anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Spironolactone
Trial phase: Phase 2
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Spironolactone 25 mg daily

Spironolactone 25mg: Spironolactone 25 mg daily for 12 months
Eligibility criteria:
Inclusion Criteria:

Fibrosis index ≥29%, or

Evidence of cardiovascular dysfunction including any of the following:

Systemic ejection fraction <55%,
NYHA 2-3
6-minute walk distance <500 m.
Completion of Visit 1 of the study Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" (eIRB # 3665) including meeting all inclusion for that study (Aged 18-80, Known congenital heart disease).
Tetralogy of Fallot, cyanotic congenital heart disease, or a systemic right ventricle.

Exclusion Criteria:

Patient currently taking spironolactone or previously taking spironolactone within the last 6 months.
Serum potassium ≥5.0 mmol/L at the initial visit, if not taking potassium supplements. Patients will be eligible if a repeat potassium is <5.0 mmol/L after potassium supplements have been discontinued.
Moderate/severe systemic atrioventricular valve regurgitation,
Likely to undergo cardiac surgery, pacemaker implantation, or possible transplantation within one year (all self-reported),
Unwilling to commit to return visits including mandatory blood draws for potassium,
Renal insufficiency (estimated creatinine clearance < 30 ml/min/1.73m2),
Positive urine pregnancy test.
Any contraindication to MRI.
Intervention: Sodium fluoride and triclosan
Trial phase: Phase 3
SMILES: Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Triclosan/copolymer/Fluoride
Eligibility criteria:
Inclusion Criteria:

Male and female subjects, ages 30-70.
Availability for the six-month duration of the clinical research study.
Good general health.
Subjects who have lost teeth for periodontal disease reasons and who have been restored with implants.
Minimum of 5 remaining teeth and a minimum of 2 implants.
Initial evaluation of the gingival and peri-implant mucosal tissues by determining full mouth bleeding on probing.
Initial plaque evaluation by determining full mouth presence/absence of plaque.
Signed Informed Consent Form.

Exclusion Criteria:

Tumor(s) of the soft or hard tissues of the oral cavity.
Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss or periodontal attachment or alveolar bone).
Carious lesions requiring immediate restorative treatment.
Uncontrolled Diabetes
Use of antibiotics any time during the one month prior to entry into the study.
Untreated peri-implantitis.
Participation in any other clinical research study or test panel within the three months prior to entry into the study.
Pregnant women or women who are breast feeding.
History of allergies to personal care/consumer products or their ingredients.
Medical condition which prohibits not eating/drinking for up to 2 hours.
Current alcohol or drug abuse.
Systemic or local disease conditions that would compromise post-operative healing.
Regular use of anti-inflammatory drugs.
Intervention: Metformin
Trial phase: Phase 3
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Metformin 500 mg twice daily
Eligibility criteria:
Inclusion Criteria:

has type 2 diabetes mellitus
is male, a female who cannot have children, or a female who agrees to use birth control during the study
is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Exclusion Criteria:

Patient has type 1 diabetes mellitus or ketoacidosis
Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
Patient is HIV positive
Patient is pregnant
Intervention: Methotrexate
Trial phase: Phase 4
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
Eligibility criteria:
Inclusion Criteria:

Participation in Genentech study ACD2601g, Genentech study HUPA 600 or Serono study IMP24011.
Inflammatory psoriasis disease recurrence occurring up to 2 months after discontinuation of efalizumab that required immediate therapeutic control in the opinion of the Investigator. Psoriasis had to be rapidly developing, symptomatic and inflammatory in nature.
Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to his or her future medical care.

Female subjects had to be neither pregnant nor breast-feeding, and had to lack childbearing potential, as defined by either:

Being post-menopausal or surgically sterile, or
Using an accepted form of contraception.
Confirmation that the subject was not pregnant had to be established by a negative urinary hCG test at SD1. A pregnancy test was not required if the subject was post-menopausal or surgically sterile.
Outpatient status at the time of enrolment.

Exclusion Criteria:

Disease recurrence that was part of the natural disease progression, was not inflammatory in nature, and was not related to efalizumab study medication in the previous study.
Intervention: Topiramate
Trial phase: Phase 2
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: Adult
Healthy volunteers: No
Participants at risk: 130
Group description: In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
Eligibility criteria:
Inclusion Criteria:

Participants who meet the Second Edition of the International Classification of Headache Disorders (ICHD-II), 1.1 Migraine without aura or 1.2 Migraine with aura over at least 6 months before the time of informed consent
Participants who had an average of no more than 8 migraine attacks per month during 3 months before informed consent and an average of no more than 14 headache (migraine and non-migraine) days
Participants whose number of migraine attacks during the baseline determination period (28 days) is 3 to 12 according to the 24-hour rule and number of headache days (migraine and non-migraine) is no more than 14
Participants who took no migraine preventive medications over 2 weeks before informed consent, or who can take at least 2-week washout period before baseline determination period if they are taking migraine preventive medications
Female participants must be postmenopausal, surgically sterile, abstinent, or can take adequate contraceptive measures after informed consent and continue it to the completion of investigational treatment

Exclusion Criteria:

Participants who cannot distinguish between migraine and non-migraine headache
Participants with headache other than those described in the ICHD-II, 1.1 Migraine without aura, 1.2 Migraine with aura, 2. Tension headache or 11.5 Sinus headache
If the participant has received drug therapies for prevention of migraine, the discontinued preventive therapies due to insufficient efficacy should be at least three types
Participants who excessively took medications for migraine attacks such as analgesics (drug used to control pain) as medications to be taken as needed within 3 months before informed consent
Participants who have taken topiramate (test drug in this study) in the past
Intervention: Efavirenz
Trial phase: Phase 4
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Both arms received both versions of the drug during the course of the study.
Eligibility criteria:
Inclusion Criteria:

HIV-negative, proven by ELISA
Age: ≥ 18 years old

Exclusion Criteria:

Psychiatric or psychological illness that would make adherence to protocol procedures unlikely.
Intervention: Milrinone
Trial phase: Not Applicable
ATC code: C01CE02
SMILES: Cc1[nH]c(=O)c(C#N)cc1-c1ccncc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: Subjects received a bolus intravenous (IV) infusion of 50 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.5 mcg/kg/min milrinone lactate over 24 hours.
Eligibility criteria:
Inclusion Criteria:

Gestational age > 34 weeks
Post-natal age < 10 days
Hypoxemia defined by: Oxygenation Index (OI) >15 (Mean Airway Pressure x Fraction of Inspired Oxygen (FiO2) x 100 /PaO2) as drawn from two post-ductal arterial blood gas samples (in-dwelling arterial catheter) taken at least 15 minutes apart. OR mechanically ventilated and with >75% FiO2 for >6 hours while on iNO
Absence of congenital heart disease based on a two-dimensional echocardiogram and/or clinical assessment
An in-dwelling arterial catheter to facilitate painless sampling
Currently on iNO or plan to start iNO before enrollment

Exclusion Criteria:

Lethal non-cardiac congenital anomalies including diaphragmatic hernia
Clinically apparent bleeding; thrombocytopenia <30,000 or other laboratory evidence of coagulopathy
Currently on extracorporeal membrane oxygenation (ECMO)or plan to initiate ECMO within 2 hours of enrollment
Intervention: Milrinone
Trial phase: Not Applicable
ATC code: C01CE02
SMILES: Cc1[nH]c(=O)c(C#N)cc1-c1ccncc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Subjects received a bolus intravenous (IV) infusion of 20 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.2 mcg/kg/min milrinone lactate over 24 hours.
Eligibility criteria:
Inclusion Criteria:

Gestational age > 34 weeks
Post-natal age < 10 days
Hypoxemia defined by: Oxygenation Index (OI) >15 (Mean Airway Pressure x Fraction of Inspired Oxygen (FiO2) x 100 /PaO2) as drawn from two post-ductal arterial blood gas samples (in-dwelling arterial catheter) taken at least 15 minutes apart. OR mechanically ventilated and with >75% FiO2 for >6 hours while on iNO
Absence of congenital heart disease based on a two-dimensional echocardiogram and/or clinical assessment
An in-dwelling arterial catheter to facilitate painless sampling
Currently on iNO or plan to start iNO before enrollment

Exclusion Criteria:

Lethal non-cardiac congenital anomalies including diaphragmatic hernia
Clinically apparent bleeding; thrombocytopenia <30,000 or other laboratory evidence of coagulopathy
Currently on extracorporeal membrane oxygenation (ECMO)or plan to initiate ECMO within 2 hours of enrollment
Intervention: Rabeprazole
Trial phase: Phase 2
ATC code: A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03
SMILES: COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Eligibility criteria:
Inclusion criteria:

-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.

Exclusion criteria:

Participants with neuropsychiatric disorder.
Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Intervention: Rabeprazole
Trial phase: Phase 2
ATC code: A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03
SMILES: COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
Eligibility criteria:
Inclusion criteria:

-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.

Exclusion criteria:

Participants with neuropsychiatric disorder.
Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Intervention: Rabeprazole
Trial phase: Phase 2
ATC code: A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03
SMILES: COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
Eligibility criteria:
Inclusion criteria:

-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.

Exclusion criteria:

Participants with neuropsychiatric disorder.
Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Intervention: Amiodarone
Trial phase: Phase 3
ATC code: C01BD01
SMILES: CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.

Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study
Eligibility criteria:
Inclusion Criteria - Patients must meet all of the following criteria:

> 18 and < 85 years of age
ICD implanted for primary prophylaxis against sudden cardiac death or ICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes
Coronary artery disease (CAD) with prior myocardial infarction (MI)
ICD or electrocardiogram (ECG) documentation of ventricular arrhythmia responsible for appropriate ICD therapy [antitachycardia pacing (ATP) & shocks].

Exclusion Criteria - Patients should not have any of the following criteria:

Contraindication or allergy to contrast media, routine procedural medications or catheter materials
Contraindication to an interventional procedure
Current or previous (within 3 months) amiodarone therapy
Atrial Fibrillation requiring antiarrhythmic drug therapy
Contraindication to amiodarone therapy
New York Heart Association (NYHA) functional class IV
Myocardial infarction within the past 60 days
Stroke within the past 90 days
Unstable angina
Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome
Patients with active ischemia that are eligible for revascularization
Life expectancy less than 6 months
Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation
Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
Current enrollment in another investigational drug or device study.
Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period.
Absolute contra-indication to the use of heparin and or warfarin.
Documented intra-atrial thrombus, ventricular thrombus (< 6 months after detection of thrombus), tumor, or another abnormality which precludes catheter introduction.
Females of childbearing potential who are not practicing protocol acceptable method of birth control.
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).

metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period.
Eligibility criteria:
Inclusion Criteria:

All newly diagnosed overweight/obese (BMI >/=28 kg/m2) African-American patients with new-onset DKA and/or severe hyperglycemia and without apparent precipitating cause will be considered for inclusion into the study. The diagnosis of DKA will be established by standard criteria (blood glucose > 250 mg/dL, pH < 7.3, HCO3 < 18 mmol/L, increased anion gap).
The hyperglycemic group will include patients with an admission plasma glucose > 400 mg/dL but without the presence of metabolic acidosis or ketosis.

Exclusion Criteria:

significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes;
recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism;
bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies;
pregnancy,
have an allergy to any component of metformin or sitagliptin.
Intervention: Bortezomib
Trial phase: Phase 4
ATC code: L01XG01 | L01XX32
SMILES: CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Patients with greater than 1gm of proteinuria per day will receive Velcade®.

Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 years of age or older.
Must have IgA nephropathy documented by kidney biopsy.
Must have greater than 1gm of proteinuria a day.
Must be on a stable dose of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocking agent (ARB) for at least 4 weeks prior to screening.

Exclusion Criteria:

Low platelet count and neutrophil count within certain limits defined for enrollment.
Underlying peripheral neuropathy.
Having cardiac problems, such as myocardial infarction, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Allergic to VELCADE®, boron or mannitol.
Female subjects who are pregnant or breast-feeding.
Recent use of investigational drug within 14 days before enrollment.
Having serious medical conditions and infections (including HIV,or hepatitis B or C) or psychiatric illness likely to interfere with participation in the study.
Diagnosed or treated for cancer within 3 years of participation in the study, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy.
Intervention: Oxycodone
Trial phase: Phase 4
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 239
Group description: Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
Eligibility criteria:
Study participation was offered to all pts. aged > 18 years in labor and delivery for elective or unplanned secondary cesarean in the 37th or higher week of gestation.

Inclusion Criteria:

cesarean in spinal anesthesia,
no history of opioid or metamizol treatment
written consent
ability to use a Patient-controlled analgesia device

Exclusion Criteria:

cesarean in general anaesthesia
use of peridural catheter for pre-, peri- or post cesarean analgesia
additional post cesarean metamizol use
allergy/hypersensitivity to morphine, oxycodon, acetaminophen or ibuprofen
chronic use of general anaesthesia
history of known pain syndrome
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: Child | Adult
Healthy volunteers: No
Participants at risk: 239
Group description: 1000 mg Acetaminophen Caplet
Eligibility criteria:
Inclusion Criteria:

Must be at least 16 and less than 51 years of age
Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
Must have up to four of their back teeth (third-molars) pulled

Exclusion Criteria:

Cannot be allergic to acetaminophen (Tylenol)
Cannot be pregnant (or planning to be pregnant) or nursing a baby
Cannot have any other medical conditions that the investigator determines might compromise your safety or the study results
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: Child | Adult
Healthy volunteers: No
Participants at risk: 241
Group description: 650 mg Acetaminophen Caplet
Eligibility criteria:
Inclusion Criteria:

Must be at least 16 and less than 51 years of age
Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
Must have up to four of their back teeth (third-molars) pulled

Exclusion Criteria:

Cannot be allergic to acetaminophen (Tylenol)
Cannot be pregnant (or planning to be pregnant) or nursing a baby
Cannot have any other medical conditions that the investigator determines might compromise your safety or the study results