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A multi-site randomized controlled trial comparing Schema Therapy and Dialectical Behavior Therapy for borderline personality disorder: A framework for the study of (differential) change processes and the empirical search for treatment selection criteria

The aim of the present study is to optimize treatment selection by examining patient characteristics that predict (differential) treatment response across DBT and ST. These characteristics will be investigated and converted to actuarial formulas (…

Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study
of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in
Men with Metastatic Castration-resistant Prostate Cancer.

This study has been transitioned to CTIS with ID 2024-511144-86-00 check the CTIS register for the current data. Primary objective: To determine the efficacy of the combination of olaparib and abiraterone vs placebo and abiraterone by assessment of…

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

This study has been transitioned to CTIS with ID 2022-501251-81-00 check the CTIS register for the current data. To compare disease free and overall survival of RCC patients, after adjuvant treatment with pembrolizumab after surgical renal resection…

A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

This study has been transitioned to CTIS with ID 2023-510015-19-00 check the CTIS register for the current data. The treatment options currently available for MIBC- patients remain limited, current standard therapy is likely to result in modest…

Intralesional steroid injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled trial

This study has been transitioned to CTIS with ID 2023-504905-36-00 check the CTIS register for the current data. The primary objective is to find out whether ISI in children with EA can prevent refractory strictures from developing and consequently…

A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab

Primary:• To evaluate PK noninferiority of ravulizumab SC versus ravulizumab IV in adult patients with PNH Secondary• To characterize PK of ravulizumab SC• To characterize PD of ravulizumab SC• To characterize immunogenicity of ravulizumab SC• To…

A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease

This study has been transitioned to CTIS with ID 2023-504736-18-00 check the CTIS register for the current data. Primary Objectives (Phase 2 and Phase 3):- To evaluate the clinical efficacy of guselkumab in participants with Crohn*s disease- To…

A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) with VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

This study has been transitioned to CTIS with ID 2023-507312-13-00 check the CTIS register for the current data. Primary ObjectiveThe primary objective is to determine if the addition of daratumumab to VELCADE (bortezomib),Revlimid (lenalidomide),…

A Phase 3, Open -label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin alfa for the Treatment of Anemia due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Naïve Subjects who require Red Blood Cell Transfusions.

This study has been transitioned to CTIS with ID 2022-501485-22-00 check the CTIS register for the current data. Primary objective:• To evaluate the efficacy of luspatercept on RBC transfusion independence (RBC-TI for 12 weeks [84 days] with an…

CeRebrUm and CardIac protection with Allopurinol in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass

This study has been transitioned to CTIS with ID 2024-513041-37-00 check the CTIS register for the current data. Primary objective of this study is to significantly reduce relevant (moderate/severe) parenchymatous brain injury on postoperative MRI…

A phase III randomized, open-label, multi-centre, global study of Durvalumab and Bacillus Calmette-Guerin (BCG) administered as combination therapy versus BCG alone in high-risk, BCG-naive non-muscle-invasive bladder cancer patients

This study has been transitioned to CTIS with ID 2023-505341-23-00 check the CTIS register for the current data. To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance)…

SUSTRENIM - GIMEMA CML1415 / HOVON 142 CML

This study has been transitioned to CTIS with ID 2023-510434-83-00 check the CTIS register for the current data. The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in…

A RANDOMIZED, DOUBLE-BLIND, PHASE 3 COMPARISON OF PLATINUM-BASED THERAPY WITH TSR 042 AND NIRAPARIB VERSUS STANDARD OF CARE PLATINUM-BASED THERAPY AS FIRST LINE TREATMENT OF STAGE III OR IV NONMUCINOUS EPITHELIAL OVARIAN CANCER

This study has been transitioned to CTIS with ID 2024-510605-28-00 check the CTIS register for the current data. Primary Objective• To compare the progression free survival (PFS) of programmed death-ligand 1 (PD-L1) positive patients with Stage III…

A Study Evaluating the Efficacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH Patients

This study has been transitioned to CTIS with ID 2023-509304-16-00 check the CTIS register for the current data. To demonstrate the effect of ralinepag on the time to first adjudicated protocol-defined clinical worsening event in subjects with PAH.

A Randomized, Open-label, Phase 3 study of the Combination of Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab for the First-line Treatment of Subjects with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

This study has been transitioned to CTIS with ID 2023-503469-49-00 check the CTIS register for the current data. Primary ObjectiveThe primary objective of the study is to assess progression-free survival (PFS) from treatment with ibrutinib plus…

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy

This study has been transitioned to CTIS with ID 2023-509602-29-00 check the CTIS register for the current data. Primary objectives:- To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS- To assess the efficacy of…

A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations eligible for intensive chemotherapy

This study has been transitioned to CTIS with ID 2022-502478-18-00 check the CTIS register for the current data. To compare OS between gilteritinib and midostaurin in combination with induction therapy and consolidation therapy followed by one-year…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

This study has been transitioned to CTIS with ID 2023-506994-36-00 check the CTIS register for the current data. Study M16-066 comprises three sub-studies:Sub-study 1: Randomized, double-blind, placebo-controlled maintenanceTo evaluate the efficacy…

A Phase 2/3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone with or without Abemaciclib in Patients with Metastatic Castration-Resistant Prostate Cancer

This study has been transitioned to CTIS with ID 2023-506777-36-00 check the CTIS register for the current data. Main objective:Part 1: To determine the RP2D of abemaciclib that may be safely administered to patients with mCRPC in combination with…

The ENDURRANCE-1 Study. ;Exploring durable remission with rituximab in ANCA associated vasculitis

This study has been transitioned to CTIS with ID 2023-507868-39-00 check the CTIS register for the current data. In this randomized study the primary objective is to demonstrate a clinical significant reduction of RTX retreatments in AAV patients…