anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nebivolol
Trial phase: Phase 3
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: nebivolol 1 to 4 capsules daily

nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing).
Eligibility criteria:
Inclusion Criteria:

Men and non-pregnant, non-lactating women 45 years of age or older
Able to give informed consent and complete scheduled visits
Mild-moderate bilateral lower extremity peripheral arterial disease as defined by an ankle-brachial index (ABI measurement of 0.6-0.9. If a subject has baseline claudication symptoms, the symptoms must be stable for the 3 months preceding enrollment.
History of hypertension. Blood pressure at the screening visit must be ≤160/100 mmHg and ≥100/60 mmHg for all subjects. If a subject is currently prescribed beta-blocker therapy, BP at the screening visit must be ≤140/90 mmHg. In addition, heart rate must be ≥55 beats per minute if currently prescribed a beta-blocker and ≤60 beats per minute if not currently prescribed a beta-blocker.
At least moderate risk for CAD.

Exclusion Criteria:

Participation in another clinical trial
Ongoing ischemic (resting) limb pain, or lower extremity ulceration due to arterial insufficiency, or an ABI indicating <0.6 indicating disease potentially requiring revascularization
History of limb or digit amputation due to arterial insufficiency
Revascularization of peripheral vessels within the preceding 6 months
Uncontrolled hypertension as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
Contraindication or allergy to beta blocker therapy
History of myocardial infarction , coronary revascularization, or a cerebrovascular event within the preceding 6 months
Class III or IV angina
Current or past history of New York Heart Association (NYHA) class III or IV heart failure
Inability to walk on a treadmill for any reason
Regular use of nitroglycerin or nitrates including oral, transdermal ointment or patch, or sublingual, translingual spray and/or combination agents containing nitrates
Active liver, pulmonary, infectious or inflammatory process
History of malignancy within preceding 5 years (excluding basal or squamous cell skin cancer)
History of any other condition that, in the opinion of the investigators, renders it unsafe for the subject to be enrolled
Intervention: Metoprolol Succinate
Trial phase: Phase 3
SMILES: COCCc1ccc(OCC(O)CNC(C)C)cc1.COCCc1ccc(OCC(O)CNC(C)C)cc1.O=C(O)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: metoprolol 1 to 4 capsules daily

Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing).
Eligibility criteria:
Inclusion Criteria:

Men and non-pregnant, non-lactating women 45 years of age or older
Able to give informed consent and complete scheduled visits
Mild-moderate bilateral lower extremity peripheral arterial disease as defined by an ankle-brachial index (ABI measurement of 0.6-0.9. If a subject has baseline claudication symptoms, the symptoms must be stable for the 3 months preceding enrollment.
History of hypertension. Blood pressure at the screening visit must be ≤160/100 mmHg and ≥100/60 mmHg for all subjects. If a subject is currently prescribed beta-blocker therapy, BP at the screening visit must be ≤140/90 mmHg. In addition, heart rate must be ≥55 beats per minute if currently prescribed a beta-blocker and ≤60 beats per minute if not currently prescribed a beta-blocker.
At least moderate risk for CAD.

Exclusion Criteria:

Participation in another clinical trial
Ongoing ischemic (resting) limb pain, or lower extremity ulceration due to arterial insufficiency, or an ABI indicating <0.6 indicating disease potentially requiring revascularization
History of limb or digit amputation due to arterial insufficiency
Revascularization of peripheral vessels within the preceding 6 months
Uncontrolled hypertension as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
Contraindication or allergy to beta blocker therapy
History of myocardial infarction , coronary revascularization, or a cerebrovascular event within the preceding 6 months
Class III or IV angina
Current or past history of New York Heart Association (NYHA) class III or IV heart failure
Inability to walk on a treadmill for any reason
Regular use of nitroglycerin or nitrates including oral, transdermal ointment or patch, or sublingual, translingual spray and/or combination agents containing nitrates
Active liver, pulmonary, infectious or inflammatory process
History of malignancy within preceding 5 years (excluding basal or squamous cell skin cancer)
History of any other condition that, in the opinion of the investigators, renders it unsafe for the subject to be enrolled
Intervention: Meropenem
Trial phase: Phase 3
ATC code: J01DH02 | J01DH52
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](C(=O)N(C)C)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 529
Group description: 1000 mg: IV treatment
Eligibility criteria:
Inclusion Criteria:

18 to 90 years of age inclusive

Female patient is authorized to participate if at least one of the following criteria are met:

Surgical sterilization
Age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments
Age <50 years and postmenopausal as defined by documented LH and FSH levels in the postmenopausal range PLUS amenorrhea for 12 months or more following cessation of all exogenous hormonal treatments
Patient has a negative serum pregnancy test (serum ß-human chorionic gonadotropin [ß-hCG]) within 1 day prior to study entry, and agrees to use highly effective contraception methods during treatment and for at least 7 days after last dose of IV study therapy
Intraoperative/postoperative enrollment with confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections

Exclusion Criteria:

Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious
Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
Patient is considered unlikely to survive the 6 to 8 week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality
Intervention: Lafutidine
Trial phase: Phase 3
ATC code: A02BA08
SMILES: O=C(C[S+]([O-])Cc1ccco1)NC/C=C\COc1cc(CN2CCCCC2)ccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 165
Group description: Lafutidine 20mg/day

Lafutidine 10mg bid, po
Eligibility criteria:
Inclusion Criteria:

Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification

Exclusion Criteria:

Gastric or duodenal ulcers (excluding ulcer scars)
Concurrent presence of Barrett's esophagus
A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks
Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety
Intervention: Famotidine
Trial phase: Phase 3
ATC code: A02BA03 | A02BA53
SMILES: NC(N)=Nc1nc(CSCCC(N)=NS(N)(=O)=O)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 162
Group description: Famotidine 40mg/day

Famotidine 20mg bid, po
Eligibility criteria:
Inclusion Criteria:

Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification

Exclusion Criteria:

Gastric or duodenal ulcers (excluding ulcer scars)
Concurrent presence of Barrett's esophagus
A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks
Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety
Intervention: Omeprazole
Trial phase: Phase 3
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: Omeprazole 20mg/day

Omeprazole 20mg qd(daily), po
Eligibility criteria:
Inclusion Criteria:

Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification

Exclusion Criteria:

Gastric or duodenal ulcers (excluding ulcer scars)
Concurrent presence of Barrett's esophagus
A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks
Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Vitamin D3 2000 IU/day on day of 1st cycle of oxaliplatin; continue as long as patient treated with oxaliplatin and remains on study

Vitamin D3: Vitamin D3 will be administered at a dose of 2000 IU orally daily starting on day 1 of the first cycle of oxaliplatin. The vitamin will be continued at this dose and schedule for approximately 6 months if the patient is receiving oxaliplatin in the adjuvant setting and neither dosage nor interval has been modified for neurological toxicity. The duration of therapy if oxaliplatin is given for metastatic disease will vary. Nonetheless, the study vitamin will be continued using the same criteria as in the adjuvant setting.
Eligibility criteria:
Inclusion Criteria:

Have a histologic diagnosis of a malignant solid neoplasm involving the gastrointestinal tract not necessarily restricted to the colon, rectum, and esophagus,
Will receive oxaliplatin-based chemotherapy for the first time (previous treatment with non-oxaliplatin-based chemotherapy does not preclude eligibility),
Have disease of any stage and will be treated according to established standards,
Have a performance status (ECOG) of 2 or less,
Have intact organ function as determined by laboratory tests of the kidney, liver, and bone marrow deemed appropriate to receive cytotoxic chemotherapy,
Are 18 years of age or older, and
Have signed a consent and information form to participate in the study.

Exclusion Criteria:

Are pregnant (subjects of childbearing age will have a pregnancy test performed),
Are taking calcitriol or have vitamin D levels that are >100 ng/dL,
Are receiving medication for seizures, or
Have pre-existing peripheral neuropathy grade >1.
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: 235
Group description: Fondaparinux for 45 days subcutaneous application: 2,5 mg OD

Fondaparinux: Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous
Eligibility criteria:
Inclusion Criteria:

acute symptomatic supragenual superficial vein thrombosis of the leg
at least one of the following major risk factor for VTE:
age > 65 years or
male sex or
history of DVT/PE/SVT or
history of cancer or active cancer or
autoimmune disease or
SVT of a non-varicose vein
thrombus extension of at least 5 cm
proximal thrombus end with more than 3 cm distance to the saphenofemoral junction (SFJ)
age > 18 years
written informed consent

Exclusion Criteria:

other indication for therapeutic anticoagulation such as acute deep vein thrombosis, acute pulmonary embolism, atrial fibrillation with indication for anticoagulant therapy
any PE or DVT within last 6 months before inclusion
clinical signs of PE without objective exclusion (CT or VQ scan, angiography)
SVT without signs of thrombotic/inflammatory activity (activity signs: diameter > 4 mm, pain, redness, elevated local or systemic temperature)
SVT after sclerotherapy
Duration of symptoms > 3 weeks
pretreatment of more than 72 h with therapeutic dosages of oral or parenteral anticoagulants
pretreatment of more than 5 days with subtherapeutic oral or parenteral anticoagulants
indication for escalated antiplatelet therapy (monotherapy with aspirin > 325 g/d and any dual antiplatelet therapy)
SVT closer than 3 cm to saphenofemoral junction (SVJ)
anticipated superficial vein surgery within 90 days
anticipated thrombolytic therapy within 90 days
manifest clinically relevant bleeding
clinically relevant bleeding in the last 30 days before study inclusion
major surgery within last 30 days before inclusion
ophthalmic, spinal or cerebral surgery within last 90 days
severe head trauma within last 90 days
hemorrhagic stroke within last 12 months
hereditary or acquired severe hemorrhagic diathesis
gastrointestinal bleeding within last 90 days requiring endoscopy
uncontrolled arterial hypertension (systolic > 180 mm Hg, diastolic > 110 mm Hg)
acute endocarditis
low platelet count (< 100 x 109/l)
Prothrombin time < 50 %
calculated creatinine clearance < 30 ml/min
significant liver disease such as acute hepatitis, chronic active hepatitis, cirrhosis
life expectancy < 3 months
any contraindications listed for rivaroxaban or fondaparinux
women of child bearing potential without safe contraception method
pregnant or breastfeeding women
participation in another trial with pharmacological intervention
Intervention: Rivaroxaban
Trial phase: Phase 3
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 236
Group description: Rivaroxaban for 45 days oral dose: 10 mg OD

Rivaroxaban: Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral
Eligibility criteria:
Inclusion Criteria:

acute symptomatic supragenual superficial vein thrombosis of the leg
at least one of the following major risk factor for VTE:
age > 65 years or
male sex or
history of DVT/PE/SVT or
history of cancer or active cancer or
autoimmune disease or
SVT of a non-varicose vein
thrombus extension of at least 5 cm
proximal thrombus end with more than 3 cm distance to the saphenofemoral junction (SFJ)
age > 18 years
written informed consent

Exclusion Criteria:

other indication for therapeutic anticoagulation such as acute deep vein thrombosis, acute pulmonary embolism, atrial fibrillation with indication for anticoagulant therapy
any PE or DVT within last 6 months before inclusion
clinical signs of PE without objective exclusion (CT or VQ scan, angiography)
SVT without signs of thrombotic/inflammatory activity (activity signs: diameter > 4 mm, pain, redness, elevated local or systemic temperature)
SVT after sclerotherapy
Duration of symptoms > 3 weeks
pretreatment of more than 72 h with therapeutic dosages of oral or parenteral anticoagulants
pretreatment of more than 5 days with subtherapeutic oral or parenteral anticoagulants
indication for escalated antiplatelet therapy (monotherapy with aspirin > 325 g/d and any dual antiplatelet therapy)
SVT closer than 3 cm to saphenofemoral junction (SVJ)
anticipated superficial vein surgery within 90 days
anticipated thrombolytic therapy within 90 days
manifest clinically relevant bleeding
clinically relevant bleeding in the last 30 days before study inclusion
major surgery within last 30 days before inclusion
ophthalmic, spinal or cerebral surgery within last 90 days
severe head trauma within last 90 days
hemorrhagic stroke within last 12 months
hereditary or acquired severe hemorrhagic diathesis
gastrointestinal bleeding within last 90 days requiring endoscopy
uncontrolled arterial hypertension (systolic > 180 mm Hg, diastolic > 110 mm Hg)
acute endocarditis
low platelet count (< 100 x 109/l)
Prothrombin time < 50 %
calculated creatinine clearance < 30 ml/min
significant liver disease such as acute hepatitis, chronic active hepatitis, cirrhosis
life expectancy < 3 months
any contraindications listed for rivaroxaban or fondaparinux
women of child bearing potential without safe contraception method
pregnant or breastfeeding women
participation in another trial with pharmacological intervention
Intervention: Opioid
Trial phase: Not Applicable
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1.CCOC(=O)C1(c2ccccc2)CCN(C)CC1.COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 45
Group description: This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.

Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.
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: Tapentadol
Trial phase: Phase 4
ATC code: N02AX06
SMILES: CC[C@@H](c1cccc(O)c1)[C@@H](C)CN(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: 75 mg tapentadol 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: Acetylcysteine
Trial phase: Phase 4
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.

N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours
Eligibility criteria:
Inclusion Criteria:

diagnosis of acute myocardial infarction with less than 12 hours of evolution
reperfusion therapy (primary angioplasty)

Exclusion Criteria:

Thyroid disease
Chronic renal disease with renal replacement therapy
hepatic insufficiency
immunosuppression
Intervention: Nicotine
Trial phase: Phase 3
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3816
Group description: One-on-one, proactive telephone counseling to quit smoking; The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. Counseling includes a comprehensive pre-quit session (to include motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four proactive follow-up calls.

Nicotine patches (four weeks' worth) are sent directly to clients the day after the screening intake. Dosage is 21 mg if smoking 11 or more per day, 14 mg if smoking 6-10 per day and 7mg if smoking <6 per day.

Nicotine patches: Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.
Eligibility criteria:
Inclusion Criteria:

18 years or older
Medi-Cal beneficiary with valid Medi-Cal beneficiary ID
Willing to link Helpline data with Medi-Cal utilization data
English or Spanish speaking
Valid phone number
Valid address
Gave consent to participate in study and evaluation

Exclusion Criteria:

Contraindication(s) to nicotine patches and no MD approval
Pregnant