UC Davis Health Clinical Studies

A Study of Experimental Pembrolizumab (MK-3475) in Combination With Chemotherapy & Endocrine Therapy for Breast Cancer

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The purpose of this study is to: o Test the safety of the study drug, pembrolizumab (MK-3475), with certain types of chemotherapy and endocrine therapy. o See how well the study drug, pembrolizumab, works when combined with chemotherapy and endocrine therapy. o To see if combining the study drug with chemotherapy will have a positive outcome on your surgery, compared to these treatments alone. o To see if combining the study drug with chemotherapy and endocrine therapy keeps your cancer from returning sooner. o To see if combining the study drug with chemotherapy and endocrine therapy helps you live longer. o See how your body handles the study drug. This is a study to test Pembrolizumab for your type of breast cancer. It has not been approved by the FDA to treat breast cancer, but it is approved to treat other types of cancer. The chemotherapies being used in this study (Paclitaxel, Doxorubicin, Epirubicin and Cyclophosphamide) are approved. They are widely used, as a treatment for your type of breast cancer. Endocrine therapy is also approved to treat your type of breast cancer. You will receive endocrine therapy as part of your treatment during the study. The use of these drugs together with pembrolizumab is experimental. “Experimental” means that the study drug is currently being tested. It is not approved by the U.S. FDA

Biological study, Phase 3
Any, age 18 years or older

A Study of the FamilyLink Videoconferencing System and Breastfeeding

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This research study will determine whether viewing your baby while pumping changes the amount and/or content of your breastmilk. We also want to learn if viewing your baby changes your experience with pumping. You are invited to be in this study because you are a mother of a patient in our Neonatal Intensive Care Unit (NICU) who is currently pumping breastmilk. FamilyLink is a videoconferencing software used to view your baby remotely. Participation in this study will involve three sessions pumping breastmilk while using FamilyLink. Three sessions will be done without using FamilyLink. After each session you will complete a short survey and bring your pumped milk into the NICU. Which sessions you use FamilyLink for will be randomly assigned.

Behavioral study
Female, age -1 years or older

The LIFT Study: Telemedicine Breastfeeding Support

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This research study hopes to make sure that mothers have ongoing support to establish successful breastfeeding after leaving the hospital. It will test the effect of telemedicine breastfeeding support on breastfeeding duration. You are invited to be in this study because you delivered a late preterm infant and intend to breastfeed. If you decide to be in the study, you will be randomly assigned to a study group. One group will receive standard of care. The other group will receive 4 telemedicine breastfeeding support visits in addition to regular care. Here are some reasons you may not want to participate in this research: - completing surveys may take time, - you may not want to participate in telemedicine visits. This research will help understand the effectiveness of breastfeeding support practices. It will test a telemedicine lactation support intervention.

Behavioral study
Any, age -1 years or older

A Study of Snacks and Satiety (feeling fed)

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There are still many questions about how we control our appetite and overall food intake. One theory is that fluctuations in blood glucose tell the brain to eat or stop eating. Another theory suggests that certain amino acids in proteins we eat provide ‘stop’ and ‘go’ signals for eating. Many nutrition studies point to high protein or high carbohydrate foods to influence appetite. However, it is not clear if eating snacks, high or low in protein or carbohydrate, can actually affect appetite. We are doing this study to determine if snacks affect appetite and overall food intake. The snacks being used in this study are either almonds (higher in proteins) or a cereal blend (higher in carbohydrates).

Other study
Female, age 18 to 45 years old

A Study of Outpatient Cervical Preparation to Reduce Induction Duration in Pregnant Women

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This study is to compare 2 groups in nulliparous women undergoing cervical ripening for induction of labor. The study hypothesis is that outpatient cervical preparation with a foley catheter can reduce the induction of labor (IOL) time interval from admission to delivery by 50%. A 30 ml transcervical foley catheter is a safe mode of cervical preparation in the outpatient setting, as concluded in Diederen et al, Sciscinoe et al, and Kelly et al. Findings from studies on nulliparous, term, singleton vertex (NTSV) showed patients can be applied to a wide variety of maternity unit sizes as discussed by Main et al. No previous study has evaluated the effectiveness of outpatient cervical preparation in the NTSV population by PUBMED search. Further, no previous study has assessed patient satisfaction cervical preparation in the outpatient setting and no previous study has evaluated whether outpatient cervical preparation has an impact on the length of stay and cost of hospitalization. This study will explore these important questions with the goal of improving current practices in labor induction to be more patient-centered, pragmatic, and cost-effective.

Other study
Female, age 18 years or older

Need Emergency Contraception? Participate in a research study.

We want to find out which morning-after pill is most effective in women who weigh 176 pounds or more

This study aims to find out which morning-after pill is most effective in women weighing 176 pounds or more. If you had unprotected sexual intercourse and are looking for birth control options, consider participating. Emergency contraception, also “the morning-after pill" or "plan b”, can prevent pregnancy after unprotected sexual intercourse. Unprotected intercourse includes no contraceptive used, condom breakage, and other barrier contraceptive method failures. This clinical study happens at the UC Davis Department of Obstetrics and Gynecology. All participants will receive FDA-approved emergency contraception and specialty care at no cost. Compensation for your time is available.

Drug study, Phase 4
Female, age 18 to 40 years old

A Study of Mammographic Breast Density For Hormone Receptor-Negative Breast Cancer Enrolled on Study A011502

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This study is being done as a companion study to the Alliance A011502 clinical trial. The purpose of this study is to see if the use of aspirin causes a decrease in mammographic breast density. The breast is composed of fat, milk glands and various other tissues. These determine how dense the breasts are. High breast density has been shown to be a strong risk factor for developing breast cancer. It is thought that decreasing breast density may decrease the risk for breast cancer. The main goal of this study is to see whether women treated with aspirin will have reduced breast density as seen on a mammogram. Breast density is determined by a mammogram, and cannot be determined by a physical exam.

Procedure study
Female, age -1 years or older

A Study of Atezolizumab, Guadecitabine, and CDX-1401 For Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

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This study will test the safety of the experimental combination of two drugs called SGI-110 and Atezolizumab. If this combination causes significant side effects, the dose of SGI-110 may be lowered for additional patients entering the study. Atezolizumab is not FDA approved for treating your type of cancer. SGI-110 is not approved by the FDA for any medical condition. Atezolizumab is a monoclonal antibody against PDL1 (a protein that allows tumor cells to escape the killing effect of T cells). SGI-110 is a drug that increases the effect of the genes that make tumor antigens on the surface of tumor cells. It also enhances the activity of tumor-killing T cells against those tumor cells.

Drug study, Phase [/1/,/ /2/]
Female, age 18 years or older

The Breast Cancer WEight Loss Study (BWEL Study)

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This study is being done to see if losing weight may help prevent breast cancer from coming back. Studies have found that women who were overweight or obese women when diagnosed with breast cancer have a greater risk of their breast cancer recurring. This is compared to women who were thinner when their cancer was diagnosed. At this time we do not know whether losing weight will reduce the risk of breast cancer returning. This study will help to show us whether weight loss programs should be a part of breast cancer treatment.

Other study, Phase 3
Female, age 18 years or older
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