Clinical Trials

The aim of the TARGET-IV NA trial is to demonstrate the clinical non-inferiority of the Firehawk® rapamycin eluting stent system in comparison to currently approved 2nd generation DES for the treatment of subjects with ischemic heart disease (NSTEMI, recent STEMI (>24 hours from initial presentation and in whom enzyme levels have peaked), unstable angina, and stable coronary disease), with atherosclerotic target lesion(s) in coronary arteries with visually estimated reference vessel diameters ≥2.25 mm and ≤4.0 mm.

This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.

The purpose of this study is to compare the usual treatment (enzalutamide) alone to using rucaparib plus the usual treatment. The addition of rucaparib to the usual treatment could make patients live longer, or prevent cancer from growing or spreading for a longer time, or both.

This is a retrospective controlled survey-study to assess the safety of treating migraine with Nerivio during pregnancy and 3 months postpartum. We will compare migraine and pregnancy related health and baby health between women with migraine who treated migraine attacks during pregnancy with Nerivio (Nerivio group), to women with migraine who did not treat migraine attacks during pregnancy with Nerivio (control group). Nerivio group participants will be recruited from Theranica’s user base. Control group participants will be recruited by health care providers, including headache specialists and OBGYNs (study co-investigators). The study is fully electronic, including an e-eligibility questionnaire, an e-ICF, and an e-survey. Participants will be compensated for their time.

This clinical trial for patients with HER2-positive endometrial cancer. Cancer cells that are making too many copies of a certain protein are called HER2. This trial is testing if adding one of two HER2-targeted drug combinations to standard chemotherapy can improve outcomes for patients with HER2-positive endometrial serous carcinoma or carcinosarcoma.

Participants are assigned to one of three groups:
Group 1: Standard treatment with paclitaxel and carboplatin.
Group 2: Standard chemotherapy plus Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk).
Group 3: Standard chemotherapy plus Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf).

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.

The trial wants to find out two things:
First, it will test if a new drug called cabozantinib is safe to give along with the usual chemotherapy drugs (methotrexate, doxorubicin, and cisplatin).
Second, it will see if adding cabozantinib to the usual chemotherapy works better than chemotherapy alone.
Cabozantinib is a medicine that helps slow down cancer growth. The doctors are hoping that adding it to the standard treatment will help fight the osteosarcoma more effectively.

Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

The primary objective of this study is to assess the effect of adjuvant treatment with olaparib on Invasive Disease-Free Survival (IDFS).
Note: This study is closed to accrual, meaning that the research team is no longer enrolling new subjects.