anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hydroxychloroquine
Trial phase: Phase 3
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg.

Hydroxychloroquine
Eligibility criteria:
Inclusion Criteria:

Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as:

aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or
aβ2GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or
Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations

Selected Exclusion Criteria:

History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis
History of Transient Ischemic Attack Confirmed by a Neurologist
SLE Diagnosis based on the ACR Classification Criteria > 4/11
Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria
Current Hydroxychloroquine or another antimalarial treatment (-3 months)
Current warfarin treatment (-3 months)
Current heparin therapy( -3 months)
Current pregnancy
History of Hydroxychloroquine eye toxicity
History of Hydroxychloroquine allergy
Known glucose-6-phosphate dehydrogenase deficiency
Intervention: Prochlorperazine
Trial phase: Phase 2
ATC code: N05AB04
SMILES: CN1CCN(CCCN2c3ccccc3Sc3ccc(Cl)cc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: intravenous Prochlorperazine

Standard Care: 10 mg Intravenous injection of Prochlorperazine
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years old
Diagnosis of benign or primary headache

Exclusion Criteria:

Hypersensitivity or allergy to bupivacaine (amide anesthetics) or prochlorperazine or other drugs in the same class, dopaminergic blockers.
Overlying signs of infection at site of injection (Erythema, purulence, open skin)
Neck pathology ( History of surgery to the cervical spine, History of surgical hardware in place, Documented disc abnormality, History of vertebral artery or carotid artery dissection, Torticollis)
Intracranial abnormality/pathology (Tumor, Hemorrhage, Concussion or post concussive syndrome)
History of increased intracranial pressure (ICP)
A known history of extrapyramidal symptoms, dystonia, parkinsonism, tardive dyskinesia or neuroleptic malignant syndrome
Known pregnancy
Narcotic seeking patients as determined by the treating physician with optional assistance from medical record review and North Carolina Drug Database
Intervention: PF-04634817
Trial phase: Phase 1
SMILES: CO[C@@H]1COCC[C@@H]1N[C@@H]1CC[C@@](C(=O)N2C[C@@H]3C[C@H]2CN3c2cc(C(F)(F)F)ncn2)(C(C)C)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
Eligibility criteria:
Inclusion Criteria:

Male or female (non child bearing potential aged 18-75 years
Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)

Exclusion Criteria:

Subjects with acute renal failure
Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
Abnormal ECG at screening
Intervention: PF-04634817
Trial phase: Phase 1
SMILES: CO[C@@H]1COCC[C@@H]1N[C@@H]1CC[C@@](C(=O)N2C[C@@H]3C[C@H]2CN3c2cc(C(F)(F)F)ncn2)(C(C)C)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
Eligibility criteria:
Inclusion Criteria:

Male or female (non child bearing potential aged 18-75 years
Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)

Exclusion Criteria:

Subjects with acute renal failure
Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
Abnormal ECG at screening
Intervention: Laninamivir octanoate
Trial phase: Phase 2
SMILES: CCCCCCCC(=O)OCC(O)C(OC)C1OC(C(=O)O)=CC(N=C(N)N)C1NC(C)=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 211
Group description: 80 mg Laninamivir Octanoate

80 mg Laninamivir Octanoate
Eligibility criteria:
Main Inclusion Criteria:

Provide written informed consent
Males or females aged 18-64 years, inclusive

Symptomatic presumptive influenza A or B infection defined as the presence of:

a fever of ≥38.0ºC (≥100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit AND
≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND
≥1 moderate respiratory symptom (cough, sore throat and nasal congestion)

Onset of illness no more than 40 hours prior to randomization. Onset of illness is defined as the time, the first of any one of the following, occurred:

time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR
time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR
time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue)

Main Exclusion Criteria:

Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening
Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks.
History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma
History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months
Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants
Presence of clinically significant signs of acute respiratory distress during screening
Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study.
Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min
History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results
Intervention: 1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene
Trial phase: Phase 1
SMILES: COc1ccc(Br)c(F)c1[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Eligibility criteria:
Key Inclusion Criteria:

Part A: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of standard therapy or for which no standard therapy is available

Part B: Pancreatic Adenocarcinoma

Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma

Part B: NSCLC

Stage IIIB with malignant pleural effusion/pleural seeding or stage IV histologically confirmed NSCLC
Absence of known epidermal growth factor receptor (EGFR) mutation
Absence of known translocation or inversion events involving the ALK gene locus (resulting in EML4-ALK fusion)

Part B: Esophagogastric Adenocarcinoma:

Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapsed gastric adenocarcinoma
Human epidermal growth factor receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion)

Part B: First-Line Colorectal Cancer

Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
Radiographically measureable disease
No prior cytotoxic chemotherapy to treat their metastatic disease

Part B: Second-Line Colorectal Cancer

Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
Radiographically measureable disease
Received first-line combination therapy containing oxaliplatin and fluoropyrimidine with or without bevacizumab for metastatic disease with documented evidence of disease progression during or after treatment completion

Part B: Breast Cancer

Histologically or cytologically confirmed metastatic breast cancer
Radiographically measureable disease
Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed
Treatment with weekly single-agent paclitaxel is appropriate in the opinion of the treating physician
HER-2 negative tumor (primary tumor or metastatic lesion)
Adequate organ function

Key Exclusion Criteria:

Pregnant or lactating
Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids
Myocardial infarction, symptomatic congestive heart failure, unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months
Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Evacetrapib
Trial phase: Phase 1
SMILES: Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: Participants received 130-mg oral tablet fo evacetrapib QD in a fasted state for 10 days.
Eligibility criteria:
Inclusion Criteria:

Healthy participants as determined by medical history and physical examination
Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
Are able to eat a high fat breakfast and abide by the food restrictions throughout the study

Exclusion Criteria:

Have known allergies to evacetrapib, related compounds or any components of the formulation
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes
Intervention: DCFBC F-18
Trial phase: Phase 1 | Phase 2
SMILES: O=C(O)CC[C@H](NC(=O)N[C@@H](CSCc1ccc([18F])cc1)C(=O)O)C(=O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: 18F-DCFBC
Eligibility criteria:
Inclusion Criteria:

Histological confirmation of prostate cancer
Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [18F]Sodium Fluoride PET, and/or [18F]FDG PET
Rising PSA on two observations taken at least 1 week apart
Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures

Exclusion Criteria:

Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
Serum creatinine > 3 times the upper limit of normal
Total bilirubin > 3 times the upper limit of normal
Liver Transaminases > 5times the upper limit of normal
Unable to lie flat during or tolerate PET/CT
Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Intervention: Misoprostol
Trial phase: Not Applicable
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 18 years (no upper age limit)
Gestational age between 16+0 and 20+6 weeks gestation on day of D&E with confirmation of gestational age by ultrasound
Desires D&E for termination of pregnancy or for fetal demise
Able to provide written informed consent
Able to comply with study procedures
English-speaking

Exclusion Criteria:

Known allergy or contraindication to misoprostol
Pregnancy with a multiple gestation
Known bleeding disorder or current anticoagulation therapy (within one month of procedure)
Active bleeding or hemodynamically unstable at enrollment
Signs of chorioamnionitis or clinical infection at enrollment
Signs of spontaneous labor or cervical insufficiency at enrollment
Intervention: PF-05175157
Trial phase: Phase 1
SMILES: Cc1nc2ccc(C(=O)N3CCC4(CC3)CC(=O)c3c(cnn3C(C)C)C4)cc2[nH]1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
Eligibility criteria:
Inclusion Criteria:

Healthy male and/or female subjects of non child bearing potential only, between the ages of 18 and 40 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight >50 kg (110 lbs).
Subjects with maximum effort studies (peak RER >1.05) and normal exercise capacity as defined by peak VO2 ≥80% and ≤120% of predicted and no evidence of inducible ischemia or significant arrhythmia at the time of peak aerobic capacity testing 3 (±1) days prior to initiation of the study.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day -3 (±1).
Dry eye symptoms
Intervention: Evacetrapib
Trial phase: Phase 1
SMILES: Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment.
Eligibility criteria:
Inclusion Criteria:

Female participants are not of child-bearing potential
Have a body mass index of 18 to 40 kilograms per square meter (kg/m^2)
Participants with normal renal function - healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function (assessed by estimated creatinine clearance [CLcr] greater than or equal to 90 milliliters per minute [mL/min] at screening)
Participants with severe renal impairment - estimated CLcr less than 30 mL/min at screening and are not undergoing hemodialysis

Exclusion Criteria:

Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Participants who are unwilling to comply with the dietary requirements/restrictions during the study
Hemoglobin less than 9 grams/deciliter (g/dL) or significant active hematological disease from causes other than underlying renal disease
Intervention: Sildenafil
Trial phase: Phase 2
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness

Sildenafil citrate: Single dose of 100mg Sildenafil citrate
Eligibility criteria:
Inclusion Criteria:

has been diagnosed with AMD (362.50-52) or healthy controls as detailed above
at least 65 years of age
capable and willing to provide consent

Exclusion Criteria:

History of previous photodynamic therapy (PDT), intravitreal corticosteroid injection, macular focal laser photocoagulation, panretinal photocoagulation, ocular ionizing irradiation, transpupillary thermotherapy, or any vitreoretinal surgeries
History of central serous chorioretinopathy, polypoidal choroidal vasculopathy, uveitis, or diabetic retinopathy
History of amblyopia, glaucoma, retinal detachment, retinal dystrophy, ocular trauma, ocular tumor, proliferative retinopathy, or epiretinal membrane with distortion of central macula
History of myopia of more than 6 diopters (D) spherical equivalent
History of uncontrolled diabetes or hypertension
Current use of oral phosphodiesterase type 5 inhibitors (including sildenafil, avanafil, lodenafil, mirodenafil, tadalafil, vardenafil, udenafil, zaprinast)
Current use of systemic corticosteroids
Any contraindication to sildenafil use, including history of cardiovascular disease or stroke, hepatic cirrhosis (Child-Pugh A and B), severe renal impairment (creatinine clearance <30mL/min), anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), disorders predisposing to priapism (e.g. sickle cell anemia, multiple myeloma, or leukemia), or current use of organic nitrates, alpha-blockers, or potent cytochrome P450 3A4 inhibitors
Intervention: Sildenafil
Trial phase: Phase 2
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness

Sildenafil citrate: Single dose of 100mg Sildenafil citrate
Eligibility criteria:
Inclusion Criteria:

has been diagnosed with AMD (362.50-52) or healthy controls as detailed above
at least 65 years of age
capable and willing to provide consent

Exclusion Criteria:

History of previous photodynamic therapy (PDT), intravitreal corticosteroid injection, macular focal laser photocoagulation, panretinal photocoagulation, ocular ionizing irradiation, transpupillary thermotherapy, or any vitreoretinal surgeries
History of central serous chorioretinopathy, polypoidal choroidal vasculopathy, uveitis, or diabetic retinopathy
History of amblyopia, glaucoma, retinal detachment, retinal dystrophy, ocular trauma, ocular tumor, proliferative retinopathy, or epiretinal membrane with distortion of central macula
History of myopia of more than 6 diopters (D) spherical equivalent
History of uncontrolled diabetes or hypertension
Current use of oral phosphodiesterase type 5 inhibitors (including sildenafil, avanafil, lodenafil, mirodenafil, tadalafil, vardenafil, udenafil, zaprinast)
Current use of systemic corticosteroids
Any contraindication to sildenafil use, including history of cardiovascular disease or stroke, hepatic cirrhosis (Child-Pugh A and B), severe renal impairment (creatinine clearance <30mL/min), anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), disorders predisposing to priapism (e.g. sickle cell anemia, multiple myeloma, or leukemia), or current use of organic nitrates, alpha-blockers, or potent cytochrome P450 3A4 inhibitors
Intervention: 1-Bromo-2-fluoro-4-methoxy-3-nitrobenzene
Trial phase: Phase 1
SMILES: COc1ccc(Br)c(F)c1[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Participants received a single IV infusion of andecaliximab 1.0 mg/kg on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Male or Female, 18 to 65 years of age
Negative pregnancy test at screening
Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] ≤ 2 times the upper limit of the normal range [ULN])
Serum creatinine ≤ 1.5 times the ULN
Hemoglobin ≥ 10 grams per deciliter (g/dL) (both males and females)
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 milli meters [mm]^3)
Platelets ≥ 100 x 10^9/L.

Key Exclusion Criteria:

Pregnant or lactating females
Exhibit severe UC/ clinically significant active infection
Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone
Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
Crohn's disease or indeterminate colitis
History of colectomy, partial colectomy, or dysplasia on biopsy
Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or Certolizumab within 8 weeks of randomization
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.