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NCT ID: NCT01908140 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: September 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)

NCT ID: NCT01905683 Completed - Clinical trials for Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy

Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.

NCT ID: NCT01905475 Completed - Clinical trials for Large Reperfused ST-Elevation Myocardial Infarction

CXCR4 Antagonism for Cell Mobilisation and Healing in Acute Myocardial Infarction (CATCH-AMI)

CATCH-AMI
Start date: July 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effects of POL6326 (CXCR4 antagonist) as a stem cell mobilizing agent, on cardiac function and infarct size and on safety and tolerability, in patients with reperfused ST-Elevation Myocardial Infarction (STEMI).

NCT ID: NCT01900743 Completed - Sarcoma Clinical Trials

Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma

REGO-SARC
Start date: June 5, 2013
Phase: Phase 2
Study type: Interventional

This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline). Five cohorts will be defined: Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups.

NCT ID: NCT01900574 Completed - Colitis, Ulcerative Clinical Trials

A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis

Start date: August 9, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).

NCT ID: NCT01896232 Completed - Clinical trials for Chronic Kidney Disease

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Start date: August 13, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

NCT ID: NCT01896115 Completed - Parkinson's Disease Clinical Trials

CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

CUSTOM-DBS
Start date: June 2013
Phase: N/A
Study type: Interventional

The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.

NCT ID: NCT01895777 Completed - Clinical trials for Venous Thromboembolism

Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

NCT ID: NCT01895335 Completed - Multiple Sclerosis Clinical Trials

Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

TERI-PRO
Start date: June 2013
Phase: Phase 4
Study type: Interventional

Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Patient Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using Patient Reported Outcomes (PROs). To describe clinical outcomes (ie, treated relapses) in teriflunomide treated patients. To describe the change in cognition in teriflunomide treated patients. To describe safety of teriflunomide in patients treated (based on adverse events reporting). To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment. To compare Patient Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

NCT ID: NCT01894880 Completed - Clinical trials for Early Skin-to-skin Contact

Pilot Study: Sectio Bonding/Early Skin-to-skin Contact (SSC) After Caesarean Section

SSC
Start date: July 2013
Phase: N/A
Study type: Interventional

In the past decades frequency of cesarean section was increasing. Bonding or early skin-to-skin contact (SSC) starts ideally straight after birth. After vaginal delivery bonding/early SSC is already well-established. After cesarean section this important process starts after termination of operation. A Cochran review analyzed randomized studies and shows positive effects of early SSC. Possible concerns to adopt bonding in the operating room are beside organizational ones (change of established processes) also a different ambiance in the operating room (temperature, light, noise). In a prospective randomized trial, early SSC after cesarean section should be analyzed. Hypothesis Mothers, who have the chance to bond immediately after birth in the operating room, have lower cortisol, chromogranin A and alpha amylase levels as well as higher oxytocin levels. Adaptation of the newborn is within the normal range. Early bonding has a further positive effect on breast feeding, maternal pain processing and mental health.