anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: 30mg ketorolac

Ketorolac
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for knee arthroscopy

Exclusion Criteria:

Inadequate IV access.
History of allergy or hypersensitivity to any component of ibuprofen, ketorolac, aspirin (or aspirin related products), non-steroidal anti-inflammatory drugs (NSAIDs), opioids or cyclooxygenase-2 (COX-2) inhibitors.
Less than 18 years of age.
Use of analgesics less than 8 hours prior to surgery.
Patients with active, clinically significant anemia.
History or evidence of asthma or heart failure.
Pregnant.
Recent history of chronic opioid use.
Concomitant use of probenecid.
Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions and to return for the required assessments.
Refusal to provide written authorization for use and disclosure of protected health information.
Intervention: Nitroglycerin
Trial phase: Not Applicable
ATC code: C01DA02 | C01DA52 | C05AE01
SMILES: O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Nitroglycerin infusion 1-5 mcg/kg/min

Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Eligibility criteria:
Inclusion Criteria:

elective cardiac surgery

Exclusion Criteria:

heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.
Intervention: Nitroglycerin
Trial phase: Not Applicable
ATC code: C01DA02 | C01DA52 | C05AE01
SMILES: O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Nitroglycerin infusion 0-0.1 mcg/kg/min

Nitroglycerin infusion: Nitroglycerin infusion during rewarming
Eligibility criteria:
Inclusion Criteria:

elective cardiac surgery

Exclusion Criteria:

heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.
Intervention: Remifentanil
Trial phase: Phase 4
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Patients with established PVC's sedated with remifentanil IVPCA per study protocol
Eligibility criteria:
Inclusion Criteria:

Patients scheduled to undergo EP studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin
Patients between 18 and 65
ASA 1-3

Exclusion Criteria:

ASA 4 and 5
Age 18 and 65
Intervention: Buprenorphine and Naloxone
Trial phase: Phase 4
SMILES: C=CCN1CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 665
Group description: Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
Eligibility criteria:
Inclusion criteria

Signed informed consent form.
Completion of 1 of 2 primary efficacy safety studies of BNX sublingual tablets (OX219-006 or OX219-007).
Female patients of child bearing potential who used a reliable method of contraception (hormonal, condom with spermicide, intrauterine device) during the previous OX219-006 or OX219-007 study and continue to use it for the OX219-008 study. Females who are not of child-bearing potential who are either surgically sterile (by hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation), or postmenopausal, as defined by being at least 50 years of age and having had an absence of menses for at least 2 years, were also eligible.

Exclusion criteria

Females who are pregnant (positive pregnancy test result) or lactating, or planning to become pregnant during the study.
Participants who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
Participants who are participating in any other clinical study in which medication(s) are being delivered or who had used an investigational drug or device within the last 30 days.
Participants with any known allergy or sensitivity or intolerance to buprenorphine, naloxone, or any related drug, or history of any drug hypersensitivity or intolerance that, in the opinion of the investigator, would compromise the safety of the subject or the study.
Participant with a contra-indicated serious medical condition.
Participants who are at suicidal risk as determined by any of the following: a history of suicidal ideation ≤ 3 months prior to baseline with a score of 4 (intent to act) or 5 (specified plan and intent) on the Columbia Suicide Severity Risk Scale (C-SSRS).
Intervention: Cyclobenzaprine Hydrochloride
Trial phase: Phase 2 | Phase 3
SMILES: CN(C)CCC=C1c2ccccc2C=Cc2ccccc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 103
Group description: 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.

TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of primary Fibromyalgia (ACR criteria)
Male or female 18-65 years old
For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy
Willing and able to withdraw specific therapies (ask PI)
Medically acceptable form of contraception (female only)
Signed informed consent

Exclusion Criteria:

Arthritis, lupus and other systemic auto-immune diseases
Regional or persistent pain that could interfere with assessment of fibromyalgia pain
Bipolar and psychotic disorders
Increased risk of suicide
Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
Inability to wash-off specific medications (ask PI)
Known hypersensitivity to cyclobenzaprine
Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI>40
Intervention: Betamethasone
Trial phase: Phase 4
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: 71
Group description: OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of macular edema
Best corrected visual acuity of approximately 20/400 to 20/40 in the study eye

Exclusion Criteria:

Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month
Intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months
Any active ocular infection in either eye
Intervention: Ferrous Sulfate
Trial phase: Phase 4
ATC code: B03AA07
SMILES: O=S(=O)([O-])[O-].[Fe+2]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Subjects randomized to this arm received a single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, ferrous sulfate, for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 9 to < 48 months
IDA documented by hematologic indices (hemoglobin, MCV, RDW, reticulocyte count, reticulocyte hemoglobin content), serum ferritin, serum iron and total iron binding capacity

Exclusion Criteria:

Iron deficiency likely or definitely due to blood loss from the intestine or other sites.
Evidence of response to recent/current oral iron therapy, as determined by increase in hemoglobin by > 1.0 gm/dL and MCV by 5 fL above measurements prior to iron therapy
History or evidence of intestinal malabsorption
History of prior intravenous iron therapy
Major co-morbidity such as a serious chronic medical condition unrelated to iron deficiency apparent on history, physical examination, or laboratory tests
Other causes of anemia (sickle cell disease, thalassemia, other hemolytic anemia, bone marrow failure, etc.) apparent by history, physical examination, and/or laboratory tests.
High likelihood of suboptimal adherence by parents with study requirements (previous missed clinic visits)
Inability to tolerate oral medications
History of birth at < 30 weeks gestation
Other medical or social factors at discretion of treating physician
Intervention: DEFERITAZOLE MAGNESIUM
Trial phase: Phase 1
SMILES: COCCOCCOCCOc1cccc(C2=NC(C)(C(=O)[O-])CS2)c1O.[Mg+2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 28
Group description: SSP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years
Must be considered "healthy".
Serum ferritin >20ng/mL, hemoglobin >125g/L and erythrocyte indices within normal range

Exclusion Criteria:

Subject has a clinically significant history or a disorder detected during the medical interview/physical examination at the Screening Visit or any other medical condition that is capable of altering the absorption, metabolism, or elimination of drugs
Acute illness, as judged by the investigator, within 2 weeks of Day 1 of Treatment Period 1.
Known or suspected intolerance or hypersensitivity to the investigational products, closely related compounds, or any of the stated ingredients.
Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months
History of alcohol or other substance abuse within the last year.
A positive screen for alcohol or drugs of abuse at the Screening Visit.
Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
Twelve-lead ECG demonstrating QTc >450msec at screening.
Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
A positive HIV antibody screen, HBsAg, or HCV antibody screen.
Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to Day 1 of Treatment Period 1.
Intervention: DEFERITAZOLE MAGNESIUM
Trial phase: Phase 1
SMILES: COCCOCCOCCOc1cccc(C2=NC(C)(C(=O)[O-])CS2)c1O.[Mg+2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: SP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered in the morning and 40mg/kg administered 12 hours later.
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years
Must be considered "healthy".
Serum ferritin >20ng/mL, hemoglobin >125g/L and erythrocyte indices within normal range

Exclusion Criteria:

Subject has a clinically significant history or a disorder detected during the medical interview/physical examination at the Screening Visit or any other medical condition that is capable of altering the absorption, metabolism, or elimination of drugs
Acute illness, as judged by the investigator, within 2 weeks of Day 1 of Treatment Period 1.
Known or suspected intolerance or hypersensitivity to the investigational products, closely related compounds, or any of the stated ingredients.
Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months
History of alcohol or other substance abuse within the last year.
A positive screen for alcohol or drugs of abuse at the Screening Visit.
Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
Twelve-lead ECG demonstrating QTc >450msec at screening.
Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
A positive HIV antibody screen, HBsAg, or HCV antibody screen.
Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to Day 1 of Treatment Period 1.
Intervention: Minocycline
Trial phase: Phase 2
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(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 | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Minocycline 100 mg twice a day during 4 months
Eligibility criteria:
Inclusion Criteria:

Patients with a pathologically proven diagnosis of CRC seen either at MD Anderson or LBJ.
Patients > or = 18 years old.
Patients who qualify for oxaliplatin-based chemotherapy (in the adjuvant or metastatic setting) and are likely to receive at least 3 months of oxaliplatin.
Patients who speak English or Spanish (due to language options for the MDASI version being used in this study, we are only recruiting English-speaking or Spanish-speaking patients).
Patients with an NCI-CTCv4 sensory neuropathy score of 0.
Patients with adequate renal function (serum creatinine must be < 1.5 times the upper limit of the institutional normal range) and no prior renal disease that in the opinion of the attending physician would make the patient ineligible to receive the study drug . Test results must be no more than 3 months old.
Patients with adequate hepatic function (total bilirubin must be < 2.0 times the upper limit of the institutional normal range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be < 3.0 times the upper limit of the institutional normal range). Test results must be no more than 3 months old.
Patients willing and able to review, understand, and provide written consent.

Exclusion Criteria:

Patients continuously taking any minocycline within the last 15 days. Patients who have conditions that potentially preclude use of minocycline as determined by the treating physician.
Patients continuously taking systemic steroids within the last 15 days.
Patients with autoimmune disorders (for example, systemic lupus erythematosus or rheumatoid arthritis), who have been treated in the last 3 years.
Patients who are pregnant; the absence of pregnancy will be confirmed by negative urine test.
Hypersensitivity to any tetracyclines, or a history of other allergies or drug reactions that in the treating physician's judgment make the patient inappropriate for this study.
Patients receiving vitamin K antagonist (warfarin).
Patients with a BMI >40 (Obese Class III criteria).
Patients who will receive cetuximab or other targeted therapy where physicians may use topical doxycycline to reduce the rash associated with therapy.
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Ultrasound guided injection of liposomal bupivacaine

liposomal bupivacaine: (Ultrasound guided injection of liposomal bupivacaine)
Eligibility criteria:
Inclusion Criteria:

Patients having hip arthroscopy

Exclusion Criteria:

History of neurologic disease, neuropathy, diabetes
Allergy to local anesthetic solution
Chronic use of narcotics
Inability to give consent/cooperate with study
History of previous hip arthroscopy on the ipsilateral side
Pregnancy
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Bupivacaine (around the anterior, lateral and medial aspect of hip joint)

Bupivacaine: (around the anterior, lateral and medial aspect of hip joint)
Eligibility criteria:
Inclusion Criteria:

Patients having hip arthroscopy

Exclusion Criteria:

History of neurologic disease, neuropathy, diabetes
Allergy to local anesthetic solution
Chronic use of narcotics
Inability to give consent/cooperate with study
History of previous hip arthroscopy on the ipsilateral side
Pregnancy
Intervention: BENZYL ALCOHOL
Trial phase: Phase 2
ATC code: P03AX06
SMILES: OCc1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 38
Group description: Ha44 Gel 0.74% w/w Open label, one arm
Eligibility criteria:
Inclusion Criteria:

Male or female
6 months to 17 years of age
Be in good health, as determined by medical history and physical examination
Has an active head lice infestation at screening as determined by an experienced evaluator. An active infestation is defined as the presence of at least 3 live lice.

Female subjects must be:

Of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or post-menopausal for at least 2 years) OR,
If of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from Day 0 through the Day 14 visit. Acceptable methods of contraception include abstinence, vasectomized partner, tubal ligation, combined oral hormonal contraceptive, contraceptive injection, contraceptive patch, or IUD. If a hormonal contraception is the only method, the subject must have been on a stable dose for at least 3 months.
The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study.
Has signed an informed consent and/or assent form (ICF).

Exclusion Criteria:

Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results.
Has current dermatological disease or inflammation on the face, scalp, ears, neck or back, including eczema, atopic dermatitis, alopecia, psoriasis or any other chronic skin disease that, in the opinion of the Investigator, would interfere with the safety or PK evaluation.
Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
Has been using hormonal contraception for less than 3 months.
Is pregnant or currently nursing.
Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results.
Has received an investigational agent within 30 days prior to Day 0.
Intervention: Cabozantinib
Trial phase: Phase 3
ATC code: L01EX07 | L01XE26
SMILES: COc1cc2nccc(Oc3ccc(NC(=O)C4(C(=O)Nc5ccc(F)cc5)CC4)cc3)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 467
Group description: Cabozantinib (XL184) 60 mg tablet once daily

Cabozantinib tablets
Eligibility criteria:
Select Inclusion Criteria:

Histological or cytological diagnosis of HCC.
The subject has disease that is not amenable to a curative treatment approach.
Received prior sorafenib.
Progression following at least 1 prior systemic treatment for HCC.
Recovery to from toxicities related to any prior treatments.
ECOG performance status of 0 or 1.
Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
Child-Pugh Score of A.
Antiviral therapy per local standard of care if active hepatitis B (HBV) infection.
Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
Receipt of more than 2 prior systemic therapies for advanced HCC.
Any type of anticancer agent (including investigational) within 2 weeks before randomization.
Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization.
Prior cabozantinib treatment.
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
Concomitant anticoagulation, at therapeutic doses, with anticoagulants.
Serious illness other than cancer that would preclude safe participation in the study.
Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding.
Moderate or severe ascites.
Pregnant or lactating females.
Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors.
Intervention: Prednisolone
Trial phase: Phase 4
ATC code: A01AC04 | A01AC54 | A07EA01 | C05AA04 | D07AA03 | D07BA01 | D07CA03 | D07XA02 | H02AB06 | R01AD02 | R01AD52 | S01BA04 | S01BB02 | S01CA02 | S01CB02 | S02BA03 | S02CA01 | S03BA02 | S03CA02 | V03AB05
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 17
Group description: Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks

Prednisolone: 2mg/kg/day for 16weeks
Eligibility criteria:
Inclusion Criteria:

Hemangioma patient ( 0 ~ 9 months old)
No treatment before
10 ~ 20 % volume increase in 2 ~ 4 weeks
Hemangioma that caused organ function
Hemangioma that will cause aesthetic problem

Exclusion Criteria:

Cardiovascular disease (impossible to use propranolol)
Drug adverse reaction or allergy history (propranolol, steroid)
Bradycardia, Atrioventricular block, atrial block
Cardiogenic Shock
Right heart failure (pulmonary hypertension)
Congestive heart failure
Hypotension
Peripheral nerve disease (moderate)
Angina
Hormone deficiency patient
Pulmonary disease (asthma)
diabetic ketoacidosis
laser treatment history
Intervention: Propranolol
Trial phase: Phase 4
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 17
Group description: Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks

Propranolol: 2mg/kg/day for 16weeks
Eligibility criteria:
Inclusion Criteria:

Hemangioma patient ( 0 ~ 9 months old)
No treatment before
10 ~ 20 % volume increase in 2 ~ 4 weeks
Hemangioma that caused organ function
Hemangioma that will cause aesthetic problem

Exclusion Criteria:

Cardiovascular disease (impossible to use propranolol)
Drug adverse reaction or allergy history (propranolol, steroid)
Bradycardia, Atrioventricular block, atrial block
Cardiogenic Shock
Right heart failure (pulmonary hypertension)
Congestive heart failure
Hypotension
Peripheral nerve disease (moderate)
Angina
Hormone deficiency patient
Pulmonary disease (asthma)
diabetic ketoacidosis
laser treatment history