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Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis.

This study has been transitioned to CTIS with ID 2024-518684-35-00 check the CTIS register for the current data. The current project proposal continues on our findings of the performed prospective cohort study, aiming to develop a biomarker guided…

Umbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.
A feasibility study focussing on engraftment and hematopoietic recovery.

To study the feasibility of single UCBT with one ex-vivo SR-1 expanded unitTo assess side effects and TRM after single UCBT with one expanded unitTo assess engraftment and engraftment kinetics; to evaluate immune reconstitution, acute and chronic…

A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer

There is still no level I-II evidence for cytoreductive surgery in recurrent ovarian cancer. This is also the conclusion of a Cochrane Review of Galaal et al. published in June 2010. The most active chemotherapy in platinum sensitive recurrent…

Effects of dosing time on the pharmacokinetics and pharmacodynamics of sunitinib.

Primairy objective:To investigate whether the pharmacokinetics of sunitinib are influenced by circadian rhythm.Secondary objective:- to investigate whether daily variation in CYP3A4 activity exists in humans, based on midazolam and 4beta-…

Clinical and radiological evaluation of Signature* unicompartmental knee arthroplasty
A Prospective, Multi-centre, Randomized, Double blind study

Primary- To evaluate the initial and long-term clinical results in terms of function, quality of life and pain/satisfaction of the Signature* procedure compared to the standard operation instruments.- To evaluate the alignment of the Signature*…

Tinnitus suppression with electrical stimulation using cochlear implants (CI).

The main objective of the present study is to investigate the optimal stimulation pattern for tinnitus suppression in a structured way. Our study will focus on two parameters: stimulus level and anatomical stimulation site inside the cochlea.

Safety and efficacy of interleukin-1 inhibitor anakinra for the amelioration of fever during neutropenia and mucositis in patients with multiple myeloma receiving an autologous hematopoietic stem cell transplantation after high-dose melphalan

The primary objective is to evaluate the safety and efficacy of anakinra in patients with multiple myeloma receiving high-dose melphalan (HDM) in the preparation for an autologous hematopoietic stem cell transplantation (SCT). Secondary objectives…

Follow-up of immunoglobulin G4-associated cholangitis in patients resected for presumed perihilar cholangiocarcinoma

Primary objective: to investigate the incidence of IAC in patients resected for presumed PHC.Secundary objectives:- Evaluation of the diagnostic accuracy of histological criteria for IAC compared to IgG4 qPCR test- Evaluation of disease activity by…

School transition management in children with Autism Spectrum Problems

Both two transition management interventions will be effective in the reduction of the school transition problems of children with ASP. We have no hypothesis about which intervention will be most effective in the reduction of childhood…

Can we Save the rectum by watchful waiting or TransAnal microsurgery following (chemo)Radiotherapy versus Total mesorectal excision for early Rectal Cancer? - STAR-TREC study

This study has been transitioned to CTIS with ID 2024-516106-31-00 check the CTIS register for the current data. STAR-TREC is a phase II feasibility study that will evaluate whether it is possible to accelerate patient recruitment from 2 per month,…

A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of;Subcutaneously Administered Ustekinumab in the Treatment of Moderate;to Severe Chronic Plaque Psoriasis in Pediatric Subjects greater than 6 to less than 12 Years of Age

Primary Objective• To evaluate the efficacy and safety of ustekinumab in pediatric subjects aged >=6 through <12 years with moderate to severe chronic plaque psoriasis.Major Secondary Objectives• To evaluate the pharmacokinetics (PK)…

Mass Balance Study of PM01183 (lurbinectedin) Administered as 1-hour Intravenous Infusion to Patients with Advanced Cancer

The present study is aimed at identifying the specific routes of PM01183 excretion and elimination following its administration to patients with advanced tumors. Also, the study design may allow the identification and quantification, if possible, of…

Visualizing beta cells in patients with a history of gestational diabetes

This study has been transitioned to CTIS with ID 2024-520392-27-00 check the CTIS register for the current data. The primary objective is to evaluate the difference in 68Ga-exendin tracer accumulation in the pancreas of women with and without a…

Development of a platform of Patient Derived Xenografts (PDX) and 2D/3D cell cultures of Soft Tissue Sarcomas (STS): Protocol to obtain tumour material from patients with (non)-metastatic sarcomas.

To collect a platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.To collect a platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with (non-) metastatic sarcomas.To study the take rate of fresh PDX tumour…

SAKK 06/14. A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy

The objective of the trial is to determine safety, tolerability and efficacy of VPM1002BC, in order to establish this medication as a therapy for non-muscle invasive bladder cancer in the future.

The CHIP-Family intervention for young children with congenital heart disease and their family: a randomized controlled trial

The objective of this study is to investigate:1) the effectiveness of CHIP-Family on psychosocial wellbeing (i.e.: behavioral and emotional problems) in 4 to 7 year old children who underwent cardiac surgery or a catheter intrervention for CHD.2)…

Effects of a single denosumab injection on reduction of total contact cast treatment and consolidation of bonefractures caused by acute Charcotfoot in patients with diabetes mellitus (CHARCOT study)

This study has been transitioned to CTIS with ID 2024-518637-28-00 check the CTIS register for the current data. Does single subcutaneous injection with denosumab or placebo (NACL 0.9%) induces a shorter Total contact cast treatment duration and…

A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies

The chief aim of the proposed study is to compare the safety and efficacy of NiCord® single ex vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following…

A RANDOMIZED PHASE III TRIAL COMPARING CONVENTIONAL-DOSE CHEMOTHERAPY USING PACLITAXEL, IFOSFAMIDE, AND CISPLATIN (TIP) WITH HIGH-DOSE CHEMOTHERAPY USING MOBILIZING PACLITAXEL PLUS IFOSFAMIDE FOLLOWED BY HIGH-DOSE CARBOPLATIN AND ETOPOSIDE (TI-CE) AS FIRST SALVAGE TREATMENT IN RELAPSED OR REFRACTORY GERM CELL TUMORS

This study has been transitioned to CTIS with ID 2024-513509-30-00 check the CTIS register for the current data. To compare the overall survival of patients with relapsed or refractory GCT treated with conventional-dose chemotherapy using the TIP…

Multicenter Phase 2 Study to Identify the Optimal neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo) and Personalized Response-driven Adjuvant Combination (PRADO extension cohort)

OpACIN-neo:Primary objectives: - To compare safety (immune related adverse events during the first 12 weeks) of three different neo-adjuvant combination schemes of ipilimumab + nivolumab - To compare radiological and pathologic response rates at…