anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Givinostat
Trial phase: Not Applicable
ATC code: M09AX14
SMILES: CCN(CC)Cc1ccc2cc(COC(=O)Nc3ccc(C(=O)NO)cc3)ccc2c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Givinostat: oral suspension, 0,75 mg/kg b.i.d. in fed conditions
Eligibility criteria:
Inclusion Criteria:

subjects who had successfully completed the previous Dose Finding Study and were fully compliant to the inclusion/exclusion criteria described in the previous DSC/08/2357/36

Exclusion Criteria:

patients with fever related to JIA or other systemic features of JIA during 12 months before entering the study
active bacterial or mycotic infection requiring antimicrobial treatment
episode of macrophage activation syndrome over the last 6 months
baseline prolongation of QT/QTc interval, use of concomitant medications that prolong the QT/QTc interval or history of additional risk factors for TdP.
clinically significant cardiovascular disease
clinically significant illness i.e. any condition that in the opinion of the Investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
psychiatric illness/social situation that would limit compliance with study medication and protocol requirements
inherited metabolic diseases
presence of malignancy
pregnancy or lactation
positive blood test for HIV
active EBV infection, active B and/or C hepatitis
platelet count <100x10(9)/L
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.

Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) class I
Age between 18 and 45
BMI 18-28 kg/m^2

Exclusion Criteria:

Concurrent significant medical illness (heart disease including untreated hypertension, Clinically significant kidney disease, liver disease, or lung disease, History of myasthenia gravis or other muscle and nerve disease)
Anxiety disorder requiring treatment
Concurrent medications known to affect anesthesia, upper airway muscles or respiratory function (e.g., gabaergic anxiolytics, antipsychotics)
Individuals with a history of allergy or adverse reaction to lidocaine, propofol, or sevoflurane
For women: pregnancy
Suggestion of obstructive sleep apnea (OSA) or any other sleep disorder (e.g. witnessed apneas, gasping or choking during sleep, unexplained excessive daytime sleepiness)
History of drug or alcohol abuse
Acute intermittent porphyria
Intervention: Sevoflurane
Trial phase: Phase 4
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.

Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) class I
Age between 18 and 45
BMI 18-28 kg/m^2

Exclusion Criteria:

Concurrent significant medical illness (heart disease including untreated hypertension, Clinically significant kidney disease, liver disease, or lung disease, History of myasthenia gravis or other muscle and nerve disease)
Anxiety disorder requiring treatment
Concurrent medications known to affect anesthesia, upper airway muscles or respiratory function (e.g., gabaergic anxiolytics, antipsychotics)
Individuals with a history of allergy or adverse reaction to lidocaine, propofol, or sevoflurane
For women: pregnancy
Suggestion of obstructive sleep apnea (OSA) or any other sleep disorder (e.g. witnessed apneas, gasping or choking during sleep, unexplained excessive daytime sleepiness)
History of drug or alcohol abuse
Acute intermittent porphyria
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.

Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Eligibility criteria:
Inclusion Criteria:

Age: 45-80 years
ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV
VAS pain score >5/10 within 48 hrs of the phone screen and visit 1 (Screening)
Knee OA for a minimum of 12 months
Need for daily pain medication to manage symptoms of OA

Exclusion Criteria:

Currently taking MAO inhibitors or any centrally acting drug for analgesia, depression

Narrow angle glaucoma
Uncontrolled hypertension
Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state.
If a female, pregnant, trying to become pregnant, or lactating
Major depressive disorder
Substantial alcohol use or history of significant liver disease
Use of MAO inhibitors, triptans, serotonin precursors (tryptophan)
Use of potent CYP1A2 inhibitors, Thioridazine, and anti-depressants
Diabetes, type 1 or type 2
Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk

MRI safety necessitates the exclusion of subjects having one or more of the following:

Metal fragments in the eye or face, or having worked previously in the metal industry
Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac, defibrillators, and cochlear implants or nerve stimulators.
Surgery on the blood vessels of the brain
Claustrophobia (fear of enclosed places)
Piercings or tattoos
More than 250 lbs in weight
Obvious brain abnormalities
Intervention: Tesevatinib
Trial phase: Phase 1 | Phase 2
SMILES: COc1cc2c(Nc3ccc(Cl)c(Cl)c3F)ncnc2cc1OC[C@@H]1C[C@@H]2CN(C)C[C@@H]2C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Participants received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum duration: up to 36 months).
Eligibility criteria:
Inclusion Criteria:

The participant had a confirmed diagnosis of ADPKD.
The participant had a GFR >=35 mL/min/1.73m^2.
Cysts must be at least 1 centimeter in size.
Adequate bone marrow, kidney, and liver function.
Must agree to use two forms of birth control for those of child bearing potential.
Normal amylase and lipase levels.
The participant had a htTKV >= 1000 mL (htTKV was calculated using total kidney volume obtained from magnetic resonance imaging divided by height in meters).

Exclusion Criteria:

The participant has had a previous partial or total nephrectomy.
The participant had tuberous sclerosis, Hippel-Lindau disease, or acquired cystic disease.
The participant had congenital absence of one kidney and/or need for dialysis.
Presence of renal or hepatic calculi (stones) causing symptoms.
The participant had received any investigational therapy within 30 days prior to study entry.
Active treatment (within 4 weeks of study entry) for urinary tract infection.
Participant was known to be immunocompromised.
Participant was pregnant or nursing.
History of pericardial effusion or presence of pericardial effusion on screening echocardiogram
Uncontrolled hypertension.
History of pancreatitis or had known risk factors for pancreatitis.
Participant had received EGFR inhibitor at any time.
The participant was aphakic due to previous cataract surgery or congenital anomaly.
Intervention: Solifenacin
Trial phase: Phase 4
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 138
Group description: This arm comprises female partners who receive up to 16 weeks of solifenacin treatment for their UUI symptoms
Eligibility criteria:
Healthy male partners may volunteer to participate in this study along with their affected female partners. There are no inclusion or exclusion criteria for male partners.

For affected female participants, the following inclusion criteria apply:

Age ≥ 18 years
In a relationship with a male partner for at least 3 months
Not pregnant or planning to become pregnant
Have a diagnosis of UUI or Mixed Urinary Incontinence (MUI) that is urge predominant based on a 3 day voiding diary
Are interested in medical management of their symptoms
Are candidates for solifenacin
Are able to provide informed consent
Are able to complete written questionnaires.

For affected female partners, the following exclusion criteria apply:

Post Voided Residual (PVR) > 200 ml at the initial visit
History of a significant outflow obstruction
History of persistent/recurrent Urinary Tract Infection (UTI)
History of bladder stones
History of a diagnosis of chronic interstitial cystitis
History of pelvic irradiation
Current pelvic malignancy
Narrow angle glaucoma
Urinary or gastric retention
Current use of a tricyclic antidepressant
A neurologic diagnosis that could affect bladder function
History of chronic pelvic pain
Active psychotic disorder
Male partner does not speak English
Declines permission for the study team to recruit their male partner for the study
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 4
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Buprenorphine 4-16 mg/day divided 2-4 times a day for 6 months
Eligibility criteria:
Inclusion Criteria:

have a well-documented chronic pain disorder due to past back surgery,
have a chronic back pain syndrome,
have evidence of opioid addiction,
prior attempt at abstinence-oriented treatment documented by the referring physician,
be able to understand spoken and written English,
reside in Erie or Niagara counties,
have health insurance or other ability to pay for treatment with the approval from patient's primary physician;
have no prior history of methadone or BUP/NLX maintenance treatment since the last surgery,
not be a member of a vulnerable population, including prisoners

Exclusion Criteria:

homeless, or any patient without a "locator" (no means to participate in the follow-up data collection interviews by phone),
inability to give consent,
those with major co-occurring psychiatric disorders,
EKG showing prolonged QT and/or previous cardiac issues,
are taking a medication that is contraindicated with methadone,
medically unstable,
urine positive for cocaine at initial visit,
pregnant women
Intervention: Pioglitazone
Trial phase: Phase 4
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: 50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.

Pioglitazone: 30mg once daily for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Age between 20 and 65 years
BMI between 25 and 35
Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD) or depressive episode of bipolar disorder (Bipolar I, II or NOS)
Depression severity as defined by score of < 12 on the 21-item Hamilton Rating Scale for Depression and no psychiatric admission within 6 months from study entry and no suicide attempt within the last 12 months
Willingness to sign human subjects consent form

Exclusion Criteria:

Diagnosis of possible or probable cognitive impairment
For women only: pregnancy, breastfeeding
Personal history of Type I or Type II diabetes
Unstable cardiovascular disease or other major medical condition, or history of myocardial infarction within the previous year
Significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressures > 100)
Current drug or alcohol abuse
History of neurological disorder, e.g. multiple sclerosis, stroke etc
Use of any drug that may significantly affect psychometric testing or the insulin testing
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Normal Saline

Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart
Eligibility criteria:
Inclusion Criteria:

Subject must be an outpatient, male or female subjects of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study.
Subject must have moderate to severe atrophic acne scars
Subject must desire correction of his/her moderate to severe acne scarring.
Subjects of all Fitzpatrick skin types are eligible.
Subject must be willing to withhold additional aesthetic therapies to the face (eg, other soft tissue fillers: Restylane, Radiesse, Sculptra, and/or any resurfacing procedures for the duration of the study.
Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
Subject must sign an IRB-approved Informed Consent form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed

Exclusion Criteria:

Female subjects that are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
Undergo facial treatments with any listed of the prohibited treatment/procedures and/or use of any other prohibited treatment/procedure within certain time periods.
Have any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to the proposed treatment or require interfering topical, systemic or surgical therapy.
Have a recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound or clinically significant acne in the proposed treatment areas. Clinically significant acne is defined as a patient whom has >3 active inflammatory acne lesions in either the right or left treatment area.
Have a history of systemic granulomatous diseases active or inactive (eg, Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (eg, lupus, dermatomyositis, etc.).
Have hypertrophic acne scars, any evidence of keloid scarring, predominantly icepick scarring (defined as more than half of all scar area in either the left or right or treatment area) or sinus tract scars.
Have a known hypersensitivity or previous allergic reaction to any of the components of the study device (including lidocaine or any amide-based anesthetic), or has a history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges, and collagen-based sutures.
Intervention: Tigecycline
Trial phase: Phase 4
ATC code: J01AA12 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)cc(NC(=O)CNC(C)(C)C)c(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: All subjects receive a single dose of tigecycline

Tigecycline: 100 mg IV as a single infusion over 30 minutes
Eligibility criteria:
Inclusion Criteria:

Subjects fulfilling the following criteria will be eligible:

males and females, 18 to 50 years of age;
non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;
Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);
female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period

Exclusion Criteria:

history of significant hypersensitivity reaction to any components of Tygacil®;
history of significant clinical illness requiring pharmacological management;
history of blood donation in the past eight week period;
abnormal serum electrolyte or complete blood count requiring further clinical work-up;
transaminases (AST or ALT) > 2.5 x upper limit of normal;
subjects with stage 4 or 5 chronic kidney disease;
positive serum pregnancy test (if female);
abnormal electrocardiogram (ECG) as judged by study physician;
unable to tolerate venipuncture and multiple blood draws;
clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up;
unable to independently provide a written informed consent.
Intervention: Varenicline
Trial phase: Phase 2 | Phase 3
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
Eligibility criteria:
Inclusion Criteria:

Duke employees who are enrolled in a Duke Health Plan and intend to remain employed at Duke for the next six months;
Dependents of Duke employees who meet the above criteria;
18-65 years old;
Currently smoke an average of at least 10 cigarettes per day;
Willing to take Chantix or Zyban;
Express a desire to quit smoking within the next 30 days.

Exclusion Criteria:

Hypertension;
Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg);
Coronary heart disease;
Lifetime history of heart attack;
Cardiac rhythm disorder (irregular heart rhythm);
Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
Extensive active skin disorder;
Liver or kidney disorder (except kidney stones, gallstones);
Gastrointestinal disease other than gastroesophageal reflux or heartburn;
Active ulcers in the past 30 days;
Currently symptomatic lung disorder/disease (including but not limited to COPD, emphysema, and asthma);
Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
Migraine headaches that occur more frequently than once per week;
Recent, unexplained fainting spells;
Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
Other major medical condition;
Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
Pregnant or nursing mothers;
Current psychiatric disease (with the exception of anxiety disorders, OCD and ADHD);
Current depression;
Bulimia or anorexia;
Alcohol abuse;
Significant adverse reaction to bupropion/Wellbutrin/Zyban, Chantix/Varenicline or nicotine patches in the past.

Use (within the past 30 days) of:

Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
Medications that are known to affect smoking cessation.
Intervention: Prasugrel
Trial phase: Phase 3
ATC code: B01AC22
SMILES: CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: prasugrel 10 mg by mouth daily

Prasugrel: one 10 mg tablet by mouth daily
Eligibility criteria:
Inclusion Criteria:

Age 18 years or greater
Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
Undergoing clinically-indicated coronary artery bypass graft surgery

Exclusion Criteria:

Known allergy to aspirin or prasugrel
Need for concomitant cardiac procedure, such as valve repair or replacement
Increased risk of bleeding, including need for warfarin or dabigatran administration
Positive pregnancy test or breast-feeding
Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol
Serum creatinine > 2.5 mg/dL
Severe peripheral arterial disease limiting vascular access
Prior stroke or transient ischemic attack
Weight <60 kg or age >75 years
Multiple distal SVG anastomoses
Postoperative complications prolonging hospitalization
Intervention: Buprenorphine
Trial phase: Phase 2 | Phase 3
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Buprenorphine maintenance during pregnancy

Buprenorphine: Daily sublingual buprenorphine treatment of pregnant, opioid dependent women from up to 34 weeks gestation through one month of infant age.

Two severe adverse events were reported in the same infant patient. One infant had congenital heart disease and polydactyly
Eligibility criteria:
Inclusion Criteria:

Current opioid dependence as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV-R criteria
18-40 years of age with uncomplicated singleton pregnancies
Accurate gestational age dating verified by ultrasound
Gestation of less than 34 weeks
Stabilization on buprenorphine for one week prior to study procedures

Exclusion Criteria:

Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or significant risk of preterm delivery (i.e. incompetent cervix)
Evidence of fetal malformation detected by prenatal ultrasound
Significant general maternal health problems that can affect fetal functioning, including Type I or gestational diabetes, alterations in thyroid functioning, HIV infection or hypertension.
Significant maternal psychopathology that would preclude informed consent (i.e. schizophrenia)
Alcohol dependency per DSM IV R criteria (see ascertainment methods below)
Women stable on methadone maintenance (defined as more than 3 days of methadone dosing)
Women entering drug treatment reporting using "street" methadone (for more than 3 days)