JFgrading1023 - Emerson Statistics
... enrollment compared to those surviving at least 4 years after study enrollment. Also this observation is statistically significant at a 0.05 level of significance (two-sided P<0.001), we can reject the null hypothesis that the geometric means of CRP levels are not different by vital status at 4 year ...
... enrollment compared to those surviving at least 4 years after study enrollment. Also this observation is statistically significant at a 0.05 level of significance (two-sided P<0.001), we can reject the null hypothesis that the geometric means of CRP levels are not different by vital status at 4 year ...
Investigational Plan
... designated experts will review the eligibility of each subject to ensure they meet enrollment criteria and are truly candidates for the study. If a subject does not meet the criteria per the enrollment review committee, they will be withdrawn from the study and no further follow-up will be required. ...
... designated experts will review the eligibility of each subject to ensure they meet enrollment criteria and are truly candidates for the study. If a subject does not meet the criteria per the enrollment review committee, they will be withdrawn from the study and no further follow-up will be required. ...
AnnuAl RepoRt - Centre for Eye Research Australia
... but it is through research that we can potentially help thousands of people in the future. Combining research and clinical practice is in my view the best way provide excellent healthcare now while working towards improved treatments and prevention of eye disease in the future. This is particularly ...
... but it is through research that we can potentially help thousands of people in the future. Combining research and clinical practice is in my view the best way provide excellent healthcare now while working towards improved treatments and prevention of eye disease in the future. This is particularly ...
IRIS - SEARCH Thailand
... observed when there is evidence of response to HAART and while patients are still at risk for other opportunistic infections (OIs) or AIDS defining illnesses (e.g. pneumocystis jirovecii pneumonia or cytomegalovirus [CMV] retinitis). The incidence of IRIS varies depending on the studied population a ...
... observed when there is evidence of response to HAART and while patients are still at risk for other opportunistic infections (OIs) or AIDS defining illnesses (e.g. pneumocystis jirovecii pneumonia or cytomegalovirus [CMV] retinitis). The incidence of IRIS varies depending on the studied population a ...
Extract from the Clinical Evaluation Report for
... The Sponsor states the rationale for the new fixed dose combination product to be: Options for the treatment of glaucoma include: a non-selective beta-adrenoceptor blocking agent such as timolol, carbonic anhydrase inhibitor such as dorzolamide and prostaglandin analogues such as tafluprost, latanop ...
... The Sponsor states the rationale for the new fixed dose combination product to be: Options for the treatment of glaucoma include: a non-selective beta-adrenoceptor blocking agent such as timolol, carbonic anhydrase inhibitor such as dorzolamide and prostaglandin analogues such as tafluprost, latanop ...
connect20 - Parent Project Muscular Dystrophy
... This is a natural history study to characterize the Becker muscular dystrophy (Becker) clinical presentation. Investigators will collect information on Becker patients whose in-frame mutations mirror those that would be generated in Duchenne muscular dystrophy (Duchenne) patients treated with skippi ...
... This is a natural history study to characterize the Becker muscular dystrophy (Becker) clinical presentation. Investigators will collect information on Becker patients whose in-frame mutations mirror those that would be generated in Duchenne muscular dystrophy (Duchenne) patients treated with skippi ...
Montelukast as add-on therapy to b-agonists and late airway response
... subjects smoked occasionally or regularly (1–15 cigarettes?day-1; table 1) but did not change their smoking habits during the study. None of the subjects used medication that could influence the results of this study. All subjects were in good clinical condition; none had experienced a respiratory t ...
... subjects smoked occasionally or regularly (1–15 cigarettes?day-1; table 1) but did not change their smoking habits during the study. None of the subjects used medication that could influence the results of this study. All subjects were in good clinical condition; none had experienced a respiratory t ...
Industry-sponsored clinical drug trials in Egypt: Ethical
... It could also be assumed that running complex international drug trials in such a context would be risky, not least because of the limited and fragmented legislative framework covering clinical research in Egypt. With a significant proportion of people living in poverty, and a public health insuranc ...
... It could also be assumed that running complex international drug trials in such a context would be risky, not least because of the limited and fragmented legislative framework covering clinical research in Egypt. With a significant proportion of people living in poverty, and a public health insuranc ...
A CFTR Potentiator in Patients with Cystic Fibrosis and the G551D
... 90% of the predicted value for persons of their age, sex, and height.13 Subjects were randomly assigned, in a 1:1 ratio, to receive ivacaftor, at a dose of 150 mg every 12 hours, or placebo, for 48 weeks. Throughout the study, all subjects continued to take their prestudy medications with the except ...
... 90% of the predicted value for persons of their age, sex, and height.13 Subjects were randomly assigned, in a 1:1 ratio, to receive ivacaftor, at a dose of 150 mg every 12 hours, or placebo, for 48 weeks. Throughout the study, all subjects continued to take their prestudy medications with the except ...
JRO Interventional Protocol Template
... 2. Ensure consistency: refer to trial ‘participants’ throughout the protocol (not patients, subjects or volunteers), refer to ‘trial’ throughout the protocol, refer to trial ‘sites’, not ‘centres’, for a participating institution. 3. Use bullet point lists or tables where appropriate rather than lon ...
... 2. Ensure consistency: refer to trial ‘participants’ throughout the protocol (not patients, subjects or volunteers), refer to ‘trial’ throughout the protocol, refer to trial ‘sites’, not ‘centres’, for a participating institution. 3. Use bullet point lists or tables where appropriate rather than lon ...
Health research methodology
... to biological research, and is the substance of research design. Research design, above all else, must account for and maintain the role of chance in order to ensure validity. It is statistical methods which preserve the laws of probability in our inquiry, and allow proper analysis and interpretatio ...
... to biological research, and is the substance of research design. Research design, above all else, must account for and maintain the role of chance in order to ensure validity. It is statistical methods which preserve the laws of probability in our inquiry, and allow proper analysis and interpretatio ...
Berinert - CSL Behring
... of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility. Benefits of treatment of HAE attacks should be weighed against the risks of TE events in patients with underlying ...
... of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility. Benefits of treatment of HAE attacks should be weighed against the risks of TE events in patients with underlying ...
SPIRIT 2013 explanation and elaboration: guidance for
... identified through a systematic review conducted to inform the content of the SPIRIT checklist. We searched MEDLINE, the Cochrane Methodology Register, and the Cochrane Database of Systematic Reviews (limited to methodology reviews) up to September 2009, and EMBASE up to August 2007. We searched ref ...
... identified through a systematic review conducted to inform the content of the SPIRIT checklist. We searched MEDLINE, the Cochrane Methodology Register, and the Cochrane Database of Systematic Reviews (limited to methodology reviews) up to September 2009, and EMBASE up to August 2007. We searched ref ...
View PDF - CiteSeerX
... In some cases in which third categories were used, however, the study descriptions allowed us to conclude that the third category was being used to indicate an intermediate level of certainty. In such cases we converted the categories to a numerical scheme, such as 1 = yes, 2 = maybe, and 3 = no, an ...
... In some cases in which third categories were used, however, the study descriptions allowed us to conclude that the third category was being used to indicate an intermediate level of certainty. In such cases we converted the categories to a numerical scheme, such as 1 = yes, 2 = maybe, and 3 = no, an ...
Starr Study Protocol - NDM Research Building
... 3.2. Characterising COPD phenotypes Recent trends have advocated the characterisation of COPD phenotypes which relate to clinically meaningful outcomes such as symptoms, exacerbations and responses to treatment in the management of COPD16. The presence of a sputum eosinophilia in stable COPD has bee ...
... 3.2. Characterising COPD phenotypes Recent trends have advocated the characterisation of COPD phenotypes which relate to clinically meaningful outcomes such as symptoms, exacerbations and responses to treatment in the management of COPD16. The presence of a sputum eosinophilia in stable COPD has bee ...
(BEN®) Patient Enrollment Form
... By signing this Authorization, I authorize my healthcare providers, including pharmacies and insurance providers, to disclose to CSL Behring and any entities in connection with the administration of B.E.N.® and contractors appropriate protected health information (PHI) relevant to my treatment and p ...
... By signing this Authorization, I authorize my healthcare providers, including pharmacies and insurance providers, to disclose to CSL Behring and any entities in connection with the administration of B.E.N.® and contractors appropriate protected health information (PHI) relevant to my treatment and p ...
Non-Beneficial Pediatric Research and the Best Interest Standard: A
... and prevent suffering and the loss of life) will far outweigh the asserted advantage of protecting individual rights. 25 Though most commentators conclude that at least some non-beneficial pediatric research is morally permissible, they are unwilling to condone its practice on utilitarian or other c ...
... and prevent suffering and the loss of life) will far outweigh the asserted advantage of protecting individual rights. 25 Though most commentators conclude that at least some non-beneficial pediatric research is morally permissible, they are unwilling to condone its practice on utilitarian or other c ...
Anthracosis of the Lungs: Etiology, Clinical Manifestations
... TBGL antibody, were evaluated in BAF cases, but they ...
... TBGL antibody, were evaluated in BAF cases, but they ...
Major Extremity Trauma Research Consortium
... potential investigators, consultants, study staff, and applicable independent ethics committees or institutional review boards. The contents of this document shall not be disclosed to others without written authorization from METRC (or others, as applicable), unless it is necessary to obtain informe ...
... potential investigators, consultants, study staff, and applicable independent ethics committees or institutional review boards. The contents of this document shall not be disclosed to others without written authorization from METRC (or others, as applicable), unless it is necessary to obtain informe ...
Cerebral impairment : a new content scale for the MMPI-2
... The incidence of survival after traumatic brain injury (TBI) has increased at a remarkable rate with the advent of new medical technologies [Kraus et al.. 1984). Although victims are now recovering physically, they often meet with other difficulties long after making a complete physical recovery. ...
... The incidence of survival after traumatic brain injury (TBI) has increased at a remarkable rate with the advent of new medical technologies [Kraus et al.. 1984). Although victims are now recovering physically, they often meet with other difficulties long after making a complete physical recovery. ...
Viread - activatethecard.com
... VIREAD is available as tablets or as an oral powder. VIREAD tablets 150 mg contain 150 mg of tenofovir disoproxil fumarate, which is equivalent to 123 mg of tenofovir disoproxil. The tablets are triangle-shaped, white, film-coated, and debossed with “GSI” on one side and “150” on the other side. VIR ...
... VIREAD is available as tablets or as an oral powder. VIREAD tablets 150 mg contain 150 mg of tenofovir disoproxil fumarate, which is equivalent to 123 mg of tenofovir disoproxil. The tablets are triangle-shaped, white, film-coated, and debossed with “GSI” on one side and “150” on the other side. VIR ...
Extract from the Clinical Evaluation Report for Ceftaroline fosamil
... This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and reta ...
... This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and reta ...
Unanticipated Problems, Adverse Events, and Protocol Deviations
... disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. An adverse event encompasses both physical and psychological harms; and although they most commonly occur in the context of biomedical re ...
... disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. An adverse event encompasses both physical and psychological harms; and although they most commonly occur in the context of biomedical re ...
HUMAN_CLONING - HLWW Public Schools
... and against, human cloning. You will find out if there are any laws regarding the cloning of humans and what those laws state. You will identify some of the moral issues that accompany the cloning of human beings. Finally, you will form an opinion as to whether human cloning should be allowed. Once ...
... and against, human cloning. You will find out if there are any laws regarding the cloning of humans and what those laws state. You will identify some of the moral issues that accompany the cloning of human beings. Finally, you will form an opinion as to whether human cloning should be allowed. Once ...
Medical Devices - Icahn School of Medicine
... The Sponsor must provide an initial explanation to support its NSR determination. Research involving the use of a NSR device must be conducted in accordance with the abbreviated requirements of the FDA 21 CFR 812.2(b), IRB review and informed consent regulations. Clinical investigators must maintain ...
... The Sponsor must provide an initial explanation to support its NSR determination. Research involving the use of a NSR device must be conducted in accordance with the abbreviated requirements of the FDA 21 CFR 812.2(b), IRB review and informed consent regulations. Clinical investigators must maintain ...