Videx EC

", medicine to reduce swelling."

By: Richa Agarwal, MD

  • Instructor in the Department of Medicine

https://medicine.duke.edu/faculty/richa-agarwal-md

It may display small cysts , which rupture forming small granulomata , and this is also true in the desmoplastic variant . Trichilemmoma (Incorrect) Outer root sheath differentiation with pallid keratinocytes is the hallmark of this tumor , which is often small, lobular to papillated, and displays peripheral palisading of nuclei and a thickened basement membrane. In panfolliculoma, it labels the germinative cells but not the follicular papillae. Clinical features Panfolliculoma may present as a skin-toned to red, dermal or cystic-appearing nodule, often on the head or trunk, in patients from the 2nd to 6th decades. This benign follicular tumor displays differentiation towards all elements of the hair follicle, including infundibular, isthmic, inner and outer root sheath, and matrix. As such, infundibular cysts, follicular germs, trichohyaline granules, pallid keratinocytes, matrical cells and shadow cells may be encountered in varying amounts in such tumors, and in a variable arrangement. It may display a lobular contour, and in rare cases such as this one, may be cystic. An epidermal variant has also been described, in which all follicular elements are present in a papillated epidermis in a more plaque-like configuration. When the patient presented for complete excision, the lesion was noted to be a deep subcutaneous lesion with no dermal connection, mimicking a lymph node. Dermatofibroma (Incorrect) While this proliferation is also composed of spindle cells, other cells such as foamy siderophages may be present. It assumes a nodular contour in the dermis that blends into the dermis amongst thickened collagen bundles. It may also display associated epidermal hyperplasia, basilar pigmentation, and many other variable features, such as hemorrhage and folliculosebaceous induction. Schwannoma (Incorrect) these are also circumscribed tumors, but a zonal pattern is usually present, with cellular areas that may contain palisaded nuclei enclosing Verocay bodies (Antoni A), and less cellular areas containing a loose stroma with foamy cells (Antoni B). Spindle cell lipoma (“low fat” variant) (Incorrect) this tumor may or may not be circumscribed, and while also containing spindled cells, there are usually admixed adipocytes and some myxoid changes, as well as interspersed ropey collagen. In a representative sample, this tumor typically displays a storiform pattern, is infiltrative, effacing normal adipose tissue around adnexa, and involves the subcutis in a “honeycomb” pattern. S-100 protein (Incorrect) Schwannoma is in the differential diagnosis, and would label with this marker, as would some other neural tumors one might consider. These are considered biologically “borderline” neoplasms, with some cases of local recurrence, distant metastasis, rarely, at non-cutaneous sites. From 1997-2007 Only 11 additional cases were described, one “malignant” (invasive to bone, dura). This tumor when found in the skin, occurs mainly in adults, with rare pediatric cases. A dermal or subcutaneous nodule or plaque is often described, with the size not well-documented. Nonetheless, because of some lingering uncertainties as to the biologic behavior of this tumor, the recommended treatment is complete excision. Histologic features this spindle cell proliferation often assumes a so-called “patternless pattern”, and may contain irregular vessels (“staghorn”). Variants more often described in the pleural tumors, bur sometimes seen in skin tumors, include solid-spindle cell, diffuse sclerosing, fascicular, storiform, herringbone, angiofibromatous, epithelioid, hemangiopericytoid, synovial sarcoma like, and palisading. Solitary fibrous tumors of the skin: a clinicopathologic study of 10 cases and review of the literature. Diagnostically challenging spindle cell lipomas: a report of 34 “low fat” and “fat-free” variants. Many such devices contain hydrophilic polymer gel coatings that help to limit vascular spasm and increase maneuverability. Introduction of foreign material into the vasculature carries a risk of embolization and ischemic sequelae. Iatrogenic embolization of hydrophilic polymer coating has been reported, with complications ranging from pulmonary infarction, stroke, and gangrene to death. Hydrophilic polymer gel has a characteristic appearance on immunohistochemical staining and has been identified in biopsy samples and autopsy tissues from various organs. Cutaneous lesions are usually unilateral, involving most commonly lower extremities. Clinical presentations include asymptomatic livedo racemosa and purpura, usually occurring several hours postoperatively. Histologically, diagnosis can be confirmed by pauci-inflammatory occlusion of small superficial and mid-dermal vessels with pale basophilic to lavender lamellated material and dermal hemorrhage, consistent with the morphology of hydrophilic gel polymer emboli. The cutaneous lesions can occur with or without internal organ involvement, and the skin lesions usually resolve spontaneously. Spiradenocarcinoma does not show features of matrical differentiation, such as shadow cells. Squamous cell carcinoma does not show features of matrical differentiation, such as shadow cells. While pilomatricoma can show numerous mitotic figures, the widespread pleomorphism, diffuse infiltration and necrosis do not fit with a benign diagnosis. Pilomatrix carcinoma often shows shadow cells, matrical differentiation, mitotic activity, pleomorphism and diffuse infiltration. Porocarcinoma does not show features of matrical differentiation, such as shadow cells. Nuclear and cytoplasmic labeling of which protein is typical of pilomatrix tumors

The Optical Encoder for motor commutation and position feedback is mounted to one side of the Drive Unit Housing . Bearing material is stainless steel 440 C equipped with phenolic resin cages , lubricated with Fomblin Z 25 . The motor has independent stators so to provide redundancy and to allow adjustment of the two stators in rotational direction with respect to each other. This feature was included in order to further optimize the system in view of the high required velocity constancy. By rotational adjustment of the redundant stator with respect to the main stator, an additional minimization of the overall detent torque could be realized. Motor commutation and position feedback to the controller is provided by an optical 17-bit encoder in redundant configuration. Alignment cube Scanning shaft Scanning shaft Drive Unit interface provides Housing Reflector alignment provision Encoder Drive Unit interface to Base Blate Figure 7. This value was exceeded by splitting the manufacturing process into several individual sub tasks at different specialized suppliers. The coordination of the related tasks was followed and closely supported in order to minimize the technical and subsequent programmatic risks. It has linear power stages for extremely accurate, wide-bandwidth and high precision tracking control. The power stages are linear (non-switching) and are designed to operate at 27V and at a peak current of up to 2A. These power stages possess two current sensors in the output phases to support full sine-wave commutation, which ensures optimum torque and velocity control characteristics. The use of linear power control and precise control of the operational current guarantees an excellent performance at low drift, high bandwidth and high linearity. In addition there are two enable and status signals for each of the redundant power stages and encoder feedback channels. Specific Development and Test Issues Mass and Inertia Minimization of Welded Baffle In order to achieve the required scan performance (minimum time between the operational points which are earth scan, cold and hot calibration), the system had to be designed for maximum acceleration capability. Since the available torque is limited by the available motor power, the moment of inertia of the rotating part of the mechanism had to be minimized. However, for thermal reasons a cylindrical thermal baffle (“barrel”) surrounding the Reflectors was needed in order to keep the Reflector temperature as stable as possible. The thermal baffles (two of them) provide significant contribution to the overall moment of inertia and its mass and radius had therefore to be minimized. Consequently the baffle was designed as a very thin walled structural cylinder (1-mm wall thickness) manufactured out of a bent aluminium plate and stiffened up by means of a radial ring at its one end (close to the Front Ends). The other end of the baffle was attached via screws to a circular plate attached between Drive Unit and Antenna Reflectors (see Figure 8). During vibration testing, a failure of the electron weld seam was identified, so that a re-design of the thermal baffle was necessary. In order to solve the issue, it was decided to manufacture the Baffle structure in a sophisticated manufacturing process from one piece of aluminium so to avoid any welding seams and the critical welding process (Figure 9). The subsequently repeated vibration test was successfully passed without any problem. Thermal Baffles Manufactured as Monolithic Structure (Originally Welded) Minimization of Motor Detent Torque According to the requirement, a maximum scan speed error of 1% shall realized. However, due to the fact that the motor detent torque plays also an important role in achieving good velocity stability, additional measures to reduce the detent torque were identified. An overall detent torque of up to ±25 Nmm was expected on basis of analysis for the two stators. It was found that by rotation of one of the two stators by half a stator slot pitch (corresponding to 2. This design feature was consequently included into the design to further optimize for minimum velocity disturbances. Minimization of Motor Detent Torque Alignment Concept Based on the existing tolerance chain between Drive Unit and Base Plate, Drive Shafts and Reflector and between Base Plate and Feed Horn (Mounting Brackets), the implementation of a suitable alignment concept was mandatory in order to fulfil the pointing and performance requirements. In order to cope with the schedule constraints during the integration and test phase, it would have been favorable to avoid as far as possible a time intensive alignment concept. For example, concepts using in situ shimming and adjustment of the individual components during the integration and test process are time and effort intensive. Therefore, two alignment alternatives were discussed in this context: one was to manufacture the relevant mating parts with sufficiently high accuracy in order to avoid shims wherever possible. This alternative was found not to be adequate, since the involved tolerance chains did not allow to manufacture the individual parts with sufficiently high precision without high additional effort. The second alternative was to provide active adjustment and alignment provisions already by design, so to allow alignment by means of suitable adjustment screws after integration. This alternative was skipped due to the fact that it added high design complexity, imposed stiffness and load capability limitations and would have increased mass and moment of inertia. Therefore it was decided to go for a conventional shimming approach and to adjust first the Reflectors about two axis in the interface between Drive shaft and Reflector and then to shim the feed horn support structures with respect to the Reflectors. The correct Reflector alignment with respect to the feed horn was supported by using Reflector best fit analysis data as an input for the 3D measuring machine during the reflector alignment process. A zero referencing possibility in rotational direction was additionally implemented in the electronics command interface in order to allow for compensation of rotational misalignment of the Reflectors between the S/C mechanical and electrical zero. The observed phenomenon was a randomly occurring incorrect start command execution of the scanning function after switching from the redundant to the main path. After detailed check of the electronics function and also of the mechanism integrity, the detailed root cause investigation led to the suspicion that the error must be produced by the power supply used during equipment test. It was proven by test, that the probability to reproduce the random error was depending on the actually used power supply unit. Therefore the power supply characteristics were investigated in detail and it was found that the encoder supply voltage (5 V) provided to the encoder had a rise time of >20 ms.

The following subsections will describe the design , application , and functionality of these features . Sub-Mechanism Distribution Mechanism Sub-Mechanism Chassis • Power Bus Structure • Ballast Plate Release • Dyneema Cutter • Release Panels Deployment • Hinge • Array Panel • Scissor System • Rotary Damper Ballast Plate Release Panel Array Panel Hinge and Locking Latch Scissor Structure Rotary Damper Primary Scissor Joint Power Bus Structure Figure 3 . As a result, the custom design of each focuses on the versatility and machinability of the structure. The power bus idealizes this criterion in the design of the structure and internal space. It houses the release mechanisms, batteries, and power board, and also serves as the attachment between the payload bus and the array system. With connections to a variety of components that are either unknown or constantly changing in design, the layout of the bus will also need to change. The individual panels are simple to machine, allowing single panels to be removed and modified without impact to the rest of the design. Additionally, removable panels permit easy access during assembly, integration, and testing. Finally, the solid aluminum posts allow for a continuous surface for mounting internal components. The amount of mass is dependent on the geometry and mass distribution of the array and payload according to the gravity gradient stabilization theory described in the Simulations section of this paper. Exploded View of the Power Bus Showing Removable Panels and Mounting Posts Release Mechanism the release mechanism is composed of two hinged release panels and a cutter system. Motivations for the design and integration of each feature focus on low cost, low profile, and high reliability. It is composed of 4 metal film resistors wired in parallel and a single line of Dyneema wire. Each length then rests against two resistors mounted to the top surface of the bus. To deploy the release panels, an on-board 9-V source is shorted across the resistor circuit. The resulting heat generated by the resistors cuts the wire allowing the release panels swing to open. Additionally, with the placement of the panel attachments and positioning of the resistors, the entire system requires a fraction of the available volume within the bus. Furthermore, the use of redundant resistors and Dyneema was implemented on the Delphi C3 nanosat mission [12] to deploy its solar arrays, proving the reliability of the inexpensive system. Each panel is composed of a custom formed aluminum sheet and a single spring hinge. The geometry of the panels fully constrains the stowed array with minimal impact on the array panel dimensions. The side ribs will be referred to as ribs 1 and 2, and the bottom rib will be rib 3. Ribs 1 and 2, and the lower portion of each panel fit within recessed areas on the power bus. Once the system is released the spring hinge quickly rotates the release panels to the ballast plate. This prevents any interference with the deployment sequence of the array and also adds additional mass the ballast plate. The panels are also designed to protect the solar array mechanisms and structures while stowed. According to standard CubeSat requirements, the rails must cover at least 75% of the CubeSat length [5]. Release Panel Geometry and Constraint Method Deployment Mechanism the deployment mechanism is made up of the hinge system, array panel structure, scissor system, and rotary damper. Each sub-mechanism is inspired from simple known concepts that have been creativity applied to the CubeSat geometry. The hinge system is a compound mechanism that passively controls, deploys, and locks the solar array at each panel joint. The challenge was minimizing the vertical height of each compound hinge within the stowed 10cm length, as the height determined the number of solar panels in the array. The original design concept (Figure 6a) employed separate spring, damping, and locking hinges. As a result, this arrangement would need custom designed components, which proved prohibitively expensive. While stowed, these teeth rest on the outside of the hinge barrel, which pretensions the latch arms. During deployment, the teeth ride along the outside of the rotating barrel until they fall into slots machined into each hinge. Hinge Design Evolution the scissor system manages the orientation of the array during the deployment sequence. The structure coordinates a consistent deployment of each array panel and is fastened to only one side of the array, minimizing losses to the array panel area. To control this vertical motion, the final joint connection slides within a channel cut into the bus panel wall. As a result, the joint does not impact the geometry of the array and has minimal impact on the volume within the power bus.

Syndromes

  • Are a young adult under peer pressure
  • Hemorrhage (excessive bleeding)
  • Muscular dystrophy - resources
  • Spasms
  • Outward-turning leg
  • Lotion or steroid cream on the area to calm itching and irritation
  • People with risk factors for colon cancer, such as ulcerative colitis, a personal or family history of colorectal cancer, or a history of large colorectal adenomas may need a colonoscopy more often.

A number of im ease was shorter than that for anti-Ro , anti-La , anti portant lessons are clear from these observations . The estimates of time pro vided by this study are biased by the substantial pro Normal Benign Pathogenic Clinical portion of patients (69 percent) whose data were Immunity Autoimmunity Autoimmunity Illness censored because autoantibodies were present in the first available serum sample (obtained a mean of four years before the diagnosis) . If serum samples obtained before the development of autoantibodies Environmental factors had been available for all patients, our estimates of the mean time from autoantibody development to Figure 3. Consequent Normal immunity progresses to benign autoimmunity through the influence ly, this study provides a lower-boundary estimate of of genetic composition and environment. Later, benign autoimmunity pro the time before the diagnosis at which particular au gresses to pathogenic autoimmunity. In the second in our study); however, their presence does not sug phase, benign autoimmunity, there is a laboratory gest that the onset of clinical illness is imminent. The 129, but this rate was 40 times as high as that among anti-Sm response, for example, appears to be elicit subjects without rheumatoid factor. The respons prospective data from persons with positive tests for es to the first few additional epitopes follow a spe diabetes-associated autoantibodies showing that 70 cific sequence of immune structural recognition. Christie Burgin, Don Parker, and Chris Aston for statistical assistance; and to Kimmie isolated immunologic events, and that spread and Kohlhase and the cooperating military rheumatologists and rheu multiply until they are manifested as a potentially matology clinics for case identification. Philadelphia: Lippincott Williams & Wilkins, toantibody in normal sera for autoimmunity. Anti-Sm autoantibodies in ical profiles of 91 patients followed for at come of mothers of children with isolated systemic lupus target highly basic surface least 1 year. Ann N Y Acad Sci 1975;254: come of mothers and characterization of the Prediction and diagnosis of type 1 diabetes 505-15. Serologic markers of disease activity autoimmune disease after peptide immuni al. The product is indicated in adults for: Rheumatoid arthritis Systemic lupus erythematosus Discoid lupus erythematosus Dermatological conditions caused or aggravated by sunlight Prevention and treatment of uncomplicated malaria caused by Plasmodium vivax, P. This national procedure concerns a generic application claiming essential similarity with the innovator product Plaquenil 200 mg film-coated tablets which has been registered in Denmark by Sanofi-Aventis Denmark A/S since 5 May 1958. The excipients are: Tablet core – maize starch, calcium hydrogen phosphate dihydrate, silica colloidal anhydrous, polysorbate 80, dried maize starch, talc and magnesium stearate. Tablet coating hypromellose 2910, macrogol 6000, titanium dioxide (E171) and purified talc. Hydroxychloroquine sulphate is freely soluble in water and practically insoluble in ethanol (96%) and ether. The drug substance is not hygroscopic and the same polymorphic form is manufactured consistently. Manufacturing process the manufacturing process consists of two synthesis steps followed by a salt formation and a salt transformation. This is regarded to be sufficient to ensure full control of the quality of the final substance and is therefore considered suitable. Quality control of drug substance the active substance specification is considered adequate to control the quality. Batch analytical data demonstrating compliance with this specification have been provided for three commercial scale batches. On the basis of the stability data the claimed retest period of 60 months without temperature restriction can be granted (preserve in well-closed, light-resistant container). Several development formulations were tried in order to obtain a tablet with comparable dissolution characteristics as the reference product Plaquenil. The test batch shows deviating dissolution characteristics compared to the reference product at pH 1. The possible reasons for the observed discrepancies in the in vitro dissolution between test and reference product have been addressed and justified. Manufacturing process the manufacturing process consists of mixing, granulation, sifting and sizing, drying, lubrication, compressing, film-coating and packing. Process validation data on the product have been presented for six batches, three with the minimum commercial batch size and three with the maximum commercial batch size, in accordance with the relevant European guidelines. Quality control of drug product the finished product specifications are adequate to control the relevant parameters for the dosage form. The specification includes tests for appearance, identity, assay, average weight, related substances, dissolution, uniformity of dosage units, and microbiological quality. Limits in the specification have been justified and are considered appropriate for adequate quality control of the product. Batch analytical data from six batches, three with the minimum commercial batch size and three with the maximum commercial batch size, from the proposed production site have been provided, demonstrating compliance with the specification. The proposed shelf-life of three years, when stored in the original package in order to protect from light, is justified. It can be concluded from the study that the drug product is photo-stable in the proposed packaging. Sufficient controls have been laid down for the active substance and finished product. A non-clinical overview on the pharmacology, pharmacokinetics and toxicology has been provided, which is based on up-to-date and adequate scientific literature. The overview justifies why there is no need to generate additional non-clinical pharmacology, pharmacokinetics and toxicology data. The choice of the reference product in the bioequivalence study has been justified.

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