bioihbjkbjnl/mcl2 huggingface dataset:
Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: CP-751,871; docetaxel; prednisone; docetaxel; prednisone
Intervention description: CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days).; Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.; Prednisone is administered at a dose of 5 mg twice daily.; Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2.; Prednisone is administered at a dose of 5 mg twice daily.
Intervention MeSH terms: Prednisone; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: randomized; non-comparative; efficacy

Summary:

      To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of
      prostate cancer that is refractory to hormone therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of metastatic, progressive hormone refractory prostate cancer

          -  Adequate bone marrow, liver and kidney function

        Exclusion Criteria:

          -  Previous treatment with chemotherapy
Topical Ruxolitinib Lichen Planus
Condition: Lichen Planus
MeSH terms: Lichen Planus
Intervention: INCB018424
Intervention description: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Topical INCB018424
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed
      by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment
      and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and
      Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict
      responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA
      sequencing on responsive and non-responsive tissue at week 4.
    

Eligibility criteria:

        Subjects must be able to understand and comply with the requirements of the study and
        communicate with the investigator.

        Subjects must give written, signed, and dated informed consent before any study related
        activity is performed.

        When appropriate, a legal representative will sign the informed consent according to local
        laws and regulation

        Both men and women must be at least 18 years of age at the time of screening

        Subjects must have clinical and histological features of LP

        LP must involve between 2 and 20% of the BSA

        Subjects must have a minimum of 10 lesions of LP

        Subjects must have treatment naive cutaneous LP or treatment refractory disease, as defined
        by failure of at least one established treatment for LP

        Failure of prior therapy Topical treatment Systemic immunosuppressant Oral metronidazole
        Oral sulfasalazine Oral retinoid
Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Tetrahydrobiopterin (BH4); Antioxidant Cocktail
Intervention description: 12 week intervention; 12 week intervention
Intervention MeSH terms: Vitamins; Vitamin E; Thioctic Acid; Antioxidants
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Flow-Mediated Dilation; Kuvan; Antioxidant; FEV1

Summary:

      Chronic obstructive pulmonary disease (COPD) affects up to 14 million people and is among the
      top five leading causes of death worldwide. Although COPD is a disease of the lungs, recent
      evidence indicates that COPD is associated with multiple systemic consequences including
      vascular endothelial dysfunction. Recently, it has been suggested that more patients with
      COPD die from cardiovascular disease and coronary heart disease than of direct pulmonary
      complications. Examination of the mechanisms that contribute to a reduction nitric oxide (NO)
      bioavailability resulting in vascular endothelial dysfunction in patients with COPD are
      important as endothelial dysfunction has been indicated to be an independent predictor of
      future atherosclerotic cardiovascular disease and events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with medically diagnosed COPD

          -  apparently healthy controls

        Exclusion Criteria:

          -  FEV1/FVC >0.7 (normal lung function in patients only)

          -  Clinical diagnosis of heart disease or diabetes

          -  Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)

          -  uncontrolled high blood pressure

          -  high blood pressure in your lungs

          -  thyroid problems

          -  Fluid in the lungs

          -  Sleep apnea

          -  Anemia

          -  Raynaud's Phenomenon

          -  GI bleeding

          -  Gangrene of the digits

          -  History of low platelets or coagulopathies

          -  Phenylketonuria (PKU)

          -  Any allergy to Kuvan
A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
Condition: Solid Tumor
MeSH terms: Carcinoma, Renal Cell
Intervention: CVX-060 + sunitinib; CVX-060 + sunitinib; CVX-060 + sunitinib; CVX-060 + sunitinib; CVX-060 + sunitinib; Sunitinib
Intervention description: CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks); CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks); CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks); CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks); CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks); 50 mg sunitinib daily (4 out of 6 weeks)
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060

Summary:

      The safety and tolerability of CVX-060 have been established in the first-in-human clinical
      trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics
      (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and
      to subsequently assess the treatment efficacy of the combination treatment, as well as that
      of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced/metastatic solid tumor

          -  Having received at least 1 prior systemic therapy for the treatment of
             advanced/metastatic solid tumors

          -  Histologically or cytologically confirmed renal cell carcinoma with clear cell
             histology and evidence of metastasis (No previous systemic therapy for the treatment
             of metastatic renal cell carcinoma)

          -  Adequate laboratory tests

          -  Eastern Cooperative Oncology Group (ECOG) 0-1, Life expectancy > or = 12 weeks and age
             > or = 18 years

        Exclusion Criteria:

          -  Patients intolerant of prior anti-angiogenic agents

          -  Recent history of bleeding or bleeding disorders

          -  History of tumors in the brain

          -  History of heart problems

          -  History of severe allergic reaction to antibody therapy
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
Condition: Accidental Falls; Fall Due to Loss of Equilibrium; High Risk of Falls Due to Mobility Limitation; Diabetes; Arthritis; Cancer; Peripheral Arterial Disease; Parkinson's Disease; End Stage Renal Failure on Dialysis
MeSH terms: Parkinson Disease; Kidney Failure, Chronic; Peripheral Arterial Disease; Peripheral Vascular Diseases; Mobility Limitation
Intervention: MBB AFO; Control
Intervention description: Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO; Subjects will be provided with a pair of New Balance 813 shoes
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Ankle Foot Orthoses; falls; Fall Prevention; Frailty; Concern for falls; Footwear; Mobility

Summary:

      The investigators propose a randomized control trial to evaluate long term effects and
      effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of
      falling in older adults.

      Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling,
      frailty status, and adverse events

      Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical
      activities • Characterize the feasibility of the MBB AFO device on patient adherence,
      acceptability, user-friendliness, and perception of benefit for daily usage
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 65 or older

          -  High concerns or high risk of fall

          -  Ambulatory

        Exclusion Criteria:

          -  Presence of an active wound infection on either of the foot and ankle

          -  Use of medication or a medical condition that may have unstable (fluctuate over time)
             or temporary (less than one month) impact on gait and balance

          -  Acute fractures on the foot

          -  Participant of an interventional study within the last 30 days

          -  Non-ambulatory or unable to stand without help or walk a distance of at least 1.8 m
             (~six feet) without assistance

          -  Major foot amputation

          -  Unable or unwilling to participate in all procedures
A Study of Whole Brain Radiation Therapy and Capecitabine in Breast Cancer Participants With Newly Diagnosed Brain Metastasis
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Brain Neoplasms
Intervention: WBRT; Capecitabine; Standard of Care
Intervention description: 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction).; 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2.; The choice of standard of care will be at the discretion of the treating oncologist. The protocol does not specify any particular standard of care treatment.
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, randomized, parallel arm study will evaluate the effect of capecitabine
      administered concurrently with WBRT and as maintenance therapy in participants with breast
      cancer and newly diagnosed brain metastases. Participants will be randomized to receive
      either capecitabine with 10 days standard WBRT, or WBRT alone. Maintenance therapy will
      follow with capecitabine or another systemic therapy in the WBRT only group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with histologically confirmed breast cancer with known human epidermal
             receptor-2 (HER2) and hormone status

          -  Newly diagnosed CNS metastasis with at least one brain lesion measuring greater than
             or equal to (>/=) 1 centimeter (cm) or two lesions measuring >/= 0.5 to less than (<)
             1 cm in longest dimension

          -  Participant not eligible for or refusing surgery or stereotactic radiosurgery

          -  Eastern cooperative oncology group (EOCG) performance status 0 to 2

        Exclusion Criteria:

          -  Prior treatment of brain metastases

          -  Leptomeningeal disease

          -  Known contra-indication to radiotherapy or magnetic resonance imaging (MRI) or
             capecitabine
Rapid Antidepressant Effects of Leucine
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: L-Leucine; Maltodextrin
Intervention description: L-leucine is an essential amino acid which will be provided as an effervescent powder mixture to participants.; Maltodextrin is a nonsweet carbohydrate which will be provided as an effervescent powder mixture similar in taste and appearance to the L-leucine containing effervescent powder mixture
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Antidepressant; Inflammation; Biomarker; Depression; Treatment Resistant Depression; Leucine

Summary:

      This randomized double-blind placebo-controlled crossover study seeks to evaluate the
      antidepressant effect of L-leucine, an essential amino acid, in patients with Major
      Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current primary diagnosis of nonpsychotic major depressive disorder.

          -  Stable antidepressant dose of no more than one antidepressant medication for 4 weeks
             and no anticipated changes during the study period.

          -  Stable doses of all concomitant medications for over 6 weeks.

          -  No more than two failed antidepressant trials of adequate dose and duration, as
             defined by ATRQ, in the current episode.

        Exclusion Criteria:

          -  Psychiatric co-morbidity posing safety risk.

          -  Pregnant or breastfeeding or plan to become pregnant over the ensuing 2 months
             following study entry or are sexually active and not using adequate contraception

          -  Exclusionary psychiatric conditions (such as substance dependence in the last 6
             months, substance abuse in the last 2 months, or lifetime history of psychotic
             disorders.

          -  Unstable or terminal general medical condition (GMC).

          -  Concomitant medications that interact with L-leucine (e.g. sildenafil).

          -  Vagus nerve stimulation, ECT, or rTMS, or other somatic antidepressant treatment
             during current episode

          -  Inadequately controlled hypothyroidism.

          -  Therapy that is depression specific, such as CBT or Interpersonal Psychotherapy of
             Depression.

          -  Hypersensitivity to L-leucine

          -  Have Maple Syrup Urine Disease.
Auranofin in Decreasing Pain in Patients With Paclitaxel-Induced Pain Syndrome
Condition: Pain
Intervention: auranofin; placebo; questionnaire administration
Intervention description: Given PO; Given PO; Ancillary studies
Intervention MeSH terms: Auranofin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized pilot clinical trial studies whether auranofin will relieve pain following
      paclitaxel in patients who have previously experienced paclitaxel-induced pain. Auranofin is
      a drug given by mouth to treat other diseases such as rheumatoid arthritis, and is being
      studied to see if it will decrease pain following paclitaxel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Absolute neutrophil count (ANC) >= 1500/mm^3

          -  Platelet count (PLT) >= 100,000/mm^3

          -  Creatinine =< 2 x upper limit of normal (ULN)

          -  Either serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT])
             or serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])
             =< 1.5 x ULN

          -  Total/direct bilirubin =< 1.5 x ULN

          -  Alkaline phosphatase =< 1.5 x ULN

          -  Hemoglobin >= 9 mg/dL

          -  Negative urine or serum pregnancy test performed =< 7 days prior to registration, for
             women of childbearing potential only

          -  Previously experienced paclitaxel induced pain during a current or past paclitaxel
             treatment that the treating healthcare provider thinks is consistent with the
             paclitaxel-induced acute pain syndrome; note: formal documentation of prior pain is
             not required

          -  Scheduled to receive paclitaxel at a dose >= 70 mg/m^2 =< 14 days from randomization

          -  Ability to complete the questionnaires or to do so with assistance

        Exclusion Criteria:

          -  Pregnant women

          -  Nursing women

          -  Any woman of childbearing potential or male partner of a woman of childbearing
             potential unwilling to employ acceptable contraception throughout the study and for at
             least 30 days after the last dose of the study drug

          -  History of gold-induced disorders, including but not limited to, necrotizing
             enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasias or
             other severe hematologic disorders; history of severe allergic or anaphylactic
             reactions or hypersensitivity to auranofin or other gold compounds

          -  Currently receiving Dilantin (phenytoin) or auranofin or another gold-containing
             compound

          -  Anticipated use of filgrastim (G-CSF) or sargramostim (GM-CSF) within 30 days after
             receiving auranofin

          -  Currently receiving immune-modulating therapies
Buprenorphine's Dose Response Curve
Condition: Opioid-related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: Buprenorphine; Morphine; Placebo
Intervention description: Intramuscular, doses (8, 16, 32, 48, 60 mg) are blind; administered up to 1-2 times per week.; Intramuscular; up to 1-2 times per week; doses (15, 30 mg) double blind; Intramuscular; double blind; once per week
Intervention MeSH terms: Morphine; Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Opioid addiction; Opioid dependence; Buprenorphine

Summary:

      This is a residential study that looks at the effects of buprenorphine in persons who abuse
      but are not dependent on opioids. Animal studies show that very high doses of buprenorphine
      produce less effects than mid-range doses. This suggests that buprenorphine can be a very
      safe medication. However, no studies in humans have tested higher doses in a similar way. The
      goal of this study is to show the effects of single doses of buprenorphine, across a range of
      doses, in persons who are not physically dependent on opioids (but do abuse opioids).
    

Eligibility criteria:

        Inclusion Criteria:

        1. current opioid abuse but not physically dependent on opioids

        Exclusion Criteria:

          1. evidence of significant medical (e.g., insulin dependent diabetes) or psychiatric
             (e.g., schizophrenia) illness

          2. anemia defined as a hematocrit less than 30%

          3. females are required to provide a negative pregnancy test prior to study participation

          4. baseline electrocardiogram (ECG) showing prolongation of the corrected QT interval
             (QTc)

          5. current significant alcohol or sedative/hypnotic drug use

          6. Forced expiratory volume at one second (FEV1) of less than 50% at the time of
             screening

          7. applicants seeking treatment for their substance abuse will not be admitted to the
             study, and should be provided information about treatment services available
Study Effect of VIA-2291 on Vascular Inflammation
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Inflammation
Intervention: VIA-2291; Placebo
Intervention description: oral dosing, 1 time daily for 12 or 24 weeks; oral dosing, 1 time daily for 12 or 24 weeks
Intervention MeSH terms: Atreleuton
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 191.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various
      inflammatory biomarkers in patients with recent acute coronary events
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients are to be of non-childbearing potential

          -  Patient has suffered an ST elevation myocardial infarction (MI), non-ST elevation MI,
             or unstable angina 21 days (±3 days) prior to study randomization

          -  Patient has documented coronary artery disease

        Exclusion Criteria:

          -  Renal insufficiency defined as creatinine >1.5 x upper limit of normal (ULN)

          -  Cirrhosis, recent hepatitis, ALT >1.5 x ULN or ALT > 1 x ULN and at least one other
             liver function test

          -  Uncontrolled diabetes mellitus within 1 month prior to study screening

          -  Congestive heart failure (CHF) defined by the New York Heart Association as functional
             Class III or IV

          -  Previous coronary artery bypass graft (CABG) surgery

          -  Planned additional cardiac intervention

          -  Recurrence of ST elevation MI, non-ST elevation MI, or unstable angina less than 18
             days prior to randomization

          -  Current atrial fibrillation, atrial flutter, or frequent premature ventricular
             contractions

          -  Acetaminophen use in any form in the 7 days before enrollment