Active concurrent controlled study

Drug Study Designs - Information Sheet

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7/12/2018 · The alternative study design generally proposed to these kinds of studies is an active-treatment concurrent control in which a finding of no difference …

Drug Study Designs - Information Sheet

Standard treatment - Wikipedia

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Standard treatment (Active Control). The treatment that is normally provided to people with a given condition. In many studies, a control group receives the standard treatment while a treatment group receives the experimental treatment. After the clinical trial, researchers compare the outcomes of the two groups to see if the experimental treatment is better than, as good as or not as ...

Standard treatment - Wikipedia

This work is licensed under a Creative Commons Attribution ...

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Adequate and Well-Controlled Studies: 21 CFR 314.26 Generally, the following types of controls are recognized: i. Placebo concurrent control ii. Dose-comparison concurrent control iii. No treatment concurrent control iv. Active treatment concurrent control v. Historical control

This work is licensed under a Creative Commons Attribution ...

Placebo-Controlled Trials and Active-Control Trials in the ...

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9/19/2000 · Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. ... of the randomized withdrawal study is that it demonstrates a persistent effect for durations that would be difficult to study in placebo-controlled trials. ... which often cannot be accomplished without inclusion of a concurrent placebo group.

Placebo-Controlled Trials and Active-Control Trials in the ...

CFR - Code of Federal Regulations Title 21

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4/1/2018 · A placebo-controlled study may include additional treatment groups, such as an active treatment control or a dose-comparison control, and usually includes randomization and blinding of patients or investigators, or both. (ii) Dose-comparison concurrent control. At …

CFR - Code of Federal Regulations Title 21

Randomized controlled trial - Wikipedia

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A randomized controlled trial (or randomized control trial; RCT) is a type of scientific (often medical) experiment which aims to reduce bias when testing a new treatment.The people participating in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard treatment (or placebo treatment) as the control.

Randomized controlled trial - Wikipedia

Controlled study | definition of controlled study by ...

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controlled study A clinical trial in which a test agent is compared to a standard treatment with known effects. The control group may receive no treatment, active treatment, placebo or dose comparison concurrent control.

Controlled study | definition of controlled study by ...

#204 Guidance for Industry - Food and Drug Administration

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An active treatment concurrent control (active control) is a known effective therapy ... placebo-controlled study mentioned above was 20 percent , the margin of difference in the non-

#204 Guidance for Industry - Food and Drug Administration

A double-blind, randomized, placebo-controlled, active ...

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This is the first double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and tolerability of Lu AA21004 in patients with MDD. The active reference, venlafaxine XR (225 mg), was included with the purpose of validating the study methodology and patient population, and was effective on the primary efficacy analysis.

A double-blind, randomized, placebo-controlled, active ...

Basic Study Design Flashcards | Quizlet

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Basic Study Design. STUDY. PLAY. Protocol Development ... the sponsor must show, through adequate and well-controlled clinical studies, that it is effective Best way to design a study is prospective, randomized, controlled study These studies are known as Level I ... -Active-treatment concurrent control usually is designed to show no difference ...

Basic Study Design Flashcards | Quizlet

(PDF) Simultaneous Test for Superiority and Noninferiority ...

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PDF | Two stage switching between testing for superiority (SUP) and noninferiority (NI) has been an important statistical issue in the design and analysis of the active-controlled clinical trials.

(PDF) Simultaneous Test for Superiority and Noninferiority ...

Denosumab versus risedronate in glucocorticoid-induced ...

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In this randomised, active-controlled trial, denosumab was both non-inferior and superior to risedronate, a commonly used bisphosphonate for glucocorticoid-induced osteoporosis, in increasing bone mineral density at the lumbar spine at 12 months in patients already taking or …

Denosumab versus risedronate in glucocorticoid-induced ...

A Randomized, Concurrent Controlled ... - ClinicalTrials.gov

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4/25/2012 · This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D.

A Randomized, Concurrent Controlled ... - ClinicalTrials.gov

The effects of low-intensity blood flow restricted ...

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12/8/2017 · The effects of low-intensity blood flow restricted exercise compared with conventional resistance training on the clinical outcomes of active UK military personnel following a 3-week in-patient rehabilitation programme: protocol for a randomized controlled feasibility study

The effects of low-intensity blood flow restricted ...

Feasibility of high-intensity interval training and ...

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4/3/2017 · Feasibility of high-intensity interval training and moderate-intensity continuous training in adults with inactive or mildly active Crohn’s disease: study protocol for a randomised controlled trial

Feasibility of high-intensity interval training and ...

Denosumab versus risedronate in glucocorticoid-induced ...

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Our trial is among the largest randomised controlled trials in glucocorticoid-induced osteoporosis, and had a dropout rate of only 13% over 1 year, which is substantially lower than the 31% rate in the next most recent study in glucocorticoid-induced osteoporosis (of teriparatide). 9 Another strength was the active-comparator design, 6 although ...

Denosumab versus risedronate in glucocorticoid-induced ...

Movement through Active Personalised engagement (MAP) — a ...

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10/20/2018 · Multimorbidity, defined as two or more concurrent chronic diseases within the same individual, is becoming the clinical norm within primary care. Given the burden of multimorbidity on individuals, carers and health care systems, there is a need for effective self-management programmes. Promoting active participation within their clinical care and following a healthy lifestyle will help …

Movement through Active Personalised engagement (MAP) — a ...

Using a clinical pathway and education to reduce ...

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The study population was a group of randomly selected patients (n = 439) admitted to study hospitals with a discharge diagnosis of chest pain, angina, or myocardial infarction, and stratified into high, intermediate, low-risk ACS or non-cardiac chest pain: 146 intervention patients (September-November 2003), 147 historical controls (August ...

Using a clinical pathway and education to reduce ...

Organizational Controls: Feedforward, Concurrent & Feedback

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Introduction. In this video, we will explore three organizational controls used in the controlling step of the management process: feedforward controls, concurrent controls and feedback controls.

Organizational Controls: Feedforward, Concurrent & Feedback

Tuberculous constrictive pericarditis with concurrent ...

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5/18/2009 · In some particular endemic area, it is not uncommon to see patients with tuberculosis pericarditis. However, it takes a period of time from tuberculous pericarditis to constrictive pericarditis. There is still no report of tuberculous constrictive pericarditis concurrent with active pulmonary TB infection in a patient without previous pulmonary TB infection history.

Tuberculous constrictive pericarditis with concurrent ...

21 CFR § 314.126 - Adequate and well-controlled studies ...

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§ 314.126 Adequate and well-controlled studies. (a) ... Placebo concurrent control. The test drug is compared with an inactive preparation designed to resemble the test drug as far as possible. A placebo-controlled study may include additional treatment groups, such as an active treatment control or a dose-comparison control, and usually ...

21 CFR § 314.126 - Adequate and well-controlled studies ...

Reduction of fatigue in Sjögren syndrome with rituximab ...

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11/1/2008 · Objective: Primary Sjögren syndrome (pSS) causes significant systemic symptoms including fatigue as well as glandular dysfunction. There are currently no effective systemic therapies; however, open label series have suggested that rituximab may be beneficial for systemic and glandular manifestations. Therefore, we performed a double blind, placebo-controlled, randomised pilot study of …

Reduction of fatigue in Sjögren syndrome with rituximab ...

An Active-Controlled, Dose-Finding Study of SCY-078 vs ...

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8/17/2017 · This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate …

An Active-Controlled, Dose-Finding Study of SCY-078 vs ...

A randomized controlled efficacy trial of behavioral ...

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A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: Project IMPACT study protocol. Matthew J. Mimiaga, David W. Pantalone, Katie B. Biello, ...

A randomized controlled efficacy trial of behavioral ...

Application of cosmetic nail varnish does not affect the ...

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Clinical study design. In this single site, investigator‐blinded, active‐controlled, parallel‐group comparison study, subjects were randomised 1 : 1 to receive either 12‐week treatment of amorolfine 5% NL alone or amorolfine 5% NL plus a cosmetic nail varnish applied 24 h later (ClinicalTrials.gov identifier: NCT02321098).A randomisation list was generated using the Ranuni routine of ...

Application of cosmetic nail varnish does not affect the ...

Control Group: Definition, Examples and Types - Statistics ...

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10/1/2015 · Active treatment concurrent control: one group is given the treatment, the other group is given an existing therapy that is known to be effective. Historical control: ... With Chegg Study, you can get step-by-step solutions to your questions from an expert …

Control Group: Definition, Examples and Types - Statistics ...

FDA Small Clinical Trials Course White Oak December 2012

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FDA Small Clinical Trials Course White Oak December 2012 Marc K Walton MD, PhD Associate Director for Translational Medicine Office of Translational Sciences ... Concurrent case- control study ... historically controlled study. 27 .

FDA Small Clinical Trials Course White Oak December 2012

Simultaneous Test for Superiority and Noninferiority ...

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For simplicity, we assume the sample size in the current active-controlled trial is n1 per arm and n2 per arm in the historical trial. Further, we assume a common variance 12 for both arms in the current active-controlled trial and a common variance 22 for both arms in the historical trial.

Simultaneous Test for Superiority and Noninferiority ...

Concurrent use of diuretics, angiotensin converting enzyme ...

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1/8/2013 · Objectives To assess whether a double therapy combination consisting of diuretics, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers with addition of non-steroidal anti-inflammatory drugs (NSAIDs) and the triple therapy combination of two of the aforementioned antihypertensive drugs to which NSAIDs are added are associated with an increased risk of acute …

Concurrent use of diuretics, angiotensin converting enzyme ...

Concurrent transcranial direct current stimulation and ...

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7/19/2016 · Concurrent transcranial direct current stimulation and progressive resistance training in Parkinson’s disease: study protocol for a randomised controlled trial Ashlee M. Hendy 1 , Alex Tillman 1 ,

Concurrent transcranial direct current stimulation and ...

The maximum number of active concurrent statistics ...

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The maximum number of active concurrent statistics gathering jobs is controlled from CS 54778 at Hillsborough Community College

The maximum number of active concurrent statistics ...

CFR - Code of Federal Regulations Title 21

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4/1/2018 · The characteristics described in paragraph (b) of this section have been developed over a period of years and are generally recognized as the essentials of an adequate and well-controlled study. Well controlled, as used in the phrase adequate and well controlled, emphasizes an …

CFR - Code of Federal Regulations Title 21

(PDF) APOLLO-1: a randomized placebo and active-controlled ...

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APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the µ-opioid receptor, for management of moderate-to-severe ...

(PDF) APOLLO-1: a randomized placebo and active-controlled ...

Abatacept in combination with methotrexate in Japanese ...

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12/1/2018 · Objectives To evaluate efficacy and safety of abatacept+methotrexate (MTX) in biologic-naive, anticitrullinated protein antibody (ACPA)-positive Japanese patients with active rheumatoid arthritis (RA) and early erosion versus placebo+MTX. Methods In this phase IV, multicentre, double-blind study ([NCT01758198][1]), patients were randomised (1:1) to receive intravenous abatacept (~10 mg/kg) or ...

Abatacept in combination with methotrexate in Japanese ...

A randomized controlled efficacy trial of behavioral ...

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7/25/2018 · Methods. This study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL.

A randomized controlled efficacy trial of behavioral ...

Reducing hospital noise with sound acoustic panels and ...

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8/1/2016 · We conducted an observational, controlled study assessing sound levels on an active inpatient telemetry unit. Due to physical nature of sound acoustic panels, patients and staff were not blinded. Placement of panels and acoustic equipment met all institutional building management policies and national codes . The inpatient telemetry unit is ...

Reducing hospital noise with sound acoustic panels and ...

Concurrent Cognitive Control Training Augments the ...

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Both participants and clinical The current study aimed to investigate whether concurrent CCT raters remained blind to treatment condition until the end of the would enhance the antidepressant efficacy of a short course of three week follow up assessment when unmasking occurred. tDCS. ... For both active and sham cognitive R.A. Segrave et al ...

Concurrent Cognitive Control Training Augments the ...

Primary Outcomes From a Phase 3, Randomized, Double-Blind ...

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1/19/2017 · This randomized, double-blind, active-controlled trial, consisting of 2 treatment arms (protocol MK-4261-005; ClinicalTrials.gov identifier NCT01597505), was conducted between July 28, 2012 and March 20, 2015 in accordance with the Declaration of Helsinki, Good Clinical Practice Guidelines, and the approval of local institutional review boards.

Primary Outcomes From a Phase 3, Randomized, Double-Blind ...

Placebo-Controlled Phase 3 Study of Oral BG-12 or ...

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Original Article from The New England Journal of Medicine — Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis ... An active agent, glatiramer acetate, was also ...

Placebo-Controlled Phase 3 Study of Oral BG-12 or ...

Manual therapy followed by specific active exercises ...

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8/28/2012 · Recent clinical recommendations still propose active exercises (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related manifestations. Current evidences suggest that manual therapy (MT) induces an immediate analgesic effect through neurophysiologic mechanisms at peripheral, spinal and cortical levels. The aim of this pilot study was first, to assess …

Manual therapy followed by specific active exercises ...

Application of cosmetic nail varnish does not affect the ...

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In this single site, investigator-blinded, active-controlled, parallel-group comparison study, subjects were randomised 1 : 1 to receive either 12-week treatment of amorolfine 5% NL alone or amorolfine 5% NL plus a cosmetic nail varnish applied 24 h later (ClinicalTrials.gov identifier: NCT02321098). A randomisation list was generated using the ...

Application of cosmetic nail varnish does not affect the ...

AranespR Phase 3 Study in Patients with Active Cancer Not ...

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THOUSAND OAKS, Calif.--(BUSINESS WIRE)--April 16, 2007--Amgen (Nasdaq:AMGN) today presented the results from a randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of Aranesp(R) (darbepoetin alfa) for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy ("the ...

AranespR Phase 3 Study in Patients with Active Cancer Not ...

Experimental Studies in Epidemiology (ch8) Flashcards ...

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Start studying Experimental Studies in Epidemiology (ch8). Learn vocabulary, terms, and more with flashcards, games, and other study tools. Search. ... Placebo-controlled study, the subjects are blinded, but investigation are aware of who is receiving the active treatment. ... Concurrent comparison group in a nonrandom process (convenience ...

Experimental Studies in Epidemiology (ch8) Flashcards ...
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