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Effect of High-volume Online hemodiafiLtration on intra-diaLytic hemodynAmic (iN)sTability and cardiac function in chronic hemodialysis patients (the HOLLANT study)

This study aims at improving the knowledge concerning HV-HDF and thus helps to tailor the optimal ERRT for each individual patient.The following hypotheses will be tested:1. Intra-dialytic hemodynamic stability is better preserved during HV-HDF as…

Real time vs. Flash glucose monitoring in type 1 diabetes - a cross-over trial

To compare the effects on glycemic control, patient reported outcomes (PRO) and experiences (PRE) of rt-CGM with FGM in a real-life outpatient setting among persons with T1D.

A trial to assess the injection site pain experience of excipient solutions relevant for subcutaneous injection

The primary objective is to assess, in healthy subjects with a body mass index (BMI) greater than or equal to 25.0 kg/m2, the injection site pain experience of 9 excipient solutions (Trial Products 4 to 12), intended to be used in future…

A bridging trial to compare the pharmacokinetics of Glepaglutide (ZP1848) after a single subcutaneous administration by vial/syringe and by autoinjector in healthy subjects: a phase 1, randomized, open-label, three-way, reference-replicated crossover trial

- To compare the pharmacokinetics (PK) of glepaglutide after a single subcutaneous (SC) administration by vial/syringe and by autoinjector.- To evaluate the safety and tolerability of glepaglutide following SC dosing in healthy subjects.

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).

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…

An Open-label, Randomized, Crossover, Single Ascending Dose Pharmacokinetic Study of Continuous Subcutaneous Infusion of Lenalidomide Compared with Revlimid® Oral Capsules in Healthy Adult Male Subjects

The purpose of this study is to investigate how quickly and to what extend lenalidomide is absorbed and eliminated from the body (this is called pharmacokinetics). In this study the pharmacokinetics will be compared when lenalidomide is administered…

An open-label, single-sequence crossover drug-drug interaction study to evaluate the effect of multiple oral doses of itraconazole on the pharmacokinetics of PHA-022121 in healthy subjects

The purpose of this study is to investigate the effect of multiple doses of itraconazole on how quickly and to what extent the new compound PHA-022121 is absorbed into the body and eliminated from the body (this is called pharmacokinetics). It will…

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…

An open-label, randomized, single center, crossover study in healthy participants to assess lipoprotein lipase activity and levels, and triglyceride levels after heparin exposure, in both fasted and postprandial state

In this study we will investigate biomarkers in blood after exposure to heparin in the fasted state or after a high-fat meal. Biomarkers are proteins present in the blood. The biomarkers investigated in this study are proteins that are involved in…

A Two-Part, Open-Label, Single-Dose Relative Bioavailability and Food Effect Study of THB001 in Healthy Adults

Part 1:Primary objective:• To estimate the relative bioavailability of two THB001 formulations in healthy adults.Secondary objectives:• To determine the single-dose pharmacokinetics (PK) of THB001•HCl salt and THB001 free base formulations in…

Effect of dapaglifozin on serum magnesium in HNF1β patients with renal hypomagnesemia

This study has been transitioned to CTIS with ID 2024-518855-43-00 check the CTIS register for the current data. Primary objective: To evaluate the effect of SGLT2 inhibition with dapagliflozin 10 mg on serum magnesium in diabetic and non-diabetic…

The effects of timed-restricted eating on insulin sensitivity, de novo lipogenesis and liver fat in subjects with obesity and insulin resistance

Primary objectives: To determine the effects of combined isocaloric TRE and meal timing on insulin sensitivity.Secondary objectives: To determine the effects of combined isocaloric time-restricted eating and meal timing on hepatic fat content, de…

Binaural spatial enhancement study for cochlear implant users.

Determine speech understanding in noise with the AB*s bimodal BF directional hearing technology.

An exploratory single-centre cross-over study in healthy subjects to investigate the effects of sleep deprivation on driving, EEG, and PainCart.

Part A• To assess the effect of sleep deprivation on next morning driving (both on road and in simulated driving) and subjective self-reported driving performance tests;• To assess the effect of sleep deprivation on CNS functioning using the…

Evaluating the safety, tolerability, and pharmacodynamic properties of IW-6463 in healthy elderly subjects.

Primary* To evaluate the effect of IW-6463 on cerebral blood flow (CBF) in healthy elderly participants* To assess the safety and tolerability of IW-6463 vs placebo when administered to healthy elderly participants for up to 15 daysExploratory* To…

An open*label, randomized, 3*period crossover study to determine the relative bioavailability of ASN120290 from a film*coated tablet given under fasted and fed conditions as compared to a capsule given under fasted conditions in healthy subjects

Primary objective:* To determine the relative bioavailability of ASN120290 from a film*coated tablet given under fasted conditions versus a capsule formulation given under fasted conditions.Secondary objectives:* To determine the relative…

A Phase 1, Open-Label Study to Assess the Relative Bioavailability, Effect of Food, and Gastric pH Modification on the Pharmacokinetics of TAK-931 in Patients with Advanced Solid Tumors

Primary Objectives:Part 1- Estimate the relative bioavailability of the tablet formulation of TAK-931 in reference to the PIC formulation.Part 2- Assess the effect of a high-fat meal on the single dose PK of TAK-931 administered as the tablet…

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…

VertiGO! - Get up and GO! with the vestibular implant

The primary objective of the VertiGO! trial is to assess the feasibility of restoring vestibular function by making use of prolonged VI stimulation. This will be done using a combined VI and CI device: The CVI. To achieve this objective, patients…