anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tadalafil
Trial phase: Phase 4
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 250
Group description: Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

History of Erectile Dysfunction (ED) of at least 3 months duration.
Anticipate having the same adult female sexual partner during the study.
Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.

Exclusion Criteria:

Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
ED caused by untreated or inadequately treated endocrine disease.
Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
Severe renal or hepatic impairment, history of malignant hypertension.
Presence or history of specific heart conditions.
Intervention: Tadalafil
Trial phase: Phase 4
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 257
Group description: Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

History of Erectile Dysfunction (ED) of at least 3 months duration.
Anticipate having the same adult female sexual partner during the study.
Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.

Exclusion Criteria:

Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
ED caused by untreated or inadequately treated endocrine disease.
Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
Severe renal or hepatic impairment, history of malignant hypertension.
Presence or history of specific heart conditions.
Intervention: Metformin
Trial phase: Not Applicable
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: 10
Group description: Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Eligibility criteria:
Inclusion Criteria:

Systolic HF of any etiology (left ventricular ejection fraction ≤ 40%)
Previously-diagnosed, inadequately controlled DM (HbA1c≥7.5%)
On any combination of anti-diabetic medications excluding metformin

Exclusion Criteria:

Current metformin therapy
Previous intolerance to metformin therapy
Renal dysfunction (creatinine clearance < 60 ml/minute)
History of lactic acidosis.
Intervention: Difluprednate
Trial phase: Phase 3
ATC code: D07AC19
SMILES: [H][C@@]12CC[C@](OC(=O)CCC)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 39
Group description: Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
Eligibility criteria:
Inclusion Criteria:

0 to 3 years of age.
Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens.
Informed consent signed by a parent or legal guardian.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
Use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery.
Patients with posttraumatic cataract.
Active uveitis in the study eye.
Ocular neoplasm in the study eye.
Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS).
Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patient's only good eye.
Patients on systemic steroids or nonsteroidal anti-inflammatory drugs.
History of steroid-induced intraocular pressure (IOP) rise.
Currently on medication for ocular hypertension or glaucoma in the study eye.
Diabetes.
Other protocol-defined exclusion criteria may apply.
Intervention: Tretinoin
Trial phase: Phase 3
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Eligibility criteria:
Inclusion Criteria:

Subjects 18 years of age and older of any race.
Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation.
Willing and able to understand and sign informed consent.
Able to complete study and comply with study procedures.

Exclusion Criteria:

Severe self reported facial sensitivity
History of allergy to fish
Severe sun sensitivity
Severe erythematotelangiectatic rosacea requiring systemic treatment
Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
Unwilling to undergo facial biopsies
Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids
Use of topical rosacea treatments in the past 2 weeks.
Use of systemic antibiotics in the past 4 weeks.
Use of systemic retinoids within the past 6 months.
Use of topical retinoids within the past 3 months
Use of laser or light based rosacea treatments within the past 2 months.
Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months
Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments.
Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
If female, Subjects who are either of non-child bearing potential (defined as postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of childbearing potential, Subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth-control to prevent pregnancy during the study.(The type and dose of birth control must have been stable for at least 2 months prior to study entry and not be expected to change during the study).
Subjects who are lactating.
Use of any investigational therapy within the past 4 weeks.
Known hypersensitivity or previous allergic reaction to retinoids
Carcinoid, Pheochromocytoma or other systemic flushing causes
Intervention: Metyrosine
Trial phase: Phase 2
ATC code: C02KB01
SMILES: CC(N)(Cc1ccc(O)cc1)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).
Eligibility criteria:
Key Inclusion Criteria:

Females of childbearing potential cannot be at risk of pregnancy during the study.
Genetically confirmed diagnosis of VCFS at the time of screening.
Must have one of the following Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision (DSM-IV TR) diagnoses (applicable based upon clinical assessments): schizophrenia, schizoaffective disorder, psychosis not otherwise specified (NOS), bipolar disorder, or mood disorder with psychotic features.
A total PANSS composite score >65.
Willing to discontinue psychotropic medications. -

Key Exclusion Criteria:

Evidence of acute suicidality.
Known or observed clinically significant cardiovascular, pulmonary, renal, hepatic, or gastrointestinal disorders; other clinically significant psychiatric/neurological and sleep disorders by DSM-IV-TR criteria; endocrine, or hematological or metabolic diseases.
Full scale IQ of less than 50.
Pregnancy.
Not using a reliable means of contraception.
Systolic blood pressure of ≤110 mm/Hg or ≥160 mm/Hg, diastolic blood pressure ≤60 mm/Hg or ≥90 mm/Hg, or has clinically symptomatic orthostatic changes.
QTcF > 450 msec, or PR > 250 msec, or QRS > 110 msec on ECG.
History of seizure disorder. -
Intervention: Water
Trial phase: Phase 2
SMILES: O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
Eligibility criteria:
Inclusion Criteria:

An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
No current active caries or periodontal disease that may compromise the study or the health of the subjects
A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute

Exclusion Criteria:

Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Intervention: Tadalafil
Trial phase: Phase 4
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 205
Group description: 5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
Eligibility criteria:
Inclusion Criteria:

At least a 3-month history of erectile dysfunction (ED).
Are able to read, understand and provide signed informed consent.
Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 17 and less than 26 at screening.
Have been taking a maximum dose of sildenafil citrate (100 milligram [mg]), vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month prior to screening.
Anticipate having the same female sexual partner during the study who is willing to participate in the required number of sexual intercourse attempts and complete study measures during the study.
Agree to make at least four sexual intercourse attempts during both the 4-week as needed run-in period and the 4-week non-drug run-in period.
Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the 4-week non-drug, run-in, the double-blind treatment period, the open label period and for 96 hours after the end of the study.

Partner Inclusion Criteria:

Are female and at least 18 years of age at screening.
Anticipate having the same male study subject as her sexual partner during the study.
Able to read, understand and provide signed informed consent.
Agree to make the required number of sexual intercourse attempts with the male sexual study partner during the study.
Willing to participate in recording responses to the treatment satisfaction scale.

Exclusion Criteria:

Have an IIEF-EF domain score of greater than or equal to 26 at screening.
Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor
Have previously used or are currently using any PDE5 inhibitor once daily.
Present with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease.
Partner unwilling to complete all study requirements.
History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator
Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
Have previously completed or withdrawn from this study or any other study investigating tadalafil for once-daily use.
Intervention: Dopamine
Trial phase: Phase 2
ATC code: C01CA04
SMILES: NCCc1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
Eligibility criteria:
Inclusion Criteria:

A diagnosis of heart failure as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
Prior clinical diagnosis of heart failure Must be identified within 24 hours of hospital admission (24 hour clock begins when the admission orders are placed)
Estimated GFR of > 15 but < 60 mL/min/1.73m2 determined by the MDRD equation
Male or female patient ≥18 years old
Willingness to provide informed consent
Ability to have a PICC or central line placed (if needed) within 12 hours of randomization and study drug infusion started
Anticipated hospitalization of at least 72 hours

Exclusion Criteria:

Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation
Anticipated need for IV vasoactive treatment or ultra-filtration for heart failure during this hospitalization
Systolic BP <90 mmHg
Hemoglobin (Hgb) < 9 g/dl
Renal replacement therapy
History of renal artery stenosis > 50%
Hemodynamically significant arrhythmias including ventricular tachycardia or defibrillator shock within 4 weeks
Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or anginal equivalent)
Active myocarditis
Hypertrophic obstructive cardiomyopathy
Greater than moderate stenotic valvular disease
Restrictive or constrictive cardiomyopathy
Complex congenital heart disease
Constrictive pericarditis
Non-cardiac pulmonary edema
Clinical evidence of digoxin toxicity
Need for mechanical hemodynamic support
Sepsis
Terminal illness (other than HF) with expected survival of less than 1 year
Previous adverse reaction to the study drugs
Use of IV iodinated radiocontrast material in last 72 hours or planned during hospitalization
Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
Inability to comply with planned study procedures
Pregnancy or nursing mothers
Intervention: Tretinoin
Trial phase: Phase 3
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 209
Group description: Retin-A Micro 0.1%
Eligibility criteria:
Inclusion Criteria:

Normal, healthy male and female children and adult
Written and verbal informed consent must be obtained. Patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent.
Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study.
Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
Considered reliable and capable of understanding their responsibility and role in the study.

Exclusion Criteria:

Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
Abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).
Use topical acne therapy during the two week period prior to study initiation.
Use of systemic retinoid treatment within six months prior to study initiation.
Pregnant or breast-feeding.
Serious psychological illness.
Participation in any clinical research study during the 30 day period preceding study initiation.
Intervention: Topiramate
Trial phase: Phase 3
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 | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: Titration of 50 mg in weekly increments over 3 weeks to 200 mg
Eligibility criteria:
Inclusion Criteria:

Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.
Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).
Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.

Exclusion Criteria:

Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.
Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.
Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.
Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.
Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.
Have taken topiramate within the past 6 months.
Intervention: Arasertaconazole mononitrate
Trial phase: Phase 2
SMILES: Clc1ccc(C(Cn2ccnc2)OCc2csc3c(Cl)cccc23)c(Cl)c1.O=[N+]([O-])O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: placebo pessary, single dose
Eligibility criteria:
Inclusion Criteria:

Women aged between 18 to 65 years of age who have signed the informed consent.
Not pregnant, not nursing.
No indication of other vulvovaginitis or genital infections
Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.
Negative wet mount results for T. vaginalis and clue cells.
Exclusion Criteria:
Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.
Hypersensitivity to imidazole products administered topically.
Any other medical condition which in the opinion of the investigator could interfere with study conduct.
Intervention: Efavirenz
Trial phase: Phase 3
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
Eligibility criteria:
Inclusion Criteria:

HIV-infected child 3 to 5 years of age at time of screening for this trial if enrolled from outside or any age if enrolled from control arm of Neverest II.
Reliable history or documented exposure to NVP used as part of PMTCT
Initiated antiretroviral therapy with LPV/r at age less than 36 months
Receiving LPV/r-based ART for at least 12 months
At least one viral load measurement less than 50 copies/ml conducted as part of screening for the study
ALT measurement grade I or less (DAIDS Toxicity Tables 2004) (Appendix A). These may be repeated until ALTs normalize if necessary.

Exclusion criteria:

Prior treatment with any NNRTI drug as part of a therapeutic regimen
Substitution of other NRTI drugs (instead of 3TC and D4T which are the standard first line regimen) will be allowed.
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: No
Participants at risk: 41
Group description: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily

Efavirenz: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Eligibility criteria:
Inclusion Criteria:

HIV infected patients, age >18 years, meet Vietnam guideline to begin ART (CD4 count < 350 cells/mm3 and/or WHO stage III or IV disease)
Hepatitis C infection as documented by positive HCV antibodies and a detectable serum HCV RNA level
AST and ALT ≤ 2 x ULN (≤ 80 U/L)
Estimated creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

Any prior ART
Positive Hepatitis B surface antigen
Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding)
Requirement for acute therapy for other AIDS-defining illness within 14 days prior to study entry
Currently on rifampicin therapy
In the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period