Active Control

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:215c42a2f80f5d2cc7c981e367f21e84' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy. In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test, CobaSorb. .</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:215c42a2f80f5d2cc7c981e367f21e84' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6b1e8dbfa46197c0f3f5c07dbea30488' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The Absorption of Vitamin B12 Among Healthy Pregnant Women</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:6b1e8dbfa46197c0f3f5c07dbea30488' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c88f800fd75690a01ddb1fe70d318717' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>the 13 week of gestation +/- 1 week (only fore pregnant women)</li>\n<li>Between 20- 40 years</li>\n<li>Northern European</li>\n<li>abel to read and understand danish</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>treatment with vitamin B12 within the last 5 years</li>\n<li>daily intake of vitamins that contain more than 1&#181;g vitamin B12</li>\n<li>infectious disease</li>\n<li>systemic disease</li>\n<li>daily use of medicine that interferes with vitamin B12</li>\n</ul>\n</p>', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:c88f800fd75690a01ddb1fe70d318717' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9d07717d067d19ab36ce534149ccd9ec' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians\' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom. Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen was available only in tablets suspension and as a liquid gel. All these dosage form are administered orally. Rectal suppositories are often essential for treating febrile children who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:9d07717d067d19ab36ce534149ccd9ec' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:663405a9dd82be58a1f1ffc3c3c80176' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to research a new implant for the treatment of external nasal valve collapse (NVC). NVC is a condition which causes narrowness and weakness in the nostril which results in nasal obstruction. Implants will be placed in the affected nostril(s). The implants are intended to restore the shape and stabilize the nasal wall to prevent nasal valve collapse and improve the symptoms associated with nasal obstruction.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:663405a9dd82be58a1f1ffc3c3c80176' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7ed4984b8989d48555718f63bd690197' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Open Label, Baseline Controlled Study to Evaluate the Use of Polyethylene Terepthalate (PET) Implants for the Treatment of External Nasal Valve Collapse and Cosmetic Contour Deformity</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:7ed4984b8989d48555718f63bd690197' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:71ae072517042237d9e93addcff736d7' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study is designed to evaluate a new polyethylene terepthalate implant for the treatment of uni-lateral and bilateral external nasal valve collapse and cosmetic contour deformity. The focus of this investigation will be to specifically address the lateral components of nasal valve collapse caused by weakened, distorted, or absent mechanical strength of the nasal cartilages or their fibrous attachments within the lateral nasal sidewall and nasal ala. The paired upper and lower cartilages within the lateral nasal sidewall have several features worth noting which contribute to the loss of support and are important to account for during surgical correction. The Primary Hypothesis, regarding safety and effectiveness, is as follows: The polyethylene terepthalate (PET) implants when inserted into the area of the compromised external nasal valve will result in improved nasal obstruction symptoms (static and dynamic external valve obstruction), improved cosmetic contour, and an adverse event profile that is no worse than currently available treatments.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:71ae072517042237d9e93addcff736d7' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:90d886cf77eaf154415ee3b173eef9ae' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Positive response to any of the following based on patient history or office exam:\n<ul>\n<li>Breathe Rite Strips</li>\n<li>Q-Tip test</li>\n<li>Nasal stents</li>\n<li>Continuous manual distraction</li>\n</ul>\n</li>\n<li>Inspiratory lateral nasal wall collapse or static medially obstructing lateral nasal wall position identified on physical exam</li>\n<li>Nasal valve is narrow (either static or dynamic) based on a visual examination.</li>\n<li>Nasal septum is considered stable and adequate to support the treatment of each nasal valve independently.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Ability to achieve active nostril dilation and relieve obstruction using physiologic nasal alar and sidewall muscle actions</li>\n<li>Chronic or recurrent sinusitis leading to nasal obstruction</li>\n<li>Active nasal infection</li>\n<li>Skin inflammation in the nasal area</li>\n<li>Habitual chronic sniffers</li>\n<li>Allergies leading to nasal obstruction</li>\n<li>Septal Deviation believed to be causing obstruction</li>\n<li>Turbinate Hypertrophy believed to causing obstruction</li>\n<li>Polyps believed to causing obstruction</li>\n<li>Previous rhinoplasty of external nasal frame</li>\n<li>Ptotic Nose Tip believed to be causing obstruction</li>\n<li>Requires another surgery other than implants to correct the obstruction</li>\n<li>Nasal anatomy is inadequate to accommodate three 18mm implants</li>\n<li>Participating in a clinical study for another treatment for nasal valve collapse</li>\n<li>Previous surgery for external nasal valve collapse</li>\n<li>ASA rating of III or IV</li>\n<li>Any other condition believed to interfere with nasal assessments</li>\n</ul>\n</p>', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:90d886cf77eaf154415ee3b173eef9ae' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:2cb8622e81e1e3185d9f705ecbe96ebb' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:2cb8622e81e1e3185d9f705ecbe96ebb' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cbc8fdeac8bcbbad800156a4877d3b88' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:cbc8fdeac8bcbbad800156a4877d3b88' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:f59c6217e8a9c54df01a64c4926d119c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Key Inclusion Criteria:\n<ul>\n<li>Have signed the informed consent form and the HIPAA patient information form (United States only)</li>\n<li>Are &#8805; 18 years of age</li>\n<li>Are a transplant recipient of at least one HLA-mismatch kidney</li>\n<li>For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method</li>\n</ul>\n</p><p> Key Exclusion Criteria:\n<ul>\n<li>Have a history of previous renal transplant</li>\n<li>Have had a PRA &gt; 25% at any time</li>\n<li>Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ</li>\n<li>Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum</li>\n<li>Have had previous treatment with efalizumab</li>\n<li>Have used any investigational drug within 28 days or 5 half-lives of screening, whichever is longer</li>\n<li>Have a known contraindication to efalizumab</li>\n<li>Have a history of severe allergic or anaphylactic reactions to monoclonal antibodies</li>\n<li>Have had a known allergic reaction or intolerance to any of the following medications: CsA; MMF; Corticosteroids; Basiliximab</li>\n<li>Are allergic to iodinated contrast media that would preclude GFR measurement with iothalamate</li>\n</ul>\n</p>', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:f59c6217e8a9c54df01a64c4926d119c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:3ce7401da8bf251028525de271086b27' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Glomerular filtration rate [&nbsp;Time&nbsp;Frame:&nbsp;12 and 52 weeks&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:3ce7401da8bf251028525de271086b27' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:de8abdb02b71b3405719902287bf9f2f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change in glomerular filtration rate [&nbsp;Time&nbsp;Frame:&nbsp;12 weeks to 52 weeks&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:de8abdb02b71b3405719902287bf9f2f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:464e8faa426b6efbfb08bd7cd8aeba13' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Transplant renal biopsies [&nbsp;Time&nbsp;Frame:&nbsp;52 weeks&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:464e8faa426b6efbfb08bd7cd8aeba13' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:2e7a69b7419503783982f0bd99c19b67' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Change in metabolic/cardiovascular risk factors [&nbsp;Time&nbsp;Frame:&nbsp;24 weeks and 52 weeks&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:2e7a69b7419503783982f0bd99c19b67' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:2b1046d47d1ddc5ca5ac238fe2a6fd87' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF &#8804; 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:2b1046d47d1ddc5ca5ac238fe2a6fd87' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e7deef639095bc25a6e1345297b2da6b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:e7deef639095bc25a6e1345297b2da6b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d17b98f6bae084ff37504b43c94a5177' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>All patients will receive an implantable cardioverter defibrillator OVATIO&#8482; DR model 6550 or a later Sorin Group device offering the same functions. After Enrolment visit but before implant, patients will be randomized in two arms according to the parallel study design. Whenever possible before implant there will be the first Holter recording for the Tvar risk stratification procedure. In case Tvar recording could not be performed before implant it has to be performed before patient leaves the hospital post implant in unpaced rhythm. The dual-chamber arm will be programmed to 3 detection zones with PARAD+ activated. The TDI for the slow VT zone will be set to 500 ms (120 bpm - or in case the resting rate is higher than 90 bpm it is recommended to adjust this parameter to: resting rate + 30 bpm) and at least one ATP program activated as specified in table 1. A VT zone with a TDI of 353 ms (170 bpm) in case of no history of VT or a TDI cycle length equalling slowest documented VT interval (spontaneous or induced) plus 50 ms is required. In this 2nd VT zone therapies need to be activated in this group. AAIsafeR2 mode will be activated with a basic rate of 60 bpm. The single-chamber arm will be programmed to optimal detection with Acceleration (Onset), Stability and Long Cycle Search (VTLC) activated. A VT zone is requested in this group, with the same programming procedures as described above. Therapies will be set according to the clinical judgment of the participating investigators but a Slow VT-zone with TDI 500 ms in monitoring setting at least is required.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:d17b98f6bae084ff37504b43c94a5177' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7d52f0448cc6a623b2a324ebaf2f527a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system</li>\n<li>Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) &#8804; 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.</li>\n<li>An optimal (as determined by the enrolling physician) medical regimen.</li>\n<li>Patient has received all relevant information on the study, and has signed and dated a consent form.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.</li>\n<li>Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.</li>\n<li>Any contraindication for ICD therapy and the implant of a dual chamber ICD.</li>\n<li>ICD replacement</li>\n<li>Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.</li>\n<li>A PR interval &gt; 250 ms or AR interval &gt; 300 ms measured at implant.</li>\n<li>Hypertrophic obstructive cardiomyopathy.</li>\n<li>Acute myocarditis.</li>\n<li>Unstable coronary symptoms or myocardial infarction within the last month.</li>\n<li>Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.</li>\n<li>Recently performed (in the last month) or planned cardiac surgery</li>\n<li>Already included in another clinical study.</li>\n<li>Life expectancy less than 24 months.</li>\n<li>Inability to understand the purpose of the study or refusal to cooperate.</li>\n<li>Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.</li>\n<li>Unavailability for scheduled follow-up at the implanting or cooperating center.</li>\n<li>Age of less than 18 years.</li>\n<li>Pregnancy</li>\n</ul>\n</p>', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:7d52f0448cc6a623b2a324ebaf2f527a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:f15c67d7a38c5ccca048efab83df87f4' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>all cause mortality and cardio-vascular related mortality [&nbsp;Time&nbsp;Frame:&nbsp;27 months follow up&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:f15c67d7a38c5ccca048efab83df87f4' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:19da3876a45a2e7f4792ff8a5d074238' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Hospitalizations due to cardio-vascular event (specified for each type of event) [&nbsp;Time&nbsp;Frame:&nbsp;27 months follow up&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:19da3876a45a2e7f4792ff8a5d074238' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ff9bdbcf20043cd8e343145c704b6c4c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Time to first occurrence of inappropriate ICD shock therapy [&nbsp;Time&nbsp;Frame:&nbsp;27 months follow up&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:ff9bdbcf20043cd8e343145c704b6c4c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:017a47200374981a0edb42a8e56d61cd' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Evaluation of the impact of the different therapies on quality of life and heart failure status [&nbsp;Time&nbsp;Frame:&nbsp;27 months follow up&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:017a47200374981a0edb42a8e56d61cd' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5a9e7917b85a9ac3f660ff7130a4b73a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group. [&nbsp;Time&nbsp;Frame:&nbsp;27 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:5a9e7917b85a9ac3f660ff7130a4b73a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:958f8576a8c0a4007a02c917e8994111' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>time to first documented AF occurrence and number of patients moving into permanent or persistent AF [&nbsp;Time&nbsp;Frame:&nbsp;27 months follow up&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:958f8576a8c0a4007a02c917e8994111' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6eecc5f84463105feb9e990e081b5be7' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups [&nbsp;Time&nbsp;Frame:&nbsp;Baseline and 27 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:6eecc5f84463105feb9e990e081b5be7' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7b36ffc1d7a09e5f924787efad792cca' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Slow VT incidence [&nbsp;Time&nbsp;Frame:&nbsp;27 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:7b36ffc1d7a09e5f924787efad792cca' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:db7f6afe3feef4e4cdf96c5e92294e09' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Unscheduled visits and hospitalizations due to slow VT [&nbsp;Time&nbsp;Frame:&nbsp;27 months follow up&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:db7f6afe3feef4e4cdf96c5e92294e09' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:622c6785643b9554547ef23d0effc3c5' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing. [&nbsp;Time&nbsp;Frame:&nbsp;27 months follow up&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:622c6785643b9554547ef23d0effc3c5' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:accfd5923b466ef458544c17db429613' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Overall success rate of ATP in the FVT zone [&nbsp;Time&nbsp;Frame:&nbsp;27 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:accfd5923b466ef458544c17db429613' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:09afa89674633dc3ff8fec019031364d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Cost effectiveness of applied ICD therapy [&nbsp;Time&nbsp;Frame:&nbsp;27 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:09afa89674633dc3ff8fec019031364d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:09daedbd0d96b110774fbfbb19225524' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>PPV and NPV for Tvar risk stratification [&nbsp;Time&nbsp;Frame:&nbsp;27 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:09daedbd0d96b110774fbfbb19225524' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dc4bcaead478f9551df99c6a40f36444' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>To demonstrate the efficacy/safety of FOSAMAX PLUS D.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:dc4bcaead478f9551df99c6a40f36444' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5a17355d046085a5e0bf0e48b49b2f96' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Phase IV (Phase V Program), Prospective, Randomized, Open-Label, Active-Controlled, Clinical Trial to Study the Efficacy and Safety of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:5a17355d046085a5e0bf0e48b49b2f96' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a96c419049b8910de0c6df1964d421f6' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Patient has a spine or hip anatomy suitable for dual-energy x-ray absorptiometry</li>\n<li>Patient has been postmenopausal defined as\n<ul>\n<li>A) greater than and equal to 1 year beyond the lmp (last menstrual period) in women greater than and equal to 50 years of age with who did not received hysterectomy</li>\n<li>B) serum fsh greater than and equal to 30 iu/l in women who underwent hysterectomy</li>\n<li>C) post bilateral oophorectomy</li>\n</ul>\n</li>\n<li>Patient has serum 25(oh)d greater than and equal to 9 ng/ml.</li>\n<li>Patient with mean serum 25(oh)d is greater than and equal to 9 ng/ml, but not higher than 15 ng/ml (in 2 assay) is required to have serum pth and total alkaline phosphatase within the reference range</li>\n<li>Patient is suitable for treatment with oral bisphosphonate.</li>\n<li>Patient meets one of the following:\n<ul>\n<li>A) patient is a candidate for osteoporosis therapy with bisphosphonates, has bmd t-score less than and equal to 2.5 at at least one of testing locations including total hip, spine and femoral neck,</li>\n<li>B) patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or pth), has bmd t-score less than and equal to 2.0 and have 1 prior vertebral fracture (l1-l4),</li>\n<li>C) patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or pth), have greater than and equal to 2 prior vertebral fracture (l1-l4), or note: eligibility for this criterion is based on spine or femoral (neck or total) bmd</li>\n</ul>\n</li>\n<li>Patient understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to use sun cream and limit direct solar exposure in a hour/day for 16 weeks and participate by giving a written informed consent</li>\n<li>Patient with pth higher than 72 ng/l at baseline will be excluded, however, a 10 % variance would be allowed</li>\n</ul>\n</p><p> Exclusion criteria:\n<ul>\n<li>Patient has or has had a history of malignancy or active systemic diseases less than 5 years prior to signing informed consent</li>\n<li>Patient with abnormalities of the esophagus that delay esophageal emptying</li>\n</ul>\n</p>', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:a96c419049b8910de0c6df1964d421f6' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7497cd6c90908763c1bf8b8a4c09dd5d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The Jump-In study will prospectively assess the effects of impact exercise on skeletal development in young girls, including bone mass, bone mineral density, and bone geometry. We hypothesize that girls who regularly participate in impact loading exercise will accrue greater skeletal mass, increase bone density and undergo structural adaptations that in combination will improve bone strength compared to girls who do not participate in impact exercise.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:7497cd6c90908763c1bf8b8a4c09dd5d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:1b8dd8a85e9059be6ccd1a16471e1566' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Exercise and Bone Development in Young Girls</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:1b8dd8a85e9059be6ccd1a16471e1566' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:31e6a377d0f001984b933c9393e0b37f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Jump-In is a school-based, block-randomized, trial of the effects of impact-loading exercise on skeletal development in prepubescent and early pubescent girls. Fourth (n=~200) and sixth (n=~200) grade girls in 14 Tucson (Arizona) schools with no contraindication to physical exercise will be enrolled. Girls in intervention schools will participate in impact activities 3 times per week at school, progressively increasing the number (up to 40) of jumps and their height (from 6 inches to 18 inches per repetition) over the initial 2 months. Thereafter, new activities will be introduced approximately every 2-3 months to maintain interest and motivation, and continually stress the skeleton in novel ways, over 2 years of intervention. Physical and behavioral assessments will be done in both intervention and control groups at baseline, end of the initial school year, and yearly thereafter for 5 years. Assessments include height and weight, selected skeletal lengths, fat, lean soft tissue, bone mineral content and areal density from dual energy x-ray absorptiometry (DXA), and bone geometry (e.g., cortical thickness, periosteal circumference and cortical and trabecular density) and muscle area from peripheral quantitative computed tomography (pQCT). Also, maturation will be assessed via the Tanner Stage (self-assessment against standardized drawings of stages of physical development), diet from the Harvard Youth Food Frequency Questionnaire, and physical activity using pedometers and standardized questionnaires. We hypothesize that girls in intervention schools will demonstrate enhanced skeletal development, including greater mineral mass and density, and enhanced bone geometry, leading to greater bone strength compared to girls in control schools. We further hypothesize that younger (Tanner State 1) girls will experience greater adaptations than older girls (Tanner 2 and 3), and that positive adaptations will be maintained throughout the 3-year follow-up period.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:31e6a377d0f001984b933c9393e0b37f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b88bd80b1b63c9d1763aa6fac0fc4b74' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria: female; entering 4th or 6th grade at enrollment; and willing and able to undergo all of the testing requirements; no physical activity limitations; able to read and write English. Exclusion Criteria: Girls with severe learning disabilities (identified by schools), who are unable to complete questionnaires or otherwise comply with assessment protocols will be excluded. Any subjects (or potential subjects) suffering from medical conditions and/or disabilities that would limit their participation in exercise will be excluded from the study, following the American Academy of Pediatrics (AAP) guidelines. Further, any volunteers who are taking medications that would limit exercise and/or alter bone mineral accrual will also be excluded from the study. Girls with a positive pregnancy screening test at the time of the lab visit before DXA scanning will be excluded.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:b88bd80b1b63c9d1763aa6fac0fc4b74' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:aae29a526e48778f8a8d46359eca1bb4' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators\' eating style is closing to Western world. Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:aae29a526e48778f8a8d46359eca1bb4' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:3ee28aa6cf3585857a5c5ebb7bfd39d9' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Role of Mosapride in Patients With Gastroesophageal Reflux Disease</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:3ee28aa6cf3585857a5c5ebb7bfd39d9' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:1c470c2ec317ebe475cca88f3146ea46' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study. This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month. Another fifty patients receive lansoprazole 30 mg once plus placebo tid daily in the first month; and lansoprazole 30 mg once plus mosapride 5 mg tid daily in the second month.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:1c470c2ec317ebe475cca88f3146ea46' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6e3f97b1663ab2f5e5b1e3cc59b140c6' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Aged between 18 and 90 years old</li>\n<li>Outpatients</li>\n<li>Characteristic GERD symptoms: acid regurgitation, heart burn, or belching</li>\n<li>Erosive esophagitis on upper digestive endoscopy, based on Los Angeles classification</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>History of allergy to lansoprazole or mosapride</li>\n<li>Pregnant or lactating women</li>\n<li>Uremia</li>\n<li>Decompensated liver disease</li>\n<li>Age under 18 and over 90 years-old</li>\n<li>Lack of informed consent</li>\n</ul>\n</p>', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:6e3f97b1663ab2f5e5b1e3cc59b140c6' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:3c98015abb925a65fd01b5820927bb95' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:3c98015abb925a65fd01b5820927bb95' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:33ab2b184b8af9eb4c6006af1d24e399' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Comparison of the Effect of Exenatide vs. Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:33ab2b184b8af9eb4c6006af1d24e399' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8d2f43143d67bdb1308fa54b762d86e5' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Have type 2 diabetes</li>\n<li>Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.</li>\n<li>Have a fasting glucose concentration &lt;280 mg/dL at Visit 1</li>\n<li>Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.</li>\n<li>Are between 18 and 70 years of age, inclusive.</li>\n<li>Have body mass index &#8805;25 kg/m2 and &#8804;45 kg/m2.</li>\n<li>Have a history of stable body weight (not varying by &gt;10% for at least 3 months prior to screening).</li>\n<li>Can swallow oral study drug capsule, without splitting or crushing.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:\n<ul>\n<li>Are breastfeeding.</li>\n<li>Test positive for pregnancy at the time of screening.</li>\n<li>Intend to become pregnant during the study.</li>\n<li>Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant&#174;; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.</li>\n</ul>\n</li>\n<li>Treated with any of the following medications:\n<ul>\n<li>Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening</li>\n<li>Alpha-glucosidase inhibitor within 2 months of screening.</li>\n<li>Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.</li>\n<li>Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1.</li>\n<li>Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.</li>\n</ul>\n</li>\n<li>Have a history of renal transplantation or are currently receiving renal dialysis.</li>\n<li>Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.</li>\n<li>Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.</li>\n<li>Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.</li>\n<li>Have had organ transplantation.</li>\n<li>Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 3 months.</li>\n<li>Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.</li>\n</ul>\n</p>', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:8d2f43143d67bdb1308fa54b762d86e5' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone. The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable. All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:\n<ul>\n<li>Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm)</li>\n<li>VT detection rate: 150 bpm</li>\n</ul>\n</p><p> PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones. The Fast VT and VF limits are left to investigator\'s judgment. Therapy on VT, fast VT and VF are also left to the investigator\'s judgment. Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:79168775f3d3a5a91d37ff535b26ff46' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Biventricular Tachycardias Outcome Trial</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:995aa30af6ecb1e254a3fad4853da32b' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d69ff314021388e8629d29000310310a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix &#167;M.10) or ESC 16 (Update 2005, Appendix &#167; M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.</li>\n<li>Patient has signed a consent form after he/she received the appropriate and mandatory information.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Clinical history of symptomatic or not symptomatic slow VT;</li>\n<li>Permanent Atrial Fibrillation (AF);</li>\n<li>Any contraindication to the implant or replacement of CRT-ICD;</li>\n<li>Pt is unable to attend the scheduled f-up visits at the implanting Centre;</li>\n<li>Pt is already included in another ongoing clinical study;</li>\n<li>Pt is unable to understand the objectives of the ITAC04 study;</li>\n<li>Pt refuses to cooperate;</li>\n<li>Pt is unable or refuses to provide informed consent;</li>\n<li>Pt is minor (less than 18-year old);</li>\n<li>Pt has life expectancy of less than 1 year;</li>\n<li>Pt is pregnant.</li>\n</ul>\n</p>', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:d69ff314021388e8629d29000310310a' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts; [&nbsp;Time&nbsp;Frame:&nbsp;24 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:3afaf3c51a5863f6560e20ee45d841ae' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>ATP therapy efficacy on slow VTs conversion. [&nbsp;Time&nbsp;Frame:&nbsp;24 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:a26743b8537bb4473c2598a50e06b1e9' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Efficacy of ATP therapies on Slow VTs according to therapy setting (delivery in LV only, in RV only, or in LV+RV) [&nbsp;Time&nbsp;Frame:&nbsp;24 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:382c217d1147cef8fc0e9b5d2609ec39' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Tvar risk stratification [&nbsp;Time&nbsp;Frame:&nbsp;24 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:a4302cbb74ff656dbe1894c8d351e1b6' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&quot;unscheduled visits&quot; or &quot;hospital re-admissions&quot; due to slow VTs; [&nbsp;Time&nbsp;Frame:&nbsp;24 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:3c616af2e92141e60301eea1775bca74' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Incidence of adverse events (AEs) in the studied population [&nbsp;Time&nbsp;Frame:&nbsp;24 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283574979, expire = 1283661379, headers = '', serialized = 0 WHERE cid = '1:8d704a44473254d10e1a973e6a2c16e6' in /persistent/html/includes/cache.inc on line 109.

The Absorption of Vitamin B12 Among Healthy Pregnant Women

Recruitment status: 
Recruiting

During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy. In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test, CobaSorb. .

Background information
Trial ID: 
NCT00730093
Other unique IDs: 
BH12008
Official title: 

The Absorption of Vitamin B12 Among Healthy Pregnant Women

Detailed description: 

 

Number to be enrolled: 
102 patients

Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.

Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom. Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen was available only in tablets suspension and as a liquid gel. All these dosage form are administered orally. Rectal suppositories are often essential for treating febrile children who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.

Background information
Other unique IDs: 
091/08

Study to Evaluate the Use of Polyethylene Terepthalate (PET) Implants for the Treatment of External Nasal Valve Collapse (NVC)

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The purpose of this study is to research a new implant for the treatment of external nasal valve collapse (NVC). NVC is a condition which causes narrowness and weakness in the nostril which results in nasal obstruction. Implants will be placed in the affected nostril(s). The implants are intended to restore the shape and stabilize the nasal wall to prevent nasal valve collapse and improve the symptoms associated with nasal obstruction.

Background information
Trial ID: 
NCT00729781
Other unique IDs: 
925
Official title: 

Open Label, Baseline Controlled Study to Evaluate the Use of Polyethylene Terepthalate (PET) Implants for the Treatment of External Nasal Valve Collapse and Cosmetic Contour Deformity

Detailed description: 

This study is designed to evaluate a new polyethylene terepthalate implant for the treatment of uni-lateral and bilateral external nasal valve collapse and cosmetic contour deformity. The focus of this investigation will be to specifically address the lateral components of nasal valve collapse caused by weakened, distorted, or absent mechanical strength of the nasal cartilages or their fibrous attachments within the lateral nasal sidewall and nasal ala.

Number to be enrolled: 
72 patients
Acronym: 
NVC

A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation

Trial phase: 
Phase III
Recruitment status: 
Withdrawn

This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.

Background information
Trial ID: 
NCT00729768
Other unique IDs: 
ACD4230g
Official title: 

A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen

Detailed description: 

 

Number to be enrolled: 
200 patients

Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator (ICD) Patients Without Pacing Indications

Trial phase: 
Phase IV
Recruitment status: 
Recruiting

This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.

Background information
Trial ID: 
NCT00729703
Other unique IDs: 
OPTION - ITAC03
Official title: 

Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications

Detailed description: 

All patients will receive an implantable cardioverter defibrillator OVATIO™ DR model 6550 or a later Sorin Group device offering the same functions. After Enrolment visit but before implant, patients will be randomized in two arms according to the parallel study design. Whenever possible before implant there will be the first Holter recording for the Tvar risk stratification procedure. In case Tvar recording could not be performed before implant it has to be performed before patient leaves the hospital post implant in unpaced rhythm.

Number to be enrolled: 
450 patients
Acronym: 
OPTION

Efficacy and Safety Study of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis

Trial phase: 
Phase III
Recruitment status: 
Completed

To demonstrate the efficacy/safety of FOSAMAX PLUS D.

Background information
Trial ID: 
NCT00729651
Other unique IDs: 
2008_015
MK217A-263
Official title: 

A Phase IV (Phase V Program), Prospective, Randomized, Open-Label, Active-Controlled, Clinical Trial to Study the Efficacy and Safety of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis

Detailed description: 

 

Number to be enrolled: 
350 patients

Jump-In - Building Better Bones

Recruitment status: 
Recruiting

The Jump-In study will prospectively assess the effects of impact exercise on skeletal development in young girls, including bone mass, bone mineral density, and bone geometry. We hypothesize that girls who regularly participate in impact loading exercise will accrue greater skeletal mass, increase bone density and undergo structural adaptations that in combination will improve bone strength compared to girls who do not participate in impact exercise.

Background information
Trial ID: 
NCT00729378
Other unique IDs: 
HD050775
Official title: 

Exercise and Bone Development in Young Girls

Detailed description: 

Jump-In is a school-based, block-randomized, trial of the effects of impact-loading exercise on skeletal development in prepubescent and early pubescent girls. Fourth (n=~200) and sixth (n=~200) grade girls in 14 Tucson (Arizona) schools with no contraindication to physical exercise will be enrolled. Girls in intervention schools will participate in impact activities 3 times per week at school, progressively increasing the number (up to 40) of jumps and their height (from 6 inches to 18 inches per repetition) over the initial 2 months.

Number to be enrolled: 
400 patients

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Trial phase: 
Phase IV
Recruitment status: 
Completed

Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world. Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.

Background information
Trial ID: 
NCT00729339
Other unique IDs: 
OMCP-97-011
Official title: 

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Detailed description: 

This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study. This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month.

Number to be enrolled: 
114 patients

Comparison of the Effect of Exenatide Versus Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Trial phase: 
Phase IV
Recruitment status: 
Not yet recruiting

This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.

Background information
Trial ID: 
NCT00729326
Other unique IDs: 
H8O-US-GWCV
Official title: 

Comparison of the Effect of Exenatide vs. Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Detailed description: 

 

Number to be enrolled: 
64 patients

Biventricular Tachycardias Outcome Trial

Trial phase: 
Phase IV
Recruitment status: 
Recruiting

This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone. The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable. All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:

  • Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm)
  • VT detection rate: 150 bpm

PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones. The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment. Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.

Background information
Trial ID: 
NCT00729235
Other unique IDs: 
BITAC - ITAC04
Official title: 

Biventricular Tachycardias Outcome Trial

Detailed description: 

 

Number to be enrolled: 
404 patients
Acronym: 
BITAC
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