http://www .cochrane.org /sites/default/files /uploads/glossary.pdf
... An adverse event for which the causal relation between the drug/intervention and the event is at least a reasonable possibility. The term ‘adverse effect’ applies to all interventions, while ‘adverse drug reaction’ (ADR) is used only with drugs. In the case of drugs an adverse effect tends to be see ...
... An adverse event for which the causal relation between the drug/intervention and the event is at least a reasonable possibility. The term ‘adverse effect’ applies to all interventions, while ‘adverse drug reaction’ (ADR) is used only with drugs. In the case of drugs an adverse effect tends to be see ...
Explanation and elaboration document (WORD, 855KB)
... This template attempts to provide a general format applicable to all clinical trials evaluating an investigational product (drugs or medical devices). Note that instructions are indicated in blue italics and they need be deleted (or alternatively may be formatted as “hidden Text” that will not show ...
... This template attempts to provide a general format applicable to all clinical trials evaluating an investigational product (drugs or medical devices). Note that instructions are indicated in blue italics and they need be deleted (or alternatively may be formatted as “hidden Text” that will not show ...
Menopause Guideline - North Of Tyne Area Prescribing Committee
... a woman is likely to be menopausal if two FSH levels are >30IU/L (first sample should be taken within 3 days of the start of a withdrawal bleed and a second two weeks later). Peri-menopausal women taking combined hormonal contraception (CHC) may develop vasomotor symptoms in the pill-free interv ...
... a woman is likely to be menopausal if two FSH levels are >30IU/L (first sample should be taken within 3 days of the start of a withdrawal bleed and a second two weeks later). Peri-menopausal women taking combined hormonal contraception (CHC) may develop vasomotor symptoms in the pill-free interv ...
1 - VCU Massey Cancer Center - Virginia Commonwealth University
... Comments and instructions are in blue italics and should be removed from the final document. Underlined words represent place holders that should be replaced with protocol-specific information. The Virginia Commonwealth University (VCU) Internal Review Board (IRB) Informed Consent Template is append ...
... Comments and instructions are in blue italics and should be removed from the final document. Underlined words represent place holders that should be replaced with protocol-specific information. The Virginia Commonwealth University (VCU) Internal Review Board (IRB) Informed Consent Template is append ...
Clinical Practice Guidelines on Management of Osteoporosis
... institutionalised, immobile, lack outdoor activities and have a poor diet will benefit from 800 IU Vitamin D supplementation daily. ...
... institutionalised, immobile, lack outdoor activities and have a poor diet will benefit from 800 IU Vitamin D supplementation daily. ...
Major Extremity Trauma Research Consortium
... It might be anticipated that bacteria in patients with infections that develop in the treatment group might be less susceptible to Vancomycin as this is the antibiotic used in this technique. The most common bacterial isolates in infection after orthopaedic fracture care are methicillin resistant s ...
... It might be anticipated that bacteria in patients with infections that develop in the treatment group might be less susceptible to Vancomycin as this is the antibiotic used in this technique. The most common bacterial isolates in infection after orthopaedic fracture care are methicillin resistant s ...
highlights of prescribing information
... AND PROBABLE DEMENTIA See full prescribing information for complete boxed warning. Estrogen-Alone Therapy • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens (5.2) • Estrogen-alone therapy should not be used for the prevention of cardiovascular ...
... AND PROBABLE DEMENTIA See full prescribing information for complete boxed warning. Estrogen-Alone Therapy • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens (5.2) • Estrogen-alone therapy should not be used for the prevention of cardiovascular ...
Patient Information Sheet
... research participants, this should be clearly stated, noting all the implications; Whether feedback of information of potential significance to their relatives’ future health will be discussed with participants; Assurance that the participant’s genetic material and information, where identified ...
... research participants, this should be clearly stated, noting all the implications; Whether feedback of information of potential significance to their relatives’ future health will be discussed with participants; Assurance that the participant’s genetic material and information, where identified ...
FF Principal Investigator/Program Director (Last, first, middle): Orban
... cells are completely or near completely destroyed, resulting in life-long dependence on exogenous insulin. It is a chronic and potentially disabling disease that represents a major public health and clinical concern. The number of patients being diagnosed with type 1 diabetes is increasing each year ...
... cells are completely or near completely destroyed, resulting in life-long dependence on exogenous insulin. It is a chronic and potentially disabling disease that represents a major public health and clinical concern. The number of patients being diagnosed with type 1 diabetes is increasing each year ...
Cardiovascular Disease in Women
... Awareness of CVD as the primary cause of mortality in women has been slowly increasing. In 1997, only 30% of American women surveyed were aware that CVD was the leading cause of death in women; this increased to 54% in 2009 and has subsequently plateaued when last surveyed in 2012.3 Women are less l ...
... Awareness of CVD as the primary cause of mortality in women has been slowly increasing. In 1997, only 30% of American women surveyed were aware that CVD was the leading cause of death in women; this increased to 54% in 2009 and has subsequently plateaued when last surveyed in 2012.3 Women are less l ...
Introduction to causal inference from observational data
... generally used to emulate a target trial with systematic and blind outcome ascertainment Except if outcome ascertainment cannot be affected by treatment history, e.g., if the outcome is mortality independently ascertained from a death registry Hernán - Target trial ...
... generally used to emulate a target trial with systematic and blind outcome ascertainment Except if outcome ascertainment cannot be affected by treatment history, e.g., if the outcome is mortality independently ascertained from a death registry Hernán - Target trial ...
Final Report
... currently being conducted for several other smaller sites in NYS with similar VOC exposures. The larger combined review may be able to draw stronger conclusions than this review because there will be a larger population, with higher numbers of birth outcomes, birth defects, and cancers expected. 2. ...
... currently being conducted for several other smaller sites in NYS with similar VOC exposures. The larger combined review may be able to draw stronger conclusions than this review because there will be a larger population, with higher numbers of birth outcomes, birth defects, and cancers expected. 2. ...
What is the median eminence? The median eminence is the nucleus
... c. Nutritional deficit state: energy output > energy input (can be caused as a result of increasing exercise without eating extra to compensate for the energy loss) 76. What are the risks associated with amenorrhea? a. Loss of bone density as a result of low estrogen which increases the risk of oste ...
... c. Nutritional deficit state: energy output > energy input (can be caused as a result of increasing exercise without eating extra to compensate for the energy loss) 76. What are the risks associated with amenorrhea? a. Loss of bone density as a result of low estrogen which increases the risk of oste ...
Study protocol: a phase III randomised, double-blind
... ▸ Documentation and comparison of the side effects and frequency of side effects experienced in each arm. ▸ To determine which participants derive the greatest benefit from sertraline using data from baseline participant characteristics. ▸ Assessment of frequency of occurrence of common toxicities an ...
... ▸ Documentation and comparison of the side effects and frequency of side effects experienced in each arm. ▸ To determine which participants derive the greatest benefit from sertraline using data from baseline participant characteristics. ▸ Assessment of frequency of occurrence of common toxicities an ...
The protocol should describe - Manchester Metropolitan University
... STUDY SHORT NAME Protocol vX.X DD_MM_YYYY ...
... STUDY SHORT NAME Protocol vX.X DD_MM_YYYY ...
Product Monograph Template - Standard
... There is a need for caution in prescribing estrogens of any kind to women with a strong family history (first degree relative) of breast cancer or women who have nodules, fibro cystic disease or abnormal mammograms and/or atypical hyperplasia at breast biopsy. In the oral estrogen-alone arm of the W ...
... There is a need for caution in prescribing estrogens of any kind to women with a strong family history (first degree relative) of breast cancer or women who have nodules, fibro cystic disease or abnormal mammograms and/or atypical hyperplasia at breast biopsy. In the oral estrogen-alone arm of the W ...
3.1. Initial Contact, Recruitment, Pre
... may be screened for diabetic status at their first prenatal visit. Typically these patients will be administered the one hour glucose tolerance test (1 HR GTT) to determine if they have diabetes. If a patient fails the screening or is on the borderline of failing the 1 HR GTT she may be required to ...
... may be screened for diabetic status at their first prenatal visit. Typically these patients will be administered the one hour glucose tolerance test (1 HR GTT) to determine if they have diabetes. If a patient fails the screening or is on the borderline of failing the 1 HR GTT she may be required to ...
Protocol Template
... course for which the endpoint will be assessed (i.e. from baseline to end of treatment) ...
... course for which the endpoint will be assessed (i.e. from baseline to end of treatment) ...
HRT: An overview of the risks of Hormone Replacement Therapy
... many other diseases. It appeared that manufacturers had developed a wonder drug for women. However, over time concerns and evidence came to light indicating that the perceived benefits either did not exist or that HRT increased the risk of certain diseases. While there are several related drugs that ...
... many other diseases. It appeared that manufacturers had developed a wonder drug for women. However, over time concerns and evidence came to light indicating that the perceived benefits either did not exist or that HRT increased the risk of certain diseases. While there are several related drugs that ...
NIAID Protocol Template Extramural Guidance, V. 2.0 (Extra), July
... PURPOSE of a Protocol: A protocol is where the investigators clarify and document their plan for all aspects of the study. It provides a guide for the research team to reference and follow over time and ensures that the IRB approved version of the study is implemented. When the study is complete, th ...
... PURPOSE of a Protocol: A protocol is where the investigators clarify and document their plan for all aspects of the study. It provides a guide for the research team to reference and follow over time and ensures that the IRB approved version of the study is implemented. When the study is complete, th ...
NIAID Protocol Template Extramural Guidance, V. 2.0
... SJMHS Clinical Trial Protocol Template Adapted from: National Institute of Allergy and Infectious Disease Protocol Template ...
... SJMHS Clinical Trial Protocol Template Adapted from: National Institute of Allergy and Infectious Disease Protocol Template ...
FEMME Study schema - University of Birmingham
... questions about appropriate treatment for which there is insufficient reliable evidence. The prevalence of sub-fertile women with fibroids, whether the fibroids are implicated or not, will rise. If untreated this may lead to an adverse effect on fertility and pregnancy outcomes as well as menstrual ...
... questions about appropriate treatment for which there is insufficient reliable evidence. The prevalence of sub-fertile women with fibroids, whether the fibroids are implicated or not, will rise. If untreated this may lead to an adverse effect on fertility and pregnancy outcomes as well as menstrual ...
FEMME Protocol - University of Birmingham
... questions about appropriate treatment for which there is insufficient reliable evidence. The prevalence of sub-fertile women with fibroids, whether the fibroids are implicated or not, will rise. If untreated this may lead to an adverse effect on fertility and pregnancy outcomes as well as menstrual ...
... questions about appropriate treatment for which there is insufficient reliable evidence. The prevalence of sub-fertile women with fibroids, whether the fibroids are implicated or not, will rise. If untreated this may lead to an adverse effect on fertility and pregnancy outcomes as well as menstrual ...
13063_2013_1512_MOESM4_ESM
... likely to be elevated in patients with kidney damage and we would like to know whether NGAL helps predict how patients will progress over their course in hospital. After you have consented to the study but before any dialysis has started, the sample for NGAL will be taken from a tube that is already ...
... likely to be elevated in patients with kidney damage and we would like to know whether NGAL helps predict how patients will progress over their course in hospital. After you have consented to the study but before any dialysis has started, the sample for NGAL will be taken from a tube that is already ...
Running Head: PRETERM PREGNANCY PRETERM PREGNANCY
... home alive, that number being 583 infants. There were four infants that died between being discharged home and the first follow-up. Twenty-three participants were unavailable to come to the first follow-up because they were born at a facility that stopped communication with the study network of MFMU ...
... home alive, that number being 583 infants. There were four infants that died between being discharged home and the first follow-up. Twenty-three participants were unavailable to come to the first follow-up because they were born at a facility that stopped communication with the study network of MFMU ...
Women's Health Initiative
The Women's Health Initiative (WHI) was initiated by the U.S. National Institutes of Health (NIH) in 1991. The Women's Health Initiative, which consisted of three clinical trials (CT) and an observational study (OS), was conducted to address major health issues causing morbidity and mortality in postmenopausal women. In particular, randomized controlled trials were designed and funded that addressed cardiovascular disease, cancer, and osteoporosis. In its entirety, the WHI enrolled more than 160,000 postmenopausal women aged 50–79 years (at time of study enrollment) over 15 years, making it one of the largest U.S. prevention studies of its kind, with a budget of $625 million. A 2014 analysis calculated a net economic return on investment of $37.1 billion for the estrogen-plus-progestin arm of the study's hormone trial alone, providing a strong case for the continued use of this variety of large, publicly funded population study.