anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: ALBUTEROL
Trial phase: Phase 4
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 166
Group description: Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
Eligibility criteria:
Inclusion Criteria:

The participant has a documented diagnosis of asthma
The participant is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).
The participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided Albuterol eMDPI.

The participant can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the App.

Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.
The participant was hospitalized for severe asthma in the last 30 days.
The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).
The participant is a current smoker or has a greater than 10 pack-year history of smoking.
The participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.

The participant has any treatment with biologics for asthma (for example, omalizumab, anti-IL5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.

Additional criteria apply, please contact the investigator for more information
Intervention: Valbenazine
Trial phase: Phase 4
ATC code: N07XX13
SMILES: COc1cc2c(cc1OC)[C@H]1C[C@@H](OC(=O)[C@@H](N)C(C)C)[C@H](CC(C)C)CN1CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 132
Group description: Participants received valbenazine 40 mg once daily for 1 week, then 80 mg once daily for the remainder of the 8-week open label period.
Eligibility criteria:
Inclusion Criteria:

Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment, and follow-up periods of the study.
Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
Be in general good health.
Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

Exclusion Criteria:

Have an active, clinically significant unstable medical condition within 1 month before screening.
Have a known history of substance (drug) dependence, or substance or alcohol abuse.
Have a significant risk of suicidal or violent behavior.
Have been hospitalized for psychiatric disorder within 6 months before Day 1.
Have a known history of neuroleptic malignant syndrome.
Have a known history of long QT syndrome or cardiac arrhythmia.
Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine (INGREZA) within 30 days of screening.
Have received an investigational drug within 30 days before Day 1 or plan to use an investigational drug (other than NBI-98854) during the study.
Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
Are currently pregnant or breastfeeding.
Have HIV or hepatitis B.
Intervention: Valbenazine
Trial phase: Phase 4
ATC code: N07XX13
SMILES: COc1cc2c(cc1OC)[C@H]1C[C@@H](OC(=O)[C@@H](N)C(C)C)[C@H](CC(C)C)CN1CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Participants received valbenazine 80 mg once daily for 8 weeks. Randomization into this arm occurred after open-label treatment with valbenazine once daily for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment, and follow-up periods of the study.
Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
Be in general good health.
Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

Exclusion Criteria:

Have an active, clinically significant unstable medical condition within 1 month before screening.
Have a known history of substance (drug) dependence, or substance or alcohol abuse.
Have a significant risk of suicidal or violent behavior.
Have been hospitalized for psychiatric disorder within 6 months before Day 1.
Have a known history of neuroleptic malignant syndrome.
Have a known history of long QT syndrome or cardiac arrhythmia.
Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine (INGREZA) within 30 days of screening.
Have received an investigational drug within 30 days before Day 1 or plan to use an investigational drug (other than NBI-98854) during the study.
Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
Are currently pregnant or breastfeeding.
Have HIV or hepatitis B.
Intervention: Metronidazole
Trial phase: Phase 4
ATC code: A01AB17 | A02BD01 | A02BD02 | A02BD03 | A02BD08 | A02BD11 | A02BD13 | A02BD15 | D06BX01 | G01AF01 | G01AF20 | J01RA03 | J01RA04 | J01RA10 | J01RA14 | J01XD01 | P01AB01 | P01AB51 | P01AB52
SMILES: Cc1ncc([N+](=O)[O-])n1CCO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Metronidazole vaginal suppositories(1 suppositories,qd,7 days )

Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days
Eligibility criteria:
Inclusion Criteria:

Aged 18 to 65 years old, with history of sexual activity, premenopausal women；
Nugent Score ≥ 7 for diagnosing BV；
Sign informed consent.

Exclusion Criteria:

mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
History of systemic organic diseases or psychiatric diseases;
Planning for or during pregnancy, lactation, menstruation;
within 5 days of onset of the disease, any antibiotics has been used;
Long-term use of contraceptives or immunosuppressant;
Anaphylactic constitution or allergic to known ingredients of research drugs.
Intervention: Brinzolamide
Trial phase: Phase 1 | Phase 2
ATC code: G01AE10 | S01EC04 | S01EC54
SMILES: CCN[C@H]1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 320
Group description: ophthalmic suspension

brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension
Eligibility criteria:
Inclusion Criteria:

Male and females 18 years of age or older,
diagnosed with primary open-angle glaucoma or ocular hypertension.

Exclusion Criteria:

Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,
ocular hypertension.
Intervention: Brinzolamide
Trial phase: Phase 1 | Phase 2
ATC code: G01AE10 | S01EC04 | S01EC54
SMILES: CCN[C@H]1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 318
Group description: Ophthalmic suspension

Azopt 1%: Azopt 1%, RLD
Eligibility criteria:
Inclusion Criteria:

Male and females 18 years of age or older,
diagnosed with primary open-angle glaucoma or ocular hypertension.

Exclusion Criteria:

Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,
ocular hypertension.
Intervention: Flortaucipir F-18
Trial phase: Phase 3
ATC code: V09AX07
SMILES: Fc1ccc(-c2ccc3c(c2)[nH]c2ccncc23)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 205
Group description: No study drug was administered for this study. Scans were previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) and were read by five independent, blinded readers.

Flortaucipir F18: No study drug was administered for this study.
Eligibility criteria:
Scan Reader Criteria (5 total readers):

Board-certified in radiology or nuclear medicine
Professional experience interpreting PET scans

Scan Criteria (205 total scans):

Former enrollment in AZES Study
Flortaucipir scan at baseline
clinical dementia rating - sum of boxes (CDR-SB) assessment at 18 months

Scan Study Population (AZES Study):

55 to 85 years
MCI due to AD or probable AD by National Institute on Aging-Alzheimer's Association criteria (Albert 2011
mini-mental status exam (MMSE) of 20 to 30 inclusive
CDR global score of 0.5 (MCI), or 0.5 or 1 (AD) with a memory box score ≥ 0.5, and a score of ≤85 on the Delayed Memory Index of the Repeatable Battery for the Assessment of Neuropsychological Status.
Amyloid positive status confirmed by florbetapir PET or lumbar puncture
Intervention: Dihydroergotamine
Trial phase: Phase 3
ATC code: N02CA01 | N02CA51
SMILES: [H][C@@]12Cc3c[nH]c4cccc(c34)[C@@]1([H])C[C@@H](C(=O)N[C@]1(C)O[C@]3(O)N(C1=O)[C@@H](Cc1ccccc1)C(=O)N1CCC[C@]13[H])CN2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 363
Group description: Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 3.9 mg.
Eligibility criteria:
Key Inclusion Criteria:

Males or females, 18-65 years of age at the time of Screening Visit
Subject has at least 1-year history of migraines (with or without aura), according to the International Classification of Headache Disorder, 3rd Edition (ICHD3)

Exclusion Criteria:

Pregnant or breast-feeding women
Women of child-bearing potential not using or not willing to use highly effective contraception.
Diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache.
History of coronary artery disease, coronary artery vasospasm (including Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery.
History of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.
Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or Bipolar disorder), dementia. Other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety.
Any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.
Intervention: Dihydroergotamine
Trial phase: Phase 3
ATC code: N02CA01 | N02CA51
SMILES: [H][C@@]12Cc3c[nH]c4cccc(c34)[C@@]1([H])C[C@@H](C(=O)N[C@]1(C)O[C@]3(O)N(C1=O)[C@@H](Cc1ccccc1)C(=O)N1CCC[C@]13[H])CN2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 367
Group description: Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg.
Eligibility criteria:
Key Inclusion Criteria:

Males or females, 18-65 years of age at the time of Screening Visit
Subject has at least 1-year history of migraines (with or without aura), according to the International Classification of Headache Disorder, 3rd Edition (ICHD3)

Exclusion Criteria:

Pregnant or breast-feeding women
Women of child-bearing potential not using or not willing to use highly effective contraception.
Diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache.
History of coronary artery disease, coronary artery vasospasm (including Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery.
History of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.
Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or Bipolar disorder), dementia. Other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety.
Any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.
Intervention: Methergine
Trial phase: Phase 4
ATC code: G02AB01
SMILES: CCC(CO)NC(=O)C1C=C2c3cccc4[nH]cc(c34)CC2N(C)C1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Standard Oxytocin Infusion at the time of Cesarean Section plus 0.2 mg of Intramuscular Methergine

Methylergonovine: 0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.
Eligibility criteria:
Inclusion Criteria:

18 years of age
Laboring patients who undergo a cesarean section

Exclusion Criteria:

Placenta/Uterine Abnormalities
Chronic Hypertension, Gestational Hypertension, Preeclampsia
HIV/AIDS on protease inhibitors
History of Coronary Artery Disease
History of Hypersensitivity to Methylergonovine
Intervention: Terazosin
Trial phase: Phase 1 | Phase 2
ATC code: G04CA03
SMILES: COc1cc2nc(N3CCN(C(=O)C4CCCO4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Terazosin administered 5 mg once daily p.o. for 12 weeks

Terazosin 5 MG: 5 milligrams by mouth daily at bedtime
Eligibility criteria:
Inclusion Criteria:

Men or women aged 40 and older with the diagnosis of idiopathic PD per UK Brain Bank criteria
Hoehn-Yahr Stage I-III, on stable dopaminergic treatment regimen for ≥4 weeks prior to baseline.

Exclusion Criteria:

Subjects unwilling or unable to give informed consent
Secondary parkinsonism (e.g., drug induced)
Parkinson-plus syndromes
History of brain surgery for PD such as deep brain stimulation
No confounding acute or unstable medical, psychiatric, orthopedic condition. Subjects who have hypertension, diabetes mellitus, depression, or other common age-related illness will be included if their disease under control with stable treatment regimen for at least 30 days.
Neurogenic orthostatic hypotension defined as symptomatic decrease in BP > 20mmHg systolic or > 10mmHg diastolic and HR increase < 20bpm on supine to sitting or standing.
Clinically significant traumatic brain injury or post-traumatic stress disorder
Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
Presence of dementia per Movement Disorder Society Level I criteria
Major depression, bipolar affective disorder, or other mental health disorders that are sufficiently severe to increase adverse event risk or impact neuropathy assessment in the opinion of the responsible site principal investigator.
Subjects with clinically significant depression as determined by a Beck Depression Inventory score greater than 21 at the screening visit
Current suicidal ideation within one year prior to the baseline visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS)
If the participant has a Beck Anxiety Score greater than 22 at the initial screening visit.
History of exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to the baseline visit
Use of investigational drugs within 30 days before screening
Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to the baseline visit
Use of doxazosin, alfuzosin, prazosin, or tamsulosin
For female participant, pregnancy, or plans for child-bearing during study period
Participant is restricted from traveling to and from the study site
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 4
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.

Bupivacaine Hydrochloride: We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
Eligibility criteria:
INCLUSION CRITERIA

1. Women 18-85 who will be having an outpatient vaginal hysterectomy with or without concurrent prolapse repair surgery at Mayo Clinic Hospital in Arizona

EXCLUSION CRITERIA

Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater than normal values
Known history of renal (kidney) disease as evidenced by a serum creatinine that is greater than normal values
Known history of prolonged QT (QTc greater than 500 m/s)
Opiate tolerance as noted by daily use of greater than 20 mg morphine daily oral equivalents per day for a minimum of 1 month prior to surgery
Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs, acetaminophen, gabapentin, sulfa drugs, or ondansetron
Allergy to both oxycodone and hydromorphone
Patients with acute gastrointestinal bleed that has occurred less than 6 months prior to study enrollment
Adults lacking the ability to consent
Intervention: Difamilast
Trial phase: Phase 3
SMILES: CCOc1ccccc1C(=O)NCc1coc(-c2ccc(OC(F)F)c(OC(C)C)c2)n1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 182
Group description: Subjects were treated with assigned 1% OPA-15406 ointment twice daily.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of AD based on the Japanese Dermatological Association's criteria
History of AD for at least 3 years
Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
IGA score of 2 or 3 at the screening and baseline examinations

Exclusion Criteria:

Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: The patients will receive sub-dissociative ketamine at a dose of 0.75mg/k

Ketamine 0.75 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg
Eligibility criteria:
Inclusion Criteria:

Patients age 18 and older
acute and chronic abdominal, flank, back, musculoskeletal pain, and traumatic pain as well as cancer pain
initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.

Exclusion Criteria:

altered mental status,
allergy to ketamine,
weight greater than 150 kg,
unstable vital signs (systolic blood pressure <90 or>180 mm Hg,
pulse rate <50 or >150 beats/min,
respiration rate <10 or >30 breaths/min)
alcohol or drug abuse
inability to provide consent
psychiatric illness (schizophrenia),
recent (4 hours before) opioid use.
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: The patients will receive sub-dissociative ketamine at a dose of 1.0mg/k

Ketamine 1.0 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg
Eligibility criteria:
Inclusion Criteria:

Patients age 18 and older
acute and chronic abdominal, flank, back, musculoskeletal pain, and traumatic pain as well as cancer pain
initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.

Exclusion Criteria:

altered mental status,
allergy to ketamine,
weight greater than 150 kg,
unstable vital signs (systolic blood pressure <90 or>180 mm Hg,
pulse rate <50 or >150 beats/min,
respiration rate <10 or >30 breaths/min)
alcohol or drug abuse
inability to provide consent
psychiatric illness (schizophrenia),
recent (4 hours before) opioid use.
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: The patients will receive sub-dissociative ketamine at a dose of 1.5mg/k

Ketamine 1.5 mg/kg: Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg
Eligibility criteria:
Inclusion Criteria:

Patients age 18 and older
acute and chronic abdominal, flank, back, musculoskeletal pain, and traumatic pain as well as cancer pain
initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.

Exclusion Criteria:

altered mental status,
allergy to ketamine,
weight greater than 150 kg,
unstable vital signs (systolic blood pressure <90 or>180 mm Hg,
pulse rate <50 or >150 beats/min,
respiration rate <10 or >30 breaths/min)
alcohol or drug abuse
inability to provide consent
psychiatric illness (schizophrenia),
recent (4 hours before) opioid use.