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Discover 17,836 clinical trials near Boston, Massachusetts. Find research studies in your area.
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NCT02594696
Individuals with severe mental illness (SMI) including schizophrenia and bipolar disorder are dying younger than the general population; cancer is a leading cause of death in this population. People with SMI have higher rates of dying from breast, lung, and colon cancer, and disparities in treatment appear to be one contributing factor. Individuals with SMI may be diagnosed with more advanced stage cancer and less likely to receive stage-appropriate cancer treatment. Although collaborative care models integrating medical and psychiatric care have shown promise in other populations, the challenge of treating SMI and cancer is distinct and relatively understudied. Patients may have uncontrolled psychiatric symptoms that can impact their understanding of their diagnosis and treatment decisions. Oncologists have less training and inadequate time to address multiple unmet needs. Mental health care is frequently fragmented from cancer care. The investigators want to understand if it is helpful for patients with SMI to be connected to a psychiatrist and case manager when cancer is diagnosed. Optimizing psychiatric symptoms and facilitating communication between the patient, the oncology team, and mental health providers may improve care. The goal is to pilot a pragmatic intervention for patients with cancer and SMI that can be integrated into cancer care, is acceptable to patients and oncology clinicians, and may promote the delivery of stage-appropriate cancer treatment to an underserved population. Patients will be connected to a psychiatrist and case manager at cancer diagnosis who will follow the patient and communicate with the oncology team during the 12 week intervention. All participants will complete brief surveys at baseline, 4 weeks, and 12 weeks. Oncology clinicians will provide feedback about the intervention at 12 weeks. Cancer treatment received and healthcare utilization will be assessed at 6 months post-intervention.
NCT02184208
Today, the electronic medical record, microprocessor mechanical ventilators, and physiologic monitoring are under-utilized when translating research into decision support. Current medical informatic capabilities can be leveraged to calculate trends in measured parameters to initiate a paradigm shift in critical care from reaction-based treatment to proactive and plausibly preventative care. Therefore, the purpose of this study is to develop baseline understanding of our practice and how data collection utilizing a newly implemented system called T3. We would like to retrospectively review mechanically ventilated patients in which we have collected continuous data to test a newly developed analytic platform. Additionally we would like to compare these results to our standards of practice established by clinical practice guidelines.
NCT02228811
The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body.
NCT02468336
The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.
NCT00553462
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
NCT02020889
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram \[mg\] administered subcutaneously \[SC\] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.
NCT01536418
This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index \[CDAI\] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.
NCT01061944
In this research study, we are looking at performing a repeat biopsy of patients' tumors, even though they have already been diagnosed with cancer. The tumor tissue obtained from the biopsy will be studied to see what it looks like at the molecular (genetic) level. By conducting this study, we hope to learn more about how cancers work, why cancers respond to certain treatments, and how they become resistant to certain treatments. We also hope to demonstrate that biopsies like this can be performed safely in large numbers of patients. The research done on the tumor samples may help us identify which patients in the future are most likely to respond to new cancer therapies.
NCT01400685
Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify or regulate the functioning of the immune system. It is an FDA approved drug for people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL), but it does appear effective in CLL when used alone, and is being studied for use in combination with chemotherapy in this and other lymphomas and leukemias. In this research study we are hoping to learn more about the effects of lenalidomide on CLL when given in combination with bendamustine and rituximab, which is a highly effective regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest dose of lenalidomide that can be given safely, without causing any serious or unmanageable side effects.
NCT02261649
The purpose of the study is to evaluate how cerebellar resection surgery may affect pain sensation and the way the brain "reads" pain signals. By measuring brain activity in children and adolescents following surgery, the investigators hope to gain valuable information about pain processing in the brain.
NCT01712009
The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.
NCT00428844
This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.
NCT02511990
This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in HIV-infected and HIV-uninfected individuals.
NCT01808144
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
NCT02063997
The purpose of this study is to determine whether arhalofenate is effective in preventing flares and reducing serum uric acid in gout patients.
NCT02348723
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study. Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting. It is not intended to assess confirmatory hypothesis, this is an exploratory study.
NCT01632228
This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate the safety and efficacy of onartuzumab in combination with bevacizumab as compared to bevacizumab alone in participants with recurrent glioblastoma. Participants will be randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
NCT01772134
The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.
NCT01313637
This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).
NCT01494181
Plan of investigation: This is an observational cohort study to determine the effect of OSA, independent of other risk factors, on postoperative vascular events. The study is conceived, designed and will be conducted, and analyzed independent to any company. There is no commercial sponsorship.
