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Discover 15,316 clinical trials near Massachusetts. Find research studies in your area.
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NCT00977665
To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.
NCT01427283
The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.
NCT01856010
Agitation/aggression is one of the most common and serious behavioral complications of dementia. If the behavior is refractory to standard care (behavior approaches and off label use of psychotropic medications), other evidence based treatment options are not currently available. Retrospective reviews and preliminary studies have indicated Electroconvulsive Therapy (ECT) may be a safe, effective intervention in this patient population. This study will measure the impact of open-label ECT on symptoms of agitation, aggression, cognition, mood and psychosis for patients referred for ECT who accept this intervention vs. those patients referred for ECT but decline this intervention (i.e. standard care controls). It will also assess adverse events, activities of daily living and caregiver burden during study participation. The hypothesis is that subjects with dementia related aggression/agitation who receive ECT will show significantly greater reductions in these behaviors than subjects who do not consent for ECT and continue with standard care. Pine Rest is partnering with McLean Hospital (Massachusetts) to answer this question. To our knowledge, this is the first prospective study to examine whether patients receiving ECT or standard care differ in reduction of aggression and agitation symptom severity and changes in cognition pre- and post- treatment.
NCT01521507
The study objective is to evaluate the long-term treatment effectiveness for adult patients with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the LipiFlow® System to a standardized daily warm compress and eyelid hygiene control therapy over a duration of 3 Months; and 2) evaluating the LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration of up to 12 Months. This is a post-market, non-significant risk, prospective and multi-center clinical trial divided into two stages. The first stage from enrollment to 3 Months is an open-label, randomized controlled design to compare the effectiveness of a single LipiFlow® System treatment to a standardized daily warm compress and eyelid hygiene Control therapy with Crossover LipiFlow® treatment of the Control subjects at 3 Months. The second stage, occurring between 3 and 12 Months, is an observational design to evaluate the effectiveness of LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration of up to 12 Months. Subjects are entered into the following subgroups based on the subject's self-assessment of the adequacy of symptom relief and protocol-defined criteria for additional treatment. 1. One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment. 2. Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment. 3. Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed by other MGD or dry eye treatment, as prescribed by the physician.
NCT00655460
The Purpose of this study is to: 1. Refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric ICU patients. 2. Monitor how often low blood sugar levels occur during use of the bedside tool. 3. Determine how the computerized tool effects the workload of the ICU nurses.
NCT00027508
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have malignant mesothelioma that cannot be removed by surgery.
NCT01803867
This is a Phase I, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all clinical presentations of MS.
NCT01645956
The importance of exercise for weight control is well documented; however if exercise results in an increase in food intake, the beneficial effect of exercise may not be seen. This study addresses a gap in the current literature and examines why some people eat more after exercise and why some people eat less and also examines whether these responses are consistent over time. Participants in this study will be asked to come to our center on 7 different occasions over a 3-4 month period. The first visit will be an assessment visit where body weight and body composition will be measured, questionnaires will be completed, and an exercise test will be performed. During the remaining 6 visits (3 pairs of sessions with visits in each pair separated by 48-96 hours) the procedures will be nearly identical. Upon arrival at our center, participants will consume a meal replacement, complete a series of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be resting and 3 will be exercising). One hour following the exercise/resting session, individuals will be given access to a buffet of food, unaware that their food intake will be monitored. All food will be weighed and measured before and after the eating period and the amount of food consumed after each pair of exercise and resting conditions will be compared to one another. It is hypothesized that the difference in food intake will be consistent across pairs of testing sessions. Findings from this study will help us to better understand the relationship between exercise and food intake and may ultimately lead to future studies that can address the clinically significant question of why some individuals gain weight and others lose weight when engaging in exercise training programs. Findings from this study may also help to develop exercise programs that maximize the beneficial effect of exercise on body weight.
NCT01789957
This multicenter, open-label extension study of Protocol 2993-112 is designed to assess long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate long-term safety and tolerability in subjects treated with metformin who receive subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing Protocol 2993-112 are eligible to enroll.
NCT00039013
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (metformin) throughout the study.
NCT00039026
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (sulfonylurea) throughout the study.
NCT01332227
The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.
NCT01445899
This is a two-part study. The first part (Stratum I) is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be given to all patients who participate. Stratum I will determine the maximum tolerated dose and any dose-limiting toxicities. The second part (Stratum II) is a prospectively randomized, multi-center, double-masked, dose ranging study evaluating the efficacy and safety of PF-04523655 alone and in combination with ranibizumab versus ranibizumab alone in patients with DME.
NCT00099320
This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.
NCT01825200
The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.
NCT01663532
The primary purpose of this study is to evaluate the overall efficacy of aripiprazole intramuscular (IM) depot as acute treatment in subjects with schizophrenia. The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.
NCT00529503
This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.
NCT00556322
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.
NCT02255058
It was decided to develop a comprehensive disability score specifically designed for patients receiving prolonged mechanical ventilation (PMV); the collection of information included in the score should not impose any further intervention beyond what is routinely performed. So a new questionnaire was created (called the Multi-INdependency Dimensions (MIND) that included 3 sections (nurse, physiotherapist and medical doctor), 11 categories and 18 items. Each question was adapted to have a 5 item Likert scale. The primary objective of the study will be to evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time. The secondary objective will be to assess the inclusion of biological markers on the overall performance of the MIND score
NCT01080209
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.