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An open-label, multi-center, roll-over study to assess long term safety in patients with endogenous Cushing*s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat

To evaluatie the long term safety of treatment with osilodrostat for patients with Cushing Syndrome. In addition to evaluating the proportion of patients with clinical benefit (as assessed by the investigator) and determening frequency, severity and…

Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies

Dose-finding:-To determine the adult equivalent exposure/MTD/recommended Phase II pediatric dose of durvalumab monotherapy and durvalumab in combination with tremelimumab-To determine the safety profile of durvalumab monotherapy, or durvalumab in…

Relation between femoral Component Rotation And Clinical outcomes in total Knee replacement (CRACK). A prospective observational study

The aim of this prospective observational study is to assess the relation between femoral component rotation and patient reported outcomes in a large group of patients, and to define a clear cut-off point for revision for malrotated components.The…

Three randomized controlled trials with a two-year extension period on the effect of a multidisciplinary lifestyle program (1) for patients with rheumatoid arthritis, (2) for patients with ACPA positive arthralgia and (3) patients with osteoarthritis & metabolic syndrome.

Investigating the effect of a 16 week multidisciplinary lifestyle programme, based on (1) a whole foods plant based diet (WFPD), (2) exercise and (3) stress management on:- disease activity (DAS28) for patients with rheumatoid arthritis (RA), in…

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects with Heart Failure with Reduced Ejection Fraction and Decreased Exercise Tolerance

Primary Objective:* To evaluate the effect of treatment with omecamtiv mecarbil (OM) compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment with OM or placeboSecondary…

A prospective follow-up Intervention Study: Detection of Early Esophageal Cancer by Near-Infrared Fluorescence molecular Endoscopy using Bevacizumab-800CW

Primary:To evaluate the performance of FME with topical administration of Bevacizumab-800CW for detection of neoplasia in BE patients compared to HD-WLE to make an estimation of the diagnostic accuracy in terms of sensitivity and specificity in…

Prospective Multicenter Microbiota Study for Evaluation and Monitoring of Severe Acute Pancreatitis

1) To establish associations between microbiome profiles and disease severity in patients with acute pancreatitis. 2) To establish associations between specific microbial shifts and infectious complications in the subgroup of patients with…

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRATHECALLY ADMINISTERED RO7234292 (RG6042) IN PATIENTS WITH MANIFEST HUNTINGTON'S DISEASE

The primary efficacy objective for this study is to evaluate the efficacy of RO7234292 compared with placebo.The secondary efficacy objective for this study is to evaluate the efficacy of RO7234292 compared with placebo.The safety objective for this…

Clarifying the Vascular Aspects of Dementia

Objective: 1. To determine whether vascular reactivity is lowered in memory clinic patients with mixed and pure AD pathology. 2. To define whether vascular reactivity upon visual activation is associated with CAA or with other small vessel disease (…

Needle-knife incision therapy compared to usual care of recurrent gastroesophageal anastomotic strictures: a multicenter randomized controlled trial (SAMURAI-study)

The aim of the current study is to evaluate the efficacy and cost-effectiveness of NKI followed by EBD compared to standard EBD in patients with recurrent esophagogastric anastomotic strictures. The combination of NKI and EBD is estimated to achieve…

Validity and reproducibility of practical performance-based tests to estimate aerobic capacity in patients scheduled for elective colorectal surgery

We aim to determine the validity of the steep ramp test as practical performance-based aerobic capacity test in patients undergoing elective colorectal resection by correlating the tests* scores with the ventilatory anaerobic threshold and oxygen…

Putting the patient at the center of care: personalized treatment for psychological symptoms and fatigue in cancer survivors

The primary objective of the proposed study is to test the efficacy of personalized psychological care for improving functioning in cancer survivors with severe and persistent depressive and/or fear of cancer recurrence and/or cancer-related fatigue…

Identification of the posterior lobe of the human pituitary gland during surgery using its electrophysiological, neural signature

To record and analyse the electrophysiological properties and differences of the human pituitary gland, i.e. the anterior lobe, posterior lobe and adenoma.

Pharmacokinetic boosting of osimertinib in patients with non-small cell lung cancer.

The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is enhanced when osimertinib is co-administered with cobicistat in patients with relatively low blood concentrations while receiving the standard…

Establishing an etiological role of the gut microbiome in the antiphospholipid syndrome phenotype

Primary Objective: - to establish if a gut microbiome perturbation affects APS disease phenotype.Secondary Objective(s): - to identify biomarkers that are responsive gut microbiome perturbation.- to establish if gut microbiome perturbation affects…

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)

This study has been transitioned to CTIS with ID 2024-513374-22-00 check the CTIS register for the current data. 5.1 Primary ObjectiveTo evaluate the long-term safety of glepaglutide treatment in SBS patients.5.2 Secondary ObjectivesTo evaluate the…

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Apremilast (CC-10004) in Pediatric Subjects from 6 through 17 Years of Age with Moderate to Severe Plaque Psoriasis

Primary ObjectiveThe primary objective of the study is to evaluate the clinical efficacy of apremilastcompared with placebo in children and adolescents (ages 6 through 17 years) withmoderate to severe plaque psoriasis.Secondary Objectives- * To…

Multi-Interventional program for prevention and early Management of Anastomotic leakage
after total mesorectal excision in Rectal cancer patIents, IMARI-trial

To increase the one year anastomotic integrity rate in patients undergoing total mesorectal excision (TME) for rectal cancer by the routine and quality controlled implementation of a multi-interventional program, which includes:1. MBP with oral…

Transforaminal Epidural Injection in Acute Sciatica

1. To study effectivity of the epidural injection with analgesic and anti-inflammatory medication to relieve the symptoms within two weeks follow up.It will be evaluated in what percentage of patients the decrease in leg pain is satisfactory in both…

A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of midostaurin to 10-day decitabine in UNFIT (i.e. HCT-CI >= 3) adult AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients.
A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT- AML/high-risk MDS patients.

This study has been transitioned to CTIS with ID 2023-503829-18-00 check the CTIS register for the current data. Primary objectives:- To assess in a randomized comparison the effect of midostaurin added to 10-day decitabine treatment on the…