There are about 8563 clinical studies being (or have been) conducted in Sweden. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The objective is to compare the efficacy of 2 treatment strategies, catheter ablation of atrial fibrillation versus optimized pharmacological therapy, in patients with symptomatic atrial fibrillation. It is a randomized, prospective, controlled, open-label multicentre, parallel-group study including 116 patients. Inclusion criteria are patients aged 30-70 years with symptoms related to atrial fibrillation and who have failed or been intolerant to at least one anti-arrhythmic drug, with at least one atrial fibrillation episode documented on ECG during the previous 12 months and at least one symptomatic episode during the previous 2 months or at least 2 symptomatic episodes of persistent AF in the previous 12 months. Main exclusion criteria are patients who have tested 2 or more anti-arrhythmic drugs for rhythm control, uncontrolled hypertension, valvular disease requiring anticoagulation, planned valve surgery within 2 years, contraindication to treatment with anticoagulants, heart failure, left atrial diameter > 60 mm, unstable angina or acute myocardial infarction within the last 3 months, cardiac revascularization procedure within the last 6 months, prior cardiac surgery or planned cardiac corrective surgery within 1 year, prior AF ablation procedure. The primary endpoint is general health-related quality of life at 12 months follow-up. The main secondary endpoints are morbidity and mortality as composite outcome, cardiovascular hospitalization, symptoms, heart failure, left atrial and ventricular function and diameters, exercise capacity, health care economics, rhythm, atrial fibrillation burden, successful versus failed treatment, safety and "cross-overs" over time. Patients will receive a cardiac monitor, implanted subcutaneously, which will monitor the heart rhythm during a two month "Run-in" period, for the definition of the basic atrial fibrillation burden. Patients will be randomly assigned to an antiarrhythmic drug (for rhythm or rate control) or to left atrial catheter ablation. Evaluation of outcome is at 12, 24, 36 and 48 months of follow-up, while health economy will be evaluated at 24 and 48 months of follow-up.. In case of documented disease progression or unacceptable toxicity, subjects will be switched to the alternative regimen. The main statistical analysis of the primary endpoint will be based on the intention-to-treat population. The trial duration is 48 months.
Prospective and explorative clinical study. The objective is to assess the clinical efficacy of pulmonary vein isolation using the Arctic Front Advance cryoballoon in patients with longstanding persistent atrial fibrillation (AF) at one year follow up. 44 subjects will be enrolled. Patients with longstanding persistent AF, with continuous AF duration longer than one year, who have not previously undergone an AF ablation procedure, and have symptoms related to AF corresponding to at least European Heart Rhythm Association (EHRA) score 2, will be studied. Patients should have failed at least one betablocker or class I or III antiarrhythmic drug. Excluded are those with congestive heart failure with New York Heart Association (NYHA) class 3 or more, left ventricular ejection fraction < 40%, left atrial diameter ≥ 60 mm, significant valvular disease or planned cardiac intervention within next 12 months, and conventional contraindications for AF ablation procedures. Patients will be screened with echocardiography and response to electrical cardioversion. Following conversion to sinus rhythm, amiodarone will be initiated to maintain sinus rhythm. Pulmonary vein isolation will be performed using the Arctic Front Advance cryoballoon ablation catheter. Pulmonary vein conduction block will be assessed by a circular mapping catheter. All patients will be subject to electroanatomical voltage mapping during sinus rhythm for demonstration of extent of atrial myocardial lesions after ablation. Patients will be followed every third month up to one year after the ablation procedure. Arrhythmia monitoring during follow up will be performed by 7 day Holter monitoring at 6, 9 and 12 months follow up, including a 12 lead ECG. 12 months follow up for symptoms, EHRA score, and quality of life. Patients with symptomatic recurrence requiring a redo ablation procedure will be re-studied after 8-12 months while asymptomatic patients will be studied at 12 months follow up. Primary end-Point is Clinical success based on symptoms and presence of AF. Secondary end-Points include freedom from AF without antiarrhythmic drugs at 6 and 12 months according to 7 day Holter and ECG, Rhythm, AF burden, AF profile, Quality of Life, Symptoms, Adverse Events, atrial size and function, Biomarkers, extent of scar tissue, predictive factors of freedom from AF, complications, hospitalization and Health economics.
The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).
This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.
Although obstructive sleep apnea (OSA) is common, most of the patients are undiagnosed. OSA is associated with a large number of co-morbidities, and thus, it is of great importance to identify the patients and start treatment in order to reduce the risks for complications. Current screening tools are quite unspecific and the golden standard methodology for diagnosis, polysomnography, is expensive and time consuming, thus not suitable for screening. In perioperative medicine the STOP BANG screening questionnaire is currently the recomended screening tool, however this questionnaire has only been evaluated in a sleep clinic in a very limited numbers of patients.
The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome [NSTE-ACS]).
The purpose of this study is to test and refine, a subject questionnaire aimed to be used in a general population rosacea prevalence study.
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is not associated with significant adverse outcomes in early childhood. The enrolled infants and children will be followed at pre-specified intervals until they reach 24 months chronological age. This study does not require medical interventions or study visits to an investigational site, instead, parents or legal guardians will be prompted at certain time points to complete developmental questionnaires and other data on their children's health status via an electronic device. Data collected during the infant and child follow up study will be managed by a centralized research coordinating center (RCC). Regionally based pediatricians will serve as study principal investigators (referred to as RCC-PIs) for this study. All communications the RCC-PI has with the parent/legal guardian or the child's health care provider (HCP) will occur remotely; there will be no clinic visits.
The primary objective of this study is to demonstrate the superiority of retosiban to prolong pregnancy in females with spontaneous preterm labor compared with atosiban. This objective is based on the hypothesis that prolonging the time to delivery in the absence of harm may benefit the newborn, particularly in women who experience spontaneous preterm labor at early gestational ages (GA). This study is designed to test this hypothesis through a direct comparison with atosiban, a mixed oxytocin vasopressin antagonist indicated for short-term use to delay imminent preterm birth in women between 24^0/7 and 33^6/7 weeks' gestation in preterm labor. This is a randomized, double-blind, double-dummy study, which consists of 6 phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post Delivery Assessment, and Neonatal Medical Review. Approximately 330 females will be randomly assigned to retosiban or atosiban treatment in a 1:1 ratio. The duration of any one subject's (maternal or neonatal) participation in the study will be variable and dependent on GA at study entry and the date of delivery.