anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Dipyridamole
Trial phase: Phase 4
ATC code: B01AC07
SMILES: OCCN(CCO)c1nc(N2CCCCC2)c2nc(N(CCO)CCO)nc(N3CCCCC3)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: There is only a single arm

dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
Eligibility criteria:
Inclusion Criteria:

Patients > 21 years old
Patient undergoing cardiac catheterization with planned PTCA or with a significant coronary lesion of either the LAD or Circumflex

Exclusion Criteria:

Theophylline or oral Persantine use in 24hrs
Second or third degree AV block, or sick sinus syndrome without a functioning pacemaker
Active asthma or bronchospasm
Patients with severe hepatic insufficiency
Patients experiencing an acute transmural infarction at the time of the index visit
Conditions that are known to affect resistive vessel function or myocardial flow
Intervention: Timolol
Trial phase: Phase 4
ATC code: C07AA06 | C07BA06 | C07DA06 | S01ED01 | S01ED51
SMILES: [H][C@](O)(CNC(C)(C)C)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Timolol in each eye, twice daily at 9 AM & 9 PM
Eligibility criteria:
Inclusion Criteria:

≥18 years;
IOP=16-30mmHg

OH or OAG with visual filed abnormality:

≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,
Glaucoma Hemifield Test outside normal limits,
Corrected Pattern Standard Deviation with p <5%

Exclusion Criteria:

Previous damage of anterior chamber angle;
ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
contact lens wearer;
severe central field loss;
uncontrolled cardiovascular, hepatic or renal disease;
any medication within past 1 month.
Intervention: Healon
Trial phase: Phase 4
SMILES: CC(=O)NC1C(O)OC(CO)C(O)C1OC1OC(C(=O)O)C(OC2OC(CO)C(O)C(OC3OC(C(=O)O)C(O)C(O)C3O)C2NC(C)=O)C(O)C1O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 184
Group description: Healon
Eligibility criteria:
Inclusion Criteria:

Patients able to understand and sign a document of informed consent;
Patients aged ≥49 years with age-related cataract formation;
Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens;
Patients that have healthy eyes excluding the formation of cataract.

Exclusion Criteria:

pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye;
A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye;
Iris atrophy in the operative eye;
Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye;
Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye;
Ocular hypertension (lntraocular Pressure (IOP) > 21 mmHg) in the operative eye at the baseline exam;
Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement;
Baseline endothelial cell density < 1500 cells/mm2, in the operative eye;
Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy
Patients 48 years of age or younger;
Proliferative diabetic retinopathy in the operative eye;
Uncontrolled diabetes mellitus;
Marfan's Syndrome;
An ocular disease and/or condition that may compromise results;
A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye;
Lens for the correction of astigmatism may be performed;
Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion;
A non-functional fellow eye;
Participation in any other clinical study within the 30 days before surgery
Intervention: Calcitriol
Trial phase: Phase 2
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Participant has a diagnosis of plaque-type psoriasis up to 20% of body surface area (BSA) involved excluding the scalp, with a Global Severity Score of at least 3 (moderate) at Screening
Participant presents with a representative target lesion that is at least 16 cm² in area, is located on the non-bony areas of the skin, has a Scaling Score up to 2 (moderate), has a DSS of at least 4

Exclusion Criteria:

Other type of psoriasis (other than plaque)
Significant abnormal lab findings
Hypercalcemia
Intervention: Buprenorphine
Trial phase: Phase 4
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Buprenorphine provided for 12 weeks up to 32 mg daily based on clinical assessment.
Eligibility criteria:
Inclusion Criteria:

female,
history of opioid dependence,
released back to the community from a controlled environment,
criminal justice involvement.

Exclusion Criteria:

under age 19,
medical contraindications,
major psychiatric problems.
Intervention: Doxycycline
Trial phase: Phase 2
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 1.0% doxycycline gel
Eligibility criteria:
Inclusion Criteria:

Have a documented history of type I or type II diabetes mellitus as defined by the American Diabetes Association

Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and:

• Agree to use a double-barrier method of contraception during their participation in this study;

condoms (with spermicide) and hormonal contraceptives OR
condoms (with spermicide) and intrauterine device OR
intrauterine device and hormonal contraceptives OR
Abstains from sexual intercourse during their participation in this study OR
Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant
Have an ulcer on the lower extremity (distal to a line connecting the medial and lateral malleoli) that has been present for at least 3 weeks and that is 1.2 cm2 to 4.0 cm2 at initial screening
Be able to apply study drug to their ulcer, or have a caregiver do it
Adequate blood flow to target ulcer extremity as measured by transcutaneous oxygen tension (TcpO2) of >30mmHg
Target ulcer is Grade I according to the Wagner Grading Scale
Quantitative bacterial count of of < 1.0 x 1.0E5 per gram of tissue for non-infected ulcers
Quantitative bacterial count of ≥ 1.0 x 1.0E5 per gram of tissue for infected ulcers

Exclusion Criteria:

Be a pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control.
Allergy to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative
Have more than three chronic ulcers present at baseline
Have undergone treatment with system corticosteroid or immunosuppressive therapy in the past 2 months
Have connective tissue disease
Currently be going through kidney dialysis for renal failure
Have undergone treatment with doxycycline, Procuren®, or Regranex® within the last 30 days
Have participated in another clinical research trial within the last 30 days
Have a known history of osteomyelitis affecting to the area where the target ulcer is present
Have any other concomitant condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
Subject has ulcers resulting from any cause other than diabetes (electrical burn, arterial insufficiency, chemical or radiation insult)
Intervention: Qlaira
Trial phase: Phase 3
SMILES: CC12CCC3=C4CCC(=O)C=C4CCC3C1CCC2(O)CC#N.CCCCC(=O)OC1CCC2C3CCc4cc(O)ccc4C3CCC12C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 106
Group description: Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles
Eligibility criteria:
Inclusion Criteria:

OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon
Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline

Exclusion Criteria:

Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing percutaneous nephrolithotomy for kidney stone disease

Exclusion Criteria:

History of nonsteroidal antiinflammatory drug allergy
Asthma
History of long-term opioid use
Intraoperative blood loss greater than 300 mL
Postoperative hemodynamic instability
Active peptic ulcer disease
Advanced renal impairment (Creatinine > 2.0 mg/dL)
Bleeding diathesis
Current use of probenecid
Pregnancy
Intervention: Omeprazole
Trial phase: Phase 3
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Subjects who received a single dose of Zegerid per day for either 1 or 7 days.
Eligibility criteria:
Inclusion Criteria:

Normal subjects who are 18-65 years of age.
Non-childbearing potential females or those using birth control.

Exclusion Criteria:

History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
History of significant gastrointestinal disease
Any significant medical illness
Gastrointestinal disorder or surgery leading to impaired drug absorption
Currently using gastrointestinal medications
Intervention: Magnesium omeprazole
Trial phase: Phase 3
ATC code: A02BC05
SMILES: COc1ccc2[n-]c(S(=O)Cc3ncc(C)c(OC)c3C)nc2c1.COc1ccc2[n-]c(S(=O)Cc3ncc(C)c(OC)c3C)nc2c1.[Mg+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Subjects who received a single dose of Prilosec per day for either 1 or 7 days.
Eligibility criteria:
Inclusion Criteria:

Normal subjects who are 18-65 years of age.
Non-childbearing potential females or those using birth control.

Exclusion Criteria:

History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
History of significant gastrointestinal disease
Any significant medical illness
Gastrointestinal disorder or surgery leading to impaired drug absorption
Currently using gastrointestinal medications
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Eligibility criteria:
Inclusion Criteria:

Patients donating a kidney via laparoscopic donor nephrectomy

Exclusion Criteria:

History of NSAID allergy
Asthma
History of long term opioid use
Intraoperative blood loss greater than 300 mL
Postoperative hemodynamic instability
Active peptic ulcer disease
Advanced renal impairment (Cr > 2.0 mg/dL)
Bleeding diathesis
Current use of probenecid
Pregnancy
Intervention: Labetalol
Trial phase: Phase 4
ATC code: C07AG01 | C07BG01 | C07CG01
SMILES: CC(CCc1ccccc1)NCC(O)c1ccc(O)c(C(N)=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: Bolus Labetalol began at 20 mg over 2 minutes
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Systolic blood pressure ≥180 mm Hg on 2 consecutive readings(10 minutes apart)presenting in the emergency department (ED)

Exclusion Criteria:

Use of any investigational drug within 1 month prior to emergency department (ED)
Pregnant or breast-feeding females
Contraindications or allergy to beta-blockers and calcium channel blockers (see FDA approved labeling for nicardipine intravenous and labetalol)
Subjects with decompensated congestive heart failure (CHF) or with a known left ventricular ejection fraction (LVEF) <35%
History of stroke within 30 days
Known liver failure
Suspected myocardial infarction
Suspected aortic dissection
Suspected cocaine overdose
Concurrently receiving other intravenous (I.V.) hypertensive medications
Intervention: Nortriptyline
Trial phase: Phase 3
ATC code: N06AA10
SMILES: CNCCC=C1c2ccccc2CCc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: Nortriptyline Hydrochloride dose escalation from 10 mg to 75 mg

Nortriptyline Hydrochloride: Nortriptyline; 10 mg, one capsule, po qhs (by mouth at bedtime each night) x 3 weeks, f03 visit, 25 mg, one capsule, po qhs x 3 weeks, f06 visit, 50 mg, two capsules, po qhs x 3 weeks, f09 visit, 75 mg, three capsules, po qhs x 6 weeks, f15 visit: taper study drug by one capsule a week, off study drug for the last week
Eligibility criteria:
Inclusion Criteria:

Age 21 through 65 years old at registration
Documentation of delayed gastric emptying on gastric emptying scintigraphy within 2 years of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours
Symptoms of gastroparesis for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of 21 or greater
Negative upper endoscopy or upper GI series within 2 years of registration

Exclusion Criteria:

Normal gastric emptying confirmed with scintigraphy
Diabetic gastroparesis or post-surgical gastroparesis including fundoplication
Another active disorder which could explain symptoms in the opinion of the investigator
History of significant cardiac arrhythmias and/or prolonged QTc
History of seizures
Use of narcotics more than 3 days per week
Use of tricyclic antidepressants for refractory symptoms of gastroparesis within 6 weeks prior to randomization
Use of strongly anticholinergic medications
Use of calcium channel blockers
Use of erythromycin
Clear history of failed trial of nortriptyline use for gastroparetic symptoms
Symptoms of primary depression or suicidal ideation

Contraindications to nortriptyline:

hypersensitivity or allergy to any tricyclic antidepressant drug
concomitant therapy with a monoamine oxidase inhibitor (MAOI)
recent myocardial infarction
glaucoma
Pregnancy or nursing
Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
Use of a G tube, J tube,or a central catheter for nutrition
Use of a gastric electrical stimulator
Failure to give informed consent
Intervention: Oxaliplatin
Trial phase: Phase 2
ATC code: L01XA03
SMILES: NC1CCCCC1N.O=C([O-])C(=O)[O-].[Pt+2]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 31
Group description: The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment.

Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements
Eligibility criteria:
Inclusion Criteria:

Non-penetrating TBI
Age 18 - 50 years.
Admission to a North Texas Traumatic Brain Injury Model System-affiliated rehabilitation unit within 8 weeks of injury. Enrollment in TBI-MS database not required.
Randomization within 2 - 10 weeks of injury.
Rancho Los Amigos Rating IV or better at the time of randomization. Should not be at Rancho IV level for more than 4 weeks before randomization.

GH deficiency diagnosed by either of the following two criteria:

. Peak GH response to L-arginine stimulation test < 1.4 microg/L; or
. Plasma IGF-1 level 1 SD below the expected median for age and body weight.
Availability of caregiver to oversee administration of medications.
Reasonable expectation for completion of outcome measures
Residence inside the United States

Exclusion Criteria:

History of pre-existing neurologic disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis)
History of premorbid disabling condition that interfere with outcome assessments
Contraindication to rhGH therapy. (hypersensitivity to rhGH or any of the components of the supplied product, including metacresol, glycerin, or benzyl alcohol)
Penetrating traumatic brain injury
Diabetes mellitus.
Obesity (BMI > 30).
Active infection.
Active malignant disease.
Acute critical illness, heart failure, or acute respiratory failure
Previous hospitalization for TBI > 1 day
Membership in a vulnerable population (prisoner)
Pregnancy. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy.
Lactating females
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: AZD1981 1000 mg, twice daily
Eligibility criteria:
Inclusion Criteria:

Men or women 40 years or above
FEV1 between 40 and 80% of predicted normal value post-bronchodilator
Clinical diagnosis of COPD

Exclusion Criteria:

Other clinically relevant disease or disorders
Exacerbation of COPD within 30 days
Intervention: Vicriviroc
Trial phase: Phase 1 | Phase 2
SMILES: COC[C@@H](c1ccc(C(F)(F)F)cc1)N1CCN(C2(C)CCN(C(=O)c3c(C)ncnc3C)CC2)C[C@@H]1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Drug: Vicriviroc Administered orally in either tablet or liquid form at a dosage of approximately 0.8/mg/kg every 24 hours, with a ritonavir boosted protease inhibitor containing background regimen
Eligibility criteria:
Inclusion Criteria:

Confirmed HIV infection
Treatment experienced subjects: Children or adolescents on an unchanged therapeutic regimen for at least 12 weeks and experiencing virologic failure OR participants on no treatment for 4 weeks or more but with history of virologic failure on a prior therapeutic regimen.
Likely to have virus that is sensitive to at least one ritonavir boosted protease inhibitor
HIV viral load greater than or equal to 1,000 copies/ml within 90 days prior to Step I entry
Able to swallow study medication, in tablets or liquid form specific to age-assigned cohort
Parent, legal guardian or participant able and willing to provide signed informed consent and to have the participant followed at the clinic site
Willing to use effective methods of contraception

Inclusion Criteria for Step II (In addition to the inclusion criteria for Step I):

Participant's plasma HIV tested at Step I must be R5 tropic
Genotypic sensitivity enabling the participant to take optimized background therapy (OBT) consisting of at least a ritonavir-based protease inhibitor. More information on this criterion can be found in the study protocol.

Exclusion Criteria:

Presence of any currently active AIDS defining illness or history of malignancy
History of a seizure disorder that requires current anti-seizure medication for control or at risk for seizures. Those with a history of febrile seizures alone are not excluded.
Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
Any vaccinations 14 days prior to Step I, or scheduled to occur within 14 days prior to entry into Step II, and the week 24 and 48 visits in Step II
Allergy or sensitivity to study drug or its ingredients
Taking any Step II disallowed medications (see protocol) and unable or unwilling to discontinue them at least one week prior to entering Step II
Use of NNRTIs other than etravirine 21 days prior to Step II entry
Pregnancy or breastfeeding. Infants who are receiving breastmilk are allowed to enroll.

Exclusion Criteria for Step II

All exclusion criteria for Step I
Participants harboring dual or mixed tropic virus (R5/X4) or X4 virus or non phenotypable virus
Current or anticipated use of any disallowed medications
Use of efavirenz, nevirapine, and delavirdine for 21 days prior to Step II entry
Pregnant within 3 days of Step II entry