This page includes clinical trials where organization or lead sponsor is BIDMC or Lahey Clinic as reported at clinicaltrials.gov.

Clinical Trials

Clinical Trials

Description

The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.

Description

Hypothesis: The use of a mobile robotic telepresence system for off-hours rounding in the surgical intensive care unit has an impact on nurse-physician collaboration.

Study question: Does the addition of mobile video communication provided by RTP affect nurse-physician collaboration during off shift rounding in the surgical intensive care unit when compared to the more common clinical practice of off-shift rounding using the telephone?

Description

Using phase contrast MR Angiography with NOVA® Software, this study intends to identify,evaluate and map intracranial aneurysm development as well as develope a predicator for future morphological changes of aneurysms and possible risk of future rupture.

Description

RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

PURPOSE: Phase I trial to study the effectiveness of boron neuron capture therapy in treating patients with stage III melanoma.

Description

RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill breast cancer cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating women with metastatic breast cancer who have received high-dose chemotherapy and peripheral stem cell transplantation.

Description

Hypothesis:

Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in patients with IBD. These factors can be identified using qualitative testing in order to develop a validated instrument to measure the "adherence profile" of an individual patient, and design appropriate behavioral interventions to reduce non-adherence.

Objectives:

To test a novel interview instrument that determines the medication adherence profile of patients with IBD prescribed mesalamine by correlating with objective measures of adherence

Description

RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells without harming normal tissue.

PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.

Description

RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

PURPOSE: Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have melanoma.

Description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining docetaxel, carboplatin, and gemcitabine in treating patients who have previously untreated, newly diagnosed epithelial cancer.

Description

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.

Description

RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Description

With this clinical study, we hoped to find out if interactive, computer-based medical interviews, when carefully tested and honed and made available to patients in their homes on the Internet, will improve both the efficiency and quality of medical care and be well received and found helpful by patients and their physicians. We developed the computer-based medical interview consisting of over 6000 questions and a corresponding program that provides a concisely written, summary of the patient's responses to the questions in the interview. We then conducted read aloud and test/retest reliability evaluations of the interview and summary programs and determined the programs to be reliable. Results were published in the November 27, 2010 issue of the Journal of the American medical Informatics Association. We also developed, edited, and revised a program that provides a concisely written, summary of the patient's responses to the questions in the interview.

We obtained a grant from the Rx Foundation to conduct clinical trial of our medical history. At the time of the office visit, the summary of the computer-based history of those patients who had completed the interview was available on the doctor's computer screen for the doctor and patient to use together on a voluntary basis. The results of this trial were published in the January 2012 issue of the Journal of the American Informatics Association.

Description

The purpose of this study is to evaluate the ability of a new type of CT computer program(MeVis™)to accurately analyze and measure the size and changes in metastatic Liver and Lung tumors. This study will evaluate the data from current CT evaluation methods using the MeVis™ 3-D software.

Description

Aggressive intraoperative and postoperative management of blood glucose may substantially decrease perioperative cardiovascular and infectious complications in diabetic and non-diabetic patients undergoing vascular surgery.

The purpose of this study is to compare the tight versus traditional blood glucose control in diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections, overall morbidity and 30-day mortality.

Description

Percutaneous large core image-guided breast biopsy is a well established tool in diagnosing breast cancer, but the associated anxiety and pain can tax the coping mechanism of even well functioning individuals. Unabated stress during an invasive procedure not only interferes with smooth progression of the ongoing procedure, but can also have deleterious effects when patients need additional procedures and dread recurrent medical traumatization. The long-term objective of this research is to provide patients with a simple coping strategy at the vulnerable time of large core biopsy in the hope that this behavioral intervention will carry over to recovery and future medical procedures. In the largest prospective randomized study of its kind, the researchers showed that a self-hypnotic intervention during percutaneous, image-guided vascular and renal interventions resulted in less pain and anxiety, greater hemodynamic stability, and fewer procedure interruptions. The positive effects of the short initial hypnotic intervention, which was structured in the procedure room, became more pronounced the longer the procedure lasted and carried over into the immediate post-procedure recovery. The investigators therefore challenge the current paradigms that long-lasting effects require intensive presurgical preparation.

Description

The purpose of this study is to look at the effects of a procedure called radiofrequency ablation on kidney tumors from patients who are undergoing antiangiogenic treatment. Antiangiogenic treatment is a type of treatment that inhibits formation of new blood vessels that are required for tumor growth. Radiofrequency ablation (RF ablation) involves inserting a needle into tumor tissue and administering heat to the tumor tissue that is sufficient to kill the tumor cells.

Description

Sentinel lymph node (SLN) mapping is the standard of care for the surgical staging of breast cancer. We propose a method of SLN mapping based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. The present study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging system.

Description

To perform a pilot study of the S-FLARE imaging system, which uses low levels of safe, invisible, near-infrared light to measure tissue oxygenation during breast reconstructive surgery and to compare S-FLARE measurements to the gold standard, FDA-approved, the ViOptix optical probe.

Description

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 docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.

Description

The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. In plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. This new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. This study will test the system's basic operation and ergonomics in the operating room.

Description

The investigators are investigating the benefits of a mind/body intervention, Mindfulness Based Stress Reduction, for adults with Mild Cognitive Impairment.

Description

The purposes of this study is to determine if combination reduced fluence photodynamic therapy and Ranibizumab has:

Similar efficacy to Ranibizumab (Lucentis) alone. The ability to reduce the number of intravitreal injection of Ranibizumab or a 13 month period The ability to reduce the number of PDT treatments. The study will also collect information on the safety of combination therapy and single therapy.

Description

This study will compare the incidence of post-op infection after sinus surgery using conventional post-op oral antibiotics to the incidence of infection after sinus surgery when a bio-resorbable antibiotic soaked nasal sponge is used in the nasal cavity in lieu of post-op oral antibiotics. The nasal sponge is a routine nasal dressing used after sinus surgery and will therefore be placed in all patients.

Description

The purpose of our study is to explore the efficacy of combination of brain stimulation with visual rehabilitation in patients with visual field loss resulting from brain lesions. It is shown that the effect of sensorimotor training of hand can be enhanced in patients with stroke using brain stimulation. We decided to explore this combination for visual field loss because visual dysfunction following brain lesions is considered intractable. We hypothesize that combination of noninvasive brain stimulation, in the form of transcranial direct current stimulation (tDCS), with visual rehabilitation would have greater efficacy than visual rehabilitation alone.

Description

The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials.

Description

The purpose of this study is to test the effectiveness, safety and side effects of two chemotherapy drugs (gemcitabine and cisplatin) when combined with surgery after chemotherapy for patients with upper urinary tract cancer. The hypothesis is that undergoing chemotherapy prior to surgery will have a beneficial effect on prognosis and may improve overall survival as in patients with bladder cancer, and will allow better tolerance of chemotherapy than if it were given after surgery.

Description

This preliminary study will compare the effectiveness of two-dimensional and three-dimensional echocardiographic measurements of wall thickness and left ventricular mass in patients with Aortic Stenosis

Description

The investigators propose examine the effects of the dietary factor glycemic index (GI) on brain areas that control food intake and hunger. This knowledge could help design dietary approaches that decrease hunger, and thus promote new weight loss strategies.

Description

Focal myometrial (uterine) contractions occur in a substantial number of vaginal ultrasound examinations and can impede accurate cervical length measurement and placental location determination. The timing of bladder voiding is associated with the prevalence of focal myometrial contractions on vaginal ultrasound cervical assessment. We propose a blinded randomized-controlled trial of bladder voiding immediately before vaginal ultrasound for cervical assessment compared with no bladder voiding immediately before vaginal ultrasound in order to determine the prevalence of focal myometrial contractions during vaginal ultrasound cervical assessment and test whether timing of bladder voiding is associated with their incidence.

Description

The purpose of this study is to determine whether psychological intervention is effective in improving quality of life, mood, and relationships among adults with end-stage renal disease who are awaiting kidney transplantation.

Description

The purpose of this study is to evaluate the use of Capnography (Continuous recording of the carbon dioxide content of expired air)as an alternative test to measure PC02 levels in patients with asthma, chronic obstructive pulmonary (COPD,interstitial lung disease(ILD)or coronary disease who are at risk of intubation.

Description

The main purpose of this study is to test the safety of dendritic cell tumor fusion study vaccine and to determine the type and severity of any side effects associated with this study vaccine. Cancer cells have unique markers that distinguish them from normal cells of the body. These markers can potentially serve as targets for the immune system. Dendritic cells are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.

Description

To determine if the types and amount of bacteria or other germs change over time after the routine procedure of blockage of tear drainage duct in the treatment of dry eye condition or other condition benefiting from a tear drainage blockage

Description

The purpose of this study is to demonstrate that pharmacists working collaboratively with physicians and other providers in an ambulatory care setting can improve glucose, blood pressure, and lipid control, as well as improve quality of life, adherence to screening and general preventative measures.

Description

This Study will look at the effect of substances called "angiogenic factors"(development of new blood vessels) have on the development of severe liver disease. The results may help to understand the factors involved in the repair and regeneration of liver tissue and to see if different types of liver disease are associated with different types of factors, especially in the severe liver disease called hepatorenal syndrome.

Description

This pilot study will evaluate the accuracy and ease of use of the LUMA light wire and whether trans-illumination of the sinuses is comparable to fluoroscopy during balloon dilation procedures.

Description

The purpose of this study is to compare the safety & effectiveness of the two types of cataract and glaucoma surgeries. Results from this study may improve the surgical and post surgical management and long term management of patients with these conditions in the future

Description

This study is aimed at discovering the differences in outcomes, regarding quality of life issues(continence, impotence) of patients who have had either laparoscopic or open surgical technique for prostate cancer.

Description

The purpose of this study is to examine the molecular (nitric oxide) and biochemical (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR elicitation and which may counteract the effects of acute stress in the elderly.

Description

Intercessory prayer is widely believed to influence recovery from illness, but claims of benefits are not supported by well-controlled clinical trials. Prior studies have not addressed whether prayer itself or knowledge/certainty that prayer is being provided may influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.

Description

Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students.

Description

A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery.

Description

The purpose of this study is to determine whether the relaxation response is more effective than attention control in reducing blood pressure and medication dosage in elderly adults with isolated systolic hypertension.