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1

G, Girish, and Ashok Deorari. "Randomized Controlled Trial." Journal of Neonatology 20, no. 1 (2006): 64–68. http://dx.doi.org/10.1177/0973217920060112.

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Castro, Fernando J., Baker Al-Khairi, Harjinder Singh, Mosaab Mohameden, Kanwarpreet Tandon, and Rocio Lopez. "Randomized Controlled Trial." Journal of Clinical Gastroenterology 53, no. 10 (2019): 724–30. http://dx.doi.org/10.1097/mcg.0000000000001213.

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3

Vautrin, M., G. Kaminski, B. Barimani, et al. "Does candidate for plate fixation selection improve the functional outcome after midshaft clavicle fracture? A systematic review of 1348 patients." Shoulder & Elbow 11, no. 1 (2018): 9–16. http://dx.doi.org/10.1177/1758573218777996.

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Introduction The hypothesis of this study was that patient selection for midshaft clavicle fracture (open reduction internal fixation with plate versus conservative) would give better functional outcome than random treatment allocation. Methods We performed a systematic literature search for primary studies providing functional score and non-union rate after conservative or surgical management of midshaft clavicle fractures. Six randomized controlled trial and 19 non-randomized controlled trial studies encompassing a total of 1348 patients were included. Results Patients treated with surgical
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Suzuki, Yumi, Hiromi Fujii, Yuuki Haba, Aoi Onodera, Yuuka Nakamura, and Sakiko Nakamura. "Handwriting Training with a Board Prototype: A Randomized Controlled Trial." Engineering: Open Access 2, no. 4 (2024): 01–10. https://doi.org/10.33140/eoa.02.04.05.

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Purpose: This study investigated whether handwritten characters differ between letter tracing on a handwriting training system developed by the authors and letter tracing training on a paper. This study is registered in the UMIN Clinical Trials Registry (Trial registration number: UMIN000055578). Materials and methods: This study developed a training system in which patients traced lines and figures carved onto a board. A training board and a paper sheet with similar lines and shapes were prepared. In total, 62 randomly selected participants traced lines and shapes with their nondominant hand
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Takroni, Radwan, Sunjay Sharma, Kesava Reddy, et al. "Randomized controlled trials in neurosurgery." Surgical Neurology International 13 (August 26, 2022): 379. http://dx.doi.org/10.25259/sni_1032_2021.

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Randomized controlled trials (RCTs) have become the standard method of evaluating new interventions (whether medical or surgical), and the best evidence used to inform the development of new practice guidelines. When we review the history of medical versus surgical trials, surgical RCTs usually face more challenges and difficulties when conducted. These challenges can be in blinding, recruiting, funding, and even in certain ethical issues. Moreover, to add to the complexity, the field of neurosurgery has its own unique challenges when it comes to conducting an RCT. This paper aims to provide a
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Al Abdukareem, Abdulmajeed. "Randomized, placebo-controlled trial." Annals of Saudi Medicine 24, no. 2 (2004): 145. http://dx.doi.org/10.5144/0256-4947.2004.145.

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Forster, Anne, John Young, Katie Chapman, et al. "Cluster Randomized Controlled Trial." Stroke 46, no. 8 (2015): 2212–19. http://dx.doi.org/10.1161/strokeaha.115.008585.

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8

Healy, Ciaran, Aina V. H. Greig, Adrian D. Murphy, et al. "Prospective Randomized Controlled Trial." Plastic and Reconstructive Surgery 132, no. 1 (2013): 139e—146e. http://dx.doi.org/10.1097/prs.0b013e318299c6f4.

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Field, David, and Diana Elbourne. "The randomized controlled trial." Current Paediatrics 13, no. 1 (2003): 53–57. http://dx.doi.org/10.1054/cupe.2003.0409.

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Murphy, Adrian D., Aina V. H. Greig, Chris A. Powell, et al. "Prospective Randomized Controlled Trial." Plastic and Reconstructive Surgery 130 (November 2012): 50–51. http://dx.doi.org/10.1097/01.prs.0000421755.15147.58.

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Montgomery, Michelle O., Jessica J. Kram, Marie M. Forgie, Ana C. Perez Moreno, and Taylor Romdenne. "A Randomized Controlled Trial." Obstetrics & Gynecology 135 (May 2020): 167S. http://dx.doi.org/10.1097/01.aog.0000663980.54152.fb.

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12

DUFFY, MARY E. "The Randomized Controlled Trial." Clinical Nurse Specialist 20, no. 2 (2006): 62–64. http://dx.doi.org/10.1097/00002800-200603000-00004.

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Stel, Vianda S., Carmine Zoccali, Friedo W. Dekker, and Kitty J. Jager. "The Randomized Controlled Trial." Nephron Clinical Practice 113, no. 4 (2009): c337—c342. http://dx.doi.org/10.1159/000237143.

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Field, David, and Diana Elbourne. "The randomized controlled trial." Current Paediatrics 14, no. 6 (2004): 519–24. http://dx.doi.org/10.1016/j.cupe.2004.07.005.

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15

Likosky, Donald S. "A Primer on Randomized Controlled Trials." Journal of ExtraCorporeal Technology 38, no. 1 (2006): 10–13. http://dx.doi.org/10.1051/ject/200638010.

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Randomized Clinical Trials are held as the gold standard for quantifying the effect of an intervention across two or more groups. In such a trial an intervention is randomly allocated to one of two groups. The benefit of such a trial lies in its ability to establish nearly comparable groups of subjects in all manner except for the effect of the intervention. As such, the effect of a given intervention may be attributed solely to the intervention and not to any other extraneous factor. In the following editorial, we will discuss several issues that are important for understanding how to conduct
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16

Sarker, Jyotirmoy. "Ethical issues of randomized controlled trials." Bangladesh Journal of Bioethics 5, no. 1 (2014): 1–4. http://dx.doi.org/10.3329/bioethics.v5i1.18441.

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Clinical trials involve the application of different medical interventions on human participants. Randomized controlled trials involve different groups of human subjects undergoing different clinical interventions. This process ensures bias free subject allocation which leads to a way to statistically establish the research result. Strict ethical guidance is necessary from selection of participants to the analysis of trial results. Without proper guidance the trial participants would be subjected to unethical experiments. Before starting the randomized controlled trials the investigators must
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John, Joseph, and Naveen Kumar I. "Blinding Induced Risk of Bias in Randomized Controlled Trials of Physiotherapy Interventions — A Retrospective Study." JOURNAL OF CLINICAL AND BIOMEDICAL SCIENCES 13, no. 4 (2023): 108–14. http://dx.doi.org/10.58739/jcbs/v13i4.23.2.

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Introduction: In randomized clinical trials, the methodological idea of preventing bias by withholding knowledge of the allocation status is known as blinding. Blinding refers back to the concealment of group allocation from one or extra individuals concerned in scientific studies, most commonly a randomized controlled trial (RCT). Even though randomization minimizes variations among treatment groups on the outset of the trial, it does nothing to prevent differential treatment of the groups later within the trial or the differential assessment of outcomes, either of which may also bring about
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18

Golden, Isaac. "Beyond Randomized Controlled Trials." Journal of Evidence-Based Complementary & Alternative Medicine 17, no. 1 (2012): 72–75. http://dx.doi.org/10.1177/2156587211429351.

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Complementary and alternative medicine is criticized by some as lacking evidence to support the effectiveness of its methods and medicines. Such critics typically point to mixed results from using randomized controlled trials to test complementary and alternative medicine. Randomized controlled trials have been held to be the “gold standard” in pharmaceutical research, but a growing body of evidence in orthodox journals has identified their limitations. Here, 5 fundamental flaws in the randomized controlled trial–based model are discussed as well as the impact on its relevance for testing comp
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Tang, Wei-Zhen, Wei-Ze Xu, and Tai-Hang Liu. "The DecatSepsis Randomized Controlled Trial." CHEST 167, no. 1 (2025): e30. https://doi.org/10.1016/j.chest.2024.07.169.

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20

Milsom, K. M., A. S. Blinkhorn, T. Walsh, et al. "A Cluster-randomized Controlled Trial." Journal of Dental Research 90, no. 11 (2011): 1306–11. http://dx.doi.org/10.1177/0022034511422063.

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We conducted a school-based parallel cluster randomized controlled trial with 36-month follow-up of children aged 7 to 8 years. Primary schools were randomly assigned to 2 groups: 3 applications of fluoride varnish (22,600 ppm) each year or no intervention. The primary outcome was DFS increment in the first permanent molars, with the hypothesis that 9 applications of varnish over 3 years would result in a lower increment in the test group. Follow-up measurements were recorded by examiners blind to the allocation. Ninety-five schools were randomized to the test and 95 to the reference groups; 1
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21

O’Neill, Linda M., Emer Guinan, Suzanne L. Doyle, et al. "The RESTORE Randomized Controlled Trial." Annals of Surgery 268, no. 5 (2018): 747–55. http://dx.doi.org/10.1097/sla.0000000000002895.

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22

Sippel, Rebecca S., Sarah E. Robbins, Jennifer L. Poehls, et al. "A Randomized Controlled Clinical Trial." Annals of Surgery 272, no. 3 (2020): 496–503. http://dx.doi.org/10.1097/sla.0000000000004345.

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23

Sanz Rubiales, Álvaro, and María Luisa del Valle. "Placebo-Controlled Feasibility Randomized Trial?" Journal of Pain and Symptom Management 48, no. 1 (2014): e4-e5. http://dx.doi.org/10.1016/j.jpainsymman.2014.03.011.

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24

Diletti, Roberto, Patrick W. Serruys, Vasim Farooq, et al. "ABSORB II randomized controlled trial." American Heart Journal 164, no. 5 (2012): 654–63. http://dx.doi.org/10.1016/j.ahj.2012.08.010.

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25

Resteghini, Peter, Tamim A. Khanbhai, Shabaaz Mughal, and Ziali Sivardeen. "Double-Blind Randomized Controlled Trial." Clinical Journal of Sport Medicine 26, no. 1 (2016): 17–23. http://dx.doi.org/10.1097/jsm.0000000000000184.

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26

Chiarioni, Giuseppe, William E. Whitehead, and Gabrio Bassotti. "Randomized Controlled Trial of Biofeedback." Clinical Gastroenterology and Hepatology 5, no. 9 (2007): 1119. http://dx.doi.org/10.1016/j.cgh.2007.05.027.

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27

Khan, Erum Behroz, Mairah Shah, S. M. Tariq Rafi, Sadia Rizwan, and Zuhair Ahmed. "Oral Hygiene Maintenance Via Teledentistry in Orthodontic Patients: A Randomized Controlled Trial." Journal of the Pakistan Dental Association 30, no. 1 (2021): 34–38. http://dx.doi.org/10.25301/jpda.301.34.

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OBJECTIVES: To determine the extent of improvement in oral hygiene via text message reminder in patients undergoing fixed orthodontic treatment. METHODOLOGY: The participants were from 13 to 30 years of age recruited from Department of Orthodontics, Sindh Institute of Oral Health Sciences, Jinnah Sindh Medical University, Karachi, Pakistan. The sample comprised of 70 patients (59 female and 11 male) about to have fixed orthodontic treatment, 35 in text message group and 35 in control group. Patient's plaque index was evaluated at baseline and after 30 days. RESULTS: Text message group had high
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28

Manchikanti, Laxmaiah. "Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 2: Randomized Controlled Trials." December 2008 6;11, no. 12;6 (2008): 717–73. http://dx.doi.org/10.36076/ppj.2008/11/717.

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Evidence-based medicine (EBM) is a shift in medical paradigms and about solving clinical problems, acknowledging that intuition, unsystematic clinical experience, and pathophysiologic rationale are insufficient grounds for clinical decision-making. The importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy. Even though the concept of hierarchy of evidence is not absolute, in modern medicine, most researchers synthesizing the evidence may or may not follow the principles of EBM, which requires that a formal set of rules must complement me
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29

Elrggal, Mahmood E., Morooj Al-Muwallad, Areej Al-Otaibi, Jomanah Alsiddik, Alaa Shahbar, and Ejaz Cheema. "Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals." International Journal of Clinical Trials 5, no. 1 (2018): 21. http://dx.doi.org/10.18203/2349-3259.ijct20180127.

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<p class="abstract"><strong>Background:</strong> Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects.<strong> </strong>Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controll
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30

Willan, Andrew R., and Lehana Thabane. "Bayesian methods for pilot studies." Clinical Trials 17, no. 4 (2020): 414–19. http://dx.doi.org/10.1177/1740774520914306.

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Background/aims: The use of pilot studies to help inform the design of randomized controlled trials has increased significantly over the last couple of decades. A pilot study can provide estimates of feasibility parameters, such as the recruitment, compliance and follow-up probabilities. The use of frequentist confidence intervals of these estimates fails to provide a meaningful measure of the uncertainty as it pertains to the design of the associated randomized controlled trial. The objective of this article is to introduce Bayesian methods for the analysis of pilot studies for determining th
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31

Dohoo, Ian R. "The design of randomized controlled trials of veterinary vaccines." Animal Health Research Reviews 5, no. 2 (2004): 235–38. http://dx.doi.org/10.1079/ahr200474.

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AbstractRandomized controlled trials of veterinary vaccines are essential if we are to have a reasonable understanding of how those vaccines can be expected to perform when used in the field. This manuscript reviews a few (but certainly not all) of the key elements that need to be considered in the design of veterinary vaccine trials. The first step in the design of such a trial is to have a clear statement of the objective of the trial that reflects what is expected of the vaccine (e.g. should it minimize clinical disease or does it need to prevent infection?). Because domestic animals are of
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32

Porthouse, Jill, and David J. Torgerson. "The Need for Randomized Controlled Trials in Podiatric Medical Research." Journal of the American Podiatric Medical Association 94, no. 3 (2004): 221–28. http://dx.doi.org/10.7547/0940221.

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The randomized controlled trial is the most robust method available to evaluate health-care treatments. If podiatric medical practice is to be based on rigorous evidence, then high-quality randomized controlled trials are needed to inform that practice. In this article, we examine the extent to which randomized controlled trials are used in recent podiatric medical research and appraise the quality of those that are available. Using the Cochrane database of all randomized controlled trials in health care, we found only six relevant trials undertaken in podiatric medicine since 1997. These stud
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Msaouel, Pavlos, Juhee Lee, and Peter F. Thall. "Interpreting Randomized Controlled Trials." Cancers 15, no. 19 (2023): 4674. http://dx.doi.org/10.3390/cancers15194674.

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This article describes rationales and limitations for making inferences based on data from randomized controlled trials (RCTs). We argue that obtaining a representative random sample from a patient population is impossible for a clinical trial because patients are accrued sequentially over time and thus comprise a convenience sample, subject only to protocol entry criteria. Consequently, the trial’s sample is unlikely to represent a definable patient population. We use causal diagrams to illustrate the difference between random allocation of interventions within a clinical trial sample and tru
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34

Purgato, Marianna, Corrado Barbui, and Andrea Cipriani. "Assessing risk of bias in randomized controlled trials." Epidemiology and Psychiatric Sciences 19, no. 4 (2010): 296–97. http://dx.doi.org/10.1017/s1121189x00000622.

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AbstractEven though randomised controlled trials are the design of choice for evaluating the efficacy of health care interventions, they are not immune to bias that may affect research process and validity of results. In the present paper we discussed how trial quality may be appraised considering both whether a clinical trial is reported in a comprehensive and complete way (consistently with what had been declared in the study protocol), and whether the characteristics of the trial itself are associated with risk of bias.
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Tavartkiladze, Alexandre. "AminoSineTriComplex for Metastatic Colorectal Cancer: A Double-Blind, Placebo-Controlled Randomized Clinical Trial." Journal of Cancer Research 3, no. 1 (2025): 01–12. https://doi.org/10.64030/2578-3726.03.01.02.

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Background: Metastatic colorectal cancer (mCRC) remains a significant global health challenge, with high incidence and mortality rates. Current therapies, including chemotherapy, targeted agents, and immunotherapy, face challenges such as multidrug resistance (MDR), severe toxicity, and limited efficacy. AminoSineTriComplex, a novel natural therapeutic integrating bioactive compounds derived from medicinal plants and advanced nanotechnology, was evaluated for its safety and efficacy as an adjunct treatment for mCRC. Methods: This double-blind, placebo-controlled randomized clinical trial enrol
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Chikkagowdra, Shaila, Prathibha A, and Chandana KS. "Continuous versus interrupted suturing techniques for repair of episiotomy - a randomized controlled trial." New Indian Journal of OBGYN 11, no. 2 (2025): 293–96. https://doi.org/10.21276/obgyn.2025.v11.i2.20.

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37

van der Baan, Frederieke H., Olaf H. Klungel, Antoine CG Egberts, et al. "Pharmacogenetics in randomized controlled trials: considerations for trial design." Pharmacogenomics 12, no. 10 (2011): 1485–92. http://dx.doi.org/10.2217/pgs.11.95.

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38

Lockshin, Michael D. "Clinical Trial Registration and Publication of Randomized Controlled Trials." JAMA 303, no. 6 (2010): 517. http://dx.doi.org/10.1001/jama.2010.95.

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39

West, Stephen G., Naihua Duan, Willo Pequegnat, et al. "Alternatives to the Randomized Controlled Trial." American Journal of Public Health 98, no. 8 (2008): 1359–66. http://dx.doi.org/10.2105/ajph.2007.124446.

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Miller, Mary G., and Jessica Corner. "The ‘n = 1’ randomized controlled trial." Palliative Medicine 13, no. 3 (1999): 255–59. http://dx.doi.org/10.1191/026921699674890886.

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41

Olsson, Jesper, Darcey Terris, Matthias Elg, Jonas Lundberg, and Staffan Lindblad. "The One-Person Randomized Controlled Trial." Quality Management in Health Care 14, no. 4 (2005): 206–16. http://dx.doi.org/10.1097/00019514-200510000-00002.

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42

Goldstein, R. S., E. H. Gort, D. Stubbing, M. A. Avendano, and G. H. Guyatt. "Randomized Controlled Trial of Respiratory Rehabilitation." Journal of Cardiopulmonary Rehabilitation 15, no. 3 (1995): 235. http://dx.doi.org/10.1097/00008483-199505000-00013.

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43

Grimes, David A., and Kenneth F. Schulz. "A “randomized” controlled trial without randomization." American Journal of Obstetrics and Gynecology 175, no. 1 (1996): 240–41. http://dx.doi.org/10.1016/s0002-9378(96)70302-2.

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44

Vincent, Jean-Louis. "The randomized controlled trial turns pro." Intensive Care Medicine 28, no. 9 (2002): 1200–1202. http://dx.doi.org/10.1007/s00134-002-1400-9.

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Laptook, A. R. "The neo.nEURO.network Hypothermia Randomized Controlled Trial." PEDIATRICS 126, no. 4 (2010): e965-e966. http://dx.doi.org/10.1542/peds.2010-2075.

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46

Beckerman, Heleen, Jules G. Becher, and Gustaaf J. Lankhorst. "Definition of a randomized controlled trial." Clinical Rehabilitation 19, no. 3 (2005): 345–46. http://dx.doi.org/10.1191/0269215505cr872xx.

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47

Christie, Janice, Peter O'Halloran, and Mike Stevenson. "Planning a Cluster Randomized Controlled Trial." Nursing Research 58, no. 2 (2009): 128–34. http://dx.doi.org/10.1097/nnr.0b013e3181900cb5.

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48

Freeman, Brian J. C., Robert D. Fraser, Christopher M. J. Cain, David J. Hall, and David C. L. Chapple. "A Randomized, Double-Blind, Controlled Trial." Spine 30, no. 21 (2005): 2369–77. http://dx.doi.org/10.1097/01.brs.0000186587.43373.f2.

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Jain, Sumeet, and N. K. Arora. "Randomized controlled trial and economic evaluation." Indian Journal of Pediatrics 67, no. 5 (2000): 363–68. http://dx.doi.org/10.1007/bf02820689.

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Van der Does, W. "A Randomized, Controlled Trial of Prayer?" Archives of Internal Medicine 160, no. 12 (2000): 1871–72. http://dx.doi.org/10.1001/archinte.160.12.1871.

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