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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.

A Phase 1a Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX-002 in Healthy Adult Subjects

Part 1 Single Ascending Dose (SAD)- To evaluate the safety and tolerability of a single oral dose of prodrug, ABX-002, in healthy adult subjectsPart 2 Multiple Ascending Dose (MAD)-To evaluate the safety and tolerability of once daily oral doses of…

RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Primary Objective: • Efficacy: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on alkalinephosphatase (ALP) and total bilirubin at 12 months of treatment compared to placebo• Safety:…

A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in Treatment-naïve Patients with Higher Risk Myelodysplastic Syndrome

Primary (Efficacy):To evaluate the efficacy of magrolimab + azacitidine compared with that of azacitidine + placebo in previously untreated participants with intermediate/high/very high risk MDS by IPSS-R as measured by CR rateTo evaluate the…

Better nights, better days? The role of sleep in (dis)stress, anxiety and emotion regulation

This study aims to transdiagnostically evaluate effectiveness of guided Internet CBT for insomnia (ICBTI) to improve sleep, reduce emotional distress and improve responsiveness to regular treatment through sleep improvement, and to foster…

A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) and Considered Unsuitable for Hormone Replacement Therapy.

PrimaryTo evaluate the efficacy of fezolinetant 45 mg versus placebo on the frequency of moderate to severe VMSKey secondaryTo evaluate the efficacy of fezolinetant 45 mg versus placebo on the severity of moderate to severe VMSSecondary• To evaluate…

A Phase 3, Open-label, Randomized Study of Dato-DXd Versus Investigator*s Choice of Chemotherapy in Participants With Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Dual Primary objective: - To demonstrate the superiority of Dato-DXd compared to ICC by assessment of PFS in participants with inoperable or metastatic HR-positive, HER2-negative breast cancer, who have been treated with 1 or 2 lines of chemotherapy…

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)

The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren*s syndrome (pSS) versus placebo.

A phase I, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of single and multiple ascending doses of GDC-6599 and the effect of food on the pharmacokinetics and pharmacodynamics of GDC-6599 in
healthy adult subjects

In this study we will investigate how safe the new compound GDC-6599 is and how well it is tolerated when it is used by healthy participants. We also investigate how quickly and to what extent GDC-6599 is absorbed, transported, and eliminated from…

Spinal morphine in patients with hip fractures to reduce delirium

The main objective is to decrease the incidence of delirium in patients receiving surgical treatment of a proximal femur fracture with spinal anesthesia.

COrticosteroids for COVID-19 induced loss of Smell - COCOS trial
(AMENDMENT)

To determine the efficacy of a short high-dose treatment of oral prednisolone for persistent loss of smell after COVID-19 infection in the long term (>12 weeks). ADD: determining the clinical course/natural recovery of loss of smell and taste…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD

The primary objective of the study is to assess the efficacy, safety, and tolerability of ABBV 154 in comparison with placebo in subjects with moderately to severely active CD who had inadequate response to or were intolerant of prior biologics.

A three-part, phase 1, randomized, controlled, dose-escalation study of INT-787 following single or multiple dose administration in healthy subjects.

In this study we will investigate how safe the new compound INT-787 is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent multiple doses of INT-787 are absorbed, transported,…

Fasting Intervention for children with Unilateral Renal Tumours to reduce Toxicity

to investigate the effect of a pre-operative fasting diet on post-operative recovery after renal tumour surgery

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

• To assess the efficacy of rozanolixizumab as measured by seizure freedom• To assess the efficacy of ozanolixizumab as measured by change in cognitive function• To assess the efficacy of ozanolixizumab as measured by use of rescue medication• To…

Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO-study)

Primary objective:to investigate and compare the effect of EUS-GE and SGJ on patients* short- and long-term ability to eat* (time to oral intake, and reinterventions for persistent or recurrent symptoms of GOO within 6 months of follow-up,…

The value of a risk prediction tool (PERSARC) for effectvie treatment decision making: a stepped wedge Randomized Controlled Trial.

To assess whether the use of the personalized risk assessment tool (PERSARC) is (cost)effective in reducing decisional conflict and increasing informed choices in high-grade extremity STS compared to usual care (co-primary outcomes). In addition, we…

A Phase 1 Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Nipocalimab in Healthy Male and Female Participants.

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

A randomised controlled trial of the Happy Lessons approach: a school-based programme to strengthen psychosocial wellbeing and prevent depression in pre-vocational school pupils

Determine if HL meets the criteria for the higher DEI designation of effectiveness. We will investigate the effectiveness of HL in terms of an increase in well-being and a reduction of depressive symptoms after 6 months compared to care as usual.

A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study, followed by an Open-Label Extension, to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants with Amyotrophic Lateral Sclerosis

Primary• To investigate the safety and tolerability of multiple oral doses of DNL343 in participants with ALSSecondary• To characterize the PK of DNL343 in plasma following single and multiple oral doses• To characterize the concentration of DNL343…