anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Etrasimod
Trial phase: Phase 2
ATC code: L04AE05
SMILES: O=C(O)C[C@H]1CCc2c1[nH]c1ccc(OCc3ccc(C4CCCC4)c(C(F)(F)F)c3)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 112
Group description: Participants received etrasimod 2 milligrams (mg) tablet by mouth, once daily for 34 weeks in fasted state.
Eligibility criteria:
Inclusion Criteria:

Participants who completed the APD334-003 (NCT02447302) study

Exclusion Criteria:

Participants who did not complete the APD334-003 study
Intervention: Flavylium
Trial phase: Phase 2 | Phase 3
SMILES: c1ccc(-c2ccc3ccccc3[o+]2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Anthocyanin gel

Anti-inflammation gel
Eligibility criteria:
Inclusion Criteria:

Male and/or females between the ages of 18 and 35 with oral inflammation, investigated by a dentist, caused by orthodontic devices.
The inflammatory lesions are occurred at labial and/or buccal mucosa.
Be able to communicate well with the investigator and to comply with the requirements of the entire study.
Not participate in other project(s).
Be willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions and examination schedule.

Exclusion Criteria:

- Have the persistent inflammatory lesions and/or ulcers that cannot be healed more than 2 weeks or the inflammation that may lead to be oral cancer.
Have severe oral inflammation or the inflammation occur from ongoing head and neck chemotherapy or serious oral inflammatory such as periodontitis and oral lichen planus.
Taking steroid or applying topical steroid within or 7 days before participated in this study.
Have a history of allergy or hypersensitivity to any red, blue, or purple color fruits and vegetables such as berry groups.
Patients with auto-immune diseases or diseases that related to wound healing process such as diabetes.
Patients that cannot meet the follow up or drop out of the experiments.
Intervention: Bimatoprost
Trial phase: Phase 2
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: 13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Completed FSV5-004 study.
Written informed consent prior to any study procedure.
Willingness to comply with the visit schedule.

Key Exclusion Criteria:

Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
Subjects who will require contact lens use during the study period.
Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.
Intervention: Tolvaptan
Trial phase: Not Applicable
ATC code: C03XA01
SMILES: Cc1ccccc1C(=O)Nc1ccc(C(=O)N2CCCC(O)c3cc(Cl)ccc32)c(C)c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Tolvaptan.
Eligibility criteria:
Inclusion Criteria:

Males and females age 12 - 29 years
Weight ≥ 25kg (55 lbs)
Confirmed cystinuria diagnosis
Specific blood test levels (done within the past 6 months)

Exclusion Criteria:

Concurrent non-renal disease that might increase risk of complications due to aquaresis
Liver or biliary disease (chronic or acute)
Malabsorption syndrome or other gastrointestinal condition that may interfere with response to therapy
Non-cutaneous malignancy within last 5 years
History of adverse reaction or allergy to Tolvaptan or other arginine vasopressin V2-receptor antagonists
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Patients with chronic kidney disease will receive ticagrelor 90mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 60mg twice/daily for 7-10 days.
Eligibility criteria:
Inclusion Criteria:

Age >18 years.
Type 2 DM, defined according to World Health Organization (WHO) definition, on treatment with oral hypoglycemic agents and/or insulin for at least 2 months without any changes in treatment regimen;
Angiographically documented CAD.
On treatment with low-dose aspirin (81mg/day) and clopidogrel (75mg/day) for at least 30 days as part of standard of care.

Exclusion Criteria:

Patients with end-stage renal disease on hemodialysis.
Use of any antiplatelet therapy (except aspirin and clopidogrel) in past 30 days.
Use of parenteral or oral anticoagulation in past 30 day.
Active pathological bleeding.
History of intracranial hemorrhage with prior hemorrhage stroke.
Blood dyscrasia or bleeding diathesis.
Any active malignancy.
Platelet count < 80x106/µl.
Hemoglobin <10 g/dl.
Known hepatic dysfunction (known moderate and severe hepatic dysfunction).
Hemodynamic instability.
Known allergy or hypersensitivity to ticagrelor or any excipients.
Pregnant / lactating females (women of childbearing age must use reliable birth control while in the study).
Strong inhibitors of cytochrome CYP3A4 and potent inducers of cytochrome CYP3A4 (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin.
Patients with sick sinus syndrome (SSS) or high degree atrio-ventricular block without pacemaker protection.
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Patients with chronic kidney disease will receive ticagrelor 60mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 90mg twice/daily for 7-10 days.
Eligibility criteria:
Inclusion Criteria:

Age >18 years.
Type 2 DM, defined according to World Health Organization (WHO) definition, on treatment with oral hypoglycemic agents and/or insulin for at least 2 months without any changes in treatment regimen;
Angiographically documented CAD.
On treatment with low-dose aspirin (81mg/day) and clopidogrel (75mg/day) for at least 30 days as part of standard of care.

Exclusion Criteria:

Patients with end-stage renal disease on hemodialysis.
Use of any antiplatelet therapy (except aspirin and clopidogrel) in past 30 days.
Use of parenteral or oral anticoagulation in past 30 day.
Active pathological bleeding.
History of intracranial hemorrhage with prior hemorrhage stroke.
Blood dyscrasia or bleeding diathesis.
Any active malignancy.
Platelet count < 80x106/µl.
Hemoglobin <10 g/dl.
Known hepatic dysfunction (known moderate and severe hepatic dysfunction).
Hemodynamic instability.
Known allergy or hypersensitivity to ticagrelor or any excipients.
Pregnant / lactating females (women of childbearing age must use reliable birth control while in the study).
Strong inhibitors of cytochrome CYP3A4 and potent inducers of cytochrome CYP3A4 (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin.
Patients with sick sinus syndrome (SSS) or high degree atrio-ventricular block without pacemaker protection.
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Patients without chronic kidney disease will receive ticagrelor 90mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 60mg twice/daily for 7-10 days.
Eligibility criteria:
Inclusion Criteria:

Age >18 years.
Type 2 DM, defined according to World Health Organization (WHO) definition, on treatment with oral hypoglycemic agents and/or insulin for at least 2 months without any changes in treatment regimen;
Angiographically documented CAD.
On treatment with low-dose aspirin (81mg/day) and clopidogrel (75mg/day) for at least 30 days as part of standard of care.

Exclusion Criteria:

Patients with end-stage renal disease on hemodialysis.
Use of any antiplatelet therapy (except aspirin and clopidogrel) in past 30 days.
Use of parenteral or oral anticoagulation in past 30 day.
Active pathological bleeding.
History of intracranial hemorrhage with prior hemorrhage stroke.
Blood dyscrasia or bleeding diathesis.
Any active malignancy.
Platelet count < 80x106/µl.
Hemoglobin <10 g/dl.
Known hepatic dysfunction (known moderate and severe hepatic dysfunction).
Hemodynamic instability.
Known allergy or hypersensitivity to ticagrelor or any excipients.
Pregnant / lactating females (women of childbearing age must use reliable birth control while in the study).
Strong inhibitors of cytochrome CYP3A4 and potent inducers of cytochrome CYP3A4 (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin.
Patients with sick sinus syndrome (SSS) or high degree atrio-ventricular block without pacemaker protection.
Intervention: Ticagrelor
Trial phase: Phase 4
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Patients without chronic kidney disease will receive ticagrelor 60mg twice/daily for 7-10 days. Then patients will cross over to ticagrelor 90mg twice/daily for 7-10 days.
Eligibility criteria:
Inclusion Criteria:

Age >18 years.
Type 2 DM, defined according to World Health Organization (WHO) definition, on treatment with oral hypoglycemic agents and/or insulin for at least 2 months without any changes in treatment regimen;
Angiographically documented CAD.
On treatment with low-dose aspirin (81mg/day) and clopidogrel (75mg/day) for at least 30 days as part of standard of care.

Exclusion Criteria:

Patients with end-stage renal disease on hemodialysis.
Use of any antiplatelet therapy (except aspirin and clopidogrel) in past 30 days.
Use of parenteral or oral anticoagulation in past 30 day.
Active pathological bleeding.
History of intracranial hemorrhage with prior hemorrhage stroke.
Blood dyscrasia or bleeding diathesis.
Any active malignancy.
Platelet count < 80x106/µl.
Hemoglobin <10 g/dl.
Known hepatic dysfunction (known moderate and severe hepatic dysfunction).
Hemodynamic instability.
Known allergy or hypersensitivity to ticagrelor or any excipients.
Pregnant / lactating females (women of childbearing age must use reliable birth control while in the study).
Strong inhibitors of cytochrome CYP3A4 and potent inducers of cytochrome CYP3A4 (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin.
Patients with sick sinus syndrome (SSS) or high degree atrio-ventricular block without pacemaker protection.
Intervention: SODIUM FLUORIDE
Trial phase: Phase 3
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Control Arm: Subjects randomized to the Control Arm will use Biotene 4 times per day. They will also complete a study diary to record doses and any symptoms of oral mucositis. This will begin at the start of chemotherapy until for 7 days AND until ANC >500 after nadir or oral mucositis resolves (whichever occurs later)

Biotene: • Use 5 to 10 mL of Biotene to swish and spit

o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab.
Eligibility criteria:
Inclusion Criteria:

Oncology patients, at initiation of their oncology therapy, who are at risk of developing oral mucositis during their scheduled cancer therapy, defined by meeting one or more of the following criteria:

Patients receiving one or more of the following chemotherapy agents:

Actinomycin D
Carboplatin
Cisplatin
Cytarabine at doses > 1 gram/m2
Daunorubicin
Doxorubicin
Methotrexate at doses > 1 gram/m2
Mitoxantrone
Age 0 to 25 years
Voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

Exclusion Criteria:

Patients receiving glutamine treatment for oral mucositis.
Patients undergoing autologous or allogeneic hematopoietic cell transplantation are excluded from this study.
Patients receiving concurrent Head & Neck radiation therapy or within 6 weeks of completion of radiation therapy.
Pregnant or lactating patients. The agent used in this study is not known to be teratogenic to a fetus, but has not been studies, and there is no information on the excretion of the agent into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
Known allergy to Caphosol
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Subjects will receive 400mg of cannabidiol

CBD 400 mg: Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
Eligibility criteria:
Inclusion Criteria:

Must be between 21 and 65 years old
Must have an opiate dependence that meets criteria set in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Structured Clinical Interview for DSM (SCID-V) over the last three months
No opioid use in the past 7 days (will be verified via urine drug screen and opiate metabolite test)

Exclusion Criteria:

Using any psychoactive drug (other than nicotine) any time up to test session 3
Having a diagnosis of drug dependence (except for heroin or nicotine) in the past 3 months, based on the SCID-V interview criteria
Being maintained on methadone or buprenorphine, or taking opioid antagonists such as naltrexone
Having a positive a drug screen
Showing signs of acute heroin withdrawal symptoms
Having medical conditions, including Axis I psychiatric conditions under DSM-V (examined using the Mini International Neuropsychiatric Interview [MINI])
Having a a history of cardiac disease, arrhythmias, head trauma, and seizures
Having a history of hypersensitivity to cannabinoids
Arriving to the study site visibly intoxicated as determined by a clinical evaluation for signs and symptoms of intoxication and as verified by a drug screen
Participating in a another pharmacotherapeutic trial in the past 3 months
Being pregnant of breastfeeding
Not using or irregularly using appropriate methods of contraception such as hormonal contraceptives (e.g., Depo-Provera, Nuva-Ring), an intrauterine device (IUD), or double barrier method (combination of any two barrier methods used simultaneously, e.g., condoms, spermicide, diaphragms)
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Subjects will receive 800 mg of cannabidiol

CBD 800 mg: Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
Eligibility criteria:
Inclusion Criteria:

Must be between 21 and 65 years old
Must have an opiate dependence that meets criteria set in the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-V) Structured Clinical Interview for DSM (SCID-V) over the last three months
No opioid use in the past 7 days (will be verified via urine drug screen and opiate metabolite test)

Exclusion Criteria:

Using any psychoactive drug (other than nicotine) any time up to test session 3
Having a diagnosis of drug dependence (except for heroin or nicotine) in the past 3 months, based on the SCID-V interview criteria
Being maintained on methadone or buprenorphine, or taking opioid antagonists such as naltrexone
Having a positive a drug screen
Showing signs of acute heroin withdrawal symptoms
Having medical conditions, including Axis I psychiatric conditions under DSM-V (examined using the Mini International Neuropsychiatric Interview [MINI])
Having a a history of cardiac disease, arrhythmias, head trauma, and seizures
Having a history of hypersensitivity to cannabinoids
Arriving to the study site visibly intoxicated as determined by a clinical evaluation for signs and symptoms of intoxication and as verified by a drug screen
Participating in a another pharmacotherapeutic trial in the past 3 months
Being pregnant of breastfeeding
Not using or irregularly using appropriate methods of contraception such as hormonal contraceptives (e.g., Depo-Provera, Nuva-Ring), an intrauterine device (IUD), or double barrier method (combination of any two barrier methods used simultaneously, e.g., condoms, spermicide, diaphragms)
Intervention: Fulvestrant
Trial phase: Phase 2
ATC code: L02BA03
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])c3ccc(O)cc3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 500mg fulvestrant administered intramuscularly

Fulvestrant
Eligibility criteria:
Inclusion Criteria:

Female
18 years of age or older
Scheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS
Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy or lumpectomy
Estrogen Receptor-positive pathology
ECOG performance scale of 0-1

Adequate organ function as defined by the following criteria:

Absolute neutrophil count (ANC) ≥ 1500/μl
Platelets ≥ 100,000/μl
Hemoglobin ≥ 9.0 g/dl
Creatinine ≤ 2 times upper limit of normal
Bilirubin ≤ 2 times upper limit of normal
Transaminases (AST/SGOT and ALT/SGPT) ≤ 2.5 times upper limit of normal
Able to sign informed consent
Willing to use effective contraception for at least 100 days post study drug administration.

Exclusion Criteria:

Concurrent treatment with another anti-estrogen
Presence of an active infection requiring systemic therapy

The following conditions contra-indicating fulvestrant administration:

Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use (excluding aspirin and anti-inflammatories)
Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate.
Severe hepatic impairment.
Prior surgery on the ipsilateral breast which interrupts communication of the ductal systems with the nipple
Prior radiation to the breast
Pregnant or lactating
Impaired cardiac function or history of cardiac problems of NYHA Class 111 and IV
Poor nutritional state as indicated by a BMI below 20.
Presence of serious infection not controlled with systemic therapy
History of allergies to Lidocaine or Novocain
Concurrent participation in an experimental drug study
Intervention: Fulvestrant
Trial phase: Phase 2
ATC code: L02BA03
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])c3ccc(O)cc3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: up to 500mg fulvestrant administered intraductally

Fulvestrant
Eligibility criteria:
Inclusion Criteria:

Female
18 years of age or older
Scheduled to undergo non-nipple sparing mastectomy for Invasive Breast Cancer or DCIS
Pathological diagnosis of Invasive Ductal Breast Cancer or Ductal Carcinoma in Situ requiring mastectomy or lumpectomy
Estrogen Receptor-positive pathology
ECOG performance scale of 0-1

Adequate organ function as defined by the following criteria:

Absolute neutrophil count (ANC) ≥ 1500/μl
Platelets ≥ 100,000/μl
Hemoglobin ≥ 9.0 g/dl
Creatinine ≤ 2 times upper limit of normal
Bilirubin ≤ 2 times upper limit of normal
Transaminases (AST/SGOT and ALT/SGPT) ≤ 2.5 times upper limit of normal
Able to sign informed consent
Willing to use effective contraception for at least 100 days post study drug administration.

Exclusion Criteria:

Concurrent treatment with another anti-estrogen
Presence of an active infection requiring systemic therapy

The following conditions contra-indicating fulvestrant administration:

Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use (excluding aspirin and anti-inflammatories)
Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate.
Severe hepatic impairment.
Prior surgery on the ipsilateral breast which interrupts communication of the ductal systems with the nipple
Prior radiation to the breast
Pregnant or lactating
Impaired cardiac function or history of cardiac problems of NYHA Class 111 and IV
Poor nutritional state as indicated by a BMI below 20.
Presence of serious infection not controlled with systemic therapy
History of allergies to Lidocaine or Novocain
Concurrent participation in an experimental drug study
Intervention: Warfarin
Trial phase: Phase 1
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Single oral dose of 15 mg warfarin on Day 1. Warfarin: Administered orally
Eligibility criteria:
Inclusion Criteria:

Male participants: will be sterile (including vasectomy) or agree to use an effective method of birth control and will not donate sperm during the study and for 3 months following the last dose of the investigational product
Female participants: women not of childbearing potential

Exclusion Criteria:

Have a history of or current, significant ophthalmic disease, as determined by the investigator or ophthalmologist
Have vitiligo or any other clinically significant disorder of skin pigmentation as determined by the investigator or dermatologist
Have a history or presence of significant bleeding disorders
Have a history of gastrointestinal ulcers with hemorrhage
Have a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations
Self-reported history of increased bleeding from trauma
Have a history of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within the last 3 months prior to screening
History of major surgery within 3 months of screening
Planned surgery within 14 days after the last day of dosing
International Normalized Ratio (INR)/ Prothrombin Time (PT) or activated partial thromboplastin time above the normal reference range at screening
Abnormal Protein S antigen and/or Protein C activity as determined by the investigator
History of deep vein thrombosis and/or pulmonary embolism