anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Trans sodium crocetinate
Trial phase: Phase 1
SMILES: CC(C=CC=C(C)C(=O)[O-])=CC=CC=C(C)C=CC=C(C)C(=O)[O-].[Na+].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: TSC 0.5 mg/kg given as a one-time IV bolus injection

Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
Eligibility criteria:
Inclusion Criteria:

Healthy male or female, age 18-50
Able and willing to lie quietly supine or semi-recumbent for up to 2.5 hours
Abstinence from exercise, caffeine, alcohol, nicotine, and a heavy meal prior to testing on the day of the Treatment Visit
Subject is able to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and directions from the study staff
Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control (e.g. condom and spermicide), during the study and at least 30 days after the last dose of study drug. Females of non-childbearing potential should be surgically sterile or at least one year post-menopausal.
Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug

Exclusion Criteria:

Allergy to study medication
Pregnant or breastfeeding
Current smoker and/or any nicotine use within 4 hours of the start of tcpO2 procedures, to include e-cigarette vaping, snuff, chew, nicotine gum and nicotine patches
Body Mass Index (BMI) > 30
Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Antibody (HCVAb)
Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
Plasma donation within 7 days prior to screening
Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
Any skin condition on limbs to be tested that could impair testing (rash, wound, prior radiation therapy, other skin conditions, per Principal Investigator (PI) discretion)
Known cardiovascular disease, including treated or untreated hypertension
Significant respiratory disease and/or any other significant medical condition
Subject has an acute illness (gastrointestinal infection, influenza, or known inflammatory process) at the Treatment Visit
Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and enrollment)
Concomitant medications used to treat a diagnosed medical condition
Subject who, for any reason, is deemed by the Investigator to be unsuitable for the study; or has any condition that would interfere with the evaluation of tissue oxygen measurements or PK of the investigational drug; or is otherwise unable to comply with the protocol
Intervention: Trans sodium crocetinate
Trial phase: Phase 1
SMILES: CC(C=CC=C(C)C(=O)[O-])=CC=CC=C(C)C=CC=C(C)C(=O)[O-].[Na+].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: TSC 1.0 mg/kg given as a one-time IV bolus injection

Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
Eligibility criteria:
Inclusion Criteria:

Healthy male or female, age 18-50
Able and willing to lie quietly supine or semi-recumbent for up to 2.5 hours
Abstinence from exercise, caffeine, alcohol, nicotine, and a heavy meal prior to testing on the day of the Treatment Visit
Subject is able to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and directions from the study staff
Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control (e.g. condom and spermicide), during the study and at least 30 days after the last dose of study drug. Females of non-childbearing potential should be surgically sterile or at least one year post-menopausal.
Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug

Exclusion Criteria:

Allergy to study medication
Pregnant or breastfeeding
Current smoker and/or any nicotine use within 4 hours of the start of tcpO2 procedures, to include e-cigarette vaping, snuff, chew, nicotine gum and nicotine patches
Body Mass Index (BMI) > 30
Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Antibody (HCVAb)
Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
Plasma donation within 7 days prior to screening
Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
Any skin condition on limbs to be tested that could impair testing (rash, wound, prior radiation therapy, other skin conditions, per Principal Investigator (PI) discretion)
Known cardiovascular disease, including treated or untreated hypertension
Significant respiratory disease and/or any other significant medical condition
Subject has an acute illness (gastrointestinal infection, influenza, or known inflammatory process) at the Treatment Visit
Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and enrollment)
Concomitant medications used to treat a diagnosed medical condition
Subject who, for any reason, is deemed by the Investigator to be unsuitable for the study; or has any condition that would interfere with the evaluation of tissue oxygen measurements or PK of the investigational drug; or is otherwise unable to comply with the protocol
Intervention: Trans sodium crocetinate
Trial phase: Phase 1
SMILES: CC(C=CC=C(C)C(=O)[O-])=CC=CC=C(C)C=CC=C(C)C(=O)[O-].[Na+].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: TSC 1.5 mg/kg given as a one-time IV bolus injection

Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
Eligibility criteria:
Inclusion Criteria:

Healthy male or female, age 18-50
Able and willing to lie quietly supine or semi-recumbent for up to 2.5 hours
Abstinence from exercise, caffeine, alcohol, nicotine, and a heavy meal prior to testing on the day of the Treatment Visit
Subject is able to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and directions from the study staff
Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control (e.g. condom and spermicide), during the study and at least 30 days after the last dose of study drug. Females of non-childbearing potential should be surgically sterile or at least one year post-menopausal.
Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug

Exclusion Criteria:

Allergy to study medication
Pregnant or breastfeeding
Current smoker and/or any nicotine use within 4 hours of the start of tcpO2 procedures, to include e-cigarette vaping, snuff, chew, nicotine gum and nicotine patches
Body Mass Index (BMI) > 30
Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Antibody (HCVAb)
Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
Plasma donation within 7 days prior to screening
Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
Any skin condition on limbs to be tested that could impair testing (rash, wound, prior radiation therapy, other skin conditions, per Principal Investigator (PI) discretion)
Known cardiovascular disease, including treated or untreated hypertension
Significant respiratory disease and/or any other significant medical condition
Subject has an acute illness (gastrointestinal infection, influenza, or known inflammatory process) at the Treatment Visit
Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and enrollment)
Concomitant medications used to treat a diagnosed medical condition
Subject who, for any reason, is deemed by the Investigator to be unsuitable for the study; or has any condition that would interfere with the evaluation of tissue oxygen measurements or PK of the investigational drug; or is otherwise unable to comply with the protocol
Intervention: Trans sodium crocetinate
Trial phase: Phase 1
SMILES: CC(C=CC=C(C)C(=O)[O-])=CC=CC=C(C)C=CC=C(C)C(=O)[O-].[Na+].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: TSC 2.0 mg/kg given as a one-time IV bolus injection

Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
Eligibility criteria:
Inclusion Criteria:

Healthy male or female, age 18-50
Able and willing to lie quietly supine or semi-recumbent for up to 2.5 hours
Abstinence from exercise, caffeine, alcohol, nicotine, and a heavy meal prior to testing on the day of the Treatment Visit
Subject is able to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and directions from the study staff
Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control (e.g. condom and spermicide), during the study and at least 30 days after the last dose of study drug. Females of non-childbearing potential should be surgically sterile or at least one year post-menopausal.
Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug

Exclusion Criteria:

Allergy to study medication
Pregnant or breastfeeding
Current smoker and/or any nicotine use within 4 hours of the start of tcpO2 procedures, to include e-cigarette vaping, snuff, chew, nicotine gum and nicotine patches
Body Mass Index (BMI) > 30
Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Antibody (HCVAb)
Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
Plasma donation within 7 days prior to screening
Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
Any skin condition on limbs to be tested that could impair testing (rash, wound, prior radiation therapy, other skin conditions, per Principal Investigator (PI) discretion)
Known cardiovascular disease, including treated or untreated hypertension
Significant respiratory disease and/or any other significant medical condition
Subject has an acute illness (gastrointestinal infection, influenza, or known inflammatory process) at the Treatment Visit
Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and enrollment)
Concomitant medications used to treat a diagnosed medical condition
Subject who, for any reason, is deemed by the Investigator to be unsuitable for the study; or has any condition that would interfere with the evaluation of tissue oxygen measurements or PK of the investigational drug; or is otherwise unable to comply with the protocol
Intervention: Nicotinamide riboside
Trial phase: Phase 2
SMILES: NC(=O)c1ccc[n+]([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days

Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
Eligibility criteria:
Inclusion Criteria:

Provision of signed and dated informed consent form from a participant or legally authorized representative (LAR);
Male or female, >18 years old;
Hospitalized participants with a laboratory diagnosis of COVID-19 infection
Evidence of persistent AKI as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (Table 3);
Willing to adhere to the study intervention regimen;

Exclusion Criteria:

Hypersensitivity to nicotinamide riboside (NR);
Pregnant or lactating women confirmed with positive laboratory pregnancy tests as per local requirements;
eGFR <15 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration equation at admission lab;
Maintenance renal replacement therapy or initiation of renal replacement therapy before randomization
Currently on NR or nicotinamide or vitamin B3 (niacin) supplementation (multivitamins are allowed);
Concomitant cirrhosis of liver or acute liver failure;
Any medical history or condition that might, in the opinion of the attending physician, put the participant at significant risk if he/she were to participate in the trial;
Individuals with kidney transplant;
Individuals with blood platelet count <100,000/microL
Intervention: Iloperidone
Trial phase: Phase 3
ATC code: N05AX14
SMILES: COc1cc(C(C)=O)ccc1OCCCN1CCC(c2noc3cc(F)ccc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 206
Group description: Iloperidone: Oral iloperidone
Eligibility criteria:
Inclusion Criteria:

Male or female patients 18 to 65 years of age (inclusive)
Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria
Voluntary hospitalization for current manic episode

Exclusion Criteria:

Patients with a DSM-5 diagnosis of a psychiatric disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Patients who are experiencing a first manic episode or meeting criteria for rapid cycling
Intervention: N-[(2S,3S)-2-[[3-(3,5-difluorophenyl)-2-fluorophenyl]methyl]-1-(2-hydroxy-2-methylpropanoyl)pyrrolidin-3-yl]methanesulfonamide;hydrate
Trial phase: Phase 2
SMILES: CC(C)(O)C(=O)N1CCC(NS(C)(=O)=O)C1Cc1cccc(-c2cc(F)cc(F)c2)c1F.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
Eligibility criteria:
Inclusion Criteria:

1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.

Exclusion Criteria:

1. Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.
Intervention: N-[(2S,3S)-2-[[3-(3,5-difluorophenyl)-2-fluorophenyl]methyl]-1-(2-hydroxy-2-methylpropanoyl)pyrrolidin-3-yl]methanesulfonamide;hydrate
Trial phase: Phase 2
SMILES: CC(C)(O)C(=O)N1CCC(NS(C)(=O)=O)C1Cc1cccc(-c2cc(F)cc(F)c2)c1F.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
Eligibility criteria:
Inclusion Criteria:

1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.

Exclusion Criteria:

1. Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.
Intervention: N-[(2S,3S)-2-[[3-(3,5-difluorophenyl)-2-fluorophenyl]methyl]-1-(2-hydroxy-2-methylpropanoyl)pyrrolidin-3-yl]methanesulfonamide;hydrate
Trial phase: Phase 2
SMILES: CC(C)(O)C(=O)N1CCC(NS(C)(=O)=O)C1Cc1cccc(-c2cc(F)cc(F)c2)c1F.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Following the Active Drug Extension Period, participants randomized to active treatment 30 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 30 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
Eligibility criteria:
Inclusion Criteria:

1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.

Exclusion Criteria:

1. Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.
Intervention: N-[(2S,3S)-2-[[3-(3,5-difluorophenyl)-2-fluorophenyl]methyl]-1-(2-hydroxy-2-methylpropanoyl)pyrrolidin-3-yl]methanesulfonamide;hydrate
Trial phase: Phase 2
SMILES: CC(C)(O)C(=O)N1CCC(NS(C)(=O)=O)C1Cc1cccc(-c2cc(F)cc(F)c2)c1F.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Following the Active Drug Extension Period, participants randomized to active treatment 90 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 90 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
Eligibility criteria:
Inclusion Criteria:

1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.

Exclusion Criteria:

1. Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.
Intervention: N-[(2S,3S)-2-[[3-(3,5-difluorophenyl)-2-fluorophenyl]methyl]-1-(2-hydroxy-2-methylpropanoyl)pyrrolidin-3-yl]methanesulfonamide;hydrate
Trial phase: Phase 2
SMILES: CC(C)(O)C(=O)N1CCC(NS(C)(=O)=O)C1Cc1cccc(-c2cc(F)cc(F)c2)c1F.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.
Eligibility criteria:
Inclusion Criteria:

1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.

Exclusion Criteria:

1. Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.
Intervention: Lidocaine
Trial phase: Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 167
Group description: A lidocaine patch (4% topical) will be placed on the breast for at least one hour prior to radioactive tracer injection.
Eligibility criteria:
Inclusion Criteria:

greater than or equal to 18 years of age
biopsy proven breast cancer
standard radiotracer injection (intradermal injection in the upper outer quadrant of the involved breast)
radiotracer injection occurs on the same day as sentinel lymph node surgery

Exclusion Criteria:

males
pregnancy

local anesthetic allergy or active use of the following medications:

Abametapir (risk X)
Conivaptan (risk X)
Fusidic Acid (risk X)
Idelalisib (risk X)
Mifepristone (risk D)
Stiripentol (risk D)
Amiodarone (risk C)
Dofetilide (risk C)
Dronedarone (risk C)
Ibutilide (risk C)
Sotalol (risk C)
Vernakalant (risk C)
Non-English speaking/reading
Unable to provide informed consent
Unable to participate with surveys

Undergoing radiotracer injection the day prior to surgery or intra-operatively at the time of initial surgical scheduling

If patients are initially scheduled for same-day preoperative injection, complete all enrollment procedures (including randomization), and surgery is re-scheduled for a day prior to surgery or for intra-operative injection, they will be excluded if:

randomized to a lidocaine patch arm (Arms C or D)
re-scheduled for an intra-operative injection • Planned non-standard radiotracer injection site
Intervention: Sodium pyruvate
Trial phase: Phase 2 | Phase 3
SMILES: CC(=O)C(=O)[O-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 30
Group description: In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVID-19 infections.

Sodium Pyruvate: Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
Eligibility criteria:
Inclusion Criteria:

Individuals with a confirmed COVID-19 viral infection, as determined by a qualified laboratory test. A nasal swab or saliva test analyzed by qPCR for COVID19.
Individuals who agree to abstain from sexual intercourse, or agree to use condoms or vaginal diaphragms or other devices designed to prevent contraception, during the entire course of the study

Exclusion Criteria

Viral infections other than COVID-19.
Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
Pregnancy
Females of child bearing potential age not on adequate contraception or lactating
Subjects receiving systemic corticosteroid treatment within one month of Screening Visit
Subjects Less than 18 years of age
Hospitalization within last 6 months due to acute exacerbation of airway disease
Subjects with a clinically significant abnormal chest x-ray within past 12 months
Medication changes within one month of study entry
Subjects who have participated in another investigation drug treatment study within the previous month.
Subjects with a current history of alcohol or recreational drug abuse.
Subjects who have taken dietary supplements containing pyruvate within 24 hours prior to the screening visit.

Inclusion of Women and Minorities Every attempt will be made to include all genders, and minorities that present with an active COVID-19 infection that are not exempted due to exclusion criteria.

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Intervention: Bupivacaine hydrochloride
Trial phase: Phase 3
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Participants will receive local wound infiltration with 0.25% Bupivacaine alone.

Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine.
Eligibility criteria:
Inclusion Criteria:

Pediatric patients 6 years and older undergoing minor pediatric urologic surgery
Patients who are otherwise eligible to receive routine care following minor urologic surgery

Exclusion Criteria:

Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal, hepatic dysfunction)
Pediatric patients younger than 6 years of age
Pediatric patients with a history of pain syndromes or are unable to tolerate opiate medication
Unwilling to participate in 48 hours and 10-14 day follow-up phone calls