20 results on '"Anna Parker"'
Search Results
2. Medical nutrition therapy for patients with malnutrition post–intensive care unit discharge: A case report of recovery from coronavirus disease 2019 (COVID‐19)
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Ryan Burslem and Anna Parker
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Clinical Observations ,medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,medicine.medical_treatment ,Medicine (miscellaneous) ,intensive care unit ,rehabilitation ,law.invention ,Quality of life (healthcare) ,COVID‐19 ,law ,Pandemic ,medicine ,Humans ,Medical nutrition therapy ,Intensive care medicine ,Nutrition and Dietetics ,Rehabilitation ,SARS-CoV-2 ,business.industry ,Malnutrition ,COVID-19 ,medicine.disease ,Intensive care unit ,Patient Discharge ,Intensive Care Units ,Quality of Life ,Nutrition Therapy ,business ,medical nutrition therapy ,Recovery phase - Abstract
Patients discharged from an intensive care unit (ICU) are frequently malnourished and experience ongoing inadequate nutrition intake because of a variety of barriers, which may lead to further declines in nutrition status. The coronavirus disease 2019 (COVID‐19) pandemic has drawn increased awareness to this vulnerable patient population and the importance of nutrition rehabilitation to promote optimal recovery from acute illness. Despite this, there are no formal guidelines addressing medical nutrition therapy during the post‐ICU recovery phase. This review provides an overview of the nutrition management of patients during the post‐ICU recovery phase with a specific focus on COVID‐19. A case study will demonstrate how medical nutrition therapy improved the nutrition status and quality of life for a patient who became severely malnourished after a prolonged hospitalization for COVID‐19.
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- 2021
3. The Emergence of Wernicke's Encephalopathy After Gastric Sleeve
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Anna Parker and Terry Brown
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medicine.medical_specialty ,Nutrition and Dietetics ,business.industry ,Internal medicine ,Medicine ,Gastric sleeve ,business ,medicine.disease ,Gastroenterology ,Wernicke's encephalopathy - Published
- 2021
4. Vitamin D Status of Children With Attention-Deficit Hyperactivity Disorder
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Stephani Johnson, Rena Zelig, and Anna Parker
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medicine.medical_specialty ,Nutrition and Dietetics ,business.industry ,Vitamin D and neurology ,medicine ,Attention deficit hyperactivity disorder ,medicine.disease ,Psychiatry ,business - Published
- 2020
5. Prophylactic supplementation of phosphate, magnesium, and potassium for the prevention of refeeding syndrome in hospitalized individuals with anorexia nervosa
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Donna M. Gallagher, Hamed Samavat, Rena Zelig, and Anna Parker
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Adult ,Pediatrics ,medicine.medical_specialty ,Anorexia Nervosa ,Adolescent ,Hypophosphatemia ,Encephalopathy ,Medicine (miscellaneous) ,Refeeding syndrome ,Anorexia nervosa ,law.invention ,Phosphates ,Randomized controlled trial ,law ,medicine ,Humans ,Magnesium ,Refeeding Syndrome ,Nutrition and Dietetics ,business.industry ,medicine.disease ,Eating disorders ,Respiratory failure ,Dietary Supplements ,Potassium ,business ,Rhabdomyolysis - Abstract
Medical stabilization, nutrition rehabilitation, and weight restoration, while minimizing risk for the potentially fatal complication of refeeding syndrome, are the primary goals for the treatment of hospitalized individuals with anorexia nervosa and other restrictive-type eating disorders. The purpose of this review was to examine the literature exploring the prophylactic supplementation of phosphate, magnesium, and potassium, in addition to routine thiamin and multivitamin supplementation, for the prevention of refeeding syndrome in adolescents and adults with anorexia nervosa. Through evaluation of outcomes (including serum electrolyte levels and clinical signs and symptoms such as respiratory failure, cardiac failure, peripheral edema, rhabdomyolysis, and encephalopathy), three studies found that prophylactic supplementation of potassium, magnesium, and/or phosphate were effective in preventing refeeding syndrome or refeeding hypophosphatemia (a characteristic of refeeding syndrome). Although all studies found that prophylactic supplementation was effective in preventing refeeding syndrome, refeeding approaches (including the method, amount, and duration of nutrient delivery) as well as the populations studied varied considerably, making it difficult to arrive at specific recommendations for practice. Randomized controlled trials are needed to further examine the safety and effectiveness of prophylactic supplementation of phosphate, magnesium, and potassium on the prevention of refeeding syndrome, utilizing similar feeding and supplementation protocols.
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- 2021
6. The Relationship Between Vitamin D and Postpartum Depression
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Anna Parker, Kelly A. Tiderencel, and Rena Zelig
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Postpartum depression ,medicine.medical_specialty ,Nutrition and Dietetics ,Obstetrics ,business.industry ,Vitamin D and neurology ,medicine ,Current (fluid) ,business ,medicine.disease - Published
- 2019
7. Low-carbohydrate, high-fat enteral formulas for managing glycemic control in patients who are critically ill: A review of the evidence
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Diane Rigassio Radler, Ryan Burslem, Anna Parker, and Rena Zelig
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medicine.medical_specialty ,030309 nutrition & dietetics ,Critical Illness ,Carbohydrates ,Medicine (miscellaneous) ,Glycemic Control ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Enteral Nutrition ,Randomized controlled trial ,law ,Diabetes mellitus ,Medicine ,Humans ,In patient ,Enteral formulas ,Intensive care medicine ,Glycemic ,Randomized Controlled Trials as Topic ,0303 health sciences ,Nutrition and Dietetics ,business.industry ,Critically ill ,medicine.disease ,Parenteral nutrition ,Hyperglycemia ,Critical illness ,030211 gastroenterology & hepatology ,business - Abstract
Hyperglycemia is associated with increased morbidity and mortality. Low-carbohydrate, high-fat (LCHF) enteral formulas are marketed to improve glycemic control; however, given the multifactorial mechanisms contributing to hyperglycemia in patients who are critically ill, the effect that LCHF formulas may have on improving glycemic control in this patient population is unclear. Current guidelines for the use of LCHF formulas among patients who are critically ill are limited by a lack of evidence. This review explores recent research published in the past 7 years to determine whether LCHF enteral formulas improve glycemic control compared with standard enteral formulas in patients who are critically ill. Four randomized controlled trials met the inclusion criteria for this review. Their results suggest that LCHF formulas may improve glycemic control in patients who are critically ill with diabetes mellitus and/or who are hyperglycemic. Further large-scale randomized controlled trials are warranted to validate these findings among different subgroups of patients with critical illness. The potential benefits of LCHF formulas need to be weighed against specific limitations, including that LCHF formulas typically do not contain sufficient protein to meet the recommended needs of patients who are critically ill.
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- 2021
8. Associations between maternal size and health outcomes for women undergoing caesarean section: a multicentre prospective observational study (The MUM SIZE Study)
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Jospeh Lew, S.W. Simmons, Karen E. Lamb, Dan Casalaz, Philip Clarke, David A Story, Anna Parker, Michelle Tew, Kim Dalziel, Gyln Teale, Alicia Dennis, and Elizabeth Hessian
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Adult ,Pediatrics ,medicine.medical_specialty ,obesity ,Referral ,Adolescent ,medicine.medical_treatment ,Operative Time ,Overweight ,Body Mass Index ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Pregnancy ,Risk Factors ,Obstetrics and Gynaecology ,Outcome Assessment, Health Care ,Medicine ,Humans ,Mass index ,Caesarean section ,030212 general & internal medicine ,Prospective Studies ,Prospective cohort study ,030219 obstetrics & reproductive medicine ,business.industry ,Cesarean Section ,Research ,General Medicine ,Middle Aged ,medicine.disease ,Hospitalization ,Pregnancy Complications ,caesarean section ,Quality in health care ,Observational study ,Female ,medicine.symptom ,business ,Health economics ,Body mass index - Abstract
ObjectivesTo investigate associations between maternal body mass index (BMI) at delivery (using pregnancy-specific BMI cut-off values 5 kg/m2higher in each of the WHO groups) and clinical, theatre utilisation and health economic outcomes for women undergoing caesarean section (CS). DesignA prospective multicentre observational study. SettingSeven secondary or tertiary referral obstetric hospitals. ParticipantsOne thousand and four hundred and fifty-seven women undergoing all categories of CS. Data collectionHeight and weight were recorded at the initial antenatal visit and at delivery. We analysed the associations between delivery BMI (continuous and pregnancy-specific cut-off values) and total theatre time, surgical time, anaesthesia time, maternal and neonatal adverse outcomes, total hospital admission and theatre costs. ResultsMean participant characteristics were: age 32 years, gestation at delivery 38.4 weeks and delivery BMI 32.2 kg/m2. Fifty-five per cent of participants were overweight, obese or super-obese using delivery pregnancy-specific BMI cut-off values. As BMI increased, total theatre time, surgical time and anaesthesia time increased. Super-obese participants had approximately 27% (17 min, p ConclusionsIncreased maternal BMI was associated with increased total theatre time, surgical and anaesthesia time, increased total hospital admission costs and theatre costs. Clinicians and health administrators should consider these clinical risks, time implications and financial costs when managing pregnant women.
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- 2020
9. Severe Protein Calorie Malnutrition in the Context of Alcoholic Liver Cirrhosis
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Elizabeth Kaliszewski and Anna Parker
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medicine.medical_specialty ,Nutrition and Dietetics ,Cirrhosis ,Protein–energy malnutrition ,business.industry ,media_common.quotation_subject ,Encephalopathy ,Context (language use) ,Appetite ,medicine.disease ,Gastroenterology ,03 medical and health sciences ,Malnutrition ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,Severe protein calorie malnutrition ,medicine ,030211 gastroenterology & hepatology ,business ,media_common - Published
- 2018
10. Vitamin E Supplementation in Pediatric Nonalcoholic Fatty Liver Disease
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Rena Zelig, Anna Parker, and Rachael Patusco
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0301 basic medicine ,medicine.medical_specialty ,Nutrition and Dietetics ,business.industry ,Vitamin e supplementation ,medicine.disease ,Gastroenterology ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Internal medicine ,Nonalcoholic fatty liver disease ,Medicine ,030211 gastroenterology & hepatology ,business - Published
- 2018
11. The Role of FTO Gene Alleles on the Diet and Metabolic Risk Factors in the Subjects with Diabetes
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Fariha Shaheen, Anna Parker, Iftikhar Ahmed Siddiqui, Rubina Hakeem, Abdul Basit, Nazish Waris, Asher Fawwad, Syeda Nuzhat Nawab, and Syed Muhammad Shahid
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Genetics ,business.industry ,Endocrinology, Diabetes and Metabolism ,Diabetes mellitus ,Metabolic risk ,Internal Medicine ,Medicine ,Allele ,business ,medicine.disease ,FTO gene - Published
- 2017
12. The Association Between Vitamin D Status and Pulmonary Function in Pediatric Patients With Cystic Fibrosis
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Anna Parker, Rena Zelig, and Allison Gomes
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medicine.medical_specialty ,Nutrition and Dietetics ,business.industry ,Internal medicine ,Vitamin D and neurology ,Medicine ,business ,medicine.disease ,Cystic fibrosis ,Gastroenterology ,Pulmonary function testing - Published
- 2019
13. Identification of Generalist Registered Dietitian Nutritionist Knowledge Gaps in Diabetes Medical Nutrition Therapy Compared to Diabetes-Credentialed Registered Dietitian Nutritionists: Results of a Survey to Inform Educational Opportunities
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Joan Thomas, Anna Parker, Kimberly Bisanz, Juliet Mancino, Cecily Byrne, Rosa K. Hand, and Sandra A. Parker
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0301 basic medicine ,Adult ,Male ,medicine.medical_specialty ,Health Knowledge, Attitudes, Practice ,Dietetics ,MEDLINE ,030209 endocrinology & metabolism ,Generalist and specialist species ,Credentialing ,03 medical and health sciences ,0302 clinical medicine ,Education, Professional ,Diabetes mellitus ,Surveys and Questionnaires ,Diabetes Mellitus ,Medicine ,Humans ,Medical nutrition therapy ,Nutritionists ,030109 nutrition & dietetics ,Nutrition and Dietetics ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Identification (information) ,Nutritionist ,Family medicine ,Needs assessment ,Female ,Clinical Competence ,business ,Needs Assessment ,Food Science - Published
- 2017
14. Insulin Omission for Weight Control in Adolescents With Type 1 Diabetes Mellitus
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Jane Ziegler, Kimberly Gottesman, and Anna Parker
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medicine.medical_specialty ,Type 1 diabetes ,Nutrition and Dietetics ,business.industry ,Insulin ,medicine.medical_treatment ,Diabulimia ,Weight control ,medicine.disease ,Eating disorders ,Endocrinology ,Internal medicine ,medicine ,business - Published
- 2015
15. Vitamin A Supplementation for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants: An Update
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Anna Parker, Rena Zelig, Emily Schwartz, and Stephani Johnson
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Vitamin ,Pediatrics ,medicine.medical_specialty ,Birth weight ,Medicine (miscellaneous) ,Infant, Premature, Diseases ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,030225 pediatrics ,medicine ,Birth Weight ,Humans ,030212 general & internal medicine ,Dosing ,Vitamin A ,Bronchopulmonary Dysplasia ,Nutrition and Dietetics ,business.industry ,Vitamin A Deficiency ,Infant ,medicine.disease ,Vitamin A deficiency ,Low birth weight ,Observational Studies as Topic ,chemistry ,Bronchopulmonary dysplasia ,Premature birth ,Dietary Supplements ,medicine.symptom ,Complication ,business ,Infant, Premature - Abstract
Bronchopulmonary dysplasia (BPD) is a common complication of premature birth and is associated with significant morbidity. Vitamin A supplementation has been suggested as a potential preventative measure against BPD due to its role in lung maturation and because preterm infants are particularly predisposed to vitamin A deficiency. The aim of this review was to determine whether vitamin A supplementation reduces BPD risk among preterm infants. PubMed, CINAHL, and Web of Science databases were searched with the keywords "bronchopulmonary dysplasia," "vitamin A," and "preterm infants" and with the time frame of 2006-2016, and 4 studies were selected for review per the inclusion criteria. Only 1 study found a significant reduction in BPD risk associated with vitamin A supplementation; however, 2 studies indicated a nonsignificant benefit and may have been underpowered to show statistical significance. One study revealed an increased risk of sepsis associated with vitamin A supplementation (for infants weighing >1000 g at birth), but no risk was seen with vitamin A supplementation in the other studies. Because intramuscular vitamin A has shown benefit with minimal risk, continued supplementation for preterm infants is warranted. Future studies aimed at assessing infant groups that are most likely to benefit from supplementation (based on birth weight or other conditions), as well as determining the optimal dosing while minimizing injections, would be beneficial.
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- 2017
16. The Effect of Medical Nutrition Therapy by a Registered Dietitian Nutritionist in Patients with Prediabetes Participating in a Randomized Controlled Clinical Research Trial
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Peter J. Winkle, Anna Parker, Laura Byham-Gray, and Robert Denmark
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Adult ,Male ,medicine.medical_specialty ,Diabetes risk ,Diet, Reducing ,Pilot Projects ,Motor Activity ,Overweight ,California ,Body Mass Index ,Cohort Studies ,Prediabetic State ,chemistry.chemical_compound ,Patient Education as Topic ,Risk Factors ,Internal medicine ,Diet, Diabetic ,medicine ,Humans ,Nutritionists ,Prediabetes ,Medical nutrition therapy ,Life Style ,Glycated Hemoglobin ,Nutrition and Dietetics ,business.industry ,Repeated measures design ,Type 2 Diabetes Mellitus ,General Medicine ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Clinical research ,Diabetes Mellitus, Type 2 ,chemistry ,Physical therapy ,Female ,Lost to Follow-Up ,Glycated hemoglobin ,medicine.symptom ,business ,Food Science - Abstract
Background Prior studies have provided evidence that lifestyle change prevents or delays the occurrence of type 2 diabetes mellitus. The challenge is to translate research evidence for type 2 diabetes mellitus prevention into health care settings. Objective We investigated the effect of medical nutrition therapy (MNT) compared with usual care on fasting plasma glucose values, glycated hemoglobin (HbA1c), serum lipid levels, and Diabetes Risk Score, from baseline to the end of a 12-week intervention in overweight or obese adults with prediabetes. Design Prospective, randomized, parallel group study of 76 adults with impaired fasting plasma glucose or an HbA1c of 5.7% to 6.4%, recruited between April 2010 and May 2011 who completed a 12-week intervention period. Main outcome measures The primary outcome measure was fasting plasma glucose. Secondary outcome measures were HbA1c, serum lipid levels, and Diabetes Risk Score. Statistical analyses A factorial repeated measures analysis of variance was used to make comparisons between the two groups (the MNT and usual care groups) and two measures of time (baseline and 12 weeks postintervention). Data analysis was performed using the Statistical Package for the Social Sciences (release 19.0, 2010, SPSS Inc). Results There was a significant interaction for group assignment and HbA1c ( P =0.01), with the MNT group experiencing significantly lower HbA1c levels than the usual care group (5.79% vs 6.01%) after the 12-week intervention. There was a significant interaction for group assignment and Diabetes Risk Score ( P =0.001). Diabetes Risk Score for the MNT group decreased from 17.54±3.69 to 15.31±3.79 compared with the usual care group score, which went from 17.23±4.69 to 16.83±4.73. Regardless of group assignment, both groups experienced a reduction in total cholesterol ( P =0.01) and low-density lipoprotein cholesterol ( P =0.04) level. Conclusions The results demonstrate that individualized MNT is effective in decreasing HbA1c level in patients diagnosed with prediabetes.
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- 2014
17. Insulin Resistance and Serum Magnesium Concentrations among Women with Polycystic Ovary Syndrome
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Kristen P Hamilton, Amina Haggag, Anna Parker, and Rena Zelig
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0301 basic medicine ,medicine.medical_specialty ,endocrine system diseases ,Medicine (miscellaneous) ,Physiology ,030209 endocrinology & metabolism ,Review ,English language ,Carbohydrate metabolism ,serum magnesium ,Hypomagnesemia ,03 medical and health sciences ,Dietary interventions ,0302 clinical medicine ,Insulin resistance ,insulin resistance ,Epidemiology ,medicine ,polycystic ovary syndrome (PCOS) ,030109 nutrition & dietetics ,Nutrition and Dietetics ,business.industry ,Polycystic ovary syndrome (PCOS) ,medicine.disease ,Polycystic ovary ,supplementation ,glycemic control ,diet ,business ,Food Science - Abstract
Polycystic ovary syndrome (PCOS) affects ∼1 in 10 women worldwide. Hypomagnesemia may worsen insulin resistance (IR) due to the role magnesium (Mg) plays in glucose metabolism. This review explores the relation between serum Mg and IR among women with PCOS. A review of primary research focusing on both serum Mg and women with PCOS was conducted from 2011 to 2019. Studies reviewed included human subjects, written in the English language, and limited to community-dwelling women aged ≥18 y. A total of 7 articles were reviewed. The findings from 4 epidemiological analytic studies evaluating serum Mg status suggest there may be a relation between serum Mg concentrations and IR among women with PCOS. However, among the 3 experimental trials, Mg supplementation inconsistently impacted IR among women with PCOS. Women with PCOS are more likely to underconsume Mg-rich foods and have a greater likelihood of lower serum Mg concentrations. Although it remains unclear if dietary Mg and/or supplementation should be a nutritional strategy for all women with PCOS, current research indicates an association between adequate Mg status and improved IR. Further research evaluating dietary interventions and supplementation is warranted.
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- 2019
18. Kidney Injury in Abdominal Compartment Syndrome
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Lakhmir S. Chawla and Anna Parker Sattah
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medicine.medical_specialty ,Abdominal compartment syndrome ,Acute decompensated heart failure ,business.industry ,Acute kidney injury ,Disease ,medicine.disease ,Inferior vena cava ,Pathophysiology ,medicine.vein ,medicine ,Kidney injury ,Intensive care medicine ,business ,Pulmonary wedge pressure - Abstract
Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) represent a spectrum of disease with wide-reaching effects. While often thought of as a surgical disease, a number of medical management strategies may be utilized, in some cases obviating the need for surgical intervention. Central to this issue are the interrelated pressures within the abdominal, thoracic, and vascular compartments within the body. Fluid management and the treatment of renal dysfunction in patients at risk for IAH and ACS is a complex problem and one that cannot be easily separated from concurrent multiorgan system effects. We therefore provide a brief overview of the systemic effects that affect many patients developing acute kidney injury in this setting. We will review in more detail the relevant renal pathophysiology as well as the medical and surgical management strategies for treating patients with IAH and ACS.
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- 2014
19. Abstract #506: The Effect of Medical Nutrition Therapy by A Registered Dietitian Nutritionist in Patients with Prediabetes Participating in A Randomized Controlled Clinical Research Trial
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Robert Denmark, Anna Parker, Laura Byham-Gray, and Peter J. Winkle
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medicine.medical_specialty ,business.industry ,Endocrinology, Diabetes and Metabolism ,General Medicine ,medicine.disease ,Endocrinology ,Clinical research ,Nutritionist ,Family medicine ,medicine ,Registered dietitian ,In patient ,Medical nutrition therapy ,Prediabetes ,business - Published
- 2015
20. ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing
- Author
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Clare Shakeshaft, Carlo Giaquinto, Tim R. Cressey, Adeodata Kekitiinwa, David M. Burger, Pauline Amuge, Pablo Rojo, Cecilia L. Moore, Osee Behuhuma, Yacine Saϊdi, Linda Barlow-Mosha, James Hakim, Alexandra Compagnucci, Lorna Atwine, Diana M. Gibb, Ebrahim Variava, Hilda Mujuru, Mark F. Cotton, Victor Musiime, Moherndran Archary, Deborah Ford, Cissy Kityo, Thanyawee Puthanakit, Anna Turkova, Avy Violari, Abbas Lugemwa, Medical Research Council Clinical Trials Unit (MRC CTU), University College of London [London] (UCL), University of Zimbabwe (UZ), Baylor College of Medicine Children's Foundation [Kampala, Uganda] (BCMCF), Joint Clinical Research Centre, MUJHU Research Collaboration [Kampala, Uganda] (MUJHURC), Chiang Mai University (CMU), Harvard T.H. Chan School of Public Health, University of Liverpool, Perinatal HIV Research Unit [Johannesburg, South Africa] (PHRU), University of the Witwatersrand [Johannesburg] (WITS), Klerksdorp Tshepong Hospital Complex [Matlosana, South Africa] (KTHC), Family Center for Research with Ubuntu [Cape Town, South Africa] (FCRU), Durban International Clinical Research Site [Durban, South Africa] (DICRS), Essais Thérapeutiques et Maladies Infectieuses, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), Chulalongkorn University [Bangkok], Africa Health Research Institute [Hlabisa, South Africa] (AHRI), Hlabisa Hospital [Hlabisa, South Africa] (HH), Radboud University Medical Center [Nijmegen], Università degli Studi di Padova = University of Padua (Unipd), Hospital Universitario 12 de Octubre [Madrid], ODYSSEY Trial Team: Shabinah Ali, Abdel Babiker, Chiara Borg, Anne-Marie Borges Da Silva, Joanna Calvert, Deborah Ford, Joshua Gasa, Diana M Gibb, Nasir Jamil, Sarah Lensen, Emma Little, Fatima Mohamed, Samuel Montero, Cecilia L Moore, Rachel Oguntimehin, Anna Parker, Reena Patel, Tasmin Phillips, Tatiana Sarfati, Karen Scott, Clare Shakeshaft, Moira Spyer, Margaret Thomason, Anna Turkova, Rebecca Turner, Nadine Van Looy, Ellen White, Kaya Widuch, Helen Wilkes, Ben Wynne, Carlo Giaquinto, Tiziana Grossele, Daniel Gomez-Pena, Davide Bilardi, Giulio Vecchia, Alexandra Compagnucci, Yacine Saidi, Yoann Riault, Alexandra Coelho, Laura Picault, Christelle Kouakam, Tim R Cressey, Suwalai Chalermpantmetagul, Dujrudee Chinwong, Gonzague Jourdain, Rukchanok Peongjakta, Pra-Ornsuda Sukrakanchana, Wasna Sirirungsi, Janet Seeley, Sarah Bernays, Magda Conway, Nigel Klein, Eleni Nastouli, Anita De Rossi, Maria Angeles Munoz Fernandez, David Burger, Pauline Bollen, Angela Colbers, Hylke Waalewijn, Cissy M Kityo, Victor Musiime, Elizabeth Kaudha, Annet Nanduudu, Emmanuel Mujyambere, Paul Ocitti Labeja, Charity Nankunda, Juliet Ategeka, Peter Erim, Collin Makanga, Esther Nambi, Abbas Lugemwa, Lorna Atwine, Edridah Keminyeto, Deogratiuos Tukwasibwe, Shafic Makumbi, Emily Ninsiima, Mercy Tukamushaba, Rogers Ankunda, Ian Natuhurira, Miriam Kasozi, Baker Rubinga, Adeodata R Kekitiinwa, Pauline Amuge, Dickson Bbuye, Justine Nalubwama, Winnie Akobye, Muzamil Nsibuka Kisekka, Anthony Kirabira, Gloria Ninsiima, Sylvia Namanda, Gerald Agaba, Immaculate Nagawa, Annet Nalugo, Florence Namuli, Rose Kadhuba, Rachael Namuddu, Lameck Kiyimba, Angella Baita, Eunice Atim, Olivia Kobusingye, Clementine Namajja, Africanus Byaruhanga, Rogers Besigye, Herbert Murungi, Geoffrey Onen, Philippa Musoke, Linda Barlow-Mosha, Grace Ahimbisibwe, Rose Namwanje, Monica Etima, Mark Ssenyonga, Robert Serunjogi, Hajira Kataike, Richard Isabirye, David Balamusani, Monica Nolan, Mark F Cotton, Anita Janese van Rensburg, Marlize Smuts, Catherine Andrea, Sumaya Dadan Sonja Pieterse, Vinesh Jaeven, Candice Makola, George Fourie, Kurt Smith, Els Dobbels, Peter Zuidewind, Hesti Van Huyssteen, Mornay Isaacs, Georgina Nentsa, Thabis Ncgaba, Candice MacDonald, Mandisa Mtshagi, Maria Bester, Wilma Orange, Ronelle Arendze, Mark Mulder, George Fourie, Avy Violari, Nastassja Ramsagar, Afaaf Liberty, Ruth Mathiba, Lindiwe Maseko, Nakata Kekane, Busi Khumlo, Mirriam Khunene, Noshalaza Sbisi, Jackie Brown, Ryphina Madonsela, Nokuthula Mbadaliga, Zaakirah Essack, Reshma Lakha, Aasia Vadee, Derusha Frank, Nazim Akoojee, Maletsatsi Monametsi, Gladness Machache, Yolandie Fourie, Anusha Nanan-Kanjee, Juan Erasmus, Angelous Mamiane, Tseleng Daniel, Fatima Mayat, Nomfundo Maduna, Patsy Baliram, Chaiwat Ngampiyasakul, Pisut Greetanukroh, Wanna Chamjamrat, Praechadaporn Khannak, Pornchai Techakunakorn, Thitiwat Thapwai, Patcharee Puangmalai, Ampai Maneekaew, Pradthana Ounchanum, Yupawan Thaweesombat, Areerat Kongponoi, Jutarat Thewsoongnoen, Suparat Kanjanavanit, Pacharaporn Yingyong, Thida Namwong, Rangwit Junkaew, Ussanee Srirompotong, Patamawadee Sudsaard, Siripun Nuanbuddee, Sookpanee Wimonklang, Sathaporn Na-Rajsima, Suchart Thongpaen, Pattira Runarassamee, Watchara Meethaisong, Arttasid Udomvised, Ebrahim Variava, Modiehi Rakgokong, Dihedile Scheppers, Tumelo Moloantoa, Abdul Hamid Kaka, Tshepiso Masienyane, Akshmi Ori, Kgosimang Mmolawa, Pattamukkil Abraham, Moherndran Archary, Rejoice Mosia, Sajeeda Mawlana, Rosie Mngqibisa, Rashina Nundlal, Elishka Singh, Penelope Madlala, Allemah Naidoo, Sphiwee Cebekhulu, Petronelle Casey, Collin Pillay, Subashinie Sidhoo, Minenhle Chikowore, Lungile Nyantsa, Melisha Nunkoo, Terence Nair, Enbavani Pillay, Sheleika Singh, Sheroma Rajkumar, Osee Behuhuma, Olivier Koole, Kristien Bird, Nomzamo Buthelezi, Mumsy Mthethwa, James Hakim, Hilda Mujuru, Kusum Nathoo, Mutsa Bwakura-Dangarembizi, Ennie Chidziva, Shepherd Mudzingwa, Themelihle Bafana, Colin Warambwa, Godfrey Musoro, Gloria Tinago, Shirley Mutsai, Columbus Moyo, Ruth Nhema, Misheck Nkalo Phiri, Stuart Chitongo, Joshua Choga, Joyline Bhiri, Wilber Ishemunyoro, Makhosonke Ndlovu, Thanyawee Puthanakit, Naruporn Kasipong, Sararut Chanthaburanun, Kesdao Nanthapisal, Thidarat Jupimai, Thornthun Noppakaorattanamanee, Torsak Bunupuradah, Wipaporn Natalie Songtaweesin, Chutima Saisaengjan, Stephan Schultze-Straber, Christoph Konigs, Robin Kobbe, Felicia Mantkowski, Steve Welch, Jacqui Daglish, Laura Thrasyvoulou, Delane Singadia, Sophie Foxall, Judith Acero, Gosia Pasko-Szcech, Jacquie Flynn, Gareth Tudor-Williams, Farhana Abdulla, Srini Bandi, Jin Li, Sean O'Riordan, Dominique Barker, Richard Vowden, Colin Ball Eniola Nsirim, Kathleen McClughlin, India Garcia, Pablo Rojo Conejo, Cristina Epalza, Luis Prieto Tato, Maite Fernandez, Luis Escosa Garcia, Maria José Mellado Peña, Talia Sainz Costa, Claudia Fortuny Guasch, Antoni Noguera Julian, Carolina Estepa, Elena Bruno, Alba Murciano Cabeza, Maria Angeles Muñoz Fernandez, Paula Palau, Laura Marques, Carla Teixeira, Alexandre Fernandes, Rosita Nunes, Helena Nascimento, Andreia Padrao, Joana Tuna, Helena Ramos, Ana Constança Mendes, Helena Pinheiro, Ana Cristina Matos, Flavia Kyomuhendo, Sarah Nakalanzi, Cynthia Mukisa Williams, Ntombenhle Ngcobo, Deborah Pako, Jacky Crisp, Benedictor Dube, Precious Chandiwana, Winnie Gozhora, Ian Weller, Elaine Abrams, Tsitsi Apollo, Polly Clayden, Valériane Leroy, Anton Pozniak, Jane Crawley, Rodolphe Thiébaut, Helen McIlleron, Alasdair Bamford, Hermione Lyall, Andrew Prendergast, Felicity Fitzgerald, Anna Goodman, Malbec, Odile, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), Radboud University Medical Centre [Nijmegen, The Netherlands], and Universita degli Studi di Padova
- Subjects
0301 basic medicine ,Male ,Pediatrics ,[SDV]Life Sciences [q-bio] ,HIV Infections ,Basket trial ,Dolutegravir ,Efficacy ,HIV ,Paediatric ,Pharmacokinetic ,Randomized control trial ,Safety ,Adolescent ,Body Weight ,Child ,Child, Preschool ,Cohort Studies ,Drug Dosage Calculations ,Europe ,Female ,HIV Integrase Inhibitors ,HIV-1 ,Heterocyclic Compounds, 3-Ring ,Humans ,Oxazines ,Piperazines ,Pyridones ,RNA, Viral ,South Africa ,Thailand ,Treatment Outcome ,Uganda ,Viral Load ,World Health Organization ,Zimbabwe ,law.invention ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,Heterocyclic Compounds ,law ,Clinical endpoint ,Medicine ,Viral ,030212 general & internal medicine ,3. Good health ,[SDV] Life Sciences [q-bio] ,Infectious Diseases ,Viral load ,Cohort study ,Research Article ,medicine.medical_specialty ,030106 microbiology ,3-Ring ,lcsh:Infectious and parasitic diseases ,03 medical and health sciences ,lcsh:RC109-216 ,Dosing ,Preschool ,Pregnancy ,business.industry ,Clinical study design ,medicine.disease ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,chemistry ,RNA ,business - Abstract
Background Dolutegravir (DTG)-based antiretroviral therapy (ART) is highly effective and well-tolerated in adults and is rapidly being adopted globally. We describe the design of the ODYSSEY trial which evaluates the efficacy and safety of DTG-based ART compared with standard-of-care in children and adolescents. The ODYSSEY trial includes nested pharmacokinetic (PK) sub-studies which evaluated pragmatic World Health Organization (WHO) weight-band-based DTG dosing and opened recruitment to children Methods ODYSSEY (Once-daily DTG based ART in Young people vS. Standard thErapY) is an open-label, randomised, non-inferiority, basket trial comparing the efficacy and safety of DTG + 2 nucleos(t) ides (NRTIs) versus standard-of-care (SOC) in HIV-infected children Results Between September 2016 and June 2018, 707 children weighing ≥14 kg were enrolled; including 311 ART-naïve children and 396 children starting second-line. 47% of children were enrolled in Uganda, 21% Zimbabwe, 20% South Africa, 9% Thailand, 4% Europe. 362 (51%) participants were male; median age [range] at enrolment was 12.2 years [2.9–18.0]. 82 (12%) children weighed 14 to Conclusions By employing a basket design, to include ART-naïve and -experienced children, and nested PK sub-studies, the ODYSSEY trial efficiently evaluates multiple scientific questions regarding dosing and effectiveness of DTG-based ART in children. Trial registration NCT, NCT02259127, registered 7th October 2014; EUDRACT, 2014–002632-14, registered 18th June 2014 (https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002632-14/ES); ISRCTN, ISRCTN91737921, registered 4th October 2014.
- Published
- 2021
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