anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Eplerenone
Trial phase: Not Applicable
ATC code: C03DA04
SMILES: [H][C@@]12CC[C@@]3(CCC(=O)O3)[C@@]1(C)C[C@H]1O[C@@]13[C@@]2([H])[C@H](C(=O)OC)CC1=CC(=O)CC[C@@]13C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: hypoglycemia (50 mg/dl) with pretreatment with two doses of eplerenone (100 mg of eplerenone per dose) Eplerenone: 100mg x 2
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers
Males and females age 18 to 40 years

Exclusion Criteria:

Pregnancy
Lactation
Menopause
Any medical condition other than treated hypothyroidism.
Alcoholism
Active tobacco use
In all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
Use of medications other than physiological thyroxine replacement
Serum potassium >5.0 mmol/L
Estimated glomerular filtration rate < 60 mL/min
Intervention: Fluorocholine F-18
Trial phase: Phase 2
ATC code: V09IX07
SMILES: C[N+](C)(CF)CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Patients undergo 18F-fluoromethylcholine PET/CT scan within 14 days of surgical resection.

Computed Tomography: Undergo FCH PET/CT

18F-fluoromethylcholine: Undergo FCH PET/CT

Laboratory Biomarker Analysis: Correlative studies

Positron Emission Tomography: Undergo FCH PET/CT
Eligibility criteria:
Inclusion Criteria:

Liver tumor diagnosed histologically as HCC or suspected of being HCC in association with serum alpha-fetoprotein level > 200 or tumor mass with characteristics of malignancy on diagnostic imaging
Under the care of a surgical attending
Deemed a surgical candidate and has agreed to surgery to remove a portion of the liver containing tumor
Child-Pugh A/B

Exclusion Criteria:

Weight > 350 lbs
Pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks or less before the date of the FCH PET/CT scan in all women capable of becoming pregnant
Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure
Concurrent treatment with chemotherapy, molecule-selective, biological, or radiotherapeutic agent
Intervention: Pemoline
Trial phase: Phase 1 | Phase 2
ATC code: N06BA05
SMILES: NC1=NC(=O)C(c2ccccc2)O1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 82
Group description: Low dose pio comparator.

Pioglitazone: 0, 15, and 45 mg per day.
Eligibility criteria:
Inclusion Criteria:

21-55 years of age
Physically healthy
Able to perform study procedures

Exclusion Criteria:

Pregnancy
Physical dependence on any other drugs besides caffeine, heroin and nicotine
Intervention: Pemoline
Trial phase: Phase 1 | Phase 2
ATC code: N06BA05
SMILES: NC1=NC(=O)C(c2ccccc2)O1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 82
Group description: High dose pio comparator.

Pioglitazone: 0, 15, and 45 mg per day.
Eligibility criteria:
Inclusion Criteria:

21-55 years of age
Physically healthy
Able to perform study procedures

Exclusion Criteria:

Pregnancy
Physical dependence on any other drugs besides caffeine, heroin and nicotine
Intervention: Pemoline
Trial phase: Phase 1 | Phase 2
ATC code: N06BA05
SMILES: NC1=NC(=O)C(c2ccccc2)O1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 82
Group description: Control condition for active arms.

Pioglitazone: 0, 15, and 45 mg per day.
Eligibility criteria:
Inclusion Criteria:

21-55 years of age
Physically healthy
Able to perform study procedures

Exclusion Criteria:

Pregnancy
Physical dependence on any other drugs besides caffeine, heroin and nicotine
Intervention: Anamorelin hydrochloride
Trial phase: Phase 3
SMILES: CN(C)N(C)C(=O)C1(Cc2ccccc2)CCCN(C(=O)C(Cc2c[nH]c3ccccc23)NC(=O)C(C)(C)N)C1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 343
Group description: Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
Eligibility criteria:
Inclusion Criteria:

Has completed the Day 85 Visit in the original trial (Study HT-ANAM-301 or HT-ANAM-302) and is considered appropriate to continue to receive additional study drug; must start dosing on the extension study within 5 days of completing dosing on the original trial
ECOG performance status ≤2
Life expectancy of >4 months at time of screening
If woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method)
Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures

Exclusion Criteria:

Women who are pregnant or breast-feeding
Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to enrollment into the extension study; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period
Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol
Inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded
Has an active, uncontrolled infection
Has known or symptomatic brain metastases
Receiving strong CYP3A4 inhibitors
Receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration
Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation
Patients actively receiving a concurrent investigational agent, other than Anamorelin HCl
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: esomeprazole 20 mg once daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Male of female aged 20 years or more
History of reflux esophagitis
Ongoing (until date of Visit 1) treatment with rabeprazole 10 mg, given once daily, for at least 4 weeks.The subject must take rabeprazole at least 4 days a week in the past 7 days prior to Visit 1.
Persisting symptoms of heartburn experienced at least 2 days during the past 7 days prior to Visit 1.

Exclusion Criteria:

Use of other PPIs and/or H2RA during rabeprazole treatment
History or having other gastrointestinal diseases
History of upper gastrointestinal surgery
Initiation of medications that can affect digestive functions within 4 weeks before study treatment
Inability to complete questionnaires
Intervention: Teprenone
Trial phase: Phase 2 | Phase 3
ATC code: A02BX15
SMILES: CC(=O)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CCC=C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 158
Group description: Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
Eligibility criteria:
Inclusion Criteria

Require long-term administration of low-dose aspirin (81 mg/day or 100 mg/day)
Confirmed to have a history of gastric or duodenal ulcer

Exclusion Criteria

-Confirmed to have acute gastro duodenal mucosal lesions, gastric or duodenal ulcer, or upper gastrointestinal (esophagus, stomach, duodenum) bleeding Confirmed to have reflux esophagitis or long segment Barrett's esophagus
Intervention: Ozenoxacin
Trial phase: Phase 3
ATC code: D06AX14
SMILES: CNc1ncc(-c2ccc3c(=O)c(C(=O)O)cn(C4CC4)c3c2C)cc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 465
Group description: 1% cream

ozenoxacin 1% cream: 1% cream
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients < 12 years the total area will not exceed a maximum of 2% of the body surface area.
Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 1

Exclusion Criteria:

Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)
Intervention: Retapamulin
Trial phase: Phase 3
ATC code: D06AX13
SMILES: [H][C@@]12C(=O)CC[C@]13CC[C@@H](C)[C@@]2(C)[C@H](OC(=O)CS[C@@H]1C[C@H]2CC[C@@H](C1)N2C)C[C@@](C)(C=C)[C@@H](O)[C@@H]3C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 465
Group description: 1% ointment

retapamulin 1% ointment: ointment
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients < 12 years the total area will not exceed a maximum of 2% of the body surface area.
Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 1

Exclusion Criteria:

Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)
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: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded

Dexamethasone: 10 mg/mL injected into lumbar spine, one level, one injection
Eligibility criteria:
Inclusion Criteria:

Chronic low back pain of radicular origin of > 4 weeks but < 6 months
Failure of conservative therapy to include physical therapy and pharmacotherapy
Patient is at least 21 years of age
Patient is willing to be blinded to treatment until after the 12 week post injection visit.
Patient is willing and able to review and sign the study informed consent form.

Exclusion Criteria:

Patient has a mental or physical condition that would invalidate evaluation results.
Patient has had prior lumbar surgery at any level.
Patient is scheduled to have more than one level of steroid injection.
Patient is pregnant
Patient has systemic infection at the proposed injection site
Patient has osteopenia osteoporosis, or osteomalacia
Patient has a disease of bone metabolism
Patient has history of renal insufficiency or kidney disease of any kind
Patient is undergoing chemotherapy or radiation treatment
Patient is currently involved in a study of another product for similar purpose
Patient requires post op management with NSAIDS
Patient has know allergy to corticosteroids, contrast dye or anesthetics
Patient is unable to speak/read English
Patient is a prisoner
Intervention: METHYLPREDNISOLONE ACETATE
Trial phase: Not Applicable
SMILES: CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded

methylprednisolone acetate: 80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time
Eligibility criteria:
Inclusion Criteria:

Chronic low back pain of radicular origin of > 4 weeks but < 6 months
Failure of conservative therapy to include physical therapy and pharmacotherapy
Patient is at least 21 years of age
Patient is willing to be blinded to treatment until after the 12 week post injection visit.
Patient is willing and able to review and sign the study informed consent form.

Exclusion Criteria:

Patient has a mental or physical condition that would invalidate evaluation results.
Patient has had prior lumbar surgery at any level.
Patient is scheduled to have more than one level of steroid injection.
Patient is pregnant
Patient has systemic infection at the proposed injection site
Patient has osteopenia osteoporosis, or osteomalacia
Patient has a disease of bone metabolism
Patient has history of renal insufficiency or kidney disease of any kind
Patient is undergoing chemotherapy or radiation treatment
Patient is currently involved in a study of another product for similar purpose
Patient requires post op management with NSAIDS
Patient has know allergy to corticosteroids, contrast dye or anesthetics
Patient is unable to speak/read English
Patient is a prisoner
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Matched pill placebo
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients 18 to 75 years of age
Must have no current DSM-IV Axis I diagnosis as measured by the SCID (Structured Clinical Interview for DSM-IV-TR axis 1 disorders) with a trained study investigator. Past history of anxiety disorders, major depressive episodes or substance abuse disorders at least six months prior to baseline are not exclusionary.

Exclusion Criteria:

Patients will be excluded from entry into the study for current serious medical conditions or other conditions deemed likely to result in surgery or hospitalization.
Patients with a history of trauma resulting in head injury related seizures, or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary).
Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded.
Concurrent use of other antidepressants, benzodiazepines or antipsychotic medications.
Patients with a history of hypersensitivity to escitalopram are excluded.
Individuals must have discontinued MAO inhibitors more than 14 days before starting study drug.
Additional contraindicated drugs during the study are pimozide, furazolidine, isocarboxazid, lazabemide, and St. John's Wort.
Participants meeting DSM-IV or SCID criteria for a substance use disorder in the last six months other than nicotine dependence and those with a positive toxicology screen at baseline consistent with evidence of current substance abuse or dependence as determined by clinical interview.
A lifetime history of Bipolar or any psychotic disorder is excluded.
Current claustrophobia is exclusionary.
Patients currently taking any narcotic will be excluded.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
Eligibility criteria:
Inclusion Criteria:

-Pre-operative eligibility:

Patients above the age of 18, no upper age limit
English-speaking
Delayed reconstruction (mastectomy already performed) or immediate reconstruction (mastectomy at the same time as reconstruction)
Reconstruction using abdominal tissues including free MS-TRAM or DIEP

Exclusion Criteria:

Patient refusal
Inability to give informed consent
BMI > 40
Allergy to Bupivacaine
Known cardiac or liver disease (contraindicated for Bupivacaine use)

Patients who will undergo any of the following:

Implant breast reconstruction
Combined implant and autologous tissue reconstruction
Non-abdominally based autologous tissue reconstruction
Nonmicrosurgical abdominally based breast reconstruction (pedicled TRAM flap)
Drug addiction
Opioid tolerance defined as preoperative opioid use of >50 mg PO morphine equivalent
Psychiatric illness
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Saline IV Q8hr x3

Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for bilateral total knee replacement
Between 50-90 years of age

Exclusion Criteria:

Patients on steroid therapy
Patients that require stress-dose steroid pre-operatively
Patients that smoke
Patients that are diabetic
Patients younger than 50 or older than 90 years
Intervention: Amoxicillin
Trial phase: Phase 3
ATC code: A02BD01 | A02BD03 | A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD10 | A02BD11 | A02BD12 | A02BD13 | A02BD14 | A02BD15 | A02BD16 | J01CA04 | J01CR50
SMILES: [H][C@]12SC(C)(C)[C@H](C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 263
Group description: Amoxicillin 45mg/kg 12 hourly
Eligibility criteria:
Inclusion Criteria:

Clinical signs of WHO-defined severe pneumonia
Age 2 months to 59 months

Exclusion Criteria:

Clinical signs of WHO-defined very severe pneumonia
Clinical or laboratory diagnosis of meningitis
Clinical diagnosis of severe malnutrition (marasmus/kwashiorkor)
Clinical or laboratory diagnosis of severe anaemia requiring transfusion
HIV-exposure on rapid HIV antibody test (only observational data will be collected from these patients)
Elimination of signs of severe pneumonia in a child with wheeze after outpatient bronchodilator therapy
Chronic condition that may underlie or contribute to a presentation with respiratory distress such as: known chronic renal or cardiac disease, presence of cerebral palsy predisposing child to aspiration/hypostatic pneumonia
Established bronchiectasis or congenital abnormality of the lower respiratory tract
Upper airway obstruction producing stridor
Admission from outpatient clinic specifically for treatment of TB
Referral from another inpatient facility following treatment with injectable antibiotics for more than 24 hours or because the initial regimen is considered to have failed
Documented history of >48hours treatment with oral amoxicillin
Failure to obtain informed consent
Penicillin allergy
Intervention: Amphetamine
Trial phase: Phase 2
ATC code: N06BA01 | N06BA02
SMILES: CC(N)Cc1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 1
Group description: ADHD Medication: For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
Eligibility criteria:
Inclusion Criteria

Male or female adults ages 18-55 years.
A diagnosis of childhood onset Attention Deficit Hyperactivity Disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment. Childhood onset will be defined according to established research criteria, requiring onset of two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.

A score of 24 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS), or, for those individuals stably treated with a medication approved by the Food and Drug Administration for ADHD, a Clinical Global Impression (CGI) ADHD severity score of no greater than 4 ("moderately ill").

Those subjects treated with traditional ADHD pharmacotherapy must be on a stable, effective dose (per clinician evaluation) of an FDA-approved treatment for ADHD for at least one month at the time of enrollment.

A Deficient Emotional Self Regulation (DESR) T-score on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Emotional Control Scale of at least 65 and/or a score of 99 or more on the DESR.

Exclusion Criteria

For those subjects not treated for their ADHD at the time of enrollment, a history of non-response or intolerance to methylphenidate at adequate doses as determined by the clinician.
A history of intolerance to omega-3 fatty acids as determined by the clinician.
Pregnant or nursing females.
Serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease.
Glaucoma.
Clinically unstable psychiatric conditions including suicidality, homicidality, bipolar disorder, psychosis, or lifetime history of a clinically serious condition potentially exacerbated by a stimulant such as mania, or psychosis.
Tics or a family history or diagnosis of Tourette's syndrome.
Current (within 3 months) DSM-IV criteria for abuse or dependence with any psychoactive substance other than nicotine.
Allergies to fish or shellfish; multiple adverse drug reactions.
Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol.
Current use of Monoamine Oxidase (MAO) Inhibitor or use within the past two weeks.
Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.