Study protocol: a phase III randomised, double-blind
... A placebo-controlled study was chosen because there is no registered medication for the pharmacological treatment of chronic breathlessness, and there is clinical equipoise regarding the net benefit of SSRIs in this clinical setting. A 20 participant phase II study was initially conducted at one site ...
... A placebo-controlled study was chosen because there is no registered medication for the pharmacological treatment of chronic breathlessness, and there is clinical equipoise regarding the net benefit of SSRIs in this clinical setting. A 20 participant phase II study was initially conducted at one site ...
AusPAR: Immunoglobulin - normal (human)
... Gamunex at doses between 1.2 and 1.5 times the IV dose maintained blood levels of IgG that were comparable to those achieved by IV administration. The maximum clinical IV dose of 600 mg/kg (6 mL/kg) every 3 to 4 weeks for Primary Humoral Immunodeficiency is to remain, however the proposed weekly SC ...
... Gamunex at doses between 1.2 and 1.5 times the IV dose maintained blood levels of IgG that were comparable to those achieved by IV administration. The maximum clinical IV dose of 600 mg/kg (6 mL/kg) every 3 to 4 weeks for Primary Humoral Immunodeficiency is to remain, however the proposed weekly SC ...
FEMME Study schema - University of Birmingham
... Average length of stay for hysterectomy is 4.4 days, for myomectomy 3.6 days and UAE 1 day, and studies have shown that UAE offers a faster return to normal life. UAE is more cost effective than surgery in the short term, although recent evidence suggests this advantage is lost at five years due to ...
... Average length of stay for hysterectomy is 4.4 days, for myomectomy 3.6 days and UAE 1 day, and studies have shown that UAE offers a faster return to normal life. UAE is more cost effective than surgery in the short term, although recent evidence suggests this advantage is lost at five years due to ...
Confirmation of previous minutes - Health and Disability Ethics
... the information widely so it can be best utilised. The Committee queried whether the company will be given access to the participant’s health information/medical records. The researchers explained that this would only be for audit reasons or regulatory reasons. The committee noted that as the compan ...
... the information widely so it can be best utilised. The Committee queried whether the company will be given access to the participant’s health information/medical records. The researchers explained that this would only be for audit reasons or regulatory reasons. The committee noted that as the compan ...
Guidelines on the practice of ethics committees 4th ed
... welcomed, and this one will stand high given its provenance and clarity of content. John Saunders and his committee are to be congratulated on creating a comprehensive, clear and accessible monograph which is easy to navigate and provides valuable information and advice on how the system works and w ...
... welcomed, and this one will stand high given its provenance and clarity of content. John Saunders and his committee are to be congratulated on creating a comprehensive, clear and accessible monograph which is easy to navigate and provides valuable information and advice on how the system works and w ...
FEMME Protocol - University of Birmingham
... Average length of stay for hysterectomy is 4.4 days, for myomectomy 3.6 days and UAE 1 day, and studies have shown that UAE offers a faster return to normal life. UAE is more cost effective than surgery in the short term, although recent evidence suggests this advantage is lost at five years due to ...
... Average length of stay for hysterectomy is 4.4 days, for myomectomy 3.6 days and UAE 1 day, and studies have shown that UAE offers a faster return to normal life. UAE is more cost effective than surgery in the short term, although recent evidence suggests this advantage is lost at five years due to ...
FF Principal Investigator/Program Director (Last, first, middle): Orban
... 2. BACKGROUND AND SIGNIFICANCE 2.1. Type 1 Diabetes (T1DM) 2.1.1. Definition and metabolic characteristics of Type 1 diabetes mellitus Type 1 diabetes mellitus (T1DM) is an immune-mediated disease in which insulin-producing beta cells are completely or near completely destroyed, resulting in life-lo ...
... 2. BACKGROUND AND SIGNIFICANCE 2.1. Type 1 Diabetes (T1DM) 2.1.1. Definition and metabolic characteristics of Type 1 diabetes mellitus Type 1 diabetes mellitus (T1DM) is an immune-mediated disease in which insulin-producing beta cells are completely or near completely destroyed, resulting in life-lo ...
Eng - UNESDOC
... This Conference comes at an opportune time when Kenyans are gearing for debate on abortion – is it ethical or unethical? That is the big question. As you are already aware from the Invitation Letters sent to you for this Conference, the theme is “Bioethical Perspectives and Practices in Research, Me ...
... This Conference comes at an opportune time when Kenyans are gearing for debate on abortion – is it ethical or unethical? That is the big question. As you are already aware from the Invitation Letters sent to you for this Conference, the theme is “Bioethical Perspectives and Practices in Research, Me ...
... furthermore Ohlsson et al. affirms that indomethacin is related with higher risk of NEC. In conclusion, both drugs are equal effective, but they have different complications profile. Despite the existence of quality studies, there are different conclusions about safety, so there is not a consensus a ...
Access to unapproved biologicals
... The schemes apply to the testing of any biologicals not entered on the ARTG, including any new preparations or uses, as well as use of an included biological in a clinical trial beyond the conditions of its marketing approval. The clinical trial arrangements (for both schemes) are based on the same ...
... The schemes apply to the testing of any biologicals not entered on the ARTG, including any new preparations or uses, as well as use of an included biological in a clinical trial beyond the conditions of its marketing approval. The clinical trial arrangements (for both schemes) are based on the same ...
SOME SOCIAL ASPECTS OF DISCOVERY, SYNTHESIS AND
... We can say that the outbreak of World War II had a crucial role for the investments in adrenal research, understandable in the light of the emerging steroid research activity. Luckily enough, one of the compounds turned out to be physiologically active in a way no one could anticipate. However, the ...
... We can say that the outbreak of World War II had a crucial role for the investments in adrenal research, understandable in the light of the emerging steroid research activity. Luckily enough, one of the compounds turned out to be physiologically active in a way no one could anticipate. However, the ...
Biomedical Consent Template
... standard of care.] [For Phase I studies, include the following:] This research study is a Phase I clinical trial, which tests the safety of an investigational [drug//device/intervention] and also tries to define the appropriate dose of the investigational [drug/device/intervention] to use for furthe ...
... standard of care.] [For Phase I studies, include the following:] This research study is a Phase I clinical trial, which tests the safety of an investigational [drug//device/intervention] and also tries to define the appropriate dose of the investigational [drug/device/intervention] to use for furthe ...
2015 Program Book - Center for Undergraduate Research and
... Social and Historical Context Apartment buildings have been an important part of Buffalo’s residential scene since the late 1800’s. Never were they so important however as between the years 1880-1920, when social and economic forces shaped a unique architectural climate in Buffalo. The 1901 Pan Americ ...
... Social and Historical Context Apartment buildings have been an important part of Buffalo’s residential scene since the late 1800’s. Never were they so important however as between the years 1880-1920, when social and economic forces shaped a unique architectural climate in Buffalo. The 1901 Pan Americ ...
1 - VCU Massey Cancer Center - Virginia Commonwealth University
... Investigator-Initiated Therapeutic Clinical Protocol Template (For Use with Protocols Requiring an IND) Version 2 TEMPLATE INSTRUCTIONS This template is meant to serve as a tool to help you through the process of writing a clinical trial protocol. Although the template contains typical sections and ...
... Investigator-Initiated Therapeutic Clinical Protocol Template (For Use with Protocols Requiring an IND) Version 2 TEMPLATE INSTRUCTIONS This template is meant to serve as a tool to help you through the process of writing a clinical trial protocol. Although the template contains typical sections and ...
Developing a consortium for ALS clinical research: the Canadian
... and expedite the requirements of pharmaceutical industry in preparing for clinical trials. The start process is streamlined whereby the study sponsors negotiate directly with CALS instead of contacting each individual site. A single confidentiality disclosure agreement can be signed by the CALS Chai ...
... and expedite the requirements of pharmaceutical industry in preparing for clinical trials. The start process is streamlined whereby the study sponsors negotiate directly with CALS instead of contacting each individual site. A single confidentiality disclosure agreement can be signed by the CALS Chai ...
Committee - Health and Disability Ethics Committees
... o Patient autonomy is protected because information is provided and they can opt out (remove their data) if they wish. o Clinical opinion can override the oxygen protocol at any time deemed necessary. Analysis will be by intention to treat. 9. The Committee explained right 7(4) of the Code of Rights ...
... o Patient autonomy is protected because information is provided and they can opt out (remove their data) if they wish. o Clinical opinion can override the oxygen protocol at any time deemed necessary. Analysis will be by intention to treat. 9. The Committee explained right 7(4) of the Code of Rights ...
Clinical Study Protocol
... There has been few properly conducted clinical trials done on traditionally used herbal medicines in South Africa and S. frutescens is no exception. Nevertheless this herbal medicine is being used widely without any apparent recorded adverse effects and has the potential to be of immense benefit. Ho ...
... There has been few properly conducted clinical trials done on traditionally used herbal medicines in South Africa and S. frutescens is no exception. Nevertheless this herbal medicine is being used widely without any apparent recorded adverse effects and has the potential to be of immense benefit. Ho ...
Vaneechoutte. 2016. Research at the LBR at the dawn of
... Hardcastle, I. Huys, E. Kutter, R. Lavigne, M. Merabishvili, E. Olchawa, K. J. Parikka, O. Patey, F. Pouilot, G. Resch, C. Rohde, J. Scheres, M. Skurnik, M. Vaneechoutte, L. Van Parys, G. Verbeken, M. Zizi, and G. Van den Eede. 2015. Quality and safety requirements for sustainable phage therapy prod ...
... Hardcastle, I. Huys, E. Kutter, R. Lavigne, M. Merabishvili, E. Olchawa, K. J. Parikka, O. Patey, F. Pouilot, G. Resch, C. Rohde, J. Scheres, M. Skurnik, M. Vaneechoutte, L. Van Parys, G. Verbeken, M. Zizi, and G. Van den Eede. 2015. Quality and safety requirements for sustainable phage therapy prod ...
Product Monograph
... The overall safety profile of RiaSTAP was derived from the standardized collection of safety data from the Pivotal study combined with the data collected in the 4 supporting clinical studies and the report from the clinical survey. RiaSTAP was well tolerated in the Pivotal study. AEs were reported i ...
... The overall safety profile of RiaSTAP was derived from the standardized collection of safety data from the Pivotal study combined with the data collected in the 4 supporting clinical studies and the report from the clinical survey. RiaSTAP was well tolerated in the Pivotal study. AEs were reported i ...
A New Spinal Cord Stimulation System Effectively Relieves Chronic
... primary concern in conducting this study, which was conducted pursuant to the Declaration of Helsinki. At all times, investigators followed the approved study plan and abided by all Good Clinical Practice requirements and any Institutional Review Board regulations. To be considered for study entry, ...
... primary concern in conducting this study, which was conducted pursuant to the Declaration of Helsinki. At all times, investigators followed the approved study plan and abided by all Good Clinical Practice requirements and any Institutional Review Board regulations. To be considered for study entry, ...
Department of Health and Huma Services Part II
... Protection of Human Subjects of Biomedical and Behavioral Research states in The Belmont Report that: Respect for persons incorporates at least two basic ethical convictions: first. that individuals should be treated as autonomou agents, and second, that persons with diminished autonomy are entitled ...
... Protection of Human Subjects of Biomedical and Behavioral Research states in The Belmont Report that: Respect for persons incorporates at least two basic ethical convictions: first. that individuals should be treated as autonomou agents, and second, that persons with diminished autonomy are entitled ...
Protecting Human Subjects in Clinical Trials
... in the global search for effective new therapies. With the knowledge that many potential adverse events will not emerge until much larger populations of patients are exposed, proactive pharmacovigilance planning is a growing focus for the biopharmaceutical industry. Voluntary reporting of adverse ev ...
... in the global search for effective new therapies. With the knowledge that many potential adverse events will not emerge until much larger populations of patients are exposed, proactive pharmacovigilance planning is a growing focus for the biopharmaceutical industry. Voluntary reporting of adverse ev ...
The Benefits Of Medical Research And The Role Of The NIH
... Longevity is worth trillions of dollars. U.S. longevity has increased as the overall U.S. death rate has dropped by one-third since 1970. A recent study found that these longevity increases have created net “value of life” gains to Americans of about $2.4 trillion every year. Such estimates place a ...
... Longevity is worth trillions of dollars. U.S. longevity has increased as the overall U.S. death rate has dropped by one-third since 1970. A recent study found that these longevity increases have created net “value of life” gains to Americans of about $2.4 trillion every year. Such estimates place a ...
Extract from the Clinical Evaluation Report for adalimumab
... except for the investigation in polyarticular juvenile idiopathic arthritis. The only other anti-TNF agent approved for the treatment of Crohn’s disease in a paediatric population is infliximab. The paediatric CD indication for infliximab applies to patients aged from 6 to 17 years with moderate to ...
... except for the investigation in polyarticular juvenile idiopathic arthritis. The only other anti-TNF agent approved for the treatment of Crohn’s disease in a paediatric population is infliximab. The paediatric CD indication for infliximab applies to patients aged from 6 to 17 years with moderate to ...