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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): 50.0-75.0, Osteoporosis Prostate Cancer Biopsy-confirmed early stage prostate cancer Disease localized within the capsule No evidence of regional or distant spread (i.e., T1-2, N0, M0 disease) A cohort of patients must have undergone a prior radical prostatectomy Prostate specific antigen < 12 ng/mL Gleason score ≥ 6 Creatinine clearance ≤ 2.0 mg/dL No Paget's disease No hyperthyroidism or hypothyroidism No Cushing's disease | 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, Painful Joint Prostheses Patients selected for entry into this study will be men or women of any ethnic background who are scheduled to undergo clinical and diagnostic evaluation by a member of the Department of Orthopedic Surgery at the Hospital of the University of Pennsylvania Health System or by the collaborating physicians at the Rothman Institute or the VA Philadelphia Medical Center. Study I: FDG-PET imaging in painful partial or total joint prostheses Each patient who is a candidate will be evaluated by one of the collaborators mentioned above for a painful partial or total joint prosthesis. The patient will undergo an appropriate routine evaluation including history, physical examination, radiographic, scintigraphic, and necessary laboratory evaluation. An initial diagnosis must be made for each patient. The diagnosis of loosening will be established based on clinical examination and/or radiographic evaluation demonstrating clear evidence of this complication. Other etiologies for the joint pain, except for infection and aseptic loosening, need to be excluded. Surgical intervention (prosthesis revision) may or may not be planned for the patient who is a candidate for this study. Study II: FDG-PET imaging following uncomplicated partial or total joint arthroplasty All patients fulfilling the below will be considered potential candidates for this study. Each patient must have a diagnosis of degenerative joint disease caused by osteoarthritis (no previous hip surgery) and have undergone primary partial or total joint arthroplasty by a member of the Department of Orthopedic Surgery at the Hospital of the University of Pennsylvania or referring hospitals. Other causes of degenerative joint disease will be excluded by physical, radiographic and laboratory evaluation as clinically indicated. Osteoarthritis is the most common cause of degenerative joint disease, and in order to avoid any confounding factors in experimental results that may be caused by other types of disorders, only this group of patients will be studied. A patient will be eliminated from this group at anytime if the post-operative course is complicated by any process that is thought to influence the outcome. Variations from an uncomplicated postoperative course will be determined by the operating surgeon and clinical signs or other evidence to suggest infection, early loosening, or any other process directly involving the prosthesis Patients with other etiologies for pain, other than for infection and aseptic loosening, will be excluded from enrollment into the study | 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, Heart Valve Diseases Parkinson's Disease Age > 18 years Diagnosis of Morbus Parkinson Written informed consent Patients with a history of carcinoid syndrome Patients with a history of post-inflammatory (rheumatic), degenerative (calcified) or ischaemic coronary heart or valvular heart disease Previous medication with ergot-derived drugs (eg. Methysergide, Ergotamine) except dopamine receptor agonists or anorectic drugs (eg. Fenfluramine, Dexfenfluramine) | 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 UK Parkinson's Disease Society (UKPDS) brain bank (Step 1 and 2) for PD. 2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale. 3. On levodopa/DCI for at least one year, stable dose in past 4 weeks. 4. Currently take at least three doses of levodopa/DCI per day. 5. Predictable end of dose wearing off. 6. Able to satisfactorily complete Hauser version of a Parkinson's diary. 7. Have an average of 120 minutes of OFF time on two 24 hour diaries. 8. On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization. 9. Be at least 30 years of age Neurosurgical treatment for PD. 2. History of psychosis. 3. Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant. 4. Diagnosis of cancer within 5 years. 5. Diagnosis of clinically significant illness of any organ system. 6. Mini-mental status examination score of 25 or less. 7. Taking any excluded medications. 8. History of drug or alcohol abuse or dependence within the past two years. 9. History of seizures or neurological malignant syndrome. 10. Clinical depression. 11. Pregnant or lactating females | 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 UK Parkinson's Disease Society (UKPDS) brain bank (Step 1 and 2) for PD. 2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale. 3. On levodopa/carbidopa for at least one year, stable dose in past 4 weeks. 4. Currently take at least three doses of levodopa/carbidopa per day. 5. Predictable end of dose wearing off. 6. Able to satisfactorily complete Hauser version of a Parkinson's diary. 7. Have an average of 180 minutes of OFF time on two 24 hour diaries. 8. Be at least 30 years of age Neurosurgical treatment for PD. 2. History of psychosis. 3. Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes. 4. Diagnosis of cancer within 5 years. 5. Mini-mental status examination score of 25 or less. 6. History of seizures or neurologic malignant_syndrome. 7. Clinical depression | 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 UK Parkinson's Disease Society (UKPDS) brain bank (Step 1 and 2) for PD. 2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale. 3. On levodopa/carbidopa for at least one year, stable dose in past 4 weeks. 4. Currently take at least three doses of levodopa/carbidopa per day. 5. Predictable end of dose wearing off. 6. Able to satisfactorily complete Hauser version of a Parkinson's diary. 7. Have an average of 180 minutes of OFF time on two 24 hour diaries. 8. Be at least 30 years of age Neurosurgical treatment for PD. 2. History of psychosis. 3. Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes. 4. Diagnosis of cancer within 5 years. 5. Mini-mental status examination score of 25 or less. 6. History of seizures or neurologic malignant_syndrome | 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's Disease Clinical diagnosis of Parkinson's disease No clinical diagnosis of Parkinson's disease | 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): 30.0-85.0, Parkinson's Disease With End of Dose Wearing Off Males or females 30-80 years of age (inclusive). Patients aged 81-85 years were eligible to participate if the principal investigator considered the patient to be in otherwise good health Clinical diagnosis of Parkinson's disease exhibiting two of three symptoms (rigidity, resting tremor, bradykinesia) All patients were required to have end-of dose wearing off (EODWO, re-emergence of PD symptoms at the end of at least two daily doses of levodopa during waking hours) Taking regular doses of immediate release carbidopa/levodopa Unstable Parkinson's Disease requiring booster doses or treatment with as needed dose regimens of levodopa Female subjects who are pregnant, trying to become pregnant or nursing an infant Other protocol-defined inclusion/ applied to this 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): 35.0-999.0, Parkinson Disease Male or female outpatients Age >=35 years at screening Diagnosis of Parkinson's syndrome, on at least two of the three key Parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity Duration of the disease of less than 3 years since diagnosis Modified Hoehn and Yahr stage <= 2.5 Patient optimized on monotherapy by levodopa or a dopamine agonist· Generally healthy and ambulatory Patient has given his informed written consent and is capable of following study procedures Any indication of forms of parkinsonism other than PD Severe resting tremor. Presence of either dyskinesia, fluctuations, or loss of postural reflexes· Treatment with amantadine, anticholinergics, catechol-o-methyltransferase (COMT ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa. Electroconvulsive therapy (ECT).Use of CYP3A4 strong, and moderate inducers or inhibitors. Participation in another clinical trial with an investigational drug within two months prior to randomization Dementia, uncontrolled depression, psychotic disorder. History of substance-related disorders including alcohol or other substance use disorders Females of child bearing potential Evidence (detected by history, physical examination and/or laboratory/ECG tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. Alterations of laboratory tests or ECG findings of potential clinical significance | 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): 35.0-999.0, Parkinson Disease Male or female outpatients Age >=35 years at screening.· Diagnosis of Parkinson's syndrome, on at least two of the three key Parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity Duration of the disease of less than 3 years since diagnosis· Modified Hoehn and Yahr stage <= 2.5 Untreated patients Generally healthy and ambulatory Patient has given his informed written consent and is capable of following study procedures Any indication of forms of parkinsonism other than PD Severe resting tremor Presence of either dyskinesia, fluctuations, or loss of postural reflexes· Treatment with L-Dopa, dopamine agonist, amantadine, anticholinergics, catechol-o-methyltransferase (COMT ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa Electroconvulsive therapy (ECT) Use of CYP3A4 strong, and moderate inducers or inhibitors Participation in another clinical trial with an investigational drug within two months prior to randomization Dementia, uncontrolled depression, psychotic disorder History of substance-related disorders including alcohol or other substance use disorders Females of child bearing potential | 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's Disease Patients diagnosed with Parkinson's disease aged between 18 and 85 years fulfilling UK Brain Bank criteria Current levodopa therapy prescribed on a regular basis three or more times per day but requiring entacapone because of 'wearing off' Able to manipulate electronic monitoring bottles and complete questionnaires Current use of compliance aid such that study participation would be detrimental to patient's adherence Pregnancy or breast feeding Excess alcohol (over 21 units per week for women and 28 units for men) Mini mental state examination of less than 26 Severe depression (Geriatric depression score over 20) | 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): 20.0-999.0, Parkinson Disease Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism) (1) Patients meeting all of the following 1. Patients of at least 20 years of age 2. In or outpatients of either sex. 3. Patients in any stage on the modified Hoehn and Yahr severity scale Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour Patients with subjective symptoms derived from orthostatic hypotension Patients with hypotension (systolic blood pressure <100 mmHg) Patients with concomitant illness such as severe cardiac, renal, and hepatic disease Patients with a current or past history of epilepsy Pregnant, possibly pregnant, or lactating women Patients receiving any other investigational products or who have received any other investigational product within 6 months of the study Patients who judged incompetent to give consent Others judged by the investigator or co-investigator to be ineligible as subjects | 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): 18.0-75.0, Hepatic Encephalopathy Hepatitis C Liver Cirrhosis Phase A Subject is 18 to 70 years of age, inclusive Subject has cirrhosis due to chronic HCV infection as documented by Subject has evidence of hepatic encephalopathy as evidenced by Neuro-psychometric Testing (Number Connection Test, Trails Test, etc.) Subject is non-azotemic (creatinine <1.5mg/dL) and ambulatory at screening Subject has cirrhosis due to chronic HCV as documented by: pathologic or clinical and radiographic evidence of cirrhosis with a positive HCV RNA PCR level. Phase A Subject has received active interferon therapy within 2 weeks of enrollment Subject is pregnant or lactating Subject has a life expectancy of less than 100 days Subject has a history of alcohol abuse within 6 months of enrollment Subject has active gastrointestinal bleeding at time of enrollment Subject has used an agent that alters intestinal motility, eg, methadone, cholestyramine, tricyclic antidepressants Subject is unable to take oral medication Subject has used neomycin or other antibiotic within 2 weeks of enrollment or is actively using lactulose at time of enrollment Subject is taking or has hypersensitivity or allergy to rifaximin or rifampin Subject requires long term antibiotic therapy (eg, Lyme Disease, tuberculosis) | 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's Disease Patients must have a clinical diagnosis of probable idiopathic PD Demonstrated response to dopaminergic therapy, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the UPDRS motor examination subscore, following the administration of their dopamine agonist (DA) drug(s) during the screening neurological examination Hoehn and Yahr (H&Y) stage II when OFF medication No contraindications to surgery Age between 50 and 75 years old Available for follow-up for four years Informed Consent: The subject understands the risks, benefits, and alternatives to the study procedures and participation in the study MRI within normal range for age Levodopa or dopamine agonist therapy for greater than six months but less than or equal to four years Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by features unusual early in the clinical course: Prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades in the first year; severe, symptomatic dysautonomia unrelated to medications; documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months) Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension) Evidence of dementia Major psychiatric disorder Previous brain operation or injury Active participation in another clinical trial for the treatment of PD Patients who have demand cardiac pacemakers or implantable cardioverter defibrillators (ICD's) Patients who have medical conditions that require repeat MRI scans or diathermy treatments Evidence of existing dyskinesias or motor fluctuations | 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): 30.0-85.0, Parkinson's Disease PD, defined with at least two of the following cardinal features: rest tremor, bradykinesia, rigidity with PD diagnosis less than or equal to 5 years. 2. Hoehn and Yahr stage less than 3. 3. No clinical evidence of other parkinsonian syndromes (Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, lewy body dementia). 4. The patient must not be on any drug therapy for symptomatic control of parkinsonism, specifically levodopa, dopamine agonist, amantadine, anticholinergic drugs, COMT-inhibitors, selegiline while participating in the initial 6 months of the study. 5. Patients must express a willingness and intent to remain off all medications that could affect parkinsonism for the first 6 months of the study without first informing the site PI. Starting an anti-Parkinson medication does not necessarily disqualify a patient from continuing with the study. After the initial 6 months of participation, the patients will be allowed to start a anti-Parkinson medications. 6. Patient must express a willingness and intent to remain off of all medications that could affect parkinsonism for the first 6 months of the study without first informing the site PI. Starting an anti-Parkinson medication does not necessarily disqualify a patient from continuing with the study. After the initial 6 months of participation, the patients will be allowed to start anti-Parkinson medications. 7. Patient must demonstrate proficiency in the use of the At Home Testing Program in an office setting. 8. Participants must be willing to have a technician come to their homes to set up the equipment, check on it periodically, and remove it at study end Patients who have comorbid neurological or psychiatric disorders (even if they don't require medications). 2. Patients who have had Parkinson's disease for more than 5 years. 3. Patients who have another movement disorder (Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, Lewy body dementia). 4. Disruptive non-compliance with requirements of the study causing an inability to collect valid and clean data. 5. Inability to accurately perform the task required of this study (i.e. cannot use the equipment properly and to transfer data using a simple USB connection). Please note that there is no or based on depression or dementia. However, if these problems interfered with proficiency of data acquisition during the screening phase, they will not be eligible. The Hamilton Depression Rating Scale will be the measure used. Depression scale scores will be used as potential co-variants to compliance in exploratory analysis. Furthermore, treatment of other medical conditions will be allowed during the treatment period. Treatment of any feature of Parkinson's disease that does not involve the exclusionary medications (see inclusion/ ) will be allowed | 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): 30.0-75.0, Parkinson's Disease UK PD Society Brain Bank for the diagnosis of idiopathic PD Patients with stable levodopa-induced dyskinesias present greater than 25% of the day (Unified Parkinson's Disease Rating Scale (UPDRS), item 32, rating > 2) and be moderately to completely disabling (UPDRS item 33, rating > 2) All anti-parkinsonian medications must be stable for at least one month prior to study enrollment prior surgery for PD Hoehn and Yahr score of 5 when "off" History of nephrolithiasis Renal impairment Liver disease Pregnancy Premenopausal females and males not using adequate contraception Cognitive impairment (Mini Mental State Exam score less than 24) History of glaucoma or seizures Use of other antiepileptic drugs | 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, Chronic Prostatitis Pelvic Pain Male subjects aged 18 and older. 2. Male subjects with at least 3 months of symptoms of CP/CPPS who are refractory to other therapies 3. Subjects with a minimum score of 15 on the CPSI. 4. Male subjects must give written informed consent. 5. Male subjects must be willing an able to comply with the most recent version of the FDA-mandated S.T.E.P.S.â Program to He understands and can reliably carry out all instructions He is capable of complying with the mandatory contraceptive measures that are appropriate for male patient registration, and patient surveys as described in the S.T.E.P.S.â program He has received both oral and written warning of the hazards of taking thalidomide and exposing a fetus to the drug He has received both oral and written warning of the risk of possible contraception failure and of the presence of thalidomide in semen. He has been instructed that he must always use a late condom during any sexual contact with a woman of childbearing potential, even if he has undergone a successful vasectomy He acknowledges in writing his understanding of these warning and of the need to use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy He agrees NOT to be a sperm or blood donor while being treated with thalidomide - Subjects who are female. 2. Subjects with a documented positive urine culture (>100,000 CFU/mL) within the past six months 3. Subjects with duration of symptoms less than three months 4. Subjects with active genital infections 5. Subjects with prior urologic surgeries 6. Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate 7. Subjects having received prior radiation to the abdominal or pelvic area 8. Subjects with known bladder or ureteral calculi 9. Subjects unable to complete a voiding diary 10. Subjects diagnosed with neuropathy 11. Subjects with neutropenia 12. Subjects with a history of deep venous thrombosis, pulmonary embolism, or hypercoagulable state 13. Any patient who is not willing to comply with the most recent version of the FDA-mandated S.T.E.P.Sâ program 14. Subjects with orthostatic hypotension 15. Subjects with known malignancies in the last 2 years | 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): 18.0-55.0, Attention Deficit Hyperactivity Disorder Signed written informed consent to participate in the study. 2. Male and female outpatients older than 18 and younger than 55 years of age. 3. If female, non-pregnant, non-nursing with a negative urine pregnancy test and using medically accepted means of birth control (abstinence, birth control pills, IUD, barrier devices, or progesterone rods stabilized for at least three months) while in this study. 4. Responders to methylphenidate IR on stable treatment (Stable treatment is defined as a score on the NIMH CGI improvement scale of much or very improved (compared to pre-treatment) from a period of 4 weeks on a stable dose of MPH IR TID). 5. Responders to methylphenidate IR on stable treatment who are satisfied with their treatment (satisfaction with treatment is defined as a score of 1 or 2 on the Treatment Satisfaction Rating scale from a period of 4 weeks on a stable dose of MPH IR TID). 6. Responders to methylphenidate IR on stable treatment who tolerate their treatment (toleration of treatment is defined as a score on the Tolerability Index of 0 or 1) from a period of 4 weeks on a stable dose of MPH IR TID). 7. Mild cases of asthma and allergy. 8. Acid reflux syndrome. 9. Hypercholesterolemia. 10. Subjects with a past history of tics but tic free for > 1 year. 11. Subjects with past history of depression, anxiety disorder (including OCD) without current disorder for > 6 months as ascertained through structured diagnostic interview and clinical exam. 12. Subjects treated for anxiety disorders (including OCD), and depression who are on a stable medication regimen for at least three months, and who have a disorder specific CGI-severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-anxiety rating scale below 15 (mild range) will be included in the study. 13. Subjects receiving non-MAOI antidepressants (e.g., SSRI's, venlafaxine), benzodiazepines, on a stable regimen for > 3 months for any of the conditions listed above Diagnosis of, or family history of Tourette's syndrome, or Autism. 2. History of seizures. 3. Subjects with history of tics in the past year. 4. Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence. 5. Any clinically unstable psychiatric conditions including the following: bipolar disorder, acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, acute substance use disorders (alcohol or drugs), acute OCD, sociopathy, criminality or delinquency. 6. Subjects currently (within the past 4 weeks) receiving bupropion. 7. Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease. 8. Clinically significant abnormal baseline laboratory values, which the following Values larger than 20% above the upper range of the laboratory standard of a basic metabolic screen Exclusionary blood pressure parameters will any values above 140 (systolic) and 90 (diastolic) Exclusionary ECG parameters will a QTC> 460msec, QRS>120 msec, and PR>200 msec. Any subject having ECG evidence of ischemia or arrhythmia as reviewed by an independent cardiologist. 9. Organic brain disorders. 10. Mental impairment as evidenced by an I.Q. <70 as determined by an abbreviated version of the Wechsler Adult Intelligence Scales (Wechsler Adult Intelligence Scales-Revised (WAIS-III) and the Wide Range Achievement Test (WRAT-III). 11. Pregnancy or lactation. 12. Glaucoma. 13. Non English speaking subjects will not be allowed into the study for the following reasons: a) the assessment instruments are not available and have not been adequately standardized in other languages; b) our clinical trials facility is located in Cambridge and not in the MGH main campus without the availability of translators; and c) even if such translation services were to be available, the assessments in the English language conducted by English speaking clinicians and raters with English speaking subjects is already extremely time consuming lasting many hours making it unfeasible, unrealistic, and of dubious clinical validity to conduct them with a translator with non English speaking subjects; d) psychiatric questionnaires and evaluations are taxing and adding the complexity of a translator has the potential to make the patient experience even more exhausting | 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): 18.0-90.0, Alzheimer's Disease Mild Cognitive Impairment Healthy for patients with dementia Patients: clinical diagnosis of AD or mild cognitive impairment primary language German for healthy subjects and patients with dementia/MCI Known allergy to levodopa or tetrazine History of medication/drug abuse Acute nicotine withdrawal or > 15 cigarettes per day > 6 cups/glasses of coffee, caffeine drinks or energy drinks per day > 50 grams of alcohol per day Severe hypertonia (systole >160 mm Hg) Severe arteriosclerosis Diabetes, asthma, or glaucoma Severe hearing disability | 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): 30.0-80.0, Parkinson's Disease Advanced Parkinson's disease (Hoehn & Yahr II-IV) Age of 30 to 80 years Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior Written informed consent Atypical parkinsonian syndromes Treatment with antipsychotics Epilepsia or seizure in the history Deep brain stimulation other than DBS in STN Pregnant or lactating women Severe dementia | 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 Informed consent 2. 30 yrs or older 3. Diagnosis of PD (2 or more of bradykinesia; rest tremor, rigidity) 4. Adequate contraceptive measures (females) Malignancy within last 2 years 2. Pregnancy & breast-feeding 3. Treatment with any anti-PD drugs within 30 days of enrolment 4. Prior treatment with anti-PD medication exceeding 42 days in total 5. Medication-induced PD/PD not of idiopathic origin 6. CoQ10/idebenone doses of 300mg/day or higher within 120 days, >25mg/day within 7 days of enrolment 7. Methylphenidate HCl, neuroleptics, reserpine, amphetamines, selegeline or MAOIs within 6 months of enrolment 8. CNS medications at unstable doses within 60 days of enrolment 9. Dietary supplements > 5 x RDI 10. Hypersensitivity to CoQ10, idebenone or any components of the study drug 11. Unable to swallow 12. Diseases with features of PD 13. Seizure(s) within 12 months prior to enrolment 14. UPDRS tremor score of 4 15. Hamilton Depression Rating Scale score > 10 16. History of stroke 17. Requirement for dopaminergic drugs 18. Modified Hoehn & Yahr score > 2.5 19. History of brain surgery for Parkinson's disease 20. History of structural brain disease / congenital brain abnormality 21. History of ECT 22. Any other clinically significant medical or psychiatric condition or lab abnormality 23. Enrolment in any other pharmacological study within 30 days of enrolment | 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): 21.0-999.0, Parkinson's Disease Idiopathic PD treated with levodopa and experiencing motor fluctuations At least 21 years of age Male or female Cardiovascular disease, psychosis, extreme anxiety, dementia and other unstable medical conditions | 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's Disease Men or Women between 18 and 80 years Patient has idiopathic Parkinson's Disease according to Brain Bank criteria. Reference Hughes A J, Daniel S E, Kilford L, Lees A J, Accuracy of Clinical Diagnosis of Idiopathic Parkinson's disease; A clinical Pathological study of 100 cases, JNNP 1992, 55(3): 181 Patient is on stable doses of anti-Parkinson's disease medication, which are not expected to change during the study period Patient is taking levodopa and/or dopamine agonist treatment Patient (assisted by a carer where appropriate) is able to take their medication using the MEMS (electronic monitoring) containers Patients using a dosette box or similar device for their medication are willing to use the MEMS containers for their PD medication The investigator judges that the patient's care and symptom control will not be adversely affected by entering the study and using the MEMS device Patient is taking anti-Parkinson's disease therapy intermittently or on "as required" basis (such as rescue therapy for off periods). Intermittent Domperidone is allowed Severe co-morbid condition such as severe heart, liver, or kidney disease or cancer diagnosis where the co-morbid condition is of greater health significance than the Parkinson's disease in terms of life expectancy and levels of care required Patient is expected to undergo hospital admission during the study period (such as elective surgery) Patient is on non standard drug treatment / combination therapy. This would e.g. a combination of 2 different oral dopamine agonists, doses of dopamine agonist taken at higher than recommended for routine practice New antiparkinson treatment is being introduced at the time of recruitment or during the one month monitoring period Patient is taking only adjunct therapy (eg. Selegiline, Amantadine, anticholinergic therapy) Patient is taking part in a clinical 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): 30.0-70.0, Parkinson's Disease Parkinson Disease Dyskinesias Must be on 600mg or less of levodopa therapy for two years or less Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening Current or past history of Dyskinesia State of dementia or have a MMSE score < 26 at screening | 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, Prostate Cancer Patients with histologically confirmed diagnosis of prostate cancer who have not yet developed bone metastases Prostate cancer patients with a rise in PSA under hormone therapy. PSA Patients who have undergone prostatectomy: any rise in PSA or Patients without prostatectomy: 2 consecutive rises in PSA levels relative to a previous reference value, separated by one month. The first measurement must occur one month after the reference value and must be above the reference value. The second confirmatory measurement taken one month after the first measurement must be greater than the first measurement Previous chemotherapy or radiotherapy must have been performed ≥ 8 weeks prior to study entry Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (patients that spend less than 50% of time in bed during the day) Adequate liver function serum total bilirubin concentration less than 1.5 x upper limit of normal value Age: ≥ 18 years Patient has given written informed consent prior to any study-specific procedures. Patients with psychiatric or addictive disorders which prevent them from giving their informed consent must not enter the study Prior treatment with a bisphosphonate Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L) Patients with clinically symptomatic brain metastases History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG Known hypersensitivity to zoledronic acid or other bisphosphonates Use of other investigational drugs 30 days prior to the date of randomization Known history or present abuse of alcohol or drugs Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study | 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): 50.0-999.0, Hypertension ACEi or ARB naive or not taking ACEi or ARB concurrently for at least one month before the run-in period Be able to carry out his or her own daily activity Be at least 50 years old at in the study Be diagnosed with mild to moderate hypertension, treated or untreated Literate Not taking any cognitive-enhanced agent at baseline Present with a memory complain ( spontaneous or informed by caregiver) Congestive heart failure with NYHA class >2 Renal failure or renal insufficiency with serum creatinine >1.4mg/dl chronic severe liver disease with abnormal GPT and GOT >2 times of upper normal limits Diagnosed with major depression when entering the study Foreign language as his or her mother tongue so that the test results will not be reliable History of stroke or transient ischemic attack (stroke is defined as focal neurological sign progressing stepwise) Hypersensitive to the active ingredient and any other component of losartan potassium and indapamide tablets Major hearing loss/deafness and/or major visual impairment/blindness preventing from performing the tests Myocardial infarction within the past 6 months Single functioning kidney | 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, Cardiovascular Diseases Patient is male or female older 18 years of age. 2. Patients with a diagnosis of primary hypercholesterolemia and who are defined as being "high risk" (10-year risk of coronary artery disease greater than 20 % based on the Framingham model and history of cardiovascular disease or) 3. Patients who have not reached their recommended LDL-C target levels of 2.5 mmol/L while on a statin alone. 4. According to the judgment of the treating physician patient enrollment is in the best interest of the patient. 5. Patient agrees to participate and signs an informed consent allowing follow up and sharing of patient related data Individuals with poor mental function, drug or substance abuse, or individuals with unstable psychiatric illnesses, which, in the opinion of the investigator, may interfere with optimal participation in the observational study. Alcoholic substance abuse would be defined as a patient with alcohol consumption > 14 drink per week. (A drink is: a can of beer, glass of wine, or single measure of spirits.) 2. Patients who have been treated with any investigational drug within 30 days prior to Visit 1. (If <30 days, contact the clinical monitor for a case-by-case evaluation.) 3. Patients with clinically significant concomitant illnesses of liver, muscle or kidney abnormalities | 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, Hypertension Diabetes Hypercholesterolemia Vasculitis Coronary Heart Diseases All inpatients in a hospital environment Inability to give an informed consent | 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, Bradycardia Slow Heart Beat Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker Subject available for follow-up at study center for length of study Subject able and willing to undergo elective MRI scanning without sedation Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD) Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period Pregnant women, or women of child bearing potential who are not on a reliable form of birth control Subject with required by local law Subject who intends to participate in another clinical study during this clinical study | 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): 0.0-999.0, Parkinson's Disease Patients on anti-parkinson medication who Have been on monotherapy for a prolonged period, or Use anti-parkinson medications intermittently, or Do not have the expected change in medication over time in keeping with degenerative Parkinson's disease Patients on anti-parkinson medication for reasons other than Parkinson's disease Patients with significant co-morbidity (end stage liver, cardiac or renal disease) | 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's Disease Willing and able to give informed consent and willing to commit to long-term follow-up PD (asymmetric features including slowness (bradykinesia) plus resting tremor and/or rigidity) within 5 years of diagnosis Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at least 90 days, but not more than 2 years Use of creatine 14 days prior to baseline or during the study History of known hypersensitivity or intolerability to creatine Any unstable or clinically significant condition that would impair the subject's ability to comply with long term study follow-up Other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.), or any significant features suggestive of a diagnosis of atypical parkinsonism | 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): 18.0-90.0, Parkinson Disease Multiple System Atrophy Progressive Supranuclear Palsy Huntington Disease Dystonia Diffuse Lewy Body Disease Diagnosis of Parkinson's disease Ability to understand the aim of the study Ability to sign the consent form Non ability to understand the aim of the study Non ability to sign the consent form To be over 18 | 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): 32.0-999.0, Parkinson Disease Male or female patient with advanced idiopathic Parkinsons disease confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity. 2. Parkinsons disease diagnosed for at least 2 years. 3. Patients 30 years of age or older at the time of diagnosis. 4. Modified Hoehn and Yahr stage of 2 to 4 at on-time. 5. Treatment with standard or controlled release Levodopa combined with a Dopa-Decarboxylase-inhibitor, or with Levodopa combined with a Dopa-Decarboxylase-inhibitor/entacapone, at an optimised dose according to investigators judgement, this dose being stable for at least 4 weeks prior to baseline visit. 6. Motor fluctuations, with at least 2 cumulative hours of off-time every day during waking hours (documented on a patient diary completed for 2 consecutive days before baseline visit). 7. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular, after training, it has to be documented at baseline visit that the patient is able to recognise the off-time and on-time periods during waking hours and that the patient (or a family member or a guardian) is able to record them accurately in the patient diary. 8. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation-Good Clinical Practice guidelines and local legislation) Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases 2. Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit 3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders 4th edition that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study 4. History of psychosis, except history of drug induced hallucinations 5. History of deep brain stimulation 6. Clinically significant Electrocardiogram abnormalities at screening visit 7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at screening or baseline visit 8. Malignant melanoma or history of previously treated malignant melanoma 9. Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study 10. Pregnancy or breast-feeding 11. Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the screening visit and throughout the study period 12. Serum levels of Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase), Alanine Aminotransferase (Serum Glutamic Pyruvic Transaminase), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal 13. Patients with a creatinine clearance < 50 millilitres/minute 14. Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit 15. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit 16. Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines 17. Flunarizine within 3 months prior to baseline visit 18. Known hypersensitivity to pramipexole or its excipients 19. Drug abuse according to investigators judgement, within 2 years prior to screening 20. Participation in other investigational drug studies, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline visit | 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): 18.0-80.0, Parkinson's Disease Men or Women between 18 and 80 years Patient has idiopathic Parkinson's Disease according to Brain Bank criteria. - Reference Hughes A J, Daniel S E, Kilford L, Lees A J, Accuracy of Clinical - Diagnosis of Idiopathic Parkinson's disease; A clinical Pathological study of 100 cases, JNNP 1992, 55(3): 181 Patient is on stable doses of anti-Parkinson's disease medication, which are not expected to change during the study period Patient is taking levodopa and/or dopamine agonist treatment Patient (assisted by a carer where appropriate) is able to take their medication using the MEMS (electronic monitoring) containers Patients using a dosette box or similar device for their medication are willing to use the MEMS containers for their PD medication The investigator judges that the patient's care and symptom control will not be adversely affected by entering the study and using the MEMS device Patient is taking anti-Parkinson's disease therapy intermittently or on "as required" basis (such as rescue therapy for off periods). Intermittent Domperidone is allowed Severe co-morbid condition such as severe heart, liver, or kidney disease or cancer diagnosis where the co-morbid condition is of greater health significance than the Parkinson's disease in terms of life expectancy and levels of care required Patient is expected to undergo hospital admission during the study period (such as elective surgery) Patient is on non standard drug treatment / combination therapy. This would e.g. a combination of 2 different oral dopamine agonists, doses of dopamine agonist taken at higher than recommended for routine practice New antiparkinson treatment is being introduced at the time of recruitment or during the one month monitoring period Patient is taking only adjunct therapy (eg. Selegiline, Amantadine, anticholinergic therapy) Patient is taking part in a clinical 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): 21.0-999.0, Dyskinesias Movement Disorders Parkinson Disease Clinical diagnosis of probable idiopathic Parkinson's Disease or no neurologic disease (no disease for controls only) At least 21 years of age Mini Mental Status Exam Score>=25 Evidence of psychosis (hallucinations or delusions) by history Any unstable medical condition Currently using dopamine blocking medication Currently taking anticoagulants or MAO inhibitors | 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): 35.0-85.0, Parkinson's Disease Have idiopathic Parkinson's disease treated with levodopa and experiencing motor fluctuations Response to levodopa had to be documented by a 10 percent increase in finger or foot tapping speed Clinically significant cardiovascular, cerebrovascular, hepatic and renal diseases Psychosis Allergy to apomorphine or 5ht3 inhibitors Prolonged qt interval Pregnancy/breast-feeding Hemodynamic instability Severe nausea Alcohol/drug abuse Other unstable medical conditions | 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): 20.0-999.0, Parkinson Disease Parkinson's Disease Subjects eligible for enrollment in the study must meet all of the following criteria. Note that both inpatients and outpatients are eligible Patients with a diagnosis of PD (including juvenile parkinsonism) with Modified Hoehn & Yahr Stages I to IV Patients who have been receiving another dopamine agonist for at least 4 weeks prior to the start of the screening phase and are expected to benefit from conversion to ROP Age: 20 years (at the time of written informed consent) Informed consent: Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own) Gender: Male or female Females of childbearing potential are eligible for enrollment in the study, only if the subject has a negative pregnancy test at the start of the screening phase and agrees to conduct pregnancy testing at the protocol-specified visits during the study and use one of the following acceptable methods of contraceptions properly and accurately Abstinence Oral contraceptive, either combined or progestogen alone Injectable progestogen Implants of levonorgestrel Subjects meeting any of the following must not be enrolled in the study Patients who present with any serious medical condition other than PD (e.g., cardiac, hepatic or renal disorder or hematopoietic disorder). Serious is defined as Grade 3 as a rule according to the Classification of the Severity of Adverse Experiences Patients with postural hypotension with any subjective symptoms (e.g., dizziness and syncope) Patients who have had any serious psychiatric symptoms (e.g., confusion, hallucination, delusion, abnormal behavior) (including symptoms caused by anti-PD drugs) within 6 months (26 weeks) prior to written informed consent Patients who have initiated any of the following drugs within 4 weeks of the start of the screening phase and have the dosing regimen of the drug changed within 4 weeks of the start of the screening phase L-dopa (+DCI) (NOTE: This does not apply to the monotherapy group.) Anticholinergic agents: trihexyphenidyl hydrochloride, piroheptine hydrochloride, mazaticol hydrochloride, metixene hydrochloride, biperiden, profenamine amantadine hydrochloride droxidopa citicoline | 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, Walking Cognitive Function cerebral ischemia with our without hydrocephalus and gait apraxia all other conditions which contribute to walking difficulty e.g. bad knees; or spondylosis; parkinson's or paralytic strokes | 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): 30.0-999.0, Parkinson Disease A subject will be eligible for study participation if he/she meets all the following 1. Age of at least 30 years 2. Diagnosis of symptomatic, idiopathic Parkinson' disease using The United Kingdom Parkinson's Disease Society Brain Bank Diagnostic (Appendix 3 in the protocol) 3. Stage 1-4 on the modified Hoehn and Yahr scale (Appendix 4 in the protocol) 4. Possesses three of the four cardinal signs of Parkinson's disease, i.e. rigidity, bradykinesia, resting tremor and postural instability, without any other known or suspected cause for their parkinsonism 5. If receiving levodopa or other symptomatic treatments, the subject should have shown a good response to it and have been on a stable dosage for at least 1 month prior to study entry 6. Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures A subject will be excluded from the study if he/she meets any of the following 1. Presence of atypical parkinsonian syndromes 2. Dementia as defined by the Mini-Mental State Examination score (Appendix 5 in the protocol) of 22 or less 3. Serious concurrent illness, such as active cardiac, renal, liver, or neoplastic disease 4. Used centrally active therapies, e.g. hypnotics, antidepressants, anxiolytics, within 60 days before study entry 5. Used methylphenidate, cinnarizine, reserpine, amphetamine, or monoamine oxidase-A inhibitors, e.g. pargyline, phenelzine, or tranylcpromine, within 3 months of study entry 6. Has history of receiving any neuroleptics 7. Used alpha-methyldopa or flunarizine within 6 months of study entry 8. Females who are pregnant or breastfeeding. 9. Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study (Visit 1). 10. Subjects who are taking any traditional Chinese medication, or has been taking any traditional Chinese medication within the last 2 weeks prior to screening of this study (Visit 1). 11. Any which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol | 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): 35.0-85.0, Parkinson's Disease Gait Impairment Patients with a definite diagnosis of Parkinson's disease for at least 5 years Patients with mild to severe gait disturbance Patients on a stable dose of anti-parkinsonian medications that will not be expected to require medication adjustments Mini-Mental State Examination (MMSE) score of 25 or greater Patients with musculoskeletal disorders such as severe arthritis, post knee surgery, hip surgery, or any other condition that the investigators determine may impair assessment of gait Previous treatment with DBS (deep brain stimulation) Those with history of stroke Those with cerebellar, vestibular, or sensory ataxia Concurrent use of, or within two weeks from discontinuing, MAO inhibitor drugs (selegiline, rasagiline) Women of childbearing potential | 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, Cardiovascular Diseases Males or females at least 18 years old. 2. Patient has not been previously enrolled in the genebank registry. 3. Patient able to give informed consent. 4. Patient to undergo cardiac catheterization or had a left heart cath at The Cleveland Clinic or at The University of North Carolina at Chapel Hill, or at MetroHealth Medical Center within 1 year. 5. Patients > or = to 50 y/o with normal cardiac catheterizations (< 30% in all coronary vessels per angio). (If subjects enrolled as normal controls are later deemed to have significant CAD, the subject's blood and data will still be useful in the Genebank under the broader scope of the study). 6. Any patient with history of myocardial infarction. (If a subject reports history of MI at another facility, outside records will be obtained to confirm the diagnosis. If MI cannot be confirmed by data in the record, the subject's blood and data will still be useful in the Genebank under the broader scope of the study). 7. Non-caucasian patients or of Hispanic Ethnicity (UNC and MetroHealth Medical; Center only). 8. All Patients undergoing Cardiac CT or had Cardiac CT within 1 year (CCF only). (Cleveland Clinic will follow 1-7, 9, UNC and MetroHealth Medical Center will follow criteria1-8). 9. Any patients coming to the Heart and Vascular Institute for outpatient scheduled appointments. 10. Any patients that have had or are going to have an implanted cardioverter defibrillator (ICD) or Cardiac Resynchronization Defibrillator (CRT-D). 11. Any patients with cardiac arrhythmias or a family history of cardiac arrhythmias None except as noted in the | 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): 40.0-999.0, Upper Extremity Tremor Subjects must provide written informed consent prior to the initiation of any study related procedures; 2. Subjects ≥ 40 years of age; 3. Subjects with upper extremity tremor for < 2 years duration Any clinically significant acute or unstable physical or psychological illness based on medical history or physical examination at Visit 1, as determined by the Principal Investigator; 2. Any unexpected clinically significant abnormal laboratory or ECG results obtained at Visit 1 and as determined by the Principal Investigator; 3. Any history of drug, narcotic, or alcohol abuse within 2 years prior to the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM-IVR {American Psychiatric Association, 1994 #2}); 4. Positive urine drug screen at Visit 1; 5. Participation in an investigational drug or device clinical trial within 30 days prior to the date of informed consent; 6. Previous participation in any 123I-ALTROPANE® trial; 7. Any exposure to radiopharmaceuticals within 30 days prior to the date of informed consent; 8. Positive (+) pregnancy test at Visit 1 and/or Visit 2; 9. Breast-feeding; 10. Inability to lie supine for 1 hour; 11. Any significant active thyroid disease; 12. Known sensitivity or allergy to Iodine or Iodine containing products; 13. A history of repeated head injury or sustained severe head injury in year prior to onset of tremor; 14. A definitive diagnosis of encephalitis; 15. Any uncontrolled hypertension or diabetes; 16. Any history of cerebrovascular disease; 17. Previous evaluation by a Movement Disorder Specialist (MDS); 18. Treatment within the previous six (6) months prior to informed consent with bupropion, metoclopramide, cinnarizine, flunarizine, methylphenidate, reserpine, modafinil, alpha methyldopa, amphetamine, or any anti-psychotic medication; 19. Any treatment with anti-Parkinson's drugs or anti-tremor medications within three (3) months prior to the date of the subject signing the informed consent; 20. Any new prescription or change in dose of medications for chronic conditions within four (4) weeks of Visit 2 | 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): 18.0-75.0, Hepatic Encephalopathy Male or female between the ages of 18 and 75 years Signed written informed consent by subject's representative Current diagnosis of chronic liver disease with cirrhosis West Haven score of Grade 3 or 4 Hepatic Encephalopathy Weight between 45 and 150 kg Elevated venous ammonia concentration, defined as a value above the normal range at the local laboratory Estimated creatinine clearance of > 30 mL/min/1.73m², calculated using the Cockcroft-Gault formula, or serum creatinine < 2.5 mg/dL [Cockcroft-Gault formula: creatinine clearance = (140 age) x weight in kg divided by (72 x serum creatinine in mg/dL); multiply result by 0.85 for females] Adequate urinary output of ≥ 30 mL/hour for the last 2 hours if estimated creatinine clearance is < 50 mL/min/1.73 m² Negative pregnancy test or documented sterilization procedure (tubal ligation or hysterectomy) or 5 years post-menopausal Major gastrointestinal bleeding (hematemesis, melena, or hematochezia) requiring blood transfusion within the last 24 hours Uncontrolled sepsis, as defined by hemodynamic instability requiring vasopressor agents (renal-dosed dopamine allowed) Current diagnosis of acute hepatic failure Alcohol ingestion during last 24 hours Post liver transplant Serum sodium < 120 mEq/L Serum potassium ≤ 3.5 mEq/L Use of probenecid, valproate, penicillin or its derivatives, or corticosteroids (oral or IV) within the last 24 hours Use of any sedatives, benzodiazepines, or any neuro or psycho-active drugs in the last 6 hours and a positive urinary drug screen | 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): 30.0-80.0, Levodopa-induced Dyskinesia Male and female patients aged 30-80 years old (both ages included) Use of adequate and effective birth control measures (not including the rhythm method) during the study period and up to 3 months after the end of study in men and women of child-bearing potential or within two years of menopause (these women will perform a urine pregnancy test at the screening visit) Idiopathic Parkinson Disease (UK PD Society Brain Bank Clinical Diagnosis Criteria) diagnosed for at least 3 years Hoehn and Yahr "ON" time (good medication response) stage II-III Treatment with levodopa at an optimized dose alone or with dopamine agonists, MAO-B inhibitors or COMT inhibitors that are stable for at least 4 weeks prior to visit 1 Use of hypnotics, sedatives, beta-blockers, anxiolytics and antidepressant only if stable for at least 4 weeks prior to visit 1 A minimal baseline Levodopa induced dyskinesia score of 2 or more on question 32 (dyskinesias present during more than 25% of the waking day); a score of 2 or more on question 33 of UPDRS (severely disabling dyskinesias) Part IV (historical information) A minimal basal level of motor fluctuations of 25% or more cumulative hours of OFF time every day during waking hours on the UPDRS Part IV (a minimal score of 1 on question 39 of UPDRS, historical information) Patients have at least 33% motor improvement in response to their levodopa challenge dose based on UPDRS motor score (Part III) at visit 1 Patients experiencing peak-dose dyskinesia with a score of at least 2 on 2 or more (≥2) areas (a score of at least 4) on the modified AIMS scale in response to their levodopa challenge dose at visit 1 Patient has Non-idiopathic Parkinson's disease (e.g drug-induced or other form of secondary or atypical Parkinsonism) Neuropsychiatric exclusions: dementia (Mini Mental State Exam < 23, history or presence of psychosis (such as visual hallucinations while taking dopamine agonists), history of or current Axis I or Axis II mental disorders according to DSM-IV; severe depression (Hamilton scale > 17) Any clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives History or presence of gastrointestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs Pregnant or breast feeding women Drug abuse or history of drug abuse (including alcohol), known drug addiction Patients with severe postural hypotension (> 20 % variability between standing and supine) The following medications are forbidden for at least one month prior to visit 1 and during the course of the study: NMDA receptor antagonists (amantadine, memantine, budipine, dextromethorphan), medication with central dopaminergic antagonist activity (neuroleptics), CNS stimulants and sodium valproate (may exacerbate dyskinesias) Hoehn and Yahr score V when OFF (wheelchair-bound) The patient is participating in another study or has been participating in a study within the last 2 months | 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): 20.0-999.0, Parkinson's Disease Men and women aged 20 years or older at the time of giving informed consent Patients who have idiopathic Parkinson's disease Patients who have been on a stable regimen of levodopa (at least three times daily) plus at least one other antiparkinsonian agent being administered or more frequently for at least 30 days before the preliminary evaluation and who have predictable end-of-dose wearing-off Patients who meet both of the following on the Modified Hoehn and Yahr Scale during the preliminary evaluation and on the day before starting study drug (Day -1) Stage IV or V while in the OFF state Stage II to III while in the ON state Patients who have experienced a 30% or more improvement in UPDRS Part 3 score when tested for responsiveness to levodopa during the baseline period Patients who have at least one wearing-off episode per day and a daily average OFF time of at least two hours two days before starting study drug (Day -2) and on Day -1 Patients who can understand the OFF state or have a family member who can understand it Patients who have given written informed consent. (Alternatively, the patient's legally acceptable representative may give written consent following the patient's oral consent, if his/her condition makes handwriting difficult.) Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system or a tumor that is clinically significant for their participation in the study Patients with orthostatic hypotension Patients with a history of drug allergies Patients with a history of intolerance to morphine or its derivatives, sulfur, sulfur-containing pharmaceutical products, or sulfite Patients with a history of malignant syndrome Patients with a diagnosis of cancer or evidence of continued disease within five years before starting study drug Patients who have been taking domperidone at a dose level of more than 30 mg/day since before the preliminary evaluation Patients who do not test negative in the direct Coombs' test as part of the preliminary evaluation Pregnant or lactating women, women who are planning to have children, women who test positive in the pregnancy test during the preliminary evaluation or on Day -1, or women who cannot adhere to a reliable method of contraception throughout the study Patients who have received MAO inhibitors except selegiline within three months before starting study drug | 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): 30.0-80.0, Idiopathic Parkinson's Disease Male and female between the ages of 30 to 80 years with diagnosis of idiopathic Parkinson's Disease of more than 5 years duration, with a Hoehn and Yahr stage of I-IV during an "off" phase. Be levodopa-responsive and have been receiving treatment with a stable dose of levodopa for at least 4 weeks. Have motor fluctuations, with >1.5 hours "off" time during the day. Be able to maintain an accurate and complete diary (18-hour) Patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;. Be in a late stage of Parkinson's Disease, and experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms. Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months. Have received treatment with safinamide previously. History of, or current depression psychosis (e.g. schizophrenia or psychotic depression) Evidence of dementia or cognitive dysfunction. History of allergic response to anticonvulsants, levodopa, or other anti-Parkinsonian agents. Hypersensitivity or contraindications to MAO-B inhibitors. Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy | 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): 18.0-89.0, Cancer Adults, at least 18 years old, who have been diagnosed with cancer (any form) and are in active treatment Treatment must intravenous chemotherapy (either as an outpatient or an inpatient) with or without surgery and/or radiation Each participant will be fluent in English, able to hear and speak, fully alert and oriented, able to verbalize both concrete and abstract ideas, and able to comprehend and sign consent for participation Anyone else | 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): 30.0-999.0, Parkinson Disease Parkinson's Disease A subject will be eligible for in this study only if all of the following apply Subjects must have completed studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down titration at the end of treatment/early withdrawal) Subjects must not have a break in medication between completing the feeder study (including the down titration phase for studies 168 and 169) and beginning treatment in study 248 Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant System) Provide written informed consent for this study Be willing and able to comply with study procedures A subject will not be eligible for in this study if any of the following apply Patients with any ongoing clinically significant adverse events at the end of the "feeder" studies Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma) Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the feeder study (REQUIP study 165, 168 or 169) Subjects with severe dizziness or fainting due to postural hypotension on standing Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit cytochrome P 450 1A2 (CYP1A2 [e.g. ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol]) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period Women who are pregnant or breast-feeding Use of an investigational drug throughout the treatment period | 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): 18.0-89.0, Ileus All patients admitted to one surgical unit (3-1) from November 1, 2007 to August 1, 2008 with a non emergent laparoscopic colectomy All patients with History of metastatic disease History of inflammatory bowel disease Abdominal radiation treatment Mint allergy (the gum is mint flavored) Dentures Nasogastric tube drainage beyond the first postoperative morning More than one bowel anastomosis during this surgery Conversion to pen colectomy Admission to an ICI post-operatively | 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): 0.0-999.0, Parkinson's Disease Idiopathic PD as diagnosed by a neurologist a movement disorders specialist, according to the Parkinson Disease Brain Bank with asymmetrical bradykinesia, rigidity, tremor and postural instability (at least 3 from the above) 2. Significant clinical response to Levodopa (improvement of UPDRS motor score > 20%). 3. Disease duration > 5 years 4. Advanced stage of disease: 5. UPDRS motor score in off condition >/= 40/108 6. Hoehn & Yahr stage >/= 3 7. DBS surgery not indicated or expressly refused by the patient 8. Antiparkinsonian therapy stable for at least one month prior to implant 9. Capability to give informed consent to surgery and to the study Severe cognitive impairment or dementia 2. Psychiatric disturbances with the exception of mild anxiety or depression and drug-induced psychiatric symptoms (i.e. benign hallucinations) 3. History of epilepsy or documented electroencephalographic abnormalities suggesting epilepsy 4. Previous neurosurgery of the brain (DBS or lesioning of the basal ganglia, fetal tissue transplantation ) 5. Lack of informed consent 6. History of drug or alcohol abuse 7. Poor general conditions increasing surgical risk or severe illness with poor prognosis | 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, To Determine the Bioavailability of Tranylcypromine Subjects will be normal, healthy adult men and women who volunteer to participate Is the individual healthy, nonsmoking, normal adult man or woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, exclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse, or by the use of barrier methods. (diaphragm, condom, foams/jellies, sponge), and IUD, or has she has been surgically sterile or post menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has/s/he provided written informed consent? A no answer to any of the above questions indicates taht the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to tranylcypromine? Does/ s/he have clinically significant laboratory abnormalities that would interface with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interface with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history ( within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-1 , or hepatitis B or C screen, or a positive pregnancy test?-Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the alst blood sample has been taken? Is s/he unable to refrain from the ingestion of smoked meat, cheese (except cream cheese and cottage cheese), wine and beer during periods beginning 48 hours prior to study initiation and ending seven days after the last blood sample has been taken in study period two? Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications during the study? | 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, Dementia Alzheimer's Disease Parkinson Disease Huntington Disease Capable of providing informed consent and having a legal representative able to consent out of concern for future competency to consent (as defined by a Mini Mental State Exam score of <24) or capable of assent but incapable of giving competent informed consent, but with a legal representative able to provide informed consent Subject or family voices concern about their memory or possess knowledge that they have been diagnosed with a memory disorder such as Age Associated memory Impairment, Alzheimer's disease, Parkinson disease, Huntington disease, vascular dementia, mixed dementia, dementia with Lewy Bodies, or frontotemporal dementia Children (less than 18 years of age) | 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): 0.0-999.0, Parkinson's Disease Helicobacter Infections Motor Fluctuations Adults diagnosed with idiopathic Parkinson's disease, Hoehn & Yahr stage 2-4 in the "off" state, with no other concomitant neurologic diseases Stable (≥30 days) Parkinson's disease therapy, with demonstrable medication efficacy, but with wearing off phenomenon present between levodopa doses (average off time ≥3 hours off time/day) Levodopa therapy required; Any formulation (e.g. Sinemet, Sinemet CR, Stalevo) is acceptable. Parkinson's disease treatment may also any of the following medications or classes: non-ergot dopamine agonists, COMT inhibitors, MAO-B inhibitors, amantadine, anticholinergics Positive for H. pylori IgG Ab by serum ELISA (before in randomized treatment arms) Current abdominal pain, unexplained nausea/vomiting, or gastrointestinal bleeding History of gastric cancer, peptic ulcer, duodenal ulcer, or other gastric or duodenal lesions History of previous gastric surgery History of previous brain surgery for Parkinson's disease Family history of gastric cancer Prior treatment for H. pylori+ status Recent use (previous 4 weeks) of proton-pump inhibitor, amoxicillin, or clarithromycin Allergy or sensitivity to penicillin, amoxicillin, clarithromycin, or omeprazole Use of drugs affecting gastric motility (e.g. domperidone, metoclopramide) Inability to tolerate or participate in testing in the morning in an "off" state | 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): 40.0-90.0, Parkinson Disease male or a female at least 40 years of age or older neurologist diagnosed idiopathic PD (using UK Brain Bank Criteria) ambulatory and medically cleared by their physician to participate in an exercise regimen clinical signs of hypokinesia (reduced movement amplitude during ADL tasks) or postural instability have a Folstein Mini-Mental State Examination score > 23 currently taking dopamine replacement medication previous surgical management of PD (pallidotomy, DBS) motor fluctuations and or dyskinesias uncontrolled by medications. central nervous system disorder (e.g., other than Parkinson's disease) myopathic disease (e.g., focal myopathy) that affects skeletal muscle structure/function rheumatological disease that has an effect on muscle and/or mobility unstable cardiovascular disease that limits exercise abilities impaired knee flexion, <90 degrees, extreme claustrophobia (secondary to the inability to perform the MRI scans) regular (2-3x/week) aerobic or resistance exercise performed over the past 6 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): 30.0-80.0, Parkinson's Disease Age 30-80 Idiopathic PD Hoehn & Yahr stage 2-4 diagnosed by 2 of the 3 cardinal motor features Fluctuation response to levodopa Dyskinesia No other historical, laboratory or physical signs to suggest an alternate diagnosis No significant dementia, MMSE>24 On oral levodopa therapy dementia psychosis severe anxiety unstable cardiovascular disease uncontrolled hypertension history of cardiac arrhythmias active peptic ulcer disease anemia (HCT<32%) | 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's Disease People with Parkinson's Disease None | 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, Advanced Cancer Patient with advanced cancer (local recurrence or metastatic) at the time of their follow up visit to the outpatient palliative care clinic or at an agreed date after the first visit to the outpatient palliative care clinic. 2. Patient designates a family member who is a patient's parent, spouse, adult child, sibling, other relative, or significant other (any other person defined by the patient as a partner) to answer the family questionnaire. 3. Patient is 18 years of age or older (as the assessment tools used in this study have not been validated in the pediatric population). 4. Patient with normal cognitive status as determined by the interviewer and by her/his ability to understand the nature of the study and consent process. 5. Patient willing to participate in the study and sign informed consent. 6. Family member is 18 years of age or older (as the assessment tools used in this study have not been validated in the pediatric population). 7. Family member with normal cognitive status as determined by the interviewer and by her/his ability to understand the nature of the study and consent process. 8. Family member willing to participate in the study and sign informed consent. 9. All participants in the international centers must be from Argentinian, Chilean, or Guatemalan descendence respectively. 10. All participants in the U.S. must be from self-reported Hispanic descendence, first or second generation immigrants, and reside in the U.S. for at least 5 years Either patient or family member can not complete the assessments independently. 2. Either patient or family member refuses to participate in the study | 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, Hepatic Encephalopathy Must sign an Informed Consent Form In remission from past HE Appropriate birth control measures More than or equal to 18 years of age Must be potential for benefit from treatment Recent HE episodes Capable and willing to comply with all study procedures Participant has support network Significant medical conditions or Investigator decision not to the participant Allergies to the study drug or similar drugs Laboratory abnormalities Recent participation in another clinical trial Problems experienced in a previous HE trial Pregnant or at risk of pregnancy Recent alcohol consumption Active or latent bacterial or viral Infections Bowel issues Recent Active Cancer | 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): 18.0-80.0, Parkinson's Disease Clinical diagnosis of Parkinson's disease Able to withdraw Parkinson's disease medication for 12 hours prior to a study visit Must be currently using levodopa to qualify for the levodopa part of the study History of seizures Presence of any metal in the body, including DBS stimulators, pacemakers, metal plates or pins Severe cognitive deficits or psychosis Evidence of any clinically unstable disease, such as cancer, HIV/AIDS; unstable heart condition or other conditions that might require hospitalization Evidence of another neurological disease, such as multiple sclerosis, amyotrophic lateral sclerosis, or Huntington's disease | 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, Metabolic Diseases Hyperlipidemias Metabolic Disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders Diagnosis of statin intolerance Diagnosis of Coronary Artery Disease (CAD) Diagnosis of hypercholesterolemia Stable weight for > 6 weeks Significant health problems in the recent past (≤24 weeks) including heart attack, heart surgery, heart failure, uncontrolled hypothyroidism, blood disorders, digestive problems, disease of central nervous system, cancer, liver or renal disease | 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): 18.0-89.0, Amyotrophic Lateral Sclerosis Neurodegenerative Disease Motor Neuron Disease Diagnosis of definite or possible ALS by the El Escorial Between ages of 18 to 89 years Scored two or less in the ALS FRS category 1 (Speech) Scored two or less in the ALS FRS category 4 (Handwriting) Cognitively intact with no other neurological diseases No unstable medical problems Any subject not meeting the Patients unable to give informed consent either themselves or via a legally authorized personnel Patients diagnosed with neurological problems other than ALS (upon examination by the principal investigator) | 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): 7.0-999.0, Hereditary Elliptocytosis (HE) Hereditary Pyropoikilocytosis (HPP) > 7 years of age Consenting family members Anyone not meeting the above | 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): 18.0-75.0, Coronary Heart Disease Hypercholesterolemia Male and Female, from 18 to 75 years old Established diagnosis of CHD Previous (at least, within 1 month before in the present study) treatment with statin Levels of plasma TC and LDL-C above the recommended target values (TC> 4.5 mmol\L; LDL-C> 2.5 mmol/L) The written informed consent signed prior to the start of participation in the study Contraindications for statin and ezetimibe (Ezetrol) administration in accordance with local Russian Federation medical instructions Patients refused to participate in the study and/or did not sign informed consent form | 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): 50.0-85.0, Parkinson's Disease Subjects considered for will be female or male subjects either currently enrolled or eligible for care at the VA aged 50-85 years, or community volunteers The racial, gender and ethnic characteristics of the proposed subjects population reflect the demographics of the patient population of the VA. However, extra efforts will be made to recruit women and minorities (see table 5) Children will be excluded from the study shall be based on race, ethnicity, gender, or asymptomatic HIV status Inability to stand or walk independently (i.e., patients in Hoehn and Yahr stage IV and V) Vertiginous disorder Orthostatic hypotension or unstable cardiovascular disease at risk of syncope (drop in systolic blood pressure of > 20 mm Hg upon standing) History of stroke with focal cortical lesions Cerebellar, myelopathic or significant radiculopathy syndrome Diminished light perception in both eyes (< 20/40 corrected OU) Intracranial surgery Subjects who have participated in other research protocols such that their cumulative radiation absorbed dose to whole body, gonads, bone marrow or lens of the eye would exceed 5 Rem, or dose to other body organs is more than 15 Rem in preceding 12 months Pregnancy (beta-HCG test within 48 hours of PET study) or breastfeeding | 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): 21.0-999.0, Parkinson's Disease idiopathic Parkinson's Disease clear response to levodopa (sinemet) "off" at least 20% of waking day dyskinesias present for at least two hours of waking day subject or caregiver able to master use of drug delivery system (injector pen or pump) physical complications that would preclude safe participation standing systolic BP of <80 lack of tolerance or response to apomorphine drug/alcohol abuse | 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, Healthy Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is she willing .to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the stndy? Is s/he considered .reliable and capable of understanding his/her responsibility and role in the study Has s/he provided written informed consent? A no answer to any of the above questions indicated that the individual was ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to amlodipine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety'? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant h/story (within the past year) or clinical evidence of alcohol or drug abuse? • Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation? Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)? | 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): 18.0-64.0, Healthy Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is she willing .to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the stndy? Is s/he considered .reliable and capable of understanding his/her responsibility and role in the study Has s/he provided written informed consent? A no answer to any of the above questions indicated that the individual was ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to amlodipine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety'? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant h/story (within the past year) or clinical evidence of alcohol or drug abuse? • Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation? Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)? | 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): 18.0-88.0, Coronary Disease Adult patients with slow flow or coronary artery occlusion All other patients | 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): 21.0-999.0, Parkinson's Disease Parkinson's Disease At least 21 years of age Must be taking Oral levodopa Must have dyskinesias by history or previous clinical observation Significant cognitive impairment as measured by the Montreal Cognitive Assessment (MOCA) score of < 25 Subjects with unstable medical or psychiatric conditions (including hallucinations) Use of dopamine receptor blocking medications (e.g., neuroleptics, certain antiemetics, tetrabenazine) History of unstable medical conditions (ie active cardiovascular disease, recent unwellness or surgery etc.) Use of anticoagulants Current substance abuse Previous adverse event on amantadine | 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, Head And Neck Cancer Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck cancer 2. Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of 2 or less 3. Part 2. Patient has a spouse or significant other with whom he/she resides 4. Part 2. Patient is able to vocalize well enough to complete the spousal interaction task 5. Parts 1 and 2. Patient and spouse are able to read and speak English 6. Parts 1 and 2. Patient and spouse are able to provide informed consent 7. Parts 1 and 2. Patient and spouse are at least 18 years of age 8. Part 1. Individual is a patient who was diagnosed with head and neck cancer or the spouse or partner of an patient who was diagnosed with head and neck cancer and resides with the patient None | 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): 40.0-999.0, Parkinson's Disease Depression Anxiety for STN-DBS subjects Age 40 or older DBS STN Surgery in past 2 to 36 months Ability to tolerate turning off Stimulators Ability to read and comprehend questions English speaking for STN-DBS subjects Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness Clinically determined Dementia ( Most recent MMSE score of >24) for Control subject Age 40 or older Ability to read and comprehend questions English speaking for Control subject Other severe complications post surgery: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries(i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness Clinically determined Dementia ( Most recent MMSE score of >24) Plans to have DBS STN surgery in the next 24 months | 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): 60.0-999.0, Parkinson's Disease Subjects may be enrolled if they (inclusion criteria) Are males or females ≥60 years of age Meet research diagnostic for Parkinson's disease Diagnosis of a parkinsonian syndrome Bradykinesia (slowness of initiation of voluntary movement with progressive reduction in speed and amplitude of repetitive actions) At least one of the following: muscle rigidity, rest tremor, postural instability not due to visual, vestibular, cerebellar or proprioceptive causes Supportive for diagnosis of PD (two or more required) Unilateral onset of symptoms and persistent asymmetry Rest tremor present Progressive illness Subjects may not be enrolled if any of the following are present ( History of repeated strokes, repeated head injury, definite encephalitis Use of neuroleptics at onset of symptoms Sustained remission Strictly unilateral feature persisting > three years after onset Significant supranuclear gaze palsy Cerebellar, pyramidal and early severe autonomic findings Early severe dementia suggesting a diagnosis of dementia with Lewy bodies (DLB) Imaging study showing structural abnormality that could explain parkinsonism Negative response to an adequate levodopa 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): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken? | 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): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI between 19 and 30, inclusive? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does he have serious psychological illness? Does he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Has he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is he unable to refrain from the use of all concomitant medications during the study? | 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): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken? | 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): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken? | 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): 18.0-45.0, Healthy Is the individual a healthy, normal adult man who volunteers to participate? Is he 18-45 years of age, inclusive? Is his BMI ≤30? Is he considered reliable and capable of understanding his responsibility and role in the study? Has he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to bupropion, milk or eggs? Does he smoke more than 25 cigarettes/day? Is he unable to refrain from smoking during the period beginning two hours before and ending four hours after study drug administration? Does he have a history of seizure, cranial trauma, or other predisposition to seizure? Does he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, renal or other diseases, conditions or surgeries that would interfere with the conduct or interpretation of the study or jeopardize his safety? Does he have serious psychological illness? Does he have significant history (within the past six months) or clinical evidence of alcohol or drug abuse? Does he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-l, or hepatitis B or C screen? Is he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 24 and 48 hours, respectively, prior to study drug administration and ending when the last blood sample has been taken? | 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, Hypercholesterolemia Outpatient men or women, age 18 years and above Patients with primary (heterozygous familial and non-familial) hypercholesterolemia Known hypersensitivity to Ezetimibe and Simvastatin Moderate to severe hepatic insufficiency Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal Pregnancy or lactation Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine | 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): 21.0-999.0, Parkinson's Disease Age over 21 Diagnosis of Parkinson's disease Treated with dopaminergic medication for at least 1 year Must be ambulatory (can use walker or cane) No obvious remediable cause of falls Falls are on basis of non-CNS etiologies (cardiogenic, orthopedic, peripheral neuropathy, etc) Dementia present (MMSE < 25) Not taking cholinergic or anticholinergic medications 10 days prior to screening visit No Warfarin use | 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's Disease Parkinsons disease Older than 18 Must be participating in a Parkinsons disease study at Oregon Health & Science University | 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): 20.0-120.0, Alzheimer's Disease Parkinson's Disease Multiple Sclerosis Patients who have elective craniotomy or Patients who have elective ventriculostomy surgery or Patients who have elective muscle biopsy or nerve biopsy Patient who have emergency craniectomy for life threatening from emergency medical and surgical conditions such as Brain herniation or head injury Central nervous system infection for example tuberculous or any bacterial infection, Viral infection, fungal infection Central nervous system Tumor, Malignancy and metastasis | 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): 30.0-95.0, Parkinson's Disease Subject satisfactorily completed study IN 09 004 and, in the opinion of the investigator, will benefit from participation in the extension study Subject with Parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2 hours OFF a day at the discretion of the PI (does not early morning akinesia or nocturnal akinesia) Subject that has been treated for at least 3 months prior to the study with 500-1000 mg Levodopa + DDCI, in 4 or more divided doses per day Hoehn and Yahr stages I-III Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study Prepared and able to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study Subject has undergone Deep brain stimulation (DBS) or any other neurological surgical procedure that affects neurological symptoms (e.g tremor, rigidity, stiffness, slowed movement, and walking problem) Subjects with any gastrointestinal surgery other than appendectomy or herniotomy, recent history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, intestinal obstruction, or frequent nausea or emesis or diarrhea which, in the opinion of the investigator, contraindicates his/her participation Subjects with a recent history of clinically defined GERD, peptic ulcer or any gastrointestinal disorder likely to influence drug absorption which, in the opinion of the investigator, contraindicates his/her participation | 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 Eligible subjects were male or female at least 30 years of age had completed participation in a prior double-blind istradefylline trial met United Kingdom's Parkinson's Disease Society (UKPDS) brain bank (Step 1 and Step 2) for Parkinson's disease and the severity of the Parkinson's disease was defined as Stages 2-4 on the Modified Hoehn and Yahr Scale while in the OFF state had been treated with levodopa for at least 1 year had been on a stable Parkinson's disease regimen within normal therapeutic ranges including levodopa for at least 4 weeks before Baseline were currently taking at least 4 doses of levodopa per day (3 doses per day if at least 2 doses contained slow-release formulation) had predictable end-of-dose wearing-off none | 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): 6.0-11.0, Epilepsy Age 6-11 years (prepubertal based on tanner staging) Patients with epilepsy (diagnosis based on ILAE) Normal intelligence based on school placement (defined as age appropriate; an IEP due to epilepsy related causes is acceptable as is placement in a higher grade) or IQ>70 (testing done with in 12 months of enrollment) No history of significant snoring loud snoring every night outside of a room with closed door Combined score of 30 or more on sleep fragmentation, parasomnia and daytime drowsiness subscales on SBQ History of significant snoring loud snoring every night heard outside of a room with closed door Diagnosis of obstructive sleep apnea (OSA) or periodic limb movement disorder on PSG Vagus nerve stimulator implanted History of a major psychiatric disease (e.g. psychosis, major depression) History of autism or pervasive development disorder Severe neuro-developmental disabilities, as determined by PI Clinically significant systemic organic disease, as determined by PI Current use of melatonin or sustained release melatonin Prior use of sustained release melatonin | 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): 40.0-999.0, Hypertension Cardiovascular Disease patients older than 40 years of age with stage I hypertension low life expectancy other indications for the use of diuretics, such as cardiovascular disease intolerance to the study drugs pregnancy | 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 HIV Infections years of age or older healthy controls with no significant medical conditions diagnosed HIV positive patients on or off ARVs diagnosed Parkinson's Disease patients capacity to provide informed consent none | 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): 60.0-999.0, Dementia, Alzheimer Type Problem Behavior veterans age 60 and over with an Alzheimer's-like dementia diagnosis, documented in medical record with International Codes for Diagnosis (ICD-9) codes that all 290 diagnoses and 331.0 Mini Mental State Examination (MMSE) 24 or less evidence of pre-elopement behaviors operationalized as scoring 1 standard deviation (SD) above mean on any one of the three items that comprise the Revised Algase Wandering Scale-Community Version (RAWS-CV) eloping subscale (#16 He/she attempts to get outside; #27 He/she stands at the out door wanting to go out; #30 He/she attempts to find or go to familiar locations, even unrealistic ones) living in a non-institutional private family home or foster home independently ambulatory (with or without canes, walkers or wheelchairs to assist) living within a 60-mile radius of the James A. Haley Veterans Administration Medical Center (VAMC), Tampa, Florida living with a caregiver (CG) who is willing and able to serve as a study partner and provide informant reports, and who intends to be with the PDW for three months (allowing for being away for seven days or less during the three-month study period) living in a nursing home, group home or assisted living facility at point of entry (foster homes allowed) previous exposure to any visual exit barrier for wandering management no live-in CG bilaterally deaf or blind currently taking anti-psychotic medications current use of any visual exit barrier on any main exit doorway. CG will be allowed to use other wandering management interventions that are not specific to the exit doorways. For example, they may use a stop sign at the entrance to the kitchen, but may not use a stop sign on an experimentally monitored door | 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): 21.0-999.0, Infective Complications Post-transrectal Prostate Biopsy All subjects scheduled at Vancouver General & UBC Hospitals for a transrectal ultrasound guided prostate biopsy are eligible for this study. The indication for biopsy is made according to standard clinical reasoning and judgment, and is not affected by this study All subjects must be willing and able to sign an informed consent and to take the ciprofloxacin prophylaxis before biopsy | 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): 21.0-100.0, Parkinson's Disease Diagnosis of Parkinson's disease At least 21 years of age Levodopa treatment that will be orally initiated no more than 1 month after the screening visit for the study Unable to stand for 1 minute intervals Sensory deficits in the feet Significant cognitive impairment Unstable medical or psychiatric conditions (including hallucinations) History of dopamine receptor blocking medications (Haldol, Orap, Zyprexa) | 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): 18.0-64.0, Parkinson's Disease age 18-64 best corrected visual acuity of 20/25 or better in each eye - evidence of any form of eye disease, inability to understand and sign 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): 45.0-75.0, Parkinson Disease Hohen and Yahr´s Scale between I and III One or more years of evolution of PD Good response to levodopa (more that 30 % of change)valued in motor UPDRS An acceptable general health status Chronic psychiatric or other neurological diseases Previous polyglobulin Hematocryte, same or inferior to 50 | 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's Disease Tourette's Syndrome Tic Disorders Dystonia Movement Disorders FOR Patients will either have a well-defined diagnosis or be a diagnostic dilemma, depending upon the sub-study Age 18 or older Able to give informed consent Agree to not drink caffeine or alcohol for 48 hours before certain study sessions because both agents can modify brain activity and may confound outcome measures. FOR Age 18 or older Able to give informed consent Agree to not drink caffeine or alcohol for 48 hours before certain study sessions because both agents may modify the activity of the brain during the study FOR Have used illegal drugs within the past 6 months Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man Have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures Have a psychotic disorder, Bipolar Disorder or a current depressive episode Have another neurologic disorder than a movement disorder Have had a head injury where there was a loss of consciousness for more than a few seconds FOR Have abnormal findings on a neurological examination that we will perform Have used illegal drugs within the past 6 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): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 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, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 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): 35.0-75.0, Parkinson Disease Stable medication usage Hoehn and Yahr stage II to IV At least 1 score of 2 or more for at least 1 limb of either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS) Able to walk independently No severe cognitive impairments (Mini-Mental State Examination Chinese Cantonese version) score greater than 24 Other severe neurological, cardiopulmonary, or orthopedic disorders Having participated in a physiotherapy or rehabilitation program in previous 2 months | 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, Hypertension Angina Pectoris Hypercholesterolemia Familial Hypercholesterolemia Male or Female subjects intend to treat their cardiovascular disease who are prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets by their Physicians Subjects who have been prescribed Amlodipine /Atorvastatin (Caduet®) Combination Tablets before | 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): 18.0-70.0, Hepatic Encephalopathy Patients diagnosed as having cirrhosis of liver at the Inpatient/Outpatient Liver Clinic of Department of Hepatology, Chandigarh, will be candidates for enrollment The diagnosis of cirrhosis of liver will be based on clinical, biochemical, and ultrasonographical or liver histological data Alcohol intake during the past 6 weeks Hepatocellular carcinoma Previous transjugular intrahepatic portosystemic shunt or shunt surgery Significant comorbid illness such as heart, respiratory, or renal failure Any neurologic diseases such as Alzheimer's disease, Parkinson's disease, and nonhepatic metabolic encephalopathies Patients on psychoactive drugs, such as antidepressants or sedatives Those who restart alcohol consumption during follow-up will also be excluded | 0 |
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