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Peto, R., and Baigent, C. Trials: The next 50 years. Large scale randomised evidence of moderate benefits. BMJ, 317: 1170-1171, 1998. Peto, R.; Collins, R.; and Gray, R. Large-scale randomized evidence: Large, simple trials and overviews of trials. Journal of Clinical Epidemiology, 48 1 ; : 23--40, 1995. Sackett, D.L.; Richardson, S.; Rosenberg, W.; and Haynes, R.B. Evidence-Based Medicine: How to Practise and Teach EBM. London, U.K.: Churchill-Livingstone, 1997. Sackett, D.L., and Wennberg, J.E. Choosing the best research design for each question. BMJ, 315 7123 ; : 1636, 1997. Schwartz, D., and Lellouch, J. Explanatory and pragmatic attitudes in therapeutic trials. Journal of Chronic Diseases, 20: 637-648, 1967. Shekelle, P.G.; Woolf, S.H.; Eccles, M.; and Grimshaw, J. Clinical guidelines: Developing guidelines. BMJ, 318 7183 ; : 593-596, 1999. Smith, R. The failings of NICE. BMJ, 321 7273 ; : 13631364, 2000. Streiner, D.L., and Geddes, J.R. Intention to treat analysis in clinical trials when there are missing data. Evidence-Based Mental Health, 4: 70-71, 2001, for instance, premphase side effects.
According to the The World Health Organization WHO ; , preterm labor PTL ; is defined as labor starting before 37 complete weeks of gestation and with intact fetal membranes WHO 1977 ; . Preterm delivery PTD ; or preterm birth is defined as the birth of a baby before 37 completed weeks of gestation. Rupture of the fetal membranes before the onset of labor is called premature rupture of the fetal membranes PROM ; . Using the word preterm less than 37 weekgestation ; PPROM ; or term more than 37 weeksgestation ; before PROM indicates the presence or absence of fetal maturity at the time of the complication Romero et al. 1999 ; . Traditionally, pediatricians have defined prematurity as a birth weight of 2, 500 g or less; and it is also commonly known as low birth weight LBW ; Schlesinger and Allaway 1955 ; . This list of definitions has been further expanded with the term "very preterm birth" Keirse 1989 ; , or "very low birth weight" VLBW ; which means the birth of a baby before 32 weeks of gestation or at a weight of 1, 500 g or less. "Extremely low birth weight" ELBW ; or "very, very low birth weight" 1, 000 g or less ; also are terms used, and in the literature has also been used the term "incredibly low birth weight" 750 g or less ; Amon 1999 ; . Not all preterm babies are born spontaneously; often labor must be induced before 37 weeks due to maternal or fetomaternal indications: this is defined as "iatrogenic prematurity." Of all women giving birth preterm, 30% to 40% experience PROM, 28% to 64% PTL, and 20% to 29% iatrogenic PTD Meis et al. 1987, Savitz et al. 1991, Romero et al 1999 ; . Furthermore, cervical insufficiency may be associated with 8% to 15% of all preterm births Parisi 1988 ; . Preterm birth is.
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What can be done? Internationally TRIPs At the international level, the agreement on trade related aspects of intellectual property rights TRIPs ; , which is part of the WTO Agreements of 1994 and is mandatory for all World Trade Organisation members, requires that the trademark laws of member jurisdictions are compatible with each other, a quality which is known as `harmonisation.' LDCs that are members of the WTO should therefore have TRIPs-compliant trademark recognition. However, the only way for aggrieved countries to enforce breaches of the TRIPs agreement is through trade sanctions. This is often not a particularly desirable option, for several reasons. First, trade sanctions hurt both parties people in the offending country will lose much-needed export revenue and associated employment opportunities, while people the aggrieved country will lose the economic benefits of importing goods from a country that has a comparative advantage in production. To the extent that employment falls in the offending country, more people may end up with a smaller disposable income and thereby more likely to purchase cheaper counterfeit medicines. Secondly, the enforcement of TRIPs can, in certain cases, undermine popular support for intellectual property protection, making future enforcement more difficult politically. For example, in 2001 the research-based pharmaceutical companies sought to challenge in the courts a South African law that seemingly contravened TRIPS. In response to a very vocal campaign by AIDS activists, the pharmaceutical companies withdrew their case. While the dispute was and provera.
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Claims were invalid. In so ruling, the Federal Circuit answered in the negative the question: "for purposes of 112, 6, is sufficient corresponding structure disclosed when the specification simply recites that a claimed function can be performed by known methods or using known equipment where prior art of record and the testimony of experts suggest that known methods and equipment exist?" The court instructed that under 112, 6, "the applicant must indicate in the specification what structure constitutes the means." "[A] bare statement that known techniques or methods can be used does not disclose structure[, ]" and therefore does not meet the statutory requirements. Instead, "[t]he inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing a structure." Biomedino, LLC v. Waters Technologies Corp., No. 2006-1350, 2007 WL 1732121, * 1- * 6 Fed. Cir. June 18, 2007 ; . Claim Construction In a claim directed to a medical device requiring a "pneumatic cylinder, " the Federal Circuit held that the district court erred in narrowly construing the claim to further require that the cylinder have a pressure activated seal. The district court narrowly construed the claim since the written description only described embodiments of the invention with a pressure activated seal. The Federal Circuit held that under the particular circumstances this was error. Instructing that "[a] patent that describes only a single embodiment is not necessarily limited to that embodiment, " the court noted that the specification, while only describing cylinders with a pressure activated seal, did not describe the presence of the pressure activated seal as being "essential" to the operation of the invention. Accordingly, the specification did not provide a restrictive description that dictated a narrow claim construction. Further, the prosecution history showed that while all the claims from the parent application included the pressure activated seal as an express claim limitation, the inventor had omitted that limitation from the asserted claims issuing from a continuation application while retaining the limitation in other claims of the continuation application. According to the court, this provided strong evidence that the inventor intended to broadly claim the device as not requiring the pressure activated seal in the asserted claims. Further, the inventor had also submitted a petition to make special and in that petition accused products that did not have a pressure activated seal as, for example, side affects.
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| Figure 6. Proarrhythmic effect of moxifloxacin in presence of 3 nM ATX-II is reduced by ranolazine, in a female rabbit isolated heart paced at 1 Hz. Representative LV monophasic action potentials MAP, top record in each panel ; and electrocardiograms ECG, bottom record ; recorded during A ; control no drug ; , B ; moxifloxacin 1 M ; alone, C ; ATX-II 3 nM ; alone, D ; ATX-II + moxifloxacin in absence and presence E ; of ranolazine, and after washout of ranolazine in the continuous presence of ATX-II + moxifloxacin F ; . Arrows indicate early afterdepolarizations, extra-ventricular beats and ventricular tachycardias.
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In various embodiments, the pharmaceutical compositions of the present invention result in rate of degradation of the drug between about 0- 6% of the total weight of the drug during about the first three months after the compositions are formed and between about 0- 4% of the total weight of the drug during a period of at least about 36 months after the pharmaceutical composition are formed.
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Seated position. Symptoms vary, but include lower back pain, pelvic pain, or groin pain with or without weight-bearing. The pain is usually severe and often makes ambulation extremely difficult to intolerable. Physical examination is commonly unremarkable except for possible sacral tenderness and limited lower back range of motion.1 A clinical clue may be the disparity between the patient's severe symptoms and the nearly absent clinical signs. Laboratory tests are usually normal. However, alkaline phosphatase levels are elevated above normal limits in up to one-third of cases.1 The best method of diagnosis is a high index of suspicion and Nuclear Medicine Imaging in the form of 99mTc-MDP bone scan. While sacral fractures are difficult to detect on plain radiographs due to vessel calcification and overlying bowel, bone scintigraphy is both highly sensitive and highly specific.3 Scintigraphy commonly displays a characteristic H-shaped delayed uptake pattern extending across the sacrum often referred to as the "Honda sign" in reference to the automobile manufacturer's emblem however, partial uptake patterns are also possible.4 Since associated vertebral compression fractures as well as pubic rami and iliac fractures are common comorbidities, whole-body bone scan has the added advantage of uncovering other unsuspected additional foci of injury.2 CT is sensitive but is not practical for extensive regional survey and may fail to detect transversely oriented fractures. MRI is also highly sensitive but has limited availability and its use may be limited in the elderly population since this form of imaging cannot be used for patients who have a pacemaker or other implanted metallic devices. CT and MRI are very useful imaging modalities should bone scintigraphy be equivocal.3 The treatment of sacral insufficiency fractures is conservative. Bed rest and non-narcotic analgesia is recommended until pain control is improved. Since sacral insufficiency fractures are stable, early exercise and ambulation with partial weight bearing using a cane or walker ; is suggested to avoid immobility, deconditioning and formation of deep vein thrombosis.1 Sacroplasty using percutaneous injection of polymethylmethacrylate PMMA ; under fluoroscopic or CT guidance has also been described in the literature.5 Results have been favourable, demonstrating faster pain relief and earlier return to function. Although further evaluation is necessary, sacroplasty may gain broader clinical acceptance in the near future. Once symptomatic improvement is observed, prognosis is good. Most patients return to their normal level of functioning within six to twelve months.1.
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