anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: CO-TRIMOXAZOLE
Trial phase: Phase 2
ATC code: J01EE01
SMILES: COc1cc(Cc2cnc(N)nc2N)cc(OC)c1OC.Cc1cc(NS(=O)(=O)c2ccc(N)cc2)no1
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 308
Group description: Azithromycin 1 gm po daily x 3 days at enrollment and at each 4 week follow up visit.

TMPS double strength 1 tablet po daily.

Azithromycin/TMPS: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Eligibility criteria:
Inclusion Criteria:

Confirmed HIV-infection (documented in medical record)
Age ≥16 years
Confirmed pregnancy, <28 weeks estimated gestational age (by best obstetric estimate which may include ultrasound or fundal height and LMP)
Live singleton pregnancy
Receiving prenatal care at Mboppi Hospital or Mutengene Hospital
Plan to receive follow up prenatal care and deliver at study facility
Capable of providing written informed consent
Able and agree to come to facility for febrile episodes or acute illness during pregnancy (with reimbursement of transportation costs).
Agree to avoid antimalarial medications outside of study protocol.

Exclusion Criteria:

Severe anemia (last hemoglobin <6)
History of severe adverse reaction to co-trimoxazole or azithromycin
Active medical problem requiring inpatient evaluation at the time of screening
Intention of moving far away from the facility during pregnancy or not likely to return for follow up care or delivery
Signs or symptoms of early or active labor
History of severe cardiac disease (including congestive heart failure, severe valvular disease or arrhythmias).
Intervention: Amoxicillin
Trial phase: Phase 4
ATC code: A02BD01 | A02BD03 | A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD10 | A02BD11 | A02BD12 | A02BD13 | A02BD14 | A02BD15 | A02BD16 | J01CA04 | J01CR50
SMILES: [H][C@]12SC(C)(C)[C@H](C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: Amoxicillin 875 mg/clavulanate 125 mg + amoxicillin 875 mg twice a day x 7 days
Eligibility criteria:
Inclusion Criteria:

Adults 18 and older who are patients at the Albany Medical Center Internal Medicine and Pediatrics practice (study site).
Clinical diagnosis of acute bacterial sinusitis in accordance with the guidelines of the Infectious Disease Society of America (fitting into one of 3 categories: persistent sinus symptoms for 10 days or more; severe sinus symptoms for 3 days or more; or worsening sinus symptoms after initial improvement (double sickening).

Exclusion Criteria:

Previous enrollment in the current study
Allergy or intolerance to any penicillin or to amoxicillin/clavulanate
Serious hypersensitivity reaction to any beta lactam
Elevated risk of amoxicillin-resistant bacteria: a. amoxicillin, penicillin, or other beta-lactam within the past month; b. known to have had methicillin-resistant Staph aureus
Chronic or recurrent "sinus" problems (defined as a) persistent symptoms of "sinus" congestion, not attributed to nasal allergies, for 8 weeks or more or b) 2 or more episodes of antibiotic-treated "sinusitis" in past 3 months
Need to use high-dose amoxicillin/clavulanate or levofloxacin or to send to emergency department or to hospitalize because of a) signs of severe infection or b) immunocompromise
Cognitive impairment, so unable to give reliable symptom ratings (even if a health proxy can give consent)
Pregnant women and nursing mothers
Drug warnings: a) taking allopurinol; b) current mononucleosis; c) chronic kidney disease stage 4 (estimated glomerular filtration rate <30); d) hepatic impairment (not including isolated transaminase elevated < 2 times upper limit of normal); e) history of antibiotic-associated colitis (C. difficile)
Intervention: Norepinephrine
Trial phase: Phase 3
ATC code: C01CA03
SMILES: NC[C@H](O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 782
Group description: The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.

Early Vasopressors: Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. "Rescue fluids" may be administered as 500ml boluses if predefined rescue criteria are met.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years
A suspected or confirmed infection (broadly defined by administration or planned administration of antibiotics)
Sepsis-induced hypotension defined as systolic blood pressure < 100 mmHg or MAP < 65 mmHg after a minimum of at least 1 liter of fluid (*Fluids inclusive of pre-hospital fluids; blood pressure must be below any known or reported pre-morbid baseline).

Exclusion Criteria:

More than 4 hours elapsed since meeting inclusion criteria or 24 hours elapsed since admission to the hospital
Patient already received 3 liters of intravenous fluid (includes prehospital volumes)
Unable to obtain informed consent
Known pregnancy
Hypotension suspected to be due to non-sepsis cause (e.g. hemorrhagic shock)
Blood pressure is at known or reported baseline level
Severe Volume Depletion from an acute condition other than sepsis. In the judgment of the treating physician, the patient has an acute condition other than sepsis causing (or indicative) of *severe volume depletion; Examples include: Diabetic ketoacidosis, high volume vomiting or diarrhea, hyperosmolar hyperglycemic state, and nonexertional hyperthermia (heat stroke); severe is defined by the need for substantial intravenous fluid administration as part of routine clinical care
Pulmonary edema or clinical signs of new fluid overload (e.g. bilateral crackles, new oxygen requirement, new peripheral edema, fluid overload on chest x-ray)
Treating physician unwilling to give additional fluids as directed by the liberal protocol
Treating physician unwilling to use vasopressors as directed by the restrictive protocol.
Current or imminent decision to withhold most/all life-sustaining treatment; this does not exclude those patients committed to full support except cardiopulmonary resuscitation
Immediate surgical intervention planned such that study procedures could not be followed
Prior enrollment in this study
Intervention: Meloxicam
Trial phase: Phase 3
ATC code: M01AC06 | M01AC56 | N01BB59
SMILES: Cc1cnc(NC(=O)C2=C(O)c3ccccc3S(=O)(=O)N2C)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: N1539 (meloxicam injection for IV use) 30 mg every 24 hours

N1539: Once Daily
Eligibility criteria:
Inclusion Criteria:

Voluntarily provide written informed consent.
Be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral total knee arthroplasty (TKA), and be expected to require IV analgesia, remain in an inpatient setting for ≥24 hours, and receive at least two doses of study drug.
ASA physical status category 1, 2, or 3.
Female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study.
Have a body mass index <40 kg/m^2

Exclusion Criteria:

Have a known allergy or hypersensitivity to any study treatment.
Have a history of previous TKA.
Has plans for a concurrent surgical procedure (eg, bilateral TKA).
Has TKA planned to be performed under general anesthesia.
Have a history of myocardial infarction within the preceding 12 months.
Have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation.
Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.
Have a known bleeding disorder which may be worsened with the administration of an NSAID.
Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within 48 hours prior to surgery.
Have previously received N1539/IV meloxicam or received any investigational product within 30 days before dosing with study medication.
Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up.
Intervention: TENOFOVIR ALAFENAMIDE
Trial phase: Phase 2
ATC code: J05AF13 | J05AR17 | J05AR18 | J05AR19 | J05AR20 | J05AR22
SMILES: CC(C)OC(=O)C(C)NP(=O)(COC(C)Cn1cnc2c(N)ncnc21)Oc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Groups 1-3 and 5:

Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment

Group 4:

HBV deoxyribonucleic acid (DNA) ≤ 20 IU/mL at Screening by Central Lab.
Have been on a commercially available HBV NUC treatment(s)

Key Exclusion Criteria:

Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV).
Extensive bridging fibrosis or cirrhosis
Evidence of hepatocellular carcinoma on imaging
Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
Chronic liver disease of a non-HBV etiology
Current alcohol or substance abuse

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Lincomycin
Trial phase: Phase 2
ATC code: J01FF02
SMILES: [H][C@@]1(C(=O)N[C@@H]([C@H]2O[C@H](SC)[C@H](O)[C@@H](O)[C@H]2O)[C@@H](C)O)C[C@@H](CCC)CN1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Enrolled subjects will be randomized to receive Lacosamide.

Lacosamide: LCM 100mg twice a day.
Eligibility criteria:
Inclusion Criteria:

Patients with a suspected diagnosis of new, recurrent, or transformed glioma (WHO grade I-IV) or brain metastasis scheduled for neurosurgical procedure (gross-total resection, sub-total resection or biopsy) at Duke University Medical Center (DUMC);
Safe for surgery per treating neurosurgeon;
Due to the potential implications of the treatment on the developing central nervous system (CNS), all patients must be ≥ 18 years of age at the time of entry into the study;

Laboratory Studies:

Total bilirubin, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), Alkaline Phosphatase (ALK) ≤ 1.5 x upper limit of normal (ULN)
Creatinine ≤ 1.5
A signed informed consent form approved by the Duke University Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study.
Patients of child bearing potential or with partners of child-bearing potential must agree to practice recommended contraceptive methods to prevent pregnancy during treatment and for 1 month after the last dose of AED for women and men.

Exclusion Criteria:

Pregnant or need to breast feed during the study period (Negative urine β-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study and for 1 month after the last dose of AED;
Patients already on AED(s);
Known history of epilepsy/seizure disorder;
Known history of dependency/abuse of psychopharmaceuticals, alcohol, illicit drugs or narcotics;
Any significant medical or psychiatric illness that cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate therapy, per the discretion of the treating investigator;
Known allergy to LCM or LEV.
Intervention: Tacrolimus
Trial phase: Phase 1 | Phase 2
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: 18
Group description: This is standard of care

immediate-release tacrolimus: Standard of care for transplant patients
Eligibility criteria:
Inclusion Criteria:

Male or female kidney transplant recipient;
18-65 years of age;
receiving a kidney transplant from a living or deceased donor;
if female, premenopausal and heterosexually active, must be using two forms of highly effective birth control (at least one of which must be a barrier method) which includes consistent and correct usage of established oral contraception, established intrauterine device or intrauterine system, or barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, starting at screening and throughout the study period and for 90 days after the final study drug administration;
written informed consent to participate in the study

Exclusion Criteria:

younger than 18 years of age;
older than 65 years of age;
Non-native level English speaker;
pregnant women
breastfeeding women
Intervention: Ceftobiprole
Trial phase: Phase 3
SMILES: Nc1nc(C(=NO)C(=O)NC2C(=O)N3C(C(=O)O)=C(C=C4CCN(C5CCNC5)C4=O)CSC23)ns1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 94
Group description: Ceftobiprole medocaril is the water-soluble prodrug of ceftobiprole, an advanced-generation cephalosporin developed for IV administration. Ceftobiprole is characterized by potent, broad-spectrum antimicrobial activity against both Gram-positive and Gram-negative pathogens.
Eligibility criteria:
Inclusion Criteria:

Male of female aged 3 months to < 18 years with a body weight of at least 5 kg
Diagnosis of either hospital-acquired pneumonia or community-acquired pneumonia requiring hospitalization and administration of IV antibiotic therapy
New or progressive imaging findings consistent with bacterial pneumonia
Requirement for IV antibacterial treatment for pneumonia
Other inclusion criteria may apply

Exclusion Criteria:

Known resistance of the causative pathogen to ceftobiprole or IV standard-of-care cephalosporin treatment (± vancomycin)
On mechanical ventilation
Chest trauma with severe lung contusion or flail chest
Acute respiratory distress syndrome
Empyema or lung abscess
Anatomical bronchial obstruction
Active or currently treated pulmonary tuberculosis
Atypical bacterial pneumonia, or viral pneumonia without bacterial superinfection, or need for antibiotic coverage with a macrolide
Pertussis, chemical pneumonitis, or cystic fibrosis
Severe immunodeficiency
Significant laboratory abnormalities including: Hematocrit <20%; absolute neutrophil count <0.5x10⁹/L; platelet count <50x10⁹/L; alanine aminotransferase, aspartate aminotransferase, or bilirubin >5 times the age-specific upper limit of normal;
Creatinine clearance <50 mL/min/1.73 m²
Use of systemic antimicrobial therapy for more than 24 hours in the 48 hours before randomization
History of a previous clinically-relevant hypersensitivity or serious adverse reaction to beta lactam antibiotics or to vancomycin
Poorly controlled seizure disorder
Other exclusion criteria may apply
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 225
Group description: Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.

Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
Eligibility criteria:
Inclusion Criteria:

Adult ED patients aged 18 and older
Chief complaint of mild to moderate musculoskeletal pain, headache, or dental pain intensity of less than 4 on a standard 0 to 10 numeric rating scale.
Acute pain (within 30 days of onset)
Patients who would routinely be treated with oral ibuprofen

Exclusion Criteria:

pregnancy or breastfeeding,
active peptic ulcer disease,
acute gastrointestinal hemorrhage,
known history of severe renal or hepatic insufficiency, allergy to nonsteroidal anti-inflammatory drugs,
patients having already received analgesic medication.
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 225
Group description: Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.

Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
Eligibility criteria:
Inclusion Criteria:

Adult ED patients aged 18 and older
Chief complaint of mild to moderate musculoskeletal pain, headache, or dental pain intensity of less than 4 on a standard 0 to 10 numeric rating scale.
Acute pain (within 30 days of onset)
Patients who would routinely be treated with oral ibuprofen

Exclusion Criteria:

pregnancy or breastfeeding,
active peptic ulcer disease,
acute gastrointestinal hemorrhage,
known history of severe renal or hepatic insufficiency, allergy to nonsteroidal anti-inflammatory drugs,
patients having already received analgesic medication.
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 225
Group description: Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.

Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
Eligibility criteria:
Inclusion Criteria:

Adult ED patients aged 18 and older
Chief complaint of mild to moderate musculoskeletal pain, headache, or dental pain intensity of less than 4 on a standard 0 to 10 numeric rating scale.
Acute pain (within 30 days of onset)
Patients who would routinely be treated with oral ibuprofen

Exclusion Criteria:

pregnancy or breastfeeding,
active peptic ulcer disease,
acute gastrointestinal hemorrhage,
known history of severe renal or hepatic insufficiency, allergy to nonsteroidal anti-inflammatory drugs,
patients having already received analgesic medication.
Intervention: Eluxadoline
Trial phase: Phase 4
ATC code: A07DA06
SMILES: COc1ccc(CN(C(=O)[C@@H](N)Cc2c(C)cc(C(N)=O)cc2C)[C@@H](C)c2nc(-c3ccccc3)c[nH]2)cc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Adult men or women aged 18 to 75 years inclusive with a diagnosis of IBS-D per Rome IV criteria.
Participants with evidence of BAM must have a fasting serum 7a-hydroxy-4-cholesten-3-one (7αC4) level ≥ 52.5 ng/mL or total fecal bile acid (BA) > 2337 micromoles/48 hours (positive result) at screening or within 1 calendar year prior to screening.
Participants without BAM must have a fasting serum 7αC4 level ≤ 47.1 ng/mL or total fecal BA < 2200 micromoles/48 hours (negative result) at screening or within 1 calendar year prior to screening.
Has an average daily Bristol Stool Form Scale (BSFS) score ≥ 5.0 or ≥ 25% of diary entry days with a BSFS score of 6 or 7 during the 14 days prior to Day 1.
Women of childbearing potential must use hormonal or double barrier contraception or maintain a monogamous relationship with a vasectomized male partner from the date of informed consent until 24 hours after final dose of study drug.
Completed the electronic diary (eDiary) on ≥ 10 of the 14 days prior to Day 1.
Has not used loperamide rescue medication on > 3 of the 14 days prior to Day 1.

Exclusion Criteria:

Has a diagnosis of IBS with a subtype of irritable bowel syndrome with constipation (IBS-C), mixed IBS, or unsubtyped IBS per Rome IV criteria.
Does not have a gallbladder.
Has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction. (Participants with a history of gallstones may be enrolled).
Has a history of alcoholism, alcohol abuse or alcohol addiction, or drinks more than 3 alcoholic beverages per day.
Has a history of pancreatitis; structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.
Has a history of mild, moderate, or severe hepatic impairment according to Child-Pugh classification. History or current diagnosis of inflammatory or immune-mediated gastrointestinal (GI) disorders.
Has Celiac disease or a positive serological test for celiac disease.
Has known lactose or fructose intolerance associated with diarrhea, abdominal pain or discomfort, that could confound assessments in the study.
Women who are currently pregnant or nursing, or plan to become pregnant or nurse during the study.
Has known allergies or hypersensitivity to opioids.
Intervention: Eluxadoline
Trial phase: Phase 4
ATC code: A07DA06
SMILES: COc1ccc(CN(C(=O)[C@@H](N)Cc2c(C)cc(C(N)=O)cc2C)[C@@H](C)c2nc(-c3ccccc3)c[nH]2)cc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Adult men or women aged 18 to 75 years inclusive with a diagnosis of IBS-D per Rome IV criteria.
Participants with evidence of BAM must have a fasting serum 7a-hydroxy-4-cholesten-3-one (7αC4) level ≥ 52.5 ng/mL or total fecal bile acid (BA) > 2337 micromoles/48 hours (positive result) at screening or within 1 calendar year prior to screening.
Participants without BAM must have a fasting serum 7αC4 level ≤ 47.1 ng/mL or total fecal BA < 2200 micromoles/48 hours (negative result) at screening or within 1 calendar year prior to screening.
Has an average daily Bristol Stool Form Scale (BSFS) score ≥ 5.0 or ≥ 25% of diary entry days with a BSFS score of 6 or 7 during the 14 days prior to Day 1.
Women of childbearing potential must use hormonal or double barrier contraception or maintain a monogamous relationship with a vasectomized male partner from the date of informed consent until 24 hours after final dose of study drug.
Completed the electronic diary (eDiary) on ≥ 10 of the 14 days prior to Day 1.
Has not used loperamide rescue medication on > 3 of the 14 days prior to Day 1.

Exclusion Criteria:

Has a diagnosis of IBS with a subtype of irritable bowel syndrome with constipation (IBS-C), mixed IBS, or unsubtyped IBS per Rome IV criteria.
Does not have a gallbladder.
Has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction. (Participants with a history of gallstones may be enrolled).
Has a history of alcoholism, alcohol abuse or alcohol addiction, or drinks more than 3 alcoholic beverages per day.
Has a history of pancreatitis; structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.
Has a history of mild, moderate, or severe hepatic impairment according to Child-Pugh classification. History or current diagnosis of inflammatory or immune-mediated gastrointestinal (GI) disorders.
Has Celiac disease or a positive serological test for celiac disease.
Has known lactose or fructose intolerance associated with diarrhea, abdominal pain or discomfort, that could confound assessments in the study.
Women who are currently pregnant or nursing, or plan to become pregnant or nurse during the study.
Has known allergies or hypersensitivity to opioids.