bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: VVN539 Ophthalmic Solution 0.02%; VVN539 Ophthalmic Solution 0.04%; VVN539 Ophthalmic Solution Vehicle
Intervention description: Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days; Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days; Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-masked, randomized, parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple masking
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, parallel-comparison, multi-center, double-masked, randomized,
      vehicle-controlled dose-response study assessing the safety and ocular hypotensive efficacy
      of VVN539 in subjects with POAG or OHT. Three different dosing regimens (once a day [q.d.] in
      the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days, each.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older.

          -  Diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes that are
             untreated, or if treated, in the opinion of the investigator are well controlled on 2
             or fewer ocular hypotensive medications prior to Visit 1.

          -  Unmedicated intraocular pressure of ≥ 22 mm Hg and ≤ 36 mm Hg in the study eye, with
             no more than 5 mm Hg inter-eye difference at 08:00AM and 10:00AM at Visit 2.

          -  Corrected visual acuity in each eye +1.0 or better by Early Treatment Diabetic
             Retinopathy Scale in each eye (equivalent to Snellen 20/200)

        Exclusion Criteria:

          -  Known hypersensitivity to any kinase inhibitors, any excipient or preservative of the
             formulation or to topical anesthetics or fluorescein.

          -  Unmedicated IOP of > 36 mm Hg in either eye at any time point at Visit 2.
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: GS-9674; Placebo to match GS-9674
Intervention description: Tablet administered orally once daily; Tablet(s) administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Non-alcoholic fatty liver disease (NAFLD); Fibrosis; GS-9674

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in
      participants with nonalcoholic steatohepatitis (NASH).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Meets the following conditions:

               -  A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)

               -  Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF)
                  with ≥ 8% steatosis

               -  Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5
                  kilopascal (kPa) OR

               -  A historical liver biopsy within 12 months of screening consistent with NASH with
                  fibrosis, but not cirrhosis, and

               -  No documented weight loss > 5% between the date of the liver biopsy and
                  screening.

          -  Platelet count ≥ 150,000/mm^3

          -  Albumin ≥ 3.3 g/dL

          -  Serum creatinine ≤ upper limit of normal (ULN)

        Key Exclusion Criteria:

          -  Pregnant or lactating females

          -  Alanine aminotransferase (ALT) > 5x upper limit of the normal range (ULN)

          -  Other causes of liver disease including autoimmune, viral, and alcoholic liver disease

          -  Cirrhosis of the liver

               -  Prior history of decompensated liver disease, including ascites, hepatic
                  encephalopathy, or variceal bleeding

          -  Body mass index (BMI) < 18 kg/m^2

          -  Uncontrolled diabetes mellitus (hemoglobin A1c > 9% at screening)

          -  International normalized ratio (INR) > 1.2 unless on anticoagulant therapy

          -  Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Varenicline; Placebo
Intervention description: 0.5 mg once daily for 1 week followed by 0.5 mg twice daily for 1 week followed by 1 mg twice daily for 4 weeks; Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Efficacy; Safety; Pharmacokinetics; Alzheimer's disease

Summary:

      1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure
           of cognition in patients with mild to moderate Alzheimer's disease

        2. Evaluate the effects of varenicline on clinically relevant measures including attention
           and executive function, behavior, and clinician rated global change.

        3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients
           with mild to moderate Alzheimer's disease

        4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate
           Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, age 55-85

          -  Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1)
             National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's
             Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and
             Statistical Manual of Mental Disorders (DSM IV)

          -  Mini-mental status exam score of 14-26 inclusive

          -  Rosen-Modified Hachinski Ischemia Score of < or = 4

        Exclusion Criteria:

          -  Diagnosis or history of other dementia or neurodegenerative disorders

          -  Diagnosis or history of clinically significant cerebrovascular or cardiovascular
             disease

          -  Subjects with pulmonary disease or evidence of clinically significant pulmonary
             symptoms
A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Psychomotor Agitation; Aggression
Intervention: Group 1 ELND005; Group 2 ELND005
Intervention MeSH terms: Inositol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 296.0
Sex: All
Minimum age: 50 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Agitation; Aggression; AD patients

Summary:

      To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in
      Moderate to Severe AD patients with agitation and aggression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Complete Week 12 visit of AG201

          -  Both patient and study partner/caregiver are willing and able to participate in all
             scheduled evaluations and complete all required tests

        Exclusion Criteria:

          -  Is currently using any other investigational or experimental drugs or devices

          -  Has significant worsening of medical conditions or dementia such that it may preclude
             completion of this safety extension study
Proton Therapy in Reducing Toxicity in Anal Cancer
Condition: Anus Neoplasms
MeSH terms: Anus Neoplasms
Intervention: Proton therapy; Chemotherapy
Intervention description: Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions; 5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anal Cancer

Summary:

      The purpose of this research study is to determine whether the amount of radiation given to
      the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing
      the side effects that are seen with standard therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Karnofsky Performance Status >70%

          -  Histologically documented squamous or basaloid carcinoma of the anal canal

          -  Stage T2-4 disease with any N category

        Exclusion Criteria:

        • Patients with a life expectancy of < 3 months.
Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients
Condition: Epidermolysis Bullosa; Pruritus
MeSH terms: Epidermolysis Bullosa; Pruritus
Intervention: VPD-737; Placebo
Intervention description: VPD-737 inhibits the receptor neurokinin-1.; Matching tablets to VPD-737 tablets without active drug
Intervention MeSH terms: Serlopitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2 investigator-initiated, randomized, double-blind, placebo-controlled, parallel-arm trial evaluating the comparative effect of serlopitant 5 mg by mouth daily versus placebo in treatment of chronic pruritus in pediatric and adult EB patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Research personnel not involved in this study was responsible for blinding. This was the only personnel with access to the code linking study drug bottle numbers to treatment (i.e. active or placebo). The code was broken when all data was captured and locked on an electronic data capture system.
Enrollment: 14.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      Our goal is to determine whether daily oral administration of VPD-737 (5 mg) is effective and
      safe in treating moderate to severe pruritus in patients with Epidermolysis Bullosa (EB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Epidermolysis Bullosa (EB) and pruritus

        Exclusion Criteria:

          -  Chronic liver or renal disease
Weight-based Dosing in Hemophilia A
Condition: Hemophilia
MeSH terms: Hemophilia A
Intervention: rFVIII
Intervention description: Recombinant FVIII concentrate is an FDA approved, and both efficacious and safe, therapy for the treatment and prevention of bleeding in hemophilia A. The rFVIII infusion dose will be calculated as follows: [(weight in kg x desired FVIII increase of 100 IU/dL)/(2)].
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Hemophilia A is an inherited (genetic) disease where a protein, factor VIII (FVIII), which
      promotes blood clotting is missing or does not work properly. Individuals with hemophilia A
      are at risk for bleeding. Bleeding is prevented and/or treated with recombinant factor VIII
      (rFVIII), which is an FDA-approved treatment for Hemophilia A. Obesity is common among
      patients with hemophilia. Some studies have shown that obese hemophilia patients may be able
      to prevent bleeding with a lower dose of clotting factor than the dose they are currently
      receiving. The lower dose is calculated based on what a patient should weigh rather than what
      he does weigh. This is a clinical research study to test whether calculating rFVIII dosing
      based on lean body mass and ideal body weight (what a person should weigh based on his
      height) in overweight and obese patients with hemophilia is more accurate than calculating
      rFVIII dosing based on what a person actually weighs.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult males age 18 or older.

          2. Hemophilia A (FVIII activity 40% or less).

          3. Overweight or obesity defined as a BMI of 25.0-29.9 and ≥ 30 mg/m2, respectively.

        Exclusion Criteria:

          1. Prior history of, or currently detectable, FVIII inhibitor defined as greater than or
             equal to 0.6 Bethesda Units (BU); however, a subject with a past low-level
             non-responding inhibitor defined as less than 5 BU, with no increase in titer
             following FVIII exposure, and not detectable within 12 months of the study, despite
             FVIII exposure during that period, will be allowed to enroll on study.

          2. Allergy to FVIII products.

          3. Current rFVIII requirements do not include at least a 72-hour period without rFVIII
             administration.
Protocol for Women at Increased Risk of Developing Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: letrozole
Intervention description: Letrozole 2.5 mg daily
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast atypia; open label pilot study; letrozole; fine needle aspiration; high risk for breast cancer; breast epithelial hyperplasia; Ki-67; hormones plus chemoprevention; chemoprevention

Summary:

      A pilot study to assess the effects of six months of letrozole on breast tissue risk markers
      in postmenopausal women on hormone replacement therapy at high risk of developing breast
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  evidence of hyperplasia with/without atypia upon random periareolar fine needle
             aspiration of breast

          -  on hormone replacement therapy

          -  postmenopausal

          -  increased risk of developing breast cancer based on personal or family history

          -  never have taken aromatase inhibitors or selective estrogen receptor modulators in
             last six months

          -  women who have a high risk of breast cancer

          -  older than 18 years

        Exclusion Criteria:

          -  anticoagulants

          -  marked breast tenderness

          -  pregnant or within twelve months of breast feeding/childbirth
Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab; Radiation Therapy
Intervention description: 400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7; Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: head and neck cancer

Summary:

      The standard treatment of surgery followed by radiation therapy can stop tumors from growing
      in the head and neck region in most patients. However, the cancer can recur or can spread to
      other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by
      blocking certain cellular chemical pathways that lead to tumor development. It was approved
      by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and
      neck cancer.

      The purpose of this study is to determine how easily cetuximab can be added to treatment with
      radiation therapy in patients with cutaneous cancer of the head and neck. This study will
      also look at how well cetuximab added to radiation therapy works over time and how well this
      treatment is tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically (histologically) proven diagnosis of cutaneous squamous cell carcinoma
             of the head and neck

          -  Clinical stage >/= T3 or >/= N1, M0 including no distant metastases

          -  Gross total resection of the primary tumor with curative intent must be completed
             within 7 weeks of registration

          -  Performance status of 0-1 within 2 weeks prior to registration

          -  Age >/= 18

          -  Adequate labs within 2 weeks prior to registration

        Exclusion Criteria:

          -  Prior invasive malignancy unless disease free for a minimum of 3 years; noninvasive
             cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all
             permissible) are permitted even if diagnosed and treated < 3 years ago. Patients with
             a history of T1-2, N0, M0 resected differentiated thyroid carcinoma are considered
             eligible.

          -  Prior systemic chemotherapy or anti-epidermal growth factor therapy for the study
             cancer or for a different prior cancer

          -  Prior radiotherapy to the region of the study cancer that would result in overlap of
             radiation therapy fields
Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Dasatinib; Letrozole
Intervention description: Tablets, Oral, 100 mg once daily, up to 2 years; Tablets, Oral, 2.5 mg, once daily, up to 2 years
Intervention MeSH terms: Letrozole; Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out what effect the combination of letrozole (brand
      name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to
      letrozole alone
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable
             locally recurrent or metastatic disease

          -  Has measurable or evaluable-only disease

          -  Is female, ≥18 yrs of age, post menopausal or surgically sterile

          -  HER2 negative, HR+, ER+ and/or PgR+ breast cancer

          -  0-1 prior chemotherapy regimen for metastatic disease.

          -  Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior

          -  Prior tamoxifen therapy is allowed

          -  No AI therapy for >1 year without recurrence

        Exclusion Criteria:

          -  Pregnant or breast feeding

          -  Prior hormonal therapy for metastatic or locally recurrent disease

          -  >1 chemotherapy regimen for metastatic disease

          -  Pleural or pericardial effusion

          -  Serious cardiac condition
BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Belotaxel; Belloxa
Intervention description: 60 mg/m2 3 weekly (day 1); 70 mg/m2 3 weekly (day 2)
Intervention MeSH terms: Docetaxel; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC

Summary:

      Lung cancer is the leading cause of cancer death in Korea as well as in other countries.
      About 80% of lung cancer is non-small cell lung cancer(NSCLC). The majority of patients with
      NSCLC require cytotoxic chemotherapy in the course of their illness. Combination chemotherapy
      using third generation anticancer drugs (paclitaxel, docetaxel, gemcitabine) with
      platinums(cisplatin or carboplatin) reached a plateau in their efficacy. Oxaliplatin, another
      platinum being used for colorectal, gastric and pancreatic cancer has lower adverse effects
      such as nausea and nephrotoxicity. In this phase II trial, we will observe efficacy and
      safety of docetaxel and oxaliplatin for patients with NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IIIB/IV or Relapsed NSCLC

          -  Age >= 18 years

          -  At least one measurable lesion by RECIST (version 1.1)

          -  ECOG PS 0, 1, 2

          -  Hematologic profile

               -  Hgb > 8 g/dL, ANC >= 2,000/m3, Platelet >= 100,000/m3

          -  Hepatic profile

               -  Total bilirubin <= 1.5 x upper normal value

               -  Transaminases <= 3 x upper normal value <= 5 x upper normal value in case of
                  liver metastasis

          -  Creatinine <= 1.5mg/dL

          -  Patients should be recovered from toxicities of previous treatment.

          -  Written informed consent by patient or surrogates

        Exclusion Criteria:

          -  Patients who had been previously treated with chemotherapy for NSCLC

          -  Active infection requiring antibiotics treatment

          -  Prior diagnosis of other malignancy except radically treated basal cell or squamous
             cell carcinoma of the skin and carcinoma in situ of the uterine cervix

          -  Peripheral neuropathy >= grade 2 by NCI CTCAE 4.0

          -  Uncontrolled hypertension, Acute myocardial infarction within 6 months Unstable
             angina, Congestive heart failure >= NYHA grade 2 Uncontrolled significant arrhythmia

          -  Patients who entered other clinical trials within 4 weeks

          -  Pregnant or lactating women. women with child bearing age who are not willing to a
             contraceptive measure