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NCT ID: NCT02240680 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin as Add on to Basal Insulin in the Elderly

Start date: September 23, 2014
Phase: Phase 4
Study type: Interventional

To investigate the efficacy, safety, and tolerability of linagliptin 5 milligrams once a day compared to placebo as as add-on therapy for 24 weeks to stable basal insulin treatment in elderly patients, 60 years of age and older, with Type 2 Diabetes Mellitus and insufficient glycaemic control.Stable background therapy of metformin and/or alpha-glucosidase inhibitors is also allowed. In addition, this trial will assess if linagliptin reduces the risk of hypoglycaemia when added to background basal insulin therapy. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in glycosylated Haemoglobin, a well-accepted measurement of chronic glycaemic control.

NCT ID: NCT02235207 Completed - Neck Pain Clinical Trials

Effectiveness of Fustra—Exercise Program in Neck and Low Back Pain

FUSTRA
Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the effectiveness of Fustra® exercise program in relieving recurrent pain in the neck or/and back, and thus improve quality of life in female and male office workers. The hypothesis is that neuromuscular exercise will improve control of posture and movement, neck shoulder and trunk flexibility, trunk muscular endurance and leg strength, and thus decrease intensity of pain by 30% compared to non-exercise group. In addition, financial feasibility of the exercise program and effects of training on quality of life and perceived work ability are studied.

NCT ID: NCT02234843 Completed - Clinical trials for Venous Thromboembolism

EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

EINSTEIN Jr
Start date: November 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

NCT ID: NCT02234583 Completed - Clinical trials for Pain Associated With Fibromyalgia

An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia

Start date: February 4, 2015
Phase: Phase 3
Study type: Interventional

This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period. After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on protocol-specified criteria.

NCT ID: NCT02232399 Completed - Clinical trials for Congenital Heart Defects

Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?

MiLe-1
Start date: October 15, 2014
Phase: Phase 2
Study type: Interventional

The aim of the study is to assess the ability of Levosimendan to reduce the postoperative acute kidney injury in pediatric patients undergoing surgery for congenital heart disease (CHDs).

NCT ID: NCT02226120 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

Start date: October 16, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

NCT ID: NCT02224404 Completed - Pressure Ulcers Clinical Trials

Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended

Start date: September 2014
Phase: N/A
Study type: Interventional

The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of Exufiber when used as intended in Stage II-IV pressure ulcers (PU).

NCT ID: NCT02222272 Completed - Clinical trials for Myeloid Leukemia, Chronic

Effect of 2nd Gen TKI in CML

Start date: January 1, 2010
Phase:
Study type: Observational

Stem cell transplantation will continue to be a treatment option for patients with chronic myeloid leukaemia, despite the introduction of tyrosine kinase inhibitors. However, many patients will have received prior therapy with TKIs, including Nilotinib or Dasatinib at the time of allogeneic stem cell transplantation. While the use of Imatinib prior to stem cell transplantation seems to have no adverse impact on the outcome of allogeneic stem cell transplantation little is known on the impact of prior use of second generation TK inhibitors. Therefore this non interventional prospective study addresses this question and patients undergoing allogeneic stem cell transplantation after prior use of 2nd generation TKIs will be followed by the data office office on engraftment, treatment related mortality, relapse rate and survival, prospectively. Details on TKI therapy will be collected by the participating centers, retrospectively. This is a non interventional prospective study. There is no upper limit to the number of patients entered, but it is estimated that up to 450 patients will be included in 150 centres for this non interventional prospective study. The registry will include patients for three years plus one more year for follow up and data analysis which should then be followed-up until the projected end of the non interventional prospective study.

NCT ID: NCT02219932 Completed - Multiple Sclerosis Clinical Trials

Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis

ENHANCE
Start date: September 2014
Phase: Phase 3
Study type: Interventional

The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on patient-reported walking ability over a 24-week study period. The secondary objectives are: To determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of Multiple Sclerosis (MS), and upper extremity function over a 24-week study period; To evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; To assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.

NCT ID: NCT02219698 Completed - Diverticulitis Clinical Trials

Symptomatic Treatment of Acute Uncomplicated Diverticulitis

Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.