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Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids.
A prospective double-blind placebo-controlled randomized phase III trial

To improve the response rate to treatment of severe acute GVHD (grade II-IV with gut involvement ) by adding infusion of Mesenchymal Stroma Cells to standard high dose prednisolone.

The protective effect of azelastine/fluticasone propionate (Dymista) on exercise-induced airway obstruction

To analyze the protective effect of azelastine/fluticasone propionate against exercise-induced airway narrowing by measuring inspiratory and expiratory airflow limitation and airway resistance and reactance in asthmatic children.

Gut microbial substrate switch to improve metabolic health

The objective of this proposal is to test in a proof-of-concept manner, whether the dietary fiber product WholeFiberTM yields an optimal gut and circulating SCFA concentration to reverse insulin resistance.

The effects of a colon-delivered multivitamin supplement on vigilance and cognitive performance under stressful working conditions in military subjects

This current study aims to examine the effects of a 6-week colon-delivered multi-vitamin supplement intervention on cognitive performance and stress levels in military under real-life, stressful working conditions.

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

The objective of this Phase 3 study is to investigate the safety and efficacy of benralizumab as a treatment for patients with eosinophilic gastritis and/or gastro-enteritis.

Endocalyx for heart failure (GLYCO-HF)

To assess the efficacy of treatment with Endocalyx for chronic heart failure.

A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Determine the Pharmacodynamics and Pharmacokinetics of OPC-214870 Following Repeated Oral Administration to Healthy Subjects

- To assess the CNS functional effects of OPC-214870 following dosing using Neurocart test battery

Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with heterozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-16)

Study CKJX839C12301 (ORION-16) is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (aged 12 to <18 years) with HeFH and LDL-C >130 mg/dL (3.4 mmol/L). The use of inclisiran…

A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis.

Primary: To determine the efficacy of SAR442168 compared to a daily dose of 14 mgteriflunomide (Aubagio) in decreasing relapses in RMS.Secondary:1. To evaluate safety, tolerability, and efficacy of SAR442168 compared to placebo on clinical endpoints…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Navitoclax in Combination with Ruxolitinib Versus Ruxolitinib in Subjects with Myelofibrosis

Primary objective: To evaluate the effect of navitoclax in combination with ruxolitinib on splenomegaly response when compared to ruxolitinib in subjects with myelofibrosis.Secondary objectives:• To evaluate the effect of navitoclax in combination…

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…

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 randomized, placebo-controlled, patient and investigator blinded study investigating the safety, tolerability and preliminary efficacy of 8-week treatment with intra-articular LRX712 to regenerate articular cartilage in patients with mild/moderate knee osteoarthritis

Primary objective - To assess the efficacy of q4w x3 i.a. injections of LRX712 in restoring the morphometrics of articular cartilage in the medial femoral condyleSecondary objectives- To evaluate LRX712 and metabolite MAE344 pharmacokinetics in…

A randomized, double-blind, placebo-controlled phase III multi-center study of azacitidine with or without MBG453 for the treatment of patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

The anti-TIM-3 monoclonal antibody MBG453 is a novel immunotherapeutic agent with promising activity seen in AML and MDS. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with…

A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension.

The purpose of this study is to explore the efficacy and safety of LTP001 in participants with WHO Group 1 pulmonary hypertension (PH), also referred to as Pulmonary Arterial Hypertension (PAH).This proof of concept study will be executed as the…

A 2-Part, Randomized, Double-blind, Double-Dummy, Placebo- and Active Comparator-controlled, Repeat Dose Study to Establish Proof-of-Concept of GRX-917 in Experimentally Induced Panic and to Further Characterize its Repeated Dose Pharmacokinetics and Pharmacodynamics in Healthy Subjects

Part 1:Primary Objective- To investigate whether repeated dose GRX-917 reduces panic symptoms elicited by an experimental 35% CO2 -induced fear challenge administered in healthy CO2-sensitive subjects. Secondary Objectives- To investigate whether…

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, EFFICACY, AND PHARMACODYNAMICS OF 52 WEEKS OF TREATMENT WITH BASMISANIL IN PARTICIPANTS AGED 2 TO 14 YEARS OLD WITH DUP15Q SYNDROME FOLLOWED BY A 2-YEAR OPTIONAL OPEN-LABEL EXTENSION

Part 1:To evaluate the effects of 52 weeks of treatment with basmisanil on core symptom domains of Dup15q syndrome (language and social skills) and dailyfunctioning. Part 2:• To evaluate the tolerability and safety of up to 3 years of treatment with…

A randomized, double-blind, placebo-controlled, Phase 2b trial with an open-label extension to determine the safety and efficacy of GH001 in patients with treatment-resistant depression.

To determine the efficacy of a single day individualized dosing regimen (IDR) of GH001 compared with placebo in improving depressive symptoms as assessed by MADRS in patients with treatment-resistant depression (TRD) at the end of the 7-day double-…

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

Primary objective* To assess the efficacy of EP547 compared to placebo on pruritus as assessed by the Worst Itch Numeric Rating Scale (WI-NRS)Secondary* To assess the efficacy of EP547 compared to placebo on the following:* Pruritus-related quality…

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients with Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet

Primary objective:To assess the efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with NRCD as measured by the Abdominal Symptoms domain of the Celiac Disease Patient- Reported Outcome (CeD PRO)…