anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Doripenem
Trial phase: Phase 4
ATC code: J01DH04
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](CNS(N)(=O)=O)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
Eligibility criteria:
Eligibility Criteria:

Inclusion Criteria:

Male or female participants with 18 years old age and above
Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections
Must have evidence of a systemic inflammatory response syndrome with at least one of the these: fever (body temperature greater than 38 degree celcius) or hypothermia (body temperature less than 36 degree celcius) or elevated total peripheral white blood cell count greater than or equal to 12,000 cells per cubic millimeter or leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood pressure relative to Baseline of greater than 15 millimeter of mercury systolic or increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater than 20 bpm
Candidate for treatment with carbapenems, with at least one of these conditions: Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial infection with failure of previous treatment or modified therapy; known pathogens with resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/ batalactamase intibitor and susceptible to carbapenem or known infection caused by gram negative bacteria
Signed informed consent

Exclusion Criteria:

Pregnant or lactating female participants
History of severe allergies to antibiotics such as penicillins, cephalosporins and carbapenems
Hypersensitivity to doripenem and/or excipients
Previous use of carbapenems within 7 days of study entry
Participants in terminal stage of malignancy
Intervention: Doripenem
Trial phase: Phase 4
ATC code: J01DH04
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](CNS(N)(=O)=O)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
Eligibility criteria:
Eligibility Criteria:

Inclusion Criteria:

Male or female participants with 18 years old age and above
Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections
Must have evidence of a systemic inflammatory response syndrome with at least one of the these: fever (body temperature greater than 38 degree celcius) or hypothermia (body temperature less than 36 degree celcius) or elevated total peripheral white blood cell count greater than or equal to 12,000 cells per cubic millimeter or leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood pressure relative to Baseline of greater than 15 millimeter of mercury systolic or increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater than 20 bpm
Candidate for treatment with carbapenems, with at least one of these conditions: Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial infection with failure of previous treatment or modified therapy; known pathogens with resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/ batalactamase intibitor and susceptible to carbapenem or known infection caused by gram negative bacteria
Signed informed consent

Exclusion Criteria:

Pregnant or lactating female participants
History of severe allergies to antibiotics such as penicillins, cephalosporins and carbapenems
Hypersensitivity to doripenem and/or excipients
Previous use of carbapenems within 7 days of study entry
Participants in terminal stage of malignancy
Intervention: Doripenem
Trial phase: Phase 4
ATC code: J01DH04
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](CNS(N)(=O)=O)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
Eligibility criteria:
Eligibility Criteria:

Inclusion Criteria:

Male or female participants with 18 years old age and above
Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections
Must have evidence of a systemic inflammatory response syndrome with at least one of the these: fever (body temperature greater than 38 degree celcius) or hypothermia (body temperature less than 36 degree celcius) or elevated total peripheral white blood cell count greater than or equal to 12,000 cells per cubic millimeter or leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood pressure relative to Baseline of greater than 15 millimeter of mercury systolic or increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater than 20 bpm
Candidate for treatment with carbapenems, with at least one of these conditions: Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial infection with failure of previous treatment or modified therapy; known pathogens with resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/ batalactamase intibitor and susceptible to carbapenem or known infection caused by gram negative bacteria
Signed informed consent

Exclusion Criteria:

Pregnant or lactating female participants
History of severe allergies to antibiotics such as penicillins, cephalosporins and carbapenems
Hypersensitivity to doripenem and/or excipients
Previous use of carbapenems within 7 days of study entry
Participants in terminal stage of malignancy
Intervention: Lovenox
Trial phase: Phase 4
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients with the diagnosis of advanced stage (unresectable or metastatic) adenocarinoma of the pancreas. Patients with borderline resectable will also be eligible if they are starting chemotherapy and/or chemo/radiation therapy (RT) prior to attempting resection.
Patients must be planning to initiate systemic chemotherapy within 2 weeks. Chemotherapy that is being given concurrently with radiation is allowed.
Age >/= 18 years old
Adequate renal function defined as a calculated creatinine clearance of > 50 mL/min (as reported by the MDACC laboratory using MDRD method or using Cockroft and Gault formula).
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
Negative urine or serum pregnancy test in women with childbearing potential, within one week prior to initiation of treatment.
Patients must sign an Informed Consent.
Patient must agree to transfusion of blood products, when indicated.
Ability to administer subcutaneous injections of the study drug by the patient and/or care giver.

Exclusion Criteria:

Patients with evidence of venous thrombosis on the initial lower extremity screening ultrasound or incidental VTE of other sites (e.g. PE, Abdominal/pelvic vein thrombosis, etc.).
Patients already taking prophylactic or full dose anticoagulation (eg. heparin, low-molecular weight heparin, fondaparinux, or coumadin).
Patients with currently active bleeding.
The presence of a condition with a high risk for bleeding, including but not limited to active peptic ulcer, recent neurosurgery, or cirrhosis with esophageal varices.
Patients with known brain metastases.
Patients with a known bleeding diathesis.
Patients with a platelet count < 50,000.
Patients with known hypersensitivity to dalteparin.
Patients who regularly use medications known to increase the risk of bleeding such as >/= 325 mg of aspirin daily, or daily clopidogrel, or daily non-steroidal antiinflammatory medications (eg., ibuprofen, naproxen).
Intervention: Mycapssa
Trial phase: Phase 4
ATC code: H01CB02
SMILES: CC(O)C(CO)NC(=O)C1CSSCC(NC(=O)C(N)Cc2ccccc2)C(=O)NC(Cc2ccccc2)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)N1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 260
Group description: treat with octreotide IV for 5 days and endoscopic treatment

Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days
Eligibility criteria:
Inclusion Criteria:

liver cirrhosis
age between 16 and 75 years
Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours before enrollment
Patients whose systolic blood pressure <100 mmHg or pulse rate >100/min at the enrollment
Patients who were not performed endoscopic or pharmacologic therapy for varices
Signed informed consent

Exclusion Criteria:

Pregnancy
Positive anti-HIV Ab
A history of severe side-effects or contraindications to study drugs
Severe cardiovascular diseases: acute myocardial infarction, A-V block, congestive heart failure, ischemic heart disease, hypertension (systolic blood pressure >170 mmHg or diastolic pressure >100 mmHg)
Chronic renal failure
Hepatocellular carcinoma with protal vein thrombosis
Coexisting malignancy except hepatocellular carcinoma
Intervention: Somatostatin
Trial phase: Phase 4
ATC code: H01CB01
SMILES: CC(N)C(=O)NCC(=O)NC1CSSCC(C(=O)O)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(Cc2ccccc2)NC(=O)C(C(C)O)NC(=O)C(CCCCN)NC(=O)C(Cc2c[nH]c3ccccc23)NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccccc2)NC(=O)C(CC(N)=O)NC(=O)C(CCCCN)NC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 259
Group description: treat with somatostatin IV for 5 days and endoscopic treatment

Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days
Eligibility criteria:
Inclusion Criteria:

liver cirrhosis
age between 16 and 75 years
Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours before enrollment
Patients whose systolic blood pressure <100 mmHg or pulse rate >100/min at the enrollment
Patients who were not performed endoscopic or pharmacologic therapy for varices
Signed informed consent

Exclusion Criteria:

Pregnancy
Positive anti-HIV Ab
A history of severe side-effects or contraindications to study drugs
Severe cardiovascular diseases: acute myocardial infarction, A-V block, congestive heart failure, ischemic heart disease, hypertension (systolic blood pressure >170 mmHg or diastolic pressure >100 mmHg)
Chronic renal failure
Hepatocellular carcinoma with protal vein thrombosis
Coexisting malignancy except hepatocellular carcinoma
Intervention: TERLIPRESSIN
Trial phase: Phase 4
ATC code: H01BA04
SMILES: NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSC[C@H](NC(=O)CNC(=O)CNC(=O)CN)C(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 261
Group description: treat with terlipressin IV for 5 days and endoscopic treatment

Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
Eligibility criteria:
Inclusion Criteria:

liver cirrhosis
age between 16 and 75 years
Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours before enrollment
Patients whose systolic blood pressure <100 mmHg or pulse rate >100/min at the enrollment
Patients who were not performed endoscopic or pharmacologic therapy for varices
Signed informed consent

Exclusion Criteria:

Pregnancy
Positive anti-HIV Ab
A history of severe side-effects or contraindications to study drugs
Severe cardiovascular diseases: acute myocardial infarction, A-V block, congestive heart failure, ischemic heart disease, hypertension (systolic blood pressure >170 mmHg or diastolic pressure >100 mmHg)
Chronic renal failure
Hepatocellular carcinoma with protal vein thrombosis
Coexisting malignancy except hepatocellular carcinoma
Intervention: Naproxen
Trial phase: Phase 1 | Phase 2
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 34
Group description: Active comparator

Naproxen: Single orally administered dose of 500 mg naproxen
Eligibility criteria:
Inclusion Criteria:

Age 18-75 years, inclusive.
Subject has a Body Mass Index (BMI) between 20 and 32, inclusive.
Normal physical examination as determined by the Investigator.
Normal clinical laboratory test results or clinically insignificant results as determined by the Investigator during the screening visit.
If female and of child-bearing potential, the subject must have a negative pregnancy test and is not nursing.
If female and of child-bearing potential, the subject must agree to use adequate birth control for the duration of the study.

Exclusion Criteria:

Subject has a history of chronic alcohol consumption or abuse of narcotics or alcohol.
Subject has had an acute illness within 5 days of study medication administration.
Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.
Intervention: Glucagon-like peptide-I(7-36) amide
Trial phase: Phase 2
SMILES: CCC(C)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CCC(=O)O)NC(=O)C(CCCCN)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCCN)C(=O)NCC(=O)NC(CCCNC(=N)N)C(N)=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: GLP-1 (7-36) amide

GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.
Eligibility criteria:
Inclusion Criteria:

Males and Females age > 18 years of age
Able to consent
Scheduled for non-emergent coronary artery bypass graft (CABG)
Have an ejection fraction < 35%
Ischemic patients with Left Ventricular Dysfunction (LVD) who need a valve procedure with their CABG

Exclusion Criteria:

Emergency coronary artery bypass graft surgery
Patients with an ejection fraction > 35%
Repeat or redo CABG patients
Patients with a history of pancreatitis
Pregnant or lactating females
Intervention: NITROUS OXIDE
Trial phase: Phase 4
ATC code: N01AX13 | N01AX63
SMILES: [N-]=[N+]=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
Eligibility criteria:
Inclusion Criteria:

Adults aged 18-40
American Society of Anesthesiologists Physical Classification System (ASA) Status 1-2
Nil per os (NPO) prior to study (2 hrs clear liquids, 4 hrs milk, 6 hrs light food, 8 hrs heavy/greasy food)

Exclusion Criteria:

Lack of volunteer consent
Pregnancy
History of features suggestive of a difficult airway on pre-anesthetic evaluation and physical examination
Active gastroesophageal reflux disease
Active obstructive sleep apnea
History of recent trauma
History of pneumothorax or lung cyst
History of Vitamin B12 deficiency
History of recent middle ear surgery (<3months)
Current or recent (<3 weeks) respiratory tract infection
Any acute illness or exacerbation of chronic illness such as asthma, chronic lung disease etc.
Any history of cardiac ischemia (angina), myocardial infarction, or cardiac dysrhythmia.
Myopia greater than -3 spherical equivalents or hyperopia greater than +3 spherical equivalents
History of eye surgery of any sort, including refractive surgery, cataracts, and vitrectomy
History of any ocular disease or infection
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: Child | Adult
Healthy volunteers: No
Participants at risk: 59
Group description: 0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.

Omegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday
Eligibility criteria:
Inclusion Criteria:

Clinical evidence of parenteral nutrition associated cholestasis
Direct bilirubin greater or equal to 2 mg/dL on 2 consecutive measurements
Expected parenteral nutrition course greater than 30 days
Acquired or congenital gastrointestinal disease
> 2 weeks of age and < 18 years of age
> 60% calories from parenteral nutrition
Failed standard therapies to prevent progression of liver disease (Actigal, cyclic parenteral nutrition, avoidance of overfeeding, reduction/removal of copper from parenteral nutrition if elevated my laboratory analysis, advancement of enteral feeds)

Exclusion Criteria:

Inborn errors of metabolism
Extracorporeal Membrane Oxygenation
Seafood, egg, or Omegaven allergy
Documented case of liver disease other than Parenteral Nutrition Associated Cholestasis
Hemorrhagic disorder
Anticoagulant therapy
Hemodynamically unstable or in shock
Comatose state
Stroke, pulmonary embolism, recent myocardial infarction
Diabetes
Fatal chromosomal disorder
Enrollment in any other clinical trial involving an investigational agent
Patient, parent, or legal guardians unable or unwilling to give consent
Patient expected to be weaned from parenteral nutrition in 30 days
unable to tolerate necessary monitoring
Patient requiring aspirin or toradel or motrin
Patient requiring dialysis
Intervention: Healon
Trial phase: Not Applicable
SMILES: CC(=O)NC1C(O)OC(CO)C(O)C1OC1OC(C(=O)O)C(OC2OC(CO)C(O)C(OC3OC(C(=O)O)C(O)C(O)C3O)C2NC(C)=O)C(O)C1O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: ACTIVE CONTROL
Eligibility criteria:
Inclusion Criteria:

Be age 30 to 79
Give written informed consent for trial participation
Must have shoulder pain for a minimum of 6 months but less than 5 years
Must have a Pain Intensity Score of > 5
Must be willing to discontinue all pain medications 24 hours prior to each clinic visit
Must have a stable pain medication regime 1 month prior to treatment
Agrees to maintain pain medication doses within 30% (increase or decrease) of the Baseline dose

Exclusion Criteria:

Any history of full thickness rotator cuff tear or joint effusion
A diagnosis of chronic acromioclavical disease, active epicondylitis, or active Carpal Tunnel Disease
Has had more than 2 corticosteroid injections in the previous 3 months
Has an infection or an inflammatory condition of the trial shoulder
Has acute or inflammatory arthropathy in the trial shoulder, e.g. gouty arthritis, psoriatic arthritis or rheumatoid arthritis. Has a history of systemic inflammatory arthropathies, e.g. polyarthritis, rheumatoid arthritis, psoriatic arthritis or gout
Has severe joint effusion of the trial shoulder
Has a diagnosis of cancer within the past 5 years (basal cell carcinoma is not excluded)
Has had any hyaluronate agent or other chondroprotective agents in the trial shoulder
Has a hypersensitivity to HA products, eggs, birds or feathers
Has a history of substance abuse, alcohol abuse or psychiatric condition, that in the opinion of the Investigator, will potentially interfere with participation
Has any medical condition that may increase the risk associated with intra-articular injections, to include (but are not limited to): thrombocytopenia, blood disorders treated with warfarin or anticoagulants, anemia or other concomitant diseases that, in the opinion of the Investigator, will interfere with the evaluation of the trial treatment, e.g., renal or liver disease, uncontrolled diabetes, significant cardiovascular, immune deficiency, or infectious disease
Is actively involved in a litigation involving Workers' Compensation
Is a female that is pregnant, planning to become pregnant or is lactating
Has participated in a clinical trial within the past four weeks
Intervention: Celecoxib
Trial phase: Phase 1 | Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
Eligibility criteria:
Inclusion Criteria:

Age 18 years or older
Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck or lymphoepithelioma
Prior radiation to the head and neck, surgery or chemotherapy is allowed
Karnofsky performance status of >= 70%
Intact organ and bone marrow function
Obtained informed consent

Exclusion Criteria:

Demonstration of metastatic disease (i.e. M1 disease).
Incomplete healing from previous surgery
Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician.
Uncontrolled active infection unless curable with treatment of their cancer.