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12 Study Matches

Role of exogenous and endogenous sex hormones on tenofovir and emtricitabine disposition in female genital tract

This study aims to determine the role of menopause and exogenous hormone use in regulating antiretroviral disposition in the female genital tract.

Melanie Nicol
Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03218085
1610M98383
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Inclusion Criteria:

• Female, or transgender female with a cervix, age 18 years or older
• HIV-positive
• Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment.
• Virally suppressed (HIV-RNA copies <50 copies/mL) for at least 6 months at time of enrollment.
• Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
• Willing and able to give signed informed consent.
Drug: Tenofovir, Drug: Emtricitabine
HIV/AIDS, Menopause, Inflammation Vagina
tenofovir, prevention, microbiome, cervicovaginal, biopsy, swab, cytokines, inflammation, pharmacology
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COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, 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.

Emily Greengard
All
Not specified
Phase 3
This study is NOT accepting healthy volunteers
NCT03067181
STUDY00003824
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Inclusion Criteria:

• There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])
• Standard risk 1: Patient must be < 11 years of age at enrollment
• Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
• Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment
• Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages
• Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
• Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
• Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11
• Standard risk 2 (SR2)
• Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
• Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) <
• 0 x normal; age (years) >= 11 and < 25
• Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
• Notes:
• IGCCC criteria only apply to SR2 patients with a testicular primary tumor
• Use post-op tumor marker levels to determine IGCCC risk group
• Stage 1 seminoma patients are not eligible for the standard risk arms of the study
• For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
• Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
• Adequate renal function defined as:
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR
• A serum creatinine based on age/gender as follows: (mg/dL)
• 1 month to < 6 months male: 0.4 female: 0.4
• 6 months to < 1 year male: 0.5 female: 0.5
• 1 to < 2 years male: 0.6 female: 0.6
• 2 to < 6 years male: 0.8 female: 0.8
• 6 to < 10 years male: 1 female: 1
• 10 to < 13 years male: 1.2 female: 1.2
• 13 to < 16 years: male: 1.5 female: 1.4
• >= 16 years male: 1.7 female: 1.4
• Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L)
• Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 AND
• Platelet count >= 100,000/mm^3
• Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
• Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
• >= 11 and < 25 years old at enrollment
• Able to fluently speak and read English
• Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
• Followed for cancer or survivorship care at one of the following institutions:
• Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
• Dana Farber/Harvard Cancer Center
• Hospital for Sick Children
• Children's Hospital of Eastern Ontario
• Oregon Health and Science University
• Seattle Children's Hospital
• Yale University
Exclusion Criteria:

• Patients with any diagnoses not listed including:
• Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
• Pure dysgerminoma
• Pure mature teratoma
• Pure immature teratoma COG stage I, grade I
• Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) >= 1000 ng/mL
• Pure immature teratoma COG stage II - IV or FIGO stage IC to IV
• "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or
• Primary central nervous system (CNS) germ cell tumor
• Germ cell tumor with somatic malignant transformation
• Spermatocytic seminoma
• Patients must have had no prior systemic therapy for the current cancer diagnosis
• Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)
• Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
• Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
• Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
• Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
Other: Best Practice, Biological: Bleomycin Sulfate, Drug: Carboplatin, Drug: Cisplatin, Drug: Etoposide, Other: Laboratory Biomarker Analysis, Other: Pharmacogenomic Study, Other: Quality-of-Life Assessment, Other: Questionnaire Administration
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma, Germ Cell Tumor, Malignant Germ Cell Tumor, Malignant Ovarian Teratoma, Stage I Ovarian Choriocarcinoma, Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage I Ovarian Teratoma AJCC v6 and v7, Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage I Testicular Choriocarcinoma AJCC v6 and v7, Stage I Testicular Embryonal Carcinoma AJCC v6 and v7, Stage I Testicular Seminoma AJCC v6 and v7, Stage I Testicular Yolk Sac Tumor AJCC v6 and v7, Stage II Ovarian Choriocarcinoma, Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage II Testicular Choriocarcinoma AJCC v6 and v7, Stage II Testicular Embryonal Carcinoma AJCC v6 and v7, Stage II Testicular Yolk Sac Tumor AJCC v6 and v7, Stage III Ovarian Choriocarcinoma, Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7, Stage III Testicular Choriocarcinoma AJCC v6 and v7, Stage III Testicular Embryonal Carcinoma AJCC v6 and v7, Stage III Testicular Yolk Sac Tumor AJCC v6 and v7, Stage IV Ovarian Choriocarcinoma, Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7, Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7, Testicular Mixed Choriocarcinoma and Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Teratoma, Testicular Mixed Choriocarcinoma and Yolk Sac Tumor
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The role of cytomegalovirus and inflammation on patient symptoms and outcomes in ovarian cancer

The central research idea for this award is that CMV reactivation is an unrecognized complicating factor in the treatment of ovarian cancer. Based on preliminary data, our hypotheses are: a) ovarian cancer patients with elevated biomarkers of CMV report greater fatigue and poorer quality of life; b) CMV and inflammation (C-reactive protein; CRP) levels in ovarian cancer patients are higher post-chemotherapy than baseline; c) ovarian cancer patients who experience increases in CMV and/or CRP report greater fatigue and poorer quality of life; d) ovarian cancer patients who experience increases in CMV and CRP will have shorter recurrence-free and overall survival. We propose the following specific aims and studies to address these research questions: Aim 1: Determine the relationship between CMV and ovarian cancer patient-reported symptoms post-treatment. A cross-sectional study of 200 women with ovarian cancer within two years of completing first line chemotherapy will be recruited for a one-time blood draw and survey. We will assess CMV status by measuring IgG serology and CMV DNA levels in serum (indicative of active infection/reactivation) and determine their relationship with patient-reported symptoms including fatigue and quality of life. Aim 2: Characterize the changes in CMV and CRP levels following chemotherapy and their association with patient symptoms and outcomes. A prospective study of 150 women with newly diagnosed ovarian cancer will evaluate the association between serum CMV IgG, CRP IgG, and CMV DNA levels and patient-reported symptoms, recurrence-free and overall survival. Planned blood samples include before, after and 6 months post-chemotherapy completion with planned surveys and clinical follow-up at least every six months for five years.

Rachel Vogel
Female
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT03921658
STUDY00005451
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Inclusion Criteria:

• Age ≥18
• Ability to read and write in English
• women with newly diagnosed with ovarian, primary peritoneal, or fallopian tube cancer
• Treatment plan includes chemotherapy
• Able to provide written voluntary consent before performance of any study related procedure.
• Cohort 1 only: within 2 years of completing initial chemotherapy treatment
• Cohort 2 only: prior to starting chemotherapy
Exclusion Criteria:

• Inability to provide informed written consent
• Previous exposure to chemotherapy
• Life expectancy < 3 months or in hospice care or nursing home
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Clinics and Surgery Center (CSC)
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The MOMENTUM Study (Monitoring Maternal Emergency Navigation and Triage on Mfangano): A 12-month community-based cohort study to evaluate delays in access to maternal and newborn emergency care in Western Kenya (MOMENTUM)

This study is a 12-month socio-behavioral observational cohort study assessing delays, barriers, and current standard of care among women and newborns seeking access to emergency pregnancy, obstetrical and neonatal care among at health facilities on Mfangano Island, Lake Victoria Kenya.

Chas Salmen
Female
18 Years and over
NA
This study is NOT accepting healthy volunteers
NCT03942536
STUDY00004030
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Overall
Inclusion Criteria:

• Must be ≥18 years of age as of the date of study eligibility, or qualify as an emancipated minor (ie: person aged less than 18 years who was married, pregnant, or a parent, consistent with Government of Kenya guidelines and previous research such as Kenya AIDS Indicator Survey-KAIS)
• Must be conversant with one of the commonly spoken languages within the study area (i.e. DhoLuo, Swahili or English; prior experience indicates that this represents >99% of the adult population)
• Must be willing to share confidential information about prenatal history, pregnancy course, obstetrical complications, clinical course, and experiences navigating health care system.
• Must have the ability to provide informed consent. Emergency Cohort-Specific Criteria:
• Participants will be either patients who have experienced a critical pregnancy-related, obstetric, or neonatal health emergency, or appropriate family member in the case that patient is not able to participate in interview due to death or illness or other circumstance. Birth Planning Cohort-Specific Criteria:
• All pregnant women who register a birth plan through the Health Navigation Birth Planning service will be eligible to enroll in the Birth Planning Cohort Focus Group Cohort-Specific Criteria:
• All participants from the emergency cohort and the birth planning cohort will be eligible, as well as CHW volunteers, and OHR-EKC and MoH health facility staff
Exclusion Criteria:

• Individuals under the age of 18 and who do not qualify as emancipated minors
• Individuals who do not speak either English, Dholuo or Swahili
• Individuals who are not comfortable sharing confidential information about prenatal history, pregnancy course, obstetrical complications, clinical course, and experiences navigating health care system.
Other: Focus Group Discussion
Pregnancy, Neonatal Care, Emergency Care
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Bupropion for the Prevention of Postpartum Smoking Relapse

Sharon Allen, PhD
Female
18 Years to 40 Years old
Phase 4
This study is also accepting healthy volunteers
NCT04098874
STUDY00007684
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Inclusion Criteria:

• Ability to provide informed consent
• Age 18 to 40 years old
• Stable health
• 7-day point prevalence abstinence demonstrated at randomization
• Lifetime history of at least 100 cigarettes smoked
• Quit smoking during the current pregnancy
• Self-report of intention to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
• Uncomplicated delivery
• Denies plans to become pregnant again during the trial.
• Full-term delivery ≥ 37 weeks gestation
• Home within 10 days of delivery
Exclusion Criteria:

• Current use of other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
• Current use of cessation aids (e.g., varenicline, NRT)
• Current use of illicit drugs or alcohol dependence
• Current use of antidepressant medication
• Bipolar disorder, eating disorder, or psychotic disorder based on the Structured Clinical Interview
• Medications & conditions that may increase the risk of taking bupropion (e.g., current or history of pulmonary embolus, stroke, heart disease, kidney disease, glaucoma, diabetes, seizure disorder, traumatic head injury, use of medications metabolized by CYP2D6)
• Family history of seizures or seizure disorder
• Maternal use of medications that lower seizure threshold
• Newborn with an elevated risk of seizure
Drug: Bupropion Extended Release Oral Tablet, Drug: Placebo oral tablet
Postpartum Smoking Relapse
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Autonomic regulation of blood pressure in premature and early menopausal women

The goal of this study is to learn more about the effects of menopause on women's blood pressure and heart health. We are looking for women between the ages of 35 and 70 years to participate in the study. Participants may be pre- or postmenopausal; we are specifically interested in evaluating the influence of premature (< age 40 years) and early (< age 46 years) menopause.

Manda Keller-Ross
Female
35 Years to 70 Years old
This study is also accepting healthy volunteers
NCT04439370
STUDY00004979
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Inclusion Criteria:

• Aged 35-49 or 50-70 years of age who experienced premature (<40) or early (≤45) menopause
• Premenopausal 35-49 years of age
• Typical-age menopause (i.e., after 45 years of age), who are between 50-70 years old
• Menopause will be confirmed by subject report of amenorrhea for 12 months and serum FSH of >30 mIU/mL
Exclusion Criteria:

• Current nicotine/tobacco use within the past six months
• Are diabetic or asthmatic
• Have diagnosed significant carotid stenosis
• Have a history of significant autonomic dysfunction, heart disease, respiratory disease or a severe neurologic condition such as stroke or traumatic brain injury.
• Have existing metabolic or endocrine abnormities
• Take any heart/blood pressure medications that are determined to interfere with study outcomes
• IF the participant is premenopausal AND currently taking OC or other exogenous steroids that are determined to interfere with study outcomes
• Females who classify as having early or premature menopause AND are not willing to discontinue OC or MHT in order to complete the study
• Are pregnant or breastfeeding
Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA), Diagnostic Test: Baroreflex sensitivity testing, Diagnostic Test: Sympathoexcitatory Maneuvers, Diagnostic Test: Blood tests
Hypertension, Menopause, Premature, Menopause, Blood Pressure
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Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers

To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase progression-free survival relative to the standard / control regimen of cisplatin and radiation in women with uterine cervix and vaginal cancer

Deanna Teoh
Female
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02466971
STUDY00006358
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Inclusion Criteria:

• Patient has a new, unrated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of para-aortic lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; NOTE: if the baseline 18F-FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan
• Patient must provide study specific informed consent prior to study entry
• Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent
• Absolute neutrophil count > 1,500/uL
• Platelets > 100,000/uL
• Hemoglobin > 10 g/dL
• Total bilirubin < 2.0 mg/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
• Prothrombin time (PT)/activated partial thromboplastin time (aPTT) < 1.5 X institutional upper limit of normal
• Creatinine =< 1.5 mg/dL to receive weekly cisplatin
• Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if the estimated creatinine clearance (CCr) is >= 30 ml/min; for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used
• Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL)
• Patient has a life expectancy of greater than 20 weeks
• Patient does not have known brain metastases (testing optional)
• Patient does not have known human immunodeficiency virus syndrome (HIV, testing optional); known HIV-positive patients receiving combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with triapine
• Patient does not have a known allergy to compounds of similar or biologic composition as triapine
• Patient does not have known glucose-6-phosphate dehydrogenase (G6PD) deficiency as the condition interferes with triapine antidote metabolism (G6PD testing optional)
• Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)
Exclusion Criteria:

• Patient has another concurrent active invasive malignancy
• Patient has had a prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix); patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician
• Patient has uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within six months of protocol initiation, cardiac arrhythmia within six months of protocol initiation; known inadequately controlled hypertension; clinically significant pulmonary disease including dyspnea at rest, or patients requiring supplemental oxygen, or poor pulmonary reserve; or clinically significant renal function impairment (baseline serum creatinine > 2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements
• Patient is receiving another investigational agent for the treatment of cancer
• Patient is currently pregnant
• Patient does not agree to use two forms of birth control if they are of child-bearing potential
• Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible (05/30/2017)
• Patients scheduled to be treated with adjuvant consolidation chemotherapy or other anti-neoplastic therapy at the conclusion of their standard chemoradiation (05/30/2017)
• Patients with self-reported or known diagnosis of G6PD deficiency (05/30/2017)
• Patients with vaginal cancer may have previously undergone a hysterectomy for various indications; patients with vaginal cancer who underwent a hysterectomy for treatment of cervical cancer less than five years prior to their diagnosis of vaginal cancer are ineligible
Radiation: Brachytherapy, Drug: Cisplatin, Radiation: External Beam Radiation Therapy, Radiation: Intensity-Modulated Radiation Therapy, Other: Laboratory Biomarker Analysis, Radiation: Radiation Therapy, Drug: Triapine
Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma, Advanced Vaginal Squamous Cell Carcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Stage IB2 Cervical Cancer AJCC v6 and v7, Stage II Cervical Cancer AJCC v7, Stage II Vaginal Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage III Vaginal Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IV Vaginal Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7, Stage IVA Vaginal Cancer AJCC v6 and v7, Unresectable Vaginal Carcinoma, Vaginal Adenocarcinoma, Vaginal Adenosquamous Carcinoma, Vaginal Carcinoma, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
Clinics and Surgery Center (CSC)
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A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

Phase III
This study is NOT accepting healthy volunteers
NCT02488967
0123456789
Breast Adenocarcinoma, Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIC Breast Cancer, Triple-Negative Breast Carcinoma
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OPTIMIZING ENDOCRINE THERAPY THROUGH MOTIVATIONAL INTERVIEWING AND TEXT INTERVENTIONS

Nicole Hartung
NA
This study is NOT accepting healthy volunteers
NCT04379570
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2 Negative Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8
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MAYFLOWERS-0B-20: A Prospective Study Evaluating Maternal and FetaL Outcomes in the ERa of ModulatorS (MAYFLOWERS)

This is a prospective, multi-center, observational study in pregnant women with cystic fibrosis (CF) to characterize forced expiratory volume in 1 second (FEV1) changes based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The key factors contributing to the change in lung function during pregnancy and for 2 years post-delivery will be evaluated along with assessment of fetal and maternal outcomes.

Joanne Billings
NA
This study is NOT accepting healthy volunteers
NCT04828382
STUDY00012925
Cystic Fibrosis, Pregnancy Related
CFTR modulators, Clinics and Surgery Center (CSC), Cystic Fibrosis, Pregnancy, Pregnancy/obstetric health in women with cystic fibrosis
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The Cardiovascular Impact of Hot Flushes

Female
40 Years to 70 Years old
This study is also accepting healthy volunteers
NCT05251324
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Inclusion Criteria:

• Postmenopausal (may have or may not have hot flushes)
• Have not started hormone therapy and/or will discontinue hormone therapy for the duration of the study
Exclusion Criteria:

• Reported nicotine/tobacco use within the last six months
• Diabetic or asthmatic
• Diagnosed significant carotid stenosis
• History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
• Existing metabolic or endocrine abnormalities
• Use of heart/blood pressure medications that are determined to interfere with study outcomes
• Unwilling to discontinue use of OC (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or MHT
• Pregnant or breastfeeding
• Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two or three
• Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
• Unwilling or unable to fast in the eight hours before visit two or three
• Body mass index greater than or equal to 35 kg/m^3
Other: Hot Flush Induction
Hot Flashes, Menopause
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EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response

Nicole Hartung
Phase III
This study is NOT accepting healthy volunteers
NCT04266249
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Invasive Breast Carcinoma, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8
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