anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Estradiol
Trial phase: Phase 4
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 | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
Eligibility criteria:
Inclusion Criteria:

Males and female greater than 18 years of age
Positive stool C. difficile cytotoxin assay and/or biopsy evidence of Pseudomembranous Colitis (PMC) at onset of illness
Current history of severe, relapsing CDAD or Current history of severe, refractory CDAD
A score of 6 or 7 on the C.Diff Severity and Prognosis Score (CDSPS) scale27,28,29,30 OR failure to respond (as identified by a score of 4 or more on the CDSPS scale below) to any of the following: a 4-day or more course of oral or IV metronidazole 500 mg po TID or QID; or to a 4-day course of oral vancomycin 125-500 mg po Q6 hours; or to a 4-day course of vancomycin enemas; or failure to respond to a 4-day course of combination therapy of oral vancomycin 125-500 mg po Q6 hours and IV metronidazole 500mg IV Q8 or Q6 hours and/or vancomycin enemas.

CDSPS SCALE (each item is scored as one point for a 7 point maximum total)

underlying immunosuppression/chronic medical condition
altered or depressed mental status as defined by medical chart documentation
abdominal pain and/or distention
WBC > 20,000 or < 1,500 and/or bandemia > 10%
hypoalbuminemia (<3 mg/dL)
ascites (clinically or per CT scan findings per medical chart)
abnormal CT scan findings per medical chart -

Exclusion Criteria:

Pregnant or lactating women
Selective IgA deficiency
Hypersensitivity to immune globulin, human albumin, or thimerosal -
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 75
Group description: saline: 0.3cc/kg of saline, subq, once
Eligibility criteria:
Inclusion Criteria:

Ages 6-18 y.o. presenting to Vanderbilt Children's Hospital (VCH) Emergency Room with:
Established history of insulin dependent diabetes

AND:

Chief c/o hyperglycemia or vomiting
Venous pH < 7.24
Serum Bicarbonate < 18
Blood glucose > 150
Urinary Ketones

Exclusion Criteria:

Age < 6y.o.
New onset diabetes
Received IV insulin bolus prior to arrival to VCH Emergency Room (ER)
Venous pH > 7.24
Serum Bicarbonate > 18
Pregnancy
Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit
Intervention: Anastrozole
Trial phase: Phase 2
ATC code: L02BG03
SMILES: CC(C)(C#N)c1cc(Cn2cncn2)cc(C(C)(C)C#N)c1
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg
Eligibility criteria:
Inclusion Criteria:

Subject must be a male between the ages of 18 and 50 years.
Subject must have localization-related epilepsy with complex partial and/or secondary generalized seizures.
Subject will meet criteria for hypogonadism (abnormally low bioactive testosterone levels and abnormally low scores on questionnaires of reproductive and sexual function).
Subject will have had a normal urogenital and rectal/prostate exam during the year prior to entry.
Subject will have had documentation of therapeutic range serum AED levels, a normal CBC, and hepatic enzyme (ALT,AST, alkaline phosphatase) levels that are less than twofold elevated during the 6 months prior to entry.

Exclusion Criteria:

Subject that has taken hormones, major tranquilizers or antidepressants in the three months prior to entry.
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: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)

Normal Saline: Nebulised Normal Saline
Eligibility criteria:
Inclusion Criteria:

All they patients undergoing laparoscopic cholecystectomy will be included.

Exclusion Criteria:

Patients with local anaesthetic allergy, patients on chronic opiate medication or those with neurological diseases that make pain evaluation unreliable will be excluded.
Intervention: Simvastatin
Trial phase: Phase 1 | Phase 2
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: 19
Group description: Simvastatin 40mg od for 1 month, then uptitrated to 80mg od for 11 months.

Simvastatin: Simvastatin 40mg od for 1 month, then 80mg od for 11 months
Eligibility criteria:
Inclusion Criteria:

Patients with idiopathic PAH or PAH related to collagen vascular disease
Age 18 years or over
Receiving conventional therapy with diuretics, digoxin, warfarin, sildenafil and bosentan. Stable for 1 month
6 minute walk distance between 150m and 450m
Modified NYHA functional class II or III

Exclusion Criteria:

PAH from a cause other than permitted by entry criteria
Change in PAH treatment in past 4 weeks
Patients requiring prostanoid therapy
Patients already taking a statin
Clinically significant disturbance of liver function - AST or ALT >3xULM; bilirubin >1.5xULM
Contraindication for a magnetic resonance scan
Intervention: Allopurinol
Trial phase: Phase 2
ATC code: M04AA01 | M04AA51
SMILES: Oc1ncnc2[nH]ncc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Each participant received pre and post MRS images following infusion of 50 cc of Aloprim 300mg in 5% Dextrose.
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
The patient is willing and able to provide informed consent
Clinical diagnosis of chronic heart failure
Ejection fraction (EF) < 40% by echocardiography, nuclear multigated acquisition (MUGA) or cath ventriculography
No significant coronary disease at cardiac catheterization
New York Heart Association (NYHA) Class I-IV symptoms
Clinical stabilization for two weeks if following recent congestive heart failure (CHF) decompensation.

Exclusion Criteria:

Metallic implant prohibiting magnetic resonance (MR) evaluation
Inability to lie flat for MR study
Administration of additional investigational drugs
Calculated creatinine clearance < 50 mL/min
Allergy to allopurinol
Current gout flare
Currently taking oral allopurinol
Intervention: Sertraline
Trial phase: Phase 4
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Sertraline group received study medication every day for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Admission to the Shriners Hospital or Massachusetts General Hospital for an acute burn, injury, or reconstructive surgery following a burn
Between the ages of 6 - 20 years
Recent experience of an acute burn, injury, or surgery meeting the Diagnostic and Statistical Manual(DSM-IV) A1 stressor criterion
Child's response to the stressor meets Diagnostic and Statistical Manual(DSM-IV) A2 response criterion
Proficiency in either English or Spanish

Exclusion Criteria:

No memory of the injury
Current use of an anti-depressant
Known hypersensitivity to sertraline
Diagnosis of Bipolar Disorder
Diagnosis of PTSD
Mental Retardation
Traumatic Brain Injury
New onset or marked worsening of a seizure disorder
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: 75
Group description: Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
Eligibility criteria:
Inclusion Criteria:

Age 18-75
History of acromegaly with biochemical cure documented with a normal oral glucose tolerance test (OGTT) and/or a non-elevated IGF-I without concurrent use of somatostatin analogs, dopamine agonists or GH receptor antagonists. Subjects will have been treated with medication, surgery, radiation, or a combination of these
At the time of enrollment a minimum of 6 months must have elapsed since surgery.
No malignancy on colonoscopy performed since the diagnosis of acromegaly
GHD due to surgical or radiation treatment
GHD will be defined as a peak plasma GH of less than 5 ng/ml in response to an insulin tolerance test or a GH-releasing hormone (GHRH) plus arginine stimulation test
GHD will also be diagnosed if IGF-I levels are below 2 standard deviations for the age-sex normal range in a patient with at least two other documented anterior pituitary hormone deficiencies

Exclusion Criteria:

Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
History of malignancy except for non-melanoma skin cancer
Hemoglobin <11.0 gm/dl
Uncontrolled hypertension
Hepatic or renal disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x upper limit of normal (ULN) or creatinine level >2.5 mg/dl)
Congestive heart failure (New York Heart Association's classification system Class II-IV congestive heart failure (CHF) will be excluded)
Unstable cardiovascular disease (coronary artery or cerebrovascular disease) or symptoms within one year prior to entry into the study
Initiation or discontinuation of gonadal steroid therapy within 3 months of entry
Diabetes mellitus, impaired fasting glucose, impaired glucose tolerance
Pregnancy or nursing
Active carpal tunnel syndrome
Subjects who have received GH therapy within one year prior to entry into the study
For female subjects age >40 a screening mammogram must have been obtained within one year prior to their baseline visit.
Sensitivity to m-cresol
Intervention: Ethanol
Trial phase: Phase 2
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 193
Group description: Results by beverage condition.
Eligibility criteria:
Inclusion Criteria:

Ages 21-30
Currently enrolled in college/university
Have had 5 or more drinks (4 if female) in the last 30 days
Score less than a 5 on the Short Michigan Alcohol Screening Test (SMAST)
No self-reported history of counseling or treatment for substance abuse
Not taking any medication contraindicated for alcohol use or that disrupts sleep
Doesn't have a health condition contraindicated for alcohol use
Has not been diagnosed with a primary sleep disorder
Has not been diagnosed with a mental health disorder
Not currently working night shifts at a job
Not routinely taking medications that affect sleep
If female, is using reliable birth control when necessary
Not a regular smoker
Likes the taste of beer

Exclusion Criteria:

Less than age 21 and greater than age 30
Not currently enrolled in college/university
Hasn't had 5 or more drinks (4 if female) in the last 30 days (not a regular drinker)
Score greater than or equal to 5 on the Short Michigan Alcohol Screening Test (SMAST)
Self-reported history of counseling or treatment for substance abuse
Taking any medication contraindicated for alcohol use or that disrupts sleep
Has a health condition contraindicated for alcohol use
Has been diagnosed with a primary sleep disorder
Has been diagnosed with a mental health disorder
Currently working night shifts at a job
Routinely taking medications that affect sleep
Is a regular smoker
Is currently pregnant or nursing
If female, is not using reliable birth control when necessary
Not a regular drinker
Dislikes the taste of beer
Intervention: Divalproex Sodium
Trial phase: Phase 3
SMILES: CCCC(CCC)C(=O)O.CCCC(CCC)C(=O)[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Participants will receive divalproex ER at a therapeutic dose, plus placebo

Divalproex-extended release (DVP-ER): Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of bipolar I disorder or schizophrenia
Experiencing symptoms of mania at study entry
Able to speak and understand English
Willing and able to comply with all study requirements

Exclusion Criteria:

History of partial response or nonresponse to any of the drugs or drug combinations given in this study
History of intolerance to DVP, DVP-ER, lithium, or quetiapine
Disorders that would contraindicate the use of DV, DV-ER, lithium, or quetiapine
Use of antidepressants within 1 month prior to study entry
Use of fluoxetine within 3 months prior to study entry
Impaired cardiac function, as evidenced by abnormal EKG in participants 50 or over
Unstable medical illness within 2 months prior to study entry
At risk for suicide
Substance abuse or dependence within 1 month prior to study entry
Pregnancy, breastfeeding, or plans to become pregnant during the study
Intervention: Memantine
Trial phase: Phase 4
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Memantine for 12 weeks

Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.
Eligibility criteria:
Inclusion Criteria:

Admission to a skilled nursing facility for rehabilitation within 3 months of recent disabling medical event (e.g., hip fracture)
Medically stable (e.g., no active seizures, delirium, unstable pulse/blood pressure)

Exclusion Criteria:

Aphasia or cognitive impairments sufficiently severe to prevent valid assessment (e.g., a score of less than 22 on the Mini Mental State Examination)
Current major depressive episode
History of or current psychosis or mania
Current substance or alcohol abuse or dependence (within 3 months of study entry)
Current use of memantine
Sensitivity or contraindication to memantine
End-stage kidney, liver, heart, or lung disease
Recent hemorrhagic stroke
A FIM score of greater than 70 (on a 91 point scale)
Intervention: Magnesium Sulfate
Trial phase: Not Applicable
ATC code: A06AD04 | A12CC02 | B05XA05 | D11AX05 | V04CC02
SMILES: O=S(=O)([O-])[O-].[Mg+2]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Preterm labor treatment with Magnesium Sulfate.

Magnesium Sulfate: Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.
Eligibility criteria:
Inclusion Criteria::- Uterine contractions and cervical change or ruptured membranes in a preterm gestation Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis
Intervention: Nifedipine
Trial phase: Not Applicable
ATC code: C07FB03 | C08CA05 | C08CA55 | C08GA01
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1ccccc1[N+](=O)[O-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Preterm labor treatment with Nifedipine.

Nifedipine: Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.
Eligibility criteria:
Inclusion Criteria::- Uterine contractions and cervical change or ruptured membranes in a preterm gestation Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis
Intervention: Olanzapine
Trial phase: Phase 4
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Olanzapine/Zyprexa 2.5 mg up to 8 per day for 1 week

Olanzapine/Zyprexa: Olanzapine was started at 2.5-10mg/day and adjusted by 2.5-5mg/day on a daily basis with a maximum dose of 20mg/day.
Eligibility criteria:
Inclusion Criteria:Patients must meet the following criteria to be eligible to participate in the study:

Male or female outpatients, 18 to 70 years of age
Female patients of childbearing potential must be using a medically accepted means of contraception
Able to communicate intelligently with the investigator, and study coordinator
Able to give informed consent
DSM-IV diagnosis of bipolar I, bipolar II, cyclothymic disorder or bipolar disorder not otherwise specified, experiencing an acute exacerbation of their illness at Visit 1 (hypomania, subsyndromal depression, hypomania and subsyndromal depression, depression and hypomania, or depression if diagnosed with bipolar II) as verified by SCID-I/P
CGI-BP Overall Severity score greater than or equal to mildly ill at Visit 1
Must have been on prior medications for at least 2 weeks (6 weeks for fluoxetine) immediately prior to study entry Exclusion Criteria:Patients may not participate in the study if they have any of the following conditions:
Pregnant, nursing, or intending to become pregnant during the study
Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease such that hospitalization for the disease is anticipated within 3 months or death is anticipated within 3 years.
A history of seizure disorder
History of leukopenia without a clear and resolved etiology.
DSM-IV substance (except nicotine or caffeine) dependence within the past month
Judged clinically to be at serious suicidal risk
Participation in clinical trial of another investigational drug within 1 month (30 days) prior to study entry.
Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to study entry
Treatment resistance, non-response, or intolerability with olanzapine by the investigator's judgment
Treatment with clozapine within 3 months prior to study entry
Treatment with remoxipride within 6 months (180 days) prior to study entry
Treatment with an oral antipsychotic within 2 days prior to study entry
A course of ECT (electroconvulsive therapy) in the preceding 4 weeks
Excluded mood symptoms noted in Table 1 [of protocol]
Unstable thyroid pathology and treatment-initiated or altered within the past 3 months
Meet criteria for antisocial personality disorder
Intervention: Olanzapine
Trial phase: Phase 4
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Placebo taken in same manner as study drug up to 8 per day for 1 week
Eligibility criteria:
Inclusion Criteria:Patients must meet the following criteria to be eligible to participate in the study:

Male or female outpatients, 18 to 70 years of age
Female patients of childbearing potential must be using a medically accepted means of contraception
Able to communicate intelligently with the investigator, and study coordinator
Able to give informed consent
DSM-IV diagnosis of bipolar I, bipolar II, cyclothymic disorder or bipolar disorder not otherwise specified, experiencing an acute exacerbation of their illness at Visit 1 (hypomania, subsyndromal depression, hypomania and subsyndromal depression, depression and hypomania, or depression if diagnosed with bipolar II) as verified by SCID-I/P
CGI-BP Overall Severity score greater than or equal to mildly ill at Visit 1
Must have been on prior medications for at least 2 weeks (6 weeks for fluoxetine) immediately prior to study entry Exclusion Criteria:Patients may not participate in the study if they have any of the following conditions:
Pregnant, nursing, or intending to become pregnant during the study
Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease such that hospitalization for the disease is anticipated within 3 months or death is anticipated within 3 years.
A history of seizure disorder
History of leukopenia without a clear and resolved etiology.
DSM-IV substance (except nicotine or caffeine) dependence within the past month
Judged clinically to be at serious suicidal risk
Participation in clinical trial of another investigational drug within 1 month (30 days) prior to study entry.
Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to study entry
Treatment resistance, non-response, or intolerability with olanzapine by the investigator's judgment
Treatment with clozapine within 3 months prior to study entry
Treatment with remoxipride within 6 months (180 days) prior to study entry
Treatment with an oral antipsychotic within 2 days prior to study entry
A course of ECT (electroconvulsive therapy) in the preceding 4 weeks
Excluded mood symptoms noted in Table 1 [of protocol]
Unstable thyroid pathology and treatment-initiated or altered within the past 3 months
Meet criteria for antisocial personality disorder
Intervention: Mifepristone
Trial phase: Not Applicable
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: 31
Group description: Patients received mifepristone for 6 days

Mifepristone: Glucocorticoid antagonist
Eligibility criteria:
Inclusion Criteria::

21-item HAM-D score of 20 or above.
If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least three weeks prior to entering the study.
At least 2 failed antidepressant medication trials of adequate dose and duration.
Between 18 and 75 years of age.
Not currently pregnant or trying to become pregnant. Exclusion Criteria:-History of schizophrenia or other psychotic disorders.
Transcranial magnetic stimulation treatment or ECT in the 3 months prior to starting the study.
History of vagus nerve stimulation treatment.
No unstable or untreated cardiovascular disease, hypertension, or endocrine disorder.
Current use of oral contraceptives or any other drug that may result in adverse drug-mifepristone interactions effects (including Amiodarone, Clarithromycin, Erythromycin, Fluconazole, Fluvoxamine, Indinavir, Intraconazole, Ketoconazole, Metronidazole, Miconazole, Nefazodone, Nelfinavir, Norfloxacin, Omeprazole, Quinine, Ritonavir, Saquinavir, Troleandomycin, Zafirlukast, Carbamazepine, Dexamethasone, Ethosuximide, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Troglitazone). A 30-day wash-out period for oral contraceptives is required before mifepristone begins.
Previous allergic reaction to mifepristone or drugs of similar chemical structure.