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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Paroxysmal Supraventricular Tachycardia A patient will be eligible for study participation if they meet all of the following 1. Has been diagnosed with PSVT by a medical professional, and reports having at least one previous episode of PSVT. For clarity, PSVT refers to episodic Supraventricular Tachycardia (SVT) that includes the atrioventricular (AV) node as a critical part of reentrant circuit. 2. Is at least 18 years of age; 3. Signed NODE-303 written informed consent 4. Women of child-bearing potential must be willing to use at least 1 form of contraception during the trial, and must be willing to discontinue from the study should they become or plan to become pregnant 5. Willing and able to comply with study procedures A patient will be excluded from the study if they meet any of the following 1. Patients with only a history of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g. atrial fibrillation, atrial flutter, intra-atrial tachycardia) are not eligible. Patients with a history of these tachycardias who are also diagnosed with PSVT are eligible. 2. History of allergic reaction to verapamil 3. Current therapy with digoxin, or any Class I or III antiarrhythmic drug. Patients may be eligible if these drugs are stopped at least five half-lives before the administration of etripamil NS. The only exception is amiodarone which must be stopped 30 days before enrollment. 4. History of ventricular pre-excitation, e.g., delta waves, Wolff Parkinson-White syndrome 5. History of a second or third-degree AV block 6. Symptoms of congestive heart failure New York Heart Association Class II to IV 7. Significant physical or psychiatric condition including alcoholism or drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of the patient, or impede the patient's capacity to follow the study procedures 8. History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope 9. Is pregnant or breastfeeding 10. Previously enrolled in a clinical trial for etripamil and received study drug 11. History of Acute Coronary Syndrome (ACS) or stroke within 6 months of screening 12. Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows: 1. <60mL/min/1.73m2 for patients <60 years of age; 2. <40mL/min/1.73m2 for patients ≥60 and <70 years of age c) <35mL/min/1.73m2 for patients ≥70 years of age
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 22.0-999.0, Arrhythmias, Cardiac Atrial Fibrillation Patients aged≥22 years at the time of screening will be included Patients with known cardiac arrhythmias; i.e. AF before and after cardioversion, hemodynamically stable Bradycardias, SVT and VT during EP procedures and implants can also be included Pregnancy
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Atrioventricular Node Arrhythmia Documented supraventricular tachycardia (SVT) Planned to undergo electrophysiology (EP) study and ablation PR interval on ECG <220ms (Group 1) or >220ms (Group 2) Pregnancy Age <18 years Inability to provide consent High likelihood of tachycardia mechanism other than AVNRT (e.g. Pre-excitation on surface ECG, atrial tachycardia)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 2.0-999.0, Inherited Cardiac Arrhythmias Long QT Syndrome Arrhythmogenic Right Ventricular Cardiomyopathy Brugada Syndrome Catecholaminergic Polymorphic Ventricular Tachycardia Inherited Heart Rhythm (IHR) patient with breakthrough symptoms on best medical care that does not warrant an ICD, or patient declines ICD Syncope or seizure that is suspected to be arrhythmic in nature with a Brugada pattern on ECG Long QT syndrome (LQTS)or Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) on beta blocker Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) with at least 2 minor or 1 major 2010 task force must be more than isolated disease causing gene positive 2. Asymptomatic IHR patient with extreme phenotype, does not warrant an ICD spontaneous persistent type 1 Brugada pattern macroscopic T wave alternates on resting ECG, Holter monitor or exercise test (especially Long QTS) QTc > 500 msec in LQTS, other than LQT1 persistent asymptomatic bidirectional couplets or non-sustained PMVT in CPVT with exercise on therapy (including beta blocker and flecainide) definite ARVC with some high risk feature (first degree relative with SCD, couplets or nsVT on Holter) 3. Double mutation carrier IAC patient (at least one definite and one probable disease causing) 4. Patient with class 1 indication for ICD who declines it (patient or parent declines, example: young patient with cardiac arrest) 5. High-risk Cardiac arrest survivors with preserved ejection fraction (CASPER) unexplained cardiac arrest (UCA) patients and family members, defined as 2 or more of 1) previous syncope suspected to be arrhythmic 2) exercise recovery QTc ≥455 msec 3) epinephrine 0.10 μg/kg/min Δ QT ≥30 msec 4) Valt>0, k>3during Holter9 5) QTVI >95th %ile (>-1) on Holter9. 6. High-risk patient not otherwise described above presented to an adjudication Committee with ≥75% consensus of risk. 7. Willing signed informed consent form 8. Ages 2 and over may participate (pediatric cases will be considered in Pediatric Centres only after the first 10 pilot cases are completed and reviewed by the DSMB Specialized pediatric procedures will be in developed by the pediatric clinicians) Unable or unwilling to give informed consent 2. ICD or pacemaker in place or considered preferable by the treating physician and/or patient/parent
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 20.0-999.0, Atrial Fibrillation patients with atrial fibrillation taking Elxaban (patients with age more than 19) 2. Patients who agree with study patients who do not agree with study 2. patients with age less than 19 3. Pregnancy, Breastfeeding
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-99.0, Cardiomyopathy, Dilated, 3B ≥ 18 years of age at the time of screening Documented non-ischemic HF with an LVEF ≤ 35 QRS≥130ms; NYHA class II-IV Signed written informed consent NT-proBNP above 200 pg/ml Uncorrected congenital heart disease or valve obstruction obstructive cardiomyopathy active myocarditis constrictive pericarditis untreated hypothyroidism or hyperthyroidism adrenal insufficiency active vasculitis due to collagen vascular disease Presence on the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent) Patients on the non-urgent waiting list for a heart transplant (UNOS category 2 or 7, or equivalent) are eligible for in the study Recipient of any major organ transplant (e.g., lung, liver, heart)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-85.0, NSTEMI - Non-ST Segment Elevation MI ACS - Acute Coronary Syndrome Acute onset (>1 hour) chest pain (or angina pectoris equivalent) suspected of non-ST-elevation myocardial infarction (NSTEMI) Hospital admission and scheduling for ICA Hs-cTn levels meeting the 'observe' (figure 2, p17) Age between 18 years years old Written informed consent Refractory angina or on-going severe ischemia requiring immediate ICA Patients requiring ICA < 24 hours after admission (see previous bullet) Hemodynamic instability and/or cardiogenic shock (mean arterial pressure <60 mmHg) Heart failure (Killip Class ≥ III) requiring intravenously medication (nitroglycerine, diuretics, etc.) ST-Elevation Myocardial Infarction (ST-elevation in 2 contiguous leads: ≥0.2mV in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new left bundle branch block) Symptoms highly suggestive of non-cardiac origin at presentation (as judged by the cardiac ED physician/cardiologist) Symptoms highly suggestive of AAD, PE, or acute peri-myocarditis Inability to organize ICA and CMR <72 hours after admission (especially for patients admitted on Friday evenings/nights (logistic restrictions) Life threatening arrhythmias prior to or during presentation (sustained ventricular tachycardia, repetitive non-sustained ventricular tachycardia, ventricular fibrillation, sinoatrial or atrio-ventricular block) Atrial fibrillation with persistent ventricular rate ≥100 beats per minute (bpm) after treatment
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Pulmonary Hypertension Right heart catheterization for PH diagnosis in Giessen informed consent missing
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Ventricular Tachycardia Myocardial Infarction Heart Disease Structural Disorder Structural heart disease: ischemic or non-ischemic cardiomyopathy diagnosed with cardiac imaging demonstrating either segmental myocardial dysfunction, or presence of scar, AND One of the following monomorphic VT events despite prior attempted catheter ablation (or contraindication for ablation), AND despite treatment with a class III antiarrhythmic drug (contraindicated, ineffective or not tolerated): A: Documented sustained monomorphic VT terminated by pharmacologic means, DC cardioversion or manual ICD Therapy. B: ≥3 episodes of monomorphic VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic C: ≥ 5 episodes of monomorphic VT treated with antitachycardia pacing (ATP) regardless of symptoms D: ≥1 appropriate ICD shocks, E: ≥3 monomorphic VT episodes within 24 hours ** VT events must be confirmed by ECG/monitor or ICD download Unable or unwilling to provide informed consent Have received prior radiotherapy to the likely treatment field Inotrope-dependent heart failure or an anticipated life-expectancy of < 1 year in the absence of VT Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF) Pregnancy Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Tachycardia, Ventricular Catheter Ablation Age >18 years. 2. Able to give written, informed consent 3. Structural heart disease. 4. Implanted and normally functioning ICD or undergoing ICD implant at index admission. 5. Undergoing initial radiofrequency ablation procedure for sustained monomorphic VT. 6. Receiving a class III AADs prior to VT ablation. 7. No VT inducible at the end of VT ablation. 8. No VT inducible on non-invasive programmed stimulation following VT ablation LV assist device in place 2. Decompensated heart failure and/or requiring continuous inotropic therapy and/or awaiting cardiac transplantation 3. Ongoing acute coronary syndrome. 4. Mechanical prosthetic aortic and mitral valves. 5. Pedunculated or mobile left ventricular thrombus. 6. Persistent VT at the end of index catheter ablation. 7. Absolute contraindications for class III AADs. 8. Participation in other trial. 9. VT induced on NIPS after VT ablation. 10. Another reason for continuation of class III AADs (i.e., atrial fibrillation)
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-0.635, Intraventricular Hemorrhage Preterm infants (<33 weeks gestation at birth, stratified < and ≥28 weeks) with any grade IVH/intraparenchymal hemorrhage/infarction on head ultrasound in the first 10 days of life. Diagnostic will be based on the Papile definitions as used by the study sites/Toronto Centre for Neonatal Health for PHVD management, outlined in the document "Intraventricular Hemorrhage and Measurements of Lateral Ventricular Size from Head Ultrasound" Disorders associated with neurodevelopmental delays or impairment (i.e. Trisomy 21) 2. Moribund/critically ill infant or known lethal diagnosis with plans by medical team to redirect care 3. Choanal atresia or anomalies that would not allow intranasal treatment 4. Surgical condition (e.g. esophageal atresia) for which team feels intranasal HM is contraindicated 5. Enrolled in other intervention trials in which primary target is neurodevelopmental outcome 6. Parent with lactation contraindication(s) (i.e. HIV) or parent who declines lactation initiation 7. Lactating parent unable to provide fresh HM: unable/unwilling to pump at study site or unable to have fresh HM delivered by designee at least once/day for 3 days within 3 hours of pumping AND located (in hospital or home) >30km from study sites (for courier services)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Syncope patients undergoing pacemaker implantation for bradyarrhythmic syncope age <18 years
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Sudden Cardiac Death Due to Cardiac Arrhythmia Dilated Cardiomyopathy ALL of the following must be fulfilled: 1. Dilated cardiomyopathy diagnosis based on the ESC proposed criteria1: Dilation based on left ventricular end-diastolic diameter or volume >2SD larger than age, gender, and body surface area adjusted normal values, hypokinesia based on left ventricular ejection fraction ≤50%, not attributable to loading conditions or coronary artery disease. In cases of LVEF<45%, otherwise unexplained, and no evident ventricular dilation, the diagnosis of hypokinetic, nondilated CMP will be made 2. Patients will have to have been diagnosed >6 months prior to enrolment in order to reversible myocarditis cases 3. Be on sinus rhythm or with paroxysmal atrial fibrillation to facilitate noninvasive risk factor (NIRF) presence assessment 4. Age >18 years and <80 years 5. On optimal medical therapy for at least 3 months A patient will be excluded from the study if any of the following are present: 1. Significant ventricular extrasystole burden (>10,000/24hrs or >10% PVCs) on 24hr ambulatory ECG (PVC-induced cardiomyopathy)38, 39, persisting even after all pharmacologic and/or interventional (ablation) attempts 2. Permanent atrial fibrillation 3. More than moderate left-sided valvular heart disease 4. Epicardial vessel lumen stenoses >70% detected on coronary angiogram36 in a major coronary artery 5. Expected survival <12months 6. Pregnancy (planned and accidental) 7. Stage IIIb chronic kidney disease (estimated glomerular filtration rate <30ml/hr). This mainly relates to the non-tachycardic SCD mechanisms in this population (bradycardia/pulseless electrical activity)40-42, not amenable to antitachycardic ICD interventions 8. NYHA IV functional class 9. Participation in another study with an active treatment arm 10. Contraindication to either MRI performance or insertion of a transvenous ICD system
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Arrhythmias, Cardiac Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, ages 18-80 4. Patients must be diagnosed with a condition that necessitates an EPS. They must also be deemed to be in good enough medical health to be eligible to safely undergo an EPS. Medical will be determined by the Attending Electrophysiologist performing the EPS. 5. For females of reproductive potential a negative pregnancy tes Patients with a resting left ventricular outflow gradient > 30mmHg Patients with severe aortic stenosis Patients with prior sustained ventricular tachycardia or ventricular fibrillation Patients who are not able to consent for themselves Patients with a prior allergic reaction to Dobutamine or any of its compounds including sulfites Pregnant patients Patients receiving B-blockers
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-84.0, Myocarditis Acute Ventricular Arrythmia secured myocarditis via MRT / endomyocardial biopsy ventricular arrhythmias (≥ 5 beats) in the ECG / LZ ECG with clinical indication for a WCD system/ biomonitor/ or the indication for primary/secondary prophylactic ICD implantation presence of informed consent age >18 and <85 years Participation in another study with an active treatment group Pregnant or breastfeeding women
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Dialysis; Complications Life Quality years or older Being on HD for 4 hours a day on 3 days per week for at least 6 months No communication problem Volunteering to participate to the study Younger than 18 years Shorter being on HD for 4 hours a day on 3 days per week for at least 6 months Have communication problem Not volunteering to participate to the study
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Arrhythmia Ventricular Tachycardia (VT) Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy Age > 18 years old Underlying sinus rhythm with heart rate > 50 bpm Provision of signed/dated informed consent and stated willingness to comply with all study procedures Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (>70%), or stress testing. (Note: positive troponin assay due to Internal Cardiac Defibrillator (ICD) shocks is not an criterion) Status post orthotopic heart transplantation Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) Unable or unwilling to comply with protocol requirements Known channelopathy such as long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic VT Known peripheral neuropathy or history of autonomic dysfunction due to non-cardiac causes New York Heart Association Class IV heart failure or use of current vasopressor medications Incessant VT Persistent atrial fibrillation Frequent premature atrial or ventricular contractions
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 65.0-999.0, Atrial Fibrillation Age ≥65 years Is willing to give informed consent Known medical history with Atrial Fibrillation Not mental competent
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-80.0, Cardiac Arrhythmia Prior myocardial infarction or non-ischemic disease resulting in myocardial dysfunction A left ventricular ejection fraction (EF) <50% An implanted ICD device as secondary prevention for monomorphic VT/VF. This includes patients who receive a device for primary prevention and then have recurrent sustained monomorphic VT or VT Have failed a prior catheter-based ablation for VT/VF after device implantation or have a contraindication to repeat ablation and and have failed reasonable drug options over the 3 months prior to consideration of particle therapy Repeat ablation from an epicardial venue in the absence of prior cardiac surgery, or where such an ablation if felt to be inappropriate in the view of the primary investigator Electrocardiographic documentation of 2 additional episodes of recurrent, sustained monomorphic ventricular tachycardia (MMVT) and/or pre-ventricular contraction (PVC) induced VT or VF that are terminated by ATP or ICD shocks by device interrogation over the past 3 months, since the sentinel ablation (see #4) Age ≤ 80 yrs VT in the absence of cardiomyopathy Reversible causes of VT including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, trauma, or VT clearly produced by recurrent ischemia Multiple (e.g. >3) clinical VT morphologies, that are thought to originate from widely disparate right ventricular (RV) or left ventricular (LV) areas Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months, or anticipated in the next 3 months Hypertrophic obstructive cardiomyopathy > Class IV Progressive Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation) Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs Prior surgical interventions for VT such as an encircling ventriculotomy procedure Contraindication to appropriate anti-coagulation therapy after ablation Renal failure requiring dialysis
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 65.0-999.0, Silent Stroke Silent Cerebral Infarct Fibrillation Age ≥ 65 years Written informed Consent Any clinically silent ischemic lesions of the brain parenchyma detected on neuroimaging defined according to established as either Diffusion weighted imaging (DWI) positive lesions: Focus of restricted diffusion (high DWI signal and low apparent diffusion coefficient value) occurring in either white or gray matter, located in the cerebrum, cerebellum, or brain stem AND not satisfying the diagnostic for multiple sclerosis OR Cavitatory Lesions: ≥ 3 mm in size that follow cerebro-spinal fluid on all sequences that are slit or wedge shaped with an irregular margin AND NOT longitudinally aligned with perforating vessels or with a multiple, bilateral symmetrical distribution OR T2 weighted (T2W) hyperintense/T1 weighted (T1W) hypointense lesions Focal lesion with high T2W signal and low T1W signal that have prior evidence of restricted diffusion; OR Present within cortical gray matter or deep gray matter nuclei OR A lesion that is new, compared with an MRI performed within 3 months OR T2W hyper/T1W hypointense lesions in the white matter, which are discontinuous but associated with the classic confluent periventricular T2 intense change of leukoaraiosis (Fazekas ≥2) AND NOT satisfying the diagnostic for multiple sclerosis or with a significant patient history of severe trauma, radiation, drug toxicity, or carbon monoxide poisoning History of AF or atrial flutter Patients with a history of symptoms compatible with an AIS, covert neurological deficits are allowed Cardiac implantable electronic devices (pacemaker, implantable cardiac defibrillator (ICD), implantable cardiac monitor (ICM)) Indication for cardiac implantable electronic device implantation (pacemaker, ICD, ICM) History of or indication for major cardiac surgery or transcutaneous aortic valve implantation Indication for permanent oral anticoagulation Contraindication for permanent oral anticoagulation Projected life expectancy of less than 2 years Active intra or extracranial high-grade malignancy
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-99.0, Heart Failure Heart Failure With Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction Subject has provided informed consent 2. Male or female over the age of 18 years 3. The patient is either hospitalized with a primary diagnosis of acute heart failure or was discharged with a primary diagnosis of acute heart failure within 2 weeks prior to enrollment; or carries a diagnosis of heart failure and is seen as an outpatient at Hershey Medical Center. 4. NYHA functional class II-IV at time of enrollment 5. Subject willing to wear the WHOOP for the 90-day study period. 6. Subject owns a phone for pairing with the WHOOP device (required for data storage and transfer) Subjects who are limited by angina. 2. Subjects with severe aortic stenosis. 3. Subjects who are hemodynamically unstable requiring support with intravenous vasoactive medications or mechanical circulatory support 4. Subjects with symptomatic ventricular arrhythmias within the past 6 months
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Gonarthrosis Adult man or woman who has signed consent to participate in the study Patient with uni or bilateral primary gonarthrosis For which an indication for total knee arthroplasty has been established History of knee arthroplasty or osteotomy History of knee fracture Inflammatory rheumatic disease or any other progressive concomitant disease that may affect the patient's functional prognosis Joint or extra-articular deformities of the lower limb of traumatic origin Neurological diseases, stroke sequelae Mental disability or any other reason that may hinder the understanding or strict application of the protocol Patient not affiliated to the French social security scheme Patient under legal protection, guardianship or trusteeship Patient already included in another therapeutic study protocol or having participated in another trial within the previous three months Arthroplasty actually performed
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardia Ventricular Fibrillation Gut Microbiome for all groups age >18 years-old competent and willing to provide consent presence of implantable cardioverter-defibrillator diagnosis of cardiomyopathy left ventricular ejection fraction of 35% or less as assessed by echocardiogram within 1 year prior to enrollment for control group: • no VT/VF on device interrogation for a period of at least 3 months preceding study enrollment for high ventricular arrhythmia burden group at least one episode of sustained VT/VF or VT/VF requiring ICD therapies within the preceding 3 months as assessed on device interrogation at the time of study enrollment currently pregnant or have been pregnant in the last 6 months antibiotic treatment within 5 months of study enrollment (i.e. antibiotic therapy in the two months prior to the 3-month period of analysis for VT/VF) chronic use of medications/supplements that can potentially affect gut microbiota (i.e. probiotics, anti-inflammatory agents, glucocorticoids, other immune modulating medications, antacids or proton pump inhibitors) history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis, or other malabsorption disorder
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Generalized Anxiety Disorder years of age or older Have consistent and reliable access to the internet Be diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) by a clinician Meet the for GAD according to the GAD-7 Screener (GAD-7) Be competent to consent to participate Speak and read English Patients will be deemed ineligible for participation in the study if they are in acute distress
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-99.0, Ventricular Tachycardia Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18 or greater Patient with ≥ 1 episode of VT (i.e., Sustained VT more than 30 seconds or VT with any ICD therapy) Patients with ischemic cardiomyopathy, EF less than 50%, documented history of CAD Patients with ventricular fibrillation Reversible causes of VT Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors Patients with prior procedure involving opening the pericardium or entering the pericardial space (e.g., CABG, heart transplantation, valve surgery) were adhesions are suspected Any prior ablation for the ventricles or any prior epicardial ablation Documented history of myocardial infarction within 1 month prior to the planned study intervention Documented symptomatic carotid disease defined as > 70% stenosis or > 50% stenosis with symptoms Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer Active pericarditis Active endocarditis\Any documented history or autoimmune disease associated with pericarditis
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Ventricular Arrhythmia Ventricular Tachycardia Premature Ventricular Contraction (PVC) Cardiomyopathy All patients undergoing catheter ablation for ventricular tachycardia (VT) or premature ventricular contractions (PVCs)
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Myocarditis Ventricular Arrythmia Inflammatory Cardiomyopathy Genetic Predisposition Autoimmunity Arrhythmia Cardiomyopathies Immunosuppression Catheter Ablation Written informed consent Age ≥ 18 years Clinically suspected myocarditis Enrollment performed by one of the participating Centers Absence of written informed consent Age < 18 years (paediatric population)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-75.0, Atrial Fibrillation to 75 years of age Symptomatic AF Symptomatic AF is defined by AF with patient-reported perception of one or more of the following symptoms: palpitations, dizziness/presyncope, syncope, dyspnea, chest pain, malaise, and fatigue and activity intolerance There is at least one ECG-documented AF episode within 6 months before signing the consent Unresponsive to conventional therapy is defined by not responding to at least 1 antiarrhythmic drug (class I, class III, or atrioventricular nodal blocker) The left atrial size <50 mm by transthoracic echocardiography documented by visit echocardiogram Documented atrial fibrillation as defined as atrial fibrillation >30 seconds in duration recorded on the visit 7 day continuous rhythm recording Patients without AF episodes during monitoring period will be excluded from the study and count as screen failure Left ventricular ejection fraction <40% Heart failure with functional classes III or IV Recurrent vasovagal syncope Valvular AF (severe mitral regurgitation, mitral stenosis) Congenital heart diseases Wolff Parkinson-White Syndrome Stroke within the past 6 months Any history of myocardial infarction Malignancies with a life expectancy of < 1 year
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 40.0-999.0, Syncope Presyncope Adult patients 40 years of age or older who present to the Emergency Department with syncope or presyncope Subjects must read and speak English or Spanish Subjects must have a working phone number and fixed address Patient who have a syncope mimic such as seizure, stroke, head trauma with loss of consciousness, altered mental status, hypoglycemia, intoxication, or require an intervention to restore consciousness Patients who have a new serious diagnosis found in the Emergency Department, such as death, significant cardiac arrhythmia (see below), myocardial infarction, significant structural heart disease, stroke (both ischemic and hemorrhagic), pulmonary embolism, aortic dissection, hemorrhage or anemia requiring blood transfusion, subarachnoid hemorrhage, cardiopulmonary resuscitation, acute surgical illness, pregnancy, or major traumatic injury Significant cardiac arrhythmia includes Ventricular Fibrillation, Ventricular tachycardia (>30 secs), Symptomatic ventricular tachycardia, (<30 secs), Sick sinus disease with alternating sinus bradycardia and tachycardia, Sinus pause > 3 seconds, Mobitz type II atrioventricular heart block, Complete heart block, Symptomatic supraventricular tachycardia (including PSVT, rapid atrial fibrillation/ flutter), Symptomatic bradycardia (pulse<40), Pacemaker or implantable cardioverter-defibrillator malfunction with cardiac pauses
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Heart Failure Owns or has access to a smartphone Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%) Earlier atrial fibrillation/atrial flutter with indication for oral anticoagulant (OAC) treatment Pacemaker Cardiac resynchronization device Indications for OAC treatment (also low molecular weight heparin) due to atrial arrhythmias, mechanical heart valve, deep vein thrombosis, or pulmonary embolism Expected survival ≤ 6 months Absolute contraindications for starting OAC treatment
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Cancer First time administration of ICI Willing and able to return in 4-6 weeks for follow-up study Patients with previous heart conditions included (while this may impact MFR the delta MFR is what we are assessing) Age < 18 years Women who are pregnant, or breast-feeding Unable or unwilling to give consent to undergo PET/CT
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Pulmonary Hypertension Arrhythmias, Cardiac Heart Rate Variability Pulmonary hypertension patients >18 years of age Voluntary participation after giving informed verbal and written consent Patients naïve to PAH-specific treatments Patients on current PAH specific medication independent of duration of therapy Patients can be in WHO group 1 classified by one of the following subgroups Idiopathic pulmonary arterial hypertension (IPAH) Heritable pulmonary arterial hypertension (HPAH) Drugs and toxins Associated with (APAH): specifically, connective tissue disease (CTD), HIV infection and congenital heart disease Diagnosis of PAH confirmed by right heart catheterization Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction at Screening: BMI >30 kg/m2; diabetes mellitus of any type; systemic hypertension, significant coronary artery disease; or left atrial volume index (LAVi) >30 mL/m2 Evidence or history of left-sided heart disease and/or clinically significant cardiac disease Acutely decompensated heart failure within 30 days prior to Screening Evidence of significant parenchymal lung disease Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (SBP) >160 mmHg or sitting diastolic blood pressure (DBP) >100 mmHg at Screening. • Systolic blood pressure >160 mmHg or < 90 mmHg; or diastolic blood pressure > 100 mgHg at Screening Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec, and female subjects with QTcF >470 msec on ECG measured at Screening or Baseline Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Stroke, Ischemic Atrial Fibrillation Patients will be recruited within 3 months of an acute ischaemic stroke. It must also be feasible to perform a cardiac MRI on all patients enrolled within 3 months of the acute ischaemic stroke. includes patients with Patient consent or advice given by consultee can be obtained Confirmed acute ischaemic stroke with evidence on brain CT and/or MRI within 3 months of study enrolment • Ischaemic stroke of unknown source Expected survival >12 months At least one additional stroke risk factor (i.e. CHA2DS2VASc>=3) Sinus rhythm on 12 lead ECG, telemetry and a regular pulse on clinical examination Above 18 years of age Unable to obtain patient consent or advice by consultee History of atrial fibrillation Atrial fibrillation detected on ECG and/or telemetry (AF duration of at least 30 seconds required for diagnosis) eGFR <30ml/min Indication for pacemaker/implantable cardioverter-defibrillator Contra-indication to undergo cardiac MRI (e.g. severe claustrophobia, unable to lie flat for prolonged period, contrast allergy) Carotid stenosis >50% on Duplex ultrasound associated with anterior circulation infarction Vertebrobasilar stenosis >50% on CT/MR angiography associated with posterior circulation infarction Single, isolated lacunar stroke with a corresponding lacunar infarct on brain CT/MRI Specific aetiology for cause of stroke (e.g. arteritis, dissection, drug abuse)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including Chronic and/or permanent atrial fibrillation with 2° or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or Normal sinus rhythm with 2° or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and 2. Subject is ≥18 years of age; and 3. Subject has a life expectancy of at least one year; and 4. Subject is not enrolled in another clinical investigation; and 5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and 6. Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC; and 7. Subject is not pregnant and does not plan to get pregnant during the course of the study Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or 2. Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP); 3. Subject has a mechanical tricuspid valve prosthesis; or 4. Subject has a pre-existing endocardial pacing or defibrillation leads; or 5. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or 6. Subject has an implanted vena cava filter; or 7. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or 8. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or 9. Subject has an implanted leadless cardiac pacemaker
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 45.0-74.0, Hypertension,Essential Own a mobile phone and able to use Able to communicate with Cantonese and read Chinese Diagnosed with hypertension and taking at least one anti-hypertensive medication SBP = 131~159 mmHg or DBP = 81~99 mmHg Renal hypertension Mini-Cog < 3
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-65.0, Hypertension; Heart Disease, Hypertensive Age 18-65 years The diagnostic of hypertension were blood pressure systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg in the clinic or receiving antihypertensive drug treatment The normal high-value diagnostic for hypertension were systolic blood pressure 130-139mmhg and or diastolic blood pressure 85-90mmhg in the clinic LVEF > 50% coronary atherosclerotic heart disease or symptoms of angina Cardiomyopathy Valvular heart disease Diabetes Atrial fibrillation Renal function damage Pregnancy Secondary hypertension Chemotherapy for malignant tumors
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 1.0-18.0, Syncope all cases of syncope
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-65.0, Syncope, Vasovagal Vasovagal syncope as the cause of transient loss of consciousness (Clinical diagnosis AND Calgary Syncope Symptom Score ≥ -2; Head-up tilt test is not mandatory for diagnosis) ≥2 episodes of syncope during the last year Medication-naïve or have at least a 2-week washout period prior to randomization The capability of giving informed consent Signed written informed consent Other causes of transient loss of consciousness including orthostatic hypotension, postural tachycardia, carotid sinus hypersensitivity, or seizure Cardiac rhythm disorders including ventricular tachycardia, long QT syndrome, Brugada syndrome, arrhythmogenic right ventricular cardiomyopathy, complete heart block, and any conduction abnormality on electrocardiogram Severe valvular heart disease Hypertrophic cardiomyopathy Cardiac systolic dysfunction (ejection fraction≤40%) Obstructive coronary artery disease Hypertension Diabetes mellitus Cirrhosis Renal failure stage≥3
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Non-ischemic Cardiomyopathy Adult with NICM Previous history of ventricular tachycardia (VT) and no previous history of VT Inherited cardiomyopathies Previous history of myocarditis oedema/scar at the MRI
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-100.0, Arrhythmias, Cardiac Monitoring Any patient who needs to be monitored for at least 48 hours can be included in the study allergic to sticking plaster refusing to participate will be excluded from the study planed MRI examination open wound Severe thorax deformity making recording not possible
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardia Adult inpatients admitted to St George's Hospital London with sustained ventricular tachycardia or outpatients identified from the arrhythmia clinic with significant monomorphic ventricular tachycardia noted on cardiac monitoring who Have sustained, monomorphic scar-dependent ventricular tachycardia Are symptomatic Failed, unable or unwilling to tolerate anti-arrhythmic medications Able to have a cardiac MRI Have a life expectancy > 1 year At least 40 days following a myocardial infarction Patients under the age of 18 Patients who are unable to give informed consent Pregnant patients Unable to have cardiac MRI Prohibitive procedural risk Unable to tolerate the ablation procedure due to haemodynamic instability
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardia Patients with structural heart disease and implantable cardioverter defibrillator (ICD) Clinically significant arrhythmia with at least 3 VT episodes per month despite adequate pharmacological treatment At least one episode of monomorphic VT registered in electrophysiological examination Recurrent VT despite at least one prior catheter ablation and adequate pharmacotherapy OR contraindications to catheter ablation and/or pharmacotherapy (i.e., patient with medically contraindicated catheter ablation is obliged to undergo only pharmacotherapy prior to study enrollment) Patient must be able to understand and be willing to sign a written informed consent document Heart failure requiring inotropic treatment or mechanical assistance Arrhythmia due to cardiac channelopathy Reversible source of arrhythmia NYHA (New York Heart Association) stage IV hearth failure Hearth infarction or cardiac surgery in last 3 months Life expectancy <6 months Polymorphic VT Pregnancy Prior radiotherapy to the thoracic region (relative contraindication) Failure to induce VT during electrophysiological examination
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-35.0, Overweight Female Participants with a BMI > 25-29 kg/mm2 Aged 18-35 years Subjects having a sedentary lifestyle, performing only activities of daily living without engaging in any previous exercise training protocol throughout the week, evaluated by Rapid Assessment Disuse Index (RADI) Questionnaire History of recent surgeries or trauma that hinders in performing high impact exercises Severe orthopedic, musculoskeletal, cardiopulmonary, neurovascular, psychiatric, inflammatory, metabolic, or endocrine diseases and taking any prescribed medications Pregnant females and nursing mothers
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-90.0, Hypertension Participants must be age 18 years or older Self-identified as a black or African American male Have uncontrolled hypertension defined as SBP>135 mmHg or DBP>85 mmHg and SBP >130 mmHg or DBP >80 mmHg (in those with diabetes) at the screening Under the age of 18 Does not consent to participate
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Dialysis Recovery Time years or older Being on HD for 4 hours a day on 3 days per week for at least 6 months No communication problem Volunteering to participate to the study Younger than 18 years Shorter being on HD for 4 hours a day on 3 days per week for at least 6 months Have communication problem Not volunteering to participate to the study
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 12.0-999.0, Cardiac Arrest, Sudden Ventricular Tachycardia Ventricular Fibrillation Sudden Cardiac Death -Non-traumatic OHCA in adults, treated by a BLS team and connected to an AED equipped either with the 2017 or with the 2020 algorithm Use of AED in a pediatric mode CPR administered in 15:2 mode Patient already connected to another defibrillator at the arrival of the BLS Team No shock administration within the first 10 minutes after the first analysis has started. Secondary Surviving patients' opposition to the use of their data Patients with unreadable electrocardiographic or impedance data
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardia Myocardial Fibrosis Indication for VT ablation in patients with SHD (indications according to the 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death) Structural heart disease (clinical history, EKG, multimodality imaging) Signed informed consent Age <18 y ICD not already implanted nor expected within 1 month High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) Inability to give written informed consent Pregnancy (suspected or confirmed) Acute coronary syndrome in the previous 3 months Creatinine clearance < 15 ml/min (stage 5 CKD) (according to clinical history or out/in-patient tests performed upon enrollment) Severe chronic liver disease (Child-Pugh score C) (according to clinical history or out/in-patient tests performed upon enrollment) Heart surgery for valve disease in the previous 6 months or expected within 6 months NYHA functional class IV heart failure or CCS functional class IV angina
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-85.0, Acute Respiratory Distress Syndrome Intensive Care Unit The study included patients who required invasive mechanical ventilation but was not initially diagnosed with ARDS 9, had a LIPS (Lung Injury Prediction Score) of > 7, and have been staying in the ICU for more than 24 hours pregnancy intracranial hypertension (suspected or confirmed by measurement with external ventricular drainage catheter) severe chronic obstructive pulmonary disease or type II respiratory failure confirmed bronchopleural fistula documented barotrauma history of pneumonectomy
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Long QT Syndrome • Adult patients who will undergo open-heart surgery Under the age of 18 years Bundle branch block in preoperative ECG Arrhythmia in preoperative ECG allergies specific to known drugs Electrolyte disorders
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 50.0-999.0, Atrial Fibrillation General AGE > 50 years No history of supraventricular arrhythmia Sinus rhythm at score > 2 in men (> 3 in female) More than 3 specific for Written informed consent is obtained before any study-related assessment is performed Specific Age > 65 Age > 75 BMI > 30 History of any supraventricular or ventricular arrhythmia (excluding premature contractions and 1st degree AV block) Therapy with anticoagulants at the time of Acute coronary syndrome less than 1 month prior to History of cardiac surgery Diabetes mellitus type 2 Reduced LVEF (<50%) Acute or decompensated heart failure at the time of Cardiomyopathy Systemic inflammatory disease or acute inflammatory disease Active malignancy
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Hypertension, Pulmonary Informed consent as documented by signature (Appendix Informed Consent Form) PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization resting partial pressure of oxygen <8 kilopascal at Zürich altitude on ambient air exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study inability to follow the procedures of the study patients who take nitrates other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Atrial Fibrillation Syncope Cryptogenic Stroke Patient is indicated to be implanted with the LUX-Dx ICM for one of the following reasons (grouped in three "Reason for Monitoring" subgroups): 1) Cryptogenic stroke, 2) Syncope, 3) AF management, Post-AF ablation, or Suspected AF Patient is willing to enroll and be monitored in Clarity Patient is willing and able to be followed remotely via the ICM patient mobile app Patient is willing and capable of providing informed consent (which is not to the use of a legally authorized representative (LAR) for documentation of informed consent) and agrees to participate in all protocol required activities Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law. The following criterion is applicable for patients participating in the Holter study: • Patient can tolerate the adhesive used in the Holter monitoring for an extended period of time Patient is indicated for implantation of, or is currently implanted with an active implantable cardiac device (e.g., LVAD, ICD, CRT D, PPM*) Patient cannot tolerate a subcutaneous, chronically-inserted device due to medical condition Patient has a documented life expectancy of less than 12 months (per investigator's discretion) Patient is known to be pregnant at the time of study enrollment (method of assessment upon investigator's discretion) Patient is currently enrolled in another clinical study including observational studies/registries, unless prior written approval from BSC is obtained. Mandatory governmental registries are accepted for co-enrollment without approval by BSC. The following are applicable for patients participating in the Holter study Patient has known allergies to the adhesive materials or hydrogel used in the extended Holter monitoring Patient has broken, damaged, or irritated skin over the chest area where the extended Holter monitor will be attached
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-90.0, Ventricular Tachycardia Age ≥ 18 years Indication for catheter ablation intervention with planned preoperative cardiac CT scan Prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non- ischemic cause with documentation of prior ischemic injury) and One of the following monomorphic VT events within last 6 months A: ≥3 episodes of symptomatic VT treated with antitachycardia pacing (ATP) B: ≥1 appropriate ICD shocks C: ≥3 VT episodes within 24 hr D: sustained VT below detection rate of the ICD documented by ECG or any cardiac monitor E: Sustained VT recorded on 12 leads ECG in the absence of ICD Signed informed consent Unable or unwilling to provide written informed consent Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves Have had a prior catheter ablation procedure for VT Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF) Are in renal failure (Creatinine clearance <30 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to <1 year Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control. (French HAS or following methods are considered adequate) Combined hormonal contraception Injected hormonal contraception Implanted hormonal contraception
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 14.0-999.0, Syncope, Neurogenic Syncope Patients must be in sinus rhythm and have ≥3 syncopes during the last 18 months* and a previous positive tilt table test (TTT) with a cardioinhibitory or mixed response (VASIS I, IIA or IIB classification). * syncopes occurring during TTT are not taken into account Patients have a 'preserved cholinergic SN reserve', defined as ≥20% sinus heart rate increment during a pharmacological test with atropine <14 years age Any unstable medical condition, life expectancy <12 months Inability to provide consent or undergo follow-up Syncope due to a non-cardiac disease or due to an advanced neuropathy Moderate to severe valvular or subvalvular aortic stenosis or mitral stenosis Overt heart failure or left ventricular ejection fraction <45% Current pregnancy Chronotropic negative medications unless judged mandatory g amiodarone intake during the 2 months preceding enrollment Alternating RBBB and LBBB, HV interval >70 ms
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardia Patients must be ≥ 18 years old Patients must have documented sustained monomorphic VT by 12-lead ECG or intracardiac ICD interrogation Minimum VT burden: 4 or more documented VT episodes (including sustained VT, ICD anti-tachycardia pacing [ATP], or ICD shock) in the 5 months preceding enrollment on this trial. Patients must have at least two episodes of electrocardiographically documented symptomatic, recurrent, sustained monomorphic VT in the 3 months prior to enrollment *ATP and appropriate ICD shock are acceptable surrogates for VT-associated symptoms Patients must have an ICD Patients must have ischemic or non-ischemic cardiomyopathy previously diagnosed with LVEF ≤ 35% Patients must have received at least one antiarrhythmic medication (i.e. amiodarone, sotalol, mexiletine) without control of symptoms or with poor toleration. AND Patients must have undergone at least one catheter-ablation procedure (or have a contraindication to catheter-ablation) or have VT arising from an inaccessible location Contra-indications to endocardial catheter ablation procedure dual aortic and mitral mechanical valves, active left ventricular thrombus, and anesthesia intolerance Contra-indications to epicardial catheter ablation prior cardiac surgery or anesthesia intolerance Patients with ischemic cardiomyopathy should have failed at least one endocardial ablation performed at an academic center Patients who have received any prior radiotherapy to the internal organs of the thorax or upper abdomen (with treatment field extending superior to L1 vertebral body) at any time in the past are excluded Patients found to have multiple scars on electrocardiographic imaging where the source of reentrant focus is unclear despite positron emission tomography (PET)/magnetic resonance imaging (MRI) are excluded Patients who have congestive heart failure on inotropes (NYHA class 4B) or left-ventricular assist device are excluded Patients felt to be unlikely to live 12 months in the absence of VT are excluded Patients with polymorphic VT or ventricular fibrillation, >3 distinct clinical VT morphologies on ICD interrogation, or >5 induced VT morphologies during noninvasive testing are excluded Patients with multiple, spatially separate target substrates (targets with presumed of nonadjacent ventricular segments) deemed unsafe to treat with CRA by the treating physician will be excluded Patients with incessant VT that is hemodynamically unstable are excluded Patients in VT storm are excluded Patients must not be pregnant and must have a negative pregnancy test within 14 days of study entry if they are females of childbearing age
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 45.0-999.0, Hypertension Coronary Artery Disease Hypertension Coronary artery disease Age over 45 years Male gender Secondary hypertension Significant heart valve diseases Hypertrophic cardiomyopathy Signs and/or symptoms of myocardial ischemia during an ergometric test Uncontrolled arrhythmia Neurological and or orthopedic conditions contraindicating or limiting exercises Significant chronic obstructive pulmonary disease (FEV1 <50%) Symptomatic peripheral arterial disease
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1
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Death, Sudden Ventricular Tachycardia Implantable Defibrillator User Myocardial Infarction Myocardial Dysfunction AMI patients over 18 years old LVEF equal or lower than 40% determined by a transthoracic echocardiography 4 days after the onset of the AMI Revascularization during hospitalization according to the clinical practice guidelines Signed informed consent Non-ischemic etiology of left ventricular dysfunction by cMRI Patient already implanted with a cardiac device (pacemaker, ICD or ICD-TRC) Indication of pacemaker, ICD or ICD-TRC implantation during hospitalization Allergy or hypersensitivity to any implatable device component Contraindication for cMRI performance Life expectancy under 1 year due to a non-cardiac cause Concomitant valvulopathy with indication for surgery High functional class (NYHA IV) No possibility to connect to the remote monitoring
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Tooth Wear Randomized Controlled Trial Vertical Dimension of Occlusion Composite Resins Generalized moderate to severe tooth wear with patient demand for treatment Full dental arches, one diastema due to one missing posterior tooth was allowed Estimated need for an increase in VDO of at least 3 mm in the first molar region Limited mouth opening (History of) Temporomandibular dysfunction Advanced periodontitis, deep caries lesions, or multiple large restorations including teeth with endodontic problems Patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with Gastro-Oesophageal Reflux Disease (GORD), were not excluded
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Tachycardia, Ventricular Arrhythmia, Ventricular Patient who meets Class I, IIa, or IIb guideline ICD indications[i],[ii], or who has an existing TV-ICD[iii] or S-ICD[iv] Patient who is deemed to be at risk for MVT based on at least ONE of the following History of Non-Sustained MVT with LVEF ≤ 50% History of sustained VT/VF (secondary prevention) with LVEF ≤ 50% or significant cardiac scar* History of syncope deemed to be arrhythmic in origin History of ischemic cardiomyopathy with LVEF ≤35% History of non-ischemic cardiomyopathy with LVEF ≤35% and significant scar* Patient who is willing and capable of providing informed consent (which is not to the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing associated with this investigation at an approved study site and at the intervals defined by this protocol Patient who is age 18 years or above, or of legal age to give informed consent specific to state and national law Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant Transvenous lead remnants within the heart from a previously implanted CIED (Note: transvenous lead remnants outside the heart (e.g., in the SVC) are allowed) Patient with a known LA thrombus Patient with a ventricular arrhythmia due to a reversible cause Patient indicated for implantation of a dual chamber pacemaker or cardiac resynchronization therapy (CRT) Patient with another implanted medical device that could interfere with implant of the leadless pacemaker, such as an implanted inferior vena cava filter or mechanical tricuspid heart valve Patient requires rate-responsive pacing therapy Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 bpm) Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable Angina) within 40 days Inability to access femoral vein with a 21-French (inner diameter)/ 23.5-French outer diameter) introducer sheath due to known anatomy condition, recent surgery, and/ or other relevant condition
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 0.0-999.0, Pulmonary Hypertension Pulmonary Arterial Hypertension Pulmonary Hypertension Due to Left Heart Disease Pulmonary Hypertension, Primary Pulmonary Hypertension Due to Lung Diseases and Hypoxia Pulmonary Hypertension, Primary, 4 Pulmonary Hypertension, Primary, 2 Pulmonary Hypertension, Primary, 3 Chronic Thromboembolic Pulmonary Hypertension The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP) 2. The participant has a diagnosis of pulmonary hypertension confirmed by right heart catheterization 3. Patient is ≥ 18 years of age or older Participant declines to participate (living patients only) 2. Participant is unable to provide informed consent (living patients only)
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Bradyarrhythmia Heart Failure Meets American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for bradycardia, or Meets ACC/AHA/HRS guidelines for cardiac resynchronization therapy (CRT) Age < 18 years Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity Pregnancy Difficulty with follow-up
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2
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Syncope patients with recurrent, unexplained, traumatic syncope patients underwent implantable loop recorder implantation patients unable to attend scheduled outpatient visits
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Supraventricular Arrhythmia Septic Shock Age >= 18 years 2. Septic shock since a maximum of 72 hours, defined by the association of the following Documented or suspected infection, with initiation of antibiotic therapy Initiation of vasopressors (norepinephrine, epinephrine) for at least 1 hour and at most 72 hours 3. Invasive mechanical ventilation 4. NOSVA with heart rate ≥ 110 bpm lasting 5 minutes or more 5. Written informed consent (patient, next of skin or emergency situation) 6. Affiliation to a social security system 1. Refractory shock defined by a dose of noradrenaline BASE or adrenaline BASE > 1.2 µg/kg/min 2. Cardiac surgery or cardiac transplant in the previous month 3. Aortic or mitral mechanical prosthesis, significant mitral stenosis (mitral surface < 1.5 cm2) 4. Congenital heart disease other than bicuspid aortic valve, atrial defect or patent foramen ovale. 5. History of supraventricular arrhythmia before septic shock 6. NOSVA lasting at most 36 hrs (or 24 hrs with vasopressors) 7. Electrical cardioversion or use of amiodarone, other antiarrhythmic, or drug inducing bradycardia (beta-blockers, bradycardic calcium channel blocker, digitalis, flécaïnamide) in the previous 6 hours before 8. Contraindication to amiodarone: history of serious adverse event related to amiodarone, history of lung disease related to amiodarone, history of hyperthyroidism related to amiodarone, PR interval > 240 ms, severe sinus node dysfunction with no pacemaker, 2°/ 3° atrioventricular block with no pacemaker, QTc>480 ms, known or treated hyperthyroidism, hypersensitivity to iodine, amiodarone or to any of the excipients, severe hepatocellular insufficiency (prothrombin rate <20%), diffuse Interstitial Lung Disease. 9. Kalemia < 3 mmol/L 10. Pregnant or breast feeding women 11. Moribund patient or death expected from underlying disease during the current admission; Patient deprived of liberty and persons subject to institutional psychiatric care 12. Participation to another interventional trial on septic shock and/or arrhythmic disease
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0
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65 yo man with history of CAD and prior MI, HLD, HTN, ventricular tachycardia, and syncope was admitted earlier today evaluation of syncope and ventricular arrhythmias. He was recently discharged after a negative work-up for syncope which included the implantation of a cardiac monitoring device. It was interrogated at the OSH and per report the monitor read from yesterday: 40 seconds of VT and then bradycardia with a rate of 39 shortly thereafter corresponding with his symptoms. Overnight, the patient went into monomorphic VT on telemetry. The patient was found to be unresponsive. CPR was initiated, unclear if the patient had a pulse. Within one minute the patient returned to sinus rhythm. The patient does not report any symptoms prior to this episode. Currently, the patient feels presyncope and nausea, but denies chest pain. Patient is to be transferred to the CCU for catheterization and EPS.
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eligible ages (years): 18.0-999.0, Ventricular Tachycardia Ischemic Cardiomyopathy Ventricular tachycardia ablation between October 2014 and April 2021 Patient for whom electroanatomical data are available Ischemic cardiomyopathy / previous myocardial infarction At least 30 points of pace-mapping during the VT procedure Incomplete data Poor quality ECG recordings Absence of ventricular tachycardia isthmus identified during the procedure
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, HIV Infections Pregnancy A patient may be eligible for this study if she Is an HIV-positive woman Is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available Had a baby on or after January 1, 1998
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 8.0-99.0, Pulmonary Disease Patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of CPB will be eligible for participation in this protocol. Only standard diagnostic procedures and conventional therapy will be performed. Patients will not be subjected to any research procedures. This protocol does not commit the NIH to medical or surgical treatment of protocol participants after discharge. Patients will be discharged to the referring physician. Consenting to pregnancy testing in minors of childbearing age: We will inform the minor during the assent process that for safety, we need to do a pregnancy test. She will also be told that if it is positive, we will counsel her and help her tell her parents. If the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end Patients without symptoms of pulmonary disease will be excluded from this protocol
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Acromegaly Pituitary Neoplasm Male or female patients, 18 years of age or older. Newly diagnosed patients with acromegaly, or previously untreated. Presence of a pituitary tumor greater than 10 mm at greatest diameter (macroadenoma). Lack of suppression of GH to less than 2.0 ng/mL using a regular GH RIA, or less than one ng/mL using a two-site immunoradiometric or chemiluminescent GH assay, after oral administration of 100 g of glucose. IGF-1 levels above the upper limits of normal (adjusted for age and gender). Demonstrated tolerance to a test dose of s.c. Sandostatin Injection. Demonstrated responsiveness to a 100 ug s.c. Sandostatin Injection test dose, as evidenced by suppression of mean 4HR GH to less than 5 ng/mL, or to greater than 50 % of the baseline value. Patients who are able to provide written informed consent Patients demonstrating intolerance to a s.c. Sandostatin (octreotide acetate) test dose. Patients who have received any prior treatment for their acromegaly, including radiotherapy, octreotide, bromocriptine, lanreotide, or prior surgery. Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Patients with compression of the optic chiasm significant enough to cause visual field defects on automated testing. Patients who require surgery for relief of any neurologic signs or symptoms associated with their tumor. Patients with symptomatic cholelithiasis. Patients who have congestive heart failure (NYHA Class III and IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction within the three months preceding study entry. Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, or alkaline phosphatase 2X greater than upper limit of normal; or direct bilirubin more than 10% greater than upper limit of normal. Patients with abnormal clinical laboratory values considered by the Investigator or the Sponsor's Medical Monitor to be clinically significant and which could affect the interpretation of the study results. Patients who have any current or prior medical condition that may interfere with the conduct of the study or of the evaluation of its result in the opinion of the Investigator or Sponsor's Medical Monitor. Patients who have a history of alcohol or drug abuse in the six month period prior to Visit 1. Patients who have received any investigational drug within one month prior to Visit 1, or who plan to take an investigational drug during the study. Patients with any mental impairment limiting their ability to comply with all study requirements. Patients who, for any reason, will be unable to complete the entire study
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-65.0, Acromegaly ENTRY --Disease Characteristics- Active acromegaly with growth hormone (GH) hypersecretion confirmed within 1 month prior to entry, i.e.: Somatomedin C elevated GH not below 2 ng/mL on standard 100 g oral glucose tolerance test Postmenopausal and hypogonadal women eligible Volunteers aged 18 to 30 recruited for up to 3 stimulation tests Weight within 15% of ideal Physical exam normal No history of disease No requirement for medication No medical or mental contraindication to protocol participation, including heavy alcohol or tobacco use No pregnant women --Prior/Concurrent Therapy- Not specified --Patient Characteristics-- Age: 18 to 65 Hematopoietic: No anemia Hepatic: No hepatic disease Renal: No renal disease Cardiovascular: No uncontrolled hypertension No heart disease Other: No requirement for replacement gonadal steroids, glucocorticoids, or thyroxine No mental illness No heavy alcohol use No tobacco use No drug abuse No medical contraindication to protocol therapy
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-35.0, Hypogonadism ENTRY --Disease Characteristics-- Diagnosis of hypogonadotropism Men: Small testes, abnormal semen analysis, and subnormal plasma testosterone levels without an elevation in gonadotropin levels Women: Amenorrhea and subnormal plasma estradiol levels, or lack of cornification of the vaginal mucosa without an elevation in gonadotropin levels OR Hypothalamic amenorrhea in normally estrogenized women with amenorrhea or oligomenorrhea and normal plasma free testosterone and gonadotropin levels Patients with hyperprolactinemia eligible only if hypogonadotropism persists after correction of hyperprolactinemia by dopamine agonist therapy --Prior/Concurrent Therapy- At least 2 months since sex hormone treatment --Patient Characteristics-- Other Not pregnant No chronic systemic, metabolic, or endocrine disease
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-75.0, Acromegaly ENTRY --Disease Characteristics-- Diagnosis of acromegaly and treated with transsphenoidal surgery Biochemically and histologically confirmed growth hormone secreting tumor OR Healthy volunteers --Prior/Concurrent Therapy-- Surgery See Disease Characteristics Greater than 6 months since prior surgery Other: At least 1 month since prior bromocriptine or octreotide --Patient Characteristics-- Performance status: Ambulatory Hepatic: No active hepatic disease Renal: No active renal disease Other No diabetes mellitus No glucose intolerance Hypopituitarism allowed if on stable doses of replacement therapy
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 1.0-55.0, Purpura, Schoenlein-Henoch Graft Versus Host Disease Anemia, Hemolytic, Autoimmune Rheumatoid Arthritis Churg-Strauss Syndrome Hypersensitivity Vasculitis Wegener's Granulomatosis Systemic Lupus Erythematosus Giant Cell Arteritis Pure Red Cell Aplasia Juvenile Rheumatoid Arthritis Polyarteritis Nodosa Autoimmune Thrombocytopenic Purpura Takayasu Arteritis Autoimmune thrombocytopenia purpura: platelet count less than 20,000/mm3 Adequate or increased marrow megakaryocytes Presence of detectable platelet associated immunoglobulins not due to alloreactive antibodies or posttransfusion purpura Prior response to immunosuppressive therapy Platelet count chronically less than 20,000/mm3 with petechial bleeding or less than 50,000/mm3 with other bleeding OR Any history of life threatening hemorrhage Refractory to conventional therapy for at least 21 days Splenectomy At least 1 additional immunosuppressive therapy applied after splenectomy OR Controlled on conventional therapy but at price of unacceptable toxicity: Serious steroid related toxicity Absolute neutrophil count less than 500/mm3 25% of time, pure red blood cell transfusion dependent or other toxicities (e.g., hemorrhagic cystitis) that are a consequence of chronic or cytotoxic therapy Unable to wean from chronic daily or intermittent cytotoxic therapy Autoimmune hemolytic anemia or pure red cell aplasia, AIHA: Hemolytic anemia Hemoglobin less than 10.0 g/dL without transfusion Hemolysis as evidenced by both: Sustained reticulocytosis (greater than 125,000/mm3) without evidence of active bleeding or increasing hemoglobin Laboratory evidence of hemolysis Positive direct antiglobulin test or equivalent immune adherence test No evidence for paroxysmal nocturnal hemoglobinuria Negative Ham's test and sucrose hemolysis. For PRCA: Anemia due to selective decrease in marrow erythroid precursors Hemoglobin less than 10.0 g/dL without transfusion Severe reticulocytopenia (less than 20,000/mm3 despite anemia) Severely decreased marrow erythroid precursors Positive marrow coculture with serum or cells or response to immunosuppression No evidence for PNH Negative Ham's test and sucrose hemolysis Severe disease: Chronic (i.e., greater than 1 year) Transfusion dependent or untransfused hemoglobin less than 8.0 g/dL Ferritin greater than 2,000 or evidence of organ dysfunction due to iron overload Refractory to conventional therapy after all 3 of the following: High dose steroids (at least 1 mg/kg) for at least 21 days Splenectomy (except cold reactive antibodies) 1 additional immunosuppressive therapy OR Controlled on conventional therapy but at price of unacceptable toxicity Rheumatoid arthritis: Morning stiffness for at least 6 weeks Arthritis of 3 or more joint areas Arthritis of hand joints Symmetric arthritis Rheumatoid nodules Serum rheumatoid factor Radiographic changes Active rheumatoid disease as evidenced by all of the following: Elevated Westergren erythrocyte sedimentation rate Minimum of 16 swollen or tender joints using the 28 joint count method Must be at high risk for developing deforming joint disease as defined by at least 2 of the following: High titer IgM-IgG rheumatoid factor Radiographic evidence of erosive arthritis developing within the first 24 months of clinical disease Functional class II or III Refractory to conventional therapy after 12 months of: Methotrexate used in combination with cyclosporine, hydroxychloroquine, or sulfasalazine OR Intramuscular gold therapy (total dose greater than 1.0 g and duration at least 6 months) OR Controlled on conventional therapy but at price of unacceptable toxicity Juvenile rheumatoid arthritis: Under 16 years of age at onset Arthritis in 1 or more joints as defined by swelling or effusion, or presence of 2 or more of the following: Limitation of range of motion Tenderness or pain on motion Increased heat Duration of disease 6 weeks or longer Onset type defined by type of disease in first 6 months: Polyarthritis (i.e., 5 or more inflamed joints) Oligoarthritis (i.e., less than 5 inflamed joints) Systemic (i.e., arthritis with characteristic fever) of other forms of juvenile arthritis Active disease evidenced by 1 of the following: Minimum of 2 swollen or tender joints using the 71 joint count method Endocardial or myocardial disease, or serositis Anemia or thrombocytosis of chronic disease High risk for developing deforming joint disease or evidence of potential life threatening involvement for at least 1 internal organ system Radiographic evidence of erosive arthritis developing within first 24 months of clinical disease Functional class II or III Endocardial, myocardial, pericardial, and/or pleural disease Hemoglobin less than 10.0 g/dL or platelet count greater than 600,000/mm3 Refractory to conventional therapy after 12 months of methotrexate used in combination with hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine, or cyclophosphamide OR Controlled on conventional therapy but at price of unacceptable toxicity Systemic lupus erythematosus: Malar rash Discoid rash Photosensitivity Oral ulcers Arthritis Serositis Renal disorder Neurologic disorder Hematologic disorder Immunologic disorder Antinuclear antibody Must have at least 4 of 7 variables on the lupus activity scale measured Evidence of potential life threatening involvement of at least 1 internal organ system Endocardial and/or myocardial disease Central nervous system disease Pulmonary parenchymal disease Renal disease defined as WHO III, IV or V and a high activity and low chronicity index Immune mediated cytopenias Refractory to conventional therapy after attempts to control disease with at least 2 drugs, including prednisone and 1 of the following: Azathioprine Cyclophosphamide (greater than 500 mg/m2 monthly for 6 months) Cyclosporine OR Controlled on conventional therapy but at price of unacceptable toxicity Vasculitis Definitive diagnosis of 1 of the following forms: Churg-Strauss syndrome Giant cell arteritis Henoch-Schonlein purpura Hypersensitivity vasculitis Polyarteritis nodosa Takayasu arteritis Wegener's granulomatosis Evidence of active disease defined as reversible manifestations of the underlying inflammatory process Must have 1 or more of the following: Elevated Westergren erythrocyte sedimentation rate Elevated C reactive protein Decrease serum complement levels Evidence of potential life threatening involvement of at least 1 internal organ system Endocardial and/or myocardial disease Central nervous system disease Pulmonary parenchymal disease Renal disease defined as WHO III, IV or V and a high activity and low chronicity index Immune mediated cytopenias Refractory to conventional therapy (i.e., failed or relapsed within 6 months) after attempts to control disease with at least 2 drugs, including prednisone and 1 of the following: Methotrexate Azathioprine Cyclophosphamide Cyclosporine OR Controlled on conventional therapy but at price of unacceptable toxicity Performance status: ECOG 0-1 ECOG 2 allowed provided symptoms directly related to autoimmune disease Hepatic: No history of severe, prior or ongoing chronic liver disease Bilirubin less than 2.0 mg/dL AST less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 2.5 mg/dL OR Creatinine no greater than 2 times normal baseline for age in pediatric patients Cardiovascular: No symptoms of cardiac disease No active ischemic heart disease Ejection fraction greater than 45% by MUGA No uncontrolled hypertension Pulmonary: FEV1/FVC at least 60% OR Resting PO2 at least 80 mm Hg DLCO greater than 50% predicted O2 saturations greater than 94% in children unable to perform PFTs Neurologic: No active or ongoing ischemic or degenerative CNS disease not attributable to underlying disease Other: Not pregnant No poorly controlled diabetes HIV negative
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, McCune Albright Syndrome Polyostotic Fibrous Dysplasia Diagnosis of PFD/MAS as required in Protocol 98-D-0145 Growth hormone excess will be determined as a non-suppressible serum growth hormone by oral glucose tolerance test (OGTT). The OGTT parameter will be serum GH greater than 2.0 ng/ml at 60 minutes after an oral load of 75g glucose. Two consecutive and duplicate measurements of serum IGF-I level should be at least 1.3 times greater than the upper limit of normal (age and sex adjusted according to laboratory normal range)
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.5-999.0, Lipodystrophy All ethnic groups. Males and females Age greater than or equal to 6 months Clinically significant lipodystrophy, identified by the study physician during the physical examination as an absence of fat outside the range of normal variation and/or identified as a disfiguring factor by the patient. Circulating leptin levels less than 12.0 ng/ml in females and less than 8.0 ng/ml in males as measured by Linco assay on a specimen obtained after an overnight fast. In children ages 6 months 5 years, a circulating leptin level of less than 6 ng/mL will be used. Leptin samples will be run through Millipore Laboratories, who use the Linco Assay, which has been the assay previously used to measure leptin levels throughout this study period. Presence of at least one of the following metabolic abnormalities: 1. Presence of diabetes as defined by the 2007 ADA 1. Fasting plasma glucose greater than or equal to 126 mg/dL, or 2. 2 hour plasma glucose greater than or equal to 200 mg/dL following a 75 gram (1.75gm/kg) oral glucose load, or 3. Diabetic symptoms with a random plasma glucose greater than or equal to 200 mg/dl 2. Fasting insulin greater than 30 micro units/ml. 3. Fasting hypertriglyceridemia greater than 200 mg/dL or postprandially elevated triglycerides greater than 500 mg/dL when fasting is clinically not indicated (e.g. in infants) -Persons with impaired decision-making capacity and who may be unable to provide informed consent may participate in this study per the discretion of the Principal Investigator Pregnant women, women in their reproductive years who do not use an effective method of birth control, and women currently nursing or lactating within 6 weeks of having completed nursing. Exclusions for underlying diseases likely to increase side effects or hinder objective data collection Known infectious liver disease Known HIV infection Current alcohol or substance abuse Psychiatric disorder impeding competence or compliance Active tuberculosis Use of anorexiogenic drugs Other condition(s) which in the opinion of the clinical investigators would impede completion of the study Subjects who have known hypersensitivity to E. Coli derived proteins Subjects with acquired lipodystrophy and a hematologic abnormality such as neutropenia and/or lymphadenopathy
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Breast Cancer Patients must be enrolled on protocol 98-C-0123 (MB #402) or this same protocol at the National Naval Medical Center
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Extensive Stage Small Cell Lung Cancer Patients must have histologically-confirmed small cell carcinoma of the lung or unequivocally positive cytological evidence (sputum [at least 2] or aspirate biopsy), with extensive disease (disease beyond the hemithorax and adjacent nodes, supraclavicular node involvement or pleural effusion with positive cytology), who have required induction chemotherapy, who have responding or stable disease, and who meet the following Induction chemotherapy including platinum (cisplatin or carboplatin) plus either etoposide (VP-16) or irinotecan (CPT-11) A minimum of 3 and a maximum of 6 cycles of induction chemotherapy have been administered Recovered from all toxicity related to prior chemotherapy (except alopecia and/or neuropathy) No less than 4 and no more than 8 weeks have elapsed between the last treatment of induction chemotherapy and randomization No more than 32 weeks have elapsed between the first dose of induction chemotherapy and date of randomization The patient has responding or stable disease using since the initiation of systemic chemotherapy (i.e., patients who have exhibited disease progression are NOT Patients must be disease-free for >= 5 years if they have had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix Baseline measurements/evaluations of disease must be obtained =< 4 weeks prior to randomization WBC >= 4000/mm³ or
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Diagnosis of acromegaly Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations Patients on current medical therapy other than Sandostatin LAR AST/ALT >= 3xULN (upper limits of normal) Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI Visual field defects (except post-surgical stable residual defects) Unable to self administer drug Radiotherapy within 12 months of entering the study
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1
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Diagnosis of acromegaly IGF-I levels >=1.3xULN (upper limit of normal) at screening No history of radiotherapy or prior treatment with other drugs for acromegaly Minimum of two months must have elapsed post surgery prior to screening Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations AST/ALT >= 3xULN (upper limit of normal) Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI Visual field defects (except post surgical stable residual defects) Unable to self administer drug
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Patients must have advanced unresectable hepatocellular carcinoma based on the following Histologically or cytologically confirmed, OR Alpha-fetoprotein > 400 ng if patient is not hepatitis surface antigen positive, OR Alpha-fetoprotein > 4000 ng if patient is hepatitis surface antigen positive NOTE: If available, tissue should be submitted to assess EGFR/pathway expression Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan, assessed within 4 weeks prior to randomization/registration Prior use of liver-directed therapy (radio-frequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization and hepatic artery infused FUDR) is allowed, provided the patient has either progressive hepatic disease or measurable extrahepatic disease ECOG performance status of 0, 1 or 2 Leukocytes >= 2,000/uL OR Absolute neutrophil count >= 1,000/uL
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-120.0, Anemia Drug/Agent Toxicity by Tissue/Organ Lung Cancer Neutropenia Histologically or cytologically confirmed* non-small cell lung cancer of 1 of the following subtypes Squamous carcinoma Basaloid carcinoma Adenocarcinoma Bronchoalveolar carcinoma Adenosquamous carcinoma Large cell carcinoma Large cell neuroendocrine carcinoma Giant cell carcinoma Sarcomatoid carcinoma
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Acromegaly Patients with active acromegaly due to a pituitary adenoma Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study Patients with compression of the optic chiasm causing any visual field defect Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression Patients who have received radiotherapy in the 2 years prior to the start of the trial Patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment Patients with gallstone disease Patients with chronic liver disease Known hypersensitivity to Sandostatin or Sandostatin LAR Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control and highly effective method for birth control History of immunocompromise, including a positive HIV test result Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-60.0, AIDS HIV Infections Men and women age 18-60 Previously diagnosed HIV infection Stable antiviral regimen for at least 12 weeks prior to enrollment Waist-to-hip ratio >0.90 for men and >0.85 for women Evidence of at least one of the following recent changes: *increased abdominal girth, *relative loss of fat in the extremities, *relative loss of fat in the face Simulated peak GH response to arginine/GHRH of less than 7.5 mcg/dL Use of Megace, anti-diabetic agents, GH, or other anabolic agents, pharmacologic glucocorticoid (prednisone >5 mg/day or its equivalent) for 3 months prior to enrollment. Patients on a standard dose of testosterone for documented hypogonadism will be allowed to enter the protocol. Women taking standard estrogen replacement therapy for >3 months will be allowed in the study Diabetes mellitus Other severe chronic illness HgB <9.0 g/dL, creatinine >1.4 mg/dL, or PSA >4 ng/mL Positive BHCG or failure to use appropriate birth control during study. Acceptable methods oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, IUD's, barrier devices (condoms, diaphragms), and abstinence Carpal tunnel syndrome Active malignancy or history of pituitary malignancy, history of colon cancer or prostate malignancy
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 0.0-999.0, Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage III Renal Cell Cancer Stage IV Renal Cell Cancer Patients must have histologically or cytologically confirmed renal cell carcinoma which is either metastatic (M1) or unresectable (M0); patients must have a component of conventional clear cell renal carcinoma; patients with true papillary renal cell carcinoma, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors and transitional cell carcinoma are NOT eligible Patients must have measurable disease; soft tissue disease, which has been radiated in the 2 months prior to registration, is not assessable as measurable disease; X-rays, scans, or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or physical examinations for non-measureable disease must have been completed within 42 days prior to registration; all disease must be assessed Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery Patients must not have received any prior systemic therapy for renal cell carcinoma, including chemotherapy, interferon, interleukin-2, other biologic response modifiers, anti-angiogenic therapy, hormonal therapy, or any other experimental systemic therapy; prior treatment with thyroid medications is allowed Patients may have received prior radiation therapy to less than 25% of the bone marrow; at least 28 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration Total bilirubin =< institutional upper limit of normal SGOT or SGPT =< 2.5 x institutional upper limit of normal Serum creatinine =< institutional upper limit of normal or calculated creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal Patients who have had a prior nephrectomy must have a serum creatinine =< 2 x institutional upper limit of normal Patients must be offered the opportunity to consent for specimen submission
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 1.0-21.0, Childhood Myelodysplastic Syndromes de Novo Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Refractory Anemia Refractory Anemia With Excess Blasts Refractory Anemia With Ringed Sideroblasts Refractory Cytopenia With Multilineage Dysplasia Secondary Myelodysplastic Syndromes Unspecified Childhood Solid Tumor, Protocol Specific Diagnosis of 1 of the following Histologically confirmed solid tumor No brain tumors Myelodysplastic syndromes (MDS) No refractory anemia with excess blasts in transformation or other forms of acute myeloid leukemia (AML) No FAB diagnosis of refractory anemia with excess blasts in transition and other forms of AML Newly diagnosed MDS with chromosome 5q abnormalities Relapsed or refractory disease including relapse after stem cell transplantation Measurable or evaluable disease (solid tumor patients only) No known curative or life-prolonging therapy exists
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 65.0-999.0, Malnutrition Aging Men and women aged 65 years or older who are under-nourished, as defined by a Mini Nutritional Assessment (MNA) score <24 AND 1 or more of the following: *a body mass index (BMI) of less than 22 kg/m2; *weight loss of > 7.5% in the 3 months before enrolling in the study Living independently in the community (not in a hospital, nursing home or hostel) Understand and sign informed consent document, able to communicate with the investigator, and understand and comply with the requirements of the study Women who are taking oestrogen or other hormone replacement therapy (HRT) may take part (see for exceptions), as may women who are not taking HRT. If a woman is taking HRT she must have been on a stable dose for at least 3 months before enrolment in the study. If not on HRT, she must not have been taking it for at least 3 months before enrolment Dementia as indicated by a Folstein's Mini Mental State Examination (MMSE) score of < 23 Elevated haematocrit (HCT) levels (>50%) Past or present history of prostatic cancer in men (Prostate Specific Antigen (PSA) levels [> age-related normal range and/or irregular prostate on prostate examination]) or breast cancer Pre-existing androgenic signs or symptoms in women of concern to either subject or investigator (deep voice, hirsutism, acne, androgenic hair loss) Depression (Yesavage Geriatric Depression Scale (GDS) Score > 11) Inability to attend DEXA scan or complete other requirements of the study Significant cardiac failure (NYHA Class III and above) Significantly abnormal liver function tests (ALT, GGT, bilirubin or ALP more than 2 times the upper limit of normal) Nephrotic syndrome; 24h urine protein excretion > 3 grams (if baseline urinalysis reveals > 1+ proteinuria, quantification will be performed) AND/OR calculated creatinine clearance (by the equation of Baracskay and Jarjoura for ambulatory elderly subjects [Cr clearance = 4.4/serum creatinine (mmol/L) + (88-age)](63) < 30 ml/min) AND/OR serum creatinine concentration > 0.2mmol/l
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 3.0-999.0, Insulin-Like Growth Factor-1 Deficiency Growth Disorders Chronological age ≥ 3 Chronological age or bone age ≤ 12 for boys and ≤ 11 for girls Prepubertal at Visit 1 Height SD score of < -2 IGF-1 SD score of < -2 Prior treatment with GH, IGF-1, or other growth-influencing medications Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality) Chronic illness such as diabetes, cystic fibrosis, etc
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Acromegaly Newly diagnosed or previously untreated acromegalic patients Lack of suppression of growth hormone (GH) nadir to <1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test [OGTT]) Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender) Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass No evidence of pituitary adenoma on magnetic resonance imaging (MRI) Symptomatic cholelithiasis
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 21.0-40.0, Hypoactive Sexual Desire Disorder pre-menopausal females, hypoactive sexual disorder, age 21-40, able to plan intercourse with partner -
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-46.0, Hirsutism Hirsute subjects Belonging to group 1 or 2 Age: 20-46 Hirsute score: >7 Written informed consent Control group Age: 20-46 Hirsute score: 0 (without razing) Regular menses Written informed consent Previous cosmetic treatment for hirsutism Use of contraceptive pill (within the past 6 months) Systemic steroid treatment > 6 weeks (ever) Age above 46 years/post menopause (increased FSH) Recognized diabetes mellitus or other endocrine disease Eating disorder Serious, treatment demanding disease
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 20.0-75.0, Acromegaly Patients with acromegaly who have received at least one dose of B2036-PEG in the preceding study (A6291009) Switching to other therapeutic methods for acromegaly
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-45.0, Hirsutism Type 2 Diabetes Polycystic Ovary Syndrome The patients which had been included in the previous study between 1997 oral glucose tolerance test included Pregnancy
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 22.0-72.0, Acromegaly All the patients which receive octreotide LAR can be included New diagnosed patients with clinical and biochemical acromegaly , if medicine therapy is indicated As long as they do not fit in the Which had not given their consent after they received standard information about the study Current malign disease Somatostatin analogues intolerance Elevation of lever enzymes Pregnancy
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Head and Neck Cancer Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly The patient must have a clinical diagnosis of acromegaly The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening The patient must be able to store study medication in a refrigerator in their own home The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening The patient has received pituitary radiotherapy within one year prior to screening The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Acromegaly Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies ALT/AST>3 times the ULN or have hepatic disease have severe visual field loss, cranial nerve palsies or intracranial HTN that requires surgery to decompress the tumor unwilling to self-administer the medication
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-999.0, Polycystic Ovary Syndrome Criteria-PCOS Probands: 1) Aged 18 yrs or above 2) Oligomenorrhea or amenorrhea (<9 menses/yr); 3) clinical and/or biochemical evidence of hyperandrogenemia; 4) normal TSH and prolactin <25 ng/mL; 5) on no hormonal or insulin sensitizing medication for at least 3 months and have not taken Provera for at least ten days prior to enrollment. If the subject has previously had hormone levels drawn and processed in the Reproductive Endocrine Laboratory, it is not necessary to discontinue hormonal or insulin sensitizing medication. A second group of PCOS probands with a documented diagnosis of PCOS will also be recruited. These subjects will meet all of the above except that they will be on hormonal medication. Criteria-Female Unaffected Relatives: 1) Aged at 18 yrs or above; 2) Regular menstrual cycles 21-35 days or history of regular menstrual cycles in the past if menopausal; 3) no clinical or biochemical evidence of hyperandrogenism; 4) normal TSH and prolactin <25 ng/mL; 5) on no hormonal or insulin sensitizing medication for at least 3 months. Criteria-Male Relatives: 1) Aged 18 yrs or above; 2) normal TSH and prolactin <25 ng/mL; 5) on no hormonal or insulin sensitizing medication for at least 3 months. Criteria-Control Subjects: All control subjects will meet the outlined for the female unaffected relatives. In Iceland, control subjects will be recruited from the Icelandic national registry, matched by age and sex to PCOS subjects and their family members. They will otherwise be recruited at random. In Boston, control subjects will be recruited from email and newspaper listings PCOS Probands: Subjects will not have 1) late onset congenital adrenal hyperplasia as defined by a fasting 17OH progesterone level <200 ng/mL or a cortrosyn stimulated 17 OH progesterone level <500 ng/mL (Female unaffected relatives): None Male Relatives: None -Control Subjects: Control subjects chosen at random will be excluded if they are already participating in the study as a PCOS subject or are a first degree family member of the PCOS subject
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-80.0, Acromegaly Males and females 18 and < 80 years old Recently diagnosed not previously treated patients with acromegaly Presence of a pituitary tumor (microadenoma or macroadenoma), documented by a MNR performed in the 12 weeks before enrolment Absence of nadir suppression of the nadir of GH to < 1.0 ng/mL, after oral administration of 75 g of glucose (OTTG) IGF-I levels over normal upper limits, e.g. 97 percentile (age and sex-matched) Tolerance shown with a test of a subcutaneous injection of octreotide Written Informed Consent before any procedure specific to the study. Inclus Previously treated patients with any therapy for acromegaly, including surgery, radiotherapy, bromocriptin, and somatostatin analogues Compression of optic chiasm that produces any impairment of field of vision Need of surgery to improve any neurological sign or symptom associated with a direct incidence on the tumour Intolerance to octreotide or to any component of Sandostatin® LAR® preparation Patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution Pregnant women History of alcohol or drug abuse in the six months prior to the visit Patients suffering from any condition that may jeopardize the interpretation of study results or may impede to obtain informed consent Intake of an investigational drug during the study and 30 days before patient in this study Other protocol-defined /
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2
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-85.0, Acromegaly Growth Hormone Deficiency Pituitary Disease Age 18-75 History of acromegaly with biochemical cure documented with a normal oral glucose tolerance test (OGTT) and/or a non-elevated IGF-I without concurrent use of somatostatin analogs, dopamine agonists or GH receptor antagonists. Subjects will have been treated with medication, surgery, radiation, or a combination of these At the time of enrollment a minimum of 6 months must have elapsed since surgery No malignancy on colonoscopy performed since the diagnosis of acromegaly GHD due to surgical or radiation treatment GHD will be defined as a peak plasma GH of less than 5 ng/ml in response to an insulin tolerance test or a GH-releasing hormone (GHRH) plus arginine stimulation test GHD will also be diagnosed if IGF-I levels are below 2 standard deviations for the age-sex normal range in a patient with at least two other documented anterior pituitary hormone deficiencies Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study History of malignancy except for non-melanoma skin cancer Hemoglobin <11.0 gm/dl Uncontrolled hypertension Hepatic or renal disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x upper limit of normal (ULN) or creatinine level >2.5 mg/dl) Congestive heart failure (New York Heart Association's classification system Class II-IV congestive heart failure (CHF) will be excluded) Unstable cardiovascular disease (coronary artery or cerebrovascular disease) or symptoms within one year prior to entry into the study Initiation or discontinuation of gonadal steroid therapy within 3 months of entry Diabetes mellitus, impaired fasting glucose, impaired glucose tolerance Pregnancy or nursing
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 18.0-40.0, Bipolar Disorder Mental Health for All Participants Have been menstruating for at least 4 years prior to study entry Participants must be willing to travel to Stanford University at own expense for study visits for Bipolar Disorder Participants Participants should have a diagnosis of Bipolar I, Bipolar II, or Bipolar not otherwise specified (NOS), and be under the treatment of a physician who can be contacted in case of an emergency Current treatment with any mood-stabilizing agent for a period of at least 3 months (e.g., divalproex sodium, lithium, other mood stabilizer, or atypical antipsychotic) for Healthy Controls No past or present diagnosis of mental illness for All Participants Current alcohol or substance abuse or dependence within 6 months prior to study entry Meets for another DSM-IV Axis I disorder Contraceptive steroid use within 3 months prior to study entry Current use of medication that may affect steroid metabolism Menopausal Endocrine disease such as diabetes or hypothyroidism Uncontrolled medical illness History of long-term corticosteroid use Organic mood disorder
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0
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A 35-year-old woman presents with history of acne and mild hirsutism. The primary evaluation revealed elevated testosterone levels. She recently noticed gradual enlargement of her hands and feet and recognized that her ring is getting small for her finger. There is some irregularity in her menstrual cycle as well as some nipple discharge. She also has positive history for snoring and headache. The physical examination revealed subtle facial features of acromegaly and prognathism. Visual fields are normal by confrontation. Hirsutism, soft tissue thickening and diaphoresis of the hands and feet are noted. Laboratory evaluation in the fasting state reveals IGF-1 of 968 ng/mL and random GH of 19.7 ng/mL. MRI reveals a macroadenoma with no invasion. She is on stable doses of octreotide LAR since her diagnosis was confirmed. She is married and has 2 children. She is using IUD as her contraceptive method.
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eligible ages (years): 13.0-17.0, Primary or Secondary Hypogonadism Constitutional Delay in Growth and Puberty (CDGP) Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP) Skin intolerance to alcohol or allergy to soy Generalized skin disease Contraindication to testosterone or androgen products
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0
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