anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pioglitazone
Trial phase: Phase 2
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.

Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.
Eligibility criteria:
Inclusion Criteria:

Patients with Pulmonary Arterial Hypertension (PAH) must be stable on therapy for at least 3 months prior to enrollment in the trial. We will include patients with idiopathic PAH and Familial PAH as well as PAH associated with collagen vascular disease or drug or toxin exposure. With the exception of PAH, subjects must be free of major medical illnesses, including diabetes mellitus (must have fasting plasma glucose < 126 mg/dL and taking no anti-hyperglycemic agent), malignancy or significant hepatic or renal disease. Subjects may be hypertensive and on anti-hypertensive medications as long as blood pressure is < 150/100 mm Hg. Subjects may also be dyslipidemic and/or taking drugs to improve abnormalities of lipid metabolism, but they will be excluded if they are taking medications known to alter insulin sensitivity, including glucocorticoids, niacin, anti-retrovirals, thiazolidinediones, or metformin. Use of oral contraceptives or estrogen and/or progesterone replacement therapy is permitted. Weight must be stable and the subjects agree not to change their eating habits or exercise regimen during the study period. There will be no restrictions with regard to race or socioeconomic status, and the racial/ethnic composition of the study population will be reflective of the communities surrounding the Stanford University Medical Center.

Exclusion Criteria:

* Vulnerable subject status.

Concurrent Endothelin-1 antagonist therapy
Concurrent Thiazolidinedione therapy
New York Heart Class III or IV
PAH related to other etiologies.
Diabetes Mellitus with Fasting Glucose Levels > 126 mg/dL
Allergy or hypersensitivity to pioglitazone or bosentan administration.
Current treatment with statin therapy.
Initiation of PAH therapy (prostacyclin analogues, phosphodiesterase-5 inhibitors) within three months of enrollment.
Inability or unwillingness to avoid systemic steroid containing medications for four months. Inhaled steroid use is acceptable.
Current or recent use or planned treatment with: glyburide, cyclosporine, nilotinib, nisoldipine, ranolazine, thioridazine
Hepatic transaminases > 2x the upper limit of normal at the center at screening.
Current or recent (< 6 months) chronic heavy alcohol consumption.
Current use of another investigational drug (non-FDA approved) for PAH.
Lung transplant recipients.
History of myositis.
Renal failure (Cr 2.0).
Hospitalized or acutely ill.
Chronic liver disease (cirrhosis, chronic hepatitis, etc.).
Abnormalities of the arm or hand or radical mastectomy (preventing brachial artery ultrasound).
Pregnant or lactating women.
Intervention: Hydromorphone
Trial phase: Phase 3
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 167
Group description: 1 mg IV hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, "Do you want more pain medication?"

Hydromorphone: 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later
Eligibility criteria:
Inclusion Criteria:

Age 21 to 64 years.
Pain with onset within 7 days.
Emergency Department attending physician's judgment that patient's pain warrants use of intravenous opioids.
Normal mental status.

Exclusion Criteria:

Prior use of methadone.
Use of other opioids, tramadol, or heroin in the past seven days.
Prior adverse reaction to morphine, hydromorphone, or other opioids.
Chronic pain syndrome.
Alcohol intoxication.
Systolic Blood Pressure < 90 mm Hg.
Use of monoamine oxidase (MAO) inhibitors in past 30 days.
Weight less than 100 pounds.
Baseline room air oxygen saturation less than 95%.

C02 measurement greater than 46: In accordance with a number of similar studies that we have performed, four subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46, then the patient will be excluded from the study. The 4 subsets are as follows:

All patients who have a history of chronic obstructive pulmonary disease (COPD)
All patients who have a history of sleep apnea
All patients who report a history of asthma together with greater than a 20 pack-year smoking history
All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation
Intervention: Lansoprazole
Trial phase: Phase 4
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 123
Group description: Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
Eligibility criteria:
Inclusion Criteria:

Adults with H.pylori infection.

Exclusion Criteria:

Pregnancy,
Nursing,
Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,
Known sensitivity to Urea or citrica.
Intervention: Pantoprazole
Trial phase: Phase 4
ATC code: A02BC02 | A02BD04 | A02BD11
SMILES: COc1ccnc(CS(=O)c2nc3ccc(OC(F)F)cc3[nH]2)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 123
Group description: Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
Eligibility criteria:
Inclusion Criteria:

Adults with H.pylori infection.

Exclusion Criteria:

Pregnancy,
Nursing,
Antibiotic, bismuth or PPI treatment 2 weeks prior to trial,
Known sensitivity to Urea or citrica.
Intervention: Sugammadex
Trial phase: Phase 3
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 29
Group description: At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
Eligibility criteria:
Inclusion Criteria:

-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).

For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.

Exclusion Criteria:

-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the (family of) study/sponsor staff.
Intervention: Neostigmine
Trial phase: Phase 3
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 31
Group description: At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
Eligibility criteria:
Inclusion Criteria:

-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).

For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.

Exclusion Criteria:

-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the (family of) study/sponsor staff.
Intervention: Sugammadex
Trial phase: Phase 3
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 120
Group description: At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
Eligibility criteria:
Inclusion Criteria:

-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).

For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.

Exclusion Criteria:

-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the (family of) study/sponsor staff.
Intervention: Neostigmine
Trial phase: Phase 3
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 111
Group description: At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
Eligibility criteria:
Inclusion Criteria:

-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).

For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.

Exclusion Criteria:

-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the (family of) study/sponsor staff.
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Includes all subjects who received escitalopram in one of the three medication periods
Eligibility criteria:
Inclusion Criteria:

Healthy male aged 21 to 50 years.
Capable of providing informed consent.
Has an established residence and phone.

Exclusion Criteria:

Meets DSM-IV criteria for an Axis I or II disorder.
History of substance dependence or abuse within the past month.
Use of NSAID's, beta blockers, calcium channel blockers, antidepressants, antipsychotic medications, lithium or other medication which in the opinion of the investigator would alter vascular responsivity.
Regular use of sedative hypnotic or narcotic medication, or other medication that might affect the individual's perception of visual stimuli.
History of cataracts or significant visual impairment.
A medical condition, which in the opinion of the investigator is likely to affect the individual's perception of the visual stimuli or vascular response.
Participation in a research protocol that included administration of medication within the past 3 months.
Cigarette smoking.
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Includes all subjects who received citalopram in one of the three medication periods
Eligibility criteria:
Inclusion Criteria:

Healthy male aged 21 to 50 years.
Capable of providing informed consent.
Has an established residence and phone.

Exclusion Criteria:

Meets DSM-IV criteria for an Axis I or II disorder.
History of substance dependence or abuse within the past month.
Use of NSAID's, beta blockers, calcium channel blockers, antidepressants, antipsychotic medications, lithium or other medication which in the opinion of the investigator would alter vascular responsivity.
Regular use of sedative hypnotic or narcotic medication, or other medication that might affect the individual's perception of visual stimuli.
History of cataracts or significant visual impairment.
A medical condition, which in the opinion of the investigator is likely to affect the individual's perception of the visual stimuli or vascular response.
Participation in a research protocol that included administration of medication within the past 3 months.
Cigarette smoking.
Intervention: Lovaza
Trial phase: Not Applicable
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
Eligibility criteria:
Inclusion Criteria:

Women age 40 and older in the peri- or postmenopausal period, as defined in Soules et al. 2001
Meet criteria for Major Depressive Disorder on the MINI (Mini-International Neuropsychiatric Interview)
Score of 18 or greater on MADRS (Montgomery-Asberg Depression Rating Scale) at screening visit
Do not meet criteria for placebo response during placebo run-in phase; placebo response is defined as a > 50% decrease in MADRS from screening to end of placebo run-in phase
Willing to receive treatment on an outpatient basis
Presence of general good health

Exclusion Criteria:

Currently pregnant, trying to conceive, or breastfeeding
Treatment with an antidepressant medication currently or in the past 1 month
Treatment with hormone replacement therapy currently or in the past 1 month
Treatment with Omega-3 supplements currently or in the past 1 month
Use of birth control pills currently or in the past 1 month
Presence of suicidal ideation
Meet criteria for current or within the past month for panic disorder, obsessive compulsive disorder (OCD), psychosis, mania or hypomania, as assessed by the MINI
Diagnosis of treatment resistant Major Depressive Disorder, defined as patients who have been treated with two or more therapeutic courses of antidepressant medication without remission of symptoms for the current episode of depression, as assessed by the MINI
Any medical condition that would make participation in the study unsafe, as determined by investigator
Presence of a known allergy to fish or fish oil that would put participant at risk, as determined by a study investigator
Intervention: Promega
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)O.CCCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients.

Omegaven™: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.
Eligibility criteria:
Inclusion Criteria:

Patients must be enrolled in the Intestinal Rehabilitation Program at the University of Nebraska Medical Center, AND:
Be unable to meet nutritional needs solely by enteral nutrition and be expected to require PN for at least another 30 days
Have clinical evidence of parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. A liver biopsy is desirable but not necessary for treatment
Signed patient informed consent

Exclusion Criteria:

Parent or guardian or child unwilling to provide consent or assent
Inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the Intestinal Rehabilitation Program
Allergies or clinical conditions precluding safe use of Omegaven™
Intervention: Sugammadex
Trial phase: Phase 3
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 115
Group description: At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
Eligibility criteria:
Inclusion Criteria:

-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using

rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).

For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.

Exclusion Criteria:

-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the

(family of) study/sponsor staff.
Intervention: Cetirizine
Trial phase: Phase 4
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: cross over = all participants received all interventions
Eligibility criteria:
Inclusion Criteria:

patients 18 years of age or older

patients with perennial allergic rhinitis sensitized (positive RAST within the last 3 years or wheal greater than or equal to 3 mm within the last 3 years) to either:

dust mite
cat (if they own an indoor cat)
dog (if they own an indoor dog)
will allow for sensitization to tree, grass, or weed pollen, cockroach, or mold
history of reported sedation/somnolence when taking cetirizine
patient must have taken cetirizine for at least 1 week prior to discontinuing it
patients must have either tolerated levocetirizine in the past or have never tried levocetirizine.

Exclusion Criteria:

chronic urticaria requiring ongoing antihistamine or steroid treatment
atopic dermatitis requiring ongoing antihistamine or steroid treatment
URI or sinus infection during the 2 weeks preceding the beginning of the study
vasomotor (non-allergic) or irritant rhinitis
afrin use
elderly or over 77 years of age (could affect creatinine clearance) or chronic renal insufficiency
patients who have not tolerated levocetirizine in the past due to sedation.
taking other prescription or over the counter antihistamines and unwilling to stop them during the study
the presence of a sleep disorder such as sleep apnea or narcolepsy
the use of as needed sleeping aid medication
the presence of other chronic medical conditions which in the opinion of the investigator would prevent the subject from being able to participate effectively
Intervention: Tetracaine
Trial phase: Not Applicable
ATC code: C05AD02 | D04AB06 | N01BA03 | N01BA53 | S01HA03
SMILES: CCCCNc1ccc(C(=O)OCCN(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: betadine: betadine 5%

Topical Anesthetic
Eligibility criteria:
Inclusion Criteria:

greater or equal to 18 years old
uni- or bi-lateral visually significant cataracts

Exclusion Criteria:

hypersensitivity to betadine5%, topical tetracaine0.5%, or lidocaine2% jelly
pregnancy
Intervention: Carvedilol
Trial phase: Phase 4
ATC code: C07AG02 | C07FX06
SMILES: COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions

Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
Eligibility criteria:
Inclusion Criteria:

on hemodialysis > 30 days
aged 18 to 80 years old
ability to provide informed consent
Primary nephrologist deems patient is at target dry weight
Predialysis SBP >140 or postdialysis SBP>130

Exclusion Criteria:

Patients with active wounds
Blood pressure unable to be measured by routine mechanisms in the upper extremity
Change in blood pressure medications in the previous 2 weeks
Intolerance of beta or alpha-blockers
pregnancy
Resting heart rate <50
Life expectancy < 6 months
Current therapy with carvedilol or contraindication to carvedilol (ONLY in the intervention arm)