anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: BENZYL ALCOHOL
Trial phase: Phase 3
ATC code: P03AX06
SMILES: OCc1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 107
Group description: Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Benzyl Alcohol Lotion 5%: White topical lotion
Eligibility criteria:
Inclusion Criteria:

Healthy males or non-pregnant females aged 6 month or over with an upper age limit of 60 years.
Prospective participants upon examination are confirmed to have at least 3 live head lice (defined as lice adults or nymphs) and at least 5 viable appearance louse eggs (nits).
Prospective participants who give written informed consent or, if the participant is under 17 years of age, whose parent/guardian gives written informed consent to participate in the study.
Prospective participants who will be available for follow up visits over the 21 days following first treatment.
Prospective female participants (including female caregivers) of childbearing potential who are willing to provide a urine pregnancy test.
Prospective participants who agree not to shave their hair or use any other pediculicide, nit combing, or louse treatment method during the course of the study.

Exclusion Criteria:

Prospective participants with a known sensitivity to any of the ingredients in benzyl alcohol lotion 5% (Hi-Tech Pharmacal Inc) or Ulesfia 5% (Shionogi Inc).
Prospective participants with a known history of irritation or sensitivity to pediculicides or hair care products.
Prospective participants with a secondary bacterial infection of the scalp (eg. impetigo/pyoderma) or have a secondary or long term scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g., psoriatic lesions of the scalp, extensive seborrheic dermatitis).
Prospective participants who have been treated with other head lice products within 4 weeks prior to randomization.
Prospective participants who regularly shave their hair, have bleached their hair, used a permanent color on their hair, or their hair has been permanently straightened or waved within the previous 2 weeks.
Prospective participants who have been treated with Trimethoprim containing products within the previous 4 weeks, or who are currently taking such a course.
Females who are pregnant, planning to become pregnant, during the course of the study period, or are currently breast feeding mothers.
Females of childbearing potential who are unwilling to use an adequate method of contraception from at least 4 weeks prior to the first application of treatment and until 4 weeks after the last application of treatment, or who are unwilling to take a urine pregnancy test.
Prospective participants who have participated in another clinical study or used an investigational new drug within 1 month before entry into this study.
Participants who have already participated in this clinical study.
Intervention: BENZYL ALCOHOL
Trial phase: Phase 3
ATC code: P03AX06
SMILES: OCc1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 108
Group description: Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Ulesfia (benzyl alcohol lotion) 5%: White topical lotion
Eligibility criteria:
Inclusion Criteria:

Healthy males or non-pregnant females aged 6 month or over with an upper age limit of 60 years.
Prospective participants upon examination are confirmed to have at least 3 live head lice (defined as lice adults or nymphs) and at least 5 viable appearance louse eggs (nits).
Prospective participants who give written informed consent or, if the participant is under 17 years of age, whose parent/guardian gives written informed consent to participate in the study.
Prospective participants who will be available for follow up visits over the 21 days following first treatment.
Prospective female participants (including female caregivers) of childbearing potential who are willing to provide a urine pregnancy test.
Prospective participants who agree not to shave their hair or use any other pediculicide, nit combing, or louse treatment method during the course of the study.

Exclusion Criteria:

Prospective participants with a known sensitivity to any of the ingredients in benzyl alcohol lotion 5% (Hi-Tech Pharmacal Inc) or Ulesfia 5% (Shionogi Inc).
Prospective participants with a known history of irritation or sensitivity to pediculicides or hair care products.
Prospective participants with a secondary bacterial infection of the scalp (eg. impetigo/pyoderma) or have a secondary or long term scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g., psoriatic lesions of the scalp, extensive seborrheic dermatitis).
Prospective participants who have been treated with other head lice products within 4 weeks prior to randomization.
Prospective participants who regularly shave their hair, have bleached their hair, used a permanent color on their hair, or their hair has been permanently straightened or waved within the previous 2 weeks.
Prospective participants who have been treated with Trimethoprim containing products within the previous 4 weeks, or who are currently taking such a course.
Females who are pregnant, planning to become pregnant, during the course of the study period, or are currently breast feeding mothers.
Females of childbearing potential who are unwilling to use an adequate method of contraception from at least 4 weeks prior to the first application of treatment and until 4 weeks after the last application of treatment, or who are unwilling to take a urine pregnancy test.
Prospective participants who have participated in another clinical study or used an investigational new drug within 1 month before entry into this study.
Participants who have already participated in this clinical study.
Intervention: Nilotinib
Trial phase: Phase 3
ATC code: L01EA03 | L01XE08
SMILES: Cc1cn(-c2cc(NC(=O)c3ccc(C)c(Nc4nccc(-c5cccnc5)n4)c3)cc(C(F)(F)F)c2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Nilotinib 400 mg, tablets, orally, twice daily up to approximately 42 months.
Eligibility criteria:
Inclusion Criteria:

Have CP-CML and are resistant to first-line imatinib treatment.
Be male or female ≥18 years old.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Have adequate renal function as defined by the following criterion:

• Serum creatinine ≤1.5 × upper limit of normal (ULN) for institution.

Have adequate hepatic function as defined by all of the following criteria:

Total serum bilirubin ≤1.5 × ULN, unless due to Gilbert's syndrome
Alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 × ULN if leukemic infiltration of the liver is present
Aspartate aminotransferase (AST) ≤2.5 × ULN or ≤5 × ULN if leukemic infiltration of the liver is present.

Have normal pancreatic status as defined by the following criterion:

Serum lipase and amylase ≤1.5 × ULN.

Exclusion Criteria:

Have previously been treated with any approved or investigational TKIs other than imatinib or treated with imatinib within 14 days prior to receiving study drug.
Have previously been treated with any anti-CML therapy other than hydroxyurea, including interferon, cytarabine, immunotherapy, or any cytotoxic chemotherapy, radiotherapy, or investigational therapy.
Underwent autologous or allogeneic stem cell transplant.
Are in CCyR or MMR.

Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:

Any history of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (TIA)
Any history of peripheral vascular infarction, including visceral infarction
Any history of a revascularization procedure, including vascular surgery or the placement of a stent
History of venous thromboembolism, including deep venous thrombosis, superficial venous thrombosis, or pulmonary embolism, within 6 months prior to enrollment
Congestive heart failure (New York Heart Association [NYHA] class III or IV) within 6 months prior to enrollment or left ventricular ejection fraction (LVEF) less than 45% or less than the institutional lower limit of normal (whichever is higher) within 6 months prior to enrollment.
Intervention: CID 5768
Trial phase: Phase 1 | Phase 2
SMILES: C=CC1CN2CCC1CC2C(O)c1ccnc2ccc(OC)cc12.C=CC1CN2CCC1CC2C(O)c1ccnc2ccc(OC)cc12.O=S(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Each study participant randomized into the experimental arm will receive 28 tubes with 1mg/ml (6 mls total) of quinine sulfate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes. Patients will apply 3 mls of quinine sulfate to each nostril twice per day. Thus the patients will be exposed to a maximum of 12mls or 12.0 mg of quinine per day.
Eligibility criteria:
Inclusion Criteria:

Patients who have undergone Functional Endoscopic Sinus Surgery (FESS)
Purulent drainage on nasal endoscopy
Male or female subjects, 18 years of age or older
Patients seen at the Dept. of Otorhinolaryngology clinic at Hospital of the University of Pennsylvania (HUP), a tertiary care clinic

Exclusion Criteria:

Pregnant women
Immunocompromised patients
Granulomatous diseases with rhinologic manifestations (Wegner's, Sarcoid, Churg-Strauss)
Primary ciliary dyskinesia
Intervention: Augmentin
Trial phase: Phase 3
SMILES: CC1(C)SC2C(NC(=O)C(N)c3ccc(O)cc3)C(=O)N2C1C(=O)O.O=C([O-])C1C(=CCO)OC2CC(=O)N21.[K+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 112
Group description: amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg in two divided doses for 10 days; oral, liquid (formulation 2)
Eligibility criteria:
Inclusion Criteria:

Age range: 6 to 23 months
Evidence of AOM
Recent (within 48 hours) onset of signs and symptoms.
Middle ear effusion evidenced by the presence of at least 2 of the following: decreased or absent mobility of the tympanic membrane (TM), yellow of white discoloration of the TM, and/or opacification of the TM
Acute inflammation evidenced by one of the following: 1+ bulging of the TM with either intense erythema or otalgia or 2+ or 3+ bulging of the TM

Exclusion Criteria:

Toxic appearance (capillary refill >3 seconds, systolic blood pressure <60 mm Hg)
Inpatient hospitalization
Clinical or anatomical characteristics that might obscure response to treatment (e.g., tympanostomy tubes in place, cleft palate, Down syndrome)
Sensorineural hearing loss (unilateral or bilateral)
Allergy to amoxicillin or amoxicillin clavulanate
Recent treatment of AOM within the last 14 days
Intervention: Melatonin
Trial phase: Phase 2
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 6 weeks

Melatonin: 2mg controlled release melatonin tablet
Eligibility criteria:
Inclusion Criteria:

Body Mass Index (BMI) ≥ 30 kg/m2
Hemoglobin A1c (HbA1c) 6.7-6.4%
Self reported sleep < 7 hours per night

Exclusion Criteria:

Inability to extend sleep by one hour each night
Current or prior history of diabetes OR random serum glucose ≥200mg/dL
Pregnancy
Preexisting lung disease requiring oxygen
Preexisting cardiovascular disease
Active or uncontrolled psychotic disorder
Active or uncontrolled bipolar illness
Active malignancy with in the prior 5 years
Use of hypoglycemic medication
estimated glomerular filtration rate (eGFR) <60ml/min/1.73m2
Use of antihypertensive medications
Hepatic impairment
Job requiring rotating overnight shifts
Bariatric surgery within prior 12 months
Use of hypnotic medications
Hematocrit <34% (women), <36% (men)
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.

Propofol: Total intravenous anesthesia based on propofol
Eligibility criteria:
Inclusion Criteria:

Female patients over 18 years old classified by the American Society of Anesthesiologists as physical status I or II, undergoing elective breast surgery with general anesthesia.

Exclusion Criteria:

History of: illegal drug and alcohol abuse
Pregnancy on course or suspicion of
Neuromuscular disorders
Cerebral vascular disease
Dysphagia
Dysphonia
Gastroesophageal reflux disease
Previous larynx and/or upper gastrointestinal tract surgery
Allergy to any drug to be used and malignant hyperthermia.
Patients who develop hemodynamic instability in the surgery and need blood transfusion were excluded from the study.
Patients unable to swallow 20 ml of water in an upright position were also excluded.
Intervention: Desflurane
Trial phase: Phase 4
ATC code: N01AB07
SMILES: FC(F)OC(F)C(F)(F)F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.

Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
Eligibility criteria:
Inclusion Criteria:

Female patients over 18 years old classified by the American Society of Anesthesiologists as physical status I or II, undergoing elective breast surgery with general anesthesia.

Exclusion Criteria:

History of: illegal drug and alcohol abuse
Pregnancy on course or suspicion of
Neuromuscular disorders
Cerebral vascular disease
Dysphagia
Dysphonia
Gastroesophageal reflux disease
Previous larynx and/or upper gastrointestinal tract surgery
Allergy to any drug to be used and malignant hyperthermia.
Patients who develop hemodynamic instability in the surgery and need blood transfusion were excluded from the study.
Patients unable to swallow 20 ml of water in an upright position were also excluded.
Intervention: Ledipasvir and sofosbuvir
Trial phase: Phase 4
ATC code: J05AP51
SMILES: CC(C)OC(=O)C(C)NP(=O)(OCC1OC(n2ccc(=O)[nH]c2=O)C(C)(F)C1O)Oc1ccccc1.COC(=O)NC(C(=O)N1CC2(CC2)CC1c1ncc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5nc(C6C7CCC(C7)N6C(=O)C(NC(=O)OC)C(C)C)[nH]c5c4)ccc2-3)[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: LDV/SOF monotherapy x 12 weeks

Sofosbuvir/Ledipasvir x 12 weeks
Eligibility criteria:
Inclusion Criteria

At least 18 years of age and able to give informed consent
History of HCV genotype 1 or 4
Normal EKG
At least 91 days post orthotopic liver transplant
Screening laboratory values within defined thresholds
Detectable HCV RNA at screening
Creatinine Clearance of at least 40ml/min using the Cockcroft Gault equation
Negative pregnancy test for female subjects within 48 hours prior to receiving study medication
Use of two effective contraception methods if female of childbearing potential or sexually active male unless status post bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy

Exclusion Criteria

Serious or active medical or psychiatric illness
History of significant or unstable cardiac disease
Stomach disorder that could interfere with the absorption of the study drug
Pregnant or nursing females or males with a pregnant female partner
Co-infected with Hepatits B (HBV) or HIV
Recipients of an allograft from a donor that was infected with HCV with an unknown genotype or non-genotype 1 or 4 unless the recipient is demonstrated to have only genotype 1 or 4 HCV replication post-transplant
Allergic to or intolerant of sofosbuvir, ledipasvir, or ribavirin
History of exposure to an Nonstructural protein (NS5A) inhibitor
Within 1 year of transplant AND history of Hepatocellular Carcinoma (HCC) with tumor burden outside of the Milan Criteria (See Appendix II) prior to transplant
Participated in a clinical study with an investigational drug or biologic within the last 30 days
Combined liver/kidney transplant
History of organ transplant other than liver
Childs Turcotte Pugh (CTP) B or C
Patients with fibrosing cholestatic hepatitis
Platelet count of ≤ 30 k/mm3
Hemoglobin < 10g/dL
Total bilirubin > 10mg/dL
Alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase ≥ 10x upper limit normal
Serum sodium < 125mmol/L
Current use of any of the Prohibited Interventions (Section 5.3.2) and un-willing to discontinue use, or use of amiodarone within 6 months of screening
Intervention: Viloxazine Hydrochloride
Trial phase: Phase 2
SMILES: CCOc1ccccc1OCC1CNCCO1.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 48
Group description: Treatment B: 100mg SPN-812 was administered once daily and compared to placebo
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
CGI-S score of at least 4
Weight of at least 20 kg.
Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.

Exclusion Criteria:

Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
Significant systemic disease.
Evidence of suicidality within the six months before Screening or at Screening.
BMI greater than 95th percentile for the appropriate age and gender.
Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
Substance or alcohol use during the last three months.
Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.
Intervention: Viloxazine Hydrochloride
Trial phase: Phase 2
SMILES: CCOc1ccccc1OCC1CNCCO1.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 48
Group description: Treatment C: 200mg SPN-812 was administered once daily and compared to placebo
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
CGI-S score of at least 4
Weight of at least 20 kg.
Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.

Exclusion Criteria:

Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
Significant systemic disease.
Evidence of suicidality within the six months before Screening or at Screening.
BMI greater than 95th percentile for the appropriate age and gender.
Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
Substance or alcohol use during the last three months.
Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.
Intervention: Viloxazine Hydrochloride
Trial phase: Phase 2
SMILES: CCOc1ccccc1OCC1CNCCO1.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 48
Group description: Treatment D: 300mg SPN-812 was administered once daily and compared to placebo
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
CGI-S score of at least 4
Weight of at least 20 kg.
Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.

Exclusion Criteria:

Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
Significant systemic disease.
Evidence of suicidality within the six months before Screening or at Screening.
BMI greater than 95th percentile for the appropriate age and gender.
Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
Substance or alcohol use during the last three months.
Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.
Intervention: Viloxazine Hydrochloride
Trial phase: Phase 2
SMILES: CCOc1ccccc1OCC1CNCCO1.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 49
Group description: Treatment E: 400mg SPN-812 was administered once daily and compared to placebo
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
CGI-S score of at least 4
Weight of at least 20 kg.
Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.

Exclusion Criteria:

Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
Significant systemic disease.
Evidence of suicidality within the six months before Screening or at Screening.
BMI greater than 95th percentile for the appropriate age and gender.
Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
Substance or alcohol use during the last three months.
Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.