anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Betamethasone
Trial phase: Phase 4
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: 45
Group description: Dexamethasone 8 mg

Dexamethasone: Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Eligibility criteria:
Inclusion Criteria:

ASA physical status I or II, who will scheduled to undergo surgical treatment of lower limb fractures

Exclusion Criteria:

Patients who:

(i) refused to participate in the study;

(ii) were not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease;

(iii) presented with contraindication to any of the drugs used in the present study;

(iv) had history of alcohol or drug abuse and

(v) had surgery in the last 10 days were excluded.

Reasons for exclusion after randomisation will be protocol violations or if the anesthesia technique was changed from a spinal to a general approach.
Intervention: Ondansetron
Trial phase: Phase 4
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Ondansetron 4 mg

Ondansetron: Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Eligibility criteria:
Inclusion Criteria:

ASA physical status I or II, who will scheduled to undergo surgical treatment of lower limb fractures

Exclusion Criteria:

Patients who:

(i) refused to participate in the study;

(ii) were not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease;

(iii) presented with contraindication to any of the drugs used in the present study;

(iv) had history of alcohol or drug abuse and

(v) had surgery in the last 10 days were excluded.

Reasons for exclusion after randomisation will be protocol violations or if the anesthesia technique was changed from a spinal to a general approach.
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: 45
Group description: Normal saline (5 mL total volume)

Saline: Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
Eligibility criteria:
Inclusion Criteria:

ASA physical status I or II, who will scheduled to undergo surgical treatment of lower limb fractures

Exclusion Criteria:

Patients who:

(i) refused to participate in the study;

(ii) were not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease;

(iii) presented with contraindication to any of the drugs used in the present study;

(iv) had history of alcohol or drug abuse and

(v) had surgery in the last 10 days were excluded.

Reasons for exclusion after randomisation will be protocol violations or if the anesthesia technique was changed from a spinal to a general approach.
Intervention: AZELAIC ACID
Trial phase: Phase 2 | Phase 3
ATC code: D10AX03
SMILES: O=C(O)CCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face

Azelaic acid: 15% gel twice daily for four weeks to one side of face
Eligibility criteria:
Inclusion Criteria:

Male and female subjects, ages 18 and over, with mild to moderate paulopustular rosacea with bilateral facila involvement, who agrees to participate and provide written consent.
Positive Demodex folliculorum SSSB, defined as >5 mites/cm on at least on of two different SSSB specimens on bilateral sides of teh face.
Have an IGA of mild to moderate rosacea, rating between 2 and 5.

Exclusion Criteria:

Use of topical therapy for rosacea or other skin conditions on the face within two weeks of Baseline.
Use of oral medications for the treatment of rosacea that have been started or altered within the past three months.
Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
Subjects with known allergy or sensitivity to azelaic acid gel or components therein, such as propylene glycol.
Subjects with known allergy or sensitivity to cyanoacrylates or formaldehyde.
Presence of more than two nodules.
Female subjects who are not postmenopausal for at least 1 year, surgically sterile or willing to practice effective contraception during the study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device, DepoProvera, tubal ligation or vasectomy of the partner in a monogamous relationship. An acceptable, though less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2368
Group description: Dapagliflozin 10 mg, given once daily per oral use.
Eligibility criteria:
Inclusion Criteria:

Provision of signed informed consent prior to any study specific procedures
Male or female, aged ≥18 years
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
LVEF≤40%
Elevated NT-proBNP levels
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)

Exclusion Criteria:

Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
Type 1 diabetes mellitus
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
Symptomatic bradycardia or second or third degree heart block without a pacemaker
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/ nonlactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV coinfection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimens for ≥8 weeks prior to screening.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/ nonlactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV coinfection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimens for ≥8 weeks prior to screening.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: Velpatasvir
Trial phase: Phase 2
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: 59
Group description: SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV co-infection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks prior to screening.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: Fluorouracil
Trial phase: Phase 3
ATC code: L01BC02 | L01BC52
SMILES: O=c1[nH]cc(F)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Carac cream (fluorouracil) 0.5% applied daily on the face for one week

Carac Cream: Carac Cream will be used once daily for seven consecutive days
Eligibility criteria:
Inclusion Criteria:

Must be male or female and at least 18 years of age. Each subject must demonstrate good health as determined by a baseline medical history.
Female subjects myst be of either non-childbearing potential, or childbearing potential provided: negative urine pregnancy test and using two acceptable methods of effective contraception (abstinence, birth control pills.patch, DepoProvera, tubal ligation, vasectomy of the partner in a monogamous relationship, condoms and spermicidal form or gel and/or cervical cap or sponge), as determined by the investigator
At least eight clinically typical, visible and discrete AK lesions within the treatment area on the face or balding scalp
Subjects must be able and willing to comply with study procedures and have provided written informed consent.

Exclusion Criteria:

Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the selected treatment area in the previous four weeks.
Treatment with systemic medications that suppress the immune system within the previous four weeks.
Field treatments with topical 5-FU, imiquimod, diclofenac, or photodynamic therapy, or more widespread field treatment with dermabrasion, medium or greater depth chemical peel, or laser resurfacing within the previous six months.
Any known dihydropyrimidine dehydrogenase enzyme deficiency.
In addition, subjects who have any skin condition or disease that may require concurrent therapy or may confound the evaluation as determined by the investigator, or a history of hypersensitivity to any of the formulation components will be excluded from study.
Subjects may not use other topical agents such as glycolic acid products, alpha-hydroxy acid products, retinoids and chemical peel agents on teh treatment area while on study. The use of these products are not allowed four weeks prior to study enrollment. Introduction of any other prescription medication, topical or systemic for actinic keratosis while participating in the study is not permitted.
Pregnant women, women who are breast feeding, or women of childbearing potential who are not practicing two acceptable methods of effective contraception.
Intervention: Ropinirole
Trial phase: Phase 1 | Phase 2
ATC code: N04BC04
SMILES: CCCN(CCC)CCc1cccc2c1CC(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study

Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
Eligibility criteria:
Inclusion Criteria:

Ages 18-70 years
Prolactin level (PRL) ≥2 times upper limit of normal
Pituitary adenomas on MRI ≤ 1.5cm in greatest diameter and ≥ 5mm from the optic chiasm
Normal renal and liver function
Agrees to barrier contraception if pre-menopausal

Exclusion Criteria:

Use of medications known to interfere with PRL secretion and PRL and Ropinirole (ROP) metabolism
Use of another dopamine agonist during the 4 weeks prior
Pituitary stalk compression on MRI
History of visual field abnormalities or previous radiation
Untreated hypothyroidism
Consumption of > 2 alcoholic drinks per day
Pregnancy
Intervention: Duloxetine
Trial phase: Phase 2
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 69
Group description: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week

Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
Eligibility criteria:
Inclusion Criteria:

Healthy men aged 18-65 years old;
normal or borderline semen analysis (sperm concentration > 10 million/mL, sperm motility > 30%, sperm morphology > 3%);
willing to engage in sexual activity (alone or with a partner) at least once per week for the duration of the study;
capable of providing semen sample.

Exclusion Criteria:

Clinically detected varicocele;
oligoasthenoteratospermia or azoospermia on semen analysis;
ongoing attempts to initiate pregnancy;
current sexual dysfunction (classified as moderate or worse on IIEF);
history of seizure disorder;
history of previous chemotherapy or radiation therapy;
current psychiatric history or history of bipolar disorder;
family history of bipolar disorder, depression, or suicide;
use of any psychotropic medications or anticonvulsants;
use of sleeping pills more than once per week;
use of any hormonal medications on a daily or intermittent basis during the preceding 3 months;
use of medications which may affect hormone measures and/or sexual function;
inability to read, follow instructions, or complete questionnaires in English;
consumption of tobacco or illicit drugs;
consumption of >2oz of alcohol daily.
Intervention: SULFUR HEXAFLUORIDE
Trial phase: Phase 4
ATC code: V08DA05
SMILES: FS(F)(F)(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy;
Eligibility criteria:
Inclusion Criteria:

Males and females
Age 18 years or greater
Scheduled to undergo liver biopsy with ultrasound guidance at a performance site

Exclusion Criteria:

Liver biopsy is not intended to obtain tissue from a specific lesion
Known or suspected cardiac shunt
History of hypersensitivity to any active or inactive ingredients in Lumason
Intervention: FOSMETPANTOTENATE
Trial phase: Phase 3
SMILES: COC(=O)CCNC(=O)[C@H](O)C(C)(C)COP(=O)(N[C@@H](C)C(=O)OC)Oc1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.

Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.

Includes data over the entire study for those who completed the double-blind period and entered the open-label period.
Eligibility criteria:
Inclusion Criteria:

The participant had a diagnosis of PKAN as indicated by confirmed mutations in the pantothenate kinase 2 gene.
The participant was male or female aged 6 to 65 years, inclusive.
The participant had a score of ≥ 6 on the PKAN-specific activities of daily living measure.

Exclusion Criteria:

The participant had required regular or intermittent invasive ventilatory support to maintain vital signs within 24 weeks prior to randomization.
The participant had a deep brain stimulation device implanted within 6 months prior to screening.
The participant had taken deferiprone within 30 days prior to screening.
The participant was unable to maintain stable doses of allowed concomitant medications for the first 24 weeks of the study.
Intervention: Calcium sulfate
Trial phase: Phase 4
SMILES: O=S(=O)([O-])[O-].[Ca+2]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Calcium Sulfate: Calcium Sulfate with abx will be used in the defect
Eligibility criteria:
Inclusion Criteria:

Open tibia shaft fracture treated with an IMN

Exclusion Criteria:

None
Intervention: Talazoparib
Trial phase: Phase 1
ATC code: L01XK04
SMILES: Cn1ncnc1[C@H]1c2n[nH]c(=O)c3cc(F)cc(c23)N[C@@H]1c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Talazoparib capsule was administered orally at 1 mg once daily (QD) for up to 22 days.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age and willing and able to provide informed consent.
Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the investigator.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Estimated life expectancy of ≥ 3 months.
Able to swallow the study drug, have no known intolerance to the study drug or excipients, and comply with study requirements.
Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after last dose of study drug.
Male patients must use a condom when having sex with a pregnant woman or with a woman of childbearing potential from the time of the first dose of study drug through 105 days after last dose of study drug. Contraception should be considered for a nonpregnant female partner of childbearing potential.
Male and female patients must agree not to donate sperm or eggs, respectively, from the first dose of study drug through 105 days and 45 days after the last dose of study drug, respectively.
Female patients may not be breastfeeding at screening and must not breastfeed during study participation through 45 days after the last dose of study drug.

Exclusion Criteria:

Use of antineoplastic therapies within 21 days before day 1.
Use of any other investigational agent within 21 days before day 1.
Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ≤ 1) from the acute toxicities of previous therapy, except treatment related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
Electrolyte abnormality that has not responded to correction, including hypokalemia or hypocalcemia less than the lower limit of normal, or hyperkalemia or hypercalcemia greater than the upper limit of normal (ULN).
Major surgery within 14 days before day 1.
Diagnosis of myelodysplastic syndrome (MDS) or a hematologic malignancy.
Clinically significant cardiovascular disease.
Significant organ dysfunction.
Gastrointestinal disorder affecting absorption.
Current or anticipated use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BCRP.
Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator or medical monitor.
Intervention: OXYTOCIN
Trial phase: Phase 2
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 31
Group description: oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)
Eligibility criteria:
Inclusion Criteria:

18-45 years old;
BMI greater than or equal to 30 kg/m2

Exclusion Criteria:

Use of drug affecting metabolism, glucose, or appetite (Metformin is allowed if dose and weight are stable for at least 3 months);
history of medication changes within 4 weeks of enrollment;
active substance use;
history of cardiovascular disease, gastrointestinal disorders, bariatric surgery, epilepsy, untreated thyroid disease;
hematocrit >2% below normal;
fasting glucose > 125 mg/dL or hemoglobin A1c ≥ 7% ;
ALT or AST >2.5 times upper limit of normal;
Cr >1.5 mg/dL; hyponatremia;
pregnancy or breastfeeding;
unwilling to use medically acceptable form of contraception (females only)
follows a nonstandard diet (e.g., gluten free, pescatarian, vegetarian, vegan, Paleo, Atkins, raw diet, macrobiotic diet)
current smoking or tobacco use
Intervention: Cangrelor
Trial phase: Phase 4
ATC code: B01AC25
SMILES: CSCCNc1nc(SCCC(F)(F)F)nc2c1ncn2[C@@H]1O[C@H](COP(=O)(O)OP(=O)(O)C(Cl)(Cl)P(=O)(O)O)[C@@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: The final subject count in this arm is 13.
Eligibility criteria:
Inclusion Criteria:

Patients with an acute STEMI with the University of Kentucky as the institution of presentation with plans for PCI
English-speaking

Exclusion Criteria:

Pregnant patients
Prisoners
Patients who are unable to provide his/her own consent
Patients with a prior history of myocardial infarction
Patients who have received thrombolytics
Patients on systemic anticoagulation
Patients who are hemodynamically unstable with evidence of shock
Patients who are mechanically intubated
Patients with devices not MRI compatible
Patients with chronic kidney disease, glomerular filtration rate less than 30
Patients who are already on dual antiplatelet therapy