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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Ranging Study in Healthy Volunteers to Assess Safety, Tolerability, and Evaluate the Pharmacokinetics and Pharmacodynamics of R2R01

In this study we will investigate how safe the new compound R2R01 is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent R2R01 is absorbed and eliminated from the body. In addition…

Nutrition to Relieve IBS symptoms by targeting the Microbiota

The primary objective is to determine the bifidogenic effects of a 4-week intervention with one of four dietary supplements (Chondroitin sulfate, NOVELOSE® 3490, and Pea Fiber, and Lactium®) in IBS patients. The secondary objective is to determine…

A phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, of oral FT011 in participants with diffuse systemic sclerosis

Primary objective: To assess the PK of oral FT011 in participants with diffuse SSc.Secondary objectives: • To assess the safety and tolerability of oral FT011 compared to placebo in participants with diffuse SSc.• To evaluate the short-term efficacy…

A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

PART A and PART DTo assess the safety and tolerability of TAK-994 following multiple oral doses in subjects with narcolepsy with or without cataplexy (NT1 or NT2).PART B and PART C To assess the efficacy of TAK-994 on reducing excessive daytime…

A randomised double-blind placebo-controlled clinical trial investigating the effect and
safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE plus)

This study has been transitioned to CTIS with ID 2023-506918-45-00 check the CTIS register for the current data. Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with…

A randomized, double-blind, placebo-controlled, multicenter study of ensovibep (MP0420) in ambulatory adult patients with symptomatic COVID-19

The study has the purpose and rationale to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID…

Randomised, double-blind (within dose groups), placebocontrolled and parallel group trial to investigate the effects of different doses of oral BI 685509 given over 20 weeks on UACR reduction in patients with diabetic kidney disease

The main objectives of the trial are to demonstrate the effectiveness of BI 685509 and to characterize the dose-response relationship for BI 685509 in patients with DKD by assessing 3 doses and placebo.

PERSONALIZED IMMUNOTHERAPY IN SEPSIS: A MULTICENTRE AND MULTINATIONAL, DOUBLE-BLIND, DOUBLE-DUMMY RANDOMIZED CLINICAL TRIAL

The aim of ImmunoSep is to study if personalized immunotherapy targeting either fulminant hyper-inflammation or immunoparalysis is able to improve sepsis outcomes.

Rescue Alkaline Phosphatase In Defense against all cause Acute Kidney Injury

To study the potential renoprotective effects of supplementation of alkaline phosphatase in hospitalized patients with AKI

Effect of Bacillus Calmette-Guérin vaccination on the immunogenicity of the mRNA BNT162b2 COVID-19 vaccine in health care workers

To determine the impact of prior BCG vaccination on the duration of immunogenicity of the BioNTech/Pfizer mRNA COVID*19 vaccine.

A multi-center, randomized, double-blind, placebo controlled study of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled by H1-antihistamines

The purpose of this study is to establish efficacy and safety of ligelizumab (QGE031) versus placebo in participants with chronic inducible urticaria who remain symptomatic despite treatment with H1 antihistamine.

RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19

• To demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care based on the clinical severity status in adult hospitalized patients with COVID-19• To show that ATR-002 in addition to standard of care shortens the time to…

SeMaglutide and Albuminuria Reduction Trial in obese individuals without diabetes

The main objective of the study is to assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria.

A Randomized, Double-blind, Placebo-controlled study to investigate the efficacy of oleuropein on skeletal muscle energy metabolism and fatigue in humans

The objective of this exploratory trial is to explore the acute and chronic effects of daily olive leaf extract supplementation on muscle energy and fatigue in healthy male adults

Complement Inhibition: Attacking Overshooting inflammation @fter Subarachnoid Hemorrhage (CIAO@SAH trial)

This study has been transitioned to CTIS with ID 2025-520540-15-00 check the CTIS register for the current data. Primary Objective: To determine the safety and efficacy of 6000 IU C1-INH in patients with subarachnoid hemorrhage (SAH)Primary…

A Randomised controlled Trial on the Effect of local analgesia for pain relief after Minimal Invasive Sacro-Iliac joint fusion

To determine whether SI infiltration with 1.5-5cc bupivacaine 0.25% is superior to placebo (intraarticular injection of 1.5-5cc NaCl 0.9%) in reducing wound pain in patients after MISJF, and to determine whether opioid use in the 2 days after…

The effect of plant stanol ester consumption on the vaccination response to a COVID-19 vaccine

The primary objective of this study is to demonstrate clinical benefits of consumption of plant stanols (delivered via products enriched with plant stanol esters) on the vaccination response to a COVID-19 vaccine in overweight or obese patients aged…

Randomized, double-blind, placebo-controlled, study of spesolimab in patients with moderate or severe hidradenitis suppurativa.

The primary objective is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscessand inflammatory nodule count at Week 12. Secondary objectives are the evaluation of efficacy of spesolimab…

A randomised double-blind placebo-controlled clinical trial investigating the effect and
safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE)

This study has been transitioned to CTIS with ID 2023-506919-18-00 check the CTIS register for the current data. Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with…

An RCT on cognitive bias modification for alcohol use disorders in a religion-based rehabilitation program

The present study aims to assess the effectiveness of a religion-adapted CBM intervention compared to a standard, non-religion CBM intervention, and sham intervention based on approach bias modification (ApBM).