anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Loratadine
Trial phase: Phase 4
ATC code: R06AX13
SMILES: CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Pediatrics 7 to 15 years of age received loratadine 10 mg/day for 28 days
Eligibility criteria:
Inclusion Criteria:

Patients with perennial allergic rhinitis who satisfy all of the following criteria were enrolled in the study:

Pediatric patients between the ages of 3 and 15 years and adult patients between the ages of 16 and 64 at the time of providing informed consent.
Outpatients of either sex.
Pediatric patients for whom written informed consent can be obtained from the guardian before the start of the study. Adult patients from whom written informed consent can be obtained (for patients between the ages of 16 and 19, the guardian must also provide written informed consent).
Pediatric patients who have the ability to make entries in the patient diary (Record of Drugs and Nasal Symptoms) or entry in the diary is made possible by the guardian. Adult patients who have the ability to make entries in the patient diary.
Patients for whom treatment with loratadine monotherapy is judged appropriate based on symptoms of allergic rhinitis during the pretreatment observation period.
Patients confirmed to be allergic to perennial allergen

Exclusion Criteria:

Patients with a history of epileptic seizures or organic brain disorder in whom there is a possibility that epileptic seizures may be induced
Patients with a history of hypersensitivity to any component of this drug
Patients who are pregnant or who may be pregnant, and nursing women
Patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications and whose general condition is poor
Patients participating in another clinical study or who have been in a clinical study within the last 30 days.
Other patients judged inappropriate for study by the investigator or sub-investigator
Patients allergic to pollen (cedar, mugwort, common ragweed, orchard grass, etc.) and the pollen season is during the period from 7 days before registration to the end of study drug administration
Patients who developed diseases which might affect nasal symptoms (acute upper respiratory tract infection, acute pharyngo-laryngitis, or acute tonsillitis) in the 7 days before registration
Patients who received treatment for allergic rhinitis in the 7 days before registration
Intervention: Loratadine
Trial phase: Phase 4
ATC code: R06AX13
SMILES: CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Adults 16 to 64 years of age received loratadine 10 mg/day for 28 days
Eligibility criteria:
Inclusion Criteria:

Patients with perennial allergic rhinitis who satisfy all of the following criteria were enrolled in the study:

Pediatric patients between the ages of 3 and 15 years and adult patients between the ages of 16 and 64 at the time of providing informed consent.
Outpatients of either sex.
Pediatric patients for whom written informed consent can be obtained from the guardian before the start of the study. Adult patients from whom written informed consent can be obtained (for patients between the ages of 16 and 19, the guardian must also provide written informed consent).
Pediatric patients who have the ability to make entries in the patient diary (Record of Drugs and Nasal Symptoms) or entry in the diary is made possible by the guardian. Adult patients who have the ability to make entries in the patient diary.
Patients for whom treatment with loratadine monotherapy is judged appropriate based on symptoms of allergic rhinitis during the pretreatment observation period.
Patients confirmed to be allergic to perennial allergen

Exclusion Criteria:

Patients with a history of epileptic seizures or organic brain disorder in whom there is a possibility that epileptic seizures may be induced
Patients with a history of hypersensitivity to any component of this drug
Patients who are pregnant or who may be pregnant, and nursing women
Patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications and whose general condition is poor
Patients participating in another clinical study or who have been in a clinical study within the last 30 days.
Other patients judged inappropriate for study by the investigator or sub-investigator
Patients allergic to pollen (cedar, mugwort, common ragweed, orchard grass, etc.) and the pollen season is during the period from 7 days before registration to the end of study drug administration
Patients who developed diseases which might affect nasal symptoms (acute upper respiratory tract infection, acute pharyngo-laryngitis, or acute tonsillitis) in the 7 days before registration
Patients who received treatment for allergic rhinitis in the 7 days before registration
Intervention: Elocon
Trial phase: Phase 3
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 351
Group description: Mometasone furoate nasal spray 200 mcg QD (once per day)
Eligibility criteria:
Inclusion Criteria:

A subject must be 12 years of age or older, of either sex, and of any race.
A subject must have at least a 2-year history of SAR which exacerbates during the study season.
A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
A subject who is participating in any other clinical study.
A subject who is part of the staff personnel directly involved with this study.
A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
A female subject who is breast-feeding, pregnant, or intends to become pregnant.
A subject previously randomized into this study.
A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
Intervention: Elocon
Trial phase: Phase 3
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 324
Group description: Mometasone furoate nasal spray 200 mcg QD (once per day)
Eligibility criteria:
Inclusion Criteria:

A subject must be 12 years of age or older, of either sex, and of any race.
A subject must have at least a 2-year history of SAR which exacerbates during the study season.
A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
A subject who is participating in any other clinical study.
A subject who is part of the staff personnel directly involved with this study.
A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
A female subject who is breast-feeding, pregnant, or intends to become pregnant.
A subject previously randomized into this study.
A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
Intervention: Darusentan
Trial phase: Phase 2
SMILES: COc1cc(OC)nc(O[C@H](C(=O)O)C(OC)(c2ccccc2)c2ccccc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Darusentan 100mg during Phase 1, Placebo during Phase 2
Eligibility criteria:
Inclusion Criteria:

Subjects must be competent to provide written informed consent. Subjects must sign an IRB approved ICF and HIPAA Authorization prior to the initiation of any study procedures. All men must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking study drug, and queried regarding their understanding of the potential risks as described in the ICF.
Subjects must be greater than 18 years of age.
Female subjects must be surgically sterile or documented as post-menopausal for at least 2 years.
Subjects must have documented coronary artery disease as evidenced by previous myocardial infarction, interventional procedure, significant stenosis by cardiac catheterization, or an abnormal perfusion study.
Subjects must have an abnormal PET scan.

Exclusion Criteria:

Subjects with acute heart failure
Subjects with sustained or symptomatic hypotension (SBP 90 mmHg)
Subjects with uncontrolled hypertension (SBP of 170 mmHg or DBP of 100 mmHg) at Screening
Subjects with unstable angina pectoris
Subjects with acute myocardial infarction, stroke, transient ischemic attack, or coronary angioplasty within the last 6 months
Subjects with primary valvular disease
Subjects with significant vascular aneurysm
Subjects with a documented history of renal failure
Subjects with liver disease (total bilirubin 3 mg/dL or serum ALT or AST >2X ULN)
Subjects with active malignancy
Subjects with a fatal non-cardiovascular disease that they are expected to succumb to within 1 year
Female subjects that are pregnant or lactating
Female subjects with the potential for child-bearing
Female subjects being treated with hormone therapies
Subjects with uncontrolled diabetes mellitus
Subjects with diabetes with gastro paresis or severe neuropathy
Subjects with a history of substance abuse within the last 2 years
Subjects who have participated in a clinical study involving another investigational drug or device within 1 month of the Screening Visit
Subjects with known hypersensitivity or allergy to L-arginine, aminophylline, adenosine, or dipyridamole
Subjects who have a planned surgical procedure during the course of the study
Subjects taking herbal food supplements (L-carnitine, L-arginine or Ginko biloba)
Subjects with known active or dormant type 2 herpes simplex virus infections
Subjects with a contraindication to treatment with an ERA. Contraindications may include, but are not limited to, evidence of elevated liver function tests (e.g., aminotransferases >2X ULN) or an event defined as a serious adverse event attributed to previous treatment with an ERA
Subjects who are judged by the investigator to be ineligible for this study for any other reason
Intervention: Darusentan
Trial phase: Phase 2
SMILES: COc1cc(OC)nc(O[C@H](C(=O)O)C(OC)(c2ccccc2)c2ccccc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Received placebo during Phase 1, Darusentan 100mg during Phase 2
Eligibility criteria:
Inclusion Criteria:

Subjects must be competent to provide written informed consent. Subjects must sign an IRB approved ICF and HIPAA Authorization prior to the initiation of any study procedures. All men must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking study drug, and queried regarding their understanding of the potential risks as described in the ICF.
Subjects must be greater than 18 years of age.
Female subjects must be surgically sterile or documented as post-menopausal for at least 2 years.
Subjects must have documented coronary artery disease as evidenced by previous myocardial infarction, interventional procedure, significant stenosis by cardiac catheterization, or an abnormal perfusion study.
Subjects must have an abnormal PET scan.

Exclusion Criteria:

Subjects with acute heart failure
Subjects with sustained or symptomatic hypotension (SBP 90 mmHg)
Subjects with uncontrolled hypertension (SBP of 170 mmHg or DBP of 100 mmHg) at Screening
Subjects with unstable angina pectoris
Subjects with acute myocardial infarction, stroke, transient ischemic attack, or coronary angioplasty within the last 6 months
Subjects with primary valvular disease
Subjects with significant vascular aneurysm
Subjects with a documented history of renal failure
Subjects with liver disease (total bilirubin 3 mg/dL or serum ALT or AST >2X ULN)
Subjects with active malignancy
Subjects with a fatal non-cardiovascular disease that they are expected to succumb to within 1 year
Female subjects that are pregnant or lactating
Female subjects with the potential for child-bearing
Female subjects being treated with hormone therapies
Subjects with uncontrolled diabetes mellitus
Subjects with diabetes with gastro paresis or severe neuropathy
Subjects with a history of substance abuse within the last 2 years
Subjects who have participated in a clinical study involving another investigational drug or device within 1 month of the Screening Visit
Subjects with known hypersensitivity or allergy to L-arginine, aminophylline, adenosine, or dipyridamole
Subjects who have a planned surgical procedure during the course of the study
Subjects taking herbal food supplements (L-carnitine, L-arginine or Ginko biloba)
Subjects with known active or dormant type 2 herpes simplex virus infections
Subjects with a contraindication to treatment with an ERA. Contraindications may include, but are not limited to, evidence of elevated liver function tests (e.g., aminotransferases >2X ULN) or an event defined as a serious adverse event attributed to previous treatment with an ERA
Subjects who are judged by the investigator to be ineligible for this study for any other reason
Intervention: Zoledronic acid
Trial phase: Phase 4
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants received single re-treatment dose of zoledronic acid 5 mg IV infusion.
Eligibility criteria:
Inclusion Criteria:

Written Informed Consent
Participants with Paget's disease randomized to the zoledronic acid arm from the CZOL446K2304 and CZOL446K2305 core studies and who were responders by 6 months
Confirmed relapse of Paget's disease of bone (i.e., serum alkaline phosphatase (SAP) above upper limit of normal (ULN), bone scan, worsening clinical symptoms)

Exclusion Criteria:

A participant previously treated with zoledronic acid who relapsed and was retreated with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months
Bisphosphonate Hypersensitivity
Participants with suspected/proven metastases at re-treatment
Calculated creatinine clearance <35 milliliter/minute (mL/min) at screening
Serum calcium level <2.07 millimole/liter (mmol/L) at screening
Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or hypothyroidism

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Dexmedetomidine
Trial phase: Not Applicable
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.

Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
Eligibility criteria:
Inclusion Criteria:

Patients requiring mechanical ventilation in the medical or surgical ICUs.
Currently receiving lorazepam or midazolam by continuous infusion for the purpose of sedation therapy.
Sedation in these ICUs is provided using an ICU-wide order form that preferentially uses either lorazepam or midazolam with the infusion rate titrated by the bedside nurse to the desired Riker sedation-agitation score(s). Continuous analgesia is provided with fentanyl only with the infusion rate titrated by the bedside nurse to PABS ≤ 3 .
Anticipated duration of continuous sedation > 12 hours with the level of sedation expected to be maintained at Riker sedation-agitation score(s) of 3 - 4.

Patients qualifying for daily awakenings as determined by all of the following:

fraction of inspired oxygen (FiO2) ≤ 70% or
positive end expiratory pressure (PEEP) ≤ 14 cmH2O,
hemodynamically stable, and
NOT receiving pharmacologic neuromuscular blockade.
Informed consent and HIPAA authorization within 24 hours of qualifying for daily awakenings.

Exclusion Criteria:

Patients < 18 years of age or > 85 years of age.
Patients receiving intermittent or "as needed" administration of lorazepam or midazolam.
Patients receiving lorazepam or midazolam for purposes other than sedation (e.g. seizure control).
Patients receiving epidural administration of medication(s).
Patients with Childs-Pugh class C liver disease.
Comatose patients by metabolic or neurologic affectation.
Patients with active myocardial ischemia or second- or third-degree heart block.
Moribund state with planned withdrawal of life support.
Patients with known or suspected severe adverse reactions to midazolam (or any other benzodiazepine) or dexmedetomidine (or clonidine).
Patients with alcohol abuse within six months of study eligibility.
Pregnant females or females suspected of being pregnant.
Intervention: Travoprost
Trial phase: Phase 3
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 353
Group description: One drop self-administered in the study eye(s) once daily for 90 days
Eligibility criteria:
Inclusion Criteria:

18 years or older.
Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears.
Best corrected visual acuity of -0.6 logMAR or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
Use of contact lenses within 30 days of Visit 1.
Use of contact lenses during the study.
Participation in an investigational drug or device study within 30 days of entering this study.
Other protocol-defined exclusion criteria may apply.
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Travoprost 0.004% Ophthalmic Solution
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years
Chronic Angle Closure Glaucoma (CACG)
21-35 millimeters mercury mean intraocular pressure on Eligibility visit day at 9 AM
Peripheral iridotomy performed ≥ 1 Month prior to the Screening visit
Anterior chamber angle in which the trabecular meshwork is not visible for ≥180 degrees in gonioscopy without indentation
Peripheral anterior synechiae (PAS)

Exclusion Criteria:

Traumatic damage of the anterior chamber angle
History of ocular inflammation or surgery (except for iridotomy) ≤ 3 months
Patients who cannot be safely discontinued from use of all ocular hypotensive medication(s) for 12 days to 14 weeks
Visual Acuity ≥ 1.0
Contact lenses wearer
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Travoprost at 9 AM + Placebo & 9 PM
Eligibility criteria:
Inclusion Criteria:

≥18 years;
IOP=16-30mmHg

OH or OAG with visual filed abnormality:

≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p <5% on the prepapillary diameter plot, one of which must have p <1%,
Glaucoma Hemifield Test outside normal limits,
Corrected Pattern Standard Deviation with p <5%

Exclusion Criteria:

Previous damage of anterior chamber angle;
ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) <1.0;
contact lens wearer;
severe central field loss;
uncontrolled cardiovascular, hepatic or renal disease;
any medication within past 1 month.
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Participants were administered one 5 mg asenapine tablet, sublingually BID for 21 days
Eligibility criteria:
Inclusion Criteria:

Each participant must be at least 18 years of age
Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception
Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
Each participant must have discontinued the use of all prohibited psychotropic medications

Exclusion Criteria:

A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).