73 result(s) found
Acute Myeloid Leukemia
The purpose of the study is to see if a medicine called gilteritinib (ASP2215) is both effective and safe as maintenance treatment (treatment you will receive to maintain the response achieved during the first course of your treatment) for AML patients who are in a first complete remission (no residual leukemia cells in your bone marrow), with mutations in the FLT3 gene compared to placebo given alone.
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Amyloidosis
This is a phase 3, randomized, controlled, open-label, multicenter study of the oral formulation of dexamethasone plus MLN9708 (investigational study drug) compared with treatment chosen by the investigator from a prespecified list of regimens available in clinical practice. Treatment options will include: dexamethasone alone, dexamethasone plus an alkylating agent (melphalan or cyclophosphamide), or dexamethasone plus an immunomodulatory drug ([IMiD], thalidomide or lenalidomide) in patients with relapsed or refractory AL amyloidosis. The sponsor is Millennium Pharmaceuticals Inc. For any questions, please call the number listed above. Participants may also view clinicaltrials.gov for any additional information.
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Ankylosing Spondylitis
BE AGILE 1 is evaluating a new drug called bimekizumab for patients with Ankylosing spondylitis. Bimekizumab is investigational, which means it is still being tested and has not yet been approved for treatment by health authorities. Bimekizumab may help lower the level of activity of interleukin-17A (IL-A) and interleukin-17F (IL-17F); two proteins that are involved in an inflammatory response believed to cause the symptoms of anklysing spondylitis. The purpose of this study is to help us understand how safe and effective different doses of bimekizumab are in treating your condition. It will also help us understand how bimekizumab acts in your body, and how your body reacts to bimekizumab.
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Babesiosis
Babesiosis is an emerging infectious disease in the United States, The disease is caused by a parasite that invades and eventually ruptures red blood cells. The parasite is transmitted by the deer tick but also can be acquired during blood transfusion. Symptoms include fever, fatigue, chills and sweats. In some individuals, the disease is so severe that hospitalization is required. In others, the infection is mild or event silent. The study is designed to identify factors that determine whether a given individual is prone to experience severe or mild babesiosis or no disease at all.
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Bone Marrow Transplant
The main purpose of the study is to find out about whether the study drug, Remestemcel-L, is safe in humans and an effective product in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD may occur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue or cells from a donor (called an allogeneic transplant). The new, transplanted cells attack the recipient's body (the host) because they regard it as foreign.
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Brain Tumors
The main purposes of this study are to evaluate whether combining ABT-414 with usual RT and TMZ treatment controls GBM better than usual RT and TMZ without ABT-414, and whether ABT-414 makes patients live longer. This study will only include people whose tumors are tested and confirmed to have EGFR amplification.
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The purpose of this study is to: 1) see if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in subjects who have been diagnosed with cancer and are experiencing fatigue; and 2) see the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue. In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent). Subjects will not take both. Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders. However, it is not been studied in people with cancer related fatigue.
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Breast Cancer
The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.
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The purpose of this study is to test the theory that therapy designed for each individual’s tumor will improve outcomes over standard of care in a population that needs a better standard. Using tumor tissue samples from a prior surgery, treatment reccomendations will be made based on DNA sequencing of the tumor cells by a Cancer Genomics Tumor Board facilitated by the Hoosier Cancer Research Network. Subjects will be randomized to one of several treatment options based on their specific tumor genetic make-up, prior treatment history and tolerance, and medical history.
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The purpose of this study is to compare any good and bad effects of using 2 years of Palbociclib in combination with standard anti-hormone therapy to using standard anti-hormone therapy alone and to evaluate the likelihood that invasive breast cancer returns.
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Cardiovascular Disease
This is a study to evaluate the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site’s local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group). Approximately 610 subjects will be randomized with approximately 305 subjects targeted to receive the study device.
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Cholesterol
Inflammation plays an important role in several chronic diseases including cardiovascular disease, diabetes mellitus, and neurodegenerative disorders. Fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), has been shown to reduce the risk or severity of these diseases. While it is generally assumed that EPA and DHA have similar effects, evidence is emerging of different modes of action of EPA and DHA. The objective of this study is to assess the differential and common effects of EPA and DHA on inflammation and lipid metabolism.
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Chronic Lymphocytic Leukemia
The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs. This study will also investigate how safe GS-9973 is and how well the drug is tolerated.
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Congestive Heart Failure
The purpose of this study is to test if an investigational drug, Sodium Nitrite Solution (AIR-001) inhaled through a nebulizer (a hand held breathing device), is safe and can improve the ability to tolerate all forms of physical activity, including exercise, and thus improve quality of life in people who have chronic diastolic heart failure. "Investigational" means that the study drug is currently being tested in research studies and is not approved by the US Food and Drug Administration (FDA) for standard medical use to treat heart failure.
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COPD
Patients affected with severe chronic obstructive pulmonary disease (COPD) and other lung disease experience shortness of breath and increased load on respiratory muscles, making it harder to breath. These patients may progressively become dependent on oxygen therapy and sometimes they may need noninvasive ventilation (a mask covering mouth and nose and connected to a blowing machine) to help them in reducing the breathing effort. Optiflow is a nasal high flow oxygen delivery system that, providing warm and humidified air/oxygen blend, could be better tolerated and increase oxygen levels in the blood more than standard oxygen therapy.
Our aim is to generate pilot data that can be used to inform sample size calculations for future studies that will compare outcomes at several different flow rates. We will ask 15 adult patients affected with stable COPD requiring oxygen to participate in our research. Subjects participating in the study will be asked to come in to the sleep lab at Tufts Medical Center. As part of the study 2 small tubes will be inserted through the nostril into the stomach and the esophagus. Baseline data like breathing rate, heart rate, and oxygen level in the blood will be recorded. Then each patient will receive oxygen via High Flow Nasal Cannula, using 3 different settings, and 3 different levels of positive pressure (CPAP) via a nasal mask.
Subjects will be randomized to receive 2 different treatments in a crossover fashion. They will be randomized to different setting within each treatment arm using a computer generated randomization scheme. Each setting will last 1-0 minutes and data will be collected at the end of each setting. Then the tubes will be removed.
We will describe the effects of varying settings of high-flow nasal oxygen on respiratory rate, tidal volume and diaphragmatic work of breathing in patients with severe COPD. We will also describe changes in gas exchange and effects on the subjects' comfort and dyspnea.
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Crohn's Disease
To find out more about children with Crohn’s Disease (CD) to help doctors improve the care of patients with this disease.
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Nationwide Pediatric Inflammatory Bowel Disease quality improvement collaborative, using collective patient data to generate better care practices for patients with Ulcerative Colitis and Crohn's Disease
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Diabetes
A clinical trial to test whether taking vitamin D daily lowers the risk of diabetes in people who are at high risk for diabetes (e.g. overweight, older than 40 years, family history of diabetes, or had diabetes during pregnancy). Participants will take 1 pill a day (vitamin D or placebo) for the duration of the 4 year study. Participants will visit the study site for up to 13 scheduled visits during their participation. All participants receive education on diabetes prevention and are monitored twice a year for diabetes.
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Diabetes Mellitus
A clinical trial to test whether taking vitamin D daily lowers the risk of diabetes in people who are at high risk for diabetes (e.g. overweight, older than 40 years, family history of diabetes, or had diabetes during pregnancy). Participants will take 1 pill a day (vitamin D or placebo) for the duration of the 4 year study. Participants will visit the study site for up to 13 scheduled visits during their participation. All participants receive education on diabetes prevention and are monitored twice a year for diabetes.
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Ependymoma
This study is being done to evaluate what effects, if any, chemotherapy can have when added to the standard of care for this type of cancer. The current standard of care for this type of cancer is a surgery, to remove as much of the tumor as possible, followed by radiation. It will look at if chemotherapy, when added to the standard of care, affects the cancer from coming back.
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Epilepsy
This is an open-label, randomized, parallel-group, active-controlled study to assess the efficacy and safety of brivaracetam (BRV) administered intravenously as treatment for increased seizure activity in an epilepsy monitoring unit (EMU) setting. The primary objective is to assess the efficacy of intravenous (iv) BRV compared to iv lorazepam (LZP) in subjects with epilepsy undergoing EMU evaluation who experience seizures that require prompt treatment.
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Fallopian Tube Cancer
This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.
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Fetal Growth Restriction
This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preterm preeclampsia with severe features and/or fetal growth restriction in addition to samples from a control group to aid in the development of a Next Generation Sequencing (NGS)-based assay to detect molecular markers associated with preterm preeclampsia.
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Glioma
The purpose of this study is to: 1) see if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in subjects who have been diagnosed with cancer and are experiencing fatigue; and 2) see the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue. In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent). Subjects will not take both. Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders. However, it is not been studied in people with cancer related fatigue.
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GVHD
The main purpose of the study is to find out about whether the study drug, Remestemcel-L, is safe in humans and an effective product in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD may occur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue or cells from a donor (called an allogeneic transplant). The new, transplanted cells attack the recipient's body (the host) because they regard it as foreign.
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Head and Neck Cancer
There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel 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 giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
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Hematologic Disorders
The purpose of this study is to perform interval urine analyses in patients with plasma cell diseases to determine if epidermal growth factor (EGF) can serve as a clinically useful indicator of kidney function over time in this patient population. This study will enroll 100 plasma cell disease patients over 2 years. No additional visits for this study are required. Patients will make interval donations of first morning urine samples that coordinate with standard follow-up clinic visits to Tufts Medical Center. The patient will bring their first morning urine to Tufts Medical Center in provided container, and the study team will bring the sample to the laboratory for EGF analysis.
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Hematologic Malignancies
The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs. This study will also investigate how safe GS-9973 is and how well the drug is tolerated.
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High Blood Pressure
The REDUCE HTN: REINFORCE study is testing a new procedure that could treat high blood pressure. This procedure is called renal (kidney) denervation. The study will be evaluating patients that have high blood pressure when they do not take medications. The study will compare the blood pressure of people who undergo the study procedure (renal denervation) with the blood pressure of those who undergo a sham procedure (a renal angiogram that will not include the renal denervation). The study’s purpose is to collect data about the safety and effectiveness of this renal denervation (disabling of kidney nerves) treatment for patients with uncontrolled hypertension.
The Vessix™ Renal Denervation System consists of a catheter (a thin tube) and a radio frequency (RF) generator (power generator). The procedure involves the nerves that surround the blood vessel (artery) that supplies blood to the kidney (kidney artery). The generator sends energy through the kidney artery to disable the surrounding nerves. These nerves have a role in causing the kidneys to keep sodium (salt) in the body and in causing the amount of blood flowing into the filters in the kidney to be lower. These two things, among others, can then cause high blood pressure. By disabling these nerves, the Vessix system aims to reduce the amount of salt kept in the body and therefore reduce blood pressure in the body.
Renal denervation is not a treatment currently used for high blood pressure management in the U.S. The device is investigational in the United States. It is not approved by the U.S. FDA. The sponsor of this study is Boston Scientific Corporation.
The study will include 100 subjects at up to 20 hospitals in the US (about 20 of these subjects will be enrolled at Tufts Medical Center). About 67 people of the 100 total will get the renal denervation procedure (study group) and about 33 people will get a “sham” procedure (control group). People will be randomly selected to one or the other group. The doctor doing the procedure will know which group you are in when he is doing the procedure. Your Study Doctor will tell you whether you received the renal denervation procedure or the sham procedure at your 6 month follow-up visit. Until then, neither you nor your Study Doctor will know which procedure you received. The sham procedure is done to get data that is not influenced by knowing what procedure you received.
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Hodgkin Lymphoma
This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.
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Hypertension
The REDUCE HTN: REINFORCE study is testing a new procedure that could treat high blood pressure. This procedure is called renal (kidney) denervation. The study will be evaluating patients that have high blood pressure when they do not take medications. The study will compare the blood pressure of people who undergo the study procedure (renal denervation) with the blood pressure of those who undergo a sham procedure (a renal angiogram that will not include the renal denervation). The study’s purpose is to collect data about the safety and effectiveness of this renal denervation (disabling of kidney nerves) treatment for patients with uncontrolled hypertension.
The Vessix™ Renal Denervation System consists of a catheter (a thin tube) and a radio frequency (RF) generator (power generator). The procedure involves the nerves that surround the blood vessel (artery) that supplies blood to the kidney (kidney artery). The generator sends energy through the kidney artery to disable the surrounding nerves. These nerves have a role in causing the kidneys to keep sodium (salt) in the body and in causing the amount of blood flowing into the filters in the kidney to be lower. These two things, among others, can then cause high blood pressure. By disabling these nerves, the Vessix system aims to reduce the amount of salt kept in the body and therefore reduce blood pressure in the body.
Renal denervation is not a treatment currently used for high blood pressure management in the U.S. The device is investigational in the United States. It is not approved by the U.S. FDA. The sponsor of this study is Boston Scientific Corporation.
The study will include 100 subjects at up to 20 hospitals in the US (about 20 of these subjects will be enrolled at Tufts Medical Center). About 67 people of the 100 total will get the renal denervation procedure (study group) and about 33 people will get a “sham” procedure (control group). People will be randomly selected to one or the other group. The doctor doing the procedure will know which group you are in when he is doing the procedure. Your Study Doctor will tell you whether you received the renal denervation procedure or the sham procedure at your 6 month follow-up visit. Until then, neither you nor your Study Doctor will know which procedure you received. The sham procedure is done to get data that is not influenced by knowing what procedure you received.
More
Inflammation
Inflammation plays an important role in several chronic diseases including cardiovascular disease, diabetes mellitus, and neurodegenerative disorders. Fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), has been shown to reduce the risk or severity of these diseases. While it is generally assumed that EPA and DHA have similar effects, evidence is emerging of different modes of action of EPA and DHA. The objective of this study is to assess the differential and common effects of EPA and DHA on inflammation and lipid metabolism.
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Inflammatory Bowel Disease
Nationwide Pediatric Inflammatory Bowel Disease quality improvement collaborative, using collective patient data to generate better care practices for patients with Ulcerative Colitis and Crohn's Disease
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Intracerebral Hemorrhage
This study is being conducted to determine if fever prevention, using the Arctic Sun Temperature Management System, improves outcomes in brain injured patients who have suffered from a stroke, intracerebral hemorrhage or subarachnoid hemorrhage. There will be two groups in this study. The fever prevention group (treatment group) will use the Arctic Sun® Temperature Management System to monitor and control body temperature. The standard care group (control group) will be treated according to standard medical practice such as medication and/or cooling blankets.
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Leukemia
The purpose of the study is to see if a medicine called gilteritinib (ASP2215) is both effective and safe as maintenance treatment (treatment you will receive to maintain the response achieved during the first course of your treatment) for AML patients who are in a first complete remission (no residual leukemia cells in your bone marrow), with mutations in the FLT3 gene compared to placebo given alone.
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This is a protocol for people with newly diagnosed Standard Risk Acute Lymphoblastic Leukemia. The study is broken up into parts. Each part of the study will be exploring different phases of chemotherapy such as Induction, Post-Induction, and Maintenance. In each phase of the study, researchers will be testing different experimental drug regimens versus standard treatments to see which one works better. Additionally, participants will be grouped based on their risk level and may receive different chemotherapy regimens based on their risk.
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The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.
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This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer growth by finding cancer cells and helping to kill them or carrying cancer-killing substances to them. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.
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Lung Cancer
The purpose of the study is to collect information to determine if an investigational drug called ASP8273 is effective, safe and comparable to the treatments erlotinib or gefitinib that are already approved in the US, Europe and Asia, respectively, for patients with your type of NSCLC.
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Lyme Disease
Recent studies have shown that the causative agent of Lyme disease, the organism (Borrelia burgdorferi), may persist in animals after antibiotic treatment and can be detected by using the natural tick vector (Ixodes scapularis) to acquire the organism through feeding (xenodiagnosis). The aim of this study is to investigate the utility of xenodiagnosis for identifying persistence of infection with B. burgdorferi in treated human Lyme disease.
Our objectives include: (1) assessing the link between the detection of B. Burgdorferi by xenodiagnosis and the persistence of symptoms in patients diagnosed with Lyme disease, (2) comparing the rate of detection of B. burgdorferi by xenodiagnosis after therapy in participants with posttreatment Lyme disease symptoms, (3) identifying subject characteristics related to the likelihood of detecting B. burgdorferi by xenodiagnosis, and (4) continuing to evaluate the safety of xenodiagnosis in humans.
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Lymphomas
The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs. This study will also investigate how safe GS-9973 is and how well the drug is tolerated.
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This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.
More
The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.
More
Mantle Cell Lymphoma
The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs. This study will also investigate how safe GS-9973 is and how well the drug is tolerated.
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Multiple Myeloma
This study will assess whether taking ixazomib as maintenance therapy after standard treatments extends the period of time that a patient’s cancer stays inactive.
Maintenance therapy means that a drug is taken for a relatively long period (in this study, up to 24 months) to prolong the time that the myeloma remains under control after a prior therapy; in this study the prior therapy must not include autologous stem cell transplant. It is not yet proven whether maintenance therapy given to people with multiple meyloma is better than waiting until the myeloma comes back to receive additional treatment. The study will assess whether taking ixazomib immediately after responding to a prior therapy allows people with multiple myeloma to live longer by preventing or delaying the return of their disease.
This study is also being performed for these additional research purposes:
- To evaluate the safety of ixazomib and to learn about the side effects associated with the use of this drug when it is used as a maintenance therapy.
- To find out whether the presence of certain genes and proteins in the cancer cells of patients with multiple myeloma can predict whether ixazomib will work on cancers similar to yours.
- To evaluate the health and overall well-being of patients while they are taking ixazomib.
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Myelodysplastic Syndromes
The primary objective of this study is to compare the overall survival (OS) of patients receiving intravenous (IV) rigosertib to the OS of patients receiving the physician’s choice of treatment (PC) in a population of patients with myelodysplastic syndrome (MDS) after failure of treatment with a hypomethylating agent (HMA), azacitidine (AZA) or decitabine (DEC).
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This is a Phase 2, open-label, 3-arm randomized, multicenter study designed to determine the safety, pharmacokinetics, and efficacy of venetoclax when administered with azacitidine, compared to azacitidine alone, in subjects with treatment-naïve higher-risk MDS.
Approximately 90 subjects, from approximately 50 sites, will be enrolled with approximately 30 subjects to be randomized to each arm.
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Neonatal Abstinence Syndrome
The purpose of this research study is to find better ways to treat infants with Neonatal Abstinence Syndrome (NAS) and improve long-term outcome. The goal is to compare two common drugs and see which one works the best.
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Neonatal Conditions
The purpose of this research study is to find better ways to treat infants with Neonatal Abstinence Syndrome (NAS) and improve long-term outcome. The goal is to compare two common drugs and see which one works the best.
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Neuroblastoma
In this study we are using new biologic features, in addition to the standard risk factors, to help decide which subjects need treatment and what the best treatment is. People with non-high-risk NBL generally respond well to treatment and the majority of patients can be treated successfully with standard therapy. But standard therapy can include risks from surgery and/or side effects from chemotherapy.Based on the evaluation of non-high-risk NBL patients treated in the past, we think that we can change the amount of therapy for subjects and still treat the cancer successfully. Small studies have shown that some subjects can be watched without having surgery or getting chemotherapy and still have an excellent outcome. By not having surgery or lowering the amount of chemotherapy we hope to prevent complications and harmful side effects. For other subjects we think a change in therapy will treat the cancer more successfully.
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The purpose of this research study is to evaluate an investigational drug (DFMO) for Neuroblastoma that is in remission. Remission means that there are no current signs of active cancer. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the ability of this study drug to keep neuroblastoma in remission and will also look at the safety and tolerability of DFMO.
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Non Small Cell Lung Cancer
The purpose of the study is to collect information to determine if an investigational drug called ASP8273 is effective, safe and comparable to the treatments erlotinib or gefitinib that are already approved in the US, Europe and Asia, respectively, for patients with your type of NSCLC.
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Ovarian Cancer
The purpose of this study is to compare the effect on ovarian cancer of using either olaparib by itself or the combination of cediranib and olaparib to the usual chemotherapy given for ovarian cancer.
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This research is being done to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), chemotherapies (anticancer drugs) that are used to treat ovarian cancer, work better alone or when given with an investigational drug called farletuzumab.
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This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.
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Pancreatic Cancer
This clinical study is in subjects with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment.
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Parkinson's Disease
This study is looking at how sensor, audio, and video recordings can be used to identify unique characteristics that can be compared and monitored in patients with Parkinson’s disease.
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Peritoneal Cancer
This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.
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Polycystic Kidney Disease
This study will involve patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and is supported by the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Program. The study has started at Tufts Medical Center and the University of Maryland (Baltimore). Drs. Ronald Perrone and Dana Miskulin of Tufts Medical Center and Drs. Terry Watnick and Steve Seliger of the University of Maryland will conduct the study at these clinical sites. The study will test the safety and tolerability of the antidiabetic drug metformin, which has been shown in animal models to slow the progression of PKD. Metformin is a widely used generic drug that is FDA approved for the treatment of diabetes.
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Post-Operative Pain
We are studying a medication called VVZ-149. We want to know how well it works for pain, after colon surgery that uses a camera-based approach. We will also be looking for any bad reactions that people may have to it. Patients in the study receive VVZ-149 for a total of about 11 hours. They also receive the usual pain medicines.
Some pain medicines have a lot of side effects, like opioids. These medicines include morphine, hydromorphone, and heroin. When we give less opioid, patients have fewer side effects, like dangerously slow breathing or addiction. However, there are only a few medicines that help as well for pain. The medicine we are studying works on pain in a different way. VVZ-149 is not an opioid.
So far, there have been a few early studies. In animals, VVZ-149 has been shown to work as well as morphine for pain. It has also been given to people. When healthy people took it, they sometimes complained of feeling sick to one’s stomach, dizzy, or sleepy. It has also been given to patients who have had stomach surgery. These patients needed less opioid. They did not have any more problems than healthy people did.
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Preeclampsia
This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preterm preeclampsia with severe features and/or fetal growth restriction in addition to samples from a control group to aid in the development of a Next Generation Sequencing (NGS)-based assay to detect molecular markers associated with preterm preeclampsia.
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Premature Birth
This study is being conducted to find out what genes are turned on or off (called "gene expression") in babies born preterm and how that may be related to complications of prematurity or other health conditions they may experience during or after their initial hospitalizations
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Preterm Birth
This study is being conducted to find out what genes are turned on or off (called "gene expression") in babies born preterm and how that may be related to complications of prematurity or other health conditions they may experience during or after their initial hospitalizations
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Renal Disease
The purpose of this study is to perform interval urine analyses in patients with plasma cell diseases to determine if epidermal growth factor (EGF) can serve as a clinically useful indicator of kidney function over time in this patient population. This study will enroll 100 plasma cell disease patients over 2 years. No additional visits for this study are required. Patients will make interval donations of first morning urine samples that coordinate with standard follow-up clinic visits to Tufts Medical Center. The patient will bring their first morning urine to Tufts Medical Center in provided container, and the study team will bring the sample to the laboratory for EGF analysis.
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Retinopathy of Prematurity
The RAINBOW study is a clinical research study that will help doctors learn whether a drug called ranibizumab works in treating retinopathy of prematurity. Ranibizumab is a drug that blocks a substance in the body called vascular endothelial growth factor, or VEGF. This controls the growth of blood vessels in the back of the eye, and premature babies who develop retinopathy of prematurity have too much of this substance. The purpose of the study is to determine if ranibizumab can help those blood vessels grow normally again, and the study will look at whether one or both doses of the drug work, compared to the current treatment, laser therapy.
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Short Bowel Syndrome
NPS Pharmaceuticals Inc. wants to collect information about the long-term safety profile of people with short bowel syndrome (SBS) who are treated with teduglutide. The purpose of this registry is to evaluate the long-term safety profile and clinical course for people with SBS who are treated with teduglutide in a routine clinical setting, as well as those who are not being treated with teduglutide. The primary objective is to determine the occurrence of colorectal cancer in people with SBS with a remnant colon taking teduglutide. The study will also evaluate the long-term clinical outcomes in people with SBS.
Participants who decide to take part in this registry study have informaiton collected about their health as part of their routine medical care and give this information to NPS Pharmaceuticals, Inc. or its designee to include in the registry.
Each person who joins this registry study will have his/her information collected for the registry for at least 10 years.
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Stroke
This study is being conducted to determine if fever prevention, using the Arctic Sun Temperature Management System, improves outcomes in brain injured patients who have suffered from a stroke, intracerebral hemorrhage or subarachnoid hemorrhage. There will be two groups in this study. The fever prevention group (treatment group) will use the Arctic Sun® Temperature Management System to monitor and control body temperature. The standard care group (control group) will be treated according to standard medical practice such as medication and/or cooling blankets.
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The purpose of this study is to find out whether a new anti-clotting medication called rivaroxaban leads to fewer blood clots in your brain (stroke) or in other blood vessels in your body when compared with aspirin.
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Subarachnoid Hemorrhage
This study is being conducted to determine if fever prevention, using the Arctic Sun Temperature Management System, improves outcomes in brain injured patients who have suffered from a stroke, intracerebral hemorrhage or subarachnoid hemorrhage. There will be two groups in this study. The fever prevention group (treatment group) will use the Arctic Sun® Temperature Management System to monitor and control body temperature. The standard care group (control group) will be treated according to standard medical practice such as medication and/or cooling blankets.
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Tickborne Diseases
Babesiosis is an emerging infectious disease in the United States, The disease is caused by a parasite that invades and eventually ruptures red blood cells. The parasite is transmitted by the deer tick but also can be acquired during blood transfusion. Symptoms include fever, fatigue, chills and sweats. In some individuals, the disease is so severe that hospitalization is required. In others, the infection is mild or event silent. The study is designed to identify factors that determine whether a given individual is prone to experience severe or mild babesiosis or no disease at all.
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Twin Pregnancy
The purpose of the study is to determine whether current testing for fetal chromosomal
abnormality using maternal blood to analyze fetal DNA can be used also to determine
chorionicity (i.e., the arrangement of placentas and fetal membranes) in patients with twin pregnancies.
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Ulcerative Colitis
Nationwide Pediatric Inflammatory Bowel Disease quality improvement collaborative, using collective patient data to generate better care practices for patients with Ulcerative Colitis and Crohn's Disease
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Valvular Heart Disease
This is a study to evaluate the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site’s local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group). Approximately 610 subjects will be randomized with approximately 305 subjects targeted to receive the study device.
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