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EXPOSOMICS - Enhanced exposure assessment and OMIC profiling for high priority environmental exposures in Europe.

The primary objective is to improve prediction of individual disease risk related to air pollution, by characterizing the internal and external exposome related to air pollution in Europe. The specific research questions are:1. Can novel biomarkers…

Validation of *in vitro counterpart* models to enable personalized care in CF

The specific objectives are:1. What is the difference of in vitro CFTR function in CF patients with either mild (compound heterozygote A455E) mutations or severe (homozygote F508del) mutations with mild or severe clinical disease? 2. What is the…

Six-Month Clinical and Angiographic Follow up of Everolimus eluting bioresorbable vascular scaffold in patients presenting with ST-segment elevation myocardial infarction

The primary objective of the present study is the evaluation of the vascular healing process in patients previously treated with BVS implantation for ST-segment elevation myocardial infarction (STEMI). The healing process will be assessed evaluating…

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant

The primary objectives of this study are:•To explore the antiviral efficacy of combination therapy with SOF/LDV FDC + RBV for12 or 24 weeks in subjects with advanced liver disease (either pre-liver transplant or notcurrently wait-listed) and post-…

Study of Safety, Tolerability, and Pharmacokinetics of BG00010 (Neublastin) Intravenous and Subcutaneous Single Ascending Doses in Healthy Volunteers, and Subcutaneous Multiple Ascending Doses in Subjects with Painful Lumbar Radiculopathy

The primary objective of the study is to evaluate the safety and tolerability of a range of single IV and SC doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in subjects with painful lumbar radiculopathy.Secondary…

A Multi-Centre, Randomised, Double Blind, Placebo Controlled, Parallel Group Study of TA 8995 in Patients with Mild Dyslipidaemia, Alone and In Combination with Statin Therapy

The primary objective of this study is to evaluate the efficacy of different doses of TA 8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high density lipoprotein cholesterol (HDL C) and reduction of low density…

The association between coronary atherosclerosis and periodontitis: A clinical study

The aim of this study is to determine whether the presence and the extent of periodontitis are independently related to the presence and extent of coronary calcification.To determine if periodontal treatment has an positive effect on the…

Walking the Isobole of drug Interaction: Comparison of hemodynamic effects, cerebral and tissue oxygenation for 4 equipotent combinations of propofol and remifentanil

To investigate the effects of the different combinations of propofol and remifentanil on the isobole of TOL90 and to compare hemodynamics, cerebral and tissue oxygenation for each equipotent combination. To describe the combination of propofol and…

An exploratory, open-label, single centre, phase II, proof of concept study of gevokizumab treatment in patients with Schnitzler syndrome.

The objective of this study is to explore the efficacy and safety of gevokizumab in patients with Schnitzler syndrome.

Exploratory open label study to investigate the effect of teriflunomide on immune cell subsets in the blood of patients with relapsing forms of multiple sclerosis

Primary:- To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects.Secondary:- To assess…

Randomised controlled study comparing AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent or metastatic endometrial cancer

1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…

TELEHYPE TELEmonitoring and self-management of uncontrolled HYPErtension

To assess the one-year (cost)effectiveness of telemonitoring of blood pressure and self-management support via an internet-based service in addition to usual care as compared to usual care alone in a pragmatic trial in patients with uncontrolled…

RCT comparing insertion of levonorgestrel releasing intrauterine system (Mirena) during the menstruation compared with random insertion beyond menstruations in patient-perceived pain.

In this randomized study, timing during (day 1-7 of the menstruation cycle WITH vaginal blood loss) or beyond menstruation (in menstruation cycle day 8 and further WITHOUT vaginal blood loss) will be compared regarding differences in patient-…

Pelvic floor therapy in the treatment of all anal fissures; a multicentre, randomized controlled trial

To assess the potential benefit of pelvic floor therapy for anal fissure. Measured primarily in pain, measured by the VAS score. Secondary outcomes are healing rates and recurrence.

A Randomised, Open-label, Three-part, Phase I Study to Determine the
Effect of Food on the Pharmacokinetics of Olaparib and to Provide Data on
the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet
Formulation in Patients with Advanced Solid Tumours

The primary objective of this study is to investigate the effect of food on the pharmacokinetics(PK) of olaparib following oral dosing of the tablet formulation in patients with advancedsolid tumours.The secondary objectives are to investigate the…

A phase 1, open-label multicenter, 3-period, fixed-sequence study to investigate the effect of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in patients with BRAFV600 mutation positive metastatic malignancy

The primary objective of this study is to evaluate the effect of multiple oral doses of vemurafenib (960 mg BID) on the PK of a single oral dose of acenocoumarol (4 mg).The secondary objective of this study is to assess the safety and tolerability…

An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study of the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients with Advanced Solid Tumours and Normal Renal Function or Renal Impairment.

-The primary objective of this study is to investigate the pharmacokinetics of olaparib after a single oral dose of 300 mg to patients with advanced solid tumours and mild or moderate renal impairment compared to those with normal renal function.-…

A Phase 1, Open Label, Exploratory Study for the Intra-operative Imaging of Folate Receptor Alpha Positive Ovarian, Lung, Breast Cancer and Parathyroid adenomas using the Tumor Specific Imaging Agent EC17

To assess the safety of a single dose of intravenous EC17 injection in patients with ovarian, lung, breast cancer and parathyroid adenomas. To assess concordance of fluorescent signal and tumor status of resected tissue, in the case of ovarian, lung…

Neural correlates of healthy food viewing and food choice in tweens and their parents

To determine the differences in brain activation during (un)healthy food choice between normal weight and overweight groups of children (10-13 y) and their parents and relate those to subject characteristics.

A phase 1, double blind (3rd party open), randomized, placebo controlled, crossover single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06372865 in healthy subjects

The objective of the first two cohorts of this study is to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06372865 after a single dose across a wide exposure range up to the maximum tolerated dose or the maximum…