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NCT02637856
This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.
NCT01072981
The purpose of this study is to assess overall survival after treatment with a regimen of adjuvant therapy (Gemcitabine alone or with 5-FU chemoradiation) with or without HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in subjects who have undergone surgical resection.
NCT01774578
The purpose of this study is to assess overall survival of anti-tumor immunization using HyperAcute®-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed non-small cell lung cancer (NSCLC) that have been previously treated.
NCT01971684
The purpose of this study is to understand physician treatment decisions in selecting specific second line treatments in pediatric ITP and to determine the effectiveness of different second line ITP treatments. Eligible patients are those ages 1-18 years who are starting on a new second line treatment for ITP, defined as any treatment other than IVIG, steroids, anti-D globulin, or aminocaproic acid. Enrolled patients remain on the study for approximately one year.
NCT02351258
The overall goal of this Community Central Line Infection Prevention (CCLIP) trial, supported by grant R01 HS022870 from the Agency for Healthcare Research and Quality, is to determine whether use of a promising new intervention, namely 70% isopropyl alcohol embedded protective caps on central lines, in the home setting is associated with a reduction in ambulatory central line-associated bloodstream infections (CLABSI) in a high-risk population of pediatric hematology/oncology patients. Despite successes in CLABSI reduction efforts for inpatients, it remains unknown what generalizable best practices should be with chronic central lines in the home setting and how effective involving patients and caregivers across multiple institutions in CLABSI reduction efforts will be. This research will involve a cluster-randomized, cross-over design, clinical trial. This proposal will focus on the caregivers integral to ambulatory pediatric central line care: patients and families. The specific aims of the proposed research program are: Specific Aim #1: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on central lines reduces the rate of CLABSI in ambulatory pediatric hematology/oncology patients. Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25% reduction in the ambulatory CLABSI rate for pediatric hematology/oncology patients. Specific Aim #2: Evaluate whether use of 70% isopropyl alcohol embedded protective caps on central lines reduces the rate of all positive blood cultures in ambulatory pediatric hematology/oncology patients. Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will be associated with at least a 25% reduction in the positive blood culture rate at home for pediatric hematology/oncology patients. Specific Aim #3: Evaluate whether the use of 70% isopropyl alcohol embedded protective caps on central lines changes the distribution of bacteria isolated from blood cultures of pediatric hematology/oncology patients. Hypothesis: Use of 70% isopropyl alcohol embedded protective caps on central lines will reduce Gram-positive CLABSI, secondary blood steam infections, and single positive blood cultures at home for pediatric hematology/oncology patients.
NCT00569387
To assess the response for subjects with pancreatic cancer that have undergone surgical resection and treatment with a vaccine given with chemotherapy and chemoradiation.
NCT02343406
This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.
NCT00804973
This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.
NCT02616614
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris
NCT00261274
The purpose of this study is to demonstrate that small amounts of a person's own red cells, when treated with an enzyme to make A-ECO Red Blood Cells, can be safely re-infused, repeatedly. Each participant will have some blood drawn, treated with an enzyme, washed and re-infused five times. Additional samples of blood will be drawn for testing and evaluation.
NCT02187302
This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101 in combination with bevacizumab compared to treatment with a standard of care therapy. The study will compare which treatment resulted in longer time before progression of the RCC. Patients will be treated and followed for progression of their disease on average for up to 6 months.
NCT03071276
This study will be done in two parts: Phase I (NCT02212561) has been completed and published. The goal of the Phase I portion of this study was to find the highest tolerable dose of selinexor (KPT-330) that can be given to patients with leukemia or myelodysplastic syndrome (MDS), when it is combined with fludarabine and cytarabine. The Phase II portion of the protocol is reflected in this registration. The goal of the Phase II portion of this protocol is to give the highest dose of selinexor (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe for children with acute myeloid leukemia (AML). The investigators will examine the effect of this combination treatment.
NCT03558997
The primary objective is to assess whether 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass Subcutaneous Immunotherapy (SCIT) improves upon the efficacy of Timothy Grass SCIT to reduce provoked allergic rhinitis symptoms, as measured by Total Nasal Symptom Score (TNSS) after nasal allergen challenge (NAC) with Timothy Grass extract at week 17. The secondary objectives of the study are: * To assess whether 16 weeks of treatment with dupilumab as compared to placebo reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge (NAC) with Timothy Grass extract * To assess whether 16 weeks of treatment with dupilumab as compared to dupilumab + SCIT reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge (NAC) with Timothy Grass extract * To assess changes in serum Timothy-grass-specific immunoglobulin G4 (IgG4), serum Timothy grass-specific immunoglobulin E (IgE), and ratio of serum Timothy Grass-specific IgG4 to IgE over 16 weeks of treatment with dupilumab + SCIT as compared to SCIT monotherapy * To evaluate the safety and tolerability of 16 weeks of treatment with dupilumab as an adjunct to Timothy Grass SCIT
NCT03579147
This study will evaluate the clinical safety and patient satisfaction with the high power magnet system for the aesthetic improvement of buttocks. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and three follow-up visits - 1 month, 3 months and 12 months after the final treatment. Study will be conducted at several study sites. At the baseline visit, subject's weight will be recorded. Subjects will receive Buttocks Evaluation Questionnaire to fill in. The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the gluteal area. Visible contractions will be induced by the device. At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Subject Satisfaction, Buttocks Evaluation and Therapy Comfort Questionnaires to fill in. Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment. Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3 months and 12 months after the final treatment. A weight measure will be conducted. Also, subject's satisfaction and buttocks evaluation will be noted.
NCT03688412
This prospective, multicenter, post-market clinical study was designed to evaluate the outcomes of lead extraction of cardiovascular implantable electronic devices (CIED) using Cook catheter and lead extraction devices for any indication it is used in the commercial setting within the United States and Europe. The purpose of this clinical study is to collect data on the performance of the Cook lead extraction devices for the purpose of supporting publications and presentations
NCT02949245
272 subjects with "high risk" adult spinal deformity requiring surgical correction were enrolled in the previous prospective multi-center international Scoli-RISK-1 study. "High risk" patients were defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurological complications in the form of new motor and sensory deficits were monitored prospectively in all patients at hospital discharge, at 6 weeks (± 2 weeks), 6 months (± 2 months) and 24 months (± 2 months) after the surgery. The relationship to the surgical intervention was assessed in all new deficits. Regression analyses were used to evaluate the association between patient demographics, co-morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery. All enrolled Scoli-RISK-1 participants will be re-consented and asked to return for a 5 year FU visit.
NCT03770637
This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial hypoglycemia. Twelve eligible subjects will be randomly assigned to receive Glucagon RTU or placebo at the first of two clinical research center (CRC) visits, followed by the other treatment at the second CRC visit. Subjects will be randomly assigned to either Glucagon RTU or Placebo for the duration of a 12-week Outpatient Stage. A follow-up safety assessment visit will occur 14 to 28 days after a subject's last dose of study drug.
NCT03119389
The necessity of Hand hygiene (HH) before donning non-sterile gloves is unknown. Furthermore, because of the additional time required to cleanse hands and then don gloves, as well as the cumbersome nature of applying gloves to recently washed hands, this practice leads to non-compliance with both HH and glove use - placing patients at risk. In a pilot study, the investigators performed a randomized trial of 230 healthcare workers and demonstrated no difference in total bacterial colony counts or identification of pathogenic bacteria from the gloves of persons who either performed HH or did not perform HH prior to putting on non-sterile gloves. If unnecessary, HH before non-sterile glove use wastes valuable time, which might otherwise be spent engaged in direct patient care. And removing this unnecessary step may lead to increased compliance with infection prevention measures. In Aim A, the investigators will perform a multi-center randomized control trial to evaluate the efficacy of a direct gloving strategy to improve compliance with infection prevention practices. In Aim B, the investigators will perform a nested multi-center validation study, where the gloved hands of healthcare workers will be randomly sampled to determine bacterial contamination of non-sterile gloves after donning.
NCT01826448
The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.
NCT03177447
Background: Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. This pilot study engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). An EPC feasibility study (4/1/14-8/31/15) was conducted for patients with New York Heart Association (NYHA) Functional Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. Patient- and caregiver-reported outcomes were collected for quality of life (QOL), symptom, health, anxiety, and depression outcomes at baseline, 12- and 24-weeks. Linear mixed-models were used to assess baseline to week 24 longitudinal changes. The intervention was tailored to rural, older adults (age≥65) with advanced HF in reducing HF morbidity and improving patient and caregiver QOL and quality of care.
