anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Crisaborole
Trial phase: Phase 4
ATC code: D11AH06
SMILES: N#Cc1ccc(Oc2ccc3c(c2)COB3O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Crisaborole: Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
Eligibility criteria:
Inclusion Criteria:

Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
Male or female subjects 18 to 70 years of age.
Able to complete the study and to comply with study instructions.
Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must agree to use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, or intrauterine devices) during the entire duration of the study
Mild to moderate seborrheic dermatitis on the face with an ISGA of 2 or 3 at baseline.

Exclusion Criteria:

Use of systemic antifungal agents, corticosteroids or other immunosuppressive therapies, or systemic retinoids within 4 weeks prior to the baseline visit.
Use of topical antifungal therapy, corticosteroid therapy, or calcineurin inhibitors to the face, within 2 weeks prior to the baseline visit. Topical, over-the-counter antifungal shampoo will be allowed as long as it has remained constant for 4 weeks prior to baseline.
Use of any investigational drugs within 4 weeks prior to the baseline visit, or subjects scheduled to receive an investigative drug other than the study product during the period of the study.
History of known or suspected intolerance to any of the ingredients of the study product.
Female subjects who are pregnant, trying to become pregnant or lactating.
Any clinically relevant abnormal vital signs or findings on the physical examination which in the opinion of the investigator might interfere with the study assessments.
A clinically relevant history of abuse of alcohol or other drugs.
Any major illness within 30 days prior to the baseline visit.
Subjects with any clinically significant condition which would, in the opinion of the investigator, compromise the subject's participation in the study.
Subjects who are immunocompromised (ex: HIV).
Considered unable or unlikely to attend the necessary visits.
Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product
Subjects who have significant neurological conditions (Parkinson's disease or Stroke), who in the opinion of the investigator are not eligible for the study due to the severity of neurological condition.
Subjects with a history of non-melanoma skin cancer of the face within 6 months
Intervention: Perflutren
Trial phase: Phase 3
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 153
Group description: Each patient will undergo an unenhanced ultrasound examination and a single dose DEFINITY contrast-enhanced ultrasound during the same imaging session
Eligibility criteria:
Inclusion Criteria:

Men and women ≥ 18 years of age in sinus rhythm
Able to communicate effectively with trial personnel
Has undergone a 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial -

Exclusion Criteria:

Female subjects who are pregnant or lactating. All women of child bearing potential [WOCBP] must have a negative urine pregnancy test at screening regardless of contraceptive use history.

Women of child-bearing potential are excluded unless they:

are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).

Unstable cardiovascular status defined as:

myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
clinically significant congenital heart defects
current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
acute pulmonary embolus or pulmonary infarction
acute myocarditis or pericarditis
acute aortic dissection
atrial fibrillation
any major surgery within 4 weeks prior to screening
known contraindications to undergoing CMR or claustrophobia
participation in any investigational drug, device, or placebo study within 30 days prior to screening
known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease) -
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).

Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.

Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
Eligibility criteria:
Inclusion Criteria:

Men and Women age>18 years old
Presence of renal or ureteral stones suitable for ureteroscopy or percutaneous nephrolithotomy.
Uncomplicated ureteroscopy or percutaneous nephrolithotomy

Exclusion Criteria:

Pregnant/Breastfeeding/Possibly Pregnant Patients
Pediatric Patients
Sensitive or Allergic to Opioids, Ketorolac, or Acetaminophen
Significant Renal Disease
Peptic Ulcer Disease
Chronic Pain and recovering opiate use
Inability to complete questionnaires
Non-mobile patients
Patients on methadone
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).

Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Eligibility criteria:
Inclusion Criteria:

english speaking
candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
scheduled for surgery at Texas Sinus Institute

Exclusion Criteria:

allergy to either NSAIDs or opioids
contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
surgical plan exceeding basic endoscopic sinus surgery
use of anticoagulation
the presence of any pain disorder
the current usage of any analgesic medication
history of opioid addiction
pregnancy
history of chronic pain or fibromyalgia
current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)
Intervention: Oxycodone
Trial phase: Early Phase 1
ATC code: N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19
SMILES: COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone
Eligibility criteria:
Inclusion Criteria:

males or females, ages 18-30
for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning
ability to provide written, informed consent
eligibility and willingness to participate in fMRI scanning and to receive oxycodone
normal weight, as indicated by a body mass index (BMI) between 18.5 to 25

Exclusion Criteria:

current DSM-5 Axis I disorder
any psychotropic medication or medication known to interfere with metabolism of opioids
medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician
known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder
not eligible for MRI scanning
positive drug screen
recent (past 6 months) medical or non-medical opioid-use
current or previous chronic pain disorder
significant lifetime use of prescription opioids (>7 days of consecutive medical use or nonmedical use on more than 5 occasions)
Intervention: Siponimod
Trial phase: Phase 3
ATC code: L04AA42 | L04AE03
SMILES: CCc1cc(/C(C)=N/OCc2ccc(C3CCCCC3)c(C(F)(F)F)c2)ccc1CN1CC(C(=O)O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 185
Group description: Participants received titrated doses of siponimod tablets, orally, once daily of 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and maintenance dose of siponimod 2.0 mg tablets, orally, once daily from Day 6 up to 6 months.

As of protocol amendment 3, participants entering the trial converting from fingolimod started directly with 2 mg dose of siponimod.
Eligibility criteria:
Key Inclusion Criteria:

Signed informed consent.
Male or female aged 18 to 65 years (inclusive).
Patients with advancing RMS as defined by the principal investigator.
Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).
EDSS score of >/= 2.0 to 6.5 (inclusive).
Having been continuously treated with RMS Disease Modifying Therapies.

Key Exclusion criteria:

Pregnant or nursing (lactating) women.
Patients with any medically unstable condition as determined by the investigator.
Certain cardiac risk factors defined in the protocol
History of hypersensitivity to the study drug or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: hydrocodone 5 mg/APAP 325 mg

Norco: hydrocodone 5 mg/APAP 325 mg
Eligibility criteria:
Inclusion Criteria:

Informed consent: Signed informed consent form obtained at screening prior to any procedures being performed.
Gender: Male or non-pregnant and non-lactating female.
Age: 18 years or older at time of consent.
Foot condition: Primary unilateral first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
Pain Severity: Presence of moderate or severe pain on a categorical pain intensity scale at Baseline
Pain Confirmation: On the 0-10 numerical pain intensity scale at Baseline.
Diary Completion: Be willing and able to record safety and efficacy ratings in the Diaries.
Safe Transportation Home: Patient must have arrangements for transportation home from the research center accompanied by a responsible adult.

Exclusion Criteria:

Medical condition: Presence of a serious medical condition, intolerance to NSAIDs, or any other medical condition which, in the opinion of the Investigator, makes the patient unsuitable for participation.
Infection: Acute infection of the surgical site at the time of surgery that could confound post-surgical evaluation.
Drug Allergy: History of hypersensitivity to an opioid drug (such as hydrocodone), promethazine, acetaminophen, NSAID (such as ibuprofen or aspirin), midazolam, propofol, mepivacaine, ropivacaine or ketorolac.
Confounding and Contraindicated Drugs: Other than protocol-permitted medications administered pre-operatively or during surgery: use within 14 days before or during the surgical procedure of any systemic corticosteroid or use within 24 hours or during the surgical procedure of any confounding prescription or non-prescription drug or any drug contraindicated with hydrocodone, acetaminophen, or promethazine. [Note: Antibiotic for endocarditis prophylaxis (except if known to cause nausea) and aspirin (ASA) ≤ 325 mg for cardiovascular prophylaxis are permitted during the study.] History of consuming more than 2 alcoholic drinks per day every day for the last month or a positive urine test for opiates, benzodiazepines, barbiturates, tetrahydrocannabinol, methamphetamines, cocaine, oxycodone, cotinine at screening or the morning of surgery will exclude the patient from the trial.
Investigational Drug Use: Use of an investigational drug within the past 30 days.
Participated in Study: Previous participation in this study.
Pregnancy, Lactation: Women who are pregnant or lactating.
Compliance: Inability to swallow capsules whole.
Participant relationship: Employee at the research center, employee of the Principal Investigator, Sub-Investigators, or sponsor or relative of the Investigator, Sub-Investigators or research staff who is involved in this study.
Intervention: Abemaciclib
Trial phase: Phase 2
ATC code: L01EF03
SMILES: CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 200 mg abemaciclib given twice a day (BID) orally with a meal.
Eligibility criteria:
Inclusion Criteria:

Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).

Have all of the following:

Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
Prior treatment with chemotherapy for locally advanced or metastatic disease.
No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
Have adequate organ function.
Women of child-bearing potential must have a negative pregnancy test.
Are able to swallow tablets/capsules.

Exclusion Criteria:

Are currently receiving treatment in a clinical study involving an investigational product.
Have a serious concomitant systemic disorder.
Have symptomatic central nervous system (CNS) malignancy or metastasis.
Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
Have a history of any other cancer.
Had major surgery within 14 days prior to randomization.
Are breastfeeding.
Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
Intervention: Hydrocortisone
Trial phase: Phase 2
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h

Combination (Hydrocortisone and Fludrocortisone): Hydrocortisone 50 mg IV Q6h and Fludrocortisone 50 mg PO/PFT Q24h
Eligibility criteria:
Inclusion Criteria:

Critically ill medical patients requiring addition of stress dose steroid therapy (hydrocortisone) in addition to pressors for septic shock management during ICU stay
Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in combination therapy group

Exclusion Criteria:

Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock management during ICU stay
Fludrocortisone/hydrocortisone initiated by any service other than critical care medicine
Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside facility)
Patients not appropriate for study inclusion as determined by provider discretion
Patients receiving steroid therapy not in accordance with assigned group per location (MCC1 or MCC2)
Patients re-admitted to the MCC during the same admission and restarted on vasopressor therapy will be noted during data collection and only the initial admission will be included for analysis
Any patient receiving greater than one dose of hydrocortisone 100 mg
Physical or medical contraindication to receiving PO or PER FT (per feeding tube) fludrocortisone
Intervention: Hydrocortisone
Trial phase: Phase 2
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Hydrocortisone 50 mg IV Q6h

Hydrocortisone: Hydrocortisone 50 mg IV Q6h
Eligibility criteria:
Inclusion Criteria:

Critically ill medical patients requiring addition of stress dose steroid therapy (hydrocortisone) in addition to pressors for septic shock management during ICU stay
Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in combination therapy group

Exclusion Criteria:

Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock management during ICU stay
Fludrocortisone/hydrocortisone initiated by any service other than critical care medicine
Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside facility)
Patients not appropriate for study inclusion as determined by provider discretion
Patients receiving steroid therapy not in accordance with assigned group per location (MCC1 or MCC2)
Patients re-admitted to the MCC during the same admission and restarted on vasopressor therapy will be noted during data collection and only the initial admission will be included for analysis
Any patient receiving greater than one dose of hydrocortisone 100 mg
Physical or medical contraindication to receiving PO or PER FT (per feeding tube) fludrocortisone
Intervention: Topiramate
Trial phase: Not Applicable
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.

Topiramate: An antiepileptic agent used for migraine prophylaxis.
Eligibility criteria:
Inclusion Criteria:

Migraine diagnosis according to ICHD-2
Ages between 15 -45 Volunteering
Monthly attack number between 5-14
BMI between 18-30
w/o history of nephrolithiasis
w/o history of DM, peripheral vascular disease
w/o history of chronic systemic diseases (lung, heart,liver, kidney)
w/o any detected CNS disease (including MS, movement disorders, CVD, primary or secondary tumors)
w/o history of acute or chronic psychiatric disease
w/o history of antiplatelet and anticoagulant medication
w/o any combination of medication overuse headache or other primary headaches
w/o previous medication of flunarizine and topiramate
w/o previous application of GONB

Exclusion Criteria:

Pregnancy

Lost to follow up

exited with his/her own will
detected primary headache during follow up
cessation due to adverse effects of topiramate
cessation due to adverse effects of flunarizine
Intervention: Perflutren
Trial phase: Phase 3
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 160
Group description: Each patient will undergo an unenhanced ultrasound examination and a DEFINITY® contrast-enhanced ultrasound

DEFINITY®: All subjects will receive a single dose of DEFINITY®
Eligibility criteria:
Inclusion Criteria:

Men and women ≥ 18 years of age in sinus rhythm
Able to communicate effectively with trial personnel
LVEF measurements obtained via 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial

Exclusion Criteria:

Female subjects who are pregnant or lactating. All women of child bearing potential [WOCBP] must have a negative urine pregnancy test at screening regardless of contraceptive use history.

Women of child-bearing potential are excluded unless they:

are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).

Unstable cardiovascular status defined as:

myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
clinically significant congenital heart defects
current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
acute pulmonary embolus or pulmonary infarction
acute myocarditis or pericarditis
acute aortic dissection
atrial fibrillation
any major surgery within 4 weeks prior to screening
known contraindications to undergoing CMR (e.g. implanted pacemakers, cardioverter, defibrillators) or claustrophobia
participation in any investigational drug, device, or placebo study within 30 days prior to screening
known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease).