anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Donepezil
Trial phase: Phase 2
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Donepezil
Eligibility criteria:
INCLUSION CRITERIA:

Diagnosis of an Autism Spectrum Disorder (DSM-IV diagnoses of autistic disorder or Pervasive Developmental Disorder, Not Otherwise Specified).
Male or Female subjects between the ages of 24 and 50 months.
Language scores (from the Mullen Scales of Early Learning) that are at least 1.5 SD lower than the mean.

5. Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study.

6. Each subject must be stable for at least 6 weeks on any medication or therapy regimen prior to entry into study and must have no newly (within 6 weeks) recognized or intolerable adverse effects from that medicine or therapy. No subjects will be asked to discontinue any medication in order to qualify for enrollment but subjects taking contraindicated drugs will not qualify for enrollment.

7. Demonstrated REM% two standard deviations or more below the normative values for age for the randomized controlled trial part.

8. English language is primarily spoken at home.

EXCLUSION CRITERIA:

Serious, unstable illnesses including gastroenterologic, respiratory, cardiovascular endocrinologic, immunologic, or hematologic disease.
Renal or hepatic dysfunction that would interfere with excretion or metabolism of donepezil as evidenced by increase above upper limits of normal for BUN/creatinine, or two-fold elevation of serum transaminases (ALT/SGPT, AST/SGOT) or gamma glutamate (GGT).
Documented history of hypersensitivity or intolerance to donepezil or other piperidine derivative.

Subjects must not be taking any medication known to affect REM sleep (or sleep

architecture in general) or that is contraindicated for co-administration with donepezil.

Presence or history of other unstable neurological disorders such as seizure disorders,

metabolic disorders, narcolepsy or movement disorders.
Intervention: Tacrolimus
Trial phase: Not Applicable
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.

Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.
Eligibility criteria:
Inclusion Criteria:

Donor:

age 15-65 years macrovesicular steatosis < 40% (macroscopy or biopsy) sodium <165 mmol/l ICU stay and ventilation < 11 days cold ischemia time < 13 hours AST < 200 U/l ALT < 200 U/l bilirubin < 50 μmol/l application of norepinephrine is allowed

Recipient age: 18-69

Exclusion Criteria:

Recipient:

live donor liver transplant
reduced and split grafts
multi organ failure
Intervention: Ranolazine
Trial phase: Phase 2
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
Eligibility criteria:
Inclusion Criteria:

Male or non-pregnant female > 18 years of age;
Documentation of heart failure and who are in NYHA class II or III;
Documented history of symptomatic AF < 6 months in duration at the time of presentation, currently in AF at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
Percutaneous coronary intervention (PCI) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
Demonstration of preserved ejection fraction (EF) by echocardiography;
Echocardiographic evidence of impaired diastolic filling.

Exclusion Criteria:

Known history of permanent or long-standing AF (> 6 months);
Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
Known history of cirrhosis;
NYHA Class IV;
Myocardial Infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
Percutaneous coronary intervention (PCI) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
Clinically significant valvular disease;
Clinically significant pulmonary disease;
Stroke within 3 months prior to screening;
Creatinine clearance < 30 mL/min as calculated by Cockcroft-Gault formula;
Use of anti-arrhythmic drugs (Class Ia or IIIc) within 3 months prior to screening;
Concurrent use of drugs considered strong inhibitors of CYP3A;
Concurrent use of drugs considered as CYP3A inducers;
Prior treatment with ranolazine.
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Suicidal with depression and no substance use 0.2 mg/kg IV ketamine administered as a one time dose

Ketamine
Eligibility criteria:
Inclusion Criteria:

Age : 19-64
Significant suicidality score on the Columbia Suicide Severity Rating Scale (C-SSRS)
Willing and able to provide informed consent.
Individuals with current substance abuse are allowed

Exclusion Criteria:

Pregnant or lactating; women of reproductive potential must have a negative urine pregnancy test (urine dipstick method)
Post-Partum state : defined as being within 2 months of delivery or miscarriage
Homicide risk as determined by clinical interview
Treatment with any medication known to specifically target the glutamate-NMDA receptor system (ie lamotrigine, acamprosate, memantine, riluzole or lithium)
Any known hypersensitivity or serious adverse effect associated with ketamine treatment.
Any clinically significant medical condition or therapy that would preclude treatment with ketamine, to include recent myocardial infarction or unstable angina
Medically unstable, including acute withdrawal from alcohol or benzodiazepines requiring the use of benzodiazepine treatment.

Any of the following DSM-IV diagnoses or categories:

Any current psychosis or history of a non-mood psychotic disorder (e.g., schizophrenia)
Currently in a manic or mixed episode
Current use (defined by urine dipstick test) or abuse of hallucinogenic drugs (except marijuana) such as phencyclidine
Any dissociative disorder
Any pervasive developmental disorder (e.g., autism)
A cognitive disorder (e.g., Alzheimer's Disease)
Cluster A personality disorder (e.g., schizoid or schizotypal); note that cluster B and C personality disorders may be included
Any eating disorder
Intervention: Filgotinib
Trial phase: Phase 2
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Eligibility criteria:
Inclusion Criteria:

have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at Screening and at Baseline,
Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range (ULN),
have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.

Exclusion Criteria:

current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX,
current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Intervention: Filgotinib
Trial phase: Phase 2
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Eligibility criteria:
Inclusion Criteria:

have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at Screening and at Baseline,
Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range (ULN),
have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.

Exclusion Criteria:

current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX,
current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Intervention: Filgotinib
Trial phase: Phase 2
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Eligibility criteria:
Inclusion Criteria:

have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at Screening and at Baseline,
Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range (ULN),
have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.

Exclusion Criteria:

current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX,
current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Intervention: Filgotinib
Trial phase: Phase 2
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Eligibility criteria:
Inclusion Criteria:

have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at Screening and at Baseline,
Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range (ULN),
have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.

Exclusion Criteria:

current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX,
current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Intervention: Filgotinib
Trial phase: Phase 2
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Eligibility criteria:
Inclusion Criteria:

have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at Screening and at Baseline,
Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range (ULN),
have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.

Exclusion Criteria:

current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX,
current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Intervention: Filgotinib
Trial phase: Phase 2
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Eligibility criteria:
Inclusion Criteria:

have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
have ≥6 swollen joints (from a 66 joint count) and ≥8 tender joints (from a 68 joint count) at Screening and at Baseline,
Screening serum c-reactive protein ≥0.7 x upper limit of laboratory normal range (ULN),
have received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.

Exclusion Criteria:

current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX,
current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Intervention: Enzalutamide
Trial phase: Phase 2
ATC code: L02BB04
SMILES: CNC(=O)c1ccc(N2C(=S)N(c3ccc(C#N)c(C(F)(F)F)c3)C(=O)C2(C)C)cc1F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 118
Group description: Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause (up to a maximum of 87 Weeks).
Eligibility criteria:
Inclusion Criteria:

Women at least 18 years of age;
Advanced AR+ TNBC;
Availability of a representative tumor specimen:
Either measurable disease or bone only nonmeasurable disease;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

Any severe concurrent disease, infection, or comorbid condition;
Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data;
Current or previously treated brain metastasis or active leptomeningeal disease;
Current hormone replacement therapy;
Local palliative radiation therapy within 7 days before day 1;
History of another invasive cancer within 5 years of day 1;
Absolute neutrophil count < 1500/µL, platelet count < 75,000/µL, or hemoglobin < 9 g/dL (5.6 mmol/L) at the screening visit;
Creatinine > 1.5 times upper limit of normal (ULN) at the screening visit;
History of seizure or any condition that may predispose to seizure;
Clinically significant cardiovascular disease;
Active gastrointestinal disorder affecting absorption;
Major surgery within 4 weeks before day 1;
Treatment with any commercially available anticancer agent within 14 days before day 1;
Treatment with any investigational agent within 2 weeks before day 1;
Treatment with any of the following medications within 2 weeks before day 1: Estrogens, including hormone replacement therapy; Androgens (testosterone, dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or strontium);Vaccine therapy;
Hypoglycemic episode requiring medical intervention while on insulin treatment within 12 months before day 1;
Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
Intervention: N-(2-(((2,3-Difluorophenyl)methyl)thio)-6-(((1R,2S)-2,3-dihydroxy-1-methylpropyl)oxy)-4-pyrimidinyl)-1-azetidinesulfonamide
Trial phase: Phase 1
SMILES: CC(Oc1cc(NS(=O)(=O)N2CCC2)nc(SCc2cccc(F)c2F)n1)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: AZD5069 45mg oral twice daily (BID)
Eligibility criteria:
Inclusion Criteria:

Male or female patients of Caucasian origin, aged between 18 to 65 years, inclusive, at the time informed consent is obtained.
Physician based (according to GINA 2011) diagnosis of asthma for at least 6 months prior to the date informed consent is obtained and confirmed by 1 of the detailed respiratory criteria stated in the CSP
Morning prebronchodilator (ie, after abstinence from short-acting and long-acting ß-agonist treatment for ≥ 6 and ≥ 12 hours, respectively) FEV1 of ≥70% of predicted normal (PN) for age, sex and height at enrolment
Increased number of neutrophils in induced sputum samples at baseline, with a relative neutrophil count of ≥ 50% of total sputum cell count
Physician prescribed daily use of medium or high dose ICS (≥ fluticasone 250 μg to ≤ 1.000 µg or the equivalent daily, as defined in GINA 2011; see CSP Appendix E) plus LABA.

Exclusion Criteria:

History of clinically relevant allergies or idiosyncrasies to AZD5069 or other investigational CXCR2 antagonists, or any inactive ingredient(s) of the IMP, or tool-substances (eg, salbutamol, local anaesthetics) used for the purpose of this study
History of severe asthma exacerbation requiring hospitalization within the last 12 months before screening.
Asthma exacerbation requiring a treatment course of systemic (ie, oral or parenteral) corticosteroids within the 3 months before screening or ≥ 3 courses within the last 12 months before screening.
Moderate to severe airflow limitation (FEV1 <70% PN)

Any chronic lower respiratory disease other than asthma (see CSP for details) that, as judged by the Investigator or Medical Monitor, would interfere with the evaluation of the IMP or interpretation of patient safety or study results.

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