anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: intranasal administration

Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET.
Eligibility criteria:
Inclusion Criteria:

Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Subjects must meet DSM-IV criteria for current marijuana dependence (within the past three months). While individuals may also meet criteria for abuse of other substances, they must identify marijuana as their primary substance of abuse and must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days.
Subjects must consent to remain abstinent from alcohol for 24 hours and other drugs of abuse (except nicotine and marijuana) for three days immediately prior to study procedures. Subjects must abstain from marijuana for 24 hours prior to testing. By restricting marijuana use as proposed, subjects should not be under the acute effects of marijuana.
Subjects must consent to random assignment.

Exclusion Criteria:

Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect physiological/subjective responses.
Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements.
Subjects who pose a current suicidal or homicidal risk.
Subjects taking any psychotropic medications, including SRI's or other antidepressants, opiates or opiate antagonists because these may affect test response. Individuals who take stimulants for treatment of ADHD will be allowed to participate.
Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
Subjects who are unwilling or unable to maintain abstinence from alcohol and marijuana for 24 hours and other drugs of abuse (except nicotine) for three days prior to study procedures.
Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or marijuana) within the past 60 days.
Subjects who, in the investigator's opinion, would be unable to comply with study procedures or assessments.
Intervention: Ibuprofen
Trial phase: Phase 2
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Ibuprofen 800 mg
Eligibility criteria:
Inclusion Criteria:

Adult patients who presented to the emergency department with pain (a verbal numeric pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an acute musculoskeletal injury of less than 24 hours of duration when one of the study investigators was present were eligible for enrollment

Exclusion Criteria:

Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.
Intervention: OXYTOCIN
Trial phase: Phase 4
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: 50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.

Oxytocin
Eligibility criteria:
Inclusion Criteria:

Subject is a volunteer between 18 and 50 years of age.
If female, subject is non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).
Subject is able to read and speak English.
Subject is able and willing to provide written informed consent.
Subject is able to understand and follow the instructions of the investigator and understand all screening questionnaires.
Subject is in good health.

Exclusion Criteria:

Positive urine drug screen (except marijuana).
Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 2 weeks of the start of the study (except marijuana) OR more than 10 times in the last year (except marijuana).
Marijuana use more than 3 times/week.
Has a current dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol OR a recent history of substance abuse other than alcohol, tobacco or marijuana.
Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and/or physical exam performed or reviewed by the study physician.
BAC level > 0.05% at the beginning of screening visit (within margin of error of detection).
Has a neurological dysfunction or psychiatric disorder (confirm with study physician).
Has a history of brain trauma (confirm with study physician).
Has an allergy or intolerance to oxytocin.
Subject has received an investigational drug within 30 days of Screening Visit.
Subject is considered unsuitable for the study in the opinion of the investigator, nurse practitioner, or study physician for any other reason.
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: 233
Group description: Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of glaucoma or ocular hypertension

Exclusion Criteria:

Active ocular disease other than glaucoma or ocular hypertension
Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)
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: 233
Group description: Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of glaucoma or ocular hypertension

Exclusion Criteria:

Active ocular disease other than glaucoma or ocular hypertension
Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)
Intervention: Lacosamide
Trial phase: Phase 3
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 473
Group description: At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Safety Set (SS).
Eligibility criteria:
Inclusion Criteria:

Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657]

Exclusion Criteria:

Subjects who withdrew from EP0008 [NCT01710657]
Intervention: Victoza
Trial phase: Phase 1 | Phase 2
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.

liraglutide: daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose
Eligibility criteria:
Inclusion Criteria:

Age 18-60 years
Diagnosis of severe obstructive sleep apnea (OSA) AHI ≥ 8 /hour of sleep
Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule
BMI of ≥ 27
For Cohort 1: If female of childbearing capacity, willing to use acceptable birth control during use of study drug

Exclusion Criteria:

A major medical condition such as renal or hepatic failure
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 inhibitors or insulin within the last 3 months prior to screening
Diagnosis of type 1 or type 2 diabetes per judgment of the investigator
BMI < 27
History of glycosylated hemoglobin (HbA1c) equal to or above 6.5%
Significant craniofacial abnormalities that may cause OSA
Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator
Use of central stimulants, hypnotics, mirtazepine, opioids, trazodone or drugs in the incretin family within the previous 3 months prior to screening
Previous surgical treatment for obesity
Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial Medullary Thyroid Carcinoma
Personal or immediate family history of thyroid cancer
History of chronic pancreatitis or idiopathic acute pancreatitis
History of Major Depressive Disorder or suicide attempts
Systolic blood pressure equal to or above 160 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
History of alcoholism
Pregnancy or breastfeeding
Intervention: Dronabinol
Trial phase: Phase 1 | Phase 2
ATC code: A04AD10
SMILES: [H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)Oc1cc(CCCCC)cc(O)c12
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 13
Group description: dronabinol 10 mg given oral one dose
Eligibility criteria:
Inclusion Criteria:

Male and females
18 and 50 years of age
Diagnosis of schizophrenia
Chronic cannabis users who have used for at least 1 year
Using cannabis at least once weekly
Currently being treated with antipsychotic medication
Must be on a the same dose of antipsychotic medication for at least 3 months.
Females of childbearing potential must use an adequate form of birth control while participating.
Participants will be required to have blood pressures greater than 90/60 and less than 140/90.

Exclusion Criteria:

Use of illicit drugs other than cannabis
Any psychiatric hospitalizations within 3 months
pregnancy in females
taking clozapine
Intervention: 6-Acryloyloxyhexyl phosphate
Trial phase: Phase 3
SMILES: C=CC(=O)OCCCCCCO.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 161
Group description: PA21
Eligibility criteria:
Inclusion Criteria:

Receiving stable maintenance hemodialysis 3 times a week.
Dialysis patients with hyperphosphatemia

Exclusion Criteria:

Patients having history of a pronounced brain / cardiovascular disorder.
Patients having severe gastrointestinal disorders.
Patients having severe hepatic disorders.
Intervention: Evofosfamide
Trial phase: Phase 1
SMILES: Cn1c(COP(=O)(NCCBr)NCCBr)cnc1[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Participants received evofosfamide infusion intravenously at a dose of 480 mg/m^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or participant withdrawal.
Eligibility criteria:
Inclusion Criteria:

At least 20 years of age
Signed written informed consent form
Histologically or cytologically confirmed advanced or metastatic solid tumor previously treated with one or more standard treatment regimen(s) or for which no effective therapy is available
Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic adenocarcinoma previously untreated with chemotherapy or systemic therapy
Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 3 months
Acceptable liver function, renal function, hematologic status and coagulation status as defined in the protocol
No clinically significant abnormalities in urinalysis
Effective contraception for both male and female subjects if the risk of conception exists
Other inclusion criteria apply

Exclusion Criteria:

Prior anti-cancer treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
Prior treatment with gemcitabine for their advanced or metastatic pancreatic cancer, except for radiosensitizing doses of gemcitabine
Prior radiotherapy to more than 30 percent of the bone marrow within 6 months prior to the trial entry
Cardiac disease with New York Heart Association (NYHA) Class 3 or 4, within 6 months prior to the trial entry
Clinically significant (that is, active) cardiovascular disease
Seizure disorders requiring anticonvulsant therapy
Known brain, leptomeningeal or epidural metastases (unless previously treated and well controlled for at least 3 months at the trial entry)
Previously treated malignancies other than the current disease for at least 5 years at the trial entry
Severe chronic obstructive or other pulmonary disease major surgery, within 4 weeks prior to the trial entry, without complete recovery
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Anti-cancer treatment prior to trial entry
Participation in an investigational drug or device trial within 4 weeks prior to the trial entry
Known infection with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
A history of allergic reactions
Taking a medication that is either moderate or strong inhibitor or inducer of cytochrome P450 (CYP)3A4 or is a sensitive substrate of other cytochrome P450
Pregnancy or lactation period
Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial
Unwillingness or inability to comply with the trial protocol for any reason
Legal incapacity or limited legal capacity
Other exclusion criteria apply
Intervention: Bimatoprost
Trial phase: Phase 4
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: 1137
Group description: Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
Determined by the treating physician to require treatment with LUMIGAN® RC

Exclusion Criteria:

None
Intervention: Qsymia
Trial phase: Phase 4
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
Eligibility criteria:
INCLUSION CRITERIA:

Obese subjects with BMI> 30 Kg/m^2. Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease.
Women of childbearing potential will have negative pregnancy test before initiation of medication.

EXCLUSION CRITERIA:

Weight >300 lbs, which is the limit of safety for the SPECT scanner
Concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or orlistat (Xenical®)
Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg)
Concentration of fasting glucose greater than 240 mg/dl
Concentration of triglycerides greater than 400 mg/dl
Type 1 Diabetes
Use of anti-diabetic drugs other than metformin,
History of nephrolithiasis,
Recurrent major depression, presence or history of suicidal behavior or ideation with intent to act, and current substantial depressive symptoms (Patient Health Questionnaire-9, 21 total score ≥10).
Concomitant use of Monoamine Oxidase Inhibitors (MAOI) (i.e., phenelzine, selegiline), serotonergic agents, and other centrally acting appetite suppressants
Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale [HADS] self-administered alcoholism screening test (SAAST, substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a Hospital Anxiety and Depression Scale (HADS) score ≥11 in any of the subscales or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
End stage renal disease or liver cirrhosis
Intake of medication that could interfere with the interpretation of the study or cause drug interaction (i.e., ketoconazole, erythromycin). Specifically, birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible.
Intervention: Deferiprone
Trial phase: Phase 1
ATC code: V03AC02
SMILES: Cc1c(O)c(=O)ccn1C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
Eligibility criteria:
Inclusion Criteria:

Male or female, 18-45 years of age (inclusive)
Diagnosis of sickle cell disease, confirmed by Hb electrophoresis
Body weight ≥ 50 kg
Body mass index (BMI) ≥ 18 and ≤ 32 kg/m^2
Absolute neutrophil count (ANC) of >1.5 x 10^9/L
Women of childbearing potential must agree to either be sexually inactive or use an acceptable method of birth control for 14 days prior to dosing and for 30 days afterwards
A fertile heterosexual male must agree that he or his partner will use an effective method of contraception for 14 days prior to dosing and for 30 days afterwards

Exclusion Criteria:

History or presence of hypersensitivity or idiosyncratic reaction to Ferriprox
Use of Ferriprox within the past 3 months
History of malignancy
Evidence of abnormal liver function (serum Alanine Transaminase (ALT)level > 5 times upper limit of normal or creatinine levels >2 times upper limit of normal)
A serious, unstable illness, as judged by the Investigator, within the past 3 months before screening visit including but not limited to hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic or immunologic disease
Hemodialysis during the week prior to dosing or planned for the day of dosing
Known difficulty in providing blood samples
Disorders or surgery of the gastrointestinal tract that may interfere with drug absorption or may otherwise influence the Pharmacokinetic (PK) results (e.g., resection of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections, acute inflammations, etc.)
Clinically significant abnormalities on 12-lead ECG (e.g., QT interval corrected using Fridericia's formula (QTcF) ≥ 430 ms in males or ≥ 450 ms in females)
Use of tobacco/nicotine-containing products for at least 3 months prior to study drug administration
Use of any drugs within the past 14 days that are metabolized by the Uridine diphosphate glucosyltransferase enzyme (UGT1A6) and hence could affect the PK of Ferriprox
Treatment with an investigational drug within the past 30 days or 5 half-lives of that drug (whichever is longer) prior to study drug administration
Pregnant or nursing female
Intervention: Adomeglivant
Trial phase: Phase 1
SMILES: Cc1cc(O[C@@H](CCC(F)(F)F)c2ccc(C(=O)NCCC(=O)O)cc2)cc(C)c1-c1ccc(C(C)(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Part A, Period 1. Participants received a single 20-mg oral dose of LY2409021 on Day 1.
Eligibility criteria:
Inclusion Criteria:

Participants are overtly healthy males or females, as determined by medical history and physical examination
Participants have a body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m^2), inclusive, at screening
Participants have a fasting blood glucose of 54 to 110 milligrams per deciliter (mg/dL) (3.0 to 6.1 micromoles per liter [mmol/L])

Exclusion Criteria:

Participants that have a contraindication to use of clarithromycin
Participants that have a personal or family history of long QT syndrome
Participants with a family history of sudden unexplained death or cardiac death in an immediate family member under 60 years of age
Participants with a personal history of unexplained syncope within the last year
Participants who have taken drugs or substances known to be an inducer or inhibitor of cytochrome P450 (CYP)3A4 or CYP2C8 or CYP2J2 (for example, St. John's wort, rifampin, ketoconazole, trimethoprim) within 30 days prior to the first dose