Clinical trials: in Monaco
Cardiac Arrythmias
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
The objective of the RHAPSODY study is to evaluate the performance of new software features in subjects undergoing standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial…
- Trial name
- RHAPSODY (NCT03053141)
- Testing
- Rhythmia Mapping System
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Pulsed Field Ablation
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation
The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field…
- Conditions
- Atrial Fibrillation, Pulsed Field Ablation, FARAPULSE
- Trial name
- OPALISE (NCT06808217)
- Testing
- FARAPULSE Pulsed Field Ablation System
- Where
- 22 sites in Austria, France and 8 more
- Volunteers
- 550 people
- Sponsor
- Boston Scientific Corporation
Hypertension, Vascular Diseases
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases
- Trial name
- NCT05198674
- Testing
- Renal Denervation (Symplicity Spyral™)
- Where
- 97 sites in United States, Australia and 9 more
- Volunteers
- 1,899 people
- Sponsor
- Medtronic Vascular
Lewy Body Dementia, Lewy Body Dementia With Behavioral Disturbance
tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
The goal of this pilot prospective study is to evaluate the effect of tDCS on psychotic-like symptoms in patients with Lewy Body Dementia (LBD).
- Conditions
- Lewy Body Dementia, Lewy Body Dementia With Behavioral Disturbance, Burden, Caregiver, Lewy Body Disease
- Trial name
- MCL-tDCS (NCT06785948)
- Testing
- active-tDCS
- Where
- Monaco
- Volunteers
- 21 people
- Sponsor
- Association de Recherche Bibliographique pour les Neurosciences
Parkinson Disease, Idiopathic
Video-oculography and Parkinson's Disease
This study aims to study, in patient with Parkinson's disease, mild to moderate stage (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, Postuma et al., 2015): the evolution of…
- Trial name
- NCT04731246
- Testing
- Video-oculography / Neuropsychological evaluations
- Where
- Monaco
- Volunteers
- 30 people
- Sponsor
- Association de Recherche Bibliographique pour les Neurosciences
Major Depressive Episode (MDE), Unipolar Disorder
Evaluating the Therapeutic Potential of Focal Electrically Administered Seizure Therapy (FEAST) in the Treatment of Depression: A Multicenter Randomized Clinical Trial
A significant proportion of patients remain resistant to antidepressant therapies, even when treatment is well managed. Electroconvulsive therapy (ECT) is a well-established method for treating certain severe and resistant…
- Conditions
- Major Depressive Episode (MDE), Unipolar Disorder, Bipolar 1 Disorder
- Trial name
- FEAST-AFT (NCT07857122)
- Testing
- Stimulation by the Sigma ECT/FEAST device, Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL), Stimulation by Sigmastim ECT 200J device administered in bilateral (BT)
- Where
- 5 sites in France, Monaco
- Volunteers
- 108 people
- Sponsor
- Centre Hospitalier St Anne
Rheumatoid Arthritis
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055 Period 1 [NCT01519791].
- Trial name
- C-early (NCT01521923)
- Testing
- Certolizumab Pegol + Methotrexate (MTX)
- Where
- 178 sites in United States, Argentina and 20 more
- Volunteers
- 359 people
- Sponsor
- UCB Pharma
Rheumatoid Arthritis
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug…
- Trial name
- C-early (NCT01519791)
- Testing
- Certolizumab Pegol, Methotrexate
- Where
- 178 sites in United States, Argentina and 20 more
- Volunteers
- 880 people
- Sponsor
- UCB Pharma SA
Atrial Fibrillation
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System
The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response.
- Trial name
- FARADISE (NCT05501873)
- Testing
- FARAPULSE Pulsed Field Ablation system
- Where
- 48 sites in Australia, Austria and 19 more
- Volunteers
- 1,173 people
- Sponsor
- Boston Scientific Corporation
Lobular Breast Carcinoma
Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
Lobular Breast cancer staging with 18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) is not optimal due to the poor accumulation of 18F-FDG in the tumour.
- Trial name
- GALILEE (NCT05931302)
- Testing
- 68Ga-FAPI-46 PET scan
- Where
- Monaco
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Drug Use
Drug Wastage : Observational Study in the Operating Rooms of France
Environmental awareness is leading medical field to question its responsibility and possibilities for action. Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence…
- Trial name
- GAME-OvBLOC (NCT05609864)
- Testing
- Quantification of injectable drugs wastage
- Where
- 83 sites in France, Guadeloupe and 2 more
- Volunteers
- 3,763 people
- Sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Drug Use
Drug Wastage : Observational Study in Intensive Care Units in France
Environmental awareness leads medical field to question its responsibility and possibilities for action. Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics…
- Trial name
- GAME-OVER (NCT05553054)
- Testing
- Quantification of IV drugs wastage
- Where
- 61 sites in France, Mayotte and 1 more
- Volunteers
- 1,066 people
- Sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Atherosclerosis
Strategy for Unstable Coronary Plaque in Patients Presenting to Emergency Department for Chest Pain Suspected of Coronary Artery Disease
Primary prevention of coronary disease and especially its major complication, inaugural myocardial infarction, is based on any prodromal symptoms identification and on risk profile establishment.
- Trial name
- SPECTRE (NCT06013722)
- Testing
- 18F-Na PET Scan
- Where
- Monaco
- Volunteers
- 22 people
- Sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Neoplasms Malignant, Covid19
Thromboembolic Risk Screening in Patients With Cancer and COVID-19
Study Rational Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue.
- Conditions
- Neoplasms Malignant, Covid19, Thromboembolism
- Trial name
- NEOTHROCOVID (NCT04616846)
- Testing
- Peripheral venous ultrasound
- Where
- 6 sites in France, Monaco
- Volunteers
- 88 people
- Sponsor
- Centre Antoine Lacassagne
Rheumatoid Arthritis (RA)
Comparison of Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis
The aim of this study is to offer patients two treatment options: morning or evening administration of a JAK inhibitor prescribed within the framework of its marketing authorization, according to the EULAR response.
- Trial name
- JAK-INHI (NCT07674134)
- Where
- Monaco
- Volunteers
- 90 people
- Sponsor
- Centre Hospitalier Princesse Grace
Ovarian Cancer
Validation of KELIM as a Predictive/Prognostic Factor for Maintenance Treatment With iPARP in First-Line Ovarian Cancer
This study aims to understand whether it is possible to predict the effectiveness of maintenance treatment with PARP inhibitors following first-line chemotherapy in ovarian cancer, and thus better target the patients who benefit…
- Trial name
- KELI-PAOLA (NCT06660147)
- Where
- 24 sites in France, Monaco
- Volunteers
- 243 people
- Sponsor
- ARCAGY/ GINECO GROUP
Hypertension
The "Global Paradise System" Registry
The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect…
- Trial name
- GPSRegistry (NCT05027685)
- Testing
- The Paradise Ultrasound Renal Denervation System
- Where
- 55 sites in Austria, Belgium and 7 more
- Volunteers
- 3,000 people
- Sponsor
- ReCor Medical, Inc.
Breast Neoplasm Malignant Female
Study of the Impact of DPD Activity on the Efficacy of Capecitabine
This study evaluates the Impact of DihydroPyrimidine Dehydrogenase (DPD) activity on the efficacy of Capecitabine in patients with metastatic breast cancer.
- Trial name
- DPDMAX (NCT04198727)
- Testing
- DPD activity assessment, Capecitabine
- Where
- 5 sites in France, Monaco
- Volunteers
- 155 people
- Sponsor
- Centre Antoine Lacassagne
Hypo or Hyperthyroidism
Thyroid Uptake Quantification Validation on a Three-dimensional (3D) Cadmium-Zinc-Telluride (CZT) New Generation Gamma Camera
Thyroid scintigraphy using technetium-99m (99mTc) pertechnetate is traditionally performed using planar imaging to estimate thyroid uptake.
- Trial name
- QThy2Dvc3D (NCT07610460)
- Testing
- No Intervention: Observational Cohort
- Where
- Monaco
- Volunteers
- 27 people
- Sponsor
- Centre Hospitalier Princesse Grace
Rapide Sequence Induction, Tracheal Intubation
Pain Assessment During Rapid Sequence Induction
Rapid sequence induction (RSI) is a standard anesthesia technique used in patients at risk of aspiration. Although tracheal intubation following RSI is a frequent and painful procedure, no study has yet evaluated nociception…
- Conditions
- Rapide Sequence Induction, Tracheal Intubation, Nociception, General Anesthesia
- Trial name
- NARSI (NCT07588165)
- Testing
- No Intervention: Observational Cohort
- Where
- Monaco
- Volunteers
- 150 people
- Sponsor
- Centre Hospitalier Princesse Grace