Iris Publishers- Open access Journal of Pediatrics & Neonatal Care | Immunoglobulin Levels (IgG, IgM And IgA): Normal Values for Healthy Infants and Children in Sana’a City- Yemen

Authored by Hassan A Al Shamahy*

Abstract

Background: Ig level assessment is often used in the diagnosis and follow up of immunodeficiency, as well as in studies investigate the prevalence of low serum levels in specific diseases.

Objectives: The main objective of this study was to determine the level of immunoglobulin in healthy infants and children in Yemen, to establish a national standard for immunoglobulin level among healthy children based on local data.

Methods:m Immunoglobulin concentration was estimated in 448 healthy children of both sexes of different age groups in Sana’a city. IgG, IgM and IgA serum immunoglobulins were determined by the commercial immunoturbidimetry method. The mean Levels ±SD, 95%CI, minimum, maximum and mode of immunoglobulins (Igs) were calculated and cross tabulation of significant variations were obtained by χ2 and p value.

Results: Four-point two percentage of children showed a high level of IgG, 78.6 % within normal level, and 17.4 % showed a low level. There was no one of tested children showed a high level of IgM, and 94.2 % of them were within normal level, and only 5.8% with low level. Also, 2.2 % showed high level of IgA, 57.6% within normal level and 40.2 % with a low level. The mean level of IgG for both sexes was 910±424mg/dl, while for males was 912±452mg/dl, and for females was 902±404mg/dl. The total mean level of IgM was 96.7±50mg/dl, for males was 96±56mg/dl, and for females was 97±41mg/dl and the variation between sexes was non-significant. The total mean level of IgA was 105±79mg/dl, for males was 98±76mg/dl, and for females was 112±82mg/dl, but the variation was non-significant. The mean values level of all immunoglobulins tested in this study were well correlated with age, where level increase with increasing age.

Conclusion: The study has provided useful information about the normal level of serum immunoglobulins concentration in infants and children, and the results can be taken as a reference values for Yemen. The serum IgG, IgM and IgA levels in most healthy children in our study were within normal range of the international standard, with mean value equal to that reported worldwide.

Keywords: Immunoglobulin; IgG; IgM; IgA; Normal Values; Infants; Children; Yemen

Introduction

Activated B cells differentiate into antibody-producing cells called plasma cells that secrete dissolved antibodies or memory cells that remain in the body for years afterwards in order to allow the immune system to remember the antigen and respond faster at future exposure. Immunoglobulin concentrations (IgG, IgM, and IgA) in sera for healthy children and infants in different age groups were measured and reported in several studies. It was believed to be very diverse among different nations due to environmental and genetic factors [1]. In Yemen, there was no study discussing this issue, and this is the first study of this type while other research studies have been conducted in Yemen to study HLA, immune status against bacterial and viral infections recently [2-6]. There is an important reason to know the concentration of immunoglobulin among children in Yemen as doctors need a precise age-normal range and ethnic-normal range of Igs, so they can diagnose primary immunodeficiency, some autoimmune disorders, HIV Syndromes and various isolated clinical conditions [1,7].

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Iris Publishers- Open access Journal of Pediatrics & Neonatal Care | Transfusion Management of a Patient with IgA Deficiency

Authored by Ranu Jain*

Abstract

Immunoglobulin (Ig) A deficiency is the most common primary immunodeficiency characterized by a decreased serum level of IgA in the presence of normal serum levels of other immunoglobulin isotypes. Patients with severe IgA deficiency may experience transfusion reactions when administered blood products that are not IgA deficient. There are complexities involved in organizing safe transfusion support, especially when the specific timing and transfusion needs of the procedure are unpredictable. While a history of IgA deficiency is certainly not a contraindication to surgical procedures requiring blood or blood product transfusions in the perioperative period, careful planning and a multidisciplinary approach are paramount in ensuring successful treatment as well as patient safety.

Introduction

Immunoglobulin (Ig) A deficiency is defined as the decreased serum level of IgA in the presence of normal serum levels of other immunoglobulin isotypes, IgG and IgM [1]. It is the most common primary immunodeficiency disease in patients greater than 4 years of age, with a reported frequency of 1/328 in the United States blood donors [2]. IgA is the most abundant antibody isotype produced in the body and it functions to protect against bacterial infections, especially in the pulmonary and digestive systems. While most patients who have IgA deficiency are asymptomatic, some patients develop allergies, recurrent sinopulmonary infections, chronic diarrhea, and lymphoid malignancies [1].

Patients with IgA deficiency, who have serum IgA levels less than 7mg/dL may experience transfusion reactions to blood products which often contain small amounts of IgA [3]. Transfusion reactions may range in severity from minor reactions with signs and symptoms such as; fever, urticaria, chills, and pruritus to severe reactions presenting with more serious symptoms such as anaphylaxis, high fever, hypotension, respiratory distress, organ failure, and even death [3]. The cause of transfusion reactions in IgA deficient patients has not been conclusively demonstrated, however some studies have extrapolated that these reactions are due to anti- IgA antibodies (IgG anti-IgA, IgE anti-IgA) [4]. IgA deficient patients requiring therapeutic transfusion or transfusion for major surgery must be screened caref

Discussion

Preoperatively, patients with known IgA deficiency should be screened by thorough history and physical exam for symptomology of IgA deficiency including; recurrent respiratory tract infections, pneumonia, otitis, asthma, allergies, recurrent gastrointestinal infections and recurrent urinary tract infections [5]. Ideally, these conditions should be optimized prior to surgery.

Because of the association between anti-IgA antibodies and transfusion reactions in IgA deficient patients, current guidelines recommend screening for IgA antibodies in all patients with severe IgA deficiency or in patients who have experienced a transfusion reaction to a blood product in the past [6].

IgA deficient blood products are regarded as the “gold standard” in treatment/safety for these patients. In cases where blood and cellular products from IgA deficient donors is not readily available, washed blood cells and cellular products can be used [4]. Washing red blood cells (RBCs) with 0.9% saline and cycling three times removes 99% of IgA content from the product, effectively making the RBCs IgA deficient [7]. Autologous blood donation is also an option if cell salvage is available. Platelet products can be similarly washed and suspended in crystalloid solution [4,8]. Cryoprecipitate and fresh frozen plasma (FFP) obtained from IgA deficient donors can be stored frozen for 1 year and thawed 24 to 72 hours [9]. The goal is to avoid IgA containing products in patients with severe deficiency.

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Iris Publishers- Open access Journal of Modern Concepts in Material Science | Brief Overview on the Application of Finite Element Method on Flat Rolling Processes

Authored by Antonio M Locci*

Abstract

The Finite Element Method (FEM) is a widely used method for the simulation of bulk forming. So far, the contribution of FEM has been significant in the field of flat rolling, making it an established and accurate approach for process simulation. This mini review highlights some of the typical applications of the FEM that have emerged throughout the years of FEM utilization.

Keywords: FEM; Rolling; Simulation

Introduction

Amongst forming, flat rolling processes consist most of the selected methods for all applied technical alloys and materials used in various applications. Flat rolling is a bulk forming process where a metal plate or strip passes through counter rotating rolls and deforms plastically to reduce its thickness. Complicated phenomena take place in the material and the mill during their interaction, which in turn have a significant influence on the quality of the final product. Many tools have been developed through the years that would help the engineers predict and, thus, control the process result. A very prominent and widely used computational tool is FEM. The FEM is a numerical technique that discretizes a complicated system into finite simpler systems (finite elements) and solves partial differential equations to approximate the solution. Considering the cost related to industrial trials, the use of FEM has gained great popularity amongst engineers. Figure 1 shows indicative results that are typically extracted when FEM is applied, such as the stress field during rolling, see Figure 1(a), and the calculated Force diagram, see Figure 1(b), which are usually also validated using industrial and/or laboratory/actual data.

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Iris Publishers- Open access Journal of Modern Concepts in Material Science | Estimation of Surface Roughness of Aluminum Reinforced Metal Matrix Composites

Authored by JO Hamed*

Abstract

This study has been designed to evaluate the surface roughness of an aluminum reinforced metal matrix composites produced by stir casting techniques at constant cutting speed of 1000 rpm, three (3) different feed rates at various aluminum weight ratio. Response surface methodology was adopted to formulate a surface roughness model in terms of metal matrix constituents such as aluminum, barite and zircon under three (3) different feed rate. The model adequacy was verified using analysis of variance. The increase in weight ratio of aluminum matrix reduces the surface roughness and vice versa. However, increase in barite, zircon weight ratios and feed rate increase the surface roughness. The F-values obtained at 95 % confidence interval revealed that the selected model adequately represent the data for the matrix composites. Therefore, the mathematical model developed is an effective tool for evaluating surface roughness.

Keywords: Surface roughness; Metal matrix; Composites; Feed rate; Stir casting

Introduction

In rocketry development, the temperature induced by the combustion process are of the order of 1000 °C to 3000 °C. However, when metals are continuously and plastically deformed at high temperature, both work hardening and annealing take place simultaneously, and creep in metals occur [1,2]. High temperature allows metal to deform more easily since atoms can move more freely, hence, greater movement of dislocations. Grain-boundary movement are also possible at higher temperatures [3]. Therefore, engineering alloys utilized at high temperatures is susceptible to creep as well as recrystallization and grain coarsening. In the case of age-hardened metals, over-ageing is feasible, which results in reduced hardness and strength due to the coarsening of the second phase precipitates. Furthermore, metals generally oxidize at high temperatures, thus experiencing creep problems [4].

Generally, The properties of a metal matrix such as high strength to-weight ratio, plasticity, capacity for crucial shape forming along with their ease for joining and good corrosion resistance have become increasingly focused for versatile applications such as design of armour structures, rocket, missile casing, light-weight defense vehicle, cars, and marine structures [5]. Also, varieties of metal matrix composites have been developed by manipulating the compositions and tailoring the fabrication technology to combats the inherent problem [6]. The requirements for producing high-quality matrix composites are inevitably associated with precision metal alloy design, innovative technology development in processing and enhancement of mechanical properties [7].

The development of an aluminum reinforced metal matrix composite is therefore a way to combat these problems and provide materials with enhanced mechanical properties. This is for example, the development of aluminum-barite-zircon matrix composites for aerospace and high-performance applications. Metal matrix composites (MMC) are new class of engineering materials which find its application in automotive, aircraft and defense mainly because of its improved property than alloys. There various matrix and reinforcement available out of which aluminum reinforced with ceramics particles finds to be important [8]. The particles are harder which improve the mechanical properties of the composites. The hard reinforcement makes the composites difficult to machine and get into required shape. Hence, the particles make the surface rough and increases tools wear. This discourage the use of metal matrix composite in many applications [9]. In order to overcome the difficulty, some amount of soft reinforcement material such as Barite, Zircon are added to form a hybrid MMC. The aluminumbarite- zircon MMC is easier to machine and shape into required specification [10].

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Iris Publishers- Open access Journal of Dentistry & Oral Health| Phototoxic Effect of Visible Blue Light on Porphyromonas Gingivalis and Aggregatibacter Actinomycetemcomitans

Authored by Hassan A Al-Shamahy*

Abstract

Background: Chronic gingivitis is a common disease, especially among adult patients who often develop periodontal pocket and the occurrence gradual loss of the periodontal attachment. A wide range of microorganisms is known to be associated with periodontal disease, including Porphyromonas gingivalis (Pg) and Aggregatibacter actinomycetemcomitans (Aa).

Objectives: Therefore, a study was conducted to determine the effect of phototoxicity of visible blue light (vBL) on Aa and Pg Clinical isolates from chronic periodentitis patients, and to study their antibiotic sensitivity against selected antibiotics. Methods: The test was carried out on 15 strains of Aa and 15 strains of Pg isolated from pockets of chronic periodentitis patients aged between 30-50 years old with pocket depths of 5-6mm. Bacteria cultured, isolated, identified by standard bacteriological methods, and then exposed to visible blue light for different periods of time. After bacterial cultures were exposed to light, bacterial killing rates were calculated from a colony forming unit (CFU) after 48 hours of anaerobic incubation.

Results: There was a decrease in CFU for both microorganisms and the result is increased with the increase of exposure to vBL, from zero, 20, 40 and 60 secs.

Conclusion: There was a phototoxic effect of visible blue light emitted by a light therapy device against anaerobic gingival pathogens and exposure to blue light is effective in reducing gum pathogens. It is recommended to use an adjuvant external optical enhancer and to expose pathogens to visible light for clinical antimicrobial treatment.

Keywords:

Blue light; CFU; Anaerobic periodontal pathogen

Introduction

PVL is a toxin produced by Staphylococcus aureus. It induces soft tissue breakdown and necrosis increasing the virulence of the associated microorganism. It is commonly associated with cutaneous abscesses and carbuncles however it can cause complications such as bacteraemia, septic arthritis and necrotizing pneumonia. This case reports discusses a clinical scenario where a patient attended to a maxillofacial unit with an infection to his lip, which was found to be PVL positive.The result of vBL in the 400-450nm range has been reported in a number of studies as it has been effective as a topical treatment for eczema and psoriasis and is assumed to help inhibit the immune response [1-3]. Studies have also shown improvement in facial acne when exposed to LED emissions at 414nm [4,5]. A combination of red and blue light exposure is used in clinical dermatological treatments [6,7]. Creators such as Philips are currently developing devices and technologies that emit a blue visible spectrum for use in the treatment of skin diseases [8-10]. The presence of blue light has also been reported in a number of studies that have been effective in killing bacteria associated with periodontal disease, such as Pg and Aa [11-13] Periodontal disease, also known as gum disease, is a group of inflammatory conditions that affect the tissues surrounding the teeth [14]. The disease start as acute tenderness of the gum tissue and untreated cases can develop to form dental pockets, and finally tooth death [14]. Wide group of microorganisms have been associated with periodontal disease, out of which Pg and Aa. Treatment of periodontal disease has long involved non-surgical cleaning of the gums under a procedure called “root surface instrumentation” (RSI), which causes mechanical disruption of the bacterial biofilms below the gums. It makes it difficult to completely remove bacterial deposits and biofilms from the root surface by mechanical methods [15]. Also, there have been many treatment options available to support the effectiveness of the instrumentation, such as the use of local antibiotics and antimicrobials-photodynamic therapy [16].

One of the problems that address the use of chemical agents is the failure to maintain therapeutic concentrations at the target site and the disruption of oral microflora [17]. Thus, photodynamic therapy (PTD) was introduced to open a new course in the treatment of periodontal disease without hindering the above obstacles and problems. An innovative non-antibiotic approach, the blue light antimicrobial in the spectrum of 400-470nm demonstrated its intrinsic antimicrobial properties resulting from the presence of endogenous photosynthetic chromophores in pathogenic microbes. Microbes are expected to be less able to develop resistance to blue light than conventional antibiotics, due to the multi-target properties of blue light (aBL) [11]. In addition, it is well accepted that aBL is less harmful to host cells than UVC irradiation. [12,13]. The objectives of this study were to determine the phototoxic effect of visible blue light on Pg and Aa isolates of chronic gingivitis patients, and to study their antibiotic sensitivity against selected antibiotics.

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Iris Publishers- Open access Journal of Otolaryngology and Rhinology | Single-Stage Drug-Induced Sleep Endoscopy, Nasal Surgery and Modified Barbed Soft Palatal Posterior Pillar Flap Palatopharyngoplasty for Treatment of Obstructive Sleep Apnea

Authored by Ahmed Mohamed Mohye El Din Elbassiouny*

Abstract

Objective: To investigate the overall efficacy of a single-stage surgical procedure based on localizing the site of anatomic obstruction with simultaneous combined nasal-palatopharyngeal surgery for the treatment of OSA.

Methods: A total of 35 consecutive OSA patients were enrolled in the study. All patients had OSA, were type I Fujita classification, stage 1 or 2 Friedman classification and had nasal septal deviation and inferior turbinate hypertrophy. Intraoperative drug-induced sleep endoscopy (DISE) was performed in all patients. Modified barbed palatopharyngoplasty with septoplasty and reduction of the size of inferior turbinate were used to correct the upper airway abnormalities. Baseline and 6 months postoperative overnight portable polysomnography was performed. Surgical results (Subjective symptoms improvement, reduction of OSA), patient satisfaction, complications were recorded. Surgical success was defined as a reduction of at least 50% in the preoperative apnea-hypopnea index (AHI) and a final AHI of less than 20 per hour.

Results: The Surgical success was 89% (31/35) of patients, 26 males, and 9 females. Snoring was improved with a snoring scale reduced from 9.4±2.8 to 1.07±0.3 (p<0.0001). The nasal blockage was improved with the nasal Obstruction Visual Analog Scale from 8.6±1.3 to 0.57±0.2 (p<0.0001). The Epworth Sleepiness score (ESS) was decreased from 8.9±1.3 to 1.11±0.2(p< 0.0001). The pre-operative to post-operative AHI statistically improved from 38.4±23.3 to 12.3±21.1 (p <0.0001) and lowest O2 saturation from 73.9±12.6% to 87.8±9.4%(p<0.001). There were no significant complications. All patients were satisfied with the single-stage treatment.

Conclusion: Our data indicate that Single-staged modified barbed soft palatal posterior pillar flap palatopharyngoplasty with nasal surgery is a safe, effective. It has the potential to serve as an effective alternative for the staged surgery without adding to the cost-effectiveness in terms of total hospitalization.

Keywords: Single stage; Nasal surgery; Palatopharyngeal surgery; Drug induced sleep endoscopy; OSA

Introduction

Obstructive sleep apnea (OSA) is a disorder caused by the repetitive collapse of the upper airway during sleep that may occur at any level including the nasal cavity, nasopharynx, oropharynx, and hypopharynx, and may be either single-level or multilevel. Data from observational studies suggest that nasal obstruction contributes to the pathogenesis of snoring and OSA [1]. In most studies, nasal obstruction is partially related to the development | or aggravation of OSA [2,3]. Nasal obstruction is related to OSA in several ways:

1. Increasing upper airway resistance as nasal obstruction can cause an increase in negative pressure in the upper airway and induces an inspiratory collapse at the pharyngeal level.

2. Patients become mouth breathers during sleep, which destabilizes the upper airway and aggravates sleep-related breathing disorder.

3. Interferes with the nasal reflexes that stimulate ventilation [4].

Data on OSA patients treated for nasal obstruction alone has shown consistent improvement in subjective symptoms such as daytime somnolence and snoring despite a minimal change in their sleep study results [5]. However, in other words, the effect of nasal surgery alone in sleep-disordered breathing (SDB) with nasal obstruction is controversial [6,7]. Nasal surgery alone has also been shown to significantly improve CPAP tolerance and adherence [8].

Obstruction at the level of the soft palate, pharynx, and tonsillar pillars is a more common finding in patients with snoring and OSA. These sites are the focus of many of the surgical procedures traditionally labeled phase I therapies. Soft palatal procedures serve to reduce or reconstruct the collapsible portions of the soft palate. Recently, there has been a paradigm shift within the field of sleep surgery in recent years with an emphasis on mucosalsparing reconstruction of the soft palate rather than ablation [9]. Surgical management of retropalatal airspace obstruction now focuses on the concept of lateral pharyngeal port opening [10- 12]. The complete lateral oropharyngeal collapse was significantly associated with increased severity of OSA. The complete concentric collapse of the velum and complete lateral oropharyngeal collapse were associated with higher BMI values [13].

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Iris Publishers- Open access Journal of Otolaryngology and Rhinology| Neck Metastasis from A Papillary Thyroid Cancer with no Detectable Primary Tumor in Thyroid-Case Report and Current State

Authored by Andres Ignacio Chala*

Abstract

Neck metastasis from a differentiated thyroid cancer with no detectable primary in the thyroid gland is rare, with few cases reported in the literature. Due to this there is no clear consensus about its etiology, treatment or prognosis. A new case in 41-year-old women with a 3cm neck metastasis is presented, she had a cystic metastasis from a papillary thyroid carcinoma with no detectable primary despite a meticulous clinical and imaging inspection. Even after surgery the primary tumor couldn’t be found on the thyroid gland. She had surgery and Iodine therapy. During active surveillance a central neck compartment recurrence was detected requiring surgery. A complete revision of literature shows only 9 cases reported; the theories about its origin are not clear. It seems to have as good prognosis as its counterpart with primary found in the gland.

Keywords: Unknown primary; Thyroid cancer; Neck metastasis cancer; Papillary thyroid cancer

Introduction

Thyroid cancer is the most frequent endocrine tumor of the head and neck. Most of them are papillary thyroid cancer with an incidence of neck metastasis between 20 to 60%, most of them located in the central compartment. At least 30% will have a concurrent lateral neck metastasis (level II to V) or a recurrence in the lateral neck during the follow up. It is frequent to come upon an asymptomatic cystic lateral neck metastasis from a papillary thyroid cancer usually with no clinical tumor in the thyroid gland. With the increasing and improving in resolution of thyroid ultrasound, even microscopic thyroid nodules can be found, so the identification of the primary in the thyroid usually is a not a big challenge. Small nodules up to 3-5 mm can be responsible of a lateral neck metastasis. Fine needle aspiration biopsy (FNAB) is being used as the main method to obtain enough cytological sample in the metastatic node and in the thyroid nodule to do the diagnosis. Some other studies as CT scan or MRI are usually unnecessary and only done if the preoperative plan changes. A PET CT in these cases are not required since the primary is identified in the thyroid. Some cases when the FNAB is insufficient may require a trucut or even an open biopsy to obtain tissue. The initial treatment is a total thyroidectomy with a comprehensive neck dissection. There are few cases reported in literature presented with a neck metastasis from a thyroid cancer with no primary identified in the thyroid neither by ultrasound nor by a pathological exam of all the thyroid excised gland, so this clinical case is another contribution to this strange tumor behavior.

Case Presentation

A 41-year-old female attended at the head a neck service with a right lateral neck node level II. She noticed it for the last year, but only recently was aware due to the progressive growing. She did not refer weight loss, dysphagia, or dysphonia. Physical evaluation revealed neck nodes between 1-3cm in level II with no fixation and with no thyroid palpable nodule. Fiberoptic Larynx evaluation was completely normal. She has no risk factors nor radiation history. Blood thyroid test was normal. (TSH: 1,5 ui/ml). Neck ultrasound showed a round cystic and solid lymph node in level II size 2.7cm (Figure 1) and three additional suspicious round neck lymph nodes with microcalcifications levels II and III between 1-3cm. A complete and accurate ultrasound of the thyroid gland was performed finding a normal gland with no nodes (Figure 2). A FNAB was perform on the level II node identifying irregular cells with clear nuclei, nuclear clefts and fine chromatin suggestive of papillary carcinoma metastatic to the lymph node (Figure 3). A Ct scan showed similar findings to the ultrasound and the chest Rx was normal.

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Iris Publishers- Open access Journal of Forensic Science & Medicine | Rare Disease: Impact on Development of New Drug Treatments

Authored by Fizza Batool*

Abstract

Background: Low prevalence, lack of knowledge about the disease course, and phenotype heterogeneity hamper the development of drugs for rare diseases. Rare disease registries can be helpful by playing a role in understanding the course of the disease, and providing information necessary for clinical trial design, if designed and maintained properly. We describe the potential applications of a rare disease and what type of information should be incorporated to support the design of clinical trials in the process of drug development supported a broad inventory of written record expertise. We evaluated two existing Rare disease in more detail to check the completeness of these Rare disease for trial design.

Results: Before and during the application for regulatory approval rare diseases can improve the efficiency and quality in clinical trial design by informing the sample size calculation and expected disease course. In exceptional circumstances information from rare diseases has been used as historical controls for a one-armed clinical trial, and high-quality rare diseases may be used for registry-based randomized controlled trials. In the post marketing phase of (conditional) drug approval disease-specific rare diseases is likely to provide more relevant information than a productspecific registry.

Conclusion: A rare disease registries can be very helpful to improve the efficiency and quality of clinical trial design in several ways. To alter the pertinence and optimum use of rare un-wellness longitudinal information assortment is indispensable, and specific data collection, prepared for repeated measurement, is needed. The developed listing will facilitate to outline the suitable variables to incorporate. Attention should be paid to the inclusion of patient-relevant outcome measures in the rare diseases from the start. More research and experience is needed on the possibilities and limitations of combining rare diseases information with clinical trial data to maximize the availability of relevant evidence for regulatory decisions in rare diseases.

Abbreviations: Asterix: Advances in tiny Trials style for regulative Innovation and excellence; CDE: Common data elements; CHMP: Committee for medicinal products for human use; DIPG: Diffuse intrinsic pontine glioma; ECFS: European Cystic Fibrosis Society; EPAR: European Public Assessment Report; ERN: European Reference Network; FDA: US Food and Drug Administration; FEV: Forced expiratory volume; ICHOM: International Consortium for Health Outcomes Measurement; RCT: Randomized controlled trial; RDR: Rare disease registry; VOD: Veno-occlusive disease

Introduction

In rare illness the clinical development of effective medicine is difficult because of low prevalence of the disease and sometimes sizable composition heterogeneousness. The small numbers give limited opportunity for confirmatory clinical trials, as it is difficult to recruit enough patients. For much rare illness the disease course is insufficiently identified, resulting in uncertainties with relevancy the optimum run style, including choice of endpoints, for a new drug. Even if the endpoints are clear, there is often insufficient information about their occurrence - in case of binary endpoints-, or distribution - in case the endpoint is a continuous variable. This lack of information, combined with heterogeneity, has consequences for the efficiency of preparing and designing a clinical trial. More specifically, assessing the practicableness of a shot, which is directly connected with robust sample size calculations, becomes a difficult task. When the sample size is calculated based on limited information, this increases the risk of under- or overestimation of the sample size, and possibly a failed trial [1]. Furthermore, such scarcity of information can have considerable impact on the regulatory process and evaluation of the available evidence for the risk/benefit assessment of a new drug, and possible market authorization.

In this respect rare diseases can be an invaluable source of information. With an estimated number of 5000–7000 distinct rare diseases, in Europe over 700 rare diseases are active for a similar number of rare diseases. Rare diseases can give insight in the natural history of the disease and the variability of the patient population. The decision to start rare diseases is often made at a stage when the available information about the rare disease is still scarce, and the development of a treatment might lie secluded within the future. Even in such an early phase, it is important to be aware of and prepared for all possible future functions of the information contained in the rare diseases; the identification of relevant endpoints or the use as a data source for the design of a therapeutic clinical trial are two notable examples. Therefore, rare diseases should be designed in such a way that all relevant information is incorporated and can be used most efficiently. The term ‘registry’ will denote any form of information assortment. However, not all information collections that are given as illness registries are appropriate for run style or as further info for restrictive analysis. Several types of registries can be distinguished, and there is no consensus on the nomenclature and classification.

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Iris Publishers- Open access Journal of Forensic Science & Medicine | Collecting and Preserving Procedures of Electronic Evidence: Analysis of Qvod Player Case in China

Authored by Yiyang Cao*

Abstract

Electronic evidence is a new type of evidence emerged in this information society, which challenges modern evidence collecting and preserving. There are two main disputes in Qvod Player Case, one is extraction of electronic evidence, the other is the identification process of collecting electronic evidence. Qvod is a peer-to-peer video-streaming platform, which provided a way for users to watch mostly pirated video and pornography online. In the Qvod Player case, the dispute between the prosecution and the defense mainly focused on the relevance, authenticity, and legitimacy of electronic evidence collected from four servers and obscenity videos. The debate on extraction of electronic evidence focuses on the legitimacy of third-party assistance, the timeliness and the integrity of electronic evidence extraction. The identification problems of electronic evidence are as follows: the qualification of the examiner and the procedure of the identification. This essay will try to analyze the pros and cons of Qvod Player case and explore the ways to promote the ways of collecting and preserving procedures of electronic evidence, which makes the evidence more convincing.

Keywords: Electronic evidence; Qvod player case; Forensic science; Evidence Collection

Introduction

Recently, in the big data era, with the widespread usage of the internet, various new types of criminal activities are emerging. The proliferation of the internet brings out new challenges and opportunities in forensic science theoretically and practically. Due to the complicated characteristic of the internet world and lack of relevant laws and regulations, collecting and preserving electronic evidence has become a hotly debated topic after the case of Qvod Player. On January 7, 2016, the Beijing Haidian District Court heard the case of Shenzhen Qvod Player (Kuaibo) Technology Co., Ltd (hereinafter referred to as Qvod Player Company). Qvod Player Company was suspected of making, copying, publishing, selling, and distributing obscene videos to obtain profit. In the course of the trial, there was a big dispute centering on the authenticity and legitimacy of electronic evidence. The defendant and the prosecution had a fierce cross-examination due to the extraction of electronic evidence. The debate centers on the following aspects:

1. The originality and integrity of evidence collected from the four servers has been influenced.

2. The seizure and search procedure of the four servers does not match legal provisions.

3. There is a high possibility that the evidence may be contaminated in the transfer of evidence and should be ruled out.

4. The evidence procedure of collecting, opening, and identifying electronic evidence is illegal. This paper aims at exploring some ways to promote the development of electronic evidence collection in China.

Case Report

The defendant Wang Xin is the legal representative and CEO of Qvod Player Company. The Co-defendant Wu Ming is the manager, Zhang Kedong is the deputy general manager and technology platform of Qvod Player Company. In December 2007, since the establishment of the Qvod Player Company, this company has provided a network for users by releasing free QVOD Media Server Installer (hereinafter referred to as QSI) and player software to the Internet. During the period, the supervisors of Qvod Player company, Wang Xin, Wu Ming, Zhang Kedong, who knew their QSI and player software were used for broadcasting, searching, and downloading obscene videos for profit, they still turned a blind eye to these behaviors, resulting in a large number of obscene videos spread on the Internet.

On November 18, 2013, Beijing Haidian District Cultural Committee seized 4 servers hosted by Qvod Player company from Beijing Netlink Guangtong Technology Co., Ltd. (hereinafter referred to as Guangtong Company) located in Haidian District. Having extracted 29, 841 video files from the above three servers for identification by the Beijing Municipal Public Security Bureau, 21,251 of which were confirmed to be obscene videos. According to the provisions of Article 365, Article 366, Article 30 and Article 31 of the Criminal Law of the People’s Republic of China, Wang Xin, Wu Ming, and Zhang Kedong should be convicted and sentenced respectively [1]. In the first instance of this case, due to the live broadcast of the court, the arguments and evidence of this case aroused the attention of the public.

The judgment of this case has won praises from all walks of life. However, this case also illustrates that some difficulties in collecting and preserving electronic evidence in China. There are three aspects of problems in this case in judicial practice: the extraction of electronic evidence, the identification of electronic evidence and the authenticity of electronic evidence. In this case, the disputes on extraction of electronic evidence mainly centers on the legitimacy of third-party assistance, timeliness, and integrity of electronic evidence extraction. Firstly, the legitimacy of third-party assistance is not guaranteed. The extraction of electronic evidence cannot be verified, which directly determines whether the data collected from the four servers can be used as electronic evidence.

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