anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: 44
Group description: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose
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 (other than a maxillary first, second, or third molar) 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.
Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.

Exclusion Criteria:

Inadequately controlled hypertension (blood pressure greater than 140/90 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 last 24 hours.
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 30 days prior to study participation.
Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
History of congenital or idiopathic methemoglobinemia
Intervention: DABIGATRAN ETEXILATE
Trial phase: Phase 1
ATC code: B01AE07
SMILES: CCCCCCOC(=O)NC(=N)c1ccc(NCc2nc3cc(C(=O)N(CCC(=O)OCC)c4ccccn4)ccc3n2C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
Eligibility criteria:
Inclusion criteria:

Male and female patients aged 18 years and older
Impaired renal function defined as a stable Cockcroft-Gault and/or actual creatinine clearance between 15-30 ml/min over the last 3 months before study participation.
The single use of either aspirin or Vitamin K Antagonists
Provision of informed consent.

Exclusion criteria:

Unstable renal function and Creatinin Clearance <15mL/min
Patients treated with two or more platelet aggregation inhibitors
Use of or indication for therapeutic heparin
Patients with prosthetic heart valves
Haemorrhagic disorder or bleeding diathesis
Platelet count <100 109/L) at screening or during the last 30 days before screening.
Participation in another drug trial in the last 30 days before screening.
Intervention: Utibron Neohaler
Trial phase: Phase 3
SMILES: CCc1cc2c(cc1CC)CC(NCC(O)c1ccc(O)c3[nH]c(=O)ccc13)C2.C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 250
Group description: 27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
Eligibility criteria:
Inclusion Criteria:

Male and female patients that have signed informed consent and are >/= 40 years of age.
Patients with stable COPD according to GOLD 2011.
Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
Patients who had a COPD exacerbation within 6 weeks prior to screening.
Patients who have a respiratory tract infection within 4 weeks prior to screening.
Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
Patients with concomitant pulmonary disease.
Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
Patients with active pulmonary tuberculosis.
Patients in the active phase of a pulmonary rehabilitation programme.
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Indacaterol
Trial phase: Phase 3
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 251
Group description: 27.5 ug b.i.d.
Eligibility criteria:
Inclusion Criteria:

Male and female patients that have signed informed consent and are >/= 40 years of age.
Patients with stable COPD according to GOLD 2011.
Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
Patients who had a COPD exacerbation within 6 weeks prior to screening.
Patients who have a respiratory tract infection within 4 weeks prior to screening.
Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
Patients with concomitant pulmonary disease.
Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
Patients with active pulmonary tuberculosis.
Patients in the active phase of a pulmonary rehabilitation programme.
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Glycopyrrolate
Trial phase: Phase 3
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 251
Group description: 12.5 ug b.i.d.
Eligibility criteria:
Inclusion Criteria:

Male and female patients that have signed informed consent and are >/= 40 years of age.
Patients with stable COPD according to GOLD 2011.
Patients with a post-bronchodilator FEV1 of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/FVC <0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC grade 2 or greater.

Exclusion Criteria:

Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
Patients who had a COPD exacerbation within 6 weeks prior to screening.
Patients who have a respiratory tract infection within 4 weeks prior to screening.
Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
Patients with concomitant pulmonary disease.
Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
Patients with active pulmonary tuberculosis.
Patients in the active phase of a pulmonary rehabilitation programme.
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Eligibility criteria:
Inclusion criteria

AO/OTA (Orthopedic Trauma Association) fracture classification 31B
Surgically treated with either hemiarthroplasty or total hip arthroplasty
Acute fracture treated within 72 hours of injury
Low energy isolated injury
Age greater than 18 years old

Exclusion Criteria

Transfusion received during admission, prior to surgery
Creatinine clearance less than 30 mL/min
History of unprovoked Venous Thromboembolism (VTE) and/or recurrent VTE
Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
History of cerebrovascular accident (CVA), Myocardial infarction (MI), or VTE within the previous 30 days
Coronary stent placement within the previous 6 months
Disseminated intravascular coagulation
Subarachnoid hemorrhage
Intervention: Glycopyrrolate
Trial phase: Phase 3
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 216
Group description: NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
Eligibility criteria:
Inclusion criteria: 1. Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011). 2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and <80 % of the predicted normal, and FEV1/FVC < 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide.

3. Current or ex-smokers with at least 10 cigarette pack years smoking history.

Exclusion criteria:

Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception.
Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study.
Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment.
Patients with a body mass index (BMI) of more than 40 kg/m2.
Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines.
Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening.

Other protocol-defnied inclusion/exclusion criteria may apply.
Intervention: Sodium Nitrite
Trial phase: Phase 2
ATC code: V03AB08
SMILES: O=N[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Sodium Nitrite will be administered at three time points:

At the time of organ procurement, a pre-prepared syringe of sodium nitrite will be added to each of the 2.8L bags of Perfadex solution to flush the donor lungs.

At the time of transplant just prior to reperfusion of lungs, , the donor lungs are flushed with a cold pneumoplegia solution after the bronchial (1st) anastomosis and with warm pneumoplegia solution after the PV (3rd, last) anastomosis. The drug will be added to pneumoplegia solution just prior to both the flushes.

Sodium Nitrite will be delivered intravenously to the recipient immediately prior to lung reperfusion as a single infusion at rate of 4 mL/min for the first 30 min, followed by 2.2 mL/min for the next 60 min.

Sodium Nitrite: Same as the details in Arm Description.
Eligibility criteria:
Inclusion Criteria:

Subjects undergoing lung transplantation.
Subjects in the age range of 18-70 years
Ability to understand and provide consent. Proxy consent will not be accepted.

Exclusion Criteria:

Donor exclusion criteria
Age > 55 years.
Mechanical ventilation > 5 days prior to procurement
Significant chest trauma or lung contusion
Smoking history > 20 pack-year
Ratio of arterial oxygen partial pressure to fractional inspired oxygen < 300
Donor radiograph with 2 quadrant infiltrates
Donor that are determined single lung donors prior to transplant will be excluded.

Recipient exclusion criteria

Recipient age > 70 years.
Recipient history of pulmonary hypertension (idiopathic pulmonary arterial hypertension, or secondary pulmonary arterial hypertension with mean arterial pressure > 30 mm Hg)
Recipient history of abnormal cardiac function defined as prior coronary artery bypass graft (CABG) or left ventricular ejection fraction (LVEF) < 45 %
Recipient history of open thoracotomy/prior pleurodesis as exclusion criteria. However patients who have had limited video-assisted thoracic surgery procedures for biopsies would NOT be excluded from the study.
Recipient history of cirrhosis
Recipient history of mechanical ventilation or extracorporeal support pre-operatively
Recipient pre-operative hypotension defined by a systolic blood pressure less than 90 mm Hg not responsive to intravenous fluids or requirement for vasoactive medications
Recipient preoperative history of renal insufficiency, dialysis or estimated glomerular filtration rate <30 ml/min/1.73 m2 body surface area
Patients undergoing retransplantation
Recipient history of significant coronary artery disease that is flow limiting and unable to be corrected by further percutaneous coronary artery interventions.
Intervention: Ibuprofen
Trial phase: Not Applicable
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 2
Group description: Pfizer 200 mg caplets (Advil)

Ibuprofen
Eligibility criteria:
Inclusion Criteria:

Must have signed the informed consent.
Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain

Exclusion Criteria:

May not have taken ibuprofen or other pain medication within the last 12 hours.
Must not have a contraindication for taking ibuprofen e.g:
No history of allergic reactions to ibuprofen or aspirin
No recent history with the last year of bleeding from GI tract
Not pregnant or suspected of being pregnant
Intervention: Alovudine
Trial phase: Phase 2
SMILES: Cc1cn([C@H]2C[C@H](F)[C@@H](CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: FLT PET/CT imaging ordered pre-radiation therapy, during weeks 1 and 2 of radiation therapy, and then at 1 month and 12 months after radiation therapy. The FLT PET/CT imaging ordered pre-radiation therapy is used for bone marrow sparing IMRT radiation therapy.

Fluorothymidine F 18: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.
Eligibility criteria:
Inclusion Criteria:

Ability to understand and willingness to sign a written informed consent document.
Recommended to undergo pelvic irradiation with concurrent chemotherapy.
At least 18 years of age. Pediatrics would be best served by a protocol designed for their specific needs.
Karnofsky Performance Status of at least 60% at time of screening.
Life expectancy of greater than 6 months.

Subject must have normal organ and marrow function (as defined below) within 30 days of study enrollment:

leukocytes at least 3,000 / µL
absolute neutrophil count of at least 1500 / µL
platelets of at least 100,000 / µL
creatinine equal to or less than the upper limit of normal
not pregnant (as applicable)

Exclusion Criteria:

history of allergic reactions attributed to compounds of similar chemical or biologic composition to FLT
an oncology research protocol requiring full pelvic radiation (i.e., 4 field box technique)
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
subjects taking nucleoside analog medications such as those used as antiretroviral agents.
Intervention: Testosterone
Trial phase: Phase 2
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: 17
Group description: Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days

TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
Eligibility criteria:
Inclusion Criteria:

Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum testosterone < 300 ng/dL (based on the average of 2 morning samples taken at least 1 week apart)
Men over the age of 18 years with a body mass index (BMI) < 39.0 kg/m2 and weighing ≥ 55 kg
Hemoglobin levels at screening and baseline > 12.5 g/dL
Testosterone treatment not contraindicated
No evidence of suspected reversible hypogonadism
Willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate washout period before study participation (for nondepot formulations of testosterone only)
Understands the requirements of the study and voluntarily consents to participate in the study

Exclusion Criteria:

-
Intervention: Testosterone
Trial phase: Phase 2
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: 17
Group description: Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days

TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
Eligibility criteria:
Inclusion Criteria:

Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum testosterone < 300 ng/dL (based on the average of 2 morning samples taken at least 1 week apart)
Men over the age of 18 years with a body mass index (BMI) < 39.0 kg/m2 and weighing ≥ 55 kg
Hemoglobin levels at screening and baseline > 12.5 g/dL
Testosterone treatment not contraindicated
No evidence of suspected reversible hypogonadism
Willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate washout period before study participation (for nondepot formulations of testosterone only)
Understands the requirements of the study and voluntarily consents to participate in the study

Exclusion Criteria:

-
Intervention: Testosterone
Trial phase: Phase 2
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: 4
Group description: Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.

Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.

TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
Eligibility criteria:
Inclusion Criteria:

Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum testosterone < 300 ng/dL (based on the average of 2 morning samples taken at least 1 week apart)
Men over the age of 18 years with a body mass index (BMI) < 39.0 kg/m2 and weighing ≥ 55 kg
Hemoglobin levels at screening and baseline > 12.5 g/dL
Testosterone treatment not contraindicated
No evidence of suspected reversible hypogonadism
Willing to abstain from current treatment for hypogonadism in accordance with approved labeling to facilitate an appropriate washout period before study participation (for nondepot formulations of testosterone only)
Understands the requirements of the study and voluntarily consents to participate in the study

Exclusion Criteria:

-