anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Gemcitabine
Trial phase: Phase 2
ATC code: L01BC05
SMILES: Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)C2(F)F)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Combination CT-011 and Gemcitabine

CT-011: 3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.

Gemcitabine: 1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.
Eligibility criteria:
Adult patients with histologic verification of carcinoma of the pancreas (T1-3, N0-1) who have undergone surgical resection within the past 4 - 12 weeks. Patients with R1 resections are excluded.
Must meet all laboratory safety criteria and not have active or history of autoimmune disease or conditions, be treated with immunosuppressive drugs, or require the use of systemic steroids. Primary intraoperative chemotherapy will be allowed.
Pregnant or nursing women will be excluded. Subjects with active infection, HIV, Hepatitis B or C will be excluded.
Intervention: Oseltamivir
Trial phase: Not Applicable
ATC code: J05AH02
SMILES: CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 277
Group description: Oseltamivir: Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
Eligibility criteria:
Inclusion Criteria:

Written informed consent prior to initiation of any study procedures

History of an influenza-like illness defined as:

1) One or more respiratory symptom (cough, sore throat, or nasal symptoms)

Onset of illness no more than 48 hours before screening, defined as when the participant experienced at least one respiratory symptom
Willing to have samples stored
Positive test for influenza (either rapid antigen or polymerase chain reaction [PCR]); randomization could proceed in cases of discrepant results (one positive and one negative)

Exclusion Criteria:

Hospitalization at the time of screening

Presence of a medical condition(s) that had been associated with increased risk of complications from influenza

Aged 65 years of age or older
Asthma
Neurological and neuro-developmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle, such as cerebral palsy, epilepsy [seizure disorders], stroke, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury)
Chronic lung disease (such as chronic obstructive pulmonary disease [COPD] or cystic fibrosis)
Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease)
Blood disorders
Endocrine disorders (such as diabetes mellitus)
Kidney disorders
Liver disorders
Metabolic disorders (such as inherited metabolic disorders or mitochondrial disorders)
Weakened immune system due to disease or medication (such as people with HIV/AIDS or cancer, or use of chronic steroids or other medications causing immune suppression)
Pregnant or 4 weeks postpartum
Body mass index (BMI) greater than or equal to 40
Breastfeeding
Inability to take oral medication or a history of gastrointestinal malabsorption that would preclude the use of oral medication
Received more than one dose of any antiviral influenza medication since onset of influenza symptoms
Known end stage kidney dysfunction (e.g., creatinine clearance less than 30 mL/min)
Known hypersensitivity to oseltamivir, peramivir, or zanamivir
Received live attenuated influenza virus vaccine within 3 weeks prior to study entry
Use of any investigational drug within 30 days or 5 half-lives (whichever was longer) prior to study entry
Participated in other research protocols that required more than 100mL of blood to be drawn in a 4-week period that overlapped with this study.
Intervention: Desmopressin
Trial phase: Not Applicable
ATC code: H01BA02
SMILES: N=C(N)NCCC[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSCCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Injection of epidural steroids into the lumbar spine

Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine
Eligibility criteria:
Inclusion Criteria:

Lumbar spinal stenosis (LSS) with neurogenic claudication where the Visual Analog Scale (VAS) of back and leg pain average is ≥ 5.
Prior failure of conservative therapy.
Oswestry Disability Index (ODI) score of ≥ 31%.
Radiologic evidence of LSS, with unilateral or bilateral ligamentum flavum ≥ 4.1mm confirmed by pre-op MRI performed within 6-12 months of baseline visit.
Able to walk ≥ 10 feet before being limited by pain.
Available to complete 24-months of follow-up.
Adults ≥ 50 years of age.

Exclusion Criteria:

Prior surgery at intended treatment level.
History of spinal fractures with current related pain symptoms.
Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, vascular claudication symptoms, etc.).
Significant/symptomatic disc protrusion or osteophyte formation judged by the Investigator as possible confounding factor to study results.
Excessive facet hypertrophy judged by the Investigator as possible confounding factor to study results.
Significant symptomatic foraminal stenosis.
Confirmed anterior or retro-listhesis ≥ 3mm.
Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure.
Able to walk ≥ 200 yards unaided in erect non-flexed position before being limited by pain.
Able to stand ≥ 15 minutes in erect, non-flexed position before being limited by pain.
Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment.
Pregnant and/or breastfeeding.
Body mass index (BMI) ≥ 32 as calculated using the patient's weight multiplied by 703 then divided by height in inches squared.
Epidural steroid, systemic steroid or any spine interventional procedure within prior six weeks of study procedure.
Dementia and/or inability to give informed consent and to understand and complete follow-up patient reported outcomes forms.
Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
Unable to tolerate MRI (pacemaker, spinal cord stimulator, etc.).
Intrathecal pump.
Any medical condition determined by the Investigator that would not allow subject to fulfill trial requirements or safely tolerate procedures in this study.
Intervention: Midazolam
Trial phase: Not Applicable
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:

Recommended Versed:

a. Prior to intubation

patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed
patient is > 75 kg = 2 mg Versed

Recommended Fentanyl

Prior to intubation = 0.5 ug/kg
Total procedural dose = 1 ug/kg

Propofol+Benzo/Opioids: 1. Recommended Versed:

a. Prior to intubation

patient is < 50 kg = 1 mg Versed
patient is 50-75 kg = 1.5 mg Versed

patient is > 75 kg = 2 mg Versed

2. Recommended Fentanyl

a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg
Eligibility criteria:
Inclusion Criteria:

Ability to provide informed consent
Age greater than or equal to 18 years

Presence of at least 1 of the following criteria:

ASA class 3 or higher
BMI of 30 or greater
At risk for OSA (score of 3 or greater on the STOP-BANG screening tool)

Exclusion Criteria:

drug allergy to Propofol, Benzodiazepines, or Opioids
patients who received Benzodiazepines or Opioids within 24 hours of the procedure
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:

Induction Dose: 2-2.5 mg/kg
Maintenance Dose: 0.1-0.2 mg/kg/min

Propofol Alone: Recommended Propofol doses before considering crossover:

Induction: 2-2.5 mg/kg
Maintenance: 0.1-0.2 mg/kg/min
Eligibility criteria:
Inclusion Criteria:

Ability to provide informed consent
Age greater than or equal to 18 years

Presence of at least 1 of the following criteria:

ASA class 3 or higher
BMI of 30 or greater
At risk for OSA (score of 3 or greater on the STOP-BANG screening tool)

Exclusion Criteria:

drug allergy to Propofol, Benzodiazepines, or Opioids
patients who received Benzodiazepines or Opioids within 24 hours of the procedure
Intervention: Lansoprazole
Trial phase: Not Applicable
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: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).

dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Eligibility criteria:
Inclusion Criteria:patients with an abnormal Restech pH probe study and also have an RSI of 14 or greater will be invited to participate in the study

Exclusion Criteria:known intolerance or allergy to proton pump inhibitors, hypersecretory conditions (Zollinger-Ellison), self-reported anxiety/depression (shown to affect RSI),16 history of laryngeal irradiation, or have been on twice daily Proton pump inhibitors (PPI) therapy for greater than 2 months without symptomatic relief (with an RSI ≥14)
Intervention: Alogliptin/pioglitazone
Trial phase: Phase 2 | Phase 3
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1.Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the start of the treatment period (Week 0).
Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after the start of the observation period (Week -2).
Had HbA1c difference within 10.0%* at 10 weeks after the start of the observation period (Week -6) and 14 weeks after the start of the observation period (Week -2) from 10 weeks after the start of the observation period (Week -6) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

Had taken a diabetic medications other than pioglitazone within 16 weeks before the start of the treatment period (Week 0).
Had a history or symptoms of cardiac failure.
Intervention: Alogliptin/pioglitazone
Trial phase: Phase 2 | Phase 3
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1.Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 113
Group description: Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the start of the treatment period (Week 0).
Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after the start of the observation period (Week -2).
Had HbA1c difference within 10.0%* at 10 weeks after the start of the observation period (Week -6) and 14 weeks after the start of the observation period (Week -2) from 10 weeks after the start of the observation period (Week -6) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

Had taken a diabetic medications other than pioglitazone within 16 weeks before the start of the treatment period (Week 0).
Had a history or symptoms of cardiac failure.
Intervention: Alogliptin Benzoate
Trial phase: Phase 2 | Phase 3
SMILES: Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O.O=C(O)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12).
Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

1. Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0).
Intervention: Alogliptin Benzoate
Trial phase: Phase 2 | Phase 3
SMILES: Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O.O=C(O)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12).
Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

1. Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0).
Intervention: Glimepiride
Trial phase: Phase 2 | Phase 3
ATC code: A10BB12 | A10BD04 | A10BD06
SMILES: CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)cc2)C1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 103
Group description: Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12).
Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

1. Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0).
Intervention: Glimepiride
Trial phase: Phase 2 | Phase 3
ATC code: A10BB12 | A10BD04 | A10BD06
SMILES: CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)cc2)C1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 150
Group description: Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
Was capable of understanding and complying with protocol requirements.
Signed a written informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).

Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:

1. With history or symptoms of lactic acidosis.
Intervention: Pituitrin
Trial phase: Not Applicable
SMILES: NC(=O)CCC1NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CCCN=C(N)N)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC1=O.NCCCCC(NC(=O)C1CCCN1C(=O)C1CSSCC(N)C(=O)NC(Cc2ccc(O)cc2)C(=O)NC(Cc2ccccc2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy
Eligibility criteria:
Inclusion Criteria:

Infants less than 24 hours of age
Infants with birth weight of <1001 grams and/or gestational age of <29 weeks
Not initiated on any continuous pressor therapy prior to enrollment
Intravenous line in place
Outborn infants meeting eligibility criteria

Exclusion Criteria:

Infants not meeting eligibility criteria
Infants with life-threatening congenital defects
Infants with congenital hydrops
Infants with frank hypovolemia (perinatal history consistent with decreased circulating blood volume plus clinical signs of hypovolemia)
Infants with other unresolved causes of hypotension (air leaks, lung overdistention, or metabolic abnormalities).
Intervention: Nepafenac
Trial phase: Phase 2
ATC code: S01BC10
SMILES: NC(=O)Cc1cccc(C(=O)c2ccccc2)c1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 506
Group description: Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
Eligibility criteria:
Inclusion Criteria:

Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens;
Patients who, in the opinion of the Investigator, would have improvement in best-corrected visual acuity after surgery;
Able to understand and sign an informed consent;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit;
Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit;
History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye;
Diabetic retinopathy in the operative eye;
Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article;
Other protocol-defined exclusion criteria may apply.
Intervention: Vercirnon sodium
Trial phase: Phase 3
SMILES: CC(C)(C)c1ccc(S(=O)(=O)N=C2C=CC(Cl)=CC2=C([O-])c2cc[n+]([O-])cc2)cc1.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 398
Group description: Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug.
Eligibility criteria:
Inclusion Criteria:

Previous participation in a GSK-sponsored study with GSK1605786A
Written informed consent prior to any study-specific procedures
Female subjects: To be eligible, females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with less than 1% failure rate

Exclusion Criteria:

If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is planning to become pregnant
Subjects with known or suspected coeliac disease or a positive screening test for anti-tissue transglutaminase antibodies should have been excluded from enrolment into any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result
Fixed symptomatic stenoses or strictures of small bowel or colon
Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
Current sepsis or infections requiring intravenous antibiotic therapy greater than 2 weeks
Evidence of hepatic dysfunction or viral hepatitis
Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.