bioihbjkbjnl/mcl2 huggingface dataset:
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Condition: Locally Advanced Breast Carcinoma; Metastatic Breast Carcinoma; Recurrent Breast Carcinoma; Stage III Breast Cancer AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7
MeSH terms: Carcinoma; Breast Neoplasms
Intervention: Laboratory Biomarker Analysis; Nab-paclitaxel; Questionnaire Administration
Intervention description: Correlative studies; Given IV; Ancillary studies
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects of nab-paclitaxel in treating older patients
      with breast cancer that has spread from where it started to nearby tissue or lymph nodes
      (locally advanced) or to other places in the body (metastatic). Drugs used in chemotherapy,
      such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by
      killing the cells, by stopping them from dividing, or by stopping them from spreading.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic breast cancer

          -  Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth
             factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel
             alone

          -  First or second line chemotherapy treatment for metastatic disease

          -  Karnofsky performance status (KPS) >= 70%

          -  Resolution of grade >= 2 toxicity from prior therapy (other than alopecia)

          -  Peripheral neuropathy =< grade 1

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Platelets >= 100,000 cells/mm^3

          -  Hemoglobin (Hb) >= 9.0 g/dl

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x
             institutional upper limit of normal

          -  Alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present
             in the absence of liver metastases

          -  Bilirubin =< 1.5 mg/dl

          -  Creatinine clearance (calculated or 24 hour) >= 30 ml/min

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients may not be receiving any other investigational agents

          -  Untreated central nervous system (CNS) metastases or symptomatic CNS metastases
             requiring escalating doses of corticosteroids

          -  Known history of allergic reactions to paclitaxel

          -  Presence of any serious or uncontrolled infection

          -  Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
A Pilot Study of TRV130 for the Treatment of Fracture Pain
Condition: Pain
MeSH terms: Fractures, Bone
Intervention: TRV130
Intervention description: Drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain; Long bone; Fracture

Summary:

      The primary objective is to evaluate the analgesic efficacy of TRV130 for moderate to severe
      acute pain in patients presenting to the emergency department (ED) with a suspected/known,
      unilateral, closed long bone fracture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65 years, inclusive

          -  Has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both)
             OR tibia, fibula (or both) BUT not fractures in more than 1 extremity

          -  Able to understand and comply with study procedures and requirements, and provide
             written informed consent

        Exclusion Criteria:

          -  Significant concomitant head, chest, or abdominal trauma

          -  Multiple extremity trauma

          -  Open fracture

          -  Clinically significant medical condition or history of such condition that may place
             the patient at an unacceptable risk in the trial, may interfere with the
             interpretation of efficacy, safety, or tolerability data obtained in the trial, or may
             interfere with the absorption, distribution, metabolism, or excretion of drugs
Low Dose Naltrexone for Glioma Patients
Condition: Malignant Glioma
MeSH terms: Glioma
Intervention: LDN; Placebo
Intervention description: Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.; Randomized patients received placebo to be taken every night before bed.
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: malignant glioma; glioblastoma multiforme; quality of life; naltrexone

Summary:

      To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in high
      grade glioma patients undergoing standard chemoradiation
    

Eligibility criteria:

        Inclusion Criteria:

          -  written informed consent prior to beginning specific protocol procedures

          -  histologically proven high-grade glioma

          -  planned treatment with concurrent radiotherapy and daily oral temozolomide (with or
             without Avastin)

          -  ≥ 18 years of age

          -  Karnofsky performance index ≥ 70%

          -  must be able to ambulate unassisted for 6 minutes safely

          -  The Preston Robert Tisch Brain Tumor Center (PRT-BTC) neuro-oncologist's approval

          -  hematocrit ≥ 29%, hemoglobin ≥ 9, absolute neutrophil count (ANC) ≥ 1,500
             cells/microliter, platelets ≥ 100,000 cells/microliter

          -  serum creatinine < 1.5 times upper limit of normal, serum glutamic oxaloacetic
             transaminase (SGOT) < 2.5 times upper limit of normal and bilirubin < 2.0 times upper
             limit of normal

          -  if sexually active, patients will take contraceptive measures for the duration of the
             treatments

          -  Women of childbearing potential must have a negative serum pregnancy test within 48
             hours prior to administration of study drug

        Exclusion Criteria:

          -  prior therapy with naltrexone or naloxone

          -  co-medication that may interfere with study results, e.g. opioids,

          -  known hypersensitivity to any component of naltrexone

          -  pregnant (positive pregnancy test) or lactating
A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Gemcitabine; Carboplatin; Herceptin
Intervention description: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion).; Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion).
Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).
Intervention MeSH terms: Carboplatin; Gemcitabine; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purposes of this study are to determine the safety of gemcitabine and paraplatin either
      with or without trastuzumab Any side effects that might be associated with these compounds.
      Whether the two or three drugs listed above when given in combination can help patients with
      metastatic breast cancer. How long the treatment will stop the growth of the cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of metastatic breast cancer

          2. Able to visit the doctor's office at least every 14 days during the actual treatment

          3. Able to care for yourself, even if you cannot work or participate in other normal
             activities

          4. Your blood results must be adequate for therapy.

          5. If you are a female of childbearing potential and test negative for pregnancy, use a
             reliable method of birth control during and for three months following the last dose
             of study drug.

        Exclusion Criteria:

          1. Have received gemcitabine, paraplatin, or trastuzumab for your cancer.

          2. Be pregnant or breastfeeding

          3. Have cancer to the brain and has not been treated

          4. Have another active cancer besides breast cancer

          5. Have received stem cell or bone marrow transplant for hematologic (blood type) cancer
A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
Condition: Obesity; Overweight
MeSH terms: Overweight
Intervention: LIK066; Placebo
Intervention description: LIK066 will be supplied in different doses as tablets to be taken orally.; Placebo
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Obesity; Overweight

Summary:

      This was a dose-finding study that evaluated the change in weight after 24 weeks treatment
      with 8 different doses of LIK066 compared to placebo in obese or overweight adults, followed
      by 24 weeks treatment with 2 doses of LIK066 and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. informed consent

          2. (BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia,
             pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)

          3. willing to comply with life-style intervention and treatment during the full duration
             of the study (approximately 54 weeks)

        Exclusion Criteria:

          -  Hypersensitivity to any of the study medications

          -  Pregnancy or lactating women

          -  History of malignancies

          -  Use of pharmacologically active weight loss products

          -  Bariatric surgery

          -  Ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening
             visit.

          -  HbA1c >10% at the screening visit.
Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Condition: Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Gefitinib; AZD9291; Selumetinib+Docetaxel; Tremelimumab
Intervention description: Gefitinib once daily followed by MEDI4736; AZD9291 once daily followed by MEDI4736; Selumetinib twice daily + docetaxel, followed by MEDI4736; Tremelimumab every 4 weeks followed by MEDI4736
Intervention MeSH terms: Docetaxel; Gefitinib; Tremelimumab; Osimertinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Lung cancer; NSCLC

Summary:

      Primary objective: To assess the efficacy of various sequences of either a small molecule or
      an IMT (IMT-A) followed by a IMT-B (MEDI4736) .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of archived tumor tissue sample and mandatory tissue biopsy

          -  Patients must have either histologically or cytologically documented NSCLC who present
             with locally advanced or metastatic stage IIIB-IV disease

          -  Life expectancy ≥12 weeks

          -  Patients must have measurable disease and at least 1 lesion not previously irradiated

          -  World Health Organization (WHO) performance status of 0 or 1

        Exclusion Criteria:

          -  Mixed small cell and NSCLC histology

          -  Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation
Condition: Atrial Fibrillation; Thromboembolism
MeSH terms: Atrial Fibrillation; Thromboembolism
Intervention: Edoxaban (DU-176b); Edoxaban (DU-176b); Edoxaban (DU-176b); Edoxaban (DU-176b); warfarin
Intervention description: 30mg tablet once daily; 60mg tablet once daily; 30mg tablet two times a day; 60mg tablet two times a day; warfarin tablets
Intervention MeSH terms: Warfarin; Edoxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1146.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Anti-coagulant; Non-valvular; Venous Thromboembolism; Prevention of Blood Clots; Atrial Fibrillation; Non-valvular atrial fibrillation

Summary:

      This study is to assess the safety of a potential new drug DU-176b for the prevention of
      stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation
      (AF). The duration is 3 months of treatment and a 30 day follow-up visit.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, 18 to 80 years old.

          2. Able to provide written informed consent.

          3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)

          4. A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke
             (CHADS2) index score of at least 2

        Exclusion Criteria:

          1. Subjects with mitral valve disease or previous valvular heart surgery

          2. Known contraindication to any anticoagulant including vitamin K antagonists such as
             warfarin

          3. Known or suspected hereditary or acquired bleeding or coagulation disorder
Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Ibodutant; Ibodutant; Ibodutant; Placebo
Intervention description: Oral tablet, dose level 1 (10 mg), once daily; Oral tablet, dose level 2 (30 mg), once daily; Oral tablet, dose level 3 (60 mg), once daily; Oral tablet matching the three dose levels of ibodutant, once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 554.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome; Bowel disease

Summary:

      The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant
      (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients aged 18 - 70 years.

          2. Clinical diagnosis of IBS .

          3. For patients older than 50 years or patients with positive family history of
             colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy.

          4. Use of appropriate contraceptive methods.

          5. Normal physical examination or without clinically relevant abnormalities.

        Exclusion Criteria:

          1. Patients with organic abnormalities of the gastro-intestinal tract including history
             of colonic or major abdominal surgery, current or previous diagnosis of neoplasia,
             inflammatory bowel diseases, symptomatic gallbladder stone disease,
             diverticulosis/diverticulitis, ectopic endometriosis.

          2. History of gluten enteropathy.

          3. Lactose intolerance as assessed by response to diet

          4. Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.

          5. Previous diagnosis of Diabetes Mellitus (either type 1 or 2)

          6. Unstable medical condition.

          7. Concomitant medication within 7 days prior to screening with drugs known to interfere
             with gastro-intestinal motility and sensitivity.

          8. Pregnancy or breastfeeding.

          9. Patient not able to understand or collaborate throughout the study.

         10. Participation in other clinical trials in the previous 4 weeks.
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Intervention: Oral testosterone undecanoate (containing 300 mg T)
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Primary hypogonadism; Secondary hypogonadism

Summary:

      The purpose of the study is to determine the effect of food with various amounts of fat on
      the absorption of an oral testosterone undecanoate formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male

          -  Age 18-65

          -  Morning serum testosterone (T) <300 ng/dL on two occasions

        Exclusion Criteria:

          -  Significant intercurrent disease

          -  Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history
             of prostate cancer.

          -  Serum transaminases >2 times upper limit of normal

          -  Serum bilirubin >2.0 mg/dL

          -  Hematocrit <35% or >50%

          -  BMI >36

          -  Untreated, obstructive sleep apnea.
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: PF-06700841; Placebo
Intervention description: Starting after the Week 16 visit, subjects receiving PF-06700841 10 mg once daily will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.; Starting after the Week 16 visit, subjects receiving placebo will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Spondyloarthritis

Summary:

      This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to
      evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3
             swollen joints.

          -  Active plaque psoriasis at screening and baseline.

        Exclusion Criteria:

          -  Non-plaque forms of psoriasis (with exception of nail psoriasis).

          -  History of autoimmune rheumatic disease other than PsA; also prior history of or
             current, rheumatic inflammatory disease other than PsA.
Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Condition: Growth Hormone Deficiency (GHD)
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Intervention: ACP-001; Human Growth Hormone
Intervention description: Once weekly subcutaneous injection; Once daily subcutaneous injection of human Growth Hormone
Intervention MeSH terms: Hormones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Human Growth Hormone; rhGH; hGH; GHD

Summary:

      A six month study of ACP-001, a long-acting growth hormone product, versus standard human
      growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone
      (hGH) will be given on a daily basis. The primary aim is to demonstrate safety,
      pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is
      the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH
      treatment group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prepubertal children, Tanner stage 1

          -  Diagnosis of GHD, confirmed by two stimulation tests

          -  Bone age not greater than chronological age

          -  Impaired height and height velocity

          -  BMI within +/- 2 SD (standard deviations)

          -  Baseline IGF-1 (insulin-like growth factor)

          -  Normal fundoscopy

          -  Stable hormonal replacement therapy (other than hGH)

          -  Written Informed Consent

        Exclusion Criteria:

          -  Prior exposure to rhGH or IGF-I

          -  Past or present intracranial tumor; history or presence of malignant disease

          -  Small for gestational age (SGA)

          -  Malnutrition

          -  Psychosocial dwarfism

          -  Coeliac disease

          -  Anti-hGH antibodies

          -  Diabetes mellitus

          -  Chromosomal abnormalities (e.g. Turner syndrome, SHOX)

          -  Closed epiphyses

          -  Known or suspected HIV infection