A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications
Seasonal influenza is responsible for approximately 226,000 excess hospitalizations annually
and despite effective antivirals causes significant morbidity and mortality (estimated
24,000-50,000 deaths each year in the United States alone). The influenza virus that emerged
in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the
U.S) but in contrast to seasonal flu, nearly 90 percent of the deaths with the 2009 H1N1
occurred among people younger than 65 years of age. The CDC has defined an at-risk
population that is responsible for the majority of hospitalization and morbidity associated
with influenza. This study will evaluate the use of combination antivirals as compared to
oseltamivir alone in the treatment of influenza in an at-risk population.
Subjects who meet the CDC definition for being at-risk and that present with an
influenza-like illness will be screened for the study. Those subjects with a confirmatory
test for influenza (rapid antigen or PCR) will be randomized in a 1:1 manner to receive a
blinded study treatment consisting of either the combination of amantadine, oseltamivir, and
ribavirin or oseltamivir alone for 5 days. Clinical, virologic, and laboratory assessments
on Days 1, 3, 7, 14, and 28 will be used for both safety and efficacy analysis.
Objectives:
- To evaluate the effectiveness of combined treatment with oseltamivir, amantadine, and
ribavirin compared with oseltamivir alone for at-risk individuals with confirmed influenza
infection.
Eligibility:
- Individuals at least 18 years of age who have one or more medical conditions that may
cause complications from influenza, and have developed an influenza-like illness.
Design:
- Participants will be screened with a physical examination and medical history, along
with blood tests and throat swabs to confirm influenza infection.
- Eligible participants will be randomly assigned to take either oseltamivir alone (the
current standard treatment for influenza) or to take oseltamivir, amantadine, and
ribavirin. Participants will have additional blood samples and throat swabs taken at
the start of the study, and will be shown how to complete a study diary at home.
- Participants will receive a study medication kit containing the medication to take at
home twice a day for 5 days.
- Participants will return, with the medication kit, to the clinic on days 1 (the first
day after the start of the study), 3, 7, 14, and 28. The first visit may take 2 to 3
hours, but each subsequent visit should take approximately 1 to 2 hours. Additional
blood samples and throat swabs will be taken at these visits.
Advancing Postmenopausal Preventive Therapy (APPT), a progestogen-free estrogen therapy to potentially reduce atherosclerosis: a randomized-controlled trial
<p> Cardiovascular disease (narrowed or blocked blood vessels) is the leading cause of death, killing 1 of every 2 women. Atherosclerosis (hardening of the arteries) is the major cause of cardiovascular disease. More than 90% of deaths due to atherosclerosis occur after menopause when a women’s production of estrogen disappears. Research over the last decade has shown that estrogen provides potential cardiovascular benefits with low-risk to women. However, most women have a uterus that requires co-treatment with a progestogen (Provera, progesterone, etc.) to prevent thickening of the uterine lining due to estrogen. Compared to estrogen-alone therapy, traditional progestogen-estrogen therapy appears to have a greater health risk for women. </p><p>The goal of this study is to learn whether a new type of progestogen-free hormone therapy, one that protects the uterus differently so that estrogen can be delivered without risk from progestogen, has beneficial effects on hardening of the arteries in postmenopausal women. Participants in the study will be randomized, split into two groups, to receive either an FDA-approved medication designed to deliver estrogen without a progestogen (Bazedoxifene /estrogen) or placebo, a pill that does not contain an active ingredient. </p>
0C-14-7: A Phase 1/2A, Multicenter, Open-Label Study of Oral RxDx-101 in Adult Patients with Locally Advanced or Metastatic Cancer Confirmed to be Positive for TRKA, TRKB, TRKC, ROS1, or ALK Molecular Alterations
RXDX-101-01 is a multicenter, open-label, Phase 1/2a study in which the safety and efficacy of RXDX-101 will be evaluated in adult patients with any locally advanced or metastatic solid tumor.
The primary objective of the Phase 2a expansion cohorts is Objective Response (OR) defined as Complete Response(CR) and Partial Response (PR) at the recommended phase 2 dose of RXDX-101.
RXDX-101 is an orally available inhibitor of the tyrosine kinases TrkA, TrkB, TrkC, ROS1, and ALK. Molecular alterations to these targets are present in several different tumor types, including non-small cell lung cancer, colorectal cancer, papillary thyroid cancer, pancreatic cancer, and neuroblastoma.
The Phase 2a segment of this study will consist of 5 cohorts as described below:
Cohort #1: Participants that express TrkA. Cohort #2: Participants that express TrkB. Cohort #3: Participants that express TrkC. Cohort #4a: Participants that express ALK with an associated molecular alteration who are nave to prior treatment with ALK inhibitors. Cohort #4b: Participants that express ALK with an associated molecular alteration who have received prior treatment with one or more ALK inhibitors. Cohort #5: Participants that express ROS1
USC will only participate in Phase 2 of the study. The length of participation is about 2 months
An End of Treatment Visit will be conducted within 7 days of last dose of RXDX-101.
A Safety Follow-Up telephone call will be conducted approximately 30 days following the last dose of RXDX-101.
Primary endpoint will be first cycle dose limiting toxicities and maximum tolerated dose
The baseline, clinical outcome, laboratory, PK, and safety data from both segments of the study will be analyzed descriptively
Study at USC is developing active sitting technology. Join today!
<p> Older adults can spend nearly 80% of their day sitting, doing sedentary activities such as watching TV, reading, and using the computer. FitSitt is an innovative device tailored to older adults and designed to improve health by increasing the convenience of breaking up sedentariness and incorporating movement into in-home daily routines. Whereas many interventions aim to increase physical activity by focusing on dedicated exercise sessions such as daily workouts, research suggests that key improvements to health can occur when regular movement is woven into the day, thereby reducing long inactive periods. </p><p> The purpose of this study is to refine and tailor a working prototype of FitSitt, and test the system to see if it is feasible to use and acceptable to older adults. This project will ultimately help the development of an optimized, in-home, comprehensive sedentary activity solution for older adults and countless other populations that could benefit from reducing the deleterious health effects of extended inactive behavior through convenient and comfortable-to-use intervention. </p>
Not yet recruiting | sedentary activity | Not Multisite
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