anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Somatostatin
Trial phase: Phase 2
ATC code: H01CB01
SMILES: CC(N)C(=O)NCC(=O)NC1CSSCC(C(=O)O)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(Cc2ccccc2)NC(=O)C(C(C)O)NC(=O)C(CCCCN)NC(=O)C(Cc2c[nH]c3ccccc23)NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccccc2)NC(=O)C(CC(N)=O)NC(=O)C(CCCCN)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Type 1 diabetes and Hypoglycemia unawareness

somatostatin: Somatostatin may be used to suppress endogenous insulin secretion
Eligibility criteria:
Inclusion Criteria:

Age 18-65
Healthy control
Must be able to provide informed consent
Type 1 diabetes with hypoglycemia unawareness with hemoglobin A1c < 7.5%
Poorly controlled diabetics with hemoglobin A1c > 7.5%
Subjects with hypoglycemia unawareness must report an inability to recognize at least some blood glucose values <58 mg/dL during the 3 months prior to the study.

Exclusion Criteria:

Over 300 pounds
Claustrophobic
History of ischemic heart disease, arrhythmia, of seizure disorder
Pregnant
On medications known to alter blood flow or carbohydrate metabolism
Have internally located pieces of metal
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 109
Group description: Placebo (Saline) Group
Eligibility criteria:
Inclusion Criteria:

scheduled for painless diagnostic procedures
are ASA I or ASA II

Exclusion Criteria:

have an indwelling central venous catheter
have received an analgesic or sedative medication in the previous four hours prior to enrollment
have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations
known hypersensitivity to lidocaine or any component of the formulation
hypersensitivity to another local anesthetic of the amide type
Adam-Stokes syndrome
severe degrees of SA, AV, or intraventricular heart block
allergy to corn-related products
contraindication to propofol
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 109
Group description: 0.25 mg/kg Lidocaine Group
Eligibility criteria:
Inclusion Criteria:

scheduled for painless diagnostic procedures
are ASA I or ASA II

Exclusion Criteria:

have an indwelling central venous catheter
have received an analgesic or sedative medication in the previous four hours prior to enrollment
have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations
known hypersensitivity to lidocaine or any component of the formulation
hypersensitivity to another local anesthetic of the amide type
Adam-Stokes syndrome
severe degrees of SA, AV, or intraventricular heart block
allergy to corn-related products
contraindication to propofol
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 109
Group description: 0.50 mg/kg Lidocaine Group
Eligibility criteria:
Inclusion Criteria:

scheduled for painless diagnostic procedures
are ASA I or ASA II

Exclusion Criteria:

have an indwelling central venous catheter
have received an analgesic or sedative medication in the previous four hours prior to enrollment
have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations
known hypersensitivity to lidocaine or any component of the formulation
hypersensitivity to another local anesthetic of the amide type
Adam-Stokes syndrome
severe degrees of SA, AV, or intraventricular heart block
allergy to corn-related products
contraindication to propofol
Intervention: Warfarin Sodium
Trial phase: Phase 2
SMILES: CC(=O)CC(c1ccccc1)c1c([O-])c2ccccc2oc1=O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: The appropriate dose of warfarin sodium, as 2 mg tablet, to achieve the target prothrombin time - international normalization ratio (PT-INR: 2.0-3.0 for under 70 years old; 2.0-2.6 for 70 years or older) was administered once a day every morning after meal for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 20 years outpatient (regardless of sex)
Patients diagnosed as non-valvular atrial fibrillation (NVAF)
One or more following risks of stroke.

Exclusion Criteria:

Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.
Intervention: Apixaban
Trial phase: Phase 2
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: One apixaban 2.5 mg tablet and 1 apixaban 5.0 mg placebo tablet were administered twice a day (morning and evening) after a meal for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 20 years outpatient (regardless of sex)
Patients diagnosed as non-valvular atrial fibrillation (NVAF)
One or more following risks of stroke.

Exclusion Criteria:

Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.
Intervention: Bivalirudin
Trial phase: Not Applicable
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 69
Group description: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.

Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
Eligibility criteria:
Inclusion Criteria:

Age 18-60
Healthy nulliparous or multiparous women
Term (>36 week gestation)
Singleton pregnancy
Spontaneous labor or with spontaneous rupture of membranes
Receive oxytocin
Request neuraxial analgesia

Exclusion Criteria:

Under 18 years of age
Presence of any systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
Use of chronic analgesic medications
Prior administration of systemic opioid labor analgesia
Non-vertex presentation
Induction of labor
Contraindication to neuraxial analgesia.
Intervention: Carbon
Trial phase: Not Applicable
ATC code: A07BA01 | A07BA51
SMILES: [C]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.

Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Eligibility criteria:
Inclusion Criteria:

Age 18-60
Healthy nulliparous or multiparous women
Term (>36 week gestation)
Singleton pregnancy
Spontaneous labor or with spontaneous rupture of membranes
Receive oxytocin
Request neuraxial analgesia

Exclusion Criteria:

Under 18 years of age
Presence of any systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
Use of chronic analgesic medications
Prior administration of systemic opioid labor analgesia
Non-vertex presentation
Induction of labor
Contraindication to neuraxial analgesia.
Intervention: ASPARTIC ACID
Trial phase: Not Applicable
SMILES: N[C@@H](CC(=O)O)C(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.

Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Eligibility criteria:
Inclusion Criteria:

Age 18-60
Healthy nulliparous or multiparous women
Term (>36 week gestation)
Singleton pregnancy
Spontaneous labor or with spontaneous rupture of membranes
Receive oxytocin
Request neuraxial analgesia

Exclusion Criteria:

Under 18 years of age
Presence of any systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
Use of chronic analgesic medications
Prior administration of systemic opioid labor analgesia
Non-vertex presentation
Induction of labor
Contraindication to neuraxial analgesia.
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 183
Group description: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Eligibility criteria:
Inclusion Criteria:

The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
Current or past history of aspirin-induced asthma or hypersensitivity to NSAIDs.
Past or planned surgery affecting gastric acid secretion.
Clinically significant hepatic or renal disorder.
Serious cardiac dysfunction, hypertension, or hematological disorder.
Intervention: Gefarnate
Trial phase: Phase 3
ATC code: A02BX07 | A02BX77
SMILES: [H]/C(CC/C(C)=C(\[H])CCC(=O)OC/C([H])=C(\C)CCC=C(C)C)=C(/C)CCC=C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 181
Group description: Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Eligibility criteria:
Inclusion Criteria:

The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
Current or past history of aspirin-induced asthma or hypersensitivity to NSAIDs.
Past or planned surgery affecting gastric acid secretion.
Clinically significant hepatic or renal disorder.
Serious cardiac dysfunction, hypertension, or hematological disorder.
Intervention: Telapristone acetate
Trial phase: Phase 1 | Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: 50 mg Proellex single dose Female subjects with mild renal impairment function.

50 mg Proellex: Single dose
Eligibility criteria:
Inclusion Criteria:

Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred
Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function
Subject with renal impairment must have evidence of stable disease
If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.
Negative urine pregnancy test at screening visit
Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control
Healthy subject must have no significant abnormal findings at the screening physical examination
Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days)
Additional inclusion criteria may apply

Exclusion Criteria:

Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant
Subject with clinically significant abnormal liver function
Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study
An acute illness within five (5) days of study medication administration
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system
Additional exclusion criteria may apply
Intervention: Telapristone acetate
Trial phase: Phase 1 | Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: 50 mg Proellex, Female subjects with moderate renal impairment function.

50 mg Proellex: Single dose
Eligibility criteria:
Inclusion Criteria:

Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred
Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function
Subject with renal impairment must have evidence of stable disease
If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.
Negative urine pregnancy test at screening visit
Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control
Healthy subject must have no significant abnormal findings at the screening physical examination
Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days)
Additional inclusion criteria may apply

Exclusion Criteria:

Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant
Subject with clinically significant abnormal liver function
Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study
An acute illness within five (5) days of study medication administration
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system
Additional exclusion criteria may apply
Intervention: Telapristone acetate
Trial phase: Phase 1 | Phase 2
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: 50 mg Proellex, Female subjects with normal renal function.

50 mg Proellex: Single dose
Eligibility criteria:
Inclusion Criteria:

Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred
Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function
Subject with renal impairment must have evidence of stable disease
If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.
Negative urine pregnancy test at screening visit
Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control
Healthy subject must have no significant abnormal findings at the screening physical examination
Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days)
Additional inclusion criteria may apply

Exclusion Criteria:

Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant
Subject with clinically significant abnormal liver function
Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study
An acute illness within five (5) days of study medication administration
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system
Additional exclusion criteria may apply
Intervention: Pioglitazone
Trial phase: Phase 2
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Pioglitazone: Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
Eligibility criteria:
Inclusion Criteria:

Asthma diagnosed by a physician at least 1 year prior to study enrollment
Poorly-controlled asthma at study enrollment
Non smokers (stopped smoking at least 1 year ago) and limited lifetime history of smoking
Body mass index 30-60
Responds to methacholine challenge test with PC20 of <16 mg/ml
On a stable dose of inhaled corticosteroid for at least 4 weeks prior to study entry
FEV1 > 60% predicted
Able to obtain weekly weights at home

Exclusion Criteria:

Systemic steroids within the past 4 weeks
Lung pathology other than asthma
Other significant non-pulmonary co-morbidities such as: coronary artery disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure with an ejection fraction <50%, liver disease or elevated liver enzymes at baseline, malignancy (excluding non-melanoma skin cancers), AIDS, renal failure with serum creatinine >3.0, or disorders requiring steroid treatment such as vasculitis, lupus, rheumatoid arthritis
B-type natriuretic peptide (BNP) >400pg/ml
Pregnant or lactating
Currently taking a beta blocker, a CYP2C8 inhibitor or inducer such as gemfibrozil or rifampin, a TZD (thiazolidinedione), or allergic to TZD
Taking antioxidants (if taking a multivitamin must be on a stable regimen prior to enrollment)
Illicit drug use within the past year
Current/active upper respiratory infection (if active URI, wait until asymptomatic for 1 week to enroll)
Asthma exacerbation within the past 4 weeks (includes ER, urgent care, or hospital visits due to asthma resulting in an increase in asthma-related medications)
Undergoing evaluation for sleep apnea, or plans to institute treatment for sleep apnea (patients on a stable treatment regimen for sleep apnea for the last 3 months will be allowed to participate)
Clinically significant abnormalities present on screening 12-lead electrocardiogram
Women of childbearing potential using oral contraceptives who are not willing to use a second method of contraception during the study
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 200
Group description: Inhalational anesthesia with isoflurane
Eligibility criteria:
Inclusion Criteria:

patients (aged 65 years or older) scheduled for elective spine or major joint replacement (total hip or total knee arthroplasty) at Duke University Medical Center or the Durham VA Medical Center

Exclusion Criteria:

not fluent in English and able to comprehend the English language
have severe visual or auditory handicaps
Carry a diagnosis of dementia or score < 18 on the Mini-Mental State Examination (MMSE) as calculated from the Modified Mini-Mental State (3MS) (see D4 below)
have allergies to eggs, propofol, isoflurane, fentanyl, remifentanil, or pregabalin
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 200
Group description: Total intravenous anesthesia with propofol
Eligibility criteria:
Inclusion Criteria:

patients (aged 65 years or older) scheduled for elective spine or major joint replacement (total hip or total knee arthroplasty) at Duke University Medical Center or the Durham VA Medical Center

Exclusion Criteria:

not fluent in English and able to comprehend the English language
have severe visual or auditory handicaps
Carry a diagnosis of dementia or score < 18 on the Mini-Mental State Examination (MMSE) as calculated from the Modified Mini-Mental State (3MS) (see D4 below)
have allergies to eggs, propofol, isoflurane, fentanyl, remifentanil, or pregabalin