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NCT02320149
To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris
NCT01874054
The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.
NCT00697632
In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.
NCT02130765
To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia \[MMVT\] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.
NCT01875874
This phase 2 study is developed to evaluate the effect of ELAD on overall survival (OS) in subjects with acute liver failure (ALF) compared to matched historical controls.
NCT00095589
RATIONALE: New diagnostic procedures such as microsatellite analysis of sediment in the urine may improve the ability to detect bladder cancer without invasive procedures. PURPOSE: Diagnostic trial to study the effectiveness of microsatellite analysis of sediment in the urine in detecting bladder cancer in healthy participants, participants who have genitourinary conditions requiring cystoscopy, and patients who have bladder cancer.
NCT03143517
The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.
NCT03202992
This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.
NCT00842634
This research study is being carried out to study a new way to possibly treat HIV. This agent is called a "Zinc Finger Nuclease" or ZFN for short. ZFNs are proteins that can delete another protein named CCR5. This CCR5 protein is required for certain common types of HIV (CCR5 tropic) to enter into and infect T-cells. T-cells are one of the white blood cells used by the body to fight HIV. The most important T-cells are those called "CD4 T-cells." Some people are born without CCR5 on their T-cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and their HIV disease is less severe and is slower to cause disease (AIDS). In order to delete the CCR5 protein on the T cells, this study will isolate large numbers of T-cells from subjects, and then deliver the ZFNs using a delivery vehicle called a viral vector. The viral vector used in this study is called an adenoviral vector. The vector is added to the cells at the beginning of the manufacture process and the ZFNs knock out the CCR5 protein. By the time T-cells are returned to subjects, there is minimal adenovirus or ZFN present. The removal of the CCR5 protein on the T-cells subjects receive, however, is permanent. The purpose of this research study is to find out whether "zinc finger" modified T-cells are 1. safe to give to humans and 2. find how "zinc finger" modified T cell affects HIV This is an experimental study. Laboratory studies have shown that when CD4 T-cells are modified with "zinc fingers", HIV is prevented from killing the CD4 T cells. On the basis of these laboratory results, there is the potential that "zinc fingers" may work in humans infected with HIV and improve their immune system by allowing their CD4 T-cells to survive longer (HIV usually kills T cells it infects). All subjects who receive ZFN Modified CD4+T cells will enroll in a Long Term, Follow-up study to monitor subjects. Subjects will be followed every 3 months for four years. If the ZFN Modified CD4+T cells are no longer found in the blood after four years, then subjects will be contacted yearly for the next 6 years. If the ZFN Modified CD4+T cells are found in the blood at year four, then the subjects will continue to be seen once a year until the ZFN Modified CD4+T cells are no longer found in the blood for a maximum of 10 years.
NCT02277509
This study is being conducted in two phases. The first phase was a pilot implementation of the study protocol, which provided preliminary data from seeking funding for a larger scale trial. The study focused on testing the effects of a Diabetes Prevention Program (DPP) that has been adapted culturally and linguistically to address diabetes prevention among Chinese immigrants. Study implementation involves a variety capacity building community partnership initiatives. Partnering organizations within New York City (NYC) have included the Chinese Community Partnership for Health (CCPH) of New York Presbyterian Hospital of Lower Manhattan Hospital, the Chinese American Independent Practice Association (CAIPA), the Diabetes Research and Training Center of Albert Einstein College of Medicine (Einstein), and the City University of New York (CUNY) School of Public Health. More recently, our collaboration has expanded the potential for wider dissemination in collaboration with the Pace University Confucius Center of the Confucius Institute. By supporting Chinese language and cultural programs, the Confucius Institute facilitates communication with the 2 billion native Chinese speakers as migration and trade increase interactions globally.
NCT03060733
The primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.
NCT01737658
Obese Adolescents will be evaluated for insulin resistance and cognitive dysfunction.
NCT01083043
It is well known that lowering average blood glucose decreases the risk of diabetic complications involving the small vessels, such as those found in the eyes, nerves and kidney. It is less clear however, if controlling fluctuations in blood glucose will further help to prevent such complications. The purpose of this study is to examine the relationship between extreme fluctuations in glucose and damage to the blood vessel lining.
NCT02779062
Infants sometimes experience sudden symptoms such as breathing irregularities or limpness that frighten parents and prompt them to seek emergency medical care. While few of these episodes are truly life-threatening and require hospital admission, some parents may have been so frightened that they will resist returning home from the emergency department with their baby even if the objective risk is extremely small. Study subjects (parents of infants with an apparent life threatening event) will be contacted and interviewed. Investigators want to learn whether or not study subjects would accept returning home after a brief period of observation in the emergency department if the physician determines that it is safe to do so.
NCT01376349
RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors. PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.
NCT03448081
A Phase 2 study evaluating safety, tolerability, and efficacy of SNA-120 ointment when administered topically with calcipotriene ointment for the treatment of pruritus and psoriasis.
NCT03537248
The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately 3 months (12 weeks).
NCT02346370
A Phase 1b study for participants with Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) to participate in 1 of 2 portions of this study. The first portion is Dose Escalation in which participants are tested with PEGPH20 at various doses (1.6, 3.0, 2.2 and 2.8 micrograms/kilogram (ug/kg)) in addition to dosing with the standard dose of docetaxel (PDoc) of 75 milligrams/meter squared (mg/m\^2) once every 21-day cycle. Based on observations on the safety and tolerability of study treatment from dose escalation cohorts dosed to date (1.6 and 3.0 ug/kg of PEGPH20), two additional dose levels will be tested, 2.2 and 2.8 ug/kg. Up to 30 additional participants may be enrolled to test these dose levels. The second portion of Phase 1b is Cohort Expansion in which the recommended Phase 2 dose (RP2D) of PDoc identified in dose escalation is administered every 21 days to approximately 50 participants with high hyaluronan (HA-high) prospectively measured in their tumor tissue.
NCT00728936
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
NCT02398981
In the developed world critical illness is routinely treated in an intensive care unit (ICU) by highly specialized physicians, nurses and support staff. This model of intensive care is spreading rapidly to low and middle income countries and as it spreads, challenges and limitations to this model arise. In resource-poor settings, inadequate human resources, training, and equipment all present barriers to safe and effective use of life-saving procedures. The advances in medical informatics and human factors engineering have provided tremendous opportunity for novel and user-friendly clinical decision support (CDS) tools that can be applied in a complex and busy hospital setting. Real-time data feeds and standardized patient care tasks in a simulated acute care environment have been proven to have a significant advantage of a novel interface (compared to a conventional) in reducing provider cognitive load and errors. Currently researchers within the investigator's research group have developed and are pilot testing a simple electronic decision support tool: CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness). This tool has been successfully tested and validated in simulated settings and is being implemented as pilot study in 18 countries. Worldwide infant and early childhood mortality continues to be very high partly due to the inability to recognize and respond aggressively to critical illnesses. Investigators expect that adaptation of the algorithms from CERTAIN has potential to be a powerful tool to improve on the medical care of children in developing countries. Investigators aim in this project is 1) to develop a pediatric adaptation of CERTAIN (CERTAINp) and 2) to implement it into clinical practice in resource-poor settings and evaluate the impact of the tool on the processes and patient outcomes.