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NCT02484690
This multiple-center, multiple-dose and regimen, randomized, double-masked active comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study was designed to allow the evaluation of RO6867461 in a treatment-naive population (comparison of Arms A, B, C, and D) and an anti-VEGF-incomplete responder population that met a predefined criterion at Week 12 (comparison between Arms A and E). Only one eye per participant was chosen as the study eye.
NCT03608787
The Responsible Retailing Forum ("RRF") seeks to develop a new intervention, Stop Service to Obviously- Impaired Patrons ("S-STOP"), to reduce the incidence and harm associated with overservice of alcohol. Modeled after RRF's effective program to reduce alcohol sales to minors using Mystery Shopper feedback on staff ID-checking conduct, SSTOP would (1) conduct "Pseudo-Intoxicated" Mystery Shop" ("P-I/MS") inspections of serving establishments, employing actors who seek to purchase an alcohol beverage while showing obvious signs of intoxication, (2) provide licensees with confidential feedback on actual staff conduct and a video link to view the behavior of the P-I/MS that visited their establishments, (3) provide staff with brief online training in the recognition and skillful refusal of service to intoxicated patrons, and (4) provide communities with a measure of the prevalence of overservice. The proposed study will: (1) determine the effectiveness of S-STOP in improving recognition and refusal to serve an obviously- impaired customer. To do this, we will implement S-STOP in 10 pairs of demographically matched college and university communities, employing a cross-over design. After a 3-month baseline, we will implement S- STOP in one community in each pair (Cohort 1), while the second community serves as a control (Cohort 2). After 6 months, we will end S-STOP in Cohort 1 communities but continue inspections to measure the effects of decay; and we will begin S-STOP in Cohort 2. (2) examine how licensees utilize the S-STOP program and the extent to which utilization moderates the effectiveness of the program. To do this, we will measure the number and percentage of managers who visit the S-STOP website and register their staff for training, measure the number of staff that complete the training, and conduct analyses to investigate the dose-response relationship between utilization of the S-STOP program and likelihood of overservice. (3) investigate why some owner/managers did not participate in S-STOP. To achieve this, we will interview 20 owner-managers who did not access the S-STOP website.
NCT03609749
The purpose of this study is to investigate changes in functional neural activation during self-regulation tasks before compared to after the Mindfulness Training for Primary Care intervention (see MINDFUL-PC (Phase 3) clinical trial). The study will also look at whether chronic disease self-management action plan initiation and successful engagement of self-report and behavioral self-regulation targets relates to the observed brain activation changes after compared to before the mindfulness intervention.
NCT01589107
To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.
NCT02260752
The overall goal of this project is to better enable patients with uterine fibroids (UF) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. The foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for UF. Specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.
NCT01325519
The purpose of this study is to compare the decision making of hospitalized subjects having a verbal discussion about CPR compared to subjects using a video.
NCT00031083
In this study an investigational replication-defective, recombinant adenovirus expressing the interferon-beta gene (BG00001) will be directly injected into tumors, in patients with recurrent Grade III and Grade IV Gliomas, in order to deliver the hIFN-beta gene. The purpose of the study is to evaluate the safety and any harmful effects of injection of BG00001 into brain tumors. Also, this study will help determine whether the virus carrying the beta interferon gene will enter brain tumor cells and cause the cancer cells to die. This study will require one hospital admission for the actual procedure of drug administration. All other visits will be conducted on an out-patient basis
NCT02503241
The goal of this interventional crossover study in morbidly obese intubated and mechanically ventilated patients is to describe the respiratory mechanics and the heart-lung interaction at titrated positive end-expiratory pressure levels following a recruitment maneuver with transthoracic echocardiography and electric impedance tomography imaging.
NCT01589120
The purpose of this study is to compare the decision making of subjects with advanced CHF having a verbal discussion about goals of care compared to subjects using a video.
NCT04138485
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period. Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.
NCT02603120
The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.
NCT04268069
Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.
NCT03032380
The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.
NCT03484065
The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.
NCT03030599
This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.
NCT00471497
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.
NCT01265667
Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16 weeks. All subjects will receive open-lable CF101 in weeks 17-32.
NCT01036529
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as persistent or recurrent pain following one or more lumbosacral spine surgical procedures. Surgical procedures that can result in FBSS can be categorized as either decompression or decompression followed by fusion with or without instrumentation. The pain of FBSS is categorized as neuropathic, which involves pathological nerve activity and is commonly characterized by patients as shooting or burning and/or nociceptive, which signals actual or impending tissue damage or inflammation.
NCT03744507
The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.
NCT01888874
Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram \[mg\], 100 mg and 200 mg daily -, each evaluated as once daily \[QD\] and twice daily \[BID\] regimen) or matching placebo for 24 weeks. •During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.