anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Asenapine Maleate
Trial phase: Phase 4
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability

Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID
Eligibility criteria:
Inclusion Criteria:

-130 male or female patients, 18-65 years of age, with:

DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI)
MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and randomization
Inadequate therapeutic response during their current depressive episode; an inadequate therapeutic response will be defined as continued depressive psychopathology (see criterion 2) following > six weeks of therapy at adequate doses (according to the US label) of any non-tricyclic, non-MAOI antidepressant medication

Exclusion Criteria:

Additional DSM-IV Axis I diagnoses other than Generalized Anxiety Disorder, Panic Disorder with or without Agoraphobia, or Social Phobia within 6 months prior to enrollment
DSM-IV Axis II diagnoses that significantly impact the current psychiatric status
Current MDD episode lasting > 12 months
Electroconvulsive therapy within the preceding 6 months
Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment
Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE <24)
Risk of suicide as defined by MADRS item 10 score > 4
Prior failure to respond to asenapine
Pregnancy or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline
Hepatic impairment and history of low WBC, by medical history and interview.
Intervention: Prednisone
Trial phase: Not Applicable
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.

Prednisone: See "Prednisone" arm description
Eligibility criteria:
Inclusion Criteria:

Age 18 to 70 years

Current episode of cellulitis

Erythema greater than 5 centimeters in any dimension
Pain, swelling, warmth, and tenderness in the area without elevated borders
Dispositioned for discharge from the Emergency Department or Observation
Able to consent

Exclusion Criteria:

Steroid use in the past 2 weeks
History of adrenal insufficiency
Any infection treated with antibiotics in the past 2 weeks

Allergy to:

Steroids
Acetaminophen
Trimethoprim-Sulphamethoxazole (TMP/SMX), Cephalexin, and Clindamycin (must be allergic to all three for exclusion)
Oxycodone and Hydrocodone (must be allergic to both for exclusion)

If subject is going to the Observation unit, allergy to:

Clindamycin and Vancomycin (must be allergic to both for exclusion)
Morphine and Hydromorphone (must be allergic to both for exclusion)
Suspicion or presence of abscess
Suspicion or presence of deep vein thrombosis

Suspicion or presence of severe sepsis, as defined by:

Sepsis
Hypotension (systolic pressure < 90 mmHg or reduction of 40 mmHg from baseline)
Failure of single end organ

Suspicion or presence of septic shock, as defined by:

Severe sepsis
Hypotension that is refractory to fluid management
Failure or more than one end organ
Crepitus
Change in mentation
Tachycardia greater than 120 beats per minute
Fever greater than or equal to 39 degrees Celsius
Hospital admission
Under 18 years of age, or over 70 years of age
Pregnancy or breast feeding
Police custody or prisoner
Cognitive impairment
Inability to consent
Nursing home residents
Intervention: Naltrexone
Trial phase: Not Applicable
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 34
Group description: Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.

Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria for the study require that participants be in good health, between the ages of 18 and 35, fluent in English, have access to text messaging technology, and have at least 8 close friends and family members who would be willing to be contacted in regards to the study (for the social connection lab task) and be willing to provide 2 pictures of a close other (for the threat of shock task).

Exclusion Criteria:

Following an email screening and structured telephone interview, prospective participants with the following conditions will not advance to the in- person screening session: pregnant or planning to become pregnant in the next 6 months, presence of chronic mental or physical illness, history of allergies, liver, or other severe chronic diseases, current and regular use of prescription medications, or previous history of fainting during blood draws.

Furthermore, the absence of significant health problems or medication use history will be confirmed by an in-person screening session. Any participant who has any of the following conditions will be ineligible for the study: (1) Any and all medical conditions, especially hepatitis or liver failure.

Psychiatric Disorders. (2) current and/or lifetime history of a major Depressive Disorder or other Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) psychiatric disorder (e.g. substance dependence) (3) current and/or past regular use of analgesics such as opioids; (4) current and/or past regular use of psychotropic medications, including selective serotonergic reuptake inhibitors, antidepressants, anxiolytics, hypnotics, sedatives and barbiturates. Health factors. (5) current smokers (13) body mass index (BMI) greater than 35, (14) shows evidence of drug use from a urine test, (15) has a positive pregnancy test, if female, or (16) shows any abnormalities on screening laboratory tests.
Intervention: Flutemetamol
Trial phase: Phase 3
ATC code: V09AX04
SMILES: CNc1ccc(-c2nc3ccc(O)cc3s2)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 276
Group description: No adverse event data collected because no subjects were dosed in this study , therefore no subjects were at risk.
Eligibility criteria:
Inclusion Criteria:

Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq.

The subject was classified as one of the following:

End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status.
Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status.
Elderly healthy volunteer (age ≥55).
Young healthy volunteer (age ≤40).
Subject with probable Alzheimer Disease (pAD).
Subject with amnestic Mild Cognitive Impairment (aMCI).

Exclusion Criteria:

Not Applicable
Intervention: IC Green
Trial phase: Not Applicable
ATC code: V04CX01
SMILES: CC1(C)C(=CC=CC=CC=CC2=[N+](CCCCS(=O)(=O)[O-])c3ccc4ccccc4c3C2(C)C)N(CCCCS(=O)(=O)[O-])c2ccc3ccccc3c21.[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 430
Group description: One arm only: Receives IC Green for testing of study objective

IC Green: IC Green
Eligibility criteria:
Inclusion Criteria:

Patients must be women 18 years and older who have biopsy proven endometrial or cervical carcinoma (of any histologic subtype).
Surgical staging with the da Vinci Si robotic tool must be planned with a planned pelvic and, in the case of endometrial cancer, a para-aortic lymphadenectomy
Patients must meet criteria for robotic surgical approach:
Patients must have either a clinical stage I endometrial (of any histologic grade) or FIGO stage IA2 or IB1 (<4cm) cervical squamous, adenocarcinoma or adenosquamous carcinoma.
Patients must be able to sign an informed consent in English language.
Patients with known liver disease will require normal range liver function tests as determined by pre-operative labs drawn within 30 days of surgery.

Exclusion Criteria:

Patients who have iodide allergies
Patients who have had previous retroperitoneal surgery
Patients on whom pelvic+/- para-aortic lymphadenectomy is not planned as part of their surgical staging.
Patients who have received previous treatment for their endometrial or cervical cancer (particularly hysterectomy or pelvic radiation).
Patients who are pregnant.
Patients with documented liver disease who have abnormalities of liver function tests.
Intervention: Lidocaine
Trial phase: Phase 4
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: 21
Group description: Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.

Lidocaine: See associated Arm Description
Eligibility criteria:
Inclusion Criteria:

Greater than or equal to 18 years old
Able to consent
Has cutaneous abscess less than or equal to 2 centimeters requiring incision and drainage in the Emergency Department

Exclusion Criteria:

Less than 18 years old
Unable to consent
Pregnant or breastfeeding
Prisoner or in police custody
Known sensitivity to vapocoolant or lidocaine
Cold hypersensitivity
Chronic steroid use
Peripheral neuropathy
Diabetes
HIV
Malignancy
Immunosuppressive state
Sickle cell disease
Sarcoidosis
Abscess greater than 2 centimeters in any dimension
Abscess requiring procedural sedation and analgesia for incision and drainage, or further intervention outside the Emergency Department
Abscess located on the hands, feet, face, or perineal areas
Pilonidal cyst
hidradenitis suppurativa
Not a good candidate per attending physician
Intervention: Pasireotide
Trial phase: Phase 2
ATC code: H01CB05
SMILES: NCCCC[C@@H]1NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](c2ccccc2)NC(=O)[C@@H]2C[C@@H](OC(=O)NCCN)CN2C(=O)[C@H](Cc2ccccc2)NC(=O)[C@H](Cc2ccc(OCc3ccccc3)cc2)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Enrolled patients were randomized to 20mg pasireotide LAR.
Eligibility criteria:
Inclusion Criteria:

Patients with medication naïve acromegaly or pituitary gigantism
Patients with inadequately controlled acromegaly or pituitary gigantism

Exclusion Criteria:

Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c >8%
Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF > 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT syndrome, or patients receiving a concomitant medication known to prolong QT interval
Intervention: Pasireotide
Trial phase: Phase 2
ATC code: H01CB05
SMILES: NCCCC[C@@H]1NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](c2ccccc2)NC(=O)[C@@H]2C[C@@H](OC(=O)NCCN)CN2C(=O)[C@H](Cc2ccccc2)NC(=O)[C@H](Cc2ccc(OCc3ccccc3)cc2)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Enrolled patients were randomized to 60mg pasireotide LAR.
Eligibility criteria:
Inclusion Criteria:

Patients with medication naïve acromegaly or pituitary gigantism
Patients with inadequately controlled acromegaly or pituitary gigantism

Exclusion Criteria:

Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1c >8%
Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF > 470 ms, hypokalemia, hypomagnesemia, hypocalcemia, family history of long QT syndrome, or patients receiving a concomitant medication known to prolong QT interval
Intervention: Simvastatin
Trial phase: Phase 3
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
Eligibility criteria:
Inclusion Criteria:

Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose of study medication). Accepted contraceptive methods are implants, injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.
between 18 (inclusive) and 80 years

With mixed dyslipidemia with fasting lipid results of a blood sample taken at inclusion and after at least 3 months of any statin monotherapy (excluding simvastatin 80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):

TG higher than/equal to 1.71 mmol/L (higher than/equal to 150 mg/dL) and
LDL-C higher or equal to 1.81 mmol/L (higher or equal 70 mg/dL) but smaller than/equal to 3.36 mmol/L (smaller than/equal to 130 mg/dL)
High risk or very high risk based on known CardioVascular Disease (CVD) or type 2 diabetes or type 1 diabetes with microalbuminuria or a Systematic Coronary Risk Estimation (SCORE) chart risk ≥ 5percent
Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2 times the Upper Normal of Limit (UNL)

Exclusion Criteria:

Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts or arachis oil or soy lecithin, or related products,
Pregnant or lactating women,
Unable or unwilling to comply with the protocol and the recommended diet,
Likely to withdraw from the study before its completion,
Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at Visit 1
Intervention: Simvastatin
Trial phase: Phase 3
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 115
Group description: Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
Eligibility criteria:
Inclusion Criteria:

Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose of study medication). Accepted contraceptive methods are implants, injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.
between 18 (inclusive) and 80 years

With mixed dyslipidemia with fasting lipid results of a blood sample taken at inclusion and after at least 3 months of any statin monotherapy (excluding simvastatin 80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):

TG higher than/equal to 1.71 mmol/L (higher than/equal to 150 mg/dL) and
LDL-C higher or equal to 1.81 mmol/L (higher or equal 70 mg/dL) but smaller than/equal to 3.36 mmol/L (smaller than/equal to 130 mg/dL)
High risk or very high risk based on known CardioVascular Disease (CVD) or type 2 diabetes or type 1 diabetes with microalbuminuria or a Systematic Coronary Risk Estimation (SCORE) chart risk ≥ 5percent
Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2 times the Upper Normal of Limit (UNL)

Exclusion Criteria:

Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts or arachis oil or soy lecithin, or related products,
Pregnant or lactating women,
Unable or unwilling to comply with the protocol and the recommended diet,
Likely to withdraw from the study before its completion,
Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at Visit 1
Intervention: Fenofibrate
Trial phase: Phase 3
ATC code: C10AB05 | C10BA03 | C10BA04 | C10BA09 | C10BA12
SMILES: CC(C)OC(=O)C(C)(C)Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 112
Group description: Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
Eligibility criteria:
Inclusion Criteria:

Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose of study medication). Accepted contraceptive methods are implants, injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.
between 18 (inclusive) and 80 years

With mixed dyslipidemia with fasting lipid results of a blood sample taken at inclusion and after at least 3 months of any statin monotherapy (excluding simvastatin 80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):

TG higher than/equal to 1.71 mmol/L (higher than/equal to 150 mg/dL) and
LDL-C higher or equal to 1.81 mmol/L (higher or equal 70 mg/dL) but smaller than/equal to 3.36 mmol/L (smaller than/equal to 130 mg/dL)
High risk or very high risk based on known CardioVascular Disease (CVD) or type 2 diabetes or type 1 diabetes with microalbuminuria or a Systematic Coronary Risk Estimation (SCORE) chart risk ≥ 5percent
Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2 times the Upper Normal of Limit (UNL)

Exclusion Criteria:

Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts or arachis oil or soy lecithin, or related products,
Pregnant or lactating women,
Unable or unwilling to comply with the protocol and the recommended diet,
Likely to withdraw from the study before its completion,
Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at Visit 1
Intervention: RISEDRONIC ACID
Trial phase: Phase 4
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 247
Group description: Active comparator: Administer Risendronate one tablet once a week for 12months.

Risedronate: once a week
Eligibility criteria:
Inclusion Criteria:

Male osteoporosis patients over 19 years of age

Female osteoporosis patients with menopause

Definition of osteoporosis

They had a BMD T-score -2.5 or less at mean Lumbar spine(L1-L4), Femoral neck or total. Or evidence of at least one vertebral fracture

Definition of menopause(can be one of three condition)

For 12months spontaneous amenorrhea
For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40mlU/mL and over
6weeks after bilateral ovariectomy whether hysterectomy or not.

Exclusion Criteria:

Patients with esophagus disorder (i.e:esophagostenosis)
Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
Patients with serum calcium concentrations 8.0mg under
Patients with severe nephropathy (CCr 30mL/min less)
Patients with unable to sit upright or stand for 30minutes
Intervention: Noroxycodone Hydrochloride
Trial phase: Phase 3
SMILES: COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)NCCC314.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: To determine the efficacy and safety of OxyNorm Capsules.

OxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours
Eligibility criteria:
Inclusion Criteria:

Patients of either sex aged 18 to 80 years inclusive.
Patients who have given written informed consent to participate in the study.
Able and willing to communicate with the investigator and his/her staff.
Free of anesthesia as assessed through question and answer interaction with nurse at which time oral medication is indicated.
Reporting "moderate" or "severe" pain (VAS ≥ 4) related to surgery and requesting analgesics for pain relief.

Exclusion Criteria:

Patients have developed tolerance to or dependence on narcotic analgesics and/or alcohol.
Patients with ASA ≥ 3 .
Have any concomitant medical condition that would be adversely affected by analgesics or confound the quantification of analgesia, or could affect the absorption, metabolism or excretion of the study drugs in any clinically significant fashion.
Have known hypersensitivity to any of the study medications or related agents.
Have taken analgesic medications within three hours (wash-out) prior to dosing.
Have developed complications from the surgical procedure that would confound the study.
Have a history of severe iatrogenic adverse experiences.
Mothers nursing their infant during the 24 hours following study drug administration, or pregnant women.
Patient with Nothing Per Os (NPO) as stated in patient's chart or physician's order.
Surgery in patients with epidural anesthesia
Patients with Severe impairment of liver at preoperative stage (ALT, AST ≥ 1.5 times upper limit) and abnormal renal function.
Patients with medical history of recovering from abnormal surgery anesthesia.
Patients with medical history of hypertension (Systolic blood pressure ≥ 180Hg, Diastolic blood pressure 110Hg).
Patients with shock.
Patients with COPD.
According to investigator to determine, patients are in addition the inclusion criteria and exclusion criteria for any other reason than not suitable in this study.