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Individual albuminuria lowering response to dapagliflozin in a decentralized
clinical trial in patients with type 2 diabetes mellitus and elevated albuminuria

Primary: To determine the individual response to the SGTL2 inhibitor dapagliflozin in urine albumin-to-creatinine ratio (UACR) Secondary:- To determine the individual response to the SGLT2 inhibitor dapagliflozin in: - Systolic blood pressure - Body…

An open-label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, oral dissolution study to assess sugar free and sugared cetylpyridinium chloride (CPC-1.4mg) and benzocaine (10mg) lozenges in healthy subjects

The primary objective of this study is to confirm that the dissolution profiles of a sugar-free and sugared lozenge containing CPC/benzocaine (1.4mg/10 mg) are comparable following a single dose in healthy adult subjects.The secondary objectives of…

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…

Effectiveness of methylphenidate in children and adults with Smith Magenis syndrome and attention-deficit/hyperactivity disorder: An N-of-1 series

The primary objective is to determine the efficacy of methylphenidate on ADHD symptoms in Smith Magenis syndrome.The secondary objectives include the efficacy of methylphenidate on emotion dysregulation and specific goals that are important to the…

Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.

This study has been transitioned to CTIS with ID 2023-509881-39-00 check the CTIS register for the current data. The aim of this study is to evaluate the difference in the fraction of patients that have disease progression within 6 months after…

Targeted glucocorticoid administration to improve safety learning in PTSD patients with HPA axis dysregulation

This study has been transitioned to CTIS with ID 2024-516427-13-00 check the CTIS register for the current data. Substudy A: The primary objective will be to investigate the relationships between HPA axis dysfunction, early life adversity (ELA), and…

Impact of A2 milk versus conventional milk on intestinal health: a proof-of-concept study in Irritable Bowel Syndrome patients

This study will be done to gain insights in the effects of A2 milk on GI symptoms, and immune and defense parameters, in IBS patients. The information will gain more insights in the working mechanism of different types of beta-casein in individuals…

A single-center, prospective, placebo-controlled, double-blind, randomized, cross-over mechanistic intervention study to investigate the effect of empagliflozin on kidney function in people with either preserved or impaired kidney function with or without type 2 diabetes

We aim to investigate the renal hemodynamic effects of empagliflozin in people with either preserved or impaired renal function with T2DM and people with impaired renal function without T2DM, all with and without adenosine blockade.

An open-label, single-sequence cross-over drug-drug interaction study to evaluate the effect of single and multiple oral doses of PHA-022121 on the pharmacokinetics of selective CYP1A2, CYP2C19, and CYP3A4 substrates in healthy subjects

The main purpose of this study is to investigate the effect of multiple doses of PHA-022121 on how quickly and to what extent a drug cocktail (a combination of agents consisting of caffeine, omeprazole, and midazolam) is absorbed, distributed,…

Butyrate/hexanoate-enriched triglycerides for metabolic health

The objective of this project is to identify a well consumable butyrate/hexanoate-enriched oil that increase circulating SCFA levels and improves postprandial substrate metabolism. We will investigate the effects of acute intake of four different…

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Coadministration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions

- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…

A randomized, double-blind, placebo- and active comparator-controlled, crossover trial to examine the effect of multiple doses of CVL-865 on panic symptoms induced by carbon dioxide inhalation in healthy subjects

Primary: To investigate if CVL-865 decreases subjective anxiety symptoms elicited by a 35% CO2 inhalation challenge.Secondary: To investigate if CVL-865 decreases subjective fear symptoms elicited by a 35% CO2 inhalation challenge. To investigate if…

Quantifying various effects of closed-loop Spinal Cord Stimulation (SCS) on pathophysiological mechanisms in Complex Regional Pain Syndrome (CRPS); an explorative study

To evaluate and quantify the various clinical effects of closed-loop SCS versus open-loop SCS on the underlying pathophysiological effects in CRPS.

Liver glycogen dynamics and substrate oxidation in lean healthy volunteers (Follow-up study on study entitled *The effect of modulating hepatic glycogen content on hepatic fat oxidation*)

The primary objective of this study is to examine to what extent hepatic glycogen is decreased after a prolonged overnight fast in healthy volunteers with a normal weight and low liver fat percentage.

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).

Understanding mechanisms of prevention of depression: a mechanistic cross-over trial of mindfulness vs. fantasizing to reduce perseverative cognition underlying vulnerability for depression

The main objective of study 1 is to test whether psychological and psychophysiological indices of PC are differentially affected by fantasizing vs. mindfulness in a cross-over design in 50 remitted MDD patients vulnerable for depressive relapse. The…

LIBRETTO-431: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Platinum-Pemetrexed Chemotherapy Plus Investigator*s Choice of Pembrolizumab in Patients with Advanced, Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

This study has been transitioned to CTIS with ID 2023-506783-14-00 check the CTIS register for the current data. The proposed Study J2G-MC-JZJC (hereafter referred to as JZJC) will evaluate selpercatinib in comparison to platinum-based (carboplatin…

Comparison of different transfusion strategies for red blood cell transfusion dependent MDS and MPN patients - a cross-over study with remote patient monitoring

Compare the effect of three different RBC transfusion strategies* (Standard of care (SoC), SoC+1 and SoC+2**) on heart rate in a population of chronically transfused patients (with on average at least 1 RBC transfusion each 8 weeks as personal…

Randomized, double-blind, placebo-controlled, two way crossover, single centre study evaluating the acute and chronic effect of clonazepam on cognitive tests and patient-reported outcome measures in patients with ARID1B-related intellectual disability

* To test the hypothesis that clonazepam administration has acute beneficial effects compared to placebo on body sway, adaptive tracking, smooth eye pursuit, tapping frequency and the animal fluency test.* To test the hypothesis that multiple-doses…

Recovery of carotid body function after full recovery neuromuscular block

To study the time needed for full recovery of carotid body response to hypoxia (ie. hypoxic ventilatory response, HVR) after full recovery of neuromuscular block with and without reversal with sugammadex