anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lipsovir
Trial phase: Phase 3
SMILES: CC12CCC(=O)C=C1CCC1C2C(O)CC2(C)C1CCC2(O)C(=O)CO.Nc1nc2c(ncn2COCCO)c(=O)[nH]1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 54
Group description: commercial product being used

acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days
Eligibility criteria:
Inclusion Criteria:

Male or female, age 6-11 years at time of enrollment
General good health, as judged by the Investigator
History of recurrent herpes labialis with at least two (2) recurrences during the last twelve (12) months, as based on interview with the subject or subject's caregiver
Agreement to refrain from using other topical medical, over-the counter (OTC), or cosmetic products in or around the oral area during the herpes recurrence
Agreement to refrain from mechanical disruption of the area affected by herpes labialis during the study recurrence
Subjects and their legally acceptable representative(s) must voluntarily sign and date the informed assent (subject) and consent (legally authorized representative).
Willingness to comply with all requirements of the study.

Exclusion Criteria:

Any evidence of an immunosuppressed state of the subject due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy)
Significant skin conditions that occur in the area typically affected by herpes recurrences, and that would interfere with assessment of lesions such as atopic dermatitis, acne, eczema, psoriasis or chronic vesiculobullous disorders
Administration of an investigational drug or within 30 days prior to inclusion, or concurrent participation in another research study
Administration of an immunomodulatory agent within the past 30 days
History of immediate hypersensitivity or serum sickness reaction to any nucleoside analog antiviral agent, or to any topical steroid, or to the vehicle
Clinically relevant abnormal physical findings at screening which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures Nursing or pregnant (Pubescent females require pregnancy testing)
Intervention: Champix
Trial phase: Phase 4
SMILES: O=C(O)C(O)C(O)C(=O)O.c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1192
Group description: This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
Eligibility criteria:
Inclusion Criteria:

Subjects will be eligible if they were randomized to study A3051123.

Exclusion Criteria:

Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
Intervention: Bupivacaine
Trial phase: Phase 2
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.

Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon.
Eligibility criteria:
Inclusion Criteria:

ASA physical status I or II
Patients > 4 years of age
Weight less than or equal to 60 kg
Presenting for laparoscopic appendectomy

Exclusion Criteria:

ASA physical status > II
Patients < 4 years of age
Weight greater than 60 kg
Patients presenting for ruptured appendectomy surgical procedures
Co-morbid diseases (cardiac, pulmonary (not including asthma), neurological disease)
Patients having concomitant procedures (circumcision, orchiopexy, etc.)
Intervention: Ropivacaine
Trial phase: Phase 2
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Patients will receive a transversus abdominis plane (TAP) block.

Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally
Eligibility criteria:
Inclusion Criteria:

ASA physical status I or II
Patients > 4 years of age
Weight less than or equal to 60 kg
Presenting for laparoscopic appendectomy

Exclusion Criteria:

ASA physical status > II
Patients < 4 years of age
Weight greater than 60 kg
Patients presenting for ruptured appendectomy surgical procedures
Co-morbid diseases (cardiac, pulmonary (not including asthma), neurological disease)
Patients having concomitant procedures (circumcision, orchiopexy, etc.)
Intervention: OXYTOCIN
Trial phase: Not Applicable
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 144
Group description: Participants will be administered 40 IUs of oxytocin nasal spray at one study visit.

Oxytocin: 40 IUs of oxytocin administered intranasally one time
Eligibility criteria:
Inclusion Criteria:

Females and males age 18 - 45 who smoke at least an average of 5 cigarettes per day for at least past 6 months
Females must be post menarche and pre-menopausal, have a regular menstrual cycle between 25 and 35 days, and, if recently pregnant, be at least three months post-delivery/breast feeding
Participants must submit a carbon monoxide sample of ≥ 5 ppm at their screening visit

Exclusion Criteria:

Any serious or unstable medical or psychiatric disorder that may, in the judgment of the study physician, interfere with study completion
Participants must not meet criteria for PTSD
Any medication (e.g., propranolol) that may interfere with psychophysiological (e.g., heart rate) monitoring
Current substance dependence other than nicotine and caffeine use, in the past month
Use of other tobacco products
Females must not be pregnant, breast feeding, status post hysterectomy or bilateral oophorectomy, or taking birth control or hormone replacement medication that would affect the menstrual cycle
Males must not be status post orchiectomy
Intervention: Bromfenac
Trial phase: Phase 3
ATC code: S01BC11
SMILES: Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 169
Group description: 0.075% bromfenac in DuraSite dosed BID
Eligibility criteria:
Inclusion Criteria:

Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
Signature of the subject on the Informed Consent Form
Willing to avoid disallowed medication for the duration of the study.
Willing and able to follow all instructions and attend all study visits
Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
Additional inclusion criteria also apply

Exclusion Criteria:

Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
Currently suffer from alcohol and/or drug abuse
Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Additional exclusion criteria also apply
Intervention: FLUTICASONE PROPIONATE
Trial phase: Phase 2
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 154
Group description: Nasal Spray

Fluticasone propionate: Nasal Spray
Eligibility criteria:
Inclusion Criteria:

Male or female at least 12 years of age with a demonstrated history of Mountain Cedar pollen allergy

Exclusion Criteria:

No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Intervention: Methylprednisolone
Trial phase: Not Applicable
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 81
Group description: Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.

Methylprednisolone: Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.
Eligibility criteria:
Inclusion Criteria:

Age < 1 month
Male and female patients who are scheduled to undergo cardiac surgery involving CPB

Exclusion Criteria:

Prematurity: < 37 weeks post gestational age at time of surgery
Treatment with intravenous steroids within the two days prior to scheduled surgery.
Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization.
Suspected infection that would contraindicate steroid use (eg - Herpes)
Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (eg - gastrointestinal bleeding).
Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization.
Intervention: Phenylephrine and ketorolac injection
Trial phase: Phase 3
SMILES: CNCC(O)c1cccc(O)c1.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 202
Group description: OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.

OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle.
Eligibility criteria:
Inclusion Criteria:

Competent and willing to voluntarily provide informed consent
18 years of age or older
In good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia

Exclusion Criteria:

No allergies to the medications and/or the active ingredients of any of the study medications
No medications with the same activities of the active ingredients in OMS302 for defined time intervals prior to and after surgery
No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
Intervention: Aprepitant
Trial phase: Not Applicable
ATC code: A04AD12
SMILES: C[C@@H](O[C@H]1OCCN(Cc2n[nH]c(=O)[nH]2)[C@H]1c1ccc(F)cc1)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Capsule filled with 125 mg of aprepitant
Eligibility criteria:
Inclusion Criteria:

50 years of age or older
diagnosis of COPD
former smoker > 10 pack-years
clinical diagnosis of chronic bronchitis
post-bronchodilator forced expiratory volume in one second (FEV1) 30 - 80% predicted
FEV1/forced vital capacity ratio less than or equal to 70%

Exclusion Criteria:

current smoker
pregnant women
concomitant disease that might interfere with study procedures
peripheral vascular disease or cold hypersensitivity
drugs that might interfere with aprepitant
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2 | Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Loculated pleural effusion infused with normal saline twice a day for three days.
Eligibility criteria:
Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Age > 18 years
Adult, non-gravid patients with malignancy and symptomatic loculated pleural effusion who has undergone percutaneous drainage will be eligible to participate. A loculated effusion is defined as an effusion whose contents cannot be completely drained at the time of initial catheter placement as documented by the initial imaging guided procedure or within 48 hours of catheter placement by chest radiography. Malignant cells need not be found within the pleural fluid.

Exclusion Criteria:

Active internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
History of stroke within 3 months
Intracranial neoplasm, arteriovenous malformation, or aneurysm.
Uncorrectable bleeding diathesis (INR > 1.5 despite therapy)
Recent intracranial or intraspinal surgery or trauma
Pregnancy (positive pregnancy test)
Severe uncontrolled hypertension
Documented empyema
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Participation in another simultaneous medical investigation or trial
Participation in another clinical investigation within previous 30 days of catheter placement
Prior enrollment in the study
Known allergy to TNK or any of its components
Intervention: Ethanol
Trial phase: Phase 2 | Phase 3
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Loculated pleural effusion infused with TNK twice a day for three days.
Eligibility criteria:
Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Age > 18 years
Adult, non-gravid patients with malignancy and symptomatic loculated pleural effusion who has undergone percutaneous drainage will be eligible to participate. A loculated effusion is defined as an effusion whose contents cannot be completely drained at the time of initial catheter placement as documented by the initial imaging guided procedure or within 48 hours of catheter placement by chest radiography. Malignant cells need not be found within the pleural fluid.

Exclusion Criteria:

Active internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
History of stroke within 3 months
Intracranial neoplasm, arteriovenous malformation, or aneurysm.
Uncorrectable bleeding diathesis (INR > 1.5 despite therapy)
Recent intracranial or intraspinal surgery or trauma
Pregnancy (positive pregnancy test)
Severe uncontrolled hypertension
Documented empyema
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Participation in another simultaneous medical investigation or trial
Participation in another clinical investigation within previous 30 days of catheter placement
Prior enrollment in the study
Known allergy to TNK or any of its components
Intervention: Acipimox
Trial phase: Not Applicable
ATC code: C10AD06
SMILES: Cc1cnc(C(=O)O)c[n+]1[O-]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visi

Acipimox: Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
Eligibility criteria:
Inclusion Criteria:

Sedentary adults not participating in a regular exercise program (≤ one bout of scheduled exercise per week)
Subjects must have Type 2 Diabetes
Subjects must be otherwise healthy
Ages of 30-60 years
BMI of 25-39 and stable weight for 3 months prior to the start of the study
Diabetes controlled by diet +/- insulin secretagogues (sulfonylureas or glinides), metformin, or glucose absorption blockers (acarbose).
Total glycosylated hemoglobin levels (HbA1C) ≤9% (fair control) on current therapy.

Exclusion Criteria:

Any comorbid condition which could limit exercise performance including Chronic Obstructive Pulmonary Disease (COPD) or asthma
Concurrent enrollment in an interventional study.
Any tobacco use either current or within the last year
Clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded.
Autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded.
Evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (EKG) (> 1 mm ST segment depression) on screening exercise test.
Angina or any other cardiovascular, pulmonary or musculoskeletal symptoms
Presence of systolic blood pressure >190 at rest or >250 with exercise or diastolic pressure >95 at rest or >105 with exercise
Proteinuria (urine protein >200 mg/dl) or a creatinine > 2 mg/dl, suggestive of severe renal disease
Proliferative retinopathy
Insulin, incretin, or glitazone treatment
Niacin treatment
History of peptic ulcers
A history of hereditary angioedema
C1 esterase deficiency
Women who are pregnant or breastfeeding
Use of fibrate drugs
Intervention: VALACYCLOVIR
Trial phase: Phase 2
ATC code: J05AB11
SMILES: CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Valacyclovir 500 mg po bid

Valacyclovir: Valacyclovir 500 mg po bid
Eligibility criteria:
Inclusion Criteria:

Chronic hepatitis C infection with a detectable HCV RNA in the serum on two occasions, 6 months apart
Focus HSV-2 IgG negative and Focus HSV-1 IgG positive, using manufacturer's cut-offs

Exclusion Criteria:

Antiherpes or immunomodulatory therapy during the past 30 days,
HIV or chronic hepatitis B infection,
Decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy, jaundice/icterus),
Creatinine clearance <50 ml/min.,
Female subject who is pregnant or nursing,
Gastrointestinal disorder which might result in malabsorption of valacyclovir,
History of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic uremic syndrome,
Allergy to valacyclovir or related drug.
Intervention: Vildagliptin
Trial phase: Phase 4
ATC code: A10BD08 | A10BH02
SMILES: N#C[C@@H]1CCCN1C(=O)CNC12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Eligibility criteria:
Inclusion criteria

Outpatients who were 20 years of age and older with diagnosis of T2DM.
Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
Understood the nature of the study, and had signed informed consent form.

Exclusion criteria

Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
Patients with renal dysfunction defined as creatinine clearance < 60 ml/min at Visit 1.
Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT > 3 ULN at Visit 1.
Female patients who needed to lactate during the study.
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks

Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
Eligibility criteria:
Inclusion Criteria:

Outpatients with severe treatment-resistant MDD
Currently depressed
Currently under regular psychiatric care
On an aggressive antidepressant regimen, stable for 4 weeks

Exclusion Criteria:

No history of other major psychiatric illnesses, including bipolar disorder
No history of psychosis
No history of drug abuse
No major medical illness or unstable medical conditions
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine
Eligibility criteria:
Inclusion Criteria:

Scheduled to undergo mid-urethral sling for incontinence without concomitant procedures

Exclusion Criteria:

Undergoing procedure in addition to the sling
Not competent to give consent
Using intermittent self catheterization pre-operatively
Known allergy to local anesthetic
Undergoing spinal anesthesia for the procedure
Prisoners
Non-English speaker
Under 18 years of age
Has a condition that would contra-indicate the use of local anesthetic or epinephrine
Intervention: Buprenorphine
Trial phase: Not Applicable
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block

Buprenorphine: added to nerve block, 0.3mg one time peripheral block use
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status 1-3
Age 18-79, inclusive
BMI <36 kg/m^2
Patient consenting to single injection brachial plexus nerve block as primary anesthetic for a procedure

Exclusion Criteria:

Patients with coagulation disorders
Clinically significant pulmonary disease
Clinically significant cardiac disease
Neurologic deficit in surgical extremity
Allergy to bupivacaine or buprenorphine
Intolerance of narcotics
Local infection over intended area of needle insertion
Hepatic failure or renal failure
Significant psychiatric disease, including drug abuse
Seizure disorder
Possible pregnancy or lactation by patient report
Use of narcotic medication greater than 2 times a week for greater than 1 week.
Patients for whom the surgeon requests a shorter-acting block