anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: 120
Group description: Participants were treated with nilotinib 300mg BID for 24 months and, thereafter, entered the 36-month TFR phase
Eligibility criteria:
Key Inclusion Criteria:

Confirmed diagnosis of chronic phase Ph+ CML
Previous first-line treatment with imatinib for a minimum of 2 years;
Patient in complete cytogenetic response;

Key Exclusion Criteria:

Previous achievement of MR4.0 at study entry;
Previous treatment with other target cells inhibitors other than imatinib;
Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening;
Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction;
Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol;
History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively;
Patients who have not recovered from prior surgery;
Treatment with other investigational agents within 4 weeks of Day 1;
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug

Other inclusion/exclusion criteria might apply.
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: 118
Group description: Participants were treated with nilotinib 300mg BID for 36 months and, thereafter, entered the 24-month TFR phase
Eligibility criteria:
Key Inclusion Criteria:

Confirmed diagnosis of chronic phase Ph+ CML
Previous first-line treatment with imatinib for a minimum of 2 years;
Patient in complete cytogenetic response;

Key Exclusion Criteria:

Previous achievement of MR4.0 at study entry;
Previous treatment with other target cells inhibitors other than imatinib;
Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening;
Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction;
Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol;
History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively;
Patients who have not recovered from prior surgery;
Treatment with other investigational agents within 4 weeks of Day 1;
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug

Other inclusion/exclusion criteria might apply.
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: 381
Group description: Participants were treated with nilotinib 300mg BID for 24 months, but did not achieve a sustained molecular response after 24 months of treatment and were not randomized.
Eligibility criteria:
Key Inclusion Criteria:

Confirmed diagnosis of chronic phase Ph+ CML
Previous first-line treatment with imatinib for a minimum of 2 years;
Patient in complete cytogenetic response;

Key Exclusion Criteria:

Previous achievement of MR4.0 at study entry;
Previous treatment with other target cells inhibitors other than imatinib;
Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening;
Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction;
Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol;
History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively;
Patients who have not recovered from prior surgery;
Treatment with other investigational agents within 4 weeks of Day 1;
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug

Other inclusion/exclusion criteria might apply.
Intervention: Doxycycline
Trial phase: Not Applicable
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Doxycycline x 100 mg BID (orally) for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Documented HIV infection
CD4 cell count greater than 200 cells/mm3
HIV RNA less than 400 copies/ml
Stable antiretroviral therapy for greater than or equal to 12 weeks
Fulfills GOLD definition for COPD (post-bronchodilator FEV1/FVC less than 0.7) and/or has radiographic evidence of emphysema
Current or history of smoking with minimum 3 pack-year history
ALT and AST less than 3 x upper limit of normal
For women of childbearing potential: willingness to use 2 forms of birth control
Subjects on therapy for COPD must be on stable therapy for at least 4 weeks

Exclusion Criteria:

Pulmonary infection, COPD exacerbation, or acute opportunistic infection within 30 days of entry
Conditions associated with increased sedation of bronchoscopy risk, including but not limited to Gold class 3 or 4 COPD, requirement for home oxygen, hypercapneic respiratory failure, poorly controlled hypertension
Known allergy/intolerance to doxycycline, atropine, or any local anesthetic
Inability to provide informed consent
Pregnant or lactating women
Men must agree not to attempt to make a woman pregnant or participate in sperm donation during the study and for 6 weeks after discontinuing the drug
End stage renal disease
Cirrhosis
INR greater than 1.4
Platelets less than 80,000
Any condition including active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements or increase the risk of bronchoscopy
Active or planned participation in any other clinical trial or observational study without prior approval from the PI
Intervention: Kovacaine
Trial phase: Phase 3
SMILES: CCCCNc1ccc(C(=O)OCCN(C)C)cc1.Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1.Cl.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Eligibility criteria:
Inclusion Criteria:

Male or female 18 years of age or older.
Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (anterior or premolar tooth #4 to #13) with no evidence of pulpal pathology.
Normal lip, nose, eyelid, and cheek sensation.
Able to understand and sign the study informed consent document, communicate with the Investigators, and understand and comply with the requirements of the protocol.
Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure (the treatment tooth).
Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
Seated systolic blood pressure (SBP) between 95 and 150 mm Hg, inclusive, and seated diastolic blood pressure (DBP) between 60 and 100 mm Hg, inclusive.

Exclusion Criteria:

Inadequately controlled hypertension (blood pressure greater than 150/100 mm Hg).
Inadequately controlled active thyroid disease of any type.
Frequent nose bleeds (≥ 5 per month).
Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.
Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
Having received any investigational drug and/or participation in any clinical trial within the 30 days prior to study participation.
History of congenital or idiopathic methemoglobinemia.
Intervention: Tenofovir
Trial phase: Phase 3
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 331
Group description: tenofovir disoproxil fumarate, 300 mg tablets

tenofovir disoproxil fumarate: administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum
Eligibility criteria:
Inclusion Criteria:

Pregnancy
At least 18 years of age
Negative Human Immunodeficiency Virus (HIV) serology
Positive HBsAg and hepatitis B e antigen (HBeAg) tests
Gestational age of 28 weeks (+ or - 10 days) as determined by obstetrician
Alanine Aminotransferase (ALT)≤30 U/L, confirmed ≤60 U/L on a subsequent blood draw
Agreeing to bring their infants at the planned study visits at one study site until one year after delivery and to inform the site investigators if they plan to move to another place and not be able to return to the clinic.
Understanding the need for adequate infant immunization and agreeing to the blood draws from their infants and the need for close follow up to manage possible exacerbation of hepatitis.

Exclusion Criteria:

History of tenofovir treatment at any time, or any other anti-HBV treatment during the current pregnancy
Creatinine clearance <50 ml/min, calculated using the Cockcroft-Gault formula
Dipstick proteinuria>1+ (>30 mg/dL) or normoglycemic glucosuria confirmed on two separate occasions
Positive serology for Hepatitis C infection less than 12 months prior to enrollment
Evidence of pre-existing fetal anomalies incompatible with life
Any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or satisfactory follow up in the study.
Concurrent participation in any other clinical trial without written agreement of the two study teams
Intervention: Roflumilast
Trial phase: Phase 4
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Roflumilast 500 μcg, once daily, for 30 days
Eligibility criteria:
Inclusion Criteria:

Subjects between the ages of 50 and 70 with a minimum of ten-pack years of tobacco exposure, airflow obstruction (FEV1/FVC < 0.70) with an FEV1 < 70%
baseline sputum production at least some of the time as reported on the Saint George's Respiratory Questionnaire, and at least one exacerbation within the past year

Exclusion Criteria:

Subjects with chronic prednisone use, antiresorptive therapy use (bisphosphonates, calcitonin, parathyroid hormone)
Subjects with a body mass index less than 18 or greater than 34
Intervention: ETHINYL ESTRADIOL
Trial phase: Phase 1
ATC code: G03AA07 | G03CA01 | L02AA03
SMILES: C#C[C@]1(O)CC[C@H]2[C@@H]3CCc4cc(O)ccc4[C@H]3CC[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily for 28 days (lead-in period). Then, Ortho-Cyclen orally for 28 Days (Days 1 to 28) in one of two treatment periods.

Ortho-Cyclen: Oral administration
Eligibility criteria:
Inclusion Criteria:

Are pre-menopausal females, and who are healthy as determined by medical history and physical examination
Have a body mass index of 18 to 30 kilograms per square meter (kg/m^2)

Exclusion Criteria:

Have known allergies to evacetrapib and Ortho-Cyclen (ethinyl estradiol and norgestimate), related compounds or any components of the formulation
Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Have taken injectable contraceptives within 12 months prior to the first dose of the lead-in period or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of the lead-in period
Use of any tobacco- or nicotine-containing products within 6 months prior to the lead-in phase and during the study
Intervention: Fluticasone
Trial phase: Phase 3
ATC code: D07AC17 | R01AD08 | R01AD58 | R03AK06 | R03AK11 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.

Fluticasone: Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
Eligibility criteria:
Inclusion Criteria:

Pediatric population: 6 months to 15 years of age

2 or more episodes of croup in 12 month period

croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress.

Exclusion Criteria:

Grade 3 or 4 subglottic stenosis
Subglottic hemangioma
Posterior laryngeal cleft
Recurrent respiratory papillomatosis
External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc)
Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body
Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress
Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease.
Other medical conditions necessitating chronic steroid utilization
Intervention: Neostigmine
Trial phase: Phase 4
ATC code: N07AA01 | N07AA51 | S01EB06
SMILES: CN(C)C(=O)Oc1cccc([N+](C)(C)C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.
Eligibility criteria:
Inclusion Criteria:

Able to give written informed consent
American Society of Anaesthesiologists class I, II or III
Obese or morbid obese as defined by BMI > 30 and >40 kg/m2 respectively

Exclusion Criteria:

Neuromuscular disorders
Allergies to, or contraindication for muscle relaxants, neuromuscular reversing agents, anaesthetics, narcotics
Malignant hyperthermia
Pregnancy or lactation
Renal insufficiency defined as serum creatinine of 2x the upper normal limit, glomerular filtration rate < 60ml/min, urine output of < 0.5ml/kg/h for at least 6h
Chronic obstructive pulmonary disease GOLD classification 2 or higher.
Clinical, radiographic or laboratory findings suggesting upper or lower airway infection
Congestive heart failure.
Pickwick syndrome
Psychiatric illness inhibiting cooperation with study protocol or possibly obscuring results
Intervention: Betamethasone
Trial phase: Not Applicable
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Patients receive dexamethasone IV at the time of surgery and PO every 8 hours for up to 4 days following surgery.

Dexamethasone: Given IV

Dexamethasone: Given PO

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Transoral Robotic Surgery: Undergo TORS
Eligibility criteria:
Inclusion Criteria:

Patients must be diagnosed with oropharyngeal squamous cell carcinoma (SCC) that are surgical candidates
Macroscopic resection of the tumor via TORS must be planned with curative intent
Patient must be willing to remain on corticosteroid therapy for 4 days postoperatively
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients with known distant metastases or other malignancies
Patients with a history of allergy or adverse reaction to corticosteroids
Patients with a history of diabetes
Patients with fasting capillary blood glucose of > 140 on the day of surgery
Patients on chronic corticosteroids
Chronic alcohol abuse (> 6 alcoholic beverages daily)
Patients with a history of severe chronic pain on high dose narcotics (> 25 mg of oxycodone or equivalent daily) preceding diagnosis of cancer
Patients taking significant cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers, i.e. protease inhibitors (ritonavir, nelfinavir, etc), clarithromycin, ketoconazole, fluconazole, verapamil, diltiazem, carbamazepine, phenytoin, phenobarbital, Rifampin, efavirenz, nevirapine
Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study
Patients who will undergo complex head and neck surgery in addition to the TORS procedure requiring reconstruction with a free flap
Patients who have had any previous head and neck surgery that has affected swallowing, voice or speech or who have had previous radiation to the head or neck
Patients who have any confounding medical or neurological conditions that have the potential to affect cognition, speech or swallowing function; i.e. stroke, neurodegenerative disease, neuromuscular movement disorders, head injury, etcetera
Psychiatric illness/social situations that would limit compliance with study requirements
Excluded patients will be allowed to participate in the trial on an observational basis only
Intervention: Paroxetine
Trial phase: Phase 4
ATC code: N06AB05
SMILES: Fc1ccc([C@@H]2CCNC[C@H]2COc2ccc3c(c2)OCO3)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Participants will receive Paroxetine CR for 8 weeks.

Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment.
Eligibility criteria:
Inclusion Criteria:

Patient suffering from an episode of major depressive disorder (MDD)
Age range 18-65 years
History of a past suicide attempt or score > 2 on HDRS item #3 (suicide) at in-person screening interview. Patients with suicidal plan or intent will only be enrolled as inpatients if independent inpatient treatment team agrees with the plan to enroll the patient.
Patients 60 years of age and older must score at least 25 on MMSE at screening.
Patients 60 years of age and older must have a normal ECG within the past year.

Exclusion Criteria:

Bipolar disorder; current psychotic symptoms; bulimia or anorexia that is current or within the past year, or current purging at least twice a week for three months; persons already taking SSRIs or bupropion for other indications (such as anxiety disorders).
Primary disorder is an anxiety disorder such as Panic disorder/GAD/OCD/ Social anxiety disorder, with secondary depression.
Drug or alcohol dependence within past six months; persons with current drug or alcohol abuse may be enrolled if this is assessed as being of lesser importance than the major depressive episode.
Blood pressure reading ≥ 140/90
Active and/or unstable medical problems including a significant risk for seizures
Antipsychotic medication required
Patients who have become hypomanic or manic on antidepressants
Contraindication to the use of an SSRI or bupropion, or currently using Zyban. Anorexia nervosa in remission at least one year is not an exclusion.
Failure to respond to adequate trials of 3 SSRIs or paroxetine or bupropion in the last 2 years (failure to respond to therapeutic trial defined as: at least 2/3 maximal PDR dose for at least 6 weeks).
Lacks capacity to consent
Pregnancy, lactation, or plans to conceive during the course of study participation.
Patients currently on effective treatment, who require adjunctive antipsychotic or mood stabilizing medication, or who are unlikely to respond to single agent treatment for depression will be excluded.
Patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes MRI, will be excluded.
Patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.