anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Remimazolam
Trial phase: Phase 3
ATC code: N05CD14
SMILES: COC(=O)CC[C@@H]1N=C(c2ccccn2)c2cc(Br)ccc2-n2c(C)cnc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 296
Group description: Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.
Eligibility criteria:
Inclusion Criteria:

Male and female patients, aged ≥18, scheduled to undergo a diagnostic or therapeutic colonoscopy (therapeutic procedures could include hemostasis, resection, ablation decompression, foreign body extraction, for example).
American Society of Anesthesiologists Score 1 through 3
Body mass index ≤40 kg/m2.
For female patients with child-bearing potential, negative result of pregnancy test (serum or urine) as well as use of birth control during the study period (from the time of consent until all specified observations were completed).
Patient voluntarily signed and dated an informed consent form that was approved by an Independent Review Board prior to the conduct of any study procedure.
Patient was willing and able to comply with study requirements and return for a Follow-up Visit on Day 4 (+3/-1 days) after the colonoscopy.

Exclusion Criteria:

Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
Chronic use of benzodiazepines for any indication (eg, insomnia, anxiety, spasticity).
Chronic use of opioids for any indication.
Female patients with a positive serum human chorionic gonadotropin pregnancy test at screening or baseline.
Lactating female patients.
Patients with positive drugs of abuse screen or a positive serum ethanol at baseline.
Patient with a history of drug or ethanol abuse within the past 2 years.
Patients in receipt of any investigational drug within 30 days or less than seven half-lives (whichever was longer) before screening, or scheduled to receive one during the study period.
Participation in any previous clinical trial with remimazolam.
Patients with an inability to communicate well in English with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).
Intervention: Midazolam
Trial phase: Phase 3
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Open-label Midazolam iv arm: 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance.

*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill
Eligibility criteria:
Inclusion Criteria:

Male and female patients, aged ≥18, scheduled to undergo a diagnostic or therapeutic colonoscopy (therapeutic procedures could include hemostasis, resection, ablation decompression, foreign body extraction, for example).
American Society of Anesthesiologists Score 1 through 3
Body mass index ≤40 kg/m2.
For female patients with child-bearing potential, negative result of pregnancy test (serum or urine) as well as use of birth control during the study period (from the time of consent until all specified observations were completed).
Patient voluntarily signed and dated an informed consent form that was approved by an Independent Review Board prior to the conduct of any study procedure.
Patient was willing and able to comply with study requirements and return for a Follow-up Visit on Day 4 (+3/-1 days) after the colonoscopy.

Exclusion Criteria:

Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
Chronic use of benzodiazepines for any indication (eg, insomnia, anxiety, spasticity).
Chronic use of opioids for any indication.
Female patients with a positive serum human chorionic gonadotropin pregnancy test at screening or baseline.
Lactating female patients.
Patients with positive drugs of abuse screen or a positive serum ethanol at baseline.
Patient with a history of drug or ethanol abuse within the past 2 years.
Patients in receipt of any investigational drug within 30 days or less than seven half-lives (whichever was longer) before screening, or scheduled to receive one during the study period.
Participation in any previous clinical trial with remimazolam.
Patients with an inability to communicate well in English with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).
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: No
Participants at risk: 6
Group description: ticagrelor 90mg bid

ticagrelor: ticagrelor 90 mg bid
Eligibility criteria:
Inclusion Criteria:

Written informed consent before any study related procedures are performed.
A qualifying post-operative T or I troponin elevation (≥2x ULN of assay within 7 days of index surgery and during the index hospitalization).
Men and women ≥40 years of age if troponin elevation was identified as part of routine post-operative clinical care OR
Men and women ≥55 years of age if troponin elevation was identified post-operatively as part of screening for the study.
Undergone non-cardiac surgery requiring an overnight hospital stay.
Women of childbearing potential who are sexually active must have a negative pregnancy test at enrollment and agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug.
Able to be randomized within 35 days following the index surgery.

Exclusion Criteria:

Post-operative ST-elevation Myocardial Infarction (STEMI).

Post-operative high-risk non-STEMI, defined as patients with elevated troponin with either:

active Ischemic EKG changes (≥2 mm of ST-segment depression in at least 2 adjacent leads)
ongoing hemodynamic instability thought to be ischemia mediated or
persistent anginal symptoms.
Planned or urgent coronary angiography/revascularization.
A current or ongoing indication for dual antiplatelet therapy (DAPT) as determined by the patient's physician.
History of intracranial hemorrhage
Bleeding disorder or active bleeding that prevents ticagrelor or aspirin administration.
Taking any of the following medications at the time of randomization: vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban , fondaparinux, cilostazol, vorapaxar or LMWHs.
Renal dialysis.
Hepatic impairment with transaminase ≥3x ULN at time of randomization.
Known contra-indication for use of ticagrelor.
Estimated life expectancy of <1 year.
Enrolled in another ongoing drug or device research protocol
A definite non-ischemic explanation for troponin elevation, such as myocarditis or pulmonary embolism.
A documented hypersensitivity to aspirin.
Hypersensitivity to ticagrelor or any component of the product.
Neurological or ophthalmic surgery during the index hospitalization.
Patients taking strong CYP3A inhibitors and/or CYP3A inducers that cannot be stopped for the course of the study.
Intervention: ASPIRIN
Trial phase: Phase 4
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Patients in the aspirin arm will receive aspirin 81 mg daily orally

aspirin: aspirin 81 mg daily
Eligibility criteria:
Inclusion Criteria:

Written informed consent before any study related procedures are performed.
A qualifying post-operative T or I troponin elevation (≥2x ULN of assay within 7 days of index surgery and during the index hospitalization).
Men and women ≥40 years of age if troponin elevation was identified as part of routine post-operative clinical care OR
Men and women ≥55 years of age if troponin elevation was identified post-operatively as part of screening for the study.
Undergone non-cardiac surgery requiring an overnight hospital stay.
Women of childbearing potential who are sexually active must have a negative pregnancy test at enrollment and agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug.
Able to be randomized within 35 days following the index surgery.

Exclusion Criteria:

Post-operative ST-elevation Myocardial Infarction (STEMI).

Post-operative high-risk non-STEMI, defined as patients with elevated troponin with either:

active Ischemic EKG changes (≥2 mm of ST-segment depression in at least 2 adjacent leads)
ongoing hemodynamic instability thought to be ischemia mediated or
persistent anginal symptoms.
Planned or urgent coronary angiography/revascularization.
A current or ongoing indication for dual antiplatelet therapy (DAPT) as determined by the patient's physician.
History of intracranial hemorrhage
Bleeding disorder or active bleeding that prevents ticagrelor or aspirin administration.
Taking any of the following medications at the time of randomization: vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban , fondaparinux, cilostazol, vorapaxar or LMWHs.
Renal dialysis.
Hepatic impairment with transaminase ≥3x ULN at time of randomization.
Known contra-indication for use of ticagrelor.
Estimated life expectancy of <1 year.
Enrolled in another ongoing drug or device research protocol
A definite non-ischemic explanation for troponin elevation, such as myocarditis or pulmonary embolism.
A documented hypersensitivity to aspirin.
Hypersensitivity to ticagrelor or any component of the product.
Neurological or ophthalmic surgery during the index hospitalization.
Patients taking strong CYP3A inhibitors and/or CYP3A inducers that cannot be stopped for the course of the study.
Intervention: (r)-2-(1-(6-Amino-5-chloropyrimidine-4-carboxamido)ethyl)-n-(5-chloro-4-(trifluoromethyl)pyridin-2-yl)thiazole-5-carboxamide
Trial phase: Phase 1
SMILES: CC(NC(=O)c1ncnc(N)c1Cl)c1ncc(C(=O)Nc2cc(C(F)(F)F)c(Cl)cn2)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants received 3200 µg/day AMG 211 administered as a cIV infusion for 14 days followed by a 2-week treatment-free interval.
Eligibility criteria:
Inclusion Criteria:

Informed consent provided
18 years or older
Advanced relapsed/refracted gastrointestinal adenocarcinoma
At least 1 measurable tumor lesion
Tumor tissue available or is willing to undergo biopsy of a tumor lesion before the start of treatment
Adequate hematological, renal, and liver function
Body weight ≥ 45 kg
Other inclusion criteria may apply

Exclusion Criteria:

Malignancy other than gastrointestinal (GI) adenocarcinoma requiring current therapy
Evidence of uncontrolled systemic disease, active infection, Hepatitis B and/or C, human immunodeficiency virus (HIV), history of cardiac disease, history of significant central nervous system (CNS) disease, history of chronic autoimmune disease (with the exception of stable type 1 diabetes)
Major surgery within 28 days of study day 1
Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded. Exception to this criterion is the participation in the optional Imaging Study and all procedures related to this study.
Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for cancer within 14 days prior to study entry and not recovered from treatment
Unresolved toxicities from prior anti-tumor therapy
Males or Females of reproductive potential, and unwilling to practice an acceptable method of effective birth control while on study through 30 days after receiving the last dose of study drug
Females who are pregnant, planning to become pregnant, lactating/breastfeeding or who plan to breastfeed while on study through 30 days after receiving the last dose of study drug
Other exclusion criteria may apply
Intervention: Linaclotide
Trial phase: Phase 3
ATC code: A06AX04
SMILES: CC1NC(=O)C2CCCN2C(=O)C(CC(N)=O)NC(=O)C2CSSCC(N)C(=O)NC3CSSCC(NC1=O)C(=O)NC(C(C)O)C(=O)NCC(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)O)CSSCC(NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCC(=O)O)NC3=O)C(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 411
Group description: 72 μg oral linaclotide, once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Patient has completed a colonoscopy if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
Patient has no clinically significant findings on a physical examination and clinical laboratory tests
Patient meets protocol criteria for CIC: reports < 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
Patient is compliant with daily interactive voice response system (IVRS) calls
Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.

Exclusion Criteria:

Patient has history of loose or watery stools
Patient has symptoms of or been diagnosed with irritable bowel syndrome (IBS)
Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.
Intervention: Linaclotide
Trial phase: Phase 3
ATC code: A06AX04
SMILES: CC1NC(=O)C2CCCN2C(=O)C(CC(N)=O)NC(=O)C2CSSCC(N)C(=O)NC3CSSCC(NC1=O)C(=O)NC(C(C)O)C(=O)NCC(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)O)CSSCC(NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCC(=O)O)NC3=O)C(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 411
Group description: 145 μg oral linaclotide, once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Patient has completed a colonoscopy if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
Patient has no clinically significant findings on a physical examination and clinical laboratory tests
Patient meets protocol criteria for CIC: reports < 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
Patient is compliant with daily interactive voice response system (IVRS) calls
Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.

Exclusion Criteria:

Patient has history of loose or watery stools
Patient has symptoms of or been diagnosed with irritable bowel syndrome (IBS)
Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.
Intervention: Tetrabenazine
Trial phase: Phase 3
ATC code: N07XX06 | N07XX16
SMILES: COc1cc2c(cc1OC)C1CC(=O)C(CC(C)C)CN1CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

History of using a dopamine receptor antagonist for at least 3 months
Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
History of being compliant with prescribed medications
Able to swallow study drug whole
Be in good general health and is expected to attend all study visits and complete study assessments
Female subjects must not be pregnant and must agree to an acceptable method of contraception throughout the study

Exclusion Criteria:

Currently receiving medication for the treatment of tardive dyskinesia
Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
Have a serious untreated or undertreated psychiatric illness
Have recent history or presence of violent behavior
Have unstable or serious medical illness
Have evidence of hepatic impairment
Have evidence of renal impairment
Have known allergy to any component of SD-809 or tetrabenazine
Has participated in an investigational drug or device trial and received study drug or device within 30 days
Have acknowledged use of illicit drugs
Have a history of alcohol or substance abuse in the previous 12 months
Intervention: Tetrabenazine
Trial phase: Phase 3
ATC code: N07XX06 | N07XX16
SMILES: COc1cc2c(cc1OC)C1CC(=O)C(CC(C)C)CN1CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
Eligibility criteria:
Inclusion Criteria:

History of using a dopamine receptor antagonist for at least 3 months
Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
History of being compliant with prescribed medications
Able to swallow study drug whole
Be in good general health and is expected to attend all study visits and complete study assessments
Female subjects must not be pregnant and must agree to an acceptable method of contraception throughout the study

Exclusion Criteria:

Currently receiving medication for the treatment of tardive dyskinesia
Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
Have a serious untreated or undertreated psychiatric illness
Have recent history or presence of violent behavior
Have unstable or serious medical illness
Have evidence of hepatic impairment
Have evidence of renal impairment
Have known allergy to any component of SD-809 or tetrabenazine
Has participated in an investigational drug or device trial and received study drug or device within 30 days
Have acknowledged use of illicit drugs
Have a history of alcohol or substance abuse in the previous 12 months
Intervention: Tetrabenazine
Trial phase: Phase 3
ATC code: N07XX06 | N07XX16
SMILES: COc1cc2c(cc1OC)C1CC(=O)C(CC(C)C)CN1CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
Eligibility criteria:
Inclusion Criteria:

History of using a dopamine receptor antagonist for at least 3 months
Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
History of being compliant with prescribed medications
Able to swallow study drug whole
Be in good general health and is expected to attend all study visits and complete study assessments
Female subjects must not be pregnant and must agree to an acceptable method of contraception throughout the study

Exclusion Criteria:

Currently receiving medication for the treatment of tardive dyskinesia
Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
Have a serious untreated or undertreated psychiatric illness
Have recent history or presence of violent behavior
Have unstable or serious medical illness
Have evidence of hepatic impairment
Have evidence of renal impairment
Have known allergy to any component of SD-809 or tetrabenazine
Has participated in an investigational drug or device trial and received study drug or device within 30 days
Have acknowledged use of illicit drugs
Have a history of alcohol or substance abuse in the previous 12 months
Intervention: Benfotiamine
Trial phase: Phase 2
ATC code: A11DA03
SMILES: CC(=C(CCOP(=O)(O)O)SC(=O)c1ccccc1)N(C=O)Cc1cnc(C)nc1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: The patients in this arm will be treated with placebo

To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).

• To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients. Placebo group received identical capsules without benfotiamine
Eligibility criteria:
Inclusion Criteria:

60 years of age or older
Clinical diagnosis of AMCI by the Peterson criteria or probable AD dementia according to the National Institute of Neurological Disorders and stroke and the Alzheimer's Disease related Disorders Association (NINCDS/ADRDA)
MMSE score > or equal to 21
CDR score > or equal to 0.5 and < or equal to1
Cornell Scale for Depression in Dementia(CSDD) score <10.
Ambulatory or ambulatory with aide
Have a caregiver willing to accompany the patient to each visit, accept responsibility for supervising treatment and provided input to clinical outcome assessments
Reside at home
Speak English
Amyloid positive PET-scan
If they are on AD medications they must be stable on AD medications for at least three months prior to baseline
Subjects ore willing/able to provide informed consent.

Exclusion Criteria:

Patients with significant neurological disorder other than AD including hypoxia, stroke, traumatic brain injury
A current psychiatric disorder according the DSM-IV diagnosis of major depression unless successfully treated on a stable dose of an antidepressant for at least 4 weeks and continues on stable dose throughout the study
Any other DSM-IV Axis l diagnosis including other primary neurodegenerative dementia schizophrenia or bipolar depression
A current diagnosis of uncontrolled diabetes mellitus (glucose values > 200 mg/ml).
Patients with uncontrolled diabetes will be excluded because high glucose will alter the FDG-PET studies. The clinic that does PET (Columbia University Medical Center) excludes patients if glucose values exceed 200 mg/ml.
A current diagnosis of active, uncontrolled seizure disorder
A current diagnosis of probable or possible vascular dementia according to NINDS-AIREN
An investigational drug during the previous 4 weeks
A current diagnosis of severe unstable cardiovascular disease
A current diagnosis of acute severe, or unstable asthmatic condition (e.g., severe chronic obstructive pulmonary disease (COPD),
A current diagnosis of cardiac, renal or hepatic disease
History of alcoholism, current or within past 5 years
A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty)
A1C less than or equal to 8
Current diagnosis of cancer/active treatments