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A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric acute myeloid leukemia: the U-DANCE-anti-AML trial

Although DC vaccinations have been used in allo-HCT settings, no previous studies have been performed using a CBDC vaccine after CBT. This study will therefore be subdivided into 2 parts:- Part A: to determine a safe dose of the vaccination, and -…

Phase 2 multicenter study determining the response to Cabazitaxel in metastatic prostate cancer (mCRPC) patients with AR-V7 positive or negative circulating tumor cells (CTCs): CARVE

The primary objective of this study is to explore the PSA response rate to cabazitaxel in mCRPC patients who have progressed to docetaxel and to correlate the PSA response to AR-V7 expression in CTCs. Exploratory objectives include documenting the…

A RANDOMIZED, PARTIALLY-BLINDED, MULTI-CENTER, ACTIVE-CONTROLLED, DOSE
RANGING STUDY ASSESSING THE SAFETY, EFFICACY, AND PHARMACODYNAMICS OF THE
REG1 ANTICOAGULATION SYSTEM COMPARED TO UNFRACTIONATED HEPARIN OR LOW
MOLECULAR HEPARIN IN SUBJECTS WITH ACUTE CORONARY SYNDROME

To evaluate the safety and efficacy of the REG1 Anticoagulation System in Acute Coronary Syndrome patients undergoing cardiac catheterization by determination of the clinically acceptable dose range of RB007, which can be used to reliably reverse…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Postherpetic Neuralgia and Post-Traumatic Neuralgia, Followed by a Double Blind Safety Extension and an Open-Label Safety Extension

Primary Objectives• To evaluate the analgesic efficacy of JNJ-42160443 (1, 3, and 10 mg; administered as a single, subcutaneous injection every 28 days) in reducing average pain intensity, in subjects with postherpetic neuralgia neuralgia • To…

EMDR in the treatment of Chronic Fatigue Syndrome (CFS): can EMDR make the perception of fatigue less negative?
A sequential randomized and replicated single-case experimental phase design with multiple measurements.

Primary Objective: The main aim of this study is to investigate if EMDR diminishes negative associations with fatigue in CFS-patients who follow CBT.Secondary Objective(s): Second, we will investigate if EMDR strengthens the belief of the patient…

Clinical Evaluation of the Edwards Lifesciences Monarc system for the treatment of Mitral Regurgitation

To demonstrate the safety, efficacy, and performance of the Edwards Lifesciences MONARCTM system for the treatment of functional mitral regurgitation

A phase IIb, Double Blind, Randomized, placebo- controlled, Double-Dummy, Dose Rangining Study To Evaluate the Clinical Efficacy and Safety of Induction and Maintenance therapy with BMS- 945429 in subjects with Moderate to Severe Crohn's Disease.

Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…

The effect of explantation of silicone breast implants on neuroimages of the brain in ASIA-syndrome patients: a pilot fMRI-study

To investigate the effect of explantation of silicone breast implants on neuroimaging of the brain (fMRI) in ASIA syndrome patients to gain more insight in the neurophysiological basis and nociceptive system of ASIA syndrome due to SIIS and the…

Pan Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab

Primary:Long-term safety of nivolumab in participants on treatment and in follow upExploratory:To follow participants who have completed therapy and are in or have completed follow-up on a parent study investigating nivolumab or nivolumab…

A Two-Cohort Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients with Surgically Resectable Non-Small Cell Lung Cancer

Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy.Timepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To evaluate the activity of FL-101…

A PHASE II, RANDOMISED, ADAPTIVE, OPEN-LABEL
PLATFORM TRIAL TO EVALUATE EFFICACY AND
SAFETY OF MULTIPLE COMBINATION THERAPIES IN
PARTICIPANTS WITH CHRONIC HEPATITIS B

Primary* To estimate the effect of NME combination therapies on inducing a functional cure over the control arm.Secondary * To characterize the efficacy profile of NME combination therapies.* To characterize the PD profile of NME combination…

A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia)

The primary objective of this study is:* To assess the safety and tolerability of TPN-101 in patients with C9ORF72 ALS/FTDThe exploratory objectives of this study are:* To assess the concentrations of TPN-101 in plasma and cerebrospinal fluid (CSF…

A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients with Surgically Resectable Non-Small Cell Lung Cancer

Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy and in combination with nivolumabTimepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To…

ORACLE: A long-term follow-up study to evaluate the safety and durability of GT005 in participants with geographic atrophy, secondary to age-related macular degeneration treated in a Gyroscope-sponsored antecedent study.

The overall objectives of the study are to evaluate the long-term safety and durability of GT005 in participants with GA secondary to AMD who have been treated in an antecedent study.