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Allergies


Study Title: A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-3641, a Ragweed (Ambrosia artemisiifolia) Sublingual Immunotherapy Tablet, in Children With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma

The purpose of this study is to assess the efficacy and safety of MK-3641 (short ragweed [Ambrosia artemisiifolia] extract, MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy tablets in children aged 5 to 17 years with ragweed-induced rhinoconjunctivitis with or without asthma. The primary hypothesis of this study is that administration of MK-3641 sublingual immunotherapy tablets to children 5 to 17 years of age, compared with placebo, will result in a significant reduction in rhinoconjunctivitis symtoms and medication use over the peak ragweed season (RS).

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Amyloidosis


A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis

The purpose of this study is to evaluate whether NEOD001, the study drug, will improve survival in subjects with AL amyloidosis and/or increase the interval of time that they can go without requiring hospitalization for problems with their hearts.  This study will also evaluate whether NEOD001 improves the function of subjects’ organs that have been affected by amyloid deposits.

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AL Amyloidosis - Examining Tolerated Dose of NEOD001

The purpose of this study is to determine the maximum tolerated dose of the study drug NEOD001 when administered intravenously in AL amyloidosis participants.

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Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients with Relapsed AL Amyloidosis

The study is being done to see if the combination of bendamustine and dexamethasone will help people with AL amyloidosis that has returned after standard treatment. AL Amyloidosis is a disease involving special cells called “antibodies” that make up your immune system. These cells are not functioning the way they are supposed to and they start to produce fibers in your body that form groups called “light chains.” These light chains then can cause damage to your organs, especially the kidneys, heart, skin, liver, and lungs. 

Researchers are looking for ways to get stop the light chains from being formed to treat the disease. Under some circumstances, patients will receive chemotherapy drugs in order to manage the disease. However, researchers do not know what the best treatment is for relapsed AL amyloidosis is, so they are testing new drugs or new combinations of drugs to see what will work best with the least side effects. 

The study drug, Bendamustine, is investigational, meaning it is not currently approved by the Food and Drug Administration (FDA) for treatment of AL amyloidosis, but has been approved for other types of cancer. This drug acts on cells in order to disrupt their growth, and is thought to work better on fast-growing cells, such as cancer cells. The researchers want to find out if bendamustine in addition to a drug called dexamethasone will help slow the growth of AL amyloidosis cells.

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Aneurysms


Pivotal Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms

The purpose of the study is to evaluate the safety and effectiveness of the FRED device, which is intended for use in treating wide-neck brain aneurysms. The FRED device is a small metallic mesh tube (or “flow-diverting stent”) that will be placed across the neck of the aneurysm and is intended to redirect blood flow away from the aneurysm. By blocking blood flow into the aneurysm, it is hoped the aneurysm will thrombose (clot) to decrease the chance for rupture.

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Prospective Study on Embolization of Intracranial Aneurysms with Pipeline Embolization Device (PREMIER)

The purpose of this clinical study is to collect information about how the Pipeline™ Embolization Device works in the treatment of brain aneurysms. The PipelineTM device is a cylinder-shaped mesh implant that is inserted into a blood vessel near your aneurysm. This device is designed to stop the aneurysm from getting bigger by slowing down the flow of blood into the aneurysm. Slowing down the flow of blood through the aneurysm may cause the aneurysm to get smaller over time.

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Safety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL Aneurysms with the Neuroform Atlas™ Stent

The purpose of this study is to evaluate the safety and effectiveness of the Neuroform Atlas stent, which is intended for use in wide-neck brain aneurysms. The Neuroform Atlas stent is a small metallic mesh tube that will be placed across the neck of the aneurysm and is intended to remodel the blood vessel as well as provide support for the coils which will be placed inside the aneurysm. These coils are small filaments of metal that are meant to help close off the aneurysm by blocking blood flow into the aneurysm.

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Bipolar Disorder


Event-Related Related Potentials as a Surrogate Endpoint in Psychiatric Clinical Trials: A Pilot Study of Mood Illnesses

Event-related potentials (ERPs) are electrical signals recorded over the scalp that reflect a response to a visual or auditory stimulus. In this pilot study, ERPs are examined as a measure of response to medication treatement for patients experiencing an acute major depressive episode. It is possible ERPs could be used to evaluate treatment response to antidepressant or other medications for psychiatric illness, and thus could serve to enhance drug development in clinical trials.

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Bone Marrow Transplant


A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients who Have Failed to Respond to Steroid Treatment for Acute 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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Brain Cancer


A Randomized, Phase III Trial Of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases

The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation plus memantine to using the usual whole-brain radiation plus memantine. The hippocampus is a brain structure that is important for memory. The addition of the hippocampal avoidance technique to the usual whole-brain radiation plus memantine will decrease the dose of radiation to your hippocampus. It is hoped hippocampal avoidance technique will decrease the chance of cognitive side effects, however it is possible hippocampal avoidance could have no impact on cognitive side effects and could even cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Memantine is already FDA-approved for use in patients with dementia and is commonly used off-label (that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain radiation therapy for cancer that has spread to the brain.

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A071101: A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, Alliance IND# 15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)

The purpose of this study is to compare the effects of a vaccine called heat shock protein peptide complex 96 (HSPPC-96) given with a drug called bevacizumab to bevacizumab alone. HSPPC-96 is experimental and is made from tissue taken from the brain tumor. Specifically, HSPPC-96 is a protein (a naturally occurring substance) that is taken from a person's brain tumor tissue and given back to them in the form of a preparation called a vaccine that may work to help their body have a response against remaining brain tumor cells. Bevacizumab blocks a protein called VEGF (Vascular Endothelial Growth Factor), which is produced by normal cells but over produced by cancer cells. Bevacizumab has been approved by the Food and Drug administration for treating brain tumors that grow back. In this study, subjects will either get HSPPC-96 vaccine at the same time as bevacizumab, HSPPC vaccine first and then bevacizumab if their tumor comes back, or bevacizumab alone. The use of HSPPC-96 in combination with bevacizumab is also investigational

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A071101: A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, Alliance IND# 15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)

The purpose of this study is to compare the effects of a vaccine called heat shock protein peptide complex 96 (HSPPC-96) given with a drug called bevacizumab to bevacizumab alone.  HSPPC-96 is experimental and is made from tissue taken from the brain tumor.  Specifically, HSPPC-96 is a protein (a naturally occurring substance) that is taken from a person's brain tumor tissue and given back to them in the form of a preparation called a vaccine that may work to help their body have a response against remaining brain tumor cells.   Bevacizumab blocks a protein called VEGF (Vascular Endothelial Growth Factor), which is produced by normal cells but over produced by cancer cells. Bevacizumab has been approved by the Food and Drug administration for treating brain tumors that grow back.  In this study, subjects will either get HSPPC-96 vaccine at the same time as bevacizumab, HSPPC vaccine first and then bevacizumab if their tumor comes back, or bevacizumab alone.  The use of HSPPC-96 in combination with bevacizumab is also investigational.

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A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade 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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Phase II Trial Of SMO/AKT/NF2 Inhibitors In Progressive Meningiomas With SMO/AKT/ NF2 Mutations

The purpose of this study is to test good and bad effects of two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients. Researchers have looked at the DNA material (genes) that can be affected in meningioma and have found several genes that are altered, or mutated. These include the genes called SMO and NF2. When the SMO or NF2 genes are altered, it can cause a tumor to grow. There are drugs that target these 2 genes.

The study drug, vismodegib, blocks the SMO receptor. Vismodegib has already been FDA-approved to treat basal cell cancer, which is a type of skin cancer. Vismodegib could shrink cancer, but it could also cause side effects. The study drug, GSK2256098, blocks FAK, and seems to work better in tumors that have NF2-mutations. GSK2256098 has been tested in other cancers. Researchers hope to learn if either of the study drugs will shrink cancer.

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Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastoma

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Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to compare a different radiation schedule and higher radiation dose [higher dose group] to the standard dose of radiation [standard dose group]. Both groups will receive usual chemotherapy, temozolomide. The higher radiation dose could shrink brain cancer, but it could also cause side effects. This study will allow the researchers to know whether this higher dose is better, the same, or worse than the usual approach.

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Brain Malformations


Prenatal diagnosis of Fetal Brain Malformations: Improving assessment of prognosis through Gene expression and imaging studies

The study includes 60 pregnant women - 15 carrying fetuses that have been prenatally diagnosed with brain malformations for each of following malformations: ventriculomegaly, agenesis of corpus callosum and cerebellar malformations, and 15 carrying fetuses that do not have brain malformations - matched for the same stage of pregnancy. The pregnant women whose fetuses have brain malformation will undergo MRI examination as a part of advanced obstetric care (most commonly in the second trimester at 18-24 weeks). For pregnant women whose fetuses do not have malformations, the women may be offered a fetal MRI scan at no cost to the women. Since brain growth slows in fetuses with brain malformations, Dr. Tarui will look for differences and changes in the fetal brains with brain malformations compared to unaffected children.

The study also includes children of women who participate in the study. Children will be followed up after the birth and their neurodevelopmental outcome will be precisely recorded by battery of neurodevelopmental testing at 18 month of age.

The study’s goal is to establish anatomical landmarks for fetal brain development in brain malformations that can subsequently predict future neurodevelopmental outcome of affected children.

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Brain Tumors


A Randomized, Phase III Trial Of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases

The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation plus memantine to using the usual whole-brain radiation plus memantine. The hippocampus is a brain structure that is important for memory. The addition of the hippocampal avoidance technique to the usual whole-brain radiation plus memantine will decrease the dose of radiation to your hippocampus. It is hoped hippocampal avoidance technique will decrease the chance of cognitive side effects, however it is possible hippocampal avoidance could have no impact on cognitive side effects and could even cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Memantine is already FDA-approved for use in patients with dementia and is commonly used off-label (that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain radiation therapy for cancer that has spread to the brain.

More

A071101: A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, Alliance IND# 15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)

The purpose of this study is to compare the effects of a vaccine called heat shock protein peptide complex 96 (HSPPC-96) given with a drug called bevacizumab to bevacizumab alone. HSPPC-96 is experimental and is made from tissue taken from the brain tumor. Specifically, HSPPC-96 is a protein (a naturally occurring substance) that is taken from a person's brain tumor tissue and given back to them in the form of a preparation called a vaccine that may work to help their body have a response against remaining brain tumor cells. Bevacizumab blocks a protein called VEGF (Vascular Endothelial Growth Factor), which is produced by normal cells but over produced by cancer cells. Bevacizumab has been approved by the Food and Drug administration for treating brain tumors that grow back. In this study, subjects will either get HSPPC-96 vaccine at the same time as bevacizumab, HSPPC vaccine first and then bevacizumab if their tumor comes back, or bevacizumab alone. The use of HSPPC-96 in combination with bevacizumab is also investigational

More

A071101: A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, Alliance IND# 15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)

The purpose of this study is to compare the effects of a vaccine called heat shock protein peptide complex 96 (HSPPC-96) given with a drug called bevacizumab to bevacizumab alone.  HSPPC-96 is experimental and is made from tissue taken from the brain tumor.  Specifically, HSPPC-96 is a protein (a naturally occurring substance) that is taken from a person's brain tumor tissue and given back to them in the form of a preparation called a vaccine that may work to help their body have a response against remaining brain tumor cells.   Bevacizumab blocks a protein called VEGF (Vascular Endothelial Growth Factor), which is produced by normal cells but over produced by cancer cells. Bevacizumab has been approved by the Food and Drug administration for treating brain tumors that grow back.  In this study, subjects will either get HSPPC-96 vaccine at the same time as bevacizumab, HSPPC vaccine first and then bevacizumab if their tumor comes back, or bevacizumab alone.  The use of HSPPC-96 in combination with bevacizumab is also investigational.

More

A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade 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.

More

Phase II Trial Of SMO/AKT/NF2 Inhibitors In Progressive Meningiomas With SMO/AKT/ NF2 Mutations

The purpose of this study is to test good and bad effects of two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients. Researchers have looked at the DNA material (genes) that can be affected in meningioma and have found several genes that are altered, or mutated. These include the genes called SMO and NF2. When the SMO or NF2 genes are altered, it can cause a tumor to grow. There are drugs that target these 2 genes.

The study drug, vismodegib, blocks the SMO receptor. Vismodegib has already been FDA-approved to treat basal cell cancer, which is a type of skin cancer. Vismodegib could shrink cancer, but it could also cause side effects. The study drug, GSK2256098, blocks FAK, and seems to work better in tumors that have NF2-mutations. GSK2256098 has been tested in other cancers. Researchers hope to learn if either of the study drugs will shrink cancer.

More

Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastoma

More

Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to compare a different radiation schedule and higher radiation dose [higher dose group] to the standard dose of radiation [standard dose group]. Both groups will receive usual chemotherapy, temozolomide. The higher radiation dose could shrink brain cancer, but it could also cause side effects. This study will allow the researchers to know whether this higher dose is better, the same, or worse than the usual approach.

More

Breast Cancer


A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients.

The purpose of this study is to compare the effects, both good and/or bad, of giving participants either niraparib or the standard chemotherapy for HER2-negative , BRCA mutation positive breast cancer to find out which is better

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Bronchopulmonary Dysplasia


Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome

Recombinant human CC10 protein (rhCC10) is a novel therapeutic agent used to prevent the development of chronic respiratory morbidity (CRM; repeated respiratory infections, asthma, re-hospitalizations) in preterm infants. Native CC10 is a natural anti-inflammatory and immunomodulatory factor produced by Clara Cells in the lung and is the most abundant protein in respiratory mucosa. Animal data demonstrate that a single intratracheal dose of rhCC10 administered shortly after birth reduces lung inflammation (important biomarkers linked to lung injury in preterm infants), promotes normal lung development, preserves lung architecture, improves pulmonary function, suppresses the response to endotoxin and enhances resistance to pulmonary infections. In preterm infants who die or develop lung inflammation and subsequent bronchopulmonary dysplasia (BPD), both the concentration and activity of CC10 are significantly reduced indicating that CC10 is essential for preventing lung injury and promoting normal lung development. In a small phase I study, rhCC10 significantly decreased several indices of pulmonary inflammation in the lungs of premature infants who were at risk of developing BPD and associated CRM. The drug appeared to be safe, well-tolerated, and reduce risk of re-hospitalization due to respiratory illness for 9-10 months after a single intratracheal dose at the time of birth (0/11 rhCC10-treated infants vs. 3/6 placebo-treated). This supports the protective role of rhCC10 against damage from hyperoxia, mechanical ventilation, inflammation, and infection in the immature lung. A more normal airway epithelium will produce significantly more endogenous CC10, with both factors contributing to enhanced resistance to infections, less asthma, and improved long-term respiratory outcome. We propose to conduct a Phase 2 clinical trial to evaluate rhCC10 in extremely premature infants (<29 weeks gestation) for the prevention of BPD and CRM. This will be a randomized, double-blind, placebo-controlled dose escalation study in 88 premature infants. A single intratracheal dose of study drug (rhCC10 or placebo) will be administered to preterm infants receiving surfactant and mechanical ventilation for treatment of RDS. Infants will be followed to evaluate safety, pharmacokinetics, and short and long term efficacy of this approach. Safety will be evaluated through serious adverse event (SAE) and adverse event monitoring and by Bayley neurodevelopmental assessments at 18 months corrected gestational age (CGA). Efficacy measurements will include the primary combined endpoint of alive without evidence of CRM at 12 months CGA (defined by parental diaries and pulmonary questionnaires) comparing rhCC10 treated to placebo controls. The availability of a therapy which prevents lung injury, promotes lung development, and prevents serious respiratory infections and asthma in high risk preterm infants would be a highly significant advancement in care.

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Chronic Lymphocytic Leukemia


A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients ( ≥ 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

This study is being done to evaluate what effects, if any, the study drug Ibrutinib has when given alone or in combination with Rituximab and how it compares to the current standard chemotherapy drug combination of Bendamustine and Rituximab. It will look at how the study drug alone, or the study drug plus Rituximab, compares to the standard of care chemotherapy in keeping the cancer from progressing.

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A Randomized Phase III Study of Ibrutinib(PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL).

The purpose of this study is to compare the effects, good and/or bad, of two different therapies that include combinations of the drugs rituximab, fludarabine, cyclophosphamide and Ibrutinib have on you and your CLL. The first three of these drugs are standard treatments for CLL. Fludarabine and cyclophosphamide have been approved by the Food and Drug Administration (FDA) for the treatment of CLL. Rituximab is approved for the treatment of CLL when given in combination with fludarabine and cyclophosphamide and is also approved for treatment of non-Hodgkin lymphoma and rheumatoid arthritis. Although Ibrutinib has been previously studied in patients with CLL, it is investigational and has not been approved by the FDA for use in CLL. In this study, ibrutinib will be given in combination with rituximab.

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Colon Cancer


Colon Cancer - FOLFOX and celecoxib vs. FOLFOX for Patients with Resected Stage III Colon Cancer

This study is being done to determine if the addition of celecoxib to standard chemotherapy (FOLFOX) improves disease-free survival when compared to standard chemotherapy alone (FOLFOX) after surgery in patients with stage III colon cancer. This study will also look at whether receiving FOLFOX chemotherapy for 12 weeks is as good as receiving it for 24 weeks in preventing recurrence of colon cancer.

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Colorectal Cancer


Colon Cancer - FOLFOX and celecoxib vs. FOLFOX for Patients with Resected Stage III Colon Cancer

This study is being done to determine if the addition of celecoxib to standard chemotherapy (FOLFOX) improves disease-free survival when compared to standard chemotherapy alone (FOLFOX) after surgery in patients with stage III colon cancer. This study will also look at whether receiving FOLFOX chemotherapy for 12 weeks is as good as receiving it for 24 weeks in preventing recurrence of colon cancer.

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Depression


Event-Related Related Potentials as a Surrogate Endpoint in Psychiatric Clinical Trials: A Pilot Study of Mood Illnesses

Event-related potentials (ERPs) are electrical signals recorded over the scalp that reflect a response to a visual or auditory stimulus. In this pilot study, ERPs are examined as a measure of response to medication treatement for patients experiencing an acute major depressive episode. It is possible ERPs could be used to evaluate treatment response to antidepressant or other medications for psychiatric illness, and thus could serve to enhance drug development in clinical trials.

More

Diabetes Type 2


Assessment of Coagulation Factors in Nonalcoholic Fatty Liver Disease (NAFLD) and Related Conditions

This non-interventional study seeks to determine the validity of the hypothesis that individuals with Nonalcoholic Fatty Liver Disease and/or its related conditions such as Type 2 Diabetes and obesity have elevated levels of two related coagulation proteins on their circulating blood cells, which are believed to play an important role in the development and progression of liver disease.

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Dry Eye


Dry Eye Assessment and Management Trial

Dry Eye Disease, phase III double masked, 1 year primary study and 2 year extension study for patients to be treated with Omega 3 fatty acids or placebo.

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Dystonia


An International Observational Prospective Study on Long-term Response to Botulinum Toxin Type A (BoNT-A) Injections in Subjects Suffering from Idiopathic Cervical Dystonia- Pharmaco- Economic Impact

This is a registry study to examine the long-term response to Botulinum toxin type A (BoNT-A) injections in subjects with idiopathic cervical dystonia. Focal dystonias are abnormal muscular contractions leading to twisting of body parts and abnormal postures. Cervical dystonia is the most common of the focal dystonias leading to the twisting of the head and neck. Botulinum toxin type A is a medication that has been shown to be effective in treating cervical dystonia. The effect of the treatment is not permanent and usually wears off after about 3 months, but sometimes the benefits may last longer. This is an observational study that involves subject’s medical data to be recorded, stored, and analyzed.

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Eosinophilic Esophagitis


A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients with Active Eosinophilic Esophagitis

The primary objective of the study is to assess the clinical efficacy of repeat subcutaneous (SC) doses of dupilumab, compared with placebo, to relieve symptoms in adult patients with active, moderate to severe eosinophilic esophagitis (EoE).

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Ependymoma


ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

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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Fibromyalgia


A Pilot fMRI Study of Fibromyalgia

A pilot fMRI study, funded by the National Center for Complementary and Alternative Medicine, will investigate the effects of Tai Chi classes on people with fibromyalgia. We are currently recruiting healthy volunteers who will serve as a matched control to compare brain structure and function. This study will involve a 30 minute evaluation at Tufts Medical Center as well as an fMRI scan at Massachusetts General Hospital (Charlestown Navy Yard).

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A Randomized, Double-Blind, Placebo-And Active-Controlled Study Of DS-5565 In Subjects With Pain Associated With Fibromyalgia

This is a phase 3 trial evaluating microgabalin for the treatment of pain associated with fibromyalgia. The primary objective of the study is to compare change in weekly ADPS (average daily pain score) from baseline to Week 13 in patients receiving a total daily dose of either 15 mg or 30 mg of microgabalin versus placebo. Patients that complete the initial study are eligible to enroll in an extension study which aims to assess the long-term safety of a total daily dose of mirogabalin 15 mg or mirogabalin 30 mg in patients with pain associated with fibromyalgia. Eligible subjects will be randomized in the ratio of 1:1:1:1 to receive 13 weeks of treatment with DS-5565 15 mg once daily (QD), DS-5565 15 mg twice daily (BID), placebo, or pregabalin 150 mg BID.

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Glioblastoma


Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastoma

More

Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to compare a different radiation schedule and higher radiation dose [higher dose group] to the standard dose of radiation [standard dose group]. Both groups will receive usual chemotherapy, temozolomide. The higher radiation dose could shrink brain cancer, but it could also cause side effects. This study will allow the researchers to know whether this higher dose is better, the same, or worse than the usual approach.

More

Glioblastoma Multiforme


A071101: A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, Alliance IND# 15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)

The purpose of this study is to compare the effects of a vaccine called heat shock protein peptide complex 96 (HSPPC-96) given with a drug called bevacizumab to bevacizumab alone.  HSPPC-96 is experimental and is made from tissue taken from the brain tumor.  Specifically, HSPPC-96 is a protein (a naturally occurring substance) that is taken from a person's brain tumor tissue and given back to them in the form of a preparation called a vaccine that may work to help their body have a response against remaining brain tumor cells.   Bevacizumab blocks a protein called VEGF (Vascular Endothelial Growth Factor), which is produced by normal cells but over produced by cancer cells. Bevacizumab has been approved by the Food and Drug administration for treating brain tumors that grow back.  In this study, subjects will either get HSPPC-96 vaccine at the same time as bevacizumab, HSPPC vaccine first and then bevacizumab if their tumor comes back, or bevacizumab alone.  The use of HSPPC-96 in combination with bevacizumab is also investigational.

More

Glioma


A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade 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.

More

GVHD


A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients who Have Failed to Respond to Steroid Treatment for Acute 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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Hand Osteoarthritis


A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-981 to Placebo in Subjects with Erosive Hand Osteoarthritis

This is the first multiple dose study of ABT-981, a novel biologic drug that targets IL-1α and IL-1β, in subjects with erosive hand osteoarthritis. It is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ABT-981 compared to placebo in subjects with erosive hand osteoarthritis. The primary objective is to evaluate the effect of ABT-981 on pain using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN NR3.1) pain subdomain score, in subjects with erosive hand OA at Week 16. The duration of the study and subject participation will be approximately 32 weeks.

Eligible subjects will be randomized in a ratio of 1:1 to receive either 200 mg of ABT-981 or placebo.

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Healthy Volunteers


A Pilot fMRI Study of Fibromyalgia

A pilot fMRI study, funded by the National Center for Complementary and Alternative Medicine, will investigate the effects of Tai Chi classes on people with fibromyalgia. We are currently recruiting healthy volunteers who will serve as a matched control to compare brain structure and function. This study will involve a 30 minute evaluation at Tufts Medical Center as well as an fMRI scan at Massachusetts General Hospital (Charlestown Navy Yard).

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Assessment of Coagulation Factors in Nonalcoholic Fatty Liver Disease (NAFLD) and Related Conditions

This non-interventional study seeks to determine the validity of the hypothesis that individuals with Nonalcoholic Fatty Liver Disease and/or its related conditions such as Type 2 Diabetes and obesity have elevated levels of two related coagulation proteins on their circulating blood cells, which are believed to play an important role in the development and progression of liver disease.

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Event-Related Related Potentials as a Surrogate Endpoint in Psychiatric Clinical Trials: A Pilot Study of Mood Illnesses

Event-related potentials (ERPs) are electrical signals recorded over the scalp that reflect a response to a visual or auditory stimulus. In this pilot study, ERPs are examined as a measure of response to medication treatement for patients experiencing an acute major depressive episode. It is possible ERPs could be used to evaluate treatment response to antidepressant or other medications for psychiatric illness, and thus could serve to enhance drug development in clinical trials.

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High Blood Pressure


Hypertension - SPRINT

About two-thirds of those over age 60 have high blood pressure. Lowering blood pressure further than current practice might help prevent heart disease, stroke, and kidney disease. In addition, high blood pressure can cause changes in memory and thinking as people get older. The purpose of this study is to determine whether lowering blood pressure will reduce the rate of heart disease and stroke, memory decline or worsening of kidney disease in adults over the age of 55 who already have high blood pressure. Specifically, the SPRINT trial will test whether keeping systolic blood pressure (top number in your blood pressure reading) less than 120 mmHg is better than the current recommendation of keeping it less than 140 mmHg. This study does not involve experimental drugs. The trial is approximately 5 years long and participants receive free blood pressure medications for the duration of the study.

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Hodgkin Lymphoma


Lymphoma - Sequential SGN-35 Therapy (S-AVD) for Untreated Hodgkin Lymphoma

This study involves administration of an investigational drug called SGN35 (brentuximab vedotin) in combination with standard chemotherapy (adriamycin, vinblastine, and dacarbazine, or AVD) for participants 60 years old or older with untreated Hodgkin Lympoma     

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Hypertension


Hypertension - SPRINT

About two-thirds of those over age 60 have high blood pressure. Lowering blood pressure further than current practice might help prevent heart disease, stroke, and kidney disease. In addition, high blood pressure can cause changes in memory and thinking as people get older. The purpose of this study is to determine whether lowering blood pressure will reduce the rate of heart disease and stroke, memory decline or worsening of kidney disease in adults over the age of 55 who already have high blood pressure. Specifically, the SPRINT trial will test whether keeping systolic blood pressure (top number in your blood pressure reading) less than 120 mmHg is better than the current recommendation of keeping it less than 140 mmHg. This study does not involve experimental drugs. The trial is approximately 5 years long and participants receive free blood pressure medications for the duration of the study.

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Intracranial Pressure


Assessment of intracranial pressure, cerebral microcirculation, and tissue oxygenation with non-invasive near-infrared spectroscopy

This study is being done to find out if an external and painless method of measuring and monitoring intracranial pressure (ICP) is possible. The goal is to show this simple external monitor can provide the same information that standard, surgically-implanted monitors do.

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Leukemia


A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients ( ≥ 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

This study is being done to evaluate what effects, if any, the study drug Ibrutinib has when given alone or in combination with Rituximab and how it compares to the current standard chemotherapy drug combination of Bendamustine and Rituximab. It will look at how the study drug alone, or the study drug plus Rituximab, compares to the standard of care chemotherapy in keeping the cancer from progressing.

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A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)Transplant- Plerixafor prior to Autologous Stem Cell Transplantation

This study is being done to evaluate what effects, if any, the study drug Ibrutinib has when given alone or in combination with Rituximab and how it compares to the current standard chemotherapy drug combination of Bendamustine and Rituximab. It will look at how the study drug alone, or the study drug plus Rituximab, compares to the standard of care chemotherapy in keeping the cancer from progressing.

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A Randomized Phase III Study of Ibrutinib(PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL).

The purpose of this study is to compare the effects, good and/or bad, of two different therapies that include combinations of the drugs rituximab, fludarabine, cyclophosphamide and Ibrutinib have on you and your CLL. The first three of these drugs are standard treatments for CLL. Fludarabine and cyclophosphamide have been approved by the Food and Drug Administration (FDA) for the treatment of CLL. Rituximab is approved for the treatment of CLL when given in combination with fludarabine and cyclophosphamide and is also approved for treatment of non-Hodgkin lymphoma and rheumatoid arthritis. Although Ibrutinib has been previously studied in patients with CLL, it is investigational and has not been approved by the FDA for use in CLL. In this study, ibrutinib will be given in combination with rituximab.

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A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

This study looks at how well an antibiotic prophylaxis, called levofloxacin, can prevent bacterial infection from developing in children and young adults receiving intensive cancer treatment or a stem cell transplant. The levofloxacin drug which prevents bacterial infection is experimental.

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AALL0932:  Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

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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AALL1331, Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

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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E2906: Phase III Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age ≥60 Years

To evaluate the effect of Clofarabine induction and consolidation therapy on overall survival in comparison with standard therapy ( Daunorubicin and Cytarabine) in newly diagnosed AML patients ages 60 and over.

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S1203: A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)

This study is being done to evaluate what effects, if any, different drug combinations have on your Leukemia. The first drug combination is Daunorubicin + AraC; this is the standard of care for your Leukemia. The second drug combination is another standard of care consisting of Idarubicin plus AraC. The third drug combination is Idarubicin + AraC + Vorinostat, with Vorinostat being the investigational drug. This study will compare the three different drug combinations in how well they work to get rid of the cancer and keep it from coming back.

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Liver Diseases


Assessment of Coagulation Factors in Nonalcoholic Fatty Liver Disease (NAFLD) and Related Conditions

This non-interventional study seeks to determine the validity of the hypothesis that individuals with Nonalcoholic Fatty Liver Disease and/or its related conditions such as Type 2 Diabetes and obesity have elevated levels of two related coagulation proteins on their circulating blood cells, which are believed to play an important role in the development and progression of liver disease.

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Lung Cancer


RTOG 1306: A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC)

Cancer is a disease caused by alterations in the functions of genes within the cells. In approximately 15% of patients with non-small cell lung cancer, one of two genes is altered significantly (known as EGFR mutation or ALK rearrangement). Erlotinib, a pill, taken on a daily basis produces significant decrease in the size of tumors in patients with advanced stage lung cancer with EGFR mutation. Similarly, another pill, crizotinib, produces significant decrease in the size of tumors in patients with advanced stage lung cancer with ALK rearrangement. However it is not clear how useful these two drugs will be in patients with a less advanced form of lung cancer in the presence of these gene alterations.  The purpose of this study is to find out what effects, good and/or bad, one of the following treatments has on locally advanced, non-operable lung cancer with specific gene alterations (EGFR mutation or ALK rearrangement).

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Lyme Disease


Xenodiagnosis After Antibiotic Treatment for Lyme Disease – Phase 2 study

A substantial proportion of patients with Lyme disease continue to have symptoms after antibiotic treatment but the cause of these symptoms is controversial.  Recent animal studies have suggested that the Lyme disease bacteria, or their components, may persist even after antibiotic treatment. 

 

The goal of this study is to determine whether the symptoms of Lyme disease after treatment are associated with xenodiagnostic detection of the Lyme disease bacteria. Xenodiagnosis is a method used to detect an infectious organism by using that organism’s natural vector.  Because the bacteria are highly adapted to find their natural host, studies have shown that xenodiagnosis can be a very sensitive method for detecting continued presence of infections, including Lyme disease. 

 

This study will involve placing laboratory reared ticks on patients who have early or late stage Lyme disease. All ticks will then be removed from the patient and tested for evidence of the Lyme bacteria.  Participants will complete a series of questionnaires to assess their level of function and symptomology at different time points after treatment.  The study will look for correlations between levels of function/improvement in symptoms and the continued presence of infection as determined by xenodiagnosis. 

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Lymphomas


A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients ( ≥ 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

This study is being done to evaluate what effects, if any, the study drug Ibrutinib has when given alone or in combination with Rituximab and how it compares to the current standard chemotherapy drug combination of Bendamustine and Rituximab. It will look at how the study drug alone, or the study drug plus Rituximab, compares to the standard of care chemotherapy in keeping the cancer from progressing.

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A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)Transplant- Plerixafor prior to Autologous Stem Cell Transplantation

This study is being done to evaluate what effects, if any, the study drug Ibrutinib has when given alone or in combination with Rituximab and how it compares to the current standard chemotherapy drug combination of Bendamustine and Rituximab. It will look at how the study drug alone, or the study drug plus Rituximab, compares to the standard of care chemotherapy in keeping the cancer from progressing.

More

A Randomized Phase III Study of Ibrutinib(PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL).

The purpose of this study is to compare the effects, good and/or bad, of two different therapies that include combinations of the drugs rituximab, fludarabine, cyclophosphamide and Ibrutinib have on you and your CLL. The first three of these drugs are standard treatments for CLL. Fludarabine and cyclophosphamide have been approved by the Food and Drug Administration (FDA) for the treatment of CLL. Rituximab is approved for the treatment of CLL when given in combination with fludarabine and cyclophosphamide and is also approved for treatment of non-Hodgkin lymphoma and rheumatoid arthritis. Although Ibrutinib has been previously studied in patients with CLL, it is investigational and has not been approved by the FDA for use in CLL. In this study, ibrutinib will be given in combination with rituximab.

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Lymphoma - Sequential SGN-35 Therapy (S-AVD) for Untreated Hodgkin Lymphoma

This study involves administration of an investigational drug called SGN35 (brentuximab vedotin) in combination with standard chemotherapy (adriamycin, vinblastine, and dacarbazine, or AVD) for participants 60 years old or older with untreated Hodgkin Lympoma     

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Transplant- Plerixafor prior to Autologous Stem Cell Transplantation

Plerixafor is a drug developed to block the effects of SDF1a and has been approved by the Federal Drug Administration (FDA) for use in humans to help release blood stem cells from the bone marrow for use in transplantation.  The use of plerixafor to interrupt communication between stromal cells and cancer has not been approved by the FDA and is experimental.

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Macular Degeneration


A Phase 1, Open-Label, Multi-Center Trial with Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients with Neovascular Age-Related Macular Degeneration (AMD)

The purpose of this study is to assess the safety and tolerability of the investigational eye drop solution, PAN-90806. The biological response to the eye drops will also be assessed to see if the drug helps slow the progression of neovascular age-related macular degeneration.  Participants (age 50 years and older) enrolled in the study will be randomized into one of three study arms (1 mg/ml BID, 2 mg/ml BID, 4 mg/ml QD).

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A Randomized, Double Masked, Placebo Controlled Study Evaluating ORACEA in Subjects with Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration

The purpose of this study is to assess the safety and effectivness of the investigational drug ORCEA to determine if it can slow the progresssion of geographic atrophy in your study eye in participants who have geographic atrophy secondary to non exudative age related macular degneration (dry AMD).

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Multiple Myeloma


Multiple Myeloma - An Open-label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax® CD38) (Anti-CD38 Monoclonal Antibody) in Combination with Backbone Regimens for Subjects with Multiple Myeloma

The purpose of this research study is to assess the safety, tolerability and dosing of daratumumab when given to subjects with multiple myeloma in combination with various backbone treatment regimens: Velcade-dexamethasone (VD), Pomalidomide-dexamethasone (Pom-dex). Other purposes of this study are to find out how long daratumumab when combined with the backbone treatments stays in and acts on the body (this is shown by laboratory blood and urine tests) and how your body responds to daratumumab given with backbone.

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Neuroblastoma


DFMO: A Phase II Preventative Trial of DFMO (eflornithine HCl) as a Single Agent in Patients with High Risk Neuroblastoma in Remission

This study is being done to evaluate what effects, if any, DFMO (eflornithine HCL) has when taken as a single agent for neuroblastoma that is in remission. It will look at how effective the study drug is at keeping the cancer from coming back.

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Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

The purpose of this study is to observe the effects of an investigational biologic drug, ch14.18, in combination with two other drugs (isotretinoin and aldesleukin) on preventing cancer from coming back in children with neuroblastoma

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Non-Hodgkin Lymphoma


A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients ( ≥ 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

This study is being done to evaluate what effects, if any, the study drug Ibrutinib has when given alone or in combination with Rituximab and how it compares to the current standard chemotherapy drug combination of Bendamustine and Rituximab. It will look at how the study drug alone, or the study drug plus Rituximab, compares to the standard of care chemotherapy in keeping the cancer from progressing.

More

A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)Transplant- Plerixafor prior to Autologous Stem Cell Transplantation

This study is being done to evaluate what effects, if any, the study drug Ibrutinib has when given alone or in combination with Rituximab and how it compares to the current standard chemotherapy drug combination of Bendamustine and Rituximab. It will look at how the study drug alone, or the study drug plus Rituximab, compares to the standard of care chemotherapy in keeping the cancer from progressing.

More

A Randomized Phase III Study of Ibrutinib(PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL).

The purpose of this study is to compare the effects, good and/or bad, of two different therapies that include combinations of the drugs rituximab, fludarabine, cyclophosphamide and Ibrutinib have on you and your CLL. The first three of these drugs are standard treatments for CLL. Fludarabine and cyclophosphamide have been approved by the Food and Drug Administration (FDA) for the treatment of CLL. Rituximab is approved for the treatment of CLL when given in combination with fludarabine and cyclophosphamide and is also approved for treatment of non-Hodgkin lymphoma and rheumatoid arthritis. Although Ibrutinib has been previously studied in patients with CLL, it is investigational and has not been approved by the FDA for use in CLL. In this study, ibrutinib will be given in combination with rituximab.

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Ophthalmology


A Phase 1, Open-Label, Multi-Center Trial with Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients with Neovascular Age-Related Macular Degeneration (AMD)

The purpose of this study is to assess the safety and tolerability of the investigational eye drop solution, PAN-90806. The biological response to the eye drops will also be assessed to see if the drug helps slow the progression of neovascular age-related macular degeneration.  Participants (age 50 years and older) enrolled in the study will be randomized into one of three study arms (1 mg/ml BID, 2 mg/ml BID, 4 mg/ml QD).

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A Randomized, Double Masked, Placebo Controlled Study Evaluating ORACEA in Subjects with Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration

The purpose of this study is to assess the safety and effectivness of the investigational drug ORCEA to determine if it can slow the progresssion of geographic atrophy in your study eye in participants who have geographic atrophy secondary to non exudative age related macular degneration (dry AMD).

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Dry Eye Assessment and Management Trial

Dry Eye Disease, phase III double masked, 1 year primary study and 2 year extension study for patients to be treated with Omega 3 fatty acids or placebo.

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Eplerenone for Central Serous Chrioretinopathy: A Pilot Study

Patients diagnosed with central serous chorioretinopathy (CSCR) will take Eplerenone, a medication FDA approved for heart failure and high blood pressure, for 1 month. The objective is to assess whether or not there is resolution of fluid under the retina and improvement in vision. The study duration will be one month.

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Osteoarthritis


A multi-center, parallel, double-blind, randomized, placebo-controlled study to evaluate the effectiveness of HYMOVIS, a new viscoelastic hydrogel, for the treatment of osteoarthritis of the knee

This is a multi-center, parallel, double-blind, randomized, placebo-controlled study to evaluate the safety and effectiveness of HYMOVIS, a new viscoelastic hydrogel, for the treatment of osteoarthritis of the knee.  A large number of experimental and clinical studies in OA have demonstrated that intra-articular (IA) administration of hyaluranan (HA) may improve the altered rheological properties of synovial fluid, improve signs and symptoms of patients, and in some studies exert protective and reparative effects on the joint structure.

Subjects will undergo intra-articular injections of the study treatment (HYMOVIS or placebo), and subjects will receive a second IA injection 7 days following the first injection and will be followed for up to 180 days after the first treatment. Other study procedures include X-ray, physician assessment, urine pregnancy test, urine drug test, saliva alcohol test and subject questionnaires.

The primary outcome is to evaluate the effectiveness of two 3 mL intra-articular (IA) injections of HYMOVIS in comparison with 3 mL IA injections of Placebo in providing superior pain relief for the treatment of subjects with symptomatic primary osteoarthritis of the knee measured by the Western Ontario and McMaster Universities Arthritis (WOMAC) Pain Subscale.

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A Phase 2a Study Evaluating the Safety, Efficacy,and Pharmacodynamic Effects of ABT-981 in Patients with Knee Osteoarthritis

This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability and efficacy of ABT-981, a novel biologic drug that targets IL-1α and IL-1β, in male and female subjects ages 35 through 74, inclusive, with symptomatic and radiographic knee osteoarthritis. The main objective of the study is to assess the effect of ABT-981 on OA knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 16 and synovitis/effusion volume of the index knee using quantitative measures and semi-quantitative MRI scoring at Week 26.

Eligible subjects will be randomized in the ratio of 1:1:1:1 to receive study drug every 2 weeks for  50 weeks of treatment with  25 mg ABT-981 SC, 100 mg ABT-981 SC, 200 mg ABT-981 SC or Matching placebo SC

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A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-981 to Placebo in Subjects with Erosive Hand Osteoarthritis

This is the first multiple dose study of ABT-981, a novel biologic drug that targets IL-1α and IL-1β, in subjects with erosive hand osteoarthritis. It is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ABT-981 compared to placebo in subjects with erosive hand osteoarthritis. The primary objective is to evaluate the effect of ABT-981 on pain using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN NR3.1) pain subdomain score, in subjects with erosive hand OA at Week 16. The duration of the study and subject participation will be approximately 32 weeks.

Eligible subjects will be randomized in a ratio of 1:1 to receive either 200 mg of ABT-981 or placebo.

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Effect of Intra-Articular Steroids on Structural Progression of Knee OA: A Randomized Controlled Trial

To study the effects of intra-articular corticosteroid injections on the progression of knee osteoarthritis

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Ovarian Cancer


A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer

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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NRG-GY003: Phase II Randomized Trial of Nivolumab with or without Ipilimumab in Patients with Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer

The purpose of this study is to test any good and bad effects of the study drugs called nivolumab and ipilimumab.  These are drugs that work in slightly different ways by stimulating the immune system. Nivolumab, or the combination of nivolumab and ipilimumab could shrink your cancer but these drugs could also cause side effects. Researchers hope to learn if nivolumab, or the combination of nivolumab with Ipilimumab followed by nivolumab will shrink the cancer by at least one-quarter compared to its present size. Shrinkage of a cancer by at least one-quarter compared to initial size is considered a response. Both nivolumab and ipilimumab have been tested separately in several types of human tumors (i.e., melanoma, lung cancers and others), and ipilimumab is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of melanoma that has spread. The combination of nivolumab and ipilimumab is now undergoing testing for a variety of cancer types.

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Polycystic Kidney Disease


A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease

Living with the pain, high blood pressure, and other symptoms of autosomal dominant polycystic kidney disease (ADPKD) can be overwhelming. And because ADPKD may be passed from one generation to the next, you may have seen how it has affected your family and wonder how the disease will affect you.

If you have ADPKD, and have participated in a previous Tolvaptan research study, you may want to learn more about the Open Label clinical research study.

What is the Open Label study?

The purpose of the Open Label study is to evaluate the long-term safety and effectiveness of an investigational medication called tolvaptan in patients with ADPKD.

Who can participate?

You may be able to join the study if you:

  • Have participated in a previous Tolvaptan research study
  • Are diagnosed with ADPKD

What is the investigational medication?

Tolvaptan is being investigated in this study as a potential treatment to slow the progression of cyst growth in the kidneys of adults with ADPKD.

What are the potential risks and benefits?

Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.

The information learned from the study and your participation may help us learn about how to develop future treatment options for people with ADPKD.

Study participation is voluntary. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have. Your health is very important to them.

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A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

Living with the pain, high blood pressure, and other symptoms of autosomal dominant polycystic kidney disease (ADPKD) can be overwhelming. And because ADPKD may be passed from one generation to the next, you may have seen how it has affected your family and wonder how the disease will affect you.

If you have ADPKD, you may want to learn more about the REPRISE clinical research study.

What is the REPRISE study?

The purpose of the REPRISE study is to evaluate the safety and effectiveness of an investigational medication called tolvaptan in patients with late stage 2 to early stage 4 chronic kidney disease caused by ADPKD.

Who can participate?

You may be able to join the study if you:

  • Are between the ages of 18 to 55 years old; patients aged 56 to 65 may be able to participate in some circumstances
  • Are diagnosed with ADPKD

What is the investigational medication?

Tolvaptan is being investigated in this study as a potential treatment to slow the progression of cyst growth in the kidneys of adults with ADPKD.

What are the potential risks and benefits?

Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.

Study participation is voluntary. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have. Your health is very important to them.

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Polycystic Kidney Disease - PKD Registry

This project consists of the development of a Polycystic Kidney Disease Research Registry database for the purpose of conducting retrospective research on Polycystic Kidney Disease using information from patient encounters in the Nephrology clinic at Tufts Medical Center, obtaining permission from patients in order to contact them in the future to ascertain any interest in participating in research studies that they may be eligible for, and permitting review of information contained within the registry to identify patients who may be eligible for future research studies.

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Preventive Medicine


CS SCARLETT: Covert Strokes – Semi-structured interviews of Clinicians Assessing Risk, Logical inference, and Equipoise of Treatments and Testing decisions

This study is a qualitative exploration of the beliefs, attitudes, and behaviors of clinicians who provide care for patients with covert brain infarcts (silent strokes). We hope to better understand how clinicians are currently approaching incidentally discovered strokes without apparent symptoms.

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CS SPECTRE: Covert Strokes – Semi-structured interviews of Patient Experiences, Concerns, information Transfer, and Risk Estimation

This study is a qualitative exploration of the experiences and concerns of patients following the detection of incidentally discovered strokes without apparent symptoms (covert strokes, or silent strokes). We hope to better understand the needs of patients in order to orient future studies in screening, treatment, and prevention to meet those needs.

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Prostate Cancer


A031201: Phase III Trial of Enzalutamide (NSC # 766085) versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cance

This study is being done to evaluate what effects, if any, the study drug Enzalutamide has on prostate cancer when given alone or in combination with hormonal agents Abiraterone and Prednisone. It will look at how the study drug alone compares to the study drug plus these hormonal agents in keeping the cancer from progressing.

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Respiratory Distress Syndrome in Premature Infant


Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome

Recombinant human CC10 protein (rhCC10) is a novel therapeutic agent used to prevent the development of chronic respiratory morbidity (CRM; repeated respiratory infections, asthma, re-hospitalizations) in preterm infants. Native CC10 is a natural anti-inflammatory and immunomodulatory factor produced by Clara Cells in the lung and is the most abundant protein in respiratory mucosa. Animal data demonstrate that a single intratracheal dose of rhCC10 administered shortly after birth reduces lung inflammation (important biomarkers linked to lung injury in preterm infants), promotes normal lung development, preserves lung architecture, improves pulmonary function, suppresses the response to endotoxin and enhances resistance to pulmonary infections. In preterm infants who die or develop lung inflammation and subsequent bronchopulmonary dysplasia (BPD), both the concentration and activity of CC10 are significantly reduced indicating that CC10 is essential for preventing lung injury and promoting normal lung development. In a small phase I study, rhCC10 significantly decreased several indices of pulmonary inflammation in the lungs of premature infants who were at risk of developing BPD and associated CRM. The drug appeared to be safe, well-tolerated, and reduce risk of re-hospitalization due to respiratory illness for 9-10 months after a single intratracheal dose at the time of birth (0/11 rhCC10-treated infants vs. 3/6 placebo-treated). This supports the protective role of rhCC10 against damage from hyperoxia, mechanical ventilation, inflammation, and infection in the immature lung. A more normal airway epithelium will produce significantly more endogenous CC10, with both factors contributing to enhanced resistance to infections, less asthma, and improved long-term respiratory outcome. We propose to conduct a Phase 2 clinical trial to evaluate rhCC10 in extremely premature infants (<29 weeks gestation) for the prevention of BPD and CRM. This will be a randomized, double-blind, placebo-controlled dose escalation study in 88 premature infants. A single intratracheal dose of study drug (rhCC10 or placebo) will be administered to preterm infants receiving surfactant and mechanical ventilation for treatment of RDS. Infants will be followed to evaluate safety, pharmacokinetics, and short and long term efficacy of this approach. Safety will be evaluated through serious adverse event (SAE) and adverse event monitoring and by Bayley neurodevelopmental assessments at 18 months corrected gestational age (CGA). Efficacy measurements will include the primary combined endpoint of alive without evidence of CRM at 12 months CGA (defined by parental diaries and pulmonary questionnaires) comparing rhCC10 treated to placebo controls. The availability of a therapy which prevents lung injury, promotes lung development, and prevents serious respiratory infections and asthma in high risk preterm infants would be a highly significant advancement in care.

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Seizures


A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects with Super-Refractory Status Epilepticus

The purpose of the study is to find out if SAGE-547 has any effect on continuous seizures and if it is safe to use in patients in super-refractory status epilepticus (SRSE). SAGE-547 Injection (SAGE-547) is an investigational drug being studied in patients with continuous seizures (seizures that have little or no break between them) that do not respond to seizure medications.

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Stroke


A Randomized, Double-Blind, Multinational Study to Prevent Major Vascular Events with Ticagrelor Compared to Aspirin (ASA) in Patients with Acute Ischemic Stroke or TIA

This study is to compare the effect and safety of the investigational drug, ticagrelor, given twice daily compared to aspirin, given once daily for the prevention of death, heart attack, and stroke in patients with acute ischemic stroke or TIA. Ticagrelor is not FDA approved for these indications.

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CS SCARLETT: Covert Strokes – Semi-structured interviews of Clinicians Assessing Risk, Logical inference, and Equipoise of Treatments and Testing decisions

This study is a qualitative exploration of the beliefs, attitudes, and behaviors of clinicians who provide care for patients with covert brain infarcts (silent strokes). We hope to better understand how clinicians are currently approaching incidentally discovered strokes without apparent symptoms.

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CS SPECTRE: Covert Strokes – Semi-structured interviews of Patient Experiences, Concerns, information Transfer, and Risk Estimation

This study is a qualitative exploration of the experiences and concerns of patients following the detection of incidentally discovered strokes without apparent symptoms (covert strokes, or silent strokes). We hope to better understand the needs of patients in order to orient future studies in screening, treatment, and prevention to meet those needs.

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Secondary Stroke Prevention in Patients with Patent Foramen Ovale: The International PFO-Consortium

The purpose of this study is to learn more about how often people with PFOs have a second stroke after having the first one. This registry will investigate the impact of age, blood thinning drugs (such as aspirin and Coumadin), and closure of the PFO on the risk of stroke.

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Stroke Hyperglycemia Insulin Network Effort Trial

The purpose of this study is to find out the effects of controlling blood sugar within a narrow range by giving IV insulin in patients with high blood sugar within 12 hours of developing symptoms of a stroke. The study is to determine if giving IV insulin to people with high blood sugar and who have had a stroke can improve recovery as compared to those who receive insulin by an injection under the skin. Studies have shown that high blood sugar levels during a stroke could be associated with more damage to the brain than normal blood sugar levels. Blood sugar levels can be lowered with insulin. The five different insulins that will be used in this study are approved by the FDA and are approved for this use as well. A subject will be assigned to one of 2 study groups: IV insulin and subcutaneous insulin. The subject will have a 50% chance to be assigned in one of the two groups by an internet-based randomization system.

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Thrombocytopenia


A Phase 3, Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults with Thrombocytopenia Associated with Liver Disease Prior to an Elective Procedure

The main purpose of this research study is to investigate the effectiveness of avatombopag (the study drug under investigation) in increasing the amount of platelets (a type of cell found in the blood) in patients with chronic liver disease who need to have an elective procedure but have thrombocytopenia (low platelet counts) related to chronic liver disease. This study will look if avatrombopag has the ability to increase your platelet count high enough for you to have an elective procedure and lower the need for procedure-related platelet transfusions.

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Transient Ischemic Attack


A Randomized, Double-Blind, Multinational Study to Prevent Major Vascular Events with Ticagrelor Compared to Aspirin (ASA) in Patients with Acute Ischemic Stroke or TIA

This study is to compare the effect and safety of the investigational drug, ticagrelor, given twice daily compared to aspirin, given once daily for the prevention of death, heart attack, and stroke in patients with acute ischemic stroke or TIA. Ticagrelor is not FDA approved for these indications.

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Jon Davis, MD a doctor at pediatric hospital Floating Hospital for Children in Boston, MA talks about clinical trials.

Why are clinical trials important?

Jonathan Davis, MD, Chief of Newborn Medicine at Floating Hospital and other clinician leaders discuss the importance of clinical studies.

Watch the video, produced by the NIH