anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 110
Group description: Participants were administered with brexpiprazole oral tablets, daily, dose titrated up to 0.5 mg by Day 4, 1 mg by Day 7, 2 mg by Day 14, then between 2-4 mg after Day 21 up to Week 6 with a 1 mg increase or decrease, based on the Investigator's decision.
Eligibility criteria:
Inclusion Criteria:

Male & female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to screening.
PANSS score >= 80, inclusive, at screening and baseline

Exclusion Criteria:

Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia or other cognitive disorders
Subjects who have been hospitalized > 21 days for a current exacerbation of schizophrenia at the time of baseline.
Any neurological disorder other than Tourette's Syndrome
Subjects at significant risk of committing violent acts, serious self-harm or suicide based on history
Subjects with epilepsy, a history of seizures, severe head trauma or stroke
Subjects who test positive for drugs of abuse at screening
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 102
Group description: Participants were administered with aripiprazole oral tablets, daily, dose titrated up to 2 mg by Day 4, 5 mg by Day 7, 10 mg by Day 14, then 10, 15 or 20 mg after Day 21 up to Week 6 with a 5 mg increase or decrease, based on the Investigator's decision.
Eligibility criteria:
Inclusion Criteria:

Male & female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to screening.
PANSS score >= 80, inclusive, at screening and baseline

Exclusion Criteria:

Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia or other cognitive disorders
Subjects who have been hospitalized > 21 days for a current exacerbation of schizophrenia at the time of baseline.
Any neurological disorder other than Tourette's Syndrome
Subjects at significant risk of committing violent acts, serious self-harm or suicide based on history
Subjects with epilepsy, a history of seizures, severe head trauma or stroke
Subjects who test positive for drugs of abuse at screening
Intervention: Sodium Sulfate
Trial phase: Phase 4
ATC code: A06AD13 | A12CA02
SMILES: O=S(=O)([O-])[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participants in Group A will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes. Participants must finish drinking the bowel preparation by 7:00 PM, and may continue to drink clear liquids until midnight.

Golytely: bowel preparation
Eligibility criteria:
Inclusion Criteria:

- Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will be eligible to participate.

Exclusion Criteria:

Creatinine clearance less than 30 ml/min
History of heart failure with current shortness of breath at rest causing limited physical activity, arrhythmia, unstable angina or acute myocardial infarction
Small bowel obstruction, ileus or bowel perforation
Dementia or cognitive dysfunction to an extent that they cannot perform the study related documentation or consent to participate in the study.
Gastroparesis
Toxic megacolon or undergoing colonoscopy for decompression
Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin, chlorpromazine and penicillamine within 2 hours before or 6 hours after administration of Clenpiq or stimulant laxatives within 24 hours
History of prior colorectal surgery
Allergy to any of the ingredients in Clenpiq or golytely
if the procedure is planned in the intensive care unit (ICU)
Intervention: Sodium Sulfate
Trial phase: Phase 4
ATC code: A06AD13 | A12CA02
SMILES: O=S(=O)([O-])[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participants in Group B will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes for a total of 8 glasses, and must complete drinking the bowel preparation by 5:30 PM. Participants may continue to drink clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will be asked to drink an 8 ounce glass of bowel preparation every ten minutes for a total of 8 glasses over no more than 1.5 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.

Golytely: bowel preparation
Eligibility criteria:
Inclusion Criteria:

- Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will be eligible to participate.

Exclusion Criteria:

Creatinine clearance less than 30 ml/min
History of heart failure with current shortness of breath at rest causing limited physical activity, arrhythmia, unstable angina or acute myocardial infarction
Small bowel obstruction, ileus or bowel perforation
Dementia or cognitive dysfunction to an extent that they cannot perform the study related documentation or consent to participate in the study.
Gastroparesis
Toxic megacolon or undergoing colonoscopy for decompression
Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin, chlorpromazine and penicillamine within 2 hours before or 6 hours after administration of Clenpiq or stimulant laxatives within 24 hours
History of prior colorectal surgery
Allergy to any of the ingredients in Clenpiq or golytely
if the procedure is planned in the intensive care unit (ICU)
Intervention: Prepopik
Trial phase: Phase 4
SMILES: O=C(O)CC(O)(CC(=O)O)C(=O)O.O=S(=O)([O-])Oc1ccc(C(c2ccc(OS(=O)(=O)[O-])cc2)c2ccccn2)cc1.O=[Mg].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participants in Group C will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM. At 10:00 PM, participants will drink another 5 ounces of the bowel preparation, and will then be asked to drink at least three (3) additional glasses of clear liquids by midnight.

Clenpiq: bowel preparation
Eligibility criteria:
Inclusion Criteria:

- Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will be eligible to participate.

Exclusion Criteria:

Creatinine clearance less than 30 ml/min
History of heart failure with current shortness of breath at rest causing limited physical activity, arrhythmia, unstable angina or acute myocardial infarction
Small bowel obstruction, ileus or bowel perforation
Dementia or cognitive dysfunction to an extent that they cannot perform the study related documentation or consent to participate in the study.
Gastroparesis
Toxic megacolon or undergoing colonoscopy for decompression
Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin, chlorpromazine and penicillamine within 2 hours before or 6 hours after administration of Clenpiq or stimulant laxatives within 24 hours
History of prior colorectal surgery
Allergy to any of the ingredients in Clenpiq or golytely
if the procedure is planned in the intensive care unit (ICU)
Intervention: Prepopik
Trial phase: Phase 4
SMILES: O=C(O)CC(O)(CC(=O)O)C(=O)O.O=S(=O)([O-])Oc1ccc(C(c2ccc(OS(=O)(=O)[O-])cc2)c2ccccn2)cc1.O=[Mg].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participants in Group D will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM, and may continue drinking clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will drink another 5 ounces of the bowel preparation and at least three (3) 8 ounce glasses of clear liquids within the next 2 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.

Clenpiq: bowel preparation
Eligibility criteria:
Inclusion Criteria:

- Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will be eligible to participate.

Exclusion Criteria:

Creatinine clearance less than 30 ml/min
History of heart failure with current shortness of breath at rest causing limited physical activity, arrhythmia, unstable angina or acute myocardial infarction
Small bowel obstruction, ileus or bowel perforation
Dementia or cognitive dysfunction to an extent that they cannot perform the study related documentation or consent to participate in the study.
Gastroparesis
Toxic megacolon or undergoing colonoscopy for decompression
Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin, chlorpromazine and penicillamine within 2 hours before or 6 hours after administration of Clenpiq or stimulant laxatives within 24 hours
History of prior colorectal surgery
Allergy to any of the ingredients in Clenpiq or golytely
if the procedure is planned in the intensive care unit (ICU)
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 78
Group description: Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group

Sodium Chloride 0.9%, Intravenous: The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
Eligibility criteria:
Inclusion Criteria:

Male or Female
18 years of age or older
patients scheduled for elective colorectal, pancreatic, and other major abdominal procedure.
Patient consent will be obtained preoperatively for eligible study participants.

Exclusion Criteria:

Patients who refuse to participate in the study or part of any other enhanced recovery after surgery (ERAS) research protocol.
Patients with a documented allergy to acetaminophen.
Chronic alcoholism
Hypovolemia
Chronic malnutrition
Preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis
Patients with a history of hepatic impairment, history of hepatic impairment or active hepatic disease
severe chronic pain condition that required daily preoperative opioid dependence
Patients with pre-existing dementia and/or other neuropsychiatric conditions impeding accurate assessment of pain scores or other study measures will be excluded.
Intervention: Lorazepam
Trial phase: Phase 4
ATC code: N05BA06 | N05BA56
SMILES: O=C1Nc2ccc(Cl)cc2C(c2ccccc2Cl)=NC1O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: 1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)

Oxycodone and Lorazepam (Active Comparator): Oxycodone and Lorazepam
Eligibility criteria:
Inclusion Criteria:

Women aged 18-50 years
English speaking
With an intrauterine pregnancy (either viable or non-viable) between the gestational ages of 17w0d and 23w6d
Have a support person present with participant
Have a cell phone capable of text messaging (optional)

Exclusion Criteria:

Non-English-speaking
Taking a daily benzodiazepine or opiate
Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines
Intervention: Betamethasone Sodium Phosphate
Trial phase: Not Applicable
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)COP(=O)([O-])[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).

Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
Eligibility criteria:
Inclusion Criteria:

A greater than 6-month history of segmental pain of thoracic vertebral body metastasis origin.
Unsatisfactory pain control with oral pharmacotherapy including strong opioid with VAS >5 .
Absence of a chronic or progressive motor deficit.
Absence of significant sensory deficit.
No indication for percutaneous or open surgical intervention.
Magnetic resonance imaging and Computed Tomogrophy evidence of thoracic involvement.
ASA status of II to III .
Age > 18 .
Body mass index (BMI) :less than forty and more than twenty .
Informed consent

Exclusion Criteria:

Known sensitivity or contraindication to injected materials: local anesthetics.
History of psychological disorders.
Evidence of significant neurological deficit.
Inability to lie prone.
Local contraindication to procedure e.g. local sepsis at the site of intervention, coagulopathy.
Patient refusal.
Intervention: Licogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc([C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1Cc1ccc2c(c1)OCCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Film coated tablet of LIK066 30 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
Eligibility criteria:
Inclusion Criteria:

EITHER

-Histologic confirmed NASH based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of F1, F2 or F3 in the absence of a histological diagnosis of alternative chronic liver disease AND ALT greater than or equal to 50 IU/L (males) or greater than or equal to 35 IU/L (females) at screening.

OR

Phenotypic diagnosis of NASH based on presence of ALL three of the following at screening:

ALT greater than or equal to 50IU/L (males) or greater than or equal to 35 IU/L (females) AND
BMI greater than or equal to 27 kg/m^2 (in patients with a self-identified race other than Asian) or greater than or equal to 23 kg/m^2 (in patients with a self identified Asian race) AND
Diagnosis of Type 2 diabetes mellitus by HbA1c: greater than or equal to 6.5 % and less than or equal to 10%
Patients must weigh no more than 150 kg (330 lbs) to participate in the study.
Male and female patients 18 years or older at the time of screening visit.

Exclusion Criteria:

History or presence of other concomitant liver diseases
History or current diagnosis of ECG abnormalities
Use of GLP-1 agonists, SGLT2 inhibitors, TZDs, FXR agonists and any pharmacologically active weight loss drugs within 6 weeks of screening and until end of study
Patients with contraindications to MRI imaging
Current or history of significant alcohol consumption
Clinical evidence of hepatic decompensation or severe liver impairment
Women of child bearing potential (unless on basic contraception methods)
Presence of liver cirrhosis
Intervention: Licogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc([C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1Cc1ccc2c(c1)OCCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Film coated tablet of LIK066 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
Eligibility criteria:
Inclusion Criteria:

EITHER

-Histologic confirmed NASH based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of F1, F2 or F3 in the absence of a histological diagnosis of alternative chronic liver disease AND ALT greater than or equal to 50 IU/L (males) or greater than or equal to 35 IU/L (females) at screening.

OR

Phenotypic diagnosis of NASH based on presence of ALL three of the following at screening:

ALT greater than or equal to 50IU/L (males) or greater than or equal to 35 IU/L (females) AND
BMI greater than or equal to 27 kg/m^2 (in patients with a self-identified race other than Asian) or greater than or equal to 23 kg/m^2 (in patients with a self identified Asian race) AND
Diagnosis of Type 2 diabetes mellitus by HbA1c: greater than or equal to 6.5 % and less than or equal to 10%
Patients must weigh no more than 150 kg (330 lbs) to participate in the study.
Male and female patients 18 years or older at the time of screening visit.

Exclusion Criteria:

History or presence of other concomitant liver diseases
History or current diagnosis of ECG abnormalities
Use of GLP-1 agonists, SGLT2 inhibitors, TZDs, FXR agonists and any pharmacologically active weight loss drugs within 6 weeks of screening and until end of study
Patients with contraindications to MRI imaging
Current or history of significant alcohol consumption
Clinical evidence of hepatic decompensation or severe liver impairment
Women of child bearing potential (unless on basic contraception methods)
Presence of liver cirrhosis
Intervention: (4-(2-(4-fluoro-2-methylphenoxy)-4-(trifluoromethyl)benzamido)-2-oxopyridin-1(2H)-yl)methyl dihydrogen phosphate
Trial phase: Phase 2
SMILES: Cc1cc(F)ccc1Oc1cc(C(F)(F)F)ccc1C(=O)Nc1ccn(COP(=O)(O)O)c(=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
Eligibility criteria:
Inclusion Criteria:

Prior to Surgery:

Body mass index (BMI) of 18.0 to 38.0 kg/m2, inclusive
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic block) not to include base wedge procedure

After Surgery:

Subject reported pain of ≥4 on the NPRS, and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within 9 hours after removal of the popliteal sciatic block on Day 1
Subject is lucid and able to follow commands
All analgesic guidelines were followed during and after the bunionectomy

Exclusion Criteria:

Prior to Surgery:

History in the past 10 years of malignancy, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
History of abnormal laboratory results ≥2.5 × upper limit of normal (ULN)
History of peripheral neuropathy
A known or clinically suspected infection with human immunodeficiency virus or hepatitis B or C viruses
Prior medical history of bunionectomy or other foot surgery
Intolerant of or unwilling to receive hydrocodone, acetaminophen, or ibuprofen
For female subjects: Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose
For male subjects: Male subjects with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last study drug dose

After Surgery:

Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization

Other protocol defined inclusion/exclusion criteria may apply.
Intervention: Epclusa
Trial phase: Phase 4
ATC code: J05AP55
SMILES: CC(C)OC(=O)C(C)NP(=O)(OCC1OC(n2ccc(=O)[nH]c2=O)C(C)(F)C1O)Oc1ccccc1.COCC1CC(c2ncc(-c3ccc4c(c3)COc3cc5c(ccc6[nH]c(C7CCC(C)N7C(=O)C(NC(=O)OC)C(C)C)nc65)cc3-4)[nH]2)N(C(=O)C(NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.

Epclusa: Patients will be treated with this drug for 12 weeks post lung transplant.
Eligibility criteria:
Inclusion Criteria:

HCV RNA >= 10^3 IU/ml at screening
Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening
HCV Genotype 1, 2, 3, 4, 5 or 6
Otherwise eligible for lung transplant at study site

Exclusion Criteria:

Age <18

Treatment with any of the following agents:

Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 SOF/VEL
Carbamazepine, phenytoin, phenobarbital, oxcarbazepine
Rifabutin, rifampin or rifapentine
HIV regimens containing tenofovir or tipranavir/ritonavir
St John's wort
PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole
Modafinil
Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance
Hepatitis B surface antigen positive
History of hepatic encephalopathy or variceal hemorrhage

Abnormal hematological and biochemical parameters, including:

Hemoglobin <8g/dL
Platelets <= 50,000/mm^3
ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline phosphatase >=10 times ULN
Total bilirubin >3mg/dL
Severe renal impairment, ie creatinine clearance (CrCl) <30mL/min
Pregnant women or women planning to become pregnant
Women or are breastfeeding
Active or recent history (<=1 year) of drug or alcohol abuse
Intervention: Guaifenesin
Trial phase: Phase 4
ATC code: R05CA03
SMILES: COc1ccccc1OCC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: 12 weeks of HCV treatment with medically appropriate direct acting antiviral

Treatment with Direct Acting Antiviral tablet: HCV Treatment for 12 Weeks
Eligibility criteria:
Inclusion Criteria:

Recipient is Age ≥ 18 years
Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
HCV naïve
Able to sign informed consent

Exclusion Criteria:

Pregnant or nursing (lactating) women
Human immunodeficiency virus (HIV) positivity
Need for dual organ transplant
Any contra-indication to liver transplantation per center protocol