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NCT00000102 | Inclusion Criteria: diagnosed with Congenital Adrenal Hyperplasia (CAH) normal ECG during baseline evaluation Exclusion Criteria: history of liver disease, or elevated liver function tests history of cardiovascular disease | All | 0 |
NCT00000104 | Inclusion Criteria: Pregnant mothers of the Phillips neighborhood in Minneapolis, Minnesota. Subject recruitment will take place in local clinics which serve pregnant women and offspring | Female | 1 |
NCT00000105 | Inclusion Criteria: Patients must have a diagnosis of cancer of any histologic type. Patients must have a Karnofsky performance status great or equal to 70%. Patients must have an expected survival for at least four months. Normal healthy volunteers to serve as control for this study. All patients must sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota Exclusion Criteria: Pregnant or lactating women. Females of child-bearing potential will be asked to take a pregnancy test before receiving vaccines. Serious intercurrent medical illnesses which would interfere with the ability of the patient to carry out the follow-up monitoring program. Immunization should not be administered during the course of any febrile illness or acute infection. Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury derivative. The occurrence of any type of neurologic symptoms to tetanus vaccine in th past. Patients with a history of seafood allergy are excluded from receiving KLH. Subjects who have had tetanus toxoid within the last 7 years are not eligible for tetanus vaccine component of this protocol. | All | 2 |
NCT00000106 | Inclusion Criteria: Patients are required to meet the criteria of the American College of Rheumatology (ACR)for rheumatoid arthritis. Patients should be in functional class II, or III according to the criteria of the ACR. All candidates must be unsuccessfully treated (lack of efficacy) with at least two of the following disease-modifying antirheumatic drugs: hydroxychloroquinine, oral or injectable gold, methotrexate, azathioprine, penicillamine, and sulfasalazine. Patients receiving nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids (<= 10 mg per day), or both are eligible if the dosage has been stable for at least four weeks before treatment and remained so throughout the study and follow-up period (the use of narcotics for pain flares is allowed). The necessary degree of disease activity at enrollment should be confirmed by a finding of 10 or more swollen joints, 12 or more tender joints, and one of the following two criteria: a Westergren erythrocyte sedimentation rate of at least 28 mm per hour or a serum C-reactive protein level of more than 2.0 mg per deciliter; or morning stiffness for at least 60 minutes. Patients must have adequate bone marrow function, adequate liver function, adequate renal function, calcium and electrolytes. Patients must have a dobutamine stress ECHO, or exercise cardiac MUGA, or exercise ECHO scan prior to entry and must fulfill certain criteria to be eligible. The spirit of the criteria are to rule out organic heart disease. Respiratory status: Patients who have FEV1 of >= 60% of predicted, as well as a maximum voluntary volume (MVV) of >= 60% of predicted, and blood gases with a PO2 of >= 60 or oxygen saturation of >= 90% are eligible. | All | 3 |
NCT00000107 | Inclusion Criteria: Resting blood pressure below 140/90 | All | 4 |
NCT00000108 | Inclusion Criteria: Postmenopausal and preferably on hormone replacement therapy In good general health Have a body mass index (BMI, weight in kg/height in m2) of between 25 and 40 Exercise less than 20 min/day two days a week | Female | 5 |
NCT00000110 | Inclusion Criteria: Healthy volunteers (developmental phase) Healthy endurance-trained subjects Maximum age for males is 39 Maximum age for females is 49 | All | 6 |
NCT00000111 | Inclusion Criteria: Lack sufficient attached keratinized tissue at recipient surgical site in question | All | 7 |
NCT00000112 | Inclusion Criteria: Obesity: BM +/- 95% for age general good health | All | 8 |
NCT00000113 | Children between the ages of 6 and 12 years with myopia in both eyes (defined as spherical equivalent between -1.25 D and -4.50 D in each eye as measured by cycloplegic autorefraction), astigmatism less than or equal to 1.50 D, and no anisometropia (defined as a difference in spherical equivalent between the two eyes greater than 1.0 D) are eligible for inclusion. Exclusion criteria include visual acuity greater than 20/25, strabismus, use of contact lenses, birth weight less than 1,250 grams, use of bifocal or progressive addition lenses, or any conditions precluding adherence to the protocol. | All | 9 |
NCT00000114 | Men and nonpregnant women between ages 18 and 49 years with common forms of RP were included. All eligible patients had retinal arteriolar attenuation, elevated dark adaptation thresholds, and reduced ERGs. Patients had best corrected Snellen visual acuity of 20/100 or better, central visual field diameter on the Goldman perimeter with V4 e white test light of 8 degrees or greater, and ERG amplitude of 2.5 or greater in response to 0.5-Hz white light or of 0.12 ultraviolet light or greater in response to 30-Hz white flickering light in at least one eye. In addition, patients had normal fasting serum retinol and serum liver function profile and weight above the lower fifth percentile for age, sex, and height. All patients had a total estimated pre-trial intake of vitamins A and E from diet plus pills not greater than 11,500 IU/day and 40 IU/day, respectively. | All | 10 |
NCT00000115 | Males and females 8 years of age or older and weighing at least 35 kg (77 lb) were eligible for the study. Patients had to have a best corrected visual acuity of 20/40 or worse in at least one eye with cystoid macular edema demonstrable on fluorescein angiography. Patients were allowed to receive systemic therapy for their uveitis. Exclusion criteria included current use of acetazolamide as part of a therapeutic regimen; a history of hypersensitivity reactions to acetazolamide, sulfonamides, or angiography dye; unclear ocular media that would obscure fluorescein angiography; macular subretinal neovascularization or a macular hole; or inability to take acetazolamide for medical reasons. | All | 11 |
NCT00000116 | Inclusion Criteria: Eligible patients must: Be between the ages of 18 and 56 Be able to see the entire face of someone sitting across the table from them without scanning Read newspaper-size print without special magnifying aids Walk unaided in daylight Have a normal fasting serum vitamin A and normal liver function profile Be in good general health Reside in the United States Exclusion Criteria: Women who are pregnant or planning to become pregnant cannot be included because of the risk of birth defects that could occur while they are on a vitamin A supplement. | All | 12 |
NCT00000117 | To be eligible, patients must have a history of one or more episodes of previous demyelinating optic neuritis occurring in the setting of classic, adult-onset definite MS (clinically definite or laboratory-supported definite MS, or cranial MRI changes consistent with MS). In most cases, onset of MS will have occurred between the ages of 18 and 45. Patients must be younger than 50 years and must have apparently irreversible loss of visual acuity that meets the following criteria: Visual acuity must be worse than 20/40 for at least 6 months. Patients must be able to read at least one letter on the 1-meter eye chart. Patients with no light perception or hand movement vision only are not eligible. The above level of visual dysfunction must be observed on at least two serial examinations (separated by at least 1 month) in the Department of Ophthalmology at the Mayo Clinic. Optic disc pallor must be present. Patients must have impairment in the affected eye(s) on perimetry consistent with optic nerve dysfunction and must have a visual field mean deviation of less than -4.00. Patients must not have received ACTH or corticosteroids within the preceding 2 months. | All | 13 |
NCT00000118 | All patients must have had AIDS as defined by the Centers for Disease Control and Prevention and non-sight-threatening CMV retinitis Patients could not have been previously treated with systemic ganciclovir or foscarnet and must not have had evidence of other organ involvement with CMV. Patients must have had an absolute neutrophil count (ANC) greater than 1,000 cells/mL and a platelet count greater than 25,000/mm3 | All | 14 |
NCT00000119 | Women and men 18 years or older with a documented history of uveitis in an eye requiring cataract surgery are eligible for the study. In all patients, the eye must be free of active inflammation for at least 3 months before surgery, with or without anti-inflammatory medications. Exclusion criteria include corneal pathology or hazy media that preclude evaluation of the intraocular lens, uncontrolled glaucoma, and diabetes mellitus. Monocular patients and patients who cannot be followed for at least 1 year are also excluded. | All | 15 |
NCT00000120 | The study included male and female infants delivered at University Hospital in Seattle, Washington. Women were recruited after the 28th week of pregnancy and had to be English-speaking. In addition, they planned to stay at the hospital at least 48 hours following delivery and lived in the greater Seattle metropolitan area. Infants were eligible whether they were delivered vaginally or by cesarean section. Excluded from the study were siblings of infants enrolled in the study, women who were culture-positive for gonorrhea, infants receiving systemic antimicrobials for reasons other than conjunctivitis, women receiving antimicrobials at the time of delivery, and families unlikely to be available for followup after delivery. | All | 16 |
NCT00000121 | An eligible male or female must have been age 3 years or older (adults were included) and must have had esotropia that occurred at age 6 months or older, with no history of previous eye muscle surgery. | All | 17 |
NCT00000122 | Men and women with uncontrolled intraocular pressure greater than 21 mm Hg in one or both eyes despite maximal tolerated therapy and who were aphakic or had undergone previous filtering surgery were eligible to participate. | All | 18 |
NCT00000123 | Myopic volunteers, ages 20 to 35, who had not worn contact lenses were eligible to participate in the study if they were free of ocular disease, were in good physical health, and were not taking systemic medications that could have ocular side effects. In addition, eligibility was limited to persons with corneal curvature between 40.50 and 47.00 D (flatter keratometry reading), corrected visual acuity of 6/6 (20/20) or better in each eye, astigmatism less than 0.75 D, anisometropia less than 1 D, and myopia between 1 and 4 D. | All | 19 |
NCT00000124 | Men and women eligible for the study must be age 21 or older, have primary choroidal melanoma in only one eye, and have no evidence of metastatic disease. Accurate estimation of tumor thickness by echography must also be possible. | All | 20 |
NCT00000125 | Men and nonpregnant women between the ages of 40 and 80 with IOP greater than or equal to 24 mm Hg but less than or equal to 32 mm Hg in at least one eye and IOP greater than or equal to 21 but less than or equal to 32 mm Hg in the fellow eye, as well as normal visual fields and optic discs are eligible for the trial. Patients presenting with best-corrected visual acuity worse than 20/40 in either eye, previous intraocular surgery, a life-threatening or debilitating disease, secondary causes of elevated IOP, angle-closure glaucoma or anatomically narrow angles, other diseases that can cause visual field loss, background diabetic retinopathy, optic disc abnormalities that can produce visual field loss or obscure the interpretation of the optic disc, or unwillingness to undergo random assignment are excluded from the trial. | All | 21 |
NCT00000126 | All living patients from the 420 patients originally enrolled in the IONDT have been asked to participate in the IONDT Followup Study. No new patients are being recruited. | All | 22 |
NCT00000127 | Men and women age 50 years or older, with acute NAION and visual symptoms for 14 days or less since the onset of symptoms, and visual acuity worse than or equal to 20/64 were eligible for randomization. | All | 23 |
NCT00000128 | Boys must have been between 6 and 12 years of age; girls between 6 and 11 years of age. All children must have had at least 0.5 diopters of myopia in both eyes, near-point esophoria, at least 20/25 acuity in each eye, and 40 seconds of stereopsis and must have been free of ocular disease or systemic disease that may have altered refraction. All subjects were willing to wear bifocal spectacle lenses for 30 months. | All | 24 |
NCT00000129 | All men and women had 2 to 8 diopters of simple myopia and were correctable to 20/20 or better with glasses or contact lenses. All patients had the stability of their myopia documented by previous records. Patients were at least 21 years of age and lived in the metropolitan area of the study centers. Each patient agreed to have surgery on one eye and to wait 1 year for surgery on the other eye. Patients with systemic diseases that might affect corneal wound healing and patients with high corneal astigmatism were excluded from the study. | All | 25 |
NCT00000130 | Men and women were eligible for entry into the EVS if they had clinical signs and symptoms of bacterial endophthalmitis in an eye that had cataract surgery or lens implantation within 6 weeks of onset of infection. The involved eye had to have either hypopyon or enough clouding of anterior chamber or vitreous media to obscure clear visualization of second-order arterioles, a cornea and anterior chamber in the involved eye clear enough to visualize some part of the iris, and a cornea clear enough to allow the possibility of pars plana vitrectomy. The eyes had to have a visual acuity of 20/50 or worse and light perception or better. Patients were ineligible when the involved eye was known at the time of study entry to have had any pre-existing eye disease that limited best-corrected visual acuity to 20/100 or worse before development of cataract, any intraocular surgery before presentation (except for cataract extraction or lens implantation), any treatment for endophthalmitis before presenting at the study center, or any ocular or systemic condition that would prevent randomization to any of the study groups. | All | 26 |
NCT00000131 | Men and women must have been age 21 or older and willing to return for followup visits for 3 years following assignment into the appropriate group and randomization. Each of the four groups has specific eligibility criteria. Patients with retinal vascular disease other than that specified in the criteria, such as diabetic retinopathy, were ineligible. Patients with macular disease other than that due to CVO were ineligible for that portion of the study. | All | 27 |
NCT00000132 | Men and women between ages 50 and 80 years who have newly detected and untreated chronic open-angle glaucoma with repeatable visual field defects by Humphrey perimetry are eligible for inclusion. Exclusion criteria include the following: advanced visual field loss (MD less than or equal to 16 dB) or threat to fixation; mean IOP > 30 mm Hg or any IOP > 35 mm Hg in at least one eye; VA < 0.5 in either eye; or any conditions precluding reliable fields or photos, use of study treatment, or 4-year followup. | All | 28 |
NCT00000133 | Premature infants of either gender who were eligible for the natural history study had weighed less than 1,251 grams at birth and had survived the first 28 days of life. They had no major ocular or systemic congenital anomalies. Infants who met these criteria and also had a threshold level of ROP (defined as stage 3+ of the International Classification of Retinopathy of Prematurity occupying five or more contiguous or eight cumulative 30 degree sectors [clock hours] of stage 3 ROP in zone I or II in the presence of plus disease) could be referred for examination to determine eligibility for entry to the cryotherapy trial. | All | 29 |
NCT00000134 | inclusion criteria: Males and females eligible for the CRRT must have been age 18 years or older and have had AIDS and CMV retinitis. They must have had active CMV despite a minimum of 28 days of previous treatment with an anti-CMV drug. Furthermore, they must have had an absolute neutrophil count greater than or equal to 500 cells/µL, platelet count greater than or equal to 20,000 cells/µL, and a serum creatinine < 2.5 mg/dL in order to tolerate the drug regimens. exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of therapy involving the combination of foscarnet and ganciclovir, unwillingness to practice appropriate birth control, active drug or alcohol abuse, media opacity, retinal detachment not scheduled for surgical repair | All | 30 |
NCT00000135 | Inclusion criteria: 13 years or older at entry Diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC) definition Diagnosis of active CMV retinitis as determined by a SOCA-certified ophthalmologist at time of enrollment At least one lesion whose size is one-quarter or more optic disc area Currently receiving (for relapsed patients) or scheduled to receive (for newly diagnosed patients) drugs for primary treatment of CMV retinitis that are not contraindicated for use with MSL-109 Visual acuity, in at least one eye that meets other eligibility criteria, of 3 or more letters on ETDRS chart at 1 meter distance (Snellen equivalent 5/200). Patients with poorer visual acuity may be enrolled if the visual acuity impairment is possibly reversible (eg, due to optic disc edema) and vision is at least light perception in that eye Karnofsky score of 60 or more Willingness and ability, with the assistance of a caregiver if necessary, to comply with treatment and follow up procedures signed consent statement Exclusion criteria: Current treatment with intravenous immune globulin (IVIG), CMV immune globulin (CMVIG), alpha-interferon (alpha-IFN), gamma-interferon (gamma-IFN) or interleukin-2 (IL-2) Media opacity that precludes visualization of the fundus in all eyes meeting eligibility criteria Active medical problems, including drug or alcohol abuse, that are considered sufficient to hinder compliance with treatment or follow up procedures Retinal detachment, not scheduled for surgical repair, in all eyes meeting other eligibility criteria | All | 31 |
NCT00000136 | Inclusion criteria: CMV retinitis in one or both eyes At least 1/4 disk are of one CMV lesion photographable Diagnosis of AIDS as defined by Center for Disease Control criteria or documented HIV infection Age 13 and greater Visual acuity ≥ 3/200 in at least one eye diagnosed with CMV retinitis Absolute neutrophil count ≥ 1,000 cells/µl Platelet ≥ 25,000 cells/µl Serum creatinine ≥ 2.0 mg/dl Karnofsky score ≥ 60 Informed consent Exclusion criteria: Previous treatment of CMV retinitis Treatment with anti-CMV therapy for an extra-ocular CMV infection currently or in the past 28 days Known or suspected allergy to study drugs Pregnant or Lactating | All | 32 |
NCT00000137 | Males and females age 10 years or older with two to four quadrants of corneal stroma vascularization or a history of allograft rejection in the eye considered for surgery were eligible for both studies in the CCTS. Patients must have been willing to participate in 3 years of followup. No one was eligible for the CCTS who had a condition that would greatly increase the risk of nonrejection graft failure, such as xerophthalmia or severe exposure keratopathy. Also excluded were patients with systemic diseases or with medication usage that might alter their immune response. | All | 33 |
NCT00000138 | Eligibility criteria common to the three protocols included age 12 years or older, no active HSV epithelial keratitis, no prior keratoplasty of the involved eye, and not pregnant. Protocol-specific criteria are noted in the description above. | All | 34 |
NCT00000139 | Protocol-specific criteria are noted in the description above. | All | 35 |
NCT00000140 | Eligibility criteria included but were not limited to PVR of Grade C-3 or greater according to the Retina Society Classification and visual acuity of light perception or better. | All | 36 |
NCT00000142 | Inclusion criteria: diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC) 13 years or older Diagnosis of CMV (cytomegalovirus) retinitis as determined by a SOCA-certified Ophthalmologist. At least one lesion whose size is one-quarter disc area or more that can be photographed. Visual acuity in an affected eye of 3 or more lines on the (ETDRS) Early Treatment Diabetic Retinopathy Study chart at 1 meter distance (Snellen equivalent 8/200). score of 60 or more on the Karnofsky scale. Serum creatinine of 1.5mg/dL or less less than 1+ proteinuria on urinalysis Total bilirubin of 3.0 mg/dL or less Hepatic transaminase levels that do not exceed 5 times the normal levels Absolute neutrophil count of 750 cells/µL or greater Platelet count of 50,000 cells/µL or greater Hemoglobin of 7.5 g/dL or greater Negative pregnancy test (females of childbearing potential) All men/women of childbearing potential should practice birth control to prevent pregnancy while on study and for 3 months afterwards Willingness/ability, with the assistance of a caregiver if necessary to comply with treatment and follow-up procedures Signed consent statement Exclusion criteria: Evidence of a CMV (cytomegalovirus) retinitis lesion within zone 1. A lesion less than 1,500 µ from the margin of the optic disc or less than 3,000 µ from the center of the fovea in either eye excludes a patient. Evidence of a CMV retinitis lesions that involves 25% or more of the retinal area regardless of location. Previous or ongoing therapy for CMV (cytomegalovirus) disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents solely as prophylaxis are eligible for enrollment. Retinal detachment(s) in the affected eye(s) media opacity that precludes visualization of the fundus of both eyes. patients with a diagnosis of extraocular CMV (cytomegalovirus) disease. Patients with history of clinically significant renal disease or renal dialysis. Patients with history of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. pregnant or lactating patients with active medical problems including drug or alcohol abuse which could hinder compliance with treatment or follow-up procedures. patients receiving therapy within the previous 7 days with nephrotoxic drugs, including: Amphotericin B, Vidarabine, Aminoglycoside antibiotics, Intravenous pentamidine. Patients receiving any of these drugs must discontinue the drug(s) at least one week prior to the time of enrollment, and for the duration of the trial period. history of clinically significant probenecid allergy. | All | 37 |
NCT00000143 | Inclusion criteria: Age 13 years or older Diagnosis of AIDS according to current Centers for Disease Control and Prevention (CDC) definition Diagnosis of active CMV retinitis by a SOCA-certified ophthalmologist (involvement of any zone or amount of retina is allowed) Best corrected visual acuity of 20/100 or better in at least one eye At least one lesion 750 cells/µL or greater Platelet count 50,000 cells/µL or greater Willingness and ability, with the assistance of a caregiver if necessary to comply with treatment and follow up procedures Willingness of all men and women of childbearing potential to practice adequate birth control to prevent pregnancies during the study and for 3 months afterwards Collection of all baseline data within 5 days prior to randomization Signed consent statement Exclusion criteria: Media opacities that preclude visualization of the fundus of all otherwise eligible eyes Treatment for CMV retinitis with the ganciclovir intraocular implant within 9 months of study entry Medical problems or drug or alcohol abuse sufficient to hinder adherence to treatment or follow up procedures Unwillingness to refrain from breast-feeding during the study and for 3 months afterwards | All | 38 |
NCT00000144 | At the time of recruitment, patients had to be at least 35 years old with an intraocular pressure of at least 22 mm Hg or greater in each eye and evidence of optic nerve damage in at least one eye. | All | 39 |
NCT00000145 | Men and women between the ages of 55 and 80 years whose macular status ranges from no evidence of AMD in either eye to relatively severe disease with vision loss in one eye but good vision in the fellow eye (20/30 or better) are eligible for the study provided that their ocular media are clear enough to allow good fundus photography. | All | 40 |
NCT00000146 | The major eligibility criteria for enrollment into the ONTT included the following: Age range of 18 to 46 years Acute unilateral optic neuritis with visual symptoms for 8 days or less A relative afferent pupillary defect and a visual field defect in the affected eye No previous episodes of optic neuritis in the affected eye No previous corticosteroid treatment for optic neuritis or multiple sclerosis No systemic disease other than multiple sclerosis that might be the cause of the optic neuritis | All | 41 |
NCT00000147 | The major eligibility criteria for enrollment into the ONTT included the following: Age range of 18 to 46 years Acute unilateral optic neuritis with visual symptoms for 8 days or less A relative afferent pupillary defect and a visual field defect in the affected eye No previous episodes of optic neuritis in the affected eye No previous corticosteroid treatment for optic neuritis or multiple sclerosis No systemic disease other than multiple sclerosis that might be the cause of the optic neuritis | All | 42 |
NCT00000148 | Men and women between the ages of 35 and 80 with open-angle glaucoma that was not successfully controlled by medication were eligible for enrollment. | All | 43 |
NCT00000149 | Patients must be at least 25 years old with an intraocular pressure of 20 mm Hg or greater and evidence of optic nerve damage and/or visual field loss in one or both eyes. The ocular findings must exclude causes of glaucoma other than primary open-angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma. | All | 44 |
NCT00000150 | Group B: Patients with evidence of large hemorrhages from subfoveal neovascular AMD lesions, visual acuity (SST protocol) of 20/100 to light perception, with the area of hemorrhage larger than the area of fluorescein angiographically visible CNV, with any visible CNV less than or equal to 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for the Group B (Blood) protocol. Group N: Patients with new CNV (no prior laser) due to AMD, visual acuity (SST protocol) of 20/100 to 20/800, fluorescein angiographic evidence of subfoveal CNV lesion which is less than or equal to 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for the Group N (New CNV) protocol. Group H: Patients with evidence of CNV due to OHS or idiopathic cause, visual acuity (SST protocol) 20/50 to 20/800, fluorescein angiographic evidence of subfoveal CNV lesion (new or recurrent) which is < 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for inclusion in the Group H (Histoplasmosis/Idiopathic CNV) protocol. Exclusion criteria include other ocular diseases compromising vision, history of submacular surgery in the study eye, history of subfoveal laser photocoagulation that extends under the foveal avascular zone, recent intraocular surgery, or previous investigational therapy for CNV. | All | 45 |
NCT00000151 | Men and women between the ages of 18 and 70 years with moderate or severe nonproliferative diabetic retinopathy or mild proliferative retinopathy in both eyes, with no previous photocoagulation treatment, and with visual acuity of 20/40 or better (20/200 or better if macular edema is present) were eligible for this study. | All | 46 |
NCT00000152 | When the Physicians Health Study was established in the early 1980s by the NHLBI to collect data on a stable population at risk for heart attack, only male physicians were studied because males were thought to be at higher risk than females for ischemic heart problems. The study population consists of 22,071 male U.S. physicians who were aged 40 to 84 years in 1982. The subjects have no history of myocardial infarction, cancer, kidney disease, renal disease, or any other contraindication to the use of aspirin or beta-carotene, including regular use of corticosteroids. | Male | 47 |
NCT00000153 | Men and women ages 18 through 79 diagnosed with diabetes mellitus and who had neovascularization on the optic nerve head (NVD) were eligible. NVD in one or both eyes of each patient had to be greater than or equal to DRS Standard Photograph 10A. NVD was defined as new vessels on the surface of the retina, further forward in the vitreous cavity over the disc, or within one disc diameter of the disc in any direction. Patient's ocular media must have been clear enough for fundus photography, which allowed the extent of neovascularization on the optic nerve head to be assessed. (If vitreous hemorrhage or other media opacity prevented adequate visualization of the neovascularization, it would greatly impair the ability to assess the effect of photocoagulation.) Another requirement for patient eligibility was the presence of an area of at least three quadrants of the retina in which full argon or krypton laser panretinal photocoagulation could be placed. (Vitreous hemorrhage and/or traction retinal detachment that interfered with treatment was less than one quadrant in extent.) | All | 48 |
NCT00000154 | Men and women eligible for the vitreous hemorrhage group had at least one eye with recent severe vitreous hemorrhage (within 5 months) and visual acuity of 5/200 or less. Patients eligible for the "very severe proliferative retinopathy with useful vision" group had extensive active fibrovascular proliferations and visual acuity of 10/200 or better. | All | 49 |
NCT00000155 | Patients with keratoconus were eligible if they were at least 12 years old; had an irregular cornea as determined by keratometry, retinoscopy, or direct ophthalmoscopy in at least one eye; had Vogt's striae, Fleischer's ring, or corneal scarring characteristic of keratoconus in at least one eye; and planned to stay in the area for at least 3 years. They were ineligible if they had bilateral corneal transplants or bilateral nonkeratoconic eye disease (cataract, intraocular lenses, macular disease, or optic nerve disease other than glaucoma). | All | 50 |
NCT00000156 | Premature infants weighing less than 1,251 grams at birth and having a gestational age of less than 31 weeks were eligible for randomization. Consent must have been obtained within 24 hours of birth. Patients with major congenital anomalies are excluded. | All | 51 |
NCT00000157 | The study population consisted of 22,071 male U.S. physicians, aged 40 to 84 years in 1982, with no history of myocardial infarction, cancer, kidney disease, renal disease, or any other contraindication to the use of aspirin or beta-carotene, including regular use of corticosteroids. | Male | 52 |
NCT00000158 | Common Eligibility Criteria for the Argon, Krypton, and Foveal Studies: To be eligible, men and women must have been experiencing visual symptoms attributable to the macular lesion, such as decreased visual acuity or Amsler grid distortion, at the time of entry into the study. They also must have had visible, well-demarcated hyperfluorescence characteristic of classic choroidal neovascularization on fluorescein angiography. AMD patients were 50 years of age or older and had drusen visible in the macula of at least one eye. POH patients were at least 18 years old and had at least one characteristic histo spot in one or both eyes. INVM patients were at least 18 years old and had no evidence of AMD, POH, angioid streaks, high myopia, diabetic retinopathy, or any other condition that could be the cause of the neovascularization. In particular, INVM patients had neither drusen greater than MPS Standard Photograph No. 1.1 nor histo spots in either eye. Additional Patient Eligibility Criteria for the Argon Study: Each patient had a visible serous detachment of the sensory retina with a diffuse area of leakage, discrete choroidal neovascularization outside the fovea (200-2,500 microns from the center of the FAZ), and visual acuity of 20/100 or better in the study eye. Additional Patient Eligibility Criteria for the Krypton Study: All patients had a neovascular lesion consisting of neovascularization and possibly blood and/or pigment that extended into the FAZ. The posterior border of CNV could extend as close as 1 micron to the FAZ center. Visual acuity of the study eye was 20/400 or better. Additional Patient Eligibility Criteria for the Foveal Study: Only patients with AMD were eligible for this study. Fluorescein angiography of the eligible eye had to show evidence of a leaking choroidal neovascular membrane, some part of which extended under the center of the FAZ, or a neovascular lesion consisting of an old laser treatment scar and contiguous leaking neovascularization within 150 microns of the center of the FAZ. New, never-treated subfoveal lesions were less than four disc areas in size. Recurrent lesions were less than six disc areas in size, including the old treatment scar and new neovascularization. Best-corrected visual acuity was no better than 20/40 and no worse than 20/320. | All | 53 |
NCT00000159 | Men and women eligible for the SRT had diabetes for 1 to 15 years and were between ages 18 and 56 at the time of enrollment. They had begun taking insulin before their 41st birthday. Their hemoglobin A1c value was within the diabetic range. On retinal examination, they showed no evidence of or only very mild retinopathy, with no more than five microaneurysms per eye. Women were postmenopausal, sterile, or had an IUD in place. | All | 54 |
NCT00000160 | Patients were eligible if they had best corrected visual acuity of 20/100 or better in each eye and the presence of proliferative diabetic retinopathy in at least one eye or severe nonproliferative retinopathy in both eyes. They could not have had prior treatment with photocoagulation or pituitary ablation, and both eyes had to be suitable for photocoagulation. All eligible patients were younger than 70 years, and the examining physician assessed the outlook for survival and availability for 5 years of followup to be good. | All | 55 |
NCT00000161 | Women's Health Study: A participant must have met all of the following criteria: (a) female; (b) aged 45 years or older; (c) postmenopausal or with no intention of becoming pregnant; (d) no reported personal history of cardiovascular disease, cancer (other than non-melanoma skin cancer), gout, peptic ulcer, chronic renal or liver disease, or other serious illness precluding participation; (e) no reported history of serious side effects to the study treatments; (f) not currently taking aspirin, aspirin containing medication, or nonsteroidal anti-inflammatory drugs (NSAIDs) more than 1 day per week or, if so doing, willing to forego use of these medications; (g) not currently taking individual supplements of vitamin E or beta carotene more than 1 day per week; (h) not currently taking anticoagulants or corticosteroids. Women's Antioxidant Cardiovascular Study: Potentially eligible female health professionals for WACS were identified from the pool of respondents to the Women's Health Study initial mailing and must have met the following criteria: (a) female; (b) date of birth before January 1, 1955; (c) a reported history of myocardial infarction (MI), stroke (CVA), angina pectoris (AP), coronary artery bypass grafting (CABG), percutaneous transluminal angioplasty (PCTA), transient ischemic attack (TIA), carotid endarterectomy (CEA), or peripheral artery surgery (PAS); (d) no history of cancer (except non-melanoma skin cancer) within the past 10 years and no active liver disease or cirrhosis; (e) pregnancy physiologically impossible due to menopause (natural or surgical) or tubal ligation, or the participant does not intend to become pregnant in the future as indicated on the initial WHS questionnaire; (f) no current use of a vitamin K-depleting anticoagulant agent (e.g., Coumadin). Individuals taking aspirin or other NSAIDs were not excluded. | Female | 56 |
NCT00000162 | Patients with three types of diagnoses were accepted: major BVO without neovascularization; major BVO with neovascularization; BVO with macular edema and reduced vision. All patients must have had onset of signs and/or symptoms of BVO less than 18 months before the initial visit, vision of 5/200 or better, and sufficient clarity of the ocular media to permit confirmation of the condition with fundus photography. Other eligibility criteria apply to each of the three major groups as well as special cases such as the occurrence of bilateral disease. | All | 57 |
NCT00000163 | Neurologically and developmentally normal infants with congenital esotropia who are between 4 and 20 weeks of age are eligible for CEOS. | All | 58 |
NCT00000167 | Patients eligible for CAPT can be either male or female and meet the following criteria: Age at least 50 years old Vision in each eye must measure 20/40 or better. At least 10 large drusen in each eye Available for follow-up examinations for 5 years after enrollment Final eligibility is determined through a detailed eye examination by a CAPT-certified ophthalmologist. | All | 59 |
NCT00000168 | Inclusion criteria: A diagnosis of AIDS according to the 1993 Centers for Disease Control and Prevention (CDC) definition (with or without clinical symptoms of CMV retinitis or other ocular complications of AIDS) Age 13 years or older Signed consent statement Patients with newly diagnosed (within 45 days of enrollment) Ocular Opportunistic Infections (OOIs) Patients without a newly diagnosed Ocular Opportunistic Infection (OOI) diagnosed with AIDS after 1 Jan 2001 Exclusion criteria: - none. | All | 60 |
NCT00000169 | Children were eligible if they were enrolled in the first through eighth grades in selected schools in Eutaw, Alabama; Houston, Texas; Orinda, California; or Irvine, California in the 1997-98 academic year and in the first grade only in Eutaw, Houston, and Irvine in the 1998-99 academic year. | All | 61 |
NCT00000170 | Inclusion Criteria: Patients must be 7 years old or younger with amblyopia due to strabismus or anisometropia Visual acuity in the amblyopic eye must be between 20/40 and 20/100 Visual acuity in the sound eye or 20/40 or better At least 3 lines of acuity difference between the two eyes Exclusion Criteria: More than two months of amblyopia therapy in the past two years Myopia (more than -0.50 D) | All | 62 |
NCT00000171 | Inclusion Criteria: Patients must meet NINCDS-ADRDA criteria for probable Alzheimer's disease (AD). Patients must have disrupted sleep, documented by clinical history and by 1 to 2 weeks of recording using wrist activity monitors. A diagnosis of probable AD. MMSE score 0-26. Hachinski Ischemia Scale score less than or equal to 4. A 2-week history of two or more sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver on the Sleep Disorder Inventory. CT or MRI since the onset of memory problems showing no more than one lacunar infarct in a non-strategic area and no clinical events suggestive of stroke or other intracranial disease since the CT or MRI. Physically acceptable for study as confirmed by medical history and exam, clinical laboratory results, and EKG. Actigraph evidence of a mean nocturnal sleep time of less than 7 hours per night (at least 5 nights of complete actigraph data must be collected over a single week. Stable home situation with no planned move during the 13-week investigational period. Residing with responsible spouse, family member, or professional caregiver who is present during the night and will agree to assume the role of the principal caregiver for the 13-week protocol, including arranging transport for the patient to and from the investigators' clinic, answering questions regarding the patient's condition, and assuming responsibility for medication and actigraph procedures. Ability to ingest oral medication and participate in all scheduled evaluations. Six grades of education or work history sufficient to exclude mental retardation. 55 years of age or older. Hamilton Depression Rating Scale score of 15 or less. Stable medication (dose and type) for non-excluded concurrent medical conditions for 4 weeks prior to the screening visit. Exclusion Criteria: Sleep disturbance is acute (within the last 2 weeks). Sleep disturbance is associated with an acute illness with delirium. Clinically significant movement disorder that would interfere with the actigraph readings. Not having a mobile upper extremity to which to attach an actigraph. Severe agitation. Pain syndrome affecting sleep. Unstable medical condition. Use of investigational or unapproved medications within 4 weeks of the screening visit. Patient unwilling to maintain caffeine abstinence after 2:00 pm for the duration of the protocol. Patient unwilling to comply with the maximum limit of two alcoholic drinks per day, and only one alcoholic drink after 6:00 pm for the duration of the protocol. Use of melatonin within 2 weeks of screening visit. Clinically significant abnormal laboratory findings that have not been approved by the Project Director. Residing in a facility without a consistent caregiver present during the night who can function as the primary informant. Caregiver deemed too unreliable to supervise the wearing of the actigraph, to maintain the sleep diary, or to bring the patient to the scheduled visits. Autoimmune disease, such as rheumatoid arthritis and polymyalgia rheumatica. | All | 63 |
NCT00000172 | Inclusion Criteria: Probable Alzheimer's disease Mini-Mental State Examination (MMSE) 10-22 and ADAS greater than or equal to 18 Alzheimer's Disease Assessment Scale cognitive portion (ADAS-cog-11) score of at least 18 Opportunity for Activities of Daily Living Caregiver Subjects who live with or have regular daily visits from a responsible caregiver (visit frequency: preferably daily but at least 5 days/week). This includes a friend or relative or paid personnel. The caregiver should be capable of assisting with the subject's medication, prepared to attend with the subject for assessments, and willing to provide information about the subject. Exclusion Criteria: Conditions that could confound diagnosis Neurodegenerative disorders Acute cerebral trauma Psychiatric disease More than one infarct on CT/MRI scans History of alcohol or drug abuse Contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions (including severe asthma); unstable angina; Afib; bradycardia less than 50; and AV block. | All | 64 |
NCT00000173 | Inclusion Criteria: Memory complaints and memory difficulties which are verified by an informant. Abnormal memory function documented by scoring below the education adjusted cutoff on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised (the maximum score is 25): a) less than or equal to 8 for 16 or more years of education, b) less than or equal to 4 for 8-15 years of education, c) less than or equal to 2 for 0-7 years of education. Mini-Mental Exam score between 24 and 30 (inclusive) (Exceptions may be made for subjects with less than 8 years of education at the discretion of the project director.). Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit. No significant cerebrovascular disease: Modified Hachinski score of less than or equal to 4. Age between 55 and 90 (inclusive). Permitted medications stable for at least 1 month prior to screening. In particular: a) Subjects may take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 2 years). b) Estrogen replacement therapy is permissible. c) Ginkgo biloba is permissible, but discouraged. Hamilton Depression rating scale score of less than or equal to 12 on the 17-item scale. Informant is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), agrees to monitor administration of study drug, observe for adverse events, and accompany the subject to all clinic visits for the duration of the protocol. CT or MRI scans within 12 months prior to screening without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease. A lacune in a non-critical brain area which is not believed to contribute to the subject's cognitive impairment is permissible. Adequate visual and auditory acuity to allow neuropsychological testing. Good general health with no additional diseases expected to interfere with the study. Normal B12, RPR, and Thyroid Function Tests or without any clinically significant abnormalities that would be expected to interfere with the study. ECG without clinically significant abnormalities that would be expected to interfere with the study. Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile). Agreement not to take other vitamin supplements (including Vitamin E), multivitamins, other than those provided by the study. Exclusion Criteria: Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. Major depression or another major psychiatric disorder as described in DSM IV within the past 2 years. Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria). History of schizophrenia (DSM IV criteria). Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including: a) History of systemic cancer within the last 5 years (non-metastatic skin cancers are acceptable). b) History of myocardial infarction within the past year or unstable or severe cardiovascular disease including angina or CHF with symptoms at rest. c) Clinically significant obstructive pulmonary disease or asthma. d) Clinically significant and unstable gastrointestinal disorder such as ulcer disease or a history of active or occult gastrointestinal bleeding within two years. e) Clinically significant laboratory test abnormalities on the battery of screening tests (hematology, prothrombin time, chemistry, urinalysis, ECG). f) Insulin-requiring diabetes or uncontrolled diabetes mellitus. g) Uncontrolled hypertension (systolic BP greater than 170 or diastolic greater than 100). h) History of clinically significant liver disease, coagulopathy, or vitamin K deficiency within the past 2 years. Medications a) Use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening. b) Use of anti-Parkinsonian medications (e.g. Sinemet, amantadine, bromocriptine, pergolide and selegiline) within 2 months prior to screening. c) Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening. d) Use of long-acting benzodiazepines or barbituates within 4 weeks prior to screening. e) Use of short-acting anxiolytics or sedative hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of screening). f) Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable). g) Use of systemic corticosteroids within 3 months prior to screening. h) Medications with significant cholinergic or anticholinergic side effects (e.g. pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within 4 weeks prior to screening. i) Use of anti-convulsants (e.g. Phenytoin, Phenobarbital, Carbamazepine) within 2 months prior to screening. j) Use of warfarin (Coumadin) within 4 weeks prior to screening. Vitamin Supplements a) Use of vitamin supplements other than standard multivitamin included as part of the treatment intervention used in this protocol within 2 weeks prior to screening. Any prior use of any FDA approved medications for the treatment of Alzheimer's disease (e.g. tacrine, donepezil, or other newly approved medications). Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening. Subjects who, in the investigator's opinion, will not comply with study procedures. | All | 65 |
NCT00000174 | Inclusion Criteria: Are aged 55-85 years, inclusive. Subjects older than 85 years may be eligible to participate, with approval of the designated study medical monitor. Are male or female without child-bearing potential (i.e., surgically sterilized [via bilateral tubal ligation,bilateral oophorectomy, or hysterectomy], at least one year postmenopausal, or using adequate birth control). Are cooperative, able to ingest oral medication, and willing to complete all aspects of the study. Will provide written informed consent prior to their participation in the study. Show evidence of mild cognitive impairment (MCI) by meeting all of the following criteria: Global CDR score = 0.5, NYU Delayed Paragraph Recall less than 9, 17-item HAM-D score less than 13, and HAM-D Item 1 (depressed mood) score =1. Have a friend or family member who is willing to participate in the study as an informant. The informant must see the subject at least once a week for several hours and be available to accompany the subject to the screening and baseline visits, and at a minimum, be accessible by telephone for other scheduled visits. Exclusion Criteria: Advanced, severe, and unstable disease of any type that may interfere with primary and secondary variable evaluations including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the subject to a significant degree or put the subject at special risk. Cognitive impairment sufficient to warrant a diagnosis of dementia. Met the DSM-IV and NINCDS-ADRDA criteria for AD. A clinical diagnosis of AD. A DSM-IV Axis 1 diagnosis. However, subjects with current depression are eligible after appropriate treatment of the depressive episode. A minimum of four weeks washout of antidepressant medication should occur prior to screening. Subjects with a prior history of depression (but not currently depressed) are allowed in the study. Fewer than four years of formal education. A documented history of transient ischemic attacks. Baseline MRI findings or CT-scan findings within a year of screening that are consistent with a process other than AD, e.g., stroke, tumor, brain trauma or hydrocephalus, that may contribute to the subject's MCI. Lacunae infarcts present in areas affecting cognition (entorhinal cortex, hippocampus, medial temporal lobe) will also exclude the subject from the study. A score of greater than 4 on the Modified Hachinski Ischemic Scale. A current diagnosis of any primary neurodegenerative disorder, e.g., Parkinson's disease. A current diagnosis of uncontrolled seizure disorder. A current diagnosis of active peptic ulceration. A current diagnosis of severe and unstable cardiovascular disease. A current diagnosis of sick-sinus syndrome or conduction deficits (sino-atrial block, second or third degree atrio-ventricular block). A current diagnosis of acute, severe, or unstable asthmatic conditions. A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to Exelon or to other cholinergic compounds (e.g., pilocarpine, bethanechol, tacrine, velnacrine, donepezil, metrifonate, or physostigmine). Subjects who have experienced elevations in liver function test parameters on other cholinesterase inhibitors are still eligible. Taken any of the following substances: An investigational drug during the past four weeks; Metrifonate during the past three months; a drug or treatment known to cause major organ system toxicity during the past four weeks; other cholinergic drugs (e.g., donepezil, tacrine, succinylcholine-type muscle relaxants) during the past two weeks (topical pilocarpine will be permitted); antidepressant medication during the past four weeks. Participated in a previous clinical trial of Exelon. Clinically important laboratory abnormalities in serum B12, folate, or T3/T4 at screening. The subject should be excluded if peripheral neuropathy, macrocytic anemia, or myxedema is present. If screen values do not meet the absolutely exclusionary values given below but are still outside the normal reference range, treatment for folic acid/B12 deficiency or thyroid disorder, as appropriate, may be initiated or adjusted with re-evaluation of the subject within three months. Within these three months of treatment, the subject's cognitive condition must be clinically unchanged or worse for the subject to be acceptable. Once accepted, the subject must remain on the appropriate treatment throughout the study. Exclude if T3 uptake is less than 19%; T4 less than 2.9 ((g/dL); free T4 index is less than 0.8 Exclude if folate less than 1.7 ng/ml (normal range greater than 1.9) Exclude if B12 less than 100 pg/ml (normal range greater than 200) A positive rapid plasmin reagin test followed up by a positive serological test for syphilis. A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, severe language difficulty). | All | 66 |
NCT00000175 | Inclusion Criteria: Women and men aged 65-90 who have not received hormone replacement for the last three months. Exclusion Criteria: Previous head injury with loss of consciousness for more than one hour. Men with a history of prostate cancer. Men on testosterone replacement within the past three months. Women with a history of breast or uterine cancer. Women on estrogen replacement within the past three months. | All | 67 |
NCT00000176 | Inclusion Criteria: Healthy women 65 or older with a family history of memory problems not currently on estrogen. Exclusion Criteria: Significant neurological impairment Current estrogen use History of breast cancer | Female | 68 |
NCT00000177 | Inclusion Criteria: Women with a diagnosis of Alzheimer's disease who currently are not taking estrogen replacement therapy, who have had a hysterectomy, and who are in stable general health. Exclusion Criteria: Patients with an uncontrolled health problem, such as untreated high blood pressure or thyroid disease. | Female | 69 |
NCT00000178 | Inclusion Criteria: Patients with Alzheimer's disease who are in stable medical condition Exclusion Criteria: Patients with diabetes or severe osteoporosis | All | 70 |
NCT00000179 | Inclusion Criteria: Memory problem consistent with a probable diagnosis of Alzheimer's disease (AD) Agitation symptoms for at least the past 2 weeks Patient has caregiver who can participate Patient lives in the same household as the caregiver | All | 71 |
NCT00000205 | Inclusion Criteria: M/F ages 21-50. Opiate dependence according to 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 ETOH or benzodiazepines or other sedative/hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe | All | 91 |
NCT00000206 | Inclusion Criteria: M/F ages 21-50. Opiate dependence according to 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 ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe. | All | 92 |
NCT00000207 | Inclusion Criteria: M/F, ages 21-50. opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of the 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-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe. | All | 93 |
NCT00000208 | Inclusion Criteria: M/F ages 21-50. Opiate dependence according to DSM-IV critera. 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 ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe. | All | 94 |
NCT00000209 | Inclusion Criteria: M/F ages 21-50. Opiate dependence according to DSM-IV critera. 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 ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe. | All | 95 |
NCT00000243 | Inclusion Criteria: Meets criteria for opioid dependence Exclusion Criteria: Significant medical or psychiatric illness | All | 129 |
NCT00000244 | Inclusion Criteria: opiate addict between the ages of 18-55 Exclusion Criteria: Regular abuse of other drugs, unstable medical conditions | All | 130 |
NCT00000268 | Inclusion Criteria: current adult ADHD current cocaine dependence Exclusion Criteria: no current major depression | All | 153 |
NCT00000271 | Inclusion: Meets DSM-IV criteria for current cocaine dependence. Used cocaine at least one day in the past month. Currently meets DSM-IV criteria for Major Depression or Dysthymia. Depressive disorder is either: primary (antedates earliest lifetime substance abuse or persistent during 6 months of abstinence in the past or at least 3 months duration in the current episode Age 18-60. Able to give informed consent and comply with study procedures. Exclusion: Meets DSM-IV criteria for past mania (i.e. bipolar disorder), schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. History of seizures. History of allergic reaction to desipramine or imipramine. Chronic organic mental disorder. Significant current suicidal risk. Pregnancy, lactation or failure in sexually active female patients to use adequate contraceptive methods. Unstable physical disorders which might make participation hazardous such as hypertension, hepatitis or diabetes. Coronary vascular disease as indicated by history or suspected by abnormal ECG or history or cardiac symptoms. Cardiac conduction system disease as indicated by QRS duration >0.11. Current use of other prescribed psychotropic medications within the last 2 weeks. History of failure to respond to a previous adequate trial of desipramine or another tricyclic antidepressant. Currently meets criteria for another substance dependence disorder (DSM-IV) other than nicotine, marijuana or alcohol. | All | 156 |
NCT00000273 | Inclusion Criterion DSM IV criteria for opioid dependence No major mood, psychotic, or anxiety disorder Physically healthy Able to perform study procedures 21-45 years of age Current use of i.v. heroin in amounts/frequencies Not seeking treatment for opioid dependence Exclusion Criterion DSM IV criteria for dependence on drugs other Participants requesting treatment Participants on parole or probation Pregnancy or lactation Birth, miscarriage or abortion with 6 months Recent history of or current significant violent behavior Current major Axis I psychopathology, other than heroin dependence ( e.g., mood disorder with functional impairment or suicide risk, schizophrenia), which might interfere with ability to participate in the study Hepatitis with SGOT or SGPT > 3 times normal Significant suicide risk Current or history of chronic pain Sensitivity, allergy, or contraindication to opioids | All | 157 |
NCT00000284 | Inclusion Criteria: Male or female subjects, aged 21-45 yrs inclusive, with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. Subject must be in good health as verified by medical history, screening exam, and screening laboratory tests. Subject must provide written informed consent to participate in the study and be motivated to stop smoking for a short term. Exclusion Criteria: History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, peptic ulcer disease or any other medical condition which the physician or investigator deems inappropriate for participation, insulin-dependent diabetes; pregnant or lactating or not using adequate birth control methods; requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history; chronic use of systemic steroids or antihistamines; skin sensitivity which would preclude use of a transdermal system; abuse of alcohol or any other recreational or prescription drug; use of any other tobacco products, including smokeless tobacco and nicotine products; previous use of transdermal nicotine system; inability to fulfill all scheduled visits and examination procedures throughout the study period. | All | 167 |
NCT00000285 | Inclusion Criteria: Males/Females between the ages of 20-40. History of smoked cocaine use on the avg. of at least 2 times/week over a 6 month period. Have currently used at least 1 g of cocaine within a 4-6 hr period. Current history of good health, normal serum albumin levels and normal QTc intervals. Nonreactive for HIV. No participation in any of our studies for the past 6 months. For females: not pregnant as determined by pregnancy screening nor breat feeding, and using acceptable birth control methods (e.g. birth control pills, diaphragm, condoms plus foam). Exclusion Criteria: History of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other durgs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treated for chemical dependency within the past 6 months. Use of any psychotropic drugs including MAOIs in the past 6 months. | All | 168 |
NCT00000286 | Inclusion Criteria: Females, ages 18-55, minimum use of 8 days of the last 30, minimum of 8th grade education, current diagnosis of cocaine abuse/dependence Exclusion Criteria: Unstable medical illness, dx of MR, OBS, bipolar | Female | 169 |
NCT00000287 | Inclusion Criteria: Female, cocaine abuse or dependency by SCIS, at least 7 days of current abstinence, cocaine use of 8 out of 30 days prior to current abstinence, ages 18-60. Exclusion Criteria: Inability to participate in a 90 day longitudinal study | Female | 170 |
NCT00000288 | Inclusion Criteria: Male/Female subjects ages 21-45 yrs. inclusive, with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. Subject must be in good health as verified by medical history, screening examination, and screening laboratory tests. Subject must provide written informed consent to participate in the study and be motivated to stop smoking for a short term. Exclusion Criteria: History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, peptic ulcer disease or any other medical condition which the physician or investigator deems inappropriate for participation. Insulin-dependent diabetes. Pregnant or lactating, or not using adequate birth control methods. Requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history). Chronic use of systemic steroids or antihistamines. Skin sensitivity which would preclude use of a transdermal system. Abuse of alcohol or any other recreational or prescription drug. Use of any other tobacco products including smokeless tobacco and nicotine products. Previous use of transdermal nicotine system. Inability to fulfill all scheduled visits and examination procedures throughout the study period. | All | 171 |
NCT00000289 | Inclusion Criteria: Male/Female subjects ages 21-45 years inclusive, with a smoking history of at least 15 cigarettes daily (greater than or equal to 50) for at least 1 yr. Subject is in good health as verified by medical history, screening examination, and screening laboratory tests as outlined above. Subject has provided written informed consent to participate in the study and is motivated to stop smoking. Subject has experienced at least 4 withdrawal symptoms upon abstinence. Exclusion Criteria: History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, current peptic ulcer disease or any other medical condition which the physician investigator deems inappropriate for subject participation. Insulin-dependent diabetes. Pregnant or lactating, or not using adequate birth control methods. Requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (less than 1yr). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug (more than 3 drinks per day or 21 drinks per wk). use of any other nicotine products, including smokeless tobacco, cigars and nicotine replacement products. Inability to fulfill all scheduled visits and examination procedures throughout the study period. History of schizophrenia or manic depressive disorder. Recent history of other psychiatric illness (less than 1yr since last episode of major depressive episode). | All | 172 |
NCT00000290 | Inclusion Criteria: Males between the ages of 20-45. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. Current history of good health and normal EKG. Exclusion Criteria: History of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other drugs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treatment for chemical dependency within the past 6 months. History of sensitivity to tricyclic compounds or other prescription drugs. Use of any psychotropic drugs including MAOIs in the past 6 months. | Male | 173 |
NCT00000291 | Inclusion Criteria: Male/Female ages 20-55. History of smoked or intravenous cocaine use on the average of at least once a week over a six month period. Current history of good health and normal EKG. Not pregnant as determined by pregnancy screening nor breat feeding and using acceptable birth control methods (e.g. birth control pills diaphragm, condoms, plus foam) during the study. Exclusion Criteria: Current problems with major psychiatric illnesses including bipolar disorder, schizophrenia, or anxiety disorders. Current dependence on alcohol or on durgs other than cocaine. History of major medical illnesses including asthma and chronic obstructive pulmonary disease. Currently on a drug related parole or probation. Treated for chemical dependency within the past 6 months. | All | 174 |
NCT00000292 | Inclusion Criteria: M/F ages 21-45 with a history of smoked cocaine use at least twice a week for the past six months, including 0.5 g of cocaine in a 24hr period on at least one occasion. In good health as evidenced by physical exam and complete blood count, chest X-ray and electrolyte and liver function tests, with a normal resting 12-lead electrocardiograph (ECG) and blood pressure of less than 140/90 mmHg. Using an acceptable method of birth control. Having a urine toxicology screen positive for cocaine metabolites. Exclusion Criteria: Any DSM-IV Axis I disorder other than cocaine abuse or dependence, or dependence or daily use of psychoactive drugs other than nicotine or caffeine. A history of violence and/or currently on probation, parole or awaiting trial. Pregnant as determined by serum pregnancy screen, lactating or having delivered a child in the past 12 months. Seropositive tests for the human immunodeficiency virus (HIV) or hepatitis B. History of seizure disorder. | All | 175 |
NCT00000293 | Inclusion Criteria: Female, ages 18-55, cocaine abuse/dependence, use of cocaine 7 days of the last 30 days or of the 30 days prior to current abstinence, less than 90 days current abstinence, at least an 8th grade education. Exclusion Criteria: Unstable medical conditions; current use of Hismanal, Seldane, or Propulsid; dx of MR, OBS, bipolar, schizophrenia. | Female | 176 |
NCT00000294 | Inclusion Criteria: Male/Female between 20 and 55. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. current history of good health and normal EKG. Not pregnant as determined by pregnancy screening nor breast feeding, using acceptable birth control methods (e.g. birth control pills diaphragm, condoms plus foam) Exclusion Criteria: Current problems with major psychiatric illnesses including bipolar disorder, schizophrenia, or anxiety disorders. History of major medical illnesses including asthma and chronic obstructive pulmonary disease. Currently on a drug related parole or probation. Treated for chemical dependency withing the past 6 months. | All | 177 |
NCT00000295 | Inclusion Criteria: Female subjects aged 21-45 years with a smoking history of at least 20 cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests. Not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods other than hormonal contraceptives. Exclusion Criteria: History of heart disease, peripheral vascular disease, COPD, liver diseases, abnormal vaginal bleeding, suspected or known breast malignancy, or any other medical condition which physician investigator deems inappropriate for subject participation. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history. Amenorrhea. Current use of oral or other types of hormonal contraceptives. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products. Known allergy to progesterone or peanuts. | Female | 178 |
NCT00000296 | Inclusion Criteria: Male/Female subjects, aged 21-45 years inclusive, with a smoking history of at least 20 cigarettes daily (greater than or equal to 50) for at lease 1 year. Subject is in good health as verified by medical history, screening examination, and screening laboratory tests as outlined above. Subject has provided written informed consent to participate in the study and is motivated to stop smoking. Subject has experienced at least 4 withdrawal symptoms upon abstinence. Exclusion Criteria: History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, current peptic ulcer disease or any other medical condition which the physician investigator deems inappropriate for subject participation. Insulin-dependent diabetes. Pregnant or lactating, or not using adequate birth control methods. Requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (less than 1yr). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreation aor prescription drug (more tha 3 drinks per day or 21 drinks per week). Use of any other nicotine products, including smokeless tobacco, cigars and nicotine replacement products. Inability to fulfill all scheduled visits and examination procedures throughout the study period. History of schizophrenia or manic depressive disorder. Recent history of other psychiatric illness;less than 1 year since last episode of major depressive episode. | All | 179 |
NCT00000297 | Inclusion Criteria: Male/Female, aged 21-55 years with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests. Exclusion Criteria: History of heart disease, peripheral vascular disease, COPD, any other medical condition which physician investigator deems inappropriate for subject participation. Pregnant or lactating or not using adequate birth control methods. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics and recent psychiatric history). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products. | All | 180 |
NCT00000298 | Inclusion Criteria: Males/Females ages 21-50, opiate dependence according to 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 etoh or benzodiazepines or other sedative-hypnotics, acute hepatitis, other medical conditions that deem participation to be unsafe. | All | 181 |
NCT00000299 | Inclusion Criteria: Males/Females, ages 21-50. Opiate dependence according to 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. Dependent on etoh or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe. | All | 182 |
NCT00000300 | Inclusion Criteria: meets DSM-IV criteria for opiate dependence. M/F, 18 years or older. Certified for LAAm treatment by a physician. Able to understand english. Willing to provide names, addresses, and numbers of 3 relatives who can aid in patient location for follow-up visits. Exclusion Criteria: Hypertensive to LAAM. Pregnant or nursing women. Female of childbearing potential who refuses to use an acceptable form of birth control. Clinically significant abnormality in hematology, blood work, or UA, ETOH and/or sedative/hypnotic dependence according to DSM-IV criteria. Medical or psychiatric illness which would jeopardize safe study participation. | All | 183 |
NCT00000301 | Inclusion Criteria: M/F, ages 18-65. cocaine dependence according to DMS-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of the 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. | All | 184 |
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