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T-DM1 for treating HER2-positive, unresectable locally advanced or
T-DM1 for treating HER2-positive, unresectable locally advanced or

... The manufacturer identified no existing economic evaluations of T-DM1. A de novo cohort state transition model was developed which adheres to the NICE Reference Case. The model has three health states: progression-free survival; post-progression; and death, and follows weekly cycles. The model was b ...
Population Health Research Institute
Population Health Research Institute

... Originally formed with a focus on cardiovascular disease (CVD), the PHRI has since expanded to explore innovative projects in a variety of areas including diabetes, obesity and societal influences on health, with specific emphasis on variations by ethnicity and geographic region. The Institute is al ...
Extract from Clinical Evaluation Report: Riociguat
Extract from Clinical Evaluation Report: Riociguat

... these patients medical therapy is warranted. There are currently no approved pharmacotherapies for CTEPH and patients are frequently treated off-label. Anticoagulation may prevent further embolism and in situ thrombosis but not necessarily disease progression. There are no effective primary therapie ...
AusPAR: Ruxolitinib  - Therapeutic Goods Administration
AusPAR: Ruxolitinib - Therapeutic Goods Administration

... stem cell transplantation is potentially curative but has significant risk and is not suitable for the majority of patients. For most patients, treatment is focussed on symptoms. AusPAR Jakavi Ruxolitinib Phosphate Novartis Pharmaceuticals Australia Pty Ltd ...
Results in PLOS NTDs (2009)
Results in PLOS NTDs (2009)

... Background: Current therapies for cutaneous leishmaniasis are limited by poor efficacy, long-term course of treatment, and the development of resistance. We evaluated if pentavalent antimony (an anti-parasitic drug) combined with imiquimod (an immunomodulator) was more effective than pentavalent ant ...
Computed Tomography Workup of Patients Suspected of Acute
Computed Tomography Workup of Patients Suspected of Acute

... of infarct core and ischemic penumbra on admission. Other imaging data included Alberta Score Program Early CT Score, site of occlusion, and collateral flow. Clinical data included age, time, National Institutes of Health Stroke Scale at baseline, treatment type, and modified Rankin score (mRS) at 9 ...
Heparin therapy reduces 28-day mortality in adult severe sepsis
Heparin therapy reduces 28-day mortality in adult severe sepsis

... of the authors had discussed and reviewed the strategy, the corresponding author approved the final version of the study design strategy. The process yielded nine published studies. Two groups of researchers independently conducted a second round of data extraction from the literature. Key data were ...
S3 File.
S3 File.

... Rationale: In clinic, injections are given every 12 weeks. To ensure complete wearing-off of drug effects before re-injection and prevent possible excess weakness, we have extended this period by 4 weeks. Drug Schedule: Any changes to injection dosing or parameters will be based on kinematic measure ...
Pravin R - Pivot Pharmaceuticals
Pravin R - Pivot Pharmaceuticals

... Build and enhance the pipeline value of the company through development of early-stage preclinical assets of the company across GI, diabetes and cancer areas Integrated all the scientific and operational activities of the company across multiple sites in the United States and in India Led the Joint ...
epivir tablets and oral solution
epivir tablets and oral solution

... Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including EPIVIRHBV. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [ ...
Clinical Medicine: Therapeutics pharmacotherapy of Fibromyalgia
Clinical Medicine: Therapeutics pharmacotherapy of Fibromyalgia

... Objectives: Tricyclic antidepressants were the first drugs used to treat FMS. More recently, among serotonin-norepinephrine reuptake inhibitors, duloxetine was approved by US Food and Drug Administration to treat FMS. Duloxetine is used for the management of major depressive disorder, neuropathic pa ...
Seclusion and restraint for people with serious mental illnesses
Seclusion and restraint for people with serious mental illnesses

... Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ...
AusPAR: Selexipag - Therapeutic Goods Administration
AusPAR: Selexipag - Therapeutic Goods Administration

... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary. ...
Stroke Prevention in Atrial Fibrillation
Stroke Prevention in Atrial Fibrillation

... who are performing MAZE procedures to prevent atrial fibrillation will now over-sew or exclude the left atrial appendage (with the goal to reduce stroke). There are many echocardiographic studies that question the efficacy of left atrial appendage exclusion [28] and find that certain techniques are ...
Are Cannabinoids an Effective and Safe Treatment Option in the
Are Cannabinoids an Effective and Safe Treatment Option in the

... THC congener) 2-4 mg was not as effective as codeine sulphate 60-120 mg and no more effective than placebo in 37 patients.21 Oral THC 5-20 mg was found to have an analgesic effect when compared with placebo in 10 patients with pain related to advanced cancer.22 In this study a dose-response relation ...
Author`s personal copy - Texas Christian University
Author`s personal copy - Texas Christian University

... to disruption [11]. Because training occurs before drug administration, behavior during training is not affected directly by the drug. Because behavioral testing of drug effects usually occurs a day after drug administration (as in the present experiments), and because many psychoactive drugs are me ...
HIGHLIGHTS OF PRESCRIBING INFORMATION These
HIGHLIGHTS OF PRESCRIBING INFORMATION These

... to starting VIEKIRA XR (alternative contraceptive methods are recommended). Perform hepatic laboratory testing on all patients during the first 4 weeks of treatment. For ALT elevations on VIEKIRA XR, monitor closely and follow recommendations in full prescribing information. (5.3) • Risks Associated ...
Daily Administration of Phosphodiesterase Type 5 - EU-ACME
Daily Administration of Phosphodiesterase Type 5 - EU-ACME

... treatment alternative for nonresponders to ondemand PDE5-Is and to more closely approximate ‘‘natural’’ erectile function [7,9–12]. These PDE5-I schedules have also been investigated for other urological and nonurological indications including pulmonary and systemic hypertension, cardioprotection, a ...
Ongoing Clinical Trials Posters II
Ongoing Clinical Trials Posters II

... Study Population: Male or female, ≥ 18 years old, treated within 24 hours of symptoms onset, with a measurable focal neurological deficit lasting for a minimum of 60 minutes. Baseline NIHSS score ≥ 8, with a neuroimage compatible with the diagnosis of acute ischemic stroke and symptoms referable to ...
Programmatic Challenges of Dose Tapering Using SAS®
Programmatic Challenges of Dose Tapering Using SAS®

... Step 4: First, we are creating a ‘standard’ tapering dose using 10 mg increments (dataset taper10). We will use this dataset to calculate the following steps of tapering such as 5 mg and respectively 1 mg increments. In the last step, we need to merge the total daily dose – standard format with tape ...
Low Molecular Weight Heparins : Basic and Applied Considerations
Low Molecular Weight Heparins : Basic and Applied Considerations

... In a study performed by Houbouyan the ED 80 for thrombin inhibition was calculated in terms of anti Xa and anti-IIa activities using chromogenic methods.5 The ED 80 for the different LMWHs ranged from 0.48 - 1.26 IU/ml for anti-Xa and 0.19-0.35 for the anti-IIa. Enoxaparin and nadroparin showed simi ...
5 STUDY Endpoints
5 STUDY Endpoints

... Follicular lymphoma (FL) is a slowly growing cancer of the lymphatic system. In the WHO classification the histology is further classified into grade 1, 2 or 3 follicular lymphoma, depending on the percentage of large cells seen on high power field microscopy (Nathwani et al, 2001). Biologically FL ...
Standardized endpoint definitions for transcatheter aortic valve
Standardized endpoint definitions for transcatheter aortic valve

... trials, in which stroke was an important endpoint.20 – 29 Valve Academic Research Consortium considered five important issues in arriving at clinically relevant stroke definitions, as follows: (i) a clinical diagnosis of stroke which ruled out metabolic or toxic encephalopathy, pharmacological influ ...
Overview of pleiotropic effects of platelet P2Y12receptor inhibitors
Overview of pleiotropic effects of platelet P2Y12receptor inhibitors

... found in a wide variety of tissues including certain subregions of the brain (11), vascular smooth muscle cells (12, 13), leukocytes (14), macrophages (15), microglial (16) and dendritic cells (17), thus increasing the amount of potential effectors for P2Y12 blockers (1) (▶ Figure 2). Furthermore, t ...
Meeting Report Changing paradigms in the treatment
Meeting Report Changing paradigms in the treatment

... the EU (except Germany where Medikinet® is also licensed). l Atomoxetine is a non-stimulant with no abuse potential; it is not a controlled substance. l The efficacy of atomoxetine is similar to that of methyl phenidate. l The response to treatment with atomoxetine is slower in onset than with methy ...
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Clinical trial

Clinical trials are experiments done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial - their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.Trials can be quite costly, depending on a number of factors. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.Only 10% of all drugs started in human clinical trials become an approved drug.
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