anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Betamethasone
Trial phase: Phase 1
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan

PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
Eligibility criteria:
DISEASE CHARACTERISTICS:

Presence of ≥ 1 measurable pulmonary nodule (1.0-3.0 cm) suggestive of malignancy or chronic inflammatory process on positron emission tomography (PET) scan
No lesions consistent with malignancy or inflammation according to history, PET findings, or biopsy

Baseline scan average time between injection and start of scan within 50-70 min

Mean liver standardized uptake value (SUV) of baseline scan normal
No sign of significant partial paravenous tracer administration in the images of baseline scan
No lung nodule(s) suggestive of lymphoma
No lung lesions suggestive of tuberculosis

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Blood glucose levels ≤ 150 mg/100 mL
Not pregnant or nursing
Fertile patients must use effective contraception
Able to tolerate PET/CT imaging
No history of diabetes
No poorly controlled hypertension

No prior malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma in situ, or other cancer from which the participant has been disease free for < 3 years

No active malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

More than 5 years since prior chemotherapy or radiotherapy
No concurrent steroids
Intervention: Benazepril
Trial phase: Not Applicable
ATC code: C09AA07 | C09BA07 | C09BB13
SMILES: [H][C@]1(N[C@@H](CCc2ccccc2)C(=O)OCC)CCc2ccccc2N(CC(=O)O)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: 10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
Eligibility criteria:
Inclusion Criteria:

Males and females, age 18-70
Subjects with diabetic renal disease as defined by spot urine albumin - creatinine ratio 30-300mg/g and estimated glomerular filtration rate of >60 ml/min

Exclusion Criteria:

Intake of non-steroidal anti-inflammatory agents (NSAIDs) more than 15 days/month, excluding aspirin.
Inability to discontinue NSAIDs or aspirin for 5 days prior to GFR measurement.
History of severe adverse reaction to any of the randomized drugs required for use in the protocol or contraindication of their use.
Participation in another intervention study.
Pregnancy or likelihood of becoming pregnant during the study period; lactation
Clinical and laboratory evidence of any renal disease other than diabetic nephropathy.
History of drug abuse in the past 2 years, including narcotics, cocaine or alcohol (> 21 drinks per week). Serious systemic disease that might influence survival or the course of renal disease. (Chronic oral steroid therapy is exclusion, but steroid-containing nasal sprays are not. Inactive sarcoidosis is not an exclusion).
History of malignant or accelerated hypertension within 6 months prior to study entry; previous chronic peritoneal or hemodialysis or renal transplantation. Known secondary causes of hypertension. Spot urine albumin - creatinine ratio exceeding 300 (mg/g)
Serum potassium level > 5.5 mEq/L for those not on ACE inhibitors during Baseline, or serum potassium level > 5.9 mEq/L for those on ACE inhibitors during Baseline.

Leukopenia < 2,500/mm3 at screening and confirmed at the end of Baseline.

Doubt that the participant will be able to adhere to medications or comply with the protocol visit schedule
Arm Circumference > 52 cm, which precludes measuring blood pressure with the "thigh" blood pressure cuff. Arm length such that if the cuff circumference extended into the antecubital space so that the cuff interfered with placement of the stethoscope over the brachial artery for blood pressure measurement
Clinical evidence of lead intoxication. Clinical evidence of congestive heart failure, current or within the preceding six months. Ejection fraction below 35% measured by any method. Heart block greater than first degree or any other arrhythmia that contraindicated the use of any of the primary BP drugs.
Intervention: Benazepril
Trial phase: Not Applicable
ATC code: C09AA07 | C09BA07 | C09BB13
SMILES: [H][C@]1(N[C@@H](CCc2ccccc2)C(=O)OCC)CCc2ccccc2N(CC(=O)O)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: 40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
Eligibility criteria:
Inclusion Criteria:

Males and females, age 18-70
Subjects with diabetic renal disease as defined by spot urine albumin - creatinine ratio 30-300mg/g and estimated glomerular filtration rate of >60 ml/min

Exclusion Criteria:

Intake of non-steroidal anti-inflammatory agents (NSAIDs) more than 15 days/month, excluding aspirin.
Inability to discontinue NSAIDs or aspirin for 5 days prior to GFR measurement.
History of severe adverse reaction to any of the randomized drugs required for use in the protocol or contraindication of their use.
Participation in another intervention study.
Pregnancy or likelihood of becoming pregnant during the study period; lactation
Clinical and laboratory evidence of any renal disease other than diabetic nephropathy.
History of drug abuse in the past 2 years, including narcotics, cocaine or alcohol (> 21 drinks per week). Serious systemic disease that might influence survival or the course of renal disease. (Chronic oral steroid therapy is exclusion, but steroid-containing nasal sprays are not. Inactive sarcoidosis is not an exclusion).
History of malignant or accelerated hypertension within 6 months prior to study entry; previous chronic peritoneal or hemodialysis or renal transplantation. Known secondary causes of hypertension. Spot urine albumin - creatinine ratio exceeding 300 (mg/g)
Serum potassium level > 5.5 mEq/L for those not on ACE inhibitors during Baseline, or serum potassium level > 5.9 mEq/L for those on ACE inhibitors during Baseline.

Leukopenia < 2,500/mm3 at screening and confirmed at the end of Baseline.

Doubt that the participant will be able to adhere to medications or comply with the protocol visit schedule
Arm Circumference > 52 cm, which precludes measuring blood pressure with the "thigh" blood pressure cuff. Arm length such that if the cuff circumference extended into the antecubital space so that the cuff interfered with placement of the stethoscope over the brachial artery for blood pressure measurement
Clinical evidence of lead intoxication. Clinical evidence of congestive heart failure, current or within the preceding six months. Ejection fraction below 35% measured by any method. Heart block greater than first degree or any other arrhythmia that contraindicated the use of any of the primary BP drugs.
Intervention: Bimatoprost
Trial phase: Phase 3
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 214
Group description: Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
Eligibility criteria:
Inclusion Criteria:

Subjects who have inadequate eyelashes due to natural causes and are not satisfied with their eyelash appearance.
For the post-chemotherapy population: subjects who have inadequate eyelashes following a complete course of chemotherapy treatment and are not satisfied with their eyelash appearance, are considered free of cancer and are well enough to complete the study.

Exclusion Criteria:

Subjects with unequal right and left eyelashes, any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants, eyelash extension application.
Any use of over the counter or prescription use eyelash growth products.
Subjects requiring eye drop medications for glaucoma.
Females who are pregnant, nursing or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception.
Intervention: Ezetimibe
Trial phase: Not Applicable
ATC code: C10AX09 | C10BA02 | C10BA05 | C10BA06 | C10BA10 | C10BA11 | C10BA12
SMILES: [H][C@]1(CC[C@H](O)c2ccc(F)cc2)C(=O)N(c2ccc(F)cc2)[C@]1([H])c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)

Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

HIV positive
currently taking 10mg of rosuvastatin
recent (within three months) fasting lipid profile in which the serum total cholesterol to HDL ratio is >5.0

Exclusion Criteria:

Previous adverse reaction to ezetimibe
taken ezetimibe within 30 days of starting the study
history of vascular disease
allergic reaction or muscle problems while taking any statin
currently taking other lipid lowering medications (i.e. a fibrates or cholestyramine)
Intervention: Rosuvastatin Calcium
Trial phase: Not Applicable
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1C=CC(O)CC(O)CC(=O)[O-].CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1C=CC(O)CC(O)CC(=O)[O-].[Ca+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Increased dose of rosuvastatin to 20mg/day

Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day
Eligibility criteria:
Inclusion Criteria:

HIV positive
currently taking 10mg of rosuvastatin
recent (within three months) fasting lipid profile in which the serum total cholesterol to HDL ratio is >5.0

Exclusion Criteria:

Previous adverse reaction to ezetimibe
taken ezetimibe within 30 days of starting the study
history of vascular disease
allergic reaction or muscle problems while taking any statin
currently taking other lipid lowering medications (i.e. a fibrates or cholestyramine)
Intervention: Gadodiamide
Trial phase: Phase 4
ATC code: V08CA03
SMILES: CNC(=O)CN(CCN(CCN(CC(=O)[O-])CC(=O)NC)CC(=O)[O-])CC(=O)[O-].[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 202
Group description: OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
Eligibility criteria:
Inclusion Criteria:

The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent.
The subject has known or suspected chronic kidney disease with an eGFR greater than or equal to 30mL and <60 mL/min/1.73 m2 as measured within 30 days prior to the planned index OMNISCAN administration.
The subject agrees to be contacted for follow-up for 24 months.

Exclusion Criteria:

Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows:

skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching;
eyes - yellow raised spots on whites of eyes; or
bones and muscle - stiffness in joints; difficulty in moving or straightening of arms, hands, legs or feet; bone pain especially in hips and ribs or muscle weakness.
Patients allergic to any GBCA.
Patients with chronic renal disease with a GFR <30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration.
Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri operative liver transplantation period.
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients with pain in dermatomal distribution, in either cervical or lumbar region.
History of pain for more than 3 months.
History of herniated disc, spinal stenosis or failed back surgery.
A series of epidural steroid injections within the past 6 months.
Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes.
Patients must be cognitively capable of completing the pain questionnaires.

Exclusion Criteria:

Patients below 18 or over 65 years of age.
Patients with mostly axial spinal pain.
Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.
Workmen's compensation or disability issues.
Patients with chronic depression and on depression medications.
Addiction and/or substance abuse issues.
Patients using gabapentin or failure to respond to previous gabapentin use.
Patients with known peripheral neuropathy (e.g. DPN, PHN etc.).
Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing).
History of angioedema with pregabalin use.
Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac conduction abnormalities, and/or thrombocytopenia.
Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®, Actos®).
Pregnant patients.
Intervention: Lovenox
Trial phase: Phase 2
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).

Only patients with high TFMP status at baseline were randomized to treatment or observation.
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative therapies do not exist. Eligible malignancies include:

Adenocarcinoma of the pancreas (locally advanced or metastatic)
Colorectal (stage IV)
Non-small cell lung (unresectable stage III or IV)
Relapsed ovarian or stage IV
Surgically unresectable or metastatic gastric adenocarcinoma
First or second line therapy (within 4 weeks of initiating therapy).
Minimum age 18 years
Life expectancy of greater than 6 months
ECOG Performance Status 0, 1, or 2 (Karnofsky 60% or greater).
Participants must have normal organ and marrow function as outlined in the protocol.

Exclusion Criteria:

Participants may not be receiving any other study agents.
Known brain metastases should be excluded from this clinical trial because of their poor prognosis and higher potential for intracranial hemorrhage.
Prior history of documented venous thromboembolic event or pulmonary embolism within the last 5 years years (excluding central line associated events whereby patients completed anticoagulation > 3 months previously)
Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)
Any history of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 5 years
History of allergic reactions attributed to compounds of similar chemical or biologic composition to enoxaparin or heparin.
History of heparin-induced thrombocytopenia
Presence of coagulopathy (PT or PTT> 1.5 x upper limit of normal)
Familial bleeding diathesis
Known diagnosis of disseminated intravascular coagulation
Currently receiving anticoagulant therapy
Current use of aspirin (>81mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox), or regular use of non-steroidal anti-inflammatory agents more than twice weekly. Maximum dose of ibuprofen is 400mg no more than twice per week.
Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Intervention: Arixtra
Trial phase: Phase 4
SMILES: COC1OC(COS(=O)(=O)[O-])C(OC2OC(C(=O)O)C(OC3OC(COS(=O)(=O)[O-])C(OC4OC(C(=O)O)C(OC5OC(COS(=O)(=O)[O-])C(O)C(O)C5NS(=O)(=O)[O-])C(O)C4O)C(OS(=O)(=O)[O-])C3NS(=O)(=O)[O-])C(O)C2OS(=O)(=O)[O-])C(O)C1NS(=O)(=O)[O-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement

Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days.
Eligibility criteria:
Inclusion Criteria:

All primary unilateral TKA and THA cases will be included.

Exclusion Criteria:

Patients less than 50 kg, Patients with CrCl<30ml/min. Revision and bilateral procedures will be excluded.
Intervention: Basaglar
Trial phase: Phase 4
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 227
Group description: Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
Eligibility criteria:
Inclusion Criteria:

Diagnosed with type 2 diabetes for at least 6 months
Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
Body Mass Index (BMI) less than or equal to 35.0 kg/m^2

Exclusion Criteria:

Any contraindication to insulin detemir or insulin glargine according to the local labelling
Receipt of any investigational product within 4 weeks
Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
Intervention: Prasugrel
Trial phase: Phase 2
ATC code: B01AC22
SMILES: CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 210
Group description: One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
Eligibility criteria:
Key Inclusion Criteria:

Have coronary artery disease and clinical indication for percutaneous coronary intervention (PCI) with implantation of at least one drug-eluting stent and where percutaneous coronary intervention of all treated lesions is successful.
Have been given standard-of-care clopidogrel 600-mg loading dose between 24 hours before and at the time of PCI.
Standard of Care Aspirin use prior to PCI - at least 250-mg [intravenous (IV) or oral] within 24 hours before PCI and at the time of PCI.
VerifyNow P2Y12 reaction units > 208 measured 2-7 hours after clopidogrel maintenance dose the day after successful PCI.

Exclusion Criteria:

Non-ST segment elevation myocardial infarction within 14 days prior to randomization
ST-segment elevation myocardial infarction within 14 days prior to randomization
Have known major complications after percutaneous coronary intervention and prior to randomization
Have a body weight < 60 kilogram (kg)
Have cardiogenic shock at time of randomization
Have refractory ventricular arrhythmias
Have New York Heart Association Class IV congestive heart failure
Have received glycoprotein (GP) IIb/IIIa inhibitors eptifibatide or tirofiban within 24 hrs before or during percutaneous coronary intervention or abciximab within 10 days before or during percutaneous coronary intervention
Are receiving daily treatment with nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require > 2 weeks of daily treatment during the study
Intervention: Melatonin
Trial phase: Not Applicable
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Subjects will be administered melatonin.

Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.
Eligibility criteria:
Inclusion criteria:

blindness for at least one year, verified by an ophthalmologic exam
ability to comply with the requirements of the experimental protocol
competency to sign informed consent

Exclusion criteria (as determined by medical history and/or physical examination):

abnormal heart, liver or kidney function
a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual
possibly external demands that limit the ability to maintain a regular schedule (e.g., night shift work)
sexually active female subjects of child-bearing potential will be asked to avoid pregnancy using accepted methods and will be notified that the effects of melatonin on a fetus are not known (we will ask subjects monthly if they are pregnant or trying to become pregnant)
if a subject reports she is pregnant or is trying to become pregnant anytime during her study participation, any study medications (melatonin or placebo) will be immediately withdrawn and the subject will be excluded from the study