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NCT01980485
Narrative: Tobacco smoking remains the single biggest cause of premature death in the United States and the leading cause of cancer and death from cancer. There is therefore an urgent need to find effective but practical ways of helping smokers to quit and stay quit. This randomized trial aims to evaluate two promising methods of helping smokers to quit and to stay quit. Design: This is a randomized controlled smoking cessation trial with two stages. In Stage 1, 225 smokers will be recruited and at assessment they will be randomly allocated to receiving feedback on their "Lung Age" as estimated by their Forced Expiratory volume of air from lungs in one second (FEV1), and exhaled carbon-monoxide (CO) (Intervention group 1) or to have these measured but not fed back in a manner designed to enhance motivation to quit (Control group 1). All participants will be provided with group counseling (6 weekly sessions, with the target Quit Date on the day of the second group meeting), and transdermal nicotine patches. Main outcome measure: Stage 1, Past week tobacco abstinence biochemically validated by exhaled CO \< 10 ppm at visit 7 (4 weeks after Target Quit Date). In Stage 2 (starting visit 7), all participants attending visit 7 (28 days after their Target Quit Date), will be randomly allocated to receiving either the Forever Free relapse prevention materials (Intervention 2) http://www.smokefree.gov/pdf.html or the Surgeon General's Guide "How Tobacco Smoke Causes Disease" (Control 2) http://www.cdc.gov/tobacco/data\_statistics/sgr/2010/consumer\_booklet/index.htm. All randomized participants will receive a follow-up phone call a week later to remind them to read and use the materials they have been given, and will attend a follow up visit (8), 6 months after their initial Target Quit Date. Main outcome measure: Stage 2. Among those who have not smoked in the previous week at visit 7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by exhaled CO \< 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days during the prior 5 months (definition of a relapse in this study). Hypothesis: Smokers who are provided with lung age feedback at assessment will have higher quit rates 28 days after the target quit date.
NCT01662908
Assess the relative change in thrombus volume as determined by two assessments (Baseline and Day 14-21) with magnetic resonance venography (MRV) in subjects with deep-vein thrombosis (DVT) treated with either an edoxaban monotherapy regimen or a low molecular weight (LMW) heparin/warfarin regimen.
NCT03236194
The investigators will be studying the development of the microbiome over the first year after birth in light of various environmental influences - e.g. mode of delivery, diet (and diet changes), antibiotic exposure, GERD medication exposure.
NCT03015480
This pilot study tests the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.
NCT01841762
SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of which they will receive macitentan, 10 mg, once daily. The primary objectives are to demonstrate the final content validity of the PAH SYMPACT instrument, to demonstrate the psychometric characteristics of reliability and construct validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT instrument to detect change. The secondary objective is to assess the safety of macitentan in patients with pulmonary arterial hypertension. The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in patients with pulmonary arterial hypertension.
NCT03039634
This study evaluates the safety, effectiveness, and maintenance of effect of a novel topical silver particle solution (Sienna 755.1100, 810.1100, or 1064.1100) used in conjunction with a laser for the treatment of Acne Vulgaris.
NCT00504556
This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.
NCT02607800
The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.
NCT01364571
This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 18 to \<65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy adults aged 18 to \<65 years.
NCT01046669
To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.
NCT03327727
The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.
NCT02437890
Primary objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive systemic lupus erythematosus (SLE) compared to placebo. Secondary objectives: To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.
NCT01056328
The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.
NCT01553188
Background: * Advanced prostate cancer is treated with surgery or drugs that lower the levels of androgens (male hormones) in the body. However, some cancers become resistant to this treatment. These types of cancers are known as castration-resistant prostate cancers. * Interfering with the growth of blood vessels that feed tumors can slow prostate cancer growth. Trebananib (AMG 386), a new anticancer drug, targets the blood vessels that feed tumors. It has been tested for different types of cancer, but not for prostate cancer. Researchers want to see if AMG 386 can slow disease progression in men with castration-resistant prostate cancer. AMG 386 will be given with abiraterone and prednisone, two drugs that are also used to treat advanced prostate cancer. Objectives: \- To test the safety and effectiveness of AMG 386 with abiraterone for castration-resistant prostate cancer. Eligibility: \- Men at least 18 years of age with castration-resistant prostate cancer. Design: * Participants will be screened with a physical exam, medical history, and imaging studies. Blood and urine samples will also be collected. * Participants will be separated into two groups. * The first group will have AMG 386 once per week for a total of four doses during a 28-day cycle. They will also take abiraterone once a day and prednisone twice a day, every day of the cycle. * The second group will not have AMG 386. They will take abiraterone once a day and prednisone twice a day, every day of the 28-day cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Participants will continue to take the study drugs as long as the disease does not progress and there are no severe side effects.
NCT03221465
Project LIFT is a randomized, controlled trial that tests the effectiveness of a remotely-monitored, home-based exercise program utilizing wearable fitness trackers to monitor steps taken per day, health engagement questions, and financial incentives. 120 subjects will be randomized into 3 arms: 1) usual care - no fitness tracker or incentive, 2) a fitness tracker + no incentives, and 3) fitness tracker plus financial incentives.
NCT02444793
This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761 is estimated (dose finding), one or more expansion cohorts of patients with selected advanced solid tumors (dose-expansion ) will be enrolled to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarkers modulation.
NCT02324205
The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for biopsy after recall from screening and diagnostic work-up. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other clinical performance measures.
NCT00925054
The purpose of this study is to evaluate whether weekly injections of phenylalanine ammonia lyase (rAvPAL-PEG) can reduce blood phenylalanine concentrations in PKU subjects and whether repeated administration is safe.
NCT02003898
The purpose of this study is to evaluate the Threshold Suspend (TS) feature of the Medtronic MiniMed® 530G insulin pump in patients 16 and older with insulin requiring diabetes.
NCT02952911
This prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls. At the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes preconfigured smartphone and smartwatch. The configured smartphone and smartwatch pair will contain application software that prompts the user to perform various assessments, referred to as active tests and passive monitoring. Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test, electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive monitoring will be done to collect metrics on gait and mobility throughout the daily life of participants in a continuous and unobtrusive manner.