anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pioglitazone
Trial phase: Not Applicable
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: 15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks

Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
Eligibility criteria:
Inclusion Criteria:

Overweight (Body Mass Index ≥ 25 kilograms per meter squared (kg/m2))
Adult (18 years or older)
Chronic hemodialysis patient
Diabetic (type 2) or insulin resistant

Exclusion Criteria:

<18 years old
No insulin resistance
Active liver disease
Class III or IV New York Heart Association heart failure
Macular edema or hard exudates near macula on fundoscopy
Current active malignancy (excluding squamous and basal cell skin cancers)
Active AIDS
Chronic lung disease requiring supplemental oxygen therapy
Enrolled in interventional trials using drugs or devices
Bone break of long bones, vertebrae, or hips in the past three years
Intervention: Pitavastatin
Trial phase: Phase 4
ATC code: C10AA08
SMILES: O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Pitavastatin: Pitavastatin 4 mg QD
Eligibility criteria:
Inclusion Criteria:

Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.
Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception
Documented HIV infection.

Exclusion Criteria:

Homozygous familial hypercholesterolemia
Any conditions that may cause secondary dyslipidemia
History of coronary artery disease (CAD) or CAD equivalent
Intervention: Pravastatin
Trial phase: Phase 4
ATC code: C10AA03 | C10BA03 | C10BA11 | C10BA12 | C10BX02
SMILES: [H][C@@]12C(=C[C@@H](O)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Pravastatin: Pravastatin 40 mg QD
Eligibility criteria:
Inclusion Criteria:

Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.
Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception
Documented HIV infection.

Exclusion Criteria:

Homozygous familial hypercholesterolemia
Any conditions that may cause secondary dyslipidemia
History of coronary artery disease (CAD) or CAD equivalent
Intervention: Ketamine
Trial phase: Phase 3
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.

The patients in group ketamine received remifentanil (0.4 μg/kg/min) and (ketamine 5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.
Eligibility criteria:
Inclusion Criteria:

≥ 18 years old
both sexes
ASA physical status I or II
undergoing laparoscopic cholecystectomy

Exclusion Criteria:

chronic users of analgesics or had used opioids within 12 h of surgery
history of drug or alcohol abuse or psychiatric disorder
contraindications to self-administration of opioids (ie, unable to understand the patient-controlled analgesia [PCA] device)
contraindication for the use of ketamine, such as a psychiatric disorder, acute cardiovascular disorder, or unstable hypertension
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.

The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.
Eligibility criteria:
Inclusion Criteria:

≥ 18 years old
both sexes
ASA physical status I or II
undergoing laparoscopic cholecystectomy

Exclusion Criteria:

chronic users of analgesics or had used opioids within 12 h of surgery
history of drug or alcohol abuse or psychiatric disorder
contraindications to self-administration of opioids (ie, unable to understand the patient-controlled analgesia [PCA] device)
contraindication for the use of ketamine, such as a psychiatric disorder, acute cardiovascular disorder, or unstable hypertension
Intervention: Teneligliptin
Trial phase: Phase 3
ATC code: A10BH08
SMILES: [H][C@@]1(N2CCN(c3cc(C)nn3-c3ccccc3)CC2)CN[C@]([H])(C(=O)N2CCSC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 212
Group description: teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
Eligibility criteria:
Inclusion Criteria:

Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Patients whose HbA1c is between 6.5% - 10.0%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Exclusion Criteria:

Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients who are accepting treatments of arrhythmias
Patients with serious diabetic complications
Patients who are habitual excessive alcohol consumption.
Patients with severe hepatic disorder or severe renal disorder.
Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Intervention: Fesoterodine Fumarate
Trial phase: Phase 4
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1C(CCN(C(C)C)C(C)C)c1ccccc1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 308
Group description: Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of overactive bladder with symptoms for at least 6 months.
Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine
Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception

Exclusion Criteria:

Conditions or prior treatment that may also affect bladder function
Clinically significant urinary tract infection (UTI)
Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).
Intervention: Lidocaine
Trial phase: Phase 2
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: 2% lidocaine HCL with 1:100,000 epinephrine
Eligibility criteria:
Inclusion Criteria:

Male or female between 18 and 65 years of age
Sufficiently healthy as determined by the investigator to receive the test and control medications and undergo the scheduled dental procedure
Required an operative restorative procedure on a single maxillary tooth, other than a maxillary second or third molar, with treatment time not expected to exceed 60 minutes
Could breathe through both nostrils
Had normal lip, nose, eyelid, and cheek sensations
Could understand and sign the informed consent document
Could communicate with the investigator
Could understand and comply with the requirements of the protocol

Exclusion Criteria:

Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, musculoskeletal, neurologic, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of angle-closure glaucoma
Clinically relevant sinus/nasal surgical history
Baseline Visual Analog Scale value of > 36 (or greater than weak) at the treatment site
Had not had dental work requiring a local anesthetic within the last 24 hours or had taken pain medications within the last 48 hours
Required prophylactic antibiotics for subacute bacterial endocarditis (infectious endocarditis)
Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or p-aminobenzoic acid (PABA), as found in PABA-containing sunscreens
Allergic to or intolerant of oxymetazoline, epinephrine, or preservatives in their solutions
Had a current condition, such as nasal congestion or sinus infection, that may have influenced responses to study medications
History of alcoholism and/or drug abuse
Had taken a monamine oxidase inhibitor within the past 3 weeks
Were nursing, pregnant, suspected of being pregnant, or trying to become pregnant (females were required to take a urine pregnancy test to rule out pregnancy)
Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline
Intervention: Betamethasone
Trial phase: Not Applicable
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: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.

Dexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.
Eligibility criteria:
Inclusion Criteria:

Male patients, between ages 18-85 years old, undergoing Robot-assisted laparoscopic prostatectomy by a single surgeon at a single hospital.
Subjects are physically and mentally able to participate in the study.
Subjects are able to give fully informed consent to participating in this study after demonstrating good understanding of the risks and benefits of the proposed components of the TAP block.

Exclusion Criteria:

Demonstrated hypersensitivity or allergy to local anesthetics or dexamethasone.
Any subject whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful performance of a TAP block.
Any subject, who in the opinion of the investigator, might be harmed or be a poor candidate for participation in the study.
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: 1 ml subcutaneous injection 0.9% sodium chloride, given once
Eligibility criteria:
Inclusion Criteria:

patients at MGH Center for Pain Medicine who have clinical indication for undergoing diagnostic medial branch block of nerves to facet joints.

Exclusion Criteria:

contraindication to the clinical procedure
do not speak English
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: 1 ml subcutaneous injection of 0.9% lidocaine, given once
Eligibility criteria:
Inclusion Criteria:

patients at MGH Center for Pain Medicine who have clinical indication for undergoing diagnostic medial branch block of nerves to facet joints.

Exclusion Criteria:

contraindication to the clinical procedure
do not speak English
Intervention: FLUOCINOLONE ACETONIDE
Trial phase: Phase 3
ATC code: C05AA10 | D07AC04 | D07BC02 | D07CC02 | S01BA15 | S01CA10 | S02BA08 | S02CA05
SMILES: [H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)CO)[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: 120
Group description: Fluocinolone Acetonide: 0.2 μg/day
Eligibility criteria:
Inclusion Criteria:

Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies.
In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN.
Ability and willingness to comply with the treatment and follow up procedures.
Ability to understand and sign the Informed Consent Form. No expectation that subject will be moving out of the area of the clinical center to an area not covered by another clinical center during the next 12 months.

Exclusion Criteria:

Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD)
Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye
Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (e.g., presumed ocular histoplasmosis, high myopia (spherical equivalent > 8 diopters), macular degeneration)
Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (e.g., ocular herpes simplex virus)
Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids
History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure
History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up
Any lens opacity which significantly impairs vision, in the opinion of the investigator.
Peripheral retinal detachment in prospective area of insertion
Participation in another clinical trial within 12 weeks before the screening visit or during the study
Intervention: Modafinil
Trial phase: Phase 3
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 200
Group description: Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
Eligibility criteria:
Inclusion Criteria:

The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.
Documentation that the patient has had at least 1 previous manic or mixed episode.
The patient has had no more than 6 mood episodes in the last year.
The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.

The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:

The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician.
The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period.
The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.

Exclusion Criteria:

The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.
Intervention: Injectafer
Trial phase: Phase 2
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
Eligibility criteria:
Inclusion Criteria:

Female subjects > or = to 18 years of age
History of Heavy Uterine Bleeding within the past 6 months
Screening visit central laboratory Hgb < 12 g/dL
Screening Visit ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation (TSAT) is < or = to 30%
Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments

Exclusion Criteria:

Known hypersensitivity reaction to any component of ferric carboxymaltose or iron dextran
Previously randomized in a clinical study of ferric carboxymaltose
Requires dialysis for treatment of chronic kidney disease
Chronic kidney disease, marked by estimated glomerular filtration rate < 60 ml/min/1.73m squared
Previous kidney transplant
History of primary hypophosphatemic disorder
Hypophosphatemia < 2.6 mg/dl
No evidence of iron deficiency
During the 10 day period prior to screening has been treated with intravenous iron
During the 30 day period prior to screening or during the study period has or will be treated with erythropoiesis stimulating agents (ESA) in a regimen that is off label
During the 30 day period prior to screening or during the study period has or will be treated with a red blood cell transfusion, radiotherapy and/or chemotherapy
During the 30 day period prior to screening or during the study period has or will require a surgical procedure that necessitates general anesthesia
Any non-viral infection
Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) at screening, as determined by central labs, greater than 1.5 times the upper limit of normal
Known positive hepatitis with evidence of active disease
Received an investigational drug within 30 days of screening
Alcohol or drug abuse within the past 6 months
Hemochromatosis or other iron storage disorders
Malignancy history within the past 5 years other than basal or squamous cell skin cancer
Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
Untreated primary hyperparathyroidism
Untreated gastrointestinal malabsorption (e.g., sprue)
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Phase 3
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 715
Group description: Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects 6 to 11 years of age, as of the Screening Visit (SV)
A documented history of SAR to a relevant seasonal allergen (tree/grass pollen) for a minimum of two years immediately preceding the study Screening Visit (SV).
A demonstrated sensitivity to at least one seasonal allergen (tree/grass pollen) known to induce SAR through a standard skin prick test.
Other criteria apply

Exclusion Criteria:

History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa (all within the last 60 days prior to the Screening Visit [SV])
History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, chronic sinusitis or influenza,) within the 14 days preceding the Screening Visit (SV), or development of a respiratory infection during the Run-in Period.
Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene antagonists). History of intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable
Have any conditions that are judged by the investigator to be clinically significant and/or affect the subject's ability to participate in the clinical trial
Other criteria apply