anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Eligibility criteria:
Inclusion Criteria:

The subject is 10 to 18 years of age
The subject's American Society of Anesthesiologists physical status is ASA 1, 2 or 3 (see appendix I)
The subject is scheduled for elective posterior spinal fusion and instrumentation.
The subject's parent/legally authorized guardian has given written informed consent to participate

Exclusion Criteria:

The subject has a history or a family (parent or sibling) history of malignant hyperthermia
The subject is pregnant or nursing.
The subject has known significant renal disorders determined by medical history, physical examination or laboratory tests
The subject has a known or suspected allergy to morphine, remifentanil or ketamine
The subject is an ASA classification of 4 or greater (See Appendix I)
The subject is scheduled for a surgical sub-procedure (i.e. anterior spinal fusion)
The subject is unable to self-administer morphine using patient-controlled analgesia (PCA) pump
The subject had a recent opioid exposure (within 1 month of surgery)
The subject is obese (body mass index >30kg/m2)
The subject is planned for elective postoperative ventilation
The subject has a known ocular disease not permitting pupillometric examination
The subject has used any investigation products in the past 30 days
Intervention: Promega
Trial phase: Phase 2
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)O.CCCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.

Omegaven: initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.
Eligibility criteria:
Inclusion Criteria:

Male or Female; ages 18 to 80 years old
Receiving treatment at Cancer Treatment Centers of America
Receiving PN (either in the infusion center or at home)
Have existing hepatic dysfunction defined as Elevation of > 3x the normal level of one or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin > 2 mg/dl in the absence of biliary obstruction
Able to provide informed written consent

Exclusion Criteria:

Hypertriglyceridemia (triglycerides [TG] > 400)
Allergy to fish or egg protein
Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin
Hemodynamically unstable
Bilirubin > 5 mg/dL
Documented liver metastases
Unstable diabetes with known diabetic ketoacidosis within 7 days of screening
Recent cardiac infarction (within 6 months) and taking plavix
Severe hemorrhagic disorders
Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism
Active sepsis
Undefined coma status
In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance < 30 mL/min
Pregnancy or lactation
Intervention: Raltegravir
Trial phase: Not Applicable
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Healthy volunteers who had regular menses and were not on hormonal contraception
Eligibility criteria:
Inclusion Criteria

Volunteers must be:

Over 18 years of age.
Willing to abstain from sexual intercourse during course of study.
Able to commit to follow-up visit schedule.
Willing to abstain from use of vaginal medications or creams 48 hours prior to follow-up visits.
Willing and able to provide informed consent.

Exclusion Criteria

Volunteers will not be eligible for the study if they:

Are over 50 years of age.
Are pregnant, attempting to become pregnant, or breast-feeding.
Have irregular menstrual bleeding.
Are using a hormonal form of birth control.
Have abnormal liver/kidney function test results at screening visit.
Have HIV-positive test result at screening visit.
Intervention: Duotrav
Trial phase: Phase 4
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CC(C)OC(=O)CCCC=CCC1C(O)CC(O)C1C=CC(O)COc1cccc(C(F)(F)F)c1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye.
Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the screening visit.
IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period.
IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye).
Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
Able to follow instructions and willing and able to attend all study visits.
Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
Sign informed consent.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
Corneal dystrophies in either eye.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
History of severe allergic rhinitis.
A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
Participation in any other investigational study within 30 days prior to the Screening Visit.
Other protocol-defined exclusion criteria may apply.
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 124
Group description: This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
Eligibility criteria:
Inclusion Criteria:

ASA class I, II or III
Patients 4-12 years old requiring general anesthesia for closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx).
Patients able to understand and report their pain with the Faces Pain Scale Revised

Exclusion Criteria:

Medical contraindications to analgesic therapy.
Known allergy or sensitivity to analgesic agent.
Clinical evidence of skin inflammation precluding the 'clean' area at the site of injection.
Patients lacking the cognitive understanding to report their pain with the FSP-R (unable to complete seriation task).
Patients necessitating open reduction due to inability to obtain an acceptable closed reduction.
Comorbid diagnosis of other traumatic injury that causes any local and or global pain.
Patients presenting to ER with neurovascular injury or compartment syndrome due to fracture.
For patients in either of the two intervention arms, if after three attempts, the intraarticular injection is not successful, the patient will be dropped from the study.
Patients admitted for complications directly related to the surgery will be dropped from analysis. Any such event will be immediately reported to COMIRB with in five business days. However, patients admitted due to a late afternoon/evening surgery and patients admitted for standard observational purposes unrelated to surgical complications, will not be dropped from the study.
Known drug allergy to oxycodone and or acetaminophen.
Children 4-7 years old weighing less than 14 kg (Weight exclusion criteria is based on a 4 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
Children 8-12 years old weighing less than 20 kg (Weight exclusion criteria based on an 8 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
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: 968
Group description: Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
Eligibility criteria:
Inclusion Criteria:

Giving written informed consent
History of COPD (according to GOLD 2009) for at least 12 months prior to baseline Visit V0 associated with chronic productive cough for 3 months in each of the 2 years prior to baseline visit (with other causes of productive cough excluded)
Age ≥ 40 years
Forced expiratory volume after one second (FEV1)/forced vital capacity (FVC) ratio (post-bronchodilator) < 70%
FEV1 (post-bronchodilator) ≤ 50% of predicted
At least two documented moderate or severe COPD exacerbations within one year prior to baseline visit
Patients must be pre-treated with LABA and ICS for at least 12 months before baseline Visit V0. Up to 3 months before baseline Visit V0 free or fixed combinations of LABA and ICS are allowed, including changes in dose, active substances, and brands. In the last 3 months before baseline Visit V0 patients must be pre-treated with fixed combinations of LABA and ICS at a constant dose (maximum approved dosage strength of the combination).
Former smoker (defined as smoking cessation at least one year ago) or current smoker both with a smoking history of at least 20 pack years

Main Exclusion Criteria:

Exacerbations not resolved at first baseline visit
Diagnosis of asthma and/or other relevant lung disease
Known alpha-1-antitrypsin deficiency
Other protocol-defined exclusion criteria may apply
Intervention: Ambrisentan
Trial phase: Phase 4
ATC code: C02KX02 | C02KX52
SMILES: COC(c1ccccc1)(c1ccccc1)[C@H](Oc1nc(C)cc(C)n1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.

ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage.
Eligibility criteria:
Inclusion Criteria:

Patients followed routinely in the pulmonary vascular disease clinic at the University of Alabama in Birmingham, greater than or equal to 19 years of age.
World Health Organization (WHO) PAH Type I
WHO class I-IV symptoms (no functional class exclusion).
On bosentan, twice a day, with a maximum daily dose of 250mg, on a stable dose for 3 months with no clinical indication to discontinue the drug (i.e., increased liver function studies or other intolerance). Patients may be on other drug therapies for PAH, and also may be on oxygen therapy (intermittent or continuous).

Exclusion Criteria:

Known intolerance or allergy to ambrisentan.
Prior therapy with ambrisentan.
Current therapy with two phosphodiesterase-5 inhibitors.
Change in other approved therapy for PAH (including phosphodiesterase-5 inhibitors and prostanoids) within 4 weeks of baseline study visit.
Planned addition of prostanoid for clinical reasons within 3 months of baseline study visit.
Active participation in another clinical study involving the medical therapy of PAH.
Uncontrolled systemic hypertension or angina pectoris
Serum creatinine greater than 2.5 at or within 4 weeks of baseline.
Serum liver function studies greater than 3 x normal at or within 4 weeks of baseline study visit.
In the opinion of the investigator, a change in PAH therapy would present significant risk to the subject.
In the opinion of the investigator, the participant is unlikely to survive for 12 weeks after study entry.
In the opinion of the investigator, the participant is likely to undergo lung or heart-lung transplantation within 12 weeks of study entry.
A woman of childbearing potential who is not using an acceptable form of contraception.
Pregnancy.
In the opinion of the investigator, a participant who is not capable or willing to follow the study procedures.
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 481
Group description: lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection
Eligibility criteria:
Inclusion Criteria:

Adult patients refered to the University of Chicago Medical Centers Procedure Service for a planned medical procedure requiring local injection of lidocaine.

Exclusion Criteria:

Patient who lack decisional capacity to consent
Patients who lack the ability to answer questions in english using pain scales
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 481
Group description: lidocaine: 1% lidocaine subcutaneous injection alone
Eligibility criteria:
Inclusion Criteria:

Adult patients refered to the University of Chicago Medical Centers Procedure Service for a planned medical procedure requiring local injection of lidocaine.

Exclusion Criteria:

Patient who lack decisional capacity to consent
Patients who lack the ability to answer questions in english using pain scales
Intervention: Besifloxacin Hydrochloride
Trial phase: Phase 3
SMILES: Cl.NC1CCCCN(c2c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c2Cl)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Besifloxacin 0.6% ophthalmic suspension

Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
Eligibility criteria:
Inclusion Criteria:

Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye.

Exclusion Criteria:

Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye.
Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible.
Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
Subjects with systemic disease/disorder specified in the protocol as ineligible.
Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components.
Subjects who have a condition or are in a situation which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.
Intervention: Gatifloxacin
Trial phase: Phase 3
ATC code: J01MA16 | S01AE06
SMILES: COc1c(N2CCNC(C)C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 17
Group description: Gatifloxacin 0.3% ophthalmic solution

Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
Eligibility criteria:
Inclusion Criteria:

Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye.

Exclusion Criteria:

Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye.
Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible.
Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
Subjects with systemic disease/disorder specified in the protocol as ineligible.
Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components.
Subjects who have a condition or are in a situation which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.
Intervention: Milnacipran
Trial phase: Phase 2
ATC code: N06AX17 | N06AX28
SMILES: CCN(CC)C(=O)C1(c2ccccc2)CC1CN
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 57
Group description: oral administration, twice daily dosing

Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran

Exclusion Criteria:

Can not tolerate a minimum daily dose of 50mg milnacipran
Significant risk of suicidality
Pregnant or breastfeeding
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 46
Group description: 10,000 IU per caplet, with vitamin D dose based on weight, ranging from 240,000 IU to 600,000 IU. Patients will receive calcium/vitamin D daily soft chew as well.

Vitamin D: 10,000 IU/caplet, patients receiving 240,000 IU to 600,000 IU cumulative Vitamin D dose based on weight.
Eligibility criteria:
Inclusion Criteria:

all sickle cell genotypes including SS, SB0thal, SC, SB+Thal
Age 7-21 years old
Last PRBC transfusion >30 days prior

Exclusion Criteria:

chronic renal failure
chronic liver disease
recent hospitalization <14 days
history of malignancy
serum calcium level as defined in protocol section D 2.2
treatment with concommitant medications as defined in section D 2.2 of the protocol
known malabsorption or short gut syndrome or conditions associated with poor GI absorption
patients currently on high dose vitamin D therapy
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
Eligibility criteria:
Inclusion criteria:

- Male or females with Constipation Predominant IBS, age 18-65

Exclusion criteria:

Abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean section, vaginal or laparoscopic hysterectomy or tubal ligation
Uncontrolled hypertension
Use of medications that may interact with the study medication
Use of any of the study medications within the past 30 days
Pregnancy
History of chronic renal insufficiency (serum creatinine >1.5mg/dL)
Psychiatric or psychologic dysfunction
Current pelvic floor dysfunction
diagnosis of lactose intolerance
Intervention: Acumapimod
Trial phase: Phase 2
SMILES: Cc1ccc(C(=O)NC2CC2)cc1-n1ncc(C(=O)c2cccc(C#N)c2)c1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Single oral dose of 20mg dose of BCT197 capsules

BCT197
Eligibility criteria:
Inclusion Criteria:

Patients with COPD (Stage II to IV) with a COPD exacerbation.
Smoking history of 10 pack years.
Females must not be of child-bearing potential.

Exclusion Criteria:

Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Acumapimod
Trial phase: Phase 2
SMILES: Cc1ccc(C(=O)NC2CC2)cc1-n1ncc(C(=O)c2cccc(C#N)c2)c1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6

BCT197
Eligibility criteria:
Inclusion Criteria:

Patients with COPD (Stage II to IV) with a COPD exacerbation.
Smoking history of 10 pack years.
Females must not be of child-bearing potential.

Exclusion Criteria:

Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Acumapimod
Trial phase: Phase 2
SMILES: Cc1ccc(C(=O)NC2CC2)cc1-n1ncc(C(=O)c2cccc(C#N)c2)c1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6

BCT197
Eligibility criteria:
Inclusion Criteria:

Patients with COPD (Stage II to IV) with a COPD exacerbation.
Smoking history of 10 pack years.
Females must not be of child-bearing potential.

Exclusion Criteria:

Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Cetirizine
Trial phase: Phase 2 | Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: AC-170 0.05%: 1 drop in each eye at 3 separate times during a 21 day period
Eligibility criteria:
Inclusion Criteria:

Positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to the study enrollment or during the study.