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Active (not recruiting)

Comparative Effectiveness of Empagliflozin in the US

Diabetes Mellitus, Type 2

Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality. However, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. This study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.

Начало: 16.10.2017 Край: 31.05.2026 Възраст: от 18 г.

United States Boehringer Ingelheim NCT03363464

Active (not recruiting)

Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

Healthy Subject

This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.

Начало: 13.10.2017 Край: 20.11.2026 Възраст: от 18 г.

United States City of Hope Medical Center NCT03303846

Active (not recruiting) Phase 2

Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)

Advanced Malignant Solid Neoplasm Recurrent Ependymoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Glioma +29

This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and have come back (relapased) or does not respond to treatment (refractory). Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Начало: 23.08.2017 Край: 08.10.2026 Възраст: 12–21 г.

Puerto Rico, United States National Cancer Institute (NCI) NCT03213704

Active (not recruiting) Phase 2

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

Prostate Neoplasms Prostatic Cancer Prostate Cancer Cancer Of Prostate +1

Background: Prostate cancer is the second leading cause of cancer deaths in American men. When prostate cancer is confined to the prostate there is a high chance of cure. However, it is outside the prostate or comes back after treatment, additional therapy may be needed. Current methods of imaging prostate cancer are limited. Researchers want to see if a radiotracer called 18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment. Objectives: To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or after therapy. Eligibility: Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed after radiation or surgery Design: Participants will be divided into 2 groups. * Group 1 will be men with cancer that has been newly diagnosed as high risk by their doctor who are scheduled to have prostate removal surgery or undergo biopsy before radiation therapy. * Group 2 will be men who have presumed prostate cancer relapse after prostate removal surgery or radiation therapy. Both groups will have scans taken. Participants will lie still on a table in a machine that takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line. Participants will be contacted for follow-up after scans. Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove some prostate tissue. This procedure will be standard of care and is not a part of this study. They will also have an extra MRI scan of their prostate. For this, a tube, called an endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside of their pelvis. A contrast agent will be given by IV. Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of abnormalities found on the 18F-DCFyL scan. Participants will have data about their prostate cancer collected for up to 1 year.

Начало: 03.08.2017 Край: 01.02.2031 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT03181867

Active (not recruiting) Phase 3

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

Breast Cancer

The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

Начало: 12.07.2017 Край: 01.05.2029 Възраст: от 18 г. Treatment

Argentina, Australia, Austria +35 Eli Lilly and Company NCT03155997

Active (not recruiting)

Edtech-HPV: A Community Approach Using Education and Technology to Increase HPV Vaccination

Parents

This study is a two-arm randomized controlled trial, implemented to assess the effectiveness of a community-based educational program with and without a text messaging reminder system, in increasing the rate of HPV vaccination completion among children of Mexican Americans. The investigator's have extended the duration that participants are followed in assessing their child's uptake of the HPV vaccine to coincide with the COVID-19 related clinic closures and/or allow flexibility for participants who decide to delay their child's vaccination for fear of exposure to the COVID-19 infection. A survey will also assess the participants concerns regarding the impact COVID-19 has had in their daily life, such as financial insecurity, food access, housing insecurity and among other most common concerns during this unprecedented time. Additional navigation, referrals and interviewer notes will also be captured. Participants may be called by site or MSK staff to complete study surveys and will be informed verbally or by a mailed letter.

Начало: 28.06.2017 Край: 01.06.2027 Възраст: 21–84 г.

United States Memorial Sloan Kettering Cancer Center NCT03209713

Active (not recruiting) Phase 2

Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B

Hemophilia B

Long-term safety and efficacy follow-up for participants with Hemophilia B who were previously treated in the C0371005 (formerly SPK-9001-101) study, and a dose-escalation sub-study evaluating safety, tolerability, and kinetics of a higher dose with long-term safety and efficacy follow-up. Participants in the substudy do not need to have participated in C0371005.

Начало: 22.06.2017 Край: 25.10.2029 Възраст: 18–65 г. Treatment

Australia, Canada, Turkey (Türkiye) +1 Pfizer NCT03307980

Active (not recruiting)

Dark Adaptation in Participants With Age-Related Macular Degeneration

Age-Related Macular Degeneration

Background: Macular degeneration can cause permanent loss of central vision. This vision is important for seeing details. Age-related macular degeneration (AMD) is the leading cause of vision loss in people over 55 in the United States. Researchers want to follow people with AMD to study the early to middle stages of the disease. Objective: To follow for another 5 years participants who completed NIH study 11-EI-0147. Eligibility: Participant was enrolled in and completed study 11-EI-0147. Design: Participants will have at least 6 study visits over 5 years. Each visit takes about 5 hours. At visit 1, participants will be asked about their medical and eye disease history. They will have an eye exam. The exam will test vision, eye pressure, and eye movements. The pupil will be dilated with eye drops. Participants will have baseline exams. These include a health history and questions about problems that affect their eyes under different lighting. They will answer these questions each year. At each visit, participants will have some or all of these tests: Eye exam Dark adaptation protocol. This measures how fast the eyes recover when exposed to decreasing levels of light. The pupil will be dilated with eye drops. Participants will sit in front of a metal box with a camera inside. They will push a button when they see a light in the machine. View a bright background light for 5 minutes. After the light is turned off participants will push a button when a blue or red light is seen. Sit in the dark for about 30 minutes. Participants will push a button when they see a blue or red light.

Начало: 16.06.2017 Край: 31.12.2033 Възраст: 50–100 г.

United States National Eye Institute (NEI) NCT03225131

Active (not recruiting) Phase 2

A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia

Acute Myeloid Leukemia Myelodysplastic Syndromes

The overall aim of this study is to determine if epigenetic priming with a DNA methyltransferase inhibitor (DMTi) prior to chemotherapy blocks is tolerable and carries evidence of a clinical efficacy signal as determined by minimal residual disease (MRD), event-free survival (EFS), and overall survival (OS). Tolerability for each of the agents, as well as total reduction in DNA methylation and outcome assessments will be done to simultaneously obtain preliminary biological and clinical data for each DMTi in parallel. PRIMARY OBJECTIVES: * Evaluate the tolerability of five days of epigenetic priming with azacitidine and decitabine as a single agent DMTi prior to standard AML chemotherapy blocks. * Evaluate the change in genome-wide methylation burden induced by five days of epigenetic priming and the association of post-priming genome-wide methylation burden with event-free survival among pediatric AML patients. SECONDARY OBJECTIVES * Describe minimal residual disease levels following Induction I chemotherapy in patients that receive DMTi. * Estimate the event-free survival and overall survival of patients receiving a DMTi prior to chemotherapy courses.

Начало: 15.06.2017 Край: 01.06.2027 Възраст: 29–21 г.

United States St. Jude Children's Research Hospital NCT03164057

Active (not recruiting) Phase 1

Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma

Posterior Fossa Ependymoma (PFEPN)

This study plans to detect the presence of trastuzumab by mass spectroscopy in relapsed posterior fossa ependymoma (PFEPN) tumor specimen pre-treated with a single dose of intrathecal (IT) trastuzumab, as well as to evaluate toxicity of intrathecal trastuzumab in combination with subcutaneous (subQ) Granulocyte-macrophage colony-stimulating factor (GM-CSF) in children with relapsed PFEPN

Начало: 12.06.2017 Край: 01.03.2027 Възраст: 12–21 г.

United States University of Colorado, Denver NCT02774421

Active (not recruiting) Phase 1

Atezolizumab in Treating Patients With Cancer Following Adoptive Cell Transfer

Hematopoietic and Lymphoid Cell Neoplasm Metastatic Malignant Solid Neoplasm Unresectable Malignant Solid Neoplasm

This pilot phase I trial studies the side effects of atezolizumab in treating patients with cancer following adoptive cell transfer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Начало: 24.05.2017 Край: 21.11.2026 Възраст: от 18 г.

Canada, United States National Cancer Institute (NCI) NCT02862275

Active (not recruiting) Phase 1

Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia

Oropharyngeal Dysphagia

The primary objective of this study is to evaluate the safety of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.

Начало: 24.05.2017 Край: 01.12.2026 Възраст: от 18 г.

United States Peter Belafsky, MD NCT02838316

Active (not recruiting)

Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (EDSPD Protocol)

CRS

The purpose of this study is to establish the novel endoscopically-directed sinus potential difference (EDSPD) assay as an endpoint for therapy of sinus disease.

Начало: 18.05.2017 Край: 01.05.2027 Възраст: от 18 г.

United States University of Alabama at Birmingham NCT02997020

Active (not recruiting) Phase 1

Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

Hematological Malignancies

The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.

Начало: 16.05.2017 Край: 28.05.2027 Възраст: от 18 г.

France, Netherlands, Spain +2 Janssen Research & Development, LLC NCT03145181

Active (not recruiting) Early Phase 1

Dose Escalation Trial of Neoadjuvant Radiosurgery for the Treatment of Metastatic Brain Tumors

Brain Metastases

The purpose of this study is to study if giving radiation to a brain tumor (a procedure called radiosurgery) before neurosurgery (surgery to remove the tumor) will help to keep brain tissue healthy, while possibly eliminating the need to return for radiation once a patient has healed from neurosurgery. This study will also seek the best radiation dose on a brain tumor based on how well the radiation therapy works and asses the side-effects.

Начало: 09.05.2017 Край: 01.06.2026 Възраст: от 18 г.

United States Cedars-Sinai Medical Center NCT03163368

Active (not recruiting)

Decision Aid Website in Helping to Make Decisions About Fertility in Participants With Cancer

Breast Neoplasm Colorectal Neoplasm Female Reproductive System Neoplasm Health Care Provider +2

This trial studies how well a decision aid website works in helping to make decisions about fertility in participants with cancer. Decision aid websites that provide information about fertility preservation (maintaining your ability to have children of your own after cancer treatment) may help participants with cancer make fertility-preservation decisions.

Начало: 23.04.2017 Край: 30.04.2027 Възраст: 18–45 г.

United States M.D. Anderson Cancer Center NCT03141437

Active (not recruiting) Phase 2

A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy

Thymoma Thymic Carcinoma

Background: Thymoma and thymic carcinoma are cancers originating in the thymus gland. Platinum-based chemotherapy is standard treatment for them. But not uncommonly, the disease returns and people need more treatment to keep the cancer from growing. The drug Avelumab could help the immune system fight cancer. Objective: To test if avelumab is safe and well-tolerated, and is effective in treating relapsed or refractory thymoma and thymic carcinoma. Eligibility: People ages 18 and older with thymoma or thymic carcinoma that has returned or progressed after platinum-containing chemotherapy Design: Participants will be screened with: * Blood, urine, and heart tests * Scan: They lie in a machine that takes pictures of the body. * Physical exam * Medical history * Biopsy: a needle removes a piece of tumor. Samples can be from a previous procedure, although it is desirable to undergo a new biopsy. Participants will have treatment in 2-week cycles. They will continue until the side effects are not tolerable or their disease gets worse. Visits at the following time points are required per protocol. Patients who respond to treatment or have durable stability after at least 12 months of therapy may undergo a dose de-escalation regimen to continue on therapy. * Every 2 weeks: Participants will get avelumab by infusion in a vein (IV). They will get diphenhydramine (benadryl) and acetaminophen (tylenol) by mouth or IV before receiving avelumab to decrease the chances of developing a reaction to avelumab. They will have blood, urine, and heart tests periodically. * Cycles 4 and 7, then every 6 weeks: Scans will be performed to look for shrinkage or growth of tumor. * Cycle 4: Participants will be offered a chance to undergo a biopsy. * 2-4 weeks after stopping treatment: Blood, urine, and heart tests will be performed. Participants might undergo a scan. * 10 weeks after stopping treatment: Blood, urine, and heart tests. * About 6 months after stopping treatment, then every 3 months: Participants will have scans andcan allow genetic testing on their blood and tissue samples.

Начало: 19.04.2017 Край: 30.06.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT03076554

Active (not recruiting)

Screening for Alpha Thalassemia in Healthy Volunteers

Alpha Thalassemia

Background: Alpha thalassemia is a blood disorder. It is caused by genetic deletions. Part of the DNA is missing from a group of genes called alpha globin. Alpha thalassemias are some of the most common genetic deletions. We are testing for alpha thalassemia trait. Alpha thalassemia trait is when someone has only two out of the normal four alpha globin genes. In some people, they lead to no symptoms. Others have changes that lead to disease, including mild anemia. Researchers want to learn more about alpha thalassemia and blood vessels. This may allow them to develop new treatments for blood diseases such as sickle cell disease. Objective: To better understand how alpha globin deletions in healthy people affect blood vessels. Eligibility: Healthy volunteers ages 18-39 who self-report African ancestry. Design: Participants will provide a one-time saliva sample. This can be by mail, in-person at a study event, or at NIH. Participants will get a small kit to collect their saliva sample. The kit has easy instructions. The sample does not need to be put in the refrigerator. Participants will spit a small amount of saliva (less than half a teaspoon) into a collection tube. Participants will close the funnel lid tightly, and then unscrew the funnel lid from the tube. They will then close the tube tightly with the small cap provided and shake the tube for 5 seconds. Participants will place the tube in the provided envelope and mail it to NIH. The specimen will be stored and processed in the lab. Participants may be invited to participate in more research studies, whether or not researchers find that they have alpha thalassemia trait.

Начало: 17.04.2017 Край: 31.12.2027 Възраст: 18–39 г.

United States National Institute of Allergy and Infectious Diseases ( NCT02692872

Active (not recruiting) Phase 1/2

Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease

Sickle Cell Disease

Background: Peripheral blood stem cell transplantation procedures are used for people with sickle cell disease. Researchers want to improve the success and reduce the complications for these procedures. This might allow more people to have a transplant. Objective: To see if a new transplant regime is effective, safe and well tolerated in people with sickle cell disease. Eligibility: Adults at least 18 years old with sickle cell disease and certain complications. A relative who is a half tissue match. Design: Participants will be screened with medical history, physical exam, and blood tests. Recipients will also have: * Heart, lung, and mental health tests * Chest x-rays * Bone marrow taken from the pelvic bone * Eyes and teeth checked Recipients will have a large central line inserted into a vein for up to 6 months. Donors will have their veins tested and have an IV inserted for 1 day or on rare occasions 2 days. Donors will get a drug to activate bone marrow. It will be injected for about 6 days. Donors will have at least 1 five-hour procedure where bone marrow stem cells will be collected. Blood will be taken from a vein in one arm or in rare cases from a groin vein and put through a machine. Some blood will be saved and the rest will be returned. Stem cells will be taken from the saved blood in a lab and frozen until ready to give to the recipient. Recipients will have: * Stems cells collected and frozen * Hygiene lessons * Bone density scans * Low-dose radiation * Drugs for their immune system * Donor cells infused through their central line * Transfusions After about 30 days, recipients will leave the hospital. They must stay near NIH for 3 months after the transplant and have frequent visits. After returning home, they will have 8 visits over 5 years, then be contacted yearly.

Начало: 06.04.2017 Край: 31.08.2026 Възраст: 2–100 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT03077542

Active (not recruiting) Phase 2

Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia

Chronic Atrophic Gastritis Gastric Carcinoma

This randomized phase IIb trial studies how well curcumin works in preventing gastric cancer in patients with chronic atrophic gastritis and/or gastric intestinal metaplasia. Curcumin is an antioxidant compound found in plants that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Начало: 04.04.2017 Край: 01.04.2027 Възраст: от 21 г.

Honduras, Puerto Rico National Cancer Institute (NCI) NCT02782949

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