anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: (4-(2-(4-fluoro-2-methylphenoxy)-4-(trifluoromethyl)benzamido)-2-oxopyridin-1(2H)-yl)methyl dihydrogen phosphate
Trial phase: Phase 2
SMILES: Cc1cc(F)ccc1Oc1cc(C(F)(F)F)ccc1C(=O)Nc1ccn(COP(=O)(O)O)c(=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
Eligibility criteria:
Key Inclusion Criteria:

Before surgery:

Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure

After surgery:

Subject reported pain of greater than or equal to (>=) 4 on Numeric Pain Rating Scale (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
Subject is lucid and able to follow commands
All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

Before surgery:

History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
History of abnormal laboratory results >=2.5*upper limit of normal (ULN)
History of peripheral neuropathy
A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
Prior medical history of bunionectomy or other foot surgery on the index foot
History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen

After surgery:

Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

Other protocol defined inclusion/exclusion criteria may apply
Intervention: (4-(2-(4-fluoro-2-methylphenoxy)-4-(trifluoromethyl)benzamido)-2-oxopyridin-1(2H)-yl)methyl dihydrogen phosphate
Trial phase: Phase 2
SMILES: Cc1cc(F)ccc1Oc1cc(C(F)(F)F)ccc1C(=O)Nc1ccn(COP(=O)(O)O)c(=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Participants received VX-150 250 mg qd for 2 days.
Eligibility criteria:
Key Inclusion Criteria:

Before surgery:

Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure

After surgery:

Subject reported pain of greater than or equal to (>=) 4 on Numeric Pain Rating Scale (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
Subject is lucid and able to follow commands
All analgesic guidelines were followed during and after the bunionectomy

Key Exclusion Criteria:

Before surgery:

History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
History of abnormal laboratory results >=2.5*upper limit of normal (ULN)
History of peripheral neuropathy
A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
Prior medical history of bunionectomy or other foot surgery on the index foot
History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen

After surgery:

Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

Other protocol defined inclusion/exclusion criteria may apply
Intervention: Visomitin
Trial phase: Phase 3
SMILES: CC1=C(C)C(=O)C(CCCCCCCCCC[P+](c2ccccc2)(c2ccccc2)c2ccccc2)=CC1=O.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 151
Group description: Vehicle for SkQ1 ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Be at least 18 years of age;
Provide written informed consent;
Have a subject reported history of dry eye;
Have a history of use of eye drops for dry eye symptoms ;
Ocular Discomfort;
Schirmer's Test score;
Have corneal fluorescein staining ;
Have lissamine green conjunctival Staining ;
Have a conjunctival redness;

Exclusion Criteria:

Have participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;
Have any clinically significant slit lamp findings at Visit 1;
Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit 1;
Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned over the study period;
Have an uncontrolled systemic disease;
Be a woman who is pregnant, nursing or planning a pregnancy;
Be a woman of childbearing potential who is not using an acceptable means of birth control;
Have a known allergy and/or sensitivity to the study drug or its components ;
Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
Intervention: Vanzacaftor
Trial phase: Phase 1 | Phase 2
SMILES: CC1(C)C[C@@H]2CCCNc3cccc(n3)S(=O)(=O)NC(=O)c3ccc(-n4ccc(OCCC5C6(CC6)C56CC6)n4)nc3N1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants received single dose of VX-121 20 mg.
Eligibility criteria:
Key Inclusion Criteria:

Part A, B, and C: Healthy Volunteers

Female subjects must be of non-childbearing potential
Between the ages of 18 and 55 years, inclusive
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

Part D: Subjects with CF

Heterozygous for F508del and an MF mutation (F/MF)
FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height
Body weight ≥35 kg

Key Exclusion Criteria:

Part A, B and C: Healthy Volunteers

Any condition possibly affecting drug absorption
History of febrile illness or other acute illness within 5 days before the first study drug dose

Part D: Subjects with CF

History of clinically significant cirrhosis with or without portal hypertension
History of solid organ or hematological transplantation
Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: Vanzacaftor
Trial phase: Phase 1 | Phase 2
SMILES: CC1(C)C[C@@H]2CCCNc3cccc(n3)S(=O)(=O)NC(=O)c3ccc(-n4ccc(OCCC5C6(CC6)C56CC6)n4)nc3N1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants received single dose of VX-121 40 mg.
Eligibility criteria:
Key Inclusion Criteria:

Part A, B, and C: Healthy Volunteers

Female subjects must be of non-childbearing potential
Between the ages of 18 and 55 years, inclusive
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

Part D: Subjects with CF

Heterozygous for F508del and an MF mutation (F/MF)
FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height
Body weight ≥35 kg

Key Exclusion Criteria:

Part A, B and C: Healthy Volunteers

Any condition possibly affecting drug absorption
History of febrile illness or other acute illness within 5 days before the first study drug dose

Part D: Subjects with CF

History of clinically significant cirrhosis with or without portal hypertension
History of solid organ or hematological transplantation
Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: Vanzacaftor
Trial phase: Phase 1 | Phase 2
SMILES: CC1(C)C[C@@H]2CCCNc3cccc(n3)S(=O)(=O)NC(=O)c3ccc(-n4ccc(OCCC5C6(CC6)C56CC6)n4)nc3N1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants received single dose of VX-121 60 mg.
Eligibility criteria:
Key Inclusion Criteria:

Part A, B, and C: Healthy Volunteers

Female subjects must be of non-childbearing potential
Between the ages of 18 and 55 years, inclusive
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

Part D: Subjects with CF

Heterozygous for F508del and an MF mutation (F/MF)
FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height
Body weight ≥35 kg

Key Exclusion Criteria:

Part A, B and C: Healthy Volunteers

Any condition possibly affecting drug absorption
History of febrile illness or other acute illness within 5 days before the first study drug dose

Part D: Subjects with CF

History of clinically significant cirrhosis with or without portal hypertension
History of solid organ or hematological transplantation
Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: Leucovorin
Trial phase: Phase 2 | Phase 3
ATC code: V03AF03 | V03AF04 | V03AF06 | V03AF10
SMILES: Nc1nc2c(c(=O)[nH]1)N(C=O)C(CNc1ccc(C(=O)NC(CCC(=O)O)C(=O)O)cc1)CN2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 12
Group description: In this open-label trial, all subjects will receive the twice daily dose of folinic acid. Folinic acid will be delivered in pill form at a weight-based dose.

folinic acid: subject will take folinic acid daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Between ages 5 and 25

Exclusion Criteria:

Not currently taking folinic acid
Intervention: Metformin Hydrochloride
Trial phase: Phase 1 | Phase 2
SMILES: CN(C)C(=N)N=C(N)N.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Subjects will be exposed to 500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.

MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
Eligibility criteria:
Inclusion Criteria:

Age ≥55 and ≤85 years of age
Non-diabetic
Adjusted risk analysis index (RAI) 20-42
Estimated glomerular filtration rate >45
No evidence of hepatic dysfunction on comprehensive metabolic panel
No clinical evidence of cardiac failure
Existing University of Pittsburgh Medical Center Patients

Exclusion Criteria:

Hypersensitivity to metformin or any component of the formulation
Acute or chronic metabolic acidosis with or without coma
Pregnant or breastfeeding females
Evidence or history of hepatic, renal, or cardiopulmonary failure
Excessive acute or chronic ethanol use
Planned or known hospital admission, exposure to anesthesia, or surgical intervention 30 days prior to study or scheduled 30 days after the trial initiation
Laboratory analysis showing HbgA1c >6.1 or eGFR <44 on baseline labs
Intervention: Metformin Hydrochloride
Trial phase: Phase 1 | Phase 2
SMILES: CN(C)C(=N)N=C(N)N.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Subjects will be exposed to 1000mg of daily MetFORMIN Hydrochloride ER for up to 90 days.

MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
Eligibility criteria:
Inclusion Criteria:

Age ≥55 and ≤85 years of age
Non-diabetic
Adjusted risk analysis index (RAI) 20-42
Estimated glomerular filtration rate >45
No evidence of hepatic dysfunction on comprehensive metabolic panel
No clinical evidence of cardiac failure
Existing University of Pittsburgh Medical Center Patients

Exclusion Criteria:

Hypersensitivity to metformin or any component of the formulation
Acute or chronic metabolic acidosis with or without coma
Pregnant or breastfeeding females
Evidence or history of hepatic, renal, or cardiopulmonary failure
Excessive acute or chronic ethanol use
Planned or known hospital admission, exposure to anesthesia, or surgical intervention 30 days prior to study or scheduled 30 days after the trial initiation
Laboratory analysis showing HbgA1c >6.1 or eGFR <44 on baseline labs
Intervention: Metformin Hydrochloride
Trial phase: Phase 1 | Phase 2
SMILES: CN(C)C(=N)N=C(N)N.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Subjects will be exposed to 1500mg of daily MetFORMIN Hydrochloride ER for up to 90 days.

MetFORMIN Hydrochloride ER: Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
Eligibility criteria:
Inclusion Criteria:

Age ≥55 and ≤85 years of age
Non-diabetic
Adjusted risk analysis index (RAI) 20-42
Estimated glomerular filtration rate >45
No evidence of hepatic dysfunction on comprehensive metabolic panel
No clinical evidence of cardiac failure
Existing University of Pittsburgh Medical Center Patients

Exclusion Criteria:

Hypersensitivity to metformin or any component of the formulation
Acute or chronic metabolic acidosis with or without coma
Pregnant or breastfeeding females
Evidence or history of hepatic, renal, or cardiopulmonary failure
Excessive acute or chronic ethanol use
Planned or known hospital admission, exposure to anesthesia, or surgical intervention 30 days prior to study or scheduled 30 days after the trial initiation
Laboratory analysis showing HbgA1c >6.1 or eGFR <44 on baseline labs
Intervention: Estriol
Trial phase: Phase 2 | Phase 3
ATC code: G03CA04 | G03CC06
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)[C@H](O)C[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: no adverse events were reported
Eligibility criteria:
Inclusion Criteria:

Female patients with RRMS over the age of 40 to 65.

Being prescribed vaginal estriol to treat their urogenital symptoms such as frequency, urgency, incontinence and frequent urinary tract infections.
Patients that had underwent chemical or surgical hysterectomy.
Patients will continue their current disease modifying agent for MS during the trial.

Exclusion Criteria:

Patients with history of breast cancer, uterine or ovarian cancer.
Patients with progressive multiple sclerosis
Patients who are unable to undergo an MRI
Males
Patient is already on vaginal or oral or transdermal estrogens
Pregnant or breast-feeding patients
Patient taking sex hormones eg testosterone for libido
Patients taking DHEA or OTC related products that could influence the hormonal milieu.
Patient with prolapse uterus or conditions that would impact on transvaginal absorption of estriol
Intervention: Macitentan
Trial phase: Phase 3
ATC code: C02KX04 | C02KX54
SMILES: CCCNS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Participants received macitentan 10 milligrams (mg) tablet orally once daily with or without food from Day 1 until the end of the treatment (129 weeks) or till the sponsor decided to stop this study.
Eligibility criteria:
Inclusion Criteria:

Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures.
Subjects who have completed Week 52 of the parent AC-055H301/RUBATO DB study (NCT03153137)

Women of childbearing potential must:

have a negative serum pregnancy test prior to first intake of OL study drug, and,
agree to perform monthly pregnancy tests up to the end of the safety follow up (S-FU) period, and,
use reliable methods of contraception from enrollment up to at least 30 days after study treatment discontinuation.

Exclusion Criteria:

Clinical worsening leading to medical interventions including reoperation of Fontan circulation (Fontan take-down) during the enrollment period
Systolic blood pressure < 90 mmHg (< 85 mmHg for subjects < 18 years old and < 150 cm of height) at rest
Criteria related to macitentan use
Any known factor or disease that may interfere with treatment compliance or full participation in the study
Intervention: Prednisolone
Trial phase: Phase 1
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: Male
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Twelve subjects will be prescribed a standard clinical dose of prednisolone of 0.75 mg/kg/day or weekend dosing per sites standard of care. The prednisolone will be provided will be provided as suspension.

Prednisolone: Prednisolone will be prescribed for 6 months as the clinical standard of care.
Eligibility criteria:
Inclusion Criteria:

Duchenne muscular dystrophy (DMD) patients ≥4 to ≤7 years of age
Clinical features of DMD that include proximal predominant weakness and/or gait disturbance
Presence of a truncating mutation of the DMD gene in the patient or an affected male relative OR a muscle biopsy that demonstrates <5% dystrophin in the patient or an affected male relative
Normal left ventricular ejection fraction by screening echocardiogram
Ability to cooperate for testing
No prior treatment with glucocorticoids or vamorolone
No concomitant experimental therapies

Exclusion Criteria:

Subject amenable to or currently being treated with eteplirsen, casimersen, or viltolarsen
Hyperkalemia at screening
History of or ongoing renal failure (elevated creatinine, oliguria, anuria)
Hypersensitivity to spironolactone (rash, respiratory distress, arrhythmia, numbness or tingling of extremities)
Current treatment with an ACEi
Severe peptic ulcer disease or recent gastrointestinal perforations
Intervention: Temozolomide
Trial phase: Phase 2
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Temozolomide: Drug
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed newly diagnosed grade IV malignant glioma
Planned radiation treatments at Mayo Clinic Arizona or Mayo Clinic Rochester
Willing to sign release of information for any radiation and/or follow-up records
Provide informed written consent
Patients with estimated glomerular filtration rate (eGFR) >= 60 mg/min/1.72 m^2
Ability to complete questionnaire(s) by themselves or with assistance
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

Exclusion Criteria:

Patients diagnosed with grades I-III glioma
Currently on Avastin at time of treatment
Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)

Unable to undergo an 18F-DOPA-PET scan (e.g. Parkinson's disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)

NOTE: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline. If a patient is on any of these drugs, list which ones on the on-study form

Pregnant women, nursing women, or men or women of childbearing potential who are unwilling to employ adequate contraception.

NOTE: All women enrolled in this study will be age 65 or over, and at the determination of the principal investigator (PI), will not be of childbearing potential. If the radiology department requires a pregnancy test before administering the 18FDOPA injection, they may perform one per their standard of care
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.

Intravenous Ketamine: Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
Eligibility criteria:
Inclusion Criteria:

Children 1-18 years of age.
American Society of Anesthesiologists (ASA) I or II
Non-operative fracture requiring reduction
Body weight less than or equal to 25 kg as measured by standard weighing scale

Exclusion Criteria:

ASA classification III or above
Age less than 1 year
History of hypertension, known coronary artery disease or Kawasaki disease, congestive heart failure, acute glaucoma or globe injury, increased intracranial pressure or intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric disorder
Prior allergy to ketamine
Unavailable parent or guardian to provide consent
Non-English speaking
Intervention: Chloraprep
Trial phase: Phase 3
SMILES: CC(C)O.NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)CC(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 156
Group description: Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%

ChloraPrep: Apply topically.
Eligibility criteria:
Inclusion Criteria:

Subjects of any race
Subjects in good general health
Minimum bacterial baseline requirements on abdomen and groin
Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to screening and treatment days, excluding contraception or post-menopausal treatment.
Subjects with allergies to study materials including isopropyl alcohol or chlorhexidine gluconate.
Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
Subjects who are pregnant, attempting pregnancy or nursing.