anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bupivacaine
Trial phase: Phase 3
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: 91
Group description: Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
Eligibility criteria:
Inclusion Criteria:

Robotic or Video-Assisted Lung Resection for All Indications

Exclusion Criteria:

Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
Extra-Thoracic Procedures
Hypersensitivity to Amide Local Analgesia
Cardiac Conduction Abnormalities
Hepatic Dysfunction
Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage
Intervention: Vorinostat
Trial phase: Phase 2
ATC code: L01XH01
SMILES: O=C(CCCCCCC(=O)Nc1ccccc1)NO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Vorinostat Oral Capsules 400mg daily

Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed metastatic uterine sarcoma (endometrial stromal sarcoma, undifferentiated uterine sarcoma, leiomyosarcoma, adenosarcoma and carcinosarcoma

High HDAC-positivity of the tumor determined by immunohistochemistry
Patients must have received prior systemic antineoplastic therapy
Patient is not amenable for curative therapy
Age >= 18 years
Estimated life expectancy > 3 months
Measurable disease on CT/MRI (at least one measurable lesion >1cm) or chest X-ray (at least one measurable lesion >2cm)
Karnofsky performance status of 60-100
Adequate hematologic, renal and hepatic function
Subject is able to swallow and retain oral medication and does not have uncontrolled emesis
No fertility preserved
Written informed consent

Exclusion Criteria:

Lack of or low expression of HDAC (see 4.1 "Pre-Screening")

Significant cardiac disease
Other invasive malignant tumor diagnosed within the last 5 years (e.g. metastases from breast cancer in the last 3 years)
Significant bowel obstruction
Severe uncontrolled infection
Known HIV-positivity
Symptomatic brain metastasis or leptomeningeal disease
Pre-existing significant liver disease, severe hepatic impairment (Bilirubin no greater than 1.5 times upper limit of normal (ULN) and/or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) greater than 2.5 times ULN)
Known history of allergic reaction to vorinostat or similar medications
Systemic therapy or an investigational agent within 21 days prior to study inclusion
Uncontrolled hypertension (sustained systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg despite optimal medical management)
Major surgery within 3 weeks of enrollment when diagnosed at an early stage
Symptomatic congestive heart failure
Unstable angina pectoris or cardiac arrhythmia
Myocardial infarction within last 6 months
Known active hepatitis B or hepatitis C
Psychiatric illness/social situations that would limit compliance with study requirements-
Prior history of thrombotic or thromboembolic events, unless adequately controlled by anticoagulant therapy
Intervention: Ibuprofen
Trial phase: Phase 2 | Phase 3
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: The topical suspension of the topical NSAID was 100 mg per 5 ml concentration of ibuprofen, with similar ingredients as OTC children's ibuprofen and was compounded by an external drug service.

Non-Steroidal Anti-inflammatory Topical Rinse: Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients.
Eligibility criteria:
Inclusion Criteria:

Speak English
Have a symptomatic form of the disease.
Are at least 18 years of age.

Exclusion Criteria:

Known or suspected sensitivity to non-steroidal anti-inflammatory medication
History of asthma
History of gastrointestinal ulceration
History of bleeding disorders
Use of anti-inflammatory agents in the last 24 hours
Use of systemic steroid medication in the last 14 days.
Pregnancy
Intervention: Moxifloxacin
Trial phase: Phase 1
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: 400 mg tablet was orally administrated once a week.
Eligibility criteria:
Inclusion Criteria:

Body mass index (BMI) [body weight in kg / (height in m)2] of at least 18.5 kg/m2 and less than 25.0 kg/m2 as a result of at the screening examination
Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to start of any trial-related procedures and capable of complying with the procedures for this trial

Exclusion Criteria:

Subjects with a medical history of convulsive disorder, long QT syndrome (including family history), syncope during swimming, or any other type of syncope or cryptogenic loss of consciousness
Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc)
Subjects with a family history of sudden death
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: 4
Group description: Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
Eligibility criteria:
Inclusion Criteria:

Age 18 or older;
Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or deformity requiring surgical intervention;
Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital;
Willing to provide informed consent, participate in study, and comply with study protocol.

Exclusion Criteria:

Hypersensitivity or allergy to local anesthetics;
Pregnant or contemplating pregnancy prior to surgery;
Previous surgery in lumbar spine (i.e. other than microdiscectomy);
Prior treatment for alcohol, recreational drug, or opioid abuse;
Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
Surgery involving more than 2 vertebral levels;
Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests [21]; could also run into potential issues with reimbursement).
Lactating women
Patients with end stage liver disease
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: 4
Group description: Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
Eligibility criteria:
Inclusion Criteria:

Age 18 or older;
Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or deformity requiring surgical intervention;
Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital;
Willing to provide informed consent, participate in study, and comply with study protocol.

Exclusion Criteria:

Hypersensitivity or allergy to local anesthetics;
Pregnant or contemplating pregnancy prior to surgery;
Previous surgery in lumbar spine (i.e. other than microdiscectomy);
Prior treatment for alcohol, recreational drug, or opioid abuse;
Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
Surgery involving more than 2 vertebral levels;
Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests [21]; could also run into potential issues with reimbursement).
Lactating women
Patients with end stage liver disease
Intervention: Fenofibrate
Trial phase: Phase 2
ATC code: C10AB05 | C10BA03 | C10BA04 | C10BA09 | C10BA12
SMILES: CC(C)OC(=O)C(C)(C)Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Fenofibrate: 145mg of fenofibrate
Eligibility criteria:
Inclusion Criteria:

An adult of either sex, ages 25-85 inclusive,
Have proficiency with written and spoken English and corrected vision or hearing to complete the cognitive testing,
Are able to give informed consent,
Have good overall health status with no known problems anticipated over the course of the trial,
Have a diagnosis of HD supported by positive gene test within the past 6 months.

Exclusion Criteria:

Other major neurological disease [e.g., multiple sclerosis, parkinson's disease, cortical stroke, etc]
Clinically significant hepatic or renal disease,
Current or recent (< 1 month) use of dopamine blocking agents such as tetrabenazine, anticonvulsants, neuroleptics, HAART, antiemetics, and antipsychotics for any reason,
Current use of Warfarin (Coumadin). Enrollment in another investigational drug study within the prior three months.
Intervention: Adriforant
Trial phase: Phase 2
SMILES: CN[C@@H]1CCN(c2cc(NCC3CC3)nc(N)n2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: ZPL389 3 mg oral powder
Eligibility criteria:
Inclusion Criteria:

Subjects must give a written, signed and dated informed consent
Chronic atopic dermatitis present for at least 1 year before Baseline
Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.
Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
Candidate for systemic treatment

Exclusion Criteria:

Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.
Participation in prior ZPL389 studies
Intervention: Adriforant
Trial phase: Phase 2
SMILES: CN[C@@H]1CCN(c2cc(NCC3CC3)nc(N)n2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: ZPL389 10 mg oral powder
Eligibility criteria:
Inclusion Criteria:

Subjects must give a written, signed and dated informed consent
Chronic atopic dermatitis present for at least 1 year before Baseline
Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.
Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
Candidate for systemic treatment

Exclusion Criteria:

Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.
Participation in prior ZPL389 studies
Intervention: Adriforant
Trial phase: Phase 2
SMILES: CN[C@@H]1CCN(c2cc(NCC3CC3)nc(N)n2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: ZPL389 30 mg oral powder
Eligibility criteria:
Inclusion Criteria:

Subjects must give a written, signed and dated informed consent
Chronic atopic dermatitis present for at least 1 year before Baseline
Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.
Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
Candidate for systemic treatment

Exclusion Criteria:

Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.
Participation in prior ZPL389 studies
Intervention: Adriforant
Trial phase: Phase 2
SMILES: CN[C@@H]1CCN(c2cc(NCC3CC3)nc(N)n2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: ZPL389 50 mg oral powder
Eligibility criteria:
Inclusion Criteria:

Subjects must give a written, signed and dated informed consent
Chronic atopic dermatitis present for at least 1 year before Baseline
Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.
Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
Candidate for systemic treatment

Exclusion Criteria:

Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.
Participation in prior ZPL389 studies
Intervention: Testosterone
Trial phase: Phase 4
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2601
Group description: Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
Eligibility criteria:
Inclusion Criteria:

Men between 45 and 80 years age
Participants with low serum testosterone concentrations (< 300 ng/dL) who exhibit at least one sign or symptom of hypogonadism and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease.

Exclusion Criteria:

Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
Confirmed testosterone < 100 ng/dL
Body Mass Index (BMI) > 50
Hemoglobin A1c (HbA1C) > 11%
Hematocrit (Hct) > 50%
Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).
Intervention: Ofloxacin
Trial phase: Phase 1
ATC code: A02BD10 | J01MA01 | J01MA12 | J01RA05 | J01RA09 | S01AE01 | S01AE05 | S02AA16
SMILES: CC1COc2c(N3CCN(C)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Active ingredient: Levofloxacin 0.5%

o Dosage: 1 drop in both eyes, 8 times a day during the waking period

PRO-174: Pharmaceutical form: ophthalmic solution

Prepared by: Laboratorios Sophia, S.A. of C.V.
Description of the solution: transparent solution, free of visible particles.
Description of container: sterile multi-dose bottle
Eligibility criteria:
Inclusion Criteria:

Signed informed consent.
Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
Age between 18 to 45 years.
Both genders.
Blood tests (complete blood count, blood chemistry of three elements and liver function tests) within normal parameters specified by the reference laboratory with a lower and upper margin of 10%.
Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute).
Visual capacity 20/30 or better, in both eyes.
Intraocular pressure ≥11 and ≤ 21 mmHg.

Exclusion Criteria:

General criteria

Subjects with a history of hypersensitivity to any of the components of the research products.
Subject users of topical ophthalmic medications of any pharmacological group.
Subject users of medication by any other route of administration.
Pregnant or lactating women.
Women of childbearing age, who do not ensure a hormonal contraceptive method or intrauterine device during the study period or without a history of bilateral tubal obstruction, oophorectomy or hysterectomy; as fertile age we understand women who have not had their menopause, defined as 12 months since the last menstruation in women over 40 years.
Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
Diagnosis of liver disease or elevation to three times the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
Inability to attend or answer the evaluations made in each of the visits.
Positive smoking (specified as cigarette consumption regardless of amount and frequency)
Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
Contact lens users.
An occlusive iridocorneal angle, defined as a trabecular mesh visible at less than 90 ° from the angular circumference to gonioscopy.
Intervention: Ciprofloxacin
Trial phase: Phase 1
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: o Dosage: 1 drop in both eyes, 8 times a day during the waking period

Sophixín Ofteno®: o Active substance: Ciprofloxacin 0.3%

Pharmaceutical form: Ophthalmic solution
Prepared by: Laboratorios Sophia, S.A. of C.V.
Description of the solution: transparent solution, free of visible particles.
Description of container: sterile multi-dose bottle
Eligibility criteria:
Inclusion Criteria:

Signed informed consent.
Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
Age between 18 to 45 years.
Both genders.
Blood tests (complete blood count, blood chemistry of three elements and liver function tests) within normal parameters specified by the reference laboratory with a lower and upper margin of 10%.
Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute).
Visual capacity 20/30 or better, in both eyes.
Intraocular pressure ≥11 and ≤ 21 mmHg.

Exclusion Criteria:

General criteria

Subjects with a history of hypersensitivity to any of the components of the research products.
Subject users of topical ophthalmic medications of any pharmacological group.
Subject users of medication by any other route of administration.
Pregnant or lactating women.
Women of childbearing age, who do not ensure a hormonal contraceptive method or intrauterine device during the study period or without a history of bilateral tubal obstruction, oophorectomy or hysterectomy; as fertile age we understand women who have not had their menopause, defined as 12 months since the last menstruation in women over 40 years.
Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
Diagnosis of liver disease or elevation to three times the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
Inability to attend or answer the evaluations made in each of the visits.
Positive smoking (specified as cigarette consumption regardless of amount and frequency)
Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
Contact lens users.
An occlusive iridocorneal angle, defined as a trabecular mesh visible at less than 90 ° from the angular circumference to gonioscopy.
Intervention: Bromfenac
Trial phase: Phase 4
ATC code: S01BC11
SMILES: Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days

PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014

Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac
Eligibility criteria:
Inclusion Criteria:

Age of 18 to 90 years.
Both genders.
Clinical diagnosis of grade I to III pterygium (temporal, nasal, or bitemporal).
Possibility of going to the revisions when indicated.

Exclusion Criteria:

Subjects with topical or systemic medication that interfere decisively in the results of the study; such as topical immunomodulators, NSAIDs, antihistamines, corticosteroids, artificial tears with conservative, vasoconstrictors etc.
Subjects (female) with active sexual life who do not use a contraceptive method.
Subjects of the female sex in a pregnant state or who are breastfeeding.
Subjects of the female sex with pregnancy test in positive urine.
Positive substance abuse
Subjects who have participated in any clinical research study in the last 40 days.
Subjects legally or mentally incapacitated to give their informed consent for their participation in this study.
Subjects that can not comply with the appointments or with all the requirements of the Protocol.