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The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 45.0-80.0, Parkinson Disease With Dementia Fulfill the Movement Disorder Society Clinical Diagnostic for Parkinson's disease, age between 45-80 years old. 2. With mild cognitive impairment or dementia (Clinical Dementia Rating Scale >= 0.5) People who have 1. pre-existing and active major neurological diseases other than PD 2. with a previous history of seizures 3. with implanted metallic objects that would contraindicate rTMS 4. unable to perform fMRI 5. with skin damage on the stimulation area 6. with multiple sclerosis 7. with large ischemic scars 8. with a family history or medical history of seizures, epilepsy 9. brain damage may affect the threshold for inducing epilepsy 10. taken tricyclic antidepressants, analgesics, or anything that may lower the threshold for inducing epilepsy 11. with sleep disorders during the rTMS treatment 12. with severe alcohol abuse or use of epilepsy drugs 13. with severe heart disease or uncontrollable migraine caused by high intracranial pressure 14. who are actively suicidal during the trial period, have recurring major medical disorders, or with neurological co-morbidities such as space occupying lesions, CVA, aneurysms etc | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Shoulder Osteoarthritis First-line reverse prosthesis 2. Without prosthetic history 3. Patient who has given his consent to participate in the observational study after being informed by the surgeon 4. Patient living in France and able to answer the questionnaire alone. 5. Subject affiliated to a social security scheme or beneficiary of such a scheme 6. Lack of participation in another clinical study Minor patient 2. Major subject protected by law, under curatorship or tutorship 3. Anterior prosthesis 4. Infection 5. Parkinson's, degenerative neurological disease 6. Pregnant or breastfeeding woman | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.083-0.917, Child Mortality Community Located in one of the three selected regions: SudOuest, Centre-Ouest, Hauts-Bassins) Verbal consent of the community leader is obtained for children Aged 1 to 11 months Living in one of the communities participating in the study Community • Inaccessible or unsafe for the study team for children: • Known allergy to macrolides | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 50.0-75.0, Parkinson Disease Idiopathic Parkinson's disease diagnosis according to Parkinson's Disease Society Brain Bank of London Active treatment with levodopa Stages 1, 2, and 3 according to Hoehn and Yahr Classification Severe cognitive impairment defined as ≤ 20 in Montreal Cognitive Assessment Score greater than or equal to 6 on the geriatric depression scale Severe respiratory and / or cardiovascular conditions Visual and / or auditory deficit that cannot be corrected with glasses or a hearing aid Other previously detected orthopedic or neurological diseases, other than Parkinson's Disease, that may interfere with the individual's performance Previous experience with Microsoft XBOX Kinect® games And being in rehabilitation in another location concomitant to this training | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Parkinson's Disease Aggravated patients aged 18-years old or older with moderate to severe dyskinesia and/or motor fluctuations with incomplete or poor response to adjustments in time and dose of levodopa and other anti-parkinsonian agents such as entacapone, rasagiline, dopamine receptor agonists and amantadine in 1-2 months prior to enrollment; defined by a Movement Disorders Society Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) part IV score equal or higher than 8 following pharmacological adjustments patients with chronic renal failure, decompensated heart failure, colonic abnormalities precluding the use of evacuating enema, known allergies to prescribed medications to reduce microbiota load and patients who declined to participate in the study | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Parkinson Disease, Idiopathic *Inclusion 1. Male or Female; 2. Clinically defined idiopathic Parkinson's Disease (PD); 3. Brain MRI performed in routine care in the 12 months preceding inclusion; 4. Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before (no time limit), confirming presynaptic dopaminergic denervation; 5. Hoehn & Yahr score: 1 to 3; 6. Normal clinical examination of oculomotricity (slight impairment of smooth pursuit accepted); 7. Neuro-cognitive disorders: absent or minor (according to DSM5); 8. Sufficient written and oral expression in French; 9. Covered by a health insurance system; 10. Written informed consent signed by the patient; 11. Presence of a caregiver. * Psychiatric comorbidity (except anxiety or mild to moderate depression); 13. Neurological comorbidity, if significant; 14. Brain MRI showing: 1. significant cerebrovascular pathology (Fazekas I admitted), 2. another brain disease, including stroke. 15. Major cognitive impairment; 16. Absolute and "Red flags" of the 2015 orienting towards another degenerative pathology of the extrapyramidal system Cerebellar syndrome Vertical oculomotricity disorders on clinical examination Motor symptoms restricted to the lower limbs Bilateral and perfectly symmetrical parkinsonism Early dystonia Clinical profile suggestive of behavioral variant frontotemporal dementia (bvFTD) Progressive aphasia or apraxia Moderate or severe postural instability and / or early falls | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 40.0-85.0, Parkinson Disease Participants must meet the Movement Disorders Society (MDS) diagnostic for clinically established Parkinson disease. 2. Able to provide signed informed consent (in English or Spanish) 3. Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages I-IV) 4. Taking instant release oral carbidopa/levodopa therapy 5. Either not taking, or on stable doses of any of the following antiparkinsonian medications: dopamine agonists, monoamine oxidase B (MAO-B) inhibitors or catecholamine O-methyl transferase (COMT) inhibitors Other neurological conditions including but not limited to stroke, dementia (including Parkinson disease dementia), or traumatic brain injury 2. Co-existent major psychiatric disease 3. Uncontrolled, active medical conditions (e.g., heart, kidney, or liver failure, diabetes, etc.) 4. Status post deep brain stimulation (DBS) device placement 5. Any other condition, that in the opinion of the investigators, would place the participant at risk | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 30.0-999.0, Parkinson's Disease (PD) Completion of the parent study, Study M15-736 Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Parkinson Disease Adult individual at least 18 years old 2. Clinical diagnosis Parkinson's Disease 3. Subject has provided informed consent before initiation of any study procedure. 4. Subject has mesenchymal stem cells banked at Hope Biosciences Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine disease or any other acute or chronic medical condition that, in the opinion of the investigator, may increase the risks associated with study participation. 2. Chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study 3. Participation in concurrent interventional research studies during this trial 4. Unwillingness to return for follow-up visits | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 30.0-999.0, Parkinson's Disease Diagnosis of Parkinson's Disease consistent with UK Brain Bank 2. Age at least 30 years old at time of consent 3. Male and Female participants (Women of child-bearing potential (WOCB) are eligible for participation if they are not pregnant or breastfeeding and agree to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 30 days after the last dose of study treatment) 4. Suitable for oral retainer wear 5. A good response to Levodopa, as assessed by the Investigator 6. At least 2 hours of wearing OFF time per day, as reported by the participant 7. Predictable early morning OFF periods, in the judgement of the participant and the Investigator 8. Taking 400-1,200 mg of LD/CD per day in at least 4 doses, with stable dosing for the last 28 days prior to screening. 9. A modified Hoehn and Yahr of ≤ 3 in the ON state at screening 10. A stable regimen of anti-PD medications for the last 28 days prior to Screening 11. A Mini-Mental State Examination (MMSE) Score ≥26 12. Capable of giving signed informed consent 13. Approved for entry into the study by the Enrollment Authorization Committee (EAC) Atypical or secondary Parkinson's Disease 2. Severe Dyskinesia that might interfere with study performance in the judgement of Investigator 3. Clinically significant dysphagia or sialorrhea that might interfere with administration of study intervention in the judgement of the Investigator 4. Use of extended release levodopa within 28 days prior to screening 5. Any clinically significant medical, surgical, or psychiatric condition; laboratory value or ECG result which, in the opinion of the Investigator, makes the participant unsuitable for study entry or potentially unable to complete all aspects of the study. 6. Presence of clinically significant orthostatic hypotension at screening, in the opinion of Investigator or the EAC 7. Suicidal ideation within 1 year prior to the Screening Visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) or attempted suicide within the last 5 years. 8. History of psychosis or hallucinations in the past six months 9. Any malignancy in the past 5 years (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated.) 10. Current or previous diagnosis of malignant melanoma or the presence of any suspicious skin lesion based on physical exam findings 11. Unable to give blood required for the study 12. History of allergic reaction to plastics 13. LD infusion therapy (i.e. Duodopa); current or previous continuous apomorphine infusion treatment. 14. Participation in any other clinical trial <30 days prior to screening visit. 15. Presence of two third molars ("wisdom teeth") on the upper dentition 16. Participants who, for any reason, are judged by the Investigator or the EAC to be inappropriate for this study, including participants who are unable to communicate or cooperate with the Investigator or who have/had a clinically significant illness or abnormal physical examination that may compromise safety of the participant during the trial or affect ability of the participant to adhere to study procedures. 17. Participants taking non-selective monoamine oxidase (MAO) inhibitors 18. Participants with known hypersensitivity to the active ingredients (levodopa, carbidopa) or excipients (Benzoic Acid, Disodium Edetate, Medium Chain Triglycerides, Poloxamer 188) of the drug paste 19. Participants with narrow-angle glaucoma | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.0-999.0, Parkinson Disease Diagnosis of Parkinson Disease Inability to walk without physical assistance | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 40.0-999.0, Parkinson Disease Clinical diagnosis of Idiopathic Parkinson's disease Must have acess to internet Severe cognitive decline Severe visual impairment Severe hearing impairment | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-70.0, Obesity Age 18-70 Body mass index (BMI) between 25 and 50 kg/m-squared Diagnosis of one or more cardiovascular disease risk factors (prediabetes, type 2 diabetes, hypercholesterolemia, or hypertension) Able to walk 2 city blocks without stopping Currently participating in another weight loss program Currently taking weight loss medication Lost > 5% of their body weight in the 6 months prior to enrolling Has been pregnant within the 6 months prior to enrolling Plans to become pregnant within 6 months of enrolling Has chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling Has any medical condition that would affect the safety of participating in unsupervised physical activity Has history of bariatric surgery Has any condition that would result in inability to follow the study protocol, including terminal illness, substance abuse, eating disorder (not including Binge Eating Disorder) and untreated major psychiatric illness | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Parkinson Disease Upper Extremity Dysfunction Therapy-Related MDS Parkinson's disease diagnostic Classified as I-III on the Hoehn & Yahr motor staging scale Are over 18 years old (above this, without age restriction) Residents in the city of Porto Alegre / RS Have signed an informed consent form Do not show the understanding of the games on the first day of familiarization Have a cerebral pacemaker implant Have recent injuries or limitations that make the MMSS impossible Do not perform / abstain from two appointments out of the 16 proposed in the intervention protocol, regardless of the group that will be allocated | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-85.0, Parkinson Disease Parkinson's Disease and Parkinsonism Adult participants (aged 18 years inclusive) Have been diagnosed with PD according to the UK Brain Bank Participants must have demonstrated a positive response to medications to treat the motor symptoms of PD and have been treated with these medications for minimum of three years prior to the screening visit Report limitation to activities of daily living Participants must be able and willing to consent to participate in the study Participants must be willing and able to comply with study requirements Participants and investigators must expect that the participant will be able to remain on a stable regimen of concomitant therapies used for the management of PD motor and non-motor symptoms and not to introduce new medications used to treat motor or non-motor symptoms associated with PD during the trial Participants must have at minimum a moderate burden of NMS Participants must have a study partner (defined as someone who sees the participant for more than one hour a day, 3x per week) that is willing to consent and participate in the trial Participant anticipates being unable to attend all visits and complete all study activities Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the study trial. Women of child-bearing potential (i.e., are not yet 3 years removed from their first menopausal symptom), who are not abstinent or exclusively in same sex relationships must: 1. Test negative for pregnancy as indicated by a negative urine pregnancy test 2. Agree to use an approved contraception method for the entirety of the trial Have a history or prior diagnosis of dementia Have experienced a myocardial infarction, angina or stroke within the past 12 months Are receiving deep brain stimulation therapy Are treated with a pump for continuous delivery of dopamine replacement medication Use apomorphine rescue Have received MRI guided high intensity focused ultrasound within the past 12 months Experience frequent falls Work night shifts | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-85.0, Parkinson Disease Parkinson's Disease and Parkinsonism Completion of the study activities in the STEM-PD RCT trial. l Participants must be willing and able to give consent to participate in the study trial Participant anticipates being unable to attend all visits and complete all study activities in both the RCT and OLE study trial Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the RCT or OLE study trial | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Cirrhosis Portal Hypertension Patient with cirrhosis and portal hypertension older than 18 old Patient who underwent a CT scan or MRI in the last 3 months The Mini-Mental State (MMS) test >25 Patient capable of receiving and understanding information relating to the study and of giving his written informed consent Patient affiliated to the French social security system Cirrhotic patient with overt HE or history of persistent or recurrent HE Hepatocellular carcinoma beyond Milan criteria Portal vein thrombosis Previous transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt Presence of neurological or psychiatric disorder Patient with treatment by benzodiazepines or opioid substitution Pregnant or nursing women Patient in period of a previous study Patient under guardianship, trusteeship or the protection of justice or incapable of giving their own informed consent | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 50.0-80.0, Parkinson Disease Mild Cognitive Impairment Aged between 50 to 80 years (inclusive) at time of consent Duration of motor symptoms of at least 1 year Hoehn and Yahr stage between 1 and 3 (inclusive) in ON state Diagnosis of PD according to United Kingdom (UK) Brain Bank Score on Clinical Dementia Rating (CDR) scale = 0.5 Diagnosis of PD-MCI according to MDS PD-MCI, Level I Duration of cognitive impairment of at least 3 months (to distinguish from mild delirium) Insufficient fluency in English or local language to complete assessments Severe visual or auditory impairment that may interfere with participant's ability to complete assessments Unable to provide informed consent at screening visit Participation in a clinical study involving an investigational drug within 4 months prior to screening Smoking (cigarettes, pipes, cigars, e-cigarettes etc.) or use of smokeless tobacco products (chewing / dipping tobacco, snuff etc.) or anti-smoking nicotine containing products (patches/gum/sprays etc.), within the last 12 weeks HADS depression subscale score ≥ 11 History of deep brain stimulation or other neurosurgical procedure Diagnosis of dementia, including Parkinson's disease dementia (PDD) or Dementia with Lewy Bodies (DLB) Diagnosis of schizophrenia, bipolar disorder or other psychotic disorder Malignant neoplasms within 3 years of screening (except for basal or squamous cell carcinoma of the skin); or had curative surgery/treatment and has been free of malignancy for at least 12 months) | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 45.0-90.0, Parkinson Disease Diagnosis of Parkinson Disease Previously Untreated or treated for <4 weeks Mild to Moderate Parkinson disease (Hoehn & Yahr Stages I-II) About to start treatment with a L-Dopa preparation (Sinemet) The presence of other neurologic disease or findings on examination Depression: Geriatric Depression Scale score >11 Use of dopamine agonists or stimulants Evidence of a stroke or mass lesion on prior structural brain imaging (MRI or CT) Evidence of any confounding medical or psychiatric problem that would preclude task participation Participants with cognitive impairment that might impair their capacity to provide informed consent | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Spinal Cord Injuries Adult individual 18 years of age or older. 2. Cognitively intact and capable of giving informed consent. 3. Clinical diagnosis of Traumatic Spinal Cord Injury. 4. Subject has mesenchymal stem cells banked at Hope Biosciences. 5. The patient accepts to receive treatment and to comply with follow-up visits Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine disease or any other acute or chronic medical condition that, in the opinion of the investigator may increase the risks associated with study participation. 2. Active Alcohol or Drug addiction. 3. Participation in concurrent interventional research studies during this study. 4. Severe organ failure (heart, kidney or liver), confirmed by additional tests or medical history. 5. Unwillingness to return for follow-up visits | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 45.0-85.0, Alzheimer Disease Informed consent signed by the subject AND a reliable caregiver 2. 45-85 years of age (inclusive) 3. Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria. 4. Clinical Dementia Rating (CDR) global rating of 0.5 or 1 at screening. 5. ADAS-cog-11 score of 12-30 inclusive at screening AND baseline (with a score ≥ 4 on ADAS-cog item 1) or a Mini Mental State Examination (MMSE) of 16-28. 6. If female, post-menopausal, surgically sterile or willing to use birth control methods for the duration of the study. 7. The patient has an available caregiver or other appropriate knowledgeable informant who can reliably report on daily activities and function and signs the informed consent for participation as such. 8. Patient is living at home and likely to remain at home for the study duration. 9. General Medical Health Rating (GMHR) ≥ 3 (good or excellent general health). 10. Patient must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team. 11. Fluency (oral and written) in the language in which standardized tests will be administered. 12. The patient is taking a stable dose of cholinesterase inhibitor (AChEI) medication (donepezil, galantamine, or rivastigmine) for at least 60 days prior to signing the informed consent form and there is no intention to modify the dose over the course of the study (NOTE: These medications may NOT be initiated, discontinued or modified after study initiation for the length of study participation) Neuropsychiatric Inventory (NPI) total score ≥ 10 or score ≥ 4 in any NPI domain (clinically significant neuropsychiatric symptoms). Apathy score ≥ 4 acceptable. 2. Subjects at risk for suicide in the opinion of the investigator or the subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at the screening or baseline visit. 3. Cornell Scale for Depression and Dementia (CSDD) score > 10 at the screening visit 4. Young Mania Rating Scale (YMRS) ≥ 11 at the screening visit 5. Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit 6. The subject has attempted suicide in the 2 years prior to signing the consent to participate in the study. 7. In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study 8. History of head trauma in the 2 years prior to signing the consent to participate in the study 9. History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI 10. Active psychiatric disorder 11. Mental retardation 12. Current alcohol or substance abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) 13. Contraindications for PET scanning (e.g., insulin dependent diabetes) 14. Contraindications for MRI scanning, including implanted metallic devices (e.g. non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces. 15. Radiation exposure in the 1 year prior to signing the informed consent form that, in combination with the radiation exposure from this study, would exceed 5 rem. 16. Abnormal lab results that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study. 17. Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study. 18. Unstable dose of any medication prescribed for the treatment of memory loss or Alzheimer's disease. 19. Currently prescribed any non-AD medications that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study. 20. Is unable or unwilling to comply with protocol follow-up requirements. 21. Has a life expectancy of < 1 year. 22. Is actively enrolled in another concurrent clinical trial | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 30.0-85.0, Parkinson Disease Willing and able to give informed consent Willingness and ability to comply with study requirements PD diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity, postural instability) being present Age >30 years Men and women with mild to moderate PD: Hoehn and Yahr scale stages 1 Participants may be on current therapeutic agents (including levodopa, dopamine agonists, anticholinergics, amantadine or selegiline) to treat PD symptoms at the time of enrollment and may remain on these agents throughout the 5-month study period Women of childbearing potential (i.e., those not postmenopausal or surgically sterile) may participate provided that they are using adequate birth control methods for the duration of the study. Women of childbearing potential must have a negative pregnancy test at baseline and be non-lactating • Subjects with advanced, severe disease, including those with dementia, severe osteoarthritis, allergies, stroke, and visual impairment Presence of atypical PD syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic identified neurogenetic disorders (e.g., Wilson's disease), encephalitis, or other degenerative diseases (e.g., progressive supranuclear palsy) Any clinically significant medical condition (e.g., active neoplasm, angina) or laboratory abnormality, which would in the judgement of the investigator interfere with the subjects' ability to participate in the study or be followed | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Low Back Pain Must live in the United States Must understand and write English Must have access to a computer with e-mail and expect to have this access for at least 3 years Must be 18 years old Must have seen a doctor for back pain at least once in the past year Pregnancy Back surgery in the past 6 months Expectation of having back surgery in the next 6 months Back pain due to a car accident or other major injury within the last 6 months Back pain or sciatica due to systemic disease (inflammatory rheumatic diseases, tumor, or other) Major physical or mental health condition for which one is currently being treated that severely limits daily activities Terminal illness Receiving disability or workers compensation insurance payments for back pain or sciatica Presently involved in legal proceedings because of back pain or sciatica Difficulty with bladder or bowel control that began with back pain or sciatica | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 30.0-69.0, Arrhythmia Cardiovascular Diseases Coronary Disease Death, Sudden, Cardiac Heart Diseases Myocardial Infarction Myocardial Ischemia Ventricular Fibrillation Men and women, ages 30 to 69. Documented myocardial infarction | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 25.0-49.0, Cardiovascular Diseases Heart Diseases Hypertension Obesity Vascular Diseases Men and women, ages 25 to 49. Diastolic blood pressure between 78 and 89 mm Hg. Free of major disease. Not on a special diet or antihypertensive medication at entry. Some mild to moderately obese subjects | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-65.0, Cardiovascular Diabetes Obesity Hypertension Ethnicity: African Americans To enroll participants must self-identify as African Americans and be born in the United States, with American born parents or be born in Africa with African born parents. In the future, we plan to expand the study to other groups which self-identify as African Americans (i.e. AfroCarribeans and Hispanic blacks) Age: The age range of the participants will be between 18 and 50 years Medical History: To participate in the study subjects should identify themselves as healthy Menstrual History: Women must give a history of regular monthly cycles (24-35 days) for at least one year African American Ethnicity other than American or West African ancestry. In the future, we will expand the study to other African American groups such as individuals of Afro-Caribbean and Hispanic blacks Medications: People who take medications that are known to alter the parameters which are under investigation in this study will be excluded. An example would be medications used to treat hyperlipidemia such as statins, niacin, bile acid sequestrants and fibric acid derivatives. Subjects on thyroid hormone replacement will be included if their TSH is normal Diabetes: Because diabetes affects insulin sensitivity and TG levels all people with diabetes even if the diabetes is controlled with diet alone will not be enrolled in the study Breastfeeding: Women who are breastfeeding or have an infant that is less than four months of age will be excluded. This is because the physiologic changes associated with breastfeeding or recent childbirth affect the parameters under study Menstrual History: Women with a history of irregular menstrual cycles in the year prior to the study will be excluded. Due to the requirement for regular menses, women in the following categories, regardless of age will be excluded: history of hysterectomy, history of bilateral oophorectomy, use of Norplant or Depo-Provera for contraception History of bleeding diathesis | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 29.0-85.0, Stroke Cerebral Infarction African Americans are eligible if they had a non-cardioembolic ischemic stroke at lease 7 days, but no more than 90 days before entering the trial African American 85 years of age Non-cardioembolic cerebral infarct Onset of entry stroke at least 7 days but no more than 90 days CT or MRI following entry stroke and consistent with occurrence of entry stroke (i.e., shows entry infarct, shows old infarct, or shows no infarct) Measurable neurologic deficit that correlates with onset of entry stroke Informed consent Able to follow outpatient treatment program Volunteers with transient ischemic attack (TIA) as the potentially qualifying event, intracranial hemorrhage, nonatherosclerotic stroke, sensitivity or major allergy to the study drugs, Modified Barthel Index < 10 or childbearing potential are not eligible Non-qualifying entry events: TIA, subarachnoid hemorrhage, cardiac embolism, iatrogenic stroke, postoperative stroke within 30 days of operation, and carotid endarterectomy as preventive treatment of entry stroke Mean arterial blood pressure > 130mmHg on 3 consecutive days Modified Barthel Index < 10 History of dementia or neurodegenerative disease Severe comorbid condition such as cancer that would limit survival during 2 year follow-up period Concurrent enrollment in another clinical trial Sensitivity or allergy to aspirin or ticlopidine Women of childbearing potential Peptic ulcer disease, active bleeding diathesis, lower gastrointestinal bleeding, platelet or other hematologic abnormality currently active or clinically active in the past year, hematuria, positive stool guaiac, prolonged PT or PTT, BUN > 40mg%, serum creatinine > 2.0mg%, thrombocytopenia or neutropenia as defined by the lower limit of normal for the platelet count or white blood cell count, respectively (absolute neutrophil count of > 1800/mm3 required for participation), or > 2 times the upper range of normal on liver function tests (SGOT, SGPT, total bilirubin) | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 0.0-999.0, Cardiovascular Diseases Coronary Disease Hypertension Heart Diseases | 2 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 35.0-84.0, Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Disease Hypertension Cerebrovascular Disorders African American | 2 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 0.0-999.0, Cardiovascular Diseases Heart Diseases Hypertension | 2 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Heart Failure, Congestive In order to be considered an eligible subject, all of the following entry must be met Subjects must be competent to provide informed written consent. Subjects must sign an IRB/IEC approved informed consent form prior to the initiation of any study procedures Subjects must be 18 years of age or older Subjects must have ischemic or nonischemic cardiomyopathy with symptoms of NYHA Class III or IV chronic heart failure Subjects must have a LVEF of less than or equal to 35%, measured within 60 days of the Screening Visit. LVEF must be assessed by radionuclide ventriculography (MUGA). If the subject has experienced any cardiovascular events, has undergone any interventions, or received any changes in treatment that may have affected LV function since the most recent EF measurement, an LVEF measurement must be completed prior to the subject being randomized Subjects must have a left ventricular end diastolic dimension (LVEDD) of >2.7 cm/m2 as measured by 2-D ECHO within 12 months of the Screening Visit Subjects must be on optimal conventional heart failure therapy (with the exception of a beta-blocker), including an ACEI for at least 30 days prior to the Screening Visit, or the subject must have had a trial of an ACEI and proven to be intolerant, or the subject must be taking an ARB for at least 30 days prior to the Screening Visit or proved to be intolerant. Optimal conventional therapy may also spironolactone, digitalis glycosides, diuretics, or other vasodilators Subjects must have failed the initiation, or the up-titration, of a beta-blocker drug due to hemodynamic intolerance within 12 months prior to the Screening Visit. Failure to tolerate beta-blockade for hemodynamic reasons is defined as worsening signs and symptoms of chronic heart failure, hypotension accompanied with symptoms, or evidence of organ hypoperfusion, which in the judgment of the treating physician precluded further treatment with the beta-blocker. This beta-blocker intolerance must have been documented prior to Screening, and a narrative description of the intolerance must be approved by Myogen prior to Randomization Subjects who meet any one of the following will be deemed ineligible for participation in the study Subjects with CHF due to or associated with uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, malfunctioning artificial heart valve, uncorrected congenital heart disease, isolated right-sided heart failure, or primary pulmonary hypertension Subjects who have undergone a cardiac revascularization, valvular surgery, or bi-ventricular resynchronization procedure within 60 days prior to the Screening Visit Subjects listed for heart transplantation who are expected to be transplanted within 6 months of randomization Subjects who have had a myocardial infarction within 90 days prior to the Screening Visit Subjects with an ECG recorded at the Screening Visit showing any of the following: 1) evidence of transmural ischemia (dynamic ST elevation or ST elevation associated with ischemic symptoms), or 2) ventricular tachycardia (VT) or premature ventricular complexes (PVCs) associated with symptoms, or 3) VT of greater than or equal to 6 beats Subjects with sustained (>15 seconds) VT, unless precipitated by an event such as an acute myocardial infarction, induction by catheter placement, or by an electrophysiology procedure, or addressed by AICD placement Subjects with an AICD that has fired for any ventricular arrhythmia within 90 days of the Randomization Visit Subjects with a documented diagnosis of angina that meets either of the following 1) angina diagnosed as unstable at any time within the 60 days prior to the Screening Visit or 2) angina is the primary symptom that limits daily physical activity Subjects who have had ventricular reduction surgery or cardiac myoplasty | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-80.0, Back Pain Chronic back pain for at least 6 months Treatment by medication or physical therapy Acute or life threatening physical illness Current alcohol or substance abuse or dependence Current psychosis or suicidal ideation treatment by anesthesiology, chiropractic care or surgery | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-90.0, Kidney Failure, Chronic End-stage renal disease Hemodialysis Hypertension Written informed consent Hypotension of less than 90 mmHg systolic High-grade aortic stenosis Heart failure of NYHA stage III and IV Acute myocardial infarction (within the last 4 weeks) Acute heart failure Known allergy to the medicament amlodipine or other constituents of the medicament Severe disorders of liver function Pregnancy and breast-feeding | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 30.0-75.0, Hypertension Type 2 Diabetes Mellitus Clinical diagnosis of hypertension Clinical diagnosis of type 2 diabetes or impaired glucose tolerance History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months Taking calcium channel blocker for the purpose of angina pectoris Reduced ejection fraction (< 40%) Second or third-degree of atrioventricular block Severe hypertension (> 200/110 mmHg) or secondary hypertension History of stroke in the recent 6 months Serum creatinine > 2.5 mg/dl Estimated survival duration less than 3 years due to other conditions Pregnant woman or possibly pregnant woman | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 65.0-84.0, Hypertension Cardiovascular Diseases Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex Current antihypertensive treatment with monotherapy SBP ≥ 140mmHg or DBP ≥ 90mmHg in a sitting position on two measurements on two clinic visits At least one of the following risk factors Diabetes mellitus Type 2 History of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (more than 6 months before giving informed consent) Diagnosis of asymptomatic cerebrovascular disease History of myocardial infarction (more than 6 months before giving informed consent) Diagnosis of angina pectoris or heart failure (New York Heart Association [NYHA] functional classification I or II) Diagnosis of left ventricular hypertrophy (thickness of the wall of interventricular septum ≥ 12mm on echocardiography or Sv1+Rv5 ≥ 35mm on electrocardiography before informed consent) Secondary hypertension or malignant hypertension Heart failure (NYHA functional classification III or IV) Required treatment for malignant tumor Serious liver or renal dysfunction (serum creatinine > 2.5mg/dL or with dialysis treatment) Not appropriate for change to the test drugs from current therapy for hypertension or coronary diseases (i.e. calcium channel blockers, β-blockers, thiazide diuretics, etc.) History of serious adverse drug reactions to angiotensin II receptor blockers or calcium channel blockers Patients with other serious reasons (i.e. illness, significant abnormalities, etc.) that investigators judge inappropriate for the study | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-70.0, Hypertension Essential Hypertension SBP 140-159 mmHg DBP 90-99 mmHg Intolerance of or allergy to ACE Inhibitors or ARBS Pregnant or Breastfeeding Pre-menopausal women Uncontrolled cardiac or renal failure Diabetes mellitus | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Myocardial Ischemia Outpatients > =18 years of age with diagnosed clinically stable angina pectoris Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG | 2 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 20.0-79.0, Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke Clinical diagnosis of hypertension Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH) Patients who have already been administered ARB Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG) Severe/malignant/secondary hypertensive patients Pregnant women and women of childbearing potential History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block Severe renal impairment (Serum creatinine >3.0 mg/dl) Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.) | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-76.0, Diabetes History of diabetes for at least 5 years, with a least 2 risk factors (i.e. hypertension, elevated cholesterol levels, history of or current smoker, obese, family history of heart disease) & atypical chest pain Typical chest pain being treated with medication, unable to exercise, previous confirmed heart disease | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 8.0-18.0, Chest Pain 18 years of age Pediatric patients with referrals for innocent heart murmurs Pediatric patients experiencing chest pain English speaking Non English speaking patients | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 50.0-999.0, Coronary Disease Ischemic Heart Disease Heart Failure Patients with HF or IHD who are not currently taking the study medications of interest (ACE inhibitors/angiotensin receptor blockers for HF or statins for IHD) and whose primary care physicians are part of the study population Patients who are unable or unwilling to give informed consent previously taken the study medications according to dispensing records allergy or intolerance to study medications residents of long-term care facilities unable to confirm a diagnosis of either HF or IHD primary care physician has already contributed 5 patients to the study | 2 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Hypertension Greater than 18 years of age Patients with high blood pressure Hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months Type 1 diabetes mellitus | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 20.0-75.0, Breast Cancer Neoplasm Metastasis Hormonal therapy-resistant MBC ER (-), failure of hormonal therapy for MBC, or relapse within 6 months after adjuvant hormonal therapy No anthracyclines for MBC and no prior taxanes At least 6 months from the completion of adjuvant chemotherapy Measurable or evaluable lesions Age: 20 to 75 years PS: 0-3 WBC >= 4,000 /mm3 or ANC >=1,000 /mm3, Platelet >= 100,000 /mm3, SGOT/SGPT <= 1.5 x ULN, T-Bil <= 1.5 mg/dL, Cr <= 1.5 mg/dL normal ECG Written informed consent pregnant malignant pleural effusion, ascites, or pericardial effusion that requires emergent treatment Active infection other cancer present within the last 5 years previous stem cell transplantation brain metastasis that requires emergent treatment relapse within 6 months after completion anthracycline or during anthracycline more than 250mg/m2 of anthracyclines hypersensitivity of drug interstitial pneumonitis or pulmonary fibrosis | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-75.0, Angina Pectoris Chronic stable angina pectoris Documented coronary artery disease Previous treatment with atenolol or other beta-blocker agent Exercise tolerance test positivity and stability Heart rate < 60 bpm Congestive heart failure | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Angina Pectoris Metabolic Syndrome X Chronic stable angina to see if this improves Previous positive exercise tolerance test to ensure that repeating it yields a result Disease not suitable for coronary intervention (Coronary artery bypass grafting or angioplasty) so that best routine care is not withheld Do not have overt diabetes work on this is being undertaken elsewhere Body mass index (BMI) greater than 25 Diabetes mellitus see above Liver failure (ALT>70U/l, AST>80U/l) Renal failure (creatinine > 130mmol/l) Cardiac failure rosiglitazone is contraindicated in those with NYHA 3 and 4 cardiac failure Physical disability if it precludes treadmill testing Women of child bearing capacity Breast feeding mothers | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 50.0-999.0, Osteoporosis Women aged 50 and older Lumbar spine BMD (L1 to L4) T score between 0 and -2.0 At least 3 years postmenopausal Prior low trauma hip or vertebral fracture Total hip or femoral neck T score of <-2.0 Bone disorders other than osteopenia (e.g., hyperparathyroidism or Paget's disease) Treatment within six months of study entry with androgen, calcitonin, estrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, etidronate, prednisone or an equivalent at 5 mg/d for 12 months or greater, lithium or anticonvulsants Alendronate or risedronate use for at least four weeks, within the last three years Current treatment with nitrates Systolic blood pressure of =<100 mm Hg or diastolic blood pressure >=100 mm Hg at the baseline screening examination Abnormal electrocardiogram (ECG) at the baseline screening examination history of myocardial infarction, angina, valvular or congenital heart disease Disabling conditions that may interfere with follow-up visits | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 21.0-55.0, Low Back Pain Age 21 to 55 Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to the greatest proportion of LBP patients that have a favorable natural history of improvement Written Informed Consent A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions) LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis) Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity) Retention of legal advice related to this or a previous LBP episode: Patients with occupational or personal injuries will not be automatically excluded from the study unless they answer yes to a specific question about the retention of legal advice with respect to their LBP episode at the baseline interview Pregnancy: Pregnancy is a contraindication for exposing a patient to ionizing radiation and is a confounding factor in the usual course of LBP Inability to read or verbally comprehend English Clear evidence of narcotic or other drug abuse as determined by history and examination: injects significant confounding factors with respect to internal validity and feasibility Major clinical depression: Patients with scores greater than 17 on the Beck Depression Inventory will be excluded from the study. Patients with evidence of other psychiatric disorders as determined by history and exam will also be excluded | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Unstable Angina Myocardial Infarction Age > 18 years or older Admission to the ICCU with ACS (non-ST elevation acute coronary syndrome or 24 hours after ST elevation myocardial infarction) Presence of ischemic symptoms (≥5 minutes) during hospitalization Pain assessment of 3 out of 10 on Visual Analog Scale (VAS) 1 or dynamic ECG findings (ST segment deviation ≥0.05 mV or T wave inversion ≥ 0.3 mV) Willing and able to provide written informed consent according to the regulations of the Ministry of Health and the Helsinki committee instructions Patient who meet any of the following are excluded from the study Persistent ST-segment elevation ≥ 1 mV in 2 or more contiguous leads or new LBBB Acute pulmonary edema Sepsis Sustained systolic blood pressure < 90 mm Hg or evidence of cardiogenic shock Pregnant women Use at randomization of agents known to enhance the efficacy of nitrates Clinically significant aortic stenosis Cr > 2 mg/dL Participation in another trial of an investigational drug or device on randomization | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Chronic Thromboembolic Pulmonary Hypertension Diagnosis of CTEPH and patient consent No patient consent | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 21.0-69.0, Obesity Participating in the BWHS study Residing in New York, Los Angeles, or Chicago | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-75.0, Non-Cardiac Chest Pain Undiagnosed Chest Pain Musculoskeletal Chest Pain Ischemic Heart Disease Acute episode of chest pain of less than 7 days duration as primary reason for admission to a chest pain clinic Admitted to a chest pain clinic, suspected of acute coronary infarction, but with a negative diagnosis confirmed by normal coronary enzymes and normal ECG Pain arising from the thorax and/or neck Able to read and understand Danish Acute coronary syndrome Percutaneous Coronary Intervention Coronary Artery Bypass Grafting Other disease, diagnosed during this admission, which is likely to have caused the acute episode of chest pain No written consent Inflammatory joint disease Diabetes mellitus, type I Fibromyalgia Sharp trauma to the chest Malignant disease | 2 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 0.0-60.0, Prader-Willi Syndrome Obesity Individuals enrolling in the Prader-Willi syndrome group will have a confirmed diagnosis of Prader-Willi syndrome, as confirmed by molecular and cytogenetic testing Individuals enrolling in the Early-onset Morbid Obesity group will have a documented medical history of their weight exceeding 150% of the ideal body weight or a body mass index greater than 97% before the age of 4 years; they will also be under the age of 30 years Known genetic, chromosomal, or hormonal cause of cognitive impairment other than Prader-Willi syndrome | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 10.0-999.0, Supraventricular Tachycardia More than 10 years old Electrocardiographic diagnosis of SVT SVT not converted by the vagal manoeuvres Signs of impaired cerebral perfusion Signs of pulmonary oedema Subsequent diagnosis of other types of arrythmias rather than SVT pregnancy by history | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 15.0-40.0, Pneumothorax Male or female Age between 15 and 40 years old First episode of spontaneous pneumothorax Symptomatic (dyspnea or chest pain) or the rim of air is > 2cm on CXR requiring simple aspiration Complete or nearly complete and persistent lung expansion immediately following manual aspiration Organ Function Requirements Adequate hematological function (Hb > 10 g/dl, ANC > 1.5 x 109/L, platelets > 100 x 109/L) Normal renal and hepatic functions: serum creatinine < 1 x ULN, SGPT and SGOT< 2.5 x ULN, alkaline phosphatase < 5 x ULN Written inform consent With underlying pulmonary disease (asthma, chronic obstructive pulmonary disease, bronchiectasis, etc) With hemothorax or tension pneumothorax requiring chest tube insertion or operation A history of previous pneumothorax A history of previous ipsilateral thoracic operation Allergy to tetracycline or minocycline Pregnant or lactating patients Other serious concomitant illness or medical conditions Congestive heart failure or unstable angina pectoris History of myocardial infarction within 1 year prior to the study entry Uncontrolled hypertension or arrhythmia | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Pulmonary Hypertension Must have completed Visit 14/Week 24 of the NCT00046319 study Women of childbearing potential must have a negative urine pregnancy test at the Screening/Enrollment Visit and agree to use a reliable double barrier method of contraception until study completion and for >=4 weeks following their final study visit Must have completed the Down-titration Period of NCT00046319 prior to enrollment in AMB-220-E and will meet the following additional Subjects with a diagnosis of HIV must have stable disease status at the time of Screening/Enrollment Must be stable on conventional therapy for PAH for >=4 weeks prior to the Screening Visit Chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the Screening Visit Intravenous inotrope use within 2 weeks prior to the Screening Visit Females who are pregnant or breastfeeding Contraindication to treatment with an endothelin receptor antagonist (ERA) | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 65.0-84.0, Hypertension Cardiovascular Disease Diabetes Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex Systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg in a sitting position on two consecutive measurements at clinic during use of 1 or more antihypertensive medications Systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg in a sitting position on two consecutive measurements at clinic without antihypertensive medication Require at least one of the following medical history or risk factors Medical history Cerebrovascular accident: cerebral infarction, brain hemorrhage, subarachnoid hemorrhage（6 months or more prior to registration） Myocardial infarction, coronary revascularization (PCI or CABG) （6 months or more prior to registration） Angina pectoris (except for the patients having history of hospitalization within 6 months prior to registration) Risk factors Male Secondary hypertension or malignant hypertension History of cerebrovascular accident (including TIA) or myocardial infarction within 6 months before registration Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) done within 6 months before registration or scheduled History of hospitalization for angina pectoris or heart failure within 6 months before registration Severe heart failure (New York Heart Association [NYHA] functional class III or more severe) Complications of atrial fibrillation, atrial flutter or severe arrhythmia Severe hepatic or renal dysfunction (including current treatment of dialysis or renal dysfunction with serum creatinine ≥ 2.0mg/dL) Not appropriate for change to the study drugs from current therapy for concurrent disease including coronary diseases (i.e. calcium channel blockers, diuretics, etc) History of serious side effect from study drugs (AT1 subtype angiotensin II receptor antagonist, calcium channel blocker, diuretic) Life threatening condition (malignant tumor, etc) | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-75.0, Musculoskeletal Chest Pain Non-cardiac Chest Pain Undiagnosed Chest Pain To be included in the project the participant must Have chest pain as their primary complaint Have an acute episode of pain of less than 7 days duration before admission Consent to the standardized evaluation program at the chest pain clinic Have pain the in the thorax and/or neck Be able to read and understand Danish. Be between 18 and 75 year of age Be a resident of the Funen County Patients will not be included if any of the following conditions are present ACS Have had Percutaneous Coronary Intervention (PCI) or Coronary Artery By-pass Grafting (CABG) Participants will be excluded following baseline evaluation if any of the following conditions are present Pain not related to the joints and muscles of the neck and/or thorax (CTA negative, see below) New incidence of any of the above mentioned conditions/pathologies | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 30.0-80.0, Angina Pectoris Male Stable angina with one of Classical history of exertional angina pectoris Previous diagnostic exercise test Angiographic evidence of CAD Aged 30 to 80 years Weight between 60 and 100 Kg Regular treatment with long-acting nitrates or nicorandil where these cannot be withdrawn 72 hours prior to the study Myocardial infarction, unstable angina, stroke or transient cerebral ischaemia within 3 months Systolic BP > 170 mmHg or diastolic BP > 100 mmHg Systolic BP < 100 mmHg or diastolic BP < 60 mmHg Orthostatic hypotension (> 20 mmHg fall in systolic BP on standing) Diabetes treated with oral hypoglycaemic agents or insulin Any clinically significant disease other than stable angina, excepting other cardiovascular disease risk factors, e.g. smoking, hypercholesterolaemia and diet-controlled diabetes Taking any drug that interacts with sildenafil Evidence of drug abuse | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 20.0-999.0, Neoplasms, Gastrointestinal Tract Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject is provided in the Investigator's Brochure (IB) Pilot Part Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following Signed informed consent Male or female; ≥ 20 years (at the time of giving consent) Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of ≥50% required if normal range of LVEF is not provided by institution) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Able to swallow and retain oral medication Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study Subjects meeting any of the following must not be enrolled in the study Pregnant or lactating female at anytime during the study Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2) Peripheral neuropathy of Grade 2 or greater Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety Life threatening infection Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 30.0-999.0, Chest Pain At least one modifiable cardiovascular risk factor (smoking, hyperlipidemia, hypertension, diabetes mellitus, obesity) Patients who "rule-in" for myocardial ischemia at initial testing Terminally ill (expected to survive less than 3 months) Unavailable for 6-month follow-up Cannot be contacted by telephone Institutionalized persons (prisoners, nursing home residents) Unable to provide informed consent (impaired mental status, unable to speak English) | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 0.0-999.0, Hodgkin's Disease Biopsy-proven HL Participation in IRB-approved protocols for the first-line treatment of HL between 1975-2000 (IRB #75-104, #75-103, #79-17, #81-103, #90-44, #91-69) English speaking | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-65.0, Anxiety/Depression in Cardiological Unit investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital suffer of chest pain or palpitations do not speak norwegian properly mentally retarded psychosis last 6 month current alcohol or drug misuse | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-80.0, Active Digital Ulcers Digital gangrene, ulcers in patients with severe secondary Raynaud`s phenomenon Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the treatment with sildenafil Unchanged immunosuppressive therapy 3 months before treatment with sildenafil No effect of prostacyclin treatment, contraindications for prostacyclins, or other reasons excluding this therapy Therapy with iloprost during the last 4 weeks Sympathectomy during the last 4 weeks TIA, stroke, myocardial infarction during the last 6 months Instable angina pectoris Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia Microangiopathic hemolytic anaemia Azotaemia Hypertonus not adjustable with diuretic, clonidine, ACE inhibitors/AT II antagonists, calcium channel blockers) Left ventricular ejection fraction< 20% Hypotonus < 80/40 mm Hg | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Metastatic Cancer Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following Histologically proven pleural malignancy Typical features of pleural malignancy seen on direct vision during thoracoscopy Pleural effusion in the context of histologically proven cancer elsewhere No primary lymphoma or small cell lung carcinoma All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible Life expectancy > 1 month Not pregnant or nursing No history of GI bleeding or untreated peptic ulceration No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or paracetamol | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Cardiovascular Disease Men and women admitted for an IHD event (acute coronary syndrome or revascularization procedure) who are at low or moderate risk.91 Regular Internet access (home, work or other environment) Over 18 years of age Permission of the attending physician Able to read, write and understand English without difficulty No physical limitations to regular activity Previous experience with a cardiac rehabilitation program Patients with depression, uncontrolled diabetes and other significant co-morbidities that may interfere with effective IHD management Those patients, who in the mind of the attending physician, are unsuitable for participation Those unable to provide informed consent Pregnant women High-risk patients for safety considerations (future studies will high-risk patients) | 2 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Type 2 Diabetes New onset of Type 2 Diabetes BMI>25kg/m2 Antiobesity, oral hypoglycaemic medications or any other prescription medications that may interfere with the study results Pregnancy Unable to converse competently in English as special arrangements would need to be made for such people and this would be impractical in a group setting Attending another weight management programme Patients who would be unable to attend all the programme sessions for medical or other reasons Any patients from groups listed in A24 | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 0.0-999.0, Breast Neoplasm Patients with metastatic breast cancer History of hypersensitivity to Caelyx or its components Women who are pregnant or breast-feeding Patients with severe myelosuppression | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Clinical diagnosis of COPD > 40 years of age > 15 pack year smoking history Contra-indication to beta-blocker use Severe COPD FEV1 < 30% or 1 L Not responsive the methacholine | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 20.0-55.0, Low Back Pain Patients with low back pain between 20 and 55 years old, submitted to a physical therapy treatment Patients with no miofascial low back pain | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-50.0, HIV Current substance abuse Current high-risk sexual behavior African American racial identification Non resident of Miami-Dade county | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-80.0, Angina Pectoris Patient must be between the ages of 18 and 80 years Females of childbearing potential must have a negative pregnancy test, not be breast feeding and established on a method of contraception that in the investigator's opinion is acceptable. Females must agree to remain on their established method of contraception through their participation in the study Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes Moderate angina pectoris (Class II or Class III, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System) Naive patient or patient who's Total Exercise Duration (TED) is between 3 to 7 minutes in ETT on Standard Bruce Protocol, and the difference in TED must be no more than 15% between the two screen examinations on day -7 and day 0 All anti-angina regimen (except short-acting nitroglycerin, and one beta-blocker or calcium channel blocker), warfarin or other oral anticoagulants which were used prior to this initial visit can be discontinued Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the verbal rating scales and diary cards Patient must be able to give voluntary written informed consent With contraindication to perform treadmill Exercise Tolerance Test (ETT) Pre-exercise ST-segment depression of at least 1 mm in any lead, left bundle branch block, digoxin therapy, Left Ventricular Hypertrophy (LVH) and Wolff-Parkinson-White (WPW) syndrome or other factors that could interfere with exercise electrocardiograph interpretation Clinically significant arrhythmias or atrioventricular conduction block greater than first degree Clinically significant co-morbidities, including hepatic or renal dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, history of cerebral hemorrhage, or seizure disorders that required anticonvulsant medication History of congestive heart failure, unstable angina, severe valvular disease, severe hypertension, severe anemia, suspected or known dissecting aneurysm, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism or recent myocardial infarction within three months of study entry History of bleeding diathesis, or is on warfarin Implanted pacemaker Aspirin and/or statins started less than 14 days prior to the signing of informed consent Pregnancy or lactation Inability to discontinue existing chronic nitrate regimen (e.g. long acting nitroglycerin) and allow only short-acting nitroglycerin and one beta-blocker or calcium channel blocker | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 0.0-999.0, Heart Failure Patients eligible for the study had objective evidence of systolic dysfunction (ejection fraction ≤40%), were >18 years of age, and were on stable optimal medical heart failure therapy excluding the use of beta-blockers within the previous 30 days Patients were excluded for active viral myocarditis; hemodynamically significant valvular heart disease; hypertrophic cardiomyopathy, peripartum cardiomyopathy; contra-indications to beta-blockers (asthma or obstructive airway disease requiring scheduled bronchodilators or inhaled steroids), resting heart rate <55; supine blood pressure <85/50; second or third degree heart block); concomitant use of beta-agonists, beta-antagonists, or anti-arrhythmics; unstable angina; myocardial infarction or bypass surgery within 3 months; or significant renal insufficiency (creatinine >2.5 mg/dL), liver disease (transaminase levels > 3 fold above laboratory normal), or anemia | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-65.0, Obesity, Morbid Ischemic Heart Disease Morbidly obese patients who fulfill the NIH for surgical intervention Patients deemed unfit for surgery Pregnant women, or who are attempting conception Subjects with any history of myocardial infarction, coronary artery bypass grafting surgery, coronary angiography with angioplasty and/or stenting, or any lesion > 50% of the coronary artery luminal diameter, cerebrovascular accident, or peripheral vascular disease with abnormal electrocardiograms and/or echocardiography History of drug or alcohol abuse Chronic liver disease | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-75.0, Adipose Tissue Lean (BMI 20-25 kg/m2) subjects with normal glucose tolerance Obese (BMI >30 kg/m2) subjects also with normal glucose tolerance Obese with impaired glucose tolerance Obese with diet controlled diabetes mellitus Morbid obesity, type diabetes and post bariatric surgery (study part 2) History of severe cardiac, hepatic or renal disease Thyroid dysfunction (hyper-or hypothyroidism), or other endocrine disturbance (acromegaly, growth hormone deficiency, hypoadrenalism or cortisol overproduction) Current malignant disease Known alcohol misuse Major psychiatric disease (including current use of antidepressants) History of major eating disorder (anorexia or bulimia nervosa) | 2 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 0.0-999.0, Heart Failure Randomised control trials of beta-blocker versus control in patients with documented heart failure Unconfounded trials only (in which one treatment group differed from another only by the beta-blocker therapy of interest) Randomization process precluded prior knowledge of the next treatment (for example trials in which treatment allocation was alternate or based on odd or even dates would not be included) Trial sample size of less than 300 patients | 2 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 0.0-999.0, Acromioclavicular Joint Dislocation Surgical Procedures, Operative Patient with Tossy grade 3 AC-dislocation was recruited between the years 1989 and 1991 at Kuopio University Hospital for a randomized controlled study A written informed consent Not written informed consent | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 0.0-17.0, Congenital Heart Disease Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect Patients must be taking an ACE inhibitor prior to their operation Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study Pregnancy as ruled out by standard of care screening procedures Individuals whose weight is less than 3.5 kg at the time of enrollment Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 19.0-55.0, Low Back Pain between the age of 19 and 55 years old able to walk without assistance and /or assistive devices at least 4.7 meters have adequate hearing acuity to detect verbal instructions have adequate visual acuity to walk safely in usual ambient lighting without holding onto objects be able to speak and comprehend English have sufficient cognitive ability to follow instructions, and to provide informed consent, as defined by a Mini Mental Status Examination score of greater than 23 out of 30, performed by the research coordinator have had neurological signs and symptoms, or complications such as tumor or infection are active in a claim pertaining to a motor vehicle accident or work injury or under any litigation for their pain have had previous osteopathic treatment in the last year had more than one abdominal surgery, or spinal fracture, or structural deformity such as scoliosis or spondylolithesis (Hubley-Kozey, 2002) have severe cardiopulmonary disease as determined by a health questionnaire with symptoms such as shortness of breath or chest pain on mild exertion or at rest history of severe neurological disorder that impairs balance and mobility eg stroke, Parkinson's disease, peripheral neuropathy have pain that leads to severe discomfort with minimal movement have significant musculoskeletal impairment e.g. arthritis that leads to severe discomfort with walking that could lead to an abnormal gait have cognitive compromise impairing ability to care for oneself, and ability to provide informed consent have dizziness while standing | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Malignant Pleural Effusion Pleural Effusion Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of Histologically proven pleural malignancy OR Typical features of pleural malignancy seen on direct vision during thoracoscopy OR Pleural effusion in the context of histologically proven cancer elsewhere Expected survival more than 1 month Written informed consent Age < 18 years Primary lymphoma or small cell lung carcinoma Patients who are pregnant or lactating Inability to give informed consent History of GI bleeding or of untreated peptic ulceration Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen Hypercapnic respiratory failure Known intravenous drug abuse Severe renal or liver disease Known bleeding diathesis | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 21.0-999.0, Diabetes Mellitus, Type 2 Type 2 diabetes for more than 1 year before study entry Insulin therapy Treatment with any beta-blocker in the 30 days before study entry Asthma Chronic obstructive pulmonary disease (COPD) Greater than first degree heart block Heart rate less than 60 bpm Systolic blood pressure less than 90 mm Hg Raynaud's phenomenon Known history of angina, heart attack, heart failure, coronary revascularization, or automatic implantable cardioverter defibrillators Pregnant | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Hypertension Patients over 18 years of age Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg) Patients, who do not tolerate ACE inhibitors (must be documented in the official ambulant documentation) for the control arm (treated by ACEi) Patients over 18 years of age Arterial hypertension (SBP < 160 mmHg and DBP < 100 mmHg) Patients, who tolerate ACEi treatment Cholestasis, severe hepatic insufficiency Allergy to telmisartan Gravidity or lactation for the arm of patient treated by ACEi Cholestasis, severe hepatic insufficiency Allergy to ACEi Gravidity or lactation | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 20.0-49.0, Low Back Pain Healthy 49 years old Pregnant with a singleton Low back pain began during pregnancy and has lasted more than one week Low back pain is reproducible with palpation Health conditions such as hypertension, diabetes, cancer, thyroid condition etc Pain radiates below knee Cannot read English Plans to move away from Portland area during pregnancy Not willing to be randomized to one of the three arms of the study | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 2.0-999.0, Sickle Cell Disease for the Observational and Trial Cohorts Hemoglobin diagnosis of SS (two copies of the hemoglobin S gene), SC (one copy of the hemoglobin S gene and one copy of the hemoglobin C gene), or S-β thalassemia (β+ or β0) No clinically apparent ACS No prior participation in either part of the study for the Trial Cohort, in addition to the above sPLA2 level greater than 100 ng/mL within the same 24-hour window that coincides with fever and chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window Fever greater than 38.0º C within the same 24-hour window that coincides with elevated sPLA2 level (greater than 100 ng/mL) and chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window Chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window of an abnormal sPLA2 level and fever Hemoglobin levels equal or less than 10 g/dL at time of study entry Informed consent of parent(s) or legal guardian; informed consent or assent of participant as applicable for Observational and Trial Cohorts Existing diagnosis of a new pulmonary infiltrate diagnosed by chest radiography (pleural effusion not obscuring lung parenchyma will not the person from the study) Any coexisting medical condition for which the physician feels that a transfusion may be needed within 24 hours (e.g., severe anemia, stroke) Red Blood Cell (RBC) transfusion in the 60 days before study entry Unwillingness to sign consent form, or if a minor, unwillingness of parent/guardian to sign consent form Treatment with any investigational drug or device in the 30 days before study entry (hydroxyurea is allowable) History of alloimmunization that would prevent the participant from receiving blood within 8 hours of for study entry or history of a life-threatening transfusion reaction Objection to transfusion for religious or other reasons from either the participant or guardian History of treatment with systemic steroids within 1 week of study entry (inhaled steroids are acceptable) Pregnant | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Acute Coronary Syndromes The subject must be 18 years of age or older The subject must present to the Emergency Department with symptoms consistent with acute coronary syndromes (e.g., chest discomfort/pain, squeezing/fullness in the chest, pain radiating to left or both arms, jaw pain, pain in the back/neck/stomach, shortness of breath, cold sweat, nausea/vomiting, lightheadedness) The subject must present to the Emergency Department within 6 hours of the onset of the most recent symptoms that prompted the subject to seek medical attention in the Emergency Department The patient agrees to abide by all aspects of the protocol, including all telephone follow-up The patient is unable to provide consent or understand the consent form The ACS symptoms are clearly not the result of ACS (i.e., penetrating wounds, crush injury, etc.) | 2 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 7.0-13.0, Obesity Children enrolled in the MEND Programme who are yet to be given a start date for the programme Aged between 7-13 years old Overweight or obese as defined by a BMI which falls above the 91st centile on the boys/girls BMI chart UK cross-sectional reference data:1997/1) Clinically well with no known chronic illness Age less than 7 years or older than 13 Known chronic illness | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 30.0-75.0, Ischemic Heart Disease Patients with intermediate (>20%, <90%) risk of IHD based on age,gender,symptoms and exercise stress test results Age < 30 Yrs or > 75 yrs Pregnancy (suspected or ascertained) LV Dysfunction (LVEF < 35% by Echo or other method) Low (< =20%) or high (>=90%) probability of CAD Acute Coronary Syndrome Prolonged (> 20 minutes) chest pain De novo or accelerated angina Hemodynamic or electrical instability Recent ST-T segment or T wave changes of ischemic nature Acute myocardial infarction with or without ST segment elevation | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Pain Back Pain Low Back Pain Back Pain With Radiation At Visit 1 (study entry) patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute low back pain that is felt down to the lower leg below the knee with the onset no longer than 30 days before Visit 1 At Visit 1 patients must report qualifying pain intensity scores Patients must be appropriate candidates for treatment with oral opioid pain medication in the investigator's clinical judgment Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening History of back (cervical, thoracic or lumbosacral) pain =50% of the time in the 1 year prior to the first visit History of any low back pain episode, with the exception of the current acute low back pain episode, within 3 months prior to the first visit that was greater than mild in pain intensity, or was associated with disability (e.g., loss of time from work, family, or activities of daily living), or necessitated the use of an opioid (narcotic) analgesic including tramadol Medical history or physical examination results that suggest the acute low back pain or any of the neurological symptoms or signs are caused by a serious medical condition (e.g., fever, chills, unexplained weight loss, bowel or urinary bladder dysfunction or incontinence, bilateral leg weakness, progressive weakness, paralysis) There is a high probability for surgical intervention for the back pain during the projected time on the study or that there will be an increase in the severity of the leg pain or deficits Had either a surgical procedure involving the spine or intervertebral discs in the lower back region within 1 year prior to Visit 1 or had >1 surgical procedure(s) involving the spine or intervertebral discs in the lower back region has any painful condition that could interfere with the study assessments or with the patient's ability to differentiate the pain associated with the acute low back pain episode from pain associated with another condition History of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis history of epilepsy or recurrent seizures Unable or unwilling to discontinue all prohibited medications at the time of randomization and during the time of their participation in the study Known or suspected history of alcohol or drug abuse based on medical history, physical examination, urine drug screening, or the investigator's clinical judgment | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 20.0-90.0, Adhesive Capsulitis shoulder discomfort for at least one month limited range of motion of the glenohumeral joint in at least two directions systemic inflammatory joint disease radiological evidence of bony abnormality of the shoulder full-thickness rotator cuff tear acute systemic medical illness history of major trauma or surgery involving the shoulder contraindication to intra-articular, local anesthestic injection | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 20.0-75.0, Obstructive Sleep Apnea Hypertension Apnea and hypopnea index of more than 20 /hr, and treated with CPAP Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months Uncontrolled arrhythmia Severe hepatic or renal disorders Having poor prognosis disorders such as malignant disorders | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-80.0, Resistant Hypertension NIDDM 80 years, informed consent, hypertension, type-II-diabetes mellitus Non-compliance, s-creatinin above 200, AFli | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Atherosclerosis Over 18 years old CCT > 60 ml/min No IHD No hyper/hypoparathyroidism No active malignancy Not taking calcium, phosphate Under 18 years of age Not fulfilling | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, ST Segment Elevation Acute Coronary Syndrome The decision to randomise patients must be made by a qualified physician or paramedic who is present at the time Subjects may be included in the study if they present either via ambulance or to a centre where PCI is not performed and meet all of the following Provide written informed consent before initiation of any study related procedures. Patients randomised in the ambulance may initially sign an abridged version Be aged ≥18 years at the time of randomisation Have a presumed diagnosis of a STE-ACS with onset of symptoms of >20 minutes and <12 hours with one or more of the following ST segment elevation of ≥1 mm in ≥2 contiguous leads Presumably new left bundle branch block An infero-lateral MI with ST segment depression of ≥1 mm in ≥2 of leads V1-3) with a positive terminal T wave All patients must be scheduled for angiography +/ PCI (if indicated) <2 hours after first medical contact Subjects will be excluded from the study if any of the following apply prior to randomisation Any bleeding diathesis or severe haematological disease or history of intra-cerebral mass, aneurysm, arterio-venous malformation, haemorrhagic stroke, intra-cranial haemorrhage or gastrointestinal or genitourinary bleeding within the last 2-weeks Patients who have undergone recent surgery (including biopsy) within the last two weeks Patients on warfarin (not applicable if INR known to be <1.5) Patients who have received UFH, LMWH or bivalirudin immediately before randomisation Thrombolytic therapy within the last 48 hours Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications including aspirin or clopidogrel Contraindications to angiography, including but not limited to severe peripheral vascular disease If it is known pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 10.0-999.0, Allergic Conjunctivitis Positive bilateral conjunctival allergen challenge(CAC) reaction Known contraindications or sensitivities to the study medication or its components Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters Use of disallowed medications during the period indicated prior to study enrollment or during the study | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 30.0-80.0, Stable Angina Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI Unstable Angina/NSTEMI patients who completed PCI for main lesions Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs STEMI patients within one month Variant Angina Liver function abnormality or renal failure History of Hypersensitivity to testing drugs Severe heart failure(NYHA class>3) or uncorrectable hematologic disease Woman possible to be pregnant Uncontrolled diabetes Expected life span < one year | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 19.0-55.0, Healthy Overweight Obesity Subjects with BMI over 25.0 kg/m2 Non-smoker Excessive alcohol consumption Pregnant or lactating women Dyslipidemia, hyperglycemia, or other chronic diseases Subjects who were taking vitamin supplements | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-75.0, Acute Coronary Syndrome Coronary Artery Disease Diagnosis of unstable angina and non-Q wave myocardial infarction Age 18-75 yr Diameter stenosis of coronary artery<70% diameter stenosis by visual estimation Blood pressure >110/70 mmHg Heart rate 60-~100 bpm, No cardiac arrhythmias St-elevation myocardial infarction Lower blood pressure(<100/70mmHg) Heart rate <60 or >100 bpm, The presence of cardiac arrhythmias Allergy to study drugs Women in pregnancy Liver dysfunction Creatinine >2.5mg/dl Bleeding stroke within 6 months Left ventricular ejection fraction<30% before maximal medication | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-60.0, Abdominoplasty Bilateral Breast Reduction Bilateral Breast Lift Bilateral Brachioplasty Bilateral Lateral Thigh and Buttocks Lift Subject is >18 years of age or < 60 years old Subject is undergoing abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift, or any combination thereof Subject is able to discontinue anticoagulant therapy (including Aspirin) Subject is willing and able to comply with study follow-up procedures Subject is willing to provide written informed consent for their participation in the study Subject has a history of smoking in the last 6 months prior to surgery Subject has a history of type I or type II Diabetes Subject has an active infection of any kind at the time of enrollment Subject has a known coagulopathy | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Ischemic Heart Disease ischemic heart disease patient, and given loading or maintenance dose of clopidogrel and in need of it for 1 or more month and in need of additional drug for optimal BP control (aim blood pressure <130/90) or angina control existing use of amlodipine thrombocytopenia end stage renal failure allergy to clopidogrel/ amlodipine pregnancy/ lactation strong inhibitor or inducer of cytochrome P450 3A4 enzyme within 7 days before start of the study | 1 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Hypertension hypertension age > 18 ACE-I related cough Current treatment with telmisartan Cholestatic disorders and severe hepatic failure Allergy to telmisartan Pregnancy and lactation period | 0 |
A 58-year-old African-American woman presents to the ER with episodic pressing/burning anterior chest pain that began two days earlier for the first time in her life. The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration. The latest episode of pain ended half an hour prior to her arrival. She is known to have hypertension and obesity. She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease. She currently takes no medications. Physical examination is normal. The EKG shows nonspecific changes. | eligible ages (years): 18.0-999.0, Head and Neck Neoplasms Laryngeal Neoplasms Mouth Neoplasms Pharyngeal Neoplasms Histologically confirmed squamous cell carcinoma (with biopsy on the primary and / or lymph node metastases) of the oral cavity, oropharynx, hypopharynx, larynx supraglottix Locally advanced disease, defined by one of the following any T, N +, M0 (excluding T1, N1), T3-4, N0, M0 Not cancer nasopharynx or paranasal sinuses or salivary glands General conditions and associated diseases which does not allow to perform chemotherapy or radiotherapy in a radical view No other surgical treatments, chemotherapy or radiotherapy for cancer of head and neck or elsewhere, except non-melanoma skin cancer or in situ cervical cancer and other solid tumors for which radical treatment has been completed > three years prior to enrollment in the study and for which the patient has remained continuously free of disease Accessibility to follow-up Signing of informed consent Interval between examinations of local staging and randomization, maximum 3 weeks Interval between randomization and initiation of treatment, maximum 2 weeks Age <18 years ECOG performance status > 0-1 Hemoglobin <9 g / dL Counts of granulocytes, total <1.5 x 10 ^ 9 / L Platelet count <100 x 10 ^ 9 / L Bilirubin> 1.5 times upper limit of normal (ULN) AST or ALT> 3 times ULN Creatinine clearance > 50 mL/min Mg > 0.5 mmol/L Pregnancy or lactation | 0 |
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