SCIENTIFIC REFERENCE

Clinical Development

The following articles are hyperlinked to the abstract of the article:

2019

Influence of Rifampin-Mediated Organic Anion-Transporting Polypeptide 1B1/1B3 Inhibition on the Pharmacokinetics of Clazosentan

Pierre-Eric Juif, Christine Voors-Pette, Mike Ufer, Peter Dogterom and Jasper Dingemanse

Clinical And Translational Science (2019)

Two placebo-controlled crossover studies in healthy subjects to evaluate gastric acid neutralization by an alginate-antacid formulation (Gaviscon Double Action).

Wilkinson J, Abd-Elaziz K, den Daas I, Wemer J, van Haastert M, Hodgkinson V, Foster M, Coyle C.

Drug Development and Industrial Pharmacy (2019)

The absolute bioavailability and the effect of food on a new magnesium lactate dehydrate extended-release caplet in healthy subjects

Dogterom P, Fu CH, Legg T, Chiou YJ and Brandon S

Drug Development and Industrial Pharmacy (2018)

2018

Asenapine pharmacokinetics and tolerability in a pediatric population

Dogterom P, Riesenberg R, de Greef R, Dennie J, Johnson M, Reddy VP, Miltenburg AMM, Findling RL, Jakate A, Carrothers TJ and Troyer MD

Drug Design, Development and Therapy (2018)

Safety and clinical effect of i.v. infusion of cyclopropyl-methoxycarbonyl etomidate (ABP-700), a soft analogue of etomidate, in healthy subjects

Valk BI, Absalom AR, Meyer P, Meier S, den Daas I, van Amsterdam K, Campagna JA, Sweeney SP, Struys MMRF

British Journal of Anaesthesia (2018)

2017

A Phase 1, Single-center, Double-blind, Placebo-controlled Study in Healthy Subjects to Assess the Safety, Tolerability, Clinical Effects, and Pharmacokinetics-Pharmacodynamics of Intravenous Cyclopropyl-methoxycarbony lmetomidate (ABP-700) after a Single Ascending Bolus Dose

Michel M. R. F. Struys, Beatrijs I. Valk, Douglas J. Eleveld, Anthony R. Absalom, Peter Meyer, Sascha Meier, Izaak den Daas, Thomas Chou, Kai van Amsterdam, Jason A. Campagna, Steven P. Sweeney

Anesthesiology 2017

ERS technical standard on bronchial challenge testing: general considerations and performance of methacholine challenge tests

Coates AL, Wanger J, Cockcroft DW, Culver BH; and the Bronchoprovocation Testing Task Force: Kai-Håkon Carlsen, Diamant Z, Gauvreau G, Hall GL, Hallstrand TS, Horvath I, de Jongh FHC, Joos G, Kaminsky DA, Laube BL, Leuppi JD, Sterk PJ.

The European Respiratory Journal (May 2017)

Generic medications in precision medicine in asthma

Diamant Z, Hanania NA.

Current Opinion in Pulmonary Medicine (January 2017)

Role of biologics targeting type 2 airway inflammation in asthma: what have we learned so far?

Parulekar AD, Diamant Z, Hanania NA.

Current Opinion in Pulmonary Medicine (January 2017)

A new fully human recombinant FSH (follitropin epsilon): two phase I randomized placebo and comparator-controlled pharmacokinetic and pharmacodynamic trials

Abd-Elaziz K, Duijkers I, Stöckl L, Dietrich B, Klipping C, Eckert K, Goletz S.

Hum Reproduction (June 2017)

Toll-like Receptor 3 blockade in Rhinovirus-induced experimental asthma exacerbations: a randomized controlled study

Silkoff P, Flavin S, Gordon R, Loza MJ, Sterk PJ, Lutter R, Diamant Z, Turner RB, Lipworth BJ, Proud D, Singh D, Eich A, Backer V, Gern J, Herzmann C, Halperin SA, Mensinga T, Del Vecchio AM, Baribaud F, Barnathan ES, Johnston SL.

Journal of Allergy and Clinical Immunology (July 2017)

Phase I Study evaluating the safety, tolerability and pharmacokinetics of a novel oral dissolvable film containing dexamethasone versus fortecortin dexamethasone tablets

Diamant Z, Samuelsson Palmgren G, Westrin B, Bjermer L.

European Clinical Respiratory Journal (August 2017)

Phase I Study evaluating the safety, tolerability and pharmacokinetics of a novel oral dissolvable film containing dexamethasone versus fortecortin dexamethasone tablets

Diamant Z, Samuelsson Palmgren G, Westrin B, Bjermer L.

European Clinical Respiratory Journal (August 2017)

Club cell protein (CC16) in plasma, bronchial brushes, BAL and urine following an inhaled allergen challenge in allergic asthmatics

Stenberg H, Wadelius E, Moitra S, Åberg I, Ankerst J, Diamant Z, Bjermer L, Tufvesson E.

Biomarkers (September 2017)

Small airway involvement in the late allergic response in asthma

Stenberg H, Diamant Z, Ankerst J, Bjermer L, Tufvesson E.

Clinical & Experimental Allergy (September 2017)

2016

The Safety, Pharmacokinetics, and Nervous System Effects of Two Natural Sources of Caffeine in Healthy Adult Males

DR Krieger, DS Kalman, S Feldman, L Arnillas, D Goldberg, O Gisbert, and S Nader

Clinical and Translational Science (2016)

Randomized, double-blind, active-controlled study evaluating the safety and immunogenicity of three vaccination schedules and two dose levels of AV7909 vaccine for anthrax post-exposure prophylaxis in healthy adults

Robert J. Hopkins, Gurdyal Kalsi, Victor M. Montalvo-Lugo, Mona Sharma, Yukun Wu, Derek D. Muse, Eric A. Sheldon, Frank C. Hampel, and Laurence Lemiale

Vaccine (2016)

Revisiting the role of the mast cell in asthma

Cecilia Andersson, Ellen Tufvesson, Zuzana Diamant, and Leif Bjermer

Current Opinion in Pulmonary Medicine (January 2016)

The new look on asthma: linking phenotypes, endotypes and biomarkers to asthma management

Zuzana Diamant, and Nicola A. Hanania

Current Opinion in Pulmonary Medicine (January 2016)

Role of T2 inflammation biomarkers in severe asthma

Amit D. Parulekar, Zuzana Diamant, and Nicola A. Hanania

Current Opinion in Pulmonary Medicine (January 2016)

A randomized, 5-arm dose finding study with a mite allergoid SCIT in allergic rhinoconjunctivitis patients

O. Pfaar, E. van Twuijver, J. D. Boot, D. J. E. Opstelten, L. Klimek, R. van Ree, Z. Diamant, P. Kuna, and P. Panzner

Allergy – European Journal of Allergy and Clinical Immunology (January 2016)

Synergistic Increase of Serum BDNF in Alzheimer Patients Treated with Cerebrolysin and Donepezil: Association with Cognitive Improvement in ApoE4 Cases

X. Anton Alvarez, Irene Alvarez, Olalla Iglesias, Ignacio Crespo, Jesus Figueroa, Manuel Aleixandre, Carlos Linares, Elias Granizo, Manuel Garcia-Fantini, Jose Marey, Eliezer Masliah, Stefan Winter, Dafin Muresanu, Herbert Moessler

International Journal of Neuropsychopharmacology (April 2016)

Effects of low- versus high-dose fluticasone propionate/formoterol fumarate combination therapy on AMP challenge in asthmatic patients: A double-blind, randomised clinical trial

Frank Kanniess, Zuzana Diamant, Mark Lomax

Pulmonary Pharmacology & Therapeutics (April 2016)

Can a Single Dose Response Predict the Effect of Montelukast on Exercise-Induced Bronchoconstriction?

Elin T.G. Kersten, Anne M. Akkerman-Nijland, Jean M.M. Driessen, Zuzana Diamant, and Bernard J. Thio

Pediatric Pulmonology (May 2016)

Non-invasive Biomarkers in Asthma: Promises and Pitfalls

Helena Pite, Mário Morais-Almeida, Tjeert Mensinga, and Zuzana Diamant

Asthma – From Childhood Asthma to ACOS Phenotypes – Chapter 2 (July 2016)

A randomized, 5-arm dose finding study with a mite allergoid SCIT in allergic rhinoconjunctivitis patients

O. Pfaar, M. J. Nell, J. D. Boot, S. A. Versteeg, R. van Ree, A. Roger, H. Riechelmann, A.Sperl, J. N. G. Oude Elberink, Z. Diamant, and C. Bachert

Allergy – European Journal of Allergy and Clinical Immunology (July 2016)

Sputum RNA signature in allergic asthmatics following allergen bronchoprovocation test

Rob G.J.A. Zuiker, Catherine Tribouley, Zuzana Diamant, J. Diderik Boot, Adam F. Cohen, K. Van Dyck, I. De Lepeleire, Veronica M. Rivas, Vladislav A. Malkov, Jacobus Burggraaf, and Marcella K. Ruddy

Current Opininion in Pulmonary Medicine (July 2016)

Randomized Prospective Double-Blind Studies to Evaluate the Cognitive Effects of Inositol-Stabilized Arginine Silicate in Healthy Physically Active Adults

Douglas Kalman, Philip D. Harvey, Sara Perez Ojalvo, and James Komorowski

Nutrients (November 2016)

The Tritiated Water Skin Barrier Integrity Test: Considerations for Acceptance Criteria with and Without 14C-Octanol

Lehman PA, Beatch K, Raney SG, Franz TJ.

Pharmaceutical Research (November 2016)

2015

Guidance for the regulatory status of allergen extracts in clinical trials

Diamant Z, van Maaren M, van Wijk RG, Brouwers JR, Pieterse H.

European Respiratory Journal (October 2015)

Reproducibility of biomarkers in induced sputum and in serum from chronic smokers

Zuiker RG, Kamerling IM, Morelli N, Calderon C, Boot JD, de Kam M, Diamant Z, Burggraaf J, Cohen AF.

Pulmonary Pharmacology & Therapeutics (August 2015)

Application of nitric oxide measurements in clinical conditions beyond asthma

Malinovschi A, Ludviksdottir D, Tufvesson E, Rolla G, Bjermer L, Alving K, Diamant Z.

European Clinical Respiratory Journal (August 2015)

Kinetics of TH2 biomarkers in sputum of asthmatics following inhaled allergen

Zuiker RG, Ruddy MK, Morelli N, Mogg R, Rivas VM, van Dyck K, De Lepeleire I, Tanen MR, Boot JD, Kamerling IM, Diamant Z.

European Clinical Respiratory Journal (May 2015)

Effect of mavoglurant (AFQ056), a selective mGluR5 antagonist, on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and levonorgestrel in healthy women

Rama Sivasubramanian, Abhijit Chakraborty, Marie-Laure Rouzade-Dominguez, Srikanth Neelakantham, Annamaria Jakab, Tjeert Mensinga, Eric Legangneux, Ralph Woessner, and Mike Ufer

International Journal Of Clinical Pharmacology and Therapeutics (2015)

A Prospective Randomized Double-Blind Study Evaluating UP165 and S-Adenosyl-L-Methionine on Depression, Anxiety and Psychological Well-Being

Douglas S. Kalman, Samantha Feldman, Rafeal Rivas Vazquez and Diane R. Krieger

Foods (2015)

Efficacy and Safety of MMFS-01, a Synapse Density Enhancer, for Treating Cognitive Impairment in Older Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Guosong Liua, Jason G. Weingera, Zhong-Lin Lub, Feng Xuec, and Safa Sadeghpoura

Journal of Alzheimer’s Disease (2015)

Safety and immunogenicity of influenza whole inactivated virus vaccines: A phase I randomized clinical trial

Renée A J van Boxtel, Pauline Verdijk, Otto J de Boer, Elly van Riet, Tjeert T Mensinga and Willem Luytjes

Human Vaccines & Immunotherapeutics (2015)

A clinical evaluation to determine the safety, pharmacokinetics, and pharmacodynamics of an inositol-stabilized arginine silicate dietary supplement in healthy adult males

DS Kalman, S Feldman, A Samsom, and DR Krieger

Clinical Pharmacology: Advances and Applications (2015)

A Retrospective, Multi-Center Cohort Study Evaluating the Severity-Related Effects of Cerebrolysin Treatment on Clinical Outcomes in Traumatic Brain Injury

D.F. Muresanu, A.V. Ciurea, R. M. Gorgan, E. Gheorghita, S. Florian, H. Stan, A. Blaga, N. Ianovici, St. M. Iencean, D. Turliuc, H. B. Davidescu, C. Mihalache, F. M. Brehar, A.S. Mihăescu, D.C. Mardare, A. Anghelescu, C. Chiparus, M. Lapadat, V. Pruna, D. Mohan, C. Costea, D. Costea, C. Palade, N. Bucur, J. Figueroa and A. Alvarez

CNS & Neurological Disorders – Drug Targets (March 2015)

Antifungals in severe asthma

Parulekar AD, Diamant Z, Hanania NA.

Current Opinion in Pulmonary Medicine (January 2015)

2014

Apathy and APOE4 are associated with Reduced BDNF Levels in Alzheimer’s Disease

Anton Alvarez, Manuel Aleixandre, Carlos Linares, Eliezer Masliah and Herbert Moessler

Journal of Alzheimer’s Disease (May 2014)

A clinical evaluation to determine the safety, pharmacokinetics and pharmacodynamics of an inositol-stabilized arginine silicate dietary supplement in healthy adult males

Kalman D, Feldman S, Samson A, and Krieger D

The FASEB Journal (2014)

Amino Acid Composition of an Organic Brown Rice Protein Concentrate and Isolate Compared to Soy and Whey Concentrates and Isolates

Douglas S. Kalman

Foods (2014)

Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection

Mark S. Sulkowski, M.D., David F. Gardiner, M.D., Maribel Rodriguez-Torres, M.D., K. Rajender Reddy, M.D., Tarek Hassanein, M.D., Ira Jacobson, M.D., Eric Lawitz, M.D., Anna S. Lok, M.D., Federico Hinestrosa, M.D., Paul J. Thuluvath, M.D., Howard Schwartz, M.D., David R. Nelson, M.D., Gregory T. Everson, M.D., Timothy Eley, Ph.D., Megan Wind-Rotolo, Ph.D., Shu-Pang Huang, Ph.D., Min Gao, Ph.D., Dennis Hernandez, Ph.D., Fiona McPhee, Ph.D., Diane Sherman, M.S., Robert Hindes, M.D., William Symonds, Pharm.D., Claudio Pasquinelli, M.D., Ph.D., and Dennis M. Grasela, Pharm.D., Ph.D. for the AI444040 Study Group

New England Journal of Medicine (2014)

A randomized, double-blind, placebo-controlled clinical trial evaluating Dermytol® cream for the treatment of actinic keratosis

Malkanthi Evans, Douglas Kalman, Patricia Alvarez, Maryse Paquet, and Najla Guthrie

Clinical, Cosmetic and Investigational Dermatology (2014)

Dopamine D2R Agonist-Induced Cardiovascular Effects in Healthy Male Subjects: Potential Implications in Clinical Settings

Abou Farha K, Baljé-Volkers C, Tamminga W, den Daas I, van Os S.

ISRN Neurology (January 2014)

2013

Efficacy and safety of Elaeisguineensis and Ficusdeltoidea leaf extracts in adults with pre-diabetes

Douglas S Kalman, Howard I Schwartz, Samantha Feldman and Diane R Krieger

Nutrition Journal (2013)

The effects of 8 weeks of whey or rice protein supplementation on body composition and exercise performance

Jordan M Joy, Ryan P Lowery, Jacob M Wilson, Martin Purpura, Eduardo O De Souza, Stephanie MC Wilson, Douglas S Kalman, Joshua E Dudeck, and Ralf Jäger

Nutrition Journal (2013)

Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: Results of a randomised single heterologous booster dose study at 15 months

Risi G, Frenette L, Langley JM, Li P, Riff D, Sheldon E, Vaughn DW, Fries L

Vaccine (2013)

International Society of Sports Nutrition position stand: energy drinks

Bill Campbell, Colin Wilborn, Paul La Bounty, Lem Taylor, Mike T Nelson, Mike Greenwood,Tim N Ziegenfuss, Hector L Lopez, Jay R Hoffman, Jeffrey R Stout, Stephen Schmitz, Rick Collins, Doug S Kalman, Jose Antonio, and Richard B Kreider

Journal of the International Society of Sports Nutrition (2013)

The bioequivalence of the contraceptive steroids ethinylestradiol and drospirenone is not affected by co-administration of dehydroepiandrosterone

Yvette Zimmerman, Wout Wouters, and Herjan J. T. Coelingh Bennink

The European Journal of Contraception and Reproductive Health Care (2013)

Randomized, double-blind, placebo-controlled, safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers

Hopkins RJ, Daczkowski NF, Kaptur PE, Muse D, Sheldon E, Laforce C, Sari S, Rudge TL, Bernton E

Vaccine (2013)

International Society of Sports Nutrition Position Stand: beta-hydroxy-beta-methylbutyrate (HMB)

Jacob M Wilson, Peter J Fitschen, Bill Campbell, Gabriel J Wilson, NeloZanchi, LemTaylor,ColinWilborn, Douglas S Kalman, Jeffrey R Stout, Jay R Hoffman, Tim N Ziegenfuss, Hector L Lopez, Richard B Kreider, Abbie E Smith-Ryan, and Jose Antonio

Journal of the International Society of Sports Nutrition (2013)

Serial CSF sampling over a period of 30 h via an indwelling spinal catheter in healthy volunteers: headache, back pain, tolerability and measured acetylcholine profile

Izaak den Daas, Johan Wemer, Khalid Abou Farha, Wim Tamminga, Theo de Boer, Rob Spanjersberg, Michel M. R. F. Struys, and Anthony R. Absalom

European Journal of Clinical Pharmacology (2013)

2012

Pharmacokinetics of fingolimod (FTY720) and a combined oral contraceptive coadministered in healthy women: drug-drug interaction study results

Olivier J. David, Magdalena Ocwieja, Karin Meiser, Corinne Emotte, Annamaria Jakab,Johan Wemer, Izaak den Daas, and Robert Schmouder

International Journal of Clinical Pharmacology and Therapeutics (2012)

A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults

Sheldon EA, Schwartz H, Jiang Q, Giardina PC, Perez JL

Human Vaccines & Immunotherapeutics (2012)

Comparison of coconut water and a carbohydrate-electrolyte sport drink on measures of hydration and physical performance in exercise-trained men

Douglas S Kalman, Samantha Feldman, Diane R Krieger and Richard J Bloomer

Journal of the International Society of Sports Nutrition (2012)

Safety and long-term humoral immune response in adults after vaccination with an H1N1 2009 pandemic influenza vaccine with or without AS03 adjuvant

Ferguson M, Risi G, Davis M, Sheldon E, Baron M, Li P, Madariaga M, Fries L, Godeaux O, Vaughn D

The Journal of Infectious Diseases (2012)

Development of VAX128, a recombinant hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune response

Taylor DN, Treanor JJ, Sheldon EA, Johnson C, Umlauf S, Song L, Kavita U, Liu G, Tussey L, Ozer K, Hofstaetter T, Shaw A

Vaccine (2012)

Influence of methylsulfonylmethane on markers of exercise recovery and performance in healthy men: a pilot study

Douglas S Kalman, Samantha Feldman, Andrew R Scheinberg, Diane R Krieger and Richard J Bloomer

Journal of the International Society of Sports Nutrition (2012)

Immunogenicity of a quadrivalent Ann Arbor strain live attenuated influenza vaccine delivered using a blow-fill-seal device in adults: a randomized, active-controlled study

Sheldon EA, Jeanfreau R, Sliman JA, Charenkavanich S, Rousculp MD, Dubovsky F, Mallory RM

Influenza and Other Respiratory Viruses (2012)

2011

Absence of Excretion of the Active Moiety of Bisacodyl and Sodium Picosulfate into Human Breast Milk: an Open-label, Parallel-group, Multiple-dose Study in Healthy Lactating Women

Friedrich C, Richter E, Trommeshauser D, de Kruif S, van Iersel T, Mandel K, and Gessner U

Drug Metabolism and Pharmacokinetics (2011)

Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: results of a randomised single heterologous booster dose study at 15 months

Risi G, Frenette L, Langley JM, Li P, Riff D, Sheldon E, Vaughn DW, Fries L

Vaccine (2011)

Autosomal-dominant Alzheimer’s disease: a review and proposal for the prevention of Alzheimer’s disease

Bateman RJ, Aisen PS, De Strooper B, Fox NC, Lemere CA, Ringman JM, Salloway S, Sperling RA, Windisch M, and Xiong C.

Alzheimer’s Research & Therapy (2011)

Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study

Langley JM, Risi G, Caldwell M, Gilderman L, Berwald B, Fogarty C, Poling T, Riff D, Baron M, Frenette L, Sheldon E, Collins H, Shepard M, Dionne M, Brune D, Ferguson L, Vaughn D, Li P, Fries L

The Journal of Infectious Diseases (2011)

A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults

Block SL, Yi T, Sheldon E, Dubovsky F, Falloon J

Vaccine (2011)

The Alzheimer’s Association external quality control program for cerebrospinal fluid biomarkers

Mattsson N, Andreasson U, Persson S, Arai H, Batish SD, Bernardini S, Bocchio-Chiavetto L, Blankenstein MA, Carrillo MC, Chalbot S, Coart E, Chiasserini D, Cutler N, Dahlfors G, Duller S, Fagan AM, Forlenza O, Frisoni GB, Galask o D, Galimberti D, Hampel H, Handberg A, Heneka MT, Herskovits AZ, Herukka SK, Holtzman DM, Humpel C, Hyman BT, Iqbal K, Jucker M, Kaeser SA, Kaiser E, Kapaki E, Kidd D, Klivenyi P, Knudsen CS, Kummer MP, Lui J, Lladó A, Lewczuk P, Li QX, Martins R, Masters C, McAuliffe J, Mercken M, Moghekar A, Molinuevo JL, Montine TJ, Nowatzke W, O’Brien R, Otto M, Paraskevas GP, Parnetti L, Petersen RC, Prvulovic D, de Reus HP, Rissman RA, Scarpini E, Stefani A, Soininen H, Schröder J, Shaw LM, Skinningsrud A, Skrogstad B, Spreer A, Talib L, Teunissen C, Trojanowski JQ, Tumani H, Umek RM, Van Broeck B, Vanderstichele H, Vecsei L, Verbeek MM, Windisch M, Zhang J, Zetterberg H, and Blennow K.

Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association (2011)

Phase I study of Solulin, a novel recombinant soluble human thrombomodulin analogue

T. van Iersel, H. Stroissnig, P. Giesen, J. Wemer, and K. Wilhelm-Ogunbiyi

Thrombosis and Haemostasis (2011)

Application of dried blood spot sampling combined with LC-MS/MS for genotyping and phenotyping of CYP450 enzymes in healthy volunteers

de Boer T, Wieling J, Meulman E, Reuvers M, Renkema G, den Daas I, van Iersel T, Wemer J, Chen L.

Biomedical Chromatography (October 2011)

2010

Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials

Plennevaux E, Sheldon E, Blatter M, Reeves-Hoché MK, and Denis M

The Lancet (2010)

Safety, Tolerability and Pharmacokinetics of Sugammadex Using Single High Doses (Up to 96 mg/kg) in Healthy Adult Subjects

Dr Pierre A. M. Peeters, Michiel W. van den Heuvel, Emiel van Heumen, Paul C. C. M. Passier, Jean M. W. Smeets, Thijs van Iersel, and Alex Zwiers

Clinical Drug Investigation (2010)

Acute and 2-week exposure to prednisolone impair different aspects of ß-cell function in healthy men

Daniël H van Raalte, Valentina Nofrate, Mathijs C Bunck, Thijs van Iersel, Jeroen Elassaiss Schaap, Ulla K Nässander, Robert J Heine, Andrea Mari, Wim H A Dokter, and Michaela Diamant

European Journal of Endocrinology (2010)

ISSN exercise & sport nutrition review: research & recommendations

Richard B Kreider, Colin D Wilborn, Lem Taylor, Bill Campbell, Anthony L Almada, Rick Collins, Mathew Cooke, Conrad P Earnest, Mike Greenwood, Douglas S Kalman, Chad M Kerksick, Susan M Kleiner, Brian Leutholtz, Hector Lopez, Lonnie M Lowery, Ron Mendel, Abbie Smith, Marie Spano, Robert Wildman, Darryn S Willoughby, Tim N Ziegenfuss, and Jose Antonio

Journal of the International Society of Sports Nutrition (2010)

In a randomized, double-blinded, placebo-controlled trial, the single oral dose typhoid vaccine, M01ZH09, is safe and immunogenic at doses up to 1.7 x 10(10)colony-forming units

Lyon CE, Sadigh KS, Carmolli MP, Harro C, Sheldon E, Lindow JC, Larsson CJ, Martinez T, Feller A, Ventrone CH, Sack DA, DeNearing B, Fingar A, Pierce K, Dill EA, Schwartz HI, Beardsworth EE, Kilonzo B, May JP, Lam W, Upton A, Budhram R, and Kirkpatrick, BD

Vaccine (2010)

International society of sports nutrition position stand: caffeine and performance

Erica R Goldstein, Tim Ziegenfuss, Doug Kalman, Richard Kreider, Bill Campbell, Colin Wilborn, Lem Taylor, Darryn Willoughby, Jeff Stout, B Sue Graves, Robert Wildman, John L Ivy, Marie Spano, Abbie E Smith, and Jose Antonio

Journal of the International Society of Sports Nutrition (2010)

Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults

Langley JM, Frenette L, Ferguson L, Riff D, Sheldon E, Risi G, Johnson C, Li P, Kenney R, Innis B, Fries L.

The Journal of Infectious Diseases (2010)

2009

Oxybate SXB-26 Fibromyalgia Syndrome Study Group. Sodiumoxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial

Russell IJ, Perkins AT, and Michalek JE

Arthritis & Rheumatism (2009)

Randomized Phase II clinical trial of Wellmune WGP® for immune support during cold and flu seasons

Feldman S, Schwartz HI, Kalman DS, Mayers A, Kohrman HM, Clemens R, and Krieger DR

The Journal of Applied Research (2009)

A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms

Douglas S Kalman, Howard I Schwartz, Patricia Alvarez, Samantha Feldman, John C Pezzullo, and Diane R Krieger

BMC Gastroenterology (2009)

A pilot trial comparing the availability of vitamins C, B6, and B12 from a vitamin-fortified water and food source in humans

Douglas S. Kalman, Lidia Lou, Howard I. Schwartz, Samantha Feldman, and Diane R. Krieger

International Journal of Food Sciences and Nutrition (2009)

Safety and tolerability of the antimicrobial peptide human lactoferrin 1-11 (hLF1-11)

Walter JFM van der Velden, Thijs MP van Iersel, Nicole MA Blijlevens, and J Peter Donnelly

BMC Medicine (2009)

2008

Comparison of the effectiveness and tolerability of lidocaine patch 5% versus celecoxib for osteoarthritis-related knee pain: post hoc analysis of a 12 week, prospective, randomized, active-controlled, open-label, parallel-group trial in adults

Kivitz A, Fairfax M, Sheldon EA, Xiang Q, Jones BA, Gammaitoni AR, and Gould EM

Clinical Therapeutics (2008)

Effect of a proprietary Magnolia and Phellodendron extract on stress levels in healthy women: a pilot, double-blind, placebo-controlled clinical trial

Douglas S Kalman, Samantha Feldman, Robert Feldman, Howard I Schwartz, Diane R Krieger and Robert Garrison

Nutrition Journal (2008)

Long-term efficacy and safety of lumiracoxib 100 mg: an open-label extension of a 13-week randomized controlled trial in patients with primary osteoarthritis of the knee

Sheldon EA, Beaulieu A, Paster Z, Yu S, and Rebuli R

Clinical and Experimental Rheumatology (2008)

International Society of Sports Nutrition position stand: Nutrient timing

Chad Kerksick, Travis Harvey, Jeff Stout, Bill Campbell, Colin Wilborn, Richard Kreider, Doug Kalman, Tim Ziegenfuss, Hector Lopez, Jamie Landis, John L Ivy and Jose Antonio

Journal of the International Society of Sports Nutrition (2008)

Effect of a natural extract of chicken combs with a high content of hyaluronic acid (Hyal-Joint) on pain relief and quality of life in subjects with knee osteoarthritis: a pilot randomized double-blind placebo-controlled trial

Kalman DS, Heimer M, Valdeon A, Schwartz H, and Sheldon E

Nutrition Journal (2008)

Correlation of measures of pain, function, and overall response: results pooled from two identical studies of etoricoxib in chronic low back pain

Sheldon EA, Bird SR, Smugar SS, and Tershakovec AM

Spine (2008)

Novel Controlled-Release Lemna-Derived IFN-a2b (Locteron): Pharmacokinetics, Pharmacodynamics, and Tolerability in a Phase I Clinical Trial

Leo G.J. De Leede, John E. Humphries, Anne C. Bechet, Ewoud J. Van Hoogdalem, Ruud Verrijk, and David G. Spencer

Journal of Interferon & Cytokine Research (2008)

2007

Effect of protein source and resistance training on body composition and sex hormones

Douglas Kalman, Samantha Feldman, Michele Martinez, Diane R Krieger and Mark J Tallon

Journal of the International Society of Sports Nutrition (2007)

Active Renal Secretion of NXY-059, a Novel Neuroprotectant, Is Mediated via an Organic Acid Transporter

Dr Yi-Fang Cheng MD, PhD, Dr Stig Strid PhD, Dr Olof Borgå PhD, Dag Nilsson MD, PhD, and Dr Johan Wemer MD,PhD,RPh, DCPSA

The Journal of Clinical Pharmacology (2007)

2006

Efficacy and safety of rofecoxib 12.5 mg and celecoxib 200 mg in two similarly designed osteoarthritis studies

Birbara C, Ruoff G, Sheldon E, Valenzuela C, Rodgers A, Petruschke RA, Chang DJ, and Tershakovec AM

Current Medical Research and Opinion (2006)

Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a prospective randomized 13-week study versus placebo and celecoxib

Fleischmann R, Sheldon E, Maldonado-Cocco J, Dutta D, Yu S, and Sloan VS

Clinical Rheumatology (2006)

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of SBI-087, a CD20-Directed B-cell Depleting Agent: Phase 1 Dose Escalating Studies in Patients With Either Mild Rheumatoid Arthritis or Systemic Lupus

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2005

Efficacy and tolerability of lumiracoxib in the treatment of osteoarthritis of the knee: a 13-week, randomized, double-blind comparison with celecoxib and placebo

Sheldon E, Beaulieu A, Paster Z, Dutta D, Yu S, and Sloan VS

Clinical Therapeutics (2005)

Evaluation of the comparative efficacy of etoricoxib and ibuprofen for treatment of patients with osteoarthritis: A randomized, double-blind, placebo-controlled trial

Wiesenhutter CW, Boice JA, Ko A, Sheldon EA, Murphy FT, Wittmer BA, Aversano ML, and Reicin AS; Protocol 071 Study Group

Mayo Clinical Proceedings (2005)

2004

Lidocaine patch 5% improves pain, stiffness, and physical function in osteoarthritis pain patients. A prospective, multicenter, open-label effectiveness trial

Burch F, Codding C, Patel N, and Sheldon E

Osteoarthritis and Cartilage (2004)

Topical lidocaine patch 5% may target a novel underlying pain mechanism in osteoarthritis

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Current Medical Research and Opinion (2004)

Sports Nutrition: What the future may bring

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Journal of the International Society of Sports Nutrition (2004)

2003

Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability – a randomized, placebo-controlled, 3-month trial

Birbara CA, Puopolo AD, Munoz DR, Sheldon EA, Mangione A, Bohidar NR, and Geba GP; Etoricoxib Protocol 042 Study Group

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Effect of H. pylori status on gastric ulcer healing in patients continuing nonsteroidal anti-inflammatory therapy and receiving treatment with lansoprazole or ranitidine

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The American Journal of Gastroenterology (2002)