anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Eslicarbazepine
Trial phase: Phase 1
ATC code: N03AF04
SMILES: NC(=O)N1c2ccccc2CC(O)c2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: 450 mg of S-licarbazepine

S-licarbazepine: capsules containing 225 mg
Eligibility criteria:
Inclusion Criteria

Male or female subjects aged between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
Subjects who had clinical laboratory tests clinically acceptable at screening and admission.
Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
Subjects who were negative for drugs of abuse and alcohol at screening and admission.
Subjects who were non-smokers or who smoke < 10 cigarettes or equivalent per day.
Subjects who are able and willing to give written informed consent.
(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
(If female) She had a negative pregnancy test at screening and admission to Phase A.

Exclusion Criteria:

Subjects who did not conform to the above inclusion criteria, OR
Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
Subjects who had a clinically relevant surgical history.
Subjects who had a clinically relevant family history.
Subjects who had a history of relevant atopy.
Subjects who had a history of relevant drug hypersensitivity (especially carbamazepine or oxcarbazepine).
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 14 units of alcohol a week.
Subjects who had a significant infection or known inflammatory process on screening or admission.
Intervention: Eslicarbazepine
Trial phase: Phase 1
ATC code: N03AF04
SMILES: NC(=O)N1c2ccccc2CC(O)c2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: 450 mg of Rlicarbazepine

R-licarbazepine: capsules containing 225 mg
Eligibility criteria:
Inclusion Criteria

Male or female subjects aged between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
Subjects who had clinical laboratory tests clinically acceptable at screening and admission.
Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
Subjects who were negative for drugs of abuse and alcohol at screening and admission.
Subjects who were non-smokers or who smoke < 10 cigarettes or equivalent per day.
Subjects who are able and willing to give written informed consent.
(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
(If female) She had a negative pregnancy test at screening and admission to Phase A.

Exclusion Criteria:

Subjects who did not conform to the above inclusion criteria, OR
Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
Subjects who had a clinically relevant surgical history.
Subjects who had a clinically relevant family history.
Subjects who had a history of relevant atopy.
Subjects who had a history of relevant drug hypersensitivity (especially carbamazepine or oxcarbazepine).
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 14 units of alcohol a week.
Subjects who had a significant infection or known inflammatory process on screening or admission.
Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Patients randomized to metformin arm will receive 3 weeks of daily metformin (500 mg, am, 1000 mg, noon, 500 mg, pm) and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with metformin.
Eligibility criteria:
Inclusion Criteria:

Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma.
Patients are to be treated with hypofractionated RT.
Patient is not a surgical candidate due to medical comorbidities determined by a thoracic surgeon or patient refusal
Patient plans to receive treatment at MD Anderson
Patients must sign informed consent
Patient must have adequate renal function within 30 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance at least 60 ml/min

Exclusion Criteria:

Patient has: random glucose >200 mg/dl or is taking an oral hypoglycemic agent or insulin at the time of study entry
Patient has a history of lactic acidosis, chronic kidney disease or a creatinine >/= 1.2 mg/dl
Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant
Patients with history of allergic reaction to metformin
Intervention: Hydrocortisone
Trial phase: Not Applicable
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
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)CC[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm

Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment
Eligibility criteria:
Inclusion Criteria:

Male or non-pregnant female subjects aged 2-17 years of age.
Individuals must be diagnosed with acute-subacute AD regardless of the study.
Written informed consent must be obtained from all patients or caregivers.
Women of childbearing potential (WOCBP) must be willing to practice effective contraception for the duration of study treatment.
Subjects must be willing and able to comply with study conditions, properly apply or have caregivers apply topical medications to the selected body sites, as well as return to the clinic for required visits.
Subject caregivers must be willing and able to perform ADQ assessment test.

Exclusion Criteria:

Individuals who are immune-compromised or suffering from infectious disease, malignant disease, are known to be HIV+ or present with a general reduced level of health.
Individuals diagnosed with underlying dermatological conditions in addition to AD.
Individuals with a chronic pre-existing disease such as diabetes mellitus or others that in the opinion of the investigator would preclude their participation in the study.
Individuals who are pregnant, nursing mothers, or subjects planning a pregnancy during the course of the study.
Subjects/caregivers who are unable to communicate or comply with study conditions due to language disability, poor mental development, or impaired cerebral function.
Individuals who are simultaneously enrolled in another clinical drug or device research study.
Individuals with a history of chronic steroid use.
Individuals needing to concurrently use topical agents, medicinal products containing corticosteroids, or immunosuppressants.
Individuals who have received systemically administered corticosteroids and/or antihistamines 2 weeks prior to the start of study.
Individuals undergoing light therapy.
Individuals who have been treated with another investigation device or drug within 30 days prior to study enrollment.
Individuals with a known allergy to oregano.
Intervention: Atosiban
Trial phase: Phase 3
ATC code: G02CX01
SMILES: [H][C@@]1([C@@H](C)O)NC(=O)[C@]([H])([C@@H](C)CC)NC(=O)[C@@H](Cc2ccc(OCC)cc2)NC(=O)CCSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CCCN)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 44
Group description: All infants and children born to women who received atosiban (in 3 successive stages; an initial bolus dose of 6.75 milligram [mg] using atosiban 6.75 mg per 0.9 milliliter [mL] solution for injection, followed by continuous high dose infusion at 18 mg per hour for 3 hours, then a lower 6 mg per hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg per 5 mL concentrate for solution) in 200721 study. Current study did not require any medical interventions or study visits to an investigational site.
Eligibility criteria:
Inclusion Criteria:

Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III SPTL retosiban clinical studies.
Infant is alive at 28 days post EDD.
Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of subjects aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.

Exclusion Criteria:

There are no formal exclusion criteria for participation.
Intervention: Riboflavin
Trial phase: Phase 1
ATC code: A11HA04 | S01XA26
SMILES: Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Screening laboratory parameters within defined thresholds
Creatinine clearance must be ≥ 60 mL/min

Key Exclusion Criteria:

Females who are pregnant or nursing or males who have a pregnant partner
Infection with hepatitis B virus (HBV) or HIV
History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: Riboflavin
Trial phase: Phase 1
ATC code: A11HA04 | S01XA26
SMILES: Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Participants with normal hepatic function received a single oral dose of TAF 25 mg of on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Screening laboratory parameters within defined thresholds
Creatinine clearance must be ≥ 60 mL/min

Key Exclusion Criteria:

Females who are pregnant or nursing or males who have a pregnant partner
Infection with hepatitis B virus (HBV) or HIV
History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: Methadone
Trial phase: Not Applicable
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: methadone 0.1 mg/kg

methadone: Escalating dose of methadone up to .3mg/kg.
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years
Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours
Signed, written, informed consent

Exclusion Criteria:

History of or known liver or kidney disease.
Females who are pregnant or nursing.
Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
History of allergy to methadone
Intervention: Methadone
Trial phase: Not Applicable
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: methadone: Escalating dose of methadone up to .3mg/kg.
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years
Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours
Signed, written, informed consent

Exclusion Criteria:

History of or known liver or kidney disease.
Females who are pregnant or nursing.
Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
History of allergy to methadone
Intervention: (E)-1-(5-((E)-(3-Fluorodibenzo(b,E)oxepin-11(6H)-ylidene)methyl)-1-((R)-1-morpholinopropan-2-yl)-1H-benzo(d)imidazol-2(3H)-ylidene)urea
Trial phase: Phase 1
SMILES: CC(CN1CCOCC1)n1c(NC(N)=O)nc2cc(C=C3c4ccccc4COc4cc(F)ccc43)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
Eligibility criteria:
Inclusion Criteria:

Healthy participants as determined by medical history, physical examination, clinical laboratory tests, and electrocardiograms (ECGs).
Have a body mass index (BMI) between 18 and 32.0 kilograms per square meter (kg/m^2) inclusive, at screening
Female participants must be of non-childbearing potential

Exclusion Criteria:

In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Intervention: Amiodarone
Trial phase: Not Applicable
ATC code: C01BD01
SMILES: CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Amiodarone is a Class III antiarrhythmic agent.
Eligibility criteria:
Inclusion Criteria:

≥ 18 and ≤ 85 years of age
History of a remote MI (≥1 month)
Survival of a ventricular arrhythmic event (VT/VF) that would mandate placement of an implantable cardioverter-defibrillator (ICD) (Patients who experience a ventricular arrhythmic event (VT/VF) while already being treated with Amiodarone (100-200 mg/day) are not excluded from the study. This is permitted provided that the patient had been treated with Amiodarone for at least 2 months prior to experiencing the index VT/VF event. These patients are randomized to either a higher dose of Amiodarone (e.g., 100mg/day -> 200mg/day or 200mg/day -> 400mg/day) or a higher dose of Amiodarone plus catheter ablation.)
Patient cannot afford an ICD and thus has been planned for treatment with Amiodarone (or an increased dose of Amiodarone)
Ability to understand the requirements of the study
Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements

Exclusion Criteria:

Patients with NYHA class IV congestive heart failure
Prior ablation for a ventricular arrhythmia
Presence of an LV thrombus
Contraindication to anticoagulation
Inability to access the endocardium because of mechanical mitral and aortic valve
Life expectance <1 year for any medical condition
Intervention: 99mTc-Methylene diphosphonate
Trial phase: Not Applicable
SMILES: O.O.O=P(O)(O)CP(=O)(O)O.O=P(O)(O)CP(=O)(O)O.[Tc]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: 15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.

99Tc-MDP: 99Tc-MDP, H20000218
Eligibility criteria:
Inclusion Criteria:

(1) They were pathologically diagnosed with DTC including papillary or follicular carcinoma. (2) They received a near total thyroidectomy and radioiodine treatment. (3) TSH suppression should be at least one year before the study. (4) Bone mineral density (BMD) in lumbar spine and/or hip was tested by Dual-energy X-ray absorptiometry (DXA) at baseline, 6 month (m) and/or 12m follow up. 5) The diagnosis of osteoporosis was T-score ≤-2.5 SD at the lumbar spine, or hip.

Exclusion Criteria:

patients having medications for osteoporosis before TSH suppression treatment;
secondary osteoporosis ;
severe liver or kidney disease;
myelosuppression;
digestive disease;
long term use of immunosuppressive agent, estrogen or estrogen receptor modulators. This study was approved by the Institutional Review Board of Hospital Research Ethics. All the patients were fully acquainted with their treatment and consented to participate in the clinical trial.
Intervention: Ribavirin
Trial phase: Not Applicable
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Study subjects will self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day). All patients will complete pill diaries to document administration of study drug. Cycle length is 28 days with continuous dosing. Clinic visits for safety assessments and routine laboratory studies will occur weekly in Cycle 1, in weeks 1 and 3 of Cycle 2, and on Week 1 of subsequent cycles. Cross sectional imaging (CT or MRI) is obtained at baseline and q2 cycles and at End-of Treatment (EOT). Response assessments will follow RECIST 1.1 criteria.

Ribavirin: self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
Eligibility criteria:
Inclusion Criteria:

Recurrent and/or metastatic HPV-related carcinoma of the cervix, anus, vagina, vulva, penis, or oropharynx. The cancer diagnosis must be confirmed by slide review in the MSKCC Department of Pathology. HPV positive status must be demonstrated by HPV in situ-hybridization (ISH) and/or by p16 immunohistochemistry (IHC).

Note: For cervix squamous cancer, HPV ISH test or p16 IHC test is not required, because all cervix squamous cancers are presumed to be HPV-associated.

Adults (≥ 18 years of age)
ECOG performance status of 1 or better
Measurable disease according to RECIST 1.1 criteria
Availability of archived tumor tissue for correlative studies (5 unstained slides)
Adequate organ function, as follows:
Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 160 X 109/L, hemoglobin ≥ 10 g/dL
Hepatic: total bilirubin within ULN (upper limit of normal); alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 X ULN
Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine > 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 55 mL/min based on the standard Cockroft and Gault formula.
Ability to swallow oral medication.
Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
At least one prior systemic therapy regimen for R/M HPV-related carcinoma

Exclusion Criteria:

History of hemolytic anemia or thalassemia
Current treatment or known prior treatment with ribavirin
Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
Current therapeutic anticoagulation with Coumadin (warfarin)
Known brain metastases
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: One time intra-operative IV acetaminophen administration

Acetaminophen
Eligibility criteria:
Inclusion Criteria:

carpal tunnel release surgery candidates,
distal radius fracture surgery candidates

Exclusion Criteria:

under 18 years of age,
pregnant women,
prisoners
Intervention: Perflutren
Trial phase: Not Applicable
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.
Eligibility criteria:
Inclusion Criteria:

18 years or older.
Ipsilateral biopsy-proven invasive breast cancer <5 cm in maximal dimension by Ultrasound or Mammography.
No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign subsequent FNA biopsy.

Exclusion Criteria:

Pregnant or nursing women
Prior SLN dissection
Neoadjuvant chemotherapy.
Prior axillary lymph node surgery.
Prior history of ipsilateral breast cancer.
Known or suspected: Cardiac shunts
Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin
Known or suspected: hypersensitivity to a prior OPTISON administration