March 2016 - Positive Recommendations
... The clinical evidence presented to the PBAC was a randomised phase III trial. On the basis of direct evidence presented by the November 2015 submission, the comparison of bevacizumab plus chemotherapy and chemotherapy alone resulted in: • Approximately 3.5 months prolongation in median overall survi ...
... The clinical evidence presented to the PBAC was a randomised phase III trial. On the basis of direct evidence presented by the November 2015 submission, the comparison of bevacizumab plus chemotherapy and chemotherapy alone resulted in: • Approximately 3.5 months prolongation in median overall survi ...
Add-Aspirin protocol - MRC Clinical Trials Unit
... A phase III, multi-centre, double-blind, placebo-controlled randomised trial with four parallel cohorts. Each of the four cohorts are tumour site-specific (breast, colorectal, gastrooesophageal and prostate cancer) see figure 1 – page x. An overarching protocol ensures each cohort is as comparable a ...
... A phase III, multi-centre, double-blind, placebo-controlled randomised trial with four parallel cohorts. Each of the four cohorts are tumour site-specific (breast, colorectal, gastrooesophageal and prostate cancer) see figure 1 – page x. An overarching protocol ensures each cohort is as comparable a ...
Chemical, pharmacokinetic and pharmacodynamic properties of
... in managing cardiovascular risk in patients with relatively normal levels of plasma cholesterol. Although all statins share a common mechanism of action, they differ in terms of their chemical structures, pharmacokinetic profiles, and lipid-modifying efficacy. The chemical structures of statins gove ...
... in managing cardiovascular risk in patients with relatively normal levels of plasma cholesterol. Although all statins share a common mechanism of action, they differ in terms of their chemical structures, pharmacokinetic profiles, and lipid-modifying efficacy. The chemical structures of statins gove ...
The 6-Minute Walk Test and Person-Reported
... feasible, safe, and reliable in boys with DMD who have not yet transitioned to full time wheelchair use15,16 . We also documented that they have markedly compromised ambulation relative to healthy boys and correlated 6-minute walk distance (6MWD) with age, anthropometric characteristics, and measure ...
... feasible, safe, and reliable in boys with DMD who have not yet transitioned to full time wheelchair use15,16 . We also documented that they have markedly compromised ambulation relative to healthy boys and correlated 6-minute walk distance (6MWD) with age, anthropometric characteristics, and measure ...
Treatment Options for Glioblastoma and other Gliomas
... prescribe them. Thus, patients themselves need to become familiar with these new agents and the evidence available regarding their clinical effectiveness. It is possible, although by no means proven, that some combination of these newly repurposed agents offers the best possibility for survival. Pat ...
... prescribe them. Thus, patients themselves need to become familiar with these new agents and the evidence available regarding their clinical effectiveness. It is possible, although by no means proven, that some combination of these newly repurposed agents offers the best possibility for survival. Pat ...
PDF
... successful outcome (MRS⫽0 or 1), interpretation of P values should be made with caution because multiple analyses, considered exploratory, were performed. ...
... successful outcome (MRS⫽0 or 1), interpretation of P values should be made with caution because multiple analyses, considered exploratory, were performed. ...
Update on Fibromyalgia Therapy
... serotonin availability at the neuronal synapse. While initial reports found no improvement in pain symptoms with fluoxetine,25 follow-up studies suggested that this SSRI was as effective as amitriptyline. The 2 medications combined showed greater efficacy than either alone.26 A more recent placebo-c ...
... serotonin availability at the neuronal synapse. While initial reports found no improvement in pain symptoms with fluoxetine,25 follow-up studies suggested that this SSRI was as effective as amitriptyline. The 2 medications combined showed greater efficacy than either alone.26 A more recent placebo-c ...
Project: Abbott Course Title: REDUCTIL Module title/ID: Competition
... In early 2009 the European Medicines Agency officially decided to withdraw the marketing authorisation for Rimonabant, (Acomplia). The decision was made primarily because of the risk of depression and suicide associated with the drug. Recent studies had shown an increased risk of psychiatric disorde ...
... In early 2009 the European Medicines Agency officially decided to withdraw the marketing authorisation for Rimonabant, (Acomplia). The decision was made primarily because of the risk of depression and suicide associated with the drug. Recent studies had shown an increased risk of psychiatric disorde ...
Septic Shock Advances in Diagnosis and Treatment
... panel on circulatory shock.10,12 Serial lactate measurements are nonetheless widely used in practice,27 but the specific threshold for diagnosing shock and its role in monitoring remains unknown. One open-label randomized clinical trial in 4 ICUs tested a protocol targeting a 20% reduction in lactat ...
... panel on circulatory shock.10,12 Serial lactate measurements are nonetheless widely used in practice,27 but the specific threshold for diagnosing shock and its role in monitoring remains unknown. One open-label randomized clinical trial in 4 ICUs tested a protocol targeting a 20% reduction in lactat ...
(PSD) July 2016 PBAC Meeting
... In both arms of trial CA209-025, patients were able to continue receiving treatment beyond progression if they were assessed as still deriving clinical benefit and tolerating treatment. The submission claimed that progression based on discontinuation of treatment would be more clinically representat ...
... In both arms of trial CA209-025, patients were able to continue receiving treatment beyond progression if they were assessed as still deriving clinical benefit and tolerating treatment. The submission claimed that progression based on discontinuation of treatment would be more clinically representat ...
Full Text:PDF - The Turkish Journal of Pediatrics
... antivenom has been used for the treatment of all SE cases 8 . The aims of this study were to evaluate the epidemiological and clinical characteristics, laboratory findings and outcomes of patients with SE. Material and Methods This was a retrospective study of the medical records of all children dia ...
... antivenom has been used for the treatment of all SE cases 8 . The aims of this study were to evaluate the epidemiological and clinical characteristics, laboratory findings and outcomes of patients with SE. Material and Methods This was a retrospective study of the medical records of all children dia ...
Local anesthetics Part I
... and articaine (Septanest®, Ultracaine®, Septocaine®). Articaine, which has been used in Europe and Canada for a number of years, received FDA approval for use in the United States in April 2000 (6). Procaine (Novocain®), the last ester anesthetic available for clinical use, was removed from the U.S. ...
... and articaine (Septanest®, Ultracaine®, Septocaine®). Articaine, which has been used in Europe and Canada for a number of years, received FDA approval for use in the United States in April 2000 (6). Procaine (Novocain®), the last ester anesthetic available for clinical use, was removed from the U.S. ...
Prescribing Information - PI
... purpose. Acute symptoms should be treated with an inhaled short-acting beta2-agonist. When beginning BEVESPI AEROSPHERE, patients who have been taking inhaled, shortacting beta2-agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these medicine ...
... purpose. Acute symptoms should be treated with an inhaled short-acting beta2-agonist. When beginning BEVESPI AEROSPHERE, patients who have been taking inhaled, shortacting beta2-agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these medicine ...
Update on the Medical Treatment of Primary Open
... control groups were a small study by Holmin et al6 and the multicenter Early Manifest Glaucoma Trial.7 The Early Manifest Glaucoma Trial was a US-Swedish collaborative study performed in the early 1990s, which concluded that lowering IOP effectively slowed visual field progression in early stage gla ...
... control groups were a small study by Holmin et al6 and the multicenter Early Manifest Glaucoma Trial.7 The Early Manifest Glaucoma Trial was a US-Swedish collaborative study performed in the early 1990s, which concluded that lowering IOP effectively slowed visual field progression in early stage gla ...
Renal Clinical Pharmacy Services - E
... In the German language, the term ‘Patientenorientierte Pharmazie’ (literally translated ‘patient-oriented pharmacy’) is often used synonymously. The adjective ‘clinical’ suggests a narrow scope of clinical pharmacy services that are limited to hospitalised patients. However, clinical pharmacy can al ...
... In the German language, the term ‘Patientenorientierte Pharmazie’ (literally translated ‘patient-oriented pharmacy’) is often used synonymously. The adjective ‘clinical’ suggests a narrow scope of clinical pharmacy services that are limited to hospitalised patients. However, clinical pharmacy can al ...
UPICT Consolidated Statement-Post Call 05-03-2011
... that the test results may be valid within the context of the trial (see Sections 1.7.2, 3 and 4.2.2). Relative contraindications become absolute (i.e., Imaging Exclusion Criteria) when they cannot be remediated. When the FDG-PET/CT imaging endpoint is a trial endpoint, the subject would then be excl ...
... that the test results may be valid within the context of the trial (see Sections 1.7.2, 3 and 4.2.2). Relative contraindications become absolute (i.e., Imaging Exclusion Criteria) when they cannot be remediated. When the FDG-PET/CT imaging endpoint is a trial endpoint, the subject would then be excl ...
Herb-drug interactions
... One case report of coma induced by a combination of kava and alprazolam-a benzodiazepine Extrapyramidal side effects-4 cases of dopamine antagonism-oral, lingual and trunk dyskinesia Inhibition of CYP2E1 – clinical trial Do not combine with alcohol, sedatives, tranquilizers or ...
... One case report of coma induced by a combination of kava and alprazolam-a benzodiazepine Extrapyramidal side effects-4 cases of dopamine antagonism-oral, lingual and trunk dyskinesia Inhibition of CYP2E1 – clinical trial Do not combine with alcohol, sedatives, tranquilizers or ...
Clinical Handover
... Where possible, clinical handover should actively involve the patient and carer as well as clinicians. Patients and carers can provide information that is not necessarily available to clinicians. ...
... Where possible, clinical handover should actively involve the patient and carer as well as clinicians. Patients and carers can provide information that is not necessarily available to clinicians. ...
Fentanyl citrate - Therapeutic Goods Administration
... Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy in cancer patients. Patients should be instructed not to use two different formulations of fentanyl concurrently for the treatment of breakthrough pain and to dispose of any ...
... Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy in cancer patients. Patients should be instructed not to use two different formulations of fentanyl concurrently for the treatment of breakthrough pain and to dispose of any ...
invega sustenna
... and poor metabolizers of CYP2D6 substrates. In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicines metabolized by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5. In vitro stud ...
... and poor metabolizers of CYP2D6 substrates. In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicines metabolized by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5. In vitro stud ...
Rotarix - GlaxoSmithKline
... For subjects with a predisposition for intussusception, see CONTRAINDICATIONS. Excretion of the vaccine virus in the stools is known to occur after vaccination and lasts for 10 days on average with peak excretion around the 7th day. Viral antigen particles detected by ELISA were found in 50% (at day ...
... For subjects with a predisposition for intussusception, see CONTRAINDICATIONS. Excretion of the vaccine virus in the stools is known to occur after vaccination and lasts for 10 days on average with peak excretion around the 7th day. Viral antigen particles detected by ELISA were found in 50% (at day ...
AusPAR: Denosumab
... heavy chains and two light chains of the kappa subclass. Denosumab contains 36 cysteine residues, which are involved in both intrachain and interchain disulfide bonds. Each heavy chain contains an N-linked glycan at the consensus glycosylation site at asparagine 298. Each light chain contains 215 am ...
... heavy chains and two light chains of the kappa subclass. Denosumab contains 36 cysteine residues, which are involved in both intrachain and interchain disulfide bonds. Each heavy chain contains an N-linked glycan at the consensus glycosylation site at asparagine 298. Each light chain contains 215 am ...
Ultrasound Assessment of Severe Dehydration in Children With
... helping clinicians identify those patients who can be safely treated with oral rehydration and brief observation. This is especially true in the developing world, where resources such as IV fluids and hospital beds are scarce. Even more importantly, US could aid providers in identifying those childr ...
... helping clinicians identify those patients who can be safely treated with oral rehydration and brief observation. This is especially true in the developing world, where resources such as IV fluids and hospital beds are scarce. Even more importantly, US could aid providers in identifying those childr ...
RUBOXISTAURIN – A PROMISING THERAPY FOR DIABETIC
... Mechanism of Action In diabetes, there is increased activity of protein kinase C (PKC) found in the cell membranes. An increased concentration of intracellular diacyl glycerol (DAG), an intermediary product of metabolism, is seen in diabetes. Both isoforms of PKCβ have domains that can bind to DAG. ...
... Mechanism of Action In diabetes, there is increased activity of protein kinase C (PKC) found in the cell membranes. An increased concentration of intracellular diacyl glycerol (DAG), an intermediary product of metabolism, is seen in diabetes. Both isoforms of PKCβ have domains that can bind to DAG. ...
Imlygic : EPAR - EMA
... provides information on the thickness of the lesions (Breslow), information on the mitotic rate and ulceration, number of lymph nodes involved and regression or progression of the lesion to locoregional sites (subcutaneous invasion, lymph nodes) or distant lesions with or without the presence of ele ...
... provides information on the thickness of the lesions (Breslow), information on the mitotic rate and ulceration, number of lymph nodes involved and regression or progression of the lesion to locoregional sites (subcutaneous invasion, lymph nodes) or distant lesions with or without the presence of ele ...