anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Capsaicin
Trial phase: Not Applicable
ATC code: M02AB01 | M02AB02 | N01BX04
SMILES: COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 99
Group description: Subjects will undergo the cutaneous capsaicin test. A one inch ribbon of Capzasin-HP Cream (0.1%) will be applied to the skin on the forearm of the non-dominant arm. Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, ranging from 0 ("no discomfort") to 10 ("the worst discomfort imaginable"). The cream will then be removed by washing the affected arm with cold water. The patients will be asked follow-up questions concerning their experiences with chest pain in the past and their tolerance of spicy foods. Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion.

Capsaicin: one inch ribbon of Capzasin -HP applied to forearm for 30 minutes
Eligibility criteria:
Inclusion Criteria:

Subjects will consist of patients who have undergone clinically-indicated percutaneous coronary intervention (PCI) for the treatment of coronary artery disease.

Exclusion Criteria:

Clinically unstable patients, such as those undergoing emergency PCI, patients with documented hypersensitivity to capsaicin will be excluded and patients who have used a capsaicin-based product within the last 3 months will be excluded. Patients in whom it would be inadvisable for any reason to conduct a one-hour research study at a follow-up visit after PCI will also be excluded.
Intervention: Capsaicin
Trial phase: Not Applicable
ATC code: M02AB01 | M02AB02 | N01BX04
SMILES: COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Subjects will undergo the cutaneous capsaicin test at the time of the study visit. A one inch ribbon of Capzasin-HP Cream (0.1%) will be applied to the skin on the forearm of the non-dominant arm. Subjects will be asked to assign a numerical score to the maximum intensity of any cutaneous discomfort experienced during the subsequent 30 minutes, from 0 ("no discomfort") to 10 ("the worst discomfort imaginable"). The cream will then be removed by washing the affected arm with cold water. Efforts will then be made to examine the association between the pain score documented in response to the cutaneous capsaicin test with the pain score obtained during coronary balloon occlusion. This method should allow an individual's subjective sensitivity to the TRPV1-mediated noxious stimulus of myocardial ischemia to be compared with his/her sensitivity to the TRPV1-mediated noxious stimulus of cutaneous capsaicin in extra-cardiac tissues.

Capsaicin: 1 inch ribbon of Capzasin-HP 0.1% will be applied to the forearm for 30 minutes
Eligibility criteria:
Inclusion Criteria:

Subjects will consist of patients who have undergone clinically-indicated PCI for the treatment of coronary artery disease. This study will include clinically unstable patients, such as those undergoing emergency percutaneous coronary intervention (PCI) for acute myocardial infarction, etc.

Exclusion Criteria:

Patients with documented hypersensitivity to capsaicin will be excluded and patients who have used a capsaicin-based product within the last 3 months will be excluded
Intervention: Vinflunine
Trial phase: Phase 3
ATC code: L01CA05
SMILES: CCC12C=CCN3CCC4(c5cc(C6(C(=O)OC)CC7CC(C(C)(F)F)CN(Cc8c6[nH]c6ccccc86)C7)c(OC)cc5N(C)C4C(O)(C(=O)OC)C1OC(C)=O)C32
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 225
Group description: Vinflunine IV 280mg/m2 Day1 plus Methotrexate IV 30mg/m2 on Day 1 and Dy 8 every 3 cycles

Vinflunine
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma
Documented progressive disease after chemotherapy for locoregionally advanced or recurrent/metastatic SCCHN which included a platinum derivative
Measurable or non measurable disease
adequate haematological, hepatic and renal functions
WHO performance status < 1

Exclusion Criteria:

Nasopharyngeal carcinoma
History of brain or leptomeningeal involvement
Albumin level < 35 g/L
Patients with weight loss ≥ 5% within the last 3 months
Grade > 2 peripheral neuropathy at study entry
"Third space" fluids (pleural effusion, ascites, massive edema)
Prior treatment with vinca-alkaloids and methotrexate
Intervention: Ledipasvir
Trial phase: Phase 4
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Ability to give written informed consent in English
Age≥18 and ≤55
HCV antibody positive
HCV RNA >1,000 copies/mL plasma
HCV treatment naive
HCV genotype 1a or 1b or mixed type 1
AST, ALT <10x ULN
Direct bilirubin <3.0
Platelet count >50,000
Creatinine clearance >30mL/min as estimated by Cockroft Gault
Hemoglobin >10 if female, >11 if male
Albumin > 2.8
INR<2.0
If Group A: urine dip for opiates + and active injection drug use of heroin defined as injecting at least 3 times per week.
If Group B then no IDU for at least 4 months and a negative urine for opiates at screening.
Venous access for phlebotomy
Willingness to agree to effective contraception during the course of the study.

If Group C: - negative urine for opiates at screening

no recreational drug use for at least 2 years (excluding marijuana)
HIV, HCV and HBV uninfected

Exclusion Criteria:

HIV infection
Chronic infection with Hepatitis B
Uncompensated cirrhosis

Required use of:

Anticonvulsants: carbamazepine, oxycarbazepine, phenobarbital, and phenytoin

Antimycobacterials: rifabutin, rifampin, rifapentine

Herbal Supplements: St. John's wort

HIV Protease Inhibitors: tipranavir-ritonavir

Antiarrhythmic Drugs: amiodarone (Cordarone, Nexterone, Pacerone)

Any medical condition that in the opinion of the investigator would interfere with study participation and medical adherence

Pregnancy/breast feeding

-
Intervention: Ledipasvir
Trial phase: Phase 4
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Ability to give written informed consent in English
Age≥18 and ≤55
HCV antibody positive
HCV RNA >1,000 copies/mL plasma
HCV treatment naive
HCV genotype 1a or 1b or mixed type 1
AST, ALT <10x ULN
Direct bilirubin <3.0
Platelet count >50,000
Creatinine clearance >30mL/min as estimated by Cockroft Gault
Hemoglobin >10 if female, >11 if male
Albumin > 2.8
INR<2.0
If Group A: urine dip for opiates + and active injection drug use of heroin defined as injecting at least 3 times per week.
If Group B then no IDU for at least 4 months and a negative urine for opiates at screening.
Venous access for phlebotomy
Willingness to agree to effective contraception during the course of the study.

If Group C: - negative urine for opiates at screening

no recreational drug use for at least 2 years (excluding marijuana)
HIV, HCV and HBV uninfected

Exclusion Criteria:

HIV infection
Chronic infection with Hepatitis B
Uncompensated cirrhosis

Required use of:

Anticonvulsants: carbamazepine, oxycarbazepine, phenobarbital, and phenytoin

Antimycobacterials: rifabutin, rifampin, rifapentine

Herbal Supplements: St. John's wort

HIV Protease Inhibitors: tipranavir-ritonavir

Antiarrhythmic Drugs: amiodarone (Cordarone, Nexterone, Pacerone)

Any medical condition that in the opinion of the investigator would interfere with study participation and medical adherence

Pregnancy/breast feeding

-
Intervention: Nicotine
Trial phase: Not Applicable
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Lozenge is used immediately after smoking cue exposure

Nicotine lozenge 4 mg
Eligibility criteria:
Inclusion Criteria:

Smoking a minimum number of cigarettes per day
General good health

Exclusion Criteria:

unstable medical or psychiatric conditions
history of severe motion sickness (due to virtual reality equipment used to present cues)
women who are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not participate
Intervention: Solriamfetol
Trial phase: Phase 3
ATC code: N06BA14
SMILES: NC(=O)OC[C@H](N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Eligibility criteria:
Major Inclusion Criteria:

Males and females between 18 and 75 years of age, inclusive
Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent

Major Exclusion Criteria:

Female subjects who are pregnant, nursing, or lactating
Moderate or severe sleep apnea on the baseline PSG.
Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
History of bariatric surgery within the past year or a history of any gastic bypass procedure
Presence or history of significant cardiovascular disease
Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
Use of any medications that could affect the evaluation of cataplexy
Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Intervention: Solriamfetol
Trial phase: Phase 3
ATC code: N06BA14
SMILES: NC(=O)OC[C@H](N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Eligibility criteria:
Major Inclusion Criteria:

Males and females between 18 and 75 years of age, inclusive
Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent

Major Exclusion Criteria:

Female subjects who are pregnant, nursing, or lactating
Moderate or severe sleep apnea on the baseline PSG.
Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
History of bariatric surgery within the past year or a history of any gastic bypass procedure
Presence or history of significant cardiovascular disease
Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
Use of any medications that could affect the evaluation of cataplexy
Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Intervention: Solriamfetol
Trial phase: Phase 3
ATC code: N06BA14
SMILES: NC(=O)OC[C@H](N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Eligibility criteria:
Major Inclusion Criteria:

Males and females between 18 and 75 years of age, inclusive
Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent

Major Exclusion Criteria:

Female subjects who are pregnant, nursing, or lactating
Moderate or severe sleep apnea on the baseline PSG.
Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
History of bariatric surgery within the past year or a history of any gastic bypass procedure
Presence or history of significant cardiovascular disease
Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
Use of any medications that could affect the evaluation of cataplexy
Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Intervention: Solriamfetol
Trial phase: Phase 3
ATC code: N06BA14
SMILES: NC(=O)OC[C@H](N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: 37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Eligibility criteria:
Major Inclusion Criteria:

Male or female between 18 and 75 years of age, inclusive
Diagnosis of OSA according to ICSD-3 criteria
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent

Major Exclusion Criteria:

Female subjects who are pregnant, nursing, or lactating
Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator.
History of bariatric surgery within the past year or a history of any gastric bypass procedure
Presence or history of significant cardiovascular disease
Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
Received an investigational drug in the past 30 days or five half-lives
Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Intervention: Solriamfetol
Trial phase: Phase 3
ATC code: N06BA14
SMILES: NC(=O)OC[C@H](N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Eligibility criteria:
Major Inclusion Criteria:

Male or female between 18 and 75 years of age, inclusive
Diagnosis of OSA according to ICSD-3 criteria
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent

Major Exclusion Criteria:

Female subjects who are pregnant, nursing, or lactating
Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator.
History of bariatric surgery within the past year or a history of any gastric bypass procedure
Presence or history of significant cardiovascular disease
Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
Received an investigational drug in the past 30 days or five half-lives
Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Intervention: Solriamfetol
Trial phase: Phase 3
ATC code: N06BA14
SMILES: NC(=O)OC[C@H](N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Eligibility criteria:
Major Inclusion Criteria:

Male or female between 18 and 75 years of age, inclusive
Diagnosis of OSA according to ICSD-3 criteria
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent

Major Exclusion Criteria:

Female subjects who are pregnant, nursing, or lactating
Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator.
History of bariatric surgery within the past year or a history of any gastric bypass procedure
Presence or history of significant cardiovascular disease
Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
Received an investigational drug in the past 30 days or five half-lives
Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Intervention: Solriamfetol
Trial phase: Phase 3
ATC code: N06BA14
SMILES: NC(=O)OC[C@H](N)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 118
Group description: Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Eligibility criteria:
Major Inclusion Criteria:

Male or female between 18 and 75 years of age, inclusive
Diagnosis of OSA according to ICSD-3 criteria
Body mass index from 18 to <45 kg/m2
Consent to use a medically acceptable method of contraception
Willing and able to provide written informed consent

Major Exclusion Criteria:

Female subjects who are pregnant, nursing, or lactating
Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator.
History of bariatric surgery within the past year or a history of any gastric bypass procedure
Presence or history of significant cardiovascular disease
Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
Received an investigational drug in the past 30 days or five half-lives
Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products