772 matching studies

Sponsor Condition of Interest
The Effects of Ketamine on Respiratory Stimulation and Transpulmonary Pressures
Massachusetts General Hospital Effects of Ketamine on Respiratory Stimulation and Transpulmonary Pressure
Maintaining the patency of upper airway in sedated and anesthetized patients is challenging especially when patients are ready to be weaned from mechanical ventilation. Impairment of airway patency is a common cause of extubation failure and opioids and hypnotics can adversely... expand

Maintaining the patency of upper airway in sedated and anesthetized patients is challenging especially when patients are ready to be weaned from mechanical ventilation. Impairment of airway patency is a common cause of extubation failure and opioids and hypnotics can adversely affect airway patency. Ketamine, a noncompetitive antagonist of N-methyl-D- aspartate (NMDA), unlike other anesthetics activates respiratory effort and promotes bronchodilation. At subanesthetic plasma concentration, ketamine reduces both opioid and propofol requirements. Recent animal data suggests that when added to propofol in a sedation regimen, ketamine decreased hypoventilation when compared to propofol alone because ketamine can increase genioglossus phasic activity while abolishing the coupling between loss of consciousness and upper airway dilator muscle activity. However, this relationship has not been examined in human in combination of other drugs. The purpose of this pharmaco-physiological interaction trial is to evaluate the effects of ketamine on breathing and electroencephalography in mechanical ventilated patients. Spirometry will be utilized to evaluate upper airway patency. Polysomnography (PSG- Alice PDx) will be used to evaluate the effects of ketamine on EEG during wakefulness and sleep. An esophageal balloon will be inserted to measure esophageal pressure, which enables us to measure the effects of ketamine on transpulmonary pressure. A volumetric capnography, NICO noninvasive device from Respironics will be used to measure anatomical dead space, CO2 production, mean expiratory CO2 and slope of the alveolar plateau of the volumetric capnogram

Type: Interventional

Start Date: Jan 2014

open study

Regional Lung Inflammation and Expansion in Mechanically Ventilated Patients - a PET/CT Study
Massachusetts General Hospital Respiratory Failure
The goal of this study is to investigate acute respiratory distress syndrome (ARDS) and septic lung with positron emission tomography (PET) imaging and to examine the distribution of inflammation, as measured by neutrophil metabolic activity. expand

The goal of this study is to investigate acute respiratory distress syndrome (ARDS) and septic lung with positron emission tomography (PET) imaging and to examine the distribution of inflammation, as measured by neutrophil metabolic activity.

Type: Observational

Start Date: Jan 2008

open study

Acute Stress Response in Migraine Sufferers
Massachusetts General Hospital Migraine Headache
This study will examine the influence of stress and fasting on headache activity. Participants will receive both a control and stress session and be randomized to either fasting or not fasting for the visits. expand

This study will examine the influence of stress and fasting on headache activity. Participants will receive both a control and stress session and be randomized to either fasting or not fasting for the visits.

Type: Interventional

Start Date: Mar 2017

open study

Bucillamine Phase 2 Trial in Patients With Cystinuria
Revive Therapeutics, Ltd. Cystinuria
Subjects on a standard regimen of tiopronin (cystine binding thiol drug; CBTD) plus prescribed first-line therapy (i.e. on a hydration, alkali therapy and dietary restriction) who are failing therapy will be selected for this trial. After completing informed consent, the subject... expand

Subjects on a standard regimen of tiopronin (cystine binding thiol drug; CBTD) plus prescribed first-line therapy (i.e. on a hydration, alkali therapy and dietary restriction) who are failing therapy will be selected for this trial. After completing informed consent, the subject will have Screening consisting of medication history and physical examination with vital signs. Samples of blood and urine will be taken for clinical laboratory and urinalysis. Patients will undergo a 12-lead ECG test. A history of side effects with current CBTD as well as laboratory recordings of abnormalities attributable to treatment will also be recorded. Subjects will be dosed in a sequential manner, starting with the low dose group (300 mg/day), then proceeding to the 600 mg.day dose group.. Safety and tolerability will be monitored closely by an Independent Medical Monitor (IMM) and based on the IMM's assessment that it is safe to proceed to the higher dose (600 mg/day), subsequent subjects will be enrolled into that group. Up to 15 subjects each will be enrolled into either Group A or Group B. After 7 days on the assigned bucillamine dose, a 24-hour urine sample will be taken and after completing the Day 8 safety visit, subjects will undergo a 7 day washout where no CBTDs will be taken. Thereafter, subjects will be allowed to resume their originally prescribed CBTDs under Investigator's supervision. One week following study drug discontinuation, subjects will return to the clinic for follow-up safety assessments.

Type: Interventional

Start Date: May 2017

open study

Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study
Massachusetts General Hospital Healthy Volunteers
The purpose of this study is to define the safety and the biochemical-physiological response of prolonged exposure to a normobaric low-oxygen environment in healthy volunteers. expand

The purpose of this study is to define the safety and the biochemical-physiological response of prolonged exposure to a normobaric low-oxygen environment in healthy volunteers.

Type: Interventional

Start Date: Jan 2017

open study

Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population.
Brigham and Women's Hospital Obesity Prediabetic State
In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether sleep extension... expand

In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether sleep extension and nightly melatonin supplementation in the community is a feasible intervention with a beneficial effect on the following chronic kidney disease (CKD) risk factors: systemic and renal specific renin-aldosterone-angiotensin system (RAAS) activation (systemic plasma renin activity, plasma angiotensin II levels, 24-hour urine aldosterone excretion, and renal plasma flow response to captopril); nocturnal blood pressure measured by 24-hour ambulatory blood pressure monitor; central blood pressure measured by pulse wave analysis; and glucose metabolism measured by Minimal Model assessment of insulin resistance and β-cell response to a mixed meal protocol.

Type: Interventional

Start Date: Jan 2016

open study

Brain Mechanisms of Psychosocial Aspects of Acupuncture Therapy
Massachusetts General Hospital Physician-patient Relationship Fibromyalgia Acupuncture Therapy
The overall aim of the present proposal is to investigate how patients' and clinicians' (Licensed acupuncturists, LAc) neural and autonomic processes during treatment interaction correlate to patient outcomes. Male and female healthy clinicians and fibromyalgia patients will... expand

The overall aim of the present proposal is to investigate how patients' and clinicians' (Licensed acupuncturists, LAc) neural and autonomic processes during treatment interaction correlate to patient outcomes. Male and female healthy clinicians and fibromyalgia patients will be recruited for the study.

Type: Interventional

Start Date: Sep 2016

open study

The NGAL Test™ As An Aid in the Risk Assessment for AKI Stage II and III in an Intensive Care Population
BioPorto Diagnostics Kidney Injury
The NGAL TestTM is a particle-enhanced turbidimetric immunoassay for the quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human EDTA plasma for testing on automated clinical chemistry analyzer. The First Indication for Use: An NGAL test result... expand

The NGAL TestTM is a particle-enhanced turbidimetric immunoassay for the quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human EDTA plasma for testing on automated clinical chemistry analyzer. The First Indication for Use: An NGAL test result above the assay cutoff as an aid in the risk assessment for the development of stage II or III acute kidney injury (AKI) within 1 day of patient assessment in patients in the intensive care unit (ICU) who are hypotensive (MAP<70 mmHg) and/or receiving vasopressor support. Second Indication for Use: In patents with stage II or III AKI, NGAL measurement aids in the risk assessment of the development of persistent (≥2 days) stage 2 or 3 AKI. The Primary Objective for this clinical trial is to validate that the NGAL test using a cutoff of 140 ng/ml shows clinical performance in predicting the development of moderate or severe acute kidney injury within 1 day. The Secondary Objective is to validate that the NGAL test shows clinical performance in predicting persistent moderate or severe acute kidney injury during any contiguous 2 day interval. It is anticipated that up to 20 Clinical Sites in US will participate in the trial. The study sites will recruit consecutive patients meeting the inclusion and exclusion criteria who are admitted to hospital in an ICU or critical care setting. Patients will receive their clinical standard of care including standard laboratory and other testing as requested by each subject's physician.

Type: Observational

Start Date: Mar 2017

open study

Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
Massachusetts General Hospital Chronic Kidney Disease Acute Myeloid Leukemia (AML) Acute Lymphoblastic Leukemia (ALL) Chronic Myelogenous Leukemia (CML) Chronic Lymphocytic Leukemia (CLL)
The main purpose of this study is to examine the outcome of a combined bone marrow and kidney transplant from a partially matched related (haploidentical or "haplo") donor. This is a pilot study, you are being asked to participate because you have a blood disorder and kidney... expand

The main purpose of this study is to examine the outcome of a combined bone marrow and kidney transplant from a partially matched related (haploidentical or "haplo") donor. This is a pilot study, you are being asked to participate because you have a blood disorder and kidney disease. The aim of the combined transplant is to treat both your underlying blood disorder and kidney disease. We expect to have about 10 people participate in this study. Additionally, because the same person who is donating the kidney will also be donating the bone marrow, there may be a smaller chance of kidney rejection and less need for long-term use of anti-rejection drugs. Traditionally, very strong cancer treatment drugs (chemotherapy) and radiation are used to prepare a subject's body for bone marrow transplant. This is associated with a high risk for serious complications, even in subjects without kidney disease. This therapy can be toxic to the liver, lungs, mucous membranes, and intestines. Additionally, it is believed that standard therapy may be associated with a higher risk of a complication called graft versus host disease (GVHD) where the new donor cells attack the recipient's normal body. Recently, less intense chemotherapy and radiation regimens have been employed (these are called reduced intensity regimens) which cause less injury and GVHD to patients, and thus, have allowed older and less healthy patients to undergo bone marrow transplant. In this study, a reduced intensity regimen of chemotherapy and radiation will be used with the intent of producing fewer toxicities than standard therapy. Typical therapy following a standard kidney transplant includes multiple lifelong medications that aim to prevent the recipient's body from attacking or rejecting the donated kidney. These are called immunosuppressant drugs and they work by "quieting" the recipient's immune system to allow the donated kidney to function properly. One goal in our study is to decrease the duration you will need to be on immunosuppressant drugs following your kidney transplant as the bone marrow transplant will provide you with the donor's immune system which should not attack the donor kidney.

Type: Interventional

Start Date: Nov 2012

open study

Outpatient Treatment of PE and DVT in the Emergency Department
Massachusetts General Hospital Pulmonary Embolism Deep Vein Thrombosis
Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment. expand

Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment.

Type: Observational [Patient Registry]

Start Date: Aug 2015

open study

Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Pain
Massachusetts General Hospital Pain
The aim of this proposal is to investigate brain response and connectivity changes evoked by video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in healthy and patient populations to elucidate the underlying brain mechanisms of mind-body interaction,... expand

The aim of this proposal is to investigate brain response and connectivity changes evoked by video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in healthy and patient populations to elucidate the underlying brain mechanisms of mind-body interaction, imagery, and acupuncture.

Type: Interventional

Start Date: Jan 2017

open study

Pilot Study of the Effect of Laser on Reversing Chronic Radiation Injury
Massachusetts General Hospital Chronic Radiation Dermatitis
Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic process in the skin which can lead to increased risk of malignancy, poor wound healing, pain and limitation of movement, and permanent loss of skin appendages with hyper/hypopigmentation, decreased... expand

Radiotherapy, an essential modality in cancer treatment, frequently induces a fibrotic process in the skin which can lead to increased risk of malignancy, poor wound healing, pain and limitation of movement, and permanent loss of skin appendages with hyper/hypopigmentation, decreased sweating and xerosis, posing significant cosmetic and quality of life issues. Advances in laser therapy has led to the use of fractional laser treatment (FLT) to treat fibrosis associated with in hypertrophic scars and morphea, leading to tissue repair, scar remodeling. The investigators propose a pilot clinical study to test the hypothesis that FLT can normalize the fibrotic process and induce normal scar remodeling in patients affected by chronic radiation injury. Understanding and correcting this underlying fibrotic process can help restore normal skin functions in patients affected with chronic radiation dermatitis (RD) and other debilitating fibrotic diseases in dermatology such as scleroderma, morphea, or nephrogenic systemic fibrosis.

Type: Interventional

Start Date: Nov 2013

open study

A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth...
Massachusetts General Hospital Hemangioma
The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate 0.5% gel can help infants who have a hemangioma. The investigators also want to find out if pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too many... expand

The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate 0.5% gel can help infants who have a hemangioma. The investigators also want to find out if pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too many side effects. Hemangioma is a common type of birthmark. These birthmarks happen when many new blood vessels grow in a specific area on the skin. Blood vessels are tiny tubes that carry blood through the body. No one knows what causes blood vessels to group together. Most birthmarks don't hurt at all and they usually aren't a sign of any kind of illness. Lots of newborns have these birthmarks on their bodies, like between the eyebrows. These birthmarks usually disappear within the first few months to years of life. These birthmarks tend to disappear spontaneously. Most hemangiomas are not treated unless the hemangioma threatens the child's health, which occurs in about 1 in 3 children with hemagiomas. Pulsed dye laser is widely used in children, and is approved by the U.S. Food and Drug Administration (FDA) for treating hemangioma. The FDA has approved timolol maleate to treat glaucoma in adults, but the FDA has not approved timolol maleate to treat hemangiomas in children. About 7 infants with hemangiomas have received timolol maleate. The results so far show that timolol maleate may be helpful and safe in treating hemangiomas in infants. An important question being tested in this study is whether pulsed-dye laser or timolol maleate can prevent hemangioma from growing when used very early after birth.

Type: Interventional

Start Date: Feb 2011

open study

Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions...
Massachusetts General Hospital Toxic Epidermal Necrolysis
The purpose of this study is to determine whether isotretinoin is helpful in treating patients with an adverse cutaneous drug eruption known as toxic epidermal necrolysis (TEN). expand

The purpose of this study is to determine whether isotretinoin is helpful in treating patients with an adverse cutaneous drug eruption known as toxic epidermal necrolysis (TEN).

Type: Interventional

Start Date: Nov 2016

open study

A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV
Massachusetts General Hospital HIV
The purpose of this research study is to determine whether teduglutide can repair a "leaky" gut, decrease inflammation, and prevent or treat plaque, a build-up of fat and other materials in the blood vessels of the heart, in people with HIV. HIV disease is linked to inflammatory... expand

The purpose of this research study is to determine whether teduglutide can repair a "leaky" gut, decrease inflammation, and prevent or treat plaque, a build-up of fat and other materials in the blood vessels of the heart, in people with HIV. HIV disease is linked to inflammatory changes and leakiness of the gut. These changes or conditions may increase the risk of developing heart and blood vessel disease. The investigators believe teduglutide can help repair the gut barrier in people with HIV, leading to a decrease in inflammation and plaque in the blood vessels of the heart.

Type: Interventional

Start Date: Dec 2015

open study

DOD Long-Term Survivors of Ovarian Cancer
Massachusetts General Hospital Ovarian Cancer
: Stages III and IV serum ovarian cancer are the most lethal of all gynecologic cancers; however, some advanced-stage ovarian cancer patients are long-term survivors. These patients may provide the key to long-term survival and bring hope to all women with Stages III and IV ovarian... expand

: Stages III and IV serum ovarian cancer are the most lethal of all gynecologic cancers; however, some advanced-stage ovarian cancer patients are long-term survivors. These patients may provide the key to long-term survival and bring hope to all women with Stages III and IV ovarian cancer. There is no meaningful explanation of why some patients with ovarian cancer become long-term survivors and what their quality of life is long after their initial diagnosis. This research project will specifically determine molecular features within tumors along with genetic, quality of life, and lifestyle features that predict for long-term survival for patients with Stages III and IV ovarian cancer. It will bring together sophisticated molecular techniques, researchers with longstanding interest, a wide spectrum of consumer advocates (a number being long-term survivors), and quality of life experts to analyze the most carefully maintained patient database in the world—the Gynecologic Oncology Group database. We anticipate the results from this project will identify specific biochemical pathways and genetic features associated with long-term survival that can be used to improve the treatment, survival, and survivorship of patients with this disease. There is clearly something unique among patients who survive Stage III or IV ovarian cancer long term, and we believe that when we understand what this is, we can increase the number of long- and longer-term survivors.

Type: Interventional

Start Date: Sep 2014

open study

Neuropsychological and Behavioral Testing in Younger Patients With Cancer
Children's Oncology Group Childhood Malignant Neoplasm Cognitive Side Effects of Cancer Therapy
This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral... expand

This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function of patients with cancer.

Type: Observational

Start Date: Sep 2008

open study

Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Children's Oncology Group Ganglioneuroblastoma Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Regional Neuroblastoma Stage 4 Neuroblastoma
This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related... expand

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Type: Observational

Start Date: Nov 2000

open study

Baselines in Reproductive Disorders
Massachusetts General Hospital Amenorrhea Hypogonadotropic Hypogonadism Kallmann's Syndrome
The purpose of the study is to explore the way in which gonadotropins (pituitary hormones) are released into the body. The knowledge acquired in this study will be used for the diagnosis and treatment of reproductive endocrine disorders. We seek to investigate the baseline characteristics... expand

The purpose of the study is to explore the way in which gonadotropins (pituitary hormones) are released into the body. The knowledge acquired in this study will be used for the diagnosis and treatment of reproductive endocrine disorders. We seek to investigate the baseline characteristics of the GnRH-induced gonadotropin pulsations of patients with the following diagnoses: - Hypothalamic Amenorrhea (HA) - Idiopathic hypogonadotropic hypogonadism (IHH) - Polycystic ovarian disease (PCOD) - Acquired hypogonadotropic hypogonadism (AHH) - Premature Ovarian Failure (POF) **WE ARE CURRENTLY RECRUITING ONLY SUBJECTS WITH A DIAGNOSIS OF IHH.** This has been an extremely productive and pivotal protocol in the studies of female reproductive physiology and pathophysiology and continues to be critical for defining the neuroendocrine abnormalities in patients with reproductive disorders. In some cases, it is also helpful in the planning of subsequent therapy if so desired. It is important to note that minors have been included in this protocol, as many patients are extremely anxious to know more about their neuroendocrine disorder. With minors who would like to know if their disorder is correctable, this protocol may be followed up with administration of pulsatile gonadotropin-releasing hormone (GnRH).

Type: Interventional

Start Date: Sep 1999

open study

Study of Kidney Tumors in Younger Patients
Children's Oncology Group Clear Cell Sarcoma of the Kidney Congenital Mesoblastic Nephroma Diffuse Hyperplastic Perilobar Nephroblastomatosis Rhabdoid Tumor of the Kidney Stage I Kidney Wilms Tumor
This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify... expand

This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Type: Observational

Start Date: Feb 2006

open study

Barrett's Esophagus Patient Registry
Massachusetts General Hospital Barrett Esophagus Esophageal Adenocarcinoma Gastroesophageal Reflux
The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more effective targeted screening strategies and treatment options for Barrett's esophagus and esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a platform.... expand

The ultimate goal of the Barrett's Esophagus Patient Registry is to help develop more effective targeted screening strategies and treatment options for Barrett's esophagus and esophageal adenocarcinoma (EAC). We plan to do by developing a registry that will serve as a platform. Examples of analyses could include identifying genetic determinants and biomarkers that predict BE, progression of BE to EAC, as well as the response to therapies.

Type: Observational [Patient Registry]

Start Date: Jan 2011

open study

Cooperative Huntington's Observational Research Trial
HP Therapeutics Foundation Huntington Disease
The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments... expand

The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of HD.

Type: Observational

Start Date: Feb 2006

open study