anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Citalopram
Trial phase: Not Applicable
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.
Eligibility criteria:
Inclusion Criteria:

Men and women aged 60-90 years
Diagnosis with nonpsychotic Diagnostic and Statistical Manual (DSM) IV MDD
24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16
Willing to and capable of providing informed consent and complying with study procedures

Exclusion Criteria:

Current comorbid Axis I DSM IV disorder other than Nicotine Dependence, Adjustment Disorder, or Anxiety Disorder
diagnosis of substance abuse or dependence (excluding Nicotine Dependence) within the past 12 months
History of psychosis, psychotic disorder, mania, or bipolar disorder
Diagnosis of probable Alzheimer's Disease, Vascular Dementia, or Parkinson's Disease
MMSE < 24
HRSD suicide item > 2 or Clinical Global Impressions (CGI)-Severity score of 7 at baseline
history of allergic or adverse reaction to escitalopram, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20mg) during the current episode
current treatment with psychotherapy, antidepressants, antipsychotics, or mood stabilizers
having contraindication to MRI scanning (such as metal in body) or unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)
acute, severe, or unstable medical or neurological illness
Intervention: Elagolix
Trial phase: Phase 3
ATC code: H01CC03 | H01CC53
SMILES: COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 226
Group description: Elagolix 150 mg QD for the 6-month Treatment Period
Eligibility criteria:
Inclusion Criteria:

Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the Washout Period.
Agrees to use required birth control methods during the entire length of participation in the study.
Subject has a Composite Pelvic Signs and Symptoms Score total score of 6 or greater at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain.
Subjects must have at least two regular menstrual cycles with an interval of 24-38 days within the Screening Period, prior to Day 1.

Exclusion Criteria:

Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
Subject has a history of previous non-response to gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot medroxyprogesterone acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain.
Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
Subject has a history of osteoporosis or other metabolic bone disease.
Subject has a current history of undiagnosed abnormal uterine bleeding.
Intervention: Elagolix
Trial phase: Phase 3
ATC code: H01CC03 | H01CC53
SMILES: COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 229
Group description: Elagolix 200 mg BID for the 6-month Treatment Period
Eligibility criteria:
Inclusion Criteria:

Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the Washout Period.
Agrees to use required birth control methods during the entire length of participation in the study.
Subject has a Composite Pelvic Signs and Symptoms Score total score of 6 or greater at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain.
Subjects must have at least two regular menstrual cycles with an interval of 24-38 days within the Screening Period, prior to Day 1.

Exclusion Criteria:

Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
Subject has a history of previous non-response to gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot medroxyprogesterone acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain.
Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
Subject has a history of osteoporosis or other metabolic bone disease.
Subject has a current history of undiagnosed abnormal uterine bleeding.
Intervention: Ethanol
Trial phase: Phase 3
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 378
Group description: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.

Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
Eligibility criteria:
Inclusion Criteria:

Diagnosed atrial fibrillation
recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use
written informed consent

Exclusion Criteria:

intracardiac thrombus
pregnancy
Intervention: Nitrite
Trial phase: Phase 2
SMILES: O=N[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
Eligibility criteria:
Inclusion Criteria:

Scheduled to undergo a cardiac catheterization procedure.
Clinical symptoms of shortness of breath and fatigue
Normal left ventricular ejection fraction (≥50%)
Elevated left ventricular filling pressures at cardiac catheterization (defined as resting pulmonary capillary wedge pressure (PCWP)>15 mmHg and/or PCWP≥25 mmHg during exercise)

Exclusion Criteria:

Systolic BP <120 mmHg
Prior nitrate therapy (within previous 2 weeks)
Glucose 6-phosphate dehydrogenase (G6PD) deficiency
Other "non-HFpEF" specific causes of heart failure such as significant valvular disease (>moderate left-sided regurgitation, >mild stenosis), severe pulmonary disease, unstable coronary disease or coronary spasm, primary renal or hepatic disease, constrictive pericarditis, or infiltrative, restrictive, or hypertrophic cardiomyopathies
Intervention: Etelcalcetide
Trial phase: Phase 3
ATC code: H05BX04
SMILES: CC(=O)N[C@H](CSSC[C@H](N)C(=O)O)C(=O)N[C@H](C)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](C)C(=O)N[C@H](CCCNC(=N)N)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
Eligibility criteria:
Inclusion Criteria

Subject is 18 years of age or older at the time of informed consent.
Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.
Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).
Other Inclusion Criteria may apply.

Exclusion Criteria

Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.
Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.
Subject is pregnant or nursing.
Anticipated or scheduled parathyroidectomy during the study period.
Subject has received a parathyroidectomy within 6 months prior to dosing.
Other Exclusion Criteria may apply.
Intervention: Methylphenidate
Trial phase: Phase 4
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 20
Group description: For the first week, participants received the low-dose Methylphenidate condition (Concerta® over-encapsulated). Over the subsequent 3 weeks, the dose was titrated based on medication response and side effects to determine the optimal dose used for week 4.

The weekly dosages were low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial.
Eligibility criteria:
Inclusion Criteria:

Between ages of 6-17
Sustained Moderate to Severe TBI
TBI occurred at least 6 months prior to beginning the study
TBI occurred no earlier than 5 years of age
Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale

Exclusion Criteria:

History of developmental disability or mental retardation
Current active participation in ADHD-related behavioral intervention
History of psychiatric condition requiring an inpatient admission in past 12 months
Actively taking medications with a contraindication to Concerta that cannot be discontinued
Current use of stimulant medication or ADHD specific medications that cannot be discontinued
Non-blunt head injury
Family history of arrhythmia
Pregnancy
Intervention: Pirfenidone
Trial phase: Phase 2
ATC code: L04AX05
SMILES: Cc1ccc(=O)n(-c2ccccc2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of systemic sclerosis-related (SSc) confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis less than (<) 7 years
Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan
Screening forced vital capacity (FVC) greater than equal to (>=) 50 percent (%) of the predicted value, and screening carbon monoxide diffusing capacity (DLCO) >=40% of the predicted value
At study entry, the participant either was not taking SSc-ILD medication or was taking cyclophosphamide or mycophenolate

Exclusion Criteria:

Clinically significant pulmonary hypertension
Known underlying liver disease
Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux
History of clinically significant asthma or chronic obstructive pulmonary disease
Active infection
Diagnosis of another connective tissue disorder
Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention
History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD)
Pregnancy or lactation
Creatinine clearance <40 milliliters per minute (mL/min)
Prior use of pirfenidone
Unsuitable for enrollment or unlikely to comply with study requirements
Intervention: Cromolyn Sodium
Trial phase: Phase 1 | Phase 2
SMILES: O=C([O-])c1cc(=O)c2c(OCC(O)COc3cccc4oc(C(=O)[O-])cc(=O)c34)cccc2o1.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.

Cromolyn Sodium
Eligibility criteria:
Inclusion Criteria:

Subject is male or non-pregnant female, 18 - 80 years of age.
Subjects willing and able to give informed consent.
Subjects willing and able to comply with the requirements of the study.
Subject has the clinical diagnosis of at least mild erythema.
Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study
Subject is in general good health in the opinion of the investigator.

Exclusion Criteria:

Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans)
Subject has a history of Carcinoid, Pheochromocytoma, Serotonin Syndrome or other systemic flushing causes.

Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days

Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days.
Subject has had laser or light-based treatment for rosacea within the prior 3 months.
Subject has had systemic retinoids and retinoid derivatives over the past 6 months
Subject has any history of renal or hepatic insufficiency.
Subject has a known hypersensitivity or allergy to Cromolyn sodium or components of the vehicle.
Subject is pregnant or lactating or planning a pregnancy during the duration of the study
Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study
Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation.

Subject has a known hypersensitivity or allergy to tape or other adhesive materials
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1 | Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.

Normal Saline
Eligibility criteria:
Inclusion Criteria:

Subject is male or non-pregnant female, 18 - 80 years of age.
Subjects willing and able to give informed consent.
Subjects willing and able to comply with the requirements of the study.
Subject has the clinical diagnosis of at least mild erythema.
Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study
Subject is in general good health in the opinion of the investigator.

Exclusion Criteria:

Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans)
Subject has a history of Carcinoid, Pheochromocytoma, Serotonin Syndrome or other systemic flushing causes.

Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days

Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days.
Subject has had laser or light-based treatment for rosacea within the prior 3 months.
Subject has had systemic retinoids and retinoid derivatives over the past 6 months
Subject has any history of renal or hepatic insufficiency.
Subject has a known hypersensitivity or allergy to Cromolyn sodium or components of the vehicle.
Subject is pregnant or lactating or planning a pregnancy during the duration of the study
Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study
Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation.

Subject has a known hypersensitivity or allergy to tape or other adhesive materials
Intervention: Doxycycline
Trial phase: Phase 2
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Doxycycline 100 mg twice daily for 14 days

Doxycycline
Eligibility criteria:
Inclusion Criteria:

Non-ischemic cardiomyopathy (LVEF<40%)
Heart failure NYHA II-III

Exclusion Criteria:

Age <18
Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme [ACE] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
Hospitalization for worsening HF or acute decompensated HF within the previous 12 months
History of coronary or ischemic heart disease
Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD) or coronary revascularization or cardiac surgery
Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
Active infection including chronic infection
Active cancer (or prior diagnosis of cancer within the past 10 years)
Recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
Pregnancy
Inability to give informed consent
Other conditions limiting completion of cardiopulmonary exercise test or completion of the study
Intervention: Doxycycline
Trial phase: Phase 2
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Doxycycline 20 mg twice daily for 14 days

Doxycycline
Eligibility criteria:
Inclusion Criteria:

Non-ischemic cardiomyopathy (LVEF<40%)
Heart failure NYHA II-III

Exclusion Criteria:

Age <18
Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme [ACE] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
Hospitalization for worsening HF or acute decompensated HF within the previous 12 months
History of coronary or ischemic heart disease
Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD) or coronary revascularization or cardiac surgery
Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
Active infection including chronic infection
Active cancer (or prior diagnosis of cancer within the past 10 years)
Recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
Pregnancy
Inability to give informed consent
Other conditions limiting completion of cardiopulmonary exercise test or completion of the study
Intervention: VEROSUDIL
Trial phase: Phase 2
SMILES: CN(C)C(C(=O)Nc1ccc2c(=O)[nH]ccc2c1)c1ccsc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 0.5% Rho-Kinase Inhibitor

AR-12286
Eligibility criteria:
Inclusion Criteria:

50-85 y.o.
Male and Female
Exfoliation Syndrome and ocular hypertension or mild or moderate exfoliative glaucoma
IOP ≥22 mmHg prior to initiation of treatment in one or both eyes with two measurements taken two hours apart
No previous intraocular surgery except clear cornea phacoemulsification
Corrected visual acuity in both eyes ≥20/50 in the eligible eye
Not more than 6 diopters spherical equivalent on the study eye
Not more than 3 diopters cylinder equivalent on the study eye
Have given written informed consent, prior to any investigational procedures
Ability to attend for the 6-month duration of the study

Exclusion Criteria:

Open angle glaucoma other than exfoliative glaucoma
Closed angle glaucoma (primary or secondary)
Intraocular pressure >30 mm Hg
Severe exfoliation glaucoma
Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics
Previous intraocular surgery except clear cornea phacoemulsification
Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study
Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or lubricating drops for dry eye (which may be used throughout the study)
Any abnormality preventing reliable applanation tonometry of either eye
Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study
Changes of systemic medication that could have a substantial effect on IOP anticipated during the study
Participation in any investigational study within the past 30 days
Inability to perform reliable VF testing
Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary
Self-reported poor compliance to treatment
Reluctance to return for scheduled follow-up visits
Patients not able to understand the nature of the study