Current Issue : January - March Volume : 2014 Issue Number : 1 Articles : 9 Articles
Background: The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent,\r\nfeaturing a unique dual-polymer mix. An active bioabsorbable polymer delivers the anti-proliferative drug, sirolimus,\r\nvia controlled release, while a passive biocompatible polymeric coating shields the metallic strut from surrounding\r\ntissue, preventing interaction. To date, the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss\r\nat 9 months in a first-in-man single-arm trial. However, the efficacy and safety data for Orsiro Hybrid sirolimus-eluting\r\nstents in a broader population of all-comers are limited. The present study offers an angiographic and clinical\r\ncomparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in\r\nthe treatment of patients with coronary artery disease.\r\nMethods/design: The ORIENT trial is a multicenter, randomized, open-label, parallel-arm study designed to\r\ndemonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity\r\nzotarolimus-eluting stent. A total of 375 patients with a spectrum of coronary artery disease will undergo prospective,\r\nrandom assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent (2:1 ratio),\r\nfor a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography. Secondary\r\n12-month clinical endpoints are death, target lesion revascularization, target vessel revascularization, myocardial\r\ninfarction, stent thrombosis and target lesion failure (a composite of cardiac death, target lesion revascularization\r\nand target vessel-related myocardial infarction).\r\nDiscussion: The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with\r\nthe Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary\r\nartery disease....
Background: Smoking is the main preventable cause of morbidity and mortality in our region, it being the main\r\ncausative agent of chronic obstructive pulmonary disease. There still is no consensus on the use of spirometry as a\r\nstrategy for smoking cessation, given that there is insufficient scientific evidence from high quality studies to\r\nrecommend the use of this technique.\r\nMethods/Design: This is to be a randomized, multicentre, open-label clinical trial. A total of 444 smokers over\r\n40 years of age will be recruited by 39 general practitioners from 22 health centers. Primary objective of this study\r\nis to assess the effectiveness of spirometry together with information regarding the test for smoking cessation after\r\n1 year in smokers over 40 years of age with a more than 10 pack-year history and no previous diagnosis of chronic\r\nobstructive pulmonary disease. Groups of 45 patients who smoke will be randomly selected from the lists of the\r\nparticipating doctors. The names will be sent to the corresponding doctors who will contact candidate patients and\r\nassess whether they meet the selection criteria. Patients who meet these criteria will be randomly allocated to an\r\nintervention or control group. For patients in both groups, a nurse will conduct an interview and perform a\r\nspirometry test to measure forced vital capacity. Then, all patients will be referred for an appointment with their\r\ndoctor for brief anti-smoking intervention, patients from the intervention group additionally being informed about\r\nthe result of the spirometry test. After 1 year, smoking status will be assessed and, in those who report that they\r\nhave quit smoking, abstinence will be confirmed by co-oximetry. Data will be analyzed on an intention-to-treat\r\nbasis using the chi-squared test for outcomes and binary logistic regression if it is considered to be necessary to\r\nadjust for confounding variables.\r\nDiscussion: Performing a spirometry test and providing information on pulmonary function may increase\r\nawareness of the effect of smoking among smokers who are asymptomatic or have few symptoms and make them\r\ndecide to quit. Specifically, in patients with chronic obstructive pulmonary disease it might increase levels of\r\nmotivation to quit smoking in early stages of the disease. If this strategy were to be effective, it could be included\r\nin the health promotion activities offered in primary care....
Background: Schizophrenia is a chronic disease of global importance. The second-generation antipsychotic quetiapine\r\nhas a favorable side-effect profile, however, its clinical effectiveness has been called into question when compared with\r\nfirst-generation antipsychotics such as haloperidol. This study evaluates the efficacy and tolerability of quetiapine versus\r\nhaloperidol for first-episode schizophrenia in the outpatient setting.\r\nMethods: 156 adult patients with first-episode schizophrenia participated in an outpatient clinical trial and were\r\nrandomized to quetiapine (200 mg/d; n = 78) or haloperidol (5 mg/d; n = 78). The study medications were titrated\r\nto a mean daily dose of 705 mg for quetiapeine and 14 mg for haloperidol. The patients were assessed at baseline, six\r\nweeks, and twelve weeks. The primary outcome measures were positive and negative scores of the Positive and\r\nNegative Syndrome Scale (PANSS). Secondary measures were Global Assessment of Functioning (GAF) scale for\r\noverall psychosocial functioning, and Simpson-Angus Scale (SAS) for extra-pyramidal symptoms.\r\nResults: At twelve weeks, the quetiapine group had a greater decrease in PANSS positive (18.9 vs. 15.3, p = 0.013) and\r\nnegative scores (15.5 vs. 11.6, p = 0.012), however, haloperidol showed a greater decrease in general psychopathology\r\nscore (23.8 vs. 27.7, p = 0.012). No significant difference between groups were found for total PANSS (58.3 vs.\r\n54.8, p = 0.24) and GAF (45.7 vs. 46.2, p = 0.79).\r\nANOVA identified significant group interactions on PANSS positive (F = 18.72, df = 1.6,52.4, p < 0.0001), negative\r\n(F = 5.20, df = 1.1,35.7, p < 0.0001), depression/anxiety (F = 106.49, df = 1.14,37.8, p < 0.0001), and total scores\r\n(F = 7.51, df = 1.4,45.6, p = 0.001).\r\nSAS (8.62 vs. 0.26, p < 0.0001) and adverse events of akathisia (78% vs. 0%, p = 0.000), parkinsonism (66.6% vs.\r\n0%, p < 0.0001), and fatigue (84.6% vs. 66.6%, p = 0.009) were greater in haloperidol compared to quetiapine,\r\nwhereas headache was more common in quetiapine treated patients (11.5% vs. 35.9%, p < 0.0001).\r\nConclusions: Quetiapine has greater efficacy for positive and negative symptoms with less extra-pyramidal\r\nsymptoms than haloperidol when used for first-episode schizophrenia in the outpatient setting....
Background: This study aims to evaluate the efficacy of Black cohosh (Cimicifuga racemosa L.) in treating early\r\nmenopausal symptoms.\r\nMethods: This randomized, double-blind, placebo-controlled clinical trial was conducted on 84 early post-menopausal\r\nparticipants with Greene climacteric scale (GCS) scores of 15 to 42, who were referred to two public health care centers\r\nin Tehran, Iran, in 2011ââ?¬â??2012. The participants were randomly allocated into treatment (6.5 mg of dried extract of Black\r\ncohosh roots daily) and control (placebo) groups with a ratio of 1:1. The participants took one tablet per day for 8 weeks.\r\nThe GCS scores were recorded at baseline, and after 4 and 8 weeks of treatment. Data analysis was carried out using a\r\ngeneral linear model with repeated measures with SPSS software. The level of significance was set at P < 0.05.\r\nResults: There was no loss to follow-up during the 8 weeks of treatment. The GCS total score (primary outcome)\r\nin the treatment group was significantly lower than that in the control group at both week 4 [adjusted mean\r\ndifference: -7.8 (95% confidence interval: -11.1 to -4.4)] and week 8 [-12.9 (-16.2 to -9.3)]. The treatment group\r\nshowed significantly more improvement than the control group in all GCS subscale scores (vasomotor, psychiatric,\r\nphysical, and sexual symptoms; secondary outcomes). The differences between the treatment and control groups at\r\nweek 8 were significantly higher (P < 0.001) than those at week 4 in terms of the total scores and the vasomotor and\r\npsychiatric subscale scores. No side effects were reported.\r\nConclusions: Black cohosh reduced the GCS total score and all GCS subscale scores (vasomotor, psychiatric, physical,\r\nand sexual symptoms) during 4 and 8 weeks of treatment....
The improper use of drugs can leads to patient morbidity and even mortality. In general, problems related to the use\r\nof approved drugs can be summarized with the term drug therapy problems. This study was aimed to evaluate the drug therapy\r\nproblems in a south Indian tertiary care teaching hospital. Prospective observational study conducted in the Department of\r\nGeneral Medicine, Rajiv Gandhi Institute of Medical Sciences, Kadapa for the period of six months. Patients are randomly\r\nenrolled in the study based on inclusion and exclusion criteria. This study was approved by institutional ethical committee,\r\nRIMS, Kadapa. Adverse drug reactions were identified according to the manifestations on the patients and were notified and\r\nreported to the physician and were documented in ADR form, these ADR were classified according to Naranjo�s scale. Other drug\r\nrelated problems like untreated indication, improper drug selection, sub therapeutic dose, drug use without indication, over\r\ndosage and failure to receive drugs were analyzed from the prescription and referred from standard literature. Major\r\npredisposing risk factors were polypharmacy, age, gender and immune suppression were identified. Clinical pharmacists are the\r\nupcoming breed of pharmacists in our country....
Background: Dystonic cerebral palsy is primarily caused by damage to the basal ganglia and central cortex. The\r\ndaily care of these patients can be difficult due to dystonic movements. Intrathecal baclofen treatment is a\r\npotential treatment option for dystonia and has become common practice. Despite this widespread adoption, high\r\nquality evidence on the effects of intrathecal baclofen treatment on daily activities is lacking and prospective data\r\nare needed to judge the usefulness and indications for dystonic cerebral palsy. The primary aim of this study is to\r\nprovide level one clinical evidence for the effects of intrathecal baclofen treatment on the level of activities and\r\nparticipation in dystonic cerebral palsy patients. Furthermore, we hope to identify clinical characteristics that will\r\npredict a beneficial effect of intrathecal baclofen in an individual patient.\r\nMethods/Design: A double blind placebo-controlled multi-center randomized clinical trial will be performed in\r\n30 children with dystonic cerebral palsy. Patients aged between 4 and 25 years old with a confirmed diagnosis of\r\ndystonic cerebral palsy, Gross Motor Functioning Classification System level IV or V, with lesions in the cerebral\r\nwhite matter, basal ganglia or central cortex and who are eligible for intrathecal baclofen treatment will be\r\nincluded. Group A will receive three months of continuous intrathecal baclofen treatment and group B will receive\r\nthree months of placebo treatment, both via an implanted pump. After this three month period, all patients will\r\nreceive intrathecal baclofen treatment, with a follow-up after nine months. The primary outcome measurement will\r\nbe the effect on activities of and participation in daily life measured by Goal Attainment Scaling. Secondary outcome\r\nmeasurements on the level of body functions include dystonia, spasticity, pain, comfort and sleep-related breathing\r\ndisorders. Side effects will be monitored and we will study whether patient characteristics influence outcome.\r\nDiscussion: The results of this study will provide data for evidence-based use of intrathecal baclofen in dystonic\r\ncerebral palsy....
In recent years, pharmaceutical practice has become orientated towards achieving therapeutic results and a rational\r\nuse of drugs. In order to develop these activities in the complexity of the hospital setting, pharmacists need to become directly\r\ninvolved in patient care team in different hospital units. The objective of the study is to describe the clinical interventions of\r\nclinical pharmacist in a pediatrics department. A prospective observational study was conducted in PICU, NICU, IP and OP of\r\nPaediatrics Department, Rajiv Gandhi Institute of Medical Sciences, Kadapa for the period of 6 months. All documented\r\nmedication orders monitored for any medication misadventures. Impact of clinical pharmacist was analysed by using the chisquare\r\ntest through graph-pad prism. Result show that medication misadventures in children were common. The variables that\r\nshow the most were medication errors, adverse drug reactions and drug interactions. The importance of the clinical pharmacist\r\nin preventing medication misadventures is well established. In this paper, we found that efficient clinical pharmacist available to\r\nhealth care professionals in providing awareness regarding drugs, current prescribing guidelines and thus improving the quality\r\nand safety of care provided. The close relationship of clinical pharmacist with the healthcare professionals especially nursing\r\nstaff and acquisition of additional information about the problems faced by health professionals in the unit each day has\r\nfacilitated resolution of events and the identification of areas for improvement in the processes related to the request, receipt\r\nand optimization of use of drugs....
Background: We previously developed an immunotherapy treatment utilizing a cancer vaccine reagent KIF20A-66\r\nin order to treat pancreatic cancer. KIF20A-66 is HLA-A24-restricted epitope peptide derived from KIF20A, a member\r\nof kinesin super family protein 20A that is significantly transactivated in pancreatic cancer. In this report, we further\r\ndemonstrated non-randomized, open-label, single centered phase I/II clinical trial of immunotherapy using the\r\nKIF20A-66 peptide for the patients with advanced pancreatic cancer.\r\nMethods: Vaccination was performed to the patients with metastatic pancreatic cancer, in whom gemcitabine-based\r\ntherapy had failed. In phase I study, KIF20A-66 peptide was subcutaneously injected weekly in a dose-escalation manner\r\n(doses of 1.0 and 3.0 mg/body, 6 patients/1 cohort). After safety was assessed, phase II study was conducted using\r\n3.0 mg of KIF20A-66 peptide.\r\nResults: KIF20A-66 peptide vaccination was well tolerated in the doses we examined and tumor responses after\r\n1 month of the treatment were evaluated. Among 29 patients who completed one course of the treatment at least,\r\nstable disease (SD) was found in 21 cases, while progressive disease (PD) was found in 8 cases, indicating that the\r\ndisease control rate was 72%. Objective tumor shrinkage was observed in 8 cases, including 1 case of complete\r\nresponse (CR). The median survival time (MST) and progression free survival time (PFS) were 142 days and 56 days,\r\nrespectively. These results clearly demonstrate that overall survival of the patients was significantly prolonged,\r\ncompared to the historical controls of 9 cases with unmatched HLA in the same hospital (MST: 83 days), as well\r\nas 81 cases in our and other hospitals (MST: 63 days).\r\nConclusion: The patients vaccinated with KIF20A-66 peptide had better prognosis than the control group with best\r\nsupportive care (BSC). Thus, we concluded that KIF20A-66 vaccination is significantly effective as an immunotherapy\r\nagainst advanced pancreatic cancer. KIF20A-66 peptide was well tolerable in the dose of either 1.0 mg or 3.0 mg/body,\r\nand effectively induced peptide-specific response of cytotoxic T lymphocyte (CTL). Further clinical study using this\r\npeptide is a promising approach for advanced pancreatic cancer to achieve high potential benefit for better prognosis....
Ekbom disease or delusional parasitoses has DSM IV AND ICD 10 diagnostic entity is presenting with itching to the department of dermatology and from there referred back to department of psychiatry for no identifying causes. Incidence/prevalence is difficult to estimate because of its rarity. The effort is made to estimate their incidence and description of the patient’s complaints in 168 studied cases at dermatology OPD at RDGMC Surasa Ujjain from day 1 to day 6. Among them 2.8% had delusional parasitoses, 60% had well defined and 40% had poorly differentiated features. Male/Female ratio was 4:1 and age range was noted as 43 to 64 years of age. Conclusion was drawn from the study is the rarity can no longer remain when there is good knowledge to understand psychopahtogies of the disorder by first line professionals....
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