anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lvm0PK6ihg
Trial phase: Phase 1
SMILES: Cl.O=C(NC1CCOCC1)c1csc(C2CC2NCC2CC2)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: TAK-418 15 mg, capsule, orally, once on Day 1.
Eligibility criteria:
Inclusion Criteria:

Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m^2) at the Screening Visit.
Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months before trial drug administration of the initial dose of trial drug or invasive procedure.
Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug or invasive procedure as per principal investigator's judgment.

Female subjects with no childbearing potential, defined by at least 1 of the following criteria:

Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged greater than [>]45 years, 6 months of spontaneous amenorrhea in women aged >45 years with serum follicle-stimulating hormone [FSH] levels >40 milli-international units per milliliter [mIU/mL]). Appropriate documentation of FSH levels is required.
Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
Had a tubal ligation with appropriate documentation of surgical procedure.
Has a congenital condition resulting in no uterus.

Exclusion Criteria:

Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the Screening Visit.
Has a risk of suicide according to the investigator's clinical judgment per the Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in the 6 months before Screening.
Intervention: Lvm0PK6ihg
Trial phase: Phase 1
SMILES: Cl.O=C(NC1CCOCC1)c1csc(C2CC2NCC2CC2)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: TAK-418 40 mg, capsule, orally, once on Day 1.
Eligibility criteria:
Inclusion Criteria:

Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m^2) at the Screening Visit.
Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months before trial drug administration of the initial dose of trial drug or invasive procedure.
Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug or invasive procedure as per principal investigator's judgment.

Female subjects with no childbearing potential, defined by at least 1 of the following criteria:

Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged greater than [>]45 years, 6 months of spontaneous amenorrhea in women aged >45 years with serum follicle-stimulating hormone [FSH] levels >40 milli-international units per milliliter [mIU/mL]). Appropriate documentation of FSH levels is required.
Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
Had a tubal ligation with appropriate documentation of surgical procedure.
Has a congenital condition resulting in no uterus.

Exclusion Criteria:

Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the Screening Visit.
Has a risk of suicide according to the investigator's clinical judgment per the Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in the 6 months before Screening.
Intervention: Lvm0PK6ihg
Trial phase: Phase 1
SMILES: Cl.O=C(NC1CCOCC1)c1csc(C2CC2NCC2CC2)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: TAK-418 60 mg, capsule, orally, once on Day 1.
Eligibility criteria:
Inclusion Criteria:

Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m^2) at the Screening Visit.
Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months before trial drug administration of the initial dose of trial drug or invasive procedure.
Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug or invasive procedure as per principal investigator's judgment.

Female subjects with no childbearing potential, defined by at least 1 of the following criteria:

Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged greater than [>]45 years, 6 months of spontaneous amenorrhea in women aged >45 years with serum follicle-stimulating hormone [FSH] levels >40 milli-international units per milliliter [mIU/mL]). Appropriate documentation of FSH levels is required.
Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
Had a tubal ligation with appropriate documentation of surgical procedure.
Has a congenital condition resulting in no uterus.

Exclusion Criteria:

Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the Screening Visit.
Has a risk of suicide according to the investigator's clinical judgment per the Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in the 6 months before Screening.
Intervention: Epinephrine
Trial phase: Phase 4
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.

Epinephrine: Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.
Eligibility criteria:
Inclusion Criteria:

The inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery (ESS) in which the same sinuses and procedures on both sides are the same for CRS with or without nasal polyposis.

Exclusion Criteria:

pregnancy
known coagulopathy
an international normalized ratio greater than 1.3
a partial thromboplastin time greater than 50 seconds
use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses)
use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta)
poorly controlled hypertension with a preoperative systolic blood pressure of 160mm Hg or greater or a diastolic blood pressure of 90mm Hg or greater
having any adverse reaction to topical epinephrine or oxymetazoline.
Intervention: Methylprednisolone
Trial phase: Phase 3
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 599
Group description: IV Methylprednisolone

Methylprednisolone: IV Steroid pre-operative and intra-operative
Eligibility criteria:
Inclusion Criteria:

Age < 1 year at the time of surgery
Undergoing heart surgery with CPB as part of standard clinical care
Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria:

< 37 weeks adjusted gestational age at time of surgery
Any oral or intravenous steroid treatment within two days of surgery
Any patient receiving any of the following medications within 2 days of surgery:

Amphotericin B, aminoglutethimide, anticholinesterases, warfarin, P450 3A4 inducers including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, bosentan and nafcillin or P450 3A4 inhibitors including (but not limited to) clarithromycin, voriconazole, itraconazole, ketoconazole, ciprofloxacin, diltiazem, fluconazole, erythromycin and verapamil.

Infection contraindicating steroid use
Preoperative mechanical circulatory support or active resuscitation at the time of randomization
Emergent surgery precluding steroid administration 8-12 hours before surgery
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 601
Group description: IV Isotonic Saline

Isotonic saline: Isotonic saline pre-operative and intra-operative
Eligibility criteria:
Inclusion Criteria:

Age < 1 year at the time of surgery
Undergoing heart surgery with CPB as part of standard clinical care
Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria:

< 37 weeks adjusted gestational age at time of surgery
Any oral or intravenous steroid treatment within two days of surgery
Any patient receiving any of the following medications within 2 days of surgery:

Amphotericin B, aminoglutethimide, anticholinesterases, warfarin, P450 3A4 inducers including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, bosentan and nafcillin or P450 3A4 inhibitors including (but not limited to) clarithromycin, voriconazole, itraconazole, ketoconazole, ciprofloxacin, diltiazem, fluconazole, erythromycin and verapamil.

Infection contraindicating steroid use
Preoperative mechanical circulatory support or active resuscitation at the time of randomization
Emergent surgery precluding steroid administration 8-12 hours before surgery
Intervention: Adenosine
Trial phase: Phase 3
ATC code: C01EB10 | J05AB03 | S01AD06
SMILES: Nc1ncnc2c1ncn2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Adenosine: Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
Eligibility criteria:
Inclusion Criteria:

Patients age 1 - 25 years who are status-post OHT (≤18 years at the time of transplantation) and undergoing routine post-transplant surveillance catheterization for endomyocardial biopsy and coronary angiography

Exclusion Criteria:

The presence of sick sinus syndrome or 2nd or 3rd degree atrioventricular block (without a functioning implanted pacemaker)
Hemodynamically significant valvular disease
Severe asthma or bronchospasm, known severe CAV
Pulmonary hypertension.
Patients taking digoxin
Verapamil and dipyridamole are also excluded given known interactions with adenosine.
Intervention: Bilastine
Trial phase: Phase 2
ATC code: R06AX29 | S01GX13
SMILES: CCOCCn1c(C2CCN(CCc3ccc(C(C)(C)C(=O)O)cc3)CC2)nc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.
Eligibility criteria:
Key Inclusion Criteria:

be at least 18 years old
be willing and able to avoid all disallowed medications and contact lenses
must have a pregnancy test if of childbearing potential
must be able to read an eye chart from 10 feet away

Key Exclusion Criteria:

must not have any allergies to the study medications
must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
must not have used immunotherapy in the last 2 years
must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
Intervention: Bilastine
Trial phase: Phase 2
ATC code: R06AX29 | S01GX13
SMILES: CCOCCn1c(C2CCN(CCc3ccc(C(C)(C)C(=O)O)cc3)CC2)nc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.
Eligibility criteria:
Key Inclusion Criteria:

be at least 18 years old
be willing and able to avoid all disallowed medications and contact lenses
must have a pregnancy test if of childbearing potential
must be able to read an eye chart from 10 feet away

Key Exclusion Criteria:

must not have any allergies to the study medications
must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
must not have used immunotherapy in the last 2 years
must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
Intervention: Bilastine
Trial phase: Phase 2
ATC code: R06AX29 | S01GX13
SMILES: CCOCCn1c(C2CCN(CCc3ccc(C(C)(C)C(=O)O)cc3)CC2)nc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.
Eligibility criteria:
Key Inclusion Criteria:

be at least 18 years old
be willing and able to avoid all disallowed medications and contact lenses
must have a pregnancy test if of childbearing potential
must be able to read an eye chart from 10 feet away

Key Exclusion Criteria:

must not have any allergies to the study medications
must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
must not have used immunotherapy in the last 2 years
must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
Intervention: Bilastine
Trial phase: Phase 2
ATC code: R06AX29 | S01GX13
SMILES: CCOCCn1c(C2CCN(CCc3ccc(C(C)(C)C(=O)O)cc3)CC2)nc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.
Eligibility criteria:
Key Inclusion Criteria:

be at least 18 years old
be willing and able to avoid all disallowed medications and contact lenses
must have a pregnancy test if of childbearing potential
must be able to read an eye chart from 10 feet away

Key Exclusion Criteria:

must not have any allergies to the study medications
must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
must not have used immunotherapy in the last 2 years
must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
Intervention: Decapeptyl
Trial phase: Phase 3
SMILES: CC(C)CC(NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NCC(N)=O.O=C(O)c1cc2ccccc2c(Cc2c(O)c(C(=O)O)cc3ccccc23)c1O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 149
Group description: Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
Eligibility criteria:
Inclusion Criteria:

Female subjects aged from 18 to 45 years inclusive at the date of informed consent.
A history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6 months prior to the screening visit.
A diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years prior to the screening visit.
Requires treatment with a Gonadotrophin releasing hormone (GnRH) agonist for a period of 6 months in the judgement of the investigator.

Exclusion Criteria:

A current history of undiagnosed abnormal genital bleeding.
Received treatment with a GnRH agonist within 6 months prior to the screening visit.
Received any other hormonal treatment within 3 months prior to the screening visit (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc).
Chronic pelvic pain that is not caused by endometriosis, that would interfere with the assessment of endometriosis-associated pelvic pain.
Intervention: Triptorelin
Trial phase: Phase 3
ATC code: L02AE04
SMILES: CC(C)C[C@H](NC(=O)[C@@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 150
Group description: Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
Eligibility criteria:
Inclusion Criteria:

Female subjects aged from 18 to 45 years inclusive at the date of informed consent.
A history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6 months prior to the screening visit.
A diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years prior to the screening visit.
Requires treatment with a Gonadotrophin releasing hormone (GnRH) agonist for a period of 6 months in the judgement of the investigator.

Exclusion Criteria:

A current history of undiagnosed abnormal genital bleeding.
Received treatment with a GnRH agonist within 6 months prior to the screening visit.
Received any other hormonal treatment within 3 months prior to the screening visit (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc).
Chronic pelvic pain that is not caused by endometriosis, that would interfere with the assessment of endometriosis-associated pelvic pain.
Intervention: Netarsudil
Trial phase: Phase 2
ATC code: S01EE51 | S01EX05
SMILES: Cc1ccc(C(=O)OCc2ccc([C@@H](CN)C(=O)Nc3ccc4cnccc4c3)cc2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye
Eligibility criteria:
Inclusion Criteria:

Must be 18 years of age or older
Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first qualification visit
Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
Able to give informed consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

Clinically significant ocular disease
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
Intraocular pressure ≥30 mmHg in either eye
A difference in IOP between eyes >4mmHg at qualification visit
Use of more than two ocular hypotensive medications within 30 days of screening
Known hypersensitivity to any component of the formulation
Previous glaucoma surgery or refractive surgery
Keratorefractive surgery in either eye
Report of ocular injury in either eye within the six months prior to screening or ocular or non-refractive surgery within 3 months prior to screening
Recent or current ocular infection or inflammation in either eye
Use of ocular medication in either eye of any kind within 30 days of screening
Mean central corneal thickness greater than 620 μm in either eye
Any abnormality preventing reliable applanation tonometry of either eye

Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)

Systemic:

Clinically significant abnormalities within 6 weeks prior to screening
Clinically significant systemic disease
Participation in any investigational study within 60 days prior to screening
Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
Intervention: Zeven
Trial phase: Phase 4
ATC code: J01XA04
SMILES: CNC1C(=O)NC2Cc3ccc(cc3)Oc3cc4cc(c3OC3OC(C(=O)O)C(O)C(O)C3NC(=O)CCCCCCCCC(C)C)Oc3ccc(cc3Cl)C(O)C3NC(=O)C(NC(=O)C4NC(=O)C(NC2=O)c2cc(cc(O)c2Cl)Oc2cc1ccc2O)c1ccc(O)c(c1)-c1c(OC2OC(CO)C(O)C(O)C2O)cc(O)cc1C(C(=O)NCCCN(C)C)NC3=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: The New Critical Pathway under study is defined as (1) use of guideline-based patient identification criteria, and, for those who meet these criteria, (2) use of dalbavancin, administered as a single intravenous (IV) dose of 1500 mg over 30 minutes for the treatment of ABSSSI.
Eligibility criteria:
Inclusion Criteria:

Admitted patients who meets the clinical definition for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Known or suspected gram-positive infection.

Exclusion Criteria:

Known or suspected gram-negative infections, anaerobic infections, or fungemia
Known or suspected infections that are severe, life threatening or are not included in the ABSSSI Food and Drug Administration (FDA) guidance
Injection drug users with a fever
Severe neurological disorder leading to immobility or confined to a wheelchair
Bilateral Lower extremity involvement of the suspected infection.