anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Propranolol
Trial phase: Phase 3
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 190
Group description: Propranolol

Propranolol: Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24.
Eligibility criteria:
Inclusion Criteria:

Patients younger than 24 weeks.
Presenting a hemangioma with the following characteristics:
Subcutaneous and/or cutaneous
Minimum diameter of 1.5 cm on face, 3 cm outside face and 1.5 cm if it is ulcerated.
Consent of both parents (or the person having parental authority in families)

Exclusion Criteria:

Infant presenting contraindications for the administration of propranolol or atenolol.
Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments.
Patients with an inability to participate or to follow the study treatment and assessment plan.
Intervention: Atenolol
Trial phase: Phase 3
ATC code: C07AB03 | C07BB03 | C07CB03 | C07CB53 | C07DB01 | C07FB03
SMILES: CC(C)NCC(O)COc1ccc(CC(N)=O)cc1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 187
Group description: Atenolol

Atenolol: Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24.
Eligibility criteria:
Inclusion Criteria:

Patients younger than 24 weeks.
Presenting a hemangioma with the following characteristics:
Subcutaneous and/or cutaneous
Minimum diameter of 1.5 cm on face, 3 cm outside face and 1.5 cm if it is ulcerated.
Consent of both parents (or the person having parental authority in families)

Exclusion Criteria:

Infant presenting contraindications for the administration of propranolol or atenolol.
Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments.
Patients with an inability to participate or to follow the study treatment and assessment plan.
Intervention: TEDIZOLID PHOSPHATE
Trial phase: Phase 4
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](COP(=O)(O)O)OC4=O)cc3F)cn2)n1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.

Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Eligibility criteria:
Inclusion Criteria:

Non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers
Estimated CLcr (Cockcroft-Gault equation) ≥ 90 mL/min
Female subjects of childbearing potential (CBP) either surgically sterilized, using hormonal contraceptives or an effective barrier method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from the time of pre-study screening, during the entire study period and 4 weeks following the study period
Platelets count ≥ 140,000/mL
Absolute neutrophil count (ANC) ≥ 1800/mL

Exclusion Criteria:

History of hypersensitivity reaction to any oxazolidinone
BMI < 18.5 kg/m2
Any chronic medical condition requiring pharmacologic therapy
Transaminases (AST or ALT) > 2.5 x upper limit of normal
Total bilirubin > 1.5 x upper limit of normal
Positive urine pregnancy test (if female)
Abnormal electrocardiogram (ECG) as judged by the study physician
Unable to tolerate venipuncture and multiple blood draws
Clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up
Unable to independently provide a written informed consent
Intervention: TEDIZOLID PHOSPHATE
Trial phase: Phase 4
SMILES: Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](COP(=O)(O)O)OC4=O)cc3F)cn2)n1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.

Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Eligibility criteria:
Inclusion Criteria:

Non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers
Estimated CLcr (Cockcroft-Gault equation) ≥ 90 mL/min
Female subjects of childbearing potential (CBP) either surgically sterilized, using hormonal contraceptives or an effective barrier method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from the time of pre-study screening, during the entire study period and 4 weeks following the study period
Platelets count ≥ 140,000/mL
Absolute neutrophil count (ANC) ≥ 1800/mL

Exclusion Criteria:

History of hypersensitivity reaction to any oxazolidinone
BMI < 18.5 kg/m2
Any chronic medical condition requiring pharmacologic therapy
Transaminases (AST or ALT) > 2.5 x upper limit of normal
Total bilirubin > 1.5 x upper limit of normal
Positive urine pregnancy test (if female)
Abnormal electrocardiogram (ECG) as judged by the study physician
Unable to tolerate venipuncture and multiple blood draws
Clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up
Unable to independently provide a written informed consent
Intervention: Rifaximin
Trial phase: Phase 4
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Participants will receive a 10-day course of Rifaximin 550mg PO BID.

Rifaximin: 550mg pills
Eligibility criteria:
Inclusion Criteria:

Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2

Exclusion Criteria:

Patients with normal renal function or those with less advanced kidney disease
Inability or unwillingness to provide consent
Patients undergoing hemodialysis or peritoneal dialysis therapy or those who have undergone organ transplant
Patients who may be pregnant
Hemodynamically unstable patients
Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease
Patients with ongoing or recent infection and those with history of C-diff infection
Patients with abnormal bowel structure secondary to surgical or anatomic variations
Patients on certain medications including immunosuppressants, antidiarrheal agents, bile acid sequestrants and current or recent (within the last 3 months) use of antibiotics
Intervention: Temozolomide
Trial phase: Phase 4
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
Eligibility criteria:
Inclusion Criteria:

Male or female patients with primary malignant tumors of the central nervous system (CNS) excluding subjects with primary CNS lymphoma.
Age> 21 years.
There should be a gap of two weeks between the last surgery and/or radiotherapy procedure and the day of randomization. If the procedure were intrabdominal, the gap should be of four weeks.
Patients with neutrophils> 1.5 x 109 / L and platelets> 100 x 109 / L.
Signed written informed consent for participation in the trial.

Exclusion Criteria:

Known hypersensitivity to Temozolomide or any other ingredient of the pharmaceutical formulation.
Any situation (eg. vomiting) that may interfere with the absorption of the product under study.
Chemotherapy or biological therapy within four weeks prior to administering the products under study.
Patients who experience any symptoms of toxicity to prior antineoplastic therapies upon administration of the products under study.
Participation in other clinical research studies during the 90 days before the start of this study.
History of alcohol or drugs abuse.
History of severe allergic reactions to any type of antigen.
History of gastrointestinal surgery (except uncomplicated appendectomy, of at least three months old).
Patients whose clinical status would affect the safety of the products under study or interfere with the pharmacokinetic evaluation, at the discretion of the investigator.
Pregnant women or women planning to become pregnant during the study.
Intervention: Bupivacaine
Trial phase: Phase 2
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: subjects received Bupivacaine-infused Fibrin Sealant to the tonsillar fossa
Eligibility criteria:
Inclusion Criteria:

1. All children aged 1 through age 12 and weighing >10 kilograms who are scheduled for tonsillectomy or adenotonsillectomy for the following indications by surgical staff included in the IRB submission will be considered for inclusion in the study.

A) Chronic Pharyngitis / Recurrent Tonsillitis B) PAPFA (Periodic Aphthous Ulcers / Pharyngitis / Fevers / Adenopathy) Syndrome C) Upper Aerodigestive Obstruction Symptoms felt to be related to tonsil size. D) Adenotonsillar Hypertrophy (enlarged tonsils and adenoids) E) Obstructive Sleep Apnea (clinical diagnosis or by Polysomnogram [sleep study]) F) Chronic/Recurrent Tonsillolithiasis (tonsil stones)

Exclusion Criteria:

Undergoing additional surgical procedures within 14 days preceding or following the tonsillectomy or adenotonsillectomy which could affect pain assessment scores.
Additional concurrent surgical procedures (other than direct laryngoscopy, bronchoscopy, nasal endoscopy, ear examination under anesthesia, cerumen removal, or myringotomy with ear ventilation tube placement)

2. If decision is made to perform supraglottoplasty for laryngomalacia intraoperatively

3. Tonsillectomy or adenotonsillectomy for concern of malignancy of unknown primary

4. Documented aprotinin allergy

5. Documented amide anesthetic allergy

6. Documented bleeding disorder

7. Documented anticoagulant use

8. Documented chronic pain disorder

9. Documented chronic use of prescription narcotics or methadone

10. Documented history of substance abuse or illicit drug use

11. Documented history of alcoholism or alcohol abuse

12. Gastrostomy/orogastric/nasogastric tube placement/use

13. Planned postoperative ICU placement

14. Refusal to participate

15. Exclusion at judgment of investigator (Language barriers, Ward of Court, etc.)
Intervention: Nitroglycerin
Trial phase: Phase 3
ATC code: C01DA02 | C01DA52 | C05AE01
SMILES: O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 328
Group description: Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion

Nitroglycerin: Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion
Eligibility criteria:
Inclusion Criteria:

Indication for cardiac catheterization
Suitable candidates for transradial approach

Exclusion Criteria:

AMI
Intubated patients
Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke)
Prior inclusion in this trial
Intervention: Caffeine
Trial phase: Phase 2
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose) plus placebo saline IV (1 ml/kg followed by 0.25 ml/kg) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Caffeine is the intervention

Caffeine citrate: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose)
Eligibility criteria:
Inclusion Criteria:

Neonates at high risk for ROP as outlined by the American Academy of Pediatrics, Section on Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; and American Academy of Ophthalmology (129) will be enrolled. Inclusion criteria are:

all infants with a birth weight of less than 1250 grams;
all infants with a gestational age of 28 weeks or less; and
all infants who required oxygen therapy and ventilator support within the first 2 days of life.

Exclusion Criteria:

Exclusion criteria are:

major congenital malformations and or chromosomal anomalies including duct-dependent cardiac anomalies;
maternal antenatal NSAID exposure <72 hours before birth;
renal failure or oliguria defined as a urine flow rate <0.5 mL/kg/hour in the 8 hours prior to randomization. Anuria is acceptable if infant is less than 24 hours of life;
platelet count <75,000.mm3;
clinical bleeding such as oozing from puncture sites; and
participation in other clinical drug trials while subject participates in this study and for 7 days after last dose of study drug.
Intervention: Ibuprofen
Trial phase: Phase 2
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: Child
Healthy volunteers: No
Participants at risk: 3
Group description: Caffeine citrate as described in group 1, plus Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days plus sterile normal saline (one drop two times a day) for 14 days (n=40); Ibuprofen is the intervention

Ibuprofen: Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days
Eligibility criteria:
Inclusion Criteria:

Neonates at high risk for ROP as outlined by the American Academy of Pediatrics, Section on Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; and American Academy of Ophthalmology (129) will be enrolled. Inclusion criteria are:

all infants with a birth weight of less than 1250 grams;
all infants with a gestational age of 28 weeks or less; and
all infants who required oxygen therapy and ventilator support within the first 2 days of life.

Exclusion Criteria:

Exclusion criteria are:

major congenital malformations and or chromosomal anomalies including duct-dependent cardiac anomalies;
maternal antenatal NSAID exposure <72 hours before birth;
renal failure or oliguria defined as a urine flow rate <0.5 mL/kg/hour in the 8 hours prior to randomization. Anuria is acceptable if infant is less than 24 hours of life;
platelet count <75,000.mm3;
clinical bleeding such as oozing from puncture sites; and
participation in other clinical drug trials while subject participates in this study and for 7 days after last dose of study drug.
Intervention: Ketorolac
Trial phase: Phase 2
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Caffeine citrate plus saline IV placebo as described in group 1, and Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days (n=40); Ketorolac is the intervention

Ketorolac: Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
Eligibility criteria:
Inclusion Criteria:

Neonates at high risk for ROP as outlined by the American Academy of Pediatrics, Section on Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; and American Academy of Ophthalmology (129) will be enrolled. Inclusion criteria are:

all infants with a birth weight of less than 1250 grams;
all infants with a gestational age of 28 weeks or less; and
all infants who required oxygen therapy and ventilator support within the first 2 days of life.

Exclusion Criteria:

Exclusion criteria are:

major congenital malformations and or chromosomal anomalies including duct-dependent cardiac anomalies;
maternal antenatal NSAID exposure <72 hours before birth;
renal failure or oliguria defined as a urine flow rate <0.5 mL/kg/hour in the 8 hours prior to randomization. Anuria is acceptable if infant is less than 24 hours of life;
platelet count <75,000.mm3;
clinical bleeding such as oozing from puncture sites; and
participation in other clinical drug trials while subject participates in this study and for 7 days after last dose of study drug.
Intervention: Azithromycin
Trial phase: Phase 3
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: Male
Age groups: Child
Healthy volunteers: No
Participants at risk: 291
Group description: Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams

Azithromycin: Comparison of two different dosing strategies for the treatment of yaws
Eligibility criteria:
Inclusion Criteria:

Aged 6 to 16 years
Clinical lesion consistent with primary or secondary yaws -Primary ulcer or papilloma
Dually-Positive Chembio DPP Syphilis Screen & Confirm
Informed Consent and Assent (for children 12-16 years)

Exclusion Criteria:

Known allergy to azithromycin or macrolides.
Treatment with long-acting penicillin or alternative antibiotic with activity against T. pallidum within the last 3 months (ceftriaxone, azithromycin or doxycycline, amoxicillin).
Patients with current treatment with any drugs likely to interact with the study medication.
Patients who are unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption.
Patients who may not be able to comply with the requirements of the study protocol including follow up visits.
Patients who are not willing to give informed consent (patient and/or parent/legal representative), or who withdraw consent.
Intervention: Azithromycin
Trial phase: Phase 3
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: Male
Age groups: Child
Healthy volunteers: No
Participants at risk: 292
Group description: Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams

Azithromycin: Comparison of two different dosing strategies for the treatment of yaws
Eligibility criteria:
Inclusion Criteria:

Aged 6 to 16 years
Clinical lesion consistent with primary or secondary yaws -Primary ulcer or papilloma
Dually-Positive Chembio DPP Syphilis Screen & Confirm
Informed Consent and Assent (for children 12-16 years)

Exclusion Criteria:

Known allergy to azithromycin or macrolides.
Treatment with long-acting penicillin or alternative antibiotic with activity against T. pallidum within the last 3 months (ceftriaxone, azithromycin or doxycycline, amoxicillin).
Patients with current treatment with any drugs likely to interact with the study medication.
Patients who are unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption.
Patients who may not be able to comply with the requirements of the study protocol including follow up visits.
Patients who are not willing to give informed consent (patient and/or parent/legal representative), or who withdraw consent.
Intervention: Malathion
Trial phase: Phase 2
ATC code: P03AX03
SMILES: CCOC(=O)CC(SP(=S)(OC)OC)C(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: 3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks

AUT00063: 600 mg, orally, once a day, for 4 weeks
Eligibility criteria:
Be between ages 50-89 years old
American-English speaking
Have difficulty hearing speech in a noisy environment
No recent history of middle ear disease
No severe insomnia, major depressive disorders, severe anxiety or post-traumatic stress disorder
Not a current or previous user of hearing aids. You are eligible if you were noncompliant and stopped wearing a hearing aid device >6 months earlier for intermittent use or >3 years if you were a full-time consistent user of hearing aid devices
Not be dependent on alcohol or drugs
Have not participated in another research study within 30-days
If female, you must confirm to be non child bearing (post-menopausal for at least 12-months or surgically sterile)
If male, you must confirm to use a barrier method (condom)
Not be a professional musician
No history of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease deemed clinically significant by the study doctor

While you are in the study, you must:

Follow the instructions you are given
Come to the study centre for all visits with the study doctor or study staff
Answer the telephone at the scheduled date and time for the 2 telephone calls
Tell the study doctor or study staff about any changes in your health or the way you feel
Tell the study doctor or study staff if you want to stop being in the study at any time
Bring your Diary to each visit
Not eat or drink anything containing Grapefruit beginning 7-days before Baseline visit (Visit 3, Day 1) until the end of the study
Use sun screen if you plan to sunbathe
Not use headphones or headsets at high volume
Not use hearing aids or devices at any time during the study
Intervention: Velpatasvir
Trial phase: Phase 3
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: SOF/VEL (400/100 mg) FDC tablet orally once daily
Eligibility criteria:
Key Inclusion Criteria:

Willing and able to provide written informed consent
Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138
HCV RNA ≥ 10^4 IU/mL at screening
Classification as treatment naive or treatment experienced
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
Screening electrocardiogram (ECG) with clinically significant abnormalities
Laboratory results outside of acceptable ranges at screening
Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.