Past Studies
| Study Name | About the study | How CIU supported the study | Principal Investigator | Sponsor | Clinical Trials Identiyer |
|---|---|---|---|---|---|
| TARGET READ Phase I & II | Study to better characterize hospital readmissions in Switzerland, and to reduce the risk of readmissions. Patients who are invited to participate to the Target-READ study are all adults discharged from a medical division from one of the 4 participating hospitals: Fribourg, Bienne, Liestal and Neuchâtel. | CIU supported the telefon follow-up of study participants | Jaques Donzé, Universitätsklinik für Allgemeine Innere Medizin, Bern University Hospital | University Hospital Inselspital, Bern | Link |
| Pharmacokinetics and Pharmacodynamics of Different Nicotine Salt Concentration Vape System Pods and Free-base Nicotine | The aim of this study is to investigate the differences between nicotine solutions for electronic cigarette systems that differ in nicotine concentration and/or the chemical presence of nicotine and whether this leads to detectable differences in nicotine concentration in the blood, on well-being and on bodily functions. | The CIU has provided the infrastructure, such as the use of the examination rooms and the refrigerators. | Evangelia Liakoni, Klinische Pharmakologie, Bern University Hospital | University Hospital Inselspital Bern | Link |
| An Efficacy and Safety Study of Fremanezumab in Adults With Migraine (FOCUS) | Evaluation of the efficacy, safety, and tolerability of monthly and quarterly s/c injections of fremanezumab compared with s/c injections of placebo in participants with chronic migraine or episodic migraine who have responded inadequately to prior preventive treatments. | CIU conducted the study visits, incl. collection, processing, storage and shipping of biological samples, subcutaneous IMP administration, maintenance of the Investigator Site File, and data entry. | Prof. Dr. med. Christoph Schankin, Universitätsklinik für Neurologie | Teva Branded Pharmaceutical Products | Link |
| Post-HERCULES | Prospective Follow-up Study for Patients with acquired thrombotic thrombocytopenic purpura (aTTP), who completed Study ALX0681-C301 (HERCULES) to evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES). | CIU performed biological sample collection during the on-site follow-up visits | Prof. Dr. med. Johanna Anna Kremer Hovinga, Universitätsklinik für Hämatologie und Hämatologisches Zentrallabor | Sanofi | Link |
| CENTURION | RCT of Lasmiditan over four migraine attacks to assess how effective and safe Lasmiditan is in the acute treatment of 4 migraine attacks with or without aura. | CIU conducted the study visits, incl. collection, processing, storage and shipping of biological samples, subcutaneous IMP administration, maintenance of the Investigator Site File, and data entry. | Prof. Dr. med. Christoph Schankin, Universitätsklinik für Neurologie | Eli Lilly and Company | Link |
| STASEY | A Single-Arm, Multicenter Phase IIIB Clinical Trial to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors. | CIU conducted the study visits, incl. collection, processing, storage and shipping of biological samples, intravenous IMP administration and accountability, maintenance of the Investigator Site File, and data entry. | Prof. Dr. med. Johanna Kremer, Universitätsklinik für Hämatologie | Hoffmann-La Roche | Link |
| Continuous EEG Randomized Trial in Adults (CERTA) | RCT on impact on Clinical Outcome of Continuous Video-electroencephalography (cEEG) Monitoring in Patients With Disorders of Consciousness. | CIU performed the data entry during the follow-up phase of the trial. | Prof. Dr. med. Kaspar Schindler, Schlaf-Wach-Epilepsie-Zentrum (SWEZ) Universitätsklinik für Neurologie | Prof. Andrea Rossetti, Centre Hospitalier Universitaire Vaudois | Link |
| Steeropt | Project with further use of health-related data with consent by the participants to evaluate the improvement of neuropsychiatric symptoms and the quality of life 12 months after surgery in a large consecutive series of STN-DBS PD patients using novel implantable Neurostimulator Systems (Boston Scientific). | CIU supported the study Sponsor with the submission of the clinical trial application. | Dr. med. Ines Debove, Universitätsklinik für Neurologie | University Hospital Inselspital, Bern | Link |
| CML V / Tiger | The trial aims to improve treatment strategies in CML by improving induction therapy and deescalating maintenance therapy using low dose IFN as inducer of immunosurveillance. This was an Open lable, randomized parallel-group trial for optimization of Newly Diagnosed Ph/BCR-ABL Positive Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase With Nilotinib vs. Nilotinib Plus Interferon Alpha Induction and Nilotinib or Interferon Alpha Maintenance Therapy. | CIU conducted the study visits, IMP dispensing and accountability, maintenance of the Investigator Site File, and data entry. | Prof. Dr. Gabriela M. Bärlocher, Universitätsklinik für Hämatologie und Hämatologisches Zentrallabor | University of Jena | Link |
| A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment | The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion dependent participants myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment. | CIU planned, coordinated and conducted the study visits; collection, incl. The processing, storage and shipping of biological samples, intravenous IMP administration and accountability, maintenance of the Investigator Site File, and data entry | PD Dr. med. Michael Daskalakis, University Cancer Center Inselspital | Geron Corporation | Link |
| STIMULUS-2 MDS | A Randomized, Double-blind, Placebo-controlled Phase II Multi-center Study of Intravenous MBG453 Added to Hypomethylating Agents in Adult Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R Criteria. | CIU planned, coordinated and conducted the study visits; maintained the Investigator Site File, and performed the data entry. | PD Dr. med. Michael Daskalakis, University Cancer Center Inselspital | Novartis Pharmaceuticals | Link |
| BE HEARD I | The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS) | CIU was involved in the planning, coordination and conduct of the study visits; collection, processing, storage and shipping of biological samples, subcutaneous IMP administration and accountability, maintenance of the Investigator Site File, and data entry. | Prof. Dr. med. et. Dr. phil. nat. Robert Hunger, Universitätsklinik für Dermatologie | UCB Biopharma SRL | Link |
| Swiss Health Study | PIlotstudie zur Schweizer Gesundheitsstudie. Die Schweizer Gesundheitsstudie soll darüber Aufschluss geben, wie gesund die Schweizer Bevölkerung ist. Ziel ist es, den Einfluss von Umwelt, Chemikalien, Lebensstil Infektionskrankheiten (z.B. Covid-19) und persönlichen Merkmalen auf die Gesundheit und die häufigsten Volkskrankheiten zu untersuchen. | Die CIU hat die Studienvisiten mit Gesundheitstests, Befragung und Entnahme von biologischen Proben durchgeführt. | PD Dr. Sven Trelle, CTU Bern | BAG | Link |
| Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients (NEON) | Open-label, single ascending dose escalation followed by a multiple administration dose at the maximal suitable dose (MSD). The primary objective is to demonstrate the safety of TLN administration intravenously in Parkinson patients. Secondary objectives are the determination of the maximal suitable dose based on the safety profile and preliminary efficacy, as well as the determination of the pharmacokinetics (PK) profile. | CIU administered the first dose of IMP and monitored the study patients post-interventional, incl. drawing of PK samples. | PD. Dr. med. Michael Schüpbach, Neurologisches Institut Konolfingen | InnoMedica Schweiz AG | Link |
| First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study (NIBED pilot) | A randomized, controlled, cross-over, single-center pilot study to determine the safety of the NIBED (a novel non-invasive bladder emptying device) and to assess the efficacy of the NIBED, which is defined as the ability of the MD to aid or improve bladder emptying, i.e. leads to less residual urine compared to not using the NIBED. | The CIU Team was involved in the pre-screenig of study patients, and to perform the informec consent procedure. At the study visits, the CIU supervised the participants during the experimental intervention / use of device. Clinical study data collection was performed by the CIU team, incl. sonography, colletion of biological samples, and the administering of questionnaires. | Prof. Dr. med. Bernhard Kiss, Universitätsklinik für Urologie | University Hospital Inselspital, Bern | Link |
| Study Name | About the study |
How CIU supported the study | Principal Investigator | Sponsor | Clinical Trials Identifyer |
|---|---|---|---|---|---|
TARGET READ Phase I & II |
Study to better characterize hospital readmissions in Switzerland, and to reduce the risk of readmissions. Patients who are invited to participate to the Target-READ study are all adults discharged from a medical division from one of the 4 participating hospitals: Fribourg, Bienne, Liestal and Neuchâtel. |
CIU supported the telefon follow-up of study participants |
Jaques Donzé, Universitätsklinik für Allgemeine Innere Medizin, Bern University Hospital |
University Hospital Inselspital, Bern |
|
|
Pharmacokinetics and Pharmacodynamics of Different Nicotine Salt Concentration Vape System Pods and Free-base Nicotine |
The aim of this study is to investigate the differences between nicotine solutions for electronic cigarette systems that differ in nicotine concentration and/or the chemical presence of nicotine and whether this leads to detectable differences in nicotine concentration in the blood, on well-being and on bodily functions. |
The CIU has provided the infrastructure, such as the use of the examination rooms and the refrigerators. |
Evangelia Liakoni, Klinische Pharmakologie, Bern University Hospital |
University Hospital Inselspital Bern |
Link |
|
An Efficacy and Safety Study of Fremanezumab in Adults With Migraine (FOCUS) |
Evaluation of the efficacy, safety, and tolerability of monthly and quarterly s/c injections of fremanezumab compared with s/c injections of placebo in participants with chronic migraine or episodic migraine who have responded inadequately to prior preventive treatments. |
CIU conducted the study visits, incl. collection, processing, storage and shipping of biological samples, subcutaneous IMP administration, maintenance of the Investigator Site File, and data entry. |
Prof. Dr. med. Christoph Schankin, Universitätsklinik für Neurologie |
Teva Branded Pharmaceutical Products |
Link |
|
Post-HERCULES |
Prospective Follow-up Study for Patients with acquired thrombotic thrombocytopenic purpura (aTTP), who completed Study ALX0681-C301 (HERCULES) to evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES). |
CIU performed biological sample collection during the on-site follow-up visits |
Prof. Dr. med. Johanna Anna Kremer Hovinga, Universitätsklinik für Hämatologie und Hämatologisches Zentrallabor |
Sanofi |
Link |
| CENTURION | RCT of Lasmiditan over four migraine attacks to assess how effective and safe Lasmiditan is in the acute treatment of 4 migraine attacks with or without aura. | CIU conducted the study visits, incl. collection, processing, storage
and shipping of biological samples, subcutaneous IMP administration,
maintenance of the Investigator Site File, and data entry. |
Prof. Dr. med. Christoph Schankin, Universitätsklinik für Neurologie | Eli Lilly and Company | Link |
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