STCCNG clinical management protocols May 2014
... Rapidly enlarging lymph node, nasopharyngeal or tonsillar mass Large abdominal mass +/- ascites. Some patients can present with intussception Orthoponea, breathlessness or swelling of the face, if there is a mediastinal mass. A pleural and/or pericardial effusion may also be present, If bone marrow ...
... Rapidly enlarging lymph node, nasopharyngeal or tonsillar mass Large abdominal mass +/- ascites. Some patients can present with intussception Orthoponea, breathlessness or swelling of the face, if there is a mediastinal mass. A pleural and/or pericardial effusion may also be present, If bone marrow ...
Final Program - Society for Clinical Trials
... and India and is entitled “Clinical Trials in Asia – Crouching Tiger, Hidden Dragon.” Then on Wednesday morning, the Founders Lecture will be given by Johan Karlberg from The University of Hong Kong and is entitled “Asian Clinical Trial Trends - by Type of Sponsor, Trial Phase, Disease Area and Coun ...
... and India and is entitled “Clinical Trials in Asia – Crouching Tiger, Hidden Dragon.” Then on Wednesday morning, the Founders Lecture will be given by Johan Karlberg from The University of Hong Kong and is entitled “Asian Clinical Trial Trends - by Type of Sponsor, Trial Phase, Disease Area and Coun ...
Novexatin - NovaBiotics
... ample, in persons with lupus or other concomitant medical conditions. Terbinafine worsens lupus. There are certain patients in whom we cannot use the oral agent because they are using medications that might interact with terbinafine, although such drug interactions are uncommon. All these factors re ...
... ample, in persons with lupus or other concomitant medical conditions. Terbinafine worsens lupus. There are certain patients in whom we cannot use the oral agent because they are using medications that might interact with terbinafine, although such drug interactions are uncommon. All these factors re ...
Product Monograph Template - Standard
... was generally lower than in the adult population (18 to < 65 year age group). In addition, other clinical trials of AVAMYS® have been conducted in 1,224 patients aged 2 to 11 years treated with AVAMYS® 110 or 55 mcg. Overall adverse events for subjects in this age group were reported with approximat ...
... was generally lower than in the adult population (18 to < 65 year age group). In addition, other clinical trials of AVAMYS® have been conducted in 1,224 patients aged 2 to 11 years treated with AVAMYS® 110 or 55 mcg. Overall adverse events for subjects in this age group were reported with approximat ...
alprolix - Biogen Canada
... Protein) may vary. If bleeding is not controlled with the recommended dose, the plasma level of factor IX should be determined, and a sufficient dose of ALPROLIX should be administered to achieve a satisfactory clinical response. If the patient’s plasma factor IX level fails to increase as expected ...
... Protein) may vary. If bleeding is not controlled with the recommended dose, the plasma level of factor IX should be determined, and a sufficient dose of ALPROLIX should be administered to achieve a satisfactory clinical response. If the patient’s plasma factor IX level fails to increase as expected ...
Full Prescribing Information
... Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion (undiluted) is the preferred mode of administrati ...
... Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion (undiluted) is the preferred mode of administrati ...
AusPAR: Perampanel (as hemisesquihydrate)
... 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. ...
... 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. ...
November 2014 PBAC Meeting
... not informative for decision making purposes given the significant risk of bias in the RENCOMP study. There were substantial differences in the two studies used in the indirect comparison in terms of their design, the baseline characteristics of patients, the treatments and the methods of analyses. ...
... not informative for decision making purposes given the significant risk of bias in the RENCOMP study. There were substantial differences in the two studies used in the indirect comparison in terms of their design, the baseline characteristics of patients, the treatments and the methods of analyses. ...
arteether - WHO archives - World Health Organization
... the information provided by the Company for this second submission remained superficial, of poor quality and was difficult to analyse meaningfully; data on preclinical toxicity was not presented; data on the pharmacokinetics or pharmacodynamics of / arteether in patients with uncomplicated or seve ...
... the information provided by the Company for this second submission remained superficial, of poor quality and was difficult to analyse meaningfully; data on preclinical toxicity was not presented; data on the pharmacokinetics or pharmacodynamics of / arteether in patients with uncomplicated or seve ...
Extract from the Clinical Evaluation Report for adalimumab
... 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. ...
... 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. ...
Randomized, Open-Label Study of the Pharmacokinetics and Safety
... Study assessments. Peripheral blood samples were collected predose and at 0.25 (i.v. dose only), 0.5, 1, 1.5, 2, 2.5 (oral doses only), 3, 4, 6, 8, 12, 24, and 48 h after each dose for measuring plasma omadacycline concentrations. Plasma concentrations of omadacycline were determined (Quest Diagnost ...
... Study assessments. Peripheral blood samples were collected predose and at 0.25 (i.v. dose only), 0.5, 1, 1.5, 2, 2.5 (oral doses only), 3, 4, 6, 8, 12, 24, and 48 h after each dose for measuring plasma omadacycline concentrations. Plasma concentrations of omadacycline were determined (Quest Diagnost ...
Time-Release Lipoic Acid: More Marketing than Data
... on other hypoglycemic therapies, 2) the run-in phase was too short to eliminate potential alterations in diet and drug compliance, 3) no comparison to fructosamine-lowering effects of standard lipoic acid therapies are available (including in this paper since no placebo or QRLA control arms were use ...
... on other hypoglycemic therapies, 2) the run-in phase was too short to eliminate potential alterations in diet and drug compliance, 3) no comparison to fructosamine-lowering effects of standard lipoic acid therapies are available (including in this paper since no placebo or QRLA control arms were use ...
Feasibility, Safety, and Efficacy of a Novel Polymeric Pimecrolimus
... assess if there were differences in average injury and inflammation scores across groups. CLINICAL STUDY. This was a first-in-human pilot study designed to obtain preliminary observations and generate hypotheses for future studies. As such the sample size was not calculated on the basis of an end po ...
... assess if there were differences in average injury and inflammation scores across groups. CLINICAL STUDY. This was a first-in-human pilot study designed to obtain preliminary observations and generate hypotheses for future studies. As such the sample size was not calculated on the basis of an end po ...
- Lancaster EPrints
... of the same experimental drug, or they might relate to the use of that drug with and without one or more concurrent medications. In the public sector, a head-to-head comparison of several drugs or other forms of treatment from different sources might be of interest. The method described here conside ...
... of the same experimental drug, or they might relate to the use of that drug with and without one or more concurrent medications. In the public sector, a head-to-head comparison of several drugs or other forms of treatment from different sources might be of interest. The method described here conside ...
The right prevention and treatment Strategic Research Agenda for
... patients and healthcare providers, IMI2 will ensure that research is translated into solutions that can be implemented to address current healthcare challenges – solutions that are not purely focussed on the development of new medicines, but that provide a holistic, personalised healthcare package, ...
... patients and healthcare providers, IMI2 will ensure that research is translated into solutions that can be implemented to address current healthcare challenges – solutions that are not purely focussed on the development of new medicines, but that provide a holistic, personalised healthcare package, ...
AusPAR: Dulaglutide rch - Therapeutic Goods Administration
... T2DM is one of the most common non communicable diseases and is a global health problem. In 2011, the estimated number of people with T2DM was 366 million (8.3% of the world population), with an estimated increase to 552 million (9.9% of total world population) by 2030. There are 183 million people ...
... T2DM is one of the most common non communicable diseases and is a global health problem. In 2011, the estimated number of people with T2DM was 366 million (8.3% of the world population), with an estimated increase to 552 million (9.9% of total world population) by 2030. There are 183 million people ...
PDF - Santen Inc.
... is an important element in that strategy,” says Schalon Newton, EDM, Santen’s Vice President of Strategic Marketing & Business Development. “We are committed to expanding our current pipeline and identifying the next generation of compounds to develop and market. We also are actively pursuing new, e ...
... is an important element in that strategy,” says Schalon Newton, EDM, Santen’s Vice President of Strategic Marketing & Business Development. “We are committed to expanding our current pipeline and identifying the next generation of compounds to develop and market. We also are actively pursuing new, e ...
Mock IRAS form - Health Research Authority
... Study limited to working with human tissue samples (or other human biological samples) and data (specific project only) Study limited to working with data (specific project only) Research tissue bank Research database ...
... Study limited to working with human tissue samples (or other human biological samples) and data (specific project only) Study limited to working with data (specific project only) Research tissue bank Research database ...
AusPAR: Ivacaftor - Therapeutic Goods Administration
... Ivacaftor’s major metabolites, M1 (hydroxymethyl ivacaftor) and M6 (ivacaftor carboxylate), were approximately 6- and >50-fold less potent than ivacaftor at potentiating cAMP-stimulated chloride ion transport in human bronchial epithelial cells derived from a G551D/F508del heterozygous patient. Base ...
... Ivacaftor’s major metabolites, M1 (hydroxymethyl ivacaftor) and M6 (ivacaftor carboxylate), were approximately 6- and >50-fold less potent than ivacaftor at potentiating cAMP-stimulated chloride ion transport in human bronchial epithelial cells derived from a G551D/F508del heterozygous patient. Base ...
Alternating antipyretics in the treatment of fever in children:
... Scholar and references of the articles found. The review included randomized clinical trials published until December 2011, in which one of the arms was the alternating antipyretics therapy to treat fever in children younger than 12 years, treated on an outpatient basis. Data selection and extractio ...
... Scholar and references of the articles found. The review included randomized clinical trials published until December 2011, in which one of the arms was the alternating antipyretics therapy to treat fever in children younger than 12 years, treated on an outpatient basis. Data selection and extractio ...
Herbal medicinal products for non-ulcer dyspepsia
... human subjects were included. Results: Seventeen randomized clinical trials were identified, nine of which involved peppermint and caraway as constituents of combination preparations. Symptoms were reduced by all treatments (60–95% of patients reported improvements in symptoms). The mechanism of any ...
... human subjects were included. Results: Seventeen randomized clinical trials were identified, nine of which involved peppermint and caraway as constituents of combination preparations. Symptoms were reduced by all treatments (60–95% of patients reported improvements in symptoms). The mechanism of any ...
Carbamazepine Forensic
... Of the 547, 331 were found dead or were dead on arrival at hospital These deaths are very unlikely to be due to paracetamol A further 66 died in hospital but did not have any evidence of liver injury at autopsy These deaths were not paracetamol ...
... Of the 547, 331 were found dead or were dead on arrival at hospital These deaths are very unlikely to be due to paracetamol A further 66 died in hospital but did not have any evidence of liver injury at autopsy These deaths were not paracetamol ...
Pharmacologic insights into the future of trastuzumab
... other agents obtained in preclinical and early clinical Trastuzumab in combination with other agents trials being applied to the clinical assessment of new treatment regimens and new routes of administration. Pietras et al. [15] demonstrated that trastuzumab and Although many of these studies are in ...
... other agents obtained in preclinical and early clinical Trastuzumab in combination with other agents trials being applied to the clinical assessment of new treatment regimens and new routes of administration. Pietras et al. [15] demonstrated that trastuzumab and Although many of these studies are in ...
010203 Preventing Falls in Elderly Persons
... use of medications. Medications may be appropriately recommended for the treatment of a disease, but they also have adverse effects; falling is one of the most common adverse events related to drugs.22-24 Many elderly patients have several chronic conditions for which multiple medications are prescr ...
... use of medications. Medications may be appropriately recommended for the treatment of a disease, but they also have adverse effects; falling is one of the most common adverse events related to drugs.22-24 Many elderly patients have several chronic conditions for which multiple medications are prescr ...