anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Acetaminophen, hydrocodone and promethazine
Trial phase: Phase 1
SMILES: CC(=O)Nc1ccc(O)cc1.CC(CN1c2ccccc2Sc2ccccc21)N(C)C.COc1ccc2c3c1OC1C(=O)CCC4C(C2)N(C)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2
Group description: CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
Eligibility criteria:
Inclusion Criteria:

BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

Exclusion Criteria:

Drug or alcohol dependence within the last 12 months (except nicotine)
Subjects who had ever been in treatment for substance use disorders (except smoking cessation
History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
History or presence of hypotension, judged to be clinically significant based on investigator judgement
Intervention: Acetaminophen, hydrocodone and promethazine
Trial phase: Phase 1
SMILES: CC(=O)Nc1ccc(O)cc1.CC(CN1c2ccccc2Sc2ccccc21)N(C)C.COc1ccc2c3c1OC1C(=O)CCC4C(C2)N(C)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2
Group description: CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
Eligibility criteria:
Inclusion Criteria:

BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

Exclusion Criteria:

Drug or alcohol dependence within the last 12 months (except nicotine)
Subjects who had ever been in treatment for substance use disorders (except smoking cessation
History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
History or presence of hypotension, judged to be clinically significant based on investigator judgement
Intervention: Acetaminophen, hydrocodone and promethazine
Trial phase: Phase 1
SMILES: CC(=O)Nc1ccc(O)cc1.CC(CN1c2ccccc2Sc2ccccc21)N(C)C.COc1ccc2c3c1OC1C(=O)CCC4C(C2)N(C)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
Eligibility criteria:
Inclusion Criteria:

BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

Exclusion Criteria:

Drug or alcohol dependence within the last 12 months (except nicotine)
Subjects who had ever been in treatment for substance use disorders (except smoking cessation
History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
History or presence of hypotension, judged to be clinically significant based on investigator judgement
Intervention: Acetaminophen, hydrocodone and promethazine
Trial phase: Phase 1
SMILES: CC(=O)Nc1ccc(O)cc1.CC(CN1c2ccccc2Sc2ccccc21)N(C)C.COc1ccc2c3c1OC1C(=O)CCC4C(C2)N(C)CCC314
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
Eligibility criteria:
Inclusion Criteria:

BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

Exclusion Criteria:

Drug or alcohol dependence within the last 12 months (except nicotine)
Subjects who had ever been in treatment for substance use disorders (except smoking cessation
History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
History or presence of hypotension, judged to be clinically significant based on investigator judgement
Intervention: (4R,7R,11E,13E)-6-[4-(dimethylamino)-3,5-dihydroxy-6-methyloxan-2-yl]oxy-16-ethyl-4-hydroxy-5,9,13-trimethyl-7-(2-piperidin-1-ylethyl)-15-(piperidin-1-ylmethyl)-1-oxacyclohexadeca-11,13-diene-2,10-dione
Trial phase: Phase 2
SMILES: CCC1OC(=O)CC(O)C(C)C(OC2OC(C)C(O)C(N(C)C)C2O)C(CCN2CCCCC2)CC(C)C(=O)C=CC(C)=CC1CN1CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
Eligibility criteria:
Key Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Male and female patients of ≥ 18 years of age at screening (Visit 1).
Proven diagnosis of non-CF BE as documented by computed tomography or high-resolution computed tomography
At least 2 or more exacerbations treated with oral antibiotics OR 1 or more exacerbation requiring intravenous antibiotic treatment within 12 months prior to screening.
FEV1 ≥ 30% predicted at screening (Visit 1).
P. aeruginosa, must be documented in a respiratory sample at least 1 time within 12 months and also present in the expectorated sputum culture at Visit 1.

Key Exclusion Criteria:

Patients with a history of cystic fibrosis.
Patients with a primary diagnosis of bronchial asthma.
Patients with a primary diagnosis of COPD associated with at least a 20 pack year smoking history.
Any significant medical condition that is either recently diagnosed or was not stable during the last 3 months, other than pulmonary exacerbations, and that in the opinion of the investigator makes participation in the trial against the patients' best interests.
Clinically significant (in the opinion of the investigator) hearing loss that interferes with patients' daily activities (such as normal conversations) or chronic tinnitus. Patients with a past history of clinically significant hearing loss in the opinion of the investigator may be eligible only if their hearing threshold at screening audiometry is 25dB or lower at frequencies 0.5-4 kHz. The use of a hearing device is reflective of a clinically significant hearing loss; hence patients using hearing aids at screening are not eligible.
Patients with active pulmonary tuberculosis.
Patients currently receiving treatment for nontuberculous mycobacterial (NTM) pulmonary disease.
Patients who are regularly receiving inhaled anti-pseudomonal antibiotic (during the study inhaled anti-pseudomonal antibiotics are not allowed other than the study drug).
Intervention: Lisdexamfetamine
Trial phase: Phase 4
ATC code: N06BA12
SMILES: C[C@@H](Cc1ccccc1)NC(=O)[C@@H](N)CCCCN
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Participants who received Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning in either the first or last 6 weeks of the study.
Eligibility criteria:
Inclusion Criteria:

Males and females ages 6 to 16
Traumatic brain injury rated as mild/moderate/severe (based on Glasgow Coma Scale, estimated posttraumatic amnesia, indications of intracranial injury on CT scan, etc.)
Sustained 2-36 months earlier
Considered to be neurologically stable (absence of post-acute symptoms of confusion, disorientation, etc.)
Persistent (> 2 months) problems with focused or sustained attention
Problems with attention/concentration rated as among the most prominent cognitive changes
Accompanying features may include diminished arousal/speed/stamina and/or hyperactivity/impulsivity symptoms.

Exclusion Criteria:

Cases with primarily penetrating head trauma
Pre-injury history of diagnosed ADHD
Pre-injury history of other neurodevelopmental disorders including intellectual disabilities, major communication disorders, autism spectrum disorder
Unstable or serious psychiatric conditions, such as psychotic symptoms. Concurrent problems with depression, anxiety, or post-traumatic stress disorder may be present but are judged to be stable and not so severe as to require pharmacologic treatment
Treatment with psychotropic medication(s), including psychostimulant(s) within the last 6 months, but eligible thereafter
Lifetime history of stimulant abuse or dependence. Other (non-stimulant) substance abuse within the past 6 months.
Tics or other contraindications for psychostimulant use including cardiovascular disease, uncontrolled hypertension or hyperthyroidism, glaucoma, agitation, use of an monoamine oxidase (MAO) inhibitor within the past six weeks. Pregnancy would also be an exclusion for girls of childbearing age.
Estimated intelligence quotient (IQ) < 70
Sensory and/or motor impairment(s) seriously limiting testing options
Neurological conditions including uncontrolled epilepsy, degenerative disorders, brain tumor, or stroke
Physical condition affecting arousal, activity level, or stamina including uncontrolled thyroid dysfunction, severe or symptomatic anemia, autoimmune or metabolic disorders, untreated moderate/severe sleep apnea, etc.
Intervention: Venlafaxine
Trial phase: Phase 4
ATC code: N06AX16
SMILES: COc1ccc(C(CN(C)C)C2(O)CCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: 50mg of Venlafaxine before sleep

Venlafaxine: Venlafaxine 50mg before sleep
Eligibility criteria:
Inclusion Criteria:

Ages 18-70 years
sleep study (with apnea hypopnea index>5)
Diagnosis of obstructive sleep apnea

Exclusion Criteria:

Any known cardiac (apart from treated hypertension), pulmonary (including uncontrolled asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease.
Susceptible to stomach ulcers.
co-administration of MAO inhibitors intended to treat psychiatric disorders (concurrently or within 14 days of discontinuing the MAO inhibitor); initiation of MAO inhibitor intended to treat psychiatric disorders within 7 days of discontinuing venlafaxine; initiation in patients receiving linezolid or intravenous methylene blue
Pregnant women.
History of hypersensitivity to Afrin, Lidocaine (all Aims) or venlafaxine
History of bleeding diathesis and/or gastrointestinal bleeding.
Glaucoma and Urinary Retention
Use of any medications that may affect sleep or breathing.
Use of any medications that have known interaction with venlafaxine and the interaction may significantly increase the risk of the subject or decrease the therapeutic effect of the medication.
A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs.
More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
Desaturations to below 70% lasting greater than 10 seconds in duration per event
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: All subjects who receivedOTO-104. Subjects were included in this treatment group according to the actual treatment received regardless of their randomized assignment.
Eligibility criteria:
Inclusion Criteria includes, but is not limited to:

Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
Subject has experienced active vertigo during the lead-in period.
Subject has documented asymmetric sensorineural hearing loss.
Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

Subject is pregnant or lactating.
Subject has a history of immunodeficiency disease.
Subject has a history of previous endolymphatic sac surgery.
Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
Subject has experienced an adverse reaction to IT injection of steroids.
Subject has used an investigational drug or device in the 3 months prior to screening.
Subject has previously been randomized to a trial of OTO-104.
Intervention: Ciprofloxacin
Trial phase: Phase 2
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: 6 mg ciprofloxacin: single administration of OTO-201
Eligibility criteria:
Inclusion Criteria includes, but is not limited to:

Subject is a male or female aged 6 months to 17 years, inclusive
Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)
Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

Subject has a history of sensorineural hearing loss
Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
Subject has a history of known immunodeficiency disease
Intervention: Ciprofloxacin
Trial phase: Phase 2
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: 12 mg ciprofloxacin: single administration of OTO-201
Eligibility criteria:
Inclusion Criteria includes, but is not limited to:

Subject is a male or female aged 6 months to 17 years, inclusive
Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)
Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

Subject has a history of sensorineural hearing loss
Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
Subject has a history of known immunodeficiency disease
Intervention: Deferasirox
Trial phase: Phase 3
ATC code: V03AC03
SMILES: O=C(O)c1ccc(-n2nc(-c3ccccc3O)nc2-c2ccccc2O)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight
Eligibility criteria:
Key Inclusion Criteria for subjects:

Completed 24-weeks of study treatment as described in the core protocol (CICL670F2201).
Were deemed to have tolerated deferasirox treatment by the investigator.
Provided written informed consent/assent before any study-specific procedures were performed. For pediatric patients, consent was obtained from parent(s) or legal patient's representative. Investigators were to have also obtained assent of patients according to local, regional or national guidelines.

Key Exclusion for subjects:

The exclusion criteria followed those described for the core protocol CICl670F2201, which were as follows:

Creatinine clearance below the contraindication limit in the locally approved prescribing information.
Serum creatinine > 1.5 × upper limit of normal range (ULN) at Screening
Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) > 5 × ULN,
Significant proteinuria
Patients with significant impaired gastrointestinal function or gastrointestinal disease
Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
Patients with psychiatric or addictive disorders
Patients with a known history of HIV seropositivity (Elisa or Western blot).
History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was an evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
Patients with a history of hypersensitivity to any of the study drug or excipients.
Patients with significant medical condition that could interfere with the ability to participate in this study
Patients who were participating in another clinical trial or receiving an investigational drug.
Patients using prohibited medication,
Patients with liver disease with severity of Child-Pugh Class B or C.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using effective methods of contraception during dosing of study treatment
Intervention: Clascoterone
Trial phase: Phase 2
ATC code: D10AX06
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(=O)CC)C(=O)CO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 27
Group description: Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days

cortexolone 17α-propionate (USAN/INN: clasocoterone): is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.
Eligibility criteria:
Inclusion Criteria:

Patient must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide written informed consent for the patient.
Patient has moderate to severe facial acne vulgaris as determined by the Investigator and obvious acne on the trunk (i.e., shoulders, upper chest, and/or back).
Females of childbearing potential must be using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.
Patient must be in general good health with normal renal function and no clinically relevant abnormalities present at study start.
Patient and parent/guardian are able to communicate with the staff and are willing to comply with study instructions, reside at and/or return to the clinic for required visits.

Exclusion Criteria:

Patient is pregnant, lactating, or is planning to become pregnant during the study.
Patient has a Body Mass Index (BMI) for age percentile > 95%.
Patient has any skin or medical condition, including facial hair that could interfere with the evaluation of the test article or requires the use of interfering topical or systemic therapy.
Patient has received an investigational drug or been treated with an investigational device within 30 days prior to study start.
Patient is currently enrolled in an investigational drug or device study.
Patient has any condition which, in the investigator's opinion, would make it unsafe for the patient to participate in this research study.
Patient has known allergy or sensitivity to CB-03-01 or any of its ingredients
Patient has participated in a previous CB-03-01 study.
Intervention: Caffeine
Trial phase: Phase 1 | Phase 2
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2
Group description: Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.

SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
Eligibility criteria:
Inclusion Criteria:

Greater than 14 days old and less than 1 year of age.
Greater than 1 kg.
Mild cholestasis, defined as a conjugated bilirubin between 0.5-1.9 mg/dL
Currently standard therapy with soy-based Intralipid
Evidence of growth of weight, head circumference or length below our standards for post-menstrual age for at least 1 week.
Be expected to require intravenous nutrition for at least an additional 21 days

Exclusion Criteria:

Have a congenitally lethal condition.
Have clinically severe bleeding or clinical liver failure not able to be managed with routine measures.
Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves
Intervention: Aplaviroc
Trial phase: Phase 3
SMILES: [H][C@]1([C@H](O)C2CCCCC2)NC(=O)C2(CCN(Cc3ccc(Oc4ccc(C(=O)O)cc4)cc3)CC2)N(CCCC)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
Eligibility criteria:
Inclusion Criteria:

Ongoing participants from any completed global Roche-sponsored Herceptin trial
Participants enrolled in any Roche-sponsored Herceptin trial who have at least stable disease (or whose disease has not recurred) during Herceptin therapy at the end of the lead-in trial
Available study termination data (including tumor assessment and laboratory data) on the Case Report Form for the lead-in trial
Judged eligible by the investigator following a thorough risk/benefit assessment, if signs of chronic heart failure developed during the lead-in trial

Exclusion Criteria:

Pregnant or nursing women
Women of childbearing potential unless using effective contraception as determined by the investigator
Severe dyspnea at rest requiring supplementary oxygen therapy
Severe uncontrolled systemic disease