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Effect of High-volume Online hemodiafiLtration on intra-diaLytic hemodynAmic (iN)sTability and cardiac function in chronic hemodialysis patients (the HOLLANT study)

This study aims at improving the knowledge concerning HV-HDF and thus helps to tailor the optimal ERRT for each individual patient.The following hypotheses will be tested:1. Intra-dialytic hemodynamic stability is better preserved during HV-HDF as…

Safety and feasibility of ultra-high field magnetic resonance imaging in neonates

The primary aim of this study is to investigate the safety and feasibility of ultra-high field magnetic resonance imaging (MRI) of the brain in neonates and to optimize scan protocols.

Ovarian cancer treatment with a liposome formulated mRNA Vaccine in combination with (neo-)adjuvant chemotherapy

Systemic induction / expansion of vaccine antigen-specific T cells.

Conditioning of insulin responses: a high rist- high gain intervention for diabetes type-2

The primary objective of this study is to investigate the effects of classical conditioning with intranasal insulin on endogenous insulin and glucose levels in diabetes type-2 patients and healthy controls. Additionally, we will examine the effects…

A Randomized Open-Label, Phase 1b Study of the Safety of Pirfenidone Solution for Inhalation (AP01) in Patients with Idiopathic Pulmonary Fibrosis (ATLAS Study)

The primary objective is to evaluate safety and tolerability of treatment with AP01.This study will also evaluate the effect of AP01 on various efficacy measures as follows:* To evaluate the safety and tolerability of treatment with AP01 when given…

A Phase IIa Exploratory Study of CriPec® docetaxel Monotherapy in Subjects with Platinum Resistant Ovarian Cancer.

To determine the Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of CriPec® docetaxel monotherapy in subjects with ovarian cancer who are resistant to prior platinum-based therapy.

A Randomized, Double-blind, Placebo-Controlled, 3-Period Crossover Study Followed by 1 Open-label Comparator Period to Evaluate Central Pharmacodynamic Activity of TAK-653 in Healthy Volunteers Using Transcranial Magnetic Stimulation

The primary objective of the study is to determine whether TAK-653, in comparison to placebo, increases CNS excitability, assessed with TMS-evoked MEP in healthy subjects.Next to that, the study has the following goals: - To determine whether TAK-…

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy,
Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle
Weakness.

Primary Objective:- Efficacy of ARGX-113 as assessed by the percentage of "Myasthenia Gravis Activities of Daily Living (MG-ADL) responders" in the acetylcholine receptor (AChR)- antibody (Ab) seropositive population.Secondary Objectives:1…

An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Rich Tumors of Bone.

Primary:Subjects with salvageable giant cell rich tumors:- To evaluate subjects who do not require surgery during the study- To evaluate subjects who are able to undergo a less morbid surgical procedure compared with the planned surgical procedure…

Biocomparison study of crushed elbasvir/grazoprevir compared to the whole tablet (CRUSADE-2)/Hep-NED005

Primary objective:To assess pharmacokinetic similarity of EBR/GZR as a crushed (test) Zepatier tablet compared to a whole (reference) tablet.Secondary objective:To assess Cmax similarity of EBR/GZR as a crushed (test) Zepatier tablet compared to a…

ED90 of intrathecal 1% chloroprocaine in day-case knee arthroscopy: a Biased-Coin-Up-and-Down sequential allocation trial

To determine the effective dose ED90 of Chloroprocaine for patients undergoing knee arthroscopy.

A Phase 3, INterVentional, Double-Blind, Placebo Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients with AdvanCed Gastrointestinal Stromal TUmorS who have Received Treatment with Prior Anticancer Therapies

Primary Objectives:• To assess the efficacy (progression free survival [PFS]) of DCC 2618 by independent radiologic review in patients with advanced gastrointestinal stromal tumors (GIST) who have received prior therapiesKey Secondary Objectives:•…

Neoadjuvant capecitabine, oxaliplatin, docetaxel and atezolizumab in non-metastatic, resectable gastric and GE-junction cancer. ;The PANDA trial

This study has been transitioned to CTIS with ID 2024-519075-26-00 check the CTIS register for the current data. Primary objective: To explore the safety and feasibility of neoadjuvant capecitabine, oxaliplatin, docetaxel, and atezolizumab in GE-…

e-Exercise: Stratified blended physical therapy in patients with non-specific low back pain

To investigate the short-term (3 months) effectiveness on physical functioning, and the long-term (24 months) cost-effectiveness, of a personalized stratified blended care intervention (e-Exercise LBP) in comparison with usual physical therapy in…

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate
Mavacamten (MYK-461) in Adults with Symptomatic Obstructive
Hypertrophic Cardiomyopathy

Primary Objective* To compare the effect of a 30-week course of mavacamten with placebo on clinical response comprising of exercise capacity and clinical symptoms in participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn*s Disease (CARMEN CD 307)

Coprimary: The coprimary objectives of the study are to evaluate the efficacy of ontamalimab as maintenance treatment in subjects with moderate to severe Crohn*s disease (CD) based on:* Clinical remission based on 2 item patient-reported outcome (…

Neurotoxic changes in cerebral glucose metabolism during anaesthesia and major surgery; is the polyol pathway activated?

We will study the cerebral glucose metabolism before, during and after surgery by sampling the cerebrospinal fluid (CSF) via the spinal catheter in patients undergoing thoracic surgery. Changes in cerebral glucose metabolism and activation of the…

A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)

To assess the safety and reactogenicity of HB-101.To assess the immunogenicity of HB-101.

The influence of stress on Parkinson*s tremor * a behavioural pilot study

The goal of this research is to assess whether cognitive effort (mental arithmetic) or fear (threat of shock) have a similar or different effect on Parkinson*s tremor and noradrenergic activity. In the following, obtained knowledge and empirical…

A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

To evaluate the effect of MEDI6012 on infarct size compared with placebo.