anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Olopatadine Hydrochloride
Trial phase: Phase 4
SMILES: CN(C)CCC=C1c2ccccc2COc2ccc(CC(=O)O)cc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
Eligibility criteria:
Inclusion Criteria:

Read, sign, and date an Ethics Committee reviewed and approved informed consent form.

Females of childbearing potential who:

Are not breast-feeding;
Do not intend to become pregnant for the duration of the study;
Are using adequate birth control methods and agree to continue for the duration of the study.
Able to read, understand and answer questions by investigator.
Willing and able to attend all required study visits and follow directions as stipulated by the protocol and investigator.
History of allergic conjunctivitis (within the past 12 months) and active signs and symptoms of ocular allergies for which treatment is necessary, in the opinion of the investigator.
Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with or without glasses correction.
Ocular health within normal limits as determined by the investigator.
No contact lens wear 14 days prior to enrollment and willing to not wear contact lenses for the duration of the study.
Willing to follow a 14-day washout period due to contraindicated medication use, if deemed necessary by investigator.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Contraindications or hypersensitivity to the use of the test article or its components.
Inability or unwillingness to follow all study instructions and complete study visits as required.
Only one sighted eye or visual acuity not correctable to 20/30 (Snellen) in both eyes at the Screening Visit.
Ocular trauma within 6 months prior to Visit 1 in either eye.
Any ocular surgical intervention within six months prior to Visit 1 or anticipation of ocular surgery during the study.
Presumed or actual ocular infection within 30 days prior to Visit 1.
Any severe or serious ocular condition or significant illness.
Any abnormal slit-lamp findings at the time of the Screening Visit.
Contact lens wear within 14 days prior to the study start and unwillingness to undergo a wash-out period of 14 days; unwilling to not wear contact lenses for the duration of the study.
Use of over-the-counter (OTC) ocular medications within the past 14 days unless willing to follow wash out period.
Use of topical or systemic ocular medications requiring longer than a two-week washout period.
Participation in any other investigational study in the 30-day period before entry into this study (i.e., Visit 1) or concomitantly with this study.
Women who are pregnant, nursing, or of childbearing potential not utilizing adequate birth control measures.
Other protocol-defined exclusion criteria may apply.
Intervention: Bimatoprost
Trial phase: Phase 3
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: 157
Group description: Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Eligibility criteria:
Inclusion Criteria:

-Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).

Exclusion Criteria:

Damage to eyelid area (scarring) that may prevent growth of eyelashes
Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
Current eyelash implants of any kind
Eyelash tint or dye application within 2 months of baseline
Eyelash extensions application within 3 months of baseline
Use of eyelash growth products within 6 months of baseline
Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.
Intervention: Avanafil
Trial phase: Phase 4
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: 146
Group description: Avanafil 100 mg: One dose 15 minutes before attempting intercourse
Eligibility criteria:
Inclusion Criteria:

Males ≥ 18 years of age;
Minimum 6 months of erectile dysfunction;
In a monogamous, heterosexual relationship for at least 3 months;
Agree to make at least 4 attempts at intercourse per month;
Provide written informed consent;
Agree not to use any other ED treatments for erectile dysfunction;
Willing and able to comply with all study requirements.

Exclusion Criteria:

Allergy or hypersensitivity to PDE5 inhibitors;
History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor;

Concomitant use of one or more of the following medications:

Other prescription or OTC drugs known to interfere with metabolism by the CYP 3A4 enzyme;
Dose of an alpha blocker that has not been stable for at least 14 days;
Any nitrate;
ED as a consequence of advanced neurologic disease, spinal cord injury,or radical prostatectomy;
Myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months;
Unstable angina, angina with sexual intercourse, or congestive heart failure > NYHA Class II;
Poorly controlled type 1 or type 2 diabetes;
Evidence of prostate cancer or previous radical prostatectomy;
Untreated hypogonadism or total testosterone levels outside normal reference range;
Abnormal laboratory value(s) judged to be clinically significant by the investigator;
Positive urine drug screen;
History of retinitis pigmentosa, nonarteritic anterior ischemic optic neuropathy or glaucoma;
Previous participation in any other study with avanafil;
Use of any other investigational medication or device for any indication within 30 days prior to enrollment or at any time during this study;
Evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity or confound the interpretation of study results.
Intervention: Avanafil
Trial phase: Phase 4
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: 146
Group description: Avanafil 200 mg: One dose 15 minutes before attempting intercourse
Eligibility criteria:
Inclusion Criteria:

Males ≥ 18 years of age;
Minimum 6 months of erectile dysfunction;
In a monogamous, heterosexual relationship for at least 3 months;
Agree to make at least 4 attempts at intercourse per month;
Provide written informed consent;
Agree not to use any other ED treatments for erectile dysfunction;
Willing and able to comply with all study requirements.

Exclusion Criteria:

Allergy or hypersensitivity to PDE5 inhibitors;
History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor;

Concomitant use of one or more of the following medications:

Other prescription or OTC drugs known to interfere with metabolism by the CYP 3A4 enzyme;
Dose of an alpha blocker that has not been stable for at least 14 days;
Any nitrate;
ED as a consequence of advanced neurologic disease, spinal cord injury,or radical prostatectomy;
Myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months;
Unstable angina, angina with sexual intercourse, or congestive heart failure > NYHA Class II;
Poorly controlled type 1 or type 2 diabetes;
Evidence of prostate cancer or previous radical prostatectomy;
Untreated hypogonadism or total testosterone levels outside normal reference range;
Abnormal laboratory value(s) judged to be clinically significant by the investigator;
Positive urine drug screen;
History of retinitis pigmentosa, nonarteritic anterior ischemic optic neuropathy or glaucoma;
Previous participation in any other study with avanafil;
Use of any other investigational medication or device for any indication within 30 days prior to enrollment or at any time during this study;
Evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity or confound the interpretation of study results.
Intervention: Olopatadine
Trial phase: Phase 3
ATC code: R01AC08 | S01GX09
SMILES: CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 518
Group description: AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
Eligibility criteria:
Inclusion Criteria:

Able and willing to comply with study protocol and follow protocol instructions.
Adequate birth control methods for the duration of the study.
Best-corrected visual acuity (BCVA) of 55 or greater in each eye.
Willing to avoid contact lens wear during each of the study visits; contact lens wear also should be stable and consistent for 1 month prior to Visit 1 and expected to remain the same for the study duration.
Willing and able to sign an Informed Consent form.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Women of childbearing potential that are pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Evidence of contact lens care solution related ocular surface damage or giant papillary conjunctivitis (GPC).
Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye or have had any ocular infection within 30 days prior to Visit 1.
Using systemic medication(s) on a chronic dosing regimen for less than 30 days or changed dosage of this medication within 30 days prior to Visit 1.
Current or past history of glaucoma or ocular hypertension.
History of retinal detachment, diabetic retinopathy, or progressive retinal disease.
Presence of ocular conditions that may affect the study outcomes.
Corneal conditions affecting the corneal structure.
History or evidence of any ocular surgical procedure within 1 year prior to Visit 1.
Current or recent medical conditions that, in the opinion of the Investigator, would preclude safe participation in the study.
Prior, current, or anticipated use of ophthalmic agents other than investigational product during study participation.
Participation in any investigational study within 30 days prior to Visit 1 or concomitantly with this study.
Known contraindications or hypersensitivities to any of the study medications or their components.
Other protocol-specified exclusion criteria may apply.
Intervention: Amphetamine
Trial phase: Not Applicable
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: There is only one arm to the study. All subjects will receive amphetamine.

Amphetamine: All subjects will receive amphetamine to induce elevated dopamine levels in the brain.
Eligibility criteria:
Inclusion Criteria:

men and women, aged 18-55 years
who are able to read and write
who are able to give voluntary written informed consent
have no current uncontrolled medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology
have no history of a neurological or psychiatric disorder, e.g., no DSMIV Axis 1 diagnosis in 2 preceding years, except nicotine dependence in smokers)
drink less than 21 drinks/week for women and less than 35 drinks per week for men
have not used marijuana in the past 30 days and have not met criteria for dependence in the past 2 years
do not suffer from claustrophobia or any MRI contradictions
nonsmokers (smoked < 40 cigarettes in lifetime with urinary cotinine levels 0-30 ng/mL both at intake evaluation and on scan day)
smokers (smoked at least 10 cigarettes/day for at least one year with an FTND>3, urine cotinine >150 ng/mL and CO >12 ppm at intake)

Exclusion Criteria:

psychosis
presence of acute or unstable medical or neurological illness. Subjects will be excluded from the study if they present with any history of serious medical or neurological illness or if they show signs of a major medical or neurological illness on examination or lab testing including history of seizures, head injury, brain tumor, heart, liver or kidney disease, eating disorder, diabetes.
regular use of any psychotropic drugs including anxiolytics and antidepressants and other over-the-counter medications and herbal products within the last six months
pregnancy/breast feeding (as documented by pregnancy testing at screening or on days of the imaging studies),
suicidal ideation or behavior
pacemaker or other ferromagnetic material in body.
use of medications which affect dopamine transmission within 2 weeks of the PET study
participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for normal volunteers
Intervention: Simvastatin
Trial phase: Not Applicable
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 121
Group description: Statins (40mg/day)for an average of 12 weeks

Statin: Statins (40mg/day)for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Sedentary metabolic syndrome subjects will be 25-59 y of age
overweight to Class I or II obese (BMI 25-39 kg/m2) men and women
2 of 4 other characteristics of the metabolic syndrome including fasting glucose of 100 to 125 mg/dl; waist circumference greater than 102 cm in men and 88 cm in women, serum triglyceride concentration greater than 150 mg/dl, HDL-C concentrations less than 40 mg/dl in men and 50 mg/dl in women, and blood pressure greater than 130/85 mmHG
Women must be taking birth control or be postmenopausal.

Exclusion Criteria:

Diagnosed cardiovascular disease or diabetes or disease
Symptoms that could alter their ability to perform exercise
Fasting blood glucose of greater than 126 mg/dl
Smoking
Taking any medications or supplements (e.g., statins, fibrates, metformin, thiazolidenediones, anti-hypertensives (ACE-inhibitors and angiotensin blockers) which could affect blood lipids or insulin sensitivity.
Women who are pregnant or plan to become pregnant during the duration of the study
Individuals exercising regularly (more than one 30 min session per week)
Individuals with an orthopedic limitations for walking.
Report any allergies to the medications (statins, lidocaine)
Intervention: Desflurane
Trial phase: Phase 1 | Phase 2
ATC code: N01AB07
SMILES: FC(F)OC(F)C(F)(F)F
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
Eligibility criteria:
Inclusion Criteria:

- Elderly patients (>= 65 yr-old), long operation (> 4hours), abdominal surgery patients

Exclusion Criteria:

- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI>35)
Intervention: Sevoflurane
Trial phase: Phase 1 | Phase 2
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
Eligibility criteria:
Inclusion Criteria:

- Elderly patients (>= 65 yr-old), long operation (> 4hours), abdominal surgery patients

Exclusion Criteria:

- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI>35)
Intervention: Desmopressin
Trial phase: Phase 3
ATC code: H01BA02
SMILES: N=C(N)NCCC[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSCCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 243
Group description: ACYC active, topically applied to the face for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Male or female between the ages of 12 and 40 (inclusive)
Written and verbal informed consent must be obtained.
Subjects less than 18 years of age must sign an assent for the study and a parent or a legal guardian must sign the informed consent
Subject must have moderate to severe acne at the baseline visit
Women of childbearing potential must be willing to practice effective contraception for the duration of the study

Key Exclusion Criteria:

Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study
Dermatological conditions on the face that could interfere with clinical evaluations
Intervention: Pregabalin
Trial phase: Phase 3
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 274
Group description: Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Eligibility criteria:
Inclusion Criteria:

Subjects must have chronic peripheral neuropathic pain present for than 6 months after a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms.
Subjects must have sufficient post-traumatic neuropathic pain at screening and baseline.

Exclusion Criteria:

Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome (CTS) or with central neuropathic pain (for example, due to spinal cord injury) or with Complex Regional Pain Syndrome (CRPS, Type I or Type II).
Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.
Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses greater than or equal to 150 mg/day, who have previously participated in a pregabalin clinical trial or who have been treated with pregabalin at any time during the 6 month period prior to screening.
Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV infection; any clinically unstable cardiovascular (including a myocardial infarction [heart attack] in the 3 months prior to screening), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3 months prior to screening) respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus; untreated hypothyroidism.
Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example, schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder (GAD) or major depression that is clinically stable.
Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment.
Use of prohibited medications in the absence of appropriate washout periods.
Intervention: Febuxostat
Trial phase: Not Applicable
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Febuxostat group. The primary outcome of the study is the 24 hour ABPM differences while participants were taking allopurinol compared to taking febuxostat.
Eligibility criteria:
Inclusion Criteria:

Patients currently treated at the University of Mississippi Medical Center General Internal Medicine/Hypertension or Family Medicine Clinics.
Have a diagnosis of gout.
Taking allopurinol at a stable dose for at least 2 months.

Exclusion Criteria:

Less than 18 years old.
Severe renal impairment defined as CrCl <30 mL/min.
Previous diagnosis of severe hepatic impairment.
Currently taking azathioprine, mercaptopurine, or theophylline.
Pregnant, breastfeeding, or anticipating pregnancy or breastfeeding.
Arm circumference greater than 50 cm.
Change in antihypertensive medication within the previous 2 months.
Intervention: Simvastatin
Trial phase: Phase 1 | Phase 2
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months

Simvastatin: 40 mg, orally, once daily for 3 months
Eligibility criteria:
Inclusion Criteria:

Sickle cell disease (HbSS or S/β0 thalassemia)
≥ 3 vaso-occlusive pain episodes in the year prior to enrollment
Age ≥ 10 years
Weight > 30 kg

Exclusion Criteria:

Creatine kinase (CK) > UNL
Total cholesterol < 90 mg/dL, or triglycerides <30mg/dL
Renal dysfunction (Creatinine > 1.5-fold UNL)
Hepatic dysfunction (ALT > 2-fold UNL)
Treatment with drugs having known metabolic interactions with statins within the past 30 days
Vaso-occlusive pain requiring hospitalization within past 30 days
Red blood cell transfusion within the past 30 days
Pregnancy/lactation
Musculoskeletal disorder associated with an elevated CK level
Past or present history of substance abuse (alcohol, cocaine, amphetamines, heroin)
Chronic pain caused by avascular necrosis of the bone (AVN) or leg ulcers, and pain due to trauma or causes other than SCD.
Major cognitive or neurological impairments that may hamper the ability to use the smartphone or complete the electronic pain diary in this study