anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Topiramate
Trial phase: Not Applicable
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Diet Modification topiramate and then nortriptyline if necessary

Topiramate: Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID
Eligibility criteria:
Inclusion Criteria:

-Men and women aged 18 to 70 with untreated vestibular migraine variant as diagnosed by history.

Exclusion Criteria:

Patients with allergies to nortriptyline or topiramate and their analogs or medication interactions that preclude their use.
Patients under the care of a psychiatrist.
Patients who are pregnant or trying to become pregnant.
Patients taking more than 5 prescription medications.
Patients with cancer.
Patient has a history of immunodeficiency.
Patient has a history of substance abuse within the preceding 6 months prior to screening.
Patient has used an investigational drug or device in the the 3 months prior to screening.
Patient is using marijuana for medical or other uses.
Patient has any other clinically significant illness or medical condition that, in the investigator's opinion, would prohibit the subject from participating in the study.
Patient with traumatic brain injury.
Patients taking Nortriptyline, MAOIs
Patients with liver or kidney dysfunction or glaucoma

Due to know drug interactions, patients taking the following medications will be excluded.

Nortriptyline: monoamine oxidase inhibitors (MAO) such as phenelzine. Patients on oral contraceptives will be asked to use a secondary method as nortriptyline can reduce the effectiveness of oral contraceptives.

Topiramate: acetazolamide (kidney stones), digoxin

Exclude subjects with liver dysfunction, kidney dysfunction and glaucoma (per the risks associated with topiramate).
Intervention: Tenofovir Disoproxil Fumarate
Trial phase: Phase 2
SMILES: CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).
Eligibility criteria:
Key Inclusion Criteria:

Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study
Documented evidence of chronic hepatitis B virus (HBV) infection, for example, hepatitis B surface antigen (HBsAg) positive for more than 6 months
Screening HBV DNA ≥ 2000 IU/mL
A negative serum pregnancy test is required for females (unless surgically sterile or > 2 years post-menopausal)

Key Exclusion Criteria:

Cirrhosis
Inadequate liver function
Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
Received antiviral treatment for HBV within 3 months of screening
Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Significant cardiovascular, pulmonary, or neurological disease
Women who are pregnant or may wish to become pregnant during the course of the study
Received solid organ or bone marrow transplant
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
Use of investigational agents within 3 months of screening
Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
Documented history of yeast allergy
Known hypersensitivity to study drugs, metabolites or formulation excipients
Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Individuals under evaluation for possible malignancy are not eligible

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 33
Group description: 1000 mg every 6 hours during labor up to maximum 3 doses

Acetaminophen: administered every 6 hours by mouth up to 3 doses
Eligibility criteria:
Inclusion Criteria:

>/= 18 years of age not allergic to study medications

Exclusion Criteria:

pre-eclampsia in labor AND with demonstrated significant abnormal liver enzyme function changes non-English speaking subjects
Intervention: Clarithromycin
Trial phase: Not Applicable
ATC code: A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD09 | A02BD11 | A02BD12 | A02BD14 | J01FA09
SMILES: [H][C@]1(O[C@H]2[C@H](C)[C@@H](O[C@]3([H])O[C@H](C)C[C@H](N(C)C)[C@H]3O)[C@](C)(OC)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@](C)(O)[C@@H](CC)OC(=O)[C@@H]2C)C[C@@](C)(OC)[C@@H](O)[C@H](C)O1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 94
Group description: Clarithromycin tablet

Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months
Eligibility criteria:
Inclusion Criteria:

Meeting the CRS diagnostic criteria including CRSsNP and CRSwNP based on the EP3OS definition
Age ≥16 and ≤70 years
Chinese of either sex
Failure to conventional medical therapies according to EP3OS recommendation

Exclusion Criteria:

Pregnant or breast-feeding women
Cystic fibrosis
Congenital ciliary dyskinesia
Sinonasal fungal disease
Systemic vasculitis
Granulomatous disease
Tumor
Immunodeficiency
Allergic to clarithromycin or topical corticosteroid
With an upper respiratory tract infection within 4 weeks of entering the study
With serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects' safety such as glaucoma and tuberculosis
With emotional or mental problems
Have received immunotherapy within the previous 3 months
Have had a history of local or systemic medications, such as glucocorticoids and macrolides within 4 weeks
Have had an acute asthmatic within the 4 weeks before entering the study
Intervention: Topiramate
Trial phase: Phase 4
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks.
Eligibility criteria:
Inclusion Criteria:

History of chronic migraine
More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).

Exclusion Criteria:

Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
Previous treatment with botulinum toxin of any serotype for any reason
Previous treatment with topiramate
On a ketogenic diet (high in fat, low in carbohydrates)
History of acute myopia or increased intraocular pressure
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
Intervention: Sodium fluoride and triclosan
Trial phase: Phase 3
SMILES: Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 120
Group description: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
Eligibility criteria:
Inclusion Criteria:

Male and female subjects, ages 21-70, inclusive.
Availability for the six-week duration of the study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.

Exclusion Criteria:

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Use of antibiotics any time during the one month prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Pregnant women or women who are breast feeding.
Dental prophylaxis received in the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse
Intervention: Spironolactone
Trial phase: Phase 2
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Have a history of hypertension.

If participants are naïve to treatment of hypertension, or have not been treated with any antihypertensive medications within the 30 days immediately prior to screening:

Have seated systolic (SBP) of ≥140 and <170 millimeters of mercury (mmHg) at screening and at the end of the lead-in period.

If participants are currently being treated for hypertension:

Are taking a stable dose of 1 or 2 antihypertensive medications for at least the previous 30 days. A combination antihypertensive medication from 2 classes is considered as 2 antihypertensive medications.
Are willing to discontinue the antihypertensive medications during the study.
Have seated SBP of ≥140 and <170 mmHg at the end of the lead-in period.
Have a body mass index (BMI) ≥18.5 and <40 kilograms/m^2.

Exclusion Criteria:

Have a history of severe hypertension (defined as SBP ≥180 mmHg and/or diastolic (DBP) ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension.
Have SBP ≥180 mmHg and/or DBP ≥110 mmHg at screening, lead-in period, or randomization.
Have a history of hospitalization due to hyperkalemia, or history of drug discontinuation due to elevated serum potassium levels.
Have a serum potassium ≤3.5 or >5.0 millimoles per liter (mmol/L).
Have an estimated glomerular filtration rate (eGFR) <50 milliliters/minute/1.73 m^2.
Intervention: Topiramate
Trial phase: Phase 3
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 28
Group description: Participants received topiramate weight-based sprinkle capsule and tablet, as tolerated (not to exceed 350 milligrams per day [mg/day] for participants 2 to less than [<] 10 years of age, and not to exceed 400 mg/day for participants 10 to 15 years of age), twice daily (BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available topiramate or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.
Eligibility criteria:
Inclusion Criteria:

Participant with a clinical diagnosis of new-onset or recent-onset epilepsy characterized by partial-onset seizures (POS) (with or without secondary generalization) or primary generalized tonic-clonic seizures (PGTCS) in accordance with criteria of the International League Against Epilepsy. The epilepsy diagnosis must be within the previous 2 years before screening
Caregivers (parents or legally acceptable representatives) of the participant must be able to accurately maintain the participant take-home record and seizure diary
At screening, participant must have weight and height values within the 5th to 95th percentile for chronological age (based on standard Child Height and Weight Charts from the Centers for Disease Control [CDC])
Participant must never have been treated for epilepsy (treatment-naïve) or have been treated with no more than 1 standard antiepileptic drug (AED) if temporary or urgent AED use was necessary. Previous AED exposure must not exceed either of the following: 1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of previous AED exposure in the past if the AED has been discontinued for at least 1 year prior to enrollment
Parents (or legally acceptable representatives) of the participant must sign an informed consent/permission document, indicating that they understand the purpose of and procedures required for the study and are willing to give permission for their child to participate in the study. Participant 7 years of age and older, capable of understanding the nature of the study, must provide assent for their participation

Exclusion Criteria:

Participant has a surgically implanted and functioning vagus nerve stimulator
Participant has a history of seizures as a result of a correctable medical condition, such as metabolic disturbance, toxic exposure, neoplasm, or active infection within 2 weeks prior to the first day of Screening
Participant has had uncontrolled seizures while previously taking either topiramate or levetiracetam
Participant has a history of non-epileptic seizures within 2 weeks prior to the first day of Screening
Participant has myoclonic or absence seizures
Intervention: SB-423562
Trial phase: Phase 2
SMILES: CC(C)(CC1Cc2ccccc2C1)NCC(O)COc1cc(CCC(=O)O)ccc1C#N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: NPSP795 administered Intravenous (IV) infusion for 10 min on Day 1 if certain criteria for ionized calcium and/or blood parathyroid hormone (PTH) were met, an infusion was administered for either 10 min or 3.5 hours on Days 2 & 3, according to a predefined dose escalation scheme. NPSP795 was administered as a 3.5-hour infusion on Day 4, or the participant underwent discharge procedures.
Eligibility criteria:
Inclusion Criteria:

Subjects with a heterozygous activating mutation of the CaSR gene (ADH); if not previously confirmed, genetic testing will be performed at the screening visit
At least 18 years of age
Body mass index (BMI) ≥ 18.5 to < 39 kg/m2

Exclusion Criteria:

Diseases or conditions that might compromise any major body system or interfere with the pharmacokinetics of NPSP795
History of treatment with PTH 1-84 or 1-34 within the previous 6 months
History of hypocalcemia requiring frequent IV calcium infusions
History of hypocalcemic seizure within the past 3 months
Blood 25-hydroxy vitamin D level < 25 ng/mL. If subjects have a blood 25-hydroxy vitamin D level < 25 ng/mL at the outpatient screening visit, they will be prescribed vitamin D replacement. Once the 25-hydroxy vitamin D level is > 25 ng/mL, the subject will be eligible to continue on to the treatment phase of the study
Estimated glomerular filtration rate (GFR) < 25 mL/minute, and/or abnormal hepatic, hematologic, and/or clotting function
12 lead resting electrocardiogram (ECG) with clinically significant abnormalities
Concomitant medications with the potential to interfere with NPSP795 metabolism
History of thyroid or parathyroid surgery
Intervention: Perflutren
Trial phase: Phase 1 | Phase 2
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 30
Group description: OPTISON will be resuspended just before the performance of ceVUS examination, and 0.1%-0.5% of the bladder filling volume OPTISON / normal saline solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with the maximum OPTISON dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children.

VCUG exam will be performed using the same bladder catheter with intravesical administration of the x-ray contrast agent.
Eligibility criteria:
Inclusion criteria:

Children 2-18 years (first age cohort).
Children 0-18 years (second age cohort).
Referred to the Children's Hospital of Philadelphia (CHOP) for the performance of the clinically indicated Voiding Cystourethrography (VCUG) examination.
Parental/guardian permission (informed consent) and if appropriate, child's assent for additional performance of contrast enhanced Voiding Urosonography (ceVUS) examination.

Exclusion criteria:

Hypersensitivity to perflutren, blood, blood products or albumin.
Children requiring sedation for VCUG or ceVUS examinations.
Parents/guardians or subjects who, in the opinion of the principal investigator, may be non-compliant with study schedules or procedures.
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.

1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.
Eligibility criteria:
Inclusion Criteria:

Healthy adult volunteers

Exclusion Criteria:

any current medical condition requiring medication or abnormal electrocardiogram
current or past medical condition considered to be a contraindication for the study conditions
any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
less than high school education
lack of fluency in English
night shift work
Pregnancy, lactation or plans to become pregnant.
Use of hormonal contraception.
Daily cigarette smokers i.e., >7 cigarettes per week
Intervention: Methadone
Trial phase: Phase 4
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.

Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
Eligibility criteria:
Inclusion Criteria:

Patient age 10 - 17 years
Patients undergoing multilevel thoraco-lumbar spine surgery with instrumentation and fusion

Exclusion Criteria:

Preoperative methadone therapy
Inability to use the PCA
Allergy to methadone or morphine
Morbid obesity with a body mass index >36.0 kg/m2
Patients with chronic renal failure defined by serum creatinine >2.0 mg/dL
Liver failure defined as a history of cirrhosis or fulminant hepatic failure
Preoperative congenital heart disease or arrhythmias
Patient refusal to participate in study
Pregnancy (It is standard of care for all post menarche female patients to undergo a urine pregnancy test prior to surgery).
Intervention: Bictegravir
Trial phase: Phase 2
ATC code: J05AR20
SMILES: O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone

BCG (Immucist®)
Eligibility criteria:
Inclusion Criteria:

Histologically proven non-muscle invasive bladder cancer;
Indication to intravesical instillation of BCG according to EAU guidelines;
Age > 18 years;
Willingness, to participate to the study;
Written informed consent.

Exclusion Criteria:

Previous or ongoing BCG or different intravesical instillations;
Urinary tract infections (UTI) or other known pathologies of the lower urinary tract;
Indication for a radical cystectomy;
Severe systemic disorders, including neurological pathologies, kidney, liver or heart failure;
Contraindications to BCG use.
Intervention: Tobramycin
Trial phase: Phase 1
ATC code: J01GB01 | S01AA12
SMILES: NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: TOBI: New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler
Eligibility criteria:
Inclusion Criteria:

Age 6 years or older
Diagnosis of CF based on the following: sweat chloride>60 mEq/L or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF.
Chronically infected with a Burkholderia cepacia complex species (>50% of respiratory specimens positive in the 24 months prior to screening).
Able to produce sputum (expectorated or induced).
Able to reproducibly perform pulmonary function testing.
Written informed consent provided.

Exclusion Criteria:

Post lung transplantation.
Pregnancy.
Acute exacerbation requiring IV or oral antibiotics within 14 days
Patients currently receiving inhaled tobramycin/TOBI
A septic or clinically unstable patient, as determined by the investigator.
Intervention: Haloperidol
Trial phase: Phase 4
ATC code: N05AD01
SMILES: O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.

Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days
Eligibility criteria:
Inclusion Criteria:

At least ≥ 18 years of age and older
Undergoing a possible or scheduled thoracotomy
English speaking

Exclusion Criteria:

History of Schizophrenia and Parkinson's disease
History of Severe Dementia
History of Alcohol Abuse
On Cholinesterase Inhibitors or Levodopa
Pregnant or Nursing
Corrected QT interval > 550 milliseconds at the time of randomization
History of Neuroleptic Malignant Syndrome or Haloperidol Allergy