anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: HYDROGEN PEROXIDE
Trial phase: Phase 2
ATC code: A01AB02 | D08AX01 | D11AX25 | S02AA06
SMILES: OO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: A-101 Topical Solution

A-101 Topical Solution: A-101 Topical Solution
Eligibility criteria:
Inclusion Criteria:

Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
Male or female ≥ 8 years old.
Subject has a clinical diagnosis of common warts.
Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
Women of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target and Non-Target Warts or which exposes the subject to an unacceptable risk by study participation.
Subject is willing and able to follow all study instructions and to attend all study visits.

Exclusion Criteria:

Subject has clinically atypical warts on the trunk or extremities.
Subject is immunocompromised (e.g, due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
Subject has a history of Human Immunodeficiency Virus (HIV) infection
Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to Visit 1
Subject has a history of sensitivity to any of the ingredients in the study medications.
Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.
Intervention: Amoxicillin
Trial phase: Phase 2
ATC code: A02BD01 | A02BD03 | A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD10 | A02BD11 | A02BD12 | A02BD13 | A02BD14 | A02BD15 | A02BD16 | J01CA04 | J01CR50
SMILES: [H][C@]12SC(C)(C)[C@H](C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccc(O)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 45
Group description: Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48

Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Eligibility criteria:
Inclusion Criteria:

Women ages 18-45, inclusive.

No evidence of vaginitis (yeast, trichomonas, and BV/abnormal vaginal flora) or other vaginal conditions which in the opinion of the investigator could be confounders*.

*These causes will initially be detected by wet mount microscopy with trichomonas during the screening procedures and later confirmed by NAAT and BV/abnormal vaginal flora confirmed by Nugent scoring (Nugent score of 4-10).

Presence of GV detected by NAAT*.

*Results of NAAT testing will be available prior to return for Enrollment visit.

Willing to use condoms during vaginal intercourse while participating in the study.
Not currently menstruating at screening visit.
Willing and able to provide written informed consent.
Negative urine pregnancy test on all participants of childbearing potential at study screening.

Participant must be of non-childbearing potential* or must be using highly effective birth control** to avoid becoming pregnant.

*Non-childbearing potential is defined as being post-menopausal for at least 1 year, status after bilateral tubal ligation, or status after bilateral oophorectomy or status after hysterectomy.

**In addition to the required use of condoms by the male partner during study participation, participants must agree to avoid becoming pregnant by using one of the following acceptable method of birth control for 30 days prior to screening and for the duration of the study:

Intrauterine contraceptive device; OR
Oral contraceptives; OR
Hormonal injections; OR
Hormonal implants; OR
Contraceptive patches; OR
Monogamous relationship with vasectomized partner; OR
Exclusively same-sex relationships; OR
Abstinence
Participant is not planning on taking antibiotics or using any intravaginal microbicides from the Screening visit through the Visit 2 Follow-up (TOC).
Participant is willing and able to cooperate to the extent and degree required by this protocol at the discretion of the investigator.

Exclusion Criteria:

Pregnant or nursing.
Allergic to penicillin, amoxicillin, cephalosporins, or other ß-lactam antibiotic.
Use of antibiotics in the past 14 days prior to screening visit.
HIV infected.
Women taking immunosuppressive agents.

7. History of renal impairment. 8. Use of any investigational drug within the past 30 days prior to screening. 9. Any other condition that, in the opinion of the investigator, would interfere with participation in the study.
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 230
Group description: Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.

Does not have current active hepatitis B virus infection defined as:

positive hepatitis B surface antigen (HBsAg), OR
hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])
Platelets ≥ 150,000 cells/mm³
Albumin ≥ lower limit of normal (LLN)
Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
No past history/evidence of cirrhosis.
No history of hepatocellular carcinoma.
Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.
Intervention: Baricitinib
Trial phase: Phase 1
ATC code: L04AA37
SMILES: CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: 4 mg baricitinib tablet administered PO, taken with 240 mL water following a 10 hour fast (baricitinib R)
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy males or females, as determined by medical history and physical examination
Women not of child-bearing potential
Have a body mass index (BMI) of 18.5 to 29.9 kilograms per meter squared (kg/m²) inclusive, at screening

Exclusion Criteria:

Have received live vaccine(s) within 3 months of screening, or intend to during the study
Have a current or recent history (less than [<] 30 days prior to screening and/or <45 days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
Intervention: Luvadaxistat
Trial phase: Phase 2
SMILES: O=c1cc(CCc2ccc(C(F)(F)F)cc2)[nH][nH]c1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 14
Group description: TAK-831 75 mg, tablets, orally, twice daily for up to 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

1. Has a genetically-confirmed diagnosis (homozygous for guanine-adenine-adenine [GAA] repeat expansions in the frataxin gene [FXN] in the affected range of Friedreich ataxia [FRDA] or a compound heterozygous expansion with a point mutation or deletion), with an established disease stage of 2 to 5, inclusive, as determined by the Functional Staging for Ataxia, at Screening.

Key Exclusion Criteria:

Received a diagnosis of ataxic syndromes other than FRDA.
Has a history of cancer, except basal cell carcinoma or in situ cervical cancer that has been in remission for greater than or equal to (>=5) years prior to first dose of study drug.
Known to be currently infected or has been infected with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
Has a known hypersensitivity to any component of the formulation of TAK-831.
Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse.
Has taken any excluded medication, or has had insufficient washout of medications or is unable or unwilling to discontinue medications as required by the protocol.
If male, the participant intends to donate sperm during the course of this study or for 95 days after the last dose of study drug.
If female, the participant is of childbearing potential and lactating, pregnant (positive prerandomization serum pregnancy test), or plans to become pregnant before participating in the study, during the study, or within 35 days after last dose of the study drug, or intending to donate ova during such time period.
Has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus or other conditions that may interfere with absorption of study medication.
Intervention: Luvadaxistat
Trial phase: Phase 2
SMILES: O=c1cc(CCc2ccc(C(F)(F)F)cc2)[nH][nH]c1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 26
Group description: TAK-831 300 mg, tablets, orally, twice daily for up to 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

1. Has a genetically-confirmed diagnosis (homozygous for guanine-adenine-adenine [GAA] repeat expansions in the frataxin gene [FXN] in the affected range of Friedreich ataxia [FRDA] or a compound heterozygous expansion with a point mutation or deletion), with an established disease stage of 2 to 5, inclusive, as determined by the Functional Staging for Ataxia, at Screening.

Key Exclusion Criteria:

Received a diagnosis of ataxic syndromes other than FRDA.
Has a history of cancer, except basal cell carcinoma or in situ cervical cancer that has been in remission for greater than or equal to (>=5) years prior to first dose of study drug.
Known to be currently infected or has been infected with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
Has a known hypersensitivity to any component of the formulation of TAK-831.
Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse.
Has taken any excluded medication, or has had insufficient washout of medications or is unable or unwilling to discontinue medications as required by the protocol.
If male, the participant intends to donate sperm during the course of this study or for 95 days after the last dose of study drug.
If female, the participant is of childbearing potential and lactating, pregnant (positive prerandomization serum pregnancy test), or plans to become pregnant before participating in the study, during the study, or within 35 days after last dose of the study drug, or intending to donate ova during such time period.
Has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus or other conditions that may interfere with absorption of study medication.
Intervention: Fevipiprant
Trial phase: Phase 3
SMILES: Cc1c(CC(=O)O)c2cccnc2n1Cc1ccc(S(C)(=O)=O)cc1C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 339
Group description: QAW039 150 mg
Eligibility criteria:
Inclusion Criteria:

A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18 years.
Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.
Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
Demonstrated reversible airway obstruction.
Asthma control questionnaire (ACQ) score ≥ 1.5.

Exclusion Criteria:

Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.

A resting QTcF (Fridericia) ≥450 msec (male) or

≥460 msec (female).

Pregnant or nursing (lactating) women.
Serious co-morbidities.
Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Dasiglucagon [WHO-DD]
Trial phase: Phase 3
SMILES: CC(C)CC(NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCCCN)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(CCCNC(=N)N)NC(=O)C(C)NC(=O)C(C)(C)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CO)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)NC(C(=O)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose.

dasiglucagon: Glucagon Analog
Eligibility criteria:
Inclusion Criteria:

Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)
Availability for the entire trial period
Age between 18 and 70 years, both inclusive
Male or female patients with T1DM for at least 1 year. Diagnostic criteria as defined by the American Diabetes Association
Hemoglobin A1c (HbA1c) <10%
Stable anti-diabetic treatment for at least 1 month (e.g. within 10% insulin dose adjustment)

Exclusion Criteria:

Previous administration of dasiglucagon (previously referred to as ZP4207)
Known or suspected allergy to trial medication(s) or related products
History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
Previous participation (randomization) in this trial
Females who are pregnant according to a positive pregnancy test, actively attempting to get pregnant, or are lactating
Patients on a closed loop artificial pancreas
Receipt of any investigational drug within 3 months prior to screening
Active malignancy within the last 5 years
Congestive heart failure, New York Heart Association class II-IV
Inadequately treated blood pressure as defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥90 mmHg at screening
Current bleeding disorder, including use of anticoagulant treatment
Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin-secreting pancreas tumor)
Known or suspected HIV infection
Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial
Use of systemic corticosteroids, anti-inflammatory biological agents, kinase inhibitors or other immune modulating agents within the last 3 months prior to screening
Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening
A positive result in the alcohol and/or urine drug screen at the screening visit. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day for women.
Surgery or trauma with significant blood loss within the last 2 months prior to screening
Use of prescription or non-prescription medications known to cause QT prolongation
Intervention: Maraviroc
Trial phase: Phase 4
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: 12 Healthy subjects will dose with Maraviroc Pill and we will collect blood and hair over all three phases

Maraviroc Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly

Adverse Events (AEs) reported for participants across all dose groups as there were none to report.
Eligibility criteria:
Inclusion Criteria

Healthy volunteer between the ages of 18 and 70, inclusive on the date of screening, with an intact gastrointestinal tract. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, and clinical laboratory tests
Recent medical history in good medical standing, without evidence of fever five days prior to enrollment
HIV-negative
Able to swallow pills
Has minimum hair required to provide study samples
Not allergic to any component of the study drug
Signed and dated informed consent indicating that they have been informed of all pertinent details of the trial and are willing to participate
Willing and able to comply with scheduled visits, laboratory tests and trial procedures
Willing to use at least one form of acceptable birth control throughout the duration of the study
Negative, or receiving treatment, for syphilis at screening
Hemoglobin Grade 2 or lower, with no clinically significant medical issues that would preclude blood sampling

Exclusion Criteria

Age outside of desired range
Confirmed positive results for HIV, Hepatitis B or C at screening
Subjects of all genders actively involved in the conception process, in addition to cisgender female subjects who are in the immediate post-partum period or breastfeeding
Insufficient amount of hair or unwilling to keep hair length at least 1 centimeter throughout duration of study
Unable or unwilling to comply with all lifestyle measures and/or visits
Impaired renal function, as documented by a creatinine clearance <80 mL/min with the Cockcroft-Gault equation
Has donated blood within the past 56 days in the amount greater than 500 mL
Has taken an investigational drug in the past 4 months
Clinical, laboratory, or surgical abnormalities that would preclude sample collection
Has a condition, which, in the opinion of the investigator, is likely to interfere with follow-up or ability to take the study medication appropriately
Any clinically significant laboratory result Grade 2 or greater according to the Division of AIDS (DAIDS) Laboratory Grading Tables
History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week
Intervention: Dolutegravir
Trial phase: Phase 4
ATC code: J05AJ03 | J05AR13 | J05AR21 | J05AR25 | J05AR27
SMILES: [H][C@]12Cn3cc(C(=O)NCc4ccc(F)cc4F)c(=O)c(O)c3C(=O)N1[C@H](C)CCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: 12 Healthy volunteers will dose with Dolutegravir Pill and we will collect blood and hair over all three phases

Dolutegravir Pill: Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly

AEs reported for participants across all dose groups as there were none to report.
Eligibility criteria:
Inclusion Criteria

Healthy volunteer between the ages of 18 and 70, inclusive on the date of screening, with an intact gastrointestinal tract. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, and clinical laboratory tests
Recent medical history in good medical standing, without evidence of fever five days prior to enrollment
HIV-negative
Able to swallow pills
Has minimum hair required to provide study samples
Not allergic to any component of the study drug
Signed and dated informed consent indicating that they have been informed of all pertinent details of the trial and are willing to participate
Willing and able to comply with scheduled visits, laboratory tests and trial procedures
Willing to use at least one form of acceptable birth control throughout the duration of the study
Negative, or receiving treatment, for syphilis at screening
Hemoglobin Grade 2 or lower, with no clinically significant medical issues that would preclude blood sampling

Exclusion Criteria

Age outside of desired range
Confirmed positive results for HIV, Hepatitis B or C at screening
Subjects of all genders actively involved in the conception process, in addition to cisgender female subjects who are in the immediate post-partum period or breastfeeding
Insufficient amount of hair or unwilling to keep hair length at least 1 centimeter throughout duration of study
Unable or unwilling to comply with all lifestyle measures and/or visits
Impaired renal function, as documented by a creatinine clearance <80 mL/min with the Cockcroft-Gault equation
Has donated blood within the past 56 days in the amount greater than 500 mL
Has taken an investigational drug in the past 4 months
Clinical, laboratory, or surgical abnormalities that would preclude sample collection
Has a condition, which, in the opinion of the investigator, is likely to interfere with follow-up or ability to take the study medication appropriately
Any clinically significant laboratory result Grade 2 or greater according to the Division of AIDS (DAIDS) Laboratory Grading Tables
History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week
Intervention: Brensocatib
Trial phase: Phase 2
SMILES: Cn1c(=O)oc2ccc(-c3ccc(C[C@@H](C#N)NC(=O)[C@@H]4CNCCCO4)cc3)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Participants received brensocatib 10 mg QD before breakfast, for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections)
Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening
Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening

Exclusion Criteria:

Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
Are current smokers
Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
Have any acute infections, (including respiratory infections)