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The ORANGE II PLUS - Trial: An international multicentre randomized controlled trial of open versus laparoscopic liver surgery (hemihepatectomy and postero-superior liver segment resection).

Hypotheses: - For patients undergoing a laparoscopic left or right hemihepatectomy (with or without the need for one additional hepatic wedge resection or metastasectomy), time to functional recovery is reduced by 2 days in comparison with patients…

Treatment of Targeted Therapy-Related Fatigue in Patients with CML or GIST: A Single-Case Experimental Design

To investigate the efficacy of cognitive behaviour therapy (CBT) on reducing TTF in patients receiving TKIs for CML or GIST.

Rectal preserving treatment for early rectal cancer. A multi-centred, partially randomised patient preference trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancers.

This study has been transitioned to CTIS with ID 2024-517410-15-01 check the CTIS register for the current data. The aim of this study is to determine the oncological safety, treatment related morbidity, and the functional outcome of local excision…

Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer

The main objective is to compare overall survival of an active surveillance approach to that of standard surgery for patients with either squamous cell- or adenocarcinoma of the oesophagus or oesophago-gastric junction

A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer*s Disease Dementia (The DAYBREAK Study)

To test the hypothesis that LY3314814, administered orally at doses of 20 and 50 mg daily for 78 weeks, will slow the decline of AD ascompared with placebo in patients with mild AD dementia.

INTense Exercise foR surVivAL among men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL - MCRPC): A Multicentre, Randomised, Controlled, Phase III Study

Primary Objective is to determine if high intensity aerobic and resistance training plus psychosocial support increases overall survival compared to psychosocial support alone in patients with metastatic castrate-resistant prostate cancer.

A Phase III, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period to evaluate the safety and efficacy of LCI699 for the treatment of patients with Cushing*s disease

To assess the efficacy and safety of LCI699 in CD patients

A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

This study has been transitioned to CTIS with ID 2023-508606-26-00 check the CTIS register for the current data. Primary Objective:The primary objective is to compare the radiographic progression-free survival (rPFS) ofapalutamide in combination…

COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older.

Objectives for the Randomized Observe-Blinded Phase:Primary Objectives:Primary Efficacy Objective• To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any…

A multiple ascending dose (MAD) safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in normal healthy volunteers (NHVs) and subjects with thyroid eye disease (TED)

This study has been transitioned to CTIS with ID 2024-512244-36-00 check the CTIS register for the current data. The objectives of this are to establish the safety, tolerability, and efficacy of VRDN-001, and the pharmacokinetic (PK) and…

A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis patients with Fused in Sarcoma mutations (FUS-ALS)

This study has been transitioned to CTIS with ID 2024-512163-31-00 check the CTIS register for the current data. Primary objective: To evaluate the clinical efficacy of ION363 in clinical functioning and survival in FUS-ALS patients. Secondary…

A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS)

This study has been transitioned to CTIS with ID 2023-509137-39-00 check the CTIS register for the current data. Primary/dualco-primary. To prospectively investigate whether adjuvant treatment with pembrolizumab after completion of radical surgery (…

A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant
Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post-
Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-
Invasive Bladder Cancer

This study has been transitioned to CTIS with ID 2024-512158-12-00 check the CTIS register for the current data. Primary Objectives: - To compare the pCR rate of neoadjuvant nivolumab/BMS-986205 + GC to neoadjuvant GC alone in all randomized…

A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Ambulatory and Non-Ambulatory Participants with Spinal Muscular Atrophy with Open-Label Extension (RESILIENT)

This study has been transitioned to CTIS with ID 2024-511852-42-00 check the CTIS register for the current data. Primary Objective:To evaluate the efficacy of taldefgrobep alfa in participants who are already taking a stable dose of nusinersen or…

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to
Evaluate the Efficacy and Safety of Mitapivat in Pediatric Subjects With Pyruvate Kinase
Deficiency Who Are Regularly Transfused, Followed by a 5-Year Open-label Extension Period

This study has been transitioned to CTIS with ID 2024-515024-37-00 check the CTIS register for the current data. To determine the efficacy of treatment with mitapivat compared with placebo, as assessed by the reduction in transfusion burden in…

A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of
Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of
Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a
Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

This study has been transitioned to CTIS with ID 2022-501677-39-00 check the CTIS register for the current data. Evaluation of patient and functional graft survival of adolescent renal allograft recipients converted from CNI to belatacept-based…

Hyperbaric Oxygen Therapy for Pyoderma gangrenosum As a New Treatment Strategy

To investigate the therapeutic efficacy and feasibility of hyperbaric oxygen (HBO) in addition to standard wound care in patients with pyoderma gangrenosum wounds.

International cooperative Phase III trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children and adolescents < 18 years.

Primary objective:-To confirm that the Event-Free Survival (EFS) in patients &gt;= 3 years of age with WHO grade IV/CNS WHO grade 4 and WHO grade III/CNS WHOgrade 3 diffuse high grade gliomas as well as diffuse high grade gliomas without a…

Chronification Of migraine and Pain Experience

The main objectives of this study are: A) to evaluate the differences between chronic migraine patients, episodic migraine patients an healthy controls with respect to i) pain inhibition, ii) sensory profile and iii) corneal nerve fiber parameters;…

Low INR to Minimize bleeding with mechanical valves Trial

The objective in the vanguard phase of the LIMIT trial is to assess the feasibility of recruiting 400 subjects over approximately 3 years at 5 centres. The objectives in the full trial are to evaluate the safety and efficacy of a common, lower INR…