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Tracer-Based Imaged Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial - TRACE II

Evaluate the clinical progression free survival after randomization to either 6 months of androgen deprivation therapy (ADT) or 6 months of ADT plus a 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery.

A randomized, double-blind, placebo-controlled, 2-arm Phase III study to assess efficacy and safety of xevinapant and radiotherapy compared to placebo and radiotherapy for demonstrating improvement of disease-free survival in participants with resected squamous cell carcinoma of the head and neck, who are at high-risk for relapse and are ineligible for high-dose cisplatin

This study has been transitioned to CTIS with ID 2023-508528-36-00 check the CTIS register for the current data. The purpose of this study is to demonstrate improvement in Disease-Free Survival (DFS) with xevinapant compared to placebo when added to…

A phase 2/3 Adaptive, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease

• To evaluate the efficacy of VX-147 to reduce proteinuria• To evaluate the efficacy of VX 147 on renal function as measured by eGFR slope

Detection and Quantification of Atrial Fibrillation in High-Risk Patients Using a Smartwatch Wearable (Apple Watch) with a Photoplethysmographic sensor and ECG-functionality

The primary objective of this trial is to quantify the incidence of AF in patients at high risk for but without previously known AF using a smartwatch wearable with a photoplethysmographic sensor and to determine if the incidence is higher compared…

Clinical outcomes and cost-effectiveness of a diagnostic and treatment strategy of upfront CTCA plus selective non-invasive functional imaging compared with standard care in patients with chest pain and suspected coronary artery disease

This strategy will result in a reduction reduce the incidence of major adverse cardiovascular events (MACE) defined as death or non-fatal myocardial infarction and appear more efficient than care as usual.

Optimising surgical anastomosis in ileocolic resection for Crohn's disease to reduce recurrent disease: A Randomized controlled trial comparing hand-sewn (END-TO-END or Kono-S) to stapled anastomosis (END2END study)

To understand if handsewn (end to end and Kono S side to side) anastomoses is superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs.

A randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel + aspirin) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty

To assess whether and to what extent dual therapy clopidogrel 75 mg/acetylsalicylic acid 80 mg daily is superior to monotherapy clopidogrel 75 mg daily, in reducing the combined endpoint all-cause death and cardiovascular adverse events after one-…

A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS
PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI-H/DMMR METASTATIC COLORECTAL CANCER

This study has been transitioned to CTIS with ID 2024-512119-34-00 check the CTIS register for the current data. Comparing the efficacy of encorafenib and cetuximab plus pembrolizumab (triplet group [group A]) vs. pembrolizumab (control group [group…

Preoperative CT-imaging with patient-specific computer simulation in transcatheter aortic valve replacement: a randomized controlled trial.

The objective of this randomized controlled trial (RCT) is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide* (FHG)) adequately predicts procedural outcomes in TAVR procedures, whether it…

Precision psychiatry: Anti-inflammatory medication in Immuno-metabolic depression

This study has been transitioned to CTIS with ID 2024-513907-15-01 check the CTIS register for the current data. Among patients under treatment for depression, we will select 140 persons with IMD. In this specific group of patients, we will test…

Body surface area-based vs concentration-based dosing of cisplatin for hyperthermic intraperitoneal chemotherapy (HIPEC) in women with advanced ovarian cancer

This study has been transitioned to CTIS with ID 2024-514711-99-00 check the CTIS register for the current data. To evaluate BSA-based versus concentration-based OVHIPEC with cisplatin in patients with advanced-stage ovarian cancer.

A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (TETON-2) // A Multinational, Uncontrolled, Usability Evaluation Study of the TD-300/A Tyvaso Inhalation Device Used in RIN-PF-303

This study has been transitioned to CTIS with ID 2024-514761-19-00 check the CTIS register for the current data. The primary objective of RIN-PF-303 is to evaluate superiority of inhaled treprostinil against placebo for the annual rate of change in…

A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

This study has been transitioned to CTIS with ID 2023-508897-27-00 check the CTIS register for the current data. Primary:• To compare the efficacy of elranatamab vs lenalidomide Secondary:- To compare the efficacy of elranatamab vs lenalidomide- To…

A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults with Dyslipidemia

This study has been transitioned to CTIS with ID 2024-511331-96-00 check the CTIS register for the current data. Primary Objective• To evaluate the safety and efficacy of long-term treatment with ARO-APOC3 in adults with dyslipidemia.

A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis

This study has been transitioned to CTIS with ID 2023-509784-24-00 check the CTIS register for the current data. Core phase: The overall objective of the core phase is to investigate the efficacy, safety and tolerability of 2 dose regimens of HZN-…

A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous efzofitimod in patients with pulmonary sarcoidosis

This study has been transitioned to CTIS with ID 2023-506039-13-00 check the CTIS register for the current data. OBJECTIVESPrimary Objective• To assess the efficacy of efzofitimod in patients with pulmonary sarcoidosis Secondary Objectives• To…

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold
Agglutinin Disease (CAD)

Primary objective:- To demonstrate the efficacy of twice-weekly s.c. 1080-mg infusions of pegcetacoplan compared with that of placebo in patients with CAD.Secondary objectives:- To demonstrate the effect of pegcetacoplan on the number of PRBC…

A double-blind, randomized, placebo-controlled, Multiple Ascending Dose (MAD) study in healthy elderly volunteers and Alzheimer's Disease (AD) and Parkinson's disease (PaD) patients to investigate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) effects of multiple intravenous infusions of NX210c

Part A (Healthy volunteers)Primary:• To assess safety and tolerability of multiple doses of NX210cSecondary• To evaluate the pharmacokinetic (PK) profile of NX210c in plasma after multiple doses. • To evaluate the exposure of NX210c in cerebrospinal…

The Effect of a Combined Personalized Nutritional Intervention and a Personalized Graded Activity Functional Training Program on Physical Performance in Hospitalized Older Patients, Compared to Usual Care

This project aims to improve physical performance in older patients, by offering a personalized combined nutritional intervention with a physical activity training program. The intervention starts at hospital admittance, and is continued after…

A Three-Part, Adaptive, Randomized, Double blind, Placebo Controlled First in Human Study to Evaluate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Multiple Ascending Oral Doses of GM-1020 and the Effect of Food on Single Dose GM-1020 in Healthy Volunteers.

To characterize the safety and tolerability of ascending single oral doses (part A) and ascending repeated oral doses (part B) of GM-1020 and the effect of food on single dose GM-1020 (part C) in healthy volunteers.