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Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 study

To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…

A randomized study with cisplatinum concomitant with standard or adaptive high dose radiotherapy for advanced head and neck cancer.

The most important questions of this phase III trial is:Can adaptive high dose radiotherapy improve loco-regional control without increase of toxicity?

The added value of couple-based interventions compared to individual treatment for patients with personality disorder and their partners

Studies examining the effect of couple therapy or couple-based interventions in treatment for personality disorder are very scarce and more research is required. Therefore, the present study examines the effect of couple-based interventions in…

A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or…

Clinical evaluation of the efficacy of methylnaltrexone in resolving constipation induced by different opioid subtypes combined with laboratory analysis of immunomodulatory and antiangiogenic effects of methylnaltrexone

To compare the efficacy of a fixed dose of SC methylnaltrexone to induce laxation in patients receiving palliative care with constipation due to either fentanyl, oxycodone or morphine sulphate (opioids with different mechanisms of action). Secondary…

Hysteropexy in treatment of uterine prolapse stage >= 2: laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy (LAVA-trial)

To investigate the hypothesis that women with uterine prolapse stage 2 or more treated by laparoscopic sacrohysteropexy will have equal or lower recurrence rate of prolapse compared to women treated by vaginal sacrospinous hysteropexy.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects with Prodromal to Moderate Frontotemporal Dementia with Granulin Mutation

2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…

Effects of oral corticosteroids and DMSO on inflammatory signs and symptoms in Complex Regional Pain Syndrome type 1

In this trial we will study if treatment with oral corticosteroids or DMSO is effective in decreasing signs and symptoms of CRPS-1. Tolerance of the treatment options and effects on different subtypes of CRPS-1 patients will be evaluated as well.

A phase II study of Vorinostat in patients with Polycythaemia Vera and Essential Thrombocythaemia

1. To evaluate efficacy of vorinostat in the treatment of patients with polycythaemia vera (PV) and essential thrombocythaemia (ET) 2. To evaluate if vorinostat as monotherapy of patients with PV and ET is followed by a decline in clonal…

A phase II study of sorafenib and metformin in patients with locally advanced and/or metastatic non-smal cell lung cancer (NSCLC) with a K-Ras mutation

To assess the efficacy of combined treatment with sorafenib and metformin.

Releasing the brakes on CD8+ T cells in the melanoma sentinel lymph node by pre-operative local administration of low-dose anti-CTLA-4 (tremelimumab)

1) To determine clinical safety and tolerability of local i.d. administration of a single dose of tremelimumab in clinical stage II melanoma patients scheduled to undergo a SLN procedure. 2) To ascertain the immunological effects of local i.d.…

Targeted therapy selection based on tumor tissue kinase activity profiles for patients with advanced solid malignancies, an exploratory study

To select targeted treatment based on ex vivo kinase activity inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer for whom no standard treatment is available.

Effect of Carbon Dioxide Enriched Ambient Air on Pharmacokinetics and Deposition In Bronchiectasis Patients Using Tobramycin Inhalation: A proof of concept study.

1. To asses (with planar imaging) whether SPECT/CT scan are feasible in assessing pulmonary deposition of inhaled tobramycin.2. To evaluate the effect of CO2 enriched ambient air on deposition of inhaled tobramycin in bronchiectasis patients.3. To…

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).

A phase 2, single arm, multi center trial evaluating the efficacy of the combination of sirolimus and cyclophosphamide in metastatic or unresectable myxoid liposarcoma and chondrosarcoma.

- To evaluate the treatment efficiency by time to progression according to RECIST 1.1

Phase 2 Study Comparing Pembrolizumab with Intermittent/Short-term Dual MAPK Pathway Inhibition Plus Pembrolizumab in patients harboring the BRAFV600 mutation (IMPemBra)

Primary objectives: To explore the safety, feasibility, and the immune-activating capacity of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapySecondary…

Joint distraction in the treatment of haemophilic ankle arthropathy: clinical and structural efficacy, a pilot study

This study is designed to gather prospective data on a) the clinical effectiveness, b) the tissue structure changes, and c) the short term costs of ankle joint distraction (AJD) in 10 patients with HAA during 10 years follow-up.

Immune intervention with tolerogenic dendritic cells in type 1 diabetes. A phase 1 safety study called D-sense

Primary objectives- To evaluate the feasibility of leukapheresis and the production of human clinical-grade proinsulin-peptideC19-A3-pulsed TolDCs (PIpepTolDCs) in type 1 Diabetes Mellitus patients.- To evaluate the safety of clinical use of…

Young adult Prader-Willi (YAP) Syndrome Study: Effects of growth hormone after final height: A clinical care to the optimal dosage of growth hormone in young adults with PWS.

To evaluate the effects of GH, after final height is reached, on weight, body composition, psychosocial functioning, carbohydrate metabolism and serum lipids. To find an optimal dose growth hormone for adults with PWS. We aimed to stabilize the body…

Drug-COated Balloon Coronary Angioplasty versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion - The Co-CTO Trial.

The aim of the study is to investigate the value of DCB treatment in the residual disease of the coronary artery after successful recanalization and stenting of the actual CTO body as compared with complete stenting in a randomized fashion.