anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Epinephrine
Trial phase: Not Applicable
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Ultrasound guided posterior capsular injection of ropivacaine with epinephrine

Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
Eligibility criteria:
Inclusion Criteria:

Patients having primary, unilateral total knee arthroplasty
Age 18-80

Exclusion Criteria:

History of neurologic disease, neuropathy, diabetes, or major systemic illness
Allergy to local anesthetic solution or NSAIDs
Pregnancy
Chronic use of narcotics
Inability to give consent/cooperate with study
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Ultrasound selective tibial nerve block of ropivacaine

Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
Eligibility criteria:
Inclusion Criteria:

Patients having primary, unilateral total knee arthroplasty
Age 18-80

Exclusion Criteria:

History of neurologic disease, neuropathy, diabetes, or major systemic illness
Allergy to local anesthetic solution or NSAIDs
Pregnancy
Chronic use of narcotics
Inability to give consent/cooperate with study
Intervention: Pregabalin
Trial phase: Phase 2 | Phase 3
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total.

Pregabalin
Eligibility criteria:
Inclusion Criteria:

18 and 65 years of age
undergoing LASIK (unilateral or bilateral procedure).
Females of child-bearing age will need a negative urine or serum pregnancy test at the screening visit.
ocular and systemic medication regimen has been stable for 3 months

Exclusion Criteria:

Pregnant or lactating, participating in another study with an investigational drug within one month prior to screening
Using gabapentin, pregabalin, anti-convulsants, duloxetine, venlafaxine (SNRI), or tri-cyclic antidepressants
have a history of allergic, anaphylactic reaction, or severe systemic response to pregabalin or gabapentin
use corticosteroids chronically or during the month prior to surgery, or have a history of corneal disease (HSV or varicella zoster keratitis, prior corneal incisions (cataract surgery, radial keratotomy, LASIK), prior corneal ulcer).
patients with systemic co-morbidities that may confound DE such as HIV, sarcoidosis, graft-versus host disease or a collagen vascular disease.
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Prisoners
Intervention: Humalog
Trial phase: Phase 1
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Individualized doses of insulin lispro (Reference) administered SC immediately before meals for 14 days.
Eligibility criteria:
Inclusion Criteria:

Are male or female participants with Type 2 Diabetes Mellitus (T2DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
Have venous access sufficient to allow for blood sampling
Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria:

Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
Have previously completed or withdrawn from this study
Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
Had blood loss of more than 500 milliliters (mL) within the last month
Are treated with a continuous subcutaneous insulin infusion (insulin pump)
Intervention: Humalog
Trial phase: Phase 1
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)NC(CCCCN)C(=O)N3CCCC3C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Individualized doses of insulin lispro (Reference) administered SC immediately before meals for 14 days.
Eligibility criteria:
Inclusion Criteria:

Are male or female participants with Type 1 Diabetes Mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
Have venous access sufficient to allow for blood sampling
Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria:

Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
Have previously completed or withdrawn from this study
Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
Had blood loss of more than 500 milliliters (mL) within the last month
Are treated with a continuous subcutaneous insulin infusion (insulin pump)
Intervention: Suvorexant
Trial phase: Phase 4
ATC code: N05CJ01 | N05CM19
SMILES: [H][C@@]1(C)CCN(c2nc3cc(Cl)ccc3o2)CCN1C(=O)c1cc(C)ccc1-n1nccn1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 18
Group description: 10 to 20 mg to be administered before bedtime

suvorexant: First in class orexin antagonist recently approved by the FDA for the treatment of insomnia
Eligibility criteria:
Inclusion Criteria:

Physically healthy adults age 18-55 who meet DSM-5 criteria for insomnia and Criterion A (exposure to a traumatic event) for PTSD. The index trauma must have occurred within the past 5 years and at least 3 months before enrolling, and insomnia symptoms must have started or worsened after the exposure to the index trauma

Exclusion Criteria:

Psychiatric disorders other than insomnia, PTSD and specific phobias; including bipolar and psychotic disorders and meeting criteria for DSM-5 moderate alcohol or drug use disorders within the past year.
Diagnosis of a sleep disorder other than insomnia including PSG findings of apnea/hypopnea or periodic limb movement indices > 10/hour;
Medical conditions that require consistent use of medication or compromise sleep;
History of moderate to severe traumatic brain injury or mild traumatic brain injury with ongoing post-concussive symptoms;
Suicidal ideation with intent to act or with specific plan and intent in the past 6 months (Type 4 - 5 ideation on the Columbia Suicide Severity Rating Scale) or a concerning history of prior suicidal behavior.
Caffeine use exceeding 5 cups of coffee per day or its equivalent;
Habitual bedtimes after 3 AM, habitual rise times after 10 AM, or habitual napping > 1hour/day;
Pregnancy or breastfeeding, or expecting to conceive while in study;
Positive urine toxicology.
Intervention: Fluorouracil
Trial phase: Phase 2
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: 1
Group description: Antimetabolite will be injected 2 weeks after periocular reconstruction with full thickness skin graft. Injection will be repeated every 2 weeks for a total of up to 4 injections.

5-Fluorouracil: Treatment medication
Eligibility criteria:
Inclusion Criteria:

Outpatients
Ages 18 to 89 years of age
Has a condition (e.g. trauma, skin/tissue defect, scar) requiring a skin graft for repair
Sufficient education to understand study procedures and to give consent

Exclusion Criteria:

Women lactating, pregnant or planning to get pregnant in the near future
Immunosuppression/immunocompromise or serious/active infections
Dihydropyrimidine dehydrogenase enzyme deficiency
Severe hepatic or renal impairment or failure
Unable to give consent or understand the study
Intervention: Lovenox
Trial phase: Phase 2
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization.

After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17.

Enoxaparin
Eligibility criteria:
Inclusion Criteria:

Participants must have histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma or multiple myeloma.
Cancer diagnosis or received treatment (chemotherapy or radiotherapy) for malignancy within the previous 6 months

One or more Padua-based risk factor:

History of previous venous thromboembolic event (excluding superficial vein thrombosis)
Reduced mobility (ECOG performance status 3 or 4, see Appendix A)
Established hereditary thrombophilia (e.g. Factor V Leiden, G20210 prothrombin mutation, protein C or S deficiency, antithrombin deficiency).
Recent surgery within the last 30 days
Age ≥ 70 years
Congestive heart failure (NYHA class III or IV)
Complicated respiratory insufficiency (defined as an increased requirement for supplementary oxygen of at least 2L)
Acute myocardial infarction or ischemic stroke
Obesity (BMI ≥ 30)
Receiving hormonal agents (e.g. tamoxifen, estrogen, testosterone)
Acute infection (i.e. requiring antimicrobial therapy)
Age ≥ 18 years
Life expectancy of greater than 30 days
Platelet count ≥ 100,000/mcL
Creatinine < 1.5 mg/dL or estimated creatinine clearance ≥ 50 mL/min/1.73 m2
Ability to understand and the willingness to sign a written informed consent document
Weight between 50kg to 130 kg.

Exclusion Criteria:

History of allergic reactions attributed to heparin or low molecular weight heparin
Active bleeding or otherwise considered high risk for hemorrhage (e.g. known acute gastrointestinal ulcer)
Any history of significant hemorrhage (requiring hospitalization or transfusion) within the last 6 months (excluding hemorrhage during operative procedure).
History of heparin induced Thrombocytopenia
Presence of coagulopathy (PT or PTT> 1.2 x upper limit of normal)
Known diagnosis of disseminated intravascular coagulation
Currently receiving therapeutic anticoagulant therapy or dual antiplatelet therapy (eg. aspirin and clopidogrel)
Uncontrolled arterial hypertension (systolic blood pressure > 200mmHg, diastolic >110mmHg)
Active peptic ulcer disease
Bacterial Endocardititis
Received any type of Pharmacologic Thromboprophylaxis (e.g. low molecular weight heparin or heparin) for >48 hours during current hospitalization
Known brain metastases
Intervention: Lovenox
Trial phase: Phase 2
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg.

On study Enoxaparin will be administered for up 14 days during hospitalization.

Enoxaparin
Eligibility criteria:
Inclusion Criteria:

Participants must have histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma or multiple myeloma.
Cancer diagnosis or received treatment (chemotherapy or radiotherapy) for malignancy within the previous 6 months

One or more Padua-based risk factor:

History of previous venous thromboembolic event (excluding superficial vein thrombosis)
Reduced mobility (ECOG performance status 3 or 4, see Appendix A)
Established hereditary thrombophilia (e.g. Factor V Leiden, G20210 prothrombin mutation, protein C or S deficiency, antithrombin deficiency).
Recent surgery within the last 30 days
Age ≥ 70 years
Congestive heart failure (NYHA class III or IV)
Complicated respiratory insufficiency (defined as an increased requirement for supplementary oxygen of at least 2L)
Acute myocardial infarction or ischemic stroke
Obesity (BMI ≥ 30)
Receiving hormonal agents (e.g. tamoxifen, estrogen, testosterone)
Acute infection (i.e. requiring antimicrobial therapy)
Age ≥ 18 years
Life expectancy of greater than 30 days
Platelet count ≥ 100,000/mcL
Creatinine < 1.5 mg/dL or estimated creatinine clearance ≥ 50 mL/min/1.73 m2
Ability to understand and the willingness to sign a written informed consent document
Weight between 50kg to 130 kg.

Exclusion Criteria:

History of allergic reactions attributed to heparin or low molecular weight heparin
Active bleeding or otherwise considered high risk for hemorrhage (e.g. known acute gastrointestinal ulcer)
Any history of significant hemorrhage (requiring hospitalization or transfusion) within the last 6 months (excluding hemorrhage during operative procedure).
History of heparin induced Thrombocytopenia
Presence of coagulopathy (PT or PTT> 1.2 x upper limit of normal)
Known diagnosis of disseminated intravascular coagulation
Currently receiving therapeutic anticoagulant therapy or dual antiplatelet therapy (eg. aspirin and clopidogrel)
Uncontrolled arterial hypertension (systolic blood pressure > 200mmHg, diastolic >110mmHg)
Active peptic ulcer disease
Bacterial Endocardititis
Received any type of Pharmacologic Thromboprophylaxis (e.g. low molecular weight heparin or heparin) for >48 hours during current hospitalization
Known brain metastases
Intervention: Plecanatide
Trial phase: Phase 3
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2272
Group description: Plecanatide 6.0 mg tablets

Plecanatide
Eligibility criteria:
Inclusion Criteria:

Patients with documented diagnosis of IBS-C who:

Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the previous study's requirements, and did not experience any Serious Adverse Event (SAE) deemed related to study drug during the course of the previous study, OR
Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from Sponsor or delegate.

Key Exclusion Criteria:

Patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (ICF) and undergo all protocol related tests and procedures throughout the study.
Female patient of childbearing potential with a positive urine pregnancy test on Day 1.
Male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial.
Patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study.
In the opinion of the Investigator or Medical Monitor, it is not in the patient's best interest to participate in the study. The reason(s) for the patient's exclusion must be specified.
Intervention: Betamethasone
Trial phase: Phase 3
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: 189
Group description: Intratympanic injection of 12 mg OTO-104
Eligibility criteria:
Inclusion Criteria includes, but is not limited to:

Subject has completed the OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506) clinical study.
Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Exclusion Criteria includes, but is not limited to:

Subject is pregnant or lactating.
Subject has a history of immunodeficiency disease.
Subject has experienced an adverse reaction to intratympanic injection of steroids.
Intervention: Azithromycin
Trial phase: Phase 2
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: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 48
Group description: 10 mg/kg IV Azithromycin daily for 3 days

Azithromycin 10 mg
Eligibility criteria:
Inclusion Criteria:

Admission to the PICU with RSV infection
Need for positive pressure ventilation (invasive and non-invasive)
Randomization and drug/placebo initiation within 48 hours of admission to Pediatric Intensive Care Unit

Exclusion Criteria:

Azithromycin use within 7 days of PICU admission

Contraindication to azithromycin use including:

Patients with electrocardiogram QT interval corrected for heart rate (Qtc) ≥ 450 ms
Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)
Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug
Cardiac arrhythmia
History of pyloric stenosis
Immunocompromised children (any cause)
Current use of any medication known to cause QT prolongation
Intervention: Azithromycin
Trial phase: Phase 2
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: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 48
Group description: 20 mg/kg IV Azithromycin daily for 3 days

Azithromycin 20mg
Eligibility criteria:
Inclusion Criteria:

Admission to the PICU with RSV infection
Need for positive pressure ventilation (invasive and non-invasive)
Randomization and drug/placebo initiation within 48 hours of admission to Pediatric Intensive Care Unit

Exclusion Criteria:

Azithromycin use within 7 days of PICU admission

Contraindication to azithromycin use including:

Patients with electrocardiogram QT interval corrected for heart rate (Qtc) ≥ 450 ms
Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)
Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug
Cardiac arrhythmia
History of pyloric stenosis
Immunocompromised children (any cause)
Current use of any medication known to cause QT prolongation
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) for 8 weeks in HCV genotype(GT)1 -infected, DAA treatment-naïve participants without cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Females were postmenopausal for at least 2 years; surgically sterile or had a vasectomized partner; or, if of childbearing potential and sexually active with a male partner, were currently using at least 1 effective method of birth control at the time of Screening and agreed to practice 1 effective method of birth control from Screening through 30 days after stopping study drug. Sexually active males were surgically sterile or, if sexually active with a female partner of childbearing potential, agreed to practice 1 effective form of birth control from Screening through 30 days after stopping study drug.
Screening central laboratory result indicated HCV single genotype infection for the appropriate treatment arm, without co-infection of any other genotype.

Chronic HCV infection is defined as one of the following:

Positive for anti-HCV antibody (Ab) and/or HCV RNA at least 6 months before Screening.
A liver biopsy consistent with chronic HCV infection.
Agreed to voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) prior to the initiation of any screening or study specific procedures.
Participants who were able to understand and adhere to the study visit schedule and all other protocol requirements.
Absence of hepatocellular carcinoma (HCC) as indicated by an ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI).

Exclusion Criteria:

Females who were pregnant or planned to become pregnant, or breastfeeding or males whose partner was pregnant or planning to become pregnant during the study.
Participants co-infected with hepatitis B virus or human immunodeficiency virus.
Use of contraindicated medications or supplements within 2 weeks or 10 half-lives (if known), whichever was longer, prior to the first dose of any study drug.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Any cause of liver disease other than chronic HCV infection.
Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of decompensated liver disease.
Consideration by the investigator, for any reason, that the participant is an unsuitable candidate to receive ABT-493/ABT-530.