anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Nicotine patch given pre-quit attempt at weeks 4 through 6

nicotine patch: Nicotine patch, 7-21 mg.
Eligibility criteria:
Inclusion Criteria:

between ages of 18 and 70
smoker who has smoked 10 or more cigarettes per day during past year
current PTSD
English speaker
study physician clearance

Exclusion Criteria:

organic mental disorder, schizophrenia, current manic syndrome, lifetime but not current PTSD, or current substance abuse/dependence
pregnancy
unstable medications
myocardial infarction in past 6 months
Intervention: Nitazoxanide
Trial phase: Phase 2
ATC code: P01AX11
SMILES: CC(=O)Oc1ccccc1C(=O)Nc1ncc([N+](=O)[O-])s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days
Eligibility criteria:
Inclusion Criteria:

Age 18 to 65 years
Fever, respiratory symptoms and constitutional symptoms compatible with influenza infection
Influenza A or B infection in the local community
Onset of illness no more than 48 hours before presentation
Willing and able to provide comply with protocol requirements

Exclusion Criteria:

Severity of illness requiring or anticipated to require in-hospital care
High risk of complications from influenza per IDSA (Infectious Diseases Society of America) guidelines or current CDC (Centers for Disease Control) criteria
Females pregnant, breast-feeding or sexually active without birth control
Vaccination for seasonal influenza or H1N1 on or after August 1, 2009
Treatment with antiviral medication for influenza within 1 month prior to screening
Treatment with nitazoxanide or any investigational drug within 1 month prior to screening
Known sensitivity to nitazoxanide or any excipients
Unable to take oral medications
Chronic kidney or liver disease or known impaired hepatic and/or renal function
Other pre-existing chronic infection undergoing or requiring medical therapy
Pre-existing illness placing subject at unreasonably increased risk by participation in study
Unlikely to comply with the requirements of this protocol
Intervention: Nebivolol
Trial phase: Not Applicable
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: 53
Group description: all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.
Eligibility criteria:
Inclusion Criteria:

Diagnosis (new or established) hypertension, defined by serial measurements >/= 140/90
Evidence of diastolic dysfunction on echocardiography measured by tissue Doppler

Exclusion Criteria:

Severe bronchospastic disease/ reactive airway disease
Inability to tolerate beta blocker therapy including: >1st degree atrioventricular (AV) block, symptomatic hypotension, symptomatic bradycardia,
Subjects with physical limitations that would prevent them from participating in an exercise treadmill test
Age <18 or >90 years
Those with life expectancy <1 year
Subjects with class III/IV New York Heart Association (NYHA) heart failure symptoms
Chronic Kidney Disease 3 or greater (CrCl <30 cc/min)
Subjects with active ischemia or evidence of ischemia on initial stress echocardiography
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
Healthy volunteers: No
Participants at risk: 290
Group description: 5 mg, titrated to 20 mg, once daily oral administration
Eligibility criteria:
Inclusion Criteria:

male of female, 18 to 64 years of age at screening
mean seated heart rate at least 60 bpm
diagnosed systolic stage 2 hypertension
unremarkable physical exam findings

Exclusion Criteria:

high risk due to secondary hypertension or former stage 3 hypertension by JNC6
concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
currently taking medication that cannot be stopped during the course of the study
participating other clinical trials
member of the study center personnel
documented drug abuse
contra indication to beta blocker
abnormal lab finding
poor compliance
other conditions judged by investigator that is not suitable for the study
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: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 109
Group description: Intra-operative administration of morphine 50 mcg/kg for analgesia

Morphine 50 mcg/kg: Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia
Eligibility criteria:
Inclusion Criteria:

Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion Criteria:

Children less than 3 years
Children with uncorrected cardiac lesions
Children with heart block or liver impairment
Children with American Society of Anesthesiology Class 3 or 4.
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: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 109
Group description: Intra-operative administration of morphine 100mcg/kg for analgesia

Morphine 100 mcg/kg: Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia
Eligibility criteria:
Inclusion Criteria:

Children between ages 3 and 17 years with American Society of Anesthesiology classification 1 or 2.

Exclusion Criteria:

Children less than 3 years
Children with uncorrected cardiac lesions
Children with heart block or liver impairment
Children with American Society of Anesthesiology Class 3 or 4.
Intervention: Naltrexone
Trial phase: Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Naltrexone: Targeted dosage of 50mg PO daily
Eligibility criteria:
Inclusion Criteria:

Men or women over age 18
Current DSM-IV PG Diagnosis as determined by a score of ≥ 5A criteria and B criterion present on the SCI-PG and a score ≥ 5 on the SOGS
Gambling behavior within 2 weeks prior to enrollment
For women, stable use of a medically accepted form of contraception and negative results on urine pregnancy test at study onset
Currently entering, enrolled, or interested in treatment for PG

Exclusion Criteria:

Gambling that does not meet DSM-IV criteria for PG
Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen
Past or current acute hepatitis or liver failure
History of renal impairment
Current or recent (within one week) treatment with an opioid agonist/opioid analgesic or current opioid withdrawal
Opiate agonist maintenance therapy (e.g. methadone)
Known sensitivity to opioid antagonists
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
A need for medication with unfavorable interactions with naltrexone
Clinically significant suicidality
Lifetime history of dementia, schizophrenia, or any psychotic disorder determined by SCID
Clinically significant cognitive impairment
Previous treatment with naltrexone or nalmefene
Treatment with investigational medication or depot neuroleptics within 3 months
Lack of proficiency in written and spoken English
Unable to travel to study sites for appointments
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 140
Group description: Mesalamin: 4.8g/day, 800 mg tablets
Eligibility criteria:
Inclusion Criteria:

(1) Male or non-pregnant, non-lactating females, 18 years of age or older. (2) Documented diagnosis of UC with disease extending at least 15 cm from the anal verge.

(3) Active UC defined by:

(a) modified UC-DAI score of 4-10 with (b) sigmoidoscopy component score ≥ 2 and (c) rectal bleeding component score ≥ 1 (4) Ability of subject to participate fully in all aspects of this clinical trial.

(5) Written informed consent must be obtained and documented.

Exclusion Criteria:

Severe UC defined by the following criteria:

³6 bloody stools daily with one or more of the following:

oral temperature > 37.8°C or > 100.0°F
pulse > 90/min
hemoglobin < 10 g/dL
Previously failed treatment with a mesalazine dose of > 2.0 g/day.
Current relapse lasting > 6 weeks in the opinion of the investigator.
Treatment with 5-ASA at a dose of >2.0g/day within 1 week prior to randomisation
Treatment with systemic or rectal steroids within 4 weeks prior to randomization.
Treatment with immunosuppressants within 6 weeks prior to randomization.
Treatment with infliximab or other biologics within 3 months prior to randomization.
Treatment with systemic antibiotics for UC within 7 days prior to randomization.
Treatment with probiotics within 7 days prior to randomization.
Treatment with anti-diarrheals within 7 days prior to randomization.
Treatment with nicotine patch within 7 days prior to randomization.
Received any investigational drug within 30 days prior to randomization.
History of colectomy or partial colectomy.
History of definite dysplasia in colonic biopsies.
Crohn's disease.
Known bleeding disorders.
Immediate or significant risk of toxic megacolon.
Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
Serum creatinine > 1.5 times the upper limit of the normal range.
AST, ALT, total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range.
Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
Stools positive for clostridium difficile.
Pregnant or lactating women.
Prior enrolment in the current study and had received study treatment.
Intervention: MESALAMINE
Trial phase: Phase 3
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: Placebo to Mesalamin: 4.8g/day, 800 mg tablets
Eligibility criteria:
Inclusion Criteria:

(1) Male or non-pregnant, non-lactating females, 18 years of age or older. (2) Documented diagnosis of UC with disease extending at least 15 cm from the anal verge.

(3) Active UC defined by:

(a) modified UC-DAI score of 4-10 with (b) sigmoidoscopy component score ≥ 2 and (c) rectal bleeding component score ≥ 1 (4) Ability of subject to participate fully in all aspects of this clinical trial.

(5) Written informed consent must be obtained and documented.

Exclusion Criteria:

Severe UC defined by the following criteria:

³6 bloody stools daily with one or more of the following:

oral temperature > 37.8°C or > 100.0°F
pulse > 90/min
hemoglobin < 10 g/dL
Previously failed treatment with a mesalazine dose of > 2.0 g/day.
Current relapse lasting > 6 weeks in the opinion of the investigator.
Treatment with 5-ASA at a dose of >2.0g/day within 1 week prior to randomisation
Treatment with systemic or rectal steroids within 4 weeks prior to randomization.
Treatment with immunosuppressants within 6 weeks prior to randomization.
Treatment with infliximab or other biologics within 3 months prior to randomization.
Treatment with systemic antibiotics for UC within 7 days prior to randomization.
Treatment with probiotics within 7 days prior to randomization.
Treatment with anti-diarrheals within 7 days prior to randomization.
Treatment with nicotine patch within 7 days prior to randomization.
Received any investigational drug within 30 days prior to randomization.
History of colectomy or partial colectomy.
History of definite dysplasia in colonic biopsies.
Crohn's disease.
Known bleeding disorders.
Immediate or significant risk of toxic megacolon.
Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
Serum creatinine > 1.5 times the upper limit of the normal range.
AST, ALT, total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range.
Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
Stools positive for clostridium difficile.
Pregnant or lactating women.
Prior enrolment in the current study and had received study treatment.
Intervention: Suvorexant
Trial phase: Phase 1
ATC code: N05CJ01 | N05CM19
SMILES: [H][C@@]1(C)CCN(c2nc3cc(Cl)ccc3o2)CCN1C(=O)c1cc(C)ccc1-n1nccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Participants with severe renal impairment received a

single dose of 20 mg open-label suvorexant.
Eligibility criteria:
Inclusion Criteria:

Impaired Renal Function Participants:

Females of reproductive potential must have a negative pregnancy test and agree to use (and/or have their partner use) two acceptable methods of birth control
Body Mass Index (BMI) ≤40 kg/m^2
Diagnosis of renal insufficiency

Healthy Participants:

Females of reproductive potential must have a negative pregnancy test and agree to use (and/or have their partner use) two acceptable methods of birth control
Body Mass Index (BMI) ≤40 kg/m^2 and is matched for BMI ± 5 units to his/her corresponding renal participant
In general good health
Matched for age ± 10 years to his/her corresponding renal participant

Exclusion Criteria:

Impaired Renal Function Participants:

Is mentally or legally incapacitated
History of a clinically significant psychiatric disorder over the last year
Has rapidly fluctuating renal function or has demonstrated or suspected renal artery stenosis
Has had a kidney transplant
Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (>2 drinks/day)
Consumes excessive amounts of caffeinated beverages (>6/day)
Has had major surgery within 4 weeks
Has a history of significant multiple and/or severe allergies
Has a history of cataplexy
Participant works a night shift and is not able to avoid night shift work during the study
Current or history of illicit drug abuse
Nursing mothers

Healthy Participants:

Is mentally or legally incapacitated;
Has a history of stroke, chronic seizures, or major neurological disorder
Unstable endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary diseases
History of cancer (Some exceptions apply)
Regular user of barbiturates or sleep aides
Consumes excessive amounts of alcohol (>2 drinks/day)
Consumes excessive amounts of caffeinated beverages (>6/day)
Has had major surgery within 4 weeks
Has a history of significant multiple and/or severe allergies
Has a history of cataplexy
Participant works a night shift and is not able to avoid night shift work during the study
Current or history of illicit drug abuse
Nursing mothers
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 3
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 206
Group description: Loteprednol etabonate 0.5% ophthalmic suspension
Eligibility criteria:
Inclusion Criteria:

Subjects who are at least 18 years of age.
Subjects who are candidates for routine, uncomplicated cataract surgery.

Exclusion Criteria:

Subjects who have known hypersensitivity or contraindication to the study drug or components.
Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
Subjects with elevated intraocular pressure (>/=21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
Subjects who are monocular or have pinholed Snellen visual acuity (VA) 20/200 or worse in the non-study eye.
Intervention: Benzocaine
Trial phase: Phase 2
ATC code: C05AD03 | D04AB04 | N01BA05 | R02AD01
SMILES: CCOC(=O)c1ccc(N)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E

Polyphenon E: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on breast MRI of at least 1-cm3 in volume.
Patients may have undergone treatment with prior chemotherapy if this was greater than 12 months prior to current diagnosis.
Age >18 years.
ECOG performance status <2 (Karnofsky >60%)
Life expectancy of greater than 12 months.
Normal organ and marrow function as defined below:
leukocytes >3,000/mcL
absolute neutrophil count >1,500/mcL
platelets >100,000/mcL
total bilirubin within normal institutional limits
AST(SGOT) & ALT(SGPT)within normal institutional limits
creatinine <1.5 times institutional upper limit of normal or creatinine clearance >60 mL/min/1.73 m2
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Pregnancy
Patients who have undergone prior excisional biopsy for DCIS.
Patients who are unable to undergo MRI due to claustrophobia or other reason.
Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study.
Patients receiving any other chemotherapy or investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extracts or sensitivity to green tea.
Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Intervention: Yosprala
Trial phase: Not Applicable
SMILES: CC(=O)Oc1ccccc1C(=O)O.COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
Eligibility criteria:
Inclusion Criteria:

-healthy volunteers

Exclusion Criteria:

pretreatment with aspirin
pretreatment with non steroidal anti inflamatory drugs
pretreatment with antacids
history of peptic ulcer disease
coagulation or aggregation disorder.
Intervention: Nilotinib
Trial phase: Phase 4
ATC code: L01EA03 | L01XE08
SMILES: Cc1cn(-c2cc(NC(=O)c3ccc(C)c(Nc4nccc(-c5cccnc5)n4)c3)cc(C(F)(F)F)c2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1089
Group description: This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Eligibility criteria:
Inclusion Criteria:

Patients with diagnosis of CP-CML with cytogenetic confirmation of Philadelphia (Ph) chromosome
Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR are also eligible
WHO performance status 0-2
Laboratory assessments within normal limits
Written informed consent prior to any study procedures being performed

Exclusion Criteria:

Known impaired cardiac function
History of acute or chronic pancreatitis
Impaired gastrointestinal function or disease that may alter the absorption of study drug
Concomitant medications with potential QT prolongation, or known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8)
Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Nedocromil
Trial phase: Phase 1
ATC code: R01AC07 | R03BC03 | S01GX04
SMILES: CCCc1c2oc(C(=O)O)cc(=O)c2cc2c(=O)cc(C(=O)O)n(CC)c12
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
Eligibility criteria:
Inclusion Criteria:

History of mild to moderate Asthma
In good general health (except for asthma)
Stable and free of respiratory infection
Nonsmoker
Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control)

Exclusion Criteria:

Nursing mother
Recent or ongoing upper or lower respiratory tract infection
Unable to refrain from or anticipates the use of any prescription and non-prescription drugs
Consumes excessive amounts of alcohol or caffeine
History of stroke, chronic seizures, or major neurological disorder
History of cancer
Received a vaccination within the past 3 weeks
Intervention: Montelukast
Trial phase: Phase 1
ATC code: R03DC03 | R03DC53
SMILES: CC(C)(O)c1ccccc1CC[C@@H](SCC1(CC(=O)O)CC1)c1cccc(/C=C/c2ccc3ccc(Cl)cc3n2)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
Eligibility criteria:
Inclusion Criteria:

History of mild to moderate Asthma
In good general health (except for asthma)
Stable and free of respiratory infection
Nonsmoker
Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control)

Exclusion Criteria:

Nursing mother
Recent or ongoing upper or lower respiratory tract infection
Unable to refrain from or anticipates the use of any prescription and non-prescription drugs
Consumes excessive amounts of alcohol or caffeine
History of stroke, chronic seizures, or major neurological disorder
History of cancer
Received a vaccination within the past 3 weeks