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NCT00247351 | Prevention of Atrial Tachycardia After a Right Atriotomy | Atrial Tachycardia We performed a prophylactic peroperative linear 1-minute cryolesion connecting the tricuspidannulus and right atriotomy to prevent IART on 15 consecutive adult patients undergoingsurgery for congenital heart disease. Conduction time between electrodes placed on bothsides of the cryolesion was measured on the second postoperative day. Coronary angiographyand electrophysiology study using an electroanatomic mapping system to assess conductionacross the line were performed three month after the operation on 13 patients. Inclusion Criteria:Consecutive patients operated in the Department of Cardiothoracic Surgery, AarhusUniversity Hospital at Skejby were included. Inclusion criteria were: 1. Clinicalindication for corrective operation for congenital heart disease with the use of a rightlateral atriotomy, 2. Age >18 years, 3. Ability to give an informed consent.Exclusion Criteria:Acute operation. |
NCT00247806 | Prevalence of Lactose Intolerance Following Stem Cell Transplantation | Lactose Intolerance It is currently assumed that all patients are lactose intolerant post bone marrowtransplantation. This pilot study is to assess what the incidence of lactose intolerance isafter bone marrow transplantation in children. This will be done using a lactose breathtest. Inclusion Criteria:- All patients planned to undergo a stem cell transplant.Exclusion Criteria:- Refusal to participate- Unable to perform breath tests on request (generally under the age of 4 years.) |
NCT00247741 | Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery. | Spinal Anesthesia The purpose of this study is to compare two short-acting local anesthetics, articaine andlidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- andmotor block, recovery time until discharge and complications will be studied. Inclusion Criteria:- Age > 18 years- ASA I-III- Patients planned for a short surgical procedure on lower extremities or lowerabdomen.- Procedure in day-case setting- Procedure under spinal anesthesia- Informed consentExclusion Criteria:- Contra-indications spinal anesthesia- History of allergic reactions on amide-type local anesthetics- Pregnancy |
NCT00247780 | Cavotricuspid Isthmusblock and Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation | Atrial Fibrillation Atrial fibrillation (AF) is the most common cardiac arrhythmia. Pulmonary vein isolation(PVI) in the left atrium using radiofrequency energy is a new and promising non-medicaltreatment in patients with symptomatic AF with reported success rates of 65 % to 90 %depending on AF classification and ablation procedure. However, the risk of recurrence hasled to suggestions of how to improve the clinical outcome by tailoring a more efficientablation procedure. A prospective, randomised study with 150 patients with symptomatic AFreferred for PVI has been initiated and patients are allocated to PVI alone (75 patients) orPVI with additional ablation in the right atrium (75 patients). Patients undergo extensivemonitoring of the heart rhythm during follow-up to document symptomatic or asymptomatic AFor atrial flutter. The presence of asymptomatic AF after PVI could potentially affect themanagement of the anticoagulation therapy in these patients. The structural and functionalchanges in the atria after PVI is characterized by new imaging techniques (Tissue DopplerImaging(TDI))of the atria and cardiac neurohormones. TDI may be an effective tool forcharacterising changes in the left atrial function after PVI. Neurohormones may provide newinformation regarding the changes in left atrial function and clinical outcome after PVI inpatients with AF.We hypothesize that:- Among patients with predominant atrial fibrillation, PVI with additional ablation inthe right atrium is associated with better outcome, i.e. freedom of symptomaticAF/atrial flutter overall.- Asymptomatic AF and atrial flutter occur frequently after PVI.- Left atrial volume and systolic function correlates to AF recurrence after PVI.- Neurohormones levels correlates to AF recurrence after PVI. Inclusion Criteria:- Documented symptomatic paroxysmal or persistent atrial fibrillation where medicaltreatment has proven inefficient or related to sideeffects.Exclusion Criteria:- Prior cavotricuspid isthmus ablation (for atrial flutter) Significant valvular heartdisease Congestive heart failure (NYHA class 3-4) Contraindications to antithrombictreatment with Warfarin |
NCT00247637 | The Genetic Basis of Inherited Neurologic Deficits in People With Schizophrenia | Schizophrenia This is a study of the genetic basis of brain dysfunction in people with schizophrenia. Inclusion Criteria for Participating Families:- Families with at least one member who has schizophreniaExclusion Criteria: |
NCT00247390 | Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia. | Chronic Insomnia The purpose of this study to determine the long-term efficacy and safety of ramelteon, oncedaily (QD). Inclusion Criteria- Females of childbearing potential who are sexually active must agree to use adequatecontraception, and can neither be pregnant nor lactating from Screening throughoutthe duration of the study.- Body mass index between 18 and 34, inclusive.- Based on sleep history, has had chronic insomnia for at least 3 months.- Based on sleep history, reports a subjective sleep latency greater than or equal to45 min and a subjective total sleep time less than or equal to 6.5 hours.- Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM.- Mean latency to persistent sleep of greater than 20 minutes on two consecutivescreening nights with neither night less than 15 minutes. Also, a mean of 60 minutesof wake time during the 480 minutes in bed across two nights with no night less than45 minutes.- Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4times per week in the last 3 months.Exclusion Criteria- Known hypersensitivity to ramelteon or related compounds, including melatonin, andmelatonin related compounds.- Participated in any other investigational study and/or taken any investigational drugwithin 30 days or five half-lives prior to the first dose of single-blind studymedication, whichever is longer.- Sleep schedule changes required by employment (eg, shift worker) within three monthsprior to the administration of single-blind study medication.- Flown across greater than three time zones within 7 days prior to or duringscreening.- Participated in a weight loss program or has substantially altered their exerciseroutine within 30 days prior to the administration of single-blind study medication.- Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic legmovement syndrome, chronic obstructive pulmonary disease or fibromyalgia.- History of psychiatric disorder within the past 6 months.- History of alcohol abuse within the past 12 months, as defined in Diagnostic &Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumesmore than 14 alcoholic drinks per week, or consumed any alcoholic drinks within 24hours of any polysomnogram visits.- History of drug abuse within the past 12 months, as defined in Diagnostic &Statistical Manual of Mental Disorders, 4th Edition Revised.- Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal,pulmonary, hematologic, neurological, or metabolic disease, unless currentlycontrolled and stable with protocol-allowed medication, within 30 days prior to thefirst night of single-blind study medication.- Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the firstpolysomnogram screening night.- Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10as seen on the first polysomnogram screening night.- Positive urine drug screen at Screening Visit 1 or any of the polysomnogramassessment visits.- Positive breathalyzer test on any of the polysomnogram assessment visits.- Uses tobacco products (including nicotine gum and patch) or any other products thatmay interfere with the sleep wake cycle during nightly awakenings.- Used any central nervous system medication or other drugs or supplements known toaffect sleep/wake function within 1 week (or 5 half lives of the drug, whichever islonger) prior to the administration of single-blind study medication. Thesemedications must not have been used to treat psychiatric disorders.- Intends to continue taking any disallowed medication or any prescription medicationor over the counter medication that is known to affect the sleep/wake function orotherwise interfere with evaluation of the study medication. The subject must reportall prescription and over the counter medications taken in the three weeks prior toscreening.- Is required to take or continues taking any disallowed medication, prescriptionmedication, herbal treatment or over-the counter medication that may interfere withevaluation of the study medication, including:- Anxiolytics- Sedatives- Hypnotics- CNS active drugs (including herbal)- Antidepressants- Narcotic analgesics- Anticonvulsants- Beta blockers- Sedating H1 antihistamines- St. John's Wort- Systemic steroids- Kava-kava- Respiratory stimulants- Ginkgo-biloba- Decongestants- Over-the-counter and prescription stimulants- Antipsychotics- Over-the-counter and prescription diet aids- Muscle Relaxants- Melatonin and all other drugs or supplements known to affect sleep/wake function- Any additional condition(s) that in the Investigator's opinion would- affect sleep/wake function- prohibit the subject from completing the study- indicate that continuation in the study would not be in the best interests ofthe subject.- History of hepatitis B or hepatitis C. |
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