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Biodegradable polyurethane foam modified with 55% polyethyleneglycol as a local hemostatic agent, a pilot study.

Goal of this study is to asses the feasibility of polyurethane foam as a local hemostatic agents in sockets after dental extraction. The assessment will take place in a small number of patients. After the pilot study, a large study will be…

The effect of betahistine 48 mg three times daily on motion sickness

To assess the effect of betahistine on the severity / intensity of motion sickness

HARP-trial: *Hand-Assisted RetroPeritoneoscopic live donor nephrectomy versus standard laparoscopic living donor nephrectomy*

To determine the best approach for live donor nephrectomy to optimise donor*s safety and comfort while reducing donation related costs.

Ischemic damage control in live kidney donation

1. The objective of this pilot study is to investigate if 72 hours 30% calorie restriction + 24 hours of pre-operative fasting has a beneficial effect on post-operative recovery. 2. The perioperative cytokine response in fasting and non-fasting…

Infusion of mesenchymal stem cells as treatment for steroid resistant grade II to IV acute GVHD or poor graft function: a multicenter phase II study

This is a mulricenter phase II study examining the feasability and efficacy of this approach. Subjects will receive by intraveneus infusion a dose of MSC (aiming for 2 x 106/kg or highest avialable dose)

A Phase 1b/2 Study of AMG 655 in Combination With Doxorubiicn for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma

Part 1 (phase 1b): to identify a dose of AMG 655 in combination with doxorubicin that is safe and tolerated as determined by the incidence of dose limiting toxicity Part 2 (phase2): To estimate the efficacy, as measured by progression-free survival…

A Ranomized, Double Blinded, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination with AMG 386 or Placebo in Subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma

To estimate the treatment effect as measured by progression free survival(PFS) of subjects receiving AMG 386 (at 2 doses) in combination with cisplatin + capecitabinerelative to cisplatin + capecitabine + placebo

A Phase I Study of Oral Topotecan in Subjects with Cancer and
Impaired Renal Function

Primary• To determine the safety profile of oral topotecan in subjects with cancer andmildly moderately or severely impaired renal function (Groups C, D and E) compared to subjects with cancerwhose renal function is normal and who have received…

A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate

The objectives of this study are as follows:Primary Efficacy Objective:• To assess the effect of PG-760564 on the proportion of patients meeting the American College of Rheumatology 20 response criteria (ACR 20) at 12 weeks;11Secondary Efficacy…

A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic;Pharmacogenetics Blood Sample Amendment Number 01

The objective of this study is to determine how well two different doses of ipilimumab work in patients with prostate cancer who are no longer responding to hormone therapy (castration resistant), and whom have the best radiographic progression-…

Protein intake, gastro-Intestinal tolerance and safety after administration of a new high protein tube feed in critically ill overweight ICU patients as compared to an isocaloric standard tube feed.

As meeting protein requirements seems to be very important in critically ill patients, the primary objective of the current study is to investigate protein intake with the new tube feed.

Renal Nerves Stimulation Study

Main objectives are twofold: 1) To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities.2) To…

A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma

The primary objective is to compare the overall survival (OS) between the 2 treatment arms (tremelimumab and placebo) in subjects with unresectable malignant mesothelioma.Secondary objectives are:- to estimate and compare OS rate at 18 months…

Multi-center, randomized, comparator-controlled, single-blind, parallel-group study to
investigate the pharmacodynamics, pharmacokinetics and safety of an intrauterine
system releasing BAY 1007626, as compared with Mirena and Jaydess, in a combined
proof-of-concept and dose-finding study in healthy pre-menopausal women treated for
90 days

The primary objective of this study is to investigate local and systemic effects of BAY 1007626 on:- Number of bleeding and spotting days,- Endometrial histology,- Ovulation (as surrogate for systemic effects).The secondary objective of this study…

Nociceptive-Level (NoL)-guided analgesia versus standard practice during general remifentanil/propofol anesthesia in ASA 1-3 patients

To guide the analgesic component of anesthesia using the Nociceptive Level (NoL) index in ASA 1-3 patients under general anesthesia for elective abdominal surgery.

A Randomized, double blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CNP520 in healthy elderly subjects

Primary objective:To determine the safety and tolerability of multiple, once-daily oral doses of CNP520 over 13 weeks in healthy elderly subjectsSafety: ECG, vital signs and laboratory data; assessment of cognitive function; dermatological…

A double-blind, randomized, placebo-controlled, single-center, two-way cross-over study with KH176 in patients with the mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation and clinical signs of mitochondrial disease

Objectives: Primary Objective1. To evaluate the effect of KH176 on gait (Gaitrite®) parameters: step-length and variability in step-time and step-width in patients with a m.3243A>G mutationSecondary Objectives2. To explore the effect of KH176…

*Perception of Emotional Expressions in a different Social Contexts
Allows People to Infer Each Other Preferences*

Primary objective We investigate whether observers* inferring accuracy differs when the consumer is in the presence of a friend compared to being completely alone. We test whether observers* brain activations during inferring observation differ…

weak magnetic fields against pain in fibromyalgia

We aim to study the effects of PEMF on pain in fibromyalgia.

The role of online self-motivation to promote adherence to online interventions for depression and anxiety: a pilot study

The current pilot study aims to examine the feasibility of the module when added to an existing problem-solving intervention, *Alles onder Controle*, for reducing symptoms of anxiety and depression. Additionally, we aim to get first insight in…