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Hyperbaric Oxygen Therapy Induced Neuroplasticity in Post Stroke Patients Suffering Chronic Neurological Deficiencies

Effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficiency due to stroke.

A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 >=50%

The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet…

Safety and Efficacy of turoctocog alfa pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients with Severe Haemophilia A

Primary objective:To investigate the safety of turoctocog alfa pegol during continuous use for prevention and treatment of bleeding episodes of previously turoctocog alfa pegol treated severe haemophilia A patients.Secondary objectives:To…

BioXmark liquid fiducial markers for image guided radiotherapy in bladder cancer, a safety and performance trial

This study will evaluate usability, safety and performance of a cystoscopic guided injection of a marker (BioXmark) at the tumor site in patients with bladder cancer on planning CT and CBCT during the irradiation period.

Improving propulsion of the paretic leg in chronic stroke

The purpose of this study was to demonstrate that the PP can be improved in chronic stroke survivors using a newly developed, intensive training. The effect of the new training on the PP, walking velocity and mobility at home will be determined.…

A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX

1.3. Study Design Rationale The ATLAS-INH trial (ALN-AT3SC-003) is a multicenter, multinational, randomized, openlabel Phase 3 study designed to demonstrate the efficacy and safety of fitusiran in patients with haemophilia A or B with inhibitory…

A 24-week randomized, controlled, multicenter, open-label study to evaluate the effect of reminder notifications and motivational/adaptive messaging on treatment adherence of COPD
subjects receiving Ultibro® Breezhaler® treatment using the Concept2 inhaler for dose administration and tracking

This study will evaluate the effect of dose tracking in conjunction with reminder notificationsand motivational/adaptive messages over 24 weeks on treatment adherence behavior insubjects with COPD. The dose tracking is done by the Concept2 inhaler…

An open-label randomised cross-over study to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes

The main objective of the study is to determine the albuminuria lowering effect of the GLP1-RA exenetide, SGLT-2 inhibitor dapagliflozin and their combination in patients with type 2 diabetes and micro- or macroalbuminuria.Secondary objectives are…

A multicenter, randomized, open label, efficacy assessor-blinded study of risankizumab compared to secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systematic therapy.

The objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Rinsing of contaminated postoperative oncological wounds with tap water or an antiseptic agent * a randomized controlled clinical trial

Determine whether there is a difference in the reduction of bacterial contamination between tap water and antiseptic agent (AdvaCyn) of contaminated postoperative oncological wounds.By using the Visual Analogue Score (VAS score), to measure the…

A Phase III, randomized, multicenter, parallel-group,
non-inferiority study evaluating the efficacy, safety, and
tolerability of switching to dolutegravir plus lamivudine in
HIV-1 infected adults who are virologically suppressed

PrimaryTo demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, ART therapy (ART)-experienced, virologically suppressed subjectsSecondary- To demonstrate…

Efficacy of a predefined vitamin D dosing regimen in vitamin D-insufficient multiple myeloma patients.

The primary objective of this study is to determine the efficacy of a predefined vitamin D dosing regimen on the prevalence of vitamin D insufficiency in MM patients. Secondary objectives are to detect the influence of several variables (age, gender…

Does outpatient advance care planning by the Palliative Advice and Consultation Team (PACT) lead to cost-saving and patient-oriented care?

The goal is to gain more clarity in the wishes of the patient and family members by means of Advance Care Planning with the help of an early outpatiënt consultation of the PACT. This is hoped to show the intervention leads to a reduced number of…

Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children

Specific Aim #1: To evaluate the efficacy and safety of shortened-duration (6 weeks total) versus conventional duration (3 months total) anticoagulation for first-episode, provoked, acute venous thrombosis among children in whom thrombus resolution/…

A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX

The ATLAS-A/B trial (ALN-AT3SC-004) is a multicenter, multinational, randomized, openlabel Phase 3 study designed to demonstrate the efficacy and safety of fitusiran in patients with hemophilia A or B without inhibitory antibodies to FVIII or FIX…

ATLAS-PPX trial: an open-label, multinational, switching study to describe the efficacy and safety of fitusiran prophylaxis in patients with hemophilia A and B with inhibitory antibodies to factor VIII or IX previously receiving bypassing agent prophylaxis.

1.3. Study Design Rationale The ATLAS-PPX trial (ALN-AT3SC-009) is a multicenter, multinational, open-label Phase 3 switching study designed to demonstrate the efficacy and safety of fitusiran in patients with hemophilia A or B, with inhibitory…

A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab Versus Standard of Care Platinum-Based Chemotherapy as First Line Treatment in Patients with PD-L1-High Expression Advanced Non Small-Cell Lung Cancer (NSCLC)

To assess the efficacy of Durvalumab monotherapy compared to SoC in terms of OS in patients with PD-L1 high expression (*25%) advanced NSCLC with wild type EGFR and ALK

A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

The primary objectives of this study are to establish the efficacy and safety of APL-2 compared to eculizumab in patients with PNH who continue to have Hb levels <10.5 g/dL despite treatment with eculizumab.

A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE Extension)

This study has been transitioned to CTIS with ID 2023-509305-68-00 check the CTIS register for the current data. To evaluate the long-term safety and tolerability of ralinepag (ADP811) in subjects who participated in a preceding Phase 2 or Phase 3…

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU 285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…