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A placebo-controlled double blind randomized trial to investigate the efficacy and safety of the combination of Penicillin G / Hydrocortisone treatment in ALS patients (PHALS).

The objective is to compare the efficacy and safety of intravenous high-dose penicillin G and hydrocortisone versus placebo in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).

Prevention of rheumatoid arthritis by atorvastatin in seropositive arthralgia patients: a multi-center doubleblind randomized placebo-controlled trial

To investigate whether statin treatment can prevent or delay the development of RA in persons at increased risk of RA.

The DANCE study: Duration of ANtibiotic therapy for CEllulitis

To determine if 6 days of antibiotics has equal efficacy compared to 12 days for patients hospitalized with cellulitis.

A phase 2, double-blind, randomized, placebo-controlled pharmacokinetic trial in two parallel groups to investigate possible drug- drug interactions between stiripentol or valproate and GWP42003-P in patients with epilepsy.

Primary Objective: To determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective: To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.To assess…

Biobanking of testicular biopsies from azoospermic men undergoing testicular sperm extraction (TESE)

Biobanking of a testis biopsy from men with azoospermia who undergo a TESE procedure to allow investigation for understanding the etiology of male infertility, research about normal and aberrant male gamete formation in its natural environment of…

Combination of salvage surgery and adjuvant photodynamic therapy in management of recurrent or residual sinonasal tumors.

The main objective of this study is to develop a PDT and salvage surgery combination specific for recurrent or residual tumors of the sinonasal cavities, unsuitable for the conventional treatments like radical surgery or radiotherapy with curative…

The MPAC-study: validating craniocaudal tumor extension on MRI with histoPAthology in patients with Cervical cancer

To validate MRI for assessing craniocaudal tumor extension with histopathology using non-rigid egistration. In addition to 3 Tesla magnetic resonance T2-weighted imaging, diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE) imaging…

Radiotherapy of the head without the need of a thermoplastic mask, a clinical feasibility study.

To prove the clinical feasibility of palliative whole brain radiotherapy without using a thermoplastic mask. Clinical feasibility in this study is defined when more than 70% of the patients can complete the radiation treatment without a mask. We…

Clinical pharmacokinetics of intravenous docetaxel in patients with castration-resistant
prostate cancer and non-castration-resistant prostate cancer

To determine the exposure and clearance of intravenous docetaxel in patients with castration-resistant prostate cancer and non-castration-resistant prostate cancer. All samples will be measured with a validated LC-MS/MS method

Compromised mandibular function in Juvenile Idiopathic Arthritis: intervention

To contrast jaw exercises and corticosteroid injection via arthrocentesis in children with JIA and MRI confirmed TMJ arthritis despite 1 year regular treatment by the rheumatologist, in a randomized clinical trial, both in combination with continued…

Language representation in children with 22q11 deletion syndrome and children with Specific Language Impairment

The main objective of this study is to determine the language representation in the brain of children with SLI and 22q11DS.

An exploration of intestinal bacterial biofilms in Lynch syndrome patients as disease markers for colorectal cancer

Lynch-related tumors mostly develop in the ascending right side of the colon (70-85%). Strikingly, it was recently discovered that dense bacterial biofilms and invasive bacteria occur in the colonic mucosa of 87% of right-sided colorectal cancer (…

Effects of CPAP on the underlying mechanisms of sleep apnea

The hypothesis is that using CPAP decreases the severity of the underlying mechanisms in sleep apnea patients.

Image guided endoscopic sinus surgery

Intraoperative verification of paranasal sinus malignancy resection with cone-beam computed tomography will lead to a higher rate of radical resection

A single arm multicenter biomarker study determining the response to taxane-based chemotherapy in metastatic breast cancer (MBC) patients with ESR1 mutations in cell-free DNA: TAX-ESR1 study.

The primary objective of this study is to assess the outcome of taxane- based chemotherapy in ER-positive MBC HER2-negative patients with progression after receiving endocrine therapy (with at least an AI) who have an ESR1 mutation measured in…

An open-label, Phase I study to assess the effect of itraconazole (CYP3A4 and P-gp inhibitor) on the pharmacokinetics of anetumab ravtansine and to assess the ECG effects, safety and immunogenicity of anetumab ravtansine given as a single agent and together with itraconazole in subjects with mesothelin-expressing advanced solid cancers.

Main objective: - Evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor and a P-glycoprotein (P-gp) inhibitor, on the safety and tolerability (including "thorough" electrocardiogram [ECG] assessment) and…

Explorative trial to identify the impact of denosumab on the systemic immunity and local immunologic microenvironment in postmenopausal patients with HER2 negative breast cancer.

Primary objective• Determine the change in intratumoral T-cell (CD4, CD8 and Treg) and Myeloid cell (M1/M2 Macrophage, MDSC, DC) numbers and function between the baseline biopsy and the surgical specimen.Secondary objectives• PBMC before start…

A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of GemRIS 225 mg in Subjects with Muscle-Invasive Transitional Cell Carcinoma of the Bladder

- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 7 days per dosing cycle - Evaluate the pharmacokinetics of gemcitabine and 2',2'-difluorodeoxyuridine (dFdU, a gemcitabine-related metabolite) exposure in…

A Phase II, multicentre, double-blind, randomised, placebo-controlled study
of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn*s disease recurrence
(STOP-Postoperative Endoscopic Recurrence Study)

Primary objective:To demonstrate the efficacy of Rifaximin -EIR 400 mg Tablet (800mg /BID, total daily dose 1600 mg) versus placebo in the prevention of endoscopic Crohn*s disease recurrence following ileocolonic resection

Phase II study of preliminary diagnostic performance of [68Ga]-NeoBOMB1 in adult patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor

Primary Objective• To characterize preliminary targeting properties of [68Ga]-NeoBOMB1 in patients with malignancies known to overexpress GRPR.Secondary objectives• To assess safety and tolerability of a single diagnostic dose of [68Ga]-NeoBOMB1…