bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1
Condition: HIV-1
Intervention: UK-453,061 Dose 1; UK-453,061 Dose 2; Etravirine
Intervention description: UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir.; UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir.; Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir.
Intervention MeSH terms: Etravirine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV-1 NNRTI Treatment Experienced; may have Protease inhibitor experience

Summary:

      This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir
      and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as
      etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase
      inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral
      drugs and have NNRTI resistance mutations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age available for a follow-up period of at least
             96 weeks.

          -  HIV 1 RNA viral load of greater then 500 copies/mL.

          -  Negative urine pregnancy test.

        Exclusion Criteria:

          -  Suspected or documented active, untreated HIV-1 related opportunistic infection or
             other condition requiring acute therapy at the time of randomization.

          -  Subjects with acute Hepatitis B and/or C within 30 days of randomization.

          -  Previous use of Darunavir or etravirine
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Intervention: Placebo; Ospemifene 5 mg; Ospemifene 15 mg; Ospemifene 30 mg
Intervention description: 1 tablet per day, orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).; 1 tablet of ospemifene 5 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).; 1 tablet of ospemifene 15 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).; 1 tablet of ospemifene 30 mg (QD), orally, in the morning, with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (End of therapy, Week 12).
Intervention MeSH terms: Tamoxifen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 126.0
Sex: Female
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Menopausal symptoms; Urogenital atrophy; Vulvar and vaginal atrophy in postmenopausal women; Vaginal atrophy

Summary:

      The purpose of the study is to assess the efficacy, safety and tolerability of Ospemifene 5
      mg, 15 mg, and 30 mg in the treatment of VVA in postmenopausal women to find the minimum
      effective dose below the lowest dose of 30 mg tested earlier in Phase II.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Naturally or surgically menopausal

          -  Vaginal pH greater than 5.0

          -  5% or fewer superficial cells in maturation index of vaginal smear

        Exclusion Criteria:

          -  Evidence of endometrial hyperplasia, cancer or other pathology

          -  Abnormal PAP smear

          -  Uterine bleeding of unknown origin or uterine polyps

          -  Current vaginal infection requiring medication

          -  Use of hormonal medications

          -  Clinically significant abnormal gynecological findings other than signs of vaginal
             atrophy
Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.
Condition: Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: nilotinib
Intervention description: Nilotinib supplied in 50mg, 150mg, and 200mg capsules. It was administered orally at 230mg/m2, twice daily for up to 66 cycles (1 cycle = 28 days). Dose administration was rounded to the nearest 50mg dose (to a maximum dose of 400mg).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tasigna; nilotinib treatment; chronic phase; Ph+ CML; accelerated phase; newly diagnosed Ph+ CML; pediatric; leukemia; leukemia, pediatric; leukemia, myleiod; leukemia, mylegenous, chronic; leukemia, mylegenous, accelerated; BCR-ABL positive; myeloproliferative disorder; bone marrow disease; hematologic diseases; neoplastic processes; imatinib; dasatinib; enzyme inhibitor; protein kinase inhibitor

Summary:

      To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+
      chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant
             to either imatinib or dasatinib

          -  Karnofsky ≥ 50% for patients > 10 years of age and Lansky ≥ 50 for patients ≤ 10 years
             of age

          -  Adequate renal, hepatic and pancreatic function

          -  Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of
             normal)

          -  Written informed consent

        Key Exclusion Criteria:

          -  Treatment with strong CYP3A4 inhibitors or inducers

          -  Use or planned use of any medications that have a known risk or possible risk to
             prolong the QT interval

          -  Acute or chronic liver, pancreatic or severe renal disease

          -  History of pancreatitis or chronic pancreatitis.

          -  Impaired cardiac function

          -  No evidence of active graft vs host and <3mo since Stem Cell Transplant

          -  Total body irradiation (TBI) or craniospinal radiation therapy <6months

          -  Hypersensitivity to the active ingredient or any of the excipients including lactose.

          -  the criteria regarding pregnancy and contraception

          -  Active or systemic bacterial, fungal, or viral infection

          -  known Hepatitis B, Hepatitis C, or HIV infection
Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: bortezomib; thalidomide
Intervention MeSH terms: Thalidomide; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II multiple myeloma; stage III multiple myeloma

Summary:

      RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood
      flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide
      works in treating patients with newly diagnosed stage II or stage III multiple myeloma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Newly diagnosed Salmon-Durie stage II or III multiple myeloma

               -  Untreated disease OR patient underwent prior therapy for this cancer that lasted
                  no more than 2 weeks

          -  Measurable paraprotein in serum or urine (serum free-lite assay measurement allowed)

          -  No evidence of cord compression requiring concurrent steroids

        PATIENT CHARACTERISTICS:

          -  Creatinine clearance ≥ 30 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use 2 methods of contraception, including ≥ 1 highly effective
             method, 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment

          -  No known HIV positivity

          -  No peripheral neuropathy ≥ grade 2

          -  No hypersensitivity to bortezomib, boron, or mannitol

        PRIOR CONCURRENT THERAPY:

          -  No prior bortezomib

          -  More than 28 days since prior regimens with a duration of > 1 week but ≤ 2 weeks

          -  No steroids within 14 days prior to study entry

          -  No concurrent corticosteroids except for the treatment of a nonmalignant condition

               -  May not exceed the equivalent dose of prednisone 10 mg/day

          -  No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery

          -  No other concurrent investigational agents
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)
Condition: Parkinson Disease; Cognitive Dysfunction
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Intervention: SAGE-718
Intervention description: Oral tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The study had two parts: Part A and Part B with unique participants for each study part. Part B was started after Part A was completed.
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Cognitive Dysfunction; SAGE-718

Summary:

      The primary purpose of this two-part study was to evaluate the safety and tolerability of
      SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants
      with Parkinson's disease mild cognitive impairment (PD-MCI).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic PD
             according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria; Meet
             MDS Task Force Criteria for MCI in PD.

          2. Have a score of 20 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at
             Screening.

          3. Meet criteria for Hoehn & Yahr Stage I to III (mild to moderate motor severity) at
             Screening.

          4. Have stable motor symptoms for at least 4 weeks prior to screening, in the opinion of
             the investigator.

        Exclusion Criteria:

          1. Have a diagnosis of dementia of any etiology, including but not limited to: Dementia
             associated with PD (probable or possible), Dementia with Lewy Bodies, Alzheimer's
             Dementia, and Vascular Dementia.

          2. Have any indication of parkinsonism other than idiopathic PD.

          3. In the opinion of the investigator, be experiencing unpredictable fluctuations in
             motor and/or nonmotor symptoms associated with PD.

          4. Have an ongoing central nervous system condition other than idiopathic PD, including
             active neurologic and/or nonremitted psychiatric disorders, in the opinion of the
             investigator.

          5. Have a history of brain surgery, deep brain stimulation, a significant head injury
             causing loss of consciousness greater than 30 minutes, or hospitalization due to a
             brain injury.

          6. Have experienced significant psychotic symptoms within the past 3 months, including
             those associated with PD medications, as determined by the investigator.
The Role of Contrast Enhanced Ultrasound in Appendicitis
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Intervention: Sulfur hexafluoride lipid-type A microspheres
Intervention description: Contrast Enhanced Ultrasound of the appendix
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: The CEUS image will be read at a future time by a Children's Mercy Hospital radiologist blinded to the results of the gray scale ultrasound and computed tomography (CT) scan if one was obtained; these will be used for comparison.
Enrollment: 37.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study seeks to determine the efficacy of Contrast Enhanced Ultrasound (CEUS) in
      improving the diagnosis of acute appendicitis in children, when compared to the standard
      grey-scale ultrasound.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present to Children's Mercy Adele Hall campus with a clinical concern for acute
             appendicitis

          -  Age 8 through 17 years

          -  seen between Institutional Review Board (IRB) approval date and 12/31/2019

          -  Seen Monday- Friday between the hours of 9:00 a.m. and 4:00 pm

          -  Has had an IV catheter placed as part of their standard of care

        Exclusion Criteria:

          -  Known cardiac abnormality

          -  Pulmonary hypertension

          -  Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000,
             distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium
             (DPPG-Na), or palmitic acid

          -  Does not had an IV catheter placed

          -  Unable to roll over

          -  Unable to assent

          -  Pregnant

          -  Lactating

          -  Received an ultrasound image from a referring facility
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
Condition: Opioid Abuse
MeSH terms: Opioid-Related Disorders
Intervention: Acurox 5/30mg taken first; Oxycodone 5mg taken first
Intervention description: followed by oxycodone 5mg with 48 hour washout; followed by Acurox 5/30mg with 48 hour washout
Intervention MeSH terms: Oxycodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Abuse Liability; Abuse Prevention; Abuse Resistance; Abuse Deterrence

Summary:

      The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual
      recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40
      mg alone in subjects with a history of opioid abuse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female between 18 and 55 years of age

          -  Subject meets DSM-IV Criteria for the Diagnosis of Opioid Substance Abuse and subject
             is unlikely to experience an idiosyncratic reaction or respiratory depression after
             ingesting 40 mg of oxycodone

          -  Body weight is not more than 20% above or below ideal body weight

          -  Subject agrees to abstain from any Rx or OTC drugs (except as authorized by the
             Investigator) or alcohol

          -  Subject is in generally good health

          -  Subject is reliable, willing, cooperative, able to communicate effectively, and has a
             minimum of a 6th grade reading level

          -  Subject has an acceptable score on the MMSE for cognitive impairment

          -  For women of child-bearing potential: woman is not pregnant and not nursing, and is
             practicing an acceptable method of birth control

        Exclusion Criteria:

          -  Subject has a disease that may endanger the subject or the validity of the data

          -  Subject is currently physically dependent on opiates or alcohol

          -  Subject was exposed to any investigational drug within 30 days prior to the inpatient
             phase

          -  Subject has a history of hypersensitivity to any drug, or a known allergy to any
             component of the study drug formulation

          -  Subject has a positive urine drug screen for a non-opiate drug

          -  Subject has a predisposing condition that may place the subject at risk for receiving
             niacin or oxycodone, or confound the study analyses

          -  Subject ingested niacin at doses higher than SDI within 14 days prior to the inpatient
             phase

          -  Subject has an abnormal bleeding tendency
Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies
Condition: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplasia; Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hematologic Neoplasms
Intervention: Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Palifermin
Intervention description: 8 Gy on Day -9; 5 mg/kg/d on Day -8 to -7; 40 mg/m2/d on Day -6 to -3; 2.5 mg/kg/d on Day -5 to -2; 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Intervention MeSH terms: Fludarabine; Thiotepa; Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an
      improvement in treatment-related mortality (TRM) rate at 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid
             leukemia (AML) with one or more of the following criteria

               -  CR 1 with poor risk features

               -  CR 2, or higher order CR

          -  Acute lymphoblastic leukemia (ALL) with one of the following criteria

               -  CR 1 with poor risk features

               -  CR 2, or higher order CR

          -  Myelodysplasia, RAEB I

          -  Donor has been identified

          -  Age ≤ 65 years.

          -  Performance Status 0-1.

        Exclusion Criteria:

          -  Patients relapsing <6 months after autologous SCT are not eligible.

          -  Patients with active infections requiring oral or intravenous antibiotics are not
             eligible for enrollment until resolution of infection.

          -  Non-pregnant and non-nursing
Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Condition: Ocular Hypertension; Primary Open-Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: AGN-210961 Formulation 1; AGN-210961 Formulation 2; AGN-210961 Formulation 3; AGN-210961 Formulation 4; AGN-210961 Formulation 5; AGN-210961 Formulation 6; AGN-210961 Formulation 7; bimatoprost ophthalmic solution 0.03%
Intervention description: AGN-210961 Formulation 1 in one eye once daily for 7 days.; AGN-210961 Formulation 2 in one eye once daily for 7 days.; AGN-210961 Formulation 3 in one eye once daily for 7 days.; AGN-210961 Formulation 4 in one eye once daily for 7 days.; AGN-210961 Formulation 5 in one eye once daily for 7 days.; AGN-210961 Formulation 6 in one eye once daily for 7 days.; AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.; bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.
Intervention MeSH terms: Bimatoprost; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of
      AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in
      the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a
      formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost
      ophthalmic solution 0.03% for 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        - Ocular hypertension or primary open-angle glaucoma in each eye

        Exclusion Criteria:

          -  Any active ocular disease

          -  Anticipated wearing of contact lenses during study

          -  Anticipated use of artificial tears during study

          -  Contraindication to pupil dilatation