anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 3
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: sublingual buprenorphine: Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
Eligibility criteria:
Inclusion Criteria:

≥ 37 weeks gestation
Exposure to opiates in utero
Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment

Exclusion Criteria:

Major congenital malformations and/or intrauterine growth retardation
Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
Hypoglycemia requiring treatment with intravenous dextrose.
Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)
Concomitant benzodiazepine or severe alcohol abuse , self-report of regular use of alcohol or of benzodiazepines use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth,
Concomitant use of Cytrochrom (CYP) 3A inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole, HIV protease inhibitors) or inducers (rifampin, carbamazepine, phenobarbital) prior to initiation of NAS treatment
Seizure activity or other neurologic abnormality
Breast feeding
Inability of mother to give informed consent due to co-morbid psychiatric diagnosis
Intervention: Morphine
Trial phase: Phase 3
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 | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: oral morphine: Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
Eligibility criteria:
Inclusion Criteria:

≥ 37 weeks gestation
Exposure to opiates in utero
Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment

Exclusion Criteria:

Major congenital malformations and/or intrauterine growth retardation
Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
Hypoglycemia requiring treatment with intravenous dextrose.
Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)
Concomitant benzodiazepine or severe alcohol abuse , self-report of regular use of alcohol or of benzodiazepines use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth,
Concomitant use of Cytrochrom (CYP) 3A inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole, HIV protease inhibitors) or inducers (rifampin, carbamazepine, phenobarbital) prior to initiation of NAS treatment
Seizure activity or other neurologic abnormality
Breast feeding
Inability of mother to give informed consent due to co-morbid psychiatric diagnosis
Intervention: Glimepiride
Trial phase: Phase 3
ATC code: A10BB12 | A10BD04 | A10BD06
SMILES: CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)cc2)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
Eligibility criteria:
Inclusion Criteria:

type 2 diabetes mellitus
HbA1c between 7.5% and 11.0% at screening
FPG between 7.0mmol/L and 13.3mmol/L at screening and at randomization visit
subject was treated with diet and/or exercise alone
QTc<450mesc or QTc<480msec for patients with bundle branch block
Body Mass Index (BMI) >19kg/m2
Subject has given written informed consent

Exclusion Criteria:

Documented history of significant hypersensitivity to thiazolidinediones, sulfonylureas, or compounds with similar chemical structures
Ongoing edema or history of edema requiring pharmacological treatment in the 12 months prior to screening
Presence of ischemic heart disease and/or peripheral arterial disease, or NYHA grade I-IV congestive heart failure
Taking nitrates
Clinically significant renal or hepatic disease
Anemia
Severe hypertriglyceridemia (TG>=5.65mmol/L)
Use of oral corticosteroids and Nicotinic acid
Systolic blood pressure <170mmHg, or diastolic blood pressure > 100mmHg while on anti-hypertensive treatment
Hyperthyroidism requiring treatment
Diagnosed macular edema
Women who are lactating, pregnant, or planning to become pregnant
Presence of an active cancer or recently treated for cancer
Drug/alcohol abuse
Unwilling or unable to comply with the procedures described in the protocol
Intervention: VALACYCLOVIR
Trial phase: Phase 1
ATC code: J05AB11
SMILES: CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: Assigned patients will take 1.5 mg po valacyclovir twice daily

Valacyclovir: Valacyclovir 1.5 mg po bid
Eligibility criteria:
Inclusion Criteria:

Documentation of chronic HCV infection with genotype testing and previous positive HerpeSelect HSV-2 IgG assay

Exclusion Criteria:

Antiherpes or immunomodulatory therapy during the past 30 days
HIV or chronic hepatitis B infection
Decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy, jaundice/icterus)
Creatinine clearance < 50 ml/min.
Female subject who is pregnant or nursing
Gastrointestinal disorder which might result in malabsorption of valacyclovir
History of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic uremic syndrome
Therapy for hepatitis C in the previous 6 months
Intervention: Phenylephrine and ketorolac injection
Trial phase: Phase 3
SMILES: CNCC(O)c1cccc(O)c1.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 201
Group description: OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.

OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle.
Eligibility criteria:
Inclusion Criteria:

Competent and willing to voluntarily provide informed consent
18 years of age or older
In good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia

Exclusion Criteria:

No allergies to the medications and/or the active ingredients of any of the study medications
No medications with the same activities of the active ingredients in OMS302 for defined time intervals prior to and after surgery
No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
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: 51
Group description: All study participants used product.
Eligibility criteria:
Inclusion Criteria:

Volunteers smoking at least 12 cigarettes per day
First cigarette smoked within 60 minutes of waking up
Willing to abstain from smoking for one day in 2 consecutive weeks.

Exclusion Criteria:

Under 18 years of age
Current psychiatric illness
Pregnant or breastfeeding
Enrollment in other research projects
Used electronic cigarette and/or nicotine inhalator before
Intervention: Telotristat Etiprate
Trial phase: Phase 2
SMILES: CCOC(=O)C(N)Cc1ccc(-c2cc(OC(c3ccc(Cl)cc3-n3ccc(C)n3)C(F)(F)F)nc(N)n2)cc1.O=C(O)CNC(=O)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 500 mg telotristat etiprate (LX1606) administered orally once daily (QD).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of ulcerative colitis of at least 6 months duration
Disease extends at least 15 cm proximally from the anal verge, documented within the past 3 years
Flare occurs on 5-aminosalicylic acid (5-ASA)/mesalamine therapy and subject is willing to remain on a stable dose for the duration of the study
Age ≥18 and <70 years of age
Able and willing to provide written informed consent

Exclusion Criteria:

Prior terminal ileum or colonic surgery, except appendectomy or hemorrhoid surgery
Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
Clinical signs of fulminant colitis or toxic megacolon
History of dysplasia associated lesion or mass (DALM)
Subjects who have had surgery for ulcerative colitis, or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study
History of primary sclerosing cholangitis
Any physical or laboratory abnormality deemed by the investigator as clinically significant
Major surgery within 60 days of Screening
Use of any investigational agent within 30 days of Screening or any therapeutic protein or antibody within 90 days of Screening
Intervention: Telotristat Etiprate
Trial phase: Phase 2
SMILES: CCOC(=O)C(N)Cc1ccc(-c2cc(OC(c3ccc(Cl)cc3-n3ccc(C)n3)C(F)(F)F)nc(N)n2)cc1.O=C(O)CNC(=O)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 500 mg telotristat etiprate (LX1606) administered orally three times daily (TID).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of ulcerative colitis of at least 6 months duration
Disease extends at least 15 cm proximally from the anal verge, documented within the past 3 years
Flare occurs on 5-aminosalicylic acid (5-ASA)/mesalamine therapy and subject is willing to remain on a stable dose for the duration of the study
Age ≥18 and <70 years of age
Able and willing to provide written informed consent

Exclusion Criteria:

Prior terminal ileum or colonic surgery, except appendectomy or hemorrhoid surgery
Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
Clinical signs of fulminant colitis or toxic megacolon
History of dysplasia associated lesion or mass (DALM)
Subjects who have had surgery for ulcerative colitis, or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study
History of primary sclerosing cholangitis
Any physical or laboratory abnormality deemed by the investigator as clinically significant
Major surgery within 60 days of Screening
Use of any investigational agent within 30 days of Screening or any therapeutic protein or antibody within 90 days of Screening
Intervention: Desmopressin
Trial phase: Not Applicable
ATC code: H01BA02
SMILES: N=C(N)NCCC[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSCCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 102
Group description: The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml

control: Patients received a normal saline only
Eligibility criteria:
Inclusion Criteria:

- Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (< 1 h) were considered for the study

Exclusion Criteria:

- Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index > 30 kg/m2) and suspected difficult airway
Intervention: N,N-Diethylbenzamide
Trial phase: Not Applicable
SMILES: CCN(CC)C(=O)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 102
Group description: The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml

remifentanil 2: Patients received no remifentanil
Eligibility criteria:
Inclusion Criteria:

- Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (< 1 h) were considered for the study

Exclusion Criteria:

- Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index > 30 kg/m2) and suspected difficult airway
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 4
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: 20
Group description: Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling).

Loteprednol: Eye drops, 1 drop twice a day for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female
At least 18 years of age
Has not worn contact lenses, except for bandage contact lens or rigid gas permeable lens, for at least 2 weeks prior to the study and agrees to not wear contact lenses during study
Patient is in generally good & stable overall health
Minimum corneal fluorescein staining of 4 in at least one eye
OSDI score >22
The patient must have a diagnosis of posterior blepharitis
A negative urine pregnancy test result for women of childbearing potential
Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
Normal lid position and closure
Ability to understand and provide informed consent to participate in this study
Willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

History of Stevens-Johnson syndrome or ocular pemphigoid
History of eyelid surgery
Intra-ocular surgery or ocular laser surgery within 3 months
History of microbial keratitis, including herpes
Active ocular allergies
Corneal epithelial defect > 1mm2
Any change in use of topical anti-inflammatories, such as steroids, Restasis, or NSAID within the past 2 weeks
Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the past two weeks
Use of isotretinoin (Accutane) within the past 6 months
Pregnant or lactating women
Signs of current infection, including fever and current treatment with antibiotics
Active liver, renal, or hematologic disease
The use of any other investigational drug
Individuals with a known history of glaucoma, individuals with IOP >22 Hg in either eye and individuals with a known family history of glaucoma in primary (first degree) relatives (ie. mother, father, sibling or child)
Intervention: ICATIBANT
Trial phase: Phase 4
ATC code: B06AC02
SMILES: NC(N)=NCCCC(N)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)N1CC(O)CC1C(=O)NCC(=O)NC(Cc1cccs1)C(=O)NC(CO)C(=O)N1Cc2ccccc2CC1C(=O)N1C(C(=O)NC(CCCN=C(N)N)C(=O)O)CC2CCCCC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: Open-label study

Icatibant: 30 mg subcutaneous dose of Icatibant
Eligibility criteria:
Inclusion Criteria:

Males and females at least 18 years of age at the time of informed consent

Documented diagnosis of hereditary angioedema Type I or II based on ALL of the following criteria:

Family and/or medical history
Characteristic attack manifestations, recurrent attacks
Historical low C4, normal C1q and either low C1-INH or low C1INH function
Women of childbearing potential must use consistently and correctly a highly effective, adequate method of birth control (failure rate less than 1% per year), sexual abstinence or have a vasectomised partner during the duration of the study. Hormonal contraception can be continued if verified by a physician that it doesn't affect the course of hereditary angioedema attacks.
Mental and physical condition allowing patients to complete baseline assessment, to self-administer Icatibant and to follow other study procedures.
Ability to provide signed written informed consent after all aspects of the study have been explained and discussed with the patient.

Exclusion Criteria:

Participation in a clinical therapeutic trial of another investigational medicinal product within the past month (except a previous Icatibant study).
Diagnosis of angioedema other than Type I or Type II hereditary angioedema.
Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease.
Congestive heart failure (NYHA Class 3 and 4).
Stroke within the past 6 months.
Treatment with angiotensin converting enzyme inhibitor.
Pregnancy and/or breast-feeding.
In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
In the opinion of the investigator: unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason.
In the opinion of the investigator: inability to complete the patient diary, manage study medication or self-administration of an injection.
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 250
Group description: Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
Eligibility criteria:
Inclusion Criteria:

Pregnant women with a gestational age of 63 days or less
Desire a medical abortion with mifepristone and misoprostol

Exclusion Criteria:

- Have contraindications to ibuprofen
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 250
Group description: Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
Eligibility criteria:
Inclusion Criteria:

Pregnant women with a gestational age of 63 days or less
Desire a medical abortion with mifepristone and misoprostol

Exclusion Criteria:

- Have contraindications to ibuprofen
Intervention: Montelukast
Trial phase: Not Applicable
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: Child
Healthy volunteers: No
Participants at risk: 4
Group description: Subjects will receive two 5mg tablets of Montelukast/day.

Montelukast: Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast.
Eligibility criteria:
Inclusion Criteria:

Males and females aged 2-17
Presence of more than 15 eosinophils per hpf on original endoscopy and less than 5 eosinophils/hpf on the most recent endoscopy
Concurrent PPI for 1 month at 1-2mg/kg/dose prior to endoscopy or have a negative pH study
English speaking
Ability to undergo a follow up endoscopy between 12 and 13 weeks after the start of the study
Procurement of written informed consent signed by the subject's legal guardian and study investigator (s) and subject assent.

Exclusion Criteria:

Subjects with eosinophils in stomach and duodenum on original endoscopy.
Subjects requiring oral prednisone within 1 month of current endoscopy.
Subjects with diagnosis of other co-morbid diseases such as heart disease, renal disease, autoimmune disease, an immunodeficiency, diabetes, phenylketonuria, or thyroid disease.
Subjects using Montelukast within one month of current endoscopy
Subjects with concurrent use of phenobarbital or rifampin
Intervention: Montelukast
Trial phase: Not Applicable
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: Child
Healthy volunteers: No
Participants at risk: 4
Group description: Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.

5 mg Montelukast: Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day.
Eligibility criteria:
Inclusion Criteria:

Males and females aged 2-17
Presence of more than 15 eosinophils per hpf on original endoscopy and less than 5 eosinophils/hpf on the most recent endoscopy
Concurrent PPI for 1 month at 1-2mg/kg/dose prior to endoscopy or have a negative pH study
English speaking
Ability to undergo a follow up endoscopy between 12 and 13 weeks after the start of the study
Procurement of written informed consent signed by the subject's legal guardian and study investigator (s) and subject assent.

Exclusion Criteria:

Subjects with eosinophils in stomach and duodenum on original endoscopy.
Subjects requiring oral prednisone within 1 month of current endoscopy.
Subjects with diagnosis of other co-morbid diseases such as heart disease, renal disease, autoimmune disease, an immunodeficiency, diabetes, phenylketonuria, or thyroid disease.
Subjects using Montelukast within one month of current endoscopy
Subjects with concurrent use of phenobarbital or rifampin
Intervention: Tofacitinib
Trial phase: Phase 3
ATC code: L04AA29
SMILES: C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)c1ncnc2[nH]ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 429
Group description: Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
Eligibility criteria:
Inclusion Criteria:

Subject must be at least 18 years of age.
Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
Subjects with moderately to severely active UC based on Mayo score criteria.

Subjects must have failed or be intolerant of at least one of the following treatments for UC:

Corticosteroids (oral or intravenous).
Azathioprine or 6 mercaptopurine (6 MP).
Anti TNF therapy.

Exclusion Criteria:

Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
Subjects with disease limited to distal 15 cm.
Subjects without previous treatment for UC (ie, treatment naïve).
Subjects displaying clinical signs of fulminant colitis or toxic megacolon.