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Filter by:The trial assess the proportion of patients who resumed their professional activity within 100 days after ASCT (autologous stem cell Transplantation).
The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick, whole blood and serum from symptomatic subjects.
A Phase 1 dose escalation study to determine if axatilimab as monotherapy and axatilimab in combination with a fixed dose of durvalumab will be sufficiently safe and well-tolerated at biologically active doses to warrant further investigation in patients with solid tumors.
Cholera is an acute enteric infectious disease caused by the bacterium Vibrio cholera, leading to watery diarrhea and loss of fluids from the small intestines. The World Health Organization (WHO) estimates that up to 4.3 million cholera cases annually with more than 100,000 of them result in death in worldwide. Cholera is mainly caused by the O1 or O139 serogroups of V. cholera. Vaccination has been shown to be a cost‒effective, more immediate option for cholera control and prevention. Injectable vaccine is not recommended by the World Health Organization (WHO) mainly because of its limited efficacy and short duration of protection. However, the inactivated whole-cell, bivalent O1 and O139 cholera vaccine have provided evidence of substantial protective efficacy. With the goal of making an ideal low-cost OCV that could be used in cholera-endemic countries, a phase I trial was conducted to estimate safety of the oral O1 / O139 cholera vaccine (enteric capsules).
This phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors that have spread to other places in the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and gemcitabine hydrochloride may work better in treating patients with solid tumors.
The goal of this study is to evaluate the utilization of conventional 'thermally' polarized perfluorinated gases mixed with oxygen as an exogenous inert contrast agent to image the airway spaces in subjects with suspected lung disease, post deployment in Iraq and Afghanistan. This is an open label proof of concept study expanding on work here at Duke.
To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of TAK-906 in Japanese healthy male participants.
This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor 2 (HER-2) negative (HER2-) primary breast cancer. Patients will receive AZD9496 or fulvestrant and will have an on-treatment image -guided core biopsy after 5-14 days of commencing treatment.
An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.