Updated musculoskeletal ultrasound applications and techniques
The aim of this study is to prospectively acquire clinical ultrasound data utilizing newer versions of preexisting US applications performed with a Siemens Acuson Sequoia system, updated acquisition protocols, sequences, and transducers. This will be performed as part out the routine standard of clinical care.
Ultrasound Channel Data Analysis Using Advanced Analytics and Deep Learning
Through the collection and analysis of the ultrasound channel data using advanced analytics and deep learning will provide new information previously unavailable that may improve the sensitivity and specificity of ultrasound in HCC detection and in the detection/quantification of liver fat and iron and may also improve diagnostic efficacy of ultrasound in the detection of HCC and assessment of chronic liver diseases through the use of channel data. Once the utility of channel data is determined in the setting of liver disease, its applications may potentially be applied to other organ systems.
Phase I Pilot study of Endoscopic Ultrasound guided RFA in advanced pancreatic cancer
This study is testing how using a procedure called endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) together with chemotherapy before surgery (Neoadjuvant) can be safe and effective treatment for patients with locally advanced pancreatic cancer (LAPC) who progressed or did not respond to their cancer treatment before. All the patients will undergo the EUS-RFA procedures along with their routine endoscopy and the standard cancer treatment they are receiving. Tumor samples will be taken from all patients for genetic testing. All patients will have blood samples taken to see how they are doing. The study team will closely watch all patients for safety and side effects.
A sham-controlled pilot trial of focused ultrasound modulation of the globus pallidus interna in schizophrenia
The primary objectives of this study are to examine the tolerability of pulsed low-intensity focused ultrasound (PLIFUS) and its effects on brain function measured via fMRI functional connectivity and symptom response in individuals with schizophrenia. A neuronavigated single-element piezoelectric device will be utilized to noninvasively deliver transcranial PLIFUS sonication to the right globus pallidus interna, a brain region implicated in schizophrenia. We aim to enroll N=12 participants with schizophrenia in a random order, sham-controlled crossover trial of a single session of PLIFUS counterbalanced with a single sham sonication session, one week apart. After the participant provides written informed consent, a medical and psychiatric evaluation will be performed to determine eligibility for inclusion in the study, followed by a structural MRI to guide neuro-navigation. The first intervention visit will include a 10 minute PLIFUS sonication or sham sonication, preceded and followed by fMRI and an exit medical examination. Psychiatric symptoms will be assessed immediately prior to sonication/sham, during sonication/sham and 5 minutes, 30 minutes, 60 minutes, 1 day and 7 days after sonication/sham. The second intervention visit will consist of sonication or sham preceded and followed by fMRI in addition to symptom assessments and post-sonication/sham medical evaluation. Participants will be closely monitored during and after procedures for tolerability and adverse effects, including 1 and 7 day follow-up visits. The goal of this pilot study is to establish feasibility and tolerability and to determine whether the sonication procedure produces effects on the imaging biomarker and on symptoms prior to proceeding to therapeutic trials using repeated administration. If PLIFUS effects on fMRI and symptom ratings are not detected in the first 4 completers, subsequent participants will receive 3 sessions over 5 days.
A Multi-Center Prospective Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients with Ulcerative Colitis (ENDEAVOUR-UC)
The purpose of this research study is to observe the effectiveness of Etrasimod (Velsipity®) in adults with moderately to severely active ulcerative colitis (UC). The study consists of 52-weeks of follow-up from etrasimod initiation and an additional 28-day safety follow-up period.
A Phase 1 Study of the Polymerase Theta Inhibitor Novobiocin in BRCA-Mutant and Other DNA Damage Repair-Deficient Solid Tumors
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of novobiocin administered on a 5-days on/2-days off schedule in patients with solid tumors carrying homologous recombination (HR) or DNA damage repair (DDR) alterations that are PARP inhibitor- naïve or -resistant. Standard hematological and non-hematologic parameters, scored using CTCAE v.5.0, will be used to define dose-limiting toxicity (DLT).
ComboMATCH Treatment Trial E5: A Randomized Phase II Study of AMG 510 (Sotorasib) with or without Panitumumab in Advanced Solid Tumors
This study will have two groups of patients to test the combination of AMG 510 (Sotorasib) and panitumumab for advanced cancers with KRAS G12C mutations. Group 1 is a randomized phase II trial for patients with advanced solid tumors (except lung and colorectal cancer) who haven’t had treatment with a KRAS G12C inhibitor before. Patients will be randomly assigned to either AMG 510 alone or AMG 510 combined with panitumumab, with AMG 510 given at 960 mg once a day and panitumumab at 6 mg/kg every two weeks. Group 2 is for patients who have already used a KRAS G12C inhibitor and had their cancer progress. Patients in this group can have any type of tumor, including lung or colon cancer. Treatment will continue until the cancer grows or the side effects become too severe, and tumors will be checked every 8 weeks. The main goal of the study is to measure how well the treatment works by looking at the response rate.
A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)
In this study, patients will fill out Health-Related Quality of Life (HRQoL) questionnaires when they visit the hospital for their scheduled appointments. These questionnaires will follow the EORTC guidelines. The main copies will be sent to the hospitals, and if more copies or translations are needed, they can be requested from the EORTC contact person. Clinical report forms will ask if the HRQoL questionnaires were completed, and if they weren't, the reasons will be noted. Patients will receive the questionnaires from the doctor or a study nurse before their check-ups, and they should complete them on their own in their own language during the visit. A designated person, like a research nurse, will help make sure that patients fill out the questionnaires correctly and completely. The study will check how well patients follow through with completing the questionnaires at each visit, and this will be reviewed every six months and included in reports.
DAY101-001/PNOC026/FIREFLY-1: A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients with RAF-Altered Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors
DAY101 is an oral, selective, small-molecule, Type II pan-RAF kinase inhibitor that is being developed by DOT Therapeutics-1 Inc. (Day One, the Sponsor) for the treatment of recurrent or progressive pediatric low-grade gliomas and pediatric and adult solid tumors which harbor a known or expected to be activating RAF alteration.
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