anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Dextromethorphan
Trial phase: Phase 3
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 156
Group description: Participants received AVP-786-18 mg orally once daily (QD) in the morning and placebo orally QD in the evening for the first 7 days, followed by AVP-786-18 mg orally BID for the remaining 5 weeks (Days 8-42). Participants who completed Stage 1 were eligible to participate in Stage 2.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
Either out patients or residents of an assisted-living facility or a skilled nursing home
Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation is >= 4 (moderately ill) at screening and baseline
Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
Participant with myasthenia gravis
Intervention: Guanabenz Acetate
Trial phase: Not Applicable
SMILES: CC(=O)O.NC(N)=NN=Cc1c(Cl)cccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Guanabenz (titrate up from 8mg PO QPM to 16mg PO BID max dose)
Eligibility criteria:
Inclusion Criteria:

≥ 18 years old at the time of informed consent
Ability to provide written informed consent and HIPAA authorization
Solid organ malignancy with documented bone metastasis by imaging
Adequate liver function (serum total bilirubin <= 3 and AST/ALT <= 3 times the upper normal limit)
Adequate renal function (serum creatinine <= 2mg/dL)
Ability to swallow oral tablets

Females of childbearing potential must have a negative pregnancy test <= 28 days prior to registration. All females of childbearing potential who are sexually active, must agree to use a highly reliable method of contraception to prevent pregnancy. These include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).

NOTE: Females are considered of childbearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (> 12 months since last menses).

Patients are permitted to participate in other clinical trials while participating in this trial.
Patients will receive standard of care systemic treatment for underlying solid malignancy as deemed necessary by treating physician.

Exclusion Criteria:

No prior history of bisphosphonate ordenosumab use in the past 12 months

No history of SRE within past 3 months

Excruciating bone pain requiring RT
Cord compression
Hypercalcemia [serum calcium >10.5]
Pathologic fracture
No history of Paget's disease
No history of epilepsy/seizures
No history of hypotension (defined as resting systolic blood pressure of < 110 mm Hg or diastolic blood pressure of < 70 mm Hg) or orthostasis (defined as drop in systolic blood pressure of >20 mm Hg or increase in HR of > 20 from supine to standing position).
Intervention: Deferiprone
Trial phase: Phase 4
ATC code: V03AC02
SMILES: Cc1c(O)c(=O)ccn1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: All patients in this study received deferiprone
Eligibility criteria:
Inclusion Criteria:

Completed study LA38-0411

Females of childbearing potential must have a negative pregnancy test result at Visit 1. In addition, if applicable, they must:

Use an effective method of contraception according to local requirements, during the study and within 30 days following their last dose of study medication, OR
Have had a tubal ligation (supporting evidence required), OR
Have had a hysterectomy (supporting evidence required), OR
Participate in a non-heterosexual lifestyle, OR
Have a male sexual partner who has been sterilized (supporting evidence required)
Fertile heterosexual males and/or their partners must agree to use an effective method of contraception during the study and for 30 days following the last dose of study medication
All patients and/or their authorized legal representatives must provide signed and dated written informed consent prior to the first study intervention, and assent will be obtained from patients who are considered to be minors. Patients must be able to adhere to study restrictions, appointments, and evaluation schedules.

Exclusion Criteria:

Plan to participate in another clinical trial at any time from the day of enrollment until 30 days post-treatment in the current study
For only those patients who were treated with deferoxamine in study LA38-0411 (Group 2): Presence of any medical condition (including clinically significant laboratory abnormalities, such as ALT (alanine aminotransferase) ≥ 5 x ULN or creatinine ≥ 2 x ULN), psychological condition, or psychiatric condition which in the opinion of the investigator would cause participation in the study to be unwise.
Pregnant, breastfeeding, or planning to become pregnant during the study period.
Treatment failure after 1 year on deferiprone which in the investigator's judgment indicates the need for the patient to be started on a different iron chelator
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy.

Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy
Willing and able to understand and provide written informed consent

Exclusion Criteria:

Known pregnancy
Women who are currently nursing a child
History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder
Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation
Inability to provide informed consent (patients under guardianship)
Known hypersensitivity to local anesthetics
History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.
History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as determined by history or review of the medical record.
Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60 mL/min/body surface area (BSA) as determined by history or review of the medical record.
History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.
Intervention: Naltrexone
Trial phase: Phase 4
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: XR-NTX+CM (Extended Release Naltrexone + Care Management)

XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
Eligibility criteria:
Inclusion Criteria

Subjects must meet all of the following criteria to be eligible for study enrollment:

English or Spanish speaking*

*Non-English Spanish speaking patients will not be enrolled initially until study documents have been translated, back translated, and approved by the Institutional Review Board (IRB).

Emergency Department patient
Aged 18-80
Have had >4 emergency department visits within 12 months for 2 consecutive 12-month periods. Period of time can be extended by up to 6 months if incarcerated or institutionalized for ≥ 6 months.
Meet Diagnostic and Statistical Manual version IV (DSM-IV) criteria for alcohol dependence or & DSM-V criteria for alcohol use disorder, severe.
Have ≥2 days/week of heavy drinking (>4 drinks/day)
Capable of giving informed consent.

Exclusion Criteria

Subjects who meet any of the following criteria will be ineligible for study enrollment:

Active opioid dependence
Acute or chronic pain requiring opioid treatment
Acute liver injury (liver aminotransferase concentrations >5 times the upper limit of normal)
Health condition considered unsafe for inclusion (at discretion of PI and/or attending physician)
Lack of capacity or willingness to consent
Currently prescribed pharmacotherapy for alcohol dependence (not including treatment of acute alcohol withdrawal syndrome)
Previous significant adverse reaction to naltrexone or diluent
Pregnant, nursing, or not using effective methods of birth control
Prisoners (as defined by Office of Human Research Protection) at the time of enrollment ARE NOT ELIGIBLE for study entry. However, subjects who become prisoners after being enrolled will be included and not be withdrawn from the study. Patients on parole or probation are eligible for enrollment.
Intervention: Pibrentasvir
Trial phase: Phase 2 | 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: 44
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Patients from 18 to 70 years in Arms A, B, and C; patients 18 years of age or older in Arms D and E.
Previous treatment with DAA-containing regimen for chronic hepatitis C virus (HCV) infection resulting in either on-treatment virologic failure or post-treatment relapse
Chronic HCV genotype (GT) 1, 4, 5, or 6-infection (GT4-6 in Arms D and E)

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any drug
Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
Co-infection with more than one HCV genotype
Intervention: Pibrentasvir
Trial phase: Phase 2 | 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: 47
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
Eligibility criteria:
Inclusion Criteria:

Patients from 18 to 70 years in Arms A, B, and C; patients 18 years of age or older in Arms D and E.
Previous treatment with DAA-containing regimen for chronic hepatitis C virus (HCV) infection resulting in either on-treatment virologic failure or post-treatment relapse
Chronic HCV genotype (GT) 1, 4, 5, or 6-infection (GT4-6 in Arms D and E)

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any drug
Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
Co-infection with more than one HCV genotype
Intervention: Lidocaine
Trial phase: Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 142
Group description: Drug: vaginal 2% Xylocaine

vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block
Eligibility criteria:
Inclusion criteria:

Women ages 18 and older undergoing elective surgical abortion at 5 and 0/7 to 11 and 6/7 weeks gestational age
Use of IV sedation for pain management
English or Spanish speaking
Ability to give informed consent

Exclusion criteria:

Any pre-operative use of misoprostol (typically given at 12 weeks and above in this clinic)
Allergy to study medications: lidocaine, midazolam, fentanyl
Known uterine anomaly
Prior cervical surgery.
Intervention: ALBUTEROL
Trial phase: Phase 4
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to
Eligibility criteria:
Inclusion Criteria:

very low birthweight infant (<1500g)
gestational age at birth <32 weeks
age 14 or more days and corrected to 28w0d to 33w6d gestational age
continuing to require respiratory support and/or supplemental oxygen

Exclusion Criteria:

chromosomal abnormalities
major congenital anomalies
congenital heart disease, except atrial septal defect and patent ductus arteriosus
clinical providers determine subject too unstable to undergo pulmonary function testing
Intervention: Fulvestrant
Trial phase: Phase 4
ATC code: L02BA03
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])c3ccc(O)cc3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: fulvestrant (Faslodex®)
Eligibility criteria:
Inclusion Criteria:

Post menopausal status women
Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.
Estrogen receptor positive
Radiographic progression of disease after the prior therapy
Patients who agree to participate in this study and sign the informed consent

Exclusion Criteria:

Patients who are treated with fulvestrant
Patients who are being treated with the other antitumor agents
Pregnancy or lactating women
History of hypersensitivity to any of included ingredients (eg. Castor oil)
Patients who are considered not fit for the study by investigators
Patients who have severe dysfunction of liver or kidney
Intervention: Sufentanil
Trial phase: Phase 3
ATC code: N01AH03
SMILES: CCC(=O)N(c1ccccc1)C1(COC)CCN(CCc2cccs2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Patients may be administered one tablet every 60 minutes as needed during the study period
Eligibility criteria:
Inclusion Criteria:

Patients who present to the ER with moderate-to-severe pain due to obvious trauma or injury evident on physical examination.
Patients classified as American Society of Anesthesiologists (ASA) class I-III
Patients who are willing and capable of understanding and cooperating with the requirements of the study.
Patients able to understand and communicate in English.
Patients who have provided written informed consent and signed the IRB approved consent form.

Exclusion Criteria:

Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
Patients who have used any illicit drugs of abuse, abused prescription medication or alcohol (4 or more drinks per day) within one year before the start of the study.
Patients with an allergy or hypersensitivity to opioids.
Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the dose of study drug.
Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
Female patients who are pregnant (positive pregnancy test) or breastfeeding.
Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
Patients who present to the ER using supplemental oxygen.
Patients who have participated in a clinical trial of an investigational drug or device within 30 days of enrollment.
Patients who are active or reserve duty with the US military.
Intervention: Bimatoprost
Trial phase: Not Applicable
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 45
Group description: Bimatoprost 0.01%: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
Eligibility criteria:
Inclusion Criteria:

English speaking
Normotensive or glaucoma suspects on no ocular medications
No manicure within 2 weeks of the study.

Exclusion Criteria:

Individuals on topical or systemic essential fatty acids (EFA's) in hand lotions, creams, ointments, or medication, or on biotin.
Digits with signs of nail injury, deformity, or infection.
Nail biters, nail polishers, artificial nail wear or gels, and nail and trimming and filing until the study endpoint.
Women of childbearing age who are pregnant or who are trying to become pregnant.
Individuals with allergies or sensitivity to prostaglandin agents.
Intervention: ICENTICAFTOR
Trial phase: Phase 2
SMILES: COc1nc(C(=O)NC[C@](C)(O)C(F)(F)F)c(N)cc1C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: QBW251 (28 day treatment period) and placebo (42 days, run-in and wash-out periods)
Eligibility criteria:
Inclusion Criteria: Must have a diagnosis of GOLD II-III chronic obstructive pulmonary disease (COPD); Must have clinical diagnosis of chronic bronchitis; Must be either a current smoker (smoked ≤ 1 pack per day on average for the last 3 months with at least a 10 pack year smoking history) OR an ex-smoker with at least a 10 pack year smoking history; Exclusion Criteria: Must not be receiving chronic, daily, systemic steroids; Must not have severe emphysema (determined by HRCT); Must not have had a COPD exacerbation or respiratory tract infection requiring antibiotics or oral steroids or hospitalization within 6 weeks of screening; Must not be pregnant or nursing or a woman of child bearing potential; Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
Eligibility criteria:
Inclusion Criteria:

Adults 18 years of age or older
Planning for surgical treatment of POP with robotic sacrocolpopexy and rectocele repair under general anesthesia
Patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included

Exclusion Criteria:

Pregnant or nursing
Allergy to bupivacaine
History of drug/alcohol abuse
Severe cardiovascular, hepatic, renal disease, or neurological impairment
Long-acting opioid use within 3 days or any opioid use within 24 hours before surgery
Contraindication to: acetaminophen, oxycodone, non-steroidal anti- inflammatory drugs (NSAID)
Administration of an investigational drug within 30 days before study
Chronic pain syndromes
Daily NSAID/opioid use
Patients not undergoing general anesthesia
Patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or fistula repair
Intervention: Piroxicam
Trial phase: Phase 4
ATC code: M01AC01 | M02AA07 | S01BC06
SMILES: CN1C(C(=O)Nc2ccccn2)=C(O)c2ccccc2S1(=O)=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 102
Group description: After extraction of one lower third molar, 102 patients were treated with Piroxicam (20 mg once daily for 4 days) for pain control.
Eligibility criteria:
Inclusion Criteria:

Impacted lower third molar;
not making use of nonsteroidal anti-inflammatory drugs in the last 7 days;

Exclusion Criteria:

Local anesthetics allergy;
History of gastrointestinal bleeding or ulcers;
Kidney disease;
Asthma;
Allergy or sensitivity to aspirin or any other anti-inflammatory non-steroid agent;
Pregnant or nursing women;
Patients using antidepressant, diuretic or aspirin;
Patients received antibiotics for 30 days prior to surgery.