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Proof of Concept Study of Eurartesim® in Patients with Imported Uncomplicated Plasmodium Vivax Malaria

Primary Objective:• Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 21.Secondary Objectives: • Proportion of aparasitaemic patients (at different visits).• Proportion of afebrile patients (at different visits).• Uncorrected…

Plaque stabilization and restoration of vascular function by bioresorbable vascular scaffold in acute coronary syndrome prone patients

To assess if treatment of an intermediate vulnerable coronary lesion in symptomatic patients using a BVS is feasible, results in a more stable plaque, increases vessel luminal area, preserves or improves vasomotion and is not associated with…

A PHASE 2, RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED TRIALTO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF PF-04360365 (PONEZUMAB) IN ADULT SUBJECTS WITH PROBABLE CEREBRAL AMYLOID ANGIOPATHY

Primary Objective:- To evaluate the efficacy of PF-04360365 (ponezumab) in subjects with probableCAA as compared to placebo on a BOLD fMRI measure of cerebrovascularreactivity.Secondary Objectives:- To evaluate the efficacy of PF-04360365 (ponezumab…

A Phase 2b Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 HCV-Infected Subjects with Renal Insufficiency

(Protocol Am2 dd. 20-Feb-2014, p17/93)The primary objectives of this study are:- To evaluate the safety of sofosbuvir (SOF) 200 mg or 400 mg + ribavirin (RBV) for 24 weeks as assessed by review of the accumulated safety data in each treatment arm-…

REVERSAL OF ANTICOAGULANT EFFECT OF DABIGATRAN® BY PROTHROMBIN COMPLEX CONCENTRATE (BERIPLEX®) ASSESSED WITH A NOVEL METHOD OF BLOOD LOSS MEASUREMENT

To determine whether a single dose of 50 IE/Kg PCC is effective in reversing the anticoagulant effect of Dabigatran Etexilate 300mg b.i.d. taken for 2.5 days, as assessed by two modified skin bleeding assays: the "shed blood" and "…

PeRsOnalized treatment fOr patients with pleural eFfusions due to malignant pleural mesothelioma or lung cancer in second or third line. An open label phase II study (Acronym: the PROOF study)

The aim of this study is to evaluate the efficacy of a personalized drug profiling method using short-term cultures of malignant cells derived from the patient*s pleural fluid.

Protein and lifestyle intervention to preserve muscle mass in obese older type 2 diabetes patients - a 13-week randomised, controlled exploratory study with a 24-week follow-up period.

Primary: To investigate the effect on leg muscle mass in the test group compared to the control group in older obese type 2 diabetes patients after 13 weeks of interventionSecondary: - To investigate the effect on glycemic control in the test group…

A combined transvenous and epicardial lead placement procedure for implantation of cardiac resynchronization devices: a feasibility study

To assess the feasibility of implantation of CRT devices via a combined transvenous and epicardial procedure in patients with an unfavourable coronary venous anatomy. In addition, the safety of the procedure will be assessed in preparation for a…

The Efficacy and Safety of Irreversible Electroporation for the Ablation of Renal Masses: A Prospective, Human, In-Vivo Study.

Primary Objectives:- To determine the efficacy of IRE ablation of renal masses, measured by histopathologic examination of the targeted tumour.- To determine the safety of IRE ablation of small renal masses, by evaluating device and procedural…

Topical sinecatechins ointment in treatment of primary superficial Basal Cell Carcinoma: a double blind, randomized, placebo-controlled trial.

Primary Objective: To determine whether topical sinecatechins 10% (Veregen®) ointment application can lead to a histological clearance (efficacy) of a superficial basal cell carcinoma. Secondary Objective(s): To assess compliance and adverse…

A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis.

The overall purpose of the trial is to assess clinical efficacy and safety of three different doses of BI 655066 administered by multiple subcutaneous injections in adult patients with defined ankylosing spondylitis. We will also explore its…

Detection of early premalignant breast lesions by autofluorescence ductoscopy

Is ductoscopy with white light and autofluorescent light a useful method for diagnosing precancerous breast lesions?

RITUXIMAB IN LIFE THREATENING THERAPY RESISTANT PROGRESSIVE INTERSTITIAL PNEUMONITIS

The main objective of this study is to assess the effects of rituximab (RTX) as a rescue therapy for therapy resistant progressive IMID- IP patients. Specifically there is an objective assessment of (1) pulmonary function tests (PFTs) and (2)…

Exercise Rehabilitation Trial in Huntington*s disease

The specific aims for this study are to identify whether a structured exercise programme:a. is feasible for people with HD, in terms of adherence, process and safetyb. improves physical fitness in people with HDc. improves physical function and…

10-day decitabine, fludarabine and 2 Gray TBI as conditioning strategy for poor and very poor risk AML in CR1. PLMA34 study

The primary objective of this study is to assess the feasibility (safety and efficacy) of addition of 10-day decitabine to the standard Seattle non-myeloablative conditioning regimen (3 days fludarabine 30 mg/m2 + 2 Gray TBI) prior to allogeneic HCT…

A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects with
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous
Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy
Regimens in Subjects Who Are Not Candidates for ASCT

Research Hypothesis: Treatment with nivolumab (BMS-936558) will lead to clinical benefit, as demonstrated by a clinically meaningful objective response rate, including durable responses with substantial magnitude of tumor burden reduction.Primary…

Sentinel lymph node identification in colon and rectal cancer using a radioactive and fluorescent tracer

Aim of the present study is to investigate if a combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the SLNM technique in colon and rectal cancer by utilizing the radioactive component for preoperative…

A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the
Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C
Virus Infection and Chronic Kidney Disease

Advances in the treatment of patients with hepatitis C infection have contributed to improved efficacy in several populations. However, for patients with CKD, particularly those with stages 3-5, treatment options remain limited and suboptimal. Given…

Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects with Chronic Heart Failure

Primary:Assess the safety of repeat doses of serelaxin in chronic heart failureSecondary:- Assess the incidence rate of adverse events of special interest, indicative of hypersensitivity reactions- Assess the safety and tolerability of repeated…

LUMC 2014-01 - Transfer of Streptamer selected multiantigen-specific T cells to prevent infections and relapse after allogeneic Stem Cell Transplantation - a phase I/II study

• To evaluate the efficacy of the transfer of multiantigen specific T cells by measuring the appearance or expansion (if antigenic specific donor derived cells are already present in the circulation of the patient at time of infusion) of antigen…