anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sildenafil
Trial phase: Phase 4
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Sildenafil 20 mg three times per day, orally

Sildenafil: 20 mg TID PO for 90 days
Eligibility criteria:
Inclusion Criteria:

Known chronic heart failure appropriately treated with Angiotensin converting enzyme (ACE) inhibitors and beta blockers, unless contraindicated or poorly tolerated
indication for right heart catheterization
pulmonary artery mean pressure >25 mmHg
pulmonary capillary wedge pressure > 15 mmHg
pulmonary vascular resistance > 3 Wood units

Exclusion Criteria:

hypersensitivity, allergy, or intolerable side effect to sildenafil
history of primary pulmonary hypertension, connective tissue disorder, severe chronic obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt

co-morbidities, limited exercise intolerance:

morbid obesity (BMI >40)
COPD with oxygen dependence
severe peripheral vascular disease with intermittent claudication
status post amputation of lower extremity at any level
severe degenerative joint disease preventing normal walking
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: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 230
Group description: Those randomized to the prostaglandin arm will receive PGE1 (misoprostol) in a dose of 25mcg placed vaginally every 4 hours as per hospital protocol.

Misoprostol: Patients who are randomized to receive misoprostol will have 25mcg placed vaginally. Repeated dosing of misoprostol is based on clinical exam and clinical judgment of the provider.
Eligibility criteria:
Inclusion Criteria:

All pregnant women diagnosed with PROM without evidence of labor requiring induction
Gestational Age > 34 weeks
Bishop score < 6
Category I Fetal heart rate tracing

Exclusion Criteria:

Contraindication to Induction of Labor
Multiple gestation
Fetal Anomalies
Previous C-Section
HIV Positive Patients
Intervention: Frovatriptan
Trial phase: Phase 2
ATC code: N02CC07
SMILES: CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: IV administration of 5% Dextrose in water/D5W (vehicle) 12 mg every 12 hours plus Saline infusion at a rate of 30 mL/hour

D5W (5% Dextrose in water): D5W = 5% Dextrose Water Vehicle
Eligibility criteria:
Inclusion Criteria:

Subjects capable of giving informed consent.
lean (BMI <26 kg/m2)
normal glucose-tolerant subjects (completers) without a family history of Type 2 diabetes mellitus (DM)
Both genders. (50% males)
Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state.
All ethnic groups
Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for >=6 months.
Lab: Hematocrit >=34%, serum creatinine <=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range.
Stable body weight (+/-1%) for >=3 months.
One or less sessions of strenuous exercise/wk for last 6 months.

Exclusion Criteria:

Presence of diabetes or impaired glucose tolerance based on ADA criteria;
Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (>3months) are eligible.
Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months.
Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.
Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg).
Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.
Intervention: Frovatriptan
Trial phase: Phase 2
ATC code: N02CC07
SMILES: CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: IV Administration of 5% Dextrose in water /D5W (vehicle) 12 mg plus Intralipid infusion at a rate of 30 ml/hour

D5W (5% Dextrose in water): D5W = 5% Dextrose Water Vehicle
Eligibility criteria:
Inclusion Criteria:

Subjects capable of giving informed consent.
lean (BMI <26 kg/m2)
normal glucose-tolerant subjects (completers) without a family history of Type 2 diabetes mellitus (DM)
Both genders. (50% males)
Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state.
All ethnic groups
Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for >=6 months.
Lab: Hematocrit >=34%, serum creatinine <=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range.
Stable body weight (+/-1%) for >=3 months.
One or less sessions of strenuous exercise/wk for last 6 months.

Exclusion Criteria:

Presence of diabetes or impaired glucose tolerance based on ADA criteria;
Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (>3months) are eligible.
Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months.
Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.
Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg).
Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.
Intervention: Thiamine
Trial phase: Phase 2
ATC code: A11DA01
SMILES: Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: 200 mg thiamine in 50 mL normal saline solution

Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
Eligibility criteria:
Inclusion Criteria:

Adult (≥ 21 years)
Coronary artery bypass grafting (CABG) with or without concomitant valve procedures
EuroSCORE II > 1.5%

Exclusion Criteria:

Current thiamine supplementation
Known allergy to thiamine
Competing indication for thiamine administration as judged by the clinical team (e.g., alcoholic)
Research-protected populations (pregnant women, prisoners, the intellectually disabled)
Emergent or salvage CABG (as defined by the Society of Thoracic Surgeons)
Off-pump surgery (i.e. surgery without cardiopulmonary bypass)
Intervention: 3-(3,5-Dimethyl-1,2-Oxazol-4-Yl)-5-Ethoxybenzoic Acid
Trial phase: Phase 4
SMILES: CCOc1cc(C(=O)O)cc(-c2c(C)noc2C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: KRG capsule (3,000 mg/day) for 3 weeks

KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)
Eligibility criteria:
Inclusion Criteria:

aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis

Exclusion Criteria:

viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 64
Group description: 0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

Dexmedetomidine
Eligibility criteria:
Inclusion Criteria:

ASA Physical Status I-II
Age 3 to 10yrs
Elective surgical procedure requiring general anesthesia
Use of dexmedetomidine acceptable to the staff anesthesiologist
Un-premedicated
Ability to read and understand English (parent/legal guardian(s) and child)

Exclusion Criteria:

Long QT syndrome (LQTS)
Cardiac disease or rhythm abnormalities
Family history of LQTS or abnormal cardiac conduction
Currently taking medications known to prolong QT
Currently taking medications known to predispose to hypokalemia
Known hypersensitivity to dexmedetomidine or other study medication
Weight < 5th centile or > 95th centile for age
Previously diagnosed hypokalemia
Impaired renal or liver function
Pre-operative anxiety requiring sedatives or opioids
Refusal to participate
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 64
Group description: 0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

Dexmedetomidine
Eligibility criteria:
Inclusion Criteria:

ASA Physical Status I-II
Age 3 to 10yrs
Elective surgical procedure requiring general anesthesia
Use of dexmedetomidine acceptable to the staff anesthesiologist
Un-premedicated
Ability to read and understand English (parent/legal guardian(s) and child)

Exclusion Criteria:

Long QT syndrome (LQTS)
Cardiac disease or rhythm abnormalities
Family history of LQTS or abnormal cardiac conduction
Currently taking medications known to prolong QT
Currently taking medications known to predispose to hypokalemia
Known hypersensitivity to dexmedetomidine or other study medication
Weight < 5th centile or > 95th centile for age
Previously diagnosed hypokalemia
Impaired renal or liver function
Pre-operative anxiety requiring sedatives or opioids
Refusal to participate
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 64
Group description: 0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.

Dexmedetomidine
Eligibility criteria:
Inclusion Criteria:

ASA Physical Status I-II
Age 3 to 10yrs
Elective surgical procedure requiring general anesthesia
Use of dexmedetomidine acceptable to the staff anesthesiologist
Un-premedicated
Ability to read and understand English (parent/legal guardian(s) and child)

Exclusion Criteria:

Long QT syndrome (LQTS)
Cardiac disease or rhythm abnormalities
Family history of LQTS or abnormal cardiac conduction
Currently taking medications known to prolong QT
Currently taking medications known to predispose to hypokalemia
Known hypersensitivity to dexmedetomidine or other study medication
Weight < 5th centile or > 95th centile for age
Previously diagnosed hypokalemia
Impaired renal or liver function
Pre-operative anxiety requiring sedatives or opioids
Refusal to participate
Intervention: Chlordiazepoxide
Trial phase: Phase 2
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO

Control Solution
Eligibility criteria:
Inclusion Criteria:

Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
Age 18 years or older
If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure
Female subjects of childbearing potential must have a negative serum pregnancy test at screening
Admitted to the clinical center at the time of randomization
Clinical indication and accepted candidate for implantation of an FDA-approved (US sites only) or Health Canada-approved (Canadian sites only) implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.

Exclusion Criteria:

Planned percutaneous LVAD implantation
Anticipated requirement for biventricular mechanical support

Concomitant arrhythmia ablation at time of LVAD implantation

-- Planned aortic valve intervention for aortic insufficiency at the time of LVAD implantation

Cardiothoracic surgery within 30 days prior to randomization
Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as unstable plaque rupture, erosion or dissection within 30 days prior to randomization
Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty
Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism)
Stroke within 30 days prior to randomization
Platelet count < 100,000/ul within 24 hours prior to randomization
Acute infectious process: acute bacterial, fungal, or viral disease OR acute exacerbation of chronic infectious disease such as hepatitis
Presence of >10% anti-HLA antibody titers with known specificity to MPC donor HLA antigens
A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products
History of a known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated
Presence of human immunodeficiency virus (HIV)
Received investigational intervention within 30 days prior to randomization
Treatment and/or an incomplete follow-up treatment of any investigational cell based therapy within 6 months prior to randomization
Active participation in other research therapy for cardiovascular repair/regeneration
Prior recipient of stem precursor cell therapy for cardiac repair
Pregnant or breastfeeding at time of randomization.
History of known or suspected hypercoagulable state in the opinion of the investigator
Intervention: Perampanel
Trial phase: Phase 4
ATC code: N03AX22
SMILES: N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.

Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures
Eligibility criteria:
Inclusion Criteria:

Patients must be diagnosed with a primary glioma and have refractory partial onset seizure activity (defined as 3 or more seizures in a 28-day period) on levetiracetam monotherapy
Adult patients (≥ 18 years old)
Karnofsky ≥ 70%
Hematocrit ≥ 29%, ANC ≥ 1,500 cells/L, platelets ≥ 100,000 cells/L
Serum creatinine ≤ 1.5 mg/dL, serum AST and bilirubin ≤ 1.5 times the upper limit of normal
If sexually active, patients will take contraceptive measures for the duration of protocol treatment and continue until two months after treatment. The effectiveness of hormonal contraceptives containing levonorgestrel has been shown to be reduced by perampanel at a 12 mg dose.1 Therefore, alternative or back-up methods of contraception are recommended.
Signed informed consent approved by the Duke Institutional Review Board

Exclusion Criteria:

Pregnant or breastfeeding (Both perampanel and other Anti-epileptic drugs are classified as Pregnancy Category C drugs.)
Chronic excessive use of psycho-pharmaceuticals, alcohol, illicit drugs, or narcotics
Inability to complete or perform measures of patient-reported outcomes or neurocognitive testing on the computer
Known allergy to perampanel
Concomitant use of known cytochrome P450 inducers such as carbamazepine, phenytoin, or oxcarbazepine (see Appendix A)
Previous history of suicidal ideation, homicidal ideation, depression leading to hospitalization or mood disturbance leading to hospitalization.
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: 34
Group description: Single oral dose of Evacetrapib administered alone on Day 1 of Period 1.

Evacetrapib: Administered orally
Eligibility criteria:
Inclusion Criteria:

Overtly healthy participants, as determined by medical history and physical examination
Females must be of non-child-bearing potential
Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

Exclusion Criteria:

Have known allergies to evacetrapib, omeprazole, related compounds, or any components of the evacetrapib or omeprazole formulations
Intervention: Funapide
Trial phase: Phase 2
SMILES: O=C1N(Cc2ccc(C(F)(F)F)o2)c2ccccc2[C@]12COc1cc3c(cc12)OCO3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: TV-45070 ointment in a 4% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28.
Eligibility criteria:
Inclusion Criteria:

Patient has chronic Postherpetic Neuralgia (PHN), defined as pain present for more than 6 months and less than 10 years after onset of herpes zoster skin rash affecting a single dermatome. Patients with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous.
Patient is ≥18 years of age, with a body mass index (BMI) between 18 and 34 kg/m2, inclusive, at the screening visit.
If the patient is a woman and is fertile, the patient is not pregnant and has negative pregnancy tests at both the screening and randomization visits, and agrees to use an acceptable method of contraception for the duration of the study, including follow-up.
If the patient is a man and is capable of producing offspring, the patient must agree to use an acceptable method of contraception, unless the partner cannot become pregnant for the duration of the study, including follow-up.
Patient must sign the written Informed Consent Form (ICF) for the study and be willing to comply with all study procedures and restrictions.

Patient must be judged by the investigator to be medically healthy (except for PHN) and able to participate in the study

Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

Patient has any other severe pain that might confound assessment or self-evaluation of pain due to PHN.
Patient has PHN affecting the face (trigeminal nerve distribution).
Patient has a history, in the judgment of the investigator, of inadequate response to more than 3 adequate courses of treatment with other medications used to treat neuropathic pain (eg, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, anticonvulsants, topical lidocaine, and/or topical capsaicin).
Patient is taking oral analgesics (either opioid or non-opioid) or is receiving topical therapy such as the 5% topical lidocaine patch for the treatment of pain and is unwilling or unable to complete a washout period during which the patient will discontinue analgesic therapy or topical pain therapy.
Patient has been treated with topical capsaicin at any time in the past 6 months for neuropathic pain.

Patient has a history of fibromyalgia.

Other criteria apply, please contact the investigator for more information
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 3
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Subjects received a sham injection on Day 1. Then, subjects may receive aflibercept injection at Week 1, Week 5 and/or Week 9 if the re-treatment criteria specified in the protocol are met.

Re-treatment criteria (subjects could receive aflibercept IVT injection when all the following retreatment criteria were met) :

IOP higher than 21mmHg;
Incomplete regression of iris neovascularization and;
Aflibercept IVT deemed necessary by the investigator. (AE time frame: from first dose of study drug until 30 days after the last dose of study drug)
Eligibility criteria:
Inclusion Criteria:

Japanese men and women aged 20 years or older,
Patients diagnosed as having Neovascular glaucoma (NVG) with neovascularization in the anterior segment (both iris and anterior chamber angle),
Patients with Intraocular pressure (IOP) higher than 25 mmHg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization.

Exclusion Criteria:

Patients with angle-closure due to conditions other than Neovascular glaucoma
Patients with a known or suspected ocular or peri-ocular infection,
Patients with severe intraocular inflammation in the study eye,
Women who are pregnant, suspected of being pregnant or lactating,
Patients with known allergy to aflibercept.
Intervention: Flunisolide
Trial phase: Not Applicable
ATC code: R01AD04 | R03BA03
SMILES: [H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients will receive inhaled Flunisolide HFA 80 mcg twice per day for a total of 160 mcg per day over the 6 week study period

Flunisolide HFA
Eligibility criteria:
Inclusion Criteria:

Diagnosis of asthma
Informed consent by parent or legal guardian
6 years to 18 years of age at screening visit
ability to comply with medication use, study visits and study procedures as judged by the site investigator
FEF 25-75% <65% of predicted as a marker for small airway disease

Exclusion Criteria:

Acute wheezing at screening visit or at Baseline visit
Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding screening visit or 3 weeks preceding baseline visit
Oxygen saturation <95% at screening visit or at Baseline visit
Clinically significant upper airway obstruction as determined by the Site Investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea.
Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy
Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator
Inhaled Corticosteroids (ICS) use within 7 days of Baseline visit; systemic steroids within 30 days
Cystic Fibrosis, Interstitial lung disease (ILD) history of severe Bronchopulmonary dysplasia (BPD) or other underling significant respiratory disease apart from asthma
Potential subjects who are pregnant may not enroll in the study