The Placebo Effect: is achieving trial success all in our minds?
... Over the last decade we have observed a great in- improve the chances of achieving adequate sepacrease in the amount of dedicated experimental ration between treatment groups. work performed on these processes4,5 , and ultimately we have arrived at a consensus that they constitute real psychobiologi ...
... Over the last decade we have observed a great in- improve the chances of achieving adequate sepacrease in the amount of dedicated experimental ration between treatment groups. work performed on these processes4,5 , and ultimately we have arrived at a consensus that they constitute real psychobiologi ...
Product Monograph Feb-2016
... patients concomitantly treated with an anticoagulant, small and transient increases were observed in aPTT and PT(INR) associated with sugammadex 4 mg/kg, which did not translate into an increased bleeding risk with sugammadex compared with usual treatment (see ACTION AND PHARMACOLOGY, Clinical Safet ...
... patients concomitantly treated with an anticoagulant, small and transient increases were observed in aPTT and PT(INR) associated with sugammadex 4 mg/kg, which did not translate into an increased bleeding risk with sugammadex compared with usual treatment (see ACTION AND PHARMACOLOGY, Clinical Safet ...
Intravenous N-acetylcysteine in Pediatric Patients
... study, 336 were ineligible (Fig. 1). Ineligibility criteria remained constant throughout the study, but reasons for ineligibility were not recorded on the initial case report form for 165 participants and are shown as ‘‘reason unknown.’’ Of the remaining 171, reasons for ineligibility were recorded. ...
... study, 336 were ineligible (Fig. 1). Ineligibility criteria remained constant throughout the study, but reasons for ineligibility were not recorded on the initial case report form for 165 participants and are shown as ‘‘reason unknown.’’ Of the remaining 171, reasons for ineligibility were recorded. ...
Randomized, double-blind, placebo-controlled trial of
... global assessment of disease activity (physician’s global assessment, scored thus: much better, + 2; slightly better, + 1; the same, 0; slightly worse, ) 1; much worse, ) 2). Blood count and routine biochemistry were checked for safety purposes. After 4 weeks of treatment, all the procedures underta ...
... global assessment of disease activity (physician’s global assessment, scored thus: much better, + 2; slightly better, + 1; the same, 0; slightly worse, ) 1; much worse, ) 2). Blood count and routine biochemistry were checked for safety purposes. After 4 weeks of treatment, all the procedures underta ...
Rosiver - Galderma
... 12 weeks was statistically more effective than vehicle cream in terms of IGA success rate and absolute change in inflammatory lesion counts (p<0.001). Starting from 4 weeks of treatment, ROSIVER was significantly more effective than vehicle cream for both the co-primary efficacy endpoints (p<0.05). ...
... 12 weeks was statistically more effective than vehicle cream in terms of IGA success rate and absolute change in inflammatory lesion counts (p<0.001). Starting from 4 weeks of treatment, ROSIVER was significantly more effective than vehicle cream for both the co-primary efficacy endpoints (p<0.05). ...
Antipsychotic dosing: found in translation
... Addiction and Mental Health (CAMH), Toronto, Ont.; Remington — Campbell Family Mental Health Research Institute, Toronto, Ont., Canada ...
... Addiction and Mental Health (CAMH), Toronto, Ont.; Remington — Campbell Family Mental Health Research Institute, Toronto, Ont., Canada ...
Viread - activatethecard.com
... For the treatment of HIV-1 or chronic hepatitis B: The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food. For patients unable to swallow VIREAD tablets, the oral powder formulation (7.5 scoops) may be used. In the treatment of chronic hepatitis B, the optimal duration ...
... For the treatment of HIV-1 or chronic hepatitis B: The dose is one 300 mg VIREAD tablet once daily taken orally, without regard to food. For patients unable to swallow VIREAD tablets, the oral powder formulation (7.5 scoops) may be used. In the treatment of chronic hepatitis B, the optimal duration ...
(PSD) July 2014 PBAC Meeting
... Xeomin® and other botulinum toxin A preparations, including Botox® and Dysport®, are determined via different assay methods. Units of biological activity of Xeomin® should not be directly compared to units of any other botulinum toxin activity, unless the dose relativity between the two botulinum to ...
... Xeomin® and other botulinum toxin A preparations, including Botox® and Dysport®, are determined via different assay methods. Units of biological activity of Xeomin® should not be directly compared to units of any other botulinum toxin activity, unless the dose relativity between the two botulinum to ...
Unanticipated Problems, Adverse Events, and Protocol Deviations
... consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is consistent with the risk information described in the general investigative plan or elsewhere in the current application, as amended. Unexpected ad ...
... consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is consistent with the risk information described in the general investigative plan or elsewhere in the current application, as amended. Unexpected ad ...
Peanut oral immunotherapy in adolescents: study protocol for a
... recommendations [12]. It consists in the intake of incremental doses of peanut or placebo according to a randomized plan. A food challenge is declared positive as soon as an objective reaction occurs. At this time discontinuation and management of the clinical reaction should be considered [13]. Bli ...
... recommendations [12]. It consists in the intake of incremental doses of peanut or placebo according to a randomized plan. A food challenge is declared positive as soon as an objective reaction occurs. At this time discontinuation and management of the clinical reaction should be considered [13]. Bli ...
Guidelines on the quality, safety, and efficacy of biotherapeutic
... manufacturers with guidance on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant deoxyribonucleic acid (DNA) technology (rDNAderived biotherapeutics) and intended for use in humans. The guidelines are based on experience gained over three decades in this tec ...
... manufacturers with guidance on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant deoxyribonucleic acid (DNA) technology (rDNAderived biotherapeutics) and intended for use in humans. The guidelines are based on experience gained over three decades in this tec ...
Ongoing Clinical Trials Posters II Thursday, February 12, 2015, 6:15
... Background: The management of AVMs remains controversial. The ARUBA trial suggested that conservative management of unruptured AVMs achieved a better 5-year outcome, but the evidence remains inconclusive. Current treatment modalities include surgical resection, endovascular embolization and radiothe ...
... Background: The management of AVMs remains controversial. The ARUBA trial suggested that conservative management of unruptured AVMs achieved a better 5-year outcome, but the evidence remains inconclusive. Current treatment modalities include surgical resection, endovascular embolization and radiothe ...
AusPAR: Lixisenatide - Therapeutic Goods Administration
... 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. ...
... 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. ...
10k
... patients (eight out of 22) demonstrated clinical response from Pracinostat treatment, with 9% of patients (two out of 22) having a clinical improvement (anemia response) and 27% (six out of 22) experiencing some reduction in splenomegaly. These results were published in the September 2012 issue of L ...
... patients (eight out of 22) demonstrated clinical response from Pracinostat treatment, with 9% of patients (two out of 22) having a clinical improvement (anemia response) and 27% (six out of 22) experiencing some reduction in splenomegaly. These results were published in the September 2012 issue of L ...
AusPAR: Doxycycline monohydrate
... 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. ...
... 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. ...
Sinusotomy, Maxillary - Blue Cross Blue Shield of Nebraska
... Contraindications to intranasal corticosteroid spray include cataracts and glaucoma, as it may worsen intraocular pressure. ...
... Contraindications to intranasal corticosteroid spray include cataracts and glaucoma, as it may worsen intraocular pressure. ...
Use of antihistamines in pediatrics
... are required. In all the age groups the safety data are of greater importance, and studies involving one to three months of follow-up are demanded, with special attention to the adverse effects upon growth. The first-generation antihistamines have never been adequately studied for pediatric age grou ...
... are required. In all the age groups the safety data are of greater importance, and studies involving one to three months of follow-up are demanded, with special attention to the adverse effects upon growth. The first-generation antihistamines have never been adequately studied for pediatric age grou ...
6.2 Visit Descriptions 6.2.1 Prescreening, Screening and Baseline
... complete the C-SSRS just prior to beginning each integrative session. At the beginning of this session, the participant and both investigators conducting psychotherapy will indicate their beliefs concerning participant condition assignment. The participant and investigator will then discuss and revi ...
... complete the C-SSRS just prior to beginning each integrative session. At the beginning of this session, the participant and both investigators conducting psychotherapy will indicate their beliefs concerning participant condition assignment. The participant and investigator will then discuss and revi ...
Pharmacologic treatment of chorea in Huntington disease
... for HD studies, clinically important change on the UHDRS remains undefined. The 106-point UHDRS motor scale measures chorea, parkinsonism, dystonia, eye movements, and other signs. The 28-point maximal chorea subscore rates facial, bucco-oral-lingual, trunk, and extremity chorea.10 In early HD, a 1- ...
... for HD studies, clinically important change on the UHDRS remains undefined. The 106-point UHDRS motor scale measures chorea, parkinsonism, dystonia, eye movements, and other signs. The 28-point maximal chorea subscore rates facial, bucco-oral-lingual, trunk, and extremity chorea.10 In early HD, a 1- ...
Extract from the Clinical Evaluation Report for Fentanyl citrate
... analgesics are standard treatment for patients with cancer pain and there are a number of marketed opioid drugs in a range of formulations, used for the management of both background pain and BTP. However, the effectiveness of currently available products used in the management of BTP is limited by ...
... analgesics are standard treatment for patients with cancer pain and there are a number of marketed opioid drugs in a range of formulations, used for the management of both background pain and BTP. However, the effectiveness of currently available products used in the management of BTP is limited by ...
Efficacy of central nervous system stimulant treatment for cocaine
... is not clear whether bupropion has CNS stimulant properties in humans, as will be discussed further later, a post hoc analysis of the efficacy of all CNS stimulants without bupropion on cocaine dependence outcomes was carried out. In order to explain differences between studies in efficacy outcomes, ...
... is not clear whether bupropion has CNS stimulant properties in humans, as will be discussed further later, a post hoc analysis of the efficacy of all CNS stimulants without bupropion on cocaine dependence outcomes was carried out. In order to explain differences between studies in efficacy outcomes, ...
E 11 Clinical Investigation of Medicinal Products in the
... When a medicinal product is to be used in the pediatric population for the same indication(s) as those studied and approved in adults, the disease process is similar in adults and pediatric patients, and the outcome of therapy is likely to be comparable, extrapolation from adult efficacy data may be ...
... When a medicinal product is to be used in the pediatric population for the same indication(s) as those studied and approved in adults, the disease process is similar in adults and pediatric patients, and the outcome of therapy is likely to be comparable, extrapolation from adult efficacy data may be ...
Observational Study Protocol CA209653
... and before the decision to invite the patient to participate in the study. Physicians will be asked to enroll eligible patients consecutively until the maximum inclusion threshold is reached or at the end of a 2-year enrollment inclusion period (whichever occurs first). Patients will be followed for ...
... and before the decision to invite the patient to participate in the study. Physicians will be asked to enroll eligible patients consecutively until the maximum inclusion threshold is reached or at the end of a 2-year enrollment inclusion period (whichever occurs first). Patients will be followed for ...
Efficacy and tolerability of the new antiepileptic drugs II: Treatment of
... Almost 2 million people in the United States have epilepsy; in developed countries the age-adjusted incidence ranges from 24 to 53 per 100,000 individuals.(1,2) Between 70 and 80% of individuals are successfully treated with one of the more than 20 antiepileptic drugs (AED) now available with succes ...
... Almost 2 million people in the United States have epilepsy; in developed countries the age-adjusted incidence ranges from 24 to 53 per 100,000 individuals.(1,2) Between 70 and 80% of individuals are successfully treated with one of the more than 20 antiepileptic drugs (AED) now available with succes ...
SAS® End-to-End solutions in Clinical Trial
... The final objective of any clinical trial is to determine the safety and efficacy of the new compound, device or biological under development. The gathered, standardized, cleansed and summarized data is ready to be studied from a clinical perspective. Now how could we execute timely queries against ...
... The final objective of any clinical trial is to determine the safety and efficacy of the new compound, device or biological under development. The gathered, standardized, cleansed and summarized data is ready to be studied from a clinical perspective. Now how could we execute timely queries against ...