<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04461470</url>
  </required_header>
  <id_info>
    <org_study_id>7012</org_study_id>
    <nct_id>NCT04461470</nct_id>
  </id_info>
  <brief_title>6-Month Outcomes of PEMF to Nucleotide Sources Revealing Cell Sensory Experience in Pain Relief, Stress Relief and Anti Ageing Restoration</brief_title>
  <acronym>PEMF</acronym>
  <official_title>6-Month Outcomes of Pulsed Electro Resonance to Nucleotide Sources Revealing Cell Sensory Experience in Pain Relief, Stress Relief and Anti-ageing Homeostatic Restoration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>hz Clinic</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>East London Electric Company</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PropDesk</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MedCity</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UCL Partners</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imperial College London Partners</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Innovation Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>hz Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      The hz Clinic registry is a programme made of five scheduled cohorts designed to include&#xD;
      participants dealing with Immunity compromise, Pain, Ageing and Stress (general and pandemic&#xD;
      anxieties) who are to be followed for 6 month to five years in their structured routine of&#xD;
      pulsed electro resonance (PEMF) to determine their clinical outcome in the real world,&#xD;
      contributing evidence for benchmarking fellow cohort participant variance.&#xD;
&#xD;
      Here we report baseline characteristics, PEMF transfer events and outcomes in participants in&#xD;
      the UK. This study serves as a calibration proforma for downstream real world evidence&#xD;
      observations of PEMF in the field.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Electro resonance (PEMF) therapy is relatively new, despite the fact that it is considered a&#xD;
      gold standard approach in healthcare application.&#xD;
&#xD;
      The base premise of PEMF is to apply field (inducing force) energies to a host, producing a&#xD;
      spectrum of physiological benefits (Bagnato et al., 2015). The advantages of PEMF approaches&#xD;
      are the vast modalities available in which an inducing force is applied and is configured&#xD;
      (low to high hz intensity, frequency and polarity). The disadvantages are, however,&#xD;
      dissonances in paradigm trajectory and PEMF seldom interrogation of the in-situ / in-vivo&#xD;
      metrics of change in recipient (Funk et al., 2008; Peterchev et al., 2012).&#xD;
&#xD;
      PEMF data in healthcare enables an exercise of compelled judgement(s) across all critical&#xD;
      level (pre-clinical, phase I, phase II, phase III, phase IV) system activity. Today there is&#xD;
      an apparent disjoint of insight between systems-derived data (imaging) and treatment applied&#xD;
      data (remedial action). Some example settings of this include i) electro resonance / surgery&#xD;
      as an evidence based tool in clinical decision making (Phelps et al., 2018 and Strauch et&#xD;
      al., 2009); ii) in-vitro electro resonance in skin equivalence model (Mitchell et al., 2015&#xD;
      and Mitchell et al., 2016) and bone stimulus model (Ferroni et al., 2018) modelling in-vivo&#xD;
      benefit; iii) phase IV anticoagulation and prothrombin ratio 'observations and&#xD;
      stratification' using principle component positions, and observing all contributing variances&#xD;
      in play (Sawhney et al., 2018).&#xD;
&#xD;
      The unprecedented contribution of pandemic variance (Huang et al., 2020), is heightening a&#xD;
      public awareness of how manifold real world evidence is in resolving the insight disjoints.&#xD;
      Biomedical problems occur in forms where remote or aseptic application and self observation&#xD;
      is paramount to care; particularly in the cases of infection, healing wounds and&#xD;
      hydro-electrolyte restoration(s).&#xD;
&#xD;
      In plentiful coverage, PEMF homeostatic benefits on Immunity compromise, Pain, Stress and&#xD;
      Ageing are extensively reviewed with Mun et al., (2018); and although the mechanisms of&#xD;
      actions are underpinned; our literature search shows that there are seldom real world&#xD;
      initiatives, recording wide-spread physiological improvements that PEMF therapy enacts.&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      Here we describe the calibration proforma of PEMF correspondence scoring in longitudinal,&#xD;
      physiological and observational outcomes. This study will serve as method development for&#xD;
      downstream real world evidence observations of PEMF in the field.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Ethics statement&#xD;
&#xD;
      All participants provided written informed consent in the online basket checkout at&#xD;
      hzclinic.co.uk opting to be therapy subjects. The registry is being conducted in accordance&#xD;
      with local regulatory requirements, and the International Conference on Harmonisation-Good&#xD;
      Pharmacoepidemiological and Clinical Practice Guidelines.&#xD;
&#xD;
      Procedures and outcomes measures&#xD;
&#xD;
      Baseline data collected at screening included participant characteristics (like age), type of&#xD;
      clinical-problem (Stress, Pain, Immunity compromise), date and method of diagnosis if any&#xD;
      formal, symptoms, and PEMF treatment (delocalised resonance over nucleotide source inducing&#xD;
      post transcription modification (PTM) to ubiquitous properties (U.P.)) 2 hz PTM; 3 hz PTM; 4&#xD;
      hz PTM; 5 hz PTM [request appendix for additional I.P. support].&#xD;
&#xD;
      Data on all components of (and) the McGill Life (Sensory, Affectory, Evaluative,&#xD;
      Miscellaneous) Index Chart (recordings) were collected to assess the sensitivities of Pain,&#xD;
      Stress, Ageing and Immunity compromise states retrospectively.&#xD;
&#xD;
      hz data were collected using a proprietary electronic case report form (eCRF) captured by&#xD;
      trained personnel. Oversight of the operations and data management are managed by the&#xD;
      coordinating centre hz Clinic, with supporting entities PropDesk (London, UK) and East London&#xD;
      Electric Company (ELEC) (London, UK); and resourcing centres MedCity in conjunction with UCL&#xD;
      Partners, Imperial College Health Partners and the Health Innovation Network.&#xD;
&#xD;
      The hz protocol requires that 20% of all eCRFs are monitored against source documentation,&#xD;
      that there is an electronic audit trail for all data modifications, and that critical&#xD;
      variables are subjected to additional audit (Cohen et al., 2015).&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      This article describes the baseline characteristics, treatment patterns and 6 month outcomes&#xD;
      based on national data and for participants included in the UK; data for these analyses were&#xD;
      extracted from the registry database on 12th February 2020. Continuous variables are&#xD;
      expressed as mean ± standard deviation (SD) and categorical variables as frequency and&#xD;
      percentage. Utility of PEMF at baseline was analysed by McGill Life Chart Index scores,&#xD;
      calculated retrospectively from the data collected. Participants with missing values were not&#xD;
      removed from the study. National normalised ratio (NNR) readings during the 6 months follow&#xD;
      up were included in the analysis. We adapted the international normalised ratio (Bonar and&#xD;
      Favaloro., 2016) with the acquisition and processing of urine samples for participant&#xD;
      metabolome mass fingerprinting and hydration readings as an index, performed (request&#xD;
      appendix for additional NNR guidelines). Implausible NNR value of less than 0.8 or greater&#xD;
      than 20 were excluded. The distribution of NNR values are described by counts and percentages&#xD;
      below, within, and above the therapeutic range, and by the mean, SD, median, and&#xD;
      interquartile range (IQR).&#xD;
&#xD;
      Occurrence of major clinical response (primarily, Pain-relief, Stress-relief, anti-oxidation&#xD;
      (/ageing) and quenched inflammation) is described using the number of events, the proportion&#xD;
      of participants with the event divided by the population at burden at the beginning of the&#xD;
      follow-up-period, person-time event rate (per 100 person-years), and 95% confidence interval&#xD;
      (CI). We estimated person-year rates using a Poisson model, with the number of events. Only&#xD;
      the first occurrences of each event were taken into account. Data analysis was performed at&#xD;
      the PropDesk with MatLab (MathsWorks, Massachusetts, USA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 29, 2019</start_date>
  <completion_date type="Anticipated">September 12, 2024</completion_date>
  <primary_completion_date type="Actual">February 12, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Week</target_duration>
  <primary_outcome>
    <measure>Pain alleviation</measure>
    <time_frame>Imminence - one day</time_frame>
    <description>McGill Index Score 0 - 5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stress alleviation</measure>
    <time_frame>Imminence - one day</time_frame>
    <description>McGill Index Score 0 - 5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti ageing</measure>
    <time_frame>Imminence - one day</time_frame>
    <description>McGill Index Score 0 - 5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammation quenching</measure>
    <time_frame>Imminence - one day</time_frame>
    <description>McGill Index Score 0 - 5</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Pain</condition>
  <condition>Stress</condition>
  <condition>Ageing Signs</condition>
  <condition>Immunity Compromise</condition>
  <arm_group>
    <arm_group_label>London</arm_group_label>
    <description>pulsed electro resonance hz 4, hz 3, hz 2, hz 3.5 and residual hz 5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>All United Kingdom</arm_group_label>
    <description>pulsed electro resonance hz 4, hz 3, hz 2, hz 3.5 and residual hz 5</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>epigenetic longitudinal waves</intervention_name>
    <description>force - inducing energies using electromagnetic field(s)</description>
    <arm_group_label>All United Kingdom</arm_group_label>
    <arm_group_label>London</arm_group_label>
    <other_name>hz</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Distinct community regions - United Kingdom, London.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adept to social media / technology uses and convenience of care / health benchmarking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cardiovascular issue&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher L Davies</last_name>
    <role>Study Chair</role>
    <affiliation>East London Electric Company</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christopher A Mitchell, PhD</last_name>
    <phone>+447497611090</phone>
    <email>info@hzclinic.co.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>hz Clinic</name>
      <address>
        <city>London</city>
        <zip>E20 3BS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher A Mitchell, PhD</last_name>
      <email>info@hzclinic.co.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://opendata.ncats.nih.gov/covid19/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Bagnato GL, Miceli G, Marino N, Sciortino D, Bagnato GF. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). 2016 Apr;55(4):755-62. doi: 10.1093/rheumatology/kev426. Epub 2015 Dec 24.</citation>
    <PMID>26705327</PMID>
  </reference>
  <reference>
    <citation>Booth CM, Tannock IF. Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. Br J Cancer. 2014 Feb 4;110(3):551-5. doi: 10.1038/bjc.2013.725. Epub 2014 Jan 14. No abstract available.</citation>
    <PMID>24495873</PMID>
  </reference>
  <reference>
    <citation>Ferroni L, Gardin C, Dolkart O, Salai M, Barak S, Piattelli A, Amir-Barak H, Zavan B. Pulsed electromagnetic fields increase osteogenetic commitment of MSCs via the mTOR pathway in TNF-alpha mediated inflammatory conditions: an in-vitro study. Sci Rep. 2018 Mar 23;8(1):5108. doi: 10.1038/s41598-018-23499-9.</citation>
    <PMID>29572540</PMID>
  </reference>
  <reference>
    <citation>Funk RH. Coupling of pulsed electromagnetic fields (PEMF) therapy to molecular grounds of the cell. Am J Transl Res. 2018 May 15;10(5):1260-1272. eCollection 2018.</citation>
    <PMID>29887943</PMID>
  </reference>
  <reference>
    <citation>Kolifarhood G, Aghaali M, Mozafar Saadati H, Taherpour N, Rahimi S, Izadi N, Hashemi Nazari SS. Epidemiological and Clinical Aspects of COVID-19; a Narrative Review. Arch Acad Emerg Med. 2020 Apr 1;8(1):e41. eCollection 2020.</citation>
    <PMID>32259130</PMID>
  </reference>
  <reference>
    <citation>Mitchell CA, Long H, Donaldson M, Francese S, Clench MR. Lipid changes within the epidermis of living skin equivalents observed across a time-course by MALDI-MS imaging and profiling. Lipids Health Dis. 2015 Aug 5;14:84. doi: 10.1186/s12944-015-0089-z.</citation>
    <PMID>26243140</PMID>
  </reference>
  <reference>
    <citation>Mitchell CA, Donaldson M, Francese S, Clench MR. MALDI MSI analysis of lipid changes in living skin equivalents in response to emollient creams containing palmitoylethanolamide. Methods. 2016 Jul 15;104:93-100. doi: 10.1016/j.ymeth.2016.02.001. Epub 2016 Feb 2.</citation>
    <PMID>26845462</PMID>
  </reference>
  <reference>
    <citation>Mun EJ, Babiker HM, Weinberg U, Kirson ED, Von Hoff DD. Tumor-Treating Fields: A Fourth Modality in Cancer Treatment. Clin Cancer Res. 2018 Jan 15;24(2):266-275. doi: 10.1158/1078-0432.CCR-17-1117. Epub 2017 Aug 1.</citation>
    <PMID>28765323</PMID>
  </reference>
  <reference>
    <citation>Osler M, Rozing MP, Christensen GT, Andersen PK, Jorgensen MB. Electroconvulsive therapy and risk of dementia in patients with affective disorders: a cohort study. Lancet Psychiatry. 2018 Apr;5(4):348-356. doi: 10.1016/S2215-0366(18)30056-7. Epub 2018 Mar 6.</citation>
    <PMID>29523431</PMID>
  </reference>
  <reference>
    <citation>Peterchev AV, Wagner TA, Miranda PC, Nitsche MA, Paulus W, Lisanby SH, Pascual-Leone A, Bikson M. Fundamentals of transcranial electric and magnetic stimulation dose: definition, selection, and reporting practices. Brain Stimul. 2012 Oct;5(4):435-53. doi: 10.1016/j.brs.2011.10.001. Epub 2011 Nov 1.</citation>
    <PMID>22305345</PMID>
  </reference>
  <reference>
    <citation>Phelps DL, Balog J, Gildea LF, Bodai Z, Savage A, El-Bahrawy MA, Speller AV, Rosini F, Kudo H, McKenzie JS, Brown R, Takats Z, Ghaem-Maghami S. The surgical intelligent knife distinguishes normal, borderline and malignant gynaecological tissues using rapid evaporative ionisation mass spectrometry (REIMS). Br J Cancer. 2018 May;118(10):1349-1358. doi: 10.1038/s41416-018-0048-3. Epub 2018 Apr 19.</citation>
    <PMID>29670294</PMID>
  </reference>
  <reference>
    <citation>Reid B, Zhao M. The Electrical Response to Injury: Molecular Mechanisms and Wound Healing. Adv Wound Care (New Rochelle). 2014 Feb 1;3(2):184-201. doi: 10.1089/wound.2013.0442.</citation>
    <PMID>24761358</PMID>
  </reference>
  <reference>
    <citation>Sawhney JP, Kothiwale VA, Bisne V, Durgaprasad R, Jadhav P, Chopda M, Vanajakshamma V, Meena R, Vijayaraghavan G, Chawla K, Allu J, Pieper KS, John Camm A, Kakkar AK; GARFIELD-AF Investigators. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry. Indian Heart J. 2018 Nov-Dec;70(6):828-835. doi: 10.1016/j.ihj.2018.09.001. Epub 2018 Sep 12.</citation>
    <PMID>30580852</PMID>
  </reference>
  <reference>
    <citation>Strauch B, Herman C, Dabb R, Ignarro LJ, Pilla AA. Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery. Aesthet Surg J. 2009 Mar-Apr;29(2):135-43. doi: 10.1016/j.asj.2009.02.001.</citation>
    <PMID>19371845</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>researchers can contribute to the cohort and bridge their access to participant-centred data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04461470
org study id: 7012
nct id: NCT04461470
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Background:

      The hz Clinic registry is a programme made of five scheduled cohorts designed to include
      participants dealing with Immunity compromise, Pain, Ageing and Stress (general and pandemic
      anxieties) who are to be followed for 6 month to five years in their structured routine of
      pulsed electro resonance (PEMF) to determine their clinical outcome in the real world,
      contributing evidence for benchmarking fellow cohort participant variance.

      Here we report baseline characteristics, PEMF transfer events and outcomes in participants in
      the UK. This study serves as a calibration proforma for downstream real world evidence
      observations of PEMF in the field.
Introduction:

      Electro resonance (PEMF) therapy is relatively new, despite the fact that it is considered a
      gold standard approach in healthcare application.

      The base premise of PEMF is to apply field (inducing force) energies to a host, producing a
      spectrum of physiological benefits (Bagnato et al., 2015). The advantages of PEMF approaches
      are the vast modalities available in which an inducing force is applied and is configured
      (low to high hz intensity, frequency and polarity). The disadvantages are, however,
      dissonances in paradigm trajectory and PEMF seldom interrogation of the in-situ / in-vivo
      metrics of change in recipient (Funk et al., 2008; Peterchev et al., 2012).

      PEMF data in healthcare enables an exercise of compelled judgement(s) across all critical
      level (pre-clinical, phase I, phase II, phase III, phase IV) system activity. Today there is
      an apparent disjoint of insight between systems-derived data (imaging) and treatment applied
      data (remedial action). Some example settings of this include i) electro resonance / surgery
      as an evidence based tool in clinical decision making (Phelps et al., 2018 and Strauch et
      al., 2009); ii) in-vitro electro resonance in skin equivalence model (Mitchell et al., 2015
      and Mitchell et al., 2016) and bone stimulus model (Ferroni et al., 2018) modelling in-vivo
      benefit; iii) phase IV anticoagulation and prothrombin ratio 'observations and
      stratification' using principle component positions, and observing all contributing variances
      in play (Sawhney et al., 2018).

      The unprecedented contribution of pandemic variance (Huang et al., 2020), is heightening a
      public awareness of how manifold real world evidence is in resolving the insight disjoints.
      Biomedical problems occur in forms where remote or aseptic application and self observation
      is paramount to care; particularly in the cases of infection, healing wounds and
      hydro-electrolyte restoration(s).

      In plentiful coverage, PEMF homeostatic benefits on Immunity compromise, Pain, Stress and
      Ageing are extensively reviewed with Mun et al., (2018); and although the mechanisms of
      actions are underpinned; our literature search shows that there are seldom real world
      initiatives, recording wide-spread physiological improvements that PEMF therapy enacts.

      Aim:

      Here we describe the calibration proforma of PEMF correspondence scoring in longitudinal,
      physiological and observational outcomes. This study will serve as method development for
      downstream real world evidence observations of PEMF in the field.

      Method:

      Ethics statement

      All participants provided written informed consent in the online basket checkout at
      hzclinic.co.uk opting to be therapy subjects. The registry is being conducted in accordance
      with local regulatory requirements, and the International Conference on Harmonisation-Good
      Pharmacoepidemiological and Clinical Practice Guidelines.

      Procedures and outcomes measures

      Baseline data collected at screening included participant characteristics (like age), type of
      clinical-problem (Stress, Pain, Immunity compromise), date and method of diagnosis if any
      formal, symptoms, and PEMF treatment (delocalised resonance over nucleotide source inducing
      post transcription modification (PTM) to ubiquitous properties (U.P.)) 2 hz PTM; 3 hz PTM; 4
      hz PTM; 5 hz PTM [request appendix for additional I.P. support].

      Data on all components of (and) the McGill Life (Sensory, Affectory, Evaluative,
      Miscellaneous) Index Chart (recordings) were collected to assess the sensitivities of Pain,
      Stress, Ageing and Immunity compromise states retrospectively.

      hz data were collected using a proprietary electronic case report form (eCRF) captured by
      trained personnel. Oversight of the operations and data management are managed by the
      coordinating centre hz Clinic, with supporting entities PropDesk (London, UK) and East London
      Electric Company (ELEC) (London, UK); and resourcing centres MedCity in conjunction with UCL
      Partners, Imperial College Health Partners and the Health Innovation Network.

      The hz protocol requires that 20% of all eCRFs are monitored against source documentation,
      that there is an electronic audit trail for all data modifications, and that critical
      variables are subjected to additional audit (Cohen et al., 2015).

      Statistical analysis

      This article describes the baseline characteristics, treatment patterns and 6 month outcomes
      based on national data and for participants included in the UK; data for these analyses were
      extracted from the registry database on 12th February 2020. Continuous variables are
      expressed as mean ± standard deviation (SD) and categorical variables as frequency and
      percentage. Utility of PEMF at baseline was analysed by McGill Life Chart Index scores,
      calculated retrospectively from the data collected. Participants with missing values were not
      removed from the study. National normalised ratio (NNR) readings during the 6 months follow
      up were included in the analysis. We adapted the international normalised ratio (Bonar and
      Favaloro., 2016) with the acquisition and processing of urine samples for participant
      metabolome mass fingerprinting and hydration readings as an index, performed (request
      appendix for additional NNR guidelines). Implausible NNR value of less than 0.8 or greater
      than 20 were excluded. The distribution of NNR values are described by counts and percentages
      below, within, and above the therapeutic range, and by the mean, SD, median, and
      interquartile range (IQR).

      Occurrence of major clinical response (primarily, Pain-relief, Stress-relief, anti-oxidation
      (/ageing) and quenched inflammation) is described using the number of events, the proportion
      of participants with the event divided by the population at burden at the beginning of the
      follow-up-period, person-time event rate (per 100 person-years), and 95% confidence interval
      (CI). We estimated person-year rates using a Poisson model, with the number of events. Only
      the first occurrences of each event were taken into account. Data analysis was performed at
      the PropDesk with MatLab (MathsWorks, Massachusetts, USA).
observational model: Cohort
time perspective: Prospective
measure: Pain alleviation
time frame: Imminence - one day
description: McGill Index Score 0 - 5
measure: Stress alleviation
time frame: Imminence - one day
description: McGill Index Score 0 - 5
measure: Anti ageing
time frame: Imminence - one day
description: McGill Index Score 0 - 5
measure: Inflammation quenching
time frame: Imminence - one day
description: McGill Index Score 0 - 5
arm group label: London
description: pulsed electro resonance hz 4, hz 3, hz 2, hz 3.5 and residual hz 5
arm group label: All United Kingdom
description: pulsed electro resonance hz 4, hz 3, hz 2, hz 3.5 and residual hz 5
intervention type: Genetic
intervention name: epigenetic longitudinal waves
description: force - inducing energies using electromagnetic field(s)
arm group label: All United Kingdom
arm group label: London
other name: hz
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher L Davies
role: Study Chair
affiliation: East London Electric Company
last name: Christopher A Mitchell, PhD
phone: +447497611090
email: info@hzclinic.co.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
url: https://opendata.ncats.nih.gov/covid19/
description: Related Info
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PMID: 19371845
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: researchers can contribute to the cohort and bridge their access to participant-centred data