anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Povidone iodine
Trial phase: Phase 4
SMILES: C=CN1CCCC1=O.II
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 9
Group description: Apply locally as needed.

Betadine: Apply locally as needed.
Eligibility criteria:
Inclusion Criteria:

Children's Hospital Colorado inpatient or outpatient
31 days to 17 years (inclusive)
Needs treatment for a tracheostomy granuloma

Exclusion Criteria:

Tracheostomy granuloma has been treated in the last two weeks
Intervention: DIMETHYL FUMARATE
Trial phase: Phase 4
ATC code: L04AX07
SMILES: [H]/C(C(=O)OC)=C(/[H])C(=O)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 211
Group description: Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Have a confirmed diagnosis of relapsing-remitting multiple sclerosis according to the current McDonald Criteria and satisfy the therapeutic indication as described in the official local registration for Tecfidera (dimethyl fumarate)
Naïve to dimethyl fumarate and fumaric acid esters

Key Exclusion Criteria:

Female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant while in the study
History of significant gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries), or chronic use of gastrointestinal-related symptomatic therapy as determined by the Investigator (or ≥ 7 consecutive days of gastrointestinal-related symptomatic therapy
Known active malignancies
History of anaphylaxis or severe allergic reactions or known drug hypersensitivity
Current use of B vitamin supplements
In the opinion of the Investigator, blood test values suggestive of a low lymphocyte count or renal or hepatic impairment, as described in the product label precautions for use

NOTE: Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Heliox
Trial phase: Phase 2
SMILES: O=O.[He]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.

Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines.
Eligibility criteria:
Inclusion Criteria:

Adults 18 or older with obstructive sleep apnea syndrome (OSAS) presenting for CPAP titration.

Exclusion Criteria:

Professional singers.
Television or Radio hosts.
Disk Jockeys.
Subjects requiring oxygen therapy.
Subjects younger than 18 year old.
Pregnant women.
Patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume 1 (FEV1) less than 50%.
History of anatomic upper airway obstruction.
Uncontrolled asthma.
Intervention: Emricasan
Trial phase: Phase 2
SMILES: C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)c1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: IDN-6556 25 mg BID

IDN-6556
Eligibility criteria:
Inclusion Criteria:

Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and able to understand and willing to comply with the requirements of the study
History of orthotopic liver transplantation for HCV-induced liver disease
Diagnosis of HCV infection (HCV-RNA detectable in serum) and liver fibrosis and/or incomplete cirrhosis status post liver transplantation, and achieved a sustained virologic response (SVR) with anti-viral HCV treatment within 18 months of Day 1
Liver fibrosis on liver histology as read by central histopathologist of Ishak F2 to F6 within three months of Day 1 (Up to 15 subjects with an Ishak score of F6 can be enrolled)
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug

Exclusion Criteria:

Known infection with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)
History of renal transplant and/or severe renal impairment defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min/1.73 m2
Evidence of tumor burden >Milan criteria, or evidence of micro- or macrovascular invasion in explanted liver
Hepatocellular carcinoma (HCC) at entry into the study
Concurrent sirolimus (rapamycin) use
History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)
Subjects with diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
If female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
Intervention: Buprenorphine/samidorphan
Trial phase: Phase 3
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.NC(=O)c1ccc2c(c1O)C13CCN(CC4CC4)C(C2)C1(O)CCC(=O)C3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1485
Group description: ALKS 5461 adjunctive treatment
Eligibility criteria:
Inclusion Criteria:

Agree to use an approved method of contraception for the duration of the study
Have the potential to safely benefit from the administration of ALKS 5461
Have a diagnosis of major depressive disorder (MDD)
Additional criteria may apply

Exclusion Criteria:

Have a positive test for drugs of abuse
Currently pregnant or breastfeeding
Have a current primary Axis-I disorder other than MDD
Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
Have received electroconvulsive therapy treatment within the last 2 years, or received more than 1 course of electroconvulsive treatment during their lifetime
Have attempted suicide within the past 2 years
Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
Have had a significant blood loss or blood donation within the past 60 days
Additional criteria may apply
Intervention: Misoprostol
Trial phase: Phase 2 | Phase 3
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Participants will insert four misoprostol tablets (total of 800 micrograms) deeply into the vagina with their fingers.

Vaginal Misoprostol: Misoprostol inserted into vagina
Eligibility criteria:
Inclusion Criteria:

Women ages 18-50 who are English or Spanish speaking
First trimester pregnancy (less than 13 weeks and 0 days)
Desires medical management of an early pregnancy loss with misoprostol

Diagnosed with an early pregnancy failure by UCSD Radiology or diagnosed early pregnancy failure defined by any of the following criteria (Bourne 2013):

Crown-rump length > 7mm with no cardiac activity
Mean gestational sac diameter of > 25 mm and no embryo
Absence of an embryo with heartbeat > 2 weeks after a scan showing a gestational sac without a yolk sac
Absence of embryo with heartbeat > 11 days after a scan showing a gestational sac with a yolk sac

Exclusion Criteria:

Evidence of infection, acute hemorrhage, or hemodynamic instability
Hemoglobin less than 9.5 including use of point of care Hgb testing
Known allergy to misoprostol
Underwent surgical or medical abortion during current pregnancy
Currently breastfeeding
Currently has intrauterine device in place
Suspicion of ectopic or gestational trophoblastic disease
History of clotting disorder or on anticoagulant therapy (excluding aspirin)
Unreliable for follow up
Intervention: Misoprostol
Trial phase: Phase 2 | Phase 3
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Participants will place two tablets of misoprostol between their gum and cheek on each side (total 800 micrograms), then swish and swallow the remnants after 30 minutes.

Buccal Misoprostol: Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time.
Eligibility criteria:
Inclusion Criteria:

Women ages 18-50 who are English or Spanish speaking
First trimester pregnancy (less than 13 weeks and 0 days)
Desires medical management of an early pregnancy loss with misoprostol

Diagnosed with an early pregnancy failure by UCSD Radiology or diagnosed early pregnancy failure defined by any of the following criteria (Bourne 2013):

Crown-rump length > 7mm with no cardiac activity
Mean gestational sac diameter of > 25 mm and no embryo
Absence of an embryo with heartbeat > 2 weeks after a scan showing a gestational sac without a yolk sac
Absence of embryo with heartbeat > 11 days after a scan showing a gestational sac with a yolk sac

Exclusion Criteria:

Evidence of infection, acute hemorrhage, or hemodynamic instability
Hemoglobin less than 9.5 including use of point of care Hgb testing
Known allergy to misoprostol
Underwent surgical or medical abortion during current pregnancy
Currently breastfeeding
Currently has intrauterine device in place
Suspicion of ectopic or gestational trophoblastic disease
History of clotting disorder or on anticoagulant therapy (excluding aspirin)
Unreliable for follow up
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 21
Group description: Deep extubation receiving dexmedetomidine.

Dexmedetomidine: to arms 1,3
Eligibility criteria:
Inclusion Criteria:

Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty
ASA 1 & 2

Exclusion Criteria:

Known allergy or hypersensitivity reaction to dexmedetomidine
Organ dysfunction (renal/hepatic failure or leukemia)
Cardiac disease (congenital or acquired)
Airway or thoracic malformation
Cerebral palsy
Hypotonia
Need for premedication
Current/recent upper respiratory infection (within four weeks prior to the surgery)
Asthma
Allergy or intolerance to clonidine
Non-English speaking parents/patients.
Intervention: Sildenafil
Trial phase: Phase 2
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.

sildenafil: sildenafil 50mg BID for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0.
Presence of drug-induced dyskinesias
Age>40 years.
Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
History of stereotaxic brain surgery.
Clinical history of dementia.
Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.
History of major hematological, renal, or hepatic abnormalities.
Known coronary artery disease including angina or myocardial infarction within the last 6 months. Significant cardiovascular disease including cardiac failure, unstable angina or life-threatening arrhythmia within the last 6 months.
History of stroke within the last 6 months.
Abnormal EKG consistent with cardiac ischemia.
Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols).
Malignant hypertension or SBP . 180 or <90, or DBP .110 or <50.
History of priapism.
Known history of retinitis pigmentosa.
Positive pregnancy test.
History of bleeding disorder.
Patients with active peptic ulcer disease associated with bleeding.
Unwillingness to use adequate contraceptive methods if of childbearing potential.
Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study.
Use of Viagra or any experimental drugs within 30 days of screening visit.
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 20
Group description: Intranasal Dexmedetomidine 2 micrograms/kilogram once

Dexmedetomidine: 20 patients enrolled, 20 underwent analysis
Eligibility criteria:
Inclusion Criteria:

Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
Laceration <5 cm in total length
Require simple suture laceration repair

Exclusion Criteria:

Allergies/intolerance/contraindication to the study drugs
Lacerations requiring complex (multilayer) repair or total laceration length>5cm
Intervention: Evacetrapib
Trial phase: Phase 1
SMILES: Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks.
Eligibility criteria:
Inclusion Criteria:

Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:

Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
Hypercholesterolemia on stable statin therapy for at least 3 month
Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

Have known allergies or intolerance to evacetrapib, related compounds
Have history of recurrent rashes or chronic skin conditions
Have significant history of or current chronic, active inflammatory conditions
Have history or current evidence of significant neurological disorder
Have long-standing diabetes that is insulin requiring
Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery
Intervention: Evacetrapib
Trial phase: Phase 1
SMILES: Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks.
Eligibility criteria:
Inclusion Criteria:

Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:

Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
Hypercholesterolemia on stable statin therapy for at least 3 month
Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

Have known allergies or intolerance to evacetrapib, related compounds
Have history of recurrent rashes or chronic skin conditions
Have significant history of or current chronic, active inflammatory conditions
Have history or current evidence of significant neurological disorder
Have long-standing diabetes that is insulin requiring
Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery
Intervention: Evacetrapib
Trial phase: Phase 1
SMILES: Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: 130 mg of evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks.
Eligibility criteria:
Inclusion Criteria:

Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:

Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
Hypercholesterolemia on stable statin therapy for at least 3 month
Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

Have known allergies or intolerance to evacetrapib, related compounds
Have history of recurrent rashes or chronic skin conditions
Have significant history of or current chronic, active inflammatory conditions
Have history or current evidence of significant neurological disorder
Have long-standing diabetes that is insulin requiring
Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 1
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
Eligibility criteria:
Inclusion Criteria:

Subjects were eligible for entry into the study if they fulfilled the following inclusion criteria:

Male subjects aged between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
Subjects who were healthy as determined by pre study medical history, physical examination, neurological examination, EEG, and 12-lead ECG.
Subjects who had clinical laboratory tests clinically acceptable to the investigator.
Subjects who were negative for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab tests at screening.
Subjects who were negative for alcohol and drugs of abuse at screening and admission.
Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
Subjects who were able and willing to give written informed consent.

Exclusion Criteria:

Subjects who did not conform to the above inclusion criteria.
Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
Subjects who had a clinically relevant surgical history.
Subjects who had a clinically relevant family history.
Subjects who had a history of relevant atopy.
Subjects who had a history of relevant drug hypersensitivity.
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 21 units of alcohol a week.
Subjects who had a significant infection or known inflammatory process on screening and/or admission.
Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
Subjects who had an acute infection such as influenza at the time of screening and/or admission.
Subjects who had used prescription drugs within four weeks of first dosing.
Subjects who had used over-the-counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.
Subjects who had used any investigational drug and/or participated in any clinical trial within two months of their first admission to this study.
Subjects who had previously received BIA 2-093.
Subjects who had donated and/or received any blood or blood products within the previous two months prior to screening.
Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
Subjects who could not communicate reliably with the investigator.
Subjects who were unlikely to co-operate with the requirements of the study.
Subjects who were unwilling or unable to give written informed consent.
Intervention: Glucagon Emergency Kit
Trial phase: Phase 3
SMILES: CSCCC(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(CCCN=C(N)N)NC(=O)C(CCCN=C(N)N)NC(=O)C(CO)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)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(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Nasal Glucagon powder (3mg)
Eligibility criteria:
Inclusion Criteria:

Male or Female Person with diabetes (PWD) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
With a history of type 1 diabetes >1 year
At least 18 years of age but not older than 75 years
Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.
PWD will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).
For female subjects, a urine pregnancy test must be negative.

Exclusion Criteria:

Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.
Intervention: BEMPEDOIC ACID
Trial phase: Phase 2
ATC code: C10AX15 | C10BA10
SMILES: CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Participants received oral bempedoic acid 180 milligrams (mg) daily for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg
or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg
Fasting LDL-C between 100 and 220 mg/dL
Fasting triglycerides less than 400 mg/dL
Body mass index (BMI) between 18 and 45 kg/m2

Exclusion Criteria:

Known or suspected secondary hypertension or history of malignant hypertension
Taking more than two anti-hypertension medications at the first visit
History or current clinically significant cardiovascular disease
History or current type 1 diabetes or type 2 diabetes