bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.
Condition: Pain
MeSH terms: Acute Pain
Intervention: Hydromorphone
Intervention description: To be administered by intranasal route using mucosal atomization device.
Intervention MeSH terms: Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Intranasal; Hydromorphone; Pediatric; Emergency department

Summary:

      Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It
      has not been previously studied in children, but may be a viable option for effectively and
      safely reducing pain in children by administering an analgesic by the intranasal route.

      This study will be a prospective, open-label pilot study of intranasal hydromorphone in
      children with moderate to severe acute pain presenting to the pediatric emergency department.
      The investigators aim to describe the amount of pain reduction associated with intranasal
      hydromorphone, and to determine the optimal dose of intranasal hydromorphone associated with
      a clinically meaningful improvement in acute pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 4 to 17 years old, inclusive

          -  Moderate to severe pain (i.e. FPS-R or vNRS score of 4 or more)

          -  Requires parenteral opioid analgesic to treat their pain, as decided by treating
             physician

        Exclusion Criteria:

          -  Allergy or known contraindication to receiving opioids

          -  Receipt of any opioid or benzodiazepine within preceding 6 hours

          -  Presence of intranasal obstruction that cannot be cleared readily

          -  Cannot speak English or Spanish

          -  Patient unlikely to be able to complete self-report measures of pain or questionnaires

          -  Known liver or kidney problems

          -  Currently critically ill

          -  Chronic pain condition (e.g. sickle cell disease, fibromyalgia)
Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypertension
Intervention: Iloprost; Placebo
Intervention description: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks; matching placebo
Intervention MeSH terms: Iloprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: PH; COPD

Summary:

      This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to
      evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to
      COPD. The main objective is to investigate the effect of iloprost on exercise endurance time
      during constant work rate cardiopulmonary exercise testing. Other efficacy and safety
      endpoints will additionally be analyzed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent prior to initiation of any study mandated procedure

          2. Male or female ≥ 40 and ≤ 75 years of age

          3. Women of childbearing potential1 must use a reliable method of contraception

          4. Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on
             pulmonary function tests

          5. Current or past smokers of ≥ 10 pack years

          6. Ability to perform exercise testing without supplemental oxygen (in the best opinion
             of the investigator)

          7. Confirmed pulmonary hypertension by right heart catheterization (RHC)

        Exclusion Criteria:

          1. Other causes of pulmonary hypertension than COPD

          2. BMI > 35 kg/m2

          3. Conditions considered as contraindications for cardiopulmonary exercise testing (CPET)
             and/or inability to pedal on a cycle ergometer

          4. Pregnant or nursing

          5. Currently (within 30 days prior to RHC) taking specific pulmonary arterial
             hypertension (PAH) therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil,
             epoprostenol, treprostinil, iloprost, beraprost)

          6. Participation in any other clinical trial, except observational, or receipt of an
             investigational product within 30 days prior to RHC visit

          7. Known concomitant life-threatening disease with a life expectancy < 12 months

          8. Known hypersensitivity to iloprost or any of the excipients of the drug formulations
Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: DE-126 Ophthalmic Solution 0.002% QD; Timolol Maleate Ophthalmic Solution 0.5% BID
Intervention description: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning; Timolol Maleate Ophthalmic Solution BID (morning and evening)
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma

Summary:

      Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop
      medications has been shown to be effective in delaying or preventing the progression of
      glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field
      loss.

      This study is being conducted to determine how well DE-126 ophthalmic solution works
      (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate
      the safety and efficacy of DE-126, ophthalmic solution in subjects with Primary Open Angle
      Glaucoma (POAG) or Ocular Hypertension (OHT).

      The IOP will be measured at 3 different times throughout the day, over 4 total visits during
      a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop
      taking current eye drops to lower IOP). Safety assessments will be done throughout the study,
      including ocular signs and symptoms, and vital signs. While the most important time-point to
      measure IOP in this study and evaluate efficacy will be at the final study visit (month 3),
      IOP values will also be evaluated at other visits throughout the 3-month treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with
             OHT

          -  Completed the required wait/washout period

          -  Qualifying Day 1 IOP measurement at 3 time-points in both eyes

        Exclusion Criteria:

          -  Females who are pregnant, nursing, or planning a pregnancy

          -  Subjects who cannot safely discontinue use of ocular hypotensive medications during
             the wait/washout period.

          -  History of ocular surgery specifically intended to lower IOP in either eye. Laser
             iridotomy in history is allowed

          -  Presence of advanced glaucoma in either eye
Measures to Lower the Stress Response in Pediatric Cardiac Surgery
Condition: Tetralogy of Fallot (TOF); Ventricular Septal Defects (VSD); Atrioventricular Septal Defects (AVSD)
MeSH terms: Heart Septal Defects; Tetralogy of Fallot; Heart Septal Defects, Ventricular; Endocardial Cushion Defects
Intervention: Fentanyl (High Dose); Fentanyl (Low Dose); Fentanyl (Low Dose) + Dexmedetomidine
Intervention description: Fentanyl (High Dose) 25 mcg/kg in two divided doses. Half-dose will be given at induction and the second half-dose given prior to incision.; Fentanyl (Low Dose) 10 mcg/kg in two divided doses. Half-dose will be given at induction and the second half-dose given prior to incision.; Fentanyl (Low Dose) + Dexmedetomidine. Dexmedetomidine at 1mcg/kg loading dose over 10 minutes, followed by an infusion at a rate of 0.5mcg/kg/hr. In addition, this group will receive a total of 10 mcg/kg Fentanyl (Low Dose). Half the dose will be given at induction and the second half before incision.
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Citric Acid; Sodium Citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 1 Month
Maximum age: 3 Years
Healthy volunteers: No
Keywords: pediatric cardiac surgery; stress response; early extubation; Dexmedetomidine; TOF; VSD; AVSD

Summary:

      Cardiac surgery induces a measurable stress response in patients which leads to increased
      morbidity and mortality post-operatively. Through clinical observation, anesthesiologists
      have determined that varying the combinations of anesthesia drugs used during surgery and
      just after reduces the stress response, and by extension, morbidity and mortality. However,
      only a few studies have explored this phenomenon scientifically.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Childrens with the diagnosis of tetralogy of fallot, ventricular septal defect and
             atrioventricular septal defect who are under one year of age.

        Exclusion Criteria:

          -  Patients who are having reoperation.

          -  Patients with comorbidities, such as heart failure.

          -  Patients receiving digoxin preoperatively.
Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer
Condition: Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung; Metastases
MeSH terms: Carcinoma; Lung Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell; Small Cell Lung Carcinoma
Intervention: zoledronic acid
Intervention description: 3.0-4.0 mg by IV (in the vein), once a month for 6 months
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Zometa; bone metastasis; lung cancer; non-small cell lung cancer; small cell lung cancer; bone metabolic markers; tartrate resistant acid phosphatase

Summary:

      The purpose of this study is to evaluate a new blood test as a way to follow the effect of
      Zometa in treating bone metastases due to lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  invasive lung cancer (small cell or non-small cell lung cancer)

          -  osteolytic bone metastasis determined by clinical exam, bone scan/XR

          -  age > 18 years

        Exclusion Criteria:

          -  concurrent malignancy with a second primary

          -  renal failure (serum creatinine > 3mg/dl)

          -  pregnancy

          -  active rheumatoid arthritis

          -  intolerance to zoledronic acid
Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin degludec; insulin detemir; insulin aspart
Intervention description: The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime; Injection subcutaneously at bedtime; Injection subcutaneously immediately before each meal.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety
      (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or
      intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in
      subjects with type 1 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with type 1 diabetes mellitus more than one year

          -  Current treatment: basal (once daily at bedtime) - bolus (three times a day just
             before main meals) regimen only for at least 12 weeks using a long-acting insulin
             analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin
             and NovoRapid® as bolus insulin (a brand of basal insulin preparation has not been
             changed in the preceding 12 weeks)

          -  HbA1c below 10.0%

          -  Body Mass Index (BMI) below 30.0 kg/m^2

        Exclusion Criteria:

          -  Known hypoglycaemia unawareness or recurrent major hypoglycaemia

          -  Current treatment with total insulin dose of more than 100 U or IU/day

          -  Current treatment or expected to start treatment with systemic corticosteroid
SBRT Plus Pembrolizumab and Trametinib for Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Cyberknife plus Pembrolizumab and Trametinib; Cyberknife plus Gemcitabine
Intervention description: Radiation therapy plus drug; Radiation therapy plus drug
Intervention MeSH terms: Gemcitabine; Pembrolizumab; Trametinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stereotactic body radiation therapy; CyberKnife; Initial treatment

Summary:

      Hypothesis: Survival benefits could be found in SBRT Plus Pembrolizumab and Trametinib
      compared with SBRT plus gemcitabine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed pancreatic ductal adenocarcinoma with unequivocal first
             progression after surgery followed by chemotherapy

          2. Without any immunotherapy or targeted therapy

          3. A life expectancy of >3months

          4. ECOG of 0 to1

          5. Age of 18 years or older

          6. Analysis of surgical specimens showed KRAS mutations and positive immunohistochemical
             staining of PD-L1

          7. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×109 cells/L,
             leukocyte count≥ 3.5 ×109 cells/L, platelets ≥ 70×109 cells/L, hemoglobin ≥ 8.0 g/dl

          8. Liver and kidney function tests: Albumin > 2.5 g/dL, total bilirubin < 3 mg/dL,
             creatinine < 2.0 mg/dL, AST<2.5 × ULN(Upper Limit of Normal)(0-64U/L), ALT<2.5 ×
             ULN(0-64U/L)

          9. INR < 2 (0.9-1.1)

         10. Ability of the research subject or authorized legal representative to understand and
             the willingness to sign a written informed consent document.

        Exclusion Criteria:

          1. Prior immunotherapy or targeted therapy

          2. Evidences of metastatic disease confirmed by chest CT or FDG PET-CT

          3. Contraindication to receiving immunotherapy, targeted therapy or SBRT

          4. ECOG ≥2

          5. Age <18 years

          6. Analysis of surgical specimens showed KRAS wild type or negative immunohistochemical
             staining of PD-L1

          7. Secondary malignancy

          8. Abnormal results of blood routine examinations and liver and kidney and coagulation
             tests

          9. Patients with active inflammatory bowel diseases or peptic ulcer

         10. Gastrointestinal bleeding or perforation within 6 months

         11. Heart failure: NYHA III-IV

         12. Respiratory insufficiency

         13. Women who are pregnant

         14. Participation in another clinical treatment trial while on study

         15. Patients in whom fiducial implantation was not possible

         16. Inability of the research subject or authorized legal representative to understand and
             the willingness to sign a written informed consent document.
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
Condition: Ductal Carcinoma in Situ
MeSH terms: Carcinoma; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Intervention: Polyphenon E
Intervention description: three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DCIS

Summary:

      The purpose of this study is to find molecular signs (biomarkers) to better understand the
      role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed
      ductal carcinoma in situ (DCIS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on
             breast MRI of at least 1-cm3 in volume.

          -  Patients may have undergone treatment with prior chemotherapy if this was greater than
             12 months prior to current diagnosis.

          -  Age >18 years.

          -  ECOG performance status <2 (Karnofsky >60%)

          -  Life expectancy of greater than 12 months.

          -  Normal organ and marrow function as defined below:

          -  leukocytes >3,000/mcL

          -  absolute neutrophil count >1,500/mcL

          -  platelets >100,000/mcL

          -  total bilirubin within normal institutional limits

          -  AST(SGOT) & ALT(SGPT)within normal institutional limits

          -  creatinine <1.5 times institutional upper limit of normal or creatinine clearance >60
             mL/min/1.73 m2

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Pregnancy

          -  Patients who have undergone prior excisional biopsy for DCIS.

          -  Patients who are unable to undergo MRI due to claustrophobia or other reason.

          -  Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior
             to entering this study.

          -  Patients receiving any other chemotherapy or investigational agents.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to green tea extracts or sensitivity to green tea.

          -  Uncontrolled concurrent 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.
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Bempedoic acid 180mg; Ezetimibe 10mg; Atorvastatin 20mg; Placebo
Intervention description: bempedoic acid 180 mg; ezetimibe 10 mg; atorvastatin 20 mg; placebo
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Atorvastatin; Ezetimibe
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlididemia; LDL; cholesterol

Summary:

      The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002)
      180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients
      with elevated LDL cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-cholesterol between 130 - 189 mg/dL at screening following washout of all
             LDL-C-lowering drugs and nutritional supplements

          -  Men and nonpregnant, nonlactating women

          -  Sufficiently stable and suitable to undergo washout of all LDL-C-lowering drugs and
             nutritional supplements for 12 weeks

        Exclusion Criteria:

          -  Fasting blood triglycerides greater than or equal to 400 mg/dL

          -  Body Mass Index (BMI) greater than 50 kg/m2

          -  History of clinically significant cardiovascular disease

          -  History of type 1 or type 2 diabetes
An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Golimumab; MTX; Placebo; Infliximab
Intervention description: Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.; Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous; Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous; Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous
Intervention MeSH terms: Infliximab; Golimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; CNTO 148; Methotrexate; Joint pain; Arthritis

Summary:

      Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to
      assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at
      either 2- or 4- week intervals in subjects with active RA despite MTX therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA according to the American College of Rheumatology criteria for at
             least 3 months prior to screening

          -  Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined
             by 6 or more swollen joints and 6 or more tender joints and additional laboratory
             criteria

        Exclusion Criteria:

          -  Have other inflammatory diseases, including but not limited to ankylosing spondylitis,
             systemic lupus erythematosus, Lyme disease

          -  Received disease-modifying antirheumatic drugs ([DMARDs] eg, D penicillamine,
             hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin [IL]-1 receptor
             antagonist [anakinra], azathioprine, sulphasalazine, agents other than MTX) within 4
             weeks prior to the first study dose