Need Help Quitting Cigarettes?
<p>Do you want to quit smoking, but not sure how? Are you having a hard time finding resources to help you take the first step towards quitting?</p><p>The researchers at the USC Health, Emotion, and Addiction Laboratory are looking for cigarette smokers between the ages of 21 and 65 years old who want to kick the habit.</p><p><br></p><p><br></p>
USC study investigates the benefits or health risks of vaping and smoking
Researchers at USC are seeking study participants who vape or smoke as well as non-smokers in the Los Angeles area. The purpose of the research is to study the health benefits and risks of electronic cigarettes (e-cigs). Your participation will help to better understand the potential effects of e-cigs on the human body.
A Multicenter, Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment with Cimzia
This is a multicenter prospective study evaluating the placental transfer of certolizumab pegol (CZP) by measuring concentration of CZP in infants born to mothers who are on this drug during pregnancy. Certolizumab is a drug that is approved for use in Crohn's disease, rheumatoid arthritis and ankylosing spondylitis. Recent evidence suggests that certolizumab pegol does not cross the placenta, unlike other anti-tumor necrosis factor drugs. The primary objective of this study is to assess whether there is transfer of CZP across theplacenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants. Blood samples will be measured in the infant, mother, and umbilical cord at birth. Additionally, blood samples will be collected from the infant at Week 4 and Week 8 after birth in order to assess the pharmacokinetics (PK) of CZP in infants after birth. The secondary and exploratory objectives are to assess the concentrations of CZP, anti-CZPantibodies, and polyethylene glycol (PEG) in the 3 sources of blood samples at the time of birth(infant, mother, and umbilical cord) and in the infants at 4 weeks and 8 weeks after birth. Although this study is noninterventional regarding treatment with CZP, it is consideredinterventional due to the collection of blood samples that are not part of routine clinical practice.The study will only include pregnant women who have decided to continue or start treatment withCZP for an approved indication in accordance with their treating physician prior to beingrecruited into the study. Approximately 30 pregnant subjects are planned to be screened in order to enroll 20 subjects (blood samples provided by the mother and infant at delivery/birth). To beeligible to participate in the study, subjects must be 30 weeks pregnant at the start of screening,and expecting to use CZP within 35 days prior to expected delivery date. The primary PK variable is plasma concentration of CZP in the infant at birth. Secondary andexploratory variables include plasma concentrations of CZP, anti-CZP antibodies, and PEG. In addition, safety variables are adverse events (AEs) which will be assessed by a Safety Follow-up phone assessment for mother and infant performed 5 weeks (5 days) after the final sample is obtained. Subjects who withdraw prematurely will have a Safety Follow-Up telephone contact (for mother and infant) 5 weeks (5 days) after withdrawing from the study.
A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma
This is an open label, multi-center, single arm phase II study. The study will investigate
the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of
patients with recurrent or persistent PrR-negative endometrial cancer.
Eligible patients will be enrolled into the study and administered sodium cridanimod in
combination progestin therapy. Objective responses will be assessed at 12 week intervals.
Patients will be treated for a 12 month period, followed by an additional 12 month follow up
period or to disease progression whichever occurs first.
Important objectives of the study are to investigate the effect of sodium cridanimod in
conjunction with progestin therapy on the level of PrR in tumor tissue and how this
correlates to efficacy. To accomplish this objective, some of the patients enrolled in the
study will undergo two tumor biopsies that will allow measurement of PrR levels in the tumor
tissue before the treatment and after 4 weeks of therapy.
A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma
OBJECTIVES:
Primary
- Compare the event-free and overall survival of patients with newly diagnosed localized
Ewing's sarcoma treated with doxorubicin hydrochloride, cyclophosphamide, vincristine,
etoposide, and ifosfamide with vs without topotecan hydrochloride.
- Compare the side effects of these regimens in these patients.
Secondary
- Evaluate initial tumor size as a prognostic factor for event-free survival of these
patients.
- Evaluate histological response as a prognostic factor for event-free survival of these
patients.
- Continue evaluation of biologic markers both as related to prognosis and as eventual
therapeutic targets via encouraging concurrent enrollment on COG-AEWS02B1.
- Evaluate radiologic response by positron emission tomography as a prognostic factor for
event-free survival.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(≤ 17 vs ≥ 18 years of age) and primary tumor site (pelvic vs nonpelvic [including
extra-osseous Ewing's sarcoma]). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive vincristine IV over 1 minute once a week on day 1 in weeks 1-3,
7-9, and 13-15; doxorubicin hydrochloride IV over 15 minutes on days 1 and 2 in weeks
1, 7, and 13; cyclophosphamide IV over 1 hour on day 1 in weeks 1, 7, and 13; and
ifosfamide IV over 1 hour and etoposide IV over 1 hour on days 1-5 in weeks 4, 10, and
16. Patients undergo local therapy comprising surgical resection in approximately week
18 and/or radiotherapy beginning in approximately week 19. Patients then receive
vincristine as above in weeks 19-21, 28-30, 34-36, 40-42, and 46-51; dexrazoxane
hydrochloride IV over 15 minutes on days 1 and 2 and doxorubicin hydrochloride as above
in weeks 19 and 28; cyclophosphamide as above in weeks 19, 28, 34, 40, 46, and 49; and
ifosfamide and etoposide as above in weeks 22, 25, 31, 37, and 43.
- Arm II: Patients receive vincristine IV over 1 minute once a week on day 1 in weeks
1-3, 7-9, and 13-16; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1
and 13; cyclophosphamide IV over 30 minutes on days 1-5 in weeks 1 and 13 and IV over 1
hour on day 1 in weeks 7 and 16; ifosfamide IV over 1 hour and etoposide IV over 1 hour
on days 1-5 in weeks 4 and 10; and doxorubicin hydrochloride IV over 15 minutes on days
1 and 2 in weeks 7 and 16. Patients undergo local therapy comprising surgical resection
in approximately week 18 and/or radiotherapy beginning in approximately week 19.
Patients then receive vincristine as above in weeks 19-21, 28-33, 37-42, and 46-48;
topotecan hydrochloride as above in weeks 19, 31, and 40; cyclophosphamide IV over 30
minutes in weeks 19, 31, and 40 and IV over 1 hour in weeks 28, 37, and 46; ifosfamide
and etoposide as above in weeks 22, 25, 34, 43, and 49; dexrazoxane hydrochloride IV
over 15 minutes on days 1 and 2 in weeks 37 and 46; and doxorubicin hydrochloride as
above in weeks 28, 37, and 46.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 528 patients will be accrued for this study.
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