anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nitroglycerin
Trial phase: Not Applicable
ATC code: C01DA02 | C01DA52 | C05AE01
SMILES: O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly

Nitroglycerin ointment
Eligibility criteria:
Inclusion Criteria:

Life expectancy of at least 6 months
Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
Ability to understand and comply with the requirements of the entire study and communicate with the study team.
Written informed consent using a document that has been approved by the Duke Human Institutional Review Board.
If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test and be willing to use contraception until completion of 8 weeks of intervention. This will include abstinence, barrier methods, hormones, or intra-uterine device.

Exclusion Criteria:

Patients currently on medication that is contraindicated with nitropaste, including isosorbide nitrate therapy, nitroglycerin, minoxidil, or PDE inhibitors (i.e. Sildenafil).
Patients with a diastolic blood pressure below 65 or a systolic blood pressure below 90.
Patients with a history of illicit drug use in the previous 5 years.
Patients who would require AVF placement before completion of the initial 4 weeks of intervention therapy
Patients who are otherwise are not suitable for 8 weeks of handgrip training or nitropaste therapy.
Patients under the 18 of age are not eligible for nitropaste interventions
Intervention: Rivaroxaban
Trial phase: Phase 3
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: 5mg b.i.d. for 20 weeks (primary phase) + additional 32 weeks (extension phase)
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes duration between 2 and 20 years

Two or more components of metabolic syndrome:

HDL-cholesterol < 1.0 mmol/L (in males) or < 1.3 mmol/L (in females)
Elevated triglycerides (> 1.7 mmol/L)
Elevated blood pressure (> 130 mmHg systolic and/or >85 mmHg diastolic or antihypertensive treatment)
Elevated waist circumference (> 102 cm in males, > 85 cm in females)

Or at least one of the following

Carotid ultrasound showing an IMT > 1 mm and plaque of carotid artery or
Left ventricular hypertrophy or
Increased UACR in the absence of other renal diseases than diabetic nephropathy
Increased hsCRP (> 2 mg/l but < 10 mg/l) at or within 6 months prior to screening and/or increased PAI 1 (> 15 ng/ml) at or within 6 months prior to screening (the historical hsCRP or PAI 1 value can be used only if the patient was in stable conditions regarding the concomitant diseases and statin therapy since the time point of measurement)
Stable treatment with statins (if tolerated/clinically indicated)
Age 40 - 75 years

Exclusion Criteria:

Major cardiovascular (CV) event with need for oral anticoagulation or platelet inhibitor therapy or acute coronary syndrome < 12 month before study entry
Sustained uncontrolled hypertension: systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg
Hypersensitivity to the active substance or to any of the excipients
Active clinically significant bleeding
Lesion or condition, if considered to be a significant risk for major bleeding
Concomitant treatment of acute coronary syndrome (ACS) with antiplatelet therapy in patients with a prior stroke or a transient ischemic attack (TIA)
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
Chronic renal failure with eGFR < 15 ml/min (MDRD formula)
Pregnant or breast-feeding woman and woman without adequate method of contraception.
Intervention: ASPIRIN
Trial phase: Phase 3
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: 100mg once daily for 20 weeks (primary phase) + additional 32 weeks (extension phase)
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes duration between 2 and 20 years

Two or more components of metabolic syndrome:

HDL-cholesterol < 1.0 mmol/L (in males) or < 1.3 mmol/L (in females)
Elevated triglycerides (> 1.7 mmol/L)
Elevated blood pressure (> 130 mmHg systolic and/or >85 mmHg diastolic or antihypertensive treatment)
Elevated waist circumference (> 102 cm in males, > 85 cm in females)

Or at least one of the following

Carotid ultrasound showing an IMT > 1 mm and plaque of carotid artery or
Left ventricular hypertrophy or
Increased UACR in the absence of other renal diseases than diabetic nephropathy
Increased hsCRP (> 2 mg/l but < 10 mg/l) at or within 6 months prior to screening and/or increased PAI 1 (> 15 ng/ml) at or within 6 months prior to screening (the historical hsCRP or PAI 1 value can be used only if the patient was in stable conditions regarding the concomitant diseases and statin therapy since the time point of measurement)
Stable treatment with statins (if tolerated/clinically indicated)
Age 40 - 75 years

Exclusion Criteria:

Major cardiovascular (CV) event with need for oral anticoagulation or platelet inhibitor therapy or acute coronary syndrome < 12 month before study entry
Sustained uncontrolled hypertension: systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg
Hypersensitivity to the active substance or to any of the excipients
Active clinically significant bleeding
Lesion or condition, if considered to be a significant risk for major bleeding
Concomitant treatment of acute coronary syndrome (ACS) with antiplatelet therapy in patients with a prior stroke or a transient ischemic attack (TIA)
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
Chronic renal failure with eGFR < 15 ml/min (MDRD formula)
Pregnant or breast-feeding woman and woman without adequate method of contraception.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: One hand of each patient was randomly selected for injection of sterile saline solution (placebo).

Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).

sterile saline solution
Eligibility criteria:
Inclusion Criteria:

Aged 18 years and older
Diagnosed with scleroderma.
Symptoms of Raynaud's syndrome affecting both hands (not necessarily to equal extents)
Ability to return/be available for follow-up evaluations
Able and willing to give informed consent
Able to speak and read in the English language.

Exclusion Criteria:

A history of Myasthenia gravis.
Reported allergy or hypersensitivity to any Botulinum toxin preparation.
Active infection in either hand.
Patients who have ever received Botulinum toxin vaccine.
Pregnant or lactating women.
Females unable or unwilling to maintain abstinence or use contraception for 28 days following the injections.
Patients who have previously undergone any vascular surgery on the upper extremity, including surgical sympathectomies.
Current use of any aminoglycoside antibiotic
Intervention: Vesatolimod
Trial phase: Phase 2
SMILES: CCCCOc1nc(N)c2c(n1)N(Cc1cccc(CN3CCCC3)c1)CC(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Vesatolimod 4 mg tablet once a week for 4 weeks
Eligibility criteria:
Key Inclusion Criteria:

Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
Documented evidence of CHB infection (eg, hepatitis B surface antigen [HBsAg] positive for more than 6 months) with detectable HBsAg levels at screening
Have been on approved HBV OAV treatment for ≥ 1 year prior to screening, with HBV DNA below lower limit of quantitation (LLOQ), measured at least once, 6 or more months prior to screening, and HBV DNA < 20 IU/mL at screening
Currently taking an approved HBV OAV (tenofovir, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening
Willing to provide blood sample for toll-like receptor 7 (TLR-7) and interleukin 28 B (IL28B) single-nucleotide polymorphism (SNP) assessment
Must be willing and able to comply with all study requirements

Key Exclusion Criteria:

Extensive bridging fibrosis or cirrhosis
Laboratory parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function
Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
Evidence of hepatocellular carcinoma
Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Participants under evaluation for possible malignancy are not eligible.
Significant cardiovascular, pulmonary, or neurological disease

Any of the following conditions that may worsen in response to interferon (IFN):

Autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis)
Poorly controlled diabetes mellitus
Significant psychiatric disorders
Thyroid disorder (unless controlled under treatment)
Significant pulmonary diseases (eg, chronic obstructive pulmonary disease)
Retinal disease
Immunodeficiency disorders
Received solid organ or bone marrow transplant
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal Ab, interferon) within 3 months of screening
Use of another investigational agents within 3 months of screening
Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
Females who are pregnant or may wish to become pregnant during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Vesatolimod
Trial phase: Phase 2
SMILES: CCCCOc1nc(N)c2c(n1)N(Cc1cccc(CN3CCCC3)c1)CC(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Vesatolimod 1 mg tablet once a week for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
Documented evidence of CHB infection (eg, hepatitis B surface antigen [HBsAg] positive for more than 6 months) with detectable HBsAg levels at screening
Have been on approved HBV OAV treatment for ≥ 1 year prior to screening, with HBV DNA below lower limit of quantitation (LLOQ), measured at least once, 6 or more months prior to screening, and HBV DNA < 20 IU/mL at screening
Currently taking an approved HBV OAV (tenofovir, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening
Willing to provide blood sample for toll-like receptor 7 (TLR-7) and interleukin 28 B (IL28B) single-nucleotide polymorphism (SNP) assessment
Must be willing and able to comply with all study requirements

Key Exclusion Criteria:

Extensive bridging fibrosis or cirrhosis
Laboratory parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function
Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
Evidence of hepatocellular carcinoma
Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Participants under evaluation for possible malignancy are not eligible.
Significant cardiovascular, pulmonary, or neurological disease

Any of the following conditions that may worsen in response to interferon (IFN):

Autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis)
Poorly controlled diabetes mellitus
Significant psychiatric disorders
Thyroid disorder (unless controlled under treatment)
Significant pulmonary diseases (eg, chronic obstructive pulmonary disease)
Retinal disease
Immunodeficiency disorders
Received solid organ or bone marrow transplant
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal Ab, interferon) within 3 months of screening
Use of another investigational agents within 3 months of screening
Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
Females who are pregnant or may wish to become pregnant during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Vesatolimod
Trial phase: Phase 2
SMILES: CCCCOc1nc(N)c2c(n1)N(Cc1cccc(CN3CCCC3)c1)CC(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Vesatolimod 2 mg tablet once a week for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
Documented evidence of CHB infection (eg, hepatitis B surface antigen [HBsAg] positive for more than 6 months) with detectable HBsAg levels at screening
Have been on approved HBV OAV treatment for ≥ 1 year prior to screening, with HBV DNA below lower limit of quantitation (LLOQ), measured at least once, 6 or more months prior to screening, and HBV DNA < 20 IU/mL at screening
Currently taking an approved HBV OAV (tenofovir, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening
Willing to provide blood sample for toll-like receptor 7 (TLR-7) and interleukin 28 B (IL28B) single-nucleotide polymorphism (SNP) assessment
Must be willing and able to comply with all study requirements

Key Exclusion Criteria:

Extensive bridging fibrosis or cirrhosis
Laboratory parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function
Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
Evidence of hepatocellular carcinoma
Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Participants under evaluation for possible malignancy are not eligible.
Significant cardiovascular, pulmonary, or neurological disease

Any of the following conditions that may worsen in response to interferon (IFN):

Autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis)
Poorly controlled diabetes mellitus
Significant psychiatric disorders
Thyroid disorder (unless controlled under treatment)
Significant pulmonary diseases (eg, chronic obstructive pulmonary disease)
Retinal disease
Immunodeficiency disorders
Received solid organ or bone marrow transplant
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal Ab, interferon) within 3 months of screening
Use of another investigational agents within 3 months of screening
Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
Females who are pregnant or may wish to become pregnant during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Vesatolimod
Trial phase: Phase 2
SMILES: CCCCOc1nc(N)c2c(n1)N(Cc1cccc(CN3CCCC3)c1)CC(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Vesatolimod 4 mg tablet once a week for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
Documented evidence of CHB infection (eg, hepatitis B surface antigen [HBsAg] positive for more than 6 months) with detectable HBsAg levels at screening
Have been on approved HBV OAV treatment for ≥ 1 year prior to screening, with HBV DNA below lower limit of quantitation (LLOQ), measured at least once, 6 or more months prior to screening, and HBV DNA < 20 IU/mL at screening
Currently taking an approved HBV OAV (tenofovir, entecavir, adefovir, lamivudine, or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening
Willing to provide blood sample for toll-like receptor 7 (TLR-7) and interleukin 28 B (IL28B) single-nucleotide polymorphism (SNP) assessment
Must be willing and able to comply with all study requirements

Key Exclusion Criteria:

Extensive bridging fibrosis or cirrhosis
Laboratory parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function
Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
Evidence of hepatocellular carcinoma
Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Participants under evaluation for possible malignancy are not eligible.
Significant cardiovascular, pulmonary, or neurological disease

Any of the following conditions that may worsen in response to interferon (IFN):

Autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis)
Poorly controlled diabetes mellitus
Significant psychiatric disorders
Thyroid disorder (unless controlled under treatment)
Significant pulmonary diseases (eg, chronic obstructive pulmonary disease)
Retinal disease
Immunodeficiency disorders
Received solid organ or bone marrow transplant
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal Ab, interferon) within 3 months of screening
Use of another investigational agents within 3 months of screening
Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
Females who are pregnant or may wish to become pregnant during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Dalfampridine
Trial phase: Phase 2
ATC code: N07XX07
SMILES: Nc1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: All subjects will be randomized for the first double-blinded 8-week part of the study with 25-foot timed walking assessments every 2 weeks. Then subjects will be crossed over to the other therapy (drug or placebo) for another 8 weeks.

Dalfampridine: Dalfampridine 10 mg twice daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of transverse myelitis confirmed by MRI
Gait impairment defined as a baseline timed 25-foot walk of at least 5 seconds and no more than 60 seconds.
Age 18-70.

Exclusion Criteria:

Diagnosis of any of the following concurrent conditions: spinal dural arteriovenous malformation, multiple sclerosis, infectious myelitis and recurrent transverse myelitis of any etiology. Subjects with a positive NMO-Immunoglobulin G (IgG) biomarker test will be permitted to join the study as long as the there is only a history of monophasic, and not recurrent, TM.
History of seizure(s).
Pregnancy or positive pregnancy test (mandatory test for all women aged 18-55 to be done at first screening visit).
Known use or allergy to dalfampridine or any other formulation of 4-aminopyridine.
Patients unable to walk.
Patients with history of severe alcohol or drug abuse, severe psychiatric illness such as severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
Patients with severe uncontrolled medical problems (e.g. hypertension, cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, claudication, uncontrolled epilepsy or others).
Intervention: 4-(Fluorophenyl)-1-Cyclopropylmethyl-5-(2-Amino-4-Pyrimidinyl)Imidazole
Trial phase: Phase 3
SMILES: Nc1nccc(-c2c(-c3ccc(F)cc3)ncn2CC2CC2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 268
Group description: SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
Eligibility criteria:
Inclusion Criteria:

Are male or female aged 18-75 years at the time of signing the informed consent form.
Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria for at least 6 months but not exceeding 15 years prior to Screening.

Have moderate to severe active disease despite MTX therapy defined as:

More than or equal to six swollen joints and more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation.
Either erythrocyte sedimentation rate (Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 10 mg/dL at Screening.
Must have been treated with MTX for a total of at least 6 months prior to Randomisation and must have been on both: a stable route of administration (oral or parenteral) and stable dose of MTX (10-25 mg/week) for at least 4 weeks prior to Screening.
Female subjects who are not pregnant or nursing at Screening and Randomisation and who are not planning to become pregnant from Screening until 5 months after the last dose of IP.

Exclusion Criteria:

Have been treated previously with any biological agents including any tumour necrosis factor inhibitor.
Have a known hypersensitivity to human immunoglobulin proteins or other components of Humira or SB5.
Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus.
Have a current diagnosis of active tuberculosis (TB), have been recently exposed to a person with active TB, or are considered to have latent TB.
Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
Have a history of chronic or recurrent infection.

Have any of the following conditions:

History of congestive heart failure (New York Heart Association Class III/IV).
History of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening.
History of demyelinating disorders.
History of any malignancy within the previous 5 years prior to Screening.
History of lymphoproliferative disease including lymphoma.
Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
Have physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).