Biaxin® XL / Biaxin
... BIAXIN XL Filmtab is indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of BIAXIN XL Filmtab in treating other infections for which BIAXIN Filmtab and BIAXIN Granules are approved have ...
... BIAXIN XL Filmtab is indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of BIAXIN XL Filmtab in treating other infections for which BIAXIN Filmtab and BIAXIN Granules are approved have ...
FOxTROT Protocol - Virtual Pathology at the University of Leeds
... potential practical benefits exist: by giving drug therapy at a time when its effects are observable, an assessment of response may be made, which could potentially guide decisions about postoperative therapy. It is also possible that, as in oesophageal cancer, the preoperative setting may allow dru ...
... potential practical benefits exist: by giving drug therapy at a time when its effects are observable, an assessment of response may be made, which could potentially guide decisions about postoperative therapy. It is also possible that, as in oesophageal cancer, the preoperative setting may allow dru ...
TITLE: A Multicenter, Randomized Dose Response Study of
... Vaccination against smallpox is protective if administered before exposure or within 2-3 days thereafter (7). Following eradication of smallpox, Dryvax production for general use in the US was discontinued in 1982 and general distribution of smallpox vaccine was discontinued in 1983 (8). Few physici ...
... Vaccination against smallpox is protective if administered before exposure or within 2-3 days thereafter (7). Following eradication of smallpox, Dryvax production for general use in the US was discontinued in 1982 and general distribution of smallpox vaccine was discontinued in 1983 (8). Few physici ...
AVYCAZ (ceftazidime-avibactam for injection), for
... Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Citrobacter freundii complex, Proteus mirabilis, and Pseudomonas aeruginosa in patients 18 years or older. ...
... Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Citrobacter freundii complex, Proteus mirabilis, and Pseudomonas aeruginosa in patients 18 years or older. ...
Effective Treatment Strategies in the Management of Acne
... been targeted for the adult acne patient, notes Dr. Berson, adult female acne has received greater attention in recent years. Additionally, several roundtable contributors report that adult female acne is on the rise in their practices. “Acne is my number one diagnosis among adults,” says Dr. Alexis ...
... been targeted for the adult acne patient, notes Dr. Berson, adult female acne has received greater attention in recent years. Additionally, several roundtable contributors report that adult female acne is on the rise in their practices. “Acne is my number one diagnosis among adults,” says Dr. Alexis ...
periostat product monograph
... less effective. Drug/Laboratory Test Interactions: False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test. ADVERSE REACTIONS Adverse Reactions in Clinical Trials of Periostat™: In clinical trials of adult patients with periodontal disease 213 patien ...
... less effective. Drug/Laboratory Test Interactions: False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test. ADVERSE REACTIONS Adverse Reactions in Clinical Trials of Periostat™: In clinical trials of adult patients with periodontal disease 213 patien ...
Department of Health and Huma Services Part II
... subjects who will be eligible for this research-it is common to the majority of individuals who may be in these lifethreatening situations. FDA thinks that the protections contained in this rule including IRB review, the requirements for obtaining informed consent when it is feasible, and for commun ...
... subjects who will be eligible for this research-it is common to the majority of individuals who may be in these lifethreatening situations. FDA thinks that the protections contained in this rule including IRB review, the requirements for obtaining informed consent when it is feasible, and for commun ...
75/2009 - Repatriation Medical Authority
... For the purposes of this Statement of Principles, "adrenal insufficiency" also known as Addison’s disease, means an endocrine disease characterised by abnormally diminished production of adrenal cortical hormones, sufficient to produce clinical symptoms and signs and to necessitate glucocorticoid or ...
... For the purposes of this Statement of Principles, "adrenal insufficiency" also known as Addison’s disease, means an endocrine disease characterised by abnormally diminished production of adrenal cortical hormones, sufficient to produce clinical symptoms and signs and to necessitate glucocorticoid or ...
Hypericum perforatum Monograph
... later randomized trial of 72 patients also demonstrated a single dose (1,800 mg daily) of Hypericum extract LI 160 did not support evidence for a phototoxic effect. 77 Fair-skinned individuals should take precautions when exposed to the sun while taking St. John’s wort. It is advisable that elderly ...
... later randomized trial of 72 patients also demonstrated a single dose (1,800 mg daily) of Hypericum extract LI 160 did not support evidence for a phototoxic effect. 77 Fair-skinned individuals should take precautions when exposed to the sun while taking St. John’s wort. It is advisable that elderly ...
Guideline
... Although the definitive care of patients with snake envenoming cannot occur in small hospitals without laboratory facilities or sufficient medical or nursing care to allow close observation, antivenom treatment can be given. In patients with clear evidence of clinical envenoming or sufficient concer ...
... Although the definitive care of patients with snake envenoming cannot occur in small hospitals without laboratory facilities or sufficient medical or nursing care to allow close observation, antivenom treatment can be given. In patients with clear evidence of clinical envenoming or sufficient concer ...
HIV Research Inventory
... Tobira Therapeutics -652: A phase IIb, multicenter, double blind comparative study to evaluate the efficacy, safety and tolerability of Cenicriviroc in HIV‐1 infected, antiretroviral treatment naïve patients with only CCR5‐tropic virus. Participants will receive either once‐daily 100 mg or 200 mg do ...
... Tobira Therapeutics -652: A phase IIb, multicenter, double blind comparative study to evaluate the efficacy, safety and tolerability of Cenicriviroc in HIV‐1 infected, antiretroviral treatment naïve patients with only CCR5‐tropic virus. Participants will receive either once‐daily 100 mg or 200 mg do ...
Acupuncture involves the stimulation of specific points
... limited number of studies were found for the treatment of other joint related conditions and pneumonia but as these are not replicated robust recommendations cannot be made with confidence. There is no convincing evidence that reflexology can effectively treat any condition. There is some limited ev ...
... limited number of studies were found for the treatment of other joint related conditions and pneumonia but as these are not replicated robust recommendations cannot be made with confidence. There is no convincing evidence that reflexology can effectively treat any condition. There is some limited ev ...
(PSD) July 2016 PBAC Meeting - (Word 86KB)
... endpoint of progression of disability. Daclizumab presents more risk of serious adverse effects than IFN β-1a. Given these factors it is not clear whether use of this product should be permitted at all or whether restricting its use to patients who have failed initial treatment would be appropriate. ...
... endpoint of progression of disability. Daclizumab presents more risk of serious adverse effects than IFN β-1a. Given these factors it is not clear whether use of this product should be permitted at all or whether restricting its use to patients who have failed initial treatment would be appropriate. ...
The Effect of Expert Role Modeling on Anxiety/Self
... significant anxiety when anticipating their first clinical day in an acute care facility. This leads to decreased self-confidence in clinical judgment necessary to provide safe care for patients. Nurse educators must be aware of anxiety levels and self-confidence to intervene appropriately to foster ...
... significant anxiety when anticipating their first clinical day in an acute care facility. This leads to decreased self-confidence in clinical judgment necessary to provide safe care for patients. Nurse educators must be aware of anxiety levels and self-confidence to intervene appropriately to foster ...
Suggestion from clinicians
... goal achievement in patients with hypercholesterolemia. Trial results indicate that rosuvastatin 10 to 40 mg has greater efficacy than atorvastatin 10 to 80 mg, simvastatin 10 to 80 mg, and pravastatin 10 to 40 mg for achievement of ATP III LDL-C and non-HDL-C goals, European LDL-C goals, and Canadi ...
... goal achievement in patients with hypercholesterolemia. Trial results indicate that rosuvastatin 10 to 40 mg has greater efficacy than atorvastatin 10 to 80 mg, simvastatin 10 to 80 mg, and pravastatin 10 to 40 mg for achievement of ATP III LDL-C and non-HDL-C goals, European LDL-C goals, and Canadi ...
Comparison of efficacy between incretin
... treatment options have side effects such as weight gain which often affect patient’s willingness to continue the treatment. Effective weight loss, lack of significant hypoglycaemia, and favourable cardiometabolic profile make Incretin based therapies an attractive treatment option for type 2 diabete ...
... treatment options have side effects such as weight gain which often affect patient’s willingness to continue the treatment. Effective weight loss, lack of significant hypoglycaemia, and favourable cardiometabolic profile make Incretin based therapies an attractive treatment option for type 2 diabete ...
Comparison of efficacy between incretin-based therapies for type 2 diabetes mellitus
... treatment options have side effects such as weight gain which often affect patient’s willingness to continue the treatment. Effective weight loss, lack of significant hypoglycaemia, and favourable cardiometabolic profile make Incretin based therapies an attractive treatment option for type 2 diabete ...
... treatment options have side effects such as weight gain which often affect patient’s willingness to continue the treatment. Effective weight loss, lack of significant hypoglycaemia, and favourable cardiometabolic profile make Incretin based therapies an attractive treatment option for type 2 diabete ...
US Product Labeling @std Template for PLR
... There are no human clinical or pre-clinical animal data to support the use of this product in a chronic manner or in manners other than those described in this prescribing information. In clinical trials, 210 domestic (US) and 2,130 foreign adult subjects received BACTROBAN nasal ointment. Greater t ...
... There are no human clinical or pre-clinical animal data to support the use of this product in a chronic manner or in manners other than those described in this prescribing information. In clinical trials, 210 domestic (US) and 2,130 foreign adult subjects received BACTROBAN nasal ointment. Greater t ...
Acute Stroke Intervention A Systematic Review
... to 40% of patients achieve good outcomes (ie, functional independence).21,22 These data suggest that proximal artery occlusions (ie, middle cerebral artery and internal carotid artery) may be relatively resistant to IV rtPA alone.22-24 Because proximal artery occlusions account for one-third of AIS, ...
... to 40% of patients achieve good outcomes (ie, functional independence).21,22 These data suggest that proximal artery occlusions (ie, middle cerebral artery and internal carotid artery) may be relatively resistant to IV rtPA alone.22-24 Because proximal artery occlusions account for one-third of AIS, ...
Tree-structured gatekeeping procedures for multiple objectives in
... An important feature of the multiple testing framework considered in [1–3] is that each family of null hypotheses is examined only if all of the tests carried out before are significant. Dmitrienko et al. [4] discussed an alternative scenario in which one sequentially tests families of hypotheses pr ...
... An important feature of the multiple testing framework considered in [1–3] is that each family of null hypotheses is examined only if all of the tests carried out before are significant. Dmitrienko et al. [4] discussed an alternative scenario in which one sequentially tests families of hypotheses pr ...
Guidelines on evaluation of similar
... countries. Demonstration of structural sameness and bioequivalence of the generic medicine with the reference product is usually appropriate to infer (conclude) therapeutic equivalence between the generic and the reference product. However, the generic approach is not suitable for the licensing of S ...
... countries. Demonstration of structural sameness and bioequivalence of the generic medicine with the reference product is usually appropriate to infer (conclude) therapeutic equivalence between the generic and the reference product. However, the generic approach is not suitable for the licensing of S ...
Vascular Interventional Radiography
... to, previous studies, the size of the profession, and the amount of resources available to conduct the study. These factors affect various decisions on how to conduct the study. Perhaps the two most important decisions pertain to: (a) the type of practice-related information that is obtained; (b) th ...
... to, previous studies, the size of the profession, and the amount of resources available to conduct the study. These factors affect various decisions on how to conduct the study. Perhaps the two most important decisions pertain to: (a) the type of practice-related information that is obtained; (b) th ...
Reliance on an External IRB - Duke IRB
... IV. Responsibilities of the Investigator/Study Team The investigator/study team may not add any procedures to the sponsor’s protocol (e.g., additional biopsies, storage of biological specimens for future research at DUHS, additional laboratory or imaging studies). Such activities can only be underta ...
... IV. Responsibilities of the Investigator/Study Team The investigator/study team may not add any procedures to the sponsor’s protocol (e.g., additional biopsies, storage of biological specimens for future research at DUHS, additional laboratory or imaging studies). Such activities can only be underta ...
Safety and Efficacy of Oxcarbazepine - Deep Blue
... the 2400-mg/day group and 46 in the 300mg/day group. The percentage of patients meeting one of the exit criteria (the primary efficacy variable) was significantly lower (p<0.0001) for the 2400-mg/day group (41%) compared with the 300-mg/day group (93%). In the intent-to-treat analysis for the oxcarb ...
... the 2400-mg/day group and 46 in the 300mg/day group. The percentage of patients meeting one of the exit criteria (the primary efficacy variable) was significantly lower (p<0.0001) for the 2400-mg/day group (41%) compared with the 300-mg/day group (93%). In the intent-to-treat analysis for the oxcarb ...
CLINICAL GROUP CLINICAL MONITORING RESEARCH PROGRAM CLINICAL RESEARCH
... end of the translational spectrum under an umbrella that fosters interactions in areas of overlap and provides clinical supervision of such activities. In addition, assigning the QA programs to this directorate was necessary to provide the required autonomy and transparency required of GMP quality a ...
... end of the translational spectrum under an umbrella that fosters interactions in areas of overlap and provides clinical supervision of such activities. In addition, assigning the QA programs to this directorate was necessary to provide the required autonomy and transparency required of GMP quality a ...