anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Healon
Trial phase: Not Applicable
SMILES: CC(=O)NC1C(O)OC(CO)C(O)C1OC1OC(C(=O)O)C(OC2OC(CO)C(O)C(OC3OC(C(=O)O)C(O)C(O)C3O)C2NC(C)=O)C(O)C1O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: 0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.
Eligibility criteria:
Inclusion Criteria:

Bilateral or unilateral cataract undergoing phacoemulsification and intraocular lens (IOL) implantation at Soonchunhyang University Hospital between January 2014 and January 2015
Patients with mild to moderate dry eye (level 1 or 2) based on the dry eye severity scale adopted by the Dry Eye Workshop (DEWS) report and who used only artificial tears occasionally

Exclusion Criteria:

Presence of any complications after cataract surgery such as cystoid macular edema
Patients using any topical eye drops on a regular basis
Treatment history of dry eye beyond artificial tears
Any ocular surgery within the prior 6 months
Contact lens wear
Serious ocular surface disease (e.g., Sjögren's syndrome, ocular pemphigoid, conjunctival scarring, chemical injury)
Eyelid or lacrimal disease
Use of concomitant medications that could cause dry eye and allergy to any of the study medications
Intervention: Bisacodyl
Trial phase: Phase 2
ATC code: A06AB02 | A06AB52 | A06AG02
SMILES: CC(=O)Oc1ccc(C(c2ccc(OC(C)=O)cc2)c2ccccn2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Bisacodyl: Rectal suppository
Eligibility criteria:
Inclusion Criteria:

MS patients with mild to moderately severe disease (Multiple Sclerosis Impact Scale [MSIS-29] physical domain scores <61 or equivalent Extended Disability Severity Score [EDSS] < 6.5) of any age, gender, disease subtype, duration of illness, current use of MS disease modifying therapy, or comorbid medical condition AND who also have anorectal dysfunction (chronic constipation and/or fecal incontinence) are eligible.

Exclusion Criteria:

MS patients with severe disease (MSIS-29 physical domain scores greater than 61 or equivalently severe EDSS greater than 6.5), patients with surgically altered anorectal anatomy (i.e. proctectomy/partial colectomy, ostomy creation), active enteric infection (i.e., Clostidium Difficile), or inflammatory bowel disease (i.e. ulcerative proctitis, ulcerative colitis) will also be excluded.
Intervention: Testosterone
Trial phase: Phase 4
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: All participants will be receiving intranasal testosterone and will follow the same study procedures.

Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

1. Males between the ages of 18 and 35 years-old who participate in regular, moderate to high intensity physical activity will be recruited for the study.

Exclusion Criteria:

Individuals below the age of 18 or greater than the age of 35 on the day of enrollment
Individuals who are in a Registered Testing Pool for anti-doping purposes, or individuals who for any reason could be subject to doping control testing.
Unwilling to provide blood or urine samples
Not actively exercising
Individuals with any history of cancer, cardiovascular disease, endocrine abnormalities, renal disease, hepatic disease, neurologic disease or any psychiatric history
Individuals with a history of nasal disorders, nasal surgeries, sinus surgeries, or sinus disease
Individuals that have a baseline hematocrit value above the normal range
Individuals that are diabetic or are currently taking a diabetic medication
Individuals that are currently using any WADA prohibited substances
Individuals that have recently used or currently using anabolic androgenic steroids
Intervention: SNX-5422
Trial phase: Phase 2
SMILES: CC1(C)CC(=O)c2c(C(F)(F)F)nn(-c3ccc(C(N)=O)c(N[C@H]4CC[C@H](OC(=O)CN)CC4)c3)c2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), followed by a 7-day drug-free period. Each treatment cycle will be 28 days. Subjects will repeat this 28-day schedule until the cancer progresses or the subject is unable to tolerate SNX-5422.

SNX-5422: Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle
Eligibility criteria:
Inclusion Criteria:

Confirmed solid or hematological TP53 null type cancer.
No more than 4 prior lines of systemic anti-cancer therapy.
Males or non-pregnant, non-breastfeeding females 18 years-of-age or older.
Karnofsky performance score 60
Life expectancy of at least 3 months.
Adequate baseline laboratory assessments
Recovered from toxicities of previous anticancer therapy to CTCAE Grade ≤ 1 with the exception of alopecia.

Exclusion Criteria:

Treatment with an investigational agent within 30 days prior to the first dose of SNX-5422 or planning to receive an investigational agent during the study.
Treatment with other anticancer drugs within 28 days or 5 half-lives of anticancer therapy (whichever is shorter) is prohibited from 30 days prior to the first dose of SNX-5422 and throughout the study.
Radiation treatment within 2 weeks.
The need for treatment with medications with clinically relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422 (Appendix B).
Appropriately corrected screening ECG QTc interval 470 msec for females, 450 msec for males.
Currently receiving medications known to cause QT prolongation AND corrected QTc of 450 msec for females, 430 msec for males.
Patients with chronic diarrhea of grade 2 or greater despite maximal medical management.
Gastrointestinal diseases or conditions that could affect drug absorption, including gastric bypass.
Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
History of documented adrenal dysfunction not due to malignancy.
Seropositive for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
History of chronic liver disease.
Active hepatitis A or B.
Current alcohol dependence or drug abuse.
Clinically significant glaucoma, retinitis pigmentosa, or macular degeneration.
Other serious concurrent illness or medical condition.
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: All subjects who received OTO-104. Subjects were included in this treatment group according to the actual treatment received regardless of their randomized assignment.
Eligibility criteria:
Inclusion Criteria includes, but is not limited to:

Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
Subject has experienced active vertigo during the lead-in period.
Subject has documented asymmetric sensorineural hearing loss.
Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

Subject is pregnant or lactating.
Subject has a history of immunodeficiency disease.
Subject has a history of previous endolymphatic sac surgery.
Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
Subject has experienced an adverse reaction to IT injection of steroids.
Subject has used an investigational drug or device in the 3 months prior to screening.
Subject has previously been randomized to a trial of OTO-104.
Intervention: Gefapixant
Trial phase: Phase 2
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Women and Men between 18 and 80 years of age inclusive
Have refractory chronic cough
Women of child-bearing potential must use 2 forms of acceptable birth control - Have provided written informed consent.
Are willing and able to comply with all aspects of the protocol

Exclusion Criteria:

Current smoker
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio <60%
History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
History of opioid use within 1 week of the Baseline Visit
Body mass index (BMI) <18 kg/m^2 or ≥ 40 kg/m^2
History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with <3 excised basal cell carcinomas)
Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
Clinically significant abnormal electrocardiogram (ECG) at Screening
Significantly abnormal laboratory tests at Screening
Pregnant or Breastfeeding
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participant inappropriate for entry into this trial
Intervention: Gefapixant
Trial phase: Phase 2
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Women and Men between 18 and 80 years of age inclusive
Have refractory chronic cough
Women of child-bearing potential must use 2 forms of acceptable birth control - Have provided written informed consent.
Are willing and able to comply with all aspects of the protocol

Exclusion Criteria:

Current smoker
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio <60%
History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
History of opioid use within 1 week of the Baseline Visit
Body mass index (BMI) <18 kg/m^2 or ≥ 40 kg/m^2
History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with <3 excised basal cell carcinomas)
Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
Clinically significant abnormal electrocardiogram (ECG) at Screening
Significantly abnormal laboratory tests at Screening
Pregnant or Breastfeeding
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participant inappropriate for entry into this trial
Intervention: Gefapixant
Trial phase: Phase 2
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Women and Men between 18 and 80 years of age inclusive
Have refractory chronic cough
Women of child-bearing potential must use 2 forms of acceptable birth control - Have provided written informed consent.
Are willing and able to comply with all aspects of the protocol

Exclusion Criteria:

Current smoker
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio <60%
History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
History of opioid use within 1 week of the Baseline Visit
Body mass index (BMI) <18 kg/m^2 or ≥ 40 kg/m^2
History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with <3 excised basal cell carcinomas)
Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
Clinically significant abnormal electrocardiogram (ECG) at Screening
Significantly abnormal laboratory tests at Screening
Pregnant or Breastfeeding
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participant inappropriate for entry into this trial
Intervention: Gefapixant
Trial phase: Phase 2
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Women and Men between 18 and 80 years of age inclusive
Have refractory chronic cough
Women of child-bearing potential must use 2 forms of acceptable birth control
Have provided written informed consent.
Are willing and able to comply with all aspects of the protocol.

Exclusion Criteria:

Current smoker
Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60%
History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
History of opioid use within 1 week of the Baseline Visit
Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with <3 excised basal cell carcinomas)
Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
Significantly abnormal laboratory tests at Screening
Clinically significant abnormal electrocardiogram (ECG)
Pregnant or Breastfeeding
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participants inappropriate for entry into this trial
Intervention: Gefapixant
Trial phase: Phase 2
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Women and Men between 18 and 80 years of age inclusive
Have refractory chronic cough
Women of child-bearing potential must use 2 forms of acceptable birth control
Have provided written informed consent.
Are willing and able to comply with all aspects of the protocol.

Exclusion Criteria:

Current smoker
Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60%
History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
History of opioid use within 1 week of the Baseline Visit
Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with <3 excised basal cell carcinomas)
Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
Significantly abnormal laboratory tests at Screening
Clinically significant abnormal electrocardiogram (ECG)
Pregnant or Breastfeeding
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participants inappropriate for entry into this trial
Intervention: Gefapixant
Trial phase: Phase 2
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Women and Men between 18 and 80 years of age inclusive
Have refractory chronic cough
Women of child-bearing potential must use 2 forms of acceptable birth control
Have provided written informed consent.
Are willing and able to comply with all aspects of the protocol.

Exclusion Criteria:

Current smoker
Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60%
History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
History of opioid use within 1 week of the Baseline Visit
Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with <3 excised basal cell carcinomas)
Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
Significantly abnormal laboratory tests at Screening
Clinically significant abnormal electrocardiogram (ECG)
Pregnant or Breastfeeding
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participants inappropriate for entry into this trial
Intervention: Isoniazid
Trial phase: Phase 2
ATC code: J04AC01 | J04AC51 | J04AM01 | J04AM02 | J04AM03 | J04AM04 | J04AM05 | J04AM06 | J04AM07 | J04AM08
SMILES: NNC(=O)c1ccncc1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 150
Group description: Isoniazid (INH) ~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.

Isoniazid: HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.
Eligibility criteria:
Inclusion Criteria:

HIV exposed infants
Aged 6 weeks within (+ 4 weeks)
Born to HIV-infected mothers
Not premature and over 2.5 kg

Exclusion Criteria:

Infants with known exposure to active TB in household
Premature and < 2.5 kg
Intervention: Ledipasvir
Trial phase: Phase 3
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection
Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
Cirrhosis determination by Fibroscan
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female or male is of childbearing potential

Key Exclusion Criteria:

Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
Pregnant or nursing female
Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)
Hepatocellular carcinoma (HCC) or other malignancy
Current or prior history of clinical hepatic decompensation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Brexanolone
Trial phase: Phase 2
ATC code: N06AX29
SMILES: CC(=O)C1CCC2C3CCC4CC(O)CCC4(C)C3CCC12C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Participants received a 4-hour dose titration period of 30 microgram per kilogram per hour (microgram/kg/hr) (0 to 4 hours), then 60 microgram/kg/hr (4 to 24 hours), then 90 microgram/kg/hr (24 to 52 hours), followed by a taper to 60 microgram/kg/hr (52 to 56 hours), and 30 microgram/kg/hr (56 to 60 hours).
Eligibility criteria:
Key Inclusion Criteria:

Participant either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.
Participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).
Participant was less than or equal to (<=) six months postpartum.
Participant must be amenable to intravenous therapy.

Key Exclusion Criteria:

Active psychosis.
Attempted suicide associated with index case of postpartum depression.
Medical history of seizures.
Medical history of bipolar disorder.

Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.