anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lovaza
Trial phase: Phase 4
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Lovaza 4 grams daily (2 1-gram capsules twice daily) will be given for 8 weeks

Lovaza
Eligibility criteria:
Inclusion Criteria:

Men and non-pregnant/lactating women between the ages of 25 and 50.
Body Mass Index (BMI) ≥30 kg/m2
Participants who are able to give written informed consent and willing to comply with all study-related procedures.

Exclusion Criteria:

Diabetes Mellitus (glucose fasting >126, or random >200, Hemoglobin A1C>6.5 %, or use of any anti-diabetic agent)
Self-reported fish or shellfish allergy
Planned usage of any prescription or non-prescription medication (other than contraceptive pills or devices) during the study period.
Recent (within 6 months) use of fish oil supplements or self- reported dietary intake of >3 servings of fish/month
Blood pressure >140/90
Recent (within 6 months) use of statins, niacin, or fenofibrates
Current or planned pregnancy/lactation. Pre-menopausal women unwilling to prevent pregnancy by use of the following approved contraceptive strategies: diaphragm, cervical cap, condom with spermicide, surgical sterility, birth control pills, Depo-Provera injection, Intra-uterine device, progestin implant, or abstinence.
History of liver disease or abnormal liver function tests (aspartate aminotransferase, Alanine transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase > 1.5x Upper Limit normal; bilirubin > 2x upper limit normal) at Screening Visit
Men who are unwilling to limit alcohol consumption to < 14 alcoholic drinks per week or < 4 alcoholic drinks per occasion while participating in the study
Women who are unwilling to limit alcohol consumption to < 7 alcoholic drinks per week or < 3 alcoholic drinks per occasion while participating in the study.
Hemoglobin less than 11.0 g/dL
Any reported arrhythmia, usage of anti-arrhythmic therapy, or abnormal screening electrocardiogram
Known bleeding disorder or coagulopathy
Any major active rheumatologic, pulmonary, hematologic or dermatologic disease or inflammatory condition or minor active infection
Self-reported history of HIV positive
Patients who have undergone any organ transplant
Individuals who currently use tobacco products or have done so in the previous 30 days
Treatment with aspirin, non steroidal anti-inflammatories, COX-2 inhibitors, steroids or any immunomodulatory therapy 2 weeks prior to the Screening Visit
Participants who are unwilling to eliminate omega-3 fatty acid (EPA + DHA) supplements and/or fortified food, or have their usual intake of high omega-3 fish (tuna and other non-fried fish) be > 3 to 4 servings per month as assessed by a simple screening questionnaire
Recent (within 6 months) treatment with coumarin-type anticoagulants
Positive urine pregnancy test result.
Self-reported history of injected recreational drug use.
Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator
Intervention: Clopidogrel
Trial phase: Phase 1
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days

-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
Eligibility criteria:
Inclusion Criteria:

Age between 18 and 45 years
Body mass index between 18-25 kg/m2
No clinically significant abnormalities, as confirmed on medical history; detailed physical examination; clinical laboratory analysis (blood hematology, biochemistry, prothrombin time, bleeding time, and urinalysis)

Exclusion Criteria:

An allergy to any drug; and/or a history of drug and/or alcohol abuse.
Subjects who had donated blood within 3 months prior to the start of this study or had participated in another investigational drug study within 3 months prior to the start of this study
Participating subjects were instructed to abstain from the use of any drugs for at least 2 weeks before and throughout the study.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
Eligibility criteria:
Inclusion Criteria:

-Participants with Masseter Muscle Hypertrophy

Exclusion Criteria:

Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face
History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
History of or current temporomandibular joint disorder (TMJD)
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Exparel infiltrated into the posterior compartment of the knee
Eligibility criteria:
Inclusion Criteria:

Patients aged 18-75 years inclusive and American Society of Anesthesiologist physical status 1-3
Patients undergoing knee replacement (total knee arthroplasty)
Subjects must be physically and mentally able to participate in the study and complete all study assessments.
Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of infiltration into the posterior capsule of the knee.

Exclusion Criteria:

History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a appropriate Exparel infiltration into the posterior capsule of the knee.
Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
Any subject, who in the opinion of the Investigator, is on chronic pain medicine (opioids), including large doses of non-steroidal anti-inflammatory drugs s.
Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
History of pre-existing neurological disorders/neuropathy
Morbid Obesity
Intervention: Ronopterin
Trial phase: Phase 2
SMILES: [H][C@]1([C@@H](O)[C@H](C)O)CNc2nc(N)nc(N)c2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg

VAS203
Eligibility criteria:
Inclusion Criteria:

Written informed consent from patient's legal guardian or legal representative
18 - 65 years of age, inclusive
Head trauma within the last 12 hours
Traumatic brain injury with Glasgow Coma Score (GCS) ≥ 5 and that requires ICP monitoring
Catheter placement for monitoring and management of increased ICP
Microdialysis probe placement in penumbra zone or ipsilateral to contusion if focal
Systolic blood pressure ≥ 100 mmHg
Females of child-bearing potential must have a negative pregnancy test

Exclusion Criteria:

Penetrating head injury (e.g. missile, stab wound)
Not expected to survive more than 24 hours after admission
Concurrent, but not pre-existing, spinal cord injury
Unilateral and bilateral fixed and dilated pupil (> 4 mm)
Cardiopulmonary resuscitation performed post injury
continuing bleeding likely to require multiple transfusions (> 4 units red blood cells)
Coma due to a "pure" epidural hematoma (lucid interval and absence of structural brain damage on CT scan)
Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose)
Known or CT scan evidence of pre-existing major cerebral damage
Decompressive craniectomy, planned prior to randomization
Polytraumatic patients with Injury Severity Score > 25, or rhabdomyolysis
Injuries to ascending aorta and/or carotid arteries
serum creatinine values > 1.5 mg/dL
estimated Glomerular Filtration Rate < 60 ml/min (MDRD-formula)
body mass index (BMI) > 35, Body weight > 120 kg
Any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission
Known to have received an experimental drug within 4 weeks prior to current injury
Administration of > 100 ml of contrast media containing iodine
Intervention: Ronopterin
Trial phase: Phase 2
SMILES: [H][C@]1([C@@H](O)[C@H](C)O)CNc2nc(N)nc(N)c2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: 10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg

VAS203
Eligibility criteria:
Inclusion Criteria:

Written informed consent from patient's legal guardian or legal representative
18 - 65 years of age, inclusive
Head trauma within the last 12 hours
Traumatic brain injury with Glasgow Coma Score (GCS) ≥ 5 and that requires ICP monitoring
Catheter placement for monitoring and management of increased ICP
Microdialysis probe placement in penumbra zone or ipsilateral to contusion if focal
Systolic blood pressure ≥ 100 mmHg
Females of child-bearing potential must have a negative pregnancy test

Exclusion Criteria:

Penetrating head injury (e.g. missile, stab wound)
Not expected to survive more than 24 hours after admission
Concurrent, but not pre-existing, spinal cord injury
Unilateral and bilateral fixed and dilated pupil (> 4 mm)
Cardiopulmonary resuscitation performed post injury
continuing bleeding likely to require multiple transfusions (> 4 units red blood cells)
Coma due to a "pure" epidural hematoma (lucid interval and absence of structural brain damage on CT scan)
Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose)
Known or CT scan evidence of pre-existing major cerebral damage
Decompressive craniectomy, planned prior to randomization
Polytraumatic patients with Injury Severity Score > 25, or rhabdomyolysis
Injuries to ascending aorta and/or carotid arteries
serum creatinine values > 1.5 mg/dL
estimated Glomerular Filtration Rate < 60 ml/min (MDRD-formula)
body mass index (BMI) > 35, Body weight > 120 kg
Any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission
Known to have received an experimental drug within 4 weeks prior to current injury
Administration of > 100 ml of contrast media containing iodine
Intervention: GLUTAMINE
Trial phase: Phase 2
ATC code: A16AA03
SMILES: NC(=O)CCC(N)C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Powdered Glutamine, 10.0 grams by mouth three times a day (TID) for 30 days, so that daily dose is 30 grams per day

Glutamine: Oral glutamine for subjects undergoing breast conserving therapy
Eligibility criteria:
Inclusion Criteria:

Subject have been diagnosed with Stage I or II invasive breast cancer
Subject will undergo Accelerated Partial Breast Irradiation (APBI) as part of Breast Conserving Therapy (BCT)
Subject is eligible for APBI based on American Society of Therapeutic Radiation Oncology (ASTRO) criteria
Subject is 18 years of age or older
Subject is female

Exclusion Criteria:

History of uncontrolled, clinically significant lung, heart, endocrine, liver, or renal disease
Subject has been diagnosed with any other cancer
Subject has a known hypersensitivity reaction to the following: oral glutamine (GLN), glutamate, monosodium glutamate (MSG) (i.e., Chinese restaurant syndrome)
Subject has history of collagen vascular disease
Subject has been diagnosed with Diabetes mellitus I or II
Subject has had any prior breast radiation
Subject is pregnant or breastfeeding
Intervention: Cavosonstat
Trial phase: Phase 1
SMILES: O=C(O)c1ccc(-c2ccc3cc(O)ccc3n2)c(Cl)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: single oral daily dose of 10 mg N91115 for 14 days

N91115: Given PO daily for 14 days
Eligibility criteria:
Inclusion Criteria:

Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures and in the opinion of the PI complies with all the requirements of the study.
Subject is healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations).
Subject is Caucasian.
Female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy (HRT) are eligible to enroll.
Male subject must agree to use condoms and refrain from sperm donation from Day 1 until 30 days post last dose or have documentation of vasectomy.
Subject has a body weight > 50 kg and body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.
Subject has no clinically significant abnormal findings related to their systolic or diastolic blood pressure (BP), per the investigator's judgment, at screening or Day 1.
Subject has no clinically significant abnormal findings in 12 lead ECG, per the investigator's judgment, at screening.

Exclusion Criteria:

Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the investigator or designee.
Subject has clinically significant abnormalities on a 12 lead ECG done at screening
Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at screening
Subject has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
Subject has any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical study.
Subject is unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, unavailable for follow-up call, and/or improbability of completing the clinical study.
Intervention: Cavosonstat
Trial phase: Phase 1
SMILES: O=C(O)c1ccc(-c2ccc3cc(O)ccc3n2)c(Cl)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: single oral daily dose of 50 mg N91115 for 14 days

N91115: Given PO daily for 14 days
Eligibility criteria:
Inclusion Criteria:

Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures and in the opinion of the PI complies with all the requirements of the study.
Subject is healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations).
Subject is Caucasian.
Female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy (HRT) are eligible to enroll.
Male subject must agree to use condoms and refrain from sperm donation from Day 1 until 30 days post last dose or have documentation of vasectomy.
Subject has a body weight > 50 kg and body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.
Subject has no clinically significant abnormal findings related to their systolic or diastolic blood pressure (BP), per the investigator's judgment, at screening or Day 1.
Subject has no clinically significant abnormal findings in 12 lead ECG, per the investigator's judgment, at screening.

Exclusion Criteria:

Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the investigator or designee.
Subject has clinically significant abnormalities on a 12 lead ECG done at screening
Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at screening
Subject has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
Subject has any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical study.
Subject is unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, unavailable for follow-up call, and/or improbability of completing the clinical study.
Intervention: Cavosonstat
Trial phase: Phase 1
SMILES: O=C(O)c1ccc(-c2ccc3cc(O)ccc3n2)c(Cl)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: single oral daily dose of 250 mg N91115 for 14 days (fasted)

N91115: Given PO daily for 14 days
Eligibility criteria:
Inclusion Criteria:

Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures and in the opinion of the PI complies with all the requirements of the study.
Subject is healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations).
Subject is Caucasian.
Female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy (HRT) are eligible to enroll.
Male subject must agree to use condoms and refrain from sperm donation from Day 1 until 30 days post last dose or have documentation of vasectomy.
Subject has a body weight > 50 kg and body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.
Subject has no clinically significant abnormal findings related to their systolic or diastolic blood pressure (BP), per the investigator's judgment, at screening or Day 1.
Subject has no clinically significant abnormal findings in 12 lead ECG, per the investigator's judgment, at screening.

Exclusion Criteria:

Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the investigator or designee.
Subject has clinically significant abnormalities on a 12 lead ECG done at screening
Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at screening
Subject has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
Subject has any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical study.
Subject is unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, unavailable for follow-up call, and/or improbability of completing the clinical study.
Intervention: Cavosonstat
Trial phase: Phase 1
SMILES: O=C(O)c1ccc(-c2ccc3cc(O)ccc3n2)c(Cl)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: single oral daily dose of 500 mg N91115 for 14 days

N91115: Given PO daily for 14 days
Eligibility criteria:
Inclusion Criteria:

Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures and in the opinion of the PI complies with all the requirements of the study.
Subject is healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations).
Subject is Caucasian.
Female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy (HRT) are eligible to enroll.
Male subject must agree to use condoms and refrain from sperm donation from Day 1 until 30 days post last dose or have documentation of vasectomy.
Subject has a body weight > 50 kg and body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.
Subject has no clinically significant abnormal findings related to their systolic or diastolic blood pressure (BP), per the investigator's judgment, at screening or Day 1.
Subject has no clinically significant abnormal findings in 12 lead ECG, per the investigator's judgment, at screening.

Exclusion Criteria:

Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the investigator or designee.
Subject has clinically significant abnormalities on a 12 lead ECG done at screening
Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at screening
Subject has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
Subject has any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical study.
Subject is unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, unavailable for follow-up call, and/or improbability of completing the clinical study.