Current Issue : October - December Volume : 2012 Issue Number : 4 Articles : 7 Articles
GCP is standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. The key stake holders of ICH GCP include IRB/IEC, sponsor, investigator, investigator’s brochure etc. Some essential documents for conducting clinical trial which includes investigator’s brochure, financial aspects of trial, master randomization list etc. The most important consideration of GCP includes right, safety & well being of the trail subject should be maintained. This represents a serious challenge to the academic independent drug related research, as systems to assure GCP compliance must be developed, which in turn requires allocation of appropriate resources.GCP is regulated by drug controller general of India (DCGI). Guidelines of GCP include ICH GCP and INDIAN GCP. The prime difference between INDIAN GCP and ICH GCP include investigator’s qualification and responsibility for data analysis, power of IEC etc....
Clinical trial is a carefully & ethically designed human experiment with the aim of answering some precisely framed questions. Clinical trials shows which therapies are more effective than others and help to determine the ADR’s, Side-effects by various phases. Clinical trials in India is governed by DCGI, who has proposed some short, mid, long term goals for promotion of clinical trials. Clinical trials are registered and monitored by Clinical Trials Registry Of India (CTRI) while declaring certain registration data set. Clinical research in India is carried out with respect of ethical concerns and is followed by ICMR’S and to the guidelines in the declaration of Helsinki. Currently India is leading on road map for clinical research for its various advantages and significance in clinical trials. Challenges towards India while performing clinical research specifically are poverty and reduced govt. policy for health sector. Controversies like placebo effect etc. are adding points in barrier of clinical trials. In spite of being some pitfalls and shortcomings many MNC’S like Pfizer, GSK etc and some CRO’S are conducting clinical trials in India, which is helping to become India as a hub for clinical research as compared to their counterparts....
Background: The occiput-wall distance (OWD) is a quick and easily administered method to assess kyphosis. Thus it is likely used in epidemiologic studies. However, there are no data to warrant validity of the tool. This study evaluated concurrent validity of the OWD using a Flexicurve as a standard method.\r\n \r\nMethods: Subjects were 158 well-functioning elderly, aged at least 60 years old and had a perpendicular distance from the bony prominence of C7 to the wall >0 cm. They were assessed kyphosis using Flexicurve and OWD in a random order. The Pearson correlation coefficient was applied to determine levels of correlation.\r\n \r\nResults and conclusion: The OWD correlated extremely well with the Flexicurve (r = 0.902, p<0.001), thereby the data confirmed concurrent validity of the OWD. Although the method did not measure spinal angle, the findings suggested benefit of OWD to quantify and monitor degrees of kyphosis in a large number of populations....
Background: Chronic obstructive pulmonary disease (COPD) is an inflammatory pulmonary disorder with systemic\ninflammatory manifestations that are mediated by circulating acute-phase reactants. This study compared an\nenzyme-linked immunosorbent assay (ELISA) to a nephelometric technique for the measurement of serum Creactive\nprotein (CRP) and serum amyloid A (SAA) and investigated how the choice of assay influenced the\nestimation of inflammation in patients with stable COPD.\nMethods: CRP and SAA concentrations measured by ELISA and nephelometry in 88 patients with COPD and 45\ncontrol subjects were used to evaluate the performance of these methods in a clinical setting.\nResults: With both assays, the concentrations of CRP and SAA were higher in COPD patients than in controls after\nadjustment for age and sex. There was a moderate correlation between the values measured by ELISA and those\nmeasured by nephelometry (logCRP: r = 0.55, p < 0.001; logSAA: r = 0.40, p < 0.001). However, the concentrations\nof biomarkers determined by nephelometry were significantly higher than those obtained with ELISA for CRP\n(mean difference = 2.7 (9.4) mg/L) and SAA (mean difference = 0.31 (14.3) mg/L).\nConclusion: Although the serum CRP and SAA concentrations measured by ELISA and nephelometry correlated\nwell in COPD patients, the ELISA values tended to be lower for CRP and SAA when compared with nephelometric\nmeasurements. International standardization of commercial kits is required before the predictive validity of\ninflammatory markers for patients with COPD can be effectively assessed in clinical practice....
The pre-operative and post-operative visual acuities, IOP and Modified VF-14 (MVF-14) score were recorded prospectively in 158 eyes undergoing cataract extraction for uncomplicated cataract. The presenting visual acuity, IOP and MVF-14 score were recorded on 158 eyes seen at 4-11weeks post-operative. Among 158 patients, the mean age was 60.34 ± 9.42 years, 48.10% (76) were male and 51.90% (82) were female. Out of 158 operated eyes 53.16% had a visual acuity of less than 3/60 and 44.94% had a visual acuity of <6/18-6/60 preoperatively. Presenting vision after 4-11 weeks postoperatively showed that 128 patients out of 158 patients (81.01%) had good vision while 27patients (17.10%) had borderline vision, and 3 patients (1.90%) had poor vision. Posterior capsular opacification was responsible for poor outcome in 1.90% of eyes. The pre-operative mean IOP was 17.71±2.84 (±SD) mmHg and mean IOP at 4-11 weeks post-operative was 10.87±1.30 (±SD) mmHg. A statistically significant improvement in IOP was observed at 4-11 weeks post-operative (P<0.0001). The mean pre-operative MVF-14 score was 23.80± 17.72 (±SD) and mean 4-11 weeks post-operative MVF-14 score was 78.64±19.3 (±SD). A significant improvement in MVF-14 score was observed at 4-11 weeks post-operative (Mean± SD, P<0.0001). Significant improvements were obtained in IOP, visual acuity, functional and perceived vision by cataract surgery involving SICS or Phacoemulsification with posterior chamber intraocular lens implantations. In order to deal with cataract-related visual impairment as much emphasis on surgical quality, refractive correction, and follow-up care is necessary as on the number of surgeries....
The syndrome was first reported in 1894 by Jarisch and White, and delineated by Gorlin and Goltz in 1960. It is a rare hereditary autosomal-dominant disorder with prevalence from 1/57,000 to 1/256,000 and variable phenotypic expressivity. The syndrome is due to a mutation of the tumor suppressor Patched gene located in the 9q22.1ââ?¬â??q31 chromosome and is characterized by multiple defects involving the skin, nervous system, eyes, endocrine system, and bones. There is a 60% rate of recurrence in patients with basal cell nevus syndrome. Diagnostic criteria were defined by Evans, and modified by Kimonis on 5 major and over 100 minor criteria. The syndrome is diagnosed with two major or one major and two minor criteria. Major criteria: multiple (>2) BCCs or one under 20 years; odontogenic keratocysts of the jaws proven by histopathology; palmar or plantar pits (3 or more); bilamellar calcification of the falx cerebri; bifid, fused or markedly splayed ribs. Minor criteria: macrocephaly; cleft lip or palate, frontal bossing; hypertelorism; sprengel deformity; marked pectus deformity; marked syndactyly of the digits; bridging of the sella turcica; vertebral anomalies; modeling defects of the hands and feet; ovarian fibroma; medulloblastoma....
Post operative nausea and vomiting (PONV) are common complications and occurs in as many as 70%- 80% of high risk surgical patients. The latest prophylactic treatment recommended in the Society of Ambulatory Anesthesia Guidelines (SAMBA) for the management of Post operative Nausea and Vomiting for high risk patients is a combination of 2 or more interventions (multimodal therapy). A combination of a 5-HT3 receptor antagonist with Dexamethasone and/or Droperidol, or a 5-HT3 receptor antagonist with Droperidol alone, or Dexamethasone with Droperidol, have been the pharmacologic combination therapies suggested in these guidelines. Scopolamine ââ?¬Å?Transdermal Scopââ?¬Â is a belladonna alkaloid with anticholinergic properties. It acts as a nonselective muscarinic antagonist, approved by the FDA for PONV prophylaxis. The use of this novel drug in a triple therapy combination with Dexamethasone and/or Droperidol could be an effective treatment for the prevention of PONV. However, since the FDA issued a warning stating that Droperidol may cause life ââ?¬â?? threatening arrhythmias as well as a prolongation of the QTc interval, the need to discover new combination therapies for PONV prevention in high risk patients is still in demand. Therefore, we hypothesize that the use of a triple prophylactic therapy consisting of Scopolamine, Dexamethasone, and Ondansetron will be an effective treatment for the prevention of PONV in patients at a high risk for developing PONV during the first 120 hours after neurosurgery...
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