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Discover 17,687 clinical trials near Maryland. Find research studies in your area.
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NCT01165229
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.
NCT03542851
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.
NCT00341692
Breast cancer is the most common cancer among women in the United States. Breast cancer research has been hampered by the difficulty in collecting normal breast tissue. In this study, researchers will obtain samples of normal breast tissue from organ donors and will collect risk-factor data from next-of-kin. The purpose of this study is to learn how normal breast develops and responds to stresses that are known to increase a woman s chance of developing breast cancer. Following the breast-tissue donation from 20 volunteers, surgical technicians will make small incisions in the skin and tissue of the breast and remove several samples measuring about one-inch. Technicians also will take samples of the uterine lining to estimate the date of the last menstrual period. The tissue will then be sent to the National Cancer Institute for laboratory research studies. Steps will be taken to ensure that the identity of the participants remains confidential.
NCT00904579
Background: * Solid organ transplantation provides life-saving treatment for end-stage organ disease but is associated with an increased cancer risk because of the need for long-term immunosuppression * End-stage renal disease (ESRD), the most common type of end-stage organ disease leading to transplant, is itself linked to increased risk for some cancers * The role of immunosuppression and other factors causing cancer in this setting are not fully understood. Objectives: * To characterize cancer risk in transplant recipients and identify risk factors. * To characterize risk for transmission of cancer from organ donors to recipients. * To describe cancer risk in ESRD. Eligibility: Patients are not required for this study. Data are gathered from existing databases of ESRD patients, organ transplant patients and cancer registries. Design: * Databases of 1) U.S. transplant recipients, donors and wait list candidates and 2) U.S. ESRD patients will be linked to multiple U.S. cancer registries to identify cancers in transplant recipients and ESRD patients. * The spectrum of cancer risk in transplant recipients and ESRD patients will be evaluated in detail. * The cancer risk in transplant recipients will be examined in relation to whether the donors had cancer. * The proposed cancer risk factors (e.g., underlying medical condition, infection with cancer-causing viruses, immunosuppressive medications) documented in transplant and ESRD files will be studied for association with increased risk of particular types of cancer.
NCT04020510
OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.
NCT03340688
This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth \<34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.
NCT02596230
RE-COVERY is a large, multi-national, multi-center observational study based on new data collection. The study will enroll and characterize patients within 30 days of being diagnosed with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for cross-sectional characterization of the VTE patient population. Objective 2 will compare the safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for the occurrence of outcome events for up to one year.
NCT02783651
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.
NCT02918279
This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.
NCT03251092
Part 1 of this trial will enroll healthy volunteers into a single ascending dose (SAD), multiple ascending dose (MAD), and Food Effect (FE) treatment groups. The SAD treatment group is comprised of at least 3 ascending dose level cohorts where healthy adult subjects will be randomized to receive a single dose of either PTI-808 or placebo and will be followed for 7 days post dose. A safety review committee (SRC) will convene after the completion of each cohort to evaluate safety and pharmacokinetic (PK) data. Following the conclusion of the respective SAD level dose groups and after sufficient review of study data and approval by the SRC, a second set of healthy adult subjects will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 ascending dose level cohorts where subjects will be randomized to receive either PTI-808 or placebo daily for 7 days and will be followed for 7 days after receiving the last dose. Also following the conclusion of the respective SAD level dose groups, healthy adult subjects will participate in the FE treatment group. Part 2 of this will enroll healthy volunteers to assess the safety, tolerability, and PK of PTI 808 co administered with PTI 801 and PTI 428 to HVs with daily dosing for 7 consecutive days. Part 3 will enroll adult subjects with cystic fibrosis (CF) into a MAD treatment group consisting of 2 cohorts. Subjects will receive PTI-808 co-administered with PTI-801 and PTI-428. PTI-808 will be administered daily for 7 consecutive days followed by PTI-808 + PTI-801 + PTI-428 administered daily for 14 consecutive days. Part 4 will enroll adult subjects with cystic fibrosis (CF) into 28-day cohorts. Subjects will receive PTI-808 co-administered with PTI-801 with or without PTI-428 versus matching placebo.
NCT01080300
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in postmenopausal women
NCT02201862
This study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control.
NCT01126476
The purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies.
NCT02140580
Trial question: Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous positive airway pressure (CPAP)? Trial hypothesis: That early surfactant administration via a minimally-invasive technique to preterm infants on CPAP will result in a lesser duration of mechanical respiratory support, and a higher incidence of survival without bronchopulmonary dysplasia. Trial design: Multicentre, randomised, masked, controlled trial in inborn preterm infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP because of respiratory distress, with an FiO2 of \>=0.3 and CPAP pressure 5-8. Infants randomised to surfactant treatment receive 200 mg/kg of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP. Controls continue on CPAP. The intervention is masked from the clinical team. Care thereafter is as per usual in both groups, other than the requirement to adhere to intubation criteria. The primary outcome is incidence of death or BPD. Secondary outcomes include incidence of death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula (HFNC), oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure; and outcome at 2 years. The sample size is 303/group, allowing detection of a 33% difference in the primary outcome with 90% power. The trial commenced at Royal Hobart Hospital December 2011 and Royal Women's Hospital during 2012, and will ultimately be conducted over 5 years in multiple centres internationally.
NCT03563313
The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.
NCT03177603
GSK2586881, a purified intravenous (IV) formulation of soluble recombinant human Angiotensin Converting Enzyme (rhACE2) is being investigated as a treatment for PAH. This GlaxoSmithKline (GSK) study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK2586881 in subjects with PAH. This open-label, dose-escalation study will comprise of 4 separate groups based on the planned dose range, and subjects in each group will be administered a single dose of GSK2586881 ranging between 0.1, 0.2, 0.4 and 0.8 milligram per kilogram (mg/kg) via IV route. Dose escalation will occur after 4 subjects have been dosed per cohort and review of safety, tolerability, PK and hemodynamic data up to 24 hours post dose has taken place. A maximum of 27 subjects will be included in the study and the total duration of the study will be up to a maximum of 59 days.
NCT01260506
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.
NCT03629184
This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to \<12 years of age) with influenza-like symptoms.
NCT01734382
PART1 Participants in Part 1 (Run-in-Phase) of study will receive tocilizumab (TCZ) (RoActemra/Actemra) 12 milligrams per kilogram (mg/kg) or 8 mg/kg intravenously (IV) every 2 weeks (Q2W) for up to 24 weeks. Participants who experience a laboratory abnormality during Part 1 may be eligible to move into Part 2 of the study. PART 2 This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of tocilizumab in reduced dose frequency in participants with adequately controlled systemic juvenile idiopathic arthritis who have experienced a laboratory abnormality on twice weekly tocilizumab dosing, that has since resolved. Participants will receive tocilizumab 12 mg/kg or 8 mg/kg intravenously every 3 weeks. After 5 consecutive infusions, participants who experience an event of neutropenia, thrombocytopenia or liver enzyme abnormality will move to every 4 weeks tocilizumab administration. Anticipated time on study treatment is 52 weeks.
NCT01589185
The objectives of this study are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in addition of standard of care antibiotic treatment.
