anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cavosonstat
Trial phase: Phase 1
SMILES: O=C(O)c1ccc(-c2ccc3cc(O)ccc3n2)c(Cl)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: single oral dose of 50 mg N91115

N91115: Given PO only on Day 1
Eligibility criteria:
Inclusion Criteria:

Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures and in the opinion of the PI complies with all the requirements of the study.
Subject is healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations).
Subject is Caucasian.
Female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy (HRT) are eligible to enroll.
Male subject must agree to use condoms and refrain from sperm donation from Day 1 until 30 days post last dose or have documentation of vasectomy.
Subject has a body weight > 50 kg and body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.
Subject has no clinically significant abnormal findings related to their systolic or diastolic blood pressure (BP), per the investigator's judgment, at screening or Day 1.
Subject has no clinically significant abnormal findings in 12 lead ECG, per the investigator's judgment, at screening.

Exclusion Criteria:

Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the investigator or designee.
Subject has clinically significant abnormalities on a 12 lead ECG done at screening
Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at screening
Subject has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
Subject has any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical study.
Subject is unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, unavailable for follow-up call, and/or improbability of completing the clinical study.
Intervention: Cavosonstat
Trial phase: Phase 1
SMILES: O=C(O)c1ccc(-c2ccc3cc(O)ccc3n2)c(Cl)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)

N91115: Given PO only on Day 1
Eligibility criteria:
Inclusion Criteria:

Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures and in the opinion of the PI complies with all the requirements of the study.
Subject is healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations).
Subject is Caucasian.
Female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy (HRT) are eligible to enroll.
Male subject must agree to use condoms and refrain from sperm donation from Day 1 until 30 days post last dose or have documentation of vasectomy.
Subject has a body weight > 50 kg and body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.
Subject has no clinically significant abnormal findings related to their systolic or diastolic blood pressure (BP), per the investigator's judgment, at screening or Day 1.
Subject has no clinically significant abnormal findings in 12 lead ECG, per the investigator's judgment, at screening.

Exclusion Criteria:

Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the investigator or designee.
Subject has clinically significant abnormalities on a 12 lead ECG done at screening
Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at screening
Subject has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
Subject has any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical study.
Subject is unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, unavailable for follow-up call, and/or improbability of completing the clinical study.
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Participants were administered oral brexpiprazole tablets of 0.5 mg/day to 3 mg/day, QD for 6 weeks.
Eligibility criteria:
Main Inclusion Criteria:

Have a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation.
Have a treatment history of an inadequate ADT response to at least 1 ADT (but not > 3) for the current episode.

Have received a single, trial-approved, SSRI or SNRI at an adequate dose for

≥ 6 weeks prior to screening.

Are 18 to 65 years old at the time of consent (inclusive, and outpatients only).
Have a Hamilton Depression Rating Scale (HAM-D)-17-item Total Score ≥ 18 at screening and baseline.
Have a Hamilton Anxiety Rating Scale (HAM-A) Total Score ≥ 20 at screening and baseline.

Main Exclusion Criteria:

Subjects with any of the following current Axis I DSM-IV-TR diagnoses:

delirium
dementia
amnestic
other cognitive disorders
schizophrenia
schizoaffective disorder
other psychotic disorders
bipolar I disorder,
bipolar II disorder
bipolar disorder not otherwise specified (NOS)
eating disorders
anorexia nervosa
bulimia
obsessive compulsive disorder
post-traumatic stress disorder

Subjects with any of the following current Axis II DSM-IV-TR diagnoses:

borderline, antisocial
paranoid
schizoid
schizotypal
histrionic personality disorders
mental retardation.
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
Eligibility criteria:
Main Inclusion Criteria:

Have a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation.

Have a treatment history of an inadequate ADT response to at least 1 ADT (but not > 3) for the current episode.

Have received a single, trial-approved, SSRI or SNRI at an adequate dose for ≥ 6 weeks prior to screening.

Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).

Are (and will be) working 20 hours or more per week or a student taking 6 credit hours or more during the trial period, however minor deviations from the "part-time" concept may be acceptable on a case-by-case basis based on approval of the medical monitor.

Have a Hamilton Depression Rating Scale (HAM-D)- 17-item Total Score ≥ 18 at screening and baseline.

Have a Sheehan Disability Scale (SDS) 3-item mean score ≥ 5 at baseline.

Main Exclusion Criteria:

Subjects with any of the following current Axis I DSM-IV-TR diagnoses: delirium, dementia, amnestic, or other cognitive disorders; schizophrenia, schizoaffective disorder, or other psychotic disorders; bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified (NOS); eating disorders (including anorexia nervosa or bulimia); obsessive compulsive disorder; panic disorder; post-traumatic stress disorder; and attention deficit hyperactivity disorder.

Subjects with any of the following current Axis II DSM-IV-TR diagnoses: borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorders, or mental retardation.
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Eligibility criteria:
Inclusion Criteria: Have a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric Interview (M.I.N.I.) for Schizophrenia and Psychotic Disorders Studies and an adequate clinical psychiatric evaluation.

Had the start of their first schizophrenia episode ≤ 5 years before the time of consent.
Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).
Have a Positive and Negative Syndrome Scale (PANSS) Total Score of ≤ 80 at screening and baseline.
Exhibit schizophrenia symptoms with a score ≥ 4 on the PANSS for ≥1 items related to active social avoidance, emotional withdrawal, passive/apathetic social withdrawal, and difficulty in abstract thinking.
Have a diagnosis of schizophrenia made at least 6 months prior to screening as confirmed by subject, caregiver, or documented history.

Exclusion Criteria: Subjects presenting with a first episode of schizophrenia based on the clinical judgment of the investigator.

Subjects who have been hospitalized for psychotic symptoms within the last 6 months.
Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history or who have a history of failure to respond to clozapine or response to clozapine treatment only.
Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, MDD, bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders.
Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant.
Subjects with clinically significant tardive dyskinesia at enrollment, as determined by a score of>= 3 on Item 8 of the AIMS at screening or baseline.
Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment of akathisia at screening or baseline.
Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding nicotine.
Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Sitagliptin 100 mg a day for 12 weeks

Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator
Eligibility criteria:
Inclusion Criteria:

Male or female age >18
Type II Diabetes with glycated hemoglobin (hemoglobin A1C) of < 11
Currently on an oral hyperglycemic medication other than sitagliptin
A chronic wound defined as the lack of wound healing progress of <15% per week or 50% over a month period
Ankle brachial index of > 0.80
Wound located on the foot or ankle (Wagner Grade 1,2)
Able to comply with the requirements of the research trial

Exclusion Criteria:

Current use of dipeptidyl-peptidase four (DPP-4) inhibitor or glucagon like peptide one (GLP-1)agonist
End stage renal disease
Currently enrolled in another research trial that involves treatment of the wound
Active infection of the wound
Wound that probes to bone with osteomyelitis (Wagner Grade 3)
Intervention: Ticagrelor
Trial phase: Not Applicable
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
Eligibility criteria:
Inclusion Criteria:

Patients with known coronary artery disease who presented with and ACS and underwent PCI.
Age between 18 and 74 years old.
On therapy with low-dose aspirin (81 mg) and prasugrel 10 mg/daily for at least 14 days as per standard of care

Exclusion criteria:

History of stroke, transient ischemic attack (TIA) or intracranial bleeding.
Known allergies to ticagrelor.
Weight < 60 Kg
On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
Treatment with IIb/IIIa glycoprotein inhibitors in the last 7 days.
Blood dyscrasia or bleeding diathesis.
Platelet count <80x106/mL.
Hemoglobin <10 g/dL.
Active bleeding.
Hemodynamic instability.
Creatinine Clearance <30 mL/minute.
Known severe hepatic dysfunction.
Patients with sick sinus syndrome (SSS) or high degree atrio-ventricular block without pacemaker protection.
Current treatment with drugs interfering with cytochrom P450 3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.
Pregnant females.
Intervention: Ticagrelor
Trial phase: Not Applicable
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
Eligibility criteria:
Inclusion Criteria:

Patients with known coronary artery disease who presented with and ACS and underwent PCI.
Age between 18 and 74 years old.
On therapy with low-dose aspirin (81 mg) and prasugrel 10 mg/daily for at least 14 days as per standard of care

Exclusion criteria:

History of stroke, transient ischemic attack (TIA) or intracranial bleeding.
Known allergies to ticagrelor.
Weight < 60 Kg
On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
Treatment with IIb/IIIa glycoprotein inhibitors in the last 7 days.
Blood dyscrasia or bleeding diathesis.
Platelet count <80x106/mL.
Hemoglobin <10 g/dL.
Active bleeding.
Hemodynamic instability.
Creatinine Clearance <30 mL/minute.
Known severe hepatic dysfunction.
Patients with sick sinus syndrome (SSS) or high degree atrio-ventricular block without pacemaker protection.
Current treatment with drugs interfering with cytochrom P450 3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.
Pregnant females.
Intervention: Prasugrel
Trial phase: Not Applicable
ATC code: B01AC22
SMILES: CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
Eligibility criteria:
Inclusion Criteria:

Patients with known coronary artery disease who presented with and ACS and underwent PCI.
Age between 18 and 74 years old.
On therapy with low-dose aspirin (81 mg) and prasugrel 10 mg/daily for at least 14 days as per standard of care

Exclusion criteria:

History of stroke, transient ischemic attack (TIA) or intracranial bleeding.
Known allergies to ticagrelor.
Weight < 60 Kg
On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
Treatment with IIb/IIIa glycoprotein inhibitors in the last 7 days.
Blood dyscrasia or bleeding diathesis.
Platelet count <80x106/mL.
Hemoglobin <10 g/dL.
Active bleeding.
Hemodynamic instability.
Creatinine Clearance <30 mL/minute.
Known severe hepatic dysfunction.
Patients with sick sinus syndrome (SSS) or high degree atrio-ventricular block without pacemaker protection.
Current treatment with drugs interfering with cytochrom P450 3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.
Pregnant females.
Intervention: Omeprazole
Trial phase: Not Applicable
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: Open-label, with all subjects receiving omeprazole

Omeprazole (suspension): 1 mg/kg/day
Eligibility criteria:
Inclusion Criteria:

Zero to 4 years old
Being considered for PPI or H2RA treatment for refractory GERD
Parent is able to give informed consent

Exclusion Criteria:

Prevalent C. difficile infection (excluded via stool PCR at week 0)
Use of systemic antibiotics within the past 90 days
Use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days)
Increased risk for fracture due to vitamin D deficiency or other causes
Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome)
Congenital deficiency in immunity (e.g., such as IgA deficiency)
Cystic fibrosis
Significant dynamic or uncontrolled comorbidity such as HIV or malignancy
Use of medications with potential interaction with PPIs
Intervention: Glycopyrrolate
Trial phase: Phase 2
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: glycopyrrolate Topical Wipes, 1.0%
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 years of age or older.
Primary, axillary hyperhidrosis of at least 6 months duration.
A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
Male or non-pregnant, non-lactating females.

Exclusion Criteria:

Prior surgical procedure for hyperhidrosis.
Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
Prior axillary treatment with axillary iontophoresis within 4 weeks.
Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
Known history of a condition that may cause secondary hyperhidrosis.
Known history of Sjögren's syndrome or Sicca syndrome.
Abnormal findings on screening ECG deemed clinically significant by the Investigator.
Intervention: Glycopyrrolate
Trial phase: Phase 2
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: glycopyrrolate Topical Wipes, 2.0%
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 years of age or older.
Primary, axillary hyperhidrosis of at least 6 months duration.
A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
Male or non-pregnant, non-lactating females.

Exclusion Criteria:

Prior surgical procedure for hyperhidrosis.
Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
Prior axillary treatment with axillary iontophoresis within 4 weeks.
Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
Known history of a condition that may cause secondary hyperhidrosis.
Known history of Sjögren's syndrome or Sicca syndrome.
Abnormal findings on screening ECG deemed clinically significant by the Investigator.
Intervention: Glycopyrrolate
Trial phase: Phase 2
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: glycopyrrolate Topical Wipes, 3.0%
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 years of age or older.
Primary, axillary hyperhidrosis of at least 6 months duration.
A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
Male or non-pregnant, non-lactating females.

Exclusion Criteria:

Prior surgical procedure for hyperhidrosis.
Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
Prior axillary treatment with axillary iontophoresis within 4 weeks.
Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
Known history of a condition that may cause secondary hyperhidrosis.
Known history of Sjögren's syndrome or Sicca syndrome.
Abnormal findings on screening ECG deemed clinically significant by the Investigator.