anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Norgestrel
Trial phase: Phase 4
ATC code: G03AA06 | G03FA10 | G03FB01
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 47
Group description: African-American women

Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) was taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.
Eligibility criteria:
Inclusion Criteria:

Premenopausal, regular-cycling women 18-35 years
Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
non-smoker.

Exclusion Criteria:

Diabetes
Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, and malignant disease
Contraindications to oral contraceptive use (history of blood clots, heart attacks or stroke, vascular disease, coagulopathy, prolonged immobilization, breast cancer, migraine head-aches, major surgery within past 6 months, blood pressure >160/100 mmHg, pregnancy or lactation)
Use of hormonal contraceptives, glucose-lowering medications, anti-hyperlipidemic, anti-hypertensive or other vasoactive drugs within previous 3 months
Intervention: Norgestrel
Trial phase: Phase 4
ATC code: G03AA06 | G03FA10 | G03FB01
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 47
Group description: Caucasian women

Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) was taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.
Eligibility criteria:
Inclusion Criteria:

Premenopausal, regular-cycling women 18-35 years
Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
non-smoker.

Exclusion Criteria:

Diabetes
Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, and malignant disease
Contraindications to oral contraceptive use (history of blood clots, heart attacks or stroke, vascular disease, coagulopathy, prolonged immobilization, breast cancer, migraine head-aches, major surgery within past 6 months, blood pressure >160/100 mmHg, pregnancy or lactation)
Use of hormonal contraceptives, glucose-lowering medications, anti-hyperlipidemic, anti-hypertensive or other vasoactive drugs within previous 3 months
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 3
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: Child
Healthy volunteers: No
Participants at risk: 54
Group description: Loteprednol etabonate 0.5%

Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Eligibility criteria:
Inclusion Criteria:

Subject is a candidate for routine, uncomplicated surgery for childhood cataract

Exclusion Criteria:

Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure (IOP) lowering therapy in either eye or systemically.
Subjects with a history of steroid-induced IOP elevation in either eye.
Subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.
Intervention: Protactinium
Trial phase: Phase 3
SMILES: [Pa]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 53
Group description: Prednisolone acetate 1.0%

Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
Eligibility criteria:
Inclusion Criteria:

Subject is a candidate for routine, uncomplicated surgery for childhood cataract

Exclusion Criteria:

Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure (IOP) lowering therapy in either eye or systemically.
Subjects with a history of steroid-induced IOP elevation in either eye.
Subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.
Intervention: Cholecalciferol
Trial phase: Not Applicable
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 4,000 IU oral vitamin D3

Vitamin D3: 4,000 IU oral vitamin D3
Eligibility criteria:
Inclusion Criteria:

Age 18 - 75
Female
White race/ethnicity
With history of non-melanoma skin cancer
Has 12-16 moles upon skin examination
Consents to 6-12 moles biopsies over 2-3 clinic visits (2-4 months)
Consents to ingesting oral vitamin D3 or placebo daily for 2-4 months
Consents to abstaining from other multivitamins during study
Consents to research use of their tissue and blood samples
Agrees to apply a sunscreen of SPF 45 during study -

Exclusion Criteria:

History or current evidence of hyperparathyroidism, hypercalcemia, renal calculi, or other renal disease.
History or current evidence of malabsorptive illnesses, such as IBD, or liver disease that would impair uptake or metabolism of vitamin D.
History or current evidence of hyperthyroidism that would increase metabolism of vitamin D.
History or current evidence of immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs.
Currently taking medications that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists).
Currently taking medications that predispose to hypercalcemia (digoxin, lithium, thiazide diuretics) or other electrolyte disturbances (aluminum hydroxide)
Pregnancy
Intervention: Besifloxacin Hydrochloride
Trial phase: Phase 4
SMILES: Cl.NC1CCCCN(c2c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c2Cl)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Use of topical besifloxocin to treat acute blepharitis
Eligibility criteria:
Inclusion Criteria:Acute blepharitis, age 18-100, Signs and symptoms of blepharitis -

Exclusion Criteria: women of child bearing potential, eye surgery within three months of study, contact lens wear, use of topical or antibacterial agents in past two weeks, use of topical or oral steroids in past two weeks unless stable dosage

-
Intervention: Erythromycin
Trial phase: Phase 4
ATC code: D10AF02 | D10AF52 | J01FA01 | S01AA17
SMILES: CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(O)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Topical Erythromycin ointment for treatment of acute blepharitis
Eligibility criteria:
Inclusion Criteria:Acute blepharitis, age 18-100, Signs and symptoms of blepharitis -

Exclusion Criteria: women of child bearing potential, eye surgery within three months of study, contact lens wear, use of topical or antibacterial agents in past two weeks, use of topical or oral steroids in past two weeks unless stable dosage

-
Intervention: Lovastatin
Trial phase: Not Applicable
ATC code: C10AA02 | C10BA01
SMILES: [H][C@@]12C(=C[C@H](C)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
Eligibility criteria:
Inclusion Criteria:

Adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs, stage T1c or higher.
Tumor Gleason sum of 7 (4+3 and 3+4 allowed) in at least one core, after central review of prostate biopsy at Johns Hopkins. However, in accordance with standard clinical practices, adenocarcinoma must be present in at least two discrete biopsy sections ( may vary in Gleason score).
Age ≥18 years of age.
Radical prostatectomy scheduled at Johns Hopkins.
Willingness to sign and ability to understand informed consent.
No history of treatment with any statin-class medication within 6 months of entry into the trial.
ECOG (Eastern Cooperative Oncology Group) performance status 0-1.
Adequate bone marrow, hepatic, and renal function as determined by:

WBC (white blood cells) >3,500 cells/mm3 ANC (absolute neutrophil count) >1,500 cells/mm3 Hemoglobin >9 g/dl Platelet count >100,000 cells/mm3 Serum creatinine < 2.6 mg/dl Serum bilirubin <2 mg/dl ALT (alanine aminotransferase), AST (aspartate aminotransferase), and Alkaline Phosphatase <2 times the upper limit of normal Triglycerides and total cholesterol <3 times the upper limit of normal

Exclusion Criteria:

Patients with evidence of metastatic prostate cancer, including bone, visceral, brain, and lymph node metastases.
Other histologic prostate cancers, including ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors.
Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy including active liver disease, unexplained persistent elevation of serum transaminases, or medications that interfere with the metabolism of lovastatin, or gastrointestinal disease that would limit the ability to swallow or take oral medications or absorb them.
Concurrent malignancy other than prostate cancer.
Inability to provide informed consent.
Concomitant use of azole antifungals, cyclosporine, clarithromycin, erythromycin, fibric acid derivatives, lopinavir/ritonavir, niacin, ritonavir/saquinavir
Prior chemotherapy, radiation therapy, biologic therapy, or immunotherapy for prostate cancer.
Poor performance status (ECOG >1).
Prostatectomy at other hospital other than Johns Hopkins.
Prior history of allergy or severe reaction to statins or statin derivatives.
Intervention: miniICE
Trial phase: Not Applicable
SMILES: COc1cc(C2c3cc4c(cc3C(OC3OC5COC(C)OC5C(O)C3O)C3COC(=O)C23)OCO4)cc(OC)c1O.O=C(O)C1(C(=O)O)CCC1.O=P1(NCCCl)OCCCN1CCCl.[CH3-].[CH3-].[Pt+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: All subjects are treated with neural progenitor cell sparing radiation to 60 Gy in 2 Gy per day, 30 fractions Concurrent and adjuvant temozolomide chemotherapy

Radiation: Patients will be treated to a total dose of 60 Gy with a once daily fractionation schedule of 2 Gy per fraction, administered five days per week. All patients will undergo CT simulation with intravenous contrast. In addition they will undergo MRI simulation with both T1 with gadolinium as well as FLAIR sequences. They will be treated in a supine position using an aquaplast mask system for immobilization. CT image data will be reconstructed in approximately 3 mm slice thickness and manually coregistered with T1 post-gadolinium and FLAIR sequence MRI.

Chemotherapy: Temozolomide
Eligibility criteria:
Inclusion Criteria:

Patient must have newly diagnosed Glioblastoma Multiforme (GBM).
Patient must have undergone surgical resection and must begin radiation within 12 weeks of this procedure.
Patients must not have received previous irradiation to the brain.
Patient must be at least 18 years of age
Karnofsky performance status of greater than 60%
Patient must receive temozolomide concurrent with and following radiation.
If a woman is of child-bearing potential, a negative urine or serum pregnancy test must be demonstrated prior to treatment. Women of childbearing potential and men must agree to use adequate contraception for the duration of study participation and for up to 12 weeks following the study. Should a women become pregnant or suspect she is pregnant while participating in this study she should inform her treating physician immediately.
Patient must have the ability to understand and the willingness to sign a written informed consent document.
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

Patients may not be receiving any other agents to treat their GBM
No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient has been disease free for at least 2 years.
Patients with any other uncontrolled illness will be excluded.
Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. This applies to any woman who has not experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months). Male subjects must also agree to use effective contraception for the same period as above.
Intervention: Olopatadine
Trial phase: Phase 3
ATC code: R01AC08 | S01GX09
SMILES: CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 397
Group description: AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
Eligibility criteria:
Inclusion Criteria:

Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1.
History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
Positive bilateral CAC response at Visit 1 and Visit 2.
Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known history or presence of persistent dry eye syndrome, or currently requiring frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1.
Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study.
Any contraindications or hypersensitivities to the use of the study medication or their components.
Other protocol-defined exclusion criteria may apply.
Intervention: Olopatadine Hydrochloride
Trial phase: Phase 3
SMILES: CN(C)CCC=C1c2ccccc2COc2ccc(CC(=O)O)cc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 397
Group description: Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
Eligibility criteria:
Inclusion Criteria:

Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1.
History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
Positive bilateral CAC response at Visit 1 and Visit 2.
Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known history or presence of persistent dry eye syndrome, or currently requiring frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1.
Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study.
Any contraindications or hypersensitivities to the use of the study medication or their components.
Other protocol-defined exclusion criteria may apply.
Intervention: Rasagiline
Trial phase: Phase 3
ATC code: N04BD02
SMILES: C#CCN[C@@H]1CCc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 163
Group description: 1 mg daily; tablet; orally; 16 weeks
Eligibility criteria:
Inclusion Criteria:

Patients with idiopathic PD.
Patients with motor fluctuations averaging at least 1 hour daily in the "OFF" state during the waking hours.
Patients with a Modified Hoehn and Yahr stage ≤3 in the "ON" state.
Patients taking optimised levodopa or dopa decarboxylase inhibitor (DDI) therapy; they must be stable for at least 14 days prior to baseline.
Patients receiving at least 3 daily doses of levodopa and not more than 8 daily doses of levodopa.
Patients who have demonstrated the ability to keep accurate "24-hour" diaries prior to randomisation.

Exclusion Criteria:

Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.
Patients with a clinically significant or unstable vascular disease.
Patients who have undergone a neurosurgical intervention of PD.
Patients with severe disabling dyskinesias.
Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study.
Patients with a Mini Mental State Examination (MMSE) score ≤24.
Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion.

Other inclusion and exclusion criteria may apply.
Intervention: Sugammadex
Trial phase: Phase 3
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) Class 1 or 2 or 3

Scheduled to undergo an elective abdominal surgical procedure under general anesthesia; and:

expected to undergo neuromuscular relaxation with rocuronium for

endotracheal intubation; and

expected to require at least one maintenance dose of rocuronium; and
expected to require active reversal of neuromuscular blockade; and
expected to require clinical or subjective neuromuscular monitoring only; and

expected to recover in the PACU

Arm that is accessible for measuring the TOF ratio in the PACU
Sexually active female patient of child-bearing potential must agree to use a

medically accepted method of contraception through seven days after receiving

protocol-specified medication.

Exclusion Criteria:

Anatomical malformations that may lead to difficult intubation
Neuromuscular disorder(s) that may affect neuromuscular blockade and/or trial assessments
Dialysis-dependent or has or is suspected of having severe renal insufficiency
Significant hepatic dysfunction
Family history of malignant hyperthermia
Cardiac pacemaker
Allergy to study treatments or its/their excipients, to opioids / opiates, sugammadex, muscle relaxants or their excipients, or other medication(s) used during general anesthesia
Toremifene before or within 24 hours of study drug administration
Scheduled for an overnight stay (or >12 hours) in PACU
Expected transfer to an Intensive Care Unit after surgery
Pregnant, intention to become pregnant between randomization and the Day 30 pregnancy follow-up visit
Breast-feeding.
Investigational drug(s) within 30 days of randomization on this study
Participation in any other clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial
Participant or family member is among the personnel of the investigational or Sponsor staff directly involved with this trial
Intervention: Ropivacaine
Trial phase: Phase 4
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
Eligibility criteria:
Inclusion Criteria:

Consent to undergo robotic assisted gynecologic or urologic surgery
Between the ages of 18 and 75
Able to consent, fill out study documents, and complete all study procedures and follow-up visits

Exclusion Criteria:

Patients with an allergy to local anesthetics
Patients with severe underlying cardiovascular, renal or hepatic disease
Pregnant patients