anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lasmiditan
Trial phase: Phase 1
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Participants were administered a single oral dose of 200 mg Lasmiditan tablet on day 1 during inter-ictal period.
Eligibility criteria:
Inclusion Criteria:

Males or females with history of migraine with or without aura, as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 and 1.2) (ICHD-3 beta, Cephalalgia 2013), for at least 1 year, based on medical history
Have a body mass index (BMI) of 18.0 to 40.0 kilograms per meter squared (kg/m²) inclusive, at the time of screening

Exclusion Criteria:

Have known allergies to lasmiditan, related compounds, or any components of the formulation of lasmiditan
Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
Have an abnormal blood pressure, defined as systolic blood pressure less than or equal to (≤) 90 or greater than (>) 155 millimeters of mercury (mmHg) or diastolic blood pressure ≤ to 50 or >95 mmHg
Have clinically significant electrocardiogram (ECG) findings, including a QT interval corrected for heart rate using QT interval corrected for heart rate using Fridericia's formula (QTcF) value >450 milliseconds (ms) (males) or >470 ms (females), clinically significant bradycardia, cardiac block, or bradyarrhythmias
Have a history of, show evidence of, or are undergoing treatment for significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, major depressive disorder)
Have a history of gastrointestinal surgery, or a history of or current irritable bowel syndrome, mal-absorptive disorders, or other gastrointestinal motility disorders. Appendectomy, splenectomy, and cholecystectomy are considered as acceptable
Have used or intend to use any migraine prevention treatments (including, but not limited to, propranolol or topiramate) within 30 days prior to dosing and until the follow-up visit
Intervention: Netarsudil
Trial phase: Phase 3
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: 95
Group description: Netarsudil ophthalmic solution 0.02%, dosed topically once a day for 9 months

Netarsudil: netarsudil opthalmic solution 0.02%
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age; male or female patient undergoing Descemet membrane endothelial keratoplasty; patient is able and willing to administer eye drops; patient is able to comprehend and has signed the Informed Consent form; patient is likely to complete the nine-month course of the study.

Exclusion Criteria:

A patient exhibiting pre-operative intraocular inflammation; a patient with a known sensitivity to any of the ingredients in the study medications; a patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study; a patient with abnormal eyelid function; a patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis; a patient who has been diagnosed with uncontrolled glaucoma, prior aqueous shunt or trabeculectomy, or with preoperative intraocular pressure > 22 mm Hg in the potential study eye; presence of any ocular disease that would interfere with the evaluation of the study treatment (however, patients with a history of cystoid macular edema, age-related macular degeneration, corneal neovascularization, and other non-interfering comorbidities may be enrolled); a patient with a history of non-compliance with using prescribed medication; a patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study; patients who are pregnant or planning to become pregnant within the duration of the study.
Intervention: Lumateperone
Trial phase: Phase 3
ATC code: N05AD10
SMILES: CN1CCN2c3c(cccc31)C1CN(CCCC(=O)c3ccc(F)cc3)CCC12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 188
Group description: Lumateperone 42 mg (ITI-007 60 mg tosylate) administered once daily every evening for 6 weeks

Lumateperone: Lumateperone 42 mg (ITI-007 60 mg tosylate)
Eligibility criteria:
Major Inclusion Criteria:

male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
experiencing a current major depressive episode
able to provide written informed consent

Major Exclusion Criteria:

any female subject who is pregnant or breast-feeding
any subject judged to be medically inappropriate for study participation
Intervention: Azithromycin
Trial phase: Phase 2
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: Male
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Azithromycin 1 gm PO single dose given as directly observed

Azithromycin: Azithromycin 1 gm PO single dose given as directly observed
Eligibility criteria:
Inclusion Criteria:

1.Male between the ages of 12 and 21 years 2.Residing in a long-term gender-segregated (no co-ed) YCF 3.Diagnosed with urogenital chlamydia as determined by a screening C. trachomatis NAAT 4.Anticipated length of stay at the YCF at the time of enrollment is at least 28 days 5.Willingness to provide written consent 6.Willingness to comply with study procedures

Exclusion Criteria:

1.Diagnosed with gonorrhea as determined by a screening Neisseria gonorrhoeae NAAT 2.Clinical diagnosis of epididymitis based on review of medical records 3.Known allergy to azithromycin, erythromycin, any macrolide or ketolide drug 4.History of liver problems due to use of azithromycin 5.Having received antimicrobial therapy with activity against C. trachomatis within 21 days of the positive chlamydia screening NAAT or in the interval between the positive screening NAAT and study enrollment 6.Any concomitant infection, which requires antimicrobial therapy with activity against C. trachomatis 7.Previously enrolled in this study 8.Unable to swallow pills 9.Other exclusion criteria, per clinician judgment, that prohibits subject from enrolling in study
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine

Bupivacaine: 0.25% bupivacaine for TAP block
Eligibility criteria:
Inclusion Criteria:

Elective open abdominal hysterectomy with midline incision, age > 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.

Exclusion Criteria:

Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.
Intervention: Acetylcysteine
Trial phase: Phase 3
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: N-Acetylcysteine 50mg/Kg.d, oral
Eligibility criteria:
Inclusion Criteria:

Patients be scheduled to undergo HSCT;
Not received decitabine 6 month ago;
Without severe organ damage;
ECOG 0-2;
Informed consent were obtained.

Exclusion Criteria:

Be sensitive to NAC;
Bronchial asthma；
Peptic ulcer；
Severe organ damage；
Pregnancy and breastfeeding women；
Intervention: Fluconazole
Trial phase: Phase 2
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: 150 mg QD D1 only
Eligibility criteria:
Key Inclusion Criteria:

Subject is a female of at least 18 years of age
Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Key Exclusion Criteria:

Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
Subject is actively menstruating at the time of the Baseline visit.
Subject has uncontrolled diabetes mellitus.
Subject has a vaginal sample with pH >4.5.
Subject has a history of or an active cervical/vaginal cancer.
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 144
Group description: Group of patients to be administered a standard Propofol, Midazolam, Fentanyl anesthesia combination.

Propofol, Midazolam, and Fentanyl: Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.
Eligibility criteria:
Inclusion Criteria:

Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction
ASA Class I or II
English-speaking and Spanish-speaking subjects

Exclusion Criteria:

ASA Class III or higher
Patients taking alpha-2 agonists or benzodiazepines
Allergy or drug reaction to any of the drugs used in this study (benzodiazepines, opioids, propofol, alpha-2 agonists, NSAIDs, local anesthetic)
BMI greater than 30
History of or current substance abuse or alcoholism
History of mood-altering medications, tranquilizers, or antidepressants.
Pregnant females
Intervention: Dexmedetomidine Hydrochloride
Trial phase: Phase 4
SMILES: Cc1cccc(C(C)c2cnc[nH]2)c1C.Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 144
Group description: Group of patients to be administered the Dexmedetomidine and Midazolam anesthesia combination.

Dexmedetomidine and Midazolam: Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.
Eligibility criteria:
Inclusion Criteria:

Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction
ASA Class I or II
English-speaking and Spanish-speaking subjects

Exclusion Criteria:

ASA Class III or higher
Patients taking alpha-2 agonists or benzodiazepines
Allergy or drug reaction to any of the drugs used in this study (benzodiazepines, opioids, propofol, alpha-2 agonists, NSAIDs, local anesthetic)
BMI greater than 30
History of or current substance abuse or alcoholism
History of mood-altering medications, tranquilizers, or antidepressants.
Pregnant females
Intervention: Ketamine
Trial phase: Phase 1
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants will receive four once-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.

Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart.
Eligibility criteria:
Inclusion Criteria:

≥18 years old
Hamilton Rating Scale for Depression-24 item version (HRSD-24) score of ≥21
Voluntary admission for treatment of an acute depressive episode
Meet Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V) criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)

Exclusion Criteria:

Current involuntary admission
Medical condition rendering unfit for ketamine/midazolam
Active suicidal intention
Dementia
History of Axis 1 diagnosis other than major depression
Electroconvulsive Therapy (ECT) administered within the last two months
Alcohol/substance dependence in previous six-months
Pregnancy or inability to confirm use of adequate contraception during the trial
Breastfeeding women
Intervention: Midazolam
Trial phase: Phase 1
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants will receive four once-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.

Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart.
Eligibility criteria:
Inclusion Criteria:

≥18 years old
Hamilton Rating Scale for Depression-24 item version (HRSD-24) score of ≥21
Voluntary admission for treatment of an acute depressive episode
Meet Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V) criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)

Exclusion Criteria:

Current involuntary admission
Medical condition rendering unfit for ketamine/midazolam
Active suicidal intention
Dementia
History of Axis 1 diagnosis other than major depression
Electroconvulsive Therapy (ECT) administered within the last two months
Alcohol/substance dependence in previous six-months
Pregnancy or inability to confirm use of adequate contraception during the trial
Breastfeeding women
Intervention: Ataluren
Trial phase: Phase 4
ATC code: M09AX03
SMILES: O=C(O)c1cccc(-c2noc(-c3ccccc3F)n2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: dose of the drug administered (mg/kg body weight)

Ataluren: ataluren
Eligibility criteria:
Inclusion Criteria:

Evidence of signed and dated informed consent/assent document(s) indicating that the subject (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial.
Age ≥6 years
Body weight ≥16 kg
Diagnosis of cystic fibrosis and documentation of the presence of a nonsense mutations of the CFTR gene, as determined by historical genotyping
Ability to perform a valid, reproducible spirometry with demonstration of a forced expiratory volume in 1second (FEV1) ≥30% and ≤90% of predicted for age, gender, and height.
If the subject is sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration
Willingness and ability to comply with all study procedures and assessments.
Currently being administered ivacaftor, either alone (Kalydeco) or in combination with lumacaftor (Orkambi)

Exclusion Criteria:

Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or for CF-related conditions within 2 weeks prior to screening.
Ongoing participation in any other therapeutic clinical trial.
Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 2 weeks prior to screening.
Ongoing inhaled tobramycin therapy.
Ongoing immunosuppressive therapy (other than corticosteroids up to 10mg/d equivalent of prednisone)
Ongoing warfarin, phenytoin, or tolbutamide therapy.
History of solid organ or hematological transplantation.
A history of positive hepatitis B surface antigen test, hepatitis C antibody test, or human immunodeficiency
Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 4 weeks prior to screening.
Pregnancy or breast-feeding.
Current smoker or a smoking history of ≥10 pack-years (number of cigarette packs/day × number of years smoked).

Prior or ongoing medical condition (eg, renal failure, alcoholism, drug abuse, psychiatric condition), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.

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Intervention: Clindamycin
Trial phase: Phase 2
ATC code: D10AF01 | D10AF51 | G01AA10 | J01FF01
SMILES: [H][C@]1([C@]([H])(NC(=O)[C@@H]2C[C@@H](CCC)CN2C)[C@H](C)Cl)O[C@H](SC)[C@H](O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: topical clindamycin alone using Clindamycin 1% Gel

Clindamycin 1% Gel: topical clindamycin
Eligibility criteria:
Inclusion Criteria:

healthy volunteer
age > 18

Exclusion Criteria:

history of antibiotic use in the last month
active acne on the back
non-English speakers (the study personnel do not have adequate training to converse and consent in other languages)
Intervention: BENZOYL PEROXIDE
Trial phase: Phase 2
ATC code: D10AE01 | D10AE51
SMILES: O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: topical benzoyl peroxide alone using Benzoyl Peroxide 5% Gel

Benzoyl peroxide 5% gel: topical benzoyl peroxide
Eligibility criteria:
Inclusion Criteria:

healthy volunteer
age > 18

Exclusion Criteria:

history of antibiotic use in the last month
active acne on the back
non-English speakers (the study personnel do not have adequate training to converse and consent in other languages)
Intervention: Ondansetron
Trial phase: Phase 4
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 46
Group description: Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)

Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
Eligibility criteria:
Inclusion Criteria:

3-17 years
weight </= 100kg
scheduled for urologic or orthopedic procedure necessitating intrathecal morphine
ability to use verbal or pictorial pain assessment tools and techniques
informed consent and (if applicable) assent

Exclusion Criteria:

Inability to use verbal or pictorial pain scoring scales
hypersensitivity to selective 5-HT receptor antagonists
diagnosed congenital long QT syndrome
severe hepatic impairment
pregnancy or nursing mothers
Intervention: Vinorelbine
Trial phase: Phase 3
ATC code: L01CA04
SMILES: CCC1=CC2CN(C1)Cc1c([nH]c3ccccc13)C(C(=O)OC)(c1cc3c(cc1OC)N(C)C1C(O)(C(=O)OC)C(OC(C)=O)C4(CC)C=CCN5CCC31C54)C2
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Lap/Cap
T/Cap
T/Vino
T/Eri

Physician's choice: See drug label
Eligibility criteria:
Main Inclusion Criteria:

Female patients with histologically-confirmed, unresectable locally advanced or metastatic breast cancer;
Patients should have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment for locally advanced or metastatic disease;
HER2-positive tumor status;
Patients must have measurable or non-measurable disease that is evaluable per RECIST 1.1;
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
Estimated life expectancy > 12 weeks at randomization;
Adequate organ function and blood cell counts.

Main Exclusion Criteria:

Current or previous use of a prohibited medication as listed in the protocol;
History of infusion-related reactions and/or hypersensitivity to trastuzumab, (ado-)trastuzumab emtansine;
History of keratitis;
Severe, uncontrolled systemic disease at screening;
Left Ventricular Ejection Fraction (LVEF) < 50%, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab or (ado-)trastuzumab emtansine;
Cardiac troponin value above the Upper Limit of Normal (ULN);
History of clinically significant cardiovascular disease;
Untreated brain metastases, symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization;
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Normal saline IV

Normal saline: Normal saline IV three times daily for seven days
Eligibility criteria:
Inclusion Criteria:

Admission to the UNC Hospital Bone Marrow Transplant Unit for allogeneic stem cell transplant
At least 18 years of age
Able to speak English
Able to provide informed consent

Exclusion Criteria:

A history of adverse reaction to IV thiamine
Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment
Intervention: Fluciclovine (18F)
Trial phase: Phase 2
ATC code: V09IX12
SMILES: N[C@]1(C(=O)O)C[C@@H]([18F])C1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: 10mCi +/-20% 18F-fluciclovine injection

18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)

Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution.
Eligibility criteria:
Inclusion Criteria:

Prostate biopsy consisting of ≥ 10 tissue cores sampled
PSA </=20 ng/mL
cT1-cT2c
Either overall gleason score >/= 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with >/= half of systematic biopsy cores positive and >/= 50% of core involvement in at least one core
Patient considering focal HIFU therapy

Exclusion Criteria:

Previous local therapy for prostate cancer
Inability to receive PET tracer
Inability to receive MRI
Suggestion of extracapsular extension or seminal vesicle invasion on imaging
Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)
Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.