anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tranexamic acid
Trial phase: Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 9
Group description: Subjects will receive a 15 mg/kg bolus of tranexamic acid over 10 minutes followed by a 2mg/kg/h over 8 hours. This represents 31mg/kg total dose of TXA.

Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to.
Eligibility criteria:
Inclusion Criteria:

Less than 18 years old AND
Penetrating torso trauma, blunt torso trauma, or head trauma as defined below.

Penetrating Torso Trauma:

a. Penetrating trauma to the chest, abdomen, neck, pelvis or thigh with at least one of the following:

age-adjusted hypotension, or
age-adjusted tachycardia despite adequate resuscitation fluids, or
radiographic evidence of internal hemorrhage, or
clinician suspicion of ongoing internal hemorrhage

Blunt Torso Trauma (at least one of the following):

Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following:

age-adjusted hypotension, or
persistent age-adjusted tachycardia despite adequate resuscitation fluids
Hemothorax on chest tube placement or imaging,
Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),
Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,

Pelvic fracture with contrast extravasation or hematoma on abdominal/pelvic CT scan with at least one of the following:

Age-adjusted tachycardia, or
Age-adjusted hypotension.

Head Trauma:

Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan)

Exclusion Criteria:

Unable to administer study drug within 3 hours of traumatic event
Known pregnancy
Known prisoners
Known wards of the state
Cardiac arrest prior to randomization
GCS score of 3 with bilateral unresponsive pupils
Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury
Known bleeding/clotting disorders
Known seizure disorders
Known history of severe renal impairment
Unknown time of injury
Previous enrollment into the TIC-TOC trial
Prior TXA for current injury
Non-English and non-Spanish speaking
Known venous or arterial thrombosis
Intervention: Tranexamic acid
Trial phase: Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: Subjects will receive a 30 mg/kg bolus of tranexamic acid over 10 minutes followed by a 4 mg/kg/h over 8 hours. This represents 62 mg/kg total dose of TXA.

Tranexamic Acid: Active drug is provided to participants as described based on the TXA arm they are randomized to.
Eligibility criteria:
Inclusion Criteria:

Less than 18 years old AND
Penetrating torso trauma, blunt torso trauma, or head trauma as defined below.

Penetrating Torso Trauma:

a. Penetrating trauma to the chest, abdomen, neck, pelvis or thigh with at least one of the following:

age-adjusted hypotension, or
age-adjusted tachycardia despite adequate resuscitation fluids, or
radiographic evidence of internal hemorrhage, or
clinician suspicion of ongoing internal hemorrhage

Blunt Torso Trauma (at least one of the following):

Clinician suspicion of hemorrhagic blunt torso injury and at least one of the following:

age-adjusted hypotension, or
persistent age-adjusted tachycardia despite adequate resuscitation fluids
Hemothorax on chest tube placement or imaging,
Clinical suspicion of hemorrhagic blunt torso injury and Intraperitoneal fluid on abdominal ultrasonography (Focused Assessment with Sonography in Trauma),
Intra-abdominal injury on CT with either contrast extravasation or more than trace intraperitoneal fluid,

Pelvic fracture with contrast extravasation or hematoma on abdominal/pelvic CT scan with at least one of the following:

Age-adjusted tachycardia, or
Age-adjusted hypotension.

Head Trauma:

Initial Glasgow Coma Scale (GCS) score 3 to 13 with associated intracranial hemorrhage on cranial CT scan (enroll after cranial CT scan)

Exclusion Criteria:

Unable to administer study drug within 3 hours of traumatic event
Known pregnancy
Known prisoners
Known wards of the state
Cardiac arrest prior to randomization
GCS score of 3 with bilateral unresponsive pupils
Isolated subarachnoid hemorrhage, epidural hematoma, or diffuse axonal injury
Known bleeding/clotting disorders
Known seizure disorders
Known history of severe renal impairment
Unknown time of injury
Previous enrollment into the TIC-TOC trial
Prior TXA for current injury
Non-English and non-Spanish speaking
Known venous or arterial thrombosis
Intervention: GABAPENTIN ENACARBIL
Trial phase: Not Applicable
SMILES: CC(OC(=O)NCC1(CC(=O)O)CCCCC1)OC(=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days

Gabapentin enacarbil: 600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative
Eligibility criteria:
Inclusion Criteria:

Men or women 18-85 years of age.
Scheduled for elective knee or hip arthroplasty with spinal anesthesia.

Exclusion Criteria:

Creatinine >1.50 mg/dl.
History of clinically important current depression or currently on any prescribed anti-depressant medication.
Previously enrolled in any Xenoport trial.
Use of gabapentin or gabapentinoids (Lyrica, Horizant, Neurontin or Gralise) within one month.
Allergy to gabapentin or gabapentinoids (Lyrica, Horizant, Neurontin or Gralise).
Women who are pregnant or breastfeeding.
History of seizure disorder within the last one-year or taking medications for seizures.
Intervention: Pravastatin
Trial phase: Phase 2
ATC code: C10AA03 | C10BA03 | C10BA11 | C10BA12 | C10BX02
SMILES: [H][C@@]12C(=C[C@@H](O)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: pravastatin 40mg daily for 12 weeks

Pravastatin: 40mg daily (Weeks 2 - 14)
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection
HIV RNA below the lower limit of assay detection within 12 months of study entry
1) Documented coronary heart disease (CHD): nonfatal MI, unrecognized MI, unstable angina pectoris, and/or stable angina pectoris, as defined by the American Heart Association Case Definitions for Acute Coronary Heart Disease in Epidemiology and Clinical Research Studies, OR Or (2) Documented 10-year ASCVD risk of 15% or greater based on the ACC/AHA ASCVD Risk Estimator
Negative serum or urine pregnancy test
Men and women age 18 to 75 years of age

Exclusion Criteria:

Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
No coronary heart disease (CHD) and 10-year ASCVD risk <15.0%.
Not currently receiving antiretroviral therapy or taking any of the following antiretroviral agents: atazanavir/ritonavir, lopinavir/ritonavir.
History of statin intolerance leading to discontinuation, dose decrease, or change to less potent dose equivalent
Statin absolute contraindication
Current use of atorvastatin 20mg daily or greater or rosuvastatin 10mg daily or greater
Chronic kidney disease stage 4 or greater (including dialysis)
Systolic heart failure with last documented LVEF <35%
Pregnant or breastfeeding
Laboratory values obtained within 45 days prior to study entry:

LDL-c <80 mg/dl while not on statin or LDL-c <60 mg/dl while on statin ALT > 3 x Upper Limit of Normal (ULN) AST > 3 x ULN Creatinine kinase (CK) >3 x ULN (calculated creatinine clearance (CrCl) <50 mL/min, as estimated by the Cockcroft-Gault equation)

Life expectancy <12 months
Prior organ transplant
Active malignancy
Inflammatory muscle disease
Intervention: Rosuvastatin
Trial phase: Phase 2
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: rosuvastatin 20 - 40 mg daily for 12 weeks

Rosuvastatin: 20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK <+1.5 x ULN, and LDL-c is >60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily
Eligibility criteria:
Inclusion Criteria:

HIV-1 infection
HIV RNA below the lower limit of assay detection within 12 months of study entry
1) Documented coronary heart disease (CHD): nonfatal MI, unrecognized MI, unstable angina pectoris, and/or stable angina pectoris, as defined by the American Heart Association Case Definitions for Acute Coronary Heart Disease in Epidemiology and Clinical Research Studies, OR Or (2) Documented 10-year ASCVD risk of 15% or greater based on the ACC/AHA ASCVD Risk Estimator
Negative serum or urine pregnancy test
Men and women age 18 to 75 years of age

Exclusion Criteria:

Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
No coronary heart disease (CHD) and 10-year ASCVD risk <15.0%.
Not currently receiving antiretroviral therapy or taking any of the following antiretroviral agents: atazanavir/ritonavir, lopinavir/ritonavir.
History of statin intolerance leading to discontinuation, dose decrease, or change to less potent dose equivalent
Statin absolute contraindication
Current use of atorvastatin 20mg daily or greater or rosuvastatin 10mg daily or greater
Chronic kidney disease stage 4 or greater (including dialysis)
Systolic heart failure with last documented LVEF <35%
Pregnant or breastfeeding
Laboratory values obtained within 45 days prior to study entry:

LDL-c <80 mg/dl while not on statin or LDL-c <60 mg/dl while on statin ALT > 3 x Upper Limit of Normal (ULN) AST > 3 x ULN Creatinine kinase (CK) >3 x ULN (calculated creatinine clearance (CrCl) <50 mL/min, as estimated by the Cockcroft-Gault equation)

Life expectancy <12 months
Prior organ transplant
Active malignancy
Inflammatory muscle disease
Intervention: Quinolin-8-yl 2-(3-oxo-2-pent-2-enylcyclopentyl)acetate
Trial phase: Phase 2
SMILES: CCC=CCC1C(=O)CCC1CC(=O)Oc1cccc2cccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Active study medication

5% VDA-1102: 200 mg applied once-daily for 28 days
Eligibility criteria:
Main Inclusion Criteria:

Subject has a minimum of 4 and a maximum of 8 discrete Grade 1-2 AK lesions within a single 25 square centimeter area of skin on their scalp or face

Main Exclusion Criteria:

Subject is: (a) pregnant; (b) lactating; (c) planning to become pregnant during the study, or (d) fertile and they or their fertile partner is unable or unwilling to use the required contraceptive methods
Subject is immunosuppressed
Subject has used any of the following topical treatments in the Treatment Field: (1) topical retinoids within 8 weeks of Screening or (2) micro-dermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod, ingenol, or other topical treatments for AK or that might impact AK within 12 weeks of Screening.
Subject has used systemic retinoid therapy within 6 months of Screening Visit.
Intervention: Quinolin-8-yl 2-(3-oxo-2-pent-2-enylcyclopentyl)acetate
Trial phase: Phase 2
SMILES: CCC=CCC1C(=O)CCC1CC(=O)Oc1cccc2cccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Active study medication

10% VDA-1102: 200 mg applied once-daily for 28 days
Eligibility criteria:
Main Inclusion Criteria:

Subject has a minimum of 4 and a maximum of 8 discrete Grade 1-2 AK lesions within a single 25 square centimeter area of skin on their scalp or face

Main Exclusion Criteria:

Subject is: (a) pregnant; (b) lactating; (c) planning to become pregnant during the study, or (d) fertile and they or their fertile partner is unable or unwilling to use the required contraceptive methods
Subject is immunosuppressed
Subject has used any of the following topical treatments in the Treatment Field: (1) topical retinoids within 8 weeks of Screening or (2) micro-dermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod, ingenol, or other topical treatments for AK or that might impact AK within 12 weeks of Screening.
Subject has used systemic retinoid therapy within 6 months of Screening Visit.
Intervention: Neostigmine
Trial phase: Phase 4
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 46
Group description: intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.

Neostigmine: Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
Eligibility criteria:
Inclusion Criteria:

male gender
age 18 years and older
body mass index < 30 kg/m2.

Exclusion Criteria:

Known or suspected neuromuscular disorders impairing neuromuscular function;
allergies to muscle relaxants, anesthetics or narcotics;
a (family) history of malignant hyperthermia or any other muscle disease;
any medical, neurological or psychiatric illness (including a history of anxiety).
Intervention: Sugammadex
Trial phase: Phase 4
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 46
Group description: intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.

Sugammadex: Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
Eligibility criteria:
Inclusion Criteria:

male gender
age 18 years and older
body mass index < 30 kg/m2.

Exclusion Criteria:

Known or suspected neuromuscular disorders impairing neuromuscular function;
allergies to muscle relaxants, anesthetics or narcotics;
a (family) history of malignant hyperthermia or any other muscle disease;
any medical, neurological or psychiatric illness (including a history of anxiety).
Intervention: Voxelotor
Trial phase: Phase 2
ATC code: B06AX03
SMILES: CC(C)n1nccc1-c1ncccc1COc1cccc(O)c1C=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Parts A and B Dose 1

GBT440: Capsules which contain GBT440 drug substance in Swedish orange
Eligibility criteria:
Inclusion Criteria:

Documented diagnosis of IPF.
Oxygen desaturation with exercise.
Completion of the baseline 6MWT
Weight ≥ 50 kg
Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 3 months after the last dose of study drug.

Exclusion Criteria:

FEV1/FVC < 70%.
Subjects on supplemental oxygen therapy at rest.
History of other interstitial lung diseases.
Significant polycythemia.
Female who is breast-feeding or pregnant.
Known current malignancy or history of malignancy within the last 2 years prior to screening.
Use of cytotoxic and/or immunosuppressant medications within 30 days screening.
Hospitalization due to an exacerbation of IPF within 30 days of screening
Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening
Corticosteroids (> 10 mg per day of prednisone or an equivalent) within 30 days of screening.
Current smoker or history of smoking within 3 months of screening.
Currently or, in the opinion of the investigator, soon to be listed for lung transplant.
History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within 6 months of screening.
Any condition possibly affecting drug absorption.
Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device).
Subject who, for any reason, is deemed by the investigator to be inappropriate for this study.
Intervention: Tavapadon
Trial phase: Phase 2
SMILES: Cc1cc(Oc2ncccc2C(F)(F)F)ccc1-c1c(C)c(=O)[nH]c(=O)n1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Eligible participants were up-titrated in a double-blind fashion to an optimal dose level of PF-06649751 according to a flexible dose titration scheme (from 0.25 mg to 15 mg once daily [QD]). The 15-week treatment period included 9 weeks of dose optimization and 6 weeks of stable dosing. Blinded PF-06649751 was provided as tablets for oral administration in the outpatient setting (each morning, daily for the duration of the treatment period). Reaching of the maximum allowed dose level (15 mg) was not mandatory; participants might achieve a satisfactory clinical response at a lower dose level. There was an additional follow-up period of 28 days following discontinuation of PF-06649751.
Eligibility criteria:
Inclusion Criteria:

Females of non-childbearing potential and/or male subjects
Clinical diagnosis of Parkinson's disease.
Parkinson's Disease Hoehn & Yahr Stage I-III inclusive
Treatment naïve or history of prior incidental treatment with dopaminergic agents for no more than 28 days
Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion Criteria:

History or presence of atypical Parkinsonian syndrome.
Severe acute or chronic medical or psychiatric condition or cognitive impairment or laboratory abnormality.
Any condition possibly affecting drug absorption.
Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.
Intervention: Atogepant
Trial phase: Phase 2 | Phase 3
ATC code: N02CD07
SMILES: C[C@@H]1[C@H](c2c(F)ccc(F)c2F)C[C@H](NC(=O)c2cnc3c(c2)C[C@@]2(C3)C(=O)Nc3ncccc32)C(=O)N1CC(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Has at least a 1-year history of migraine with or without aura
Age of the patient at the time of migraine onset < 50 years
History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
Demonstrated compliance with e-diary

Exclusion Criteria:

Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine
Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
Difficulty distinguishing migraine headache from other headaches
Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
Has a history of hepatitis within previous 6 months
Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
Pregnant or nursing females
Intervention: Atogepant
Trial phase: Phase 2 | Phase 3
ATC code: N02CD07
SMILES: C[C@@H]1[C@H](c2c(F)ccc(F)c2F)C[C@H](NC(=O)c2cnc3c(c2)C[C@@]2(C3)C(=O)Nc3ncccc32)C(=O)N1CC(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 91
Group description: Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Has at least a 1-year history of migraine with or without aura
Age of the patient at the time of migraine onset < 50 years
History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
Demonstrated compliance with e-diary

Exclusion Criteria:

Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine
Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
Difficulty distinguishing migraine headache from other headaches
Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
Has a history of hepatitis within previous 6 months
Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
Pregnant or nursing females
Intervention: Morphine
Trial phase: Phase 2
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: The patient-controlled intravenous analgesia with morphine (basal flow of 0.5-2 mg / h, bolus dose of 0.5 mg, lockout interval of 20 minutes, hour limit of 3 doses), which will be carried out 72 hours after the surgery

morphine
Eligibility criteria:
Inclusion Criteria:

patients age 65 and over
fracture of the proximal femur
preoperative assessment American Society of Anesthesiologists(ASA) score I - ASA III
a written consent of the patient to participate in research

Exclusion Criteria:

patient non-compliance
ASA status IV and IV above
patients younger than 65 years
dementia, Parkinson's disease, cerebrovascular accident history; simultaneous head injuries,the use of opioids and benzodiazepines longer than a month before the surgery; alcoholism; serious liver disease (class C according to Child-Pugh's classification); severe kidney disease that require dialysis
result of MMSE test (Mini-Mental State Examination) under 17
the existence of any contraindications for the implementation of regional anesthesia and one or other form of post-operative analgesia.