anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Morphine
Trial phase: Phase 4
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation

Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
Eligibility criteria:
Inclusion Criteria:

ASA I-III
Ages 18-65 years
Presenting for lower extremity orthopedic surgery involving fracture of long bones at University of Louisville Hospital
Surgery expected to last more than one hour
Patient expected to have moderate to severe post-operative pain
Patient refused regional anesthesia or has a contraindication to regional anesthesia

Exclusion Criteria:

Any known contraindications to methadone including hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
Difficulty or inability to understand the study or protocol
Known renal or hepatic dysfunction
BMI> 35
Known respiratory or cardiovascular problems, such as obstructive sleep apnea or oxygen saturation of less than 92% on room air
Taking any of the known drugs that induce or inhibit the cytochrome p450 enzyme systems. Common examples of these drugs are antifungal, antiretroviral, barbiturates, dexamethasone, and macrolide antibiotics.
Pregnancy
Taking preoperative opioids for more than 2 weeks before the surgery
Intervention: Nebivolol
Trial phase: Phase 4
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.

Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 21
Male or female who is post-menopausal or not pregnant and using an approved contraceptive regimen
Previous beta blocker use and intolerant of beta blocker

Exclusion Criteria:

Systolic blood pressure < 100 mmHg unless another blood pressure medication is stopped at the time of study entry
Hospitalized for heart failure within the past 4 weeks
Bradycardia with a heart rate < 60
Heart block greater than first degree
History of sick sinus syndrome (unless a permanent pacemaker is in place)
History of severe hepatic or renal dysfunction; serum Creatinine > 2.0 or Amylase > 3x normal
Use of CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
Ingestion of investigational drug within the past 30 days
Intervention: Aliskiren
Trial phase: Phase 3
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 808
Group description: Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
Eligibility criteria:
Inclusion criteria:

Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 18 years of age, male or female.

Patients with a diagnosis of acute heart failure expressed by symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization.

LVEF < 40% (measured within the last 6 months).
Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP ≥ 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization.
Elevated BNP at Visit 1 or at randomization (BNP ≥ 400 pg/ml).
Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).

Exclusion Criteria:

Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
Concomitant use of ACEI and ARB at randomization.
Right heart failure due to pulmonary disease.
Diagnosis of postpartum cardiomyopathy.
Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
Patients with a history of heart transplant or who are on a transplant list.
Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.

Other protocol-defined inclusion/exclusion criteria applied.
Intervention: Midazolam
Trial phase: Not Applicable
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.

midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG
Eligibility criteria:
Inclusion Criteria:

Age 2-6 years
Toilet trained
English speaking
Already scheduled for VCUG

Exclusion Criteria:

Allergic to midazolam
Active UTI
Known urethral stricture
Known urethral reconstruction
Has history of abnormal sensation in pelvic area
Has history of sexual abuse
Has severe developmental delay
Has diagnosis of anxiety disorders
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
Eligibility criteria:
Inclusion Criteria:

An adult between 21 and 70 years of age.
Male or female (If female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
Able to speak and read English.
Willing to comply with study specific instructions, and complete all study procedures according to protocol.
Able to understand study rationale and sign informed consent.

Exclusion Criteria:

Females of child-bearing potential not using acceptable method of contraception and perimenopausal females.
History of gout
History of diabetes mellitus
History of coronary heart disease
History of, or currently experiencing, renal disease including, but not limited to, renal insufficiency, nephrolithiasis or chronic renal failure.
History of, or currently experiencing, major chronic gastrointestinal condition including gallbladder disease, liver disease and peptic ulcer disease
Known sensitivity to niacin, Aspirin or nonsteroidal anti-inflammatory agents (NSAIDs)
History of migraine or cluster headaches
Currently using antihistamines, aspirin or NSAIDS on a consistent basis
Presence or history of any medical or psychosocial condition that, in the opinion of the investigator, would limit the patient's successful participation or would compromise the patient's safe participation.
Lab abnormalities at screening, including but not limited to elevated liver enzymes or blood sugar levels that might indicate additional risk to the patient's continued participation.
Currently taking medication that might be contraindicated with the study drug or Niacin or study procedures (including Niacin, lipid-lowering drugs, chronic aspirin or laxative use).
Clinically significant finding from physical exam that would affect the patient's safe participation or completion of the study.
Intervention: Itraconazole
Trial phase: Not Applicable
ATC code: J02AC02
SMILES: CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 144
Group description: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).

itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
Eligibility criteria:
Inclusion Criteria:

Patients over 18 years, premenopausal
Negative pregnancy test
Signed informed consent
At least 4 Episodes of Candidiasis within the last year
Candida detectable by culture
Negative Hepatitis- and HIV-Serology
No Allergy to Itraconazole

Exclusion Criteria:

Under 18 years
Intervention: Omeprazole
Trial phase: Not Applicable
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Esomeprazole : 40 mg once daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Patients with an established diagnosis of EE defined as > 20 eosinophils/HPF in the setting of dysphagia or food impaction.
Males and females age > 18 years of age.
Ability to undergo ambulatory pH monitoring.
DEERS (Defense Enrollment Eligibility Reporting System) eligible.
Willingness to take a one month holiday from a PPI or steroids if they have been prescribed this prior to enrollment.
Willingness to participate and have additional biopsies taken during endoscopy and answer a questionnaire.

Exclusion Criteria:

Patients < 18 years of age.
Inability to give consent.
Inability to undergo endoscopy or contraindications to endoscopy. Any medical condition or disorder (including drug allergies), which would preclude the use of conscious sedation or the ability to tolerate upper endoscopy.
Contraindications to proton pump inhibitors or steroids.
Inability to accurately fill out a short questionnaire.
Pregnant females. A urine beta human chorionic gonadotropin (BHCG) prior to endoscopy will be offered to all female patients of child bearing potential (exceptions include post-menopausal, hysterectomy or bilateral tubal ligation). Positive BHCG results will prevent enrollment.
Known coagulation abnormalities, thrombocytopenia and patients on coumadin.
Intervention: Aripiprazole
Trial phase: Phase 4
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Participants will receive an injection of aripiprazole during the tracer-clamp study.

Aripiprazole: Single intramuscular 9.75-mg dose
Eligibility criteria:
Inclusion Criteria:

Prediabetic, defined as 2-hour post-load serum glucose between 140 and 199 mg/dl on a 75-gram standard oral glucose tolerance test (OGTT) within the past 90 days
Family history of type 2 diabetes mellitus
Body mass index (BMI) between 25 and 35 kg/m2
English speaker
Nonsmoker

Exclusion Criteria:

History of Axis I mood, anxiety, or psychotic disorder, confirmed by Structured Clinical Interview for DSM-IV
Use of psychotropic drugs
Intervention: Olanzapine
Trial phase: Phase 4
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Participants will receive an injection of olanzapine during the tracer-clamp study.

Olanzapine: Single intramuscular 10-mg dose
Eligibility criteria:
Inclusion Criteria:

Prediabetic, defined as 2-hour post-load serum glucose between 140 and 199 mg/dl on a 75-gram standard oral glucose tolerance test (OGTT) within the past 90 days
Family history of type 2 diabetes mellitus
Body mass index (BMI) between 25 and 35 kg/m2
English speaker
Nonsmoker

Exclusion Criteria:

History of Axis I mood, anxiety, or psychotic disorder, confirmed by Structured Clinical Interview for DSM-IV
Use of psychotropic drugs
Intervention: IFN alpha-IFNAR-IN-1
Trial phase: Phase 2
SMILES: CNCc1ccccc1Sc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 99
Group description: 150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
Eligibility criteria:
Inclusion Criteria:

Male or non-pregnant female
Females of child-bearing potential must practice a medically accepted form of birth control

Exclusion Criteria:

Currently exhibiting an acute upper respiratory tract infection
history of chronic respiratory disease requiring regular therapy(i.e. COPD, asthma, bronchitis, etc.)
any condition likely to increase the risk of severe or complicated influenza (i.e. cardiac disease, chronic renal disease, endocrine diseases, including diabetes and/or immunosuppressive therapy)
any condition requiring regular treatment with antihistamines, analgesics or antipyretics
known infection with HIV, hepatitis B virus or hepatitis C virus
any other serious, uncontrolled disease
any active infections requiring use of antibiotic or antiviral drugs
non-ambulatory status
suspected drug or alcohol abuse
Intervention: Acetylcysteine
Trial phase: Phase 4
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Acute liver failure population

N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.

NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.

i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour

ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours

iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours

iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours

v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours
Eligibility criteria:
Inclusion Criteria:

Written Informed consent from patient's next of kin
Altered mentation of any degree (encephalopathy)
Evidence of moderately severe clotting abnormalities (international normalized ratio ≥ 1.5)
A presumed acute illness onset of less than 26 weeks
Admitted to study site hospital intensive care units with acute liver failure and who can be evaluated and started on treatment within the first 24 hours of hospitalization
All subjects will be between 18 and 70 years
The NIH guidelines on the inclusion of women and minorities as subjects will be observed

Exclusion Criteria:

Patients less than age 18 or over 70 years of age
Acetaminophen or mushroom poisoning induced liver failure
Patients with a diagnosis of shock liver (ischemic hepatopathy)
Acute liver failure of pregnancy
Acute liver failure thought secondary to intra-hepatic malignancy
Cerebral herniation
Intractable arterial hypotension
Severe sepsis (temperature >39º C and/or significant bacteremia) present at the time of enrollment
Intervention: Leptin
Trial phase: Phase 2 | Phase 3
SMILES: CSCCC(N=C(O)C(CC(=O)O)N=C(O)C(CCC(=N)O)N=C(O)C(CC(C)C)N=C(O)C(CO)N=C(O)CN=C(O)C(CCC(=N)O)N=C(O)C(N)CC(C)C)C(O)=NC(CC(C)C)C(O)=NC(Cc1c[nH]c2ccccc12)C(O)=NC(CCC(=N)O)C(O)=NC(CC(C)C)C(O)=NC(CC(=O)O)C(O)=NC(CC(C)C)C(O)=NC(CO)C(=O)N1CCCC1C(O)=NCC(O)=NC(CS)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Randomized to Leptin Therapy for 4 months.
Eligibility criteria:
Inclusion Criteria:

age > 6 years
Partial and generalized lipodystrophy
Serum leptin levels less than the 7th percentile of normal values reported by the 3rd National Health and Nutrition Examination survey (less than 7.0 ng/mL in females and less than 3/0 ng/mL in males)

Presence of at least one of the following metabolic abnormalities:

Type 2 Diabetes Mellitus
Fasting serum insulin >20 uU/mL
Fasting serum triglycerides > 300 mg/dL
Previous participation in leptin trial (Amgen 991265, GCRC 660) - for Part B of the Study.

Exclusion Criteria:

Known liver disease due to causes other than non-alcoholic steatohepatitis.
Hematocrit of less than 30%.
Current alcohol or substance abuse.
Use of anorexigenic drugs, anabolic steroids, GH and thiazolidinediones
Active tuberculosis
Psychiatric disorder impeding competence or compliance
Malignancies
HIV infection
Subjects who have a known hypersensitivity to E. Coli derived proteins
Other condition, which in the opinion of the clinical investigators would impede completion of the study.
Intervention: Avexitide
Trial phase: Phase 1 | Phase 2
SMILES: CCC(C)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(NC(=O)C(C)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCC(N)=O)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(CC(C)C)NC(=O)C(N)CC(=O)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 min to time 360 min

Exendin-(9-39)
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of hyperinsulinism
Mutation analysis results demonstrating KATP channel defect
Age 6 months to 18 years with
Persistent hypoglycemia

Exclusion Criteria:

Current therapy with medications that may affect glucose metabolism such as octreotide, diazoxide, high dose glucocorticoids, adrenergic agents, etc. Subjects will be eligible to participate if the last dose of octreotide is given 48 hrs before study day 1 and the last dose of diazoxide is given 72 hours before study day 1
Evidence of a medical condition that might alter results or compromised the elimination of the peptide, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
Pregnancy
Subjects with milk protein allergy will be excluded for participating in studies involving protein tolerance test
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Low dose daily aspirin in healthy volunteers for two weeks

aspirin : 81 mg orally daily for two weeks
Eligibility criteria:
Inclusion Criteria:

healthy adults

Exclusion Criteria:

any underlying major medical conditions such as heart disease, hypertension, stroke, diabetes, bleeding disorders
Intervention: Citalopram
Trial phase: Phase 3
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 94
Group description: Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention

citalopram : target dose 30mg daily for 9 weeks
Eligibility criteria:
Inclusion criteria

Probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria), with Mini-Mental score of 5-28 inclusive
A medication for agitation is appropriate, in the opinion of the study physician

Clinically significant agitation for which either

the frequency of agitation as assessed by the Neuropsychiatric Inventory (NPI) is 'Very frequently', or
the frequency of agitation as assessed by the NPI is 'Frequently' AND the severity of the agitation as assessed by the NPI is 'Moderate', or 'Marked'
Provision of informed consent for participation in the study by patient or surrogate (if necessary) and caregiver
Availability of primary caregiver, who spends several hours a week with the patient and supervises his/her care, to accompany the patient to study visits and to participate in the study
No change to Alzheimer's disease (AD) medications within the month preceding randomization, including starting, stopping, or dosage modifications

Exclusion criteria

Meets criteria for Major Depressive Episode by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV (TR)) criteria
Presence of a brain disease that might otherwise explain the presence of dementia, such as extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis
Psychosis (delusions or hallucinations) requiring antipsychotic treatment in the opinion of the study physician
Prolonged measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval)
Treatment with citalopram is contraindicated in the opinion of the study physician
Failure of past treatment with citalopram for agitation after adequate trial at a minimally accepted dose (greater than or equal to 20 mg/day)
Treatment with a medication that would prohibit the safe concurrent use of citalopram, such as Monoamine oxidases (MAO) inhibitors
Need for psychiatric hospitalization or suicidal
Current participation in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes
Current treatment with antipsychotics, anticonvulsants (other than dilantin), other antidepressants (other than trazodone, less than or equal to 50 mg per day at bedtime), benzodiazepines (other than lorazepam), or psychostimulants
Any condition that, in the opinion of the study physician, makes it medically inappropriate or risky for the patient to enroll in the trial
Intervention: Zopiclone
Trial phase: Not Applicable
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
Eligibility criteria:
Inclusion Criteria:

Age 20-50 (men or women)
Current shift worker (for at least 3 months, at least 5 overnights/month and 3 consecutive)
A willingness and ability to comply with study procedures
If of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method, or intrauterine device [IUD]).

Exclusion Criteria:

Current diagnosis of DSM-IV Axis I disorder (other than insomnia)
Regular treatment (>1time/wk) with CNS-active medication within 1 month of first inpatient visit
Uncontrolled medical illness that would interfere with participation in the study
BMI>32 or < 19.8 kg/m2
Current symptoms or diagnosis of any moderate to severe sleep disorder other than SWSD
Periodic Leg Movement of Sleep Index (PLMSi)>20/hr of sleep or Respiratory Desaturation Index (RDI)>15 on polysomnography (PSG)
Current alcohol or drug dependence/abuse
Menopausal or peri-menopausal symptoms that disrupt sleep
Pregnant, lactating, or planning to become pregnant
Current smoking of more than 10 cigarettes per day
Current use of over the counter sleep aids such as Benadryl or melatonin