Your search for "Women's Health" found 47 matches:
LEAP Research Study: Exploring Reproductive Hormones Response to Different Diets

CTRC-adult

If you join this study, we will look at how your hormones change due to two different diets and how this affects your health. You will be put into one of two groups by chance, like flipping a coin. You don’t get to choose your group. The first group will eat a diet for 5 days that keeps yo...

PIKture-01: First-in-Human Study of the PI3KalphaH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants with Advanced Solid Tumors and in Combination with Endocrine Therapy or HER2 Targeted Therapy in Participants with Advanced Breast Cancer

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

You are being asked to be in this research study because you have an advanced tumor with the PI3KαH1047R mutation or breast cancer with the PI3KαH1047R mutation. OnKure has begun a study of an investigational drug called OKI-219 as a possible treatment for people who have cancer due to ...

GOG-3088: A Randomized Phase II Study of Letrozole Versus Observation in Patients with Newly Diagnosed Uterine Leiomyosarcoma

Highlands Ranch Hospital, University of Colorado Hospital

This is a randomized phase II study of letrozole (Femara) administered 2.5 mg orally daily to patients with newly diagnosed clinical stage I and II LMS. Using an adaptive randomization, patients will be assigned to either the treatment arm (letrozole group) or observation. The primary outc...

Total Cancer Care Protocol: A Lifetime Partnership with Patients Who Have or May be at Risk of Having Cancer (ORIEN)

Cherry Creek Medical Center, Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital

This study plans to learn more about how to improve standard cancer care. Cancer is a tough disease to treat because few cancers behave in the same way. Recent research suggests that information stored in your blood, tissues and body fluids can be studied to change the way we treat cancer ...

NRG-GY028, "A Phase IB and Randomized Phase II Trial of Megestrol Acetate with or without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer"

University of Colorado Hospital

PRIMARY OBJECTIVES: I. Determine the toxicity of ipatasertib in combination with megestrol acetate in women with metastatic grade 1-2 endometrioid endometrial cancer and establish the recommended phase II dose. (Phase I) II. Compare the progression free survival of the combination of ip...

Ovaprene: Non-hormonal Vaginal Disk Birth Control Study

Comprehensive Women's Health Center

Clinical trial looking at a monthly, non-hormonal vaginal product as birth control. The vaginal product, called Ovaprene, is a round piece of woven material surrounded by a soft, flexible rubber ring. The material in the vaginal product is released slowly to create an environment that make...

Ultrasound Gating for Cardiac MRI of Fetal Hemodynamics and Cardiac Function

Childrens Hospital Colorado

Do you want to volunteer to help better image the fetal cardiovascular system using MRI? We are one of a few sites in North America able to see your baby's heart beating using MRI. We specifically want to better diagnose babies suspected of having a heart abnormality. You will also be help...

CCTG MA.39 TAILOR RT: A RANDOMIZED TRIAL OF REGIONAL RADIOTHERAPY IN BIOMARKER LOW RISK NODE POSITIVE BREAST CANCER

Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital

Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiother...

Role of semaglutide in restoring ovulation in youth and adults with polycystic ovary syndrome (PCOS) (RESTORE Study)

Childrens Hospital Colorado, Outpatient CTRC

For this study, participants will complete a screening visit to determine eligibility. They will collect 4-months of daily urine to determine rates of ovulation prior to starting semaglutide treatment. They will complete an oral sugar tolerance test (drink a sugary drink) to measure their ...

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)

Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

The FLEX Registry will include all patients with stage I-III breast cancer who have received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. Approximately 30,000 patients from 125+...

NRG-GY019: 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

University of Colorado Hospital

PRIMARY OBJECTIVE: I. To examine if letrozole monotherapy/maintenance (L/L) is non-inferior to intravenous (IV) paclitaxel/carboplatin and maintenance letrozole (CT/L) with respect to progression-free survival (PFS) in women with stage II-IV primary low-grade serous carcinoma of the ova...

The early and late contribution of fasting and postprandial triglycerides on newborn subcutaneous and intrahepatic fat in pregnancy

Broomfield Hospital, Cherry Creek Medical Center, Childrens Hospital Colorado, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Longs Peak Hospital, Outpatient CTRC, Outpatient CTRC, UCHealth Central Park Medical Center, UCHealth Internal Medical Clinic - Lowry

What Happens If I Join the Study? - You will have 4 study visits during pregnancy and 1 study visit after your baby is born - You will be asked to prick your finger to monitor blood sugar and blood triglyceride levels 4 times a day for 4 days after each visit (total of 64 finger pokes) ...

Inspiring New Science in Guiding Healthcare in Turner Syndrome (INSIGHTS) Registry

Ann & Robert H. Lurie Children's Hospital of Chicago, Childrens Hospital Colorado, Childrens Hospital of Philadelphia, Childrens National Medical Center, University of North Carolina Children's Hospital, University of Texas Health Science Center at Houston

Participants who join the INSIGHTS Registry are agreeing to have their medical records be used for research. There are no additional study visits, etc. – participants just continue with their usual clinical care. In addition to the basic registry, individuals can join a recruitment list f...

Evaluation of Compensatory Reserve in Obstetrical Patients

Childrens Hospital Colorado, University of Colorado Hospital

A pulse oximeter will be applied to your finger to collect data regarding your compensatory reserve volume....

NRG-CC008: 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 [SOROC]

Highlands Ranch Hospital, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

PRIMARY OBJECTIVE: I. To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA1 germline mutations. SECONDARY OBJECTIVES: I. To pr...

A RANDOMIZED, PHASE II TRIAL OF CIRCULATING TUMOR DNA-GUIDED SECOND LINE ADJUVANT THERAPY FOR HIGH RESIDUAL RISK, ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE BREAST CANCER (DARE)

Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

Surveillance population and ctDNA screening (up to 1000 patients): Clinically high risk, stage II-III, ER positive, HER2-, breast cancer patients who are currently receiving adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen are eligible for ctDNA screening if they meet an...

A011801 - The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib

Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Lone Tree Medical Center, Medical Center of the Rockies, Memorial Hospital Central, Memorial Hospital North, Poudre Valley Hospital, University of Colorado Hospital

PRIMARY OBJECTIVE: I. To determine if the invasive disease-free survival (iDFS) with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-dire...

A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Cherry Creek Medical Center, University of Colorado Hospital

This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capi...

Contraceptive Hormone and Reward Measurement (CHARM) Study

Brain Imaging Center (BIC), Outpatient CTRC, Outpatient CTRC

The study is looking at the effects of birth control pills on brain processes and emotional wellbeing. We want to see how birth control affects your motivation, excitement for rewards, and happiness after getting a reward. During the study, you will take a birth control pill or a sugar pil...

Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double-blind placebo-controlled trial JHM IRB

Outpatient CTRC, Outpatient CTRC, SGF Colorado - Colorado Springs, SGF Colorado - Denver

This study is looking for women with endometriosis that are about to start in-vitro fertilization procedures to see how Orilissa, a drug to help with symptoms of endometriosis, affects fertility treatment. Participants can expect up to 5 study visits spanning over approximately 6 months, t...

Pilot Study of suction as a mechanism of IUD Expulsion with Concomitant Menstrual Cup Use.

Comprehensive Women's Health Center

Intrauterine devices (IUDs) are a commonly used, highly effective form of long-acting, reversible contraception in the United States (US). IUD expulsions, or displacement of the IUD from the top of the uterine cavity occur approximately 5% of the time but can have significant consequences ...

Large scale genome sequencing and integrative analyses to define genomic predictors of recurrent pregnancy loss

Outpatient CTRC, SGF Colorado - Colorado Springs, SGF Colorado - Denver

We are seeking couples who have experienced at least one prior loss and who actively experiencing a loss. We will collect a blood or saliva sample from the mom and dad and also the product of conseption (POC) from the current loss. All three samples will be sent to Yale Medical Center a...

NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE <-18 BREAST CANCER

Cherry Creek Medical Center, Greeley Campus, Harmony Campus, Highlands Ranch Hospital, Medical Center of the Rockies, Poudre Valley Hospital, University of Colorado Hospital

Breast conservation therapy for early stage breast cancer has been an important achievement of oncology practice in the last half century and breast radiotherapy (RT) has been essential in its development. Several seminal randomized clinical trials conducted in the 1980's era demonstrated ...

PHASE IB/II CLINICAL TRIAL OF ALPELISIB AND TUCATINIB IN PATIENTS WITH PIK3CA-MUTANT HER2-POSITIVE METASTATIC BREAST CANCER

CTRC Inpatient, Department Specific Free Standing Clinic, LSU Health Sciences Center, Mt. Sinai Comprehensive Cancer Center, University of Colorado Hospital, USD Moores Cancer Center, UW Carbone Cancer Center

This study is a multicenter, single arm, open-label, run-in phase Ib safety cohort with immediate roll over to a phase II clinical trial that will test the combination therapy of tucatinib with alpelisib in subjects with PIK3CA-mutant HER2+ locally advanced unresectable or metastatic breas...

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

Part 1 (Dose Escalation): This part will evaluate the safety and pharmacokinetics of a range of doses of OP-1250 administered orally (PO) daily to subjects in combination with 600 mg of ribociclib administered PO daily for 21 consecutive days followed by 7 days off treatment (Treatment Gro...

A Phase II Study of the safety, tolerability and antitumor activity of tucatinib in combination with eribulin and trastuzumab in patients with pretreated unresectable locally advanced or metastatic HER2+ breast cancer

Outpatient CTRC, University of Colorado Hospital

In view of the potency of tucatinib for the treatment of brain metastases and its modest toxicity, it is important to evaluate the combination of this drug with other established anti-HER2 therapies. There remains a need to evaluate the efficacy of tucatinib with additional active agents i...

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence

Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

This study plans to learn more about how safe an investigational drug known as imlunestrant is and how well it will work to help people with Estrogen receptor positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), early breast cancer with an increased risk of recurrenc...

Short-Term Effects of Equol (Soy metabolite) Supplementation on Blood Vessel Function in Postmenopausal Women with and without Chronic Kidney Disease

Renal Research Center, University of Colorado Hospital

-One screening visit (1.5 hours) and two testing visits (each 5 hours) -Testing visits will include a blood draw and non-invasive testing of blood vessel function -All visits will take place at CU Anschutz As a volunteer, you will receive the following information about your health: ...

Assessing accuracy and precision of home quantitative urine beta hCG with serum for pregnancy of unknown location (CONNECT).

University of Colorado Hospital

The current management of patients with PUL involves multiple trips to the clinic and/or hospital for blood draws and close monitoring of their pregnancy. Specifically, doctors are monitoring levels of a hormone called human Chorionic Gonadotropin (hCG). The hCG can be detected in blood ...

Phase 3, Open-Label, Randomized Study of Datopotamab Deruxtecan with or without Durvalumab Versus Investigator's Choice of Therapy in Patients with Stage I-III Triple Negative Breast Cancer who have Residual Invasive Disease in Breast and/or Axillary Lymph Nodes Following Neoadjuvant Systemic Therapy and Surgical Resection (TROPION-Breast03)

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection f...

The ROSIE Study

Outpatient CTRC, University of Colorado Hospital

Two, in-person visits between 1-2 hours over approximately a 3-month period....

The Impact of Low Estrogen on the Heart and Body Composition in Women (LILAC Study)

Outpatient CTRC, University of Colorado Hospital

We are asking women who have regular periods to join a study about how estrogen and menopause affect body composition and blood vessel health....

A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Childrens Hospital Colorado

A Phase 3 Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)...

A phase I/II study of VLS-1488 (an oral KIF18A inhibitor) in subjects with advanced cancer

CTRC Inpatient, University of Colorado Hospital

This a first-in-human phase I/II study designed to assess the safety, tolerability and preliminary efficacy of VLS-1488 monotherapy and consists of two parts: Dose Escalation and Dose Expansion. Dose Escalation will examine the safety and tolerability of VLS-1488 in different solid tumo...

Early-life determinants of child health: A new Denver-based cohort

Department Specific Free Standing Clinic, Highlands Ranch Hospital, University of Colorado Hospital

This study will focus on collecting information from moms and their babies to understand how the environment and things that happen early in children's life (including before they are conceived or born) influence a broad range of child health outcomes, including their development, health a...

A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin versus no HIPEC at the Time of Interval Cytoreductive Surgery followed by Niraparib Maintenance in Patients with Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Hyperthermic Ovarian Treatment Trial)

University of Colorado Hospital

This study plans to learn more about if giving heated chemotherapy into the belly, known as heated intraperitoneal chemotherapy (HIPEC), improves the treatment of your type of cancer. You are being asked to be in this research study because you have newly diagnosed ovarian, primary peri...

FONTANA: A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination with Anti-cancer Agents in Participants with Solid Tumors

CTRC Inpatient, University of Colorado Hospital

This study is a Phase I/IIa modular, open-label, multi-center study of AZD5335 administered either as monotherapy or in combination with other anti-cancer agents in participants with advanced solid malignancies...

Improving patient-centered Ob-Gyn care for Black women: Co-designing solutions to mitigate systemic racism, discrimination and bias

Department Specific Free Standing Clinic, University of Colorado Hospital

CU OB-Gyn providers are committed to addressing racial inequities in healthcare. We invite patients, advocates and members of the community who identify as Black, African American, African, Afro-Latinx or Afro-Caribbean to share your experiences and feedback, especially those that have rec...

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

Cherry Creek Medical Center, CTRC Inpatient, Highlands Ranch Hospital, Lone Tree Medical Center, Outpatient CTRC, University of Colorado Hospital

The primary objectives of the study are to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in...

A Phase 3B, Single-Arm, Open-Label Study to Evaluate Bone Mineral Density with Long-Term Use of Relugolix Combination Tablet in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids or Moderate to Severe Pain Associated with Endometriosis

Outpatient CTRC, University of Colorado Hospital

Currently, this medicine is approved by the United States (US) Food and Drug Administration (FDA) for up to 2 years of use for the management of premenopausal women with moderate to severe pain associated with endometriosis. The sponsor is investigating if this medication can be taken for ...

Protocol NRG-BR009, A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score less than or equal to 25 (OFSET)

Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, Memorial Hospital Central, Memorial Hospital North, University of Colorado Hospital

Younger age at diagnosis is an adverse prognostic factor in early breast cancer: women who are less than 35 years of age at diagnosis are more likely to die from their disease than their older counterparts following standard treatments. There remains a pressing need for advancements in the...

Lotus Study: Research about bone health with progestin-only birth control pill, Slynd

Comprehensive Women's Health Center, Outpatient CTRC, University of Colorado Hospital

Slynd is an FDA-approved birth control that is 98% effective at preventing pregnancy when taken correctly. Some birth control can affect bone mineral density (the amount of calcium and other minerals in your bones). Because of this, the company that makes Slynd, Exeltis, is researching t...

S2206: Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer,

Cherry Creek Medical Center, Highlands Ranch Hospital, Lone Tree Medical Center, University of Colorado Hospital

PRIMARY OBJECTIVE: I. To compare breast cancer event-free survival between participants randomized to standard of care neoadjuvant chemotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab. SECONDARY OBJECTIVES: I. To compare pathologic complet...

A Phase 1b study of Psilocybin Assisted Psychotherapy to address fear of recurrence in patients diagnosed with early-stage breast cancer and ovarian cancer in remission

Outpatient CTRC, University of Colorado Hospital

A study conducted to determine if a single dose of 25 mg. of psilocybin, in combination with therapy, will address fear of recurrence in patients diagnosed with early-stage breast cancer and ovarian cancer in remission...

Clinical Trial of Maternal Choline Supplements to Mitigate Effects of Prenatal Cannabis Exposure on Early Brain Development

Outpatient CTRC, University of Colorado Hospital

Have an in-person appointment every six weeks and a telephone call every two weeks starting around 16-weeks gestation up until birth. Take the study supplement by mouth every morning and evening until birth. Have 5 in-person appointments and once monthly telephone calls about your chil...

CCTG EN.10/NRG-GY032: A PHASE II STUDY OF TAILORED ADJUVANT THERAPY IN POLE-MUTATED AND p53-WILDTYPE/NSMP EARLY STAGE ENDOMETRIAL CANCER (RAINBO BLUE & TAPER) SUBSTUDY A: RAINBO POLEmut-BLUE: Refining Adjuvant treatment IN endometrial cancer Based On molecular features (RAINBO) TransPORTEC platform trials SUBSTUDY B: Tailored Adjuvant Therapy in p53-Wildtype/NSMP Early Stage Endometrial Cancer (TAPER)

University of Colorado Hospital

PRIMARY OBJECTIVE: I. Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumour molecular status. SECONDARY OBJECTIVES: I. Estimate the rate of isolated vaginal recurrence, para-aortic recurrence and dis...

Protocol 24-1819 (Thermogenic responses to fasting and overfeeding in women: a potential mechanism contributing to postmenopausal weight gain)

CTRC Inpatient, Outpatient CTRC, University of Colorado Hospital

During and after menopause, women are prone to increased weight gain. The increase in weight and body fat with menopause may be due to changes in metabolism related to the loss of estrogen. This research study plans to compare how the metabolism of premenopausal and postmenopausal women re...