anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Carfilzomib
Trial phase: Phase 1
ATC code: L01XG02 | L01XX45
SMILES: CC(C)C[C@H](NC(=O)[C@H](CCc1ccccc1)NC(=O)CN1CCOCC1)C(=O)N[C@@H](Cc1ccccc1)C(=O)N[C@@H](CC(C)C)C(=O)[C@@]1(C)CO1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
Eligibility criteria:
Key Inclusion Criteria:

Relapsed or progressive advanced malignancies (solid tumors or hematologic malignancies)
At least ≥ 2 prior treatment regimens for the underlying malignancy
Confirmed advanced solid tumor or hematologic malignancy
Measurable or evaluable disease

Clinical diagnosis of chronic hepatic impairment that is stable with no acute worsening of liver failure within one month prior to enrollment. Hepatic impairment will be assessed as per National Cancer Institute Organ Dysfunction Working Group Criteria (NCI-ODWG) schema and will fall into one of the following three categories:

Cohort 2 (mild): Bilirubin > 1-1.5 × upper limit of the normal range (ULN) or aspartate aminotransferase (AST) > ULN, but bilirubin ≤ ULN
Cohort 3 (moderate): ≥ 1.6-3 × ULN; any AST
Cohort 4 (severe): Bilirubin > 3 × ULN; any AST

Exception to Inclusion Criterion #5 for Subjects with Normal Hepatic Function:

All subjects enrolled with normal hepatic function (N=10) must meet all inclusion criteria as outlined with the exception of Inclusion Criterion

#5, which should be substituted with the following criterion to be enrolled into the study:

- Cohort 1 (normal hepatic function): Bilirubin ≤ ULN; AST ≤ ULN

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Left ventricular ejection fraction (LVEF) ≥ 40%
Adequate renal function (calculated creatinine clearance ≥ 30 mL/min)
Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment

Key Exclusion Criteria:

Subjects with symptomatic brain metastasis or central nervous system (CNS) disease
Significant neurotoxicity (Grade 2 with pain or higher) at the time of enrolment
Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection (Exception: Subjects with chronic or cleared HBV and HCV infection and stable liver function tests [bilirubin, AST] will be allowed)
Intervention: Betaine
Trial phase: Phase 2
ATC code: A09AB02 | A16AA06
SMILES: C[N+](C)(C)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Betaine:

Participants were instructed to take betaine 3300 mg (10 ml) orally twice daily for 10 days, then 4950 mg (15 ml) orally twice daily through 12 weeks.
Eligibility criteria:
Inclusion Criteria:

1) Men and women aged 21-65 years old;
2) Dysglycemia/prediabetes is defined as impaired fasting glucose (≥100 mg/dl), impaired glucose tolerance (2 hour post 75 g oral glucose load 140-200 mg/dl) or HbA1c 5.7-6.5%);
3) overweight to grade 3 obesity (BMI 25 to 45 kg/m2).

Exclusion Criteria:

1) cystathionine beta-synthase (CBS deficiency);
2) Presence of liver disease other than NAFLD;
3) Use of medications causing steatosis;
4) Known alcohol consumption ≥ 2 drink per day;
5) Use of medications known to cause insulin resistance;
6) Use of weight loss drugs (or program) within 3 months of screening;
7) Treatment with any experimental drug within the past 6 months;
8) Subjects must be willing to abstain from use of phosphodiesterase type 5 (PDE-5) inhibitors;
9) Pregnancy or lactation, and women of child bearing potential must use adequate contraception;
10) Surgery within 30 days of screening;
11) Heart disease defined as New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months;
12) Uncontrolled hypertension;
13) eGFR <60; 14) History of acquired immune deficiency syndrome;
15) History of malignancy within 5 years;
16) Hemoglobin <12 g/dL (males), <10 g/dL (females);
17) Triglycerides (TG) >500 mg/dL;
18) Poor mental function or any other reason to expect patient difficulty in complying with study requirements;
19) Metal clips or implants that preclude magnetic resonance imaging.
Intervention: Levothyroxine
Trial phase: Phase 2 | Phase 3
ATC code: C10AX01 | H03AA01 | H03AA51
SMILES: N[C@@H](Cc1cc(I)c(Oc2cc(I)c(O)c(I)c2)c(I)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.

Levothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).
Eligibility criteria:
Inclusion criteria:

-all adult patients (ages 18-70 years) with Graves' Disease (GD) who will receive radioactive iodine (RAI) ablation of the thyroid gland for treatment of GD

Exclusion criteria:

clinically manifest Graves' ophthalmopathy (GO)
recent (<1 yr.) history of arrhythmias or any history of ventricular arrhythmias
preexistent cardiomyopathy
malnutrition
psychiatric history that could get worse if patient remains persistently hyperthyroid
unlikely to return for the planned follow-up visits
unlikely to comply with the blood drawing schedule
unlikely to complete the hypothyroid-Health Related Quality of Life (HDQL) and Thyroid Specific (TSQ) questionnaires
Intervention: Ruxolitinib
Trial phase: Phase 2
ATC code: D11AH09 | L01EJ01 | L01XE18
SMILES: N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

Ruxolitinib: A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.
Eligibility criteria:
Inclusion Criteria:

Patients between 18 to 75 years of age.
Patients with a diagnosis of patch type alopecia areata.
Patients will have >30% and <95% total scalp hair loss at baseline as measured using the SALT score. Two patients with current episodes of alopecia totalis/universalis may be included in this study.
Duration of hair loss greater than 3 months.
No evidence of regrowth present at baseline.
Patients may be naïve to treatment or unresponsive to intralesional (IL) steroids or other treatments for alopecia areata.

Exclusion Criteria:

Patients with a history of or active skin disease on the scalp such as psoriasis or seborrheic dermatitis.
Patients in whom the diagnosis of alopecia areata is in question.
Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma) that in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections.
Women of childbearing potential who are unable or unwilling to use two forms of birth control for the study duration.
Women who are pregnant or nursing.
Patients known to be HIV or hepatitis B or C positive.
Patients with history or evidence of hematopoietic abnormality.
Patients with <200K platelet count at baseline.
Patients with history or evidence of renal or hepatic impairment.
Patients with history of immunosuppression or history of recurrent serious infections.
Patients unwilling or unable to discontinue treatments known to affect hair regrowth in AA.
Patients taking any medication considered a strong CYP3A4 inhibitor who is unable or unwilling to stop this medication for the duration of the study.
Patients receiving treatment deemed to affect alopecia areata within 2 weeks to one month of baseline visit depending on the specific treatment.
Intervention: Nicardipine
Trial phase: Phase 1
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: 40
Group description: Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication "failure" will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
Eligibility criteria:
Inclusion Criteria:

Adult
non-pregnant patients
(age ≥ 18 years)
undergoing general anesthesia for elective supratentorial, infratentorial, or transsphenoidal craniotomy

Exclusion Criteria:

Patients under 18 years of age
non-English speaking, pregnancy
emergent craniotomy (including trauma)
awake craniotomy
active 3 vessel coronary artery disease or left main coronary artery disease
advanced heart block
severe aortic stenosis
chronic renal failure
known or suspected allergy or intolerance to a study drug or its components
Intervention: Esmolol
Trial phase: Phase 1
ATC code: C07AB09
SMILES: COC(=O)CCc1ccc(OCC(O)CNC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication "failure" will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
Eligibility criteria:
Inclusion Criteria:

Adult
non-pregnant patients
(age ≥ 18 years)
undergoing general anesthesia for elective supratentorial, infratentorial, or transsphenoidal craniotomy

Exclusion Criteria:

Patients under 18 years of age
non-English speaking, pregnancy
emergent craniotomy (including trauma)
awake craniotomy
active 3 vessel coronary artery disease or left main coronary artery disease
advanced heart block
severe aortic stenosis
chronic renal failure
known or suspected allergy or intolerance to a study drug or its components
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 31
Group description: Ketamine, single dose, 0.3 mg/kg, IV

Ketamine
Eligibility criteria:
Inclusion Criteria:

Age: 3-17 years old
Condition (medical or trauma) requiring opioid pain management per standard of care
Need to establish an IV per standard of care
Treating physician agrees to manage the patient's pain with morphine following randomization.

Exclusion Criteria:

Trauma Team Activation
Known allergy to ketamine
Family member unable/unavailable to provide informed consent
When appropriate, patient unwilling to provide assent
High suspicion of injury related to child abuse
Patient and/or family member is non-English speaking
Patient is incarcerated
Intervention: Morphine
Trial phase: Phase 4
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 32
Group description: Morphine, single dose, 0.05 mg/kg, IV

Morphine
Eligibility criteria:
Inclusion Criteria:

Age: 3-17 years old
Condition (medical or trauma) requiring opioid pain management per standard of care
Need to establish an IV per standard of care
Treating physician agrees to manage the patient's pain with morphine following randomization.

Exclusion Criteria:

Trauma Team Activation
Known allergy to ketamine
Family member unable/unavailable to provide informed consent
When appropriate, patient unwilling to provide assent
High suspicion of injury related to child abuse
Patient and/or family member is non-English speaking
Patient is incarcerated
Intervention: Vancomycin
Trial phase: Phase 4
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days

GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days

Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
Eligibility criteria:
Inclusion Criteria:

Age between 40-75 years old
Male sex
History of known coronary artery disease (by either history of myocardial infarction, angiogram demonstrative >=50% stenosis in at least 1 major epicardial coronary artery, or a previous stress test that showed evidence of ischemia that has not been revealed to be a false positive test by angiography)

Exclusion Criteria:

Unstable angina or myocardial infarction by history, ECG, and/or enzymatic criteria within 1 month of enrollment.
Left ventricular dysfunction as defined by an left ventricular ejection fraction documented as < 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging.
Uncontrolled hypertension with a blood pressure greater than 170/100 mmHg at the screening visit.
Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.
Known history of cognitive impairment or inability to follow study procedures
Patient with an implanted defibrillator or permanent pacemaker on with the potential participant is known to rely upon for greater than 50% of ventricular depolarizations.
Patients who received probiotics, prebiotics, and antibiotics in the last 12 weeks.
Patients with dosing changes of vasoactive medications and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors in the 6 weeks prior to enrollment.
Intervention: Felcisetrag
Trial phase: Phase 1 | Phase 2
SMILES: COC(=O)N1CCC(CN2CCC(CNC(=O)c3cccc4[nH]c(C(C)C)nc34)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours

TD-8954
Eligibility criteria:
Inclusion Criteria:

Intubated, on mechanical ventilation, and anticipated to remain on mechanical ventilation for 2 days after enrollment into the study
Receiving enteral feeding and assessed to have developed EFI, as defined by a GRV measurement ≥250 mL within the 24 hours before randomization

Exclusion Criteria:

History of diabetic or idiopathic gastroparesis
Screening blood glucose >15 mmol/L (270 mg/dL) while receiving insulin
Impaired renal function, as defined by estimated glomerular filtration rate (eGFR) <30 mL/min, as determined by the Cockcroft-Gault formula -Bilirubin concentration in blood >2 times the upper limit of normal
ALT or AST >3 times upper limit of normal
Alkaline phosphatase >2 times upper limit of normal
Contraindication to enteral feeding
Opioid or other drug overdose as the primary reason for admission to Intensive Care Unit (ICU)
Receipt of a drug that can be used as a gastric prokinetic agent
Receipt of agents known to directly influence the 5 HT4/acetylcholine prokinetic mechanism
Intervention: Metoclopramide
Trial phase: Phase 1 | Phase 2
ATC code: A03FA01
SMILES: CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline

Metoclopramide
Eligibility criteria:
Inclusion Criteria:

Intubated, on mechanical ventilation, and anticipated to remain on mechanical ventilation for 2 days after enrollment into the study
Receiving enteral feeding and assessed to have developed EFI, as defined by a GRV measurement ≥250 mL within the 24 hours before randomization

Exclusion Criteria:

History of diabetic or idiopathic gastroparesis
Screening blood glucose >15 mmol/L (270 mg/dL) while receiving insulin
Impaired renal function, as defined by estimated glomerular filtration rate (eGFR) <30 mL/min, as determined by the Cockcroft-Gault formula -Bilirubin concentration in blood >2 times the upper limit of normal
ALT or AST >3 times upper limit of normal
Alkaline phosphatase >2 times upper limit of normal
Contraindication to enteral feeding
Opioid or other drug overdose as the primary reason for admission to Intensive Care Unit (ICU)
Receipt of a drug that can be used as a gastric prokinetic agent
Receipt of agents known to directly influence the 5 HT4/acetylcholine prokinetic mechanism
Intervention: Inositol
Trial phase: Phase 3
ATC code: A11HA07
SMILES: O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 313
Group description: Inositol (i.e myo-Inositol) 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. The medication is administered twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose) begining within 12-72 hours of birth and continuing until the earliest of 34 weeks postmenstrual age (PMA), 10 weeks chronologic age, or the time of discharge. The doses are administered intravenously (IV) using syringe pump over 15-30 minutes until enteral feeds reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally.
Eligibility criteria:
Inclusion Criteria:

Inborn or out born infants of either gender or any race with best obstetrical estimate of gestation <28 weeks (27 6/7 weeks and younger). Gestational age will be determined by best obstetrical estimate using the hierarchy of best obstetrical estimate using early ultrasound dating, maternal menstrual dating confirmed by examination, or neonatal gestational age assessment by physical examination.
Alive at 12 hours.
Age in hours up to 72 hours, although we will seek enrollment as early as feasible after consent and 12 hours.
Informed consent signed and dated by parent and/or guardian, which includes likelihood of completing follow-up ophthalmic examinations as an outpatient, and long-term follow-up.

Exclusion Criteria

Major congenital malformations
Congenital malformations of the eye identified prior to randomization.
Overt evidence of intrauterine congenital infections ("TORCH") or life threatening impairment of renal, hepatic, or cardiac function (considered moribund).
Intervention: AQX-1125
Trial phase: Phase 2
SMILES: C=C1CC[C@H]2[C@H](CN)[C@@H]([C@@]3(C)CC[C@H](O)C[C@@H]3CO)CC[C@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 200
Group description: 1 x AQX-1125 capsule daily

AQX-1125: Synthetic SHIP1 activator
Eligibility criteria:
Inclusion Criteria:

Male or female aged ≥40 years at screening
History of COPD for at least 18 months prior to screening, characterised by excessive sputum production
Chronic productive cough for at least 3 months in each of the 2 years prior to screening (if other causes of productive cough have been excluded) and/or an exacerbation of COPD with predominantly bronchitic symptoms at enrolment
At least 2 documented exacerbations during the last 18 months prior to screening.
Presentation of a diagnosed acute exacerbation of COPD, or have recently (within 3 days) been discharged from hospital due to an acute exacerbation of COPD
Ability to perform pulmonary function testing and with documented fixed airway obstruction determined by an FEV1 /FVC [forced vital capacity] ratio (post-bronchodilator) of <0.70 and a predicted FEV1 value of 30%-80% of normal within the 6 months prior to Visit 1.
Former smoker or current smoker, both with a smoking history of at least 10 pack years

Exclusion Criteria:

Diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis [CF] or significant non-CF bronchiectasis)
Known alpha-1-antitrypsin deficiency
Treatment with roflumilast or theophylline within 1 month prior to screening
Lobar pneumonia, with current positive chest X-ray (CXR) or within the 3 months prior to screening including the presence of any new radiological infiltrate on CXR within the previous two weeks
Hospitalisation for more than 7 days for current acute exacerbation, or the requirement for intubation during hospitalisation
For outpatients, prior medical history indicating that previous exacerbations required >3 weeks to stabilise
Intervention: Gabapentin
Trial phase: Phase 2
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Participants were randomized to receive one dose of gabapentin.

Gabapentin: Gabapentin is supplied as an oral suspension. Patients randomized to the gabapentin arm received a single dose of gabapentin as soon after enrollment as feasible, given orally, approximately 15 mg/kg with a maximum dose of 900 mg.
Eligibility criteria:
Inclusion Criteria:

Participant must have sickle cell disease (any genotype) documented in the St. Jude medical record.
Participant must be seeking care for acute vaso-occlusive pain at St. Jude Children's Research Hospital.
Participant age must be ≥1 year and <21 years.

Exclusion Criteria:

Prior randomization in this study.
Mild pain (score <4) or pain for which treatment with opioid is not indicated.
Pregnant or lactating female.
Decreased glomerular filtration rate (GFT) (<60ml/min/1.73m^2) as estimated by the revised Schwartz equation.
Current treatment with gabapentinoid drugs (gabapentin or pregabalin).
Known seizure disorder.
Current treatment with antiepileptic agents.
Pain in combination with other clinical symptoms that require additional interventions, including fever with focus, acute chest syndrome, acute injury, or splenic sequestration.
Allergy to gabapentin.
Current participation in another research study with an investigational new drug/device (IND/IDE) agent.
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.