anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Atorvastatin
Trial phase: Not Applicable
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 506
Group description: Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.

(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)
Eligibility criteria:
Inclusion Criteria:

Hypercholesterolemia patients

• Patients who have not achieved the target control levels of LDL-C in the "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007"

Type 2 diabetes patients

Patients diagnosed with type 2 diabetes and receiving diet therapy, exercise therapy, or medication
Patients who received constant therapy for three months before registration and have no plan for therapy change
Patients with kept HbA1c level (Japan Diabetes Society [JDS] level) of less than 7.0% (or, National Glycohemoglobin Standardization Program [NGSP] level of less than 7.4%) within three months before registration
Patients receiving or not receiving medication at present
Patients giving voluntary written consent to participate in the study
Male or female patients at 20 years or older

Exclusion Criteria:

Patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration
Patients with severe hypertension (systolic blood pressure [SBP] ≥ 180 mmHg or diastolic blood pressure [DBP] ≥ 110 mmHg)
Patients with type 1 diabetes
Patients judged to have familial hypercholesterolemia
Patients with a serum triglyceride level of ≥ 400 mg/dL
Patients who had the onset of cardiovascular or cerebrovascular disease within three months
Patients with serious heart failure (NYHA classification III - IV)
Patients with a history of hypersensitivity to statins
Patients with a history of drug-induced myopathy
Patients with severe complication of diabetes
Patients receiving insulin
Patients with serious liver or kidney disease
Patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan
Patients who are or may be pregnant
Patients judged by the investigators to be ineligible for participation in the study for any other reason
Intervention: Rosuvastatin
Trial phase: Not Applicable
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 516
Group description: Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.

(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Eligibility criteria:
Inclusion Criteria:

Hypercholesterolemia patients

• Patients who have not achieved the target control levels of LDL-C in the "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007"

Type 2 diabetes patients

Patients diagnosed with type 2 diabetes and receiving diet therapy, exercise therapy, or medication
Patients who received constant therapy for three months before registration and have no plan for therapy change
Patients with kept HbA1c level (Japan Diabetes Society [JDS] level) of less than 7.0% (or, National Glycohemoglobin Standardization Program [NGSP] level of less than 7.4%) within three months before registration
Patients receiving or not receiving medication at present
Patients giving voluntary written consent to participate in the study
Male or female patients at 20 years or older

Exclusion Criteria:

Patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration
Patients with severe hypertension (systolic blood pressure [SBP] ≥ 180 mmHg or diastolic blood pressure [DBP] ≥ 110 mmHg)
Patients with type 1 diabetes
Patients judged to have familial hypercholesterolemia
Patients with a serum triglyceride level of ≥ 400 mg/dL
Patients who had the onset of cardiovascular or cerebrovascular disease within three months
Patients with serious heart failure (NYHA classification III - IV)
Patients with a history of hypersensitivity to statins
Patients with a history of drug-induced myopathy
Patients with severe complication of diabetes
Patients receiving insulin
Patients with serious liver or kidney disease
Patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan
Patients who are or may be pregnant
Patients judged by the investigators to be ineligible for participation in the study for any other reason
Intervention: Estradiol
Trial phase: Phase 2
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: IVIG

IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover

No AE's.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of uncontrolled epilepsy with at least two seizures a month for three consecutive months.
Age 18 to 50.
Clinical semiology or electroencephalogram (EEG) consistent with partial onset epilepsy.
Refractory to an adequate trial of two or more main-line anti-epileptic drugs.
Ability to keep a seizure diary.
Normal brain magnetic resonance imaging (MRI) - 3 Tesla, seizure protocol; with the exception of hippocampal sclerosis

Exclusion Criteria:

History of severe prematurity or neonatal distress, febrile seizures, moderate or sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis, neurocutaneous syndromes, or intracranial metal objects.
Evidence of psychogenic epilepsy.
History of convulsive status epilepticus.
History of primary generalized epilepsy in a first degree relative.
Known serious medical illness.
Intervention: Betamethasone
Trial phase: Phase 4
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: Accepts Healthy Volunteers
Participants at risk: 20
Group description: This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.

Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration).
Eligibility criteria:
Inclusion Criteria:

The patients of Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:

Presence of visually significant cataract requiring surgery (any grade)
Patients with Non-proliferative Diabetic Retinopathy (NPDR) with/without clinically significant macular edema (CSME)
Patients with Proliferative Diabetic Retinopathy (PDR) with/without CSME where proliferative component has been adequately treated with laser photocoagulation.

All patients fulfilling criteria 1 with 2 or 3 shall be enrolled in the study. The patients of either sex up to the age of 60 years would be included for the study.

Exclusion Criteria:

The following would be the exclusion criteria:

Presence of untreated proliferative diabetic retinopathy
Patients with history of ocular hypertension or glaucoma
Presence of associated conditions that may exacerbate macular edema, i.e. uveitis, retinal vein occlusions, neovascular glaucoma
History of use of drugs such as prostaglandin analogues, adrenaline or nicotinic acid
Patients with post-operative media haze or pupillary non-dilation that does not allow good fundus photography, Fundus Fluorescein Angiography (FFA) and Optical Coherence Tomography (OCT).
Patients who develop any intraoperative complication including posterior capsular rent, vitreous loss, zonular dehiscence, etc shall be excluded from the study in both the groups
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively

Gapabentin: 400mg orally at 9pm day of surgery and the first evening post operatively.
Eligibility criteria:
Inclusion Criteria:

Undergoing a hip arthroplasty, total knee arthroplasty, hip fracture repair American Society of Anesthesiologist rating I-III as determined by your anesthesiologist

Exclusion Criteria:

Pregnancy and breast feeding

An allergy to any of the drugs to be used in the study (midazolam, Celecoxib, gabapentin, hydromorphone, bupivacaine)
History of a sleep disorder (Obstructive sleep apnea or daytime somnolence)
History of taking chronic narcotic pain medications or gabapentin
History of rheumatoid arthritis, a psychiatric disorder, or diabetes with impaired renal function
History of alcohol or illicit drug abuse.
History of a kidney or liver problem.
Inability or unwilling to use patient-controlled analgesia.
Unable to meet the criteria for removal of the endotracheal tube in the Operating Room
History of asthma, hives or an allergic type reaction following an aspirin or other NSAIDS drug such as Ibuprofen.
History of stroke or heart attack or thrombotic event within the past 3 months
Lactose intolerance
History of cardiac surgery
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1 | Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 65
Group description: Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
Eligibility criteria:
Inclusion Criteria:

Patient scheduled to undergo elective complete colonoscopy as an outpatient.
Aged 18 or older.
The patient gives written informed consent and can understand the information given.
The patient can participate in the study only once.

Exclusion Criteria:

Sodium chloride sensitivity.
Limitation to exercise.
Earlier resection of the large bowel or rectum.
Known active colitis.
Ileus or gastrointestinal obstruction.
Intervention: Bisacodyl
Trial phase: Phase 1 | Phase 2
ATC code: A06AB02 | A06AB52 | A06AG02
SMILES: CC(=O)Oc1ccc(C(c2ccc(OC(C)=O)cc2)c2ccccn2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 68
Group description: Patients followed the preparation method according to the manufacturer's standard instructions.
Eligibility criteria:
Inclusion Criteria:

Patient scheduled to undergo elective complete colonoscopy as an outpatient.
Aged 18 or older.
The patient gives written informed consent and can understand the information given.
The patient can participate in the study only once.

Exclusion Criteria:

Sodium chloride sensitivity.
Limitation to exercise.
Earlier resection of the large bowel or rectum.
Known active colitis.
Ileus or gastrointestinal obstruction.
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: 81mg, 1 capsule orally daily
Eligibility criteria:
Inclusion Criteria:

Singleton pregnancy undergoing ultrasound examination at 9 0/7 - 14 6/7 weeks
any one or more factors identified as high risk from the identified risk factors: Chronic hypertension, prepregnancy diabetes mellitus, previous preeclampsia, obesity (BMI >30), bilateral uterine artery notches preeclampsia risk score greater than 6, low PAPP-A ( < 0.52 MoM)

Exclusion Criteria:

Multiple gestations,
fetal aneuploidy
major fetal structural anomaly
bleeding disorder
allergy to aspirin
women already on aspirin or heparin.
Intervention: Mifepristone
Trial phase: Phase 2
ATC code: G03XB01 | G03XB51
SMILES: [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Korlym (mifepristone): 600 mg/day, oral pill, 7 days
Eligibility criteria:
Inclusion Criteria:

Male or female volunteers, 18-65 years of age
Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Addition (DSM-IV) criteria for current alcohol dependence
Subjects will not be seeking treatment because the medication studies are not treatment trials
Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
Negative Breath Alcohol Concentration (BAC) and a Clinical Institute Withdrawal Assessment-Alcohol (CIWA-A) score of < 8 at screening and time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures
Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent

Exclusion Criteria:

Significant medical disorders that will increase potential risk or interfere with study participation as determined by the Study Physician
Female subjects with childbearing potential who are pregnant, nursing, or refuse to use double barrier (non-hormonal) methods of birth control for the duration of the study and one month thereafter
Meets DSM-IV criteria for a major Axis I disorder including mood or anxiety disorders or substance dependence disorders other than alcohol or nicotine dependence
History of allergy or hypersensitivity to the study drugs or the ingredients
Treatment within the month prior to screening with 1.) an investigational drug or vaccine; 2.) drugs that may influence study outcomes, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), anticonvulsants, antidepressants.
In need of or currently taking any psychoactive medications.
Intervention: Morphine
Trial phase: Phase 3
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.

The abscess I&D will be followed according to protocol using topical and local anesthetic.

Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose
Eligibility criteria:
Inclusion Criteria:

Patient is 4 years of age up to their 18th birthday
Patient has a cutaneous abscess for which an I&D is to be performed

Exclusion Criteria:

Patient's parent doesn't speak English or Spanish
Patient has developmental delay or neurological impairment
Patient has altered mental status
Known hypersensitivity to study drugs (fentanyl, morphine sulfate, lidocaine, LMX4®)
The presence of significant blood or mucous in the nares despite blowing nose or suctioning
Severe renal or liver dysfunction, signs of respiratory distress or depression, any respiratory distress, chronic and severe asthma, upper airway obstruction, suspected gastrointestinal obstruction, suspected paralytic ileus
Narcotic analgesia within 4 hours of ED physician evaluation
Need for moderate sedation, deep sedation, or general anesthesia
Need for subspecialty consultation to perform the I&D
Need for I&D of more than 1 skin abscess
Cutaneous abscesses located on the genitals, breasts, face, or neck
Previous enrollment in the study
Patients with chronic pain syndromes (sickle cell disease, cancer, arthritis, inflammatory bowel disease)
Intervention: Daptomycin
Trial phase: Phase 4
ATC code: J01XX09
SMILES: CCCCCCCCCC(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC1C(=O)NCC(=O)NC(CCCN)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NCC(=O)NC(CO)C(=O)NC(C(C)CC(=O)O)C(=O)NC(CC(=O)c2ccccc2N)C(=O)OC1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol

Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.
Eligibility criteria:
Inclusion Criteria:

Admitted to RDTC to the Cellulitis Protocol
18 yrs old or greater
Able and willing to give informed consent
Hemodynamically stable (systolic blood pressure >90mmHg and heart rate <120 beats per minute)

Exclusion Criteria:

Antibiotics given prior to enrollment
Suspected necrotizing infection
Diabetic foot ulcer
Genitourinary involvement
Post operative infection (not including simple wound closure infection)
Suspected gouty or septic arthritis
Chronic Lymphangitis
Requiring routine hemodialysis
Patient reported allergy to Vancomycin
Patient reported allergy to Daptomycin
Participation in another investigational treatment study within 30 days prior to enrollment
Prisoner
Pregnant or breast-feeding
Complicated skin and skin structure infection of the face
Intervention: Vancomycin
Trial phase: Phase 4
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.

Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
Eligibility criteria:
Inclusion Criteria:

Admitted to RDTC to the Cellulitis Protocol
18 yrs old or greater
Able and willing to give informed consent
Hemodynamically stable (systolic blood pressure >90mmHg and heart rate <120 beats per minute)

Exclusion Criteria:

Antibiotics given prior to enrollment
Suspected necrotizing infection
Diabetic foot ulcer
Genitourinary involvement
Post operative infection (not including simple wound closure infection)
Suspected gouty or septic arthritis
Chronic Lymphangitis
Requiring routine hemodialysis
Patient reported allergy to Vancomycin
Patient reported allergy to Daptomycin
Participation in another investigational treatment study within 30 days prior to enrollment
Prisoner
Pregnant or breast-feeding
Complicated skin and skin structure infection of the face
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: propofol: Propofol adjusted to maintain the bispectral index at 40-60.
Eligibility criteria:
Inclusion Criteria:

Patients with idiopathic scoliosis.

Exclusion Criteria:

Patients with neuromuscular scoliosis.
Intervention: Desflurane
Trial phase: Not Applicable
ATC code: N01AB07
SMILES: FC(F)OC(F)C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
Eligibility criteria:
Inclusion Criteria:

Patients with idiopathic scoliosis.

Exclusion Criteria:

Patients with neuromuscular scoliosis.
Intervention: Buprenorphine Hydrochloride
Trial phase: Not Applicable
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Eligibility criteria:
Inclusion Criteria:

HIV+
Age ≥18 yrs
Meets DSM-IV criteria for opioid dependence
Has medical entitlements in DC
Able to provide informed consent
Able to communicate in English or Spanish

Exclusion Criteria:

Being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition
Currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine
AST and ALT >5x the upper limit of normal (AST≥175, ALT≥195)
Pregnant or unwilling to use contraception (including OCPs, patch, Depo-Provera, condoms, etc.)
Breastfeeding or unwilling to stop breastfeeding
Subject is part of another pharmacological research study
Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction)
Suicidal ideation
Hypersensitivity to buprenorphine