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NCT ID: NCT01803438 Completed - Clinical trials for Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases

Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation

Start date: June 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Frontâ„¢ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial fibrillation (AF).

NCT ID: NCT01802814 Completed - Clinical trials for Acute Lymphoblastic Leukemia (ALL)

International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010

Start date: May 2014
Phase: Phase 3
Study type: Interventional

The main goal of this study is to improve the outcome of children and adolescents with standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.

NCT ID: NCT01802424 Completed - Anxiety Clinical Trials

FRIENDS as an Indicative Prevention Program in Norway

Start date: February 2012
Phase: N/A
Study type: Interventional

The purpose of this pilot-study is to evaluate a cognitive behavioral program, the Friends-program, as indicated prevention for anxious youth. The youths are recruited by school nurses who will also lead the intervention groups applying the Friends-manual.

NCT ID: NCT01800435 Completed - Clinical trials for Hereditary Factor VIII Deficiency Disease With Inhibitor

A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor

BPATXAS
Start date: October 2011
Phase: Phase 4
Study type: Interventional

Activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII (rFVIIa) are the only two drugs that are available to treat bleeds in haemophilia A patients with high titer inhibitors. However, management of bleeds in these patients can be challenging due to variation in response and lack of standardized methods to monitor the effect. We hypothesized that significant increase in whole blood clot stability could be achieved when tranexamic acid was given concomitantly with bypassing-agents while thrombin generation remains unaffected. In this prospective crossover study the effect of aPCC and rFVIIa with and without TXA on clot stability and thrombin generation capacity (ETP) were studied, using thromboelastography (ROTEM) and thrombin generation assay (TGA), respectively. In addition, the risk of thrombosis and disseminated intravascular coagulation (DIC) was assessed.

NCT ID: NCT01798706 Completed - Type 2 Diabetes Clinical Trials

Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

GetGoal-O
Start date: June 2013
Phase: Phase 3
Study type: Interventional

Primary objective: - To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by HbA1c reduction, in older type 2 diabetes patients (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen. Main secondary objective: - To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM patients (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects). Other secondary objectives: - To assess the effect of lixisenatide compared to placebo after 24-week treatment on: - Fasting plasma glucose (FPG) - During liquid standardized breakfast meal challenge test : 2 hour- PPG and Plasma Glucose Excursion - 7-point Self-monitored plasma glucose (SMPG) profile - Body weight - Change in total daily dose of basal insulin (if taken) - Percentage of patients requiring rescue therapy - Safety and tolerability - To assess lixisenatide pharmacokinetic profile - To assess anti-lixisenatide antibody development.

NCT ID: NCT01798108 Completed - Neoplasm Metastasis Clinical Trials

Dose Escalation Study of Radium-223 Dichloride in Patients With Advanced Skeletal Metastases

Start date: August 14, 2001
Phase: Phase 1
Study type: Interventional

A new bone-seeking radiopharmaceutical drug, called Radium-223 dichloride (formerly known as "Alpharadin"), is currently under development. It is an injectable aqueous solution containing radium-223, a radionuclide that emits radiation of another quality and with a different distribution than radiopharmaceuticals currently in use. After injection of the drug into the blood, a large portion of the drug will accumulate in the bones, and irradiate the skeletal metastases. The drug is expected to be retained longer in the painful sites of bone than in other sites of the body, and may alleviate pain through its radiation. Radium-223 is expected to be both efficacious as regards the targeted localised irradiation, and also to have a favourable safety profile. The radiopharmaceutical drug Radium-223 has not been given to humans before. In this first clinical study in man, a so-called phase I study, the safety, tolerance and the toxicity of various radioactivity doses of Radium-223 will be evaluated.

NCT ID: NCT01797679 Withdrawn - Osteoarthritis Clinical Trials

Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis

Start date: March 2013
Phase: N/A
Study type: Interventional

This study is the radiological component of an earlier registered trial under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the articular cartilage. It has been proven that exercise can improve function and reduce the need for analgesics in patients with osteoarthritis. With this study, we wish to investigate if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation times of the articular cartilage, and also if this improvements are transient or permanent.

NCT ID: NCT01797003 Completed - Osteoarthritis Clinical Trials

Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.

Start date: March 2007
Phase: N/A
Study type: Interventional

Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis. Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.

NCT ID: NCT01796587 Completed - Clinical trials for Intermittent Catheterization

Non-Interventional Study Among Users Of LoFric Origo

Start date: January 2013
Phase: N/A
Study type: Observational

Primary objective: To evaluate compliance of LoFric Origo in a general intermittent catheterization (IC) population with the use of LoFric Origo, by means of a subjective assessment scale Secondary objectives: - To evaluate the subject's perception associated with the use of the LoFric Origo, by means of a subjective assessment scale - To evaluate the subject's discomfort associated with the use of the LoFric Origo, by means of a subjective assessment scale - To observe and collect data on bladder regimen/IC frequency by assessments of descriptive data of demography, catheter therapy, history and other patient reported outcomes. Study Design: Non-interventional study, multicentre, prospective study. Target Subject Population: General intermittent catheterization, LoFric Origo male users. Medical Device: LoFric Origo Study Variable(s): - Primary variable: Use or No use of LoFric Origo after 8 weeks. - Secondary variable(s): patient reported questionnaire with regards to perception, discomfort, diagnose, health status, catheter history and other patient reported outcomes.

NCT ID: NCT01796379 Completed - Physical Fitness Clinical Trials

High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

HITTS
Start date: February 2013
Phase: N/A
Study type: Interventional

Compared to end-stage heart failure, a patient's situation is usually greatly improved after a heart transplant (HTx), but the exercise capacity remains sub-normal, also long-term, ranging from 50 to 70% in most studies. While effective rehabilitation, including regular exercise, is considered an effective tool of improving health related quality of life (HRQoL) and prognosis of cardiac patients in general, the knowledge about and the effect of different rehabilitation programs among HTx recipients is limited. Exercise training is considered one of the most central parts in rehabilitation, but the mode of exercise used in different studies varies considerably. It is documented that high intensity interval training (HIT) has superior effects compared to training with moderate intensity in cardiac and heart failure patients. In contrast, HTx recipients have a denervated heart, and HIT had been considered unphysiological. However, the investigators have recently demonstrated highly beneficial effects on exercise capacity, muscle strength, body composition, reduced progression of cardiac allograft vasculopathy and HRQoL among long-term HTx recipients. In the present study the investigators want to test the hypothesis that systematic aerobic exercise with high intensity improve exercise capacity also in newly transplanted recipients, and secondarily that it gives favourable effects on the heart, peripheral circulation and a better HRQoL.