anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Daridorexant
Trial phase: Phase 3
ATC code: N05CJ03
SMILES: COc1ccc(-n2nccn2)c(C(=O)N2CCC[C@@]2(C)c2nc3c(C)c(Cl)ccc3[nH]2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 268
Group description: Film-coated tablets administered orally, once daily in the evening

Daridorexant 25 mg: Daridorexant 25 mg tablets
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure (Visit 1).
Having completed the DB study treatment and the run-out period of ID-078A301 (NCT03545191) or ID-078A302 (NCT03575104).

For woman of childbearing potential, the following is required:

Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)
Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.

Exclusion Criteria:

Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1).
For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).
Intervention: Daridorexant
Trial phase: Phase 3
ATC code: N05CJ03
SMILES: COc1ccc(-n2nccn2)c(C(=O)N2CCC[C@@]2(C)c2nc3c(C)c(Cl)ccc3[nH]2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 137
Group description: Film-coated tablets administered orally, once daily in the evening

Daridorexant 50 mg: Daridorexant 50 mg tablets
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure (Visit 1).
Having completed the DB study treatment and the run-out period of ID-078A301 (NCT03545191) or ID-078A302 (NCT03575104).

For woman of childbearing potential, the following is required:

Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)
Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.

Exclusion Criteria:

Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1).
For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).
Intervention: Daridorexant
Trial phase: Phase 3
ATC code: N05CJ03
SMILES: COc1ccc(-n2nccn2)c(C(=O)N2CCC[C@@]2(C)c2nc3c(C)c(Cl)ccc3[nH]2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Film-coated tablets administered orally, once daily in the evening

Daridorexant 25 mg: Daridorexant 25 mg tablets
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure (Visit 1).
Having completed the DB study treatment and the run-out period of ID-078A301 (NCT03545191) or ID-078A302 (NCT03575104).

For woman of childbearing potential, the following is required:

Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)
Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.

Exclusion Criteria:

Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1).
For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).
Intervention: Fevipiprant
Trial phase: Phase 3
SMILES: Cc1c(CC(=O)O)c2cccnc2n1Cc1ccc(S(C)(=O)=O)cc1C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Fevipiprant (QAW039) 150 mg once daily orally
Eligibility criteria:
Inclusion Criteria:

Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score >= 4 with minimum score of 2 in each nostril.
Concomitant diagnosis of asthma for a period of at least 6 months prior to screening.
Patients on stable asthma treatment of at least inhaled corticosteroids (any dose) alone for at least 6 months prior to screening or ICS for 6 months prior to screening with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to screening.

Exclusion Criteria:

Asthma exacerbation, within 6 weeks prior to screening, that required systemic corticosteroids, hospitalization or emergency room visit.
Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of OCS for a period of 1 month or more, within 1 year of screening
Use of biologics for asthma or any other indications, that has the potential to interfere/affect either asthma or nasal polyposis disease progression, within 6 months of screening.
Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of screening or during the run-in period.
Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of screening.
History of nasal surgery modifying the structure of the nose such that assessment of the nasal polyp score is not possible.
Patients with baseline ACQ-5≥1.5
Intervention: Fevipiprant
Trial phase: Phase 3
SMILES: Cc1c(CC(=O)O)c2cccnc2n1Cc1ccc(S(C)(=O)=O)cc1C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Fevipiprant (QAW039) 450 mg once daily orally
Eligibility criteria:
Inclusion Criteria:

Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score >= 4 with minimum score of 2 in each nostril.
Concomitant diagnosis of asthma for a period of at least 6 months prior to screening.
Patients on stable asthma treatment of at least inhaled corticosteroids (any dose) alone for at least 6 months prior to screening or ICS for 6 months prior to screening with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to screening.

Exclusion Criteria:

Asthma exacerbation, within 6 weeks prior to screening, that required systemic corticosteroids, hospitalization or emergency room visit.
Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of OCS for a period of 1 month or more, within 1 year of screening
Use of biologics for asthma or any other indications, that has the potential to interfere/affect either asthma or nasal polyposis disease progression, within 6 months of screening.
Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of screening or during the run-in period.
Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of screening.
History of nasal surgery modifying the structure of the nose such that assessment of the nasal polyp score is not possible.
Patients with baseline ACQ-5≥1.5
Intervention: Estradiol
Trial phase: Phase 1
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: 8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women without type 2 diabetes.

Estradiol patch: transdermal 17β-estradiol patch
Eligibility criteria:
Inclusion Criteria:

Willing to provide written informed consent
Stated willingness to comply with all study procedures and availability for the duration of the study
Female, postmenopausal, aged 60-80
Normal results on recommended healthcare screenings (e.g., mammogram, pap smear, colonoscopy)
BMI 20-35 kg/m2
No evidence of dementia or mild cognitive impairment (MoCA score >25)
Able to access reliable transportation to study and intervention visits

Exclusion Criteria:

Use of hormone replacement therapy within the past 3 months
History of renal, heart, liver, or neurological disease; head injury with loss of consciousness in the past 5 years; chronic pain, anxiety or depression
Presence of medical conditions that might contraindicate estrogen use (e.g., unexplained vaginal bleeding, history of reproductive tissue cancer, thrombosis)
Currently taking insulin, metformin, or any other drug or medication judged by the study physician to affect safety or research outcomes of interest
Involved in another research study
Contraindications for MRI or PET scanning
Current smoker
Intervention: Estradiol
Trial phase: Phase 1
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: 8-week administration of transdermal 17β-estradiol (Climara) patch in postmenopausal women with type 2 diabetes

Estradiol patch: transdermal 17β-estradiol patch
Eligibility criteria:
Inclusion Criteria:

Willing to provide written informed consent
Stated willingness to comply with all study procedures and availability for the duration of the study
Female, postmenopausal, aged 60-80
Normal results on recommended healthcare screenings (e.g., mammogram, pap smear, colonoscopy)
BMI 20-35 kg/m2
No evidence of dementia or mild cognitive impairment (MoCA score >25)
Able to access reliable transportation to study and intervention visits

Exclusion Criteria:

Use of hormone replacement therapy within the past 3 months
History of renal, heart, liver, or neurological disease; head injury with loss of consciousness in the past 5 years; chronic pain, anxiety or depression
Presence of medical conditions that might contraindicate estrogen use (e.g., unexplained vaginal bleeding, history of reproductive tissue cancer, thrombosis)
Currently taking insulin, metformin, or any other drug or medication judged by the study physician to affect safety or research outcomes of interest
Involved in another research study
Contraindications for MRI or PET scanning
Current smoker
Intervention: Bupivacaine
Trial phase: Phase 3
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: 26
Group description: Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Eligibility criteria:
Inclusion Criteria:

Adult at least 18 years of age
Subject needs elective lobectomy for non small cell lung cancer
Willing to comply with all aspects of protocol, including providing information about opioid usage for post-surgical pain and signed informed consent

Exclusion Criteria:

< 18 years of age, > 80 years of age
Inability or unwillingness to consent
Emergency surgery
Previous ipsilateral thoracic surgery
Need for operative pleurectomy or pleurodesis
Chronic Narcotic use
Any narcotic use in the 1 month period prior to screening
Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
Moderate to severe hepatic impairment (ALT or AST) value greater than 3 times the upper limit of normal.
Severe renal impairment or end stage renal failure disease (creatinine greater than 2.0 mg/dl).
History of peptic ulcerative disease
Severe chronic obstructive pulmonary disease (COPD) due to LVRS (lung-volume reduction surgery).
Pregnancy
Need for conversion from a Video-Assisted Thoracic Surgery procedure to an open thoracotomy
Subjects who are incarcerated
Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives. Or subject is current enrolled in another clinical trial.
Unable to follow protocol directions due to organic brain or psychiatric disease.
History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 31
Group description: Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Eligibility criteria:
Inclusion Criteria:

Subjects whose parent(s) or guardian(s) has/have signed and dated the ICF for the subject to participate in the study, and subjects who have provided written assent to participate in the study (if capable).
American Society of Anesthesiologists (ASA) Class 1-3.
Male or female subjects 6 to less than 17 years of age on the day of surgery.
Body mass index (BMI) at screening within the 5th to 95th percentile for age and sex (see Appendix 5).
A negative pregnancy test for female subjects of childbearing potential must be available prior to the start of surgery. The pregnancy test must be conducted in the preoperative holding area according to the study site's standard of care.
Subjects and their parent(s)/guardian(s) must be able to speak, read, and understand the language of the ICF and any instruments used for collecting subject-reported outcomes to enable accurate and appropriate responses to study assessments, and provide informed consent/assent.
Subjects must be able to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

Currently pregnant, breastfeeding, or planning to become pregnant during the study or within 1 month after study drug administration.
History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or to opioid medication.
Contraindication to bupivacaine HCl or other amide-type local anesthetics or to opioid medication.
Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
Subjects with coagulopathies or immunodeficiency disorders.
History of, suspected, or known addiction to or abuse of drugs or alcohol within the past 2 years.
Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures.

Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

In addition, the subject will be ineligible to receive study drug if he or she meets the following criterion during surgery:

Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Eligibility criteria:
Inclusion Criteria:

Subjects whose parent(s) or guardian(s) has/have signed and dated the ICF for the subject to participate in the study, and subjects who have provided written assent to participate in the study (if capable).
American Society of Anesthesiologists (ASA) Class 1-3.
Male or female subjects 6 to less than 17 years of age on the day of surgery.
Body mass index (BMI) at screening within the 5th to 95th percentile for age and sex (see Appendix 5).
A negative pregnancy test for female subjects of childbearing potential must be available prior to the start of surgery. The pregnancy test must be conducted in the preoperative holding area according to the study site's standard of care.
Subjects and their parent(s)/guardian(s) must be able to speak, read, and understand the language of the ICF and any instruments used for collecting subject-reported outcomes to enable accurate and appropriate responses to study assessments, and provide informed consent/assent.
Subjects must be able to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

Currently pregnant, breastfeeding, or planning to become pregnant during the study or within 1 month after study drug administration.
History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or to opioid medication.
Contraindication to bupivacaine HCl or other amide-type local anesthetics or to opioid medication.
Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
Subjects with coagulopathies or immunodeficiency disorders.
History of, suspected, or known addiction to or abuse of drugs or alcohol within the past 2 years.
Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures.

Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

In addition, the subject will be ineligible to receive study drug if he or she meets the following criterion during surgery:

Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 29
Group description: Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
Eligibility criteria:
Inclusion Criteria:

Subjects whose parent(s) or guardian(s) has/have signed and dated the ICF for the subject to participate in the study, and subjects who have provided written assent to participate in the study (if capable).
American Society of Anesthesiologists (ASA) Class 1-3.
Male or female subjects 6 to less than 17 years of age on the day of surgery.
Body mass index (BMI) at screening within the 5th to 95th percentile for age and sex (see Appendix 5).
A negative pregnancy test for female subjects of childbearing potential must be available prior to the start of surgery. The pregnancy test must be conducted in the preoperative holding area according to the study site's standard of care.
Subjects and their parent(s)/guardian(s) must be able to speak, read, and understand the language of the ICF and any instruments used for collecting subject-reported outcomes to enable accurate and appropriate responses to study assessments, and provide informed consent/assent.
Subjects must be able to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

Currently pregnant, breastfeeding, or planning to become pregnant during the study or within 1 month after study drug administration.
History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or to opioid medication.
Contraindication to bupivacaine HCl or other amide-type local anesthetics or to opioid medication.
Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug administration.
Subjects with coagulopathies or immunodeficiency disorders.
History of, suspected, or known addiction to or abuse of drugs or alcohol within the past 2 years.
Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures.

Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

In addition, the subject will be ineligible to receive study drug if he or she meets the following criterion during surgery:

Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
Intervention: Gabapentin
Trial phase: Phase 3
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Interventional use of perioperative analgesia with acetaminophen and opioids that is supplemented with gabapentin solution. Participants will then be discharged after surgery with postoperative acetaminophen, opioids, and gabapentin.

Gabapentin: Use of Gabapentin peri- and post-operatively.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing major head and neck surgery with concomitant free flap reconstruction surgery at UCDMC (oncology and non-oncologic): There will be two groups. Group 1 will include reconstruction with fibula free flap only. Group 2 will include any other free flap reconstruction, including scapular free flap, radial forearm free flap, anterolateral thigh free flap, anteromedial thigh free flap, and latissimus dorsi free flap.
Patients naïve to gabapentin
Adult patients >18 years of age and able to consent

Exclusion Criteria:

Patients who are already taking scheduled gabapentin
Patients allergic to gabapentin
Chronic opioid use not from active head and neck cancer
Illicit drug use (per report)
Patients with known renal compromise, such that Creatinine clearance is < 30
Patient with known hepatic insufficiency or cirrhosis
Adults unable to consent
Individuals less than 18 years old
Pregnant women
Prisoners