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NCT ID: NCT01355627 Completed - Clinical trials for Cerebrospinal Fluid Leaks

TASALL - TachoSil® Against Liquor Leak

Start date: April 2011
Phase: Phase 3
Study type: Interventional

The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater. The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.

NCT ID: NCT01354899 Completed - Critical Illness Clinical Trials

A Open Study to Evaluate the Performance of Dressing on Subject With High Risk of Skin Breakdown

Start date: May 2011
Phase: N/A
Study type: Observational

The rational for the study is to add a thin self-adherent dressing on critically ill patients. Evaluate if the dressing might protect the skin for further breakdown.Participants will be followed for the duration of hospital stay, an expected average of 5 days.

NCT ID: NCT01354548 Active, not recruiting - Trismus Clinical Trials

Prevention of Trismus During Radiotherapy and Quality of Life in Head and Neck Cancer Patients

Start date: February 2010
Phase: N/A
Study type: Interventional

Trismus (limited jaw mobility), can occur in patients undergoing radiotherapy to specific areas of the head or neck. Trismus leads to difficulty in eating, swallowing, speech and general mouth hygiene, which all have negative effects on quality of life. Research in the area of trismus is limited; it is not known exactly when trismus develops, one study suggests that some patients have experienced a diminished opening at as low doses as 15 Gy. Literature suggests benefits of a training programme, but there is a lack of evidence to support the use of a training programme during radiotherapy. The purpose of this study is to investigate the effectiveness of a training programme during and after radiotherapy, and report the incidence of trismus in patients who receive radiotherapy to the jaw muscles. The study also investigates quality of life during radiotherapy and up to one year after completed treatment. Patients who meet the criteria and give their consensus to the study are divided into two groups: Group 1: Training with TheraBite Jaw Motion Rehabilitation System, which is a portable system utilizing repetitive passive motion and stretching to restore mobility and flexibility of the jaw musculature. Individuals train five times a day. Group 2: Conventional treatment (jaw measurements once a week). If the individuals jaw mobility decreases 15% from the original start measurement, the patient is automatically offered a trainings program (as in group 1). During radiation therapy a hospital specialist dentist measures the jaw mobility once a week, thereafter at 3,6,12 months after completed Radiation Therapy. On 5 different occasions the patients are requested to complete a Quality of life questionnaire. Patient's record their training frequency in a log book.

NCT ID: NCT01354184 Completed - Clinical trials for Abdominal Aortic Aneurysm

CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)

Start date: n/a
Phase: Phase 2
Study type: Interventional

This is an investigation of the efficacy and safety of CRD007 compared to placebo in the treatment of patients with abdominal aortic aneurysm.

NCT ID: NCT01354067 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Single Limb Resistance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)

COPD
Start date: May 2011
Phase: N/A
Study type: Interventional

The chronic airflow limitation in chronic obstructive pulmonary disease (COPD) patients resulting in increased dyspnea during physical activity restricts many COPD patients ability to perform exercises in general and whole-body exercises in particular. Single limb training performed as one-legged cycling has been shown effective in patients with COPD. This exercise regime results in less stress on the ventilatory system as training is executed using a simultaneously smaller muscle mass. However, the positive physiological effects of exercise training only occur in the involved muscle(s). To be of benefit for patients daily life, all relevant muscles should be included in exercise training. The aim of the current randomized controlled multicenter trial (RCT) is to determine the effects of high-repetitive single limb exercises (HRSLE) in combination with COPD specific patient education, compared to the COPD specific patient education alone in patients with moderate to very severe (stage II-IV) COPD.

NCT ID: NCT01352793 Completed - Clinical trials for Meningitis, Meningococcal

A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

Start date: November 2012
Phase: Phase 3
Study type: Interventional

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

NCT ID: NCT01351974 Completed - Breast Cancer Clinical Trials

Sentinel Node Biopsy in Breast Cancer Patients

Start date: September 2000
Phase: N/A
Study type: Observational

Axillary lymph node dissection (ALND) was previously the standard axillary staging procedure in breast cancer patients. However, ALND is accompanied by a considerable morbidity, and sentinel lymph node biopsy (SLNB) evolved as a mean to decrease this morbidity. Between September 2000 and January 2004 breast cancer patients were included in the Swedish Sentinel Node Multicenter Cohort Study with the intent of studying axillary recurrence after negative SLNB for patients in which completion ALND were omitted. The patients were followed prospectively and events (local, regional and distant recurrences and deaths) were registered. The primary endpoint was axillary recurrence and secondary endpoints were disease-free, cancer-specific and overall survival.

NCT ID: NCT01350921 Completed - Clinical trials for Drug Drug Interaction

Evaluation of the Drug-drug Interaction Between Ticagrelor and Venlafaxine When Taken Together in Healthy Volunteers

Start date: May 2011
Phase: Phase 1
Study type: Interventional

Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy volunteers

NCT ID: NCT01348971 Completed - Clinical trials for Coronary Artery Disease

Coronary Artery Bypass and Nitrate Oral Supplementation

CABANOS
Start date: March 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether oral sodium nitrate administration prior to coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition, plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.

NCT ID: NCT01348529 Completed - Clinical trials for Obsessive Compulsive Disorder

Internet Cognitive Behavior Therapy (CBT) for Obsessive Compulsive Disorder (OCD)

Start date: September 2010
Phase: N/A
Study type: Interventional

The main aim of this study is to test whether cognitive behavior therapy could be effective in treating obsessive compulsive disorder. Here, the investigators test the in group effects of a 15 week long treatment delivered via the Internet for residents in Stockholm County.