anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: bupivacaine liposome injectable suspension.

Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 years of age or older.
Patients scheduled to undergo ileostomy reversal.
Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.

Exclusion Criteria:

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

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

Patients who have any concurrent surgical procedure.
Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
Patients who receive Entereg(R).
Intervention: Roflumilast
Trial phase: Phase 3
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Roflumilast 500 µg
Eligibility criteria:
Major Inclusion Criteria:

Giving written informed consent
History of COPD (according to GOLD 2009) for at least 12 months prior to baseline visit V0 associated with chronic productive cough for at least three months in each of the two years prior to baseline visit V0 (with other causes of productive cough excluded)
Outpatients 40-80 years of age
Post-bronchodilator 30% ≤FEV1 ≤80% predicted
Post-bronchodilator FEV1/FVC ratio ≤70%
Current or former smokers with smoking history ≥20 pack years

Main Exclusion Criteria:

• Criteria affecting the read-out parameters of the trial:

Clinical instability, defined as experiencing a COPD exacerbation six months prior to V0
An upper/lower respiratory tract infection which has not resolved four weeks prior to V0
Diagnosis of asthma and/or other relevant lung disease
Known alpha-1-antitrypsin deficiency
Suspicion or diagnosis of a bleeding disorders irrespective of its pathophysiological mechanism
Other protocol-defined exclusion criteria may apply
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: EXPAREL (bupivacaine liposome injectable suspension)

EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 years of age and older
Patients scheduled to undergo ileostomy reversal
Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.

Exclusion Criteria:

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

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

Patients who have any concurrent surgical procedure.
Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
Patients who receive Entereg(R).
Intervention: Diclofenac
Trial phase: Phase 3
ATC code: D11AX18 | M01AB05 | M01AB55 | M02AA15 | S01BC03 | S01CC01
SMILES: O=C(O)Cc1ccccc1Nc1c(Cl)cccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 601
Group description: Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
Eligibility criteria:
Inclusion Criteria:

Male or female ≥ [greater than or equal to] 40 years of age
If a participant in the previous DIC3-08-05 study, completed the study and did not discontinue for lack of efficacy or safety
Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ [greater than or equal to] 20 days of the last 30 days before screening

Exclusion Criteria:

Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac
Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip
Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
Has significant difficulties swallowing capsules or is unable to tolerate oral medication
Intervention: EC-17
Trial phase: Phase 2
SMILES: NC(=O)CC[C@@H](C(=O)O)N(CCNC(=S)Nc1ccc2c(c1)C(=O)OC21c2ccc(O)cc2Oc2cc(O)ccc21)C(=O)c1ccc(NCc2cnc3nc(N)[nH]c(=O)c3n2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: EC-17: One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
Eligibility criteria:
Inclusion Criteria:

Women who are:

Diagnosed with or at high clinical suspicion of primary ovarian cancer by either radiologic imaging or physical examination or biopsy or serum tumor markers
Scheduled to undergo surgical cytoreduction via laparotomy
At least 18 years of age
Capable and willing to provide informed consent

Exclusion Criteria:

Women with:

Known sarcomatous histologies
Recurrent ovarian cancer
Planned surgical approach via laparoscopy or robotic surgery
A history of anaphylactic reactions to Folate-FITC or insects
Inability or unwillingness to provide informed consent
Intervention: Domperidone Maleate
Trial phase: Phase 2
SMILES: O=C(O)C=CC(=O)O.O=c1[nH]c2ccccc2n1CCCN1CCC(n2c(=O)[nH]c3cc(Cl)ccc32)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Domperidone 10 mg orally three times daily for 28 days

Domperidone maleate: domperidone 10 mg orally three times daily for 28 days
Eligibility criteria:
Inclusion Criteria:

mothers of a preterm infant born < 30 completed weeks gestation (23 0/7-29 6/7 weeks)
postpartum period of 7-21 days
mechanically pumping a minimum average of 6 times a day in the 4-7 days prior to enrollment
experiencing inadequate milk supply defined as providing < 100% of the average of the daily nutritional intake during the previous 72-hour period prior to enrollment based on a fluid intake of 250 mL/kg/d or experiencing a clinical reduction of approximately 20% from a peak volume during the previous 72-hour period prior to enrollment

Exclusion Criteria:

history of known or suspected cardiac dysrhythmias (tachyarrhythmia, Q-Tc prolongation) or currently on an anti-arrhythmic medication
currently experiencing mastitis
previous breast surgery, including augmentation or reduction, nipple piercing and/or the use of nipple rings/studs within the last year, or any reduction
known chronic or debilitating illness, known abnormal liver function or gastric abnormalities gastrointestinal that will be exacerbated by the use of a prokinetic, examples include hemorrhage or blockage, actively treated with acid reflux which requires treatment for greater than 5 days and includes H2 blockers (occasional use of H2 blockers for heartburn or mild acid reflux is not considered an exclusion) and HIV
known to have a prolactin-releasing pituitary tumor
receiving medications known to alter the metabolism and pharmacokinetics of domperidone (eg. oral "azole" antifungals, erythromycin antibiotics, monoamine oxidase inhibitors (MAO) inhibitors) or medications that have dopaminergic or antidopaminergic activity or affect prolactin levels
mothers of higher order pregnancies (triplet, or more)
currently smoking 6 or more cigarette per day as reported by the mother
Intervention: Odanacatib
Trial phase: Phase 1
SMILES: CC(C)(F)C[C@H](N[C@@H](c1ccc(-c2ccc(S(C)(=O)=O)cc2)cc1)C(F)(F)F)C(=O)NC1(C#N)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
Eligibility criteria:
Inclusion Criteria:

Not currently pregnant, nursing or planning to be pregnant through-out the course of the study; agree to use specified contraception per protocol requirement
Body Mass Index (BMI) of ≤ 39 kg/m^2 (not obese)
Judged to be in good health (for healthy participant population)
Non-smoker for the past 6-months; social smokers (smoke less than 10 cigarettes within the past 3 months; or per discretion of the study Investigator, quit smoking within the past 3 months.
Diagnosed with chronic (more than 6 months), stable (no acute episodes of illness within the previous 2 months) hepatic insufficiency (liver dysfunction) with features of cirrhosis due to any cause (for the moderate hepatic insufficiency participant population)
Possess the ability to understand the study, grant voluntary informed consent and willingly comply with all study requirements

Exclusion Criteria:

Does not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, or a history of a clinically significant psychiatric disorder
Has been diagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results
Compromised renal (kidney) function, significant organ system disease(s) or cancer(s)
Unable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs or herbal remedies
Meets the requirements of the study in regard to current medication profile including: prescribed medications, caffeine, alcohol, over-the-counter drugs, herbals and nutritional products; with expected non-use of recreational (illicit) drugs associated with misuse, abuse and/or addiction
Had surgery, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product
History of multiple and/or severe allergies, or has had a life-threatening reaction or inability to tolerate prescription or non-prescription drugs or food
Intervention: Odanacatib
Trial phase: Phase 1
SMILES: CC(C)(F)C[C@H](N[C@@H](c1ccc(-c2ccc(S(C)(=O)=O)cc2)cc1)C(F)(F)F)C(=O)NC1(C#N)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Eligibility criteria:
Inclusion Criteria:

Not currently pregnant, nursing or planning to be pregnant through-out the course of the study; agree to use specified contraception per protocol requirement
Body Mass Index (BMI) of ≤ 39 kg/m^2 (not obese)
Judged to be in good health (for healthy participant population)
Non-smoker for the past 6-months; social smokers (smoke less than 10 cigarettes within the past 3 months; or per discretion of the study Investigator, quit smoking within the past 3 months.
Diagnosed with chronic (more than 6 months), stable (no acute episodes of illness within the previous 2 months) hepatic insufficiency (liver dysfunction) with features of cirrhosis due to any cause (for the moderate hepatic insufficiency participant population)
Possess the ability to understand the study, grant voluntary informed consent and willingly comply with all study requirements

Exclusion Criteria:

Does not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, or a history of a clinically significant psychiatric disorder
Has been diagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results
Compromised renal (kidney) function, significant organ system disease(s) or cancer(s)
Unable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs or herbal remedies
Meets the requirements of the study in regard to current medication profile including: prescribed medications, caffeine, alcohol, over-the-counter drugs, herbals and nutritional products; with expected non-use of recreational (illicit) drugs associated with misuse, abuse and/or addiction
Had surgery, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product
History of multiple and/or severe allergies, or has had a life-threatening reaction or inability to tolerate prescription or non-prescription drugs or food
Intervention: RIVOCERANIB
Trial phase: Phase 3
SMILES: N#CC1(c2ccc(NC(=O)c3cccnc3NCc3ccncc3)cc2)CCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 176
Group description: apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Eligibility criteria:
Inclusion Criteria:

≥ 18 and ≤ 70 years of age
Histological confirmed advanced or metastatic adenocarcinoma of the stomach
Have failed for at least 2 lines of chemotherapy
Life expectancy of at least 12 weeks.
Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.
At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
More than 4 weeks for operation or radiotherapy
More than 4 weeks for cytotoxic agents or growth inhibitors
Adequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets > 80 ×10 E+9/L, neutrophil > 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit of normal(ULN), bilirubin < 1.25× ULN, and serum transaminase ≤ 2.5× ULN).

Exclusion Criteria:

Pregnant or lactating women
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
Any factors that influence the usage of oral administration; Evidence of Central Nerves System(CNS) metastasis
Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+)
International Normalize Ratio (INR) > 1.5 and activated partial thromboplastin time（APPT） > 1.5 × ULN
Abuse of alcohol or drugs
Certain possibility of gastric or intestine hemorrhage
Less than 4 weeks from the last clinical trial
Prior VEGFR inhibitor treatment
Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.
Intervention: Sitagliptin Phosphate
Trial phase: Not Applicable
SMILES: NC(CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: 100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks

Sitagliptin phosphate: 100 mg/day orally
Eligibility criteria:
Inclusion Criteria:

Must be a resident of the NYC metropolitan area or be able to come for emergency unscheduled and regular weekly meetings in Manhattan.
HbA1c ≥ 6.5% and ≤ 8.5 % or a fasting glucose ≥ 126 mg/dL or a random glucose ≥ 200 mg/dL at least 12 months after GBP surgery confirmed by central laboratory.
Subject is capable and willing to give informed consent.
Subject is otherwise in good general health, based on medical history and physical examination.
Subject is a non smoker for at least 6 months prior to study start
Female subjects of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the first administration of the challenge agent. Subjects using hormonal contraception should use a barrier method in addition from the first administration of challenge agent until their next normal period following the end of the study.

Exclusion Criteria:

History of type 1 diabetes
Female subject is pregnant or breastfeeding.
Recent (< 30 days) or simultaneous participation in another clinical trial.
Any situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.
Intervention: Natrecor
Trial phase: Phase 1 | Phase 2
SMILES: CCC(C)C1NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C(CCCNC(=N)N)NC(=O)CNC(=O)C(Cc2ccccc2)NC(=O)C(NC(=O)CNC(=O)C(CO)NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C2CCCN2C(=O)C(N)CO)C(C)C)CSSCC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc2cnc[nH]2)C(=O)O)C(C)C)NC(=O)CNC(=O)C(CC(C)C)NC(=O)CNC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Subjects will receive subcutaneous (SQ) BNP bid for seven consecutive days. The initial starting dose was 5 micrograms/kg.
Eligibility criteria:
Inclusion criteria:

Subjects with resistant hypertension as defined by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guidelines, systolic blood pressure and/or diastolic blood pressure > 140/90 mm Hg. For patients with hypertension and diabetes or renal disease, blood pressure > 130/80 mm Hg despite treatment with diuretic, sympathetic depressant and vasodilators.

Medications may include a three drug regimen including:

diuretic at therapeutic dose
a second line agent such as sympatholytic (e.g. beta-blockade, central agent such as clonidine) or angiotensin converting enzyme inhibitor (ACEi) / angiotensin receptor blocker (ARB) or calcium channel blocker (CCB).
third line agent including one of the above and/or direct vasodilator, such as hydralazine or minoxidil.

Exclusion criteria:

Congestive Heart Failure (any New York Heart Association (NYHA) class)
Ejection Fraction < 50%
Known renal artery stenosis
Myocardial infarction within 3 months of screening
Unstable angina within 14 days of screening, or any evidence of myocardial ischemia
Moderate to severe pulmonary hypertension
Valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis
Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
Sustained Atrial Fibrillation
Second or third degree atrioventricular (AV) block without a permanent cardiac pacemaker
Cerebral vascular accident within 3 months of screening, or other evidence of significantly compromised central nervous system perfusion
Total bilirubin of > 1.5 mg/dL or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 1.5 times the upper limit of normal range
Renal insufficiency assessed by calculated Glomerular Filtration Rate (GFR) < 30 ml/min (Cockcroft-Gault equation)
Serum sodium of < 125 milliequivalent (mEq)/dL or > 160 mEq/dL
Serum potassium of < 3.0 mEq/dL or > 5.5 mEq/dL
Women taking hormonal contraceptives
Pregnancy
Body mass index (BMI) > 35
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
Eligibility criteria:
Inclusion Criteria:

Must be 4 years of age or older

Must have an active head lice infestation of at least 10 lice and viable nits
Agree not used any other pediculicides or medicated products during the study
Agree not to use a nit comb during the study
Must have a single place of residence

Exclusion Criteria:

Used any form of head lice treatment, prescription, OTC or home remedy for at least four weeks prior to their visit

Used topical medication of any kind on the hair for a period of 48 hours prior to visit
Individuals receiving systemic, topical drugs or medications which may interfere with the study results
Has a history of allergy or hypersensitivity to ragweed or any ingredient in either test products
Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with the evaluation
Females who are pregnant or nursing
Intervention: Clopidogrel
Trial phase: Phase 3
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 664
Group description: standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
Eligibility criteria:
Inclusion Criteria:

all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria:

pregnancy