anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: MK-1064
Trial phase: Phase 1
SMILES: COc1ccc(CNC(=O)c2cc(-c3cncc(Cl)c3)cnc2-c2ccccn2)nc1OC
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) ≤31 kg/m^2
In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
Nonsmoker and has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless legs syndrome, or narcolepsy of any duration
Participant has experienced poor quality sleep (including difficulty falling asleep, difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days prior to screening
Participant works a night shift and is not able to avoid night shift work a minimum of 1 week before each treatment period
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
Unwilling or unable to consume a standard high fat breakfast
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of seizures, epilepsy, stroke, peripheral neuropathy, or other clinically significant neurological disease or cognitive impairment
History of cancer
History of cataplexy
Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
Participant consumes >3 servings of alcohol a day
Participant consumes >6 caffeine servings a day
Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to screening
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening
Is a regular user of sedative-hypnotic agents
Intervention: MK-1064
Trial phase: Phase 1
SMILES: COc1ccc(CNC(=O)c2cc(-c3cncc(Cl)c3)cnc2-c2ccccn2)nc1OC
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) ≤31 kg/m^2
In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
Nonsmoker and has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless legs syndrome, or narcolepsy of any duration
Participant has experienced poor quality sleep (including difficulty falling asleep, difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days prior to screening
Participant works a night shift and is not able to avoid night shift work a minimum of 1 week before each treatment period
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
Unwilling or unable to consume a standard high fat breakfast
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of seizures, epilepsy, stroke, peripheral neuropathy, or other clinically significant neurological disease or cognitive impairment
History of cancer
History of cataplexy
Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
Participant consumes >3 servings of alcohol a day
Participant consumes >6 caffeine servings a day
Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to screening
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening
Is a regular user of sedative-hypnotic agents
Intervention: MK-1064
Trial phase: Phase 1
SMILES: COc1ccc(CNC(=O)c2cc(-c3cncc(Cl)c3)cnc2-c2ccccn2)nc1OC
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) ≤31 kg/m^2
In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
Nonsmoker and has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless legs syndrome, or narcolepsy of any duration
Participant has experienced poor quality sleep (including difficulty falling asleep, difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days prior to screening
Participant works a night shift and is not able to avoid night shift work a minimum of 1 week before each treatment period
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
Unwilling or unable to consume a standard high fat breakfast
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of seizures, epilepsy, stroke, peripheral neuropathy, or other clinically significant neurological disease or cognitive impairment
History of cancer
History of cataplexy
Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
Participant consumes >3 servings of alcohol a day
Participant consumes >6 caffeine servings a day
Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to screening
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening
Is a regular user of sedative-hypnotic agents
Intervention: MK-1064
Trial phase: Phase 1
SMILES: COc1ccc(CNC(=O)c2cc(-c3cncc(Cl)c3)cnc2-c2ccccn2)nc1OC
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) ≤31 kg/m^2
In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
Nonsmoker and has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless legs syndrome, or narcolepsy of any duration
Participant has experienced poor quality sleep (including difficulty falling asleep, difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days prior to screening
Participant works a night shift and is not able to avoid night shift work a minimum of 1 week before each treatment period
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
Unwilling or unable to consume a standard high fat breakfast
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of seizures, epilepsy, stroke, peripheral neuropathy, or other clinically significant neurological disease or cognitive impairment
History of cancer
History of cataplexy
Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
Participant consumes >3 servings of alcohol a day
Participant consumes >6 caffeine servings a day
Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to screening
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening
Is a regular user of sedative-hypnotic agents
Intervention: MK-1064
Trial phase: Phase 1
SMILES: COc1ccc(CNC(=O)c2cc(-c3cncc(Cl)c3)cnc2-c2ccccn2)nc1OC
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) ≤31 kg/m^2
In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
Nonsmoker and has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless legs syndrome, or narcolepsy of any duration
Participant has experienced poor quality sleep (including difficulty falling asleep, difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days prior to screening
Participant works a night shift and is not able to avoid night shift work a minimum of 1 week before each treatment period
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
Unwilling or unable to consume a standard high fat breakfast
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of seizures, epilepsy, stroke, peripheral neuropathy, or other clinically significant neurological disease or cognitive impairment
History of cancer
History of cataplexy
Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
Participant consumes >3 servings of alcohol a day
Participant consumes >6 caffeine servings a day
Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to screening
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening
Is a regular user of sedative-hypnotic agents
Intervention: MK-1064
Trial phase: Phase 1
SMILES: COc1ccc(CNC(=O)c2cc(-c3cncc(Cl)c3)cnc2-c2ccccn2)nc1OC
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) ≤31 kg/m^2
In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
Nonsmoker and has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless legs syndrome, or narcolepsy of any duration
Participant has experienced poor quality sleep (including difficulty falling asleep, difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days prior to screening
Participant works a night shift and is not able to avoid night shift work a minimum of 1 week before each treatment period
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
Unwilling or unable to consume a standard high fat breakfast
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of seizures, epilepsy, stroke, peripheral neuropathy, or other clinically significant neurological disease or cognitive impairment
History of cancer
History of cataplexy
Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
Participant consumes >3 servings of alcohol a day
Participant consumes >6 caffeine servings a day
Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to screening
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening
Is a regular user of sedative-hypnotic agents
Intervention: MK-1064
Trial phase: Phase 1
SMILES: COc1ccc(CNC(=O)c2cc(-c3cncc(Cl)c3)cnc2-c2ccccn2)nc1OC
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) ≤31 kg/m^2
In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
Nonsmoker and has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless legs syndrome, or narcolepsy of any duration
Participant has experienced poor quality sleep (including difficulty falling asleep, difficulty staying asleep) for at least 4 of 7 nights per week in the past 30 days prior to screening
Participant works a night shift and is not able to avoid night shift work a minimum of 1 week before each treatment period
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
Unwilling or unable to consume a standard high fat breakfast
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of seizures, epilepsy, stroke, peripheral neuropathy, or other clinically significant neurological disease or cognitive impairment
History of cancer
History of cataplexy
Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
Participant consumes >3 servings of alcohol a day
Participant consumes >6 caffeine servings a day
Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to screening
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening
Is a regular user of sedative-hypnotic agents
Intervention: Thymol
Trial phase: Phase 4
SMILES: Cc1ccc(C(C)C)c(O)c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 164
Group description: Administration of Live attenuated influenza vaccine (LAIV) as per national guidance. Surveillance thereafter through nasal swabbing in the event of influenza-like illness.

Live attenuated influenza vaccine: Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season

Surveillance (nasal swabbing) during influenza season

NB: Adverse Events were not monitored/assessed for the Household "Controls"
Eligibility criteria:
Inclusion Criteria:

Aged 2 - 18 years old
Written informed consent from parent/guardian (or patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible.

Exclusion Criteria:

Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue) [notwithstanding allergy to egg protein]
Previous systemic allergic reaction to LAIV
Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the site PI to confirm patient suitability

Children/adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids**.

**High-dose steroids is defined as a treatment course for at least one month, equivalent to a dose of prednisolone at 20mg or more per day (any age); or for children under 20kg, a dose of 1mg/kg/day or more.

Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
pregnancy
Febrile ≥ 38.0 'C in last 72 hours
Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
Recent admission to hospital in last 2 weeks for acute asthma
Current oral steroid for asthma exacerbation or course completed within last 2 weeks
Received any blood or blood products within the past 12 weeks
Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Intervention: Leuprolide
Trial phase: Not Applicable
ATC code: L02AE02 | L02AE51
SMILES: CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H]1CCC(=O)N1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)

Dexmedetomidine and dexamethasone: administration of dexmedetomidine and dexamethasone
Eligibility criteria:
Inclusion Criteria:

ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.

Exclusion Criteria:

uncontrolled cardiovascular disease
history of chronic pain
smoker
previous history of steroid administraion
neoajuvant chemotherapy