anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Gadoteric acid
Trial phase: Phase 4
ATC code: V08CA02
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(CC(=O)O)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: All patients who received gadoterate meglumine.
Eligibility criteria:
Male and female adult patients (age ≥ 20 years old)
Patients diagnosed with unresectable HCC [Child Pugh class A and major vascular invasion, extrahapatic metastasis, or progression after transarterial chemoembolization more than 2 times]
Presence of mRECIST target lesion within liver [lesion which can be classified as a RECIST measurable lesion (can be measured ≥ 1 cm in at least one dimension), lesion suitable for repeated measure, lesion showing intraluminal arterial enhancement on contrast-enhanced CT or MRI]
Patients planned to be treated with sorafenib
Patient with liver CT performed or planned to be performed within 4 weeks before initiation of sorafenib treatment
Patient with a life expectancy of 12 weeks or more
No previous treatment with sorafenib
Female patients who are surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or who have a documented negative urine hCG test at screening
Intervention: N-(3-((4aS,7aS)-2-amino-4a,5,7,7a-tetrahydro-4H-furo[3,4-d][1,3]thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide
Trial phase: Phase 1
SMILES: NC1=NC2(c3cc(NC(=O)c4ccc(F)cn4)ccc3F)COCC2CS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721.
Eligibility criteria:
Inclusion Criteria:

Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square meter (kg/m^2), inclusive, at screening. There are no restrictions on BMI in participants diagnosed with Alzheimer's disease.
Healthy participants should not be taking any concomitant medications. For participants with Alzheimer's disease, concomitant medications will be determined by the investigator in consultation with the Lilly clinical pharmacologist on an individual basis.

Cohort A:

Participants are defined as otherwise healthy males or females as determined by medical history and physical examination, and a diagnosis of Alzheimer's disease and must be at least 45 years of age.
Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, as determined by a clinician approved by the sponsor or designee.
Mini Mental State Examination (MMSE) score of 16 through 28 at screening.
Modified Hachinski Ischemia Scale (MHIS) score of <4.
Capable of understanding and signing their own informed consent, in the opinion of the investigator, or if the participant has a Legally Authorized Representative (LAR), then the LAR must be capable of understanding and signing the assent form, and the participant may or may not sign the informed consent, as to be determined by the investigator.
If receiving concurrent treatment with an acetylcholinesterase inhibitor (AChEI) and/or memantine, the participant has been on a stable dose for at least 4 weeks before Day 1. Dosing must remain stable throughout the study. Note: If a participant has recently stopped ACHEIs and/or memantine, he or she must have discontinued treatment for at least 4 weeks before Day 1.

Exclusion Criteria:

Have an abnormality in the 12-lead electrocardiogram (ECG).
Have abnormal blood pressure.
Have abnormal thyroid function as reflected by thyroid stimulating hormone (TSH) values outside of the normal range.
Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
Show evidence of hepatitis C and/or positive hepatitis C antibody.
Have had multiple episodes of head trauma, or have a history within the last 5 years of a serious infectious disease affecting the brain.
Have chronic hepatic disease.
Have evidence or history of significant active bleeding or a coagulation disorder.
Cohort A: have any neurological disorders other than Alzheimer's disease.
For healthy participants (Cohorts B and C) only: Use or intend to use over the- counter or prescription medication, including herbal medications within 14 days prior to dosing or during the study.
Intervention: N-(3-((4aS,7aS)-2-amino-4a,5,7,7a-tetrahydro-4H-furo[3,4-d][1,3]thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide
Trial phase: Phase 1
SMILES: NC1=NC2(c3cc(NC(=O)c4ccc(F)cn4)ccc3F)COCC2CS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721.
Eligibility criteria:
Inclusion Criteria:

Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square meter (kg/m^2), inclusive, at screening. There are no restrictions on BMI in participants diagnosed with Alzheimer's disease.
Healthy participants should not be taking any concomitant medications. For participants with Alzheimer's disease, concomitant medications will be determined by the investigator in consultation with the Lilly clinical pharmacologist on an individual basis.

Cohort A:

Participants are defined as otherwise healthy males or females as determined by medical history and physical examination, and a diagnosis of Alzheimer's disease and must be at least 45 years of age.
Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, as determined by a clinician approved by the sponsor or designee.
Mini Mental State Examination (MMSE) score of 16 through 28 at screening.
Modified Hachinski Ischemia Scale (MHIS) score of <4.
Capable of understanding and signing their own informed consent, in the opinion of the investigator, or if the participant has a Legally Authorized Representative (LAR), then the LAR must be capable of understanding and signing the assent form, and the participant may or may not sign the informed consent, as to be determined by the investigator.
If receiving concurrent treatment with an acetylcholinesterase inhibitor (AChEI) and/or memantine, the participant has been on a stable dose for at least 4 weeks before Day 1. Dosing must remain stable throughout the study. Note: If a participant has recently stopped ACHEIs and/or memantine, he or she must have discontinued treatment for at least 4 weeks before Day 1.

Exclusion Criteria:

Have an abnormality in the 12-lead electrocardiogram (ECG).
Have abnormal blood pressure.
Have abnormal thyroid function as reflected by thyroid stimulating hormone (TSH) values outside of the normal range.
Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
Show evidence of hepatitis C and/or positive hepatitis C antibody.
Have had multiple episodes of head trauma, or have a history within the last 5 years of a serious infectious disease affecting the brain.
Have chronic hepatic disease.
Have evidence or history of significant active bleeding or a coagulation disorder.
Cohort A: have any neurological disorders other than Alzheimer's disease.
For healthy participants (Cohorts B and C) only: Use or intend to use over the- counter or prescription medication, including herbal medications within 14 days prior to dosing or during the study.
Intervention: N-(3-((4aS,7aS)-2-amino-4a,5,7,7a-tetrahydro-4H-furo[3,4-d][1,3]thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide
Trial phase: Phase 1
SMILES: NC1=NC2(c3cc(NC(=O)c4ccc(F)cn4)ccc3F)COCC2CS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721.
Eligibility criteria:
Inclusion Criteria:

Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square meter (kg/m^2), inclusive, at screening. There are no restrictions on BMI in participants diagnosed with Alzheimer's disease.
Healthy participants should not be taking any concomitant medications. For participants with Alzheimer's disease, concomitant medications will be determined by the investigator in consultation with the Lilly clinical pharmacologist on an individual basis.

Cohort A:

Participants are defined as otherwise healthy males or females as determined by medical history and physical examination, and a diagnosis of Alzheimer's disease and must be at least 45 years of age.
Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, as determined by a clinician approved by the sponsor or designee.
Mini Mental State Examination (MMSE) score of 16 through 28 at screening.
Modified Hachinski Ischemia Scale (MHIS) score of <4.
Capable of understanding and signing their own informed consent, in the opinion of the investigator, or if the participant has a Legally Authorized Representative (LAR), then the LAR must be capable of understanding and signing the assent form, and the participant may or may not sign the informed consent, as to be determined by the investigator.
If receiving concurrent treatment with an acetylcholinesterase inhibitor (AChEI) and/or memantine, the participant has been on a stable dose for at least 4 weeks before Day 1. Dosing must remain stable throughout the study. Note: If a participant has recently stopped ACHEIs and/or memantine, he or she must have discontinued treatment for at least 4 weeks before Day 1.

Exclusion Criteria:

Have an abnormality in the 12-lead electrocardiogram (ECG).
Have abnormal blood pressure.
Have abnormal thyroid function as reflected by thyroid stimulating hormone (TSH) values outside of the normal range.
Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
Show evidence of hepatitis C and/or positive hepatitis C antibody.
Have had multiple episodes of head trauma, or have a history within the last 5 years of a serious infectious disease affecting the brain.
Have chronic hepatic disease.
Have evidence or history of significant active bleeding or a coagulation disorder.
Cohort A: have any neurological disorders other than Alzheimer's disease.
For healthy participants (Cohorts B and C) only: Use or intend to use over the- counter or prescription medication, including herbal medications within 14 days prior to dosing or during the study.
Intervention: Trimethoprim
Trial phase: Not Applicable
ATC code: J01EA01 | J01EE01 | J01EE02 | J01EE03 | J01EE04 | J01EE05 | J01EE07 | J04AM08
SMILES: COc1cc(Cc2cnc(N)nc2N)cc(OC)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
Eligibility criteria:
Inclusion Criteria:

Signed written informed consent

The signed informed consent
The benefits/risks of the induction chemotherapy regimen will be reviewed, and a second consent may be necessary if the regimen will be administered according to a separate protocol
AML (acute promyelocytic leukemia [APL] excepted) or high-risk MDS (10-19% blasts in marrow by morphology or flow cytometry or blood)
Treatment-related mortality (TRM) score < 9.21 corresponding to a TRM rate of 3% when chemotherapy of similar intensity as proposed here is administered to inpatients
Blast count =< 10,000
Fibrinogen > 200
Afebrile with clear chest imaging and no signs of active viral, bacterial, fungal infection unless determined to be, at the discretion of the investigator, not clinically significant in the context of this study
Adequate cardiac function as demonstrated by left ventricular ejection fraction (LVEF) of 45% or greater, by multiple gated acquisition (MUGA) or echocardiogram; no ongoing cardiac issues such as uncontrolled arrhythmias or unstable angina or congestive heart failure
Patient must have an outpatient caregiver available
Patient must live within 30 minutes of the treating physician's office during outpatient treatment
Patient must be willing to return to the treating physician's office for outpatient follow-up once outpatient treatment is completed

Logistical requirements:

Space available in infusion room
Outpatient infusion pump available if continuous infusion required
Case discussed with infusion room nursing staff
Intervention: Losartan Potassium
Trial phase: Phase 2
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nnn[n-]2)cc1.[K+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants with eosinophilic esophagitis receive Losartan daily

Losartan Potassium: The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of eosinophilic esophagitis.
Have been on a high dose proton pump inhibitor for at least 8 weeks prior to a diagnostic endoscopy of eosinophilic esophagitis without histologic resolution.
Agree to maintain the same diet throughout the duration of the study.

If participant is female: meet one of the following criteria:

Is of non-childbearing potential (pre-menarchal or surgically sterile with documentation)
Is of childbearing potential with a negative urine pregnancy test at screening.

Exclusion Criteria:

Past or planned cardiac surgeries.
Had an aortic root Z-score greater than 3 on a previous echocardiogram.
Have intolerance to the study agent such as angioedema, IgE-mediated allergy.
Have renal dysfunction with creatinine in excess of the upper normal limit for age.
Have another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome, Churg Strauss vasculitis, eosinophilic granuloma, or a parasitic infection).
Diagnosed with hepatic insufficiency.
History of abnormal gastric or duodenal biopsy or documented gastrointestinal (GI) disorders (e.g., Celiac Disease, Crohn's disease or helicobacter pylori infection.), not including chronic gastritis, chronic duodenitis, mucosal eosinophilia or other eosinophilic gastrointestinal disorders.
Used anti-immunoglobulin E [IgE] mAb, anti-tumor necrosis factor [TNF] mAb, anti-IL-5 agents, or anti-IL-13 within the last six months.
Used methotrexate, cyclosporine, interferon-α, or other systemic immunosuppressive or immunomodulating agents within the last three months.
Have a history of a stricture during an endoscopy procedure that prevents passage of the endoscope.
Taking or plan to take an angiotensin II receptor blocker (ARB) therapy, angiotensin-converting enzyme inhibitor (ACEI), beta blocker therapy (BB), or calcium channel blocker at the screening visit or at any time during the study, or have you been taking any of these medications for the last three months.
If the participant is female: pregnant or nursing.
Taking any investigative drug or device study within the last 30 days.
Had participated in any investigative biologics study within the last three months prior to the study entry.
Taking or plan to take hydrochlorothiazide, warfarin, cimetidine, phenobarbital, rifampin, or fluconazole.
If the participant is female: using a medically accepted effective method of birth control.
Will be able to complete all study procedures including endoscopy.
Taking or plan to take potassium supplements or salt substitutes containing potassium.
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: 25
Group description: Participants receiving a bolus of anti-[18F]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence.
Eligibility criteria:
Inclusion Criteria:

Patients must be 18 years of age or older.
Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive non-prostatectomy therapy for localized disease.
In the case of cryotherapy, external beam radiation, or High-Intensity Focused Ultrasound (HiFU) the procedure will have occurred at least one year in the past. In the case of brachytherapy, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump."
Patient will have suspicion of recurrent prostate carcinoma as defined by: the Radiation Therapy Oncology Group (RTOG) - American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix criteria of nadir PSA +2, and absolute PSA ≥ 4.0 ng/ml.with any doubling time (DT) or with PSA 2.0-3.99 ng/ml with DT ≤10 months
Ability to lie still for PET scanning
Patients must be able to provide written informed consent.

Exclusion Criteria:

Age less than 18.
Greater than T3 disease in past and/or treated with prostatectomy.
Less than 1 year since cryotherapy,external beam radiation therapy, or HiFU or 2 years since brachytherapy..
Does not meet above criteria of suspicious PSA elevation
Inability to lie still for PET scanning
Cannot provide written informed consent.
Bone scan findings characteristic for metastatic prostate carcinoma

Less than 1 month since any prior prostate biopsy (to decrease false positive uptake from inflammation).

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Intervention: Bromfenac
Trial phase: Phase 3
ATC code: S01BC11
SMILES: Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 170
Group description: 0.075% bromfenac in DuraSite dosed BID
Eligibility criteria:
Inclusion Criteria:

Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
Signature of the subject on the Informed Consent Form
Willing to avoid disallowed medications for the duration of the study
Willing and able to follow all instructions and attend all study visits
Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs )
Additional inclusion criteria also apply

Exclusion Criteria:

Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications
Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
Currently suffer from alcohol and/or drug abuse
Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Additional inclusion criteria also apply
Intervention: Progesterone
Trial phase: Phase 4
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 25
Group description: 400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five

Progesterone
Eligibility criteria:
Inclusion Criteria:

Diagnosed with a concussion
A 18 years or older
Diagnosis < 24 hours from injury
Consent obtained prior to concussion

Exclusion Criteria:

Pregnant
Active breast or reproductive organ cancers
Allergy to peanuts
History of or current thrombophlebitis or venous thromboembolic disorder
Females taking birth control
Known hypersensitivity or prior adverse reaction to progesterone
Known liver disease
Intervention: Nicardipine
Trial phase: Phase 2
ATC code: C08CA04
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OCCN(C)Cc2ccccc2)C1c1cccc([N+](=O)[O-])c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.

Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
Eligibility criteria:
Inclusion Criteria:

Male or female 18 years of age and older
Subarachnoid hemorrhage documented on head CT
Fisher Grade 3 or 4
Hunt Hess Grade 1-5
Cerebral aneurysm as definitive source of subarachnoid hemorrhage
Cerebral aneurysm must be treated via open or endovascular techniques
Presence of external ventricular drain
Written informed consent obtained from subject or subject's legally authorized representative

Exclusion Criteria:

Absence or inability to have an external ventricular drain (coagulopathy)
Non-aneurysmal subarachnoid hemorrhage (perimesencephalic)
Untreated cerebral aneurysm
Inability to be randomized prior to post-hemorrhage day 4
Elevated intra-cranial pressures that would preclude external ventricular drain clamping for 30-60 minutes
Inability to administer study medication (severe intra-ventricular hemorrhage, occluded external ventricular drain)
Inability to obtain angiography (coagulopathy, renal failure)
Pregnant
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
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: 1
Group description: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.

Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
Eligibility criteria:
Inclusion Criteria:

Male or female 18 years of age and older
Subarachnoid hemorrhage documented on head CT
Fisher Grade 3 or 4
Hunt Hess Grade 1-5
Cerebral aneurysm as definitive source of subarachnoid hemorrhage
Cerebral aneurysm must be treated via open or endovascular techniques
Presence of external ventricular drain
Written informed consent obtained from subject or subject's legally authorized representative

Exclusion Criteria:

Absence or inability to have an external ventricular drain (coagulopathy)
Non-aneurysmal subarachnoid hemorrhage (perimesencephalic)
Untreated cerebral aneurysm
Inability to be randomized prior to post-hemorrhage day 4
Elevated intra-cranial pressures that would preclude external ventricular drain clamping for 30-60 minutes
Inability to administer study medication (severe intra-ventricular hemorrhage, occluded external ventricular drain)
Inability to obtain angiography (coagulopathy, renal failure)
Pregnant
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data