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Goal directed fluid removal with furosemide in intensive care patients with fluid overload - A randomised, blinded, placebo-controlled trial

This study has been transitioned to CTIS with ID 2024-512186-14-00 check the CTIS register for the current data. To assess benefits and harms of goal directed fluid removal with furosemide versus placebo on patient-important outcome measures in…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP)

Primary Efficacy Objective (Blinded Treatment Period)• To demonstrate the efficacy of rilzabrutinib versus placebo in participants with refractory/relapsed ITP, based on the durability of platelet response during the last12 weeks of the 24-week…

Efficacy of Pectoral Nerve (PECS II) Block with Liposomal Bupivacaine versus Levobupivacaine for Patients undergoing a Mastectomy: A Prospective Randomized Controlled Trial.

This study has been transitioned to CTIS with ID 2024-515183-30-00 check the CTIS register for the current data. The aim of this prospective randomized, double blind study is to evaluate the analgesic effects of pre-operative PECS II-block with (…

EFFECTS AND UNDERLYING MECHANISMS OF PHOTOBIOMODULATION (PBM) ON HEALTH AND WELL-BEING

To follow up on the previous study on PBM effects on well-being by prospectively assessing mood, drowsiness and depression as well as energy/tiredness/tension/calmness, and sleep parameters, and on health by prospectively assessing resting heart…

A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects with an Acute Gout Flare

This study has been transitioned to CTIS with ID 2024-518844-20-00 check the CTIS register for the current data. Primary Objective:To evaluate the efficacy of dapansutrile as an acute gout flare treatment compared to placebo in reducing joint pain…

A randomized, placebo-controlled, double blind trial to study the effects of Etidronate on ectopic CALCIfication in FAhr*s Disease or syndrome.

This study has been transitioned to CTIS with ID 2024-512300-19-00 check the CTIS register for the current data. The objective is to determine whether etidronate can halt or attenuate disease progression in patients with Fahr*s disease or syndrome.

Effect of low dose galacto-oligosaccharides (GOS) on faecal gut microbiota in adult women

The primary objective is to investigate the effect of a 3 week intervention with either 1.,3 gram or 2 gram of GOS on the abundance of the genus Bifidobacterium in faecal samples in healthy women of 40 - 70 years old. The secondary objective is to…

The Dutch Parkinson GBA Ambroxol trial (DUPARG-AMBROXOL):
A randomised, double-blind, placebo-controlled, single-center trial with Ambroxol in Parkinson patients with a GBA mutation

The primary objective is to compare the effectiveness of ambroxol versus placebo on the MDS-UPDRS part III motor sub-score in the *practically defined OFF-medication state* in patients with moderate PD, carrying a GBA mutation. The hypothesis is…

Evaluating the effect of Agaricus bisporus powder intake on the vaccination response to an influenza vaccine

The primary objective of this study is to demonstrate the effect of consuming daily 5 grams of Agaricus bisporus powder (10 capsules) on the vaccination response to an influenza vaccine in men and women aged 60 years or older during the influenza…

A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH PEMBROLIZUMAB COMBINED WITH NAB-PACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-L1*POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER

Primary Objective: This study will evaluate the efficacy, safety, and pharmacokinetics of RO7247669 plus nab-paclitaxel compared with pembrolizumab plus nab-paclitaxel in patients with previously untreated, locally advanced, unresectable or…

The effect of collagen supplementation on human tendon protein synthesis

The main objective of the current study is to assess the impact of dietary collagen supplementation on human tendon protein synthesis.

A Dose Ranging Target Engagement Study of a Food-Grade Pectic Food Supplement (G3P-01) in Volunteers with Elevated Levels of Galectin-3 - the Galaxy study

Primary Objectives:1. To evaluate target engagement attributable to G3P-01 use in volunteers with elevated galectin-3 (>= 16.0ng/mL)2. To evaluate tolerability of G3P-01Secondary Objectives:1. To provide samples for research and development…

SLEEP DEEP: sleep deepening as treatment augmentation for post-traumatic stress disorder

The primary objective of this study is to test whether deepening post-treatment sleep each night of a 5-day treatment program for PTSD using EEG-guided acoustic stimulation, will result an augmented overall treatment effect. In addition, two…

A Partially Double-Blinded Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of AST-004 as a Short Loading Intravenous infusion Followed by AST-004 as a Continuous Infusion in Healthy Adult Subjects.

Primary objective:• To evaluate the safety and tolerability profile of single intravenous doses of AST-004 given as a short loading intravenous infusion followed by a 6-hour continuous intravenous (IV) infusion in healthy adult subjects.Secondary…

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest

Primary objective: To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile * born at 26-32 weeks GA. * According to Fenton preterm growth chart. Secondary…

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PHASE I STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES OF THN391 IN HEALTHY SUBJECTS

This study has been transitioned to CTIS with ID 2024-517955-10-00 check the CTIS register for the current data. In this study we will investigate how safe the new compound THN391 is and how well it is tolerated when it is used by healthy subjects.…

A Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment

The main objectives Investigate a first signal of efficacy, safety and tolerability of BI 706321 in combination with ustekinumab treatment compared to placebo with ustekinumab treatment in patients with moderately to severely active CD at 12 weeks.…

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

Primary objective: To assess the efficacy of treatment with ELGN-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding. Defined as first day of reaching three consecutive days of…

The therapeutical efficacy of senolytic drugs in the treatment of non-alcoholic fatty liver disease with fibrosis - the truth study

This study has been transitioned to CTIS with ID 2024-517593-21-00 check the CTIS register for the current data. To examine the effect of oral dasatinib plus quercetin on liver fibrosis as assessed by histology in individuals with biopsy-proven…

Safety and Viability of an E. coli Nissle Colibactin Knockout in Healthy Volunteers: A Randomised Controlled Safety Study

Assess the safety and tolerability of the EcNΔClbP strain relative to the EcN wildtype strain following a 1-week daily administration, through questionnaires, medical examination and measurement of inflammatory markers.