anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Estradiol
Trial phase: Phase 3
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 182
Group description: One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle)
Eligibility criteria:
Inclusion Criteria:

- Postmenopausal women >40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week

Exclusion Criteria:

The usual exclusion criteria for hormone therapy apply
Intake of medications other than hormones affecting hot flushes
Intervention: CGC-11047
Trial phase: Phase 1
SMILES: CCNCCCNC/C=C\CNCCCNCC.Cl.Cl.Cl.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
Eligibility criteria:
Inclusion Criteria:

Patients with a diagnosis of subfoveal choroidal neovascularization secondary to AMD in the study eye, with leaking present on a fluorescein angiogram as determined by the clinical investigator.
Visual acuity: BCVA in the study eye between 20/40 and 20/320 and better than or equal to 20/320 in the fellow eye.
Patients who refuse standard of care or have not benefited from standard of care in the opinion of the principal investigator.
Clear ocular media and adequate pupillary dilatation to permit good quality ophthalmologic exam.
Male or female patients aged >= 50 years.
Ability to understand and the willingness to sign a written informed consent document and return for all study visits.

Exclusion Criteria:

Patients with CNV not due to AMD in the study eye.
Patients with a retinal tear in the study eye.
Patient has a subretinal hemorrhage that comprises more than 50% of total lesion size, or has atrophy or fibrosis in the center of fovea.
Patients who have undergone intraocular surgery within 2 months or extrafoveal/juxtafoveal laser within 3 months of study entry in the study eye.
Any macular disease other than AMD causing vision loss in either eye.
Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye. Anterior segment diseases such as blepharitis, ocular rosacea, lid problems which could increase the risk of infection after study drug injection.
Uncontrolled glaucoma (defined as intraocular pressure >25 mmHg (P0) on maximum medical therapy) or clinically significant glaucomatous visual field loss in both eyes.
Significant media opacities, including cataract that might interfere with visual acuity, assessment of toxicities or fundus photography in the study eye in the judgement of the clinical investigator.
Spherical refractive error more than -8.0 diopters in the study eye.
Use of any approved or investigational AMD agent (standard of care) within four weeks of study enrollment.
Use of any systemic investigational agent within 30 days of study enrollment.
Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients with a clinically significant or symptomatic cardiac arrhythmia, recent myocardial infarction (within 6 months), or evidence of a current significant ventricular conduction abnormality.
Women who are pregnant or breast-feeding.
Women of childbearing potential and male patients who are partners of women of childbearing potential who are unwilling to use approved, effective means of contraception according to the institution's standards.
Allergy to fluorescein dye.
Intervention: Celecoxib
Trial phase: Phase 4
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
Eligibility criteria:
Inclusion Criteria:

Patients with first acute ankle sprain episode in the last six months classified as grade I or II, confirmed by X-rays, according to the following definitions:
Grade I: When the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior draw test is negative.
Grade II: Moderate sprains which usually result in partial tears af the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. Ligamentous laxity may be present and there is moderate swelling.

Exclusion Criteria:

Patients who have a similar injury of the same joint within the last six months; or
clinical evidence of complete rupture of ankle ligaments (third degree sprain), or
requirements for bed rest, hospitalization, surgical intervention for the ankle injury; or
evidence of fractures; or non-removable full cast of any tipe; or
presence of bilateral occurrence of ankle injury or ipsilateral ankle and knee injury.
Intervention: Olanzapine
Trial phase: Phase 1 | Phase 2
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 30
Group description: The patients were newly diagnosed with psychosis and this is their first exposure to an antipsychotic.

Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
Eligibility criteria:
Age 18-64
Maximum cumulative (lifetime) antipsychotic exposure of one week, and no antipsychotic use in the previous 30 days before enrolling in the study
No history of diabetes or other serious medical or neurological condition associated with glucose intolerance or insulin resistance (eg, Cushing disease),
Not taking a medication associated with insulin resistance (eg, hydrochlorothiazide, furosemide, ethacrynic acid, metolazone, chlorthalidone), beta blockers, glucocorticoids, phenytoin, nicotinic acid, cyclosporine, pentamidine, or narcotics)
No history of cocaine use in the previous 30 days, and
No laboratory evidence of diabetes at baseline (fasting glucose <126 mg/dL or 2-hour glucose <200 mg/dL on a glucose tolerance test)
Intervention: Atomoxetine
Trial phase: Phase 3
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 199
Group description: 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria:

6 to 16 years old
Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL)
Pharmacological naïve
Normal intelligence as assessed by investigator
Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.

Exclusion Criteria:

Exclusion criteria

History of bipolar disorder, any history of psychosis or autism spectrum disorder
History of any seizure disorder
Significant prior or current medical conditions
History of alcohol or drug abuse within the past 3 months
Patients who are taking concurrently any of the excluded medications in the study.
Intervention: Tamsulosin
Trial phase: Not Applicable
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 53
Group description: Intervention - Tamsulosin

Tamsulosin: Study Drug
Eligibility criteria:
Inclusion Criteria:

Emergency Department patients with acutely symptomatic renal colic pain
Confirmation of a symptomatic stone will be made by imaging (helical CT scan or intravenous pyelogram).

Exclusion Criteria:

Stones not documented on imaging
Stones >10mm
Pregnancy
Age <18 years
Evidence of infection with an obstructing stone
Obstructing stone in a solitary kidney
Currently taking tamsulosin, vardenafil, nifedipine, or steroids
Contraindications or allergy to tamsulosin
Ureteral surgery
Patients that are unable to understand consent
Patients that are unable to comply with follow-up
Intervention: Famciclovir
Trial phase: Phase 2
ATC code: J05AB09 | S01AD07
SMILES: CC(=O)OCC(CCn1cnc2cnc(N)nc21)COC(C)=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 18
Group description: Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
Eligibility criteria:
Inclusion Criteria:

Male and female patients from 1 month up to 1 year of age with herpes simplex infection

Exclusion Criteria:

Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Everolimus
Trial phase: Phase 2
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Oral RAD001 10 mg daily for 30 days
Eligibility criteria:
Inclusion Criteria:

Patients with SM; including mast cell leukemia.
Age >/= 18 years
Minimum of two weeks since any major surgery or completion of radiation.
Eastern Cooperative Oncology Group (ECOG) performance status </= 2
Adequate liver function as shown by serum bilirubin </= 1.5 x upper limit of normal (ULN), and serum Alanine transaminase (ALT) </= 3 x ULN
Prothrombin Time (PT)/Partial thromboplastin time (PTT)/International normalized ratio (INR) within normal institutional limits
Signed informed consent

Exclusion Criteria:

Treatment with any conventional (specifically, interferon or cladribine) or investigational medicine for SM within the preceding 4 weeks
Chronic treatment with systemic steroids or another immunosuppressive agent
Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin, unless patient has SM-associated clonal hematologic disease that does not require therapy, as judged by treating physician and approved by principal investigator.
Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study as judged by the Principal Investigator (i.e., severely impaired lung function, uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
A known history of Human immunodeficiency virus (HIV) seropositivity
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 as judged by the Principal Investigator (e.g., ulcerative disease; uncontrolled nausea, vomiting or diarrhea; malabsorption syndrome or small bowel resection)
Patients with a bleeding diathesis or on oral anti-vitamin K medication
Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control (women of childbearing potential must have a negative urine or serum pregnancy test within 48 hours prior to administration of RAD001; protocol definition of post-menopausal women is: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/m or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy)
Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus)
Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
Patients unwilling to or unable to comply with the protocol
Intervention: Sumatriptan
Trial phase: Phase 4
ATC code: G01AE10 | N02CC01
SMILES: CNS(=O)(=O)Cc1ccc2[nH]cc(CCN(C)C)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Sumatriptan 100 mg tablet
Eligibility criteria:
Inclusion Criteria:

Treated in the emergency department for acute primary headache

Exclusion Criteria:

Allergy, intolerance, or contra-indication to one of the study medications
Intervention: Naproxen
Trial phase: Phase 4
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Naproxen 500 mg tablet
Eligibility criteria:
Inclusion Criteria:

Treated in the emergency department for acute primary headache

Exclusion Criteria:

Allergy, intolerance, or contra-indication to one of the study medications
Intervention: Cholecalciferol
Trial phase: Not Applicable
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 30
Group description: vitamin D3 50,000 IU weekly
Eligibility criteria:
Inclusion Criteria:

Subjects seen initially at the Emory CF center between the months of September and December
Age > 16, both males and females, confirmed cystic fibrosis by genetic testing or sweat testing, FEV1 > 40%.

Exclusion Criteria:

History of lung transplant or awaiting lung transplantation
Current hospitalization or greater than 6 hospitalizations/year
History of malignancy, renal disease (calculated GFR < 50% reduced from normal), liver disease (AST or AST > 3 times upper limit of normal), greater than 10 mg of prednisone or equivalent, hypercalcemia
History of easily burned skin after sunlight exposure, taking medications with may cause photosensitivity
History of skin cancer or multiple moles or family history of skin cancer
Moderate to severe vitamin D deficiency (25(OH)D ≤ 15 ng/ml).
Intervention: Hydrogen
Trial phase: Not Applicable
SMILES: [HH]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 30
Group description: vitamin D2 50,000 IU weekly
Eligibility criteria:
Inclusion Criteria:

Subjects seen initially at the Emory CF center between the months of September and December
Age > 16, both males and females, confirmed cystic fibrosis by genetic testing or sweat testing, FEV1 > 40%.

Exclusion Criteria:

History of lung transplant or awaiting lung transplantation
Current hospitalization or greater than 6 hospitalizations/year
History of malignancy, renal disease (calculated GFR < 50% reduced from normal), liver disease (AST or AST > 3 times upper limit of normal), greater than 10 mg of prednisone or equivalent, hypercalcemia
History of easily burned skin after sunlight exposure, taking medications with may cause photosensitivity
History of skin cancer or multiple moles or family history of skin cancer
Moderate to severe vitamin D deficiency (25(OH)D ≤ 15 ng/ml).
Intervention: Ferrous Sulfate
Trial phase: Phase 2
ATC code: B03AA07
SMILES: O=S(=O)([O-])[O-].[Fe+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

Ferrous Sulfate: Iron group
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
Anemia (Hemoglobin < 13.0 g/dL)
≤ 72 hours from hospital admission
Current tolerance of enteral medications
Expected ICU LOS > 5 days

Exclusion Criteria:

Active bleeding
Chronic inflammatory disease
End-stage renal disease
Hematologic disorders
Macrocytic anemia
Current use of erythropoietin
Pregnancy
Prohibition of RBC transfusions
Moribund state in which death is imminent
Enrollment in another clinical trial
Intervention: Lidocaine
Trial phase: Phase 2
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: 5% topical lidocaine cream.
Eligibility criteria:
Inclusion Criteria:

women with the clinical diagnosis of vvs who have dyspareunia as their primary complaint. They must have a current sexual partner.

Exclusion Criteria:

postmenopausal
pure vaginismus
generalized vulvodynia
pudendal neuralgia
pregnant, breastfeeding
less than 2 months post delivery
diagnosis of dermatologic condition on biopsy
positive fungal culture
currently on treatment for vvs
history of lidocaine treatment for vvs
Intervention: Ibuprofen and famotidine
Trial phase: Phase 3
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1.NC(N)=Nc1nc(CSCCC(N)=NS(N)(=O)=O)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 415
Group description: HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
Eligibility criteria:
Inclusion Criteria:

Expected to require daily administration of a nonsteroidal anti-inflammatory drug (NSAID) for at least the coming six months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain.
Did not use a NSAID within the 30 days prior to study entry

Exclusion Criteria:

History of erosive esophagitis

History of any of the following serious gastrointestinal complications:

perforation of ulcers,
gastric outlet obstruction due to ulcers,
gastrointestinal bleeding.
Active cardiac, renal, and/or hepatic disease
Current Helicobacter pylori (H. pylori) infection
Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry.
Uncontrolled diabetes
Uncontrolled hypertension
Positive pregnancy test at screening
Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Currently participating, or participation within 30 days prior to study entry, in an investigational drug study

Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria.
Intervention: Ibuprofen
Trial phase: Phase 3
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 212
Group description: Ibuprofen 800mg
Eligibility criteria:
Inclusion Criteria:

Expected to require daily administration of a nonsteroidal anti-inflammatory drug (NSAID) for at least the coming six months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain.
Did not use a NSAID within the 30 days prior to study entry

Exclusion Criteria:

History of erosive esophagitis

History of any of the following serious gastrointestinal complications:

perforation of ulcers,
gastric outlet obstruction due to ulcers,
gastrointestinal bleeding.
Active cardiac, renal, and/or hepatic disease
Current Helicobacter pylori (H. pylori) infection
Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry.
Uncontrolled diabetes
Uncontrolled hypertension
Positive pregnancy test at screening
Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Currently participating, or participation within 30 days prior to study entry, in an investigational drug study

Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria.
Intervention: Lubiprostone
Trial phase: Phase 4
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: Child
Healthy volunteers: No
Participants at risk: 27
Group description: Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
Eligibility criteria:
Inclusion Criteria:

Less than 18 years of age
Weight of at least 12 kg and capable of swallowing a capsule
Able to refrain from use of medications known to treat or associated with constipation symptoms
Stable fiber therapy or ADHD therapy if using such medications
Patient/Caregiver able to complete daily diary
Patient able to use recommended rectal and/or oral rescue medications if needed

Exclusion Criteria:

Constipation is associated with some medical, anatomic, physical, organic, or other condition
Hirschsprung's Disease or Nonretentive Fecal Incontinence
Untreated fecal impactions or impactions requiring digital manipulation
Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion
Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss
Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion
If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
Sexually active males and females must utilize acceptable birth control methods
Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211