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NCT ID: NCT01949948 Completed - Ischemic Stroke Clinical Trials

Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke

NOR-TEST
Start date: September 2012
Phase: Phase 3
Study type: Interventional

BACKGROUND: Alteplase dissolves blood vessel clots in acute ischemic stroke and is the only approved acute drug treatment <4½ hours of stroke onset. The overall benefit from alteplase is substantial, but up to 2/3 of patients with large artery clots may not achieve reopening of the vessel and up to 40% of the patients may remain severely disabled or die, leaving substantial room for improvement. Tenecteplase, widely used in coronary heart disease, may be more effective and may have less bleeding complications than alteplase, and may be the drug of choice also in stroke. HYPOTHESIS: Tenecteplase may be given safely to patients with acute ischemic stroke at a dose that is associated with improved clinical outcome compared with existing treatment options. AIMS: To compare efficacy and safety of tenecteplase vs. alteplase given <4½ hours after symptom onset. STUDY ENDPOINTS: The primary study endpoint is excellent clinical outcome at 3 months (effect). Secondary study endpoints are major early clinical improvement (effect) and bleeding complications (safety).

NCT ID: NCT01949220 Completed - Clinical trials for Von Willebrand Disease

Willebrand International Non-interventional Global Surveillance

Start date: March 2014
Phase:
Study type: Observational

Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.

NCT ID: NCT01949129 Recruiting - Clinical trials for Acute Lymphoblastic Leukaemia

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

Start date: April 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

NCT ID: NCT01946906 Completed - Clinical trials for Common Variable Immunodeficiency (CVID)

The Rifaximin Study in CVID

Start date: October 2013
Phase: Phase 4
Study type: Interventional

Patients with Common variable immunodeficiency (CVID) have various forms of autoimmune and auto inflammatory disorders. The study will investigate if intervention with Rifaximin modifies the gut microbiota with a subsequent alteration in markers of systemic immune activation and inflammation in patients with CVID. The investigators hypothesize that the gut microbiota of CVID patients, at least partly through interaction with the innate immune system within the intestine, contribute to a low-grade systemic inflammation in these patients, and that an intervention with the non-absorbable antibiotic Rifaximin attenuates systemic inflammation through modulation of the gut microbiota. The study may lead to increased understanding of the interaction between microbiota and the immune system. The study could give new insight into important disease processes in relation to the interaction between the microbiota, the intestine and the systemic compartment, and potentially be the basis of new therapeutic strategies in these patients to prevent and down-regulate the auto-inflammatory and autoimmune complications seen in CVID. The findings could also be of relevance for other disorders where the interaction between microbiota and intestinal and systemic inflammation is involved such as various cardiovascular and metabolic disorders. The investigators hypothesize that the gut microbiota of CVID patients, at least partly through interaction with the innate immune system within the intestine, contribute to a low-grade systemic inflammation in these patients, and that an intervention with the non-absorbable antibiotic Rifaximin attenuates systemic inflammation through modulation of the gut microbiota.

NCT ID: NCT01946204 Active, not recruiting - Prostatic Neoplasms Clinical Trials

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

SPARTAN
Start date: October 14, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

NCT ID: NCT01944254 Completed - Heart Diseases Clinical Trials

The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients

TEMP2
Start date: September 2013
Phase: N/A
Study type: Interventional

The intention of this study is to determine whether the precision of the measure of cardiac output can be optimized by conducting the measurement while the participant is instructed to exhale slowly. This will be compared to measurements done at random to respiration and timed with the participant's spontaneous expiration.

NCT ID: NCT01943890 Completed - Cystic Fibrosis Clinical Trials

High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients

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

Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS volumes, including physiotherapy and aspects of breathing pattern. The aim of the study was to implement standardised and age-adjusted nebulised volumes of hypertonic saline in cystic fibrosis patients, included in physiotherapy and lung drainage techniques.

NCT ID: NCT01943071 Completed - Dementia Clinical Trials

Effects and Costs of a Day Care Centre Program Designed for People With Dementia

ECOD
Start date: August 1, 2013
Phase: N/A
Study type: Interventional

Attending day care centres with programs specifically designed for patients with dementia is believed to postpone admittance to nursing home as well as increase quality of life and well-being for both patients and their family caregivers. We aim to investigate to what degree attendance in day care centres with programs for people with dementia is effective for patient and their caregivers whilst also cost efficient for society. The study consists of a quasi-experimental trial with comparison group. 400 patients with dementia, along with a family caregiver, will be included in the trial. Effects will be measured at baseline, after one and two years. Data collection will be made at three levels; at patient level with measures of cognition, depression, quality of life, functioning in activities in daily living, neuropsychiatric symptoms and death; at caregiver level with measures of depression, level of burden and quality of life; and at societal level with measures of nursing home admittance, hospital stays and use of other health resources. Additionally,a qualitative interview study will include 20 dyads from the main trial. The main focus will be on how attending day care centre programs for patients with dementia affect the lives of both patients and caregivers. Five of these dyads will be followed closely throughout the participation period to be used as case examples.

NCT ID: NCT01941602 Completed - Meningioma Clinical Trials

A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery

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

The aim of the study is to compare different strategies for prevention of venous thromboembolism related to intracranial meningioma surgery. The investigators identified three hospitals where two have a very restrictive approach with respect to anticoagulant therapy while at the third hospital the use of anticoagulation the day before surgery was initiated as routine prophylaxis. Based on this "natural experiment" it will be explored whether the use of anticoagulant prophylaxis is associated with reduced risk of venous thromboembolism and/or associated with increased risk of postoperative hemorrhage as compared to the 2 cohorts where this intervention were absent.

NCT ID: NCT01941459 Completed - Clinical trials for Myocardial Protection

Comparison of Blood Cardioplegia and Custodiol

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

Thru the last 20 years it has been a discussion witch solution that gives the best myocardial protection during cardiac arrest by heart operations. - It has been a tendency that a blood based cardioplegia gives a better protection bye long ischemic times but it has not been possible too conclude in this matter. - The investigators have two groups of cardioplegia, the blood based and, the crystalloid based cardioplegia. - It has been done a lot of studies to see what kind of cardioplegia that gives the best myocardial protection. Different temperature, different amount and content, retrograde or antegrade or both, contentiously and further on have been tested without a clear conclusion. - The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min. - Adult patients' with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study. - Patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study. - The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the myocardial damage.