anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Methylprednisolone Sodium Succinate
Trial phase: Phase 1
SMILES: CC1CC2C(C(O)CC3(C)C2CCC3(O)C(=O)COC(=O)CCC(=O)[O-])C2(C)C=CC(=O)C=C12.[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Healthy volunteers received a single intravenous dose of 250 mg of methylprednisolone and blood was collected between one to two hours after the start of the infusion.
Eligibility criteria:
INCLUSION CRITERIA:

Age 18 to 64 years
Willingness to have samples stored for future research
Willingness to undergo genetic testing

EXCLUSION CRITERIA:

Body Mass Index less than 18 or greater than 35
Difficult peripheral venous access (as determined by study staff at screening)
History of severe allergic reaction to glucocorticoids
History of autoimmune or autoinflammatory disease
Active solid or hematologic malignancy
History of a skin condition (such as psoriasis, pemphigus, or atopic dermatitis) that could affect the results of the transcriptional analysis of the skin biopsy samples
Diabetes mellitus
Cancer chemotherapy within the past 5 years
Surgery within the past 8 weeks
History of recent (within the past 30 days) infection
A positive test for human immunodeficiency virus, or hepatitis A, B or C virus infection (viral markers hepatitis screen, which includes HBsAg, anti-HCV IgG, anti-HAV IgM).
A positive or indeterminate test for latent tuberculosis (interferon gamma release assay)
History of parasitic, amebic, fungal or mycobacterial infections, or other possible latent infections
Coagulation test (PT and PTT) results outside of normal range
History of a bleeding disorder
Use of a glucocorticoid (including topical or inhaled), a nonsteroidal anti-inflammatory drug (including aspirin), an anti-epileptic drug, an anticoagulant, a statin, fluoxetine, diltiazem, amiodarone, clarithromycin, ketoconazole, or St. John s wort, within the past 30 days
Vaccination within the past 30 days
Receipt of an immunosuppressant or immunomodulatory drug within the past 30 days
Pregnancy, current or within the past 90 days, or trying to become pregnant during the study
Current breastfeeding
Complete blood count (CBC) and/or acute care panel values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the principal investigator
Any Electrocardiogram (ECG) abnormality that is clinically significant
Any condition that, in the investigator s opinion, may put the participant at undue risk or compromise the study s scientific objectives
Participation in a clinical protocol which includes an intervention that, in the opinion of the investigator, may affect the results of the current study
Intervention: Edoxaban
Trial phase: Phase 3
ATC code: B01AF03
SMILES: CN1CCc2nc(C(=O)N[C@@H]3C[C@@H](C(=O)N(C)C)CC[C@@H]3NC(=O)C(=O)Nc3ccc(Cl)cn3)sc2C1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 492
Group description: Participants who were randomized to oral DU-176b administered at a dose of 15 mg once daily.
Eligibility criteria:
Inclusion Criteria:

Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy

Exclusion Criteria:

Patients with active bleeding
Patients who have poorly controlled hypertension
Patients who have liver dysfunction accompanied with disorder of blood coagulation
Intervention: ALBUTEROL
Trial phase: Not Applicable
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention. Patients are observed for adverse events for 4 hours after second medication.

Albuterol: Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers between the ages of 18 and 60 years

Exclusion Criteria:

Coronary artery disease, history of intolerance to beta agonists
Intervention: ALBUTEROL
Trial phase: Not Applicable
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention. Patients are observed for adverse events for 4 hours after second medication.

Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers between the ages of 18 and 60 years

Exclusion Criteria:

Coronary artery disease, history of intolerance to beta agonists
Intervention: Calcifediol
Trial phase: Phase 4
ATC code: A11CC06 | H05BX05
SMILES: C=C1CCC(O)CC1=CC=C1CCCC2(C)C1CCC2C(C)CCCC(C)(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route

Calcifediol
Eligibility criteria:
Inclusion Criteria:

Medical diagnosis of bronchial asthma
serum 25(OH)D3 levels < 30 ng/ml.

Exclusion Criteria:

smoking habit ≥ 10 pack-years,
taking vitamin D supplements,
kidney disease (creat. > 2 mg/dl),
hypercalcaemia (corrected with proteins > 10.5 mg/dl),
repeat episodes of renal colic,
any gastrointestinal disease that might interfere with vitamin D absorption,
severe psychosocial problems,
pregnant
breast-feeding
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Patients will be randomized to treatment or placebo arms preoperatively. In our treatment arm of pregnant patients with suspected placenta accreta or at high risk for placenta accreta, patients will receive 1 gram intravenous TXA administered over 10 minutes immediately after delivery of the infant. The drug will be prepared and ready to hang at the beginning of the case. The study drug will be administered only once.

Tranexamic Acid
Eligibility criteria:
Inclusion Criteria:

English and Spanish speaking pregnant women
Any order pregnancy (singleton, twin gestation, etc)
Suspected accreta based on ultrasound or MRI imaging studies
All women evaluated for placenta accreta and deemed to be high risk for this disease (≥40% risk), meaning women diagnosed with a placenta previa and greater than or equal to 2 prior c-sections

Exclusion Criteria:

Women less than 18 years of age
Women with a personal history of venous or arterial thrombosis (deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke
Women with a personal history of a high risk clotting disorder, such as anti-phospholipid syndrome
Women who do not have a good understanding of either English or Spanish will be excluded.
Women with defective color vision (color-blindness)
Intervention: Tamoxifen
Trial phase: Phase 2
ATC code: L02BA01
SMILES: CC/C(=C(\c1ccccc1)c1ccc(OCCN(C)C)cc1)c1ccccc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Tamoxifen 20mg by mouth daily

Tamoxifen: Tamoxifen 20mg by mouth daily
Eligibility criteria:
Inclusion Criteria:

Patient evaluated and treated at INCAN
Patients must provide informed consent
Patient must be ≥ 18 years of age.
Life expectancy ≥ 6 months
Clinical locally advance breast cancer (Stage IIB or III)
Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer with ER or PR Allred Score > 4
Patient must have an ECOG Performance Status of 0-2
Patients must be able to swallow and retain oral medication

Exclusion Criteria:

Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years
Patient must not be pregnant or nursing
Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
Women of childbearing age unable or unwilling to use contraception
Intervention: Phenazopyridine
Trial phase: Phase 3
ATC code: G04BX06
SMILES: Nc1ccc(/N=N/c2ccccc2)c(N)n1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Patients receiving phenazopyridine

Phenazopyridine
Eligibility criteria:
Inclusion Criteria:

1. Any female subjects scheduled to undergo Mid-Urethral Sling (MUS) through the UMass urogynecology service for incontinence.

Exclusion Criteria:

Planned concurrent prolapse or other procedure besides cystoscopy
Using intermittent self catheterization preoperatively
Undergoing spinal anesthesia for the procedure
Known allergy to phenazopyridine (AKA Pyridium)
Renal insufficiency
Any condition or situation that in the attending physician's opinion would contra-indicate the use of phenazopyridine
Subjects not competent to give consent
Prisoners
Non-English speaking patients
Age <18
Pregnant patients

Contraindications to the use of IV methylene blue including

Patients with known hypersensitivity reactions
Severe renal insufficiency
Patients with G6PD deficiency
Intervention: Solriamfetol
Trial phase: Phase 2
ATC code: N06BA14
SMILES: NC(=O)OC[C@H](N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days) in treatment period 1 or treatment period 2 in a counterbalanced order.
Eligibility criteria:
Inclusion Criteria:

Male or female, age 21 to 65 years inclusive
Diagnosis of obstructive sleep apnea (OSA) per International Classification of Sleep Disorders (ICSD-3)
BMI 18 to <40 kg/m2
Willing and able to provide written informed consent

Exclusion Criteria:

Female subjects who are pregnant, nursing, or lactating
Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria
History or presence of any unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy and/or safety assessments per the judgment of the investigator
History of bariatric surgery within the past year or a history of any gastric bypass procedure
Presence or history of significant cardiovascular disease
Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function
Intervention: Solriamfetol
Trial phase: Phase 2
ATC code: N06BA14
SMILES: NC(=O)OC[C@H](N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days)
Eligibility criteria:
Inclusion Criteria:

Male or female, age 21 to 65 years inclusive
Diagnosis of narcolepsy per International Classification of Sleep Disorders (ICSD-3) or Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)
BMI 18 to <40 kg/m2
Willing and able to provide written informed consent

Exclusion Criteria:

Female subjects who are pregnant, nursing, or lactating
Moderate or severe sleep apnea
Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
History or presence of any unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy and/or safety assessments per the judgment of the investigator
History of bariatric surgery within the past year or a history of any gastric bypass procedure
Presence or history of significant cardiovascular disease
Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function
Intervention: Ibuprofen
Trial phase: Not Applicable
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 98
Group description: Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.

Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
Eligibility criteria:
Inclusion Criteria:

Must:

Be Active Duty Service Members.
at least 18 years of age or older.
Be requiring and eligible for inactivated influenza vaccine receipt.
Be willing and able to complete the study protocol requirements.
Have a current Flu Screening Form with medical clearance to receive the influenza vaccination.

Exclusion Criteria:

Must Not:

Have already received influenza vaccine for the current season.
Have received any type of vaccine in the previous 72 hours.
Be on a medical profile resulting in current profile exemption from Physical Training of Upper 2 or Upper 3. (Upper extremity injury or illness)
Have preexisting symptoms of injury or infection or other local symptoms that would interfere with site assessment.
Be pregnant.
Have a history of allergy, intolerance, stomach bleeding or other medical exclusion for ibuprofen.
Have a history of stroke or coronary artery disease, such as uncontrolled high blood pressure or abnormal heart beat.
Has taken any topical or oral pain medications from the following medication classes in the past 24 hours prior to the start of the study: oral acetaminophen, opioids, tramadol, nonsteroidal anti-inflammatory drug (NSAID) or acetylsalicylic acid (ASA) or topical pain relievers or counterirritants of menthol, methyl salicylate, camphor menthols, and capsaicins.
Have any chronic or acute illness or treatment causing immunological suppression such as current oral steroid therapy, malignancy or chemotherapy or lung disease. (not including controlled asthma)

Currently participating in any other study

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Intervention: Cilofexor
Trial phase: Phase 1
SMILES: O=C(O)c1ccnc(N2CC(O)(c3ccc(OCc4c(-c5c(Cl)cccc5Cl)noc4C4CC4)cc3Cl)C2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Participants with mild hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Cohort 1:

Individuals with mildly impaired and normal hepatic function.
Individuals with mild hepatic impairment must have a score of 5-6 on the Child-Pugh-Turcotte (CPT) classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 2:

Individuals with moderately impaired and normal hepatic function.
Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 3:

Individuals with severely impaired and normal hepatic function.
Individuals with severe hepatic impairment must have a score of 10-15 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Cilofexor
Trial phase: Phase 1
SMILES: O=C(O)c1ccnc(N2CC(O)(c3ccc(OCc4c(-c5c(Cl)cccc5Cl)noc4C4CC4)cc3Cl)C2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Participants with moderate hepatic impairment received a single oral dose of cilofexor 30 mg (3 x 10 mg tablets) in a fed state, on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Cohort 1:

Individuals with mildly impaired and normal hepatic function.
Individuals with mild hepatic impairment must have a score of 5-6 on the Child-Pugh-Turcotte (CPT) classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 2:

Individuals with moderately impaired and normal hepatic function.
Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 3:

Individuals with severely impaired and normal hepatic function.
Individuals with severe hepatic impairment must have a score of 10-15 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Cilofexor
Trial phase: Phase 1
SMILES: O=C(O)c1ccnc(N2CC(O)(c3ccc(OCc4c(-c5c(Cl)cccc5Cl)noc4C4CC4)cc3Cl)C2)c1
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 cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Cohort 1:

Individuals with mildly impaired and normal hepatic function.
Individuals with mild hepatic impairment must have a score of 5-6 on the Child-Pugh-Turcotte (CPT) classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 2:

Individuals with moderately impaired and normal hepatic function.
Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 3:

Individuals with severely impaired and normal hepatic function.
Individuals with severe hepatic impairment must have a score of 10-15 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Cilofexor
Trial phase: Phase 1
SMILES: O=C(O)c1ccnc(N2CC(O)(c3ccc(OCc4c(-c5c(Cl)cccc5Cl)noc4C4CC4)cc3Cl)C2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Matched normal hepatic function participants to severe hepatic impairment participants, received a single oral dose of cilofexor 10 mg (1 x 10 mg tablet) in a fed state, on Day 1.
Eligibility criteria:
Key Inclusion Criteria:

Cohort 1:

Individuals with mildly impaired and normal hepatic function.
Individuals with mild hepatic impairment must have a score of 5-6 on the Child-Pugh-Turcotte (CPT) classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 2:

Individuals with moderately impaired and normal hepatic function.
Individuals with moderate hepatic impairment must have a score of 7-9 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Cohort 3:

Individuals with severely impaired and normal hepatic function.
Individuals with severe hepatic impairment must have a score of 10-15 on the CPT classification at screening without evidence of worsening clinical and/or laboratory signs of hepatic impairment within 2 months prior or within the screening period.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: GED-0507-34-Levo
Trial phase: Phase 2
SMILES: CO[C@@H](Cc1ccc(N)cc1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: GED-0507-34-Levo 80 mg BID
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18 and over at the time of signing the informed consent.
Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.
MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study
Subjects are required to have a colonoscopy if one has not been performed within 12 months prior to the Screening Visit.
Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day

Exclusion Criteria:

Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis.
UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).
Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
Clinical signs suggestive of fulminant colitis or toxic megacolon.
Evidence of pathogenic enteric infection.
History of colorectal cancer or colorectal dysplasia.
Prior use of any TNF inhibitor (or any biologic agent).
Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.
Use of budesonide-MMx within the last 8 weeks.
Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.
Use of immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]) within 8 weeks of the Screening Visit.