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Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial.

PRIMARY OBJECTIVESthe assessment if survival in grade III glioma without combined 1p/19q loss is improved by - daily temozolomide chemotherapy during radiotherapy - the administration of temozolomide after the end of radiotherapy SECONDARY…

Prevention of rheumatoid arthritis by atorvastatin in seropositive arthralgia patients: a multi-center doubleblind randomized placebo-controlled trial

To investigate whether statin treatment can prevent or delay the development of RA in persons at increased risk of RA.

The DANCE study: Duration of ANtibiotic therapy for CEllulitis

To determine if 6 days of antibiotics has equal efficacy compared to 12 days for patients hospitalized with cellulitis.

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…

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…

COBRA II Study (Use of the Cobra Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease)

In an effort to collect safety and effectiveness information on the stent, Medlogics is conducting the Cobra II study.

CHRONIC PAIN MANAGEMENT AFTER HERNIORRAPHY
PREGABALIN VERSUS PLACEBO

The primary objective of this study is to investigate whether pregabalin at a dose of 150-600 mg twice a day reduces pain in patients with chronic neuropathic pain after herniorraphy. This research question will be answered by testing of the…

Top Institute Pharma (TIP) - research UMCU-rheumatology:
*Metabolic adverse events/co-morbidity in chronic rheumatoid arthritis patients*

- To systematically determine the influence of disease activity of RA on the metabolic syndrome of patients with chronic RA (disease duration > 2 years).

EFFICACY OF VERNAKALANT IN THE CONVERSION OF ATRIAL FIBRILLATION IN CRITICAL ILLNESS

Primary objective:Investigate the efficacy and safety of Vernakalant in the acute conversion of AF, as compared to Amiodarone and rate control alone, in critically ill patients admitted to the medical and non-cardiac surgical ICU.Secondary objective…

GRAVITAS-301: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft Versus Host Disease

Primary objective: Compare the efficacy of itacitinib in combination with corticosteroids versus placebo in combination with corticosteroids in terms of overall response rate (ORR) at Day 28 in subjects with aGVHD.Secondary objectives:- Compare the…

A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of
Oral Azacitidine Plus Best Supportive Care versus Placebo Plus Best Supportive Care in
Subjects with Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia due to
IPSS Lower-risk Myelodysplastic Syndromes.

Primary Objective:To evaluate RBC transfusion independence in the 2 treatment arms (oral azacitidine plus best supportive care versus placebo plus best supportive care) in subjects with RBC transfusion-dependent anemia and thrombocytopenia (platelet…

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)…

A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute prOmyelocytic leukemia.

To compare event-free survival (EFS) of the experimental treatment arm including ATO/ATRA and idarubicin with standard treatment based on ATRA plus chemotherapy (AIDA regimen).

Post-Market Clinical Investigation of the Clareon® IOL

Primary Objective:The primary objective of this study is to demonstrate the long-term (3 years) favorable visual acuity and adverse event outcomes for the Clareon IOL compared to historical SPE rates as reported in EN ISO 11979-7:2014.Secondary…

AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS

The main objective of this trial is to investigate safety of long term use of inhaled molgramostim by collecting information on the side effects.

Effect of the moderate CYP3A4-inhibitor erythromycin on the pharmacokinetics of palbociclib

The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.The secondary objective of this trial is to compare the incidence…

Pharmacokinetic Profile of Ropivacaïne after Periarticular Local Infiltration Analgesia for Primary Total Knee Arthroplasty without the use of a Tourniquet.

The primary objective of this study is to describe the pharmacokinetic profile of total and unbound plasma concentrations of ropivacaine, when used for LIA in TKA surgery without tourniquet.

A PHASE III, MULTICENTER, RANDOMIZED,
PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB
(ANTI*PD-L1 ANTIBODY) AS MONOTHERAPY AND IN
COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY
IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR
METASTATIC UROTHELIAL CARCINOMA

The primary efficacy objective for this study is to evaluate the efficacy of atezolizumab plus gemcitabine/carboplatin or cisplatin compared with placebo plus gemcitabine/carboplatin or cisplatin on the basis of the following endpoints:- Co-primary…

Prostate Cancer Imaging with [18Flourine]Prostate Specific Membrane Antigen (PSMA) PET: a study on pharmacokinetics and test repeatability

The present study aims to:A) acquire a pharmacokinetic model of [18F]PSMA ([18F]-DCFPyl), by which simplified methods to quantify [18F]PSMA PET signal will be validated ; andB) assess the repeatability of those simplified quantitative method.

Adjustment of insulin Degludec to Reduce post-Exercise (nocturnal) hypoglycaeMia in people with diabetes - the ADREM study

To examine the effect of two different degludec dose adjustments on glucose profiles and the incidence of (nocturnal) hypoglycaemia after oxidative exercise in people with DM1 at elevated risk of hypoglycaemia.