anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pentosan polysulfate
Trial phase: Phase 2
ATC code: C05BA04 | G04BX15
SMILES: O=S(=O)(O)O[C@@H]1[C@@H](OS(=O)(=O)O)[C@H](O[C@@H]2CO[C@@H](O)[C@H](OS(=O)(=O)O)[C@H]2OS(=O)(=O)O)OC[C@H]1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: 300mg of pentosan polysulfate sodium daily for 8 weeks

Pentosan polysulfate sodium
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorders, unspecified schizophrenia spectrum and other psychotic disorders
Negative pregnancy test in females of childbearing age

Exclusion Criteria:

Urine drug screen positive for psychostimulants such as cocaine, amphetamines and ecstasy
Any infection, neoplasm, autoimmune disease or other primary inflammatory condition (3) Previous diagnosis of intellectual disability or dementia
Current treatment with heparin
Use of or allergy to non-steroidal anti-inflammatory agent or pentosan polysulfate sodium
Current or anticipated corticosteroid use
History of peptic ulcer disease, gastro esophageal reflux disease, or gastrointestinal bleeding
Those on warfarin or any anticoagulant
Current treatment with lithium or asthma medication
Individuals with pre-existing liver, cardiac, or kidney disease
Intervention: Ticagrelor
Trial phase: Phase 4
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: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)

27 patients

One major bleeding event from the gynecologic tract
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
Informed consent to participate in the study
Percutaneous coronary intervention with stent implantation due to first S T elevation myocardial infarction, or first non S T -elevation myocardial infarction
Administration of a loading dose of clopidogrel

Exclusion Criteria:

Known coagulopathy
Known history of bleeding disorder
Suspicion of intracranial haemorrhage
Need for oral anticoagulation therapy
Administration of glycoprotein (GP) II b - III a antagonists
Cardiogenic shock
Severe chronic renal failure (estimated glomerular filtration rate < 30 mL/min)
Severe liver insufficiency
Chronic dyspnea
Increased risk of bradycardia
Autoimmune disease
Infectious disease
Neoplasms
Pregnancy
Study drug intolerance
Co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors
Participation in any previous study with ticagrelor or clopidogrel
Intervention: Clopidogrel
Trial phase: Phase 4
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)

28 patients

One major bleeding event from a diabetic foot ulcer
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
Informed consent to participate in the study
Percutaneous coronary intervention with stent implantation due to first S T elevation myocardial infarction, or first non S T -elevation myocardial infarction
Administration of a loading dose of clopidogrel

Exclusion Criteria:

Known coagulopathy
Known history of bleeding disorder
Suspicion of intracranial haemorrhage
Need for oral anticoagulation therapy
Administration of glycoprotein (GP) II b - III a antagonists
Cardiogenic shock
Severe chronic renal failure (estimated glomerular filtration rate < 30 mL/min)
Severe liver insufficiency
Chronic dyspnea
Increased risk of bradycardia
Autoimmune disease
Infectious disease
Neoplasms
Pregnancy
Study drug intolerance
Co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors
Participation in any previous study with ticagrelor or clopidogrel
Intervention: Olinciguat
Trial phase: Phase 2
SMILES: NC(=O)[C@](O)(CNc1nc(-c2cc(-c3ccon3)n(Cc3ccccc3F)n2)ncc1F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Single 5-mg dose of olinciguat administered orally
Eligibility criteria:
Key Inclusion Criteria:

Patient has a diagnosis of primary Type I or II achalasia.
Patient has no contraindications to the performance of the baseline and postdose HRIM procedures per Investigator discretion.

Key Exclusion Criteria:

Patient has had any prior esophageal, periesophageal, or gastric surgery, or treatment with sclerosing agent.
More than 1 pneumatic dilation procedure to a diameter of > 2 cm in their lifetime.
Pneumatic dilation procedure to a diameter of > 2 cm within 1 year prior to randomization. Prior bougie dilation(s) or pneumatic dilation(s) ≤ 2 cm are allowed.
Prior esophageal injection of botulinum toxin (Botox) within 6 months prior to randomization or more than 2 esophageal Botox injection procedures in their lifetime.
Patients with malignant or premalignant esophageal lesions.
Patient has taken any drug that can affect gastrointestinal (GI) motility in the 72 hours before check-in through discharge from the clinic.

Other inclusion and exclusion criteria specified in the protocol.
Intervention: Ademetionine
Trial phase: Phase 2
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 28
Group description: active treatment

DSXS topical: topical treatment
Eligibility criteria:
Inclusion Criteria:

Parent/legal guardian has signed informed consent form, which meets all criteria of current FDA regulations.

Exclusion Criteria:

Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy
Intervention: Paroxetine
Trial phase: Phase 4
ATC code: N06AB05
SMILES: Fc1ccc([C@@H]2CCNC[C@H]2COc2ccc3c(c2)OCO3)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 84
Group description: Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.
Eligibility criteria:
Inclusion Criteria:

Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study.
Has a body mass index (BMI) of 18 to 35 kg/m^2, inclusive, at the Screening and Baseline Visits.
If female, has a regular menstrual cycle.
Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and Baseline Visits.
If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.

Exclusion Criteria:

Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.
Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.
Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a history of depression or any other psychiatric illness.
Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.
Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.
Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).
If female, has polycystic ovarian syndrome.
Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.
Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 231
Group description: Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Eligibility criteria:
Inclusion Criteria:

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1

Lifetime history of meeting DSM-5 criteria for:

Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder
Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
Dissociative disorder
Posttraumatic stess disorder
MDD with psychotic features
Significant suicide risk, as judged by the Investigator.
Intervention: Varenicline
Trial phase: Phase 2
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized were 0.25mg once a day, 0.25mg twice a day, 0.5mg twice a day and 1mg twice a day.
Eligibility criteria:
Inclusion Criteria:

PD diagnosis will be based on the United Kingdom Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria. The investigators will enrich the cohort by recruiting subjects at modified Hoehn and Yahr stages 2 or higher, duration of motor disease 5 years or longer, age >65 years, or the Postural Instability and Gait Disorder (PIGD) phenotype. Duration of motor disease will be defined as the time between onset of motor symptoms and time of entry into the study. The PIGD phenotype is defined as described previously. PD subjects with defined cholinergic deficits will be recruited as described in Project II. PD subjects will have cortical cholinergic deficits based on 5th percentile cutoff of the normal controls as defined previously.
Stable dopaminergic replacement therapy for 3 months prior to enrollment and expected to maintain stable dopaminergic therapy for duration of study participation.

Exclusion Criteria:

Other disorders which may resemble PD with or without dementia, such as vascular dementia, normal pressure hydrocephalus, progressive supranuclear palsy, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like vertical supranuclear gaze palsy, early and severe dysautonomia or appendicular apraxia, which may differentiate them from idiopathic PD. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism and all participants will undergo [11-Carbon]dihydrotetrabenazine PET to confirm striatal dopaminergic denervation.
Subjects on neuroleptic, anticholinergic (trihexphenidyl, benztropine), or cholinesterase inhibitor drugs.
Current or previous (within last 6 months) use of any product or medication containing nicotinic agents,including use of tobacco products such as cigarettes, cigars, pipes, chewing tobacco, etc., electronic cigarettes, over-the-counter nicotine patches, chewing gum containing nicotine, or varenicline.
Evidence of a stroke or mass lesion on structural brain imaging (MRI).
Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
Severe claustrophobia precluding MR or PET imaging
Subjects limited by participation in research procedures involving ionizing radiation.
Pregnancy (test within 48 hours of each PET session) or breastfeeding.
Significant risk of cardiovascular event.
Active, significant mood disorder.
Intervention: Varenicline
Trial phase: Phase 2
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized were 0.25mg once a day, 0.25mg twice a day, and 0.5mg twice a day.
Eligibility criteria:
Inclusion Criteria:

PD diagnosis will be based on the United Kingdom Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria. The investigators will enrich the cohort by recruiting subjects at modified Hoehn and Yahr stages 2 or higher, duration of motor disease 5 years or longer, age >65 years, or the Postural Instability and Gait Disorder (PIGD) phenotype. Duration of motor disease will be defined as the time between onset of motor symptoms and time of entry into the study. The PIGD phenotype is defined as described previously. PD subjects with defined cholinergic deficits will be recruited as described in Project II. PD subjects will have cortical cholinergic deficits based on 5th percentile cutoff of the normal controls as defined previously.
Stable dopaminergic replacement therapy for 3 months prior to enrollment and expected to maintain stable dopaminergic therapy for duration of study participation.

Exclusion Criteria:

Other disorders which may resemble PD with or without dementia, such as vascular dementia, normal pressure hydrocephalus, progressive supranuclear palsy, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like vertical supranuclear gaze palsy, early and severe dysautonomia or appendicular apraxia, which may differentiate them from idiopathic PD. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism and all participants will undergo [11-Carbon]dihydrotetrabenazine PET to confirm striatal dopaminergic denervation.
Subjects on neuroleptic, anticholinergic (trihexphenidyl, benztropine), or cholinesterase inhibitor drugs.
Current or previous (within last 6 months) use of any product or medication containing nicotinic agents,including use of tobacco products such as cigarettes, cigars, pipes, chewing tobacco, etc., electronic cigarettes, over-the-counter nicotine patches, chewing gum containing nicotine, or varenicline.
Evidence of a stroke or mass lesion on structural brain imaging (MRI).
Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
Severe claustrophobia precluding MR or PET imaging
Subjects limited by participation in research procedures involving ionizing radiation.
Pregnancy (test within 48 hours of each PET session) or breastfeeding.
Significant risk of cardiovascular event.
Active, significant mood disorder.
Intervention: Ademetionine
Trial phase: Phase 2
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: treatment with DSXS once daily for 28 days

DSXS topical product: treatment daily for 28 days
Eligibility criteria:
Inclusion Criteria:

Male or non-pregnant, non-lactating females 12-17 years of age.

Exclusion Criteria:

Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
Intervention: Ademetionine
Trial phase: Phase 2
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: treatment with DSXS once daily for 28 days

DSXS Topical product: once daily for 28 days
Eligibility criteria:
Inclusion Criteria:

Male or non-pregnant, non-lactating females 18 years of age or older.
IRE-approved, signed informed consent form that meets all criteria of current FDA regulations.

Exclusion Criteria:

Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
Intervention: Ademetionine
Trial phase: Phase 3
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 183
Group description: applied once daily for 28 days

DSXS topical: topical treatment
Eligibility criteria:
Inclusion Criteria:

Male or non-pregnant, non-lactating females 18 years of age and older.

Exclusion Criteria:

Females who are pregnant, lactating or likely to become pregnant during the study.
Intervention: Ademetionine
Trial phase: Phase 2
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 146
Group description: A thin layer of study medication will be applied to cover affected areas once daily for 12 weeks

ADPS topical product: topical product
Eligibility criteria:
Inclusion Criteria:

Healthy male or non pregnant female aged ≥ 9 years with a clinical diagnosis of acne vulgaris

Exclusion Criteria:

Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Slow infusions of ketamine will take place over a time period of 40 minutes.

Ketamine: Ketamine Hydrochloride Injection
Eligibility criteria:
Inclusion Criteria:

Be between 18-60 years of age
Meet criteria for Treatment Resistant Depression (defined as two or more unsuccessful trials of antidepressants at an adequate dose for at least 4 weeks)

Exclusion Criteria:

Diagnosed with intellectual disability, eg. Mental retardation, neurodegenerative diseases, eg. Early onset neurocognitive disturbances such as frontotemporal dementia or behavioral disorders, eg. adult onset Attention Deficit Hyperactivity Disorder,
Diagnosed with Bipolar Disorder (BD),
Diagnosed with personality disorders,
Previously or currently diagnosed with psychosis (schizoaffective disorder -SAD) or schizophrenia - SCZ),
Current major medical problems that affect brain anatomy, neurochemistry, or function, e.g., obstructive sleep apnea requiring Continuous Positive Airway Pressure (CPAP), liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, auto-immune diseases, and any brain disorder (seizure disorder, stroke, dementia, degenerative neurologic diseases); history of any brain diseases, including seizures, stroke, meningitis, encephalitis, dementia, degenerative brain diseases, and head injury with loss of consciousness for any period of time,
Diagnosed specifically with a cardiovascular disorders such as Hypertension, Arrhythmias, Chronic Heart Failure, Myocardial Infarction (MI) or suffering from Chronic Obstructive Pulmonary Disease (COPD) or asthma. Cardiac clearance prior to enrolling in the study and medical records from physician will be required per patient's Primary Care Physician.
Patients with increased risk of laryngospasm, active upper respiratory infections, respiratory depression, increased intracranial pressure, thyroid disease, or porphyria,
Current substance abuse or dependence. Only patients who achieved stable, full remission for at least 6 months will be included
Pregnancy or Breast feeding. All female in reproductive age will undergo pregnancy tests. Female participants will be required to provide evidence of use of contraceptives during the course of the study,
Unable to understand the design and requirements of the study.
Unable to sign the informed consent for any reason.
Intervention: Cetirizine Hydrochloride
Trial phase: Phase 3
SMILES: Cl.Cl.O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: JDP-205 Injection, 10 mg/mL, 1 mL

Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL
Eligibility criteria:
Inclusion Criteria:

Male or female patients with a diagnosis of acute urticaria who need treatment with antihistamine to alleviate their symptoms;
18 years of age or older;
Be willing and able to give informed consent;
Patients with a Patient rated Pruritus Severity Score ≥ 1

Exclusion Criteria:

Receipt of an investigational drug or device, within the past 30 days;
Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy);
Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg;
Receipt of any antihistamine (H1 antagonist) within the past 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
Receipt of an H2 antagonist within the past 2 hours;
Receipt of doxepin within the past 2 hours; doxepin is an antidepressant, but it also has antihistamine properties;
Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past 4 hours to manage an acute allergic reaction;
Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes;
Anaphylaxis prior to the acute anaphylactic symptoms having been treated.
Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
Pregnancy or breastfeeding;
Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication;
Patients who, based on their medical history or in the opinion of the investigator, have chronic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response;
Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;
History of HIV or other known immunodeficiency;
Major medical or psychiatric illness, other than acute urticaria, at the time of presentation;
Inability to provide informed consent.
Patients on concomitant p-glycoprotein inhibitors