bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
Condition: Peritoneal Cancer; Ovarian Cancer; Neoplasms, Ovarian; Fallopian Tube Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: GW786034
Intervention description: 800 mg GW786034 administered orally on a daily basis.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Pazopanib; Fallopian tube cancer; Ovarian epithelial cancer; Peritoneal cancer

Summary:

      This study was designed to find out how effective and safe GW786034, is in the treatment of
      epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to
      standard treatment.
    

Eligibility criteria:

        Inclusion criteria:

          -  Confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal
             carcinoma.

          -  Has received one prior platinum-based chemotherapy regimen(cisplatin,carboplatin, or
             oxaliplatin).

          -  Has psychological, familial, sociological or geographical condition that does not
             permit compliance with the protocol.

          -  Is on a specifically prohibited medication or requires these medications during
             treatment with GW786034.

        Exclusion criteria:

          -  Has had any surgery, chemotherapy, hormonal therapy, biologic, immunotherapy, or
             radiotherapy with in the last 28 days and has not recovered from such prior therapy.

          -  Poorly controlled hypertension(systolic 140mmHg or higher or Diastolic 90mmHg or
             higher).

          -  Currently taking warfarin.

          -  Low molecular weight heparin and low-dose warfarin(1mg per day)is permitted.
Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G)
Condition: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Plasma Cell Myeloma
MeSH terms: Lymphoma; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Crizotinib
Intervention description: Given PO
Intervention MeSH terms: Crizotinib; Tyrosine Protein Kinase Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crizotinib; ROS1; NCI-MATCH; Tyrosine kinase inhibitor

Summary:

      This phase II MATCH treatment trial identifies the effects of crizotinib in patients whose
      cancer has a genetic change called ROS1 translocation. Crizotinib may block a protein called
      ROS1, which may be needed for cancer cell growth. Researchers hope to learn if crizotinib
      will shrink this type of cancer or stop its growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met applicable eligibility criteria in the Master MATCH Protocol
             prior to registration to treatment subprotocol

          -  Patients must be positive for translocation or inversion events involving the ROS1
             gene via the MATCH Master Protocol

          -  Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
             assignment and must have no clinically important abnormalities in rhythm, conduction
             or morphology of resting ECG (e.g. complete left bundle branch block, third degree
             heart block)

        Exclusion Criteria:

          -  Patients must not have NSCLC with ROS1 rearrangements

          -  Patients with a history of interstitial lung disease or pneumonitis are excluded

          -  Patients must not have known hypersensitivity to crizotinib or compounds of similar
             chemical or biologic composition

          -  Patients using drugs or foods that are known potent CYP3A4 inhibitors or inducers will
             be excluded

          -  Patients must not have had prior therapy with any ROS1 inhibitor including crizotinib,
             ceritinib, foretinib, cabozantinib, AP26113, ASP3026, WZ-5-126, TAE684, KIST301072,
             KIST301080, AZD1480, PF-06463922, RXDX-101 and PF-3922
Efficacy and Safety Study of Elagolix in Women With Endometriosis
Condition: Endometriosis, Pain
MeSH terms: Endometriosis
Intervention: Placebo; Elagolix
Intervention description: Matching placebo tablets taken orally once a day; Immediate release (IR) tablets taken orally once a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Pelvic Pain,NBI-56418,Endometriosis

Summary:

      The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its
      effects on endometriosis related pelvic pain and its safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be female, aged 18 to 49 years, inclusive.

          -  Have moderate to severe pelvic pain due to endometriosis.

          -  Have a history of regular menstrual cycles.

          -  Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8
             years of the start of screening.

          -  Have a Body Mass Index (BMI) of 18 to 36 kg/m², inclusive.

          -  Agree to use two forms of non-hormonal contraception during the study.

        Exclusion Criteria:

          -  Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH
             antagonist other than NBI-56418, or danazol or have received any of these agents
             within 6 months of the start of screening.

          -  Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or
             intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these
             agents within 3 months of the start of screening.

          -  Are currently using hormonal contraception or other forms of hormonal therapy or
             received such treatment within the last month.

          -  Have had surgery for endometriosis within the last month.

          -  Have had a hysterectomy or bilateral oophorectomy.

          -  Are using systemic steroids on a chronic or regular basis within 3 months.

          -  Have uterine fibroids ≥ 3 cm in diameter.

          -  Have pelvic pain that is not caused by endometriosis.

          -  Have unstable medical condition or chronic disease.

          -  Have been pregnant within the last six months.

          -  Currently breast feeding.
PF-06372865 In Subjects With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: PF-06372865; Placebo; Naproxen
Intervention description: Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks; Placebo for PF-06372865 and placebo for naproxen daily; 500 mg BID for 4 weeks
Intervention MeSH terms: Naproxen; PF-06372865
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      PF-06372865 In Subjects With Chronic Low Back Pain
    

Eligibility criteria:

        Inclusion Criteria:

        -

        Exclusion Criteria:

        -
Phenylketonuria, Oxidative Stress, and BH4
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Intervention: Kuvan; Meal Challenge
Intervention description: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.; At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction
Phase: Phase 2
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 10 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phenylketonuria; PKU; tetrahydrobiopterin; sapropterin dihydrochloride; BH4; Kuvan; Oxidative stress

Summary:

      The purpose of this study is to see how tetrahydrobiopterin therapy (BH4; also known as
      sapropterin dihydrochloride or Kuvan) affects measures of oxidative stress and endothelial
      function in patients with Phenylketonuria (PKU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have read, understood, and signed this consent form (and assent form, if <18 years
             old)

          -  Are between the ages of 10-45 years

          -  Weigh at least 75 pounds (34 kg)

          -  Meet group-specific criteria

        Exclusion Criteria:

          -  Smoke

          -  Have any history of cardiovascular disease

          -  Have hepatic impairment, or demonstrate abnormal baseline liver function lab test
             results

          -  Have donated blood within 3 months prior to the study or are anemic as shown by the
             baseline lab results

          -  Are unwilling to discontinue dietary supplements (excluding medical food) two weeks
             prior to their first study visit

          -  Are currently take medications that will interfere with the interpretation of selected
             endpoints (such as lipid-lowering medication)

          -  Are currently pregnant or breastfeeding

          -  Excluding PKU, have a chronic illness, disorder, or condition (including but not
             limited to diabetes, hypertension, cancer)

          -  Have taken any investigational drug (including Kuvan for Kuvan-unresponsive
             participants & controls) within 3 months prior to the study

          -  In the opinion of the Investigator, should not be included in the study for any
             reason, including inability to follow study procedures
ARJ C13 Urea Breath Test System
Condition: H. Pylori Infection
Intervention: PyloPlus UBT System; Histology; Rapid Urease Test; H.pylori Culture
Intervention description: Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.; Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist; Biopsy specimen obtained and placed onto Rapid Urease Test; Biopsy specimen obtained and sent to lab for culture analysis
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 415.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label, comparative group study to evaluate the equivalency of the PyloPlus 13C Urea
      Breath Test to predicate devices on the market.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age at the time of visit

          -  Patients who are experiencing the effects of gastritis

          -  Written informed consent (and assent when applicable) obtained from subject and
             ability for subject to comply with the requirements of the study

        Exclusion Criteria:

          -  Pregnant or lactating women.

          -  Study subjects currently taking antibiotics

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the patient or the quality of the data

          -  Fasting required one hour prior to testing

          -  Study subjects shall not consume the following items prior to the test: Mouthwash,
             Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to stimulate the effect
             of ketone production that may result from some diets), Alcohol
Palliative Management of Inoperable Malignant Bowel Obstruction
Condition: Malignant Bowel Obstruction
MeSH terms: Intestinal Obstruction
Intervention: Dexamethasone; Metoclopramide; Octreotide
Intervention description: Given IV; Given IV; Given IV
Intervention MeSH terms: Dexamethasone; Octreotide; Metoclopramide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bowel obstruction

Summary:

      To identify the role of palliative medical management of inoperable malignant bowel
      obstruction (MBO) with Octreotide, Dexamethasone and Metoclopramide given together as triple
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years of age.

          -  Diagnosis of partial bowel obstruction secondary to active or prior malignancy
             (primary or metastatic GI, GYN, and carcinomatosis) caused either by tumor itself or
             adhesions inthe setting of active malignancy.

          -  Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel
             obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital
             admission.

          -  Patient must have an inoperable MBO

          -  Participant must understand the investigational nature of this study and sign an
             Independent Ethics Committee/Institutional Review Board approved writteninformed
             consent form prior to receiving any study related procedure.

        Exclusion Criteria:

          -  Evidence of complete bowel obstruction by imaging.

          -  Bacteremia/septicemia with a documented positive blood culture: If a blood culture
             comes back positive after study enrollment, patient will be excluded.

          -  Patients already taking a steroid equivalent to 8 mg of dexamethasone per day prior to
             study enrollment.

          -  Patients undergoing bowel surgery or stent placement for bowel obstruction.

          -  Those patients with MBO in setting of incarcerated hernia.

          -  Known history of QT prolongation syndrome or if QTc is > 450 msec in males or > 470
             msec in females on baseline EKG within 2 weeks of enrollment.

          -  Lack of decision making capacity/delirium.

          -  Pregnant or nursing female participants.

          -  Actively suicidal patients.

          -  Acute cholecystitis
Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children
Condition: Upper Respiratory Tract Infections
MeSH terms: Infections; Respiratory Tract Infections
Intervention: Placebo; Glucose oxidase
Intervention description: placebo containing saline+glucose; a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Maximum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Days with URTI symptoms

Summary:

      To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper
      respiratory tract infections in children beyond 4 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children below 4 years of age

        Exclusion Criteria:

          -  None
Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart; biphasic insulin aspart 30
Intervention description: The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.; The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
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/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a
      twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily
      regimen in subjects with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with type 2 diabetes mellitus

          -  Current treatment using a long-acting insulin analogue/intermediate-acting insulin
             preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue
             preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable
             insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen
             has not been changed in the preceding 12 weeks)

          -  HbA1c below 10.0%

          -  Body Mass Index (BMI) < 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

          -  Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor
             and insulin sensitizer [thiazolidinedione: TZD]) within the last 12 weeks prior to
             screening
Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Prednisolone
Intervention description: Prednisolone (5mg per kg) will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 1 Month
Maximum age: 30 Months
Healthy volunteers: No
Keywords: Duchenne Muscular Dystrophy; Corticosteroids; Infants; Young Children; Toddlers

Summary:

      While it has been known for many years that corticosteroid use benefits boys with Duchenne
      Muscular dystrophy (DMD), most clinicians do not consider treating until after age 3 or 4
      years of age. The primary reason for the delay is that daily corticosteroid use has many side
      effects including short stature, obesity, and osteoporosis. A recent randomized blinded study
      of weekend oral corticosteroid use over one year showed equal improvement in strength with
      fewer side effects, particularly as related to growth and cushingoid changes. The
      investigators will test the efficacy of oral weekend corticosteroid use in infants and young
      boys with DMD who are under age 30 months. The investigators have demonstrated that the
      Bayley-III Scales of Infant development shows that infants and young boys in this age group
      who are untreated decline in abilities when compared to their peers. Here, in this Phase 2
      historically controlled trial, the investigators will use these two measures and treat boys
      at five Muscular Dystrophy Association-DMD centers
    

Eligibility criteria:

        Inclusion Criteria:

          1. Appropriate degree of weakness for age, creatine kinase greater than 20 times the
             upper limit of normal, and genetic mutation known to be causative for Duchenne
             muscular dystrophy .

          2. Appropriate degree of weakness for age, creatine kinase greater than 20 times the
             upper limit of normal and genetic or biopsy confirmation of Duchenne muscular
             dystrophy in a primary relative (e.g. brother or maternal uncle).

          3. De-identified, genetic studies will be reviewed by collaborator Kevin Flanigan, MD
             prior to enrollment of subjects.

          4. Age at entry: one month through 30 months.

        Exclusion Criteria:

          -  Prior treatment with corticosteroids
A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: SB480848 40mg EC Tablet; SB480848 80mg EC Tablet; SB480848 160mg EC Tablet; SB480848 Placebo Tablet
Intervention description: 1 tablet once a day; 1 tablet once a day; 1 tablet once a day; 1 tablet once a day
Intervention MeSH terms: Darapladib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: SB-480848; Dyslipidaemia

Summary:

      The primary objective of this study is to examine the effects of SB-480848 on plasma
      lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a
      4-week treatment with SB-480848.
    

Eligibility criteria:

        Inclusion criteria:

        Dyslipidemic subject who is currently undergoing statin therapy and no change in
        lipid-lowering therapy or dose during the 4 week prior to randomization

        Exclusion criteria:

          1. Recent (i.e.,<6 months prior to screening) CV event and/or vascular procedure defined
             as:

             A)ST-elevation MI or non-ST-elevation MI B)Unstable angina C)Coronary
             revascularization [(percutaneous coronary intervention (PCI) or coronary artery bypass
             graft (CABG)] D)Stroke of any etiology E)Peripheral arterial disease with critical
             limb ischemia (resting pain or ischemic skin lesions, either ulcers or gangrene)
             F)Resuscitated cardiac arrest

          2. Planned CABG or planned PCI or planned major non-cardiac surgery within study period

          3. No measurable Lp-PLA2 activity in plasma (<10 nmol/min/mL) at screening

          4. Change in a lipid-lowering medication, regimen or dosage during the 4 week prior to
             randomization

          5. Poorly controlled dyslipidemia (LDL-c >=160 mg/dL) at screening