anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Midazolam
Trial phase: Phase 4
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 139
Group description: Midazolam 2 mg IV (2 ml)

Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication
Eligibility criteria:
Inclusion Criteria:

Willingness and ability to sign an informed consent document
No allergies to midazolam or propofol
18 - 70 years of age
American Society of Anesthesiologists (ASA) Class I-III adults of either sex

Exclusion Criteria:

Patients with known allergy, hypersensitivity or contraindications to midazolam, propofol, anesthetic or analgesic medications
Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases
Pregnant or lactating women
Subjects with a history of alcohol or drug abuse within the past 3 months
Patients chronically using sedative, anxiolytic drugs prior to the surgery
Morbid obesity (BMI >40 kg/m2)
Patients who are agitated or confused prior to receiving the drug ( verbal rating scale [VRS] greater then 6)
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: No
Participants at risk: 139
Group description: Saline 2 ml

Saline: Saline 2 ml IV, in the pre-op area as a premedication
Eligibility criteria:
Inclusion Criteria:

Willingness and ability to sign an informed consent document
No allergies to midazolam or propofol
18 - 70 years of age
American Society of Anesthesiologists (ASA) Class I-III adults of either sex

Exclusion Criteria:

Patients with known allergy, hypersensitivity or contraindications to midazolam, propofol, anesthetic or analgesic medications
Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases
Pregnant or lactating women
Subjects with a history of alcohol or drug abuse within the past 3 months
Patients chronically using sedative, anxiolytic drugs prior to the surgery
Morbid obesity (BMI >40 kg/m2)
Patients who are agitated or confused prior to receiving the drug ( verbal rating scale [VRS] greater then 6)
Intervention: Fondaparinux
Trial phase: Phase 3
ATC code: B01AX05
SMILES: CO[C@H]1O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]2O[C@@H](C(=O)O)[C@@H](O[C@H]3O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]4O[C@H](C(=O)O)[C@@H](O[C@H]5O[C@H](COS(=O)(=O)O)[C@@H](O)[C@H](O)[C@H]5NS(=O)(=O)O)[C@H](O)[C@H]4O)[C@H](OS(=O)(=O)O)[C@H]3NS(=O)(=O)O)[C@H](O)[C@H]2OS(=O)(=O)O)[C@H](O)[C@H]1NS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 192
Group description: Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course

Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
Eligibility criteria:
Inclusion Criteria:

Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
Males or females, age 18 and older at the time of study screening;
American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
Due to undergo major colorectal surgery via laparotomy or laparoscopy

Exclusion Criteria:

Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
American Society of Anesthesiologists (ASA) Class IV or V;
Children <18
Pregnant patients
Current/Active DVT
Patients on therapeutic anticoagulation for DVT or PE at time of surgery
Patients on anticoagulation for other medical problem (Heart Valve/atrial fibrillation) at the time of surgery
Patients with IVC filter
History of allergy to heparin products
History of heparin induced thrombocytopenia (HIT)
Patients with recent or active hemorrhage (GI/intracranial, etc) felt by the attending surgeon to be a contraindication to heparin thromboprophylaxis
Patients with Epidural analgesia
Intervention: Fondaparinux
Trial phase: Phase 3
ATC code: B01AX05
SMILES: CO[C@H]1O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]2O[C@@H](C(=O)O)[C@@H](O[C@H]3O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]4O[C@H](C(=O)O)[C@@H](O[C@H]5O[C@H](COS(=O)(=O)O)[C@@H](O)[C@H](O)[C@H]5NS(=O)(=O)O)[C@H](O)[C@H]4O)[C@H](OS(=O)(=O)O)[C@H]3NS(=O)(=O)O)[C@H](O)[C@H]2OS(=O)(=O)O)[C@H](O)[C@H]1NS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 184
Group description: Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course

Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course
Eligibility criteria:
Inclusion Criteria:

Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
Males or females, age 18 and older at the time of study screening;
American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
Due to undergo major colorectal surgery via laparotomy or laparoscopy

Exclusion Criteria:

Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
American Society of Anesthesiologists (ASA) Class IV or V;
Children <18
Pregnant patients
Current/Active DVT
Patients on therapeutic anticoagulation for DVT or PE at time of surgery
Patients on anticoagulation for other medical problem (Heart Valve/atrial fibrillation) at the time of surgery
Patients with IVC filter
History of allergy to heparin products
History of heparin induced thrombocytopenia (HIT)
Patients with recent or active hemorrhage (GI/intracranial, etc) felt by the attending surgeon to be a contraindication to heparin thromboprophylaxis
Patients with Epidural analgesia
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
Eligibility criteria:
Inclusion Criteria:

English speaking adults (age >17 years) of American Society of Anesthesiologists (ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity.

Exclusion Criteria:

Subjects will not be eligible for this trial if they report a history of an allergy to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.
Intervention: Lisdexamfetamine
Trial phase: Phase 4
ATC code: N06BA12
SMILES: C[C@@H](Cc1ccccc1)NC(=O)[C@@H](N)CCCCN
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Have no previous or present history of a DSM-IV psychiatric or substance dependence disorder within the previous year, according to the Structured Clinical Interview for Diagnosis- DSM-IV (SCID)-Non-Patient Version;
Are within 5 years of last menstrual period (LMP);
Have a follicular stimulating hormone level (FSH) of 20 IU/ml;
Are able to give written informed consent;
Must have clear urine toxicology screen upon recruitment;
Are fluent in written and spoken English;
Are right-handed;
Negative urine pregnancy test if still menstruating.

Exclusion Criteria:

Mini-mental status exam score of less than or equal to 24;
Presence of a psychiatric disorder within previous year or a life time history of ADHD or psychotic disorder including bipolar disorder, schizoaffective disorder, and schizophrenia;
Lifetime history of drug addiction or abuse, except nicotine;
Regular use of other psychotropic medication;
Regular use (more than once a week) of alcohol that is less than 3 drinks/day;
Presence of a contraindication to treatment with stimulant medication unless the condition is controlled with medication; this would include the presence of uncontrolled hypertension, coronary disease, atrial fibrillation, and arrhythmia;
History of seizures;
History of cardiac disease including known cardiac defect or conduction abnormality;
Abnormal electrocardiogram during screening;
Use of estrogen therapy within previous 2 months;
Current pregnancy or planning to become pregnant;
Metallic implant;
Claustrophobia.
Intervention: Tacrolimus
Trial phase: Phase 1
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.

Tacrolimus
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years.
Willing and able to provide written informed consent.
Willing and able to comply with study assessments for the full duration of the study.
Diagnosis of ocular GVHD.
Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye.
Ocular Surface Disease Index score >22.
In good stable overall health.

Exclusion Criteria:

History of immune disease other than GVHD.
Ocular or periocular malignancy.
Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.
Any history of topical tacrolimus use.
Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.
Current use of topical steroids more than twice a day.
Change in frequency of serum tears, topical cyclosporine and/or topical kineret within the last month.
Corneal epithelial defect >1mm2.
Any history of herpetic keratitis.
Participation in another simultaneous medical research study.
Signs of current infection, including fever and current treatment with antibiotics.
Intra-ocular surgery or ocular laser surgery within 3 months.
Pregnancy (positive pregnancy test) or lactating
Has worn contact lenses, except for bandage contact lens or rigid gas permeable lens, for the last 2 weeks prior to the study or would be unable to stay off contact lenses for the study duration.
Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
Intervention: Methylprednisolone Sodium Succinate
Trial phase: Phase 1
SMILES: CC1CC2C(C(O)CC3(C)C2CCC3(O)C(=O)COC(=O)CCC(=O)[O-])C2(C)C=CC(=O)C=C12.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.

Methylprednisolone Sodium Succinate
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years.
Willing and able to provide written informed consent.
Willing and able to comply with study assessments for the full duration of the study.
Diagnosis of ocular GVHD.
Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye.
Ocular Surface Disease Index score >22.
In good stable overall health.

Exclusion Criteria:

History of immune disease other than GVHD.
Ocular or periocular malignancy.
Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.
Any history of topical tacrolimus use.
Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.
Current use of topical steroids more than twice a day.
Change in frequency of serum tears, topical cyclosporine and/or topical kineret within the last month.
Corneal epithelial defect >1mm2.
Any history of herpetic keratitis.
Participation in another simultaneous medical research study.
Signs of current infection, including fever and current treatment with antibiotics.
Intra-ocular surgery or ocular laser surgery within 3 months.
Pregnancy (positive pregnancy test) or lactating
Has worn contact lenses, except for bandage contact lens or rigid gas permeable lens, for the last 2 weeks prior to the study or would be unable to stay off contact lenses for the study duration.
Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
Intervention: Morphine
Trial phase: Not Applicable
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 mL (150 mcg) intrathecally.

Morphine: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Eligibility criteria:
Inclusion Criteria:

Postpartum patients following vaginal delivery
Unintentional dural puncture
Functioning intrathecal catheter
Patients must be 18 years of age or older
English speaking.

Exclusion Criteria:

History of previous PDPH
Body mass index BMI > 40 kg/m2
History of obstructive sleep apnea (OSA)
Morphine allergy
Patients who receive Cesarean delivery
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 34
Group description: Patients randomized to the control group will receive normal saline 0.3 mL intrathecally.

Saline: The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
Eligibility criteria:
Inclusion Criteria:

Postpartum patients following vaginal delivery
Unintentional dural puncture
Functioning intrathecal catheter
Patients must be 18 years of age or older
English speaking.

Exclusion Criteria:

History of previous PDPH
Body mass index BMI > 40 kg/m2
History of obstructive sleep apnea (OSA)
Morphine allergy
Patients who receive Cesarean delivery
Intervention: Reserpine
Trial phase: Phase 4
ATC code: C02AA02 | C02AA52 | C02LA01 | C02LA51 | C02LA71
SMILES: [H][C@]12C[C@@H](OC(=O)c3cc(OC)c(OC)c(OC)c3)[C@H](OC)[C@@H](C(=O)OC)[C@@]1([H])C[C@]1([H])c3[nH]c4cc(OC)ccc4c3CCN1C2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Simple syrup compounded by the Oregon Health and Science University research pharmacy will be administered in the same volume as if the patient were receiving the Gabapentin both pre-operatively and every eight hours after the patient is admitted to his or her floor bed in the hospital.

Simple Syrup
Eligibility criteria:
Inclusion Criteria:

Patients of age 10-19 with an American Society of Anesthesiologists patient classification of I to III undergoing surgery to correct idiopathic or neurogenic scoliosis.

Exclusion Criteria:

Patients who require a surgical approach or technique differing from posterior spinal fusion and/or have allergies to any of the standardized or experimental study medications: acetaminophen, gabapentin, hydromorphone, ketorolac or oxycodone.
Intervention: Prepopik
Trial phase: Not Applicable
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: Accepts Healthy Volunteers
Participants at risk: 32
Group description: Low volume prep for colonoscopy (Prepopik)

Low volume prep (Prepopik): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
Eligibility criteria:
Inclusion criteria:

Inpatient colonoscopy
Age 18 years and older
Able to give consent
Split dose colonoscopies for all patients

Exclusion criteria:

Unable to give consent
Pregnant or lactating women
Renal impairment (GFR <30)
Ileus
Ascites
Toxic megacolon
Gastrointestinal obstruction
Allergy to study drugs
Toxic colitis
Not able to split the dose of bowel preparations to be used
Contraindication to bowel preparation
Risk for aspiration
Risk of severe cardiac arrhythmias
Intervention: Sodium Sulfate
Trial phase: Not Applicable
ATC code: A06AD13 | A12CA02
SMILES: O=S(=O)([O-])[O-].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: High volume prep for colonoscopy (Golytely)

High volume prep (Golytely): Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
Eligibility criteria:
Inclusion criteria:

Inpatient colonoscopy
Age 18 years and older
Able to give consent
Split dose colonoscopies for all patients

Exclusion criteria:

Unable to give consent
Pregnant or lactating women
Renal impairment (GFR <30)
Ileus
Ascites
Toxic megacolon
Gastrointestinal obstruction
Allergy to study drugs
Toxic colitis
Not able to split the dose of bowel preparations to be used
Contraindication to bowel preparation
Risk for aspiration
Risk of severe cardiac arrhythmias
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1 | Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Normal saline infusion: Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
Eligibility criteria:
Inclusion criteria

aged 12-21 years
chronic (>3 months)symptoms of orthostatic intolerance (including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and palpitations)
symptomatic orthostatic heart rate increase of greater than or equal to 40 beats per minute during a 10 minute 70 degree head up tilt study
presence of non-anemic iron deficiency, defined as serum ferritin level less than or equal to 20 ug/L with normal hemoglobin

Exclusion criteria

orthostatic hypotension within 3 minutes of 70 degree head up tilt
pregnant or lactating females
presence of other organ failure or systemic illness that can affect autonomic function
concurrent medication therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists unless medication is held for five half-lives prior to study
laboratory evidence of anemia or iron overload
personal history of hematochromatosis or first degree relative with hematochromatosis
known sensitivity to Venofer (TM) or other intravenous iron preparations
Intervention: Raltegravir
Trial phase: Not Applicable
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: All 10 participants were switched from Atripla to twice daily Raltegravir and Truvada (FTC/TDF)
Eligibility criteria:
Inclusion Criteria:

Chronic HIV-infected individuals on suppressive regimen with EFV/FTC/TDF, for at least 6 months
Undetectable HIV-1 RNA virus load for at least 6 months
No co-infections with active hepatitis B and C
Presence of at least moderate symptoms on 2 out of 3 subcores on the DASS
No known active HIV-related and non-HIV related CNS infections
Estimated glomerular filtration rate (EGFR) >60 ml/min
Consent to switching to EVG/COBI/FTC/TDF
Ages 18 - 65

Exclusion Criteria:

History of CNS opportunistic infections or active CNS infections
History of severe psychiatric disorder (excluding depression and anxiety)
History of chronic neurological disorders, such as epilepsy or multiple sclerosis
History of or current significant substance abuse or dependence and/or heavy alcohol use (>12 oz/wk)
Any women who may be pregnant (positive urine pregnancy test or unprotected sex in 2 weeks prior to scan) or known to be pregnant
Contraindications to undergoing fMRI, including metallic implants, claustrophobia, and medical conditions or medications that significantly affect cerebral blood flow or function.