anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ciprofloxacin
Trial phase: Phase 4
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 563
Group description: Patients with ciprofloxacin-susceptible bacteria on their rectal swab cultures will receive ciprofloxacin, the standard of care, as prophylaxis for their prostate biopsy

Ciprofloxacin: 500 mg orally 2 hours before prostate biopsy
Eligibility criteria:
Inclusion Criteria:

Ability and willingness to provide written informed consent.
All individuals who will undergo TRUSP as part of their standard of care are eligible for study.

Exclusion Criteria:

Men under 30 years of age
Individuals whose rectal swab indicates that they harbor CS-GNB who cannot receive ciprofloxacin as pre-procedure prophylaxis for any reason
Individuals whose rectal swab indicates that they harbor CR-GNB who cannot abide by the antimicrobial prophylaxis guidelines outlined in the study protocol for any reason
Individuals who do not wish to complete the pre-procedure risk factor questionnaire or the two post-procedure phone questionnaires to assess for infectious complications
Intervention: Sufentanil
Trial phase: Phase 3
ATC code: N01AH03
SMILES: CCC(=O)N(c1ccccc1)C1(COC)CCN(CCc2cccs2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 315
Group description: Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
Eligibility criteria:
Inclusion Criteria:

Male or female patients who are 18 years of age or older
Patients who are scheduled for an elective cemented or uncemented total unilateral knee replacement or total unilateral hip replacement, under general or spinal anesthesia that does not include use of an intrathecal opioid
Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery

Exclusion Criteria:

Patients who have undergone a replacement of the same knee or hip
Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet)
Patients with an allergy or hypersensitivity to opioids
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
Eligibility criteria:
Inclusion Criteria:

-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

Exclusion Criteria:

History of glaucoma, ocular hypertension or optic nerve head change
Any active bacterial, viral, parasitic, or fungal infections in either eye
Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start
History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start
Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start
Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start
Use of topical ophthalmic corticosticosteroids within 2 weeks of study start
Intervention: Kovacaine
Trial phase: Phase 3
SMILES: CCCCNc1ccc(C(=O)OCCN(C)C)cc1.Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1.Cl.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Tetracaine HCl 3% and oxymetazoline HCl 0.05%

Tetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose
Eligibility criteria:
Inclusion Criteria:

Male or female 18 years of age or older.
Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology.
Normal lip, nose, eyelid, and cheek sensation.
Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol.
Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.

Exclusion Criteria:

Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg).
Inadequately controlled active thyroid disease of any type.
Frequent nose bleeds (≥ 5 per month).
Having received dental care requiring a local anesthetic within the last 24 hours.
History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.
Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation.
Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
History of congenital or idiopathic methemoglobinemia
Intervention: Folfirinox Regimen
Trial phase: Phase 2
SMILES: CCc1c2c(nc3ccc(OC(=O)N4CCC(N5CCCCC5)CC4)cc13)-c1cc3c(c(=O)n1C2)COC(=O)C3(O)CC.Nc1nc2c(c(=O)[nH]1)N(C=O)C(CNc1ccc(C(=O)NC(CCC(=O)O)C(=O)O)cc1)CN2.O=C([O-])C(=O)[O-].O=c1[nH]cc(F)c(=O)[nH]1.[NH-]C1CCCCC1[NH-].[Pt+4]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Patients received FOLFIRINOX x 6 followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine (1g/m^2) on days 1, 8, 22, 29.

Intensity-modulated radiotherapy (IMRT): The prescribed dose was 50.0Gy in 2.0Gy per fraction.

Patients without metastatic disease were offered surgical exploration.
Eligibility criteria:
Inclusion Criteria:

Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
Patients must be deemed to have borderline resectable disease with no radiologic evidence of distant metastatic disease prior to registration.
Specifically, patients must have at least one designation of borderline resectable and no designation of unresectable disease.
Patients must have a life expectancy of at least 12 weeks, a Zubrod performance status of < 1 and be willing and medically able to undergo surgical resection.
Patients must have adequate organ function defined as follows: absolute neutrophil count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin < 2.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
Patients must be free of other active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial due to the unacceptable teratogenic toxicity of abdominal radiation and cytotoxic chemotherapy.
Patients must be aware of the investigational nature of the therapy and provide written informed consent.

Exclusion Criteria:

Patients with neuroendocrine tumors are excluded.
Active systemic malignancy, ongoing infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
Patients with preexisting peripheral neuropathy > grade 2 are ineligible
Pregnant or nursing women are ineligible.
Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
Patients may not have used any investigational agent within 4 weeks prior to enrollment into the study.
Intervention: Lovaza
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Eicosapentanoic acid and docosahexanoic acid

Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

≥ 40 and < 80 years of age
History of 1 or more adenomatous polyps
Consent to be contacted for future studies
Participants with known genotype for rs174535 in FADS1
Prior participation in the Tennessee Colorectal Polyp Study or the Personalized Prevention of Colorectal Cancer Trial

Exclusion Criteria:

Previously resected colorectal cancer
Coronary artery disease or congestive heart failure
Current metabolic or life-threatening disease
Currently taking fish oil supplements
Inability or unwillingness to stop NSAIDs or ASA during the study
Allergic to fish products
Diagnosis of inflammatory bowel disease
Diagnosis of any cancer (except non-melanoma skin cancer)
Diagnosis of liver or kidney disease
Pregnant or breast feeding
Intervention: Oleic Acid
Trial phase: Phase 2
SMILES: CCCCCCCC/C=C/CCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Oleic Acid

Oleic Acid: Placebo
Eligibility criteria:
Inclusion Criteria:

≥ 40 and < 80 years of age
History of 1 or more adenomatous polyps
Consent to be contacted for future studies
Participants with known genotype for rs174535 in FADS1
Prior participation in the Tennessee Colorectal Polyp Study or the Personalized Prevention of Colorectal Cancer Trial

Exclusion Criteria:

Previously resected colorectal cancer
Coronary artery disease or congestive heart failure
Current metabolic or life-threatening disease
Currently taking fish oil supplements
Inability or unwillingness to stop NSAIDs or ASA during the study
Allergic to fish products
Diagnosis of inflammatory bowel disease
Diagnosis of any cancer (except non-melanoma skin cancer)
Diagnosis of liver or kidney disease
Pregnant or breast feeding
Intervention: Lovaza
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Eicosapentanoic acid and docosahexanoic acid

Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

≥ 40 and < 80 years of age
History of 1 or more adenomatous polyps
Consent to be contacted for future studies
Participants with known genotype for rs174535 in FADS1
Prior participation in the Tennessee Colorectal Polyp Study or the Personalized Prevention of Colorectal Cancer Trial

Exclusion Criteria:

Previously resected colorectal cancer
Coronary artery disease or congestive heart failure
Current metabolic or life-threatening disease
Currently taking fish oil supplements
Inability or unwillingness to stop NSAIDs or ASA during the study
Allergic to fish products
Diagnosis of inflammatory bowel disease
Diagnosis of any cancer (except non-melanoma skin cancer)
Diagnosis of liver or kidney disease
Pregnant or breast feeding
Intervention: Oleic Acid
Trial phase: Phase 2
SMILES: CCCCCCCC/C=C/CCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Oleic Acid

Oleic Acid: Placebo
Eligibility criteria:
Inclusion Criteria:

≥ 40 and < 80 years of age
History of 1 or more adenomatous polyps
Consent to be contacted for future studies
Participants with known genotype for rs174535 in FADS1
Prior participation in the Tennessee Colorectal Polyp Study or the Personalized Prevention of Colorectal Cancer Trial

Exclusion Criteria:

Previously resected colorectal cancer
Coronary artery disease or congestive heart failure
Current metabolic or life-threatening disease
Currently taking fish oil supplements
Inability or unwillingness to stop NSAIDs or ASA during the study
Allergic to fish products
Diagnosis of inflammatory bowel disease
Diagnosis of any cancer (except non-melanoma skin cancer)
Diagnosis of liver or kidney disease
Pregnant or breast feeding
Intervention: Lovaza
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Eicosapentanoic acid and docosahexanoic acid

Eicosapentanoic acid and docosahexanoic acid: 1395 mg EPA plus 1125 mg DHA daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

≥ 40 and < 80 years of age
History of 1 or more adenomatous polyps
Consent to be contacted for future studies
Participants with known genotype for rs174535 in FADS1
Prior participation in the Tennessee Colorectal Polyp Study or the Personalized Prevention of Colorectal Cancer Trial

Exclusion Criteria:

Previously resected colorectal cancer
Coronary artery disease or congestive heart failure
Current metabolic or life-threatening disease
Currently taking fish oil supplements
Inability or unwillingness to stop NSAIDs or ASA during the study
Allergic to fish products
Diagnosis of inflammatory bowel disease
Diagnosis of any cancer (except non-melanoma skin cancer)
Diagnosis of liver or kidney disease
Pregnant or breast feeding
Intervention: Oleic Acid
Trial phase: Phase 2
SMILES: CCCCCCCC/C=C/CCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Oleic Acid

Oleic Acid: Placebo
Eligibility criteria:
Inclusion Criteria:

≥ 40 and < 80 years of age
History of 1 or more adenomatous polyps
Consent to be contacted for future studies
Participants with known genotype for rs174535 in FADS1
Prior participation in the Tennessee Colorectal Polyp Study or the Personalized Prevention of Colorectal Cancer Trial

Exclusion Criteria:

Previously resected colorectal cancer
Coronary artery disease or congestive heart failure
Current metabolic or life-threatening disease
Currently taking fish oil supplements
Inability or unwillingness to stop NSAIDs or ASA during the study
Allergic to fish products
Diagnosis of inflammatory bowel disease
Diagnosis of any cancer (except non-melanoma skin cancer)
Diagnosis of liver or kidney disease
Pregnant or breast feeding
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 100 subjects who will actually get the intervention medication

Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first
Eligibility criteria:
Inclusion Criteria:

Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy;

Exclusion Criteria:

Prior intestinal surgery
Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
American Society of Anesthesiologists (ASA) Class IV or V;
History of abdominal carcinomatosis;
History of radiation enteritis;
Children < 18 or adults > 85 years of age
Pregnant women
Current cigarette, cigar smokers and chewers of tobacco. ex smokers who quit less than 3 months ago.
Patients requiring postoperative ventilation, pressor requirement or ICU stay
Patients with prior cardiovascular disorders
Intervention: Paliperidone
Trial phase: Phase 3
ATC code: N05AX13
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 201
Group description: Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
Eligibility criteria:
Inclusion Criteria:

Have a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
Have experienced an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120 inclusive, at Screening and Baseline
Women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), practicing a highly effective method of birth control, if sexually active
Men must be using a highly effective method of birth control and must not donate sperm during the study and for 3 months after receiving the last dose of study drug
Be willing and capable to complete the questionnaires and able to take oral medications independently

Exclusion Criteria:

Has drug dependence diagnosis according to DSM-IV (excluding nicotine and caffeine dependence) within 6 months before screening
Participants with Crohn's disease and hepatic or renal diseases
Has had relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular dysfunction), renal, hepatic, endocrine, or immunologic diseases
Has had history of neuroleptic malignant syndrome (the disorder caused by antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)
Has had known or suspected Stevens Johnson Syndrome (an immune disease with symptoms of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin, carbamazepine, barbiturates, or lamotrigine
Had been treated with clozapine for treatment refractory or treatment resistant schizophrenia
Has significant risk of suicide or homicidal behavior, or significant risk of deliberate self harm or harm to others
Has taken isocarboxazid, phenelzine, selegiline and tranylcypromine within 4 weeks before screening
Has received electroconvulsive therapy within 60 days before screening
Intervention: Paliperidone
Trial phase: Phase 3
ATC code: N05AX13
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
Eligibility criteria:
Inclusion Criteria:

Have a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
Have experienced an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120 inclusive, at Screening and Baseline
Women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), practicing a highly effective method of birth control, if sexually active
Men must be using a highly effective method of birth control and must not donate sperm during the study and for 3 months after receiving the last dose of study drug
Be willing and capable to complete the questionnaires and able to take oral medications independently

Exclusion Criteria:

Has drug dependence diagnosis according to DSM-IV (excluding nicotine and caffeine dependence) within 6 months before screening
Participants with Crohn's disease and hepatic or renal diseases
Has had relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular dysfunction), renal, hepatic, endocrine, or immunologic diseases
Has had history of neuroleptic malignant syndrome (the disorder caused by antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)
Has had known or suspected Stevens Johnson Syndrome (an immune disease with symptoms of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin, carbamazepine, barbiturates, or lamotrigine
Had been treated with clozapine for treatment refractory or treatment resistant schizophrenia
Has significant risk of suicide or homicidal behavior, or significant risk of deliberate self harm or harm to others
Has taken isocarboxazid, phenelzine, selegiline and tranylcypromine within 4 weeks before screening
Has received electroconvulsive therapy within 60 days before screening
Intervention: IC Green
Trial phase: Phase 2
ATC code: V04CX01
SMILES: CC1(C)C(=CC=CC=CC=CC2=[N+](CCCCS(=O)(=O)[O-])c3ccc4ccccc4c3C2(C)C)N(CCCCS(=O)(=O)[O-])c2ccc3ccccc3c21.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Indocyanine green is used for intraoperative identification of sentinel lymph nodes in patients with early colonic cancer using near infrared laparoscopic imaging

Indocyanine green: Please see arm description
Eligibility criteria:
Inclusion Criteria:

Patients willing and able to give informed consent for participation in the study
Patients willing and able to comply with the study procedures
Male or Female, aged 18 years or above
Patients diagnosed with T1 or T2 colonic neoplasia on preoperative staging and require laparoscopic surgical excision
If female, a negative pregnancy test for women of childbearing potential prior to surgery
Patients who have clinically acceptable laboratory results pre-operatively with serum creatinine of <110 mg/dL

Exclusion Criteria:

Patients diagnosed with T3 or T4 disease on preoperative imaging
A patient who is pregnant, lactating or planning pregnancy during the course of the study
Allergy to any of the compounds being used for lymphatic mapping including Indocyanine green or sodium iodide
Patients with hyperthyroidism or those with thyroid adenomas
Patients with renal insufficiency (serum creatinine of >110 mg/dL)
Patients in whom the use of ICG is contraindicated including development of adverse events when previously or presently administered
Previous allergic reaction to shellfish