anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ephedrine
Trial phase: Phase 3
ATC code: A08AA56 | C01CA26 | R01AA03 | R01AB05 | R01BA02 | R01BA52 | R03CA02 | S01FB02
SMILES: CN[C@@H](C)[C@@H](O)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Pseudoephedrine is a 240 mg PO per day

Pseudoephedrine: Pseudoephedrine is a 240 mg PO per day
Eligibility criteria:
Inclusion Criteria:

Age 18 to 65.
History of allergic rhinitis.
The ability to be placed on placebo without significant compromise in the quality of life.
General good health.
Ability to comply with the protocol and sign an informed consent.
Have daytime sleepiness by history.
Have poor sleep by history.
Have fatigue by history.
Have a skin test or RAST test to a perennial allergen (indoor mold, dog, cat, mite) with correlating symptoms.

Exclusion Criteria:

Age fewer than 18 or over 65 years.
A history of sleep apnea.
Atopic diseases other than allergic rhinitis, such as atopic dermatitis or asthma.
Non-allergic rhinitis.
Hypertension
Diabetes Mellitus
Inability to tolerate pseudoephedrine
Significant other diseases as determined by the investigator.
Use of a research medication within 30 days.
Use of a nasal steroid or topical antihistamine or decongestant within 30 days.
Use of beta-blockers, antidepressants, oral decongestants, oral steroids, or H2-blockers.
Excessive use of alcohol or drug abuse.
Inability to stop medication use during run-in period.
Use of an oral antihistamine within 1 week of enrollment.
Failed to have benefit when pseudoephedrine was used for rhinitis or asthma in the past
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 4
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 35
Group description: Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).
Eligibility criteria:
Inclusion Criteria:

children 0-6 years of age.
clinical diagnosis of blepharoconjunctivitis
Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
Subjects who are monocular.
Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.
Intervention: Aliskiren
Trial phase: Phase 3
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 339
Group description: During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
Eligibility criteria:
Inclusion Criteria:

Outpatients ≥18 years of age.
Patients with a diagnosis of Stage II hypertension, defined as mean sitting Systolic Blood Pressure (msSBP) ≥ 160 mmHg and < 180 mmHg at Visit 2.

Exclusion Criteria:

Severe hypertension defined as msSBP ≥ 180 mmHg and/or mean sitting Diastolic Blood Pressure (msDBP) ≥ 110 mmHg.
Secondary form of hypertension.
Current diagnosis of heart failure (New York Heart Association [NYHA] Class II-IV).
Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
Second or third degree heart block without a pacemaker.
Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1.
Clinically significant valvular heart disease.
Previous history of hypertensive encephalopathy or stroke, Transcient Ischemic Attack (TIA), heart attack, coronary bypass surgery or any PCI.
Known Keith-Wagener grade III or IV hypertensive retinopathy.
In the month prior to Visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications.
Patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications.
Inability to discontinue prior antihypertensive or other CV medications as required by the protocol.
Patients with Type 1 diabetes mellitus.
Patients with Type 2 diabetes mellitus not well controlled .
Elevated Serum potassium (over 5.3 mEq/L (mmol/L).
Any surgical or medical condition or the use of any medication which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s)
Eligibility criteria:
Inclusion Criteria:

patients recently diagnosed with primary open angle glaucoma or ocular hypertension
Caucasian and African American ethnicities
Male and Female
Age 30 and above

Exclusion Criteria:

A history of ocular medication use within the last 12 months
Inflammatory/ allergic skin diseases or dermatitis
presence of periocular hyperpigmented skin lesions
Systemic pigmentation disorders
Use of systemic drugs that can affect skin pigmentation
Visitation of tanning salons, or use of self tanning products
Pregnancy or patients planning to become pregnant in the near future
Intervention: Aliskiren
Trial phase: Phase 3
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 191
Group description: Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients 65 years of age and older.
Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Exclusion Criteria:

Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
History or evidence of a secondary form of hypertension.
Known Keith-Wagener grade III or IV hypertensive retinopathy.
History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
Current diagnosis of heart failure (NYHA Class II-IV).
History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
Current angina pectoris requiring pharmacological therapy other than nitrates.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Aliskiren
Trial phase: Phase 3
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 189
Group description: Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients 65 years of age and older.
Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Exclusion Criteria:

Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
History or evidence of a secondary form of hypertension.
Known Keith-Wagener grade III or IV hypertensive retinopathy.
History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
Current diagnosis of heart failure (NYHA Class II-IV).
History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
Current angina pectoris requiring pharmacological therapy other than nitrates.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Aliskiren
Trial phase: Phase 3
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 188
Group description: Aliskiren 300 mg tablet taken once daily in the morning with a light meal.
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients 65 years of age and older.
Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Exclusion Criteria:

Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
History or evidence of a secondary form of hypertension.
Known Keith-Wagener grade III or IV hypertensive retinopathy.
History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
Current diagnosis of heart failure (NYHA Class II-IV).
History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
Current angina pectoris requiring pharmacological therapy other than nitrates.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Aripiprazole 2mg,5mg,10mg,15mg
Eligibility criteria:
Inclusion Criteria:

Patients who can provide an assent form signed by themselves and informed consent form by their legal representatives prior to performing of any study procedures.
Male or female children and adolescents aged 6 to 18 years
Patients who are diagnosed with chronic tic disorders(Motor or Phonic) or Tourette's disorder according to DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition)(using K-SADS-PL-K (Kiddle-Schedule for Affective Disorders and Schizophrenia,Present and Lifetime Version-Korean version)) and require drug therapy.
The total tic score of the K-YGTSS (Korean version of Yale Global Tic Severity Scale)is more than 22 at baseline

Exclusion Criteria:

Patients with secondary tic symptoms accompanied by Tardive tics, Huntington disease, neuroacanthocytosis, mental retardation, or autism
Patients with IQ (Intelligence quotient) (assessed using KEDI-WISC (Korean educational Development Institute-Wechsler Intelligence Scale for children)) 70 and lower than 70
Patients with a history of neuroleptic malignant syndrome
Patients with antipsychotic or alcohol use disorder (abuse, dependence, and/or withdrawal) according to DSM-IV criteria for the past 3 months
Patients with a history of allergy or hypersensitivity reaction to aripiprazole
Patients with a history of resistance to treatment with antipsychotics
Patients who have participated in another clinical study within 1 month prior to screening
Patients who have previously taken aripiprazole or participated in a clinical study with aripiprazole
Intervention: Dutasteride
Trial phase: Not Applicable
ATC code: G04CA52 | G04CB02
SMILES: [H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1([H])C(=O)Nc1cc(C(F)(F)F)ccc1C(F)(F)F
Sex: Male
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months

dutasteride: 6 months of dutasteride 3.5 mg daily
Eligibility criteria:
Inclusion criteria:

Histologically confirmed adenocarcinoma of the prostate

Clinical stage T1b, T1c, or T2a disease
Gleason score ≤ 6
Maximal prostate-specific antigen (PSA) < 10 ng/mL
Demonstrates intra-prostatic metabolite abnormalities, consistent with adenocarcinoma of the prostate (i.e., ≥ 3 voxels with magnetic resonance spectroscopy imaging [MRSI] scores 4-5) by baseline MRI and MRSI
Has symptomatic benign prostatic hypertrophy and is currently undergoing watchful waiting OR opting to undergo permanent seed implant (i.e., brachytherapy), but requires neoadjuvant androgen suppression for prostate shrinkage
No regional lymph node involvement
No evidence of distant metastases
Zubrod performance status 0-1
Able to swallow and retain oral medications

Exclusion Criteria:

Other prior or concurrent invasive cancer, other than localized basal cell or squamous cell carcinoma of the skin

Contraindications to MRI/MRSI, including any of the following:

Prostate biopsy (within the past 8 weeks) and any continued post-biopsy bleeding
Rectal bleeding
Anal fissures
Rectal surgery (end-to-end anastomosis)
Inflammatory bowel disease
Prior radical prostatectomy
Hip replacement
Certain types of penile implants
Vascular clips
Known anaphylactic reaction to latex compounds
Anticoagulant drugs
Severe claustrophobia
Cardiac pacemaker
Metal in eye
Any other metallic or foreign object in the body
Unstable serious co-morbidities including, but not limited to, myocardial infarction, coronary artery syndrome, cardiac arrhythmias, symptomatic congestive heart failure, or cerebrovascular accident
Major medical or psychiatric illness that, in the investigator's opinion, would preclude the completion of treatment and interfere with follow up
Known hypersensitivity to any 5α-reductase inhibitor or drug chemically related to the study drug
Prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
Prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
Prior or concurrent cytotoxic chemotherapy for prostate cancer
Prior hormonal therapy, such as luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide acetate), antiandrogens (e.g., flutamide or bicalutamide), or estrogens (e.g., diethylstilbestrol)
Prior or concurrent finasteride, dutasteride, other drugs with known antiandrogenic properties (e.g., spironolactone or progestational agents), or any dietary or herbal supplement (e.g., selenium, vitamin E, saw palmetto, or PC-SPES)
Intervention: Tazarotene
Trial phase: Not Applicable
ATC code: D05AX05 | D05AX55
SMILES: CCOC(=O)c1ccc(C#Cc2ccc3c(c2)C(C)(C)CCS3)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Topical imiquimod and topical tazarotene 0.1% cream group:

Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week.
Eligibility criteria:
Inclusion Criteria:

The study population will consist of eighty subjects who are 18 years or older and have a biopsy-proven lentigo maligna.
The subjects must have a LM that is in a location amenable to treatment with imiquimod, express a willingness and ability to comply with study requirements, and tolerate an outpatient surgical procedure.
All participants will sign consent documents prior to enrollment.
The typical age of patient that develops a LM is beyond the child-bearing range.

Exclusion Criteria:

In the event that a patient with a LM is pregnant, they will be excluded from the study.
inability to tolerate the surgical procedure
invasive melanoma
previous surgery on the site of interest
Intervention: Benzodiazepine
Trial phase: Phase 4
SMILES: C1=Cc2ccccc2NN=C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female participants of any race or ethnicity with any psychiatric diagnosis
Age of 50 and older
Having been treated with an BZD-derivative hypnotic drug at a steady dose for at least 4 weeks

Exclusion Criteria:

Incapacity to follow the instructions.
Unstable physical illness or significant neurological disorder
Psychiatric concerns raised by the physician of record regarding participation in the study.
Intervention: SODIUM FLUORIDE
Trial phase: Phase 3
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 55
Group description: Participants brushed their natural teeth twice daily with a full ribbon of NaMFP and NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Eligibility criteria:
Inclusion Criteria

Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Age:Aged between 18 and 78 years.
Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period.
Diagnosis: Oral - i. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F). ii. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). iii. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. iv.All restorations in a good state of repair.
Salivary Flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 ml/minute; gum base stimulated whole saliva flow rate = 0.8 ml/minute).

Exclusion Criteria

Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
Breast-feeding:Women who are breast-feeding.
Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study T3157495 where the wash in period prior to treatment is sufficient.
Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to the screening visit.
Fluoride:Taking fluoride supplements for medical reasons.
Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects.
Personnel: a) A member of the site study staff, b) An employee of the sponsor, c) Any employee of any toothpaste manufacturer or their spouse or family member.
Intervention: SODIUM FLUORIDE
Trial phase: Phase 3
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: Participants brushed their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Eligibility criteria:
Inclusion Criteria

Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Age:Aged between 18 and 78 years.
Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period.
Diagnosis: Oral - i. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F). ii. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). iii. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. iv.All restorations in a good state of repair.
Salivary Flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 ml/minute; gum base stimulated whole saliva flow rate = 0.8 ml/minute).

Exclusion Criteria

Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
Breast-feeding:Women who are breast-feeding.
Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study T3157495 where the wash in period prior to treatment is sufficient.
Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to the screening visit.
Fluoride:Taking fluoride supplements for medical reasons.
Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects.
Personnel: a) A member of the site study staff, b) An employee of the sponsor, c) Any employee of any toothpaste manufacturer or their spouse or family member.