anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 45
Group description: Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.

Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t
Eligibility criteria:
Inclusion Criteria:

Children 5 months to five years of age
ASA physical status I or II
primary cleft palate repair alone or in some combination with bilateral myringotomy with tympanostomy (BMT), alveoplasty, vomer flap, rhinoplasty, and or cleft lip repair.?

Exclusion Criteria:

Repeat/revision cleft palate repair
Contraindications to acetaminophen administration (liver or renal dysfunction, allergy)
Chronic pain medications
Diagnosis of chronic pain syndrome
Contraindications to morphine (renal impairment, allergy)
Seizure disorders and/or taking anti-seizure medications
Contraindications to oral midazolam (liver dysfunction, allergy)
Allergy to local anesthetics
Intervention: Oxycodone
Trial phase: Phase 4
ATC code: N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19
SMILES: COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 5 mg oxycodone tid
Eligibility criteria:
Healthy volunteers Inclusion criteria

Males and non-pregnant, non-breastfeeding females
18-65 years old

Exclusion criteria

Use of any mu-opioid agent in the last 3 months
Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening the shortened screening version of the Bowel Disease Questionnaire (Appendix) will be used to exclude subjects with dyspepsia, irritable bowel syndrome or significant gastrointestinal symptoms. Of 19 questions, participants have to have three or less positives to be eligible to participate.

Unable to withdraw medications 48 hours prior to the study :

Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs) and newer antidepressants.
Analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAIDs), COX 2 inhibitors
SSRI NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
Female subjects who are pregnant or breast feeding.
Clinical evidence (including physical exam, ECG, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
Subjects who have participated in another clinical study within the past 30 days
History of porphyria, renal (creatinine > 1.5mg/dL) or significant liver impairment (transaminases, alkaline phosphatase of gamma-glutamyl transpeptidase (GGT) >2 times upper limit of normal)
Intervention: Bortezomib
Trial phase: Phase 1 | Phase 2
ATC code: L01XG01 | L01XX32
SMILES: CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: IV panitumumab and bortezomib

Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle.

Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.
Eligibility criteria:
Inclusion Criteria:

Histologically proven colorectal cancer with measurable or evaluable disease
KRAS wild-type colorectal cancer
Progression on, or intolerance of, or ineligibility for all standard therapies
Progression on prior anti-EGFR therapy
Lesion that is amenable to biopsy
ECOG performance status 0-2
LVEF >/= institutional normal
Corrected QT interval less then 500 milliseconds by EKG
Grade 2 or less peripheral neuropathy
Adequate hepatic, bone marrow, and renal function
Partial thromboplastin time must be </= 1.5 x upper limit of institution's normal range and INR < 1.5. Subjects on anticoagulants will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator.
Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease and have not had treatment with steroids within 1 week of study enrollment.
Life expectancy > 12 weeks
Subject is capable of understanding and complying with parameters of the protocol and able to sign and date the informed consent form.

Exclusion Criteria:

CNS metastases which do not meet the criteria above
Prior cancer chemotherapy, radiation therapy, or any investigational agent within three weeks before starting therapy
Active severe infection or known chronic infection with HIV or hepatitis B virus
Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
Peripheral neuropathy >/= Grade 2 at baseline or peripheral neuropathy >/= Grade 1 with neuropathic pain
Life-threatening visceral disease or other severe concurrent disease
Female subject is pregnant or lactating
Diagnosed or treated for another malignancy within 3 years of enrollment with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
Patient has hypersensitivity to bortezomib, boron, or mannitol
Clinically significant and uncontrolled major medical condition(s)
Intervention: Morphine Sulfate
Trial phase: Phase 4
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O=S(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: morphine sulfate (or Sponsor-approved equivalent)

morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump.
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 years of age and older.
Patients scheduled to undergo open segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy.
Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.

Exclusion Criteria:

Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
Patients who abuse alcohol or other drug substance.
Patients with severe hepatic impairment.
Patients currently pregnant or who may become pregnant during the course of the study.
Patients with any psychiatric psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
Patients who have participated in a EXPAREL study within the last 30 days.
Patients who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.

In addition, the patient will be ineligible if he or she meets the following criteria during surgery:

Patients with unplanned multiple segmental resections of large intestine.
Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
Patients who receive Entereg(R).
Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery.
Intervention: Nacom
Trial phase: Phase 2
SMILES: CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.NC(Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
Eligibility criteria:
Inclusion Criteria:

Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on."
Patients should be able to differentiate between the "ON" and "OFF" states with an average daily "OFF" time of ≥ 2.5 hours at study entry.
On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.
Non CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.
Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).
Mini Mental State Examination (MMSE) ≥ 26 at screening visit.
Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation.

Exclusion Criteria:

Patients with atypical or drug-induced Parkinson's disease.
Patients with a known history of hypersensitivity to levodopa or carbidopa.
Patients who receive treatments with dopamine receptor blocking agents
Patients with a history of seizures except of childhood febrile seizure.
Patients with dementia.
Patients with a significant history of GI diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years.
Patients with any history of gastric surgery other than vagotomy and pyloroplasty.
Patients with an immune-compromised state.
Patients with clinically significant hepatic insufficiency with Child-Pugh total score of ≥ 5.
Patients with a calculated creatinine clearance (Clcr) < 50 mL/min using the Cockcroft-Gault equation.
Patients who have a difficulty swallowing tablets.
Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.
Patients with any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.
Intervention: Diatrizoate Sodium
Trial phase: Phase 4
SMILES: CC(=O)Nc1c(I)c(NC(C)=O)c(I)c(C(=O)[O-])c1I.[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 47
Group description: infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
Eligibility criteria:
Inclusion Criteria:

premature infants with a birthweight < 1500g and a gestational age < 32 weeks

Exclusion Criteria:

major congenital disorders
chromosomal aberrations
systemic metabolic disease and
pre-existing gastrointestinal abnormalities (i.e. Morbus Hirschsprung)
pre-existing conditions of severe hypotension
Intervention: Water
Trial phase: Phase 4
SMILES: O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 49
Group description: infants receive 9ml/kg sterile water
Eligibility criteria:
Inclusion Criteria:

premature infants with a birthweight < 1500g and a gestational age < 32 weeks

Exclusion Criteria:

major congenital disorders
chromosomal aberrations
systemic metabolic disease and
pre-existing gastrointestinal abnormalities (i.e. Morbus Hirschsprung)
pre-existing conditions of severe hypotension
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.

Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
Eligibility criteria:
Inclusion Criteria:

Man or woman aged 18-75
Documented clinical diagnosis of chronic pain.
Have been taking hydrocodone/APAP for their chronic non-cancer pain.
Subjects currently on hydrocodone/APAP must be taking minimal daily dose of 15mg of Hydrocodone for at least 30 days.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Subjects who are taking concomitant medications or Nutraceuticals that interfere with Hydrocodone metabolism as listed in Appendix 11 and/or as deemed clinically significant by a pharmacovigilance team that is contracted to monitor and advise.
Health concerns that the study physician feels may confound study results.
Individuals who are cognitively impaired or who are not able to give informed consent.
Previous participation in a clinical research trial within 30 days prior to randomization.
The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.

Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once
Eligibility criteria:
Inclusion Criteria:

Man or woman aged 18-75
Documented clinical diagnosis of chronic pain.
Have been taking hydrocodone/APAP for their chronic non-cancer pain.
Subjects currently on hydrocodone/APAP must be taking minimal daily dose of 15mg of Hydrocodone for at least 30 days.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Subjects who are taking concomitant medications or Nutraceuticals that interfere with Hydrocodone metabolism as listed in Appendix 11 and/or as deemed clinically significant by a pharmacovigilance team that is contracted to monitor and advise.
Health concerns that the study physician feels may confound study results.
Individuals who are cognitively impaired or who are not able to give informed consent.
Previous participation in a clinical research trial within 30 days prior to randomization.
The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
Intervention: PF-04937319
Trial phase: Phase 2
SMILES: Cc1cnc(NC(=O)c2cc(Oc3cnc(C(=O)N(C)C)nc3)c3cc(C)oc3c2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

Subjects with recent cardiovascular events, those with evidence of diabetic complications
Intervention: PF-04937319
Trial phase: Phase 2
SMILES: Cc1cnc(NC(=O)c2cc(Oc3cnc(C(=O)N(C)C)nc3)c3cc(C)oc3c2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

Subjects with recent cardiovascular events, those with evidence of diabetic complications
Intervention: PF-04937319
Trial phase: Phase 2
SMILES: Cc1cnc(NC(=O)c2cc(Oc3cnc(C(=O)N(C)C)nc3)c3cc(C)oc3c2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

Subjects with recent cardiovascular events, those with evidence of diabetic complications
Intervention: Tramadol
Trial phase: Phase 4
ATC code: N02AJ13 | N02AJ14 | N02AJ16 | N02AX02
SMILES: COc1cccc(C2(O)CCCCC2CN(C)C)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
Eligibility criteria:
Inclusion Criteria:

Men and women, military veterans and non-veterans, aged 21-55 years
Active PTSD as determined by diagnostic evaluation and standardized interview (Structured Clinical Interview for the DSM (SCID))
Literacy and ability to give informed consent
In women of child-conceiving potential, a negative pregnancy test and use of an approved birth control method
Glasgow Coma Scale (GCS) score of 15, Extension of GCS with 7-point Amnesia Scale score of 6 (amnesia for traumatic event of 30 min or fewer) or 7 (no amnesia for impact of head) (Nell et al 2000)
Clinically judged to be at low risk for adverse sequelae from taking tramadol
Concomitant medications must be approved by the PI

Exclusion Criteria:

Pregnant or nursing women
Homeless persons
Suicidal or homicidal ideation with plans or intent
History of opioid dependence or abuse
Psychosis or history thereof, substance dependence or abuse (other than tobacco dependence; lifetime opioid abuse is exclusionary) within the past 60 days, anorexia nervosa, antisocial personality disorder, or other psychiatric disorder judged by the investigator to be more clinically significant than PTSD
Serious or unstable illness, endocrinopathy, or metabolic instability, including renal insufficiency, liver disease, hydrocephalus, history of stroke, history of seizures, history of brain tumor
Use of non-study medications except those approved by the PI
Newly started in psychotherapy (< 3months)
History of hypersensitivity, allergy, or other significant adverse effects from tramadol
Intervention: Mannitol
Trial phase: Phase 2
ATC code: A06AD16 | A06AD18 | A06AG07 | B05BC01 | B05CX02 | B05CX04 | R05CB16 | V04CC01 | V04CX04
SMILES: OCC(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.

Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
Eligibility criteria:
Inclusion Criteria:

Renal failure requiring intermittent hemodialysis initiation; adult patients aged over 18 years; written informed consent

Exclusion Criteria:

Hyponatremia <130 mmol/L; acute myocardial infarction or stroke in previous 7 days; cardiac transplant; ventricular arrhythmia; unstable angina; use of pressors/midodrine; enrollment in conflicting research study; institutionalized individuals; pregnancy; prisoners; documented allergy to mannitol
Intervention: Rocuronium
Trial phase: Phase 4
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
Eligibility criteria:
Inclusion Criteria:

Patients older than 18 years
Scheduled for elective laparoscopic cholecystectomy
Can read and understand danish
Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives

Exclusion Criteria:

Known allergy to medications that are included in the project
Presence of severe renal disease, neuromuscular disease, reduced liver function
Nursing or pregnant
Indication for crash induction
For fertile women: Missing negative pregnancy-test
Intervention: Rocuronium
Trial phase: Phase 4
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
Eligibility criteria:
Inclusion Criteria:

Patients older than 18 years
Scheduled for elective laparoscopic cholecystectomy
Can read and understand danish
Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives

Exclusion Criteria:

Known allergy to medications that are included in the project
Presence of severe renal disease, neuromuscular disease, reduced liver function
Nursing or pregnant
Indication for crash induction
For fertile women: Missing negative pregnancy-test