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NCT ID: NCT02509832 Completed - Clinical trials for Acute Myocardial Infarction

COOL AMI EU Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction

Start date: July 2015
Phase: N/A
Study type: Interventional

COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction. Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.

NCT ID: NCT02509273 Terminated - Clinical trials for Sedation in Intensive Care

Efficacy, Safety and Pharmacokinetic Study of Intravenous Clonidine Versus Midazolam for Sedation in Paediatric Patients

CloSed1
Start date: May 2016
Phase: Phase 3
Study type: Interventional

Closed1 aims to compare the efficacy, safety and pharmacokinetics of clonidine (hydrochloride) to midazolam in the sedation of ventilated children and adolescents (0-18 years) admitted to a paediatric intensive care unit (PICU) and requiring mechanical ventilation and sedation for at least 24 hours. In particular, the proportion of subjects with sedation failure at the maximum possible dose (defined within the study protocol) will be measured. Additionally, the safety and tolerability (including withdrawal effects) of clonidine compared to midazolam will be evaluated. A pharmacokinetic-pharmacodynamic relationship of clonidine for sedation in PICU will be established. Genetic polymorphisms of clinical relevance affecting pharmacokinetics, pharmacodynamics and metabolism will be also identified. Ad hoc paediatric parenteral formulations of clonidine hydrochloride and midazolam will be manufactured. At least 300 subjects will be enrolled from study centres in five European member countries (Czech Republic, Germany, Italy, the Netherlands, and Sweden). The clinical study will enrol critically ill paediatric patients who require mechanical ventilation and sedation. Subjects will be closely followed using standard PICU monitoring of vital functions (continuous assessment of heart rate and peripheral arterial oxygen saturation, intermittent assessment of systolic and diastolic blood pressure), intermittent assessment of pain and depth of sedation, documentation of parameters of mechanical ventilation and intermittent arterial blood gas analysis. The study will be conducted in compliance with the study protocol, Good Clinical Practice (ICH-GCP) and the applicable regulatory requirement(s). In addition, qualified PICU staff will be monitoring subjects around the clock, thus minimising reaction time in case of alarms or deterioration of clinical parameters. This project has received funding from the European Union's Seventh Framework Programme for research, technological development and demonstration under grant agreement n° 602453.

NCT ID: NCT02509026 Completed - Clinical trials for Spondylitis, Ankylosing

Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA

RE-EMBARK
Start date: September 24, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.

NCT ID: NCT02508155 Completed - Chronic Pain Clinical Trials

A Study of MEDI7352 in Painful Osteoarthritis of the Knee

Start date: November 17, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, drug levels and effects on the body of MEDI7352, in subjects with painful osteoarthritis of the knee.

NCT ID: NCT02505750 Active, not recruiting - Rectal Neoplasms Clinical Trials

Safety of a Boost (CXB or EBRT) in Combination With Neoadjuvant Chemoradiotherapy for Early Rectal Adenocarcinoma

OPERA
Start date: June 24, 2015
Phase: Phase 3
Study type: Interventional

The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery. The hypothesis of this study is to determine whether the addition of an endocavitary boost with CXB after standard treatment with nCRT, increases the chance of rectum and anus preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease (organ preservation in control arm 20%, in experimental arm 40%). Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease at 3 years post treatment start, or permanent deviating stoma. Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.

NCT ID: NCT02504346 Active, not recruiting - Lung Cancer Clinical Trials

AZD9291, an Irreversible EGFR-TKI, in Relapsed EGFR-mutated Non-small Cell Lung Cancer Patients Previously Treated With an EGFR-TKI, Coupled to Extensive Translational Studies

TREM
Start date: August 2015
Phase: Phase 2
Study type: Interventional

Phase II, single-arm study to assess the safety and efficacy of AZD9291 (80 mg, orally, once daily) in second-line (or later) patients with EGFR mutation-positive, locally advanced or metastatic NSCLC, who have progressed following treatment with an approved epidermal growth factor tyrosine kinase inhibitor agent.

NCT ID: NCT02504268 Completed - Clinical trials for Rheumatoid Arthritis

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

AVERT-2
Start date: September 3, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

NCT ID: NCT02504216 Completed - Clinical trials for Peripheral Artery Disease

Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities

VOYAGER PAD
Start date: August 18, 2015
Phase: Phase 3
Study type: Interventional

The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.

NCT ID: NCT02503124 Terminated - Depression Clinical Trials

Effect of a Single Nights' Wake Followed by Bright Light Therapy for Severe Depression

Start date: July 2015
Phase: N/A
Study type: Interventional

A randomized controlled trial comparing wake therapy (single night) followed by bright light therapy to treatment as usual.

NCT ID: NCT02500654 Completed - Inflammation Clinical Trials

Regenerative Surgical Treatment of Peri-implantitis

Start date: December 2008
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate if surgical treatment of peri-implantitis with enamel matrix derivative (Emdogain®, EMD) will have an additional effect on the healing outcome, changes in the peri-implant microflora and on the inflammatory response in the periimplant pocket at 12 months.