anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: DUAC gel
Trial phase: Phase 4
SMILES: CCCC1CC(C(=O)NC(C(C)Cl)C2OC(SC)C(OP(=O)(O)O)C(O)C2O)N(C)C1.O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects with mild to moderate acne vulgaris on the face,.
Subjects of either sex aged between 12 and 39 years, inclusive.
Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study.

Exclusion Criteria:

Women who are pregnant, breast-feeding, or sexually active with the potential to have children, and not using a contraception method that is safe from a medical point of view
Subjects using anti-androgen containing contraceptives.
Subjects who, during the past month, have received oral or topical steroids or antibiotics, or acne treatment of any type, including natural or artificial UV therapy.
Subjects who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the medicinal products which will be used during the study.
Subjects using, or having used in the past month, any significant concomitant medicinal product which might affect their acne, as judged by the Investigator.
Subjects with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
Subjects with a history of photosensitivity.
Intervention: Celecoxib
Trial phase: Phase 4
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 100
Group description: Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
Eligibility criteria:
Inclusion Criteria:

Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA)
Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible
≥2 years of age and <18 years of age prior to the Baseline visit
Body weight ≥10 kg at the Baseline visit
Candidate for chronic NSAID therapy in the Investigator's judgment

Exclusion Criteria:

Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA)
Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded
Subjects with active Systemic JIA should not be enrolled
Intervention: Naproxen
Trial phase: Phase 4
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 98
Group description: Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit
Eligibility criteria:
Inclusion Criteria:

Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA)
Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible
≥2 years of age and <18 years of age prior to the Baseline visit
Body weight ≥10 kg at the Baseline visit
Candidate for chronic NSAID therapy in the Investigator's judgment

Exclusion Criteria:

Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA)
Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded
Subjects with active Systemic JIA should not be enrolled
Intervention: Carbamazepine
Trial phase: Phase 4
ATC code: N03AF01
SMILES: NC(=O)N1c2ccccc2C=Cc2ccccc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Carbamazepine

Carbamazepine
Eligibility criteria:
Inclusion Criteria:

Age ≥16yr old
Who are diagnosed as epilepsy definitely
Who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months
Who need AED therapy and no AED medication for previous 1 year (exclude emergency medication for less than 2weeks)
Who is not pregnant
Who can report seizure diary by him/herself or caregiver
Who agree to this trial and provide informed consent.
Type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial motor seizures;

Exclusion Criteria:

Who has progressive CNS disease.
Has serious systemic or psychiatric disease
Who is not suitable by investigator(uncooperative)
Who can not fill up diary check card
Is pregnant, breastfeeding, or planning to become pregnant
Exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other substance abusers, mental retardation etc.
Who cancels to agree to this trial and provide informed consent.
ALT, AST, bilirubin and BUN/Cr levels are more than twice normal range of them
WBC value is 2000 and less, Hb value is 9.0 and less, platelet count is 100,000 and less in CBC
Who took investigation products before participating this study
Intervention: Acyclovir
Trial phase: Not Applicable
ATC code: D06BB03 | D06BB53 | J05AB01 | S01AD03
SMILES: Nc1nc2c(ncn2COCCO)c(=O)[nH]1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 88
Group description: Acyclovir 400 mg orally three times daily
Eligibility criteria:
Inclusion Criteria:

HIV negative as determined by concordant rapid testing
HSV-2 seropositive (Focus HerpeSelect >3.4)
At least one prior occurrence of GUD
18-50 years of age

Exclusion Criteria:

Current use, or use w/in past 7 days of acyclovir, valacyclovir, or famciclovir
Prior hypersensitivity &/or allergic reaction to acyclovir
Use of probenicid
Current use, or use within past 28 days, of an investigational agent
Currently pregnant or nursing
Currently plan to become pregnant during next 3 months
Any condition that will interfere with successful completion of study procedures
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine. Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.

0.9% Saline: Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) Classification I - III
Scheduled for Open Posterior Lumbar Fusion over 3+ (bony) levels

Exclusion Criteria:

Allergy to dexmedetomidine
Cardiac disease with reduced ejection fraction < 30%
History of cirrhosis, active hepatitis or attenuated hepatic function
Chronic use of steroids, COX-2 inhibitors, alpha-2 agonists, or statins
Current anticoagulant therapy
Patients requiring motor evoked potential (MEP) monitoring
Positive pregnancy test
Intervention: Caffeine Citrate
Trial phase: Phase 4
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O.O=C(O)CC(O)(CC(=O)O)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 74
Group description: Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.

Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages.
Eligibility criteria:
Inclusion Criteria:

Preterm infants from 24 to 30 weeks completed PMA admitted to the neonatal intensive care unit (NICU) at St. Louis Children's Hospital. The estimated post menstrual age will be provided by the obstetrical records and compared with a Dubowitz exam at admission. The provided PMA will be used unless the Dubowitz exam has a discrepancy of greater or equal to 2 weeks, where then the Dubowitz age will be used.
Infants must be recruited within the first 24 hours of life.

Exclusion Criteria:

Infants over 30 weeks gestation.
Infants who are moribund with severe sepsis, in respiratory failure, or have severe brain injury present in the first 24 hours of life. This would be defined as physiologic instability requiring >80% FiO2 for 6 hours and/or more than 2 inotropic drugs (excluding hydrocortisone), or in the attending or recruiting physicians' opinion the infant is likely to die within 24 hours or would not tolerate any handling for the protocol.
Infants must not have received any doses of caffeine citrate prior to enrollment.
Intervention: Caffeine Citrate
Trial phase: Phase 4
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O.O=C(O)CC(O)(CC(=O)O)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 74
Group description: Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.

Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages.
Eligibility criteria:
Inclusion Criteria:

Preterm infants from 24 to 30 weeks completed PMA admitted to the neonatal intensive care unit (NICU) at St. Louis Children's Hospital. The estimated post menstrual age will be provided by the obstetrical records and compared with a Dubowitz exam at admission. The provided PMA will be used unless the Dubowitz exam has a discrepancy of greater or equal to 2 weeks, where then the Dubowitz age will be used.
Infants must be recruited within the first 24 hours of life.

Exclusion Criteria:

Infants over 30 weeks gestation.
Infants who are moribund with severe sepsis, in respiratory failure, or have severe brain injury present in the first 24 hours of life. This would be defined as physiologic instability requiring >80% FiO2 for 6 hours and/or more than 2 inotropic drugs (excluding hydrocortisone), or in the attending or recruiting physicians' opinion the infant is likely to die within 24 hours or would not tolerate any handling for the protocol.
Infants must not have received any doses of caffeine citrate prior to enrollment.
Intervention: Everolimus
Trial phase: Phase 2
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
Eligibility criteria:
DISEASE CHARACTERISTICS:

Low or intermediate-1 risk myelodysplastic syndromes by International Prognostic Scoring System (IPSS) criteria

IPSS score < 1.5
Requiring transfusion of 2 units of red blood cells at least once a month (four weeks prior to accrual on study)

High levels of endogenous epoetin alfa (i.e., > 200 mU/mL)

Unlikely to respond to epoetin alfa, or has a documented clinical non-response to epoetin alfa (at a dose of ≥ 40,000 U weekly) or darbepoetin alfa (at a dose > 200 mcg every other week) (i.e., < 2 g/dL increase in hemoglobin and no decrease in transfusion requirements after at least 4 weeks of treatment)
No chronic myelomonocytic leukemia

PATIENT CHARACTERISTICS:

ECOG Performance Status of 0-2
Liver enzymes (AST and ALT) and total bilirubin ≤ 2 times upper limit of normal
Serum creatinine ≤ 2 times upper limits of normal
No clinically significant anemia due to iron, B12, or folate deficiencies; autoimmune or hereditary hemolysis; or gastrointestinal bleeding
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other serious or poorly controlled medical condition that could be exacerbated by or complicate compliance with study therapy

PRIOR CONCURRENT THERAPY:

At least 4 weeks since prior treatment (including growth factors)
No chronic use (> 2 weeks) of physiologic doses of a corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 28 days of the first day of study drug
No concurrent use of another investigational agent
No concurrent therapy with any cytotoxic drugs, steroids, or growth factors
Intervention: Vitamin E
Trial phase: Phase 3
SMILES: Cc1c(C)c2c(c(C)c1O)CC[C@@](C)(CCC[C@H](C)CCC[C@H](C)CCCC(C)C)O2
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Vitamin E

Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy.
Eligibility criteria:
Inclusion Criteria:

Patients must have histologically or cytologically confirmed prostate cancer.
Patients must have localized prostate cancer and have decided to undergo a prostatectomy or brachytherapy.
Patient must not be taking supplemental vitamin E.
Age >18 years.
Life expectancy of greater than 6 months.
ECOG performance status =< 2.

Patients must have normal organ and marrow function as defined below:

leukocytes >= 3,000/mcL
absolute neutrophil count >=1,500/mcL
platelets >=100,000/mcL
total bilirubin within normal institutional limits
AST/ALT =< 2.5 X institutional upper limit of normal
creatinine =< 1.5 X normal institutional upper limit of normal
INR =<1.4
PTT =<1.4 X institutional upper limit of normal
Patients must have the ability to understand, and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who have metastatic prostate cancer.
Patients may not be receiving any other investigational agents.
Patients with a known bleeding diathesis or patients on therapeutic anticoagulation. (This does not include the use of aspirin but refers to warfarin, heparin, or low molecular weight heparins).
History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin E.
The patient may not receive a gonadotrophin release agonist (such as goserelin, or leuprolide), or an antiandrogen (such as bicalutamide, flutamide, or nilutamide) during the study.

Uncontrolled intercurrent illness that would limit compliance with study requirements.

Inclusion of Women and Minorities

Only men are eligible for this trial. Members of all races and ethnic groups are eligible for this trial.
Intervention: Vitamin E
Trial phase: Phase 3
SMILES: Cc1c(C)c2c(c(C)c1O)CC[C@@](C)(CCC[C@H](C)CCC[C@H](C)CCCC(C)C)O2
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Placebo (same vehicle as used for vitamin E)

Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy.
Eligibility criteria:
Inclusion Criteria:

Patients must have histologically or cytologically confirmed prostate cancer.
Patients must have localized prostate cancer and have decided to undergo a prostatectomy or brachytherapy.
Patient must not be taking supplemental vitamin E.
Age >18 years.
Life expectancy of greater than 6 months.
ECOG performance status =< 2.

Patients must have normal organ and marrow function as defined below:

leukocytes >= 3,000/mcL
absolute neutrophil count >=1,500/mcL
platelets >=100,000/mcL
total bilirubin within normal institutional limits
AST/ALT =< 2.5 X institutional upper limit of normal
creatinine =< 1.5 X normal institutional upper limit of normal
INR =<1.4
PTT =<1.4 X institutional upper limit of normal
Patients must have the ability to understand, and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who have metastatic prostate cancer.
Patients may not be receiving any other investigational agents.
Patients with a known bleeding diathesis or patients on therapeutic anticoagulation. (This does not include the use of aspirin but refers to warfarin, heparin, or low molecular weight heparins).
History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin E.
The patient may not receive a gonadotrophin release agonist (such as goserelin, or leuprolide), or an antiandrogen (such as bicalutamide, flutamide, or nilutamide) during the study.

Uncontrolled intercurrent illness that would limit compliance with study requirements.

Inclusion of Women and Minorities

Only men are eligible for this trial. Members of all races and ethnic groups are eligible for this trial.
Intervention: Avanafil
Trial phase: Phase 3
ATC code: G04BE10
SMILES: COc1ccc(CNc2nc(N3CCC[C@H]3CO)ncc2C(=O)NCc2ncccn2)cc1Cl
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
Eligibility criteria:
Inclusion Criteria:

Male subjects, age ≥ 18 years;
Minimum 6 month history of mild to severe erectile dysfunction;
Have documented diabetes (type 1 or type 2);
Subject is in a monogamous, heterosexual relationship for at least 3 months;
Subject agrees to make at least 4 attempts at intercourse per month;
Subject is willing and able to provide informed consent.

Exclusion Criteria:

Allergy or hypersensitivity to PDE5 inhibitors;
History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
Current or expected use of organic nitrates at any time during the study;
Previous or current antiandrogen therapy;
Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;
Androgen replacement therapy that has not been stable for at least 3 month;
Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;
ED as a result of spinal cord injury or radical prostatectomy;
Untreated hypogonadism or low serum total testosterone
History of or predisposition to priapism;
Any penile implant;
Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;
History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);
Uncontrolled diabetes;
Uncontrolled hypertension;
Hypotension;
Orthostatic hypotension;
Significant cardiovascular disease;
Abnormal ECG;
Hepatic or renal impairment;
Positive STD screen;
Clinically evident penile lesions, abrasions, or anatomical deformities;
Urinary tract or bladder infection;
Use of any treatment for erectile dysfunction other than study drug at any time during the study;
Participation in another investigational study within 30 days of screening or at any time during this study;
Previous participation in any other investigational study of avanafil;
History or current drug, alcohol, or substance abuse;
Any history of bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for at least 3 months;
Partners who are < 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;
Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.