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BIOSTATISTICS
Year : 2011  |  Volume : 2  |  Issue : 3  |  Page : 109-112

Intention-to-treat concept: A review


Clinical Pharmacologist, Gurgaon, India

Date of Web Publication27-Jul-2011

Correspondence Address:
Sandeep K Gupta
J-1044, First Floor, Palam Vihar, Gurgaon - 122 001, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.83221

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   Abstract 

Randomized controlled trials often suffer from two major complications, i.e., noncompliance and missing outcomes. One potential solution to this problem is a statistical concept called intention-to-treat (ITT) analysis. ITT analysis includes every subject who is randomized according to randomized treatment assignment. It ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. ITT analysis maintains prognostic balance generated from the original random treatment allocation. In ITT analysis, estimate of treatment effect is generally conservative. A better application of the ITT approach is possible if complete outcome data are available for all randomized subjects. Per-protocol population is defined as a subset of the ITT population who completed the study without any major protocol violations.

Keywords: Intention-to-treat analysis, per-protocol analysis, randomized controlled trials


How to cite this article:
Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res 2011;2:109-12

How to cite this URL:
Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res [serial online] 2011 [cited 2017 Sep 26];2:109-12. Available from: http://www.picronline.org/text.asp?2011/2/3/109/83221


   Introduction Top


Randomized controlled trials (RCTs) often suffer from two major complications, i.e., noncompliance and missing outcomes. One potential solution to this problem is a statistical concept called intention-to-treat (ITT) concept. The objective of this article is to give a basic understanding of the ITT concept to the beginners in the field of clinical research. With this objective in mind, this article will review the ITT principle, with special emphasis on need and application of this concept and its pros and cons.


   Definition of ITT Concept Top


According to Fisher et al. (1990), the ITT analysis includes all randomized patients in the groups to which they were randomly assigned, regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal from treatment or deviation from the protocol. [1]

In other words, ITT analysis includes every subject who is randomized according to randomized treatment assignment. It ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. [2],[3],[4],[5] ITT analysis is usually described as "once randomized, always analyzed". [6],[7]

ITT analysis avoids overoptimistic estimates of the efficacy of an intervention resulting from the removal of non-compliers by accepting that noncompliance and protocol deviations are likely to occur in actual clinical practice. [4]


   Need for Such a Population Top


RCTs are the ideal design in assessing the efficacy and safety of medicine. In an RCT, the study subjects is randomly allocated to receive one of the treatments under study after assessment of eligibility but before the intervention is administered. Randomization in clinical trials reduces bias. The purpose of the RCT is to ensure that the groups differ only with respect to the interventions being compared. [8]

In an ideal scenario, every subject enrolled in RCT would follow instructions and complete their allocated treatment as described in the protocol and thus contribute data which were complete in all respects. [9] But unfortunately, one practical problem that investigators usually come across in RCT is that subjects do not always follow instructions. Moreover, in some studies, drop out of the subjects is a problem. Hence, RCTs often suffer from two major complications, i.e., noncompliance and missing outcomes. One potential solution to this problem is a statistical concept called ITT analysis. [10],[11]


   Pros of Using ITT Analysis Top


ITT is better regarded as a complete trial strategy for design, conduct and analysis rather than as an approach to analysis alone. [9],[12] Full reporting of any deviations from random allocation and missing response is essential in the assessment of the necessity and appropriateness of an ITT approach, as emphasized in the Consolidated Standards of Reporting Trials (CONSORT) guidelines on the reporting of RCTs. [12] The CONSORT statement for improving the quality of reports of RCTs states that number of participants in each group should be analyzed by "intention-to-treat" principle. [13]

ITT analysis reflects the practical clinical scenario because it admits noncompliance and protocol deviations. ITT analysis maintains prognostic balance generated from the original random treatment allocation. It gives an unbiased estimate of treatment effect. [3],[4],[14] If noncompliant subjects and dropouts are excluded from the final analysis, it might create important prognostic differences among treatment groups. Moreover, subjects may be noncompliant or may drop out from the study due to their response of treatment. [3]

ITT analysis preserves the sample size because if noncompliant subjects and dropouts are excluded from the final analysis, it might significantly reduce the sample size, leading to reduced statistical power. [3]

ITT analysis limits inferences based on arbitrary or ad hoc subgroups of patients in the trial and emphasizes greater accountability for all patients enrolled in the study. Also, it minimizes type I error due to cautious approach and allows for the greatest generalizability. [15]


   Cons of Using ITT Analysis Top


Many arguments against ITT analysis appear valid. To begin with, if a subject who actually did not receive any treatment is included as a subject who received treatment, then it indicates very little about the efficacy of the treatment. In ITT analysis, estimate of treatment effect is generally conservative because of dilution due to noncompliance. Also, heterogeneity might be introduced if noncompliants, dropouts and compliant subjects are mixed together in the final analysis. Moreover, end-point data will differ markedly among noncompliant, dropouts and compliant subjects, and interpretation might become difficult if a large proportion of participants cross over to opposite treatment arms. [3],[4],[12],[16],[17] ITT analysis has been criticized for being too cautious and thus being more susceptible to type II error. [12],[15]


   Who should use ITT? Top


A better application of the ITT approach is possible if complete outcome data are available for all randomized subjects. Care must always be taken to minimize missing responses and to continue to follow up those who withdraw from treatment. [4],[18],[19] Anyone who follows these principles intelligently and has a vision to minimize bias should not worry further about "intention to treat". [9] However, in most cases, missing data could also be dealt by using the last observation carried forward (LOCF) method, whereby the last available measurement for each individual at the time point prior to withdrawal from the study is retained in the analysis. [20],[21]

US Food and Drug Administration (FDA) guidelines for "The Format and Content of the Clinical and Statistical Sections of Applications" state that as a general rule, even if the applicant's preferred analysis is based on a reduced subset of the patients with data, there should be an additional "intent-to-treat" analysis using all randomized patients. The FDA guideline further explains that the results of a clinical trial should be assessed not only for the subset of patients who completed the study, but also for the entire patient population randomized (the ITT analysis). [22],[23]

Committee for Proprietary Medicinal Products (CPMP) note for guidance "Biostatistical Methodology in Clinical Trials for Marketing Authorisations for Medicinal Products" states that decisions concerning the analysis population should be guided by the principles underlying the "intention-to-treat" and the "per-protocol" strategies. When the ITT and per-protocol (PP) analyses come to essentially the same conclusions, confidence in the study results is increased. [22],[24]

The International Conference on Harmonisation (ICH) E9 guideline on "Statistical Principles for Clinical Trials" uses the term "full analysis set" to describe the analysis set which is as complete as possible and as close as possible to the ITT ideal of including all randomized subjects. [22],[25]

One of the alternatives of ITT analysis is the PP analysis. It is defined as a subset of the ITT population who completed the study without any major protocol violations. [26] PP analyses exclude all protocol violators, including anyone who did not adhere to treatment, switched groups, or missed measurements. [27] ITT tends to make the two treatments look similar, whereas the PP removes patients who do not complete treatment and is more able to reflect treatment differences. [28]

CPMP guideline states that for a superiority trial, the ITT analysis should be considered primary and the PP supportive. [29] It is often argued that the ITT analysis tends to dilute the treatment difference of interest. [30] Whereas the importance of the ITT population analysis in superiority designs has been well accepted, however there is no consensus about its role in non-inferiority trials. [31]

It has been argued that protocol violations and poorly conducted trials may cause the results obtained from two different treatment groups to appear similar. Hence, ITT analysis alone is not preferred for noninferiority trial. A possible alternative is to conduct the PP analysis where only subjects meeting the inclusion criteria are considered. But the conservative effect of the PP analysis on noninferiority and equivalence trials has not been thoroughly explored. Therefore, it has been suggested that noninferiority should be concluded only if both ITT and PP analyses permit that. [28],[31],[32],[33],[34],[35],[36] CPMP guideline states that in a noninferiority trial, the full analysis set based on the ITT principle and the PP analysis set have equal importance and their use should lead to similar conclusions for a robust interpretation. [29]


   Modified ITT Concept Top


It is a subset of the ITT population and allows the exclusion of some randomized subjects in a justified way (such as patients who were deemed ineligible after randomization or certain patients who never started treatment). However, the definition given to the modified ITT (mITT) in randomized controlled trial has been found to be irregular and arbitrary because there is a lack of consistent guidelines for its application. The mITT analysis allows a subjective approach in entry criteria, which may lead to confusion, inaccurate results and bias. [27],[37],[38] It is mostly used in anti-infective trials where multiple mITT populations can be defined for a single study such as clinical mITT and microbiological mITT. [39],[40]


   Summary and Conclusion Top


One practical problem that investigators usually come across in RCT is that subjects do not always follow instructions. Moreover, in some studies, drop out of the subjects is a problem. Hence, RCT often suffers from two major complications, i.e., noncompliance and missing outcomes. One potential solution to this problem is a statistical concept called ITT analysis. ITT analysis includes every subject who is randomized according to randomized treatment assignment. It ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. ITT analysis is usually described as "once randomized, always analyzed". But in ITT analysis, estimate of treatment effect is generally conservative because of dilution due to noncompliance. Also, heterogeneity might be introduced if noncompliants, dropouts and compliant subjects are mixed together in the final analysis. Moreover, end-point data will differ markedly among noncompliant, dropouts and compliant subjects, and interpretation might become difficult if a large proportion of participants cross over to opposite treatment arms. A better application of the ITT approach is possible if complete outcome data are available for all randomized subjects. Care must always be taken to minimize missing responses and to continue to follow up those who withdraw from treatment. Anyone who follows these principles intelligently and has a vision to minimize bias should not worry further about "intention to treat".


   Acknowledgement Top


I gratefully acknowledge the help of anonymous reviewers for helpful comments and suggestions.


   Disclaimer Top


The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of his employer.

 
   References Top

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36 A randomized clinical trial comparing long-term clopidogrel vs aspirin monotherapy beyond dual antiplatelet therapy after drug-eluting coronary stent implantation: Design and rationale of the Harmonizing Optimal Strategy for Treatment of coronary artery stenosis-Extended Antiplatelet Monotherapy (HOST-EXAM) trial
Heesun Lee,Bon-Kwon Koo,Kyung Woo Park,Eun-Seok Shin,Sang Wook Lim,Seung-Woon Rha,Jang-Whan Bae,Dong Woon Jeon,Seok-Kyu Oh,Seung-Ho Hur,Bum-Su Kim,Jung-Hee Lee,Tae-Ho Park,Nam Ho Lee,Hyo-Soo Kim
American Heart Journal. 2017; 185: 17
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37 Feasibility and Acceptability of a Task-Shifted Intervention to Enhance Adherence to HIV Medication and Improve Depression in People Living with HIV in Zimbabwe, a Low Income Country in Sub-Saharan Africa
Melanie Abas,Primrose Nyamayaro,Tarisai Bere,Emily Saruchera,Nomvuyo Mothobi,Victoria Simms,Walter Mangezi,Kirsty Macpherson,Natasha Croome,Jessica Magidson,Azure Makadzange,Steven Safren,Dixon Chibanda,Conall O’Cleirigh
AIDS and Behavior. 2017;
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38 An Experimental Evaluation of the Impact of Intensive Supervision on the Recidivism of High-Risk Probationers
Jordan M. Hyatt,Geoffrey C. Barnes
Crime & Delinquency. 2017; 63(1): 3
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39 Impact of industry collaboration on randomised controlled trials in oncology
Anne Linker,Annie Yang,Nitin Roper,Evans Whitaker,Deborah Korenstein
European Journal of Cancer. 2017; 72: 71
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40 Quality of reporting for randomized controlled trials in the hypospadias literature: where do we stand?
L.H. Braga,M. McGrath,L. Mauro,A.J. Lorenzo
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41 Early introduction of food reduces food allergy - Pro and Con
Debra J. Palmer,Susan L. Prescott,Michael R. Perkin
Pediatric Allergy and Immunology. 2017; 28(3): 214
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42 Increasing boys’ and girls’ intentions to avoid teenage pregnancy: a cluster randomised controlled feasibility trial of an interactive video drama-based intervention in post-primary schools in Northern Ireland
Maria Lohan,Áine Aventin,Lisa Maguire,Rhonda Curran,Clíona McDowell,Ashley Agus,Cam Donaldson,Mike Clarke,Mark Linden,Carmel Kelly,Lisa McDaid,Laura Dunne,Peter O’Halloran
Public Health Research. 2017; 5(1): 1
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43 Effects of the ABC Intervention on Foster Children’s Receptive Vocabulary: Follow-Up Results From a Randomized Clinical Trial
Kristin Bernard,Amy Hyoeun Lee,Mary Dozier
Child Maltreatment. 2017; 22(2): 174
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44 Outcomes of a Randomized Controlled Trial of Genomic Counseling for Patients Receiving Personalized and Actionable Complex Disease Reports
Kevin Sweet,Amy C. Sturm,Tara Schmidlen,Joseph McElroy,Laura Scheinfeldt,Kandamurugu Manickam,Erynn S. Gordon,Shelly Hovick,J. Scott Roberts,Amanda Ewart Toland,Michael Christman
Journal of Genetic Counseling. 2017;
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45 Feeling Thanks and Saying Thanks: A Randomized Controlled Trial Examining If and How Socially Oriented Gratitude Journals Work
Brenda H. OæConnell,Deirdre OæShea,Stephen Gallagher
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46 No additional benefit of using a calcium hydroxide liner during stepwise caries removal
Maria Auxiliadora Pereira,Reginaldo Batista dos Santos-Júnior,Johnny Alexandre Tavares,Alaíde Hermínia Oliveira,Pollyana Caldeira Leal,Wilton Mitsunari Takeshita,Antônio Márcio Barbosa-Júnior,Luiz Eduardo Braga Bertassoni,André Luis Faria-e-Silva
The Journal of the American Dental Association. 2017;
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47 Effectiveness of pulmonary rehabilitation for patients with asthma: study protocol of a randomized controlled trial (EPRA)
Konrad Schultz,Hildegard Seidl,Danijel Jelusic,Rupert Wagner,Michael Wittmann,Hermann Faller,Dennis Nowak,Michael Schuler
BMC Pulmonary Medicine. 2017; 17(1)
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48 Challenges in implementing an exercise intervention within residential psychiatric care: A mixed methods study
Joseph Firth,Rebekah Carney,Michelle Pownall,Paul French,Rebecca Elliott,Jack Cotter,Alison R. Yung
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49 Incomplete descriptions of oral nutritional supplement interventions in reports of randomised controlled trials
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50 Testing the limits: Extending attachment-based intervention effects to infant cognitive outcome and parental stress
Karine Dubois-Comtois,Chantal Cyr,George M. Tarabulsy,Diane St-Laurent,Annie Bernier,Ellen Moss
Development and Psychopathology. 2017; 29(02): 565
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51 Online Self-Tracking Groups to Increase Fruit and Vegetable Intake: A Small-Scale Study on Mechanisms of Group Effect on Behavior Change
Jingbo Meng,Wei Peng,Soo Yun Shin,Minwoong Chung
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52 Outcomes of a family-based HIV prevention intervention for substance using juvenile offenders
Marina Tolou-Shams,Emily Dauria,Selby M. Conrad,Kathleen Kemp,Sarah Johnson,Larry K. Brown
Journal of Substance Abuse Treatment. 2017; 77: 115
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53 Formal Physical Therapy After Total Hip Arthroplasty Is Not Required
Matthew S. Austin,Brian T. Urbani,Andrew N. Fleischman,Navin D. Fernando,James J. Purtill,William J. Hozack,Javad Parvizi,Richard H. Rothman
The Journal of Bone and Joint Surgery. 2017; 99(8): 648
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54 The effectiveness of braces and orthoses for patients with knee osteoarthritis: A systematic review of Japanese-language randomised controlled trials
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Prosthetics and Orthotics International. 2017; 41(2): 115
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55 Resistance training prescription with different load-management methods improves phase angle in older women
Alex S. Ribeiro,Brad J. Schoenfeld,Mariana F. Souza,Crisieli M. Tomeleri,Analiza M. Silva,Denílson C. Teixeira,Luís B. Sardinha,Edilson S. Cyrino
European Journal of Sport Science. 2017; : 1
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56 Angiotensin II/Angiotensin (1–7) ratio and 24-h blood pressure throughout the menstrual cycle and in women using oral contraceptives
Gina C. Davis,Karen J. Gibson,David Casley,Mark A. Brown
Journal of Hypertension. 2017; 35(6): 1178
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57 Evaluation of the impact of disease prevention measures: a methodological note on defining incidence rates
Yin-Bun Cheung,Ying Xu,Matthew Cairns,Paul Milligan
BMC Medical Research Methodology. 2017; 17(1)
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58 Physical Activity on Prescription (PAP), in patients with metabolic risk factors. A 6-month follow-up study in primary health care
Stefan Lundqvist,Mats Börjesson,Maria E. H. Larsson,Lars Hagberg,Åsa Cider,Yvonne Böttcher
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59 Clinical and cost effectiveness of nurse-led self-management interventions for patients with copd in primary care: A systematic review
Elizabeth Baker,Francis Fatoye
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60 Ischemic compression and kinesiotherapy on chronic myofascial pain in breast cancer survivors
Flávia Belavenuto Rangon,Vânia Tiê Koga Ferreira,Monique Silva Rezende,Amanda Apolinário,Ana Paula Ferro,Elaine Caldeira de Oliveira Guirro
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61 A randomized clinical trial of oral hygiene care programmes during stroke rehabilitation
Ruoxi Dai,Otto L.T. Lam,Edward C.M. Lo,Leonard S.W. Li,Colman McGrath
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62 Long-term abstinence and predictors of tobacco treatment uptake among hospitalized smokers with serious mental illness enrolled in a smoking cessation trial
Erin S. Rogers,Rebecca Friedes,Annika Jakes,Ellie Grossman,Alissa Link,Scott E. Sherman
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63 Understanding the Mechanisms of Change in a Lifestyle Intervention for Older Adults
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64 Increasing Physical Activity Through Principles of Habit Formation in New Gym Members: a Randomized Controlled Trial
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Annals of Behavioral Medicine. 2017;
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65 Patient Satisfaction on Overactive Bladder Treatment
Kimberly Tay,Aqsa Khan
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66 Systematic Review of Yoga Interventions to Promote Cardiovascular Health in Older Adults
Jennifer L. Barrows,Julie Fleury
Western Journal of Nursing Research. 2016; 38(6): 753
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67 The effect of supervised and home based exercises on balance in elderly subjects: a randomized controlled trial to prevent falls
Erika Harumi Tanaka,Paulo Ferreira dos Santos,Marcela Fernandes Silva,Priscila Fernanda Figueiredo Borges Botelho,Patrícia Silva,Natalia Camargo Rodrigues,Matheus Machado Gomes,Renato Moraes,Daniela Cristina Carvalho de Abreu
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68 Study protocol: a cluster randomized controlled trial to assess the effectiveness of a multi-pronged behavioural intervention to improve use of personal protective equipment among migrant workers exposed to organic solvents in small and medium-sized enterprises
Wen Chen,Tongyang Li,Guanyang Zou,Xudong Li,Leiyu Shi,Shanshan Feng,Jingrong Shi,Fangjing Zhou,Siqi Han,Li Ling
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69 An Overview of Challenges and Approaches to Minimize Bias in Randomized Controlled Trials in Perioperative Medicine
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70 Comparative effectiveness and safety of antipsychotic drugs in schizophrenia treatment: a real-world observational study
A. Vanasse,L. Blais,J. Courteau,A. A. Cohen,P. Roberge,A. Larouche,S. Grignon,M.-J. Fleury,A. Lesage,M.-F. Demers,M.-A. Roy,J.-D. Carrier,A. Delorme
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71 Effects of Internet-Based Self-Efficacy Intervention on Secondary Traumatic Stress and Secondary Posttraumatic Growth among Health and Human Services Professionals Exposed to Indirect Trauma
Roman Cieslak,Charles C. Benight,Anna Rogala,Ewelina Smoktunowicz,Martyna Kowalska,Katarzyna Zukowska,Carolyn Yeager,Aleksandra Luszczynska
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72 Family-centred music therapy with preterm infants and their parents in the Neonatal Intensive Care Unit (NICU) in Colombia – A mixed-methods study
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73 Evaluating the effectiveness of combining home-start and triple P parenting support in the Netherlands
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74 The impact of trial stage, developer involvement and international transferability on universal social and emotional learning programme outcomes: a meta-analysis
M. Wigelsworth,A. Lendrum,J. Oldfield,A. Scott,I. ten Bokkel,K. Tate,C. Emery
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75 Preliminary study of a rehabilitation program based on attentional processes to treat auditory hallucinations
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76 Exercise as an intervention for first-episode psychosis: a feasibility study
Joseph Firth,Rebekah Carney,Rebecca Elliott,Paul French,Sophie Parker,Rebecca McIntyre,Jamie S. McPhee,Alison R. Yung
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77 Statistical Primer on Biosimilar Clinical Development
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78 An Evaluation of Parent–Child Interaction Therapy With and Without Motivational Enhancement to Reduce Attrition
Haley J. Webb,Rae Thomas,Leanne McGregor,Elbina Avdagic,Melanie J. Zimmer-Gembeck
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79 Development and Two-Year Follow-Up Evaluation of a Training Workshop for the Large Preventive Positive Psychology Happy Family Kitchen Project in Hong Kong
Agnes Y. Lai,Moses W. Mui,Alice Wan,Sunita M. Stewart,Carol Yew,Tai-hing Lam,Sophia S. Chan,Emmanuel Manalo
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80 Methodological issues in clinical trials of polycystic kidney disease: a focused review
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81 Randomized Trials of the Teen Outreach Program in Louisiana and Rochester, New York
William T. Robinson,Susan M. Seibold-Simpson,Hugh F. Crean,Briana Spruille-White
American Journal of Public Health. 2016; 106(S1): S39
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82 Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial
Túlio Eduardo Nogueira,Shahrokh Esfandiari,Cláudio Rodrigues Leles
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83 The Efficacy and Safety of Tetrachlorodecaoxide in Comparison with Super-oxidised Solution in Wound Healing
Romil Parikh,Girish Bakhshi,Madhushree Naik,Bhargav Gaikwad,Kavita Jadhav,Mukund Tayade
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84 Cognitive remediation to enhance mobility in older adults: the CREM study
Joe Verghese,Emmeline Ayers,Jeannette R Mahoney,Anne Ambrose,Cuiling Wang,Roee Holtzer
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85 Exergaming for Health: A Randomized Study of Community-Based Exergaming Curriculum in Pediatric Weight Management
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86 Prostate cancer: Determining optimal therapy of early-stage disease remains complicated
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87 Can the provision of a home help service for the elderly population reduce the incidence of fall-related injuries? A quasi-experimental study of the community-level effects on hospital admissions in Swedish municipalities
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88 Randomized Control Trial of Teaching Recovery Techniques in Rural Occupied Palestine: Effect on Adolescent Dissociation
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89 Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery
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90 The longitudinal mental health benefits of a yoga intervention in women experiencing chronic stress: A clinical trial
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Cogent Psychology. 2016; 3(1)
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91 Study protocol for a non-inferiority trial of a blended smoking cessation treatment versus face-to-face treatment (LiveSmokefree-Study)
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92 Study protocol RapMusicTherapy for emotion regulation in a school setting
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93 Effect of long-term vitamin E and selenium supplementation on urine F2-Isoprostanes, a biomarker of oxidative stress
Kristin A Guertin,Rachael K Grant,Kathryn B Arnold,Lindsay Burwell,JoAnn Hartline,Phyllis J Goodman,Lori M Minasian,Scott M Lippman,Eric Klein,Patricia A Cassano
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94 Cost-Utility and Cost-Effectiveness Analyses of Face-to-Face Versus Telephone-Based Nonpharmacologic Multidisciplinary Treatments for Patients With Generalized Osteoarthritis
Nienke Cuperus,Wilbert B. van den Hout,Thomas J. Hoogeboom,Frank H. J. van den Hoogen,Thea P. M. Vliet Vlieland,Cornelia H. M. van den Ende
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95 Invited review: Fermented milk as antihypertensive functional food
L.M. Beltrán-Barrientos,A. Hernández-Mendoza,M.J. Torres-Llanez,A.F. González-Córdova,B. Vallejo-Córdoba
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96 Self-training to improve UE function at the chronic stage post-stroke: a pilot randomized controlled trial
Debbie Rand,Harold Weingarden,Ronit Weiss,Anat Yacoby,Shlomit Reif,Rachel Malka,David Andrew Shiller,Gabi Zeilig
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97 Data Blind Review and Analysis Set in Clinical Trial
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98 Using Alcohol Unit-marked Glasses Enhances Capacity To Monitor Intake: Evidence From a Mixed-method Intervention Trial
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99 Increasing patient involvement in the diabetic foot pathway: a pilot randomized controlled trial
E. McBride,B. Hacking,R. OæCarroll,M. Young,J. Jahr,C. Borthwick,A. Callander,Z. Berrada
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100 Post-instrumentation pain after the use of either Mtwo or the SAF system: a randomized controlled clinical trial
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101 Adherence adjustment in the Coronary Drug Project: A call for better per-protocol effect estimates in randomized trials
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102 Do Web-based Mental Health Literacy Interventions Improve the Mental Health Literacy of Adult Consumers? Results From a Systematic Review
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103 Exercise as a treatment for depression: A meta-analysis
Siri Kvam,Catrine Lykkedrang Kleppe,Inger Hilde Nordhus,Anders Hovland
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104 Forming a Stress Management and Health Promotion Program for Women Undergoing Chemotherapy for Breast Cancer
Panagiotis Pelekasis,Georgia Zisi,Anna Koumarianou,Androniki Marioli,George Chrousos,Konstantinos Syrigos,Christina Darviri
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105 Injectable pharmacotherapy for opioid use disorders (IPOD)
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106 Evidence-based veterinary dermatology: a review of published studies of treatments forOtodectes cynotis(ear mite) infestation in cats
Ching Yang,Hui-Pi Huang
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107 The Influence of Attrition in Evaluating the Efficacy and Effectiveness of Mindfulness-Based Interventions
Seungwon Nam,Tony Toneatto
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108 Early goal-directed therapy in severe sepsis and septic shock: insights and comparisons to ProCESS, ProMISe, and ARISE
H. Bryant Nguyen,Anja Kathrin Jaehne,Namita Jayaprakash,Matthew W. Semler,Sara Hegab,Angel Coz Yataco,Geneva Tatem,Dhafer Salem,Steven Moore,Kamran Boka,Jasreen Kaur Gill,Jayna Gardner-Gray,Jacqueline Pflaum,Juan Pablo Domecq,Gina Hurst,Justin B. Belsky,Raymond Fowkes,Ronald B. Elkin,Steven Q. Simpson,Jay L. Falk,Daniel J. Singer,Emanuel P. Rivers
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109 Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer
Christine Maheu,Sophie Lebel,Christine Courbasson,Monique Lefebvre,Mina Singh,Lori J. Bernstein,Linda Muraca,Aronela Benea,Lynne Jolicoeur,Cheryl Harris,Agnihotram V. Ramanakumar,Sarah Ferguson,Souraya Sidani
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110 Effect of Domain Knowledge on Elicitation Effectiveness: An Internally Replicated Controlled Experiment
Alejandrina M. Aranda,Oscar Dieste,Natalia Juristo
IEEE Transactions on Software Engineering. 2016; 42(5): 427
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111 A Systematic Review Protocol to Assess the Effects of Physical Activity on Health and Quality of Life Outcomes in Adolescent Cancer Survivors
Amanda Wurz,Jennifer Brunet
JMIR Research Protocols. 2016; 5(1): e54
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112 Impact of adding a second layer to a single unlocked closure of a Cesarean uterine incision: randomized controlled trial
G. Bennich,M. Rudnicki,C. Wilken-Jensen,T. Lousen,P. D. Lassen,K. Wøjdemann
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113 Outcomes of Parathyroidectomy in Patients with Primary Hyperparathyroidism: A Systematic Review and Meta-analysis
Naykky M. Singh Ospina,Rene Rodriguez-Gutierrez,Spyridoula Maraka,Ana E. Espinosa de Ycaza,Sina Jasim,Ana Castaneda-Guarderas,Michael R. Gionfriddo,Alaa Al Nofal,Juan P. Brito,Patricia Erwin,Melanie Richards,Robert Wermers,Victor M. Montori
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114 Medicaid Pay for Performance Programs and Childhood Immunization Status
Tianyan Hu,Sandra L. Decker,Shin-Yi Chou
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115 Brain and behavior changes associated with an abbreviated 4-week mindfulness-based stress reduction course in back pain patients
B. Blair Braden,Teri B. Pipe,Ryan Smith,Tyler K. Glaspy,Brandon R. Deatherage,Leslie C. Baxter
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116 Stepped Care Versus Direct Face-to-Face Cognitive Behavior Therapy for Social Anxiety Disorder and Panic Disorder: A Randomized Effectiveness Trial
Tine Nordgreen,Thomas Haug,Lars-Göran Öst,Gerhard Andersson,Per Carlbring,Gerd Kvale,Tone Tangen,Einar Heiervang,Odd E. Havik
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117 A cluster randomized controlled trial of the Promoting Alternative Thinking Strategies (PATHS) curriculum
Neil Humphrey,Alexandra Barlow,Michael Wigelsworth,Ann Lendrum,Kirsty Pert,Craig Joyce,Emma Stephens,Lawrence Wo,Garry Squires,Kevin Woods,Rachel Calam,Alex Turner
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118 Service evaluation of an educational intervention to improve sexual health services in primary care implemented using a step-wedge design: analysis of chlamydia testing and diagnosis rate changes
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119 Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts
Steven Vold,Iqbal Ike K. Ahmed,E. Randy Craven,Cynthia Mattox,Robert Stamper,Mark Packer,Reay H. Brown,Tsontcho Ianchulev
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120 Art therapy for people with psychosis: a narrative review of the literature
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121 Can predilatation in transcatheter aortic valve implantation be omitted? - a prospective randomized study
Henrik Casimir Ahn,Niels-Erik Nielsen,Jacek Baranowski
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122 Home-Based Psychiatric Outpatient Care Through Videoconferencing for Depression: A Randomized Controlled Follow-Up Trial
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123 Review of head-to-head study designs in rheumatoid arthritis
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124 Long-term efficacy and safety of etravirine-containing regimens in a real-life cohort of treatment-experienced HIV-1-infected patients
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125 Effect of Sirolimus on Disease Progression in Patients with Autosomal Dominant Polycystic Kidney Disease and CKD Stages 3b-4
P. Ruggenenti,G. Gentile,N. Perico,A. Perna,L. Barcella,M. Trillini,M. Cortinovis,C. P. Ferrer Siles,J. A. Reyes Loaeza,M. C. Aparicio,G. Fasolini,F. Gaspari,D. Martinetti,F. Carrara,N. Rubis,S. Prandini,A. Caroli,K. Sharma,L. Antiga,A. Remuzzi,G. Remuzzi
Clinical Journal of the American Society of Nephrology. 2016;
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126 Implementing Family-Centered Prevention in Rural African American Communities: a Randomized Effectiveness Trial of the Strong African American Families Program
Steven M. Kogan,Man-Kit Lei,Gene H. Brody,Ted G. Futris,Megan Sperr,Tracy Anderson
Prevention Science. 2016; 17(2): 248
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127 Intention-to-treat and transparency of related practices in randomized, controlled trials of anti-infectives
Robert D. Beckett,Kathryn C. Loeser,Kathryn R. Bowman,Trent G. Towne
BMC Medical Research Methodology. 2016; 16(1)
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128 The Primary Outcome Fails — What Next?
Jeffrey M. Drazen,David P. Harrington,John J.V. McMurray,James H. Ware,Janet Woodcock,Stuart J. Pocock,Gregg W. Stone
New England Journal of Medicine. 2016; 375(9): 861
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129 TREATMENT SWITCHING: STATISTICAL AND DECISION-MAKING CHALLENGES AND APPROACHES
Nicholas R. Latimer,Chris Henshall,Uwe Siebert,Helen Bell
International Journal of Technology Assessment in Health Care. 2016; 32(03): 160
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130 Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial
In-Jae Oh,Kyu-Sik Kim,Cheol-Kyu Park,Young-Chul Kim,Kwan-Ho Lee,Jin-Hong Jeong,Sun-Young Kim,Jeong-Eun Lee,Kye-Chul Shin,Tae-Won Jang,Hyun-Kyung Lee,Kye-Young Lee,Sung-Yong Lee
BMC Cancer. 2016; 16(1)
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131 INDIVIDUO: Results from a patient-centered lifestyle intervention for obesity surgery candidates
José Camolas,Osvaldo Santos,Pedro Moreira,Isabel do Carmo
Obesity Research & Clinical Practice. 2016;
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132 Effect of choir activity in the rehabilitation of aphasia: a blind, randomised, controlled pilot study
Anna Zumbansen,Isabelle Peretz,Carole Anglade,Josée Bilodeau,Suzanne Généreux,Michelyne Hubert,Sylvie Hébert
Aphasiology. 2016; : 1
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133 Resistance training improves inflammatory level, lipid and glycemic profiles in obese older women: A randomized controlled trial
Crisieli M. Tomeleri,Alex S. Ribeiro,Mariana F. Souza,Durcelina Schiavoni,Brad J. Schoenfeld,Danielle Venturini,Décio S. Barbosa,Kamila Landucci,Luís B. Sardinha,Edilson S. Cyrino
Experimental Gerontology. 2016; 84: 80
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134 Cross-centre replication of suppressed burrowing behaviour as an ethologically relevant pain outcome measure in the rat
Rachel Wodarski,Ada Delaney,Camilla Ultenius,Rosie Morland,Nick Andrews,Catherine Baastrup,Luke A. Bryden,Ombretta Caspani,Thomas Christoph,Natalie J. Gardiner,Wenlong Huang,Jeffrey D. Kennedy,Suguru Koyama,Dominic Li,Marcin Ligocki,Annika Lindsten,Ian Machin,Anton Pekcec,Angela Robens,Sanziana M. Rotariu,Sabrina Vo,Marta Segerdahl,Carina Stenfors,Camilla I. Svensson,Rolf-Detlef Treede,Katsuhiro Uto,Kazumi Yamamoto,Kris Rutten,Andrew S.C. Rice
PAIN. 2016; 157(10): 2350
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135 Effect of a Digital Social Media Campaign on Young Adult Smoking Cessation
Neill Bruce Baskerville,Sunday Azagba,Cameron Norman,Kyle McKeown,K. Stephen Brown
Nicotine & Tobacco Research. 2016; 18(3): 351
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136 Randomized evaluation and cost-effectiveness of HIV and sexual and reproductive health service referral and linkage models in Zambia
Paul C. Hewett,Mutinta Nalubamba,Fiammetta Bozzani,Jean Digitale,Lung Vu,Eileen Yam,Mary Nambao
BMC Public Health. 2016; 16(1)
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137 Efficacy of Internet-Based Self-Monitoring Interventions on Maternal and Neonatal Outcomes in Perinatal Diabetic Women: A Systematic Review and Meta-Analysis
Ying Lau,Tha Pyai Htun,Suei Nee Wong,Wai San Wilson Tam,Piyanee Klainin-Yobas
Journal of Medical Internet Research. 2016; 18(8): e220
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138 Continuity of care by a primary midwife (caseload midwifery) increases women’s satisfaction with antenatal, intrapartum and postpartum care: results from the COSMOS randomised controlled trial
Della A. Forster,Helen L. McLachlan,Mary-Ann Davey,Mary Anne Biro,Tanya Farrell,Lisa Gold,Maggie Flood,Touran Shafiei,Ulla Waldenström
BMC Pregnancy and Childbirth. 2016; 16(1)
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139 „Intention to treat“ oder „treatment as received“ – Umgang mit Abbrechern in der Forschung zur Straftäterbehandlung
Johann Endres,Maike M. Breuer,Mark Stemmler
Forensische Psychiatrie, Psychologie, Kriminologie. 2016; 10(1): 45
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140 A Randomized Controlled Trial of the Effectiveness of Traditional and Mobile Public Health Communications With Health Care Providers
Janet Baseman,Debra Revere,Ian Painter,Mark Oberle,Jeffrey Duchin,Hanne Thiede,Randall Nett,Dorothy MacEachern,Andy Stergachis
Disaster Medicine and Public Health Preparedness. 2016; 10(01): 98
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141 PTSD REMISSION AFTER PROLONGED EXPOSURE TREATMENT IS ASSOCIATED WITH ANTERIOR CINGULATE CORTEX THINNING AND VOLUME REDUCTION
Liat Helpman,Santiago Papini,Binod T. Chhetry,Erel Shvil,Mikael Rubin,Gregory M. Sullivan,John C. Markowitz,J. John Mann,Yuval Neria
Depression and Anxiety. 2016; : n/a
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142 The effect of primary midwife-led care on womenæs experience of childbirth: results from the COSMOS randomised controlled trial
HL McLachlan,DA Forster,M-A Davey,T Farrell,M Flood,T Shafiei,U Waldenström
BJOG: An International Journal of Obstetrics & Gynaecology. 2016; 123(3): 465
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143 Evaluation of the Effectiveness and Implementation of an Adapted Evidence-Based Mammography Intervention for African American Women
Linda Highfield,Marieke A. Hartman,L. Kay Bartholomew,Philomene Balihe,Valerie A. Ausborn
BioMed Research International. 2015; 2015: 1
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144 Does neurocognitive training have the potential to improve dietary self-care in type 2 diabetes? Study protocol of a double-blind randomised controlled trial
Victoria Whitelock,Arie Nouwen,Katrijn Houben,Olga van den Akker,Iraida Neira Miller,Parth Narendan,Miranda Rosenthal,Suzanne Higgs
BMC Nutrition. 2015; 1(1)
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145 Re: Pareek A, Chandurkar N, Thomas N,et al.Efficacy and safety of hydroxychloroquine in the treatment of type 2 diabetes mellitus: a double blind, randomized comparison with pioglitazone. Curr Med Res Opin 2014;30:1257-66
Anil Pareek
Current Medical Research and Opinion. 2015; 31(6): 1087
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146 A Randomized Controlled Trial of a Financial Literacy Curriculum for Survivors of Intimate Partner Violence
Andrea Hetling,Judy L. Postmus,Cecilia Kaltz
Journal of Family and Economic Issues. 2015;
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147 Passive standing as an adjunct rehabilitation intervention after stroke: a randomized controlled trial
Francesco Ferrarello,Gabriella Deluca,Assunta Pizzi,Carlo Baldini,Francesca Iori,Niccolò Marchionni,Mauro Di Bari
Archives of Physiotherapy. 2015; 5(1)
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148 Prolonged Exposure for Treating PTSD Among Female Methadone Patients Who Were Survivors of Sexual Abuse in Israel
Miriam Schiff,Nitsa Nacasch,Shabtay Levit,Noam Katz,Edna B. Foa
Social Work in Health Care. 2015; 54(8): 687
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149 Effects of a brief mindfulness-based intervention program for stress management among medical students: the Mindful-Gym randomized controlled study
Cheng Kar Phang,Firdaus Mukhtar,Normala Ibrahim,Shian-Ling Keng,Sherina Mohd. Sidik
Advances in Health Sciences Education. 2015; 20(5): 1115
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150 Radiofrequency catheter ablation maintains its efficacy better than antiarrhythmic medication in patients with paroxysmal atrial fibrillation: On-treatment analysis of the randomized controlled MANTRA-PAF trial
M.J. Pekka Raatikainen,Antti Hakalahti,Paavo Uusimaa,Jens Cosedis Nielsen,Arne Johannessen,Gerhard Hindricks,Håkan Walfridsson,Steen Pehrson,Anders Englund,Juha Hartikainen,Ole Kongstad,Leif Spange Mortensen,Peter Steen Hansen
International Journal of Cardiology. 2015; 198: 108
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151 Interest in Employment Among People with Schizophrenia
Cassandra Westcott,Geoffrey Waghorn,Duncan McLean,Dixie Statham,Bryan Mowry
American Journal of Psychiatric Rehabilitation. 2015; 18(2): 187
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152 Use of mouth rinse during pregnancy to improve birth and neonatal outcomes: a randomized controlled trial
Hong Jiang,Xu Xiong,Pierre Buekens,Yi Su,Xu Qian
BMC Pregnancy and Childbirth. 2015; 15(1)
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153 Effect of Developmental Binocular Vision Abnormalities on Visual Vertigo Symptoms and Treatment Outcome
Marousa Pavlou,James Acheson,Despina Nicolaou,Clare L. Fraser,Adolfo M. Bronstein,Rosalyn A. Davies
Journal of Neurologic Physical Therapy. 2015; 39(4): 215
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154 The Integration of Family and Group Therapy as an Alternative to Juvenile Incarceration: A Quasi-Experimental Evaluation Using Parenting with Love and Limits
Eli A. Karam,Emma M. Sterrett,Lynn Kiaer
Family Process. 2015; : n/a
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155 Effective Implementation Strategies of Differential Response in Child Welfare: A Comparative Case Analysis
Annette Semanchin Jones
Journal of Public Child Welfare. 2015; 9(5): 528
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156 Look for good and never give up: A novel attention training treatment for childhood anxiety disorders
Allison M. Waters,Melanie J. Zimmer-Gembeck,Michelle G. Craske,Daniel S. Pine,Brendan P. Bradley,Karin Mogg
Behaviour Research and Therapy. 2015; 73: 111
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157 Effect of Deep Intramuscular Stimulation and Transcranial Magnetic Stimulation on Neurophysiological Biomarkers in Chronic Myofascial Pain Syndrome
Liciane F. Medeiros,Wolnei Caumo,Jairo Dussán-Sarria,Alicia Deitos,Aline Brietzke,Gabriela Laste,Cristina Campos-Carraro,Andressa de Souza,Vanessa L. Scarabelot,Stefania G. Cioato,Rafael Vercelino,Alexandre L. de Castro,Alex Sander Araújo,Adriane Belló-Klein,Felipe Fregni,Iraci L.S. Torres
Pain Medicine. 2015; : n/a
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158 Who responds to financial incentives for weight loss? Evidence from a randomized controlled trial
Alfredo R. Paloyo,Arndt R. Reichert,Monika Reuss-Borst,Harald Tauchmann
Social Science & Medicine. 2015; 145: 44
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159 A web-based personally controlled health management system increases sexually transmitted infection screening rates in young people: a randomized controlled trial
Nathan J Mortimer,Joel Rhee,Rebecca Guy,Andrew Hayen,Annie Y S Lau
Journal of the American Medical Informatics Association. 2015; 22(4): 805
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160 Intervention Mapping to Adapt Evidence-Based Interventions for Use in Practice: Increasing Mammography among African American Women
Linda Highfield,Marieke A. Hartman,Patricia Dolan Mullen,Serena A. Rodriguez,Maria E. Fernandez,L. Kay Bartholomew
BioMed Research International. 2015; 2015: 1
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161 Whoæs Missing? Predictors of Attrition Following Participation in Culturally Targeted Educational Breast and Cervical Cancer Outreach Programs for Latinas
Jamilia Sly,Lina Jandorf,Deborah O. Erwin
Journal of Health Communication. 2015; 20(7): 851
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162 Caring for the carer: a systematic review of pure technology-based cognitive behavioral therapy (TB-CBT) interventions for dementia carers
Jennifer L. Scott,Sarah Dawkins,Michael G. Quinn,Kristy Sanderson,Kate-Ellen J. Elliott,Christine Stirling,Ben Schüz,Andrew Robinson
Aging & Mental Health. 2015; : 1
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163 A Preliminary Evaluation of the 1-2-3-Magic Parenting Program in an Australian Community Services Setting
Renata Porzig-Drummond,Richard J. Stevenson,Caroline Stevenson
Australian Social Work. 2015; : 1
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164 A randomized controlled trial of a multi-dose bystander intervention program using peer education theater
Sarah McMahon,Samantha C. Winter,Jane E. Palmer,Judy L. Postmus,N. Andrew Peterson,Sharon Zucker,RuthAnne Koenick
Health Education Research. 2015; 30(4): 554
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165 Supporting Practices to Adopt Registry-Based Care (SPARC): protocol for a randomized controlled trial
Rebecca S Etz,Rosalind E Keith,Anna M Maternick,Karen L Stein,Roy T Sabo,Melissa S Hayes,Purvi Sevak,John Holland,Jesse C Crosson
Implementation Science. 2015; 10(1)
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166 Home-based virtual reality balance training and conventional balance training in Parkinsonæs disease: A randomized controlled trial
Wen-Chieh Yang,Hsing-Kuo Wang,Ruey-Meei Wu,Chien-Shun Lo,Kwan-Hwa Lin
Journal of the Formosan Medical Association. 2015;
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167 Effect of an integrated community-based package for maternal and newborn care on feeding patterns during the first 12 weeks of life: a cluster-randomized trial in a South African township
Petrida Ijumba,Tanya Doherty,Debra Jackson,Mark Tomlinson,David Sanders,Sonja Swanevelder,Lars-Åke Persson
Public Health Nutrition. 2015; 18(14): 2660
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168 Effectiveness of Conventional Versus Virtual Reality–Based Balance Exercises in Vestibular Rehabilitation for Unilateral Peripheral Vestibular Loss: Results of a Randomized Controlled Trial
Dara Meldrum,Susan Herdman,Roisin Vance,Deirdre Murray,Kareena Malone,Douglas Duffy,Aine Glennon,Rory McConn-Walsh
Archives of Physical Medicine and Rehabilitation. 2015; 96(7): 1319
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169 FAmily CEntered (FACE) advance care planning: Study design and methods for a patient-centered communication and decision-making intervention for patients with HIV/AIDS and their surrogate decision-makers
Allison L. Kimmel,Jichuan Wang,Rachel K. Scott,Linda Briggs,Maureen E. Lyon
Contemporary Clinical Trials. 2015; 43: 172
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170 The Effectiveness of the Within Our Reach Relationship Education Program for Couples: Findings from a Federal Randomized Trial
Galena K. Rhoades
Family Process. 2015; 54(4): 672
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171 Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12®, on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial
Dorte Eskesen,Lillian Jespersen,Birgit Michelsen,Peter J. Whorwell,Stefan Müller-Lissner,Cathrine M. Morberg
British Journal of Nutrition. 2015; 114(10): 1638
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172 General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial
B. Purwar,K. M. Ismail,N. Turner,A. Farrell,M. Verzune,M. Annappa,I. Smith,Zeiad El-Gizawy,J. C. Cooper
International Urogynecology Journal. 2015; 26(8): 1171
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173 Effect of exercises with weight vests and a patient education programme for women with osteopenia and a healed wrist fracture: a randomized, controlled trial of the OsteoACTIVE programme
K. A. Hakestad,M. K. Torstveit,L. Nordsletten,M. A. Risberg
BMC Musculoskeletal Disorders. 2015; 16(1)
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174 Evaluation of a hybrid treatment for Veterans with comorbid traumatic brain injury and posttraumatic stress disorder: Study protocol for a randomized controlled trial
Amy J. Jak,Robin Aupperle,Carie S. Rodgers,Ariel J. Lang,Dawn M. Schiehser,Sonya B. Norman,Elizabeth W. Twamley
Contemporary Clinical Trials. 2015; 45: 210
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175 Randomized Controlled Trial of an Internet Application to Reduce HIV Transmission Behavior Among HIV Infected Men Who have Sex with Men
Joel Milam,Sheldon Morris,Sonia Jain,Xiaoying Sun,Michael P. Dubé,Eric S. Daar,Gustavo Jimenez,Richard Haubrich
AIDS and Behavior. 2015;
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176 Considerations for Comprehensive Analyses of Sporozoite-Based Controlled Human Malaria Infection Studies
Andrew A. Lover
The American Journal of Tropical Medicine and Hygiene. 2015; 93(6): 1130
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177 A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial
Antoinette Schoenthaler,Franzenith De La Calle,Miguel Barrios-Barrios,Aury Garcia,Maria Pitaro,Audrey Lum,Milagros Rosal
Trials. 2015; 16(1)
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178 Multisystemic Therapy Improves the Patient-Provider Relationship in Families of Adolescents with Poorly Controlled Insulin Dependent Diabetes
April Idalski Carcone,Deborah A. Ellis,Xinguang Chen,Sylvie Naar,Phillippe B. Cunningham,Kathleen Moltz
Journal of Clinical Psychology in Medical Settings. 2015; 22(2-3): 169
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179 Assessing the treatment effect in a randomized controlled trial with extensive non-adherence: the EVOLVE trial
Yumi Kubo,Lulu Ren Sterling,Patrick S Parfrey,Karminder Gill,Kenneth W Mahaffey,Ioanna Gioni,Marie-Louise Trotman,Bastian Dehmel,Glenn M Chertow
Pharmaceutical Statistics. 2015; 14(3): 242
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180 Randomized trial of the effectiveness of a non-pharmacological multidisciplinary face-to-face treatment program on daily function compared to a telephone-based treatment program in patients with generalized osteoarthritis
N. Cuperus,T.J. Hoogeboom,C.C. Kersten,A.A. den Broeder,T.P.M. Vliet Vlieland,C.H.M. van den Ende
Osteoarthritis and Cartilage. 2015; 23(8): 1267
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181 Telepsychology for Posttraumatic Stress Disorder: A systematic review
AJ Bolton,DS Dorstyn
Journal of Telemedicine and Telecare. 2015; 21(5): 254
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182 Early Pathways Therapy for Young Children in Poverty
Sara E. Harris,Robert A. Fox,Joanna R. Love
Counseling Outcome Research and Evaluation. 2015; 6(1): 3
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183 Web-based interventions for comorbid depression and chronic illness: a systematic review
Ekaterina Charova,Diana Dorstyn,Phillip Tully,Oskar Mittag
Journal of Telemedicine and Telecare. 2015; 21(4): 189
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184 Preliminary evaluation of a self-directed video-based 1-2-3 Magic parenting program: A randomized controlled trial
Renata Porzig-Drummond,Richard J. Stevenson,Caroline Stevenson
Behaviour Research and Therapy. 2015;
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185 Intravenous estrogen is not proven effective for abnormal uterine bleeding: guidelines are based on flawed evidence
Stephen Simmer
Clinical Research in Practice: The Journal of Team Hippocrates. 2015; 1(1): 1
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186 Development and Assessment of an E-Learning Course on Breast Imaging for Radiographers: A Stratified Randomized Controlled Trial
Inês C Moreira,Sandra Rua Ventura,Isabel Ramos,Pedro Pereira Rodrigues
Journal of Medical Internet Research. 2015; 17(1): e3
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187 Taking the next step: a systematic review and meta-analysis of physical activity and behavior change interventions in recent post-treatment breast cancer survivors
Shirley M. Bluethmann,Sally W. Vernon,Kelley Pettee Gabriel,Caitlin C. Murphy,L. Kay Bartholomew
Breast Cancer Research and Treatment. 2015;
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188 Evaluation of the implementation and impact of an integrated prevention model on the academic progress of students with disabilities
Alexandra Barlow,Neil Humphrey,Ann Lendrum,Michael Wigelsworth,Garry Squires
Research in Developmental Disabilities. 2015; 36: 505
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189 Time at Risk and Intention-to-treat Analyses
Sunni L. Mumford,Enrique F. Schisterman,Stephen R. Cole,Daniel Westreich,Robert W. Platt
Epidemiology. 2015; 26(1): 112
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190 Effects of yoga on stress and inflammatory factors in patients with chronic low back pain: A non-randomized controlled study
Hye Kyung Cho,Woongjoon Moon,Jaehee Kim
European Journal of Integrative Medicine. 2014;
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191 Intervention Effects on Adolescent Physical Activity in the Multicomponent SPACE Study: A Cluster Randomized Controlled Trial
Mette Toftager,Lars B. Christiansen,Annette K. Ersbøll,Peter L. Kristensen,Pernille Due,Jens Troelsen,Marc A. Adams
PLoS ONE. 2014; 9(6): e99369
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192 Quality of Reporting Randomized Controlled Trials in Cancer Nursing Research
Jia-Wen Guo,Katherine A. Sward,Susan L. Beck,Nancy Staggers
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193 Comment on: Bari-Active: a randomized controlled trial of a preoperative intervention to increase physical activity in bariatric surgery patients
Wendy C. King
Surgery for Obesity and Related Diseases. 2014;
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194 Occupational Performance Coaching for stroke survivors: A pilot randomized controlled trial protocol
Dorothy E. Kessler,Mary Y. Egan,Claire-Jehanne Dubouloz,Fiona P. Graham,Sara E. McEwen
Canadian Journal of Occupational Therapy. 2014; 81(5): 279
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195 New Information Prompts Old Question: Is Sentinel Lymph Node Sampling Equivalent to Axillary Lymph Node Dissection?
Richard Cedric Zellars
Journal of Clinical Oncology. 2014; 32(32): 3583
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196 Reducing the risk of bias in health behaviour change trials: Improving trial design, reporting or bias assessment criteria? A review and case study
Marijn de Bruin,Jim McCambridge,Jan M. Prins
Psychology & Health. 2014; : 1
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197 Acupressure for agitation in nursing home residents with dementia: study protocol for a randomized controlled trial
Rick Yiu Kwan,Mason Chin Leung,Claudia Kam Lai
Trials. 2014; 15(1): 410
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198 Title and Abstract Screening and Evaluation in Systematic Reviews (TASER): a pilot randomised controlled trial of title and abstract screening by medical students
Lauren Ng,Veronica Pitt,Kit Huckvale,Ornella Clavisi,Tari Turner,Russell Gruen,Julian H Elliott
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199 The effect of continuous passive motion and sling exercise training on clinical and functional outcomes following total knee arthroplasty: a randomized active-controlled clinical study
Anett Mau-Moeller,Martin Behrens,Susanne Finze,Sven Bruhn,Rainer Bader,Wolfram Mittelmeier
Health and Quality of Life Outcomes. 2014; 12(1): 68
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200 Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial
Andrea Salazar-Ospina,Pedro Amariles,Dora M Benjumea,Francisco Gutierrez,Maria J Faus,Luis F Rodriguez
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201 How much did Chinaæs WTO accession increase economic growth in resource-rich countries?
Thomas Barnebeck Andersen,Mikkel Barslund,Casper Worm Hansen,Thomas Harr,Peter Sandholt Jensen
China Economic Review. 2014; 30: 16
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202 The 1-2-3 Magic Parenting Program and its Effect on Child Problem Behaviors and Dysfunctional Parenting: A Randomized Controlled Trial
Renata Porzig-Drummond,Richard J. Stevenson,Caroline Stevenson
Behaviour Research and Therapy. 2014;
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203 Zanamivir versus trivalent split virus influenza vaccine: a pilot randomized trial
Brenda L. Coleman,Shaza A. Fadel,Steven J. Drews,Todd F. Hatchette,Allison J. McGeer
Influenza and Other Respiratory Viruses. 2014; : n/a
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204 Transobturator Sling Compared With Single-Incision Mini-Sling for the Treatment of Stress Urinary Incontinence
Lucyana M. Djehdian,Maita P. Araujo,Claudia C. Takano,Carlos A. Del-Roy,Marair G. F. Sartori,Manoel J. B. C. Girão,Rodrigo A. Castro
Obstetrics & Gynecology. 2014; 123(3): 553
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205 Central Retinal Enrichment Supplementation Trials (CREST): Design and Methodology of the CREST Randomized Controlled Trials
Kwadwo Owusu Akuffo,Stephen Beatty,Jim Stack,Jessica Dennison,Sarah O’Regan,Katherine A. Meagher,Tunde Peto,John Nolan
Ophthalmic Epidemiology. 2014; 21(2): 111
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206 Efficacy of Omeprazole Powder Paste or Enteric-Coated Formulation in Healing of Gastric Ulcers in Horses
K. Birkmann,H.K. Junge,E. Maischberger,M.W. Eser,C.C. Schwarzwald
Journal of Veterinary Internal Medicine. 2014; : n/a
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207 Impact of an Exercise Intervention on Physical Activity During Pregnancy: The Behaviors Affecting Baby and You Study
Marquis Hawkins,Lisa Chasan-Taber,Bess Marcus,Edward Stanek,Barry Braun,Joe Ciccolo,Glenn Markenson
American Journal of Public Health. 2014; : e1
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208 Low- Versus High-Dose Rituximab for Rheumatoid Arthritis: A Systematic Review and Meta-Analysis
Markus Bredemeier,Fernando K. de Oliveira,Cláudia M. Rocha
Arthritis Care & Research. 2014; 66(2): 228
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209 Effects of a 12-week endurance training program on the physiological response to psychosocial stress in men: a randomized controlled trial
Sandra Klaperski,Bernadette Dawans,Markus Heinrichs,Reinhard Fuchs
Journal of Behavioral Medicine. 2014;
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210 Early intervention in psychosis: a feasibility study financed by the Italian Center on Control of Maladies
Angelo Cocchi,Andrea Balbi,Giuseppe Corlito,Guido Ditta,Walter Di Munzio,Mario Nicotera,Anna Meneghelli,Alessia Pisano,Antonio Preti
Early Intervention in Psychiatry. 2014; : n/a
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211 A 7-day oral supplementation with branched-chain amino acids was ineffective to prevent muscle damage during a marathon
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214 Impact of checklists on peri-intubation care in Emergency Department trauma patients
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215 Teaching Biomedical Statistics to Nurse-Practitioners in Sub-Saharan Africa—The Example of “Intention to Treat” Shows Our Challenges and Dilemmas
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217 The Digital Divide and Health Disparities: a Pilot Study Examining the Use of Short Message Service (SMS) for Colonoscopy Reminders
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218 Iyengar Yoga for Adolescents and Young Adults With Irritable Bowel Syndrome
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