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Proof-of-concept double-blind, placebo-controlled, randomized clinical trial with nilotinib in spondyloarthritis

To evaluate the efficacy and safety of nilotinib in spondyloarthritis

Clinical and pharmacological feasibility study with 2B3-101 in patients with breast cancer
and leptomeningeal metastases

Primary: To determine the response of 2B3-101 treatment as single agent or in combination with trastuzumab in patients with LM from breast cancer using the LM response scoreSecundary: - To determine the safety profile in patients with LM treated…

Dynamics of Androgen Receptor genomics and transcriptomics after neoadjuvant androgen ablation (DARANA)

1. To assess the effects of 3 months neoadjuvant androgen ablation with enzalutamide on the surgicial margin status of men with non-metastasized prostate cancer.2. To properly evaluate the effects of androgen ablation on gene expression, analyses of…

A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB-IV)

To assess the efficacy, measured as progression free survival, and safety of Selumetinib in combination with docetaxel, compared to docetaxel alone, in patients receiving second line treatment for KRAS mutation negative locally advanced or…

A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects with NUT Midline Carcinoma (NMC) and Other Cancers (BET115521)

Primary:To evaluate the clinical activity of GSK525762 in NUT Midline Carcinoma and other solid tumors.Secondary:Effect of treatment with GSK525762 on tumor growth and survival. Pharmacokinetics of GSK525762. Safety.

A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) (BEL114055)

Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.

A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection

The primary objective of this Registry is:*To evaluate the long term effects of Hepatitis B Virus (HBV) treatment of the parental study on the HBV serologic changes through Week 144 The secondary objective of this Registry is :*To evaluate the long…

The effect of Telmisartan on inflammatory processes in the vascular wall of abdominal aortic aneurysms.

In this study we would like to study the effects of the selective angiotensin II antagonist Telmisartan on inflammation and cell/matrix homeostasis in the human aneurysm aortic wall.

The use of indocyanine green for accurate sentinel node detection and removal in a group of high-risk nodal metastasis prostate cancer patients
To optimize and improve the sentinel node procedure in men with prostate cancer

The overall goal of this study is to further validate and improve the sentinel node procedure for prostate cancer using ICG-99mTc-nanocolloid. The first objective aims at further validation of the sentinel node procedure for prostate cancer via…

The influence of high frequency 10Hz repetitive transcranial magnetic stimulation (rTMS) on experimental pain measured through quantitative sensory testing in healthy subjects.

to investigate the analgesic effect of high frequency 10 Hz rTMS on experimental pain measured through quantitative sensory testing (QST) in healthy subjects.

A Phase II, Open-Label, Multicenter Study of Vemurafenib plus Cobimetinib (GDC-0973) in Unresectable Stage IIIc or Stage IV Melanoma; Response Monitoring and Resistance Prediction with Positron Emission Tomography and Tumor Characteristics.

To study whether either early 18F-FDG or 18F-FLT PET is superior in detecting response to treatment with the combination of vemurafenib plus cobimetinib (GDC-0973) compared to standard response assessment with CT and to evaluate whether, and which,…

An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with ankylosing spondylitis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability…

Maternal pharmacokinetics and pharmacodynamics of nicardipine (iv) during treatment of severe hypertension in pregnancy.

Our aim is to determine a Pharmacokinetic/Pharmacodynamic (PkPd) based dosing model for nicardipine used for treatment of severe hypertension in preeclamptic patients. The model is based upon determination of maternal, fetal and neonatal plasma…

Single-Center, Randomized Single-Blind Placebo-Controlled Five-Arm Parallel Group Study to Assess Efficacy of a Single Dose of TBS-2 Intranasal Gel at Four Time Points Post-Dose using Vibrotactile Stimulation combined with Visual Sexual Stimulation in Female Subjects with Primary and Secondary Anorgasmia

This clinical trial is being performed to evaluate the efficacy of a single dose of TBS-2 on the occurence of orgasm. This study will explore the effect of TBS-2 on inducing an orgasm following sexual stimuli in anorgasmic female subjects at four…

A Phase II/III Study of MK-0646 Treatment in Combination with Cetuximab and
Irinotecan for Patients with Metastatic Colorectal Cancer

There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…

The effect of helium inhalation on the coronary circulation and vessel diameter

The primary objective is to investigate whether helium influences coronary artery circulation in humans undergoing elective percutaneous coronary interventions (PCI).

Photodynamic laser therapy using Foscan for non-curatively-resectable bile duct carcinoma

To assess efficacy and safety of temoporfin (Foscan*) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS)

The purpose of this study is to determine if SAR153191 SC (subcutaneous) injection once a week or every other week is safe and effective compared to placebo (an inactive solution injection ) in reducing the recurrence and symptoms of Ankylosing…

Chemoradiation combined with panitumumab followed by surgery for patients with operable esophageal cancer

A consistent finding in many studies in patients with operable esophageal and gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy, particularly the absence of residual disease in the surgical specimen, is an indicator of…

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS

The primary objective is to characterize the change in the Pharmacodynamic (PD) biomarker, fecal calprotectin, during treatment with anrukinzumab.The secondary objectives include:* Characterization of the PK profile and total IL-13 of three multiple…