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Guidelines on Clinical Management of Chikungunya Fever
Guidelines on Clinical Management of Chikungunya Fever

... WHO’s South-East Asia Region. It has been reported from countries of South and East Africa, South Asia, South-East Asia and, in 2007, from Italy. In the South-East Asia Region, outbreaks have been reported from India, Indonesia, Maldives, Myanmar, Sri Lanka and Thailand. There have been massive outb ...
Fluoroquinolones
Fluoroquinolones

... fluoroquinolones. Indeed, several agents have been withdrawn from the market due to this rare but life threatening adverse effect. Clinical trials with moxifloxacin have reported a mean 6 msec QT prolongation in 38 patients out of 4,008. There was one cardiovascular event in these patients.20 The ma ...
History - Moodle Lille 2
History - Moodle Lille 2

... last-to-expire patent 2027 (US) polymorphic forms of active ingredient 2024 (EU) + SPC in Spain, France, Italy, Germay and the UK. Orphan drug status PIP : Treatment of diffuse large B-cell lymphoma /Myelodysplastic Syndrome ...
gamunex - Grifols
gamunex - Grifols

... Immune Globulin Intravenous (Human) (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death (22). Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, ...
[Product Monograph Template - Schedule D]
[Product Monograph Template - Schedule D]

... Animal reproduction studies have not been conducted with Hizentra. The safety of Hizentra for use in human pregnancy has not been established in controlled clinical trials. Hizentra should be given to pregnant women only if clearly needed. Continued treatment of the pregnant woman is important to en ...
ORIGINAL ARTICLE Morpho-anatomy of leaf, stem and root of
ORIGINAL ARTICLE Morpho-anatomy of leaf, stem and root of

... and sub-tropical regions of Australia and South America1. In India, five species have been recorded, out of which Alternanthera sessilis (L.) R. Br. ex DC and Alternanthera pungens Kunth are utilized extensively as raw drug sources worldwide in many traditional systems of medicine.1,2 As drugs are c ...
Ibandronate
Ibandronate

... ABSTRACT: Oral daily (2.5 mg) and intermittent ibandronate (between-dose interval of >2 months), delivering a similar cumulative exposure, were evaluated in 2946 osteoporotic women with prevalent vertebral fracture. Significant reduction in incident vertebral fracture risk by 62% and 50%, respective ...
Specific Immunotherapy—Indications and Mode of Action
Specific Immunotherapy—Indications and Mode of Action

... system interacts with only a few allergens, which are called major allergens if more than 50% of patients sensitized against the allergen extract react to this particular protein. It should be a requirement that the concentration of a major allergen is declared. This is principally unproblematic whe ...
2 objectives
2 objectives

... Spinal Muscular Atrophy (SMA) is one of the two most common inherited children’s neuromuscular disorders. There currently is no cure and there are no therapeutics approved to slow progression of the disease. SMA is characterized by a loss of alpha motor neurons in the spinal cord, severe atrophy of ...
AusPAR: Regorafenib
AusPAR: Regorafenib

... 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. ...
Panel 1: Standard definitions of the terms used to qualify
Panel 1: Standard definitions of the terms used to qualify

... without randomised medic ally managed control groups, and responses have been compared before and after surgery, sometimes with comparisons between different surgical interventions. 51-53 Based on the results of one randomised controlled trial, assessing parkinsonism in a cross -over design in patie ...
Future Therapies for chronic noninfectious Uveitis
Future Therapies for chronic noninfectious Uveitis

... including those patients with the highest degree of inflammation; patients for whom systemic corticosteroids were determined to be medically inappropriate by the investigator; and in patients with best corrected visual acuity of less than 20/200 in the study eye. In all 3 studies, 96% to 98% of post ...
New generation antipsychotics versus low
New generation antipsychotics versus low

... controls—was used because we expected low frequencies of EPS in both groups. The risk difference gives more meaningful results than relative risks and odds ratios in such situations. To combine the results of the individual studies, we used a random effects model.14 Heterogeneity—ie, significant dif ...
AusPAR: Retigabine - Therapeutic Goods Administration
AusPAR: Retigabine - Therapeutic Goods Administration

... reviewed. Model control streams and data were only provided in printable form which would prevent any evaluation or testing of the model by a reviewer. The PSC agreed that covariate analysis would have been helpful in establishing dosing protocol. ...
Required Skills Check-Off Evaluated in Simulation Lab by
Required Skills Check-Off Evaluated in Simulation Lab by

... Weekly documentation is an expectation to avoid rushing at the end of the clinical rotation. Dates are often forgotten. Only one date/setting is needed for each skill. Documentation of each experience of a skill is not required although multiple experiences may occur- such as vital signs that you ob ...
Memorin - Beximco Pharmaceuticals Ltd.
Memorin - Beximco Pharmaceuticals Ltd.

... Donepezil hydrochloride is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Dosage and Administration The dosages of Donepezil hydrochloride shown to be effective in controlled clinical trials are 5 mg and 10 mg administered once per day. The higher dose of 10 mg did ...
Meta-analysis of Oral Triptan Therapy for Migraine: Number Needed
Meta-analysis of Oral Triptan Therapy for Migraine: Number Needed

... Migraine not only adversely affects the “migraineur’s” quality of life but also, when an attack strikes, affects his or her ability to function in society. Because of the severity of the pain and the accompanying symptoms, migraineurs often must retire to quiet, dark rooms until the headache resolve ...
Comparing Treatments for Age-Related Macular Degeneration
Comparing Treatments for Age-Related Macular Degeneration

... • The higher rate of adverse events in Avastin groups, without a typical doseresponse relationship and in organ systems not targeted by the drug, remains unexplained. It may be that the difference was the result of chance, unobserved differences in the groups at baseline, or truly higher risk. Resu ...
Journal of Clinical Virology Richard J. Whitley *, Antonio Volpi
Journal of Clinical Virology Richard J. Whitley *, Antonio Volpi

... Current evidence from clinical trials is based on the initiation of therapy within 72 hours of rash outbreak.26 There are no wellcontrolled clinical trials that have compared early-onset therapy with later therapy (>72 hours). Bean et al.27 found that the time to viral shedding was reduced by acyclo ...
Australian Public Assessment Report for Fampridine
Australian Public Assessment Report for Fampridine

... · 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 work of the TGA is based on applying scientific an ...
Knowledge
Knowledge

...  Drug interactions – the increase or decrease of drug action, or emergence of a new nontypical effect of a medication, caused by the simultaneous administration of another drug.  Drug implementation – in case of clinical pharmacology it means mainly clinical trial of drugs with the aim of studying ...
clinical protocol for the use of injected local anaesthetics in
clinical protocol for the use of injected local anaesthetics in

... kidneys, they should be used with caution and at a lower maximum dose in patients with liver and renal disease. For patients with cardiac disease (such as ischemic heart disease, arrhythmia’s, angina) caution should be taken when giving any local anaesthetic, especially those containing adrenaline. ...
Final Program - American College of Clinical Pharmacology
Final Program - American College of Clinical Pharmacology

... including the Laurel for Cancer Prevention Leadership from the Prevent Cancer Foundation and the St George Medal from the American Cancer Society. In 2006, Dr. Wender was elected as the national President of the American Cancer Society, becoming the first primary care physician to serve in this capa ...
View Publication - Acceleron Pharma
View Publication - Acceleron Pharma

... • A total of 28 subjects discontinued the study drug and received rescue therapy (Table 1); among these, 1 placebo subject was discontinued from the study drug because of an adverse event (AE) of fatigue and was subsequently rescued. The most frequent reasons for early termination from the study wer ...
http://c.ymcdn.com/sites/www.aiia.com.au/resource/resmgr/Docs/AIIA_Final_Report_20150522.pdf
http://c.ymcdn.com/sites/www.aiia.com.au/resource/resmgr/Docs/AIIA_Final_Report_20150522.pdf

... In a study on blood pressure monitoring among middle-aged Korean Americans a total of 377 patients participated in the study. Instructions were to take blood pressure readings 3 times upon waking and 3 times again before bed, at least 2 or more times a week over a 48 week period. Through the use of ...
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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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