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Search Results Within Category "Women's Health"

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15 Study Matches

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

Principal Investigator: Manda Keller-Ross
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00013742
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
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
Conditions: Blood Disorders, Brain & Nervous System, Women's Health
Keywords: autonomic nervous system, Blood pressure, hot flashes, hypertension, menopause, night sweats
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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.

Principal Investigator: Sharon Allen, PhD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00007684
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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
Conditions: Mental Health & Addiction, Women's Health
Keywords: postpartum, smoking, smoking cessation
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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.

Principal Investigator: David Potter
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001846
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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
Conditions: Cancer, Women's Health
Keywords: Clinics and Surgery Center (CSC), Breast Cancer, Breast Cancer, HER2+ breast cancer, ISPY
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A Randomized Phase II Study of Letrozole Versus Observation in Patients with Newly Diagnosed Uterine Leiomyosarcoma

The purpose of this study is to find out if the drug letrozole is better or worse than not receiving treatment (called observation) following surgery for your type of cancer. Letrozole could prevent your cancer from returning but the cancer could grow while on treatment. There is currently no definitive data to support the use of Letrozole treatment for early stage Leiomyosarcoma. Letrozole has already been FDA-approved to treat other cancers, but it is investigational in this research.

Principal Investigator: Jordan N Mattson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023351
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus
• tumor expresses ER positivity by immunohistochemistry
• completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks prior
• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• able to swallow oral medication
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• any other severe disease
• also has another cancer or has been treated for cancer in the past three years
• women who are pregnant or breastfeeding
• currently receiving chemotherapy or radiation therapy
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Women's Health
Keywords: Uterine Leiomyosarcoma, Clinics and Surgery Center (CSC)
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Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function

This study is being done to learn more about the influence of the menopausal transition on autonomic and vascular function in midlife females. Participants will have their vitals taken and height, weight and waist-to-hip ratio measurements done, complete questionnaires, have blood draws, have electrical activity of a nerve in the leg measured (optional), have blood vessel function measured in the arm, perform breathing exercises, and complete a cold pressor test (putting a hand in ice-cold water). Participants will also have a scan to measure body composition and bone density.

Principal Investigator: Manda Keller-Ross
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00022683
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• women who are 45-55 years old
• premenopausal
• currently have a normal menstrual cycle
• not planning to become pregnant for the duration of participation in the study
• able to read, write & speak English
Exclusion Criteria:

• diabetes
• pregnant or breastfeeding
• cardiac or lung disorders
• severe obesity (body mass index [BMI] ≥ 40 kg/m 2 )
• hypertension
• obstructive sleep apnea
• current use of heart or blood pressure medications or antidepressants
• history of treatment with chemotherapy/radiation
• coagulopathy disorders and/or use of anticoagulant medications
• current use of hormonal contraceptives
• nicotine/tobacco use in the last six months
• current alcohol abuse
Conditions: Women's Health
Keywords: Menopause, Pre menopause, Clinics and Surgery Center (CSC)

The Women Kidney Program

The purpose of this study is to capture clinical information on how kidney disease affects the health of women, focusing on menstrual and reproductive health, the transition to menopause (the time when your menstrual periods stop permanently), and menopause itself. We also wish to learn more about how women’s health affects their kidney disease, bone and heart health.

Principal Investigator: Angie Lobo Romero
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00020957
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• female as biological sex
• diagnosis of a kidney disease or after kidney transplant
• at least 18 years old
Exclusion Criteria:

• unable to speak English
Conditions: Kidney, Prostate & Urinary, Women's Health
Keywords: Clinics and Surgery Center (CSC), Kidney disease, kidney transplant
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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.

Principal Investigator: Britt Erickson
Age Group: 35 years to 50 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001183
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Sex: Female
Age Group: 35 years to 50 years old
This study is NOT accepting healthy volunteers
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)
Conditions: Cancer, Women's Health
Keywords: Clinics and Surgery Center (CSC), BRCA1, Ovarian Cancer
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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.

Principal Investigator: Colleen Rivard
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001439
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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.
Conditions: Cancer, Women's Health
Keywords: Cervical 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.

Principal Investigator: Britt Erickson
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001733
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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
Conditions: Cancer, Women's Health
Keywords: endometrial carcinosarcoma, Endometrial Serous Adenocarcinoma, Clinics and Surgery Center (CSC)
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The University of Minnesota Perinatal Health Repository

This research is being done to collect blood and placenta samples to better understand how pregnancy impacts the health of mother and child. The goal of this research is to better understand what causes some pregnancy complications and how this impacts the longer term health of mothers and children.

Principal Investigator: Sarah Wernimont
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016978
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• pregnant women who are at least 18 years of age and their neonates/children
• seen in Obstetrics and Gynecology Clinics for pre-conception, prenatal or postpartum care
Conditions: Women's Health
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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.

Principal Investigator: Ida-Arlaine Fonkoue
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00014457
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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
Conditions: Mental Health & Addiction, Women's Health
Keywords: Cardiovascular, Cardiovascular Disease (CVD), PTSD, Post-Traumatic Stress Disorder, female, women
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The women with inflammatory Bowel Disease and Motherhood: 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.

Principal Investigator: Eugenia Shmidt
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00003958
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
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
Conditions: Digestive & Liver Health, Women's Health
Keywords: 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.

Principal Investigator: Emily Nagel
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
IRB Number: STUDY00016926
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Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
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
Conditions: Children's Health, Women's Health
Keywords: Breast Milk, Maternal Stress, Neurodevelopmental and Feeding, Preterm baby, Preterm feeding
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HEALthy Brain and Child Development Study

We are doing a study to learn how children develop early in life. There will be about 300 parent-child pairs in this study in Minnesota and about 7,500 pairs total across the country. There will be study visits from pregnancy through the first 10 years of your child’s life.

Principal Investigator: Sylia Wilson
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: SITE00001502
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• currently pregnant
• speak English
Conditions: Children's Health, Community Health, Women's Health
Keywords: D2D
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Maternal probiotic supplementation for improved neurodevelopmental outcomes in infants of diabetic mothers (IDMs)

The purpose of this study is to see whether providing pregnant women with probiotics during their pregnancy is associated with infant gut microbiome variation and improved neurodevelopmental outcomes. We expect that you and your child will be in this research study for approximately 8 months from the time you sign the consent from to the completion of your 6-month visit with your infant.

Principal Investigator: Marie Hickey
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00016313
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
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)
• single 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
Conditions: Women's Health
Keywords: women's health, pregnancy, pregnant women, gestational diabetes
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