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NCT00000302
Inclusion Criteria: M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
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185
NCT00000303
Inclusion Criteria: M/F ages 18-65. cocaine dependence according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on ethanol (ETOH) or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
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186
NCT00000306
Inclusion Criteria- Subject must: Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID. Be between 18 and 45 years old Women must agree to use contraception Have an EKG that has been confirmed by a cardiologist Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal Exclusion Criteria- Subject must not: • Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent Have any Axis I disorder that is not related to drug use Have current dependence on any psychoactive disorder other than nicotine Be on probation or parole for reasons other than those related to drug charges (ASI) Be pregnant or lactating Have been in any outside treatment in 3 months
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189
NCT00000310
Inclusion Criteria: Cocaine abuse or dependence Exclusion Criteria: Dependence on other drugs. Major psychiatric illness
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193
NCT00000317
Inclusion: good standing at methadone maintenance program DSM-IV criteria for cocaine dependence or abuse used cocaine at least 4 times in last month able to give informed consent Exclusion criteria currently meets DSM-IV criteria for Major depression or dysthymia meets DSM-IV criteria for attention deficit hyperactivity disorder, bipolar disorder, schizophrenia or any psychotic disorder history of seizures history of allergic reaction to risperidone chronic organic mental disorder significant current suicidal risk pregnancy, lactation or failure to use adequate birth control (for females) unstable physical disorders that may make participation hazardous coronary vascular disease cardiac conduction system disease as indicated by QRS duration >/= 0.11 current use of other prescribed psychotropic medications history of failure to respond to a previous adequate trial of risperidone history of neuroleptic malignant syndrome, tardive dyskinesia, or severe extrapyramidal reactions to neuroleptic medications current DSM-IV criteria for another substance dependence other than nicotine.
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200
NCT00000320
Inclusion Criteria: M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.
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203
NCT00000322
Inclusion Criteria: 18-65 years of age. Able to provide informed consent. Desire to reduce/eliminate methamphetamine use. Used within the past two weeks. Meet DSM criteria for methamphetamine dependence. Exclusion Criteria: No dependence (within the past 12 months) for other durgs except nicotine. No history or family history of tyrosine intolerance.
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205
NCT00000323
Inclusion Criteria: opiate experienced, healthy Exclusion Criteria: physical dependence on opioids, barbiturates or alcohol
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206
NCT00000324
Inclusion Criteria: Cocaine dependent Exclusion Criteria: Physically dependent on drugs of abuse other than cocaine Significant medical or psychiatric illness (besides substance abuse disorder) Pregnant
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207
NCT00000326
Inclusion Criteria: Individuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
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209
NCT00000327
Inclusion Criteria: Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
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210
NCT00000328
Inclusion Criteria: Individuals must be at least 18 years of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
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211
NCT00000329
Inclusion Criteria: Individuals must be at least 18 yrs of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use. Exclusion Criteria: Individuals with evidence of anti active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
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212
NCT00000330
Inclusion Criteria: Individuals must be at least 18 yrs of age, currently opioid dependent and must not be seeking treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
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213
NCT00000331
Inclusion Criteria: Individuals must be healthy, non-drug dependent volunteers, be at least 18 years of age, and have no prior history of drug or alcohol abuse or dependence. Subjects must have had some minimal experience with opioids (e.g. at least two prior exposures) Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
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214
NCT00000336
Inclusion Criteria: M/F ages 21-50. Meets DSM-IV criteria for cocaine. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
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219
NCT00000337
Inclusion Criteria: M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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220
NCT00000338
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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221
NCT00000339
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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222
NCT00000340
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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223
NCT00000341
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for opioid dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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224
NCT00000342
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
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225
NCT00000343
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
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226
NCT00000344
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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227
NCT00000345
Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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228
NCT00000346
Inclusion Criteria: M/F . Meet DSM-IV criteria for cocaine or methamphetamine dependence. Agree to conditions of the study and sign informed consent.
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229
NCT00000347
Inclusion Criteria: M/F ages 21-50 . Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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230
NCT00000348
Inclusion Criteria: M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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231
NCT00000349
Inclusion Criteria: M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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232
NCT00000350
Inclusion Criteria: M/F, ages 21-50. Meet DSM-IV criteria for methamphetamine and nicotine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
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233
NCT00000351
Please contact site for information Inclusion Criteria: M/F. Meet DSM-IV criteria for stimulant dependence. Agree to conditions of the study and sign informed consent.
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234
NCT00000359
Inclusion Criteria: Patients may be eligible for this study if they: Are at least 21 years old. Have a diagnosis of unilateral posterior semicircular canal BPPV according to established clinical test criteria. Have functional to normal range of motion of the neck and the back. Exclusion Criteria: Patients will not be eligible for this study if they: Have a history of prior ear surgery or prior treatment for BPPV. Have an orthopedic or connective tissue disorder that impairs functional neck or trunk range of motion. Have a significant neurological disorder or spinal cord damage. Are on vestibular suppressant medications. Have Meniere's disease or acoustic neuromas.
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242
NCT00000361
Inclusion Criteria: Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which has rapidly progressed. Are in good general health. Are sterile or use contraception (if a woman of child-bearing age). Are able to speak and understand English or Spanish. Exclusion Criteria: Have had any previous reaction to prednisone, or history of psychiatric reaction to corticosteroids. Have used corticosteroids for more than 30 days within the past 90 days. Patients who have been off corticosteroids for at least 30 days may be eligible. Have any significant heart, lung, digestive, blood, or neurologic disorders. Have tuberculosis (TB), brittle or unstable insulin-dependent diabetes mellitus, active malignancy or prior chemotherapy, pancreatitis, active peptic ulcer disease, kidney failure, history of shingles, or known (other) autoimmune disease. Have had a positive test for HIV, hepatitis C or B. Have any type of middle ear disorder. Are breast-feeding or pregnant.
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243
NCT00000362
Inclusion Criteria: Have dementia or Parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows. Exclusion Criteria: Have smoked more than a pack of cigarettes per day in the last year. Drink more than 3 alcoholic beverages per day on a regular basis. Have had any head and neck cancer treatment. Have any head and neck anatomic deformities. Have a history of 20 years or longer of insulin-dependent diabetes. Have other exclusionary neurologic diagnoses. Have had pneumonia within 6 weeks of screening. Currently have a nasogastric tube. Currently have a tracheotomy. Are a resident in non-participating nursing home or assisted living environment. Live alone. Have no regular care provider present at meals. Have no Speech-Language Pathologist to provide a 3-month follow-up.
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244
NCT00000363
Inclusion Criteria: Have had two documented prior episodes of acute otitis media. Have no current middle ear effusion (fluid). Exclusion Criteria: Have chronic otitis media. Have acute otitis media in addition to chronic otitis media.
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245
NCT00000367
Inclusion Criteria: - Patients must have: Depressive symptoms and signs. (Required for 920 of the 1200 patients; 280 patients should have no significant depressive symptomatology.)
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246
NCT00000368
Inclusion Criteria: - primary diagnosis of Panic disorder with or without Agoraphobia (all levels of agoraphobia are included). Exclusion Criteria: current substance abuse or dependence, current active suicidal potential; any history of psychosis, bipolar disorder (I or II) or cyclothymia; pending application or existing medical disability claim; significant cognitive impairment, current uncontrolled general medical illness requiring intervention, psychotherapy directed at anxiety or panic which will not be discontinued by the first treatment visit, and daily use of 2mg of Xanax or equivalent. Exclusion criteria for paroxetine study: hypersensitivity to Selective Serotonin Reuptake Inhibitors (SSRI), pregnancy, lactation, or planned pregnancy during the course of the study, contemporaneous medication that may interfere or interact with paroxetine, prior treatment with therapeutic doses of paroxetine (40mg/d for 1 mo), concurrent treatment with antidepressants.
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247
NCT00000369
Inclusion Criteria: - Patients must have: Acute bipolar I illness and be experiencing a manic or depressed episode at the time of study entry. - Required: Current treatment with lithium carbonate.
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248
NCT00000370
Inclusion Criteria: - Patients must have: Social phobia with public speaking anxiety.
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249
NCT00000371
Inclusion Criteria: Diagnosis of Schizophrenia as per DSM IV criteria Have been treated for at least 6 months with any conventional neuroleptic Have prominent negative symptoms as defined by a total score of 40 or greater on the scale for the assessment of negative symptoms (SANS) Exclusion Criteria: Active alcohol or drug abuse Unstable Medical Illness, seizure disorder, or other serious neurological disorder Pregnant or Nursing Unable to complete a cognitive battery
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250
NCT00000372
Inclusion Criteria: Diagnosis of Schizophrenia Score of 27 or greater on the Scale for the Assessment of Negative Symptoms (SANS) Treatment with stable dose of clozapine for at least 4 weeks Between 18 and 65 years old Exclusion Criteria: No other antipsychotic medications in oral for for at least 3 months or in depot form for 6 months Current major depressive episode Current substance abuse diagnosis
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251
NCT00000373
Inclusion criteria required that subjects, ages 14-70 years, have at least a 1-year duration of a current Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) principal diagnosis of OCD. Furthermore, the OCD had to be defined by a rating of "moderate" or greater on the global severity item of the Clinical Global Impressions (CGI) scale and have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 19 or greater. Exclusion criteria included primary depression, schizophrenia, or other psychotic disorders; active bipolar disorder; abuse of alcohol or other significant substance within 6 months; increased risk of seizures or history of neurosurgery, encephalitis, or significant head trauma; or a significant medical condition, such as heart, liver, or renal disease. Subjects with an intelligence quotient of less than 80 as determined with the Kaufman Brief Intelligence Test (Kaufman and Kaufman 1990) were excluded.
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252
NCT00000374
Inclusion Criteria: First episode schizophrenia, schizophreniform disorder or schizoaffective disorder Exclusion Criteria: Prior treatment with antipsychotic medications.
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253
NCT00000375
Inclusion Criteria: - Patients must have: Major depressive disorder that is responsive to acute phase ECT.
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254
NCT00000376
Inclusion Criteria: - Patients must have: Drug-resistant depression (DRD).
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255
NCT00000377
Inclusion Criteria: - Patients must have: Recurrence of major depression while in a maintenance placebo condition in the currently funded maintenance therapy protocol (Study I).
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256
NCT00000378
Inclusion Criteria: - Patients must have: Unipolar major depression (per Diagnostic and Statistical Manuel-IV criteria) with or without melancholia. Exclusion Criteria: - Patients with the following symptoms or conditions are excluded: Psychotic or atypical subtype of unipolar major depression.
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257
NCT00000379
Inclusion Criteria: - Patients must have: Post-Traumatic Stress Disorder (PTSD).
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258
NCT00000380
Inclusion Criteria: - Patients must have: Age-related sleep impairment. - Required: Estrogen replacement therapy for women.
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259
NCT00000381
Inclusion Criteria: - Patients must have: Generalized anxiety disorder. Exclusion Criteria: - Excluded: Patients with current major depression, as well as patients with panic and obsessive-compulsive disorder. - Excluded: Current substance abuse.
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260
NCT00000382
Inclusion Criteria: - Participants must have: Infants that have been maltreated by their biological caregiver during their first year of life and who continue to reside with their maternal caregiver. (Non-maltreated infants and their mothers will also be enrolled.)
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261
NCT00000383
Inclusion Criteria: - Patients must have: Post-Traumatic Stress Disorder (PTSD) symptoms (at least 5 with at least one symptom in each of 3 PTSD clusters) related to sexual abuse Confirmed child sexual abuse history Speak English Parent willing to participate in treatment Exclusion Criteria: Active psychotic disorder resulting in inability to participate in CBT Active substance abuse disorder that resulted in significant impairment 3 Serious developmental disorder precluding participation in CBT 4) If on psychotropic medication, not on stable dose for at least 4 weeks 5) Receiving ongoing psychotherapy outside of study
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262
NCT00000384
Inclusion Criteria: - Patients must have: DSM-IV diagnosed OCD.
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263
NCT00000385
Inclusion Criteria: Males and females Ages between 9 and 17 years. Conduct disorder according to DSM-IV (As rated on the DICA-IV). The aggression criterion at screening Exclusion Criteria: Mental Retardation. Pervasive Developmental Disorder(s). Major Depressive Disorder or Dysthymic Disorder. Bipolar Disorder. Psychotic Disorder (including Schizophreniform Disorder and Schizophrenia). Major medical problem such as cardiac, renal, and thyroid diseases, or seizure disorder. History of psychoactive medication in the previous 2 weeks. Current Pregnancy in females. History of Substance Dependence in the past month. Prior to the proposed study, a history of lithium treatment with serum lithium levels of 0.4 mEq/L or higher for a cumulative period of greater than 10 days.
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264
NCT00000386
Inclusion Criteria: - Patients must have: Obsessive-compulsive disorder for which he/she has not received medication.
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265
NCT00000387
Inclusion Criteria: - Patients must have: Schizophrenia as diagnosed according to DSM-IV criteria when screened by a mental health professional using the K-SADS and the DISA.
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266
NCT00000388
Inclusion Criteria: - Patients must have: Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).
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267
NCT00000389
- Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.
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268
NCT00000390
Inclusion Criteria: Patient must be ambulatory and relatively good health. Even if unable to work at least able to partially care care for self and not demented. May have been alcoholic or drug abuser 6 months previous. Unspecified CD4 Unspecified. Exclusion Criteria: Non ambulatory patients or those requiring extensive help in self care are excluded. Non ambulatory patients or those requiring extensive help in self care are excluded. Current alcohol or drug abuse. Unspecified
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269
NCT00000391
Inclusion Criteria: Patients must have: HIV infection. Ability to give informed consent. Ability to participate in an outpatient study. Allowed: Short course antimicrobials. Not breast-feeding Abstinence or agree to use barrier methods of birth control / contraception during the study Not pregnant Negative pregnancy test CD4 100 to 500 cells/mm3 (100 - 200 - 300 - 400 - 500). Creatinine > 1.6 mg/dl Hemoglobin >= 12 g/dl Platelet Count >= 100000 /mm3 Exclusion Criteria: Excluded: Asymptomatic HIV seropositive or lymphadenopathy syndrome diagnoses only (CDC criteria). Patients with the following conditions are excluded: Evidence of life-threatening opportunistic infection at time of entry into trial. Clinical evidence of active central nervous system disease secondary to immune dysregulation associated with HIV infection. Previous history of major psychiatric illness prior to 1977 or the time of initial exposure to HIV, if that is known. Evidence of clinically significant major psychiatric disturbance other than depression. Excluded within 4 weeks of study entry: Suramin. Antiretroviral agents. Anticancer treatments. Psychoactive agents. Excluded: Antivirals or immunomodulators. Excluded within 4 weeks of study entry: Radiation. Evidence of active substance abuse during 30 days prior to entry into trial. All behavior that can put patient at risk for reinfection with HIV: sexual contact with others known to have HIV infection, unsafe sexual practices, or sharing of needles or other intravenous equipment. Breast-feeding Positive pregnancy test Pregnant No abstinence or no agreement to use barrier methods of birth control / contraception during the study
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270
NCT00000392
Inclusion Criteria: Patients must have: Cognitive dysfunction on neuropsychological testing. HIV antibody positivity. Expected survival of 6 months. EITHER no use of an antiretroviral within the past 4 weeks OR use of approved regimens of AZT, ddI, or ddC. Medically stable EKG and urinalysis. Given informed, written consent to participate. Allowed: Inhaled aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis, dapsone, cotrimoxazole, topical antifungal agents, nystatin or ketoconazole, acyclovir. Amitriptyline (up to 50 mg/day) or an equivalent dose of another antidepressant for relief of peripheral neuropathy that is expected to remain unchanged throughout the first 6 months of the study. Abstinence or agree to use barrier methods of birth control / contraception during the study Negative pregnancy test within 30 days of study entry Bilirubin <= 3 CD4 (Must be <= 500 cells/mm3 if patient is without non-cognitive HIV-related symptoms. CD4 count > 500 cells/mm3 allowed if patient has other (non-cognitive) HIV-related symptoms. ( 0 - 100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 plus.) Creatinine <= 1.5 mg/dl Granulocytes >= 750 Hemoglobin > 8 g/dl (No more than two transfusions per month permitted.) Other Lab Values Prothrombin time > 70 percent of control. Platelet Count >= 75000 /mm3 SGOT(AST) < 5 x ULN (ULN = upper limit of normal). Exclusion Criteria: Patients with the following are excluded: History of mental retardation or learning disability. Evidence of current DSM-III-R Axis I disorder within 3 months prior to study entry or past history of psychotic disorder or bipolar mania. History of neurologic disorder not secondary to HIV infection (e.g., head trauma requiring medical observation or hospitalization, seizure disorder). Patients with the following symptoms or conditions are excluded: Kaposi's sarcoma or other malignancy likely to require chemotherapy during the first 6 months of the study. Serious underlying medical problems that may complicate interpretation of the treatment results, including unstable diabetes mellitus, severe arteriosclerotic heart disease, uncontrolled hypertension, or hepatic or renal failure. Non-HIV related condition that is likely to interfere with interpretation of neuropsychologic test results. Inability to participate in neuropsychologic testing or unable to comply with intranasal study medication administration. Excluded within 4 weeks prior to study entry: Antiretrovirals except as allowed in the Patient Inclusion Criteria. Psychoactive agents (e.g., benzodiazepines, antidepressants, antipsychotics, amphetamines) Excluded within 8 weeks prior to study entry: Long-acting psychoactive agents (e.g., Prozac). Active alcohol abuse in the past 3 months, or abuse judged by the investigators as likely to interfere with the analyses of neuropsychologic function. Abuse of cocaine, marijuana, heroin or other opiates (including methadone), barbiturates, amphetamines or other substances within the past 3 months, judged by the investigators as likely to interfere with the analyses of neuropsychologic tests. Positive pregnancy test within 30 days of study entry No abstinence or no agreement to use barrier methods of birth control / contraception during the study
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271
NCT00000393
Inclusion Criteria: History of either opportunistic infection and/or Kaposi's sarcoma, and/or serologic evidence of past infection with HIV. Ability to give informed consent. Allowed but discouraged: Antiretroviral medication. Immunomodulating medication. Psychoactive medication. Not breast-feeding Abstinence or agree to use barrier methods of birth control / contraception during the study Not pregnant Negative pregnancy test CD4 >= 200 cells/mm3 (200 - 300 - 400 - 500 - 600 - 700 - 800 plus). Creatinine <= 1.6 mg/dl Hemoglobin >= 12 g/dl Platelet Count >= 100000 /mm3 Exclusion Criteria: Patients with the following diseases or symptoms are excluded: Space-occupying lesion in brain. Life-threatening opportunistic infection at time of entry into trial. History of major psychiatric illness prior to 1977 or time of initial exposure to HIV, if that is known. Patients with the following diseases or symptoms are excluded: Space-occupying lesion in brain. Life-threatening opportunistic infection at time of entry into trial. History of major psychiatric illness prior to 1977 or time of initial exposure to HIV, if that is known. Excluded within 4 weeks of study entry: Antiretroviral agents. Anticancer treatments. Psychoactive agents. Excluded within 4 months of study entry: Suramin. Avoid: Antiretroviral medication. Immunomodulating medication. Psychoactive medication. Excluded within 4 weeks of study entry: Radiation. Breast-feeding Positive pregnancy test Pregnant No abstinence or no agreement to use barrier methods of birth control / contraception during the study
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272
NCT00000394
Inclusion Criteria: Hand or wrist pain combined with parathesias or numbness in any or all fingers, predominating in a median nerve distribution, and especially occurring at night Symptoms unresponsive or poorly responsive to standard conservative therapy (wrist splints, analgesics, nonsteroidal anti-inflammatory drugs) Electrodiagnostic evidence of distal median neuropathy compatible with carpal tunnel syndrome (to be confirmed at study site) Symptoms present for at least 3 months No prior treatment with acupuncture for carpal tunnel syndrome Exclusion Criteria: Evidence of pronounced abductor pollicis weakness or significant thenar wasting (probable candidate for carpal tunnel surgery) Prior carpal tunnel surgery on affected side Use of narcotic analgesia History of wrist or hand fracture on the symptomatic limb Current pregnancy or less than 3 months postpartum Corticosteroid injection into the carpal tunnel within 3 months History of generalized peripheral neuropathy or clinical or electrodiagnostic evidence of generalized polyneuropathy or mononeuropathy multiplex History of other neurologic disorders which may cause confusion with the diagnosis of carpal tunnel syndrome, including but not limited to stroke, cervical radiculopathy, myelopathy, subdural hematoma, brain tumor Inflammatory articular disease or tendinitis of the hand or wrist by history or physical examination Insulin-dependent diabetes mellitus Clinical hypothyroidism Chronic renal failure or renal dialysis or forearm fistulae Other disorder known to predispose to carpal tunnel syndrome including acromegaly, multiple myeloma, amyloidosis
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273
NCT00000395
Inclusion Criteria: Individuals starting methotrexate for rheumatoid arthritis. Study subjects should not currently be taking folic acid-containing vitamins. Exclusion Criteria: Cancer, renal, or liver disease. Previous use of methotrexate within the past 6 months or current use of folic acid-containing supplements.
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274
NCT00000396
Inclusion Criteria: Urban African Americans with arthritis 18 years or older Exclusion Criteria: None
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275
NCT00000397
Inclusion Criteria: Insomnia for more than 1 month Fibromyalgia diagnosis Participants must live within easy commuting distance of Duke Medical Center, Durham, North Carolina Exclusion Criteria: Terminal illness Major psychiatric disorder Substance abuse Dependence on hypnotic drugs Other sleep disorders (sleep apnea, restless legs, etc.) Other sleep-disturbing medical disorders (painful arthritis, thyroid condition, etc.)
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276
NCT00000398
Inclusion Criteria: Complaints of pain persisting for 6 months Meet diagnostic criteria for fibromyalgia (American College of Rheumatology criteria) Exclusion Criteria: A significant adverse medical condition that would expose the individual to increased risk of an adverse experience during the course of the trial (e.g. a recent (<6 months) myocardial infarction) An abnormal cardiac response to exercise Other significant rheumatic disease Receiving or applying for disability or compensation benefits because of fibromyalgia
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277
NCT00000399
Inclusion Criteria: Age 40-65 years. Post-menopause (3-10.9 years) due to hysterectomy or natural menopause. Post-menopausal females, 3-10 years past menopause (natural or surgical menopause); if subjects are currently taking hormone replacement therapy (HRT), they must be taking HRT for at least 1 year but no more than 6 years. The subjects must be relatively sedentary, not currently engaged in strength-training exercises. Nonsmoker. Cancer free for the last 5 years (treatment free for last 5 years) excluding skin cancers. Resident of Tucson (48 out of 52 weeks of year). Exclusion Criteria: History of bone fractures or currently have osteoporosis. Currently taking medications that control cholesterol or alter bone mineral density. Currently taking beta-blockers or steroids in large quantities/frequencies. Currently participating in any other research study. Amount of physical activity exceeds 120 minutes of moderate exercise per week. Moderate exercise examples: brisk walking, golfing, gardening, housework, house painting. Potential subject cannot be weight lifting.
Female
278
NCT00000400
Inclusion Criteria: Lumbar spine or hip BMD T-score less than or equal to minus 2.0 Postmenopausal at least 5 years Fully ambulatory Able to give informed consent Exclusion Criteria: No concurrent illnesses that cause bone loss No recent drug treatment for osteoporosis No recent fracture
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279
NCT00000401
Note: accrual into this trial has been discontinued, but patients previously enrolled are still being followed. Inclusion Criteria: Clinically stable RA and unlikely to require adjustment of doses of DMARDs, NSAIDs, prednisone, or anti-TNFα therapies for the treatment phase of the study Meets American College of Rheumatology (ACR) 1988 revised criteria for RA Onset of disease at age 16 or older Onset of disease at least 3 months prior to enrollment PBMC - IFNγ - α1(II)/PBS stimulation index greater than or equal to 1.5 in 6 months prior to baseline visit Agree to discontinue herbal remedies described in this protocol Agree to use acceptable forms of contraception Exclusion Criteria: Participation in another clinical research study involving the evaluation of another investigational drug within 90 days prior to study entry Currently taking greater than 7.5 mg prednisone daily Intra-articular corticosteroid injections within 30 days prior to study entry Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study Pregnancy Beef allergy Use of fish oil within 4 weeks of study entry Previous use of auranofin or cyclophosphamide (all other DMARDs are allowed) Previous autologous or heterologous stem cell transplantation Active malignancy or past treatment consisting of antineoplastic drugs or total lymphoid irradiation Intolerance to citrus juices or colorless carbonated beverages
All
280
NCT00000402
Inclusion Criteria: Pubertal stage II Calcium intake below a threshold level Caucasian Normal health Exclusion Criteria: Medications affecting calcium and bone metabolism Chronic diseases Metabolic bone disease Abnormality in calcium metabolism
Female
281
NCT00000403
Inclusion Criteria: Women 45-64 years of age. Upper tertile of sex-, age- and race-adjusted norms for body mass index. Unilateral knee OA at baseline. Postmenopausal status or otherwise incapable of childbearing. Ability to ambulate (move about) independently without assistive devices. Ability to read and write in English or Spanish and give informed consent. Exclusion Criteria: Premenopausal status (unless subject has had a hysterectomy). Current use of any investigational drug. Significant hematologic, renal, hepatic or cardiovascular disease (but not including mild/moderate hypertension) or any other serious medical condition that might preclude the subject's ability to participate fully in the project, keep clinic appointments, etc. Prior surgery (including arthroscopy) of the contralateral knee. Significantly abnormal laboratory values at the time of enrollment. Pigmented villonodular synovitis of the knee. Synovial chondromatosis. Charcot arthropathy. A known "secondary" cause of OA, including acute or chronic infectious OA; crystal-induced arthritis; systemic inflammatory connective tissue disease (e.g., rheumatoid arthritis, systemic lupus erythematosus); osteonecrosis; Paget's disease; or metabolic diseases, such as hemochromatosis, Wilson's disease, or ochronosis. Chondrocalcinosis, however, will not be an exclusion criterion. Conditions other than knee OA which limit lower extremity function and mobility and/or would confound the evaluation of knee pain and function (e.g., clinically significant spinal or hip arthritis, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, stroke, etc.). Steroid injection into either knee within past 3 months. A history of photosensitivity (sensitivity to light) or any other adverse reaction to a tetracycline. Failure to pass a "faintness-of-heart" test (pre-randomization compliance test). Prior chronic use of tetracycline (e.g., for severe acne). Severe OA (Kellgren and Lawrence Grade IV) of the index knee. Salicylate use, with a mean dose >2g/d. Institutionalization.
Female
282
NCT00000404
Inclusion Criteria: Study participants must be treated for chronic knee pain by a primary care physician at a participating HMO and satisfy American College of Rheumatology Clinical Criteria for the diagnosis of knee OA. All subjects will be able to read and write English, have a telephone, and give informed consent. Exclusion Criteria: Significant hematologic, renal, hepatic, or cardiovascular disease (but not including mild/moderate hypertension) or any other serious medical condition that might preclude the subject's ability to participate fully in the project, keep clinic appointments, etc. Conditions other than knee OA which limit lower extremity function and mobility and/or would confound the evaluation of knee pain and function (e.g., clinically significant spinal or hip arthritis, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, stroke, etc.). A known "secondary" cause of OA, including acute or chronic infectious arthritis; crystal-induced arthritis; systemic inflammatory connective tissue disease (e.g., rheumatoid arthritis, systemic lupus erythematosus); osteonecrosis; Paget's disease; or metabolic diseases, such as hemochromatosis, Wilson's disease, or ochronosis.
All
283
NCT00000405
Inclusion Criteria: Apparently healthy boys and girls BMI < 30kg/m2 Exclusion Criteria: BMI < 30kg/m2 Orthopedic problems that would limit physical participation Metabolic diseases that would influence bone metabolism
All
284
NCT00000406
Inclusion Criteria: Males and females 60 to 100 years of age Exclusion Criteria: Knee joint replacement surgery Diabetes mellitus Uncontrollable hypertension Neuropathies of the lower extremity Poor mental cognition (i.e., inability to follow instructions)
All
285
NCT00000407
Inclusion Criteria: Resident of Alabama Previously employed Currently unemployed due to musculoskeletal disability Feel capable of work Want to work Exclusion Criteria: Not a resident of Alabama Unable to work
All
286
NCT00000408
Inclusion Criteria: Must live in the United States Must understand and write English Must have access to a computer with e-mail and expect to have this access for at least 3 years Must be 18 years old Must have seen a doctor for back pain at least once in the past year Exclusion Criteria: Pregnancy Back surgery in the past 6 months Expectation of having back surgery in the next 6 months Back pain due to a car accident or other major injury within the last 6 months Back pain or sciatica due to systemic disease (inflammatory rheumatic diseases, tumor, or other) Major physical or mental health condition for which one is currently being treated that severely limits daily activities Terminal illness Receiving disability or workers compensation insurance payments for back pain or sciatica Presently involved in legal proceedings because of back pain or sciatica Difficulty with bladder or bowel control that began with back pain or sciatica No visits to a doctor in the past year for back pain or sciatica Numbness in crotch area that began with back pain or sciatica Age under 18
All
287
NCT00000409
Inclusion Criteria: Duration of Symptoms: 12 or more weeks. Treatments Tried: Nonsteroidal. anti-inflammatory medical therapy and physical therapy. Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms. Tests: MRI to confirm diagnosis and level(s). Exclusion Criteria: Previous lumbar spine surgery. Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months. Possible pregnancy. Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years. Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine. Age less than 18 years. Cauda equina syndrome or progressive neurologic deficit (usually requiring urgent surgery). Unavailability for followup (planning to move, no telephone, etc.) or inability to complete data surveys. Symptoms less than 12 weeks. Patient currently enrolled in any experimental "spine related" study.
All
288
NCT00000410
Inclusion Criteria: Duration of symptoms: 6 or more weeks. Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy. Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising. Tests: MRI to confirm diagnosis and level(s). Exclusion Criteria: Previous lumbar spine surgery. Not a surgical candidate for any of these reasons: Overall health which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months. Possible pregnancy. Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no clinical signs or symptoms of the malignancy for at least 5 years. Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine. Age less than 18 years. Cauda Equina syndrome or progressive neurological deficit (usually requiring urgent surgery). Unavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys. Symptoms less than 6 weeks. Patient currently enrolled in any experimental "spine related" study.
All
289
NCT00000411
Inclusion Criteria: Duration of Symptoms: 12 or more weeks. Treatments tried: Nonsteroidal anti-inflammatory medical therapy and physical therapy. Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms. Tests: MRI to confirm diagnosis and level(s). Exclusion Criteria: Previous lumbar spine surgery. Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months. Possible pregnancy. Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years. Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine. Age less than 18 years. Cauda equina syndrome or progressive neurologic deficit (usually requiring urgent surgery). Unavailability for followup (planning to move, no telephone, etc.) or inability to complete data surveys. Symptoms less than 12 weeks. Patient currently enrolled in any experimental "spine related" study.
All
290
NCT00000412
Inclusion Criteria: Cardiac transplantation Exclusion Criteria: Active peptic ulcer disease, gastrectomy, inflammatory bowel disease, malignancy, Paget's disease of bone, osteogenesis imperfecta, multiple myeloma, primary hyperparathyroidism, rheumatoid arthritis, Cushing's syndrome, or thyrotoxicosis Suppressive doses of thyroid hormone, anticonvulsant drugs, past bisphosphonate therapy, current calcitonin therapy, or fluoride therapy Cirrhosis, inflammatory liver disease, or nephrolithiasis Serum creatinine > 2.5 mg/dl
All
291
NCT00000413
Inclusion Criteria: 9- and 10-year-old premenarchal girls (girls who have not started their periods). Exclusion Criteria: Comorbid conditions or medications that are associated with decreased bone density such as the following: corticosteroids; anticonvulsants; thiazide diuretics; history of cancer; Type I diabetes; thyrotoxicosis; hyperparathyroidism; Cushing's syndrome; juvenile rheumatoid arthritis; connective tissue disease or hemolytic anemia; asthma which may limit ability to participate in the exercise intervention; known history of dietary disorder, including anorexia, bulimia or lactose intolerance; postmenarchal.
Female
292
NCT00000414
Inclusion Criteria: Physician diagnosis of OA or RA Participation in the ARAMIS longitudinal study Exclusion Criteria: Age under 18
All
293
NCT00000415
Inclusion Criteria: Enrolled in participating childcare center. Does not plan to attend kindergarten or withdraw from center in the next 12 months. Exclusion Criteria: Chronic disease that may interfere with growth and bone mass accretion (cystic fibrosis, liver disease, asthma that is being treated with steroids, juvenile rheumatoid arthritis, immobilization).
All
294
NCT00000416
Inclusion Criteria: Must currently be employed full or part time Must live in selected communities in eastern Massachusetts Exclusion Criteria: Plans to move from area Plans to have joint replacement surgery in next 6 months Plans to retire or go on disability within next 2 years
All
295
NCT00000417
Inclusion Criteria: Has partner willing to participate in study Exclusion Criteria: Unable to read and write English questionnaires Unable to be reached by phone Rheumatologist considers patient unable to participate, generally due to patient cognitive problems or severe illness
All
296
NCT00000418
Inclusion Criteria: Acute low back pain Exclusion Criteria: Chronic back pain (including surgery) Disability claim for back pain Nursing home resident Severe impairment in hearing, vision, or speech Unable to speak English Severe comorbidity Unable to contact by phone Excluded by primary care physician
All
297
NCT00000419
Inclusion Criteria: Female Unequivocal diagnosis of SLE Inactive disease or stable on 0.5 mg/kg/day or less of prednisone Chemical evidence of menopause or have stopped periods for at least 6 months Exclusion Criteria: Blood pressure >145/95 on three occasions Deep vein, arterial thrombosis or pulmonary embolus GPL >40; MPL >40; APL >50; dRVVT >37 sec APL antibody syndrome ever Gynecologic or breast cancer Hepatic dysfunction or liver tumors Diabetes mellitus (NOT due to steroids) with vascular disease Congenital hyperlipidemia Complicated migraine Severe disease activity (SLEDAI >12) Increase in SLEDAI >2 points in 3 months Unexplained vaginal bleeding Use of estrogen (HRT or OCP) for >1 month at any time after SLE diagnosis FSH <40 Premenopausal myocardial infarction
Female
298
NCT00000420
Inclusion Criteria: Female Unequivocal diagnosis of SLE Inactive disease or be stable on 0.5 mg/kg/day or less of predisone Must be between 18 and 39 years old if non-smoker Must be between 18 and 35 years old if smoker Exclusion Criteria: Blood pressure >145/95 on three occasions Deep vein, arterial thrombosis or pulmonary embolus GPL >40; MPL >40; APL >50; dRVVT >37 sec APL antibody syndrome ever Gynecologic or breast cancer Hepatic dysfunction or liver tumors Diabetes mellitus (NOT due to steroids) with vascular disease Congenital hyperlipidemia Complicated migraine Severe disease activity (SLEDAI >12) Increase in SLEDAI >2 points in 3 months Unexplained vaginal bleeding Use of estrogen (OCP) for >1 month at any time after SLE diagnosis Present pregnancy Angina or MI due to APS Age >35 yrs. for smokers; >39 yrs. for nonsmokers
Female
299
NCT00000421
Inclusion Criteria: Meets ACR criteria for SLE Inactive or stable in lupus activity History of positive dsDNA Current prednisone dose no more than 15 mg daily Exclusion Criteria: Active infections Poorly controlled diabetes mellitus Pregnancy Uncontrolled hypertension
Female
300
NCT00000422
Inclusion Criteria: Female Able to visit Seattle based clinic 9 times Meet ACR criteria for FMS Exclusion Criteria: Pregnancy Exercise contraindicated by physician due to other medical conditions Significant psychopathology Do not meet FMS criteria Cardiac problems
Female
301
NCT00000423
Inclusion Criteria: A diagnosis of fibromyalgia documented in medical records and confirmed using The American College of Rheumatology criteria for classification of FMS: (1) A history of widespread pain (pain on both sides of the body, above and below the waist, and present for at least 3 months). (2) Pain in 11 or more of 18 tender-point sites. Patient willing to attend 10 weekly meetings and 10 monthly meetings. Exclusion Criteria: Patients who do not meet ACR criteria for FMS described above. Patients who cannot attend meetings once a week for 10 weeks and once a month for 10 months were excluded.
All
302
NCT00000424
Inclusion Criteria: Knee pain attributed to osteoarthritis for at least 1 year. Meet American College of Rheumatology clinical or clinical plus x-ray criteria for knee osteoarthritis Have at least a moderate pain rating on at least one of the five Western Ontario-McMaster University Osteoarthritis Index (WOMAC) scales Exclusion Criteria: Significant conditions of the spine, hips, or feet that affect the ability to walk Significant medical conditions that affect the ability to walk and function Inflammatory arthritis, such as rheumatoid arthritis or gout Degenerative arthritis secondary to other conditions, such as hemochromatosis, Wilson's disease, or ochronosis Current significant soft tissue rheumatism such as fibromyalgia, anserine bursitis, or trochanteric bursitis
All
303
NCT00000425
Inclusion Criteria: Knee osteoarthritis Moderate radiographic evidence by Kellgren and Lawrence grade 2-4 Knee pain > 20 on VAS pain scale Exclusion Criteria: Bilateral knee replacements Unwillingness to take acetaminophen for pain relief
All
304
NCT00000426
Inclusion Criteria: Women in good health Dietary calcium-to-protein ratio (in mg:g, as assessed by 7-day food diary) does not exceed 13 Exclusion Criteria: Smoking Pregnancy Lactation Endocrine disease
Female
305
NCT00000427
Inclusion Criteria: Bone density of the spine or femoral neck two standard deviations below the mean of young adult men Normal renal and liver function tests, normal serum testosterone level, normal vitamin D and PTH levels Exclusion Criteria: Significant cardiac, renal, hepatic, or malignant disease. Disorders (e.g., Paget's disease, hyperthyroidism, hyperparathyroidism) or drugs (e.g., steroids, anticonvulsants, lithium, bisphosphonates, calcitonin, fluoride) known to affect bone metabolism Active peptic ulcer disease or severe reflux
Male
306
NCT00000428
Inclusion Criteria: Patients who meet fibromyalgia criteria as defined by the American College of Rheumatology No systemic illness (current or past) or other contraindications to taking study medications (e.g. known hypersensitivity) Age 18-60 Patient willingness, and physician agreement, to discontinue CNS medications/NSAIDs/analgesics for 1 week prior to starting their trial Patient informed consent and agreement to participate in an N-of-1 trial Exclusion Criteria: Patients who are currently pregnant or who plan to become pregnant during the study period Patients with any contraindications to using either amitriptyline or fluoxetine
All
307
NCT00000429
Inclusion Criteria: JRA Diagnosis by American College of Rheumatology diagnostic criteria Age 6-18 years Exclusion Criteria: Taking calcium supplements or calcium- containing antacids Taken systemic corticosteroids in the prior 3 months Use of oral contraceptives Smoker Have been or currently pregnant Have another chronic illness that affects growth or bone mineralization (for example, Down's Syndrome, inflammatory bowel disease, steroid-dependent asthma) Fasting random urinary calcium/creatinine ratio > 0.2
All
308
NCT00000430
Inclusion Criteria: Women at least 60 years of age. Good general health. Willingness to participate in this 3.5 year study. Ability to give informed consent. Ability to live independently and travel to the research center for visits (we will provide transportation on a limited basis). Spine bone mineral density (BMD) (L1-4) T-score between -1.0 and -2.5, or a hip T-score between -1.0 and -2.5. A T-score of -1.0 is equal to a bone mass of one standard deviation below the mean peak bone mass in healthy young adult women. Exclusion Criteria: Any history of cancer except the following: (a) superficial basal or squamous cell carcinoma of the skin which has been completely resected or resolved by a topical chemotherapeutic agent, and (b) other malignancies treated curatively at least 10 years previously, without any evidence of recurrence. Abnormal transvaginal ultrasound that has not been investigated and cleared by endometrial biopsy. History of low-trauma hip or spine fracture previously diagnosed. Serious residuals from cerebral vascular disease. Diabetes mellitus, except for easily controlled, non-insulin dependent or insulin dependent diabetes mellitus without significant microvascular or neuropathic disease. Serum creatinine >1.9 mg/dl. Chronic liver disease or alcoholism. Treatment with bone active agents such as fluoride or bisphosphonates within the previous 2 years. Treatment with calcitonin, estrogen, or a selective estrogen receptor modulator within the previous 6 months. Systemic corticosteroid therapy at pharmacologic levels for more than 6 months duration. Any corticosteroid therapy within the previous 6 months. Treatment with anticonvulsant therapy within the previous year. Clinically significant abnormalities on pre-study laboratory or clinical screens. Treatment with thyroid hormone is accepted, provided the patient is euthyroid at the time of entry, and the serum TSH by ultrasensitive assay is normal. Uncontrolled hypertension. Unstable angina. Myocardial infarction within 1 year prior to entry. Evidence of metabolic bone disease, e.g. hyper- or hypoparathyroidism, Paget's disease, osteomalacia, osteogenesis imperfecta, or others. Active rheumatoid arthritis or collagen disease. Recent major gastrointestinal disease (within the past year) such as peptic ulcer, malabsorption, chronic ulcerative colitis, regional enteritis, or any significant chronic diarrhea state. Tobacco use at a level of more than 10 cigarettes per day.
Female
309
NCT00000431
Inclusion Criteria: Patient must have a venous leg ulcer. Patient must have failed at least 6 weeks of limb compression. Wound must be free of necrotic debris. Wound must be greater than 5 cm2 and less than 20 cm2. Wound must be more than 6 months old. Affected limb must have an ankle-brachial index (ABI) > 0.85. Patient must be more than 18 years old. Exclusion Criteria: Any active cancer or cancer in remission for less than 10 years. Patients with life expectancy of less than 6 months. Liver function tests (Alanine Transaminase(ALT) Aspartate Amino Transfer (AST) Alkaline Phosphatase (ALK PHOS) and bilirubin) greater than 1.5x upper limit of normal for the reference lab. Patients with intercurrent organ damage or medical problems. Pregnant or lactating females. Any requirement for systemic corticosteroids or immunosuppressives, or history of corticosteroid or immunosuppressive use in the 4 weeks previous to study entry. Seropositive for hepatitis B surface antigen or hepatitis C antibody. Any concurrent medical illness that may be exacerbated by PDGF-B/Ad5 administration.
All
310