Are we targeting the right population? Application of eligibility criteria of 10 dementia prevention trials to the general population

Background: The concept of evaluating bioequivalence has changed over a period of time. Currently, the Average Bioequivalence approach (ABE) is the gold standard tool for the evaluation of generics. Of late, many debates had arisen about employing ABE approach for the appraisal of all drug categories. This review aims to examine the limitations of ABE approach and the significances of Population Bioequivalence (PBE) and Individual Bioequivalence (IBE) approach, current regulatory thinking for assessing different categories of the drug, whether they are adequately assessed, and the evaluation is in the right direction. Methods: We carried out an organized search of bibliographic databases for peer-reviewed research literatures, regulatory recommendations, guidance documents using a focused review question and eligibility criteria. The standard tools were used to appraise the quality of retrieved documents and to make sure the authenticity of the data. Results: In total 73 references were used in the review, the majority of the references (guidance documents) were from the different regulatory agencies and product-specific guidance. There were 29 product-specific guidance from USFDA and EMA. The limitations of the ABE approach were discussed in detail along with the significances of Population Bioequivalence (PBE) approach and Individual Bioequivalence (IBE) approaches. Conclusion: It is apparent from the review that IBE approach is a precise method for evaluating the drugs as it answers drug interchangeability (prescribability and switchability). IBE approach is followed by PBE approach and ABE approach for the evaluation of different categories of drugs in terms of precision.

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COVID-19 during pregnancy: an overview of maternal characteristics, clinical symptoms, maternal and neonatal outcomes of 10,996 cases described in 15 countries

Journal of Perinatal Medicine ◽

10.1515/jpm-2020-0364 ◽

2020 ◽

Vol 48 (9) ◽

pp. 900-911 ◽

Cited By ~ 3

Author(s):

Ernesto Antonio Figueiro-Filho ◽

Mark Yudin ◽

Dan Farine

Keyword(s):

General Population ◽

Pregnant Women ◽

Clinical Symptoms ◽

Case Series ◽

Perinatal Outcomes ◽

Neonatal Outcomes ◽

Eligibility Criteria ◽

Maternal Characteristics ◽

Th2 Immune Response ◽

Maternal And Neonatal Outcomes

AbstractThe objective of this review was to identify the most significant studies reporting on COVID-19 during pregnancy and to provide an overview of SARS-CoV-2 infection in pregnant women and perinatal outcomes. Eligibility criteria included all reports, reviews; case series with more than 100 individuals and that reported at least three of the following: maternal characteristics, maternal COVID-19 clinical presentation, pregnancy outcomes, maternal outcomes and/or neonatal/perinatal outcomes. We included eight studies that met the inclusion criteria, representing 10,966 cases distributed in 15 countries around the world until July 20, 2020. The results of our review demonstrate that the maternal characteristics, clinical symptoms, maternal and neonatal outcomes almost 11,000 cases of COVID-19 and pregnancy described in 15 different countries are not worse or different from the general population. We suggest that pregnant women are not more affected by the respiratory complications of COVID-19, when compared to the outcomes described in the general population. We also suggest that the important gestational shift Th1-Th2 immune response, known as a potential contributor to the severity in cases of viral infections during pregnancy, are counter-regulated by the enhanced-pregnancy-induced ACE2-Ang-(1–7) axis. Moreover, the relatively small number of reported cases during pregnancy does not allow us to affirm that COVID-19 is more aggressive during pregnancy. Conversely, we also suggest, that down-regulation of ACE2 receptors induced by SARS-CoV-2 cell entry might have been detrimental in subjects with pre-existing ACE2 deficiency associated with pregnancy. This association might explain the worse perinatal outcomes described in the literature.

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Camptodactyly: A Finger Deformity in a Young Violinist

Medical Problems of Performing Artists ◽

10.21091/mppa.2000.2015 ◽

2000 ◽

Vol 15 (2) ◽

pp. 75-78

Author(s):

Gerald P Melchor ◽

Alice G Brandfonbrener

Keyword(s):

Case Report ◽

General Population ◽

Surgical Correction ◽

Flexion Deformity ◽

Pip Joint ◽

Congenital Condition ◽

The Right ◽

Little Finger

This report documents a congenital condition previously undescribed in a young musician. Uncommon and affecting between 1% and 2% of the general population, camptodactyly is an atraumatic, congenital flexion deformity of the proximal interphalangeal (PIP) joint of the finger, most often the right little finger, as seen in our patient.1 While this condition is not normally of great significance, except when present as part of a wider syndrome, its occurrence as described in this case report has great implications for musicians in that it may have detrimental effects on their ability to perform. Attempts at surgical correction of such a defect, in itself controversial, might further affect a musician’s ability to return to performance as well as to continue studying his or her instrument.

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Right to be a Surrogate: Biological, Constitutional and Economic Perspectives

Space and Culture India ◽

10.20896/saci.v8i1.699 ◽

2020 ◽

Vol 8 (1) ◽

pp. 78-90

Author(s):

Meghna Borah ◽

Arup Kumar Hazarika ◽

Unmilan Kalita

Keyword(s):

Legal Framework ◽

Controversial Issues ◽

Economic Perspective ◽

Eligibility Criteria ◽

Personal Liberty ◽

Commercial Surrogacy ◽

Universal Human Rights ◽

Reproductive Techniques ◽

Economic Perspectives ◽

The Right

For the survival of all forms of life, procreation is essential. However, natural procreation is not always scientifically possible. As such, the practice of surrogacy and the use of Assisted Reproductive Techniques have become more widely recognised and accepted in societies all over the world. However, various complex and controversial issues are bounded in such practices. The Surrogacy (Regulation) Bill, 2019 introduced by Government of India makes an attempt to eradicate some of those issues associated with surrogacy. Nevertheless, the legislation seems to be in derogation to the Constitution of India and universal human rights. This study is designed to substantiate in detail the right to be a surrogate in light of the constitutional mandate along with an evaluation of the eligibility criteria to be a surrogate and its consequences with regard to the existing legal framework. Besides, the economic perspective of exploitation of surrogates via banning of commercial surrogacy has been briefly discussed. The discussion under this study is expected to put forward an essential perspective to the right to be a surrogate in relation to a woman’s right to life and personal liberty. Further, prohibiting commercial surrogacy may push practicing surrogates towards other economically unrewarding, poorly regulated and potentially hazardous forms of employment or even make them subject to human trafficking. Therefore, recognition of the right to be a surrogate vis-à-vis the Surrogacy (Regulation) Bill, 2019, would help in avoiding blatant miscarriage of universal justice while upholding the supremacy of the Constitution of India.

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Adult Male’s Penile Size Measurement and Its Affecting Factors

Indonesian Andrology and Biomedical Journal ◽

10.20473/iabj.v2i2.124 ◽

2021 ◽

Vol 2 (2) ◽

pp. 55-60

Author(s):

Mikhael San Putra Wijanarko ◽

Cathelin Stella ◽

Gian Oktavianto

Keyword(s):

Mental Health ◽

General Population ◽

Measurement Method ◽

Self Esteem ◽

Systemic Diseases ◽

Adult Males ◽

Size Measurement ◽

Affecting Factors ◽

Physical And Mental Health ◽

The Right

Background: In the general population, it is estimated that 91% of adult males perceive their penile size to be smaller than average. Concern about penile size can affect one’s self-esteem, which then affects its sexual function, satisfaction, as well as physical and mental health. Therefore, accurate penile measurements are needed for clinical and academic purposes. Reviews: Measurement of penile size can be performed in an erect, stretched, even flaccid condition. However, from various researches, there is no standardization of such a measurement method. Various researches have carried out average penile measurement but many factors can affect these results such as race, genital conditions, systemic diseases, surgical procedures, and aging. Summary: There is no internationally agreed way of measuring an adult male's penis and many other factors can make the results of penile measurements vary. Proper measurement and finding out the right average of penile size in adult male with regard to other affecting factors, will be indispensable for both clinical and academic purposes.

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A patient who does not like insulin

ABOUTOPEN ◽

10.19156/abtpn.2018.0057 ◽

2018 ◽

Vol 4 (1) ◽

pp. 122-125

Author(s):

Paola Ubaldi

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

General Population ◽

Bone Metastases ◽

Cancer Symptoms ◽

The Past ◽

The Right ◽

Hypoglycemic Therapy

Hypoglycemic therapy over the past 20 years has expanded considerably with the use of new classes of more effective and safer medicines. Alongside the aging of the general population, the survival of diabetic subjects has significantly increased, thus exposing them to a greater risk of developing co-morbidities. This represents a challenge for the diabetologist, who must acquire ever broader concepts for the management of a complex and multi-organ disease. We report the case of a 72-year-old woman with type 2 diabetes mellitus and pulmonary adenocarcinoma of the right upper lobe with brain and bone metastases who, subjected to innovative and integrated treatments agreed between specialists of different disciplines, is still alive and free of cancer symptoms 23 months after diagnosis (Diabetology)

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Exercise time cues (zeitgebers) for human circadian systems can foster health and improve performance: a systematic review

BMJ Open Sport & Exercise Medicine ◽

10.1136/bmjsem-2018-000443 ◽

2018 ◽

Vol 4 (1) ◽

pp. e000443 ◽

Cited By ~ 20

Author(s):

Philip Lewis ◽

Horst W Korf ◽

Liz Kuffer ◽

J Valérie Groß ◽

Thomas C Erren

Keyword(s):

Public Health ◽

Systematic Review ◽

Circadian System ◽

Eligibility Criteria ◽

Pubmed Database ◽

Preventative Strategy ◽

Effects On Children ◽

And Performance ◽

The Individual ◽

The Right

BackgroundCircadian system time cues (zeitgebers) acting synergistically at the right times can foster chronobiological homeostasis and ultimately health. Modern 24/7 societies are challenging chronobiological homeostasis and public health. Exercise has been discussed as a potential zeitgeber for the human circadian system. Thus, if timed correctly, exercise may help in maintenance of chronobiological homeostasis and foster public health amidst increasingly challenging 24/7 lifestyles.ObjectiveTo test, using a systematic review of the literature, the following hypothesis: exercise is a zeitgeber for the human circadian system.Data sourcesThe PubMed database was systematically searched on 19 October 2017 for relevant scientific studies and reports concerning chronobiology and exercise. Eligibility criteria were defined to include articles considering exercise as a potential zeitgeber for human circadian rhythmicity or chronobiological effects of exercise on health and/or physical performance. Cognitive effects and effects on children were excluded from the synthesis.ResultsOur systematic literature search and synthesis is compatible with the validity of the hypothesis. We report that potential exercise-zeitgeber properties may be used to improve health and performance.ConclusionsInformed timing of exercise, specific to the circadian rhythm phase and zeitgeber exposure of the individual, must be advocated in performance and disease contexts as an adjunct therapeutic or preventative strategy and physical enhancer.

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Uptake and knowledge of voting rights by adult in-patients during the 2010 UK general election

The Psychiatrist ◽

10.1192/pb.bp.110.033662 ◽

2012 ◽

Vol 36 (4) ◽

pp. 126-130 ◽

Cited By ~ 4

Author(s):

James McIntyre ◽

Masum Khwaja ◽

Venkata Yelamanchili ◽

Sobia Naz ◽

Maria Clarke

Keyword(s):

General Population ◽

Voting Rights ◽

General Election ◽

Clinical Implications ◽

Psychological Barriers ◽

Registration Process ◽

Written Information ◽

Right To Vote ◽

The Right ◽

Information Barrier

Aims and methodThis study explores knowledge and uptake of the voting rights of adult in-patients in the 2010 UK general election. A clinician-completed survey was used.ResultsEligible to vote psychiatric adult in-patients were half as likely to register as the general population and half as likely to vote if registered. Nine out of ten of those unregistered cited a lack of knowledge of their eligibility to vote or of the registration process. Long-stay patients were particularly disenfranchised.Clinical implicationsMany patients and staff remain unaware of the new rules which have given a greater proportion of in-patients the right to vote and have simplified the registration and voting processes. This information barrier may be addressed in future elections by providing timely written information to both patients and staff. Once registered, patients may need further support to overcome practical and psychological barriers, and cast their vote.

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Discrimination and the Church of England: To What Extent does the Equality Act 2010 Adequately Protect Church of England Clergy?

Oxford Journal of Law and Religion ◽

10.1093/ojlr/rwaa021 ◽

2020 ◽

Author(s):

Christopher Grout*

Keyword(s):

Sexual Orientation ◽

Church Of England ◽

Final Analysis ◽

The Other ◽

Eligibility Criteria ◽

Sensitive Question ◽

The Subject ◽

The One ◽

The Right ◽

The Church

Abstract The extent to which members of the clergy are considered ‘employees’ for the purposes of secular employment and equality legislation has been the subject of much discussion, but essentially remains a fact sensitive question. The Equality Act 2010 (‘the 2010 Act’) seeks to prevent discrimination on the basis of nine ‘protected characteristics’. While recognizing that the application of the 2010 Act to the variety of clergy offices is ‘not straightforward’, the Church of England (‘the Church’) has opined that an equitable approach to clergy appointments is to proceed as if they were subject to the provisions of the 2010 Act. What follows is in`tended to be a thorough review of the eligibility criteria for clergy appointment in the Church to assess their compatibility with the requirements of the 2010 Act. In addition, particular consideration will be given to Schedule 9(2) to the 2010 Act which makes specific provision relating to religious requirements concerning the protected characteristics of sex, sexual orientation, and marriage and civil partnership. In short, where the employment is for the purposes of an organized religion, such as the Church, requirements which relate to these protected characteristics will not constitute discrimination where they engage the ‘compliance or non-conflict principle’. What these principles mean and how they might operate in practice is discussed below, taking into account the likely canonical and theological justifications for discriminating against certain individuals. Whether the law strikes the right balance between, on the one hand protecting clergy and, on the other, providing the Church with the autonomy to act in accordance with its established doctrine, will be explored in the final analysis.

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Prospective Study of the Correlation Between Postoperative Computed Tomography Scan and Primary Surgeon Assessment in Patients With Advanced Ovarian, Tubal, and Peritoneal Carcinoma Reported to Have Undergone Primary Surgical Cytoreduction to Residual Disease 1 cm or Less

Journal of Clinical Oncology ◽

10.1200/jco.2007.12.2317 ◽

2007 ◽

Vol 25 (31) ◽

pp. 4946-4951 ◽

Cited By ~ 44

Author(s):

Dennis S. Chi ◽

Pedro T. Ramirez ◽

Jerrold B. Teitcher ◽

Svetlana Mironov ◽

Debra M. Sarasohn ◽

...

Keyword(s):

Computed Tomography ◽

Ct Scan ◽

Residual Disease ◽

Advanced Ovarian Cancer ◽

Ct Scans ◽

Eligibility Criteria ◽

Primary Surgery ◽

The Right ◽

Analysis Scale ◽

Tomography Scan

Purpose To compare surgeons' operative assessments of residual disease (RD) to those identified on postoperative computed tomography (CT) scans in patients with advanced ovarian carcinoma reported to have undergone optimal primary cytoreduction. Patients and Methods All patients at one of two institutions, who were scheduled to have primary surgery for presumed advanced ovarian cancer, were asked to consent to a postoperative CT scan if cytoreduction to ≤ 1 cm RD was reported. CT scan findings were graded using a qualitative analysis scale from 1 (normal) to 5 (definitely malignant). Results From January 2001 to September 2006, 285 patients were enrolled. A total of 78 patients met eligibility criteria and had postoperative CT scans. In 41 cases (52%), postoperative scan findings correlated with the surgical report of no RD more than 1 cm, and in seven cases (9%), the CT findings were indeterminate. In 10 cases (13%), more than 1 cm RD was noted by the radiologist as probably malignant, and in 20 cases (26%), definitely malignant. In these 30 cases, the radiologically reported median largest residual mass was 1.9 cm (range, 1.1 to 5.1), with RD more than 1 cm reported most commonly in the right upper quadrant (15 patients [50%]) and central abdomen (nine patients [30%]). Conclusion There was only a 52% correlation between surgeons' assessments and postoperative CT scan evaluations of RD in patients reported to have undergone optimal cytoreduction. Further study is required to determine whether this lack of correlation is due to rapid interval tumor regrowth, RD underestimated by the surgeons, and/or overestimated by the radiologists; and to determine the clinical implications of these discrepancies.

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