anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Efavirenz
Trial phase: Phase 2 | Phase 3
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Patients treated with Efavirenz
Eligibility criteria:
Inclusion Criteria:

Patients with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
No previous use of any ARV drug (drug-naïve patients)
Presence of clinical symptoms according to Rio de Janeiro / Caracas´ AIDS definition (Asthenia, Cachexia/Wasting, Cough, Dermatitis, persistent, Diarrhea, Fever, Lymphadenopathy, Candidiasis, oral, or hairy leukoplasia, Central nervous system dysfunction, Herpes zoster in individual younger than 60 years of age)), and/or any active AIDS-defining condition
Baseline CD4+ cells count equal or lower than 50 cells/mm3
Age equal or higher than 18 years
HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml

Exclusion Criteria:

Undetectable plasma viral load at screening
CD4 cells count>50 cells/mm3
Asymptomatic individuals
Intervention: Fentanyl
Trial phase: Phase 4
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
Eligibility criteria:
Inclusion Criteria:

women in labor at term pregnancy
healthy
epidural analgesia in place
breakthrough pain in advanced labor

Exclusion Criteria:

chronic pain syndrome
receiving systemic opioids within 4 hours
receiving chronic antidepressants, clonidine, opioids
Intervention: Spironolactone
Trial phase: Phase 3
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Active arm

Spironolactone 25 mg once daily.
Eligibility criteria:
Inclusion Criteria:

Aged 20-55 years;
Adults with ADPKD diagnosis based on Ravine criteria aged ≥ 30 years
Estimated glomerular filtration rate ≥ 60 ml/min/1.73m2
Hypertension defined as a systolic BP > 130 mm Hg and/or diastolic BP > 80 mmHg based on 3 separate measurements within the past year and currently on a minimum dose of an angiotensin converting enzyme inhibitor (minimum dose 10 mg P.O qd) or angiotensin receptor blocker (i.e., Losartan 25 mg P.O qd)
If using antioxidants and/or omega-3 fatty acids, must discontinue 4 weeks prior to participation
Free from alcohol dependence or abuse
Mini-mental state examination score ≥ 24; ability to provide informed consent
BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)
Not taking medications that interact with agents administered during experimental sessions (e.g., sildenafil interacts with nitroglycerin)

Exclusion Criteria:

• Average serum potassium >5.5 millequivalents or any single serum potassium > 6.0 millequivalents within the previous 6 months

Receiving an aldosterone antagonist within the previous 6 months
Use of a potassium sparing diuretic or any other drug that could contribute to hyperkalemia
Uncontrolled hypertension
Current smokers or history of smoking in the past 12 months
History of liver disease
History of heart failure (EF < 35%)
History of hospitalizations within the last 3 months
Active infection or antibiotic therapy
Warfarin use
Immunosuppressive therapy within the last year
Pregnancy
Intervention: Fentanyl
Trial phase: Phase 2
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of cancer with evidence of active disease
Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >/=3/10 on the numeric rating scale
Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology or Cardiopulmonary Center
Ambulatory and able to walk with or without walking aid
On strong opioids with morphine equivalent daily dose of 60-130 mg for at least one week, with stable (i.e. +/- 30%) regular dose over the last 24 hours
Karnofsky performance status >/=50%
Age 18 or older
Able to complete study assessments
Must speak and understand English.

Exclusion Criteria:

Dyspnea at rest >/=7/10 at the time of enrollment
Supplemental oxygen requirement >6 L per minute
Delirium (i.e. Memorial delirium rating scale >13)
History of unstable angina or myocardial infarction 1 month prior to study enrollment
Resting heart rate >120 at the time of study enrollment
Systolic pressure >180 mmHg or diastolic pressure >100 mmHg at the time of study enrollment
History of active opioid abuse within the past 12 months
History of allergy to fentanyl
Severe anemia (Hb <7g/L) if documented in the last month and not corrected prior to study enrollment*
Bilirubin >5X Upper limit of normal if documented in the last month and not lowered to <5x normal prior to study enrollment*
Diagnosis of acute pulmonary embolism within past 2 weeks
Diagnosis of pulmonary hypertension
Unwilling to provide informed consent
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: 1000 mg BID

Metformin: Biguanide- insulin sensitizer
Eligibility criteria:
Inclusion Criteria:

Females 18 years to 42 years of age who experienced gestational diabetes mellitus (GDM) during recent (within 12 months) pregnancy with prediabetic hyperglycemia determined by an oral glucose tolerance test (OGTT) with 75 g glucose postpartum. Study subjects will be inclusive of prior GDM women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT) postpartum.
Written consent for participation in the study

Exclusion Criteria:

Cholestasis during the past pregnancy
Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology)
Serum aspartate transaminase (AST) and/or alanine aminotransferase (ALT) level exceeding more than twice normal lab values
Presence of hypersensitivity to sitagliptin or other DPP-4 inhibitor
Current use of metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, or weight loss medications (prescription or over the counter [OTC])
Prior use of medication to treat diabetes except gestational diabetes
Use of drugs known to exacerbate glucose tolerance
History of diabetes or prior use of medications to treat diabetes except GDM
Creatinine clearance less than 60 ml/min
Pregnancy planned during the coming two years
Currently lactating
Patient not willing to use adequate contraception during study period (unless sterilized)
Intervention: Topiramate
Trial phase: Phase 2
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 34
Group description: Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.

Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial.
Eligibility criteria:
Inclusion Criteria:

BMI ≥1.2 times the 95th percentile (based on gender and age) or BMI ≥35 kg/m2
12-18 years old
Tanner stage IV or V by physical exam

Exclusion Criteria:

Tanner stage I, II, or III
Type 1 or 2 diabetes mellitus
Previous (within 6-months) or current use of weight loss medication (patients may undergo washout)
Previous (within 6-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)
Previous bariatric surgery
Recent initiation (within 3-months) of anti-hypertensive or lipid medication
Previous (within 6-months) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout)
Major psychiatric disorder
Females: Pregnant, planning to become pregnant, or unwilling to use 2 or more acceptable methods of contraception when engaging in sexual activity throughout the study
Tobacco use

Liver/renal dysfunction

ALT or AST >2.5 times the upper limit of normal
Bicarbonate <18 mmol/L
Creatinine >1.2 mg/dL
Glaucoma
Obesity associated with genetic disorder (monogenetic obesity)
Hyperthyroidism or uncontrolled hypothyroidism
History of suicidal thought/attempts
History of kidney stones
History of cholelithiasis
Current use of other carbonic anhydrase inhibitor
Intervention: Oxycodone
Trial phase: Not Applicable
ATC code: N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19
SMILES: COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 502
Group description: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.

Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.

Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
Eligibility criteria:
Inclusion Criteria:

self-reported pain or nausea identified by the initial nursing assessment

Exclusion Criteria:

unable to speak English,
< 18 y.o.,
previously diagnosed with chronic pain or cyclic vomiting
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 502
Group description: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.

Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.

Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
Eligibility criteria:
Inclusion Criteria:

self-reported pain or nausea identified by the initial nursing assessment

Exclusion Criteria:

unable to speak English,
< 18 y.o.,
previously diagnosed with chronic pain or cyclic vomiting
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes

Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
Eligibility criteria:
Inclusion Criteria:

18 years of age and older
Patient in an intensive care unit
Weight greater or equal to 50 kgs
Fever: core body temperature greater than or equal to 38.3 degrees Celsius
Clinically stable: no active resuscitation with fluids, blood products, or dose increases of vasoactive medications within 1 hour of study drug administration

Exclusion Criteria:

Acetaminophen hypersensitivity
Acute liver failure or acute liver injury
Heat stroke, malignant hyperthermia, neuroleptic malignant syndrome
Therapeutic cooling, physical cooling, extracorporeal blood circuit therapies
Administration of acetaminophen-containing medications, non-steroidal anti-inflammatory drugs, or aspirin greater than 81 mg within specified times per drug prior to fever presentation
Intervention: Doxycycline monohydrate
Trial phase: Phase 4
SMILES: CC1c2cccc(O)c2C(O)=C2C(=O)C3(O)C(O)=C(C(N)=O)C(=O)C(N(C)C)C3C(O)C21.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.

Oral dose for 12 weeks

Oracea
Eligibility criteria:
Inclusion Criteria:

Men and women
25-70 years
Diagnosis of papulopustular rosacea
Eligible for Oracea treatment

Exclusion Criteria:

Allergies to components of investigational product and/or hypersensitivity to tetracyclines
Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit
Used topical rosacea treatment within 30 days prior to baseline visit
Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist
Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics
Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive UV exposure during the course of the study
Have planned surgical procedures during the course of the study
Have used tetracycline antibiotics within 30 days prior to baseline visit or during study
At risk in terms of precautions, warnings, and contraindications
Intervention: Metformin
Trial phase: Not Applicable
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 166
Group description: Diabetic patients receiving contrast media without discontinuing metformin.

Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.
Eligibility criteria:
Inclusion Criteria:

Diabetic patients receiving metformin who were scheduled for:

coronary angiography
coronary angioplasty

Exclusion Criteria:

Patients who had contraindication for metformin administration, such as:

decompensated heart failure
severe liver disease
severe hypoxemia
GFR<60 mL/min per 1.73 m2
Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: oral metformin at 500 mg twice a day for 14-21 days followed by surgery

Metformin
Eligibility criteria:
Inclusion Criteria:

Histological confirmed diagnosis of grade I or II adenocarcinoma of the endometrium
Must be obese as defined by a body mass index (BMI) greater than or equal to 30 kg/m2
Candidate for surgical removal of their uterus as part of their endometrial cancer treatment
Subjects must have signed informed consent
Age 42 - 65 years of age
Electrocorticogram (ECOG) Performance status of 0 - 2

History of adequate renal, liver, and bone marrow function:

Hb: (adequate for surgical intervention, with transfusion if necessary) White Blood Cell (WBC): (normal range)
Platelets: (180K/cmm)
Liver Function Test(LFTs): Normal bilirubin (<2.0mg/dL), AST/ALT (2xULN)
Renal function: creatinine less than 1.4
Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of randomization to Metformin. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.

Exclusion Criteria:

Poorly differentiated cancer or any of the high-risk subtypes of endometrial cancer including serous, clear cell, or carcinosarcoma
History of diabetes mellitus Type 1 or Type 2.
Receiving metformin prior to enrollment
Known hypersensitivity to metformin.
Unable to swallow and retain oral medication.
Pregnant or lactating.
Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for > 5 years
If the physician feels that the candidate is not suitable for the study, he/she will be excluded.
Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR or DPP-4 inhibitors or having taken any of these medications during the 12 weeks prior to study participation.
Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation.
History of lactic or other metabolic acidosis.
Uncontrolled infectious disease.
History of positivity for human immunodeficiency virus (HIV).
History of congestive heart failure requiring pharmacologic treatment.
History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily.
Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.
Current use of medications for weight loss.
Currently taking cimetidine, thiazide diuretics or cephalexin. If a patient needs some of these agents, alternative agents should be substituted.
Intervention: Epirubicin
Trial phase: Phase 2
ATC code: L01DB01 | L01DB03
SMILES: COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.

IMRT: Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC

DWI MRI: The DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated.

Doxorubicin: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.

Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
Eligibility criteria:
Inclusion Criteria:

Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease.
Age ≥18 years
Karnofsky performance status ≥70%
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment.
Patients must have ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Women who are pregnant or lactating
Inability to comply with study and/or follow-up procedures
Intervention: Carmellose sodium
Trial phase: Phase 3
SMILES: CC(=O)O.O=CC(O)C(O)C(O)C(O)CO.[Na]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 73
Group description: 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Eligibility criteria:
Inclusion Criteria:

-Patients scheduled for LASIK surgery in both eyes.

Exclusion Criteria:

Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
Use of topical eye medication other than prescribed for use in pre- or post-operative care
Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
Eye infection, inflammation, or allergy
Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.
Intervention: Perflutren
Trial phase: Not Applicable
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
Eligibility criteria:
Inclusion Criteria:

Patients must have previous cross sectional imaging (CT or MRI) demonstrating renal mass or masses that is amenable to open partial nephrectomy.
Patient is scheduled for intraoperative ultrasound guided open partial nephrectomy.
Patient must sign informed consent, with risks and benefits of CEUS explained (see risks outlined on the following pages)

Exclusion Criteria:

Patients with known renal mass scheduled for total or laparoscopic partial nephrectomy.
Patients who are hypersensitive to Definity (Perflutren Lipid Microsphere)
Patients with known history of right-to-left, bidirectional or transient right-to-left cardiac shunts.
Pediatric patients less than 18 years of age.
Pregnant or nursing mothers.
Intervention: Spironolactone
Trial phase: Not Applicable
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
Eligibility criteria:
Inclusion Criteria:

Resistant hypertension defined as office BP that is uncontrolled with 3 or more antihypertensive medications
Moderate-severe OSA defined as AHI ≥15 events/hr
Self-reported adherence >80% with prescribed antihypertensive medications.

Exclusion Criteria:

Ongoing use of a potassium sparing diuretic
History of congestive heart failure (ejection fraction of <40%)
Chronic kidney disease (creatinine clearance <60 ml/min)
History of cardiovascular disease (stroke, TIA, myocardial infarction, or revascularization procedure)
Known or suspected history of secondary cause of hypertension other than primary aldosteronism
Severe nocturnal hypoxemia (O2 desaturation nadir <60%)
White coat hypertension defined as office BP >140/90 mm Hg and ambulatory daytime BP <135/85 mm Hg
Central sleep apnea (defined as 5% or more of the apneas as central apneas) and/or the presence of any Cheyne-Stokes breathing
Subjects working shift work or having other known circadian rhythm disorders such that their sleep-wake schedule is altered
Excessive daytime sleepiness as indicated by an Epworth score of >10
Pregnant Women