bioihbjkbjnl/mcl2 huggingface dataset:
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
Condition: Venous Stasis Ulcers
MeSH terms: Varicose Ulcer; Ulcer
Intervention: Thymosin Beta 4; Placebo
Intervention description: There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days; There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Venous Stasis Ulcers; venous insufficiency; leg ulcers; Thymosin Beta 4; Laminin-5

Summary:

      The purpose of this study is to evaluate the safety, tolerability and effectiveness of
      Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent Form signed by the patient

          -  Male or female, between 18 and 79 years of age

          -  At least one venous leg ulceration stable for at least 6 weeks before enrollment

          -  Surface area between 3 and 30 cm2

        Exclusion Criteria:

          -  Have clinical evidence of active infection on the index ulcer

          -  Use of any experimental drug, or participation in any clinical study, within the 60
             days before enrollment

          -  Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy
             within the 60 days before enrollment

          -  History of adverse reaction to any ingredients of the study medication

          -  Clinically significant neurological, cardiovascular, respiratory, hepatic, renal,
             metabolic and dermatologic disease other than venous ulcers

          -  Current or former malignancy

          -  Arterial disorder resulting in ulcerated ulcers

          -  Diabetes mellitus

          -  Pregnant or lactating (breastfeeding) women. A serum pregnancy test will be performed
             at screening for female patients of childbearing potential
DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DFD01 Spray; Comp01 Lotion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA
      (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily
      for 15 days.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque
             psoriasis.

          2. Subjects with psoriasis involving 20 to 50% BSA, not including the face, scalp, groin,
             axillae and other intertriginous areas.

          3. Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit

          4. Subjects whose results from the screening ACTH stimulation test are considered normal
             (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of
             abnormal HPA function or adrenal response. -

        Exclusion Criteria:

          1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
             exfoliative or pustular psoriasis.

          2. History of organ transplant requiring immunosuppression, HIV, or other
             immunocompromised state.

          3. Have received treatment for any type of cancer within 5 years of the Baseline Visit
             except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before
             the Baseline Visit.

          4. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g.,
             tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate,
             cyclosporine, hydroxyurea)

          5. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs
             (salicylic acid, anthralin, coal tar, calcipotriene)2) PUVA therapy, 3) systemic
             anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine),
             or 4) UVB therapy.

          6. Use within 30 days prior to the Screening Visit of any product containing
             corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.

          7. Subjects who have an abnormal sleep schedule or work at night.

          8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased
             adrenal output, low pituitary function or pituitary tumors.

          9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar
             test reagents.
Dalfampridine for Imbalance in Multiple Sclerosis
Condition: Multiple Sclerosis; Fatigue
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Intervention: Dalfampridine; Placebo
Intervention description: 10mg, bid, pill taken by mouth for 12 weeks; placebo pill, bid for 12 weeks
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Maximum age: 59 Years
Healthy volunteers: No
Keywords: multiple sclerosis; postural balance; gait; fatigue

Summary:

      Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in
      people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages
      the myelin insulation around nerves which slows conduction of messages from the brain to the
      leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin.
      Recent research indicates that imbalance in MS is in large part caused by poor conduction by
      the nerves that transmit information about the position of the legs to the brain. It is
      therefore likely that, by improving nerve conduction, dalfampridine will also improve
      imbalance in people with MS. Dalfampridine will be administered in this study by the same
      route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve
      walking speed in people with MS. The proposed pilot study will examine the effects of
      dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This
      small pilot study will help to show if dalfampridine improves imbalance in MS and will guide
      the design and implementation of a larger full scale study to definitively determine if
      dalfampridine improves balance and prevents falls in people with MS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 20- 59 years,

          -  Able to walk at least 100m without an aide or with unilateral assistance

          -  Prolonged APR latencies (≥ 1SD > mean for healthy people in this age range) OR,

          -  Reduced balance-related activity (ABC scores ≤ 85%),

          -  Abnormal trunk range of motion (horizontal), trunk range of motion (frontal), turning
             duration, cadence, double support time, stride length or gait cycle time (outside 1SD
             of the average for healthy people in this age range)

        Exclusion Criteria:

          -  Currently taking dalfampridine (any within the last 2 weeks),

          -  Cause(s) of imbalance other than MS,

          -  Impaired renal function (creatinine clearance ≤50mL/min),

          -  Seizure disorder

          -  Pregnancy or breast feeding
A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections
Condition: Osteoarthritis, Knee; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Intervention: Tanezumab 2.5 mg; Tanezumab 5 mg; Tanezumab 10 mg
Intervention description: Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year; Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year; Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 679.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Double-blind safety

Summary:

      This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg,
      and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times
      during the study treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Osteoarthritis of the knee or hip based on American College of Rheumatology criteria
             with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);

        Exclusion Criteria:

          -  Body mass index (BMI) of >39 kg/m2;

          -  Pregnancy or intent to become pregnant

          -  Planned surgical procedure during the duration of the study

          -  History of clinically significant cardiovascular, central nervous system or
             psychiatric disease

          -  Previous exposure to exogenous NGF or to an anti NGF antibody;

          -  Use of biologics other than study medication, Live or live-attenuated intranasal
             vaccines (eg, Flumist), are allowable exceptions
A Study of ADX-102 in Subjects With Allergic Conjunctivitis
Condition: Conjunctivitis, Allergic
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: ADX-102 Ophthalmic Drops (0.5%); ADX-102 Ophthalmic Drops (0.1%); Vehicle of ADX-102 Ophthalmic Drops
Intervention description: ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.; ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.; Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ADX-102; Allergic Conjunctivitis

Summary:

      A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the
      Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102
      Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic
      Conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be at least 18 years of age of either gender and any race

          -  have a positive history of ocular allergies and a positive skin test reaction to a
             seasonal (grasses, ragweed, and/or trees) or perennial allergen (cat dander, dog
             dander, dust mites, cockroach) as confirmed by an allergic skin test within the past
             24 months

          -  have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using
             an ETDRS chart

        Exclusion Criteria:

          -  have known contraindications or sensitivities to the use of the investigational
             product or any of its components

          -  have any ocular condition that, in the opinion of the investigator, could affect the
             subject's safety or trial parameters (including but not limited to narrow angle
             glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis,
             pterygium or a diagnosis of dry eye)

          -  have had ocular surgical intervention within three (3) months prior to Visit 1 or
             during the study and/or a history of refractive surgery within the past six (6) months

          -  have a known history of retinal detachment, diabetic retinopathy, or active retinal
             disease

          -  have the presence of an active ocular infection (bacterial, viral or fungal) or
             positive history of an ocular herpetic infection at any visit

          -  be a female who is currently pregnant, planning a pregnancy, lactating, not using a
             medically acceptable form of birth control throughout the study duration and for 14
             days prior to the installation of investigational product, or has a positive urine
             pregnancy test at Visit 1
Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
Condition: Advanced Breast Cancer; Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Neratinib; Lapatinib; Capecitabine
Intervention description: Tablets 240 mg orally once per day until disease progression or unacceptable toxicity; Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.; Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
Intervention MeSH terms: Capecitabine; Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 233.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER2; ErbB2; metastatic; neratinib; lapatinib; capecitabine; HKI-272; Nerlynx; PB-272

Summary:

      This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib
      and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced
      breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and
      extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also
      compare the safety of the two regimens and to compare quality of life of patients taking the
      two regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer

          -  Prior use of Herceptin (trastuzumab), and a taxane

          -  Adequate cardiac and renal function

        Exclusion Criteria:

          -  More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda
             (capecitabine) and / or Tykerb (lapatinib) [Tyverb]

          -  Bone as the only site of disease

          -  Active central nervous system metastases (subjects should be stable and off
             anticonvulsants and steroids)

          -  Significant gastrointestinal disorder with diarrhea as major symptom
A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection
Condition: Tendinosis; Tendinitis
MeSH terms: Tendinopathy
Intervention: Tenotomy (no injection); Ultrasound guided platelet rich plasma injection
Intervention description: Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy.; Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.
The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called "Ultrasound guided platelet rich plasma injection."
Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.
Subjects will see their referring physician two weeks after treatment to begin physical therapy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effectiveness of various treatment soft
      tendinosis also known as tendinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects with a diagnosis of tendinosis of the hip.

          -  Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis
             by tenotomy.

        Exclusion Criteria:

          -  pregnancy

          -  risk of bleeding due to anticoagulant medication

          -  presence of malignancy

          -  steroid injection less than 3 months before enrollment
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD1236; Placebo
Intervention description: oral tablet, 75 mg, twice daily during 6 weeks; Dosing to match AZD1236
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The primary aim of this study is to investigate the effects of AZD1236 compared with placebo
      ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue
      degradation in blood, urine and sputum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of COPD for 1 month

          -  Men or postmenopausal women

          -  Spirometry values indicating symptomatic patients

          -  Smoking history equivalent to using 20 cigarettes a day for 10 years.

        Exclusion Criteria:

          -  Any current respiratory tract disorders other than COPD

          -  Requirement for regular oxygen therapy

          -  Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration

          -  Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled
             steroids 14 days prior to the study
Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
Condition: Non-ischemic Cardiomyopathy; Systolic Heart Failure (NYHA II-III)
MeSH terms: Heart Failure; Cardiomyopathies; Heart Failure, Systolic
Intervention: Doxycycline; placebo
Intervention description: Doxycycline 1 tablet every 12 hours for 14 days; Placebo 1 tablet every 12 hours for 14 days
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heart failure; non-ischemic cardiomyopathy

Summary:

      Non-ischemic cardiomyopathy and heart failure are highly influenced by the presence of
      systemic inflammation.

      Doxycycline is a FDA-approved drug to treat bacterial infections which also shows powerful
      anti-inflammatory effects.

      In this study we plan to determine the effects of Doxycycline in patients with stable heart
      failure and non-ischemic cardiomyopathy on peak of aerobic exercise capacity (peak V02) and
      ventilator efficiency measured with a cardiopulmonary test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-ischemic cardiomyopathy (LVEF<40%)

          -  Heart failure NYHA II-III

        Exclusion Criteria:

          -  Age <18

          -  Recent changes (previous 3 months) in HF maintenance medications (beta-blockers,
             angiotensin converting enzyme [ACE] inhibitors, aldosterone antagonists, vasodilators,
             cardiac glycosides, diuretics)

          -  Hospitalization for worsening HF or acute decompensated HF within the previous 12
             months

          -  History of coronary or ischemic heart disease

          -  Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable
             cardioverter defibrillator (AICD) or coronary revascularization or cardiac surgery

          -  Angina or electrocardiograph (ECG) changes that limit maximum exertion during
             cardiopulmonary exercise testing

          -  Active infection including chronic infection

          -  Active cancer (or prior diagnosis of cancer within the past 10 years)

          -  Recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), Chronic
             inflammatory disorder (including but not limited to rheumatoid arthritis, systemic
             lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to
             complete the study

          -  Pregnancy

          -  Inability to give informed consent

          -  Other conditions limiting completion of cardiopulmonary exercise test or completion of
             the study