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 Table of Contents  
MISCELLANEOUS
Year : 2017  |  Volume : 2  |  Issue : 1  |  Page : 20-30

Information for Authors – Clinical Trials in Degenerative Diseases


Date of Web Publication4-Apr-2017

Correspondence Address:
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Source of Support: None, Conflict of Interest: None


Rights and PermissionsRights and Permissions

How to cite this article:
. Information for Authors – Clinical Trials in Degenerative Diseases. Clin Trials Degener Dis 2017;2:20-30

How to cite this URL:
. Information for Authors – Clinical Trials in Degenerative Diseases. Clin Trials Degener Dis [serial online] 2017 [cited 2019 Apr 21];2:20-30. Available from: http://www.clinicaltdd.com/text.asp?2017/2/1/20/203738


  About the Journal Top


Clinical Trials in Degenerative Diseases (CTDD) (ISSN: Print - 2542-3975, Online - 2542-3983) is an open access, peer-reviewed, online journal with Quarterly print on demand compilation of issues published. It covers clinical trials, research, therapeutics and education for all aspects of degenerative disorders. We publish articles on general trial methodology as well as protocols, commentaries and traditional results papers - regardless of outcome or significance of findings. The Journal aims to experiment with, and refine, innovative approaches to improving standardized reporting of trials. CTDD promises fair, rigorous peer review, broad scope, and wide readership among peers and societies. Taking advantage of online publication, we welcome investigators and researchers to provide not only all outcome measures, as well as varying analyses and interpretations, but also in-depth descriptions of what they did and what they learnt. This sharing of direct experience is fundamental to improving the quality and conduct of trials worldwide.


  Aims and Scopes Top


The areas of interest for the journal comprise clinical trial protocols and clinical translational papers of degenerative disease. Aiming to expedite the translation of scientific discovery in the field of degenerative disease into new or improved standards of care, it promotes a wide-ranging exchange between basic, preclinical, clinical and epidemiologic outcomes research, including neurodegnerative diseases, cardiovascular diseases, orthopedic degenerative diseases and other related disorders.

The following topics are covered in the journal: Design, Conduct, Analysis, Statistical Methods, Methodologies, Data Management, Synthesis, History, Ethics, Regulation and Clinical or Policy Impact.

We will also consider systematic reviews; articles describing methods, software, databases, or other tools; qualitative research; and studies reporting negative results.


  Readership Top


CTDD has emerged as an important forum for the experts from the following disciplines including medicine, biostatistics, epidemiology, computer science, management science, pharmaceutical science, and bioethics.


  Abstracting and Indexing Top


  • Baidu Scholar
  • CNKI (China National Knowledge Infrastructure)
  • EBSCO Publishing's Electronic Databases
  • Exlibris – Primo Central
  • Google Scholar
  • Hinari
  • Infotrieve
  • Journal Guide
  • National Science Library
  • Netherlands ISSN center
  • OpenJGate
  • ProQuest
  • TdNet



  Editorial Board Top


The editorial board now comprises more than 40 members who are dedicated to developing a journal presenting outstanding peer-reviewed, clinical trials research in degenerative diseases.

Recruitment of new editorial board members is ongoing.


  Criteria for Publication Top


  • The study presents the results of primary scientific research.
  • Results reported have not been published elsewhere.
  • Experiments, statistics, and other analyses are performed to a high technical standard and are described in sufficient detail.
  • Conclusions are presented in an appropriate fashion and are supported by the data.
  • The article is presented in an intelligible fashion and is written in standard English.
  • The research meets all applicable standards for the ethics of experimentation and research integrity.
  • The article adheres to appropriate reporting guidelines and community standards for data availability.



  Rigorous Peer Review Top


CTDD will rigorously peer-review submissions and publish all papers that are judged to be technically sound. Judgments about the importance of any particular paper are then made after publication by the readership, who are the most qualified to determine what is of interest to them.

Editorial process

Each submission to CTDD passes through a rigorous quality control and peer-review evaluation process before receiving a decision. The initial in-house quality control check deals with issues such as plagiarism check; competing interests; ethical requirements for studies involving human participants or animals; financial disclosures; full compliance with CTDD's data availability policy, etc. Submissions may be returned to authors for queries, and will not be seen by our Editorial Board or peer reviewers until they pass this quality control check.

Once each manuscript has passed quality control, it is assigned to the strict double-blinded peer-review process and for making a decision to accept, invite revision of, or reject the article.

The majority of CTDD submissions are evaluated by 3–5 external reviewers. Average time from the submission to the first editorial decision is 1 month. The review time could be shortened to 7 days for the paper with sophisticated comments transferred by recognized journals by CTDD. According to these comments, the academic editors will make a decision as to accept, reject, request a revision or send to another peer review.

Authors who receive a decision of Minor Revision or Major Revision have 21 days to resubmit the revised manuscript.

If you are submitting a revised manuscript, include the following items with your revised submission:

  • Response to reviewers file: Address the specific points made by each reviewer
  • Revised manuscript (marked-up copy): Include a marked-up copy of your manuscript file showing the changes you have made since the original submission
  • Revised manuscript (clean copy): Upload a clean copy of your revised manuscript that does not show your changes


Reviewer recognition

The quality of CTDD depends on the effort that is generously contributed by our reviewers who have lent their expertise and time helping to ensure we publish great science. A special thanks go out to an outstanding group of reviewers who have provided an extraordinary number of thoughtful reviews along with frequent reviewers who have reviewed four or more manuscripts each year.

We encourage the reviewers to share and discuss their review comments on Publons (www.publons.com). CTDD will also give credit to registered reviewers on Publons.


  Submission Guidelines Top


Manuscripts should be submitted electronically to http://www.journalonweb.com/ctdd.


  Initial Submission Top


Cover letter

Authors are strongly encouraged to provide as much information as possible to the reviewers, including.

  • Declaration that the manuscript is original, has not been submitted to or is not under consideration by another publication and has not been previously published in any language or any form, including electronic.
  • Indication that all authors approve the final version of the paper and of its submission to CTDD.
  • Recommendation of 2–3 scientists as peer reviewers for your paper, including their contact information. The recommenced reviewers should be in the same field of your study, but not from the same institutions and have not copublished articles previously.


Once submitted to CTDD, the paper should not be submitted to other journals within 1 month, whether it is undergoing or awaiting the paper review process.

Link your publication to ORCID

The first author or the corresponding author should provide ORCID upon manuscript submission to facilitate accurate author publication data maintained by journal or database statisticians.

Transfer of copyright agreement

Once your paper is successfully submitted, Form of Copyright Transfer Agreement should be signed by all authors and uploaded to the editorial system.


  Article Type Top


  • Study Protocol: Study protocol articles will only be considered for proposed or ongoing trials that have not completed patient recruitment at the time of submission. Please confirm the status of your study at submission. If the study has already undergone full external peer review as part of the ethics approval or funding process, the study protocol will usually only undergo editorial peer review by the handling editor. Proof of both ethics and funding will be required and we recommend that authors provide the relevant documentation on submission. Study protocols without major external funding will undergo full, external peer review. Study protocols without ethical approval will generally not be considered.
  • Research Article: CTDD will consider manuscripts on any clinical topic that is relevant to degenerative disease.
  • Invited Reviews: Invited reviews are topical reviews, generally 6,000 words in length, that cover a current topic of interest in degenerative disease.
  • Invited Perspectives and Highlight: Authors from internationally renowned laboratories who have acquired outstanding achievements are invited to write a short paper in which they provide background information that has not been previously published, offering the reasons behind their scientific hypothesis as well as answering such questions as why they chose specific patients as participants, developed a novel technique or method, used certain materials, or selected a given cell type. The invited perspectives and highlights should introduce compelling new stories about how scientists or laboratories yielded their striking thoughts or achievements, rather than simply describe their research progress or current status in the field of degenerative disease. These papers will provide readers with novel perspectives on the thoughts and insights of researchers in the field of degenerative disease. Submit an outline for your paper before writing, and submit the manuscript within 2 months after receiving permission from the CTDD editorial committee.
  • Hypotheses: Describe a hot topic in the research field of clinical trial protocols or clinical and translational medicine on degenerative disease. Present author's viewpoints and the recognition and summary of this scientific process as well as future hypotheses. Highlight translational application of novel techniques and methods described in preclinical basic studies to clinical practice. Submit an outline for your manuscript before writing the article, and then submit the manuscript within 2 months of receiving permission from the CTDD editorial committee.
  • Project Management: Project management should be a methodical approach to planning and guiding project processes from conception to completion
  • Methodology: Methodologies should present a new experimental or computational method, test or procedure. The method described may either be completely new, or may offer a better version of an existing method. The article must describe a demonstrable advance on what is currently available. The method needs to have been well tested and ideally, but not necessarily, used in a way that proves its value.
  • Letters to the Editor: Brief communications and case reports should be labeled as such and must offer an important new observation and not simply review the literature. In rare instances, we will consider case reports for this article type, but only if the topic is extraordinarily novel.



  Acceptance and Publication Top


After acceptance, the authors have access to inquiries regarding the progress of their manuscript submitted online using the account number assigned to the corresponding author at any time. Generally, accepted manuscripts will be published within 3–6 months after revision; however, authors can apply for rapid publication within 2–3 months after revision if their publications meet the following conditions:

  • Grant-funded innovative publications
  • With comments made recently by peer reviewers of international excellent journals
  • Research papers including original data with DOI register number
  • Clinical trials with Clinicaltrials.gov register number.



  Ethical Guidance Top


According to the guidelines recommended by the Committee on Publication Ethics (COPE), the authors should follow all ethical principles for medical research involving humans and experimental animals.

Requirements for ethical issues related to medical researchers

  • Medical researchers should abide by the relevant principles for medical research involving human participants, conscientiously accept supervision from the ethical review committee, and effectively protect the legitimate rights and interests of the human participants.
  • Medical researchers should objectively and accurately collect human samples, data, and information, and protect the life, health, privacy, and dignity of human participants.
  • When performing studies involving humans or experimental animals, medical researchers should provide accurate medical records, including adverse reactions and events, and report information regarding severe adverse reactions and events according to related regulations.
  • Medical researchers should be aware of public health and laboratory biology safety, consciously abide by the requirements of related laws and regulations, and accept inspection and supervision by related organizations when performing studies regarding emerging infectious diseases and diseases with unknown etiologies or known pathogen transformation.
  • Medical researchers should store, share, and destroy human or animal samples, data, or materials after study completion according to corresponding management regulations of scientific research.
  • Medical researchers should respect and protect the intellectual property rights of others and abide by the confidentiality rules of science and technology when performing academic communications and being invited to review another person's submitted research paper or topic declaration.
  • When citing previously published view-points, data, images, results, or other data, the source should be indicated, and the use of citations, annotations, and references should be consistent with academic specifications. When using another person's design thoughts, perspectives, experimental data, figures and tables, results and conclusions that have not been published, a written informed consent should be obtained from the authors, and acknowledgments and declarations should be openly stated.
  • When publishing research papers or academic contributions, medical researchers should abide by related regulations. Medical researchers cannot be authors on a published research paper when they do not participate in conducting the research or contribute to the writing of the paper.
  • Medical researchers, as supervisors or leaders of a research project, should take full responsibility for guiding students or leading members to perform scientific research and assume responsibility for dishonorable events occurring during the study or writing of scientific papers.
  • The original images, data (including computer databases), records, and samples involved in producing medical research papers should be kept in a secure storage area for potential recheck. Any errors or faults appearing in medical research achievements should be admitted and corrected publicly by the medical researchers. When performing collaborative scientific research, medical researchers should comply with good faith duty or contract, and authorship credit for publishing research papers or books, applying for patents, and acquiring awards should be based on substantial contribution.
  • Medical researchers should have a scientific attitude and social responsibility and avoid false statements and news hyperbole in academic communication, achievement generalization, and popular science propaganda. Medical researchers should treat academic criticism and questions from peer reviewers with respect.


Requirements for ethical issues related to clinical trials

  • All studies performed using the human body or involving human samples should be registered in an international clinical trials registry platform, such as www.clinicaltrials.gov, prior to participant recruitment. The registry platform and register identifier should be provided upon submission and included in the abstract of the manuscript.
  • The ethics committee that approved the trial and the associated permit number(s) should be stated in research papers. Clinical trial manuscripts submitted with no indication that ethical guidelines were followed will not be accepted by CTDD. In addition, whether participants gave informed consent should be indicated.
  • Clinical trial manuscripts should be written according to the specifications presented at www.equator-network.org. Additionally, self-assessment checklists and a flow chart should be provided upon submission.


Plagiarism

  • Each CTDD paper will be screened twice using Crosscheck to verify originality, once after submission and again prior to publication. The screening results will be provided to the authors.
  • Each CTDD paper should be original, with a similarity index of < 10% against any single paper in the database and with a total similarity index of < 30% against all papers in the database.
  • Similarity between new submitted CTDD manuscript and the papers previously published by the same research team or author should be no more than 50%.
  • No retracted articles should be cited.
  • For dishonorable events anonymously or non-anonymously reported, editors will contact the corresponding author of the paper with the issue and provide the results to the person who reported the event.
  • For dishonorable events including redundant (duplicate) publication, suspected plagiarism, and undisclosed conflicts of interest, CTDD will abide by the regulations suggested by COPE guidelines (http://publicationethics.org/resources).


Corrections and retractions

CTDD publishes corrections, retractions, and expressions of concern as appropriate, and as quickly as possible. We follow the ICMJE and COPE guidelines where applicable.

  • Correction: A notice of correction will be issued by CTDD to document and correct substantial errors that appear in online articles when these errors significantly affect the content or understanding of the work reported (e.g., error in data presentation or analysis) or when the error affects the publication's metadata (e.g., misspelling of an author's name). In these cases, CTDD will publish a correction that will be linked to the original article. In very rare cases, we may choose to correct the article itself and re-post it online. If that course is taken, a correction notice will also be created to document the changes to the original article.
  • Author-Initiated Retractions: CTDD will retract an article at the authors' request at any time unless it is under review for a possible violation of Responsible Conduct Regarding Scientific Communications. At the authors' option, the retraction notice may simply state that the article has been retracted at the authors' request. Alternatively, the authors may provide a brief explanation of the error(s) prompting the retraction. However, statements of retraction may not assign blame to specific authors or laboratories.
  • Editorial Retractions: The editors reserve the right to retract an article at any time after publication without the consent of the authors if an investigation by an appropriate authority reveals a violation of CTDD's Ethics Policy.



  Data Audibility Top


CTDD encourages to upload original experimental data on Figshare prior to or after publication, including original data, images, or tables. Such open access of data will increase study transparency, accelerate the scientific research pace, and establish a credible system of scientific research.

Figshare is an internationally respected original data hosting and management database that can upload, store, and share study data. With the permission of open-access copyright, the authors can display and share their data, which facilitates retrieval, reading, downloading, and sharing.


  Open-Access Publication Top


CTDD is co-published by MedKnow, a global open access medical publisher. Therefore, CTDD applies the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License to works we publish. This license allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

Anyone interested in reading your research can get free access to your paper at our official website (www.clinicaltdd.com).

Open Access Service Fees

The journal does not charge for submission and processing during the establishing period.


  Reprints/Subscriptions Top


We are committed to providing two journal copies and five high-quality reprints to authors for free with a variety of customizations and delivery options available. Reprints can be purchased as print or electronic reprints and as translated articles, and will be customized to your specific requirements and shrink-wrapped.


  Dissemination after Publication Top


Once the paper is published, it will be scheduled for dissemination via e-Newslettter.

After publication, the papers online can be rapidly retrieved and exposed via Google Scholar, iPhone, iPad and Android smart phones.


  Copyright/Permissions after Publication Top


  • The publisher retains all rights concerning assembling, printing, reproducing, translating, disseminating, exhibiting, publishing, retrieving and indexing part or all of the contents of the article.
  • After signing transfer of copyright with the journal, the authors retain the rights.
  • In not-for-profit circumstances, when cited appropriately, the use, dissemination and reproduction of part or all of the contents of the article is permitted.



  Contract Us Top


Submission website: http://www.journalonweb.com/ctdd

Author inquiries: stm.ctdd@gmail.com


  Formatting Guidelines Top


Study Protocol

  • Word limit: 4,000–6,000 words, 8–10 published pages.
  • Structure:


Title: 90 characters (20 words) maximum.

Abstract: This should not exceed 350 words and should be structured into separate sections headed Background, Methods/Design, Discussion, and Trial Registration (please list the trial registry, along with the unique identifying number, e.g., Trial registration: NCT02192320.

Introduction

Background

- Description of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and adverse effects of each intervention.

- Explanation for set of controls.

Objectives

- Specific objectives or hypotheses.

Trial Design/Methods

Design type

- Description of trial design, including type of trial (e.g., parallel group, crossover, factorial, single group), allocation ratio and framework (e.g., superiority, equivalence, non-inferiority, exploratory).

Participants

- Inclusion, exclusion, rejection, and withdrawal criteria for participants.

Interventions

- Interventions for each group with sufficient detail to allow replication, including how and when they will be administered; criteria for discontinuing or modifying allocated interventions for a given trial participant (e.g., drug dose change in response to harm, participant request, or improving/worsening disease); strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (e.g., drug tablet return, laboratory tests); and relevant concomitant care and interventions that are permitted or prohibited during the trial.

Outcomes

- Primary, secondary, and other outcomes, including the specific measurement variable (e.g., systolic blood pressure), analysis metric (e.g., change from baseline, final value, time to event), method of aggregation (e.g., median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended.

Participant timeline

- Schedule of enrollment-interventions (including any run-in and washout periods), assessments, and visits for participants. A schematic diagram (figure) is highly recommended.

Study setting

- Description of study settings (e.g., community clinic, academic hospital) and list of countries where data will be collected.

Sample size

- Estimated number of participants needed to achieve study objectives and how this number was determined, including clinical and statistical assumptions supporting any sample size calculations.

Recruitment

- Strategies for achieving adequate participant enrollment to reach target sample size.

Assignment of interventions (for controlled trials)

Allocation sequence generation:

- Method of generating the allocation sequence (e.g., computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (e.g., blocking) should be provided in a separate document that is unavailable to those who enroll participants or assign interventions.

Allocation concealment:

- Mechanism of implementing the allocation sequence (e.g., central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned.

Implementation:

- Who will generate the allocation sequence, who will enroll participants, and who will assign participants to interventions.

Blinding (masking):

- Who will be blinded after assignment to interventions (e.g., trial participants, care providers, outcome assessors, data analysts) and how. If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant's allocated intervention during the trial.

Data collection, management, and analysis

Data collection:

- Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (e.g., duplicate measurements, training of assessors) and description of study instruments (e.g., questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol.

- Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols.

Data management:

- Plans for data entry, coding, security, and storage, including any related processes to promote data quality (e.g., double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol.

Statistical methods:

- Statistical methods for analyzing primary and secondary outcomes. Reference to where other details of the statistical analyses plan can be found, if not in the protocol.

Data monitoring

- Composition of data monitoring committee; summary of the committee's role and reporting structure; statement of whether the committee is independent from the sponsor and competing interests.

- Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial.

Harms

- Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct.

Auditing

- Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor.

Ethics and dissemination

Research ethics approval:

- Plans for seeking research ethics committee/institutional review board approval.

Protocol amendments:

- Plans for communicating important protocol modifications (e.g., changes to eligibility criteria, outcomes, analyses) to relevant parties (e.g., investigators, research ethics committee/institutional review committee, trial participants, trial registries, journals, regulators).

Consent or assent:

- Who will obtain informed consent or assent from potential trial participants or authorized surrogates, and how will this be obtained.

- Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable.

Confidentiality

- How personal information about potential and enrolled participants will be collected, shared, and maintained to protect confidentiality before, during, and after the trial.

Access to data

- Statement of who will have access to the final trial data set, and disclosure of contractual agreements that limits such access for investigators.

Biological specimens

- Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in the current trial and for future use in ancillary studies, if applicable.

Discussion

Trial Status

- The status of the trial at the time of manuscript submission. The journal considers study protocol articles for proposed or ongoing trials provided they have not completed patient recruitment at the time of submission.

Abbreviations

- If abbreviations are used in the text they should be defined in the text at first use.

Funding

Competing interests

- After acceptance, the authors must declare potential conflicts of interest. All authors must agree with the conflict declaration in the final version of the paper.

Author contributions

- Identify the contributions of each author to the paper.

Acknowledgments

- Those who contributed to the work but do not meet the authorship criteria should be listed in this section with a description of their contribution.

References

- CTDD has adopted the 10th edition of American Medical Association (AMA) citation style.

Figures and Tables

Note: This document was reproduced based on the SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials.

Research Article

  • Word limit: 4,000–6,000 words, 8–10 published pages.
  • Structure:


Title: 90 characters (20 words) maximum.

Abstract: 350 words maximum, structured abstract.

Introduction: 1,000 words maximum.

Trial Design/Methods:

Results:

Discussion: 1,000 words maximum.

Acknowledgments:

Author contributions:

Conflicts of interest:

References: 50 minimum; 30% of cited references should have been published within the preceding 3 years; use the 10th edition of AMA citation style.

Invited Perspectives and Highlight

  • Word limit: 1,500–3,000 words, 1–2 authors, 8 references maximum (use the reference style of AMA 6th), no tables and abstract, 1 figure permissive, and 2 published pages maximum.
  • Describe the objective, significance, and current status of an issue in the field of degenerative diseases (1/5 the length of the text), introduce the author or the feature of the ongoing project (3/5 the length of the text), and state a hypothesis or guide the direction of this project (1/5 the length of the text).
  • Structure:

    Title: 90 characters (20 words) maximum.

    Body text:

    References: Use the 10th edition of AMA citation style.


Invited Reviews

  • Word limit: 6,000 words minimum including the abstract, but excluding references, tables and figures. 8–10 published pages.
  • Structure:

    Title: 90 characters (20 words) maximum.

    Abstract: 250 words maximum, unstructured abstract.

    Introduction:

    Body text:

    Acknowledgments:

    Author contributions:

    Conflicts of interest:

    References: Use the 10th edition of AMA citation style.


Hypotheses

  • Word limit: 500–1,000 words maximum, excluding references. No abstract or tables. One figure is permitted. Translational significance of techniques or methods used is required in the concluding sentences
  • Structure:

    Title: 90 characters (20 words) maximum.

    Body text:

    References: Maximum of 10. Use 10th edition of AMA citation style.


Project Management

  • Word limit: 6,000 words maximum, including the abstract, but excluding references, tables and figures. Submit an outline for your manuscript before writing the article, and then submit the manuscript within 2 months of receiving permission from the CTDD editorial committee.
  • Structure:

    Title: 90 characters (20 words) maximum.

    Abstract: Unstructured, 250 words maximum.

    Body text:

    References: Use the 10th edition of AMA citation style.


Methodology

  • Word limit: 6,000 words maximum, including the abstract, but excluding references, tables and figures.
  • Structure:

    Title: 90 characters (20 words) maximum.

    Abstract: This should not exceed 350 words and should be structured into separate sections headed Background,

    Methods, Results, Conclusions, Trial registration (If your article reports the results of a health care intervention on human participants, it must be registered in an appropriate registry and the registration number and date of registration should be stated in this section. If it was not registered prospectively (before enrollment of the first participant), you should include the words 'retrospectively registered'). Reports of randomized controlled trials should follow the CONSORT extension for abstracts.

    Background: The Background section should explain the background to the study, its aims, a summary of the existing literature and why this study was necessary or its contribution to the field.

    Methods: The methods section should include:

    - The aim, design and setting of the study

    - The characteristics of participants or description of materials

    - A clear description of all processes, interventions and comparisons. Generic drug names should generally be used. When proprietary brands are used in research, include the brand names in parentheses

    - The type of statistical analysis used, including a power calculation if appropriate

    Results: This should include the findings of the study including, if appropriate, results of statistical analysis which must be included either in the text or as tables and figures.

    Discussion: This section should discuss the implications of the findings in context of existing research and highlight limitations of the study.

    Conclusions: This should state clearly the main conclusions and provide an explanation of the importance and relevance of the study reported.

    Abbreviations: If abbreviations are used in the text they should be defined in the text at first use.

    Declarations:

    References: Use the 10th edition of AMA citation style.


Letters to the Editor

  • A letter sent to CTDD editorial ottice about issues of concern from its readers.
  • Word limit: 500–1,000 words maximum, excluding references. No abstract, tables and figures, 1 published page.
  • Structure:

    Title: 90 characters (20 words) maximum.

    Body text:

    References: 5 maximum; use the 10th edition of AMA citation style.


Preparation of Research Articles

Manuscripts must be submitted in Word format. All components of the manuscript should be typed, double-spaced, in Arial or Times New Roman font (11 pt). All pages should be numbered consecutively beginning with the title page, followed by the graphical abstract, abstract, introduction, materials/subjects and methods, results, discussion, references, individual tables/figures and figure legends.

Title page

Complete title

  • Should be brief (less than 20 words, 90 characters maximum), novel and informative.
  • Should attract the reader's attention.


Running title

  • Should accurately reflect the main points of the paper.
  • 40 characters maximum.
  • Should facilitate retrieval.


Authors

  • Full name of the first author and his/her affiliations (including department, institution, city and state/country, telephone number and fax number).
  • For corresponding author, please list name, highest academic degree earned, professional titles, detailed correspondence address, telephone number, fax number and e-mail address.
  • Indicate author contributions, grants, acknowledgments and conflicts of interest.
  • Declaration of patient consent: The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.


Abstract: The Abstract of the manuscript should not exceed 350 words and must be structured into separate sections: Background, the context and purpose of the study; Methods, how the study was performed and statistical tests used; Results, the main findings; Conclusions, brief summary and potential implications, and Trial Registration (please list the trial registry, along with the unique identifying number, e.g. Trial registration: NCT02192320.

Key words: Provide 6–10 words, not present in the title, to facilitate indexing.

Main body

Introduction

Background

  • Description of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention.
  • Explanation for choice of comparators.


Objectives

  • Specific objectives or hypotheses.


Subjects and methods

Design type

- Description of trial design, including type of trial (e.g., parallel group, crossover, factorial, single group), allocation ratio and framework (e.g., superiority, equivalence, non-inferiority, exploratory).

Study setting

- Description of study settings (e.g., community clinic, academic hospital) and list of countries where data will be collected.

Subjects

- Inclusion, exclusion, rejection, and withdrawal criteria for participants.

- Strategies for achieving adequate participant enrollment to reach target sample size.

Methods

- Interventions for each group with sufficient detail to allow replication, including but not limited to drugs, surgical procedures, devices, etc.

Sample size

- Estimated number of participants needed to achieve study objectives and how the number was determined, including clinical and statistical assumptions supporting any sample size calculations.

Statistical methods

- Statistical methods for analyzing primary and secondary outcomes. Reference to where other details of the statistical analysis plan can be found, if not in the protocol.

Ethics

- Research ethics committee/institutional review board with approval number.

Consent or assent

- Informed consent or assent from potential trial participants or authorized surrogate.

- Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable.

Results

Mainly statistical results, but not limited to the following parts:

  • Quantitative analysis of participants
  • Success probability of clinical trials
  • Intergroup comparison of participants' baseline data and results.


Discussion

  • Word limit: 1,000 words maximum.
  • Discuss the major novel findings of the study and describe the different characteristics from other studies.
  • Explain and extrapolate the major findings of the study; state whether the findings support some viewpoint or not; purpose the new problems or concerns.
  • Discuss the significance of the major findings and how they advance the knowledge in the field of nervous system diseases.
  • Provide a conclusion that clearly indicates how the results met the objectives. Do not offer a conclusion that is not supported by sufficient data.
  • Disclose the limitations and bias to embody the authenticity of the contents.
  • Make suggestions for the future direction of research that builds on your findings.
  • Indicate the theoretical significance and practical application value of the present results and make a strong conclusion.


References

Research articles should have a minimum of 50 references and over 30% of cited references should have been published within the preceding 3 years.

CTDD uses the 10th edition of AMA citation style. The general citation rules: References are listed numerically in the order they are cited in the text, for example, “..., suggesting a role of these cytokines in muscle and tissue atrophy.[1] Overall, these previous studies provide some foundational evidence that tourniquet use during TKA may increase the levels of IRI-related cytokines and induce inflammatory signaling that plays a role in muscle catabolism and atrophy.[2],[3]”; include up to 6 authors; for more than six, provide the names of the first three authors and then add et al.; if there is no author, start with the title; periodicals (journals, magazines, and newspapers) should have abbreviated titles; to check for the proper abbreviation, search for the Journal Title through LocatorPlus at the National Library of Medicine website.

Journal papers – in print

One author

Barry MA. The effect of preoperative education on postoperative pain after joint surgery: an integrative literature review. Creat Nurs. 2017;23:42-46.

2–6 authors

Salwachter AR, Freischlag JA, Sawyer RG, Sanfey HA. The training needs and priorities of male and female surgeons and their trainees. J Am Coll Surg. 2005;201:199-205.

More than 6 authors

Hammers DW, Merritt EK, Matheny RW Jr, et al. Functional deficits and insulin-like growth factor-I gene expression following tourniquet-induced injury of skeletal muscle in young and old rats. J Appl Physiol. 2008;105:1274-1281.

Journal article – online

Coppinger T, Jeanes YM, Hardwick J, Reeves S. Body mass, frequency of eating and breakfast consumption in 9-13- year-olds. J Hum Nutr Diet. 2012;25:43-49. doi: 10.1111/j.1365-277X.2011.01184.x

Note: If there is no DOI, provide the URL for the specific article.

Entire book – in print

Modlin J, Jenkins P. Decision Analysis in Planning for a Polio Outbreak in the United States. San Francisco, CA: Pediatric Academic Societies; 2004.

Book chapter – in print

Solensky R. Drug allergy: desensitization and treatment of reactions to antibiotics and aspirin. In: Lockey P, ed. Allergens and Allergen Immunotherapy. 3rd ed. New York, NY: Marcel Dekker; 2004:585-606.

Figures and Tables

  • All illustrations (e.g., graphs, drawings and photographs) are considered to be figures. Each figure should be provided with a fully descriptive title and legend. The area(s) of interest must be clearly indicated with ar-rows or other symbols. Figure legends must be self-explanatory, which should provide sufficient detail to be intelligible without reference to the main text. All micrographs should contain a magnification scale bar. Please position the scale bar in the lower right corner of one micrograph or of the last panel (for multiple panels). The length of the scale bar should be indicated on the images or in the figure legend. The images contained in a figure are arranged in the sequence from top left to bottom right. Tags (A, B, C…) are posi-tioned in the upper left corner of each image. All abbreviations and labels appearing on the image should be explained in figure legends. If figures have been reproduced from another source, written permission for reproducing the material must be attached to the covering letter. Figures should be cited consecutively in the text and number them in that order. Each figure should be placed on a separate sheet after the reference list, including the figure title and legend. The figure title should be not lettered onto the figure itself. All measurements in the figure are in SI (metric) units. Acomma should be used to separate thousands. Labels including “*, **, ***, #, ##, ### (in that order)” are used to identify the statistical difference between datasets in the histograms or line drawings.
  • Color figure: resolution: > 300 dpi; file for-mat PNG, EPS, TIFF, or PDF; CMYK mode should be used rather than RGB; use of high contrasting colors for color discrimination.
  • Line figures: resolution > 1,200 dpi; line width between 0.5 and 1 point; file format EPS, PDF or TIFF.
  • Grayscale figures: resolution > 600 dpi; file format EPS, TIFF or PDF. Figures should remain clear at 300-fold magnification. Fig-ures should be sized to fit within the column (9 cm) or the full-text width (18 cm). All labels on the figure should be typed in Arial or Times New Roman font and be clearly legible.



  Reporting Guidance Top


Manuscripts should be prepared in accordance with ICMJE Recommendation for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals. The following guidelines should be followed when writing an article:

  • CONSORT statement (Consolidated Standards of Reporting Trials): The CONSORT statement is recommended for reporting randomized controlled trials, and allows different types of medical studies to be reported using different article types. The authors are encouraged to complete 25-item checklist in their cover letter. In addition, the registration identification number and registry position of the randomized controlled trial is listed in the last line in the Abstract. See http://www.consort-statement.org/ for more information.
  • STARD statement (STAndards for the Reporting of Diagnostic accuracy studies): This checklist is recommended for reporting diagnostic accuracy studies. See http://www.stard-statement.org/ for more information.
  • STREGA statement (STrengthening the REporting of Genetic Associations): These guidelines are recommended for the reporting of genetic association studies. See http://www.strega-statement.org/ for more information.
  • STROBE statement (STrengthening the Reporting of OBservational studies in Epidemiology): These guidelines are recommended for the reporting of observational studies in epidemiology). See http://www.strobe-statement.org/ for more information.
  • TREND statement (Transparent Reporting of Evaluations with Nonrandomized Designs): These guidelines are recommended for the reporting of non-randomized evaluations of behavioral and public health interventions. See http://www.cdc.gov/trendstatement/ for more information.
  • MOOSE checklist (a Reporting Checklist for Authors, Editors, and Reviewers of Meta-analyses of Observational Studies): This checklist is recommended for meta-analyses of observational studies. See https://www.editorial-manager.com/jognn/account/MOOSE.pdf for more information.
  • PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-Analyses): The PRISMA Statement is recommended for the reporting of systematic evaluation and meta-analysis articles. See http://www.prisma-statement.org/ for more information.
  • EQUATOR Network (standards for Enhancing the QUAlity and Transparency Of health Research): This organization works to improve the reliability and value of reports on medical research studies by promoting transparent and accurate reporting of research studies. See http://www.equator-network.org/ for more information.


For more information, please see author instruction at http://www.clinicaltdd.com/contributors.asp.




 

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