CTU Bern (Clinical Trials Unit)

Projects

Only major projects listed

Project Nr. Name
Start year
End year
One-Sentence Summary
Involved divisions Sponsor Funding
1107
DapaStudy 2019   SGLT-2 inhibition using Dapagliflozin during and after physical exercise – Effects on glycemic variability, hormonal regulators of glucose homeostasis and ketone body in type 1 diabetes a randomized, placebo-controlled, open-label, cross-over intervention study.
Data Management
Monitoring
Prof. Dr. med. Markus Laimer
SNF
1096
VANCO 2019   Suprafascial vancomycin powder for prevention of surgical site infections after instrumented posterior spinal fusion: A randomized controlled trail.
Data Management
Monitoring
Dr. med. Christian Ulrich

Gottfried and Julia Bangerter & Rhyner Stiftung

1083
HDMM 2019   HDM201 and midostaurin (HDMM) in relapsed/refractory AML with FLT3mut and TP53wt and in newly diagnosed AML with FLT3mut and TP53wt not fit for intensive chemotherapy; a phase I study.
Data Management
Monitoring
Prof. Dr. med. Thomas Pabst
Novartis
1073
PedIndex 2019   Comparing intranasal dexmedetomidine with oral or rectal midazolam for procedural sedation in the pediatric emergency department: a monocenter, prospective, randomized, rater-blinded study at the Pediatric Emergency Department Bern
Data management
Monitoring
Dr. med. Julia Höffe
Stiftung Batzebär
1058
SRT Phase I
2019
  Quantitative and qualitative evaluation of selective retina therapy (SRT) in combination with real-time optical coherence tomography (OCT) for laser dosimetry
Document Development
Regulatory Support
Data Management
Monitoring
Central Data Monitoring
Prof. Dr.-Ing. Dr. med. Sebastian Wolf
Universitätsklinik für Augenheilkunde, Inselspital Bern
1052
Proaktiv 2019
  A cluster randomized controlled trial of palliative needs assessment and palliative care in general practice.
Data Management
Statistics
Prof. Dr. med. Steffen Eychmüller
SNF
0909
PSP Diagnosis of Sepsis
2019   Prognostic Value of Pancreatic Stone Protein in Adult Patient: Systemic Review and Metaanalysis
(MetaPSP)
Statistics
Prof. Dr. med. Yok-Ai Que

Abionic
0881
GCA Registry
2019   An open-ended registry of patients with giant cell arteritis.
Data Management
Statistics
Prof. Dr. med. Peter M. Villiger
 
0883
Bone Anchored Port
2019   Metaanalysis for the historical control of the Bone Anchored Port - a Novel Vascular Access for Hemodialysis Treatment
Statistics Thomas Frei
Diavantis AG
0877
PPVRP 2019   The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery.
A Randomized Controlled Trial.
Data Management
Prof. Dr. med. Steffen Berger
Department of Pediatric Surgery, Inselspital University Hospital
0866
OPTICO LM
2019   Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT
Data Management
Statistics
Monitoring
Prof. Dr. Lorenz Räber
Abbott
Heartflow
0856
EMISI Trial 2019   Efficacy of Metamizole versus Ibuprofen and a Short Educational Intervention versus Standard Care for patient with Acute and Subacute Low Back Pain: A Randomized, Factorial Trial. Methodology
Data management
Monitoring
Reporting
Dr. med. Maria Wertli
SNF
0158
CLEVER-ACS 2019   A phase II randomized double-blind multi-centre placebo-controlled trial on the effects of a short course of everolimus in patients with acute ST-Elevation Myocardial Infarction on infarct size, left ventricular remodelling and inflammation.  Data Management
Statistics
Prof. Dr. med. Frank Ruschitzka SNF
0741
BISS
2017
  A multi-center, randomized, 18-month, non-inferiority study to compare the efficacy of botulinum toxin versus conventional strabismus surgery in the treatment of secondary strabismus, in patients aged between 1 and 17 years.
Data Management
Statistics
Monitoring
Project Management
Central Data Monitoring
PD Dr. med. Mathias Abegg
SNF
0701
SWIFTdirect 2017   Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke
(SWIFT DIRECT)
Data management     
Central data monitoring         
Monitoring        
Statistics
Prof. Dr. Urs Fischer Medtronic Minneapolis, Minnesota, USA
0689
H-PACS 2016   Prophylactic mesh implantation in patients requiring emergency laparotomy for the prevention of incisional hernia: A randomized controlled trial. Data Management
Monitoring
Statistic
Prof. Dr. med. Guido Beldi Lifecell
0679
ELAN 2017   An international, multicenter randomized-controlled trial comparing early versus standard initiation of anticoagulation in patients with stroke and atrial fibrillation. Data management     
Central data monitoring         
Monitoring        
Statistics
Prof. Dr. med. Urs Fischer SNF
0677
Simpl'HIV trial 2017   Evaluation of a simplified strategy for the long-term management of HIV infection: a non-inferiority, randomized, controlled, open-label clinical trial. Data Management
Monitoring
Statistic
Prof. Dr. med. Alexandra Calmy SNF
0670
DAWN2 CH 2016   Diabetes Attitudes Wishes and Needs (DAWN)2 Study in Switzerland: A survey study of psychosocial issues in diabetes and patient-centered diabetes care. Data Management
PD Dr. med. Markus Laimer Novo Nordisk AG
0645
EVOPACS 2017   Effect of PCSK9 inhibitor with EVOlocumab on early reduction of LDL-cholesterol levels in patients with Acute Coronary Syndromes (EVOPACS)- a randomized, double-blind, placebo-controlled multicenter study. Project Management       
Data management     
Central Data Monitoring         
Monitoring        
Statistics
Prof. Dr. Stephan Windecker Amgen Switzerland AG
0640
NOSTONE 2016   A 3 year prospective, multicenter, double blind, placebo-controlled trial to assess the effectiveness of standard and low dose hydrochlorothiazide treatment in the recurrence prevention of calcium containing kidney stones. Methodology
Project Management
Data Management
Monitoring
Statistics
Prof. Dr. med. Daniel Fuster SNF
0636
SERVE 2017   Effect of phosphodiesterase-5 inhibition with Tadalafil on SystEmic Right VEntricular function – a multi-center, double blind, randomized, placebo-controlled clinical trial – SERVE Trial. Methodology
Data Management
Monitoring
Statistics
Reporting
Prof. Dr. Markus Schwerzmann SNF
0628
SCOPE I 2017   A randomized controlled non-inferiority trial evaluating early safety and clinical efficacy of the Symetis ACURATE Neo compared to the Edwards Sapien 3 bioprosthesis in transcatheter aortic valve implantation. Data Management
Statistic
Monitoring
Reporting
Prof. Dr. Stephan Windecker Symetis SA
0634
MASTER DAPT 2016   Management of high bleeding risk patients post bioresorbable polymer STEnt implantation with an abbReviated versus prolonged DAPT regimen: an international, multicenter, randomized-controlled trial. Data Management
Monitoring
Statistic
Reporting
European Cardiovascular Research Institute (ECRI) Terumo Medical Corporation
0632
SYMPTOM NAVI Pilot 2016   Implementation of the Symptom Navi© Program for cancer patients in ambulatory services: A cluster-randomized pilot study. Data Management
Monitoring
Statistic
Dr. Manuela Eicher Stiftung Lindenhof Bern
0613
SCRIPT 2016   A randomized-controlled trial evaluating the effects of regulated cannabis selling in pharmacies - The Safer Cannabis - Research In Pharmacies Trial. Project Management
Data Management
Statistics
Dr. med. Sven Trelle University of Bern
0606
REVEAL in TAVI 2016   Prospective research project investigating the incidence of arrhythmias in patients undergoing transcatheter aortic valve implantation. Data Management Prof. Dr. med. Laurent Roten SNF
Medtronic (Schweiz) AG
0536
SAAL 2015   CD34+  selected versus unselected  autologous stem cell transplantation in advanced stage mantle cell and diffuse large B-cell  lymphoma patients, a randomized phase II study (the SAAL-trial). Data Management
Monitoring
Statistics

 

Prof. Pabst Thomas  

Miltenyi Biotec GmbH

0533
OPTICO BVS

2016

 

A randomized-controlled trial to compare optical-coherence-tomography- with angiography-guided percutaneous coronary intervention in patients with de-novo coronary artery disease undergoing coronary revascularization.

Methodology
Project Management
Data management
Monitoring
Statistics
Reporting

 

Dr. Räber Lorenz St. Jude Medical
0524
Effect of anaesthetic techniques on clinical outcome after LSP, RA vs GA, a prospective RCT 2016   A randomized-controlled trial to evaluate the effect of general versus regional anesthesia on clinical outcomes in patients undergoing lumbar spine surgery. Data Management
Statistics

 

MD Bänziger Bertram  
0468
OSCAR GALILEO 2015   A global multicenter, open-label, randomized, event-driven, active-controlled study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement (TAVR) to optimize clinical outcomes. Monitoring Cardialysis BV Bayer AG
0465
Ebola vaccine trial 2015   Two trials of a new Ebola Virus vaccine: 1) ring-vaccination (cluster-) randomized-controlled trial to assess the efficacy of a single intramuscular dose of a vesicular stomatitis virus-based vaccine against Ebola virus disease (rVSV-ZEBOV) and 2) a single-arm phase II trial in front-line workers to determine the safety and activity of rVSV-ZEBOV. Project Management

Henao-Restrepo Ana Maria

 
0458
BIOSTEMI
2016   A randomized-controlled trial of a sirolimus-eluting stent with an ultrathin strut biodegradable polymer (Orsiro) versus an everolimus-eluting stent with a durable polymer (XIENCE PRIME) in patients with acute ST‐segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Methodology
Project
Management
Data management
Monitoring
Statistics
Reporting
Prof. Dr. med. Pilgrim Thomas Biotronik AG
0453
TOLERANT 2015  

A randomized, controlled trial investigating the efficacy and safety of two different aflibercept treatment regimens (strict vs. relaxed) in patients with exudative age-related macular degeneration (AMD).

Methodology
Project Management
Data management
Monitoring
Statistics
Reporting


Prof. Dr. Dr. med. Wolf Sebastian Bayer (Schweiz) AG
0449
DECO-SSI  2015   A randomized-controlled trial evaluating the effect preoperative Staphylococcus aureus decolonization on surgical site infections in patients undergoing elective orthopedic surgery. Methodology
Data management
Monitoring
Statistics

 

Dr. med. Brügger Jan  
0441
MDS Registry 2014   A multicenter observational, retro- and prospective, longitudinal study of patients with suspected or confirmed myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasia (MDS/MPN), or acute myeloid.