Your search for "Women's Health" found 76 matches:
MicroRNA as a Maternal and Neonatal Biomarker to Predict Congenital Diaphragmatic Hernia Severity

Protocol #: 21-2481

Location: Childrens Hospital Colorado

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]

Protocol #: 20-2079

Locations: Highlands Ranch Hospital; Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital

A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-positive, HER2-negative Breast Cancer

Protocol #: 20-2279

Locations: Lone Tree Medical Center; University of Colorado Hospital

Effect Of Neonatal BCG Administration On Innate And Adaptive Immune Responses To Infection With Rotavirus Live Attenuated Vaccine Strain In HIV-Exposed And Unexposed Infants

Women in this study will consent in the third trimester and have cord blood collected at the time of delivery. The infant will have four visits at Children's Hospital Colorado....more >

Protocol #: 20-0593

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Evaluation of Compensatory Reserve in Obstetrical Patients

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

Protocol #: 14-1996

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Disordered Eating, Energy Availability, and Quality of Life in Adolescent Athletes

Participants will receive a DEXA scan and will wear a FitBit for a week to track HR, sleep, and exercise. The participant will also log their food intake for the week. Compensation included. ...more >

Protocol #: 20-1681

Locations: Childrens Hospital Colorado; University of Colorado Hospital

A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b

Protocol #: 20-1524

Location: University of Colorado Hospital

A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF-07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES

Protocol #: 20-1845

Location: University of Colorado Hospital

AN EXPANDED ACCESS, SINGLE-ARM, MULTICENTER STUDY TO PROVIDE AT HOME SUBCUTANEOUS ADMINISTRATION OF PERTUZUMAB AND TRASTUZUMAB FIXED-DOSE COMBINATION (PH FDC SC) FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER DURING THE COVID-19 PANDEMIC

Protocol #: 20-1830

Location: University of Colorado Hospital

S1714: A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane Induced Peripheral Neuropathy in Cancer Patients

Protocol #: 19-2216

Location: Rocky Mountain Regional VA Medical Center

A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination with Trastuzumab Deruxtecan in Subjects with Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer

Protocol #: 20-1667

Locations: Lone Tree Medical Center; University of Colorado Hospital

In-Utero Vascular Accidents in Neonates from COVID-19 Infected Mothers

This study plans to learn more about how COVID-19 infection during pregnancy may have direct effects on the developing baby 30 days after birth. ...more >

Protocol #: 20-1399

Locations: Childrens Hospital Colorado; University of Colorado Hospital

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy...more >

Protocol #: 20-1420

Locations: Memorial Hospital Central; Memorial Hospital North

TENACITY: A Phase 2, Multicenter, Open-label, Single-arm Study of AL101 Monotherapy in Patients with Notch-activated Triple Negative Breast Cancer

Protocol #: 20-1306

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital

A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER

Protocol #: 20-0884

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital

A Phase 2A, Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Magnesium 4 mg Tablets for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS)

Protocol #: 20-0589

Location: University of Colorado Hospital

Role of Kv7 channels in the regulation of placental arteries vasoreactivity in mothers with Long QT syndrome (LQTS) Types 1 and 2

Protocol #: 20-0226

Locations: Childrens Hospital Colorado; Memorial Hospital Central; University of Colorado Hospital

ENGOT-ov50 / INNOVATE-3: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 200kHz) Concomitant with Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer

Protocol #: 20-0007

Location: University of Colorado Hospital

A Phase 1 Multi-Targeted Study to Promote Anti-Tumor Immunity in ER Positive, HER2 Negative Advanced Breast Cancer

Protocol #: 20-0036

Location: University of Colorado Hospital

Phase Ib/II trial of copanlisib in combination with trastuzumab and pertuzumab after induction treatment of HER2 positive (HER2+ ) metastatic breast cancer (MBC) with PIK3CA mutation or PTEN mutation.

Protocol #: 19-2988

Locations: Lone Tree Medical Center; University of Colorado Hospital

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

Protocol #: 19-2797

Location: University of Colorado Hospital

LIO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor

Protocol #: 19-2795

Location: University of Colorado Hospital

A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer

Protocol #: 19-2640

Location: Rocky Mountain Regional VA Medical Center

Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman with High Risk Pregnancies with Scheduled Cesarean Deliveries

Protocol #: 19-1896

Location: Childrens Hospital Colorado

Pharmacology of Marijuana During Pregnancy

This study will enroll pregnant women who use marijuana during their pregnancy and ask them to provide urine and blood samples at two prenatal visits. At delivery they will again be asked to provide blood and urine samples, the placenta, as well as blood from the baby's umbilical cord. Sur...more >

Protocol #: 19-1757

Locations: Childrens Hospital Colorado; University of Colorado Hospital

A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as a Single Agent and in Combination with Atezolizumab in HLA-A 0201-positive Patients with Advanced MAGE-A4-positive Cancer

Protocol #: 19-2311

Location: University of Colorado Hospital

Role of vascular/cardiac biomarkers in amniotic fluid of patients with Twin-Twin Transfusion Syndrome (TTTS)

Protocol #: 14-1413

Location: Childrens Hospital Colorado

NAFTNet Prenatal Diagnosis of Isolated Aqueductal Stenosis

Protocol #: 18-1076

Location: Childrens Hospital Colorado

Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer

Protocol #: 19-1977

Location: University of Colorado Hospital

A Phase 1a/b Dose-Finding Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

Protocol #: 19-1458

Location: University of Colorado Hospital

A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma.

Protocol #: 19-1337

Locations: Lone Tree Medical Center; University of Colorado Hospital

NRG-BR004: A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

Protocol #: 19-1152

Locations: 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

SGNTUC-016: Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic Her2+ breast cancer

Protocol #: 19-6076

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital

A Phase 1/2, Open Label, Dose-Escalation Study of Oral ORIN1001 with and without Chemotherapy in the Treatment of Subjects with Solid Tumors

Protocol #: 19-1118

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital

A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/Refractory Solid Tumors

Protocol #: 19-1069

Location: University of Colorado Hospital

A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors

Protocol #: 19-0604

Location: University of Colorado Hospital

Treating PCOS with Semaglutide vs Active Lifestyle Intervention (TEAL Study)

The study consists of an initial study visit to determine eligibility, 2 inpatient visits (one prior to starting treatment and one at the end of the 4 month treatment intervention), and one short visit midway between the study....more >

Protocol #: 19-0636

Locations: Childrens Hospital Colorado; University of Colorado Hospital

A randomized phase II study of anti-PD-1 and limited metastatic site radiation therapy versus anti-PD-1 alone for patients with microsatellite instability-high (MSI-H) and mismatch repair deficient (dMMR) metastatic solid tumors

Protocol #: 19-0556

Locations: Lone Tree Medical Center; University of Colorado Hospital

A large-scale multicenter phase II study evaluating the protective effect of a tissue selective estrogen complex (TSEC) in women with newly diagnosed ductal carcinoma in situ.

Protocol #: 19-0632

Locations: Highlands Ranch Hospital; Lone Tree Medical Center; University of Colorado Hospital

A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)

Protocol #: 19-0507

Location: University of Colorado Hospital

Phase 1 Dose Escalation and Expansion Cohort Trial of Carboplatin and Gemcitabine with or without M6620 (VX-970) in First or Second Recurrence Platinum-Sensitive Epithelial Ovarian, Peritoneal, and Fallopian Tube Cancer

Protocol #: 19-0457

Location: University of Colorado Hospital

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

Protocol #: 19-0476

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital

An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination with Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients with Advanced or Metastatic Solid Tumors

Protocol #: 19-0207

Location: University of Colorado Hospital

Randomized phase 2 clinical trial of nab-paclitaxel + durvalumab (MEDI4736) + neoantigen vaccine vs. nab-paclitaxel + durvalumab (MEDI4736) in patients with metastatic triple negative breast cancer

Protocol #: 19-0013

Location: University of Colorado Hospital

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER-positive, HER2 negative Advanced Breast Cancer (SERENA-1)

Protocol #: 18-2654

Location: University of Colorado Hospital

PHASE II, DOUBLE-BLIND, RANDOMIZED TRIAL OF AVOVA-1 (AUTOLOGOUS DENDRITIC CELLS LOADED WITH AUTOLOGOUS TUMOR ASSOCIATED ANTIGENS) VS. AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS (MC) IN PATIENTS WITH STAGE III OR IV EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CARCINOMA AFTER PRIMARY THERAPY

Protocol #: 18-2569

Location: University of Colorado Hospital

A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding

The study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding....more >

Protocol #: 18-2249

Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital

Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense Regimen

Protocol #: 18-6061

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36, for Intratumoral Injection Alone and in Combination with Immune Checkpoint Blockade

Protocol #: 18-1526

Location: University of Colorado Hospital

A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study to Assess the Safety and Effect of Repeated Administration of Granulocyte Colony-Stimulating Factor (G-CSF; filgrastim) on Hot Flashes and Other Vasomotor Symptoms of Menopause in Postmenopausal Women

Protocol #: 18-1254

Location: Outpatient CTRC

Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

Protocol #: 18-6055

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital

A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants with Relapsed/Refractory Solid Tumors. Protocol v.1.3

Protocol #: 18-1150

Location: University of Colorado Hospital

RT CHARM: PHASE III RANDOMIZED TRIAL OF HYPOFRACTIONATED POST MASTECTOMY RADIATION WITH BREAST RECONSTRUCTION

Protocol #: 18-0627

Locations: Memorial Hospital Central; Memorial Hospital North; University of Colorado Hospital

A Randomized Controlled Trial of Ultrasonic Aspiration versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia

Protocol #: 16-0701

Locations: Denver Health and Hospital Authority; University of Colorado Hospital; University of Oklahoma

A multi-center, single-blind, randomized clinical trial to compare two copper IUDs:Mona Lisa NT Cu380 Mini and ParaGard

A randomized, single-blind, phase IIb/III controlled clinical trial to measure contraceptive efficacy of Mona Lisa NT Cu380 Mini. ...more >

Protocol #: 17-0225

Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital

Oral Amino Acid Nutrition to Improve Glucose Excursions in PCOS

Protocol #: 18-0803

Locations: Childrens Hospital Colorado; University of Colorado Hospital

A Phase II, randomized, double-blind, study of the use of Rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancer

This is a phase II, randomized, double-blind, trial for the use of Rucaparib as maintenance therapy in metastatic and recurrent endometrial cancer. ...more >

Protocol #: 18-0567

Locations: Fox Chase Cancer Center; University of Colorado Hospital; University of Pennsylvania

PLACENTAL PROTEINS AND PREMATURITY (P3 STUDY)

This study plans to learn more about why babies born prematurely sometimes can have problems with infections, breathing, feeding, vision, and brain function....more >

Protocol #: 18-0637

Location: University of Colorado Hospital

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)

Protocol #: 18-0461

Location: Childrens Hospital Colorado

Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture

Protocol #: 17-2186

Location: University of Colorado Hospital

EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total. ...more >

Protocol #: 18-0392

Locations: Highlands Ranch Hospital; University of Colorado Hospital

A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination with Avelumab

Protocol #: 18-0187

Location: University of Colorado Hospital

A Phase 1/2 First-in-human Study of BMS-986258 Alone and in Combination with Nivolumab in Advanced Malignant Tumors

Protocol #: 18-0031

Locations: Lone Tree Medical Center; University of Colorado Hospital

Amniotic Fluid-Derived Cardiomyocyte Model to Investigate Mechanotransduction in Cardiomyocytes

Protocol #: 17-2296

Locations: Childrens Hospital Colorado; University of Colorado Hospital

Assessment of NAAT to Determine GBS Status After Initiation of Intrapartum Antibiotic Prophylaxis

This study plans to learn more about a new method of testing for GBS, to see if it can be reliably used after antibiotics have been started. ...more >

Protocol #: 17-2177

Location: University of Colorado Hospital

Electronic Cigarette Use During Pregnancy

Protocol #: 17-2033

Locations: CU John C. Hobbins Perinatal Center; CU Parker Perinatal Center; Denver Health and Hospital Authority; Department Specific Free Standing Clinic; University of Colorado Hospital

The effect of topiramate on etonogestrel concentrations in contraceptive implant users

Protocol #: 17-1047

Locations: Comprehensive Women's Health Center; Comprehensive Womens Health Center; University of Colorado Hospital

A Phase IA/IB Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Tumors

Protocol #: 17-0991

Locations: Lone Tree Medical Center; University of Colorado Hospital

A Pragmatic Multicenter Randomized Trial: Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy (CHAP Project)

Protocol #: 17-0914

Locations: Denver Health and Hospital Authority; University of Colorado Hospital

Effects of high altitude on AMPK activation

This study plans to learn more about differences in pregnancy between high and low altitudes in Colorado. Participants will be asked to complete ultrasounds and provide blood samples throughout pregnancy, and provide samples such as cord blood at the time of delivery....more >

Protocol #: 14-2178

Locations: CTRC-perinatal; CU John C. Hobbins Perinatal Center; University of Colorado Hospital

A Phase I/II, Open-Label, Multicenter, Dose Escalation and Efficacy Study of mRNA-2416, a Lipid Nanoparticle Encapsulated mRNA Encoding Human OX40L, for Intratumoral Injection to Patients with Advanced Malignancies

Protocol #: 17-0074

Locations: Lone Tree Medical Center; University of Colorado Hospital

Double-blind Trial of Phosphatidylcholine Supplementation during Pregnancy: Impact on Attention and Social Withdrawal at 4 years of Age

Protocol #: 16-1510

Locations: Colorado Research Center; Denver Health Medical Center; Department Specific Free Standing Clinic; University of Colorado Hospital

NRG-GY006: A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Protocol #: 16-0493

Locations: Lone Tree Medical Center; University of Colorado Hospital

EAY131 Molecular Analysis for Therapy Choice (MATCH)

Protocol #: 15-1111

Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital

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

Protocol #: 15-1110

Locations: Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital

PT-112-101 A Phase I, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-122 Injection in Subjects with Advanced Solid Tumors

Protocol #: 14-0151

Location: University of Colorado Hospital