anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ramelteon
Trial phase: Not Applicable
ATC code: N05CH02
SMILES: CCC(=O)NCC[C@@H]1CCc2ccc3c(c21)CCO3
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Ramelteon 8 mg will be given prior to a 2-hour nap
Eligibility criteria:
Inclusion Criteria:

Aged between 18-35 years;
Non-smoking for at least 6 months;
Healthy (no medical, psychiatric or sleep disorders);
No clinically significant deviations from normal in medical history, vital signs, physical examination, blood chemistry and hematology, and ECG;
Women of childbearing potential must agree to use an acceptable method of birth control, and must have a negative serum pregnancy test;
Body mass index of > 18 or < 30 kg/m∧2;
No drugs or medication likely to affect sleep or alertness, as determined by the investigators;
Habitual caffeine consumption < 300 mg per day on average;
Habitual alcohol consumption < 10 alcoholic units per week on average.

Exclusion Criteria:

History of alcohol or substance abuse;
Positive result on drugs of abuse screening;
Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, or any significant sleep complaint;
Psychiatric disorder, including a history of depression or dysthymia (characterized by depressed mood on the majority of days for at least two years);
Recent acute or chronic medical disorder, including but not limited to hepatic impairment and severe chronic obstructive pulmonary disease;
History of intolerance or hypersensitivity to melatonin or melatonin agonists;
Pregnancy or lactation;
Shift work;
Transmeridian travel (2 or more time zones) in past 2 months;
Any other scientific or medical reason, as determined by the PI, such as non-compliance with protocol or intolerance to inpatient study conditions.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2 | Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.

Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
Eligibility criteria:
Inclusion Criteria:

Patients with clinical activity score (CAS) of ≥4 and moderate to severe disease severity, as defined by thyroid eye disease severity scale based on the first letter of the defining characteristic of each class, the classification is known as: 'no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss' (NOSPECS) score
Euthyroid for at least 6-8 weeks
No immediate need for decompression surgery
With disease progression over the previous 1-2 months or without evident improvement in the prior 6 months.

Exclusion Criteria:

Corticosteroid use in the preceding 4 weeks
HIV, hepatitis C or hepatitis B infections
Denied consent for HIV or hepatitis testing
Mild or inactive Graves' ophthalmopathy
Orbital radiotherapy within 18 months or orbital surgery within the past year
Absolute neutrophil count < 1,500/mm^3
Pregnant or nursing patients
Coronary artery disease, congestive heart failure, significant arrhythmias, significant infection or immunodeficiency, other serious illnesses
Intervention: Salmeterol
Trial phase: Not Applicable
ATC code: R03AC12 | R03AK06 | R03AK12
SMILES: OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Arg/Arg subjects on 2 week salmeterol treatment

salmeterol: salmeterol 50 micrograms twice daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Both male and female
18 to 50 years of age
Resting FEV1 ≥ 65% of predicted normal
Exercise-induced bronchoconstriction defined as a decrease in FEV1 of ≥ 20% following a standardized exercise challenge when compared to pre-exercise baseline FEV1 value measured 5 minutes before exercise
Must be Arg/Arg or Gly/Gly genotype

Exclusion Criteria:

Long-acting beta agonist use within 12 weeks of the first exercise challenge
Smoking within past 12 months
Greater than 10-pack years smoking history
Unresolved signs and/or symptoms of an upper respiratory tract infection within 4 weeks of first exercise challenge
Asthma exacerbation within 4 weeks of first exercise challenge requiring change in type, dose or frequency of medications and/or an unscheduled visit to an health care provider, including emergency room or hospital
Subject has exercised or performed strenuous activity within 72 hours of the first exercise challenge
Subject has been exposed to cold air sufficient to provoke symptoms of bronchospasm within 2 hours of exercise challenge
In addition to asthma, the subject has an active, acute or chronic pulmonary disorder documented by history, physical examination, or chest x-ray
Subject has evidence of ischemic, valvular, hypertrophic, familial or other forms of heart disease that would put the subject at risk during exercise testing or that would interfere with the ability to achieve protocol-specified heart rates during exercise testing
Subject has used systemic corticosteroids within 1 month of first exercise challenge
Intervention: Salmeterol
Trial phase: Not Applicable
ATC code: R03AC12 | R03AK06 | R03AK12
SMILES: OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Gly/Gly subjects on 2 week salmeterol treatment

salmeterol: salmeterol 50 micrograms twice daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Both male and female
18 to 50 years of age
Resting FEV1 ≥ 65% of predicted normal
Exercise-induced bronchoconstriction defined as a decrease in FEV1 of ≥ 20% following a standardized exercise challenge when compared to pre-exercise baseline FEV1 value measured 5 minutes before exercise
Must be Arg/Arg or Gly/Gly genotype

Exclusion Criteria:

Long-acting beta agonist use within 12 weeks of the first exercise challenge
Smoking within past 12 months
Greater than 10-pack years smoking history
Unresolved signs and/or symptoms of an upper respiratory tract infection within 4 weeks of first exercise challenge
Asthma exacerbation within 4 weeks of first exercise challenge requiring change in type, dose or frequency of medications and/or an unscheduled visit to an health care provider, including emergency room or hospital
Subject has exercised or performed strenuous activity within 72 hours of the first exercise challenge
Subject has been exposed to cold air sufficient to provoke symptoms of bronchospasm within 2 hours of exercise challenge
In addition to asthma, the subject has an active, acute or chronic pulmonary disorder documented by history, physical examination, or chest x-ray
Subject has evidence of ischemic, valvular, hypertrophic, familial or other forms of heart disease that would put the subject at risk during exercise testing or that would interfere with the ability to achieve protocol-specified heart rates during exercise testing
Subject has used systemic corticosteroids within 1 month of first exercise challenge
Intervention: Omeprazole
Trial phase: Phase 3
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: 130
Group description: Esomeprazole 20 mg once daily oral
Eligibility criteria:
Inclusion Criteria:

Medical history of gastric and/or duodenal ulcer
A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion Criteria:

Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
History of esophageal, gastric or duodenal surgery
Having severe liver disease or chronic renal disease
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: This group will receive ketamine

ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.

Dosing Regimen:

All patients will begin the ketamine infusion at 0.05 mg/kg/hour.

4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:

the patient's pain has not improved to an acceptable level (pain score is still ≥5)
side effects remain acceptable
4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour
4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
The maximum dose of ketamine will be limited to 300 mg per 24 hours

The patient may receive ketamine up to 72 hours after initiation.
Eligibility criteria:
Inclusion Criteria:

CCMC: Children ages 7-22 years (inclusive) with documented sickle cell disease
UCHC: Adults 18 years (inclusive) and above with documented sickle cell disease
Sudden onset of acute pain consistent with a vasoocclusive episode -Pain requiring hospitalization, placement on pain protocol, and patient- controlled opiates
Pain score of greater than or equal to 5 out of 10 when ketamine infusion is started
Cognitive ability to report pain on a 0 to 10 Numerical Rating Scale (NRS)
At least one prior hospitalization for vasoocclusive pain at CCMC in the previous 24 months
Parental consent and child assent

Exclusion Criteria:

Children hospitalized for a primary diagnosis other than vasoocclusive episode
Concurrent Acute Chest Syndrome (ACS)
Hemoglobin < 5 mg/dL
Concurrent history of glaucoma or raised intracranial pressure
Signs or symptoms consistent with stroke
History of liver or renal dysfunction
Pregnancy (females age 12 and above must have pregnancy test)
Simultaneous participation in investigational drug study
Primary language spoken other than English
No hospitalizations to CCMC for vasoocclusive pain in the previous 24 months
Intervention: Varenicline
Trial phase: Phase 2
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 220
Group description: 2 milligrams varenicline once per day for 2-8 weeks
Eligibility criteria:
Inclusion Criteria:

At least 18 years old
Able to get to research lab in Burlington, Vermont or Omaha, Nebraska
Daily smoker
Smoke at least 8 cigarettes per day
No reduction in smoking in last 30 days
No intention to quit in the next 30 days
Never used Varenicline before
Not currently using smoking cessation medications or nicotine replacement therapy
Willing to use Varenicline for at least 2 weeks
Fluent in English

Exclusion Criteria:

Cannot be currently pregnant or breastfeeding
Kidney disease
Frequent nausea
On certain medications for asthma and/or depression
Another household member in study
Intervention: Lubiprostone
Trial phase: Phase 3
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 221
Group description: Lubiprostone : 24 mcg capsules twice daily (BID)
Eligibility criteria:
Inclusion Criteria:

Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
Diagnosis of opioid-induced bowel dysfunction (OBD) as confirmed during the screening period.
If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
Use of prescribed or Over-the-Counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
If treated for clinical depression with Selective serotonin reuptake inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.

Exclusion Criteria:

Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.
Intervention: Vancomycin
Trial phase: Not Applicable
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: 6
Group description: This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
Eligibility criteria:
Inclusion Criteria:

> 18 years old
currently receiving short-daily HD six times per week
have no other acute intercurrent illness

Exclusion Criteria:

history of a vancomycin, gentamicin or levofloxacin allergy
weight within ± 30% of their ideal body weight
Hgb < 10 mg/dl
Intervention: Ciprofloxacin Hydrochloride
Trial phase: Phase 4
SMILES: Cl.O.O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
Eligibility criteria:
Inclusion Criteria:

Must be a patient of Johns Hopkins Urology Outpatient Clinic
Must have an elevated PSA (> 2.5 ng/mL) and be selected on the basis of a serum PSA evaluation for Transrectal Ultrasound (TRUS)/biopsy
Must be able to understand and willing to adhere to the study protocol
Must be willing to take the antibiotic or placebo for two weeks prior to the biopsy and agree to have the biopsy regardless of the change in PSA

Exclusion Criteria:

Abnormal digital rectal examination
Anyone currently being treated or who have been treated for any prostatic diseases (prostatitis, prostate Benign Prostatic Hyperplasia (BPH) surgery, prostate cancer) or urinary tract infection in the past
Anyone taking medications that are likely to alter serum PSA concentration (specifically, androgen steroid hormones, antiandrogens, finasteride, Leutinizing Hormone Releasing Hormone (LHRH) analogues)
Anyone unwilling to sign the informed consent or who are unlikely to adhere to the study protocol
Anyone with a known allergy to fluoroquinolone antibiotics
Anyone on blood thinning medication (Coumadin)
Anyone taking Tizanidine
Anyone with a history of seizures or cerebral arteriosclerosis
Anyone who has taken an antibiotic medication within the past two weeks
Intervention: Pregabalin
Trial phase: Phase 3
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
Eligibility criteria:
Inclusion Criteria:

Completed the previous protocol and wish to continue to receive pregabalin.
Diagnosis of epilepsy with partial seizures

Exclusion Criteria:

Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
Intervention: Alprostadil
Trial phase: Phase 4
ATC code: C01EA01 | G04BE01
SMILES: CCCCCC(O)C=CC1C(O)CC(=O)C1CCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 416
Group description: Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.

Alprostadil: - Active Substance: Prostaglandin E1

Pharmaceutical Form: solution for infusion
Concentration: 40 μg b.d.
Route of Administration: intravenous infusion
Eligibility criteria:
Inclusion Criteria:

Subject is at least 45 years of age
Subjects with macro-angiopathy, proven PAOD Stage IV with up to 2 ischaemic skin lesions for more than 2 weeks
Subject has a complete angiography of pelvis, thigh and calf within one month of inclusion
Systolic ankle pressure ≤ 70 mmHg in subjects without media sclerosis of the lower limb artery or systolic big toe pressure ≤ 50 mmHg in diabetics with media sclerosis of the lower limb artery
Subject is not in the position to be primarily revascularized or refuses surgery

Exclusion Criteria:

Imminent or foreseeable amputation
Major amputation on the affected extremity
History of chronic alcohol or drug abuse
More than two ischemic ulcerations
One ulcer ≥ 6 cm^2, both ulcers ≤ 1 cm^2 or at least one ulcer affecting the bone or tendons
Acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin
Neuropathic or venous ulcers
Buerger's disease
Septic gangrene
Use of vasoactive medication or prostaglandins
Treatment with prostanoids within 3 months prior to inclusion
Surgical or interventional measures performed on the affected extremity within 3 months prior to study drug treatment
Intervention: Lubiprostone
Trial phase: Phase 3
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 223
Group description: Lubiprostone : 24 mcg capsules twice daily (BID)
Eligibility criteria:
Inclusion Criteria:

Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening period.
If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
Use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
If treated for clinical depression with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.

Exclusion Criteria:

Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
Intervention: Pramipexole
Trial phase: Phase 4
ATC code: N04BC05
SMILES: CCCN[C@@H]1CCc2nc(N)sc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 0.125 mg BID-0.75 mg BID - matching placebo
Eligibility criteria:
Inclusion Criteria:

Subjects between 18 and 65 years of age, who meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for BPD I or II (by SCID) and confirmed in the diagnostic consensus conference will be included.
Subjects must also meet criteria for euthymia described above.
All subjects must be taking a standard mood stabilizer at a stable therapeutic dose (i.e. lithium, carbamazepine, valproate, lamotrigine).

Exclusion Criteria:

Subjects with a history of central nervous system (CNS) trauma, neurological disorder, Attention Deficit Hyperactivity Disorder (ADHD), or learning disability will be excluded.
Subjects with a DSM-IV diagnosis of current or recent substance abuse or dependence (in the previous 1 month) will be excluded.
Moreover, subjects with rapid-cycling during the past year will be excluded (based on SCID).
Any subject with an active, unstable medical problem that may interfere with cognition will be excluded based on the investigator's judgment.

While medication status is an important consideration in any study of bipolar disorder, the exclusion of patients taking any medication is not practical, given the high prevalence of combination pharmacotherapy for bipolar disorder. To help control for medication effects on cognition, we plan to limit the types of medications allowed by excluding certain medications with a known impact on cognitive performance.

Subjects taking clozapine will be excluded due to it's potential overlapping mechanisms of action with pramipexole.
Subjects taking prescription or over-the counter medications may also be excluded if these medications have been shown to impact cognition (i.e. diphenhydramine).
The use of benzodiazepines, sedatives, or sleeping pills, within 6 hours of neurocognitive testing will not be allowed. In addition, patients taking topiramate, tricyclic antidepressants, or anticholinergic medications that are known to impact cognition will be excluded from participation.
Subjects taking any medications that are known to interact with pramipexole (i.e. Zantac, Tagamet, Reglan, Benemid, Probalan, Compazine, Phenergan, quinidine, selegiline, verapamil, and any other medication with a known interaction) will also be excluded.