anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Topiramate
Trial phase: Phase 1
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: Healthy women using an ENG implant for at least 12 months and no greater than 36 months will be administered a 6 week titration schedule of topiramate to a max dose of 200mg bid by the final week.

Topiramate: Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day:

Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily
Eligibility criteria:
Inclusion Criteria:

Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment;
Will maintain their implant during the study without modifications.

Exclusion Criteria:

Women who are taking any medications or supplements known to be

Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and
are not willing to abstain from any of these medications or supplements during the entire course of the study.
Women with liver disease (i.e. hepatitis, fatty liver disease), and
Women with abnormal liver or renal function, or
Women with abnormal electrolytes on their screening blood work.
Intervention: Fentanyl
Trial phase: Phase 2
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Intravenous Fentanyl

Fentanyl: IN Placebo + IV Fentanyl
Eligibility criteria:
Inclusion Criteria:

Voluntarily provide written informed consent
Be planned to undergo a selected office-based or outpatient procedure
Be naïve to the planned procedure, i.e. no repeated or revision procedures
Not pregnant or planning to become pregnant, or using appropriate contraceptive measures.

Exclusion Criteria:

Known allergy to any study treatment or excipient
Have another painful physical condition or anxiety related diagnosis that may confound study assessments
Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG
Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery
Intervention: Metformin
Trial phase: Early Phase 1
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
Eligibility criteria:
Inclusion Criteria:

Age 30-80 years
History of obesity and current BMI ≥ 25 kg/ m2 for study volunteers or BMI ≥ 25 kg/ m2 for those with clinically indicated CPET or known HFpEF
History of Dyspnea (Grade 1 or more)
Able to provide informed consent and willing to comply with study

Exclusion Criteria:

History of diabetes mellitus
History of primary pulmonary arterial hypertension
History of moderate to severe COPD
History of severe Obstructive Sleep apnea
History of renal disease (eGFR< 45 mL/min/1.732)
History of severe liver disease
History of cardiovascular disease (recent heart attack or stroke) except known HFpEF
History of blood clot in lung
History of Splenectomy
History of Active Cancer
Platelets count of < 75,000
International normalized ration (INR) of > 1.5
History of recent anemia (HB < 9g/dL)
Current use of Metformin
Prior LVEF < 50% on echocardiogram
Indication of severe valvular disease on echo
Pregnant or planning to become pregnant in next 4 months
History of HIV infection
Intervention: Crisaborole
Trial phase: Phase 2
ATC code: D11AH06
SMILES: N#Cc1ccc(Oc2ccc3c(c2)COB3O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Crisaborole 2% ointment applied to affected skin twice per day.

Crisaborole: Apply Crisaborole 2% ointment to affected skin twice per day.
Eligibility criteria:
Inclusion Criteria:

>= 18 years of age
Clinical diagnosis of morphea.
<20% Total body surface area involvement.
Does not require systemic immunosuppressive therapy for morphea.
No immunosuppressive systemic therapy 1 month prior to starting the study (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, prednisone >=10 mg PO daily).
No immunomodulating topical therapy (topical steroids or topical calcineurin inhibitor), and no topical vitamin D analogue, 2 weeks prior to starting study.
No allergy to crisaborole or vehicle.
No known renal disease
Able to give informed consent.

Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.

Clinical diagnosis of depression or history of suicidal ideation.
Pregnant or breastfeeding women, with pregnant women being defined as the state of a female after conception until the termination of gestation, confirmed by a positive urine human chorionic gonadotropin (hCG) laboratory test. Women with a positive urine hCG at any time during the study will be withdrawn from the study.
Intervention: Tretinoin
Trial phase: Phase 2
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Fixed low dose of ATRA 10 mg twice daily for 24 weeks.

All-trans retinoic acid: Fixed low dose of ATRA 10 mg twice daily for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Males and females ages 18-80
Diagnosis of large-duct PSC based on ERCP or MRCP, or liver biopsy findings without alternative explanation for findings, for at least 6 months.
Serum ALP levels persistently more than 1.5 x upper limit of normal over the past 6 months.
Ursodeoxycholic acid therapy must be discontinued for at least 3 months.
At least 2 forms of barrier protection for males and females of child-bearing age.

Exclusion Criteria:

Small duct PSC, overlap with autoimmune hepatitis, IgG4 disease or secondary sclerosing cholangitis.
Any malignancy, presently or within the past 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or in situ prostate cancer.
Viral hepatitis including hepatitis A, B, C, D, E.
Decompensated cirrhosis, or planned liver transplantation.
Recent diagnostic or therapeutic biliary manipulation (endoscopic, radiologic) within the past 3 months.
Ascending Cholangitis requiring antibiotics within the past 3 months.
Uncontrolled IBD, or IBD requiring the use of steroids.
Acute or Chronic Kidney Disease with serum creatinine > 2 mg/dL.
Allergy to ATRA or vitamin A compounds.
Intervention: Ribavirin
Trial phase: Phase 4
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description
Eligibility criteria:
Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis
Intervention: Ribavirin
Trial phase: Phase 4
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description
Eligibility criteria:
Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis
Intervention: Ribavirin
Trial phase: Phase 4
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description
Eligibility criteria:
Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis
Intervention: Ribavirin
Trial phase: Phase 4
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description
Eligibility criteria:
Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis
Intervention: Ribavirin
Trial phase: Phase 4
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: (e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description
Eligibility criteria:
Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis
Intervention: Ribavirin
Trial phase: Phase 4
ATC code: J05AP01
SMILES: NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description
Eligibility criteria:
Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: Metformin 1000 mg PO bid

Metformin: Oral medication daily
Eligibility criteria:
Inclusion Criteria:

Polycystic Ovary Syndrome diagnosis (Rotterdam Criteria)
Vitamin D insufficiency (serum Vitamin D <30 ng/mL)
Insulin resistance
Mild or greater severity of depression by Beck Depression Inventory-II

Exclusion Criteria:

Current metformin use
Vitamin D supplementation of > 50,000 IU following confirmation of Vitamin D insufficiency
Insulin-dependent diabetes mellitus
Pregnancy or breastfeeding
Untreated hypothyroidism
Current active substance abuse
Other major medical comorbidity: renal or hepatic dysfunction, severe pulmonary
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data