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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): 30.0-999.0, Parkinson's Disease The subject has given his/her written informed consent to participate in the trial. 2. The subject presents with a diagnosis of idiopathic Parkinson's disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnosis 3. The subject is an out-patient aged 30 years or above. 4. PD subjects with a Hoehn and Yahr disease staging of II-IV (in the ON state). 5. PD subjects experiencing levodopa induced dyskinesias, specifically predictable peak-dose dyskinesia. 6. Peak-dose dyskinesia must be considered by the subject to be problematic and/or disabling. 7. Peak-dose dyskinesia must warrant medical treatment in the Investigator's opinion. 8. The subject has participated successfully in a diary-card training session. 9. In the judgment of the Investigator based on the subject's history, previous treatments, and the clinical presentation, the subject is considered as being optimally treated at screening (i.e., further adjustments of current medication will not further improve the subject's symptoms of Parkinson's disease). 10. Stable dose of PD drugs for at least 4 weeks before Screening Visit. This may levodopa dopamine agonists, c-ortho methyl transferase (COMT) inhibitors, and anticholinergics. 11. The dose of levodopa and all PD drugs used during the trial must remain unchanged throughout the trial. 12. Female subjects must be neither pregnant or breast-feeding and must lack child-bearing potential, as defined either by: 1. be either post menopausal for at least 2 years , surgically sterilised or have undergone hysterectomy, or 2. if of child bearing potential, be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive. 13. The subject shows adequate compliance with the schedule for intake of trial medication and the completion of the diaries The subject has participated in any safinamide clinical trial before. 2. The subject is experiencing exclusively diphasic, off state, myoclonic, dystonic, or akathetic dyskinesias without peak dose dyskinesia. 3. (For female subjects) The subject is pregnant or lactating. 4. Treatment with a MAO-B inhibitor within the eight weeks prior to the screening visit. 5. Treatment with amantadine in the four weeks prior to the screening visit or budipine in the eight weeks prior to the screening visit. 6. Treatment with opioids (e.g., tramadol, meperidine derivatives), serotonin norepinephrine reuptake inhibitors (SNRIs) (e.g. venlafaxine, duloxetine), tri or tetra-cyclic antidepressants, in the past 8 weeks prior to the screening visit. Dextromethorphan will be permitted if used for treating cough. 7. The subject has received neurosurgical intervention related to PD (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the trial period. 8. Current clinically significant gastro-intestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including acute gastric ulcer, hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease (COPD), and unstable Type I diabetes. Subjects with a history of gastric ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion. 9. Neoplastic disorder, which is either currently active or has been in remission for less than one year. 10. Diagnosis of HIV, or positive test for Hepatitis C antibodies, or Hepatitis B surface antigen. 11. Concomitant disease likely to interfere with trial medication (e.g. capable of altering absorption, metabolism, or elimination of the trial drug). 12. The subject has any clinically significant illness that, in the Investigator's opinion, might interfere with the subject's ability to participate in the trial. 13. Second or third-degree atrio-ventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or a significant ECG abnormality, including corrected QT interval (QTc) msec (males) or msec (females), where QTc is based on Bazett's correction method. 14. 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 15. The subject is suffering from any dementia or other psychiatric illness that prevents him/her from giving informed consent, i.e. Montreal Cognitive Assessment (MoCA) <23 points. 16. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. 17. Known hypersensitivity to the trial treatment(s), including placebo or other comparator drug(s). 18. The subject has legal incapacity or limited legal capacity. 19. The subject is participating in another clinical trial or has done so within the past 30 days 20. Treatment with a drug that has hepatotoxic potential, e.g., tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g, chemotherapy, within one year prior to the screening visit. 21. Subjects with current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past three 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, Parkinson's Disease Deglutition Disorders Voice Disorders Clinical diagnosis of Parkinson disease Complaint of dysphagia Hoehn and Yahr stage 5 Other neurological conditions Therapy for swallowing in the last 3 months Cognitive disorders Psychiatric disorders | 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): 30.0-75.0, Parkinson's Disease Subject is a man or woman between 30 and 75 years of age, inclusive, with intact oral mucosa at Screening (Visit 1) and Randomization (Visit 2). 2. Subject has a diagnosis of idiopathic Parkinson's disease defined according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis criteria. 3. Subject has been receiving a stable regimen of at least three daily administrations of levodopa (with a peripheral dopa decarboxylase inhibitor), with no dose changes for at least 4 weeks prior to Randomization (Visit 2). 4. Subject is rated at stage 2 to 4 on the Hoehn and Yahr scale. 5. If currently taking other medications (other than levodopa), subject must be on a stable regimen, defined as no dose changes for at least 1 month prior to Randomization (Visit 2). 6. Subject demonstrates the ability to comprehend the study procedures and provide informed consent. 7. Female subjects must be either postmenopausal for at least 1 year or surgically sterilized at least 3 months prior to Randomization (Visit 2). Male subjects must either be sterile or willing to use 2 approved methods of contraception when engaged in sexual intercourse with a female partner from Randomization (Visit 2) until 30 days after the last dose of study drug. 8. Subject has an upper arm circumference of not less than 24 cm and not more than 42 cm for both arms Subject participated in an investigational medication study within the 3 months prior to Randomization (Visit 2). 2. Subject has immediate family members who are site Investigators or sponsor employees. 3. Subject has a history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results. 4. Subject has impaired renal function (defined as a creatinine level of ≥ 1.5 times the upper limit of normal) at Screening (Visit 1). 5. Subject has impaired hepatic function (defined as SGOT/AST or SGPT/ALT levels ≥ 1.5 times the upper limit of normal) at Screening (Visit 1). 6. Subject has second or third-degree atrioventricular block or sick sinus syndrome, atrial fibrillation, atrial flutter, severe or unstable angina, congestive heart failure, or myocardial infarction within 3 months of the screening visit or a significant ECG abnormality, including a QRS > 110 msec, a PR interval > 230 msec, a QTc ≥ 450 msec for male subjects, or a QTc ≥ 470 msec for female subjects. 7. Subject has a history of risk factors for Torsades de Pointes, including unexplained syncope, known long QT syndrome, or a clinically significant abnormal laboratory assessment such as hypokalemia, hypercalcemia, or hypomagnesemia. Subjects with a family history of long QT syndrome or Brugada syndrome will also be excluded. 8. Subject is at immediate risk of requiring hospitalization. 9. Subject has significant tremor or dyskinesia which, in the opinion of the Investigator, might interfere with reliable assessment of continuous Holter ECG and ABPM. 10. Subject has, in the opinion of the Investigator, a clinically important abnormality on his/her physical examination, electrocardiography, vital sign measurements, or laboratory assessment. 11. Subject is being treated with a disallowed medication that cannot be discontinued prior to Randomization (Visit 2) (See Table 6). 12. Subject has a current diagnosis of substance abuse or history of alcohol or drug abuse in the past 2 years prior to Screening (Visit 1). 13. Subject has positive findings on urine drug screen at Screening (Visit 1). 14. Subject has an allergy to fipamezole or its excipients | 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 Disease Parkinson Disease (PD) Subjects A diagnosis of Parkinson disease for 2 years or less at Screening Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit, or if applicable a VMAT-2 PET scan consistent with vesicular monoamine transporter deficit Not expected to require PD medication with at least 6 months from Baseline Male or female age 30 years or older at time of PD diagnosis. Healthy Control (HC) Subjects: • Male or female age 30 years or older at Screening Parkinson Disease (PD) Subjects Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or other PD medication Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline Has taken levodopa or dopamine agonists prior to Baseline for more than a total of 60 days Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. If applicable, currently taking medications that are known to cause QT-prolongation, or are currently taking tetrabenazine (TBZ or amphetamine type medications Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia Use of investigational drugs within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10). Healthy Control (HC) Subjects Current or active neurological disorder First degree relative with idiopathic PD (parent, sibling, child) | 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): 30.0-75.0, Parkinson's Disease Subject is a man or woman between 30 and 75 years of age, inclusive, with intact oral mucosa at Screening (Visit 1) and Randomization (Visit 2). 2. Subject has a diagnosis of idiopathic Parkinson's disease defined according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis criteria. 3. Subject has been receiving a stable regimen of at least three daily administrations of levodopa (with a peripheral dopa decarboxylase inhibitor), with no dose changes for at least 4 weeks prior to Randomization (Visit 2). 4. Subject is rated at stage 2 to 4 on the Hoehn and Yahr scale. 5. If currently taking other medications (other than levodopa), subject must be on a stable regimen, defined as no dose changes for at least 1 month prior to Randomization (Visit 2). 6. Subject demonstrates the ability to comprehend the study procedures and provide informed consent. 7. Female subjects must be either postmenopausal for at least 1 year or surgically sterilized at least 3 months prior to Randomization (Visit 2). Male subjects must either be sterile or willing to use 2 approved methods of contraception when engaged in sexual intercourse with a female partner from Randomization (Visit 2) until 30 days after the last dose of study drug Subject participated in an investigational medication study within the 3 months prior to Randomization (Visit 2). 2. Subject has immediate family members who are site Investigators or sponsor employees. 3. Subject has a history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results. 4. Subject has impaired renal function (defined as a creatinine level of ≥ 1.5 times the upper limit of normal) at Screening (Visit 1). 5. Subject has impaired hepatic function (defined as SGOT/AST or SGPT/ALT levels ≥ 1.5 times the upper limit of normal) at Screening (Visit 1). 6. Subject has second or third-degree atrioventricular block or sick sinus syndrome, atrial fibrillation, atrial flutter, severe or unstable angina, congestive heart failure, or myocardial infarction within 3 months of the screening visit or a significant ECG abnormality, including a QRS > 110 msec, a PR interval > 230 msec, a QTc ≥ 450 msec for male subjects, or a QTc ≥ 470 msec for female subjects. 7. Subject is at immediate risk of requiring hospitalization. 8. Subject has, in the opinion of the Investigator, a clinically important abnormality on his/her physical examination, electrocardiography, vital sign measurements, or laboratory assessment. 9. Subject is being treated with a disallowed medication that cannot be discontinued prior to Randomization (Visit 2) (see Table 5). 10. Subject has a current diagnosis of substance abuse or history of alcohol or drug abuse in the past 2 years prior to Screening (Visit 1). 11. Subject has positive findings on urine drug screen at Screening (Visit 1). 12. Subject has an allergy to fipamezole or the excipients | 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 Patients with idiopathic Parkinson's disease suffering from motor fluctuations H&Y >2 Dementia hearing impairment | 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 or non-child bearing potential woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides? 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? 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 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 7-day 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? 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? 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? | 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, Healthy Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides? 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? 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 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 7-day 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? 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? 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? | 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): 0.0-21.0, Brain Tumors Age:Patients must be between 0 years of age when registered on this protocol Diagnosis:Patients must have pathologically confirmed low grade glioma with histologic subtypes interpreted as WHO grade I and II including juvenile pilocytic astrocytoma (JPA) pleomorphic JPA diffuse astrocytoma (fibrillary, gemistocytic, giant cell, or pleomorphic xanthoastrocytoma) low grade oligoastrocytoma low grade oligodendroglioma low grade glioma NOS Tumors of all regions of the CNS, with appropriate histology are eligible for study. However patients with tumors intrinsic to the optic nerve and involvement of the optic nerve cannot be biopsied/resected are eligible without histological confirmation. Patients with neurofibromatosis type 1(NF1) are also eligible. Patients must have demonstrated either tumor progression or recurrence by radiographic and/or clinical as defined below: 1. Patients with progressive non-resectable disease regardless of location in the brain or spine are eligible for this study. Patients with evidence of leptomeningeal dissemination are eligible for this study. Patients do not require biopsy/histologic confirmation at the time of progression or relapse. 2. Radiographic progression is defined as >40% increase in the product of the three perpendicular diameters of initial tumor relative to the initial baseline measurement length (L)x width (W) x transverse (T) (current scan) > 1.4 x L x W x T (initial scan), or the development of any new sites of disease independent of the response of the initial tumor. See section 7.1.2 for methodology for tumor measurement. 3. Post radiation changes are often seen on post-treatment imaging studies, so that classification of a patient as having progressive disease may require several serial MRI's if the child has received radiation within the preceding 12 months. 4. Tumor volume includes the entire tumor volume seen on gadolinium enhanced T1 MR imaging plus non-enhancing abnormality seen on T2 or FLAIR. 5. All tumor cysts will be included in the tumor volume 6. Clinical progression without radiographic progression includes children with optic pathway gliomas who demonstrate sustained decrease in visual fields and/or acuity in three serial vision examinations. Each of the vision examinations must be performed >2 weeks apart. 7. Children with previously negative cerebrospinal fluid (CSF) cytology who show evidence of tumor cells in fluid obtained by lumbar puncture can be designated as having progressive disease in the absence of radiographic evidence of progression. Measurable disease: Patients must have measurable disease documented by radiographic prior to enrollment. Performance Level and Life Expectancy:Patients must have a performance status of > 50% (Appendix I). Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age. Patients must have a life expectancy of ≥ 8 weeks. Prior Therapy:Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and meet time restrictions from end of prior therapy as stated below: 1. Myelosuppressive chemotherapy patients must have received the last dose of myelosuppressive therapy at least 3 weeks prior to study registration or at least 6 weeks if nitrosourea. 2. Investigational / Biological agent: Patient must have received the last dose of other investigational or biological agent >7 days prior to study registration 3. XRT: Patients must be ≥ 8 weeks since the completion of radiation therapy. 4. Study specific limitations on prior therapy: There is no limit on the number of prior treatment regimens or received doses of radiation therapy. 5. Growth factor(s): Must not have received any hematopoetic growth factors within 7 days of study entry or 21 days for neulasta. 6. Prior Surgery: Must be ≥ 2 weeks from prior surgery. 7. Steroids: Must be on a stable steroid dose for 7 days prior to study entry. Organ Function Requirements:All patients must have adequate organ function defined as: Hematologic Function: 1. Hemoglobin: > 8.0 gm/dl (may transfuse PRBCs) 2. ANC: > 750/mm3 Must be at least 7days after last dose of growth factor 3. Platelet Count: > 50,000 (transfusion independent; ≥ 7 days from last transfusion) Renal Function: Serum creatinine ≤ 2 x normal for age (see below) or Creatinine clearance/GFR > 60 cc/min/1.73 m2 [Urine Creatinine (mg/dL)][Volume collected (ml)]/[Serum Creatinine 9mg/dL)][Hours x 60] Age (years) Maximum Serum Creatinine (mg/dL) ≤ 5 0.8 > 5 & ≤ 10 1.0 > 10 & ≤ 15 1.2 > 15 1.5 Liver Function: 1. Total bilirubin < 1.5 x ULN for age, AND 2. SGPT (ALT) < 2.5x ULN 3. SGOT (AST) < 2.5x ULN Pulmonary Function: No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry ≥ 94% if there is clinical indication for determination. Coagulation Function: Normal PT and PTT at enrollment per institutional range Reproductive Function:Due to potential teratogenic effects of (poly-ICLC), negative serum beta-HCG in females, and use of effective contraception in males and females of childbearing potential, IS Pregnant or lactating females. Women of childbearing age will agree to use contraception during the protocol Patients receiving other experimental immunotherapy Patients may not have fever (38.50C) within 7 days of enrollment No concurrent XRT or chemotherapy is allowed Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of 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): 20.0-999.0, Hypertension Hypercholesterolemia Angina Pectoris Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3) (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0) (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2 (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2 Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3) (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and who meet the following criteria; Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2 (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2 Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure < 140mmHg and diastolic blood pressure < 90 mmHg Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated | 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 Disease Subject has signed an informed consent. 2. Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease. 3. Subject is a candidate for surgery. 4. Subject is 18 to 80 years of age. 5. Subject has a history of improvement of Parkinson's symptoms as a direct result of administering L-dopa to the subject with at least a 25% improvement in UPDRS motor score or subject has been diagnosed with tremor-dominant Parkinson's disease. 6. Subject should be stable on anti-Parkinson's disease medication for at least one month prior to study enrollment Subject has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study. 2. Subject has non-treated clinically significant depression or any other significant psychiatric co-morbidities. 3. Subject has any condition requiring repeated MRI scans; 4. Subject is on anticoagulant medications and is unable to interrupt for time of procedure. 5. Subject has dementia that interferes with their ability to co-operate or comply with study requirements or comprehend the Informed Consent as determined by the investigator. 6. Subject abuses drugs or alcohol. 7. Subject has a history of seizure (Neurosurgeon must approve) 8. Subject has confirmation of diagnosis of a terminal illness associated with survival <12 months. 9. Female that is lactating or of childbearing potential with positive urine pregnancy test or not using adequate birth control. 10. Subject has participated in a drug, device or biological trial within the preceding 30 days | 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, Migraine Age 18 years or older Have had migraines for at least 3 years Have between 4 and 15 migraines a month Able to speak and read the English language Women who are pregnant or nursing, or planning on becoming pregnant in the next 10 months Individuals who have a had a heart attack, stroke, peripheral artery disease, atherosclerotic aortic disease, carotid artery disease, or diabetes individuals at high risk for cardiovascular 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): 30.0-999.0, Parkinson's Disease Parkinsonism Patients with Parkinsonism Severe dementia | 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's Disease Clinical diagnosis of Parkinson's Disease Hoehn & Yahr stages 1-3.5 Cardiovascular contraindications to aerobic exercise Reliance on walker or wheelchair Psychiatric conditions DBS or other surgeries Any other conditions that would interfere with exercise | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-70.0, Normal Physiology fMRI Participants will be 272 healthy volunteers drawn from the population in the NIH clinical research volunteer program. Healthy Right-handed Ages 18-70 (inclusive) Have completed high school or college in an English speaking country. All participants must have had a neurological examination by a NINDS physician within the last two years. All participants in the fMRI experiments must also have had a clinical MRI within the last year Individuals with conditions that could pose a risk relating to the safety of the MRI procedure will be excluded from the protocol such as: Those with ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body. Those with an implanted cardiac pacemaker or auto-defibrillator. Those with an insulin pump. Those with an irremovable body piercing. Pregnant women Individuals with conditions that could pose a risk relating to the safety of the TMS procedure will be excluded from the protocol such as Those with significant abnormality on neurological examination Those with metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body Those with an implanted cardiac pacemaker or auto-defibrillator Those with an insulin pump Pregnant women Individuals with conditions that could compromise our interpretation of the TBS and fMRI results will be excluded such as Those with significant abnormality on neurological examination Those who have a significant psychiatric illness or have a history of psychiatric illness Those using medication affecting the DA system, such as phenothiazine antihistamines (promethazine), antiemetics or decongestants within the last month | 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): 35.0-85.0, Parkinson's Disease Parkinsonism Able to give informed consent prior to study 2. Male or Female with Diagnostic of Parkinson's disease or neurodegenerative disorder undergoing a neurosurgical procedure 3. Age 35 to 85 years old 4. Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease 5. Hoehn and Yahr Stage III or IV 6. Parkinson's disease observed in the absence of Oculomotor palsy Cerebellar sign Orthostatic hypotension (drop greater than 20mmHg in mean pressure) Pyramidal sign Amyotrophy 7. Good general health or stable medical condition well controlled, without contraindications to anesthesia Patients with severe dementia and brain atrophy on MRI 2. Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV 3. Patients older than 85 or younger than 35 4. Patients who withhold informed consent 5. Patients with a history of alcohol or drug abuse 6. Sexually active women of childbearing potential without adequate form of birth control 7. Evidence of abnormal coagulation or anticoagulant therapy 8. Pregnancy or lactation 9. History of seizure disorders or current use of antiepileptic medication 10. Severe cognitive impairment 11. Clinically significant laboratory abnormality | 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): 18.0-85.0, Primary Hypercholesterolemia Mixed Dyslipidemia Has a history of primary hypercholesterolemia or mixed dyslipidemia and meets LDL-C and triglyceride criteria Is high risk coronary heart disease (CHD) and has LDL-C ≤190 mg/dL (≤4.91 mmol/L) Is not high risk CHD and has LDL-C ≤240 mg/dL (≤6.21 mmol/L) Is pregnant or breast-feeding, or expecting to conceive or donate eggs or sperm during the study Has a history of malignancy within ≤5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer Consumes more than 3 alcoholic drinks per day (14 per week) Is a high risk CHD patient on lipid modifying therapy (LMT) Is on any LMT with equivalent or greater LDL-C-lowering efficacy than simvastatin 40 mg Has Type 1 or Type 2 diabetes mellitus that is poorly controlled, or on statin therapy Currently engages in vigorous exercise or is on an aggressive diet regimen Has uncontrolled endocrine or metabolic disease, uncontrolled gout, kidney or hepatic disease, heart failure, recent peptic ulcer disease, hypersensitivity or allergic reaction to niacin or simvastatin, recent heart attack, stroke or heart surgery Is human immunodeficiency virus (HIV) positive Has taken niacin >50 mg/day, bile-acid sequestrants, 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase inhibitors, ezetimibe, Cholestin™ [red yeast rice] and other red yeast products within 6 weeks, or fibrates within 8 weeks of randomization visit (Visit 3). Note: Fish oils, phytosterol margarines and other non-prescribed therapies are allowed provided participant has been on a stable dose for 6 weeks prior to Visit 2 and agrees to remain on this dose for the duration of the study | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 40.0-90.0, Parkinson Disease Subjects will be diagnosed with Parkinson Disease (PD) by the UK Brain Bank criteria Subjects will have to be at least stage 2 on the Hoehn and Yahr staging system of PD and have a history of at least 1 fall or near fall in the last 6 months Subjects must have a stable medication regimen All subjects will be over the age of 40 in an attempt to inherited forms of parkinsonism Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG are within normal limits (results obtained from primary care physician and dated within the past 6 months or obtained at screening visit) Hoehn and Yahr stage V subjects Subjects with a history of major psychiatric disorder, deep brain stimulation surgery, recent cerebral trauma, cardiac arrhythmia, or renal insufficiency A cardiovascular procedure in the last 5 years (eg, percutaneous transluminal coronary angioplasty) or have cardiovascular instability (including myocardial infarction or unstable angina). Other cardiovascular exclusions uncontrolled hypertension, significant neurological sequelae of cerebrovascular disease, peripheral vascular disease with prior amputation, or severe congestive heart failure (New York Heart Association class III or IV) Concurrent treatment with any MAOIs, bupropion (Wellbutrin), or nicotine patches Dementia or other psychiatric illness that prevents the patient from giving informed consent (Folstein Mini Mental Status Exam score less than 25) Concurrent treatment with trihexyphenidyl (Artane) or benztropine mesylate (Cogentin) Significant degree of dysphagia, by history Legal incapacity or limited legal capacity Presence of severe renal disease (BUN 50% greater than normal or creatinine clearance <60 mL/min) or hepatic disease Abnormal creatine kinase and/or platelet count in the past 6 months (as determined by lab reports obtained from primary care physicians or conducted at baseline) | 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 Subjects enrolled in this study must meet the following 1. Subject has signed an informed consent. 2. Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease. 3. Subject is a candidate for surgery. 4. Subject is 18 to 80 years of age. 5. Subject has a history of improvement of Parkinson's symptoms as a direct result of administering l-dopa to the subject with at least a 25% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor score or subject has been diagnosed with tremor-dominant Parkinson's disease. 6. Subject should be stable on anti-Parkinson's disease medication for at least one month prior to study enrollment Subjects will be excluded from the study if they meet any of the following 1. Subject has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study. 2. Subject has non-treated clinically significant depression or any other significant psychiatric co-morbidities. 3. Subject has any condition requiring repeated MRI scans; 4. Subject has any condition requiring diathermy; 5. Subject is on anticoagulant medications and is unable to interrupt for time of procedure. 6. Subject has a history of cranial surgery. 7. Subject has dementia that interferes with their ability to co-operate or comply with study requirements or comprehend the Informed Consent as determined by the investigator. 8. Subject abuses drugs or alcohol. 9. Subject has a history of seizure 10. Subject has confirmation of diagnosis of a terminal illness associated with survival <12 months. 11. Female that is lactating or of childbearing potential with positive urine pregnancy test or not using adequate birth control. 12. Subject has participated in a drug, device or biological trial within the preceding 30 days | 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): 18.0-65.0, HIV Associated Neurocognitive Disorder HIV+ based on ELISA and confirmed by either Western blot or plasma HIV RNA capable of providing informed consent age range: 18-65 years presence of neuropsychological testing impairment as defined by performance at least 1.0 standard deviation below age-matched and education-matched controls on three or more independent neuropsychological tests at the screening visit, or performance at least 2.0 standard deviations below age-matched and education-matched controls on one independent neuropsychological test and at least 1.0 standard deviation below age-matched and education-matched controls on a second independent neuropsychological test at the screening visit a stable HAART regimen for 3 months with no plans to change the antiretroviral regimen over the study period (confirmed by discussion with a patient's primary provider) the following lab values within 2 weeks prior to entry: hemoglobin > 8.9 g/dl, absolute neutrophil count > 500 cells/mm3, platelet count > 50,000 cells/mm3, ALT < 2.5 X upper limit of normal, alkaline phosphatase < 3 X upper limit of normal, serum creatinine >= 2 X upper limit of normal a negative serum or urine beta-HCG pregnancy test for all women of reproductive potential (have not reached menopause or undergone hysterectomy, oophorectomy, or tubal ligation) neurological examination by a physician revealing no contraindication to a lumbar puncture. If an examination suggests a possible space-occupying brain mass lesion, neuroimaging with CT or MRI must confirm the absence of a mass lesion current or past opportunistic CNS infection (fungal or non-fungal) at study entry current systemic fungal infection current or past use of fluconazole within 30 days of the screening visit history or current clinical evidence of schizophrenia history of chronic neurological disorder such as multiple sclerosis or uncontrolled epilepsy active symptomatic AIDS defining opportunistic infection within 30 days prior to study entry history of abnormal medical illness or current severe affective disorder (e.g., depression with suicidal intention) which in the opinion of the investigators would constitute a safety risk for patients or interfere with the ability of a patient to complete the study treatment with anticoagulants including coumadin, heparin, or low molecular weight heparin which would be a contraindication for the lumbar puncture HIV+ individuals with moderate or severe confounding illnesses prior use of SSRI's within 1 month of screening | 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 Clinical diagnosis of Parkinson's disease Inability to follow the required clinical instruction Subjects with cognitive impairments that would prohibit them from properly using the Kinesia HomeView system Subjects without the cognitive ability to respond to researchers and let them know when any parameters of the study may become uncomfortable Subjects found on examination by our clinicians to have any physical limitations which would be counter productive to participation in this study | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 40.0-80.0, Parkinson's Disease Diagnosis of Idiopathic Parkinson's disease Outside of the age range | 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, Alzheimer's Disease Amyotrophic Lateral Sclerosis (ALS) Multiple Sclerosis (MS) Parkinson's Disease Stroke Traumatic Brain Injury All participants must have underlying neurologic conditions known to be risk factors of PBA: Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's Disease, Stroke, and Traumatic Brain Injury The population for this study will be 18 years and over | 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): 20.0-70.0, Shoulder Arthroscopy subacromial impingement disease scheduled for an elective arthroscopic surgery liver disease renal impairment psychiatric disorder alcohol abuse obesity (a body mass index of > 35 kg/m2) allergies to the drugs used 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): 32.0-87.0, Amyotrophic Lateral Sclerosis Alzheimer Disease Parkinson's Disease Clinical diagnosis of Alzheimer's Disease, Parkinson's disease and amyotrophic lateral sclerosis | 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 Idiopathic Parkinson's disease Treatment with carbidopa/levodopa Motor fluctuations Dementia Hallucinations Age greater than 85 | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Parkinson Disease Any Subject Male or female, age: >18 years Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Sufficiently fluent in English that they are able to understand written and spoken instructions in the opinion of the investigator Subjects with previous or current drug or alcohol dependence within 2 years of screening Subjects who are unable to tolerate study procedures including MRI, or who are unable to perform the study procedures (e.g. due to severe musculoskeletal disease) Use of other prescription or non-prescription centrally acting drugs, including herbal (eg khat) and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the procedures of Day 1, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety Pregnant females as determined by positive serum or urine hCG test at screening Lactating females Unwillingness or inability to follow the procedures outlined in the protocol Subject is mentally or legally incapacitated Subject meets any of the MRI Subject is left-handed. PKD Patients Diagnosis of Parkinson's disease according to the following derived from the UKPD Society brain bank diagnostic for PD (Hughes AJ et al., 1992): a) Bradykinesia must be present b) At least one of the following: muscular rigidity Resting tremor postural instability not caused by primary visual, vestibular, cerebellar or proprioceptive dysfunction c) Supportive prospective positive for Parkinson's Disease (three of the following required for definite diagnosis): Resting tremor unilateral onset progressive disorder in first 5 years following onset, persistent asymmetry affecting side on which symptoms first appeared excellent response (70-100%) to levodopa in the clinical judgement of the investigator, based on the medical notes or during standard care d) None of the following clinical features which suggest a diagnosis other than Parkinson's disease: History of repeated strokes with stepwise symptom progression History of repeated head injury History of definite encephalitis Neuroleptic treatment at symptom onset Sustained remission Strictly unilateral features after 3 years Supranuclear gaze palsy Cerebellar signs In first five years following onset, early severe autonomic involvement such as orthostatic hypotension, impotence and bladder dysfunction Early (within 2 years on symptom onset) severe dementia with disturbed memory, language, praxis Babinski sign CT/MRI scan evidence of tumour or hydrocephalus Negative response to 1000mg of levodopa daily in divided doses. 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) exposure | 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 years and older, both males and females, all races and all ethnicities Idiopathic Parkinson's disease diagnosed using United Kingdom Parkinson's Disease Society brain bank diagnostic Mild to moderate disease severity (Stage 2 to 3 on the Modified Hoehn and Yahr scale) Stable medication regimen for a minimum of 1 month before testing Ability to ambulate independently without using a walking aid Ability to give informed consent Prior enrollment in a dancing class during the last 6 months Presence of another neurological or medical disorder likely to affect gait or causing frequent falls (rheumatologic/orthopedic disease, stroke, myelopathy, severe neuropathy) Significant cognitive decline (MMSE ≤ 24) Visual deficit Hearing deficit that impairs music perception Psychotic symptoms Symptomatic heart disease Depression associated with suicidal ideation | 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, Cerebrovascular Accident Stroke, Acute Cerebral Stroke All patients of both gender from 18 years of age with a diagnosis of Fabry disease with the mutation N215S Written informed consent from patient Patients without a diagnosis of Fabry disease No written informed consent | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 25.0-65.0, Obesity Nonalcoholic Fatty Liver Disease Male 65 years Obesity (BMI > 28 kg/m2, waist/hip ratio > 0,95) Have nonalcoholic fatty liver disease (NAFLD)(intervention group) or do not have NAFLD (control group) May have hypertension and/or hypercholesterolemia Written informed consent Any other disease than NAFLD (e.g. diabetes, thyroid or parathyroid disease, heart, liver or kidney disease) Present and previous malignancy Alcohol dependency (more than 21 units of alcohol per week) History of smoking Participation in studies with radioactive isotopes within the last six months Hemoglobin under normal range regarding to sex (under 8.3 mmol/l for men) | 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 (exercise arm) Idiopathic Parkinson's disease A stable condition the last 6 months Hoehn and Yahr 2 (Deep Brain Stimulation arm) Patients referred to Deep Brain Stimulation Cardiovascular disease Conditions that contraindicate physical exercise or the examination | 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): 45.0-999.0, Parkinson's Disease Essential Tremor Parkinson´s disease patients according to UK Parkinson´s Disease Brain Bank Essential Tremor Patients according to Movement Disorder´s diagnosis consensus criteria Healthy Volunteers: paired with PD patients by age and gender Contraindication to MRI Claustrophobia Serious structural brain anomalies Condition or situation in which, in the opinion of the investigator put the patient at significant risk, which can confound the results, or substantially interfere with the individual's participation in the study | 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): 18.0-80.0, Cardiovascular Diseases FOR Lack of known cardiovascular disease (coronary acute syndrome, stable ischemic cardiopathy, peripheric arteriopathy and cerebrovascular diseases) Age between 18 and 80 years The above and diabetes mellitus or at least two of the following risk factors: 1. Active smoking (10 cigarettes or more per day). 2. Arterial hypertension (>= 140/90 mmHg). 3. Hypercholesterolemia (LDL-cholesterol >130 mg/dL and/or HDL-cholesterol < 45 mg/dL in women and 50 mg/dL in men). 4. Obesity (BMI > 30 kg/m2) FOR Stable patients who coronary syndrome, cerebrovascular accident or peripheric arteriopathy event occurred at least 6 months or more before the recruitment in the study. In addition: 1. Age between 18 and 80 years. 2. Ejection fraction of left ventricle >=45%. 3. Functional status I or II according to the New York Heart Association. 4. Clinic stability in the recruitment (no symptoms of thoracic pain during the last month). 5. Lack of residual lesions without vascularization in those patients with catheterism FOR AND Patients who do not satisfy and: 1. Known allergy to grapes 2. Pregnancy or lactation 3. Intake of nutraceuticals | 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): 22.0-999.0, Parkinson Disease i. Greater than 22 years of age ii. Successful bilateral STN DBS implants for at least 1 year iii. At least 30% improvement in the motor UPDRS following STN therapy, by history and record review iv. Improved UPDRS and self assessment questionnaire following STN DBS by at least 20%, by history and record review. v. Good STN DBS placement assessed with imaging (CT scan, MRI or fused CT-MRI imaging) vii. Persistent gait disturbance as ascertained by abnormal performance on the time-up-and-go test compared to age-matched controls as well as preoperative evaluation with posturography and quantitative gait assessment (values compared to normal age-matched controls) at least 30% difference from age-matched controls on either measure. vii. Persistent speech and swallowing problems as measured by a minimum score of I in items 5 and 7 of the UPDRS viii. Evaluation by an independent movement disorders specialist who will confirm gait disturbance in the presence of STN stimulation i. Pregnant or nursing women ii. Cognitively impaired subjects as determined by pre-operative neuropsychology evaluation, including Mattis Dementia Rating Scale (DRS). Patients scoring below 70 on the Mattis DRS will be excluded. iii. Depressed subjects as determined by the neuropsychology screen, including Beck Depression Inventory. Patients scoring above 20 on the Beck inventory will be excluded. iv. Patients with uncontrolled co-existing medical conditions: uncontrolled systemic hypertension with values above 170/100; heart disease needing intervention; respiratory disease needing intervention; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician. v. Patients with metal objects in their body that are not MRI compatible, excluding the previous STN DBS hardware vi. Patients who have a history of seizures, require repeated magnetic resonance imaging (MRI) scans or have had a cranial neurosurgical procedure since receiving an STN implant | 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): 45.0-999.0, Obstructive Sleep Apnea Patients & Ethics Committee approval and informed consent will be obtained. We plan to study patients at moderate-to-high risk for postoperative vascular complications because our data from other trials suggested that the incidence of OSA in these patients is higher than the general population. We will patients who are: 1. adult males and females, age ≥ 45 years, undergoing elective non-cardiac surgery that is expected to require a postoperative hospital stay of more than 3 nights, and 2. at increased risk for postoperative vascular events, defined as having at least one of the following risk factors (a) high-risk surgery (intra-peritoneal, intra-thoracic or supra-inguinal vascular surgery); (b) history of ischemic heart disease; (c) history of congestive heart failure; (d) history of cerebrovascular disease (d) diabetes requiring insulin therapy (e) serum creatinine > 175 µmol/L Patients will be excluded if: 1. they have a previous diagnosis of OSA or any sleep-related breathing disorder and on treatment 2. they are unwilling or physically unavailable for PSG on any night before surgery; 3. their surgery included tonsillectomy, septoplasty, uvuloplasty, pharyngoplasty, tracheostomy, or prolonged (> 48 hrs) postoperative mechanical ventilation of the lungs is anticipated. It is because these procedures/interventions are likely to cure or at least modify the severity of OSA | 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): 18.0-65.0, Hip Osteoarthritis Osteoarthritis diagnosed by MRI End stage osteoarthritis candidate for total hip replacement Pregnancy or lactating Positive tests for HIV, HCV, HBV Active neurologic disorder End organ damage Uncontrolled endocrine disorder | 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, Stress Health Knowledge, Attitudes, Practice Being a parent of a child that 1. is diagnosed with a first occurrence of a malignancy that is curatively treated 2. was diagnosed two months ago Able to talk, read and write Swedish enough to be able to participate without an interpreter Have access to a computer and an internet connection | 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 or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? 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 week prior to dosing) or has she 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? Does the individual have a history or allergy or hypersensitivity to desloratadine, milk or eggs? 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 disease 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 history (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-I, 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 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? | 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 or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? 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 week prior to dosing) or has she 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? Does the individual have a history or allergy or hypersensitivity to desloratadine? 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 disease 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 history (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-I, 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 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? | 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): 40.0-80.0, Parkinson Disease Clinical diagnosis of primary Parkinson's disease In a Hoehn and Yahr stage less than stage III Disease duration is less than 5 years Not likely to require dopaminergic therapy within 6 months Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl) Duration of previous use of medications for PD that exceeds 90 days Expected to require dopaminergic therapy in the next 6 months Poorly controlled or unstable cardiovascular disease Uncontrolled hypertension Hypo or hyperthyroidism, abnormal liver function, abnormal renal function Mild cognitive impairment (Montreal Cognitive Assessment score<26/30) Depression that precludes ability to exercise (Beck depression score>13) Disorders that interfere with ability to perform endurance exercises | 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 or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? 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 week prior to dosing) or has she 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? Does the individual have a history or allergy or hypersensitivity to desloratadine or pseudoephedrine, milk or eggs? 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 disease 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 history (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-I, 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 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? | 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): 40.0-85.0, Parkinson's Disease Mild Cognitive Impairment Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel. 2. Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable). 3. Participants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel Active suicide ideation. 2. Weighing less than 100 lbs (45 kgs). 3. History of Deep Brain Stimulation surgery. 4. Diagnosis of Dementia 5. Taking certain types of medications may be an this will be reviewed with all potential participants. 6. Females that are pregnant, planning to become pregnant, or are breastfeeding will not be included in the study. Females of childbearing potential will need to verify that they are not pregnant by a negative urine pregnancy test | 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, Advanced Idiopathic Parkinson's Disease Advanced Parkinson's disease (ie, takes Levodopa (L-DOPA)) Hoehn and Yahr stage score of 2 to 4 Subject has sleep-maintenance insomnia Significant skin disease that would make transdermal drug use inappropriate Subject received therapy with controlled-release Levodopa (L-DOPA), entacapone or Stalevo® within 28 days prior to the Baseline Visit or has received therapy with Tolcapone Atypical Parkinsonian syndromes Previous diagnosis of Narcolepsy, Sleep Apnoea Syndrome, significant Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD), moderate to severe Restless Legs Syndrome (RLS) or Periodic Limb Movement Disorder | 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, Urinary Incontinence Nocturia Clinical diagnosis of Parkinson's disease determined by a board-certified neurologist with specialty training in movement disorders ≥ 4 weekly episodes of UI and at least one episode per week associated with feelings of urgency, where urgency is defined as the complaint of a sudden compelling desire to void which is difficult to defer Willingness to attend clinic visits Willingness to keep 7-day bladder diaries throughout the study period Significant cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of < 18 Inability to produce an interpretable 7-day bladder diary at baseline Previous intensive PFME training Clinically significant depression as measured by a Geriatric Depression Scale-Short Form score ≥ 10 which could affect motivation to fully engage in the intervention Use of an indwelling urinary catheter Bladder outlet obstruction defined as having been prescribed in-and-out catheterization in the past 12 months, having a post-void residual urine volume by bladder ultrasound of ≥ 200 mL or a peak voiding flow rate of ≤ 4 mL/min on a void ≥ 125 mL in volume Severe uterine prolapse past the vaginal introitus Poorly controlled diabetes defined by a hemoglobin A1c (HgbA1c) of >8.0% Chronic renal failure and on hemodialysis Poorly controlled congestive heart failure or poorly controlled chronic obstructive pulmonary disease on physical exam | 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 Idiopathic Parkinson's disease, defined by the UK Brain Bank with a Hoehn and Yahr score of 2 to 4 Treated with levodopa for at least a year and on a stable antiparkinsonian regimen for at least one month Abnormal computerized dynamic posturography (CDP) on screening defined as a composite score below 65 (range 1-100) Dementia defined by MMSE less than 27 Other medical conditions other than PD affecting balance or gait as determined by the investigators Unable to stand unassisted for 30 minutes Current use of an acetylcholinesterase inhibitors or drugs with known anticholinergic properties Medical or psychiatric co-morbidities that may interfere with compliance or might place subject in danger as determined by the investigators | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.0-999.0, Parkinson Disease Clinical diagnosis of Parkinson Disease Patients with a limitation in the shoulder range of motion necessary to perform pointing movements | 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): 19.0-85.0, Movement Disorders (Incl Parkinsonism) Tremor Familial Essential, 1 REM Sleep Behavior Disorder Healthy Control • Age 35-85 Parkinson Disease (PD) Age 35-85 Diagnosis of clinically definite PD made by a movement disorders specialist, with evidence of the following features Presence of bradykinesia and 1 or both of the following: 1. Rest tremor 2. Rigidity Asymmetric Onset Progressive motor symptoms Levodopa responsive Duration at least 1 but not more than 10 years Hoehn and Yahr Stage 1-2 Progressive Supranuclear Palsy (PSP) Age 40-85 Diagnosis of clinically definite PSP, with the following features Gradually progressive disorder Onset after age 39 Supranuclear palsy* and postural instability with falls in the first year of disease onset* Healthy Control Pregnancy First-degree blood relative affected by PD Neurodegenerative disease History of repeated head injury, encephalitis, brain surgery, stroke, dementia, neuroleptic exposure, or serious medical illness that may interfere with participation. Parkinson Disease (PD) Any that would a healthy control patient Atypical features indicative of a Parkinson-Plus disorder Progressive Supranuclear Palsy (PSP) Any that would a healthy control patient | 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): 40.0-999.0, Parkinson's Disease Primary Parkinsonism Lewy Body Parkinson's Disease Males or females ≥ 40 years of age Presenting (within the last 3 months) for an initial evaluation to a movement disorders specialist with signs or symptoms suggestive of a movement disorder The subject's signs or symptoms were previously evaluated by a physician who was not a movement disorders specialist during the previous six months Absence of an established clinical movement disorder diagnosis Symptoms mild in intensity, this includes Hoehn & Yahr ≤ 2 (Exceptions are allowed for subjects who meet for Hoehn & Yahr stage 3 due to early onset of postural instability and/or gait impairment out of proportion to his/her other Parkinson signs and symptoms) Montreal Cognitive Assessment (MoCA) score ≥ 22 Can tolerate imaging visit procedures; and Provide written informed consent prior to study entry Have been referred to the movement disorders clinic primarily for the purpose of disease management (no diagnostic uncertainty exists on the part of the non-specialist or referring physician) Have a previous movement disorder diagnosis given by a movement disorders specialist prior to the time of enrollment Have received a total of more than 90 days treatment with dopaminergic medications, including direct dopamine agonists or precursors (levodopa) or have received a total of more than 180 days treatment with MAO-B inhibitors, amantadine, anticholinergics or primidone or beta-blockers prescribed for treatment of tremor or signs of parkinsonism Have had a sustained and clinically meaningful response to anti-parkinsonian medications Are currently taking or have taken MAO-B inhibitors in the past 4 weeks Have a known CNS structural lesion such as stroke or tumor that likely accounts for their symptoms Have clinically meaningful cognitive impairment or dementia (mild cognitive problems as might be expected in the earliest stages of PD are not exclusionary) Have current clinically significant cardiovascular disease or clinically important abnormalities on screening ECG (including but not limited to QTc > 450 msec) Are currently taking medications that are known to cause QT-prolongation Are currently taking medications with narrow therapeutic windows (e.g. warfarin or other anticoagulant therapies) | 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 Diagnosis of idiopathic Parkinson's disease according to the UK Queen Square Brain Bank Hoehn & Yahr disease stages I-II Age between 30 and 75 years Having insufficient physical activity according to the ACSM guideline for adults, 50-64 years old with a chronic condition Untreated with anti-parkinsonian medication or receiving medication, for less than two years, medication-responsive without fluctuations Unclear diagnosis with Red Flags Advanced problems in cognitive functioning: Mini Mental State Examination (MMSE)19 score < 24 Serious co-morbidity: neurological or orthopedic disorder that severely affects movement; known by specialist or medical practitioner Pulmonary diseases; known by specialist or medical practitioner Stroke High risk of cardiovascular complications Hypertension (systole >150 and diastole > 100) Diabetes Mellitus; known by specialist or medical practitioner Cardiac valve defect (especially aortic valve stenosis); known by specialist or medical practitioner Cardiac rhythm disorder; known by specialist or medical practitioner | 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): 30.0-75.0, Parkinson's Disease Male or female of non-childbearing potential (by reason of surgery or postmenopausal) Aged between 30 and 75 years, inclusive A diagnosis of PD according to the UK PDS Brain Bank diagnostic (bradykinesia and at least one of the following: muscular rigidity, rest tremor and postural instability) Predictable signs of end-of-dose deterioration despite "optimal" levodopa/carbidopa or levodopa/benserazide therapy Been treated with a stable regimen of 3 to 8 doses of standard release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide per day within at least 1 week prior to randomisation Modified Hoehn and Yahr stage of less than 5 in the off-state Mean duration of OFF stage ≥ 1.5 h during waking hours (based on historical information) Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or tolcapone) in stable doses for at least 4 weeks prior to randomisation Results of clinical laboratory tests acceptable by the investigator (not clinically significant for the well-being of the subject or for the purpose of the study) Able and willing to give written informed consent Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome) Treated with levodopa/carbidopa or levodopa/benserazide in a 10:1 ratio, or with levodopa/carbidopa in a controlled-release formulation Treated with entacapone, tolcapone, neuroleptics, antidepressants (except serotonin-specific reuptake inhibitors or imipramines [desipramine, imipramine, clomipramine and amitriptyline]), monoamine oxidase inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day) or antiemetics (except domperidone) within 4 weeks prior to randomisation Treated with apomorphine within 7 days prior to randomisation Treated with any investigational product within 2 months prior to randomisation (or within 5 half-lives, whichever is longer) A psychiatric or any medical condition that might place him/her at increased risk or interfere with assessments Known hypersensitivity to any of the ingredients of the investigational products A history of abuse of alcohol, drugs or medications within the last 2 years A clinically relevant ECG abnormality A history or current evidence of heart disease, including but not limited to myocardial infarction, angina, congestive heart failure and cardiac arrhythmia | 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 Patients will be eligible for if they have a diagnosis of idiopathic PD The subjects must speak either English or French sufficiently to fill out questionnaires and understand the instructions for dance classes (classes will be bilingual) Patients who cannot stand for at least 30 min and walk for ≥3 m without an assistive device. 2. Individuals with Hoehn and Yahr stage IV V (severe and nonambulatory) 3. Dementia, defined according to PD dementia as MMSE< 26/30 and ADL impairment secondary to cognitive loss, or inability to understand consent process60 4. Serious hearing and vision problems that could affect the participation in dance classes. 5. Change to dopaminergic therapy over the preceding three months, or changes to antiparkinsonian medication are anticipated during the study protocol 6. Serious medical conditions, including cardiac disease or evidence of musculoskeletal problem which precludes dancing or can be worsened by exercise 7. History of frequent falls, with more than 3 falls in the last 12 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): 65.0-85.0, Parkinson´s Disease Patients with Parkinson´s disease both gender on stages 1 and 2,5 of Hoehn e Yahr depression cognitive impairment deficits of visual acuity Score on Berg Balance Scale under 46 | 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): 30.0-99.0, Parkinson's Disease Parkinsonism Parkinsonian patients with Freezing of Gait or Gait hesitation Must have evidence of bradykinesia ambulating (stride reduction or reduced arm swing) Must have a constant caregiver No cardiopulmonary contraindications to ambulation, e.g., unstable angina pectoris Severe arthritis Cerebellar or sensory ataxia Recent knee or hip surgery | 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): 10.0-12.0, Child Healthy and physically active (as determined by medical and activity questionnaire) 12 years of age Within approximately 2 years of estimated age of peak height velocity (PHV) Minimum aerobic fitness of 35 ml/kg/min as assessed by the McMaster All-out Progressive Continuous Cycling Protocol Having obtained his/her informed assent Having obtained his/her legal representative's informed consent Post-pubertal Taking any medication Smoker Undergoing medical treatment or investigations Body mass index > 24 Suffer from chronic diseases (with regular intake of drugs, medical history) Vegetarians Vaccination in the last 4 months Any know food allergies or intolerance Pregnancy | 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, HIV Dementia Men and women 18 years of age or older and less than 65 years of age. Able to read and understand English. HIV infected on stable ART regimen for 5 months or greater, and not likely to change regimen for the duration of the study. Significant dementia but able to give consent (International HIV Dementia Scale score <10). Significant cognitive slowing on screening, defined as 1 SD below normal (t-score >60) on the Conner's CPT-II reaction time test. Beck Depression Inventory score <16. Documented HIV-1 RNA PCR <50 copies/mL and documented CD4 count >200 within 3 months of entry visit. Baseline CBC and chemistry panel Grade 1 or normal. For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within 24 months prior to study entry), or women who have not undergone surgical sterilization, specifically hysterectomy or bilateral oophorectomy or tubal ligation) will require a negative serum or urine pregnancy test within 48 hours prior to entry. NOTE: Subject reported history is considered acceptable documentation of hysterectomy, bilateral oophorectomy, tubal ligation, tubal micro-inserts, menopause, and vasectomy/azoospermia. All subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable methods of contraception, (condoms, without a spermicidal agent; a diaphragm or cervical cap without spermicide; an IUD; or hormone-based contraceptive), for 2 weeks before study treatment, while receiving study treatment, and for 6 weeks after receiving study treatment. Ability and willingness of subject to provide informed consent Inability to give informed consent. No proxy consent allowed. Uncontrolled hypertension (SBP >140 and DBP >90 at screening and baseline). Untreated hypogonadism, hypothyroidism or hyperthyroidism. Initiation of antidepressants, thyroid medication or anabolic steroids within 6 weeks of screening visit. Pregnancy or breast feeding. Clinically significant EKG abnormalities at screening. History of coronary artery disease, atherosclerotic disease, left ventricular hypertrophy, cardiomegaly, syncope, congestive heart failure, myocardial infarction, pacemaker, clinically significant arrhythmia, angina, history of treatment for arrhythmia. Brain related opportunistic infections, stroke, intracranial lesions/disease, or meningitis. History of epilepsy. Untreated depression. Uncontrolled diabetes (glucose <70 or >200 at screening). Use of interferon or ribavirin during study and for 1 month prior to screening. History of bipolar disorder, Alzheimer's dementia, ALS, Parkinson's disease or other medical dementias other than HIV-related. History of schizophrenia, mania or other serious mental illness. History of methylphenidate allergy. Other serious concurrent medical illness other than HIV. History of radiation therapy to the brain or brain injury. History of crystal methamphetamine, cocaine, LSD use or other recreational substance use other than marijuana within the 12 months prior to screening and for the duration of the study. Plan to use marijuana or marinol during the entire study duration and one month prior to screening visit. Plan to drink 7 or more alcoholic drinks per week during the 4 weeks prior to screen visit and for the duration of the study. History of alcohol dependence, alcohol abuse, cocaine addiction, crystal methamphetamine addiction or other recreational drug addiction or treatment for addiction or dependence within 5 years of screening visit. If subject is using prescription narcotics, should be on a stable dose for at least 1 month prior to screening and throughout the study. Previous use of Concerta™, Ritalin™, atomexitine or Adderall™ or other psychostimulants (e.g. modafinil, armodafinil) for 3 months prior to screening visit and for duration of the study. History of tic disorders in the past 3 months or any history of Tourette's syndrome. Greater than 10% below ideal body weight (IBW for men = 50 kg + 2.3 kg per inch over 5 feet of height, and IBW for women = 45.5 kg + 2.3 kg per inch over 5 feet of height) Uncontrolled migraine headaches. History of short gut syndrome, Meckel's diverticulum, or cystic fibrosis. Family history of sudden cardiac death in a young relative. History of fainting with exercise. History of attention deficit disorder will be excluded, defined as a score greater than 6 on the Childhood ADHD Symptoms Scale. - | 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): 50.0-90.0, Alzheimer's Disease Mild Cognitive Impairment Frontotemporal Dementia years of age or older (50 years of age or older for frontotemporal dementia patients) Normal memory, mild cognitive impairment (memory loss that does not significantly affect normal daily activities), or clinical diagnosis of Alzheimer's disease or frontotemporal dementia (includes primary progressive aphasia) Right-handed General good physical health History of stroke or neurological disease (other than Alzheimer's disease or frontotemporal dementia) Seizures or head injury with loss of consciousness within the last five years Ferrous (magnetic) or electronic implants (due to the magnet in the MRI scanner) Claustrophobia | 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, IDIOPATHIC PARKINSON'S DISEASE An Independent Ethics Committee (IEC)-approved written informed consent is signed and dated by the subject or by the legal representative Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule or study medication intake according to the judgment of the investigator Subject has Idiopathic Parkinson's Disease of ≤5 years' duration, defined by the cardinal sign, Bradykinesia, plus the presence of at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes, and without any other known or suspected cause of Parkinsonism Subject is Hoehn & Yahr stage ≤3 Subject is male or female aged ≥30 years at Screening (Visit 1) Subject has a Mini Mental State Examination (MMSE) score of ≥25 Subject has a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) of ≥10 at Baseline (Visit 2) If the subject is receiving an Anticholinergic agent (eg, Benztropine, Trihexyphenidyl, Parsitan, Procyclidine, Biperiden), a monoamine oxidase (MAO)-B inhibitor (eg, Selegiline), an N-methyl-d-aspartate (NMDA) antagonist (eg, Amantadine), he/she must have been on a stable dose for at least 28 days prior to Baseline (Visit 2) and be maintained on that dose for the duration of the study Subject has previously participated in this study or subject has previously received the study medication under investigation in this study Subject is participating in another study of an investigational drug or has done so within 28 days prior to the Baseline Visit (Visit 2) Subject has a history of significant skin hypersensitivity to adhesive or other transdermal preparations or recent unresolved contact Dermatitis Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) Subject has atypical Parkinson's syndrome(s) due to drugs (eg, Metoclopramide, Flunarizine), metabolic neurogenetic disorders (eg, Wilson's Disease), Encephalitis, Cerebrovascular Disease, or Degenerative Disease (eg, progressive Supranuclear Palsy) Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal tissue transplant Subject has dementia, active psychosis or hallucinations, or severe depression Subject is receiving therapy with a dopamine agonist either concurrently or has done so within 28 days prior to the Baseline Visit (Visit 2) Subject is receiving therapy with L dopa/carbidopa and/or L-dopa/benserazide within 28 days of Baseline (Visit 2) or has received L-dopa/carbidopa and/or L-dopa/benserazide for more than 6 months since diagnosis Subject is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to Baseline (Visit 2): Alpha-methyl dopa, Metoclopramide, Reserpine, Neuroleptics (except specific atypical neuroleptics: Olanzapine, Ziprasidone, Aripiprazole, Clozapine, Quetiapine), MAO-A inhibitors, Methylphenidate, or Amphetamine | 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 Disease Participants who will be included in the study have probable or definite idiopathic PD (CAPSIT (23)), Hoehn & Yahr stage 2-4 One or more of the following PD-associated motor impairments experienced in the week prior to enrollment (based on history and/or examination): motor fluctuations (end of dose wearing off with hypokinesia and/or levodopa-induced choreiform dyskinesias), tremor, freezing of gait, or frequent falls (≥ 1 per week) Neurological disorders (other than PD) or orthopedic deficits that, in the investigator's judgement, contribute substantially to impaired movement (e.g. stroke with motor sequelae Essential tremor Severe osteoarthritis) Cognitive impairment sufficiently severe to interfere with 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): 18.0-70.0, Fibromyalgia Primary fibromyalgia as defined by the American College of Rheumatology 2. Age 18-70 years 3. Male or female 4. Competent and willing to give written informed consent History of head trauma 2. Any significant neurological disorder that may confound neuro-cognitive testing | 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): 30.0-90.0, Parkinson's Disease Idiopathic Parkinson's disease patient Patient with Secondary Parkinsonism eg.Drug-induced Parkinsonism, Vascular Parkinsonism, exposure to toxin, Encephalitis 2. Patient with Atypical Parkinsonial Syndromes eg. Parkinson-plus syndrome, Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD) 3. Patient with Heredodegenerative parkinsonism eg. Spinocerebellar ataxias, Wilson's disease, Juvenile Huntington'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): 0.0-999.0, Parkinson's Disease eligible and offered treatment with DBS for PD married or cohabitant living alone | 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, Hypertension Men or women > 21 years of age Any Race/Ethnicity Pre or Stage I hypertension (BP >= 120/80 and <= 159/99) Diabetes mellitus Renal impairment (serum creatinine > 1.4 mg/dL) Any heart diseases such as congestive heart failure or sustained arrhythmia Chronic NSAID use Treatment with diuretics Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week Esophageal-gastric ulcer Chronic diarrhea Hyperkalemia (serum > 4.6 meq/L for patients on angiotension-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), serum K > 5.0 meq/L for patient not on ACE inhibitors or ARBs) Abnormal liver function test (aspartate transaminase (AST) or alanine transaminase (ALT) above upper limit of normal range) | 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, Non-Hodgkin's Lymphoma Hodgkin's Lymphoma All subjects regardless of age, sex or HIV serostatus must have biopsy-proven non-Hodgkin's (NHL), including primary effusion lymphoma, Hodgkin's lymphoma (HD) or other lymphoproliferative disorder (e.g., Castleman's disease) with measurable or evaluable stage I through IV disease. [Note: Lymphomas will be categorized on the basis of current WHO classification scheme, but it is recognized that initial pathological categorization at time of study enrollment will more than likely be classified or graded as low-, intermediate-, or high-grade lymphoma by Working Formulation criteria. This is the current standard of practice in Kenya.] All subjects must receive some form of systemic chemotherapy. Subjects not receiving chemotherapy of any kind are not eligible. Subjects must not have had any prior chemotherapy for lymphoma Subjects may have received prior radiotherapy for localized stage I or stage II disease that is clearly documented to have progressed beyond initial radiotherapy ports All subjects must give written informed consent to participate on study. In Kenya, a child is considered < 18 years of age and an adult ≥ 18 years of age. All children will have their parental or legal guardian provide consent.. Children between the ages of 7 and < 18 years old should be given the opportunity to provide their assent. For children between the ages of 7 and 11 years old this should be done using the parental consent form assent statement. For children > 11 years old assent should be documented using the IRB approved assent form Subjects who do not fulfill the as listed in Sections 3.1.1 through 3.1.4 are ineligible Subjects who received prior chemotherapy (i.e., first-line treatment) or are not receiving any chemotherapy for their non-Hodgkin's (NHL) or Hodgkin's lymphoma (HD) are ineligible | 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 Patients with primary hypercholesterolemia [Heterozygous Familial Hypercholesterolemia (heFH) or non-FH] with moderate, high or very high CV risk and a history of statin intolerance 2. Provide signed informed consent 1. Calculated serum LDL-C <70 mg/dL (1.81 mmol/L) and very high CV risk at the screening visit 2. Calculated serum LDL-C <100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the screening visit 3. A 10-year fatal cardiovascular disease risk score <1% at the screening visit (The inclusion/ provided above is not intended to contain all considerations relevant to a patient's potential participation in this 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): 18.0-70.0, Cirrhosis of Liver Hepatic Encephalopathy Hepatic cirrhosis based on clinical, biochemical, radiological and/or histological data Patients with overt acute grade 2, 3 and 4 HE, according to the West Haven with or without precipitating factors Age of patient 18-70 years Patients who are terminally ill Acute on chronic liver failure Hepatocellular carcinoma Wilson's disease as the etiological factor of liver disease Advanced cardiac or pulmonary disease Presence of underlying chronic renal failure Neuro-degenerative disease or major psychiatric illness Patients on sedatives or antidepressants Pregnancy or breastfeeding | 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 Essential Tremor Subject is indicated to undergo DBS for Parkinson's disease or Essential Tremor according to of the Study site For Parkinson Disease Person is between 18 and 75 years of age Established diagnosis of idiopathic Parkinson's disease with progression of symptoms for a minimum of 2 years Person has a history of at least 30% improvement on the Unified Parkinson's Disease Rating Scale with therapy in L-dopa (levodopa) Weak control of symptoms by dopaminergic therapy (off phenomenon, fluctuations on / off, dyskinesia on) For Essential Tremor Person is between 18 and 80 years of age Established diagnosis of Essential Tremor for a minimum of 2 years Functional disability due to tremor was not adequately controlled by medication for at least 3 months prior to implant Person suffering from an active major psychiatric disorder Mattis Dementia Rating Scale score <130 or otherwise not capable of discernment Presence of major co-morbidity or medical condition that may affect participation to the study Presence of an electrical or electromagnetic implant (e.g., cochlear implant, pacemaker) Person with a previous surgery for the treatment of Parkinson's disease or Essential Tremor Person with a previous brain ablation procedure Person who suffers from epilepsy Person who is pregnant: a pregnancy test will be performed in women of childbearing age Person with coagulopathies Abuse of drugs or alcohol | 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 A diagnosis of idiopathic PD meeting UK PD Society Brain Bank (Step 1, Step 2, and 2 items present from step 3).1 Male or female age 30 years or older at time of PD diagnosis, Hoehn & Yahr (H&Y) stage I-IV Confirmation from I-123 Ioflupane SPECT (DatScan®) of dopamine transporter deficit for de-novo, untreated patients Clinical evidence of response to dopaminergic medication (MAO-B inhibitors, dopamine agonists, levodopa, or combinations) in patients on treatment for PD Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations Able to make visits to UT Southwestern every 6 months for up to 5 years without undue hardship Idiopathic PD, H&Y stage 5, as these will be unable to participate in gait assessments Confirmed or suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases Presence of definite dementia (MoCA < 17)2 For de-novo subjects: received any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of screening For the prospective CSF cohort: current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture For the prospective CSF cohort: any condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or known clinically significant coagulopathy or thrombocytopenia Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude 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): 35.0-80.0, Osteoarthritis of the Knee Age 35 to 80 Subjects of childbearing potential and their partners must use effective contraception OA based on the ACR OA of the knee ≥ 6 months prior to Screening OA knee pain which required NSAID or other therapy for ≥ 15 days Pain on Movement in the contralateral knee be ≤ 20 mm Radiographic evidence of OA by Kellgren-Lawrence score of 2 or 3 taken 6 months prior to Screening Moderate to severe OA pain defined as POM score between 50 mm and 90 mm Baseline WOMAC pain subscale score ≥ 9 No change in physical activity and/or therapy for the past 3 months Use of Rescue Medication or any other pain medication 48 hours prior to Baseline visit Inflammatory skin condition over the target knee Extreme pain in the target knee characterized by POM score of > 90 mm Mild pain in the target knee, characterized by POM score of < 50 mm > 30 mm POM score variability in Days -2 to -1 from Baseline visit Baseline POM score of > 20 mm for the contralateral knee or any other significant joint or general pain at Baseline visit Excessive effusion in the target knee Heat and/or redness in comparison to the contralateral knee Knock-kneed or bow-legged defined by valgus or varus deformity of ≥ 15 degrees Acute or chronic injury other than OA | 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, Hepatocellular Cancer Histologically confirmed advanced HCC Barcelona Clinic Liver Cancer stage C or stage B if you cannot tolerate or failed TACE No cirrhosis or Child-Pugh A cirrhosis Measurable lesions All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 grade 1 or less Able to swallow and retain oral medication Prior systemic regimens for HCC Uncontrolled hypertension CLIP score > 3 ECOG PS > 1 Clinically apparent central nervous system metastases or carcinomatous meningitis Pregnant or breastfeeding Active or clinically significant cardiac disease Evidence or history of bleeding diathesis or coagulopathy Any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 2 or higher within 4 weeks of enrollment Presence of a non-healing wound, non-healing ulcer, or bone fracture | 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, Detrusor Function, Overactive Diagnosis of overactive bladder as a result of neurogenic condition, for example following spinal cord injury, multiple sclerosis (slowly worsening disorder of the central nervous system that causes symptoms such as weakness, incoordination, numbness, problems talking and problems seeing), Parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is slow movement [due to muscle weakness], trembling and sweating), or cerebrovascular accidents (CVAs stroke-sudden loss of blood supply to brain) Women must not be pregnant and be of either non-childbearing potential or is using adequate means of birth control Overactive bladder symptoms and/or has urge incontinence episodes Must have normal results on urine culture tests and on urinalysis ECOG (Eastern Cooperative Oncology Group) performance status score of less than or equal to 3 Participants with 1 or more treatable or conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency Any medical or unstable condition that precludes their participation in the study or may confound the outcome of the study (participants with or at risk for urinary retention, gastric retention or uncontrolled narrow angle; heart failure or kidney failure; diabetes mellitus; abnormal muscle weakness [myasthenia gravis]; paralysis or inactivity in the intestines that prevents material moving through the gut [intestinal atony or paralytic ileus]; severe inflammation of the bowel [ulcerative colitis] sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease [toxic megacolon]; history of major lower urinary tract surgery [transurethral resection will be excluded]) Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose) Pregnant or breast feeding female Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of white blood cells) in the urine | 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, Alzheimer Disease The patient's legal representative must have given his/her informed and signed consent (or the patient if he/she is judged competent) The patient must be insured or beneficiary of a health insurance plan Alzheimer's-type neurodegenerative pathology The patient has been living in the participating center for > 2 months The patient's legal representative refuses to sign the consent (or the patient if he/she is judged competent) It is impossible to correctly inform the patient's legal representative The patient has already has Snoezelen-therapy | 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, Aortic Stenosis, Non-rheumatic be over 18 carry a tight and symptomatic aortic stenosis have an indication for a ballon aortic valvuloplasty Subject have signed his written informed consent Have an absence of femoral surgical approach have a criticial hemodynamic state, considered as outdrove for the treatment have a severe aortic failure allergia to heparin contraindication to heparin or/and local anaesthetic be treted by low molecular weight heparin in less than 12 hoursbefore the intervention or by standard heparin in less than 4 hours before the valvulopasty have a tight but not symptomatic aortic stenosis | 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, Primary Care Phase I VA patients who have had some experience with care receipt through technology (e.g., home telehealth, CVT, secure messaging with providers) A second group will be conducted with patients who have not had experience receiving care through technology There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase II Veterans who receive care from VA and are comfortable using the Internet There are no other specific and the investigators plan to recruit both male and female Veterans, as well as minorities. Phase III Veterans who receive care from Hines VA or Jesse Brown VA in a primary care/PACT clinic No subjects will be excluded based on gender, race, or ethnicity (1) adult, age 18 or over (2) assigned primary care provider in PACT clinic A history of dementia Blindness | 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 Disease Dementia For all subjects: 1. Age 40 or older. 2. Able to abstain from caffeine and alcohol for 24 hours before each visit. 3. English is the first language. 4. Right handed For PD cohort: 1. Established diagnosis of PD. 2. History compatible with diagnosis of PD 3. Present with at least 3 of the following features: bradykinesia, resting tremor, cogwheel rigidity or postural reflex impairment 4. One of the 3 clinical features is either bradykinesia or resting tremor 5. Currently taking or history of taking dopaminergic therapy with symptomatic response. 6. Is able to give informed consent or, if there is evidence of cognitive decline, able to give assent and able to appoint a durable power of attorney (DPA) who can give informed consent for all subjects Use of illegal drugs within the past 6 months More than 7 alcoholic drinks a week for females or 14 alcoholic drinks a week for males History of a neurologic disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, a movement disorder, epilepsy or a history of seizures, except PD for PD patients History of any head injury with loss of consciousness Pregnancy or positive pregnancy test before the research procedure due to the risks associated with MRI scans Inability to lie flat on the back for up to 2 hours Claustrophobia or a feeling of discomfort from being in small, enclosed spaces of enough severity to prevent MRI scanning Surgically or traumatically implanted metallic foreign bodies, such as pacemakers, implanted medical pumps, implanted hearing aids, metal plates in the skull or metal implants in the skull or eyes (other than dental fillings) that may be physically hazardous during an MRI, or might distort the images Ablative surgery or implanted electrodes and generator for deep brain stimulation | 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, Homozygous Familial Hypercholesterolemia Patients of any age and sex who meet clinical or genetic for hoFH as follows Cutaneous xanthomata before the age of ten years LDLC > 13 mmol/L before treatment or > 7.76 mmol/L despite treatment Phenotypic features in keeping with HeFH in both parents Inability of patient, or, if less than 18, a parent, to sign 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): 18.0-70.0, Cirrhosis Hepatic Encephalopathy Ambulatory patient with cirrhosis Able to provide informed consent History of alcohol abuse within six months Active gastrointestinal bleeding Unable to provide informed consent | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 1.75-999.0, Parkinson Disease idiopathic Parkinson disease age >21 years able to provide written informed consent diabetes mellitus, stroke, cardiac and renal diseases and cigarette smoking major psychiatric disorder or drug and/or alcohol abuse/dependence regular use of antioxidants, dietary supplements, traditional Chinese remedies, non-steroidal anti-inflammatory drugs or immunosuppressive drugs | 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): 18.0-90.0, Movement Disorders Parkinson's Disease Patients will have a diagnosis of Parkinson Disease Age 18 or older Able to give informed consent Ability to comply by the schedule and routine of taking the at home tests with the QMAT system responsibly ability to perform the QMAT testing current or planned enrollment in 12-N-0137: A Phase 1 Open-label Dose Escalation Safety Study of Convection-Enhanced Delivery (CED) of Adeno-Associated Virus Encoding Glial Cell Line-Derived Neurotrophic Factor (AAV2-GDNF) in Subjects with Advanced Parkinson s Disease 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 major depression or any major mental disorders (axis I disorders) Have other neurologic disorder than a movement disorder Have had a head injury where there was a loss of consciousness for more than a few seconds | 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, Small Fiber Neuropathy Male and/or female subjects between the ages of 18 and 80 years. 2. Presence of a clinical diagnosis of Small Fiber Neuropathy (SFN), with at least 2 of the following clinical symptoms Burning feet Allodynia Diminished pain and/or temperature sensation Dry eyes or mouth Orthostatic dizziness Bowel disturbances (constipation, diarrhea, gastroparesis) Urinary disturbances Sweat changes (hyper-/hypohidrosis) Visual accommodation problems and/or blurred vision Subjects with predominantly signs of large nerve fiber involvement, clinically significant abnormal nerve conduction studies. 2. History or presence of illnesses known to cause SFN (excluding diabetes mellitus). 3. Subjects with other severe pain conditions which may impair the self-assessment of pain due to SFN. 4. Any condition possibly affecting drug intake and absorption. 5. History of known alcohol, analgesic or illicit drug abuse within 12 months of Screening. 6. Subjects taking medications with activity at sodium channels. These medications are prohibited until the end of the study period and require a washout period of at least 5 half lives (90 days for capsaicin patches) prior to the Screening visit. 7. 12-lead ECG demonstrating QTcF (Fridericia's correction) >450 or a QRS interval >120 msec at Screening. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTcF values should be used to determine the subject's eligibility. 8. Severe renal impairment (creatinine clearance ≤ 30 mL/min). 9. Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication. 10. Participation in other studies during the period of current study participation, or has planned surgery during the course of the study. 11. Pregnant females; breastfeeding females; females of childbearing potential not using effective contraception or not agreeing to continue effective contraception for at least 28 days after the last dose of investigational product. 12. Other clinically significant or unstable, or severe acute or chronic medical or psychiatric/psychological condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study. 13. In the case of incidental findings the patient and his/her treating physician will be informed and asked to undertake action if necessary. If a patient does not want to be informed about possible incidental findings, nor wants his treating physician to be informed, he or she cannot participate in this 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, Parkinson's Disease Tremor Medication-refractory tremor and/or Parkinson's disease as defined by UK Brain Bank with either inadequate control of motor fluctuations or dyskinesia despite optimised medical therapy Significant cognitive, psychiatric and medical co-morbidities Dementia with mini mental state examination score of less than 25/30 Limited life expectancy due to a co-morbid condition | 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): 18.0-50.0, Polymorphism- Genetic Reward Mediating System Subjects will be eligible for this study if they are between 18 and 55 years of age are in good physical health speak English well enough to understand task instructions clearly Subjects will not be eligible for this study if they have a major medical (e.g. heart disease), neurological (e.g. stroke) or psychiatric (e.g. bipolar disorder) illness have a vision and/or hearing problem that interferes with testing currently use any psychotropic medication, antidepressants, steroids or opiates currently use alcohol in excess of 14 drinks/week for males or 7 drinks/week for females have a lifetime history of or currently have alcohol or substance use or dependence (excluding nicotine) that requires independent, concurrent treatment intervention (such as, antabuse or opiate treatment). This does not self-help group treatment/intervention cannot understand the consent and procedures or cannot consent themselves to the study Smoke more than a half pack of cigarettes a day NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy. In addition to the above, additional apply for all MRI studies | 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, Essential Tremor Parkinson's Disease For Non-Caucasians Non-Caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET The participant had existing diagnostic-quality and interpretable DaTscan SPECT images of the brain. For Caucasians Caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET The participant had existing diagnostic-quality and interpretable DaTscan SPECT images of the brain The participant was matched by final clinical diagnosis, sex and age (±5 years) with a non-Caucasian participant Known/suspected structural abnormalities of the brain (e.g., hydrocephalus; brain tumor; stroke; etc.) that could grossly distort the DaTscan images Participants whose race and ethnic information could not be determined from source document review | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 40.0-75.0, Coronary Artery Disease Age between 40-75 years old 2. Male sex 3. History of known coronary artery disease (by either history of myocardial infarction, angiogram demonstrative >=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography) Unstable angina or myocardial infarction by history, ECG, and/or enzymatic within 1 month of enrollment. 2. Left ventricular dysfunction as defined by an left ventricular ejection fraction documented as < 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging. 3. Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit. 4. Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment. 5. Known history of cognitive impairment or inability to follow study procedures 6. Patient with an implanted defibrillator or permanent pacemaker on with the potential participant is known to rely upon for greater than 50% of ventricular depolarizations. 7. Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks. 8. Patients with dosing changes of vasoactive medications and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the 6 weeks prior to enrollment | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 45.0-85.0, Parkinson Disease Experimental subjects must meet the Brain Bank (Gibb & Lees, 1988) for idiopathic PD All participants must be between the ages of 45 and 85 have at least a sixth grade education fluent in English The investigators will obtain information about participant's Parkinson's disease history from medical records including age at onset current age gender handedness Individuals will be excluded with other forms of Parkinsonism such as multiple systems atrophy Lewy body dementia progressive supranuclear palsy Other exclusionary will be co-existing dementia (as indicated by score on Montreal Cognitive Assessment of below 26) neurological disease other than idiopathic PD major depression any other psychiatric illness chronic medical and neurological diseases other than PD (e.g., cardiac failure, renal disease, hepatic failure, stroke, or severe sensory deficits such as deafness or blindness (corrected visual acuity less than 20/50) | 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, Cerebral Vascular Accident (CVA) All patients, male or female, may be included if they meet the following patients with suspected ischemic CVA admitted in an acute stroke unit (thrombolysis unit) aged 18 and over MRI Scan undertaken under the current protocol which includes the following sequences: distribution, T2* (gradient echo), ARM, TOF and FLAIR after information given the consent form is signed by the patient .or for those unable to express their consent (in case of coma or severe neurological disorder) by a relative or next of kin. .the patient will be informed as soon as he has recovered his faculties in order to be able to express, if he wishes, his opposition to the pursuit of the research (sample destruction before tested) the patient must be registered with the Social Security All patients with a contraindication to MRI Scan Pacemaker Implanted cardiac defibrillator Implanted Neuro-stimulator Cochlear Implants Implanted Insulin pump Other implanted electronic medical device Vascular intracerebral Clip Cardiac Valve Other metallic implant | 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, Adhesive Capsulitis of the Shoulder patients must be diagnosed as having idiopathic adhesive capsulitis in the 'frozen' or 'thawing' phase of disease and have tried and failed at least 3 months of nonoperative therapy. OR patient with adhesive capsulitis who presents already in the 'frozen' or 'thawing' phase who demands a quicker return to function and will not try 3 months of nonoperative therapy first Age 18 or older pregnancy previously operated shoulder (same side) other documented source of shoulder pain and stiffness (same side) rotator cuff tear (same side) glenohumeral osteoarthritis (same side) calcific tendonitis (same side) impingement (same side) osteonecrosis neoplasm cervical radiculopathy | 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, Idiopathic Parkinson's Disease Patients with IPD who have been on a stable dose of anti-parkinsonian medication for at least one month Hoehn & Yahr scale I-IV More than one point in two or more items (tremor, rigidity, postural instability, and bradykinesia) in the UPDRS Part III, etc Severe psychiatric or organic brain disorders other than PD, previous or current Secondary Parkinsonism due to cerebrovascular disease, tumor, infection, etc Atypical Parkinsonian or Parkinson plus syndrome | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 40.0-85.0, Parkinson's Disease A diagnosis of idiopathic Parkinson's Disease (PD) (UK, PD Brain Bank Criteria) A Hoehn and Yahr stage of 2 Exhibiting Freezing of Gait or another gait abnormality in the ON state An ability to mobilise independently with or without a walker or walking cane for the purpose of research when in the 'ON' state A serious cognitive impairment (MMSE<24) Pregnant or currently involved in another clinical trial Pacemakers On opioid or neuropathic pain medication | 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, Treatment Resistant Depression Age 25-70 years old Ability to provide written informed consent Agrees to relocate to the Atlanta Metro region for the duration of the acute phase of the investigation (approximately 8-10 months) and to return regularly for clinical and research assessments Current depressive episode of at least two years duration OR a history of more than 4 lifetime depressive episodes Failure to respond to a minimum of four different antidepressant treatments, including at least three medications from at least three different drug classes, evidence-based psychotherapy or electroconvulsive therapy (ECT) administered at adequate doses and duration during the current episode Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode All patients must have an established outpatient psychiatrist and be willing to sign a written release to allow study investigators to give and receive information from this psychiatrist Refusal or inability to relocate to Atlanta Metro region for acute phase of protocol or to return for regular assessments in long term follow up Inability to tolerate general anesthesia Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurological disorder Other currently active clinically significant Axis I psychiatric diagnosis including bipolar disorder, schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder Current psychotic symptoms Evidence of global cognitive impairment Substance abuse or dependence not in full, sustained remission Active suicidal ideation with intent; suicide attempt within the last six months; more than three suicide attempts within the last two years Pregnancy or plan to become pregnant during the study period General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices) | 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 a diagnosis of idiopathic Parkinson's disease, with bilateral symptoms at Hoehn and Yahr Stage greater than or equal to II Documented improvement in motor signs on versus off dopaminergic medication, with a change in the Unified Parkinson's Disease Rating Scale motor (UPDRS III) score of >= 30% off to on medication The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors Subjects should be on stable doses of medications, which should remain unchanged until the DBS system is activated. After the DBS system is optimized (during which time the overall medication dose may be reduced to avoid discomfort and complications such as dyskinesias) the medication dose should remain unchanged, if possible, for the duration of the study Treatment with carbidopa/levodopa, and with a dopamine agonist at the maximal tolerated doses as determined by a movement disorders neurologist Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS Age > 18 Subjects with significant cognitive impairment and/or dementia as determined by a standardized neuropsychological battery Subjects with clinically active depression, defined according to the Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM-IV) and as scored on a validated depression assessment scale Subjects with very advanced Parkinson's disease, Hoehn and Yahr stage 5 on medication (non-ambulatory) Age > 80 Subjects with an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump Subjects, who are pregnant, are capable of becoming pregnant, or who are breast feeding Patients with cortical atrophy out of proportion to age or focal brain lesions that could indicate a non-idiopathic movement disorder as determined by MRI Subjects having a major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin) Subjects having any prior intracranial surgery Subjects with a history of seizures | 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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 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, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 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): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months | 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, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 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 Experiments will be performed on 3 groups of nondiabetic human subjects stage I (140-159/90-99 mmHg) subjects with essential hypertension stage I hypertensive subjects with primary aldosteronism normotensive controls Any evidence of cardiopulmonary disease, left ventricular hypertrophy or systolic dysfunction by echocardiography Blood pressure averaging ≥160/100 mmHg Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2 Diabetes mellitus or other systemic illness Pregnancy Hypersensitivity to nitroprusside, phenylephrine, amlodipine or eplerenone Any history of substance abuse or current cigarette use Any history of psychiatric illness History of malignancy | 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): 18.0-80.0, Parkinson's Disease Levodopa Subjects must have a definitive diagnosis of Parkinson's Disease (per United Kingdom brain bank criteria), Hoehn and Yahr stage 1-3 must exhibit unequivocal levodopa responsiveness must be able to distinguish between the "off" versus "on" state Subjects must be on a stable dose of levodopa for at least 28 days prior to enrollment and should be anticipated to maintain a stable dose throughout both study periods Subjects may be on concomitant therapy with Monoamine oxidase B inhibitors, entacapone, and amantadine, though the doses of these medications must have remained stable for at least 28 days prior to enrollment and must be expected to remain stable throughout both study periods History of deep brain stimulation for Parkinson Disease History of ablative (tissue removal) surgery for Parkinson Disease Presence of dementia (MMSE<25) Presence of active psychosis History of any chronic gastrointestinal diseases History of any prior gastrointestinal surgeries except for appendectomy, cholecystectomy, and hysterectomy Any gastrointestinal surgeries in the past 3 months Severe dysphagia (difficulty swallowing) to pills or food History of physiological or mechanical gastrointestinal obstruction History of strictures or fistulae (abnormal or narrow connections) along the gastrointestinal tract | 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, Central Nervous System Diseases Ischemic or hemorrhagic cerebrovascular lesion, 2. Parkinson's disease Seizure With metal implantation Dementia or severe cognitive impairment | 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, Multiple System Atrophy "clinical possible" or "clinical probable" MSA (Gilman et al., Neurology, 2008 26;71:670-6) 2. Hoehn & Yahr stage I III 3. A stable regimen for at least 1 month prior to V1 and willingness / no fore-seeable need to change the regimen throughout the 52 week follow-up pe-riod for 1. drugs acting against Parkinsonism (e.g. Levodopa, Dopamine-Agonists, Amantadine and MAO-B-Inhibitors) 2. drugs acting against autonomic dysfunction (e.g. ephedrin, midodrin, fludrucortison, octreotide, desmopresin, oxybutinine) 3. antidepressant and antidementive drugs. 4. No regular consumption of EGCG, green tea, or more than two cups of black tea per day 5. Capability and willingness to give written informed consent indicating that the subject has been informed of and understood all aspects pertinent to the study 6. Capability and willingness to comply with the procedures of the study 7. Contraception by adequate contraceptive methods (oral, injected or im-planted hormonal contraceptive methods, intrauterine pessar, sterilisation or real abstinence) in all female patients with childbearing potential 8. Absence of liver disease documented by transaminases and bilirubin below 2-folds of the upper normal level Hoehn & Yahr stage > III (loss of postural reflexes, no independent walking possible, inability to stand unassisted, wheelchair-bound). 2. Neurodegenerative diseases other than MSA 3. Severe liver disease with elevation of transaminases and bilirubin above 2-folds of the upper normal level or regular intake of hepatotoxic drugs 4. Known hypersensitivity to EGCG or to drugs with similar chemical structure 5. Participation in another clinical trial involving administration of an investigational medicinal product within 1 month prior to V1 6. A physical or psychiatric condition, which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial 7. Persistent abuse of medication, drugs or alcohol 8. Consumption of > 500 ml grapefruit juice per day (leading to inhibition of cytochrome P-450 isoenzyme 3A4, which may be involved in degradation of EGCG). 9. Current or planned pregnancy or breast feeding in females 10. Females of childbearing potential, who are not using medically reliable methods of contraception for the entire study duration (such as oral, inject-able, or implantable contraceptives, or intrauterine contraceptive devices). 11. Intake of COMT-inhibitors (e.g. Entacapone, Tolcapone) 12. Current or planned therapy with Bortezomib and/ or history of plasmocytoma. 13. Anemia at Screening (Hb < 10g/dl) 14. Other severe medical conditions upon discretion of the LKP | 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): 18.0-100.0, Dementia Movement Disorder For Patients Diagnosis of a movement disorder or dementia by a neurologist or other qualified professional and accompanied by sufficient clinical and/or laboratory evidence to support the diagnosis Confirmation of a movement disorder or dementia by study investigators or a qualified clinician by physical examination and/or review of medical records Ages 18 and above Able to provide consent or, in the case of minors, or cognitive impairment, have a legally-authorized representative to provide consent Able to understand and participate in study procedures or for those without consent capacity, able to participate in study procedures AND has a legally authorized representative that understands the study procedures and can consent on their behalf. For unaffected family members of patients Unaffected relative of a patient diagnosed with a movement disorder or dementia enrolled in this protocol. For these purposes, we define a family member as an individual for which there is a demonstrable relationship with the proband in the pedigree. This is a standard approach used in family-based studies. Furthermore, the related patient (defined as a family member diagnosed with the disease of interest) must be enrolled in the study Ages 18 and above Able to provide consent Able to understand and participate in study procedures For unrelated healthy control individuals For patients: -An identifiable, non-genetic etiology for the movement disorder or dementia, such as a specific environmental exposure, birth injury, metabolic disorder, or brain infection such as encephalitis For all participants Clinically significant anemia that would make phlebotomy unsafe, and participant unwilling to provide saliva sample Clinically significant bleeding that would make phlebotomy unsafe, and participant unwilling to provide saliva sample Any medical condition that would make phlebotomy unsafe or undesirable, such as a serious medical illness like unstable heart disease, or unstable chronic obstructive pulmonary disease, and participant unwilling to provide saliva sample | 2 |
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