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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…

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.

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).

DIStal versus COnventional RADIAL access for coronary angiography and
intervention: a randomized multicenter trial

The objective of this study is to demonstrate the superiority of Distal Transradial Access (DTRA) to Conventional Transradial Access (CTRA) regarding forearm radial artery occlusion (RAO) using the 6Fr Glidesheath Slender (GSS).

Long-term outcomes in immunologically low-risk kidney transplant recipients using tacrolimus.
Extension study of: Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study.

This study has been transitioned to CTIS with ID 2024-513394-42-01 check the CTIS register for the current data. To assess long-term outcomes in low-immunological risk renal transplant patients beyond one year after transplantation using tacrolimus…

Measuring the doserespons of Salbutamol (Ventolin) by means of a lungfunctiontest

n.v.t.

EvaluaTIoN of Clinical and laboratory outcomes of Rivaroxaban in short Bowel syndrome patients dEpending on Long term parenteral nutrition: a prospective cohort study (TINCRBEL study)

This study has been transitioned to CTIS with ID 2024-519078-38-00 check the CTIS register for the current data. 1) To evaluate the efficacy and safety of the standard clinical care at the AMC in this patient population by the clinical outcomes (…

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…

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…

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 randomized, multi-center, open-label, cross-over study comparing critical errors, overall errors, training/teaching time, and preference attributes of the ELLIPTA dry powder inhaler versus the BREEZHALER dry powder inhalers, in adult participants with mild to moderate asthma.

Primary objective:To compare the proportion of participants who make at least one critical error after reading the section on inhaler use in the patient information leaflets (PILs) for ELLIPTA and BREEZHALER inhalersSecondary Objectives:To compare…

VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target

This study has been transitioned to CTIS with ID 2024-514183-21-00 check the CTIS register for the current data. The primary objective of this trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a…

The glutamate/GABA balance as novel therapeutic target for psychotic and cognitive symptoms in 22q11.2 deletion syndrome

The objective of this study is to examine the effect of riluzole on the glutamate/GABA balance in the brain in patients with 22q11.2DS. The secondary objective is to examine the effects of riluzole on psychotic symptoms and cognitive functioning. In…

A MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF OBINUTUZUMAB SHORT DURATION INFUSION (SDI) IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED FOLLICULAR LYMPHOMA

This study will evaluate how safe administering obinutuzumab as a short duration infusion (SDI) during cycle 2 and from cycle 2 onwards in combination with chemotherapy in patients with previously untreated advanced FL is.

A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the effects of evolocumab added to standard lipid-lowering therapy on fasting and post fat load lipids in patients with Familial Dysbetalipoproteinemia.

To evaluate the effect of 12 weeks subcutaneous evolocumab (140 mg pre-filled pen every 2 weeks) compared to placebo on post fat load non-HDL-C levels in 30 subjects with FD, in a multicenter, randomized, placebo-controlled, double-blind, crossover…

Revised dosing recommendations of ciprofloxacin for patients with impaired renal function: a bioequivalence study.

This study has been transitioned to CTIS with ID 2024-520379-28-00 check the CTIS register for the current data. To compare exposure to ciprofloxacin between patients with impaired renal function (eGFR < 30 ml/min/1.73m2) admitted to a…

Pharmacokinetics of fluconazole given orally or intravenously as prophylaxis or therapy to children and adolescents with invasive fungal infections

This study has been transitioned to CTIS with ID 2024-518305-17-01 check the CTIS register for the current data. Primary objective:• To establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years.…

Reversal of opioid-induced respiratory depression with opioid antagonists - a study in opioid naïve individuals and chronic opioid users under real-life conditions

This study has been transitioned to CTIS with ID 2024-518041-16-00 check the CTIS register for the current data. The goal of the studies is multiple:1. To describe the pharmacokinetics of intravenously administered fentanyl and sufentanil;2. To…

A randomized clinical trial to evaluate the efficacy of polyethylene glycol vs psyllium fiber to prevent rebleeding in patients hospitalized with bleeding diverticular disease.

To evaluate the efficacy of laxatives (polyethylene glycol) versus supplementation of fibers on the incidence of rebleeding in patients hospitalized for colonic diverticular bleeding.

Exploring the Pharmacomicrobiomics of Depression

This study has been transitioned to CTIS with ID 2024-518101-18-02 check the CTIS register for the current data. The main objective of this project is to associate the gut microbial community with treatment efficacy (i.e., relieve in symptoms and…