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Digital Cardiac Counseling Trial: DCC Trial

Pre-operative comprehensive digital Cardiac Counseling (prehabilitation) will reduce the cumalative incidence of MACE at 1 year postoperatively in patients operated for a cardiovascular procedure.

Immunity against SARS-Coronavirus 2 in breast milk

1. To evaluate if breastmilk of mothers who recovered from a proven COVID-19 infection contains antibodies (IgA) against SARS-CoV2.2. To evaluate if these antibodies are still present after pasteurization according the Holder method.

The short and longterm effects of posterior colporrhaphy; the role of levator sutures.

To determine the long and short term outcomes of posterior colporrhaphy with and without levator sutures. To compare both groups and maybe give a scientifically proven answer to the question which one has a better outcome. Then we can offer our…

A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults with Relapsed or Refractory Osteosarcoma (OLIE)

Primary ObjectiveTo evaluate whether lenvatinib in combination with ifosfamide and etoposide (Arm A) is superior to ifosfamide and etoposide (Arm B) in improving progression-free survival (PFS) by independent imaging review [IIR] using Response…

EXpansion of stents after Intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries

To compare stent expansion after plaque modification by IVL or balloon predilation in severely calcified coronary lesions assessed by optical coherence tomography (OCT).

International Study for Treatment of High Risk Childhood Relapsed ALL 2010 - A randomized Phase II Study Conducted by the Resistant Disease Committee of the International BFM Study Group.

This study has been transitioned to CTIS with ID 2024-513070-21-00 check the CTIS register for the current data. Primary objectives: Improvement of CR2 rates after induction with ALL R3 with bortezomib versus withoutbortezomib in HR relapsed ALL…

In vitro human preimplantation embryo development in an adapted culture system based on human uterine fluid composition and uterine pH.

The primary objective of our proposal is to determine embryo development of donated human preimplantation embryos in four different culture media: (1) standard culture medium (control group), (2) culture medium with a uterine-like pH, (3) culture…

Stromal Vascular Fraction injectable as treatment of adherent burn scars.

To assess the change in scar pliability measured by the Cutometer (primary outcome) pre- and 12 months post grafting and to quantify clinical and histological improvements of scar characteristics with the combination therapy of SVF enriched fat…

A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine given as a series of 2 infant doses and 1 toddler dose in healthy infants

Primary Safety Objective: To describe the safety profile of 20vPnC

A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

Primary• To evaluate the effect of ravulizumab on adjudicated On-Trial Relapses in adult patients with NMOSDSecondary• To evaluate the safety of ravulizumab in adult patients with NMOSD• To evaluate the effect of ravulizumab on adjudicated…

The applicability of fieldable and rapid serological and molecular testing for Corona SARS-2 in a Dutch population during the COVID-19 outbreak- a pilot study

Examining the applicability of a fieldable serological point of care serological test Biozek and Point of care molecular Fluorescent in Situ Hybridization (FISH) technology by Biotrack for the usage of decision making, containment and management of…

First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG (PN-1007) in anti-MAG neuropathy patients.

Primary objectiveTo assess the safety and tolerability after single and multiple intravenous administrations of PPSGG in patients suffering from anti-MAG neuropathy.Secondary objectives- To evaluate the PK of PPSGG after single and multiple…

A phase I, open-label, randomized, three-way cross-over study comparing bioavailability of two formulations and assessing the food effect on tablet formulation after PXL770 single oral dose in healthy subjects

The purpose of this study is compare a tablet formulation of PXL770 to the capsule formulation of PXL770. It will be investigated how quickly and to what extent PXL770 in each formulation is absorbed and eliminated from the body. To limit the…

ReCOVer: A Randomised Controlled Trial testing the efficacy of Cognitive Behavioural Therapy for preventing chronic postinfectious fatigue among patients diagnosed with COVID-19.

To investigate whether timely delivery of CBT, i.e. 3 to 6 months after COVID-19 diagnosis or hospital discharge, will lead to a significant relevant reduction in fatigue severity (primary outcome), will lead to a clinically relevant reduction in…

A phase 3, randomized, double-blind trial of nivolumab in combination with intravesical BCG versus standard of care BCG alone in participants with high-risk non-muscle invasive bladder cancer that is persistent or recurrent after treatment with BCG

Primary objectiveTo compare the event free survival per pathological review committee (PRC) of nivolumab plus BCG vs BCG alone in all randomized ParticipantsEFS, defined as the time from randomization until any of the following events: recurrence (…

A Randomised Feasibility n-of-1 Trial of Weekly-Interval Red Cell Transfusion in myelodysplastic syndromes; Red blood cell transfusion schedule in myelodysplastic syndromes (REDDS): study 2

This protocol describes a two-part study to assess red blood cell (RBC) transfusion schedules in patients with transfusion-dependent myelodysplastic syndromes (MDS).The first part of the study is a pilot n-of-1 study to assess the feasibility of a…

Randomized, Blinded, 2 stage, 2-way Crossover Bioequivalence Study of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel Administered as a Single Application of 125 mg in Healthy Subjects

This study will compare the study compound Mentholatum 10% w/w Ibuprofen Gel to a similar product, which is already on the market in UK called Ibuleve Maximum Strength Gel. The purpose of the study is to compare these two gels in how quickly and to…

*Differences in effect of treatment with mepolizumab and benralizumab on resident and inflammatory eosinophils"

To test the hypothesis: the mode of action of benralizumab being ADCC will target both resident and inflammatoryeosinophils whereas mepolizumab only targets inflammatory eosinophils. This will achieved by a head-to-headcomparison of the presence of…

A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

To evaluate the long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.

An Open-label, Multicenter, Randomized Phase 3 Study of First line Encorafenib Plus Cetuximab With or Without Chemotherapy Agents versus Standard of Care Therapy with a Safety Lead-in of Encorafenib and Cetuximab Plus Chemotherapy In Participants with Metastatic BRAF V600E Mutant Colorectal Cancer

This study has been transitioned to CTIS with ID 2023-509405-77-00 check the CTIS register for the current data. The purpose of this Safety Lead In study is to explore if encorafenib and cetuximab in combination with a chemotherapy regimen (either…