bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder
Condition: Depressive Disorder, Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Intervention description: tablet
subjects randomly assigned to 10-200 mg/day by age group
6 month treatment period(~182 days)
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: MDD; Depression; Pediatrics; Major Depressive Disorder

Summary:

      The primary purpose of this study is to evaluate the long-term safety and tolerability of
      Desvenlafaxine Succinate Sustained-Release (DVS SR) in child and adolescent outpatients with
      major depressive disorder. A secondary aim is to evaluate the efficacy of DVS SR in the
      treatment of child and adolescent outpatients with major depressive disorder in an
      exploratory manner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients who have completed 8-weeks of treatment in the preceding study,
             3151A6-2000, and who, in the opinion of the investigator, would benefit from long-term
             treatment.

          -  Study participants who are not surgically sterile or postmenopausal must agree and
             commit to the use of a reliable method of birth control for the duration of the study
             and for 15 days after the last dose of test article. Sexually active study
             participants must agree and commit to the use of condoms in addition to other
             contraceptive methods.

        Exclusion Criteria:

          -  Clinically important abnormalities on baseline physical examination or any clinically
             significant abnormality on electrocardiogram (ECG), laboratory test results, or vital
             signs recorded before the final study day (day 56 visit) of the preceding study
             3151A6-2000.

          -  Unresolved clinically significant adverse events or serious adverse events in the
             preceding study 3151A6-2000.

          -  Poor compliance with the preceding study 3151A6-2000, as assessed by the investigator
             and the medical monitor.

          -  Other exclusion criteria apply.
Cabozantinib for Metastatic Triple Negative BrCa
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Cabozantinib
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: 18 Years
Healthy volunteers: No
Keywords: Metastatic; Triple Negative; Stage IV

Summary:

      In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in
      metastatic breast cancer. Data suggest that MET expression and activation are important for
      initiation and progression of triple-negative breast cancer (TNBC). We evaluated the efficacy
      of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases, including
      MET and VEGFR2, in patients with metastatic TNBC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed invasive breast cancer with stage IV disease

          -  Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative

          -  May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer.
             Must be off treatment for at least 21 days prior to enrollment

          -  Must have discontinued all biologic therapy at least 14 days before enrollment

          -  May have received prior radiation therapy in the early stage or metastatic setting,
             but must have completed treatment at least 14 days prior to enrollment

          -  Must agree to use medically acceptable methods of contraception

          -  Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue

          -  Able to swallow tablets

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Received another investigational agent within 14 days prior to enrollment

          -  Received prior c-Met inhibitor

          -  Known brain metastases that are untreated, symptomatic or require therapy to control
             symptoms

          -  Psychiatric illness or social situation that could limit ability to comply with study
             requirements

          -  Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet
             agents

          -  Diagnosis of another malignancy requiring systemic treatment within the last two years
             (except non-melanoma skin cancer or in-situ carcinoma of the cervix)

          -  Known to be positive for HIV

          -  Active infection requiring IV antibiotics at Day 1 of cycle 1

          -  Uncontrolled, significant intercurrent illness

          -  Requires chronic concomitant treatment of a strong CYP3A4 inducer

          -  tumor in contact with, invading or encasing major blood vessels

          -  Have experienced clinically significant gastrointestinal bleeding within 6 months,
             hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs
             indicative of pulmonary hemorrhage within 3 months of enrollment
Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer
Condition: Lung Neoplasms; Carcinoma, Non-small Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Intervention: axitinib
Intervention description: Axitinib (AG-013736) tablet administered orally at a dose of 5 milligrams (mg) twice daily (BID) in cycles of 4 weeks.
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2 study being conducted at multiple centers in the United States and Germany.
      Patients having non-small cell lung cancer that has spread to other parts of the body (i.e.,
      metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are
      eligible to participate. Patients must have disease that has been treated with at least 1
      prior treatment for metastatic disease (prior adjuvant treatment for localized disease does
      not count as prior treatment for metastatic disease). The purpose of the study is to test
      whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small
      cell lung cancer as shown by the number of patients in the study who experience significant
      and durable tumor shrinkage
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented non-small cell lung cancer with metastases (Stage IV or
             recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion.

          -  At least 1 prior systemic therapy for metastatic disease (Prior adjuvant therapy for
             localized disease does not count as a prior therapy for metastatic disease).

        Exclusion Criteria:

          -  Central lung lesions involving major blood vessels (arteries or veins). (Central
             lesions that maintain the structural integrity of vessels have the potential to bleed
             if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any
             case where there is any question as to whether blood vessels are involved.)

          -  Patients with a history of Grade 2 or worse hemoptysis are not eligible. Patients with
             a history of Grade 1 hemoptysis within 30 days of entry are not eligible
Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Psychomotor Agitation; Aggression
Intervention: LY451395; Placebo
Intervention description: 3 mg LY451395 orally twice daily for 12 weeks; may have been reduced to 1 mg if participant was unable to tolerate; Placebo orally twice daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Agitation and Aggression

Summary:

      The purpose of this study is to determine whether this drug can help symptoms of aggression
      and agitation in participants with Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Community-dwelling participants with a diagnosis of probable Alzheimer's disease (AD)
             based on disease criteria from the National Institute of Neurological and
             Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Association. Mini
             Mental State Examination (MMSE) score from 6 to 26 inclusive; Neuropsychiatric
             Inventory-10 (NPI-10) total score greater than or equal to 10.

          -  Are men or women at least 60 years old.

          -  Weight greater than or equal to 45 kilograms (kg).

          -  Have clinically significant and persistent verbal or physical agitation and/or verbal
             or physical aggression behaviors that are disruptive to daily functioning or
             potentially harmful and occurred at least 3 days per week over the past 4 weeks prior
             to study entry.

          -  Understand English.

          -  Have a reliable and actively involved caregiver who must be able to communicate in
             English and be willing to comply with protocol requirements.

        Exclusion Criteria:

          -  Meet DSM-IV-TR or Delirium Rating Scale-Revised-98 criteria for delirium.

          -  Does not score ≤4 on the Modified Hachinski Ischemia Scale for vascular dementia.

          -  Have a magnetic resonance imaging (MRI) or computer tomography (CT) scan on file since
             the onset of symptoms of AD and performed within the past 24 months that is
             inconsistent with a diagnosis of AD.

          -  Have a current, required use, or expected use of psychoactive drugs or other
             medications not allowed in this trial.

          -  Have currently active significant medical, neurological, or psychiatric problems that
             are not allowed in this trial or other brain disorders.

          -  Have received acetylcholinesterase inhibitor (AChEIs) or memantine for less than 4
             months, or have less than 2 months of stable therapy on these treatments by Visit 2.
Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Boceprevir (BOC); PegIntron (PEG); Ribavirin (RBV)
Intervention description: 100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID; 1.5 mcg/kg weekly subcutaneously; 200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight [weight-based dosing {WBD}])
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: PEG-Intron; Ribavirin; Protease Inhibitor

Summary:

      The primary objective of this study is to determine the safe and effective dose range of
      boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic
      hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy
      with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin
      provides an additional benefit when combined with PEG-Intron plus boceprevir.
    

Eligibility criteria:

        Key inclusion criteria:

          -  Documented infection with chronic hepatitis C (CHC), genotype 1.

          -  Documented failure to respond to an adequate course of treatment (minimum 12 weeks)
             with peginterferon-alfa plus ribavirin (failure defined as <2 log drop in HCV-RNA
             after 12 weeks of therapy or those who never become Hepatitis C Virus Ribonucleic Acid
             (HCV)-RNA negative)

          -  No evidence of cirrhosis on liver biopsy.

          -  Results of physical examination and laboratory tests within specified ranges.

          -  Abstinence from use of abused substances.

        Key exclusion criteria:

          -  Women who are pregnant or nursing a child.

          -  Patients with cirrhosis, co-infection with Hepatitis B or human immunodeficiency virus
             (HIV), and African-American patients (by protocol amendment 2, African-American
             patients can enroll).

          -  Previous treatment with any Hepatitis C Virus (HCV) polymerase or protease inhibitor.

          -  Patients who relapsed following response to previous treatment.

          -  Evidence of advanced liver disease, or liver disease from a cause other than CHC.

          -  Pre-existing psychiatric condition.
Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients
Condition: Induction of Labor Affected Fetus / Newborn
Intervention: Propranolol; Placebo
Intervention description: After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol.; After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Study drug and placebo will be randomized and mixed to appear identical by the Mount Sinai Investigational Drug Service (IDS). The randomization code will be kept by the lead pharmacist of the IDS until completion of the trial, at which point data will be unmasked.
Enrollment: 240.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Induction; Labor; Propranolol

Summary:

      A randomized, prospective trial will be offered to women admitted to the labor floors at
      Mount Sinai Medical Center for labor induction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nulliparous women undergoing induction of labor

          -  >37 weeks' gestational age

          -  Non-anomalous, singleton cephalic presenting fetus.

        Exclusion Criteria:

          -  Multiple gestations, known fetal anomalies

          -  Maternal cardiac or hypertensive disease

          -  Chronic beta blocker use

          -  Bronchial asthma

          -  Maternal or fetal indication for immediate delivery.
A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: PF-04383119 (tanezumab); PF-04383119 (tanezumab); PF-04383119 (tanezumab); PF-04383119 (tanezumab); PF-04383119 (tanezumab); PF-04383119 (tanezumab)
Intervention description: single dose of 10 mcg/kg IV; single dose of 100 mcg/kg IV; single dose of 200 mcg/kg IV; single dose of 25 mcg/kg IV; single dose of 50 mcg/kg IV; single dose of Placebo IV
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: monoclonal antibody

Summary:

      To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese
      patients with moderate to severe pain from OA of the knee (Part I). To evaluate the
      preliminary analgesic efficacy of PF-04383119 in Japanese patients with moderate to severe
      pain from OA of the knee in comparison with placebo (Part I and Part II).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese Male or female, Age 35-65 (Part 1), Age 35-75 (Part 2)

          -  Diagnosis of osteoarthritis (OA) of the knee based on American College of Rheumatology
             criteria

          -  Knee pain, and radiographic evidence of knee OA (Kellgren-Lawrence x-ray grade ≥2)
             obtained within 1 year of enrollment

          -  At least one of the following: age >50, morning stiffness <30 minutes in duration,
             crepitus, and OA of the knee must involve the index tibiofemoral joint and must have
             present for at least 6 months

          -  Patients who meet at least one of the following: unwilling to take non-opiate pain
             medications, or for whom non-opiate pain medications have failed, or are candidates
             for or seeking invasive interventions such as intraarticular injections, knee
             arthroplasty, or total knee surgery

          -  Pain levels as required by the protocol at Screening and Baseline

        Exclusion Criteria:

          -  Diagnosis or history of RA, any inflammatory arthritis, gout, Paget's disease or any
             other disease that in the Investigator's opinion would interfere with the assessment
             of pain and other symptoms of OA

          -  Patients with regional pain syndromes suggestive of fibromyalgia or regional pain
             caused by lumbar or cervical compressions with radiculopathy or at risk of developing
             radiculopathy.

          -  Diagnosis or history of fibromyalgia

          -  Planned surgical procedure during the duration of the study
Development of Vitamin D as a Therapy for Breast Cancer - Phase 2
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Vitamin D
Intervention description: 0, 2000, 4000, and 6000 IU per day orally
Intervention MeSH terms: Vitamin D; Calcipotriene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess whether levels of vitamin D impact the characteristics of a woman's
      breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels
      of vitamin D changes the gene expression of their breast cancers.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Undergoing core needle biopsy for a breast abnormality suspicious for breast cancer.

          -  Has undergone a core needle biopsy demonstrating breast cancer and has not yet had any
             further therapy, provided the core needle biopsy is available for analysis.

          -  No prior therapy for breast cancer within the past 5 years.

          -  18 years of age or older.

          -  Ability to understand and the willingness to sign a written informed consent document.

        EXCLUSION CRITERIA:

          -  History of parathyroid disease, hypercalcemia, or kidney stones.

          -  Supplemental vitamin D other than from a standard multiple vitamin or from standard
             formulations of calcium and vitamin D (eg, calcium citrate with vitamin D) within the
             prior 6 months.

          -  History of renal failure requiring dialysis or kidney transplantation.

          -  Pregnant or nursing

          -  Receiving supplemental calcium > 1200 mg calcium per day during study.

          -  Initial treatment of breast cancer will not be with breast-conserving surgery or
             mastectomy.

          -  Locally-advanced breast cancer

          -  Plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy

          -  Plans for preoperative radiation therapy

          -  Plans for breast cancer surgery, and does not allow for at least 10 days of vitamin D
             intervention.

          -  Any condition potentially interfering with subjects ability to comply with taking
             study medication.

          -  Any medical condition that would potentially interfere with vitamin D absorption, such
             as celiac sprue, ulcerative colitis.

          -  Current participation in another research study that would increase risk to subject,
             in the opinion of the investigators
Preschool Wheeze: Inflammation/Infection Guided Management
Condition: Asthma
Intervention: Beclometasone; Co-amoxiclav; Azithromycin
Intervention description: Beclometasone dipropionate 200mcg bd for 4 months; Co-amoxiclav 0.3ml/kg bd for 4 weeks; Azithromycin 10mg/kg od for 4 weeks
Intervention MeSH terms: Azithromycin; Amoxicillin-Potassium Clavulanate Combination; Beclomethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Preschool; Wheeze; Moderate; Severe

Summary:

      This is a single-centre, randomised-controlled trial, comparing management of preschool
      wheeze. It specifically aims to compare management of preschool wheeze using current clinical
      guidelines to management determined by eosinophilic inflammation and infection. Participants
      will be children aged 1-5 years who have recurrent wheezing and will be allocated to one of
      two treatment groups, either current clinical care or pathological phenotype based
      management. They will be asked to make 2 study visits to the Royal Brompton Hospital over the
      course of 4 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Reported recurrent wheeze, needing at least 2 courses of oral steroids in the last 12
             months, at least one course of oral steroids in the last 6 months

          -  Past wheeze confirmed by a clinician

        Exclusion Criteria:

          -  Any known cardiac disease

          -  Any chronic respiratory condition (other than preschool wheeze) diagnosed by a
             physician

          -  Any chronic condition that increases susceptibility to respiratory tract infections
             such as severe developmental delay and feeding difficulty/unsafe swallow Prematurity
             <34 weeks, or requirement of ventilation in the newborn period History of neonatal
             chronic lung disease Family not contactable by telephone