anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ferumoxides
Trial phase: Phase 3
SMILES: [Fe+2].[Fe+3].[Fe+3].[O-2].[O-2].[O-2].[O-2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 337
Group description: Participants received ferumoxytol during AMAG-FER-IDA-301 [NCT01114139]. Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.
Eligibility criteria:
Key Inclusion Criteria include:

Participants who completed participation in study AMAG-FER-IDA-301 [NCT01114139]
Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301
Female participants who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test
Intervention: Guaifenesin
Trial phase: Phase 2
ATC code: R05CA03
SMILES: COc1ccccc1OCC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
Eligibility criteria:
Inclusion Criteria:

Symptoms of cough, thickened mucus and chest congestion
Able to produce sputum
Non Smoker

Exclusion Criteria:

Pregnant
Smokers
Fever above 101°F
Any chronic illness
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: 32
Group description: Pre-Induction:

Lidocaine Loading: 1 mg/kg

Post- Induction:

Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
Eligibility criteria:
Inclusion Criteria:

Patients scheduled to undergo abdominal surgical procedures
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
18 - 80 years of age
American Society of Anesthesiologists (ASA) physical status classification: Class I - III adults of either sex
Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine or blood pregnancy test
Patients with systolic blood pressure greater than 80 and less than 150 at baseline, diastolic blood pressure less than 100 at baseline.

Exclusion Criteria:

Inability to comprehend the pain assessment tools.
Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases,
Peptic ulcer disease or bleeding disorders
Patients with history of hepatic, renal, cardiac failure, organ transplant, or diabetes
Patients with reactive airway disease (asthma)
Patients with seizures
Chronic use of ß-blocker or calcium channel blocker
Morbid obesity (body mass index >40)
Pregnant or lactating women
Subjects with a history of alcohol or drug abuse within the past 3 months
Any other conditions or use of any medication which may interfere with the conduct of the study
Intervention: Esmolol
Trial phase: Phase 4
ATC code: C07AB09
SMILES: COC(=O)CCc1ccc(OCC(O)CNC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Pre-Induction: Loading dose 750 mcg/Kg (0.75 mg/kg) Post-Induction: Infusion dose 7.5 - 15 mcg /kg/min
Eligibility criteria:
Inclusion Criteria:

Patients scheduled to undergo abdominal surgical procedures
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
18 - 80 years of age
American Society of Anesthesiologists (ASA) physical status classification: Class I - III adults of either sex
Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine or blood pregnancy test
Patients with systolic blood pressure greater than 80 and less than 150 at baseline, diastolic blood pressure less than 100 at baseline.

Exclusion Criteria:

Inability to comprehend the pain assessment tools.
Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases,
Peptic ulcer disease or bleeding disorders
Patients with history of hepatic, renal, cardiac failure, organ transplant, or diabetes
Patients with reactive airway disease (asthma)
Patients with seizures
Chronic use of ß-blocker or calcium channel blocker
Morbid obesity (body mass index >40)
Pregnant or lactating women
Subjects with a history of alcohol or drug abuse within the past 3 months
Any other conditions or use of any medication which may interfere with the conduct of the study
Intervention: Mitomycin
Trial phase: Phase 2
ATC code: L01DC03
SMILES: [H][C@]12N[C@@]1([H])CN1C3=C(C(=O)C(N)=C(C)C3=O)[C@@H](COC(N)=O)[C@]12OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 51
Group description: Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
Eligibility criteria:
Inclusion Criteria:

Age 18 to 80
Presence of primary or recurrent pterygium
Pterygium grows greater than 2mm onto cornea from limbus (using slit lamp light beam to measure size)
Pterygium is inducing astigmatism greater than 1 diopter compared to the fellow eye (to be determined by automated keratometry and manifest refraction)
The pterygium is symptomatic (irritation, inflammation, strabismus, decreased visual acuity)

Exclusion Criteria:

Age less than 18
Age greater than 80
Any systemic rheumatologic or autoimmune disorder (autoimmune hepatitis, bullous pemphigoid, celiac disease, Crohn's disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, systemic lupus erythematosus, mixed connective tissue disease, pemphigus vulgaris, psoriasis, polymyositis, rheumatoid arthritis, scleroderma, Sjogren's disease, ulcerative colitis, vasculitis, Wegener's granulomatosus)
Women who are potentially child-bearing (no possibility of pregnancy for at least one month after surgery)
Any use within the past two months of topical eye drops other than artificial tears in the study eye
Any previous intravitreal injections of any medication in the study eye
Any previous use of systemic, topical, or intravitreal bevacizumab in either eye
Any history of subconjunctival injections in the study eye within the past year
Any history of scleral or corneal laceration in the study eye
Ocular surgery within the past 3 months in the study eye
History of scleral buckle placement in the study eye
History of glaucoma
Intervention: Eplerenone
Trial phase: Phase 3
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 | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
Eligibility criteria:
Inclusion Criteria:

Japanese chronic systolic heart failure patients with LVEF =<30% by echocardiography and NYHA II or more
Patients who receive standard therapy (Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blocker or diuretic)

Exclusion Criteria:

Patients with a myocardial infarction, stroke, cardiac surgery or percutaneous coronary intervention within 30 days prior to randomization.
Patients with serum potassium >5.0 mmol/L or eGFR <30 ml/min/1.73 m2.
Intervention: Leuprolide
Trial phase: Phase 4
ATC code: L02AE02 | L02AE51
SMILES: CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H]1CCC(=O)N1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: One 3.75-mg intramuscular injection of leuprolide acetate
Eligibility criteria:
Inclusion Criteria:

Women 18-45 years old
Premenopausal
Willingness to use barrier methods of contraception during study and after completion of study until menses resume
Good general health

Exclusion Criteria:

Pregnancy or currently breastfeeding
Hot flushes
Mid-luteal phase progesterone <3ng/mL
Clinically significant abnormalities in screening blood tests
BMI > 35 kg/m2
Previously diagnosed osteoporosis or osteopenia
Clinically significant depressive symptoms
Psychiatric illness
Sleep apnea or periodic limb movement of sleep (PLMS)
Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
Current or recent use of centrally active medications
Current or recent use of systemic hormone medications
Night shift workers
Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep, or mood
Abnormal vaginal bleeding
History of any medical diseases that may put subject at risk when treated with study medication.
Intervention: Prucalopride
Trial phase: Phase 3
ATC code: A06AX05
SMILES: COCCCN1CCC(NC(=O)c2cc(Cl)c(N)c3c2OCC3)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: 1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
Eligibility criteria:
Inclusion criteria to be assessed at screening:

Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.
Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids;has been on stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on stable daily dose of opioids for at least 15 weeks after Visit 1.
Subject is suffering from OIC (i.e. secondary to chronic opioid use).
Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.

Main exclusion criteria to be assessed at screening:

Constipation is thought to be drug-induced (except for opioids)
Disallowed medication is being used
Subject was on chronic therapy for chronic constipation prior to start of opioid therapy
Subject is suffering from secondary causes of chronic constipation.
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.

Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study.
Eligibility criteria:
Inclusion Criteria:

Women age 40 years old or older
Menopausal symptoms of at least 3 months duration, including irregular periods and/or hot flushes
Minimum score of 15 on the Hamilton Rating Scale for Depression (17-item),
Patients will meet criteria for a major depressive episode, verified using the Mini International Neuropsychiatric Interview (MINI).
Subjects will be able to be treated on an outpatient basis, and
Subjects will be able to provide written informed consent

Exclusion Criteria:

Subjects presently taking antidepressant medication,
Subjects currently using hormone replacement therapy,
Other Axis I disorders, except Generalized Anxiety Disorder or Panic Disorder, according to the Mini International Neuropsychiatric Interview (MINI)
"uncontrolled" narrow angle glaucoma
known hypersensitivity to duloxetine or any of the inactive ingredients
treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.
Presence of psychotic symptoms,
History of mania or hypomania,
HAM-D suicide item score > 3,
End stage renal disease or severe renal impairment
Abnormal uterine bleeding (heavy or prolonged uterine bleeding, menstrual periods occurring more frequently than every 3 weeks, bleeding after sexual intercourse, spotting between periods) that has not been evaluated by a gynecologist.
Subjects with serious or unstable medical illness, including alcohol or substance abuse, cardiovascular, hepatic, respiratory, endocrine, neuralgic, or hematologic disease, history of seizure disorder
Subjects taking medications that may interact with duloxetine
Intervention: Lornoxicam
Trial phase: Phase 2
ATC code: M01AC05
SMILES: CN1C(C(=O)Nc2ccccn2)=C(O)c2sc(Cl)cc2S1(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
Eligibility criteria:
Inclusion Criteria:

Men and women (non-childbearing potential) with a diagnosis of Alzheimer's Disease according to the NINCDS-ADRDA clinical criteria.
Mild to moderate stage of Alzheimer's disease according to MMSE 18-26 inclusive.
Modified Hachinski Ischemic Scale equal to or below 4.
Geriatric Depression Scale below or equal 7.
If anticholinesterasic treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 1).
If Memantine treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 1).

Exclusion criteria:

1. Clinical, laboratory or neuroimaging findings consistent with:

other primary degenerative dementia, (dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Jacob-Creutzfeld Disease, Down's syndrome, etc.)
other neurodegenerative condition (Parkinson's Disease, amyotrophic lateral sclerosis, etc.)
cerebrovascular Disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions > one quarter of the total white matter)
other central nervous system diseases (severe head trauma, tumors, subdural haematoma or other space occupying processes, etc.)
seizure disorder

other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency confirmed by current analyses not older than 1 month, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.) 2. A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder.

3. Chronic daily drug intake for a time period of ≥ 14 days or expected for ≥ 14 days: "

antidepressants, benzodiazepines, neuroleptics, major sedatives or other anti-inflammatory drugs including acetylic salicylic acid defined
antiepileptics
anticholinergics
nootropics (including Ginkgo)
centrally active anti-hypertensive drugs (clonidine, alpha-methyl dopa, guanidine, guanfacine,)
opioid containing analgesics
anti-inflammatory agents, cortico-steroids or immunosuppressants
Cimetidin as gastroprotective drug 4. Severe thrombocytopenia defined as platelet counts <100.000 per mm3. 5. Coagulation disorders
Intervention: Naproxen Sodium
Trial phase: Phase 4
SMILES: COc1ccc2cc(C(C)C(=O)[O-])ccc2c1.[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
Eligibility criteria:
Inclusion Criteria:

Healthy, ambulatory, male and female volunteers between 16-45 years of age;
Scheduled to undergo surgical removal of 1 to 3 impacted third molars, one of which must be at least a partial bony mandibular impaction;
Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of >/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale by 2030 h +/- 15 minutes on the day of surgery;
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g. oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy;
Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects <18 years of age must sign a written assent and have parental or guardian consent).

Exclusion Criteria:

History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal antiinflammatory drugs (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products;
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator;
Current or past history of bleeding disorder(s);
Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator;
Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months;
Positive alcohol breathalyzer test and negative urine drug test prior to surgery;
Females who are pregnant or lactating;
Chronic or severe sleep problems that do not respond to Over the counter (OTC) medication and requires a prescription hypnotic or sedative;
Intervention: Naproxen Sodium
Trial phase: Phase 4
SMILES: COc1ccc2cc(C(C)C(=O)[O-])ccc2c1.[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
Eligibility criteria:
Inclusion Criteria:

Healthy, ambulatory, male and female volunteers between 16-45 years of age;
Scheduled to undergo surgical removal of 1 to 3 impacted third molars, one of which must be at least a partial bony mandibular impaction;
Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of >/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale by 2030 h +/- 15 minutes on the day of surgery;
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g. oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy;
Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects <18 years of age must sign a written assent and have parental or guardian consent).

Exclusion Criteria:

History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal antiinflammatory drugs (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products;
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator;
Current or past history of bleeding disorder(s);
Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator;
Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months;
Positive alcohol breathalyzer test and negative urine drug test prior to surgery;
Females who are pregnant or lactating;
Chronic or severe sleep problems that do not respond to Over the counter (OTC) medication and requires a prescription hypnotic or sedative;