Beruflich Dokumente
Kultur Dokumente
05. 01 2005.
FINAL REPORT
According to the clinical protocol of investigation (PICMFN)
Of 12.06.2004
Center of investigation
MEDICINE SCIENTIFIC CENTER OF
REHABILITATION MARFINO
Promotor or sponsor
MASTER MEDIA represented by M.MEDVEDEV Sergei
Monitor
Dr. MARASANOV A.
Medical doctor
Presentation of the DDFAO
DDFAO /ESG System makes it possible to measure:
The device is composed of a USB circuit and a circuit of converters placed on the same chart and
separated by a galvanic decoupling.
This chart is installed in a black box.
-A black box, cables , reusable metal electrodes for the feet and the hands and single use
electrodes for the face
- Instructions of the system
- European cerficat EC 0459 of the 15.11.2002.
- The certificate of the Health ministery of Russian MS RF n°2003/990 of the 07.07.2003.
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PROTOCOLE OF THE CLINICAL TESTS
Conformity or modifications of the clinical plan of investigation (PICMFN) of
12.06.2004
No modification of the device was made during the investigation.
The investigation followed in a way in conformity the clinical protocol of investigation
(PICMFN).
No side effect was recorded following the recordings.
After agreement of the ethical committee on 22.06.2004 , the clinical investigation began the
07.07.2004, in the respect of the declaration of Helsinki.
Confidentiality
The confidentiality was respected by all the parts implied throughout the clinical investigation.
All the data are protected and inaccessible to the unauthorized parts.
The confidentiality of information relative on each subject as with its private life will be
preserved in the reports/ratios and any publication of the data of the clinical investigation.
The reports/ratios will include/understand a patient code that program ESG generates
automatically according to the sex, of the name, the first name and the day of the date of birth.
During the time of the 07 07. 2004 to the 20.08.2004 , 33 patients with various pathologies
underwent a cure of rehabilitation in the Medecine scientific center of rehabilitation Marfino.
The therapeutic follow-up of these patients was evaluated according to 2 processes :
1. Conventional examinations
Anamnesis and Blood Analysis ( venous and capillary ):
The anamnesis retained the main risk and the associated risks.
We recorded 33 patients including 16 Men and 17 women . The average age being 41 years.
This assessment was carried out at the beginning of the treatment (07.07.2004) and at the end of
the treatment (20.08.2004)
3
Results
4
2. Follow-up of the risk by DDFAO system
Cardiovascular risk
Name Visit 1 Visit 2 Visit 3
2ZV09 21 21 21
1KV10 60 60 21
2LV07 50 21 21
2MN15 21 21 21
2MR24 21 21 21
2RN13 21 21 21
1SA29 21 21 21
1TV07 21 21 21
1FA14 21 21 21
2SN15 21 21 21
2VG02 50 21 21
328 270 231
Сердечно-сосудистые заболевания
Evolution of the cardiovascular risk
35
30
25
20
15
10
0
1 2 3
5
DIGESTIVE SYSTEM
Patients visit 1 visit 2 visit 3
2BN06 60 21 60
2BE21 60 21 60
1BA05 60 21 60
2CI31 21 60 60
2DE04 0 0 0
2DI03 0 0 0
2DE20 60 60 21
2DL03 0 21 21
1FA14 60 60 60
1IM18 60 60 21
2JN25 0 21 0
1KV10 21 21 60
2LL22 60 21 0
2LI17 60 60 60
2LV07 21 21 60
2MN15 60 60 60
1MA04 0 60 21
2MR24 60 60 21
2MD23 60 21 21
2MG20 60 60 60
2MT02 21 60 60
2MN06 60 60 21
1NY05 60 60 60
2OI25 0 0 60
1PS20 21 60 0
2PG25 60 60 21
1RU19 0 21 21
2RN13 60 60 60
1SM24 21 21 60
2SN15 21 21 21
1SV10 21 60 21
1SA29 60 60 60
1SA03 21 21 21
1TV07 60 21 60
2VG02 0 21 21
2ZV09 60 60 60
36,92 38,75 37,58
Система пищеварения
Digestive risks
39,00
38,50
38,00
37,50
37,00
36,50
36,00
35,50
1 62 3
URO GENITAL SYSTEM
Patients visit 1 visit 2 visit 3
2BN06 0 0 0
2BE21 0 21 21
1BA05 21 21 21
2CI31 21 21 21
2DE04 0 0 0
2DI03 0 0 0
2DE20 0 21 0
2DL03 0 60 21
1FA14 21 21 21
1IM18 0 21 0
2JN25 0 0 0
1KV10 21 21 21
2LL22 0 21 21
2LI17 21 21 0
2LV07 21 21 21
2MN15 0 0 0
1MA04 0 21 21
2MR24 0 21 60
2MD23 21 21 21
2MG20 21 21 21
2MT02 21 21 21
2MN06 21 21 21
1NY05 21 21 21
2OI25 0 0 0
1PS20 21 21 0
2PG25 21 0 60
1RU19 0 21 21
2RN13 21 21 21
1SM24 21 21 21
2SN15 21 21 21
1SV10 21 21 21
1SA29 0 21 21
1SA03 21 21 21
1TV07 21 21 21
2VG02 0 60 60
2ZV09 21 21 21
11,67 19,08 18,42
Мочеполовая
uro genital система
System
30,00
20,00
10,00
0,00
1 2 3
7
OSSEOUS DISEASE
Patients visit 1 visit 2 visit 3
2BN06 21 0 21
2BE21 0 21 21
1BA05 21 21 21
2CI31 21 21 21
2DE04 0 0 0
2DI03 0 0 60
2DE20 21 21 21
2DL03 0 21 21
1FA14 21 21 21
1IM18 21 21 0
2JN25 0 0 0
1KV10 21 21 21
2LL22 0 60 60
2LI17 21 21 21
2LV07 21 60 21
2MN15 0 0 0
1MA04 0 21 60
2MR24 0 21 21
2MD23 21 21 60
2MG20 21 21 21
2MT02 21 21 21
2MN06 21 21 21
1NY05 21 21 21
2OI25 0 0 21
1PS20 60 21 0
2PG25 21 0 21
1RU19 0 21 21
2RN13 21 21 21
1SM24 21 21 21
2SN15 60 21 60
1SV10 21 21 21
1SA29 0 21 21
1SA03 21 21 21
1TV07 0 60 21
2VG02 0 21 21
2ZV09 21 21 21
15,00 20,17 23,50
Костные заболевания
Osseous disease
30,00
20,00
10,00
0,00
1 2 3
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ENDOCRINE DYSFUNCTION
Patients visit 1 visit 2 visit 3
2BN06 0 0 21
2BE21 0 60 21
1BA05 21 60 21
2CI31 0 21 21
2DE04 21 60 21
2DI03 21 21 0
2DE20 0 21 0
2DL03 0 21 21
1FA14 21 21 21
1IM18 0 21 0
2JN25 21 0 21
1KV10 21 21 21
2LL22 0 21 21
2LI17 21 0 0
2LV07 21 21 21
2MN15 21 21 21
1MA04 0 21 0
2MR24 21 21 21
2MD23 21 21 21
2MG20 0 21 21
2MT02 21 21 21
2MN06 0 0 0
1NY05 21 21 21
2OI25 21 0 21
1PS20 21 21 21
2PG25 21 21 21
1RU19 21 21 21
2RN13 21 21 21
1SM24 21 21 21
2SN15 0 21 21
1SV10 60 21 60
1SA29 21 21 21
1SA03 60 60 60
1TV07 21 0 21
2VG02 21 21 21
2ZV09 21 21 21
16,75 21,83 19,67
Эндокринные заболевания
Endocrine dysfunction
25,00
20,00
15,00
10,00
5,00
0,00
1 2 3
9
OXIDATIVE STRESS
Patients visit 1 visit 2 visit 3
2BN06 0 21 0
2BE21 21 21 21
1BA05 21 21 21
2CI31 21 21 21
2DE04 21 21 21
2DI03 0 0 21
2DE20 21 21 0
2DL03 21 21 21
1FA14 21 21 21
1IM18 21 21 21
2JN25 0 21 0
1KV10 21 21 21
2LL22 21 21 21
2LI17 21 21 21
2LV07 21 21 21
2MN15 21 21 21
1MA04 21 21 21
2MR24 21 21 21
2MD23 21 21 21
2MG20 21 21 21
2MT02 21 21 21
2MN06 21 21 21
1NY05 21 21 21
2OI25 21 21 21
1PS20 21 21 21
2PG25 21 21 21
1RU19 21 21 21
2RN13 21 21 21
1SM24 21 21 21
2SN15 21 21 21
1SV10 21 21 21
1SA29 21 21 21
1SA03 21 21 0
1TV07 21 21 21
2VG02 0 21 21
18,67 20,42 18,67
Дерматологические заболевания
Oxidative stress
15,00
14,50
14,00
13,50
13,00
12,50
1 2 3
10
Underlying situation
Patients visit 1 visit 2 visit 3
2BN06 0 0 0
2BE21 21 21 21
1BA05 21 21 21
2CI31 21 21 21
2DE04 0 0 0
2DI03 0 0 0
2DE20 0 21 21
2DL03 0 21 21
1FA14 21 21 21
1IM18 21 21 0
2JN25 0 0 0
1KV10 21 21 21
2LL22 0 21 21
2LI17 21 21 21
2LV07 21 21 21
2MN15 21 21 21
1MA04 0 21 21
2MR24 21 21 21
2MD23 21 0 0
2MG20 21 21 21
2MT02 21 21 21
2MN06 21 21 21
1NY05 21 21 21
2OI25 21 0 21
1PS20 0 21 0
2PG25 21 21 21
1RU19 21 21 21
2RN13 21 21 21
1SM24 21 21 21
2SN15 0 21 0
1SV10 21 21 21
1SA29 0 21 21
1SA03 21 21 21
14,00 17,50 16,33
15,00
10,00
5,00
0,00
1 2 3
11
3.Correspondence of the values of the blood ionogramme and DDFAO
biochemical estimation
KALIEAMIA
Patients A.sanguine 1 DDFAO 1 A.sanguine 2 DDFAO 2
1BA05 N N
2ZV09 -5 N
2ZT04 +5 N
1KV10 -5 -5
2KU14 N N
2LV07 3,5 N 4,1 N
2MN15 3,3 -5 6,1 +5
1MA04 N N
2MR24 5,7 +5 5,7 +5
2MN06 3,2 -10 -10
1NA06 3,4 -5 -5
2OI25 4,9 +5 4,9 +5
2PG25 2,9 -10 4,1 N
2RI01 N N
1RS11 -5 -5
2RN13 4,3 +5 +5
1RU19 5,1 +5 2,6 -5
1SM24 3,9 N 3,9 N
2SI05 N N
1SA29 4,3 +5 2,8 -5
2SI23 5 +5 4,3 N
1TV07 5 +5 5 +5
1UP12 +5 +5
1FA14 3,4 N 2,2 -10
1CV11 4,6 +5 +5
2CI31 3,4 -5 3,7 -5
1SV10 4,2 +5 3,7 N
2SN15 3 -5 2,7 -10
2SE28 +5 +5
2JN25 2,9 -10 6,2 +5
2VG02 3,8 N 5,1 N
2DE20 4,3 +5 4,8 +5
2KM02 4,6 +5 2,5 -5
0,00 0,00 0,00
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NATREAMIA
Patients A.sanguine 1 DDFAO 1 A.sanguine 2 DDFAO 2
1BA05 N N
2ZV09 N N
2ZT04 N N
1KV10 N N
2KU14 N N
2LV07 155 +5 141 N
2MN15 127 -5 132 N
1MA04 N N
2MR24 142 +5 134 N
2MN06 138 N 104 -10
1NA06 137 N N
2OI25 149 +5 139 N
2PG25 110 -10 131 N
2RI01 N N
1RS11 N N
2RN13 163 +10 N
1RU19 129 N 138 N
1SM24 118 -10 86 -10
2SI05 N N
1SA29 148 N 138 N
2SI23 140 N 139 N
1TV07 120 -5 N
1UP12 N N
1FA14 165 +10 132 N
1CV11 137 N N
2CI31 135 N 138 N
1SV10 126 N 129 N
2SN15 156 +5 135 N
2SE28 N N
2JN25 166 +10 146 N
2VG02 188 +10 +10
2DE20 137 N 130 N
2KM02 117 -5 138 N
0,00 0,00
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CALCEAMIA
Patients A.sanguine 1 DDFAO 1 A.sanguine 2 DDFAO 2
1BA05 -5 -5
2ZV09 N N
2ZT04 N N
1KV10 N N
2KU14 N N
2LV07 1,15 -5 1,74 -5
2MN15 2,23 N 1,84 -5
1MA04 N N
2MR24 2,27 N 2,13 N
2MN06 1,37 -5 1,43 -5
1NA06 1,39 -5 -5
2OI25 1,88 -5 1,88 -5
2PG25 2,28 N 2,22 N
2RI01 -5 -5
1RS11 N N
2RN13 2,45 N N
1RU19 2,06 N 2,06 N
1SM24 0,89 -10 1,75 -5
2SI05 N N
1SA29 1,71 -5 1,89 -5
2SI23 1,78 -5 1,57 -5
1TV07 1,14 -5 1,92 N
1UP12 N N
1FA14 1,99 N 2,02 N
1CV11 1,77 -5 -5
2CI31 1,73 -5 1,97 -5
1SV10 1,25 -5 1,66 -5
2SN15 1,6 -5 1,5 -5
2SE28 N N
2JN25 1,62 -5 1,94 N
2VG02 1,75 N 2,25 N
2DE20 1,83 N 3,29 +5
2KM02 1,79 -5 1,55 -5
0,00 0,00 0,00
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MAGNESEAMIA
Patients A.sanguine 1 DDFAO 1 A.sanguine 2 DDFAO 2
1BA05 N N
2ZV09 N N
2ZT04 N N
1KV10 N N
2KU14 N N
2LV07 0,8 N 0,77 N
2MN15 0,48 -5 1,01 N
1MA04 N N
2MR24 0,73 N 0,51 N
2MN06 0,63 N 0,68 N
1NA06 0,86 N N
2OI25 0,61 N 0,61 N
2PG25 0,8 N 0,91 N
2RI01 N N
1RS11 N N
2RN13 0,77 N N
1RU19 0,84 N 0,6 N
1SM24 0,82 N 1,51 +5
2SI05 N N
1SA29 0,84 N 0,8 N
2SI23 0,81 N 0,74 N
1TV07 0,58 -5 0,97 N
1UP12 N N
1FA14 0,49 -5 1,09 N
1CV11 0,31 -5 -5
2CI31 0,21 -10 1,15 N
1SV10 0,64 N 0,79 N
2SN15 0,22 -10 0,96 N
2SE28 N N
2JN25 0,37 -5 0,89 N
2VG02 0,82 N 0,69 N
2DE20 0,71 N 0,9 N
2KM02 0,4 -5 0,85 N
15
4. Correspondence of the values of the percentage of fatty mass, masses thin and
total water using system AVITA BF 1 BODY FAT ANALYZER and system DDFAO
16
Conclusions
The tests carried out on 33 patients in double control as well by the conventional methods as by
DDFAO system, make it possible to conclude with the reliability of the system which gives
results of estimate of the risk, biochemical constants and body composition in conformity has
more than 89%.
In the base of recorded patients, the use of the DDFAO made it possible to note that the risk
increases during the first week, and to decrease appreciably at the end of the cure.
By its ease of use, its non-invasive and the speed of obtaining the results (3 minutes),
DDFAO system naturally finds its place in the regulation of supplementary examinations, the
estimate of the body composition and the therapeutic follow-up
References
17
17) COLE, K. S. 1968. Membranes, lons, and Impulses. University of California Press.
Berkeley/Los Angeles
18) Koryta J (1991): Ions, electrodes and membranes. John Wiley, Chichester.
19) P.Brunswick : DDFAO/Rapport d’étude issue des tests cliniques sur la spécificité et
sensibilité du système.
20) Cole KS (1940): Permeability and impermeability of cell membranes for ions. Cold
Spring Harbor Sympos Quant Biol, 8, 110 – 122
21) H. Kanai ,K Sakamoto ,M.Haeno: Electrical measurementof fluid distribution in human
legs;estimation of extra and intra cellular fluid volume. The journal of Microwave Power
1983 18: 233-243
22) J.H.Meijer, PM de Vries , HG Goovaerts, PL Oe, AJ Donker, H Schneider:
Measurement of transcellular fluidshift during haemodialysis. Part 1. Method . Medical &
biological Engineering & Computing 1989., 27 : 147 – 151
23) South Med J. 1974 Sep;67(9):1084-101. An approach to clinical disorders of acid-base
balance Brackett NC Jr. Publication Types: Review PMID: 4604081 [PubMed - indexed
for MEDLINE
24) Lancet. 1976 Sep 4;1(7984):499-500. An in-vivo representation of acid-base balance.
Grogono AW, Byles PH, Hawke W. PMID: 74465 [PubMed - indexed for MEDLINE]
25) JAMA. 1972 Oct 30;222(5):567-73. Acid-base disorders in health and disease. Klahr S,
Wessler S, Avioli LV.PMID: 4678093 [PubMed - indexed for MEDLINE
Address participants :
Dr Rasnikin S.M.
Manager of the scientific program,
Medical doctor.
Medecine scientific Center of rehabilitation MARFINO
121099 Моscow, novi Arbat Street , N°.32 Russia
Dr Marasanov V .A
Medical doctor
121099 Моscow, novi Arbat Street , N°.32 Russia
MASTER MEDIA
represented by its general manager M.Medvedev Sergei: data-processing engineer
Moscou Hlebnikov per ,7-2 , Russie
18