to sustained antiretroviral therapy (ART), and viral suppression in those treated. Meeting this target requires suc...

Feb 3rd, 2023 - Sixty patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 30) and the tramal group (group T, n =30). All patients will receive standard general anesthesia. Ultrasound-guided ESPB will be performed to group erector spinae plane block

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 parent trial that supports this ancillary research is a randomized controlled trial to evaluate the efficacy of a group-based yoga intervention to decrease the frequency and impact of urinary incontinence in ambulatory middle-aged and older women. Women aged 45 years and older who report daily or more frequent stress-, urgency-, or mixed-type incontinence, are not already engaged in formal ...

Feb 3rd, 2023 - Haemolytic and Uraemic Syndrome (HUS) is a serious disease requiring rapid diagnosis and management. The atypical HUS diagnosis has been greatly improved by anti-CS antibody (Eculizumab) wich block alternative complement pathway activation. To rise treatment success, Eculizumab introduction should be as early as possible. In some secondary HUS (infection, drugs…) complement is also involved as ...

Feb 3rd, 2023 - EO2463 Is an innovative cancer peptide therapeutic vaccine based on the homologies between tumor associated antigens and microbiome-derived peptides that will be administered alone and in combination with lenalidomide, rituximab, and lenalidomide/rituximab to generate safety and preliminary efficacy data in patients with indolent NHL

Feb 3rd, 2023 - This is a screening protocol for healthy volunteers to participate in research studies conducted by Laboratory of Malaria Immunology and Vaccinology (LMIV). Malaria-related morbidity and mortality have a major economic impact in endemic regions and present a substantial health risk to non-immune travelers and people living in endemic areas. To stem the worldwide impact of this devastating disea...

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 - The long-term goal of this research is to reduce morbidity and improve HF self-care by enhancing family problem-solving and collaborative care management among rural HF dyads. The initial step in meeting this goal is to develop and pilot-test a culturally-sensitive, telephone-based, tailored dyadic problem-solving intervention to improve HF self-care in rural HF dyads. Using a multi-phase, sequ...

Feb 3rd, 2023 - Study Description: ABCA4 retinopathy is an autosomal recessive progressive retinal dystrophy that leads to retinal pigment epithelium (RPE) and photoreceptor degeneration, with consequent central visual loss. A treatment that either reduces the rate of lipofuscin accumulation or improves the clearance of lipofuscin in the RPE could potentially slow the degeneration associated with this disease....

Feb 3rd, 2023 - This trial is an open-label, multi-center Phase Ib clinical study that will evaluate ATG-010 combined with chemotherapy regimen selected by investigators (ICE regimen ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin; Tislelizumab) sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in R/R PTCL and NK/T-cell lymphoma p...

Feb 3rd, 2023 - There is a limited body of literature regarding restrictions for gynecologic surgery. Most of these studies have looked at patients with prolapse and incontinence, and many of the postoperative recommendations are intended for both classes of procedures. Most surgeons restrict their patients' activities postoperatively but to varying degrees and for variable amounts of time. One study in 2017 s...

Feb 3rd, 2023 - The purpose of this research study is to find out about ethanol-containing e-cigarettes impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.

Feb 3rd, 2023 - This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. Participants will either get insulin icodec that participants will have to inject ...

Feb 3rd, 2023 - The primary objective of this study is: - Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of BAY 1436032 in patients with isocitrate dehydrogenase-1 (IDH1)-R132X-mutant advanced solid tumors. The secondary objectives of this study are: Evaluate the pharmacokinetics (PK) of BAY1436032 in patients with IDH1-R132X-mutant advanced solid tumors. E...

Feb 3rd, 2023 - 5. INTRODUCTION 5.1 Executive Summary ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP), a ubiquitous, naturally synthesized human peptide with extensively documented anti-inflammatory, anti-cytokine cascade properties. It has been granted FDA Fast Track Designation for treatment of Critical COVID-19 with Respiratory Failure. A phase 2/3 trial is underway that h...

Feb 3rd, 2023 - There will be 2 parts to the study: a Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (Safety Run-in), approximately 12 participants will be treated with lenvatinib in combination with pembrolizumab and chemotherapy with either capecitabine and oxaliplatin (CAPOX), or 5-fluorouracil (5-FU), Leucovorin, and oxaliplatin (mFOLFOX6). Participants will be closely followed for dose-limi...

Feb 3rd, 2023 - This is a multinational, multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TVB-009 compared to Prolia® administered subcutaneously at doses of 60 mg every 26 weeks. Approximately 326 postmenopausal women with osteoporosis will be randomized to receive either TVB-009 or Prolia®. At week 52, patients in the Prolia® arm will be re-randomized 1:1 to either co...