| Inter-rater reliability of the Abbreviated Injury Scale scores in patients with severe head injury shows good inter-rater agreement but variability between countries. An inter-country comparison study | | |
| Table_1.DOC | | 2020 |
| The Multidimensional Nature of Research Ethics: Letters Issued by a French Research Ethics Committee Included Similar Proportions of Ethical and Scientific Queries. | Journal of Empirical Research on Human Research Ethics | 2022 |
| Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, and Cardiometabolic Disorders | | 2015 |
| Ethical Issues | | 2015 |
| Acceptability of an orodispersible film compared to syrup in neonates and infants: A randomized controlled trial | European Journal of Pharmaceutics and Biopharmaceutics | 2020 |
| Sudden Caffeine Withdrawal Triggers Migraine-A Randomized Controlled Trial | Frontiers in Neurology | 2020 |
| Hemi-ablative low-dose-rate prostate brachytherapy for unilateral localised prostate cancer | BJU International | 2020 |
| Combination of Olanzapine and Samidorphan Has No Clinically Significant Effect on the Pharmacokinetics of Lithium or Valproate | Clinical Drug Investigation | 2020 |
| Understanding and Addressing Regulatory Concerns in Research | | 2019 |
| Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, Nonalcoholic Steatohepatitis (NASH) and Other Cardiometabolic Disorders | | 2019 |
| EORTC-1203-GITCG - the "INNOVATION"-trial: Effect of chemotherapy alone versus chemotherapy plus trastuzumab, versus chemotherapy plus trastuzumab plus pertuzumab, in the perioperative treatment of HER2 positive, gastric and gastroesophageal junction adenocarcinoma on pathologic response rate: a randomized phase II-intergroup trial of the EORTC-Gastrointestinal Tract Cancer Group, Korean Cancer Study Group and Dutch Upper GI-Cancer group | BMC Cancer | 2019 |
| Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials | Diabetes, Obesity and Metabolism | 2019 |
| Lack of effect of Imrecoxib, an innovative and moderate COX-2 inhibitor, on pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers | Scientific Reports | 2019 |
| Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial | Journal of Clinical Endocrinology and Metabolism | 2018 |
| Formulation and In Vitro, In Vivo Correlation Between Two Candesartan Cilexetil Tablets | Clinical Pharmacology in Drug Development | 2018 |
| Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials | Diabetes, Obesity and Metabolism | 2018 |
| What information and the extent of information research participants need in informed consent forms: a multi-country survey | BMC Medical Ethics | 2018 |
| Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes | Diabetes, Obesity and Metabolism | 2018 |
| Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial | Diabetes Care | 2018 |
| Implementing diffusion-weighted MRI for body imaging in prospective multicentre trials: current considerations and future perspectives | European Radiology | 2018 |
| Semaglutide improves postprandial glucose and lipid metabolism, and delays first-hour gastric emptying in subjects with obesity | Diabetes, Obesity and Metabolism | 2018 |
| Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study | Trials | 2017 |
| Recombinant B-domain-deleted porcine sequence factor VIII (r-pFVIII) for the treatment of bleeding in patients with congenital haemophilia A and inhibitors | Haemophilia | 2017 |
| Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1) | Diabetes Care | 2017 |
| Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects | Clinical Pharmacokinetics | 2017 |
| Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment | Clinical Pharmacokinetics | 2017 |
| Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity | Diabetes, Obesity and Metabolism | 2017 |
| Tolerability and Pharmacokinetics of Hydronidone, an Antifibrotic Agent for Hepatic Fibrosis, after Single and Multiple Doses in Healthy Subjects: an Open-Label, Randomized, Dose-Escalating, First-in-Human Study | European Journal of Drug Metabolism and Pharmacokinetics | 2017 |
| Pharmacokinetic properties and bioequivalence of orally inhaled salbutamol in healthy Chinese volunteers | Drug Development and Industrial Pharmacy | 2016 |
| Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer (PREOPANC trial): study protocol for a multicentre randomized controlled trial | Trials | 2016 |
| [When the information provided to participants of a comparative effectiveness trial ends up in the court: The opening of Pandora's box?] | Medicina Clínica | 2016 |
| Good Clinical Practice (GCP) and Scientific Misconduct | | 2016 |
| Population pharmacokinetic/pharmacodynamic modelling of the effects of axomadol and its O-demethyl metabolite on pupil diameter and nociception in healthy subjects | British Journal of Clinical Pharmacology | 2016 |
| Internet-based self-help therapy with FearFighter™ versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial | Trials | 2016 |
| Hemi-gland focal low dose rate prostate brachytherapy: An analysis of dosimetric outcomes | Radiotherapy and Oncology | 2016 |
| Prediction of non-recovery from ventilator-demanding acute respiratory failure, ARDS and death using lung damage biomarkers: data from a 1200-patient critical care randomized trial | Annals of Intensive Care | 2016 |
| PROGRESS - prospective observational study on hospitalized community acquired pneumonia | BMC Pulmonary Medicine | 2016 |
| Pharmacological interventions for delirium in intensive care patients: a protocol for an overview of reviews | Systematic Reviews | 2016 |
| A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes | Diabetes Care | 2016 |
| [Safety monitoring of cell-based medicinal products (CBMPs)] | Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz | 2015 |
| Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct | British Journal of Clinical Pharmacology | 2015 |
| Pharmacokinetic Properties and Tolerability of Cycloserine Following Oral Administration in Healthy Chinese Volunteers: A Randomized, Open-Label, Single- and Multiple-Dose 3-Way Crossover Study | Clinical Therapeutics | 2015 |
| Demographic Patterns and Outcomes of Patients in Level I Trauma Centers in Three International Trauma Systems | World Journal of Surgery | 2015 |
| Efficacy and safety of sublingual fentanyl tablets for the management of breakthrough pain in patients with chronic musculoskeletal pain with neuropathic component: multicenter prospective study | Clinical Drug Investigation | 2015 |
| Variations in observable lid wiper epitheliopathy (LWE) staining patterns in wearers of silicone hydrogel lenses | Contact Lens and Anterior Eye | 2015 |
| Clinical Research | | 2015 |
| Evaluating the efficacy, safety and evolution of renal function with early initiation of everolimus-facilitated tacrolimus reduction in de novo liver transplant recipients: Study protocol for a randomized controlled trial | Trials | 2015 |
| Mammario-arterial anastomosis versus aorto-arterial anastomosis as proximal anastomotic sites in coronary artery bypass surgery for patients with multivessel disease | The Cochrane Library | 2015 |
| A Randomised trial to investigate the erosive effect of hot drinks | Journal of Oral Rehabilitation | 2015 |
| The effects of high perioperative inspiratory oxygen fraction for adult surgical patients | The Cochrane Library | 2015 |
| Comparative fasting bioavailability of 2 bepotastine formulations in healthy male Chinese volunteers: an open-label, randomized, single-dose, 2-way crossover study | Clinical Therapeutics | 2014 |
| Pharmacokinetic-pharmacodynamic relationships of macitentan, a new endothelin receptor antagonist, after multiple dosing in healthy Korean subjects | American Journal of Cardiovascular Drugs | 2014 |
| The effects of immunotherapy with intravenous immunoglobulins versus no intervention, placebo, or usual care in patients with recurrent miscarriages: a protocol for a systematic review with meta-analyses, trial sequential analyses, and individual patient data meta-analyses of randomised clinical trials | Systematic Reviews | 2014 |
| Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study | Acta Obstetricia Et Gynecologica Scandinavica | 2014 |
| Legislative regulation and ethical governance of medical research in different European Union countries | Journal of Medical Ethics | 2014 |
| Tacrolimus versus cyclosporin as primary immunosuppression for lung transplant recipients | The Cochrane Library | 2013 |
| The Implications of Current Methodological Issues for International Guidance | Statistics in Biopharmaceutical Research | 2013 |
| [Enrolment of intensive care patients in clinical studies. Ethical, legal and organizational problems from an interdisciplinary point of view] | Medizinische Klinik - Intensivmedizin Und Notfallmedizin | 2013 |
| Impact of the new european paediatric regulatory framework on ethics committees: overview and perspectives | Acta Paediatrica, International Journal of Paediatrics | 2012 |
| Safety, tolerability, pharmacokinetics and pharmacodynamics of recombinant human parathyroid hormone after single- and multiple-dose subcutaneous administration in healthy Chinese volunteers | Basic and Clinical Pharmacology and Toxicology | 2012 |
| Clinical Trial Planning: | | |
| Clinical Trial Implementation, Analysis, and Reporting: | | |
| Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial) | Trials | 2012 |
| Regulatory and quality control | | 2012 |
| Beyond patient benefit: clinical development in hemophilia | Hematology | 2012 |
| Adverse event reporting tool to standardize the reporting and tracking of adverse events during procedural sedation: a consensus document from the World SIVA International Sedation Task Force | British Journal of Anaesthesia | 2012 |
| Pharmacovigilance methods in public health programmes: the example of miltefosine and visceral leishmaniasis | Transactions of the Royal Society of Tropical Medicine and Hygiene | 2011 |
| Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices | Trials | 2011 |
| The effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur fracture - The CAESAR study: study protocol for a randomized controlled trial | Trials | 2011 |
| Length and complexity of US and international HIV consent forms from federal HIV network trials | Journal of General Internal Medicine | 2011 |
| Prematurely ended phase III trials in Sweden during the years 2002-2008 | European Journal of Clinical Pharmacology | 2011 |
| Phytochemistry and traditional medicine – A revolution in process | Phytochemistry Letters | 2011 |
| Return of research results: general principles and international perspectives | Journal of Law, Medicine and Ethics | 2011 |
| A randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of adjunctive carisbamate treatment in patients with partial-onset seizures | Epilepsia | 2011 |
| Role of modeling and simulation in pediatric investigation plans | Paediatric Anaesthesia | 2011 |
| [Size and quality of clinical research on non-medical interventions: a systematic analysis of IQWiG reports] | Zeitschrift Fur Evidenz, Fortbildung Und Qualitat Im Gesundheitswesen | 2011 |
| Cardiotocographic abnormalities associated with misoprostol and dinoprostone cervical ripening and labor induction | European Journal of Obstetrics, Gynecology and Reproductive Biology | 2011 |
| A twenty-volunteer study using deuterium labelling to determine the kinetics and fractional excretion of primary and secondary urinary metabolites of di-2-ethylhexylphthalate and di-iso-nonylphthalate | Food and Chemical Toxicology | 2011 |
| Pediatric clinical trials in Latin America and Guyana: present views of local practitioners and ways to embrace the future | Paediatric Drugs | 2011 |
| The effects of high perioperative inspiratory oxygen fraction for adult surgical patients | | 2010 |
| Tacrolimus versus cyclosporin as primary immunosuppression for lung transplant recipients | | 2010 |
