anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Levetiracetam
Trial phase: Phase 4
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred
Eligibility criteria:
Inclusion Criteria:

Age≥16
At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least one in last 6 months
Normal brain MRI or MRI without epileptogenic lesion
Normal electroencephalography(EEG) or existence of generalized epileptiform discharges without any focal epileptiform discharges.
Signing consent form

Exclusion Criteria:

History of treatment by sodium valproate or levetiracetam
History of treatment by any anti-epileptic drug in last 6 months
Plan for pregnancy
Using no certain contraceptive method
History of past or current hepatic disease
History of past or current renal disease
History of past or current hematologic disease
History of known psychiatric disease
History of status epilepticus
Intervention: Articaine
Trial phase: Phase 2
ATC code: N01BB08 | N01BB58
SMILES: CCCNC(C)C(=O)Nc1c(C)csc1C(=O)OC
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth

Articaine Injection: Local anesthetic
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists Class I or II
Preoperative heart rate of 55 to 100 beats per minute
Maximum blood pressure reading of 166/100 mmHg
Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia

Additional Pediatric Inclusion Criteria:

Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth

Additional Endodontic Inclusion Criteria:

Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth

Additional General Practice Inclusion Criteria:

Adults who require restorations in the maxillary teeth that would need local anesthesia

Exclusion Criteria:

Inadequately controlled thyroid disease
Five or more nosebleeds in the past month
Known allergy to any study drug or para-aminobenzoic acid
History of methemoglobinemia
Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.
Intervention: Pimavanserin
Trial phase: Phase 3
ATC code: N05AX17
SMILES: CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: Pimavanserin 34 mg administered orally as a single dose once daily
Eligibility criteria:
Inclusion Criteria:

Adult patients, aged 18 years and above
A clinical diagnosis of major depressive disorder (MDD)

Is being treated with one of the following SSRI or SNRI antidepressants:

Citalopram
Escitalopram
Paroxetine
Fluoxetine
Sertraline
Duloxetine
Venlafaxine
Desvenlafaxine
Venlafaxine XR
Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception

Exclusion Criteria:

Has a history of psychotic disorder or is currently being treated or requires treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder
Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that would affect the patient's ability to participate in the program
Has a known history or symptoms of long QT syndrome
Is determined to be inappropriate for the study for any reason

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Intervention: Pimavanserin
Trial phase: Phase 3
ATC code: N05AX17
SMILES: CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 235
Group description: Pimavanserin 34 mg (administered as 2 x 17 mg pimavanserin tablets) once daily, for 52 weeks
Eligibility criteria:
Inclusion Criteria:

Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059
May benefit from longer term therapy with open-label pimavanserin treatment
If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception

Exclusion Criteria:

Is determined to be inappropriate for the study
Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Intervention: Zuranolone
Trial phase: Phase 3
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Participants self-administered SAGE-217, 30 mg, oral capsule, QD in the evening from Day 1 to Day 14.
Eligibility criteria:
Inclusion Criteria:

Participant had a diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been present for at least a 4-week period.
Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
Participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion.

Exclusion Criteria:

Participant had attempted suicide associated with the current episode of MDD.
Participant had treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) was used for this purpose.
Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.
Intervention: Zuranolone
Trial phase: Phase 3
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Following the OL Phase, participants who exhibited a HAM-D response defined as a ≥ 50% reduction from baseline in HAM-D total score to SAGE-217 were randomized to receive SAGE-217, 30 mg, oral capsule, QD, in the evening, up to study termination date (i.e., up to approximately 22 weeks) during the DB Phase of the study.
Eligibility criteria:
Inclusion Criteria:

Participant had a diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been present for at least a 4-week period.
Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
Participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion.

Exclusion Criteria:

Participant had attempted suicide associated with the current episode of MDD.
Participant had treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) was used for this purpose.
Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.
Intervention: Elocon
Trial phase: Phase 2
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot
Eligibility criteria:
Inclusion Criteria:

Diagnosis of CS.
Two trials of medical treatments for CS in the past.
Minimum CS symptom score.
Ability to tolerate topical anesthesia.
Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
Agrees to comply with all study requirements.

Exclusion Criteria:

Have undergone previous sinus surgery.
Pregnant or breast feeding.
Known history of hypersensitivity or intolerance to corticosteroids.
History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
Past or present functional vision in only one eye.
Has cataracts
Past, present, or planned organ transplant or chemotherapy with immunosuppression.
Currently participating in an investigational drug or device study
Intervention: Elocon
Trial phase: Phase 2
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot
Eligibility criteria:
Inclusion Criteria:

Diagnosis of CS.
Two trials of medical treatments for CS in the past.
Minimum CS symptom score.
Ability to tolerate topical anesthesia.
Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
Agrees to comply with all study requirements.

Exclusion Criteria:

Have undergone previous sinus surgery.
Pregnant or breast feeding.
Known history of hypersensitivity or intolerance to corticosteroids.
History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
Past or present functional vision in only one eye.
Has cataracts
Past, present, or planned organ transplant or chemotherapy with immunosuppression.
Currently participating in an investigational drug or device study
Intervention: (2-Bromo-4-imidazol-1-ylphenyl)methanamine
Trial phase: Phase 1 | Phase 2
SMILES: NCc1ccc(-n2ccnc2)cc1Br
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis

Heparin: Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Eligibility criteria:
Inclusion Criteria:

Adult hemodialysis patients ≥18 years of age.
Signed informed consent to participate in the study.
Stable on hemodialysis prescription for ≥3 months.
Hemoglobin concentration >9.5 g/dL.
Serum TSAT ≥20%.
Able to receive continuous heparin infusion as their anticoagulation protocol.
Receiving hemodialysis via AV (arteriovenous) fistula or graft.
Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.

Exclusion Criteria:

Active bleeding disorder (GI, skin, nasal…)
Receiving hemodialysis via catheter.
Receiving heparin free dialysis.
Receiving low molecular weight heparin as sole anti-coagulation for dialysis.
Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.
Receiving oral anti-coagulants or anti-platelet agents.
Any other condition, that in the opinion of the investigator would not allow completion of the 3 hemodialysis treatments in the study.
Intervention: Sivopixant
Trial phase: Phase 2
SMILES: CC(Cn1c(=O)nc(Nc2ccc(Oc3ccccn3)cc2)n(Cc2ccc(Cl)cc2)c1=O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Participants received 50 mg S-600918 tablets orally once daily for 28 days
Eligibility criteria:
Key Inclusion Criteria:

Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
Capable of giving signed informed consent.

Key Exclusion Criteria:

Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
Has chronic obstructive pulmonary disease or uncontrolled asthma.
Has a clinically unstable medical condition.
History of or ongoing significant psychiatric disorder.
History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
History of malignancy in the last 5 years.
History of severe drug allergy.
History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
Received S-600918 previously.
Received an investigational drug in the last 3 months.
Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
If female, pregnant or trying to become pregnant or breastfeeding.
Intervention: Sivopixant
Trial phase: Phase 2
SMILES: CC(Cn1c(=O)nc(Nc2ccc(Oc3ccccn3)cc2)n(Cc2ccc(Cl)cc2)c1=O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 103
Group description: Participants received 150 mg S-600918 tablets orally once daily for 28 days
Eligibility criteria:
Key Inclusion Criteria:

Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
Capable of giving signed informed consent.

Key Exclusion Criteria:

Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
Has chronic obstructive pulmonary disease or uncontrolled asthma.
Has a clinically unstable medical condition.
History of or ongoing significant psychiatric disorder.
History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
History of malignancy in the last 5 years.
History of severe drug allergy.
History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
Received S-600918 previously.
Received an investigational drug in the last 3 months.
Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
If female, pregnant or trying to become pregnant or breastfeeding.
Intervention: Sivopixant
Trial phase: Phase 2
SMILES: CC(Cn1c(=O)nc(Nc2ccc(Oc3ccccn3)cc2)n(Cc2ccc(Cl)cc2)c1=O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Participants received 300 mg S-600918 tablets orally once daily for 28 days
Eligibility criteria:
Key Inclusion Criteria:

Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
Capable of giving signed informed consent.

Key Exclusion Criteria:

Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
Has chronic obstructive pulmonary disease or uncontrolled asthma.
Has a clinically unstable medical condition.
History of or ongoing significant psychiatric disorder.
History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
History of malignancy in the last 5 years.
History of severe drug allergy.
History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
Received S-600918 previously.
Received an investigational drug in the last 3 months.
Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
If female, pregnant or trying to become pregnant or breastfeeding.
Intervention: Loratadine
Trial phase: Phase 4
ATC code: R06AX13
SMILES: CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 442
Group description: Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Eligibility criteria:
Inclusion Criteria:

Female or male adults aged 18 to 65 years of age inclusive
Were in good general health
Previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine
Agreed to not use antihistamine products 24 hours before and after the treatment
Willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing

Exclusion Criteria:

Individuals who had used oral/systemic medications 24 hours before the first administration of test product
Individuals who used medications which might influence taste perception
Individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days
Women who were pregnant or thinking of becoming pregnant or were nursing
Participants with congestion at the time of study visit
Any self-reported symptoms or conditions that might interfere with the participants ability to complete the evaluation of the product on testing day
Any current medical condition that in the opinion of the Investigator or designee might interfere with normal taste and/or temperature perception (e.g., active common cold, sinus infection, bronchial infection, adenoids, paresthesia etc.)
History of alcohol or drug abuse
History of hypersensitivity or allergic reactions to any ingredients in the test product
Individuals with a history of glaucoma, liver or kidney disease, respiratory conditions such as chronic bronchitis or swallowing difficulties
Individuals who were currently wearing any kind of dental braces or with dental work or had cavities and associated pain that might affect their ability to chew a tablet
Intervention: Metampicillin
Trial phase: Phase 1 | Phase 2
ATC code: J01CA14
SMILES: C=N[C@@H](C(=O)N[C@@H]1C(=O)N2[C@@H]1SC(C)(C)[C@@H]2C(=O)O)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Probiotic 1 billion units Supplement Once Daily

Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily
Eligibility criteria:
Inclusion Criteria:

Diagnosis of NAFLD and/or NASH
Subject aged 18 and older
Non-pregnant - Self-reported
Subject with decision making capacity to understand and consent to study procedures
Ability to follow study related activities regarding medications, diet and exercise

Exclusion Criteria:

Without diagnosis of NAFLD or NASH
History of liver disease from other causes, including but not limited to hepatitis, autoimmune, alcohol use, fatty liver of pregnancy, Wilson's disease, primary or secondary hemochromatosis
Patients aged less than 18 years
Self-reported pregnant patients
Inability to understand, follow and consent to study procedures
Hepatic decompensation defined as gastrointestinal bleeding, ascites, hepatic encephalopathy
Inability to engage in exercise
Currently immunocompromised or taking immunosuppressive drugs
Milk protein allergy
Recent or active chemotherapy for malignancy
Gastrointestinal malignancy
Gastrointestinal disease such as Ulcerative Colitis, Crohn's Disease as these alter the microbiome
Recent antibiotic therapy (within 6 months)
Known allergy to probiotics
History of major gastrointestinal surgery such as resection of the colon
No concomitant use of probiotic from any source (i.e., kefir, certain yogurts, live culture, sauerkraut)
Liver scan >2 months prior to enrollment
Weight loss >5 pounds in the last 2 months
Any implanted battery operated device (i.e. AICD, pacemaker, loop recorder, cochlear implant)