bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
Condition: Post-surgical Dental Pain
MeSH terms: Toothache
Intervention: PF-04531083; Placebo; PF-04531083; Placebo; Ibuprofen; Placebo; Placebo; Placebo
Intervention description: 2000 mg oral solution; Placebo tablets for Ibuprofen; 1000 mg oral solution; Placebo tablets for Ibuprofen; 2 x 200 mg tablets; Placebo solution for PF-04531083; Placebo solution for PF-04531083; Placebo tablets for Ibuprofen
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Post-surgical dental pain

Summary:

      The purpose of this study is to evaluate the overall pain relief of a single dose of
      PF-04531083 against placebo following third molar extraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Oral surgical procedure having removed 2 third molars (unilateral).

          -  Pre-dose pain intensity score (100 mm Visual Analog Scale [VAS]) >50 mm within 5 hours
             of oral surgery.

          -  Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.

        Exclusion Criteria:

          -  Presence or history of any significant hepatic, renal, endocrine, cardiovascular,
             neurological (including subjects with a history of frequent moderate to severe
             headaches or subjects with episodic migraines more than twice per month), psychiatric,
             gastrointestinal, pulmonary, hematologic, or metabolic disorder.

          -  Prior use of any type of analgesic or NSAID within five half-lives of that drug or
             less before taking the first dose of study medication, except for anesthesia for the
             procedure.

          -  Recent history of chronic analgesic or tranquilizer dependency.

          -  Active dental infection at the time of surgery.

          -  Any significant oral surgery complication at the time of surgery or in the immediate
             postoperative period or dental surgery lasting > 30 minutes.

          -  Subjects who are smokers.
MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
Condition: DCIS
MeSH terms: Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Intervention: MammoSite Radiation Therapy System
Intervention description: The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: No
Keywords: MammoSite; DCIS

Summary:

      This study has been designed to compile information on the efficacy of the MammoSite RTS
      providing sole radiation therapy for patients with pure DCIS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-Surgery:

               -  Unicentric pure DCIS

               -  Lesions should have a greatest dimension of 3 cm or less as determined by
                  pre-surgery mammography and MRI

          -  Post-Surgery:

               -  Negative histological margins confirmed prior to beginning radiation therapy.

               -  Margins are positive if there is tumor at the inked margin.

               -  Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS,
                  using the Philadelphia Consensus Conference Guidelines are eligible

               -  Clinically node negative

        Exclusion Criteria:

          -  Distance from the balloon surface to the surface of the skin < 5mm as determined by CT
             imaging.

          -  Distant metastases.

          -  Invasive or in-situ lobular carcinoma (post-surgery assessment).

          -  Nonepithelial breast malignancies such as sarcoma or lymphoma.

          -  DCIS that is multicentric in the ipsilateral breast.

          -  Pregnant or lactating.

          -  Prior non-hormonal therapy for the present breast cancer, including radiation therapy
             and/or chemotherapy.

          -  Collagen vascular diseases

          -  Coexisting medical conditions with life expectancy < 2 years.

          -  Serious psychiatric or addictive disorder

          -  Previously treated contralateral breast carcinoma

          -  Synchronous bilateral breast carcinoma.

          -  Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in
             the study; the disease free interval from any prior carcinoma must be continuous.

          -  Patients with diffuse disease
IN Sub-Dissociative Ketamine vs IN Fentanyl
Condition: Bone Fracture
MeSH terms: Fractures, Bone
Intervention: ketamine; fentanyl; ibuprofen or acetaminophen
Intervention description: intranasal (IN) sub-dissociative ketamine (1mg/kg); Intranasal (IN) fentanyl (1.5 micrograms/kg); 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention
Intervention MeSH terms: Acetaminophen; Ibuprofen; Fentanyl; Ketamine; Analgesics
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This single center, randomized control, double blind trial will prospectively examine the
      feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain
      control in the pediatric emergency department setting. The investigators hypothesize that IN
      ketamine may provide a safe and effective alternative to IN fentanyl for children with
      suspected, isolated extremity fractures.

      Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires
      analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the
      emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  single suspected, isolated extremity fracture that requires analgesia

        Exclusion Criteria:

          -  GCS < 15 at ED presentation,

          -  reported allergy or adverse reaction to ketamine or fentanyl,

          -  pregnancy,

          -  intoxication,

          -  hypotension (less than 70 mmHg +2x age or less than 90 mm Hg for patients greater than
             11 years of age)

          -  weight > 70 kg

          -  patients receiving opioid analgesia administered prior to arrival

          -  multiply injured patients (injuries to multiple extremities)

          -  aberrant nasal anatomy that precludes IN medications
Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma
Condition: Hodgkin's Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Adriamycin®; Vinblastine; Nitrogen Mustard; Cyclophosphamide; Vincristine; Bleomycin; Etoposide; Prednisone; G-CSF; Radiotherapy
Intervention description: Given IV on Day 1 of weeks 1, 3, 5, 7, 9 and 11.; Given IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11.; Given IV, Day 1 of weeks 1, 5 and 9. Cyclophosphamide may be substituted if nitrogen mustard is unavailable.; May be substituted if nitrogen mustard is unavailable. Given on Day 1 of weeks 1, 5 and 9.; Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.; Given IV on Day 1 of weeks 2, 4, 6, 8, 10 and 12.; Given IV on Days 1 and 2 of weeks 1-10.; Given PO every other day of weeks 1-12.; Given subcutaneously days 3-13, 16-26, 29-39, 42-52, 55-65, and 68-78 (as clinically indicated).; Participants receive radiotherapy after completion of 12 weeks of Stanford V chemotherapy.
Intervention MeSH terms: Prednisone; Hydrocortisone; Cyclophosphamide; Mechlorethamine; Nitrogen Mustard Compounds; Doxorubicin; Etoposide; Vincristine; Bleomycin; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Hodgkin's Disease

Summary:

      The main purpose of this protocol is to estimate the percentage of patients with intermediate
      risk Hodgkin lymphoma who will survive free of disease (Event-free survival) for three years
      after treatment with multi-agent chemotherapy (Stanford V) and low-dose, tailored-field
      radiation therapy. The hypothesis being studied is that this treatment will result in more
      than 80% of patients being alive and free of disease three years after starting treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is less than or equal to 21 years of age

          -  Patient has a confirmed diagnosis of previously untreated Hodgkin lymphoma

          -  Has Ann Arbor stage IB, IIIA, or IA/IIA with extranodal extension, multiple nodal
             involvement (3 or more sites), or bulky mediastinal adenopathy.

        Exclusion Criteria:

          -  Patients with favorable risk features

          -  Patients with unfavorable risk features

          -  Patients who have received prior therapy for Hodgkin lymphoma.
Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; 25 mg PF-04991532; 75 mg PF-04991532; 150 mg PF-04991532; 300 mg PF-04991532; Sitagliptin 100 mg
Intervention description: Tablets (n=4), 0 mg twice daily for 84 days; Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days; Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days; Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days; Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days; Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days.
Intervention MeSH terms: Nicotinic Acids; Sitagliptin Phosphate; 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Phase 2; safety and efficacy study with PF-04991532; Type 2 diabetes

Summary:

      B2611003 is designed to study how safe and effective an investigational medication
      (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6
      treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug,
      and another treatment will be placebo, which does not contain active ingredient.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with type 2 diabetes on stable doses of background medicines for management of
        diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

        Exclusion Criteria:

        Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled
        blood pressure, significant kidney disease.
Herceptin and GM-CSF for Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Herceptin; GM-CSF
Intervention description: 4 mg/kg IV Over 90 Minutes; 250 mcg/m^2 Subcutaneously
Intervention MeSH terms: Trastuzumab; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Healthy volunteers: No
Keywords: Breast Cancer; Carcinoma of the Breast; HER-2/neu Overexpression; Herceptin; Trastuzumab; GM-CSF; Sargramostim; Leukine

Summary:

      Primary Objectives:

        1. To determine the patient's tumor response rate that this protocol will produce.

        2. To determine the 1 year progression-free survival that this protocol will produce.

      Secondary Objective:

      1. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the mechanism
      of overcoming Herceptin-resistance by use of Granulocyte-Macrophage Colony Stimulating Factor
      (GM-CSF).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological confirmation of invasive carcinoma of the breast.

          2. HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ
             hybridization (FISH) (+).

          3. Stage IV breast cancer with measurable disease.

          4. Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin
             alone. No more than two Herceptin containing regimens.

          5. Zubrod performance status 0 or 1.

          6. Adequate hematological parameters (White Blood cells-WBC > 3,000/mm3, platelet count >
             100,000/mm3), adequate renal function (serum creatinine < 2.0 mg/dl), adequate liver
             function (total bilirubin, aspartate aminotransferase (AST or SGOT) or alanine
             aminotransferase (ALT or SGPT) < 3 x normal).

        Exclusion Criteria:

          1. Active Brain metastasis.

          2. No measurable disease at the time of registration (e.g. bone only, leptomeningeal
             disease alone or pleural effusion alone).

          3. More than 2 Herceptin containing regimens in metastatic breast cancer.

          4. Known history of HIV positive.

          5. Chronic active hepatitis or cirrhosis.

          6. Symptomatic pulmonary disease.

          7. Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week
             prior to registration.
Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer
Condition: Estrogen Receptor-negative Breast Cancer; Progesterone Receptor-negative Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Medroxyprogesterone progesterone acetate (MPA); Medroxyprogesterone with Cyclophosphamide + Methotrexate
Intervention description: 1000 mg po daily; Medroxyprogesterone Acetate Dose 1000 mg po daily Cyclophosphamide Dose 50 mg po daily Methotrexate Dose 2.5 mg po daily Days 1 and 2 of each week
Intervention MeSH terms: Cyclophosphamide; Methotrexate; Medroxyprogesterone Acetate; Medroxyprogesterone; Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Medroxyprogesterone progesterone acetate (MPA); Cyclophosphamide plus Methotrexate

Summary:

      The purpose of this study is to evaluate the impact of MPA alone and in combination with low
      dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the breast with measurable
             locally recurrent or metastatic disease

          -  Primary tumor must be ER negative and PR negative

          -  Patients must be post-menopausal

          -  Patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic
             disease

          -  Adequate organ function as evidenced by laboratory studies outlined in section 3.6 of
             the protocol

          -  Patients with treated, asymptomatic brain metastases are eligible provided chronic
             steroid therapy is not required

        Exclusion Criteria:

          -  Patients must not have extensive pleural effusion or ascites

          -  Patients must not have history of DVT or pulmonary embolism w/in past 12 mo

          -  Patients must not have had chemotherapy or hormonal therapy within 2 weeks of study
             entry

          -  Patients must not have had radiation therapy within 1 week of study entry.
A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough
Condition: Chronic Refractory Cough
MeSH terms: Cough
Intervention: BLU-5937; Placebo
Intervention description: Four escalating doses of BLU-5937 administered BID over the course of the study; Matching placebo for BLU-5937
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two-arm, Two-Period, crossover assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Unexplained or refractory chronic cough, P2X3 antagonists

Summary:

      This is a multi-center, randomized, double-blind, placebo-controlled, crossover, dose
      escalation study of BLU-5937 in subjects with unexplained or refractory chronic cough
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unexplained or refractory chronic cough for at least one year

          -  Chest radiograph or CT thorax within the last 60 months not demonstrating any
             abnormality considered to be significantly contributing to the chronic cough

          -  Cough count of ≥ 10 per hour (Awake Cough Count) at Screening

          -  Score of ≥ 40mm on the Cough Severity VAS at Screening

          -  Women of child-bearing potential must have a negative serum pregnancy test at
             Screening

          -  Women of child-bearing potential must use a highly effective contraception method from
             Screening through the Follow-Up Visit

          -  Male subjects and their partners of child-bearing potential must use 2 methods of
             acceptable birth control

        Exclusion Criteria:

          -  Current smoker or individuals who have given up smoking within the past 6 months, or
             those with >20 pack-year smoking history

          -  Diagnosis of COPD, bronchiectasis, idiopathic pulmonary fibrosis

          -  Treatment with an ACE-inhibitor as the potential cause of a subject's cough, or
             requiring treatment with an ACE-inhibitor during the study, or within 12 weeks prior
             to the Screening Visit

          -  FEV1/FVC < 60%

          -  History of upper respiratory tract infection or recent significant change in pulmonary
             status within 4 weeks of the Baseline Visit

          -  History of concurrent malignancy or recurrence of malignancy within 2 years prior to
             Screening

          -  History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years

          -  Clinically significant abnormal electrocardiogram (ECG) or laboratory tests at
             Screening

          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with trial participation or
             investigational product administration or may interfere with the interpretation of
             trial results
Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
Condition: Pain
Intervention: Eucerin plus; Amethocaine gel 4%
Intervention description: 1g, single application; 1 g, single application
Intervention MeSH terms: Tetracaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Healthy volunteers: No
Keywords: Infant,newborn; Topical anesthesia; Intramuscular injection

Summary:

      This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the
      pain response in term neonates subjected to intramuscular injection for administration of
      vitamin K.

      Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in
      decreasing the pain from intramuscular injection in term neonates.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Term neonates > 37 weeks and

          2. Birth weight > 2500 grams (appropriate for gestational age - AGA) -

        Exclusion Criteria:

        1.Neonates with major congenital anomalies 2.Neonates with known neurological abnormalities
        (antenatally diagnosed) 3.Neonates who require admission to the neonatal intensive care
        unit at birth

        -