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Search Results Within Category "Women's Health"

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17 Study Matches

A Phase IB/II Multi-Cohort Study of Targeted Agents with Atezolizumab for Patients with Recurrent or Persistent Endometrial Cancer (EndoMAP)

The purpose of this study is to learn the effects, good or bad, of several possible study treatments for EndoCA that are selected based on genetic markers that can be found in these tumors.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001240
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Inclusion Criteria:

• recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy
Exclusion Criteria:

• primary invasive ovarian or cervical cancer occurring with this cancer
• other cancer occurring in the past 5 years
• active or history of autoimmune disease or immune deficiency
• history of cardiac, respiratory or neurological conditions (study staff will review)
Cancer, Women's Health
Clinics and Surgery Center (CSC), EndoCA, Endometrial Cancer
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PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial (I-SPY)

This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.

David Potter
18 years and over
This study is NOT accepting healthy volunteers
SITE00001846
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Inclusion Criteria:

• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
Exclusion Criteria:

• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms
Cancer, Women's Health
Clinics and Surgery Center (CSC), Breast Cancer, Breast Cancer, HER2+ breast cancer, ISPY
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Bupropion for the Prevention of Postpartum Smoking Relapse

Currently, more than half of all women who are able to quit smoking cigarettes during pregnancy start smoking again within six months after they give birth. We want to find out if the drug bupropion (a commercially-available medicine) can help women who quit smoking during pregnancy to continue not smoking after they give birth. All study visits can be completed either in-person or virtually.

Sharon Allen, PhD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00007684
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Inclusion Criteria:

• age 18 to 40
• lifetime history of smoking at least 100 cigarettes, quit smoking during current pregnancy
• uncomplicated delivery, at least 37 weeks gestation
• home within 10 days of delivery
• don't want to start smoking again
Exclusion Criteria:

• currently use other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
• currently use cessation aids
• currently use illicit drugs or alcohol dependence
• taking an antidepressant
• family history of seizures or seizure disorder
Mental Health & Addiction, Women's Health
postpartum, smoking, smoking cessation
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A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen. The use of the hormonal therapy drug, letrozole without chemotherapy may shrink or stabilize your cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Half of women in this study will receive letrozole with paclitaxel/carboplatin and the other half will receive letrozole alone.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00002052
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Inclusion Criteria:

• newly diagnosed, stage II-IV low-grade serous ovarian cancer: Ovarian cancer includes ovarian, fallopian tube and primary peritoneal cancers
• must have undergone an attempt at maximal cytoreductive surgery and a bilateral salpingo-oophorectomy
• ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• surgery no more than eight weeks before starting the study
• able to take medications by mouth
• contact study staff for additional inclusion criteria
Exclusion Criteria:

• have received neoadjuvant or adjuvant chemotherapy or radiotherapy for the treatment of this disease
• received previous hormone therapy for the treatment of this disease
• history of severe cardiac disease
• central nervous system metastases
• active (except for uncomplicated urinary tract infection) or uncontrolled systemic infection
• neuropathy causing more than moderate pain and affecting daily activity
Cancer, Women's Health
Fallopian Tube Serous Cancer, Ovarian Low Grade Serous Cancer, Peritoneal Serous Cancer, Clinics and Surgery Center (CSC)
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NRG-GY026: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (Phesgo) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

We are doing this study to see if we can lower the chance of endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs. We want to find out if this approach is better or worse than the usual approach for your endometrial cancer. The usual approach is defined as care most people get for endometrial cancer, which in this case would be chemotherapy.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001733
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Inclusion Criteria:

• HER2 positive endometrial cancer
• Stage I, II, II or IV endometrial serous or carcinosarcoma
• have not had chemotherapy for treatment of this cancer
Exclusion Criteria:

• pelvic radiation therapy used to treat the tumor
• history of serious heart or lung disease
• plan for hysterectomy after chemotherapy
Cancer, Women's Health
endometrial carcinosarcoma, Endometrial Serous Adenocarcinoma, Clinics and Surgery Center (CSC)
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A Phase 1B and randomized phase 2 trial of megestrol acetate with or without ipatasertib in recurrent or metastatic endometrioid endometrial cancer

The study is divided into two portions. In the first phase, we want to test the safety of a drug called ipatasertib, by testing different doses of the drug to see which dose is safer for people when given in combination with a fixed dose of a drug called megestrol acetate (MA). In Phase II, we are studying how safe the treatment is and how well it works. We are doing this study because we want to find out if this approach is better or worse than the usual approach for endometrial cancer.

Deanna Teoh
18 years and over
This study is NOT accepting healthy volunteers
SITE00001947
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Inclusion Criteria:

• grade 1 or 2 endometrioid endometrial cancer that has returned or has spread to other parts of the body (metastatic)
• may have received unlimited prior lines of treatment
• able to walk, care for self, and active at least 50% of the day
• able to swallow oral medications
• contact study staff for additional requirements
Exclusion Criteria:

• prior treatment with an AKT inhibitor
• women who are pregnant or breast feeding
• other medical or mental health diseases (study staff will review)
Cancer, Women's Health
Endometrial Cancer, Metastatic Endometrial Cancer, Clinics and Surgery Center (CSC)
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Autonomic and Vascular Mechanisms of Cardiovascular Risk in Women with Post-traumatic Stress-Disorder (PTSD)

Having PTSD is associated with a higher risk of developing Cardiovascular Disease (CVD), which presents a major health risk for women, who are twice as likely as men to develop PTSD. The purpose of this study is to learn more about the mechanisms behind the relationship between PTSD and increased cardiovascular risk. Ultimately, our goal is to use the knowledge gained from this research study to help develop intervention and treatment strategies to protect the cardiovascular health of women with PTSD.

Ida-Arlaine Fonkoue
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014457
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Inclusion Criteria:

• female
• 18 years and older
• pre-menopausal
• must have experienced a past trauma, with or without PTSD Diagnosis
Exclusion Criteria:

• pregnant or breastfeeding
• severe traumatic brain injury
• hypertension
• diabetes
• heart disease
• vascular disease
• illicit drug use within the past 6-months prior to participation
• inability or unwillingness to abstain from nicotine use for at least 12 hours prior to Study Visits 2 & 3
Mental Health & Addiction, Women's Health
Cardiovascular, Cardiovascular Disease (CVD), PTSD, Post-Traumatic Stress Disorder, female, women
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A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial) (ROCC)

This study is to investigate if robotic assisted laparoscopy (small incision surgery), is worse than open surgery (otherwise known as a laparotomy) when performing a radical hysterectomy for cervical cancer. Previous research has been done and shown that patients receiving laparoscopy had an increased risk of recurrence of their cervical cancer. But since that time a lot has been learned and improvements have been made, hence why we are relooking at the differences between the two surgical approaches.

Colleen Rivard
18 years and over
This study is NOT accepting healthy volunteers
SITE00001439
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Inclusion Criteria:

• 18 years or older
• confirmed cervical cancer with the histological type of adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma (Including glassy cell)
• Stage IA2, IBI, IB2 cancer
• able to care for self and do light work
Exclusion Criteria:

• unable to have a MRI
• history of prior pelvic or abdominal radiotherapy
• history of cancer less than 5 years ago with the exception of non-melanoma skin cancer.
Cancer, Women's Health
Cervical Cancer
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Vasomotor symptoms of menopause and cardiovascular disease: What is the link?

Study to examine the physiological responses that occur during a hot flush in postmenopausal women

Manda Keller-Ross
18 years and over
This study is also accepting healthy volunteers
STUDY00013742
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Inclusion Criteria:
Participants must have completed menopause and experience either no menopausal hot flashes or experience three menopausal hot flashes a day.
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
• Use of oral contraceptives (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or hormone therapy
• Pregnant or breastfeeding
• Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two and 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 ? 35 kg/m2
Blood Disorders, Brain & Nervous System, Women's Health
autonomic nervous system, Blood pressure, hot flashes, hypertension, menopause, night sweats
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Sex differences in the effecTs of brEaking uP sedentary behavior on vascUlar function in Type 2 Diabetes (STEP UP T2D)

Type 2 diabetes (T2D) confers a high risk of cardiovascular disease (CVD), particularly among older adults who tend to be physically inactive. Most studies that have examined the effects of changing sedentary behavior (SB) have focused on young healthy males and prioritized glycemic outcomes. We will look at the effect of 3 different ways of breaking up sitting: 1) 4 hours of prolonged SB, 2) 4 hours of SB broken up by 5 minutes of self-paced walking every hour, and 3) 4 hours of SB with one 20-minute bout of self-paced walking. In addition to examining the overall effects of each condition, differences between men and women will be evaluated.

Mary Whipple
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018030
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Inclusion Criteria:

• 60 years or older
• postmenopausal (at least 12 months without a menstrual period)
• Type 2 diabetes (hemoglobin A1c 6.5% or more and/or previous diagnosis of type 2 diabetes)
• sedentary for at least 6 hours/day
• willing to abstain from food, caffeine, alcohol and exercise for at least 24 hours, and tobacco/smoking for at least 12 hours prior to each study visit
• able to speak and read English
Exclusion Criteria:

• Type 1 diabetes
• uncontrolled hypertension (resting systolic greater than 160 or diastolic greater than 110 mmHg)
• starting hormone therapy or changing in hormone therapy (dose/frequency/route of administration) in the previous 3 months
• on renal dialysis
• history of deep vein thrombosis (DVT)
• evidence of cognitive impairment
• physical impairment or disability that interferes with ability to engage in exercise (severe osteoarthritis, lower extremity amputation [other than toe(s)/partial foot], use of a walker or wheelchair, etc.)
• unstable medical/psychiatric condition that could impact study participation
Diabetes & Endocrine, Prevention & Wellness, Women's Health
physical activity, sedentary behavior, sitting
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A non-randomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRCA1 carriers (SOROCk)

The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.

Britt Erickson
35 years to 50 years old
This study is NOT accepting healthy volunteers
SITE00001183
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Inclusion Criteria:

• 35 to 50 years old
• women with a BRCA1 mutation
• undergoing risk-reducing salpingo-oophorectomy or who have declined or elected to defer BSO
• may be premenopausal or menopausal
Exclusion Criteria:

• history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time
• women with abnormal screening tests (TVUS, CA-125) suspicious for gross cancer within the past 180 days
• additional criteria apply (study staff will review)
Cancer, Women's Health
Clinics and Surgery Center (CSC), BRCA1, Ovarian Cancer
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Impact of Inflammatory Bowel Disease and IBD-related Surgery on Female Fertility: A Prospective Registry

This is a prospective questionnaire study that will examine the impact of IBD and its surgical treatments on fertility in women with IBD of reproductive age (18-45). Women with IBD who are attempting to get pregnant within the next year will answer questionnaires about their general, surgical and reproductive health, conception history and sexual partner information. This will help identify risk factors predictive of fertility outcomes and early fetal loss, determine time to conception, and assess efficacy of fertility services including in vitro fertilization.

Eugenia Shmidt
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003958
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Inclusion Criteria:

• age 18-45 years
• diagnosis of inflammatory bowel disease (IBD)
• not currently pregnant or trying to get pregnant
• desire to become pregnant within the next 12 months (may become pregnant while in the study)
Exclusion Criteria:

• prior pelvic surgery, including surgery of the cervix, ovary, uterus or fallopian tubes
• known female sterility
• known male infertility factors in partner
Digestive & Liver Health, Women's Health
Fertility, IBD, Inflammatory Bowel Disease
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Maternal Stress, Human Milk Composition, and Neurodevelopmental and Feeding Outcomes

This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.

Emily Nagel
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00016926
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Inclusion Criteria:

• preterm infant born between 28 0/7 and 32 6/7 weeks' gestation
• mother is 18 to 45 years of age at the time of delivery
• mother's BMI between 18.5 to 40 kg/m^2 before pregnancy or at first trimester
Exclusion Criteria:

• preterm babies with significant health issues at birth
• mothers: a) alcohol consumption >1 drink per week or any tobacco use during pregnancy, b) history/current Type I or II diabetes or gestational diabetes mellitus, c) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
Children's Health, Women's Health
Breast Milk, Maternal Stress, Neurodevelopmental and Feeding, Preterm baby, Preterm feeding
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Composur, A Patient-centric, Phase IV, Open-label, Prospective, Real World US Study to Evaluate Vibegron on Patient Treatment Satisfaction, Quality of Life, and Healthcare Resource Utilization in Patients with Overactive Bladder

This study will evaluate treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with vibegron for the treatment of OAB in the context of real-world clinical practice.

Nissrine Nakib
18 years and over
This study is NOT accepting healthy volunteers
SITE00001699
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Inclusion Criteria:

• diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
• symptoms of OAB for at least 3 months
Exclusion Criteria:

• specific previous treatments for OAB (study staff will review)
• neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
• women who are pregnant or breast feeding or planning to become pregnant
Kidney, Prostate & Urinary, Women's Health
Clinics and Surgery Center (CSC), OAB, Overactive Bladder
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Maternal probiotic supplementation for improved neurodevelopmental outcomes in infants of diabetic mothers (IDMs)

This is pilot study designed to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance. The primary aim is to determine if maternal probiotic supplementation during pregnancy and lactation is associated with improved recognition memory performance in infants of diabetic mothers (IDMs). This will involve recruitment and enrollment of pregnant mothers who have been diagnosed with gestational diabetes and randomization to an intervention or control group. Women in the intervention group will receive a standardized probiotic supplement during the third trimester of pregnancy through the first month of lactation. We will compare the IDMs who are exposed to probiotics via maternal supplementation or not with respect to auditory and visual ERPs at 1 and 6 months of age to determine if probiotic supplementation is associated with improved hippocampus function in infancy. The secondary aim is to examine whether maternal probiotic supplementation during pregnancy and lactation is associated with differences in maternal milk and infant fecal microbiome signatures as well as maternal milk and infant serum inflammatory protein levels. Microbial analysis will be performed on infant stool and maternal breast milk samples at one and six months of age. Infant serum and maternal breast milk inflammatory protein levels will be measured at one and six months postpartum.

Marie Hickey
18 years and over
This study is also accepting healthy volunteers
STUDY00016313
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Inclusion Criteria:

• pregnant women in their second or third trimester with a diagnosis of gestational diabetes
• screening for gestational diabetes involves a 2-step (screening test followed by a diagnostic test) with screening done between 24 and 28 weeks of gestation in a non-fasting state. If the screening threshold is met or exceeded, patients receive a oral glucose tolerance test (OGTT)
• BMI 18.5-45 kg/m2 at first prenatal visit
• age 21-45 at time of delivery ? Pregnant women who report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior) ? Singleton pregnancy
Exclusion Criteria:

• alcohol consumption >1 drink per week during pregnancy/lactation
• tobacco consumption during pregnancy or lactation
• inability to speak and understand English
• known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
• history of type I Diabetes
• mothers currently taking over the counter probiotic preparation
Women's Health
women's health, pregnancy, pregnant women, gestational diabetes
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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
18 years and over
This study is NOT accepting healthy volunteers
1610M98383
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Inclusion Criteria:

• at least 18 years old
• female, or transgender female with a cervix
• HIV- positive
• on a stable antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks before starting the study
Exclusion Criteria:

• currently pregnant, or previous pregnancy in the past 3 months, or breast feeding
• vaginal infection within 2 weeks before starting the study
• abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior starting the study
• use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to starting the study
Women's Health
HIV/AIDS, Inflammation Vagina, Menopause
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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
18 years and over
This study is also accepting healthy volunteers
STUDY00004979
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Inclusion Criteria:

• 35 to 70 years old
• experienced premature (less than 40 years old) or early (45 or younger) menopause OR
• premenopausal 35-49 years of age OR
• typical-age menopause who are between 50-70 years old
• menopause will be confirmed by report of amenorrhea for 12 months
Exclusion Criteria:

• nicotine or tobacco use within the past six months
• have diabetes or asthma
• diagnosed significant carotid stenosis
• additional medical diagnosis (study staff will review)
• women who are pregnant or breastfeeding
Heart & Vascular, Women's Health
Blood Pressure, Early Menopause, Hypertension, Menopause