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A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…

TropicALL study; Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with
Low-molecular-weight heparin: a randomized controlled trial

Main objective:To assess the efficacy of thromboprophylaxis with high prophylactic dose LMWH as compared with standard care without systemic thromboprophylaxis in children treated for primary ALL during asparaginase treatment.Secondary objectives:1…

Phase III Randomized Double-Blind Trial of Bepanthen® Cream Versus Cetomacrogol Cream in the Prevention of Papulopustular eruption in Patients Receiving Epidermal Growth Factor Receptor Inhibitors (EGFRI): BeCet

To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific >= grade 2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and the adherence during the 6-week skin treatment period…

A Randomized, Double-Blinded, Controlled with GARDASIL® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old men.

This study is designed to evaluate the immunogenicity and tolerability of V503 in young men, 16 to 26 years of age, in comparison to GARDASIL® in young men, 16 to 26 years of age. The safety and immunogenicity data will be used to bridge GARDASIL®…

LUX-Head & Neck 2;A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced head and neck squamous cell carcinoma

The objective is to investigate the efficacy and safety of afatinib over placebo when given as adjuvant therapy for patients with no evidence of disease after CRT in primary unresected patients with LA SCC stage III or IVa/b of the oral cavity,…

A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.

* To demonstrate efficacy of the candidate vaccine in the prevention of (1) persistent infection (6-month definition) with HPV-16 or HPV-18 (by polymerase chain reaction [PCR]) and/or (2) histopathologically-confirmed CIN1+ associated with HPV-16 or…

Prevention of radiation-induced parotid gland dysfunction by parotid-gland stem-cell sparing intensity-modulated radiotherapy (SCS-IMRT)

To investigate whether stem cell sparing radiotherapy results in a lower risk of dry-mouth syndrome than current standard treatment technique.

An open, multicentre, randomised, inter-individual comparative, prospective clinical trial with MD-3511356 versus standard sun protection measures in immunosuppressed outpatients after solid organ transplantations for the prevention of UV-induced infections and carcinogenic skin alterations

3. TRIAL OBJECTIVES AND PURPOSE3.1 Primary ObjectiveThe primary objective is the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immuno-suppressed…

Is early revaccination after ALL therapy feasible ?
Evaluation of loss of antibodies and responsiveness to (re-)vaccination in children after treatment for acute lymphocytic leukemia.

To determine effect of early (re) vaccinations after the current intensive chemotherapy for ALL. We will determine if there is a difference in respons to conjugated (T cell dependent) and polysaccharide (T cell independent) vaccines. This may result…

Self-reported influenza-like symptoms among elderly

Primary Objective: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported ILI.Secondary Objectives: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported LRTI.• To determine the incidence…

Prospective, randomized, pharmacological intervention study; evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan versus placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab

Primary objectives:1) To determine whether concurrent ATII-antagonist treatment can prevent trastuzumab-related cardiotoxicity, defined as a decline in LVEF of more than 15% or a decrease to an absolute value <45%Secondary objectives:1) To…

A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin (Pre-and Post Chemotherapy and Pre-Chemotherapy only) for Reduction in Severity of Oral Mucositis in Subjects with Multiple Myeloma (MM) Receiving High Dose Melphalan followed by Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)

The primary objective is to compare the efficacy of palifermin relative to placebo when given either pre-and post-high dose chemotherapy or pre-high dose chemotherapy only with regard to the severity of oral mucositis.

Ethanol lock solution for the prevention of tunnelled central venous catheter infections in paediatric oncology patients
A randomized controlled trial

To prove the efficacy and safety of ethanol lock solution in preventing catheter-related infections and subsequently venous thrombosis in children with a malignant disease who will have a tunnelled central venous catheter inserted.

DAVINCY trial: optimal Duration of (fos)aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in children: a double-blind placebo-controlled crossover randomized phase III trial*

This study has been transitioned to CTIS with ID 2024-517846-32-00 check the CTIS register for the current data. To evaluate the effect of prolonged duration of (fos)aprepitant prophylaxis on the prevention of delayed CINV (complete remission in the…

A Multicenter, Randomized, Double blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Basal Cell Nevus Syndrome

Primary Objective:To assess the number of new BCCs in the 2 arms (Patidegib Topical Gel, 2%, and Vehicle (placebo)) when applied twice daily to the face of subjects with Gorlin Syndrome.Secondary Objective:To assess the safety and tolerability of…

Adjuvant immunotherapy with anti-PD-1 monoclonal antibody Pembrolizumab (MK-3475) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group.

This study has been transitioned to CTIS with ID 2023-509136-25-00 check the CTIS register for the current data. To prospectively assess whether post-operative adjuvant therapy with pembrolizumab improves recurrence-free survival (RFS) as compared…

Cardiac changes after stereotactic radiotherapy for early stage NSCLC cancer or lung metastasis - HALO

We aim to optimize the radiation treatment of early stage lung cancer patients. Cardiac sparing is possible, but it comes at the cost of an increased mean lung dose. Without proof of cardiac toxicity, cardiac sparing will not be (routinely) applied…

PRophylactic cerebral Irradiation or active MAgnetic resonance imaging surveillance in small-cell Lung cancer patients

The primary objective is to show that brain MRI surveillance alone is non-inferior in terms of overall survival (OS) to brain MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC).

An open-label, randomized clinical trial on teicoplanin infection prophylaxis in pediatric patients with acute myeloid leukemia

This study has been transitioned to CTIS with ID 2023-506546-23-00 check the CTIS register for the current data. Objectives safety run-in: The primary objective is:• To assess the safety of i.v. teicoplanin prophylaxis three times per week with a…

Phase 3b Study for Management of Ocular Side Effects in Subjects with EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)

This exploratory study is designed to evaluate several depatuxizumab mafodotin-related OSE management strategies.The main objective of this trial is to estimate the percentage of subjects in each prophylactic treatment arm who require a change in…