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A single-centre, placebo-controlled, crossover study in healthy medical registrars to enable validation of the mini-neurocart with the laparoscopy box trainer

This study has the primary aim to correlate subjective fitness of medical specialists to objective scales and relate the scores to validated levels of performance, which would be considered acceptable to perform surgical procedures.Objectives of…

Effectiveness of methylphenidate in children and adults with Smith Magenis syndrome and attention-deficit/hyperactivity disorder: An N-of-1 series

The primary objective is to determine the efficacy of methylphenidate on ADHD symptoms in Smith Magenis syndrome.The secondary objectives include the efficacy of methylphenidate on emotion dysregulation and specific goals that are important to the…

Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.

This study has been transitioned to CTIS with ID 2023-509881-39-00 check the CTIS register for the current data. The aim of this study is to evaluate the difference in the fraction of patients that have disease progression within 6 months after…

LIBRETTO-431: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Platinum-Pemetrexed Chemotherapy Plus Investigator*s Choice of Pembrolizumab in Patients with Advanced, Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

This study has been transitioned to CTIS with ID 2023-506783-14-00 check the CTIS register for the current data. The proposed Study J2G-MC-JZJC (hereafter referred to as JZJC) will evaluate selpercatinib in comparison to platinum-based (carboplatin…

PSMAfore: A phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617
vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Naïve Men with Progressive Metastatic Castrate Resistant Prostate Cancer

This study has been transitioned to CTIS with ID 2023-507772-50-00 check the CTIS register for the current data. The purpose of this study is to determine whether 177Lu-PSMA-617, given for 6 cycles at a dose of 7.4 Gigabecquerel (GBq) (200…

Promoting independence in bipolar disorder. Does cognitive remediation training of executive functioning lead to an improvement in wellbeing and personal goals of daily functioning?

Goal of the study is to find out if cognitive remediation focused on executive functioning for patients with bipolar disorder improves (1) functioning on personal goals in everyday life? And (2) improves general wellbeing?Hypotheses:Cognitive…

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY OF PRALSETINIB VERSUS STANDARD OF CARE FOR FIRST-LINE TREATMENT OF RET FUSION-POSITIVE, METASTATIC NON-SMALL CELL LUNG CANCER

This study has been transitioned to CTIS with ID 2023-505035-12-00 check the CTIS register for the current data. This study is designed to assess the efficacy of pralsetinib as compared to Investigator*s choice platinum-based chemotherapy regimen…

The effect of the indoor environment quality (IEQ) on cognition and health

Main research question and primary objective: What is the effect of exposure to high vs. neutral temperature (32* C vs. 25* C) in combination with high vs. low humidity (30 %RH vs. 70 %RH) for 8 hours on cognitive performance?Secondary research…

A pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation

This study has been transitioned to CTIS with ID 2023-506270-13-00 check the CTIS register for the current data. The primary objective is to determine superiority of MB CART2019.1 treatment compared to standard-of-care (SoC) therapy with R GemOx (…

Serotonergic modulation of population receptive fields

The primary objective is to determine the effects of serotonergic stimulation, via the administration of psilocybin, on population receptive fields in different modalities and to relate these effect to specific computational aspects of the divisive…

Balloon pulmonary angioplasty in chronic thromboembolic pulmonary disease without or with mild pulmonary hypertension: BALLOON-TRIAL

to assess the effects of BPA on quality of life and exercise capacity in a group of symptomatic CTEPD patients without PH with incomplete recovery after three month of rehabilitation.

An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

This study has been transitioned to CTIS with ID 2023-507970-42-00 check the CTIS register for the current data. The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard…

Randomized phase III trial investigating the survival benefit of adding thoracic radiotherapy to durvalumab (MEDI4736) immunotherapy plus chemotherapy in extensive stage small-cell lung cancer

This study has been transitioned to CTIS with ID 2023-505514-15-00 check the CTIS register for the current data. Primary Objective:- To investigate whether adding TRT to durvalumab plus chemotherapy improves 1-year survival. Secondary Objectives:-…

Flow versus Pressure Controlled Ventilation in patients with moderate to severe Acute Respiratory Distress Syndrome

By using advanced respiratory monitoring, we will aim to gain more understanding about the physiological effects and potential benefits of FCV in comparison to PCV in patients with moderate to severe ARDS. We hypothesize that FCV results in a lower…

Effects of N-Acetyl-L-Leucine on Niemann-Pick disease type C (NPC): A Phase III, randomized, placebo-controlled, double-blind, crossover study

This study has been transitioned to CTIS with ID 2023-510278-14-00 check the CTIS register for the current data. Primary Objective:In all jurisdictions except the United States (US), the primary objective is to evaluate the efficacy of N-Acetyl-L-…

Pursuing the Tiple Aim in Hotspotters:identification and integrated care

Objective: Is proactive integrated care costeffective and does it result in better patients experience than usual care after 12 months for patients with problems on multiple life domains?This study will focus on measuring the changes in the…

A Phase 3, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE)

This study has been transitioned to CTIS with ID 2024-512745-16-00 check the CTIS register for the current data. Study AG348-C-017 is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study designed to demonstrate the clinical…

A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients with Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)

This study has been transitioned to CTIS with ID 2023-506782-56-00 check the CTIS register for the current data. To compare PFS of patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with selpercatinib versus…

A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System* Kit, in Subjects with Hypertension.

This study has been transitioned to CTIS with ID 2024-512525-83-00 check the CTIS register for the current data. Primary Objective (Randomized Controlled Trial [RCT] Cohort): to evaluate the efficacy of renal denervation by alcohol-mediated…

Leflunomide and Hydroxychloroquine combination therapy
for primary Sjögren*s Syndrome

This study has been transitioned to CTIS with ID 2024-510904-36-00 check the CTIS register for the current data. To assess clinical efficacy and safety of Leflunomide/Hydroxychloroquine in pSS patients in a phase IIb placebo-controlled randomized…