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antibiotic use for irreversible pulpitis
antibiotic use for irreversible pulpitis

... MEDLINE (1966 to 6th September 2004); EMBASE (1980 to week 36 2004). Selection criteria: This review includes one randomised controlled trial which compared pain relief with systemic antibiotics and analgesics, against placebo and analgesics in the acute preoperative phase of irreversible pulpitis. ...
Comparison of Hypertonic Saline to Epinephrine in
Comparison of Hypertonic Saline to Epinephrine in

... children are too breathless to feed and some require oxygen supplementation to maintain blood oxygen levels. These children may require hospitalization. Treatment is mostly supportive using fluids and oxygen therapy. Nebulised bronchodilators like Salbutamol, Ipravent and Epinephrine have been used ...
Product Monograph Template - Standard
Product Monograph Template - Standard

... The use of antidepressants have been associated with the development of akathisia, characterized by a subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. I ...
AusPAR: Levomilnacipran (as hydrochloride)
AusPAR: Levomilnacipran (as hydrochloride)

... endogenous level of ethanolamine and the overall risk-benefit assessment of available genotoxicity and carcinogenicity studies, it was concluded that there appeared to be no imminent risk associated with ethanolamine in the clinical use of these products which allowed for up to 20.7 mg per day PO. T ...
http://www ​.cochrane.org ​/sites/default/files ​/uploads/glossary.pdf
http://www ​.cochrane.org ​/sites/default/files ​/uploads/glossary.pdf

... [In a controlled trial:] The process of preventing those involved in a trial from knowing to which comparison group a particular participant belongs. The risk of bias is minimised when as few people as possible know who is receiving the experimental intervention and who the control intervention. Par ...
Update On OAB
Update On OAB

... • Exclusion criteria for PVR in clinical trials - greater than 30-40% of maximum capacity - or 50-200ml ...
Clinician-Reported Outcome Assessments of Treatment Benefit
Clinician-Reported Outcome Assessments of Treatment Benefit

... specific setting of a clinical trial, and 3) interpreted to reflect how those differences affect how patients feel, function, or survive. Because many efficacy end points in treatment trials are defined using a ClinRO assessment as the COA, a ClinRO assessment should be 1) well defined in terms of the co ...
drugs and cosmetics (iind amendment) rules, 2005
drugs and cosmetics (iind amendment) rules, 2005

... (1) Approval for clinical trial (i) Clinical trial on a new drug shall be initiated only after the permission has been granted by the Licensing Authority under rule 21 (b), and the approval obtained from the respective ethics committee(s). The Licensing Authority as defined shall be informed of the ...
Text - Enlighten - University of Glasgow
Text - Enlighten - University of Glasgow

... Methods/Design: This will be a cluster randomised controlled trial. General practices will be randomised to provide parents consulting because their child has an acute respiratory tract infection with either an interactive booklet, or usual care. The booklet provides information on the expected dura ...
Towards early inclusion of children in tuberculosis drugs trials: a
Towards early inclusion of children in tuberculosis drugs trials: a

... tuberculosis in all children,20,44 are serious and lifethreatening disorders with few treatment options in which affected children are potentially further harmed by the dearth of data to guide use of existing drugs. Thus, tuberculosis drug research can and does, in such instances, offer potential di ...
Guidance for Clinical Investigators, Sponsors, and IRBs
Guidance for Clinical Investigators, Sponsors, and IRBs

... marketed drug is responsible for determining whether the investigation meets the criteria for an exemption.9 If there is uncertainty about whether the exemption criteria are met, the potential sponsor or sponsor-investigator can seek advice from FDA on the applicability of the IND regulations (§ 312 ...
A multi-centre, blinded, randomised, placebo-controlled
A multi-centre, blinded, randomised, placebo-controlled

... nitroglycerine, approximately half water and half organic, with a surfactant system designed for rapid, non-irritating local delivery of the active agent topically on the skin. ...
FOI 090 1314 document 2
FOI 090 1314 document 2

... administered immediately before or with a meal, but if given after meals, the serum levels of clavulanic acil. are significantly reduced. To optimise absorption of clavulanic acid AUGMENTIN XR 1000/62.5 tablets should be administered at the start of a meal. The pharmacokinetics of amoxycillin are no ...
The effect of using an interactive booklet on childhood respiratory
The effect of using an interactive booklet on childhood respiratory

... Methods/Design: This will be a cluster randomised controlled trial. General practices will be randomised to provide parents consulting because their child has an acute respiratory tract infection with either an interactive booklet, or usual care. The booklet provides information on the expected dura ...
homeopathy - Medical Clinics of North America
homeopathy - Medical Clinics of North America

... according to a strict protocol. Although conventional researchers are looking for physiologic tolerance in healthy individuals without too many side effects, homeopaths pay attention to those side effects, trying to find as many as they can. Homeopaths use the side effects to guide their prescribing. ...
REMERON  PRODUCT MONOGRAPH
REMERON PRODUCT MONOGRAPH

... In pre-marketing clinical trials, two (one with Sjögren’s Syndrome) out of 2,796 patients treated with REMERON® Tablets and one patient treated with imipramine developed agranulocytosis. In all three cases, the patients recovered after the drug with which they were being treated was stopped. In the ...
Explanation and elaboration document (WORD, 855KB)
Explanation and elaboration document (WORD, 855KB)

... This template attempts to provide a general format applicable to all clinical trials evaluating an investigational product (drugs or medical devices). Note that instructions are indicated in blue italics and they need be deleted (or alternatively may be formatted as “hidden Text” that will not show ...
The Nortriptyline Therapeutic Window
The Nortriptyline Therapeutic Window

... that supports the safe and effective use of newly developed pharmaceuticals. However, older drugs, which may still be mainstays of treatment, are not always retrospectively subjected to the same scientific scrutiny as their newer counterparts. Some researchers have revisited the evidence supporting ...
Questions and answers EMA-FDA GCP initiative
Questions and answers EMA-FDA GCP initiative

... extremely successful and very productive, and it has further strengthened the confidence in inspections between the partner organizations. This lays the foundation for a more efficient use of limited resources, improved inspectional coverage and better understanding of each agency’s inspection proce ...
Potential Herb-Drug Interactions for Commonly
Potential Herb-Drug Interactions for Commonly

... It is recommended that St John’s wort is contraindicated in patients taking cancer chemotherapeutic drugs. In the case of gliclazide, because the trial found little effect on a clinically-relevant outcome, the potential interaction is considered low risk and a caution is recommended: the patient ...
(PSD) November 2015 PBAC Meeting
(PSD) November 2015 PBAC Meeting

... submission’s pooled analysis of all patients was potentially biased due to the heterogeneity in treatment experience across the two groups. To provide a more appropriate comparison, separate pooled analyses were performed for both treatment naïve and treatment experienced. This showed that virologic ...
Steven H - Clinical Trial Centers
Steven H - Clinical Trial Centers

... A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of XXX on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with an Oral XXX A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi ...
Slides - Science Webinar
Slides - Science Webinar

... Main interest: producing tools so that we can move (way) beyond the current over-reliance on epidemiological correlation and preclinical models ...
2 Study Objectives - University of Pennsylvania
2 Study Objectives - University of Pennsylvania

... found using the same date range as cases.] ...
For patients with severe COPD associated with chronic bronchitis
For patients with severe COPD associated with chronic bronchitis

... Intermezzo (Transcept Pharmaceuticals) should only be used when a person has at least 4 hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid. The recommended and maximum dose of Intermezzo is 1.75 mg for women and 3.5 mg for men, taken once per ...
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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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