UC Davis Health Clinical Studies

A Study of the Experimental Combination of Radiation Therapy and Olaparib For Inflammatory Breast Cancer

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The purpose of this study is to test adding the study drug (olaparib) to standard treatment. The addition of olaparib to standard treatment may or may not prevent your cancer from returning. This study will help study doctors learn if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients. The drug olaparib is approved by the FDA for use in other cancers. Olaparib is not approved for inflammatory breast cancer and is considered experimental in this study.

Drug study, Phase 2
Any, age 18 years or older

Experimental Study of a New Drug Combination - Copanlisib and Fulvestrant - in Postmenopausal Women With Advanced Breast Cancer

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The purpose of this study is to compare any good and bad effects of using a specific drug, copanlisib. It will be given along with standard therapy with fulvestrant for advanced breast cancer. The addition of copanlisib to the usual therapy of fulvestrant alone could shrink your cancer/prevent it from returning. It could also cause side effects. The genetic make up of your breast cancer will be important to know before you start treatment in the trial. If you have a protein called PI3K or PTEN, copanlisib may work better when given with fulvestrant to block cancer cell growth. PI3K and PTEN are often altered (or mutated) in cancer cells. If you do not have PI3K or PTEN alterations in your tumor you may still benefit from this therapy. Researchers hope to learn if tumor genetic information is important in predicting if your cancer will respond to fulvestrant and copanlisib. This study will allow researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the addition of copanlisib should shrink breast tumors in about 1 out of every 3 patients treated on this study. Copanlisib is already FDA approved for use in follicular lymphoma. It is usually not used for the treatment of breast cancer and is considered experimental in this study.

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

A Study of Experimental Accelerated vs Standard Chemotherapy for Germ Cell Tumors (formed from reproductive cells)

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Standard treatment for advanced germ cell tumors includes three chemotherapy drugs. This is called BEP (Bleomycin, Etoposide, and cisPlatin). BEP is given with a drug called pegfilgrastim or filgrastim. This makes white blood cells grow. These drugs are given over the course of 3 weeks. This study will compare the standard chemotherapy regimen with an accelerated chemotherapy regimen. It will use the same drugs to see if the accelerated chemotherapy regimen is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental. This method works by giving the dose of chemotherapy drugs over a shorter length of time. Instead of the standard 3 week-cycle, patients would receive their treatment in a 2 week-cycle. The overall goal of this study is to determine whether accelerated BEP will be effective and well-tolerated for patients with advanced GCTs. We don’t yet know if accelerated treatment is helpful in advanced GCTs and we are hoping this study will answer that question.

Drug study, Phase 3
Any, age 11 to 45 years old

A Study of an Experimental Combination Therapy of Radiation With or Without Cisplatin for Recurrent Endometrial Cancer

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The purpose of this research is to compare two different treatments for endometrial cancer: - radiation therapy combined with weekly treatment with the chemotherapy drug cisplatin and - radiation therapy alone. You are invited to be in this study because you have endometrial cancer that has come back (recurred) after surgery and chemotherapy. Your cancer does not appear to have spread beyond your pelvis.

Radiation study, Phase 2
Female, age -1 years or older

A Study of the Effect of an Oral Vaccine on the Digestive System

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The purpose of this study is to: 1. Determine whether ingesting the standard, 4-doses of a live, weakened typhoid fever vaccine will cause a temporary leaky gut and inflammation. Leaky gut is a condition when the gut lining becomes more permeable, or “leaky”, for substances in the gut to pass through to the tissues beneath it. 2. Compare the gut leakiness caused by this vaccine to the gut leakiness caused by a short-term ingestion of aspirin. 3. Examine whether the size of the body’s natural immune response to this vaccine is associated with gut leakiness and inflammation of similar size.

Biological study, Phase 1
Female, age 18 to 49 years old

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
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