(Opdivo) for Metastatic Renal Cell Carcinoma
... the second-line / third-line treatment of advanced and metastatic RCC based on one high-quality randomized controlled trial that demonstrated a clinically meaningful and statistically significant benefit in overall survival for nivolumab compared with everolimus. This was based on CheckMate 025 whic ...
... the second-line / third-line treatment of advanced and metastatic RCC based on one high-quality randomized controlled trial that demonstrated a clinically meaningful and statistically significant benefit in overall survival for nivolumab compared with everolimus. This was based on CheckMate 025 whic ...
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 ...
Dynamic contrast enhanced ultrasound assessment of the vascular
... magnetic resonance imaging (MRI) and ultrasound, are routinely used to monitor the response to cancer therapy. Current assessment of response is based on interval evaluation of the tumour sizes using the Response Evaluation Criteria In Solid Tumours (RECIST) [4]. However, as these anti-vascular ther ...
... magnetic resonance imaging (MRI) and ultrasound, are routinely used to monitor the response to cancer therapy. Current assessment of response is based on interval evaluation of the tumour sizes using the Response Evaluation Criteria In Solid Tumours (RECIST) [4]. However, as these anti-vascular ther ...
Treatment of Restless Legs Syndrome: An Evidence-Based Review
... severity improved in all trials. From the available published clinical trials, the incidence of adverse reactions is similar to that of other available dopamine agonists. There are no specific concerns about hypersomnolence in RLS patients. There was no specific monitoring for augmentation or dopami ...
... severity improved in all trials. From the available published clinical trials, the incidence of adverse reactions is similar to that of other available dopamine agonists. There are no specific concerns about hypersomnolence in RLS patients. There was no specific monitoring for augmentation or dopami ...
Memorandum of understanding - MYO-MRI
... of disease progression and pathology and thereby contribute to the time- and cost-effective evaluation of therapeutic interventions. Specialised protocols that have enabled the use of these techniques to quantitatively assess treatment effect earlier and with greater sensitivity than other measures ...
... of disease progression and pathology and thereby contribute to the time- and cost-effective evaluation of therapeutic interventions. Specialised protocols that have enabled the use of these techniques to quantitatively assess treatment effect earlier and with greater sensitivity than other measures ...
MEDDEV 2.7/1 revision 4, Clinical evaluation: a guide for
... medical device. [EN ISO 14155:2011] Bias: bias is a systematic deviation of an outcome measure from its true value, leading to either an overestimation or underestimation of a treatment’s effect. It can originate from, for example, the way patients are allocated to treatment, the way treatment outco ...
... medical device. [EN ISO 14155:2011] Bias: bias is a systematic deviation of an outcome measure from its true value, leading to either an overestimation or underestimation of a treatment’s effect. It can originate from, for example, the way patients are allocated to treatment, the way treatment outco ...
MEDDEV 2.7/1 revision 4, Clinical evaluation: a guide for
... medical device. [EN ISO 14155:2011] Bias: bias is a systematic deviation of an outcome measure from its true value, leading to either an overestimation or underestimation of a treatment’s effect. It can originate from, for example, the way patients are allocated to treatment, the way treatment outco ...
... medical device. [EN ISO 14155:2011] Bias: bias is a systematic deviation of an outcome measure from its true value, leading to either an overestimation or underestimation of a treatment’s effect. It can originate from, for example, the way patients are allocated to treatment, the way treatment outco ...
40131
... Voluntary Professor of Family Medicine and Community Health University of Miami Miller School of Medicine ...
... Voluntary Professor of Family Medicine and Community Health University of Miami Miller School of Medicine ...
Adjuvant Ovarian Ablation in the Treatment of Premenopausal
... The precise role of OA in the treatment of early-stage invasive breast cancer is unclear, particularly in the context of systemic chemotherapy and other hormonal therapies. In this systematic review, nine specific questions about the value of OA in the treatment of breast cancer are considered. Howe ...
... The precise role of OA in the treatment of early-stage invasive breast cancer is unclear, particularly in the context of systemic chemotherapy and other hormonal therapies. In this systematic review, nine specific questions about the value of OA in the treatment of breast cancer are considered. Howe ...
Testosterone Supplementation in Heart Failure A Meta
... used as a weighting factor to combine the study results. In studies that used the same type of exercise or metabolic measures, we determined the pooled mean differences of pretreatment and posttreatment measurements between testosterone and placebo. All P values were 2 sided, and P⬍0.05 was regarded ...
... used as a weighting factor to combine the study results. In studies that used the same type of exercise or metabolic measures, we determined the pooled mean differences of pretreatment and posttreatment measurements between testosterone and placebo. All P values were 2 sided, and P⬍0.05 was regarded ...
Inhaled heparin in cystic fibrosis D.J. Serisier* , J.K. Shute , P.M. Hockey
... analogue scores (including those pertaining to sputum clearance; table 2), overall quality of life on the CFQ, or any of the three quality-of-life modules. Heparin was associated with negative effects upon both the body image (median difference -5.56; p50.04) and social/marginalisation dimensions (m ...
... analogue scores (including those pertaining to sputum clearance; table 2), overall quality of life on the CFQ, or any of the three quality-of-life modules. Heparin was associated with negative effects upon both the body image (median difference -5.56; p50.04) and social/marginalisation dimensions (m ...
Gout
... long been used, although it has only recently (in 2009) been approved by the Food and Drug Administration (FDA) for use in patients with acute gout. In a randomized trial, colchicine (at a dose of 1.2 mg at the onset of a flare, followed by 0.6 mg 1 hour later) was significantly more likely than pla ...
... long been used, although it has only recently (in 2009) been approved by the Food and Drug Administration (FDA) for use in patients with acute gout. In a randomized trial, colchicine (at a dose of 1.2 mg at the onset of a flare, followed by 0.6 mg 1 hour later) was significantly more likely than pla ...
1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION
... analysis could result in a finding that LJP 394 is not effective in large patient populations or does not provide a meaningful clinical benefit. Our blood test to measure the binding affinity for LJP 394 is experimental and has not been validated by independent laboratories. Our other potential drug ...
... analysis could result in a finding that LJP 394 is not effective in large patient populations or does not provide a meaningful clinical benefit. Our blood test to measure the binding affinity for LJP 394 is experimental and has not been validated by independent laboratories. Our other potential drug ...
Extract from the Clinical Evaluation Report for Insulin glargine
... There are three studies that contribute materially relevant information on the pharmacokinetics, in healthy subjects, of Abasria and of Lantus EU. The studies are ABEA, ABEM and ABEI. These studies also generated pharmacodynamic data. Of these three studies, ABEI is the least important owing to its ...
... There are three studies that contribute materially relevant information on the pharmacokinetics, in healthy subjects, of Abasria and of Lantus EU. The studies are ABEA, ABEM and ABEI. These studies also generated pharmacodynamic data. Of these three studies, ABEI is the least important owing to its ...
Saw Palmetto
... Eligible trials for the effects of saw palmetto on lower urinary tract Symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) were limited to randomized controlled trials (RCTs) that compared the botanical with placebo, no saw palmetto, or an appropriate active or historical control and inc ...
... Eligible trials for the effects of saw palmetto on lower urinary tract Symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) were limited to randomized controlled trials (RCTs) that compared the botanical with placebo, no saw palmetto, or an appropriate active or historical control and inc ...
... Studies published between 1980 and 1990. A computerized search was performed in the Medline, Ringdoc and Emdrugs databases, looking for articles published in English between 1980 and 1990 that investigated the effects on humans of oral antihistamines in asthma. Bibliographies of retrieved articles w ...
(PSD) March 2015 PBAC meeting
... same diagnostic criteria for multiple sclerosis, had similar baseline characteristics, and similar relapse rates in the placebo arm. Relapse rate reduction: Glatiramer acetate 20 mg/mL versus 40 mg/mL Glatiramer acetate 20 mg/mL versus placebo Glatiramer acetate Placebo 20 mg/mL ...
... same diagnostic criteria for multiple sclerosis, had similar baseline characteristics, and similar relapse rates in the placebo arm. Relapse rate reduction: Glatiramer acetate 20 mg/mL versus 40 mg/mL Glatiramer acetate 20 mg/mL versus placebo Glatiramer acetate Placebo 20 mg/mL ...
navigating the fda
... • Phone, e-mail • Set up a face-to-face meeting: pre-IDE or pre-IND • Send in information before meeting • Include: product description, predicate comparison if applicable, suggestion on how to be classified, indications for use, protocol outline with study endpoints, suggest N size. If drug results ...
... • Phone, e-mail • Set up a face-to-face meeting: pre-IDE or pre-IND • Send in information before meeting • Include: product description, predicate comparison if applicable, suggestion on how to be classified, indications for use, protocol outline with study endpoints, suggest N size. If drug results ...
... thinner, more sensitive skin is associated with an increased susceptibility to common corticosteroid side effects. In my practice, I have prescribed Cloderm Cream for treatment of various sites. I have even prescribed the formulation for eyelid dermatitis. Data suggest topical corticosteroids can be ...
2011 Stiefel Laboratories, Inc. Vusion® Ointment
... Stiefel Laboratories, Inc. at 1-888-784-3335 (1-888-STIEFEL) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ...
... Stiefel Laboratories, Inc. at 1-888-784-3335 (1-888-STIEFEL) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ...
Dose-finding and 24-h monitoring for efficacy and safety of E.M. App
... scheduled treatment days, patients inhaled either from two (4 mg) to eight puffs (16 mg) of a single dose of NAL from the range, administered in an open-label fashion, or 12 puffs of active NAL (24 mg) versus 12 puffs of placebo, administered in a randomized double-blind fashion. Pulmonary function ...
... scheduled treatment days, patients inhaled either from two (4 mg) to eight puffs (16 mg) of a single dose of NAL from the range, administered in an open-label fashion, or 12 puffs of active NAL (24 mg) versus 12 puffs of placebo, administered in a randomized double-blind fashion. Pulmonary function ...
Featured Article
... the site of the stent placement were similar in the two treatment groups. These series of clinical trials led the FDA to approve the CYPHER stent for clinical use (April, 2003)(12). Similarly, in the TAXUS II and TAXUS IV randomized clinical trials a substantial reduction in binary restenosis in pat ...
... the site of the stent placement were similar in the two treatment groups. These series of clinical trials led the FDA to approve the CYPHER stent for clinical use (April, 2003)(12). Similarly, in the TAXUS II and TAXUS IV randomized clinical trials a substantial reduction in binary restenosis in pat ...
Adverse Event Terminology
... the investigator or sponsor, it results in any of the following outcomes: Death, a lifethreatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, ...
... the investigator or sponsor, it results in any of the following outcomes: Death, a lifethreatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, ...
Population Health Research Institute
... Originally formed with a focus on cardiovascular disease (CVD), the PHRI has since expanded to explore innovative projects in a variety of areas including diabetes, obesity and societal influences on health, with specific emphasis on variations by ethnicity and geographic region. The Institute is al ...
... Originally formed with a focus on cardiovascular disease (CVD), the PHRI has since expanded to explore innovative projects in a variety of areas including diabetes, obesity and societal influences on health, with specific emphasis on variations by ethnicity and geographic region. The Institute is al ...