bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Condition: Dry Eye; Sjogren's Syndrome; Graft vs. Host Disease
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Graft vs Host Disease
Intervention: Thymosin Beta 4 eye drops; Vehicle Control
Intervention description: Patients will be randomized and will receive the same eye drops the Thymosin Beta 4.; Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Dry Eye; Sjogren's Syndrome; Graft vs. Host Disease; Rheumatoid arthritis; Systemic lupus erythematosus; Scleroderma

Summary:

      Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced
      day-to-day function and significant discomfort. Tear substitutes are an important part of the
      treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often
      remains very irregular due to poor surface healing.

      The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal
      surface and has been studied in patients with recalcitrant corneal ulcers and erosions with
      significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May,
      2010).

      The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface
      healing, may be able to promote healing of the corneal surface allowing for more conventional
      modalities to take over and maintain a smooth and regular ocular surface. The investigators
      hope to be able to demonstrate an improvement in visual acuity, surface healing and a
      reduction in dry-eye related symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Schirmers of < 5 mm at 5 minutes

          -  TFBUT: less than 10 seconds

          -  Corneal staining of >3 of 15: conjunctival staining of >3 of 18

          -  Ocular Surface Disease Index of > 50

          -  Presumed best corrected vision of 20/60 or better

        Exclusion Criteria:

          -  Acute or inflammatory corneal disease

          -  Pregnancy or lactation

          -  Monocular status

          -  Punctal occlusion within 30 days

          -  Ocular surgery within 3 months

          -  Corneal thinning of >50%

          -  Active corneal infection

          -  History of ocular malignancy

          -  Retinal neovascularization

          -  Current use of topical cyclosporin A
A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Condition: COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: TD-4208; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 355.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Chronic Obstructive Pulmonary Disease

Summary:

      This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product
      when administered once daily for 28 days using a jet nebulizer to patients with moderate to
      severe chronic obstructive pulmonary disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female subject 40 years of age or older

          -  Subject must have a negative pregnancy test, and must be prepared to use effective
             contraception if of child-bearing potential

          -  Subject is capable of performing reproducible spirometry maneuvers

          -  Subject has post-bronchodilator FEV1/FVC ratio <0.7

          -  Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD
             Guidelines)

          -  Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80%
             of predicted normal

          -  Subject has a current or past smoking history of at least 10 pack-years.

        Exclusion Criteria:

          -  Subject has a significant respiratory disease or disorder other than COPD that would
             affect the interpretation of data from this study

          -  Subject has a history of reactions or hypersensitivity to inhaled or nebulized
             anticholinergic or beta-agonist agents

          -  Subject suffers from any medical condition that would preclude the use of inhaled
             anticholinergic agents

          -  Subject has been hospitalized for COPD or pneumonia within 12 weeks

          -  Subject requires long-term oxygen therapy (>15 hours a day)
The Safety And Efficacy Of Maintenance Therapy With CP-690,550
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Placebo; CP-690,550; CP-690,550
Intervention description: oral tablets twice daily; oral tablets twice daily; oral tablets twice daily
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: tofacitinib; Xeljanz; CP-690,550; maintenance therapy

Summary:

      This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to
      severe Crohn's disease who completed the double-blind induction treatment in Study A3921083
      and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who met study entry criteria, and who completed Week 8 visit of Induction
             Study A3921083.

          -  Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or
             clinical remission (CDAI<150) in Study A3921083.

          -  Women of childbearing potential must test negative for pregnancy prior to study
             enrolment.

        Exclusion Criteria:

          -  Subjects who had major protocol violation (as determined by the Sponsor) in the
             A3921083 study.

          -  Subjects likely to require any type of surgery during the study period.

          -  Fecal culture/toxin assay indicating presence of pathogenic infection.
Reducing Preterm Births in Underserved Pregnant Women
Condition: Preterm Birth; Low Birth Weight <2500 Grams; Verylow Birthweight <1500 Grams
MeSH terms: Premature Birth; Birth Weight
Intervention: lifestyle support
Intervention description: computer-based lifestyle improvement support and clinician support
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 482.0
Sex: Female
Minimum age: 16 Years
Maximum age: 48 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: computer-based behavioral support

Summary:

      Timely screening and management of modifiable conditions can reduce preterm births, yet
      providing effective prenatal risk management systems to meet the unique needs of medically
      underserved populations is complex. If the proposed system proves to be effective in reducing
      preterm births it can improve maternal and child quality of life as well as reduce the
      economic burden of preterm births in the U.S.
    

Eligibility criteria:

        Inclusion Criteria: Study inclusion criteria include:

          1. age 16-48 years,

          2. 1st trimester of pregnancy,

          3. race/ethnicity (non-Hispanic Black, or English-speaking Hispanic Black), and 4) a
             self-reported completion of grade 6 or higher.

        Exclusion Criteria: Exclusion criteria include:

          1. a medical condition or risk to the pregnancy that the physician or nurse midwife
             determines serious and a reason for exclusion, and

          2. a literacy level of < grade 6. No prior experience using a computer is needed. -
Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Proton Radiotherapy
Intervention description: 87.5 CGE with 2.5 Gy/fraction for 35 treatments
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Lung Cancer; Proton Radiotherapy; Proton Beam; NSCLC

Summary:

      The goal of this clinical research study is to learn if escalated/accelerated proton
      radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side
      effects. The safety of this treatment will also be studied.

      Objectives:

      To assess the therapeutic efficacy and toxicities of proton radiotherapy with
      escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0)
      NSCLC.

      Primary goals:

        1. Improve 2 years progression free survival at the primary site, and

        2. reduce acute and chronic toxicity

      Secondary goals:

        1. Improve disease specific survival at 2 years.

        2. Study the potential of pre- and post treatment PET/CT in predicting clinical outcome.

        3. Study the role of biomarkers in predicting therapeutic response and toxicities.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically documented NSCLC.

          2. Patients with inoperable centrally located tumors, defined as those within 2 cm of the
             bronchial tree, major vessels, esophagus, heart, or other mediastinal structures but
             no direct invasion, T1N0M0 (stage IA), or any location of T2N0M0 (stage IB) and T3N0M0
             (selected stage II with chest wall involvement) NSCLC.

          3. Performance score KPS 60-100.

        Exclusion Criteria:

          1. Prior radiotherapy to the chest.

          2. Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ
             of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial
             transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated
             more than 3 years ago for cure.

          3. Pregnancy. Patients, both men and women of child bearing potential should use an
             effective method of birth control throughout their participation in this study.
C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection
Condition: Antibody Mediated Rejection of Kidney Transplant
Intervention: C1-INH (Berinert)
Intervention MeSH terms: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein
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: 70 Years
Healthy volunteers: No

Summary:

      This is an open-label, single arm trial in which patient who have ongoing antibody mediated
      rejection of a kidney transplant deemed refractory to maximal medical therapy are given the
      complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing
      antibody mediated injury. A maximum of 5 patients will be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplant with acute antibody mediated rejection refractory to standard
             therapy

        Exclusion Criteria:

          -  Patients with known intolerance of or anaphylaxis to Berinert
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
Condition: Asthma; GERD
MeSH terms: Asthma
Intervention: Esomeprazole; Esomeprazole; Placebo
Intervention description: Esomeprazole 40 mg twice daily; Esomeprazole 40 mg once daily; Placebo twice daily
Intervention MeSH terms: Esomeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 961.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Moderate to severe Asthma; Gastroesophageal Reflux Disease; esomeprazole; GERD

Summary:

      The purpose of this study is to determine whether treatment with esomeprazole for 6 months
      will improve asthma in adult patients with moderate to severe asthma and symptoms of
      gastroesophageal reflux disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with diagnosis of asthma since at least 6 months.

          -  Symptoms of asthma during run-in.

          -  At least 3 months history and present symptoms of 1 or more of the following: burning
             feeling behind breastbone, pain behind breastbone, acid taste in the mouth.

        Exclusion Criteria:

          -  Patients with clinically relevant abnormalities.

          -  Patients with a smoking history of ≥10 pack-year.

          -  Patients who have had previous surgery on the esophagus or the stomach.
A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: bevacizumab [Avastin]
Intervention description: 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of intravenous Avastin in combination with
      chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum.
      The anticipated time of study treatment is until disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with metastatic colon or rectal cancer, progressing or relapsing after
             first-line treatment;

          -  Women of childbearing potential must use adequate contraception up to at least 6
             months after the last dose of bevacizumab.

        Exclusion Criteria:

          -  Patients with metastatic colon or rectal cancer scheduled for a first-line systemic
             treatment;

          -  Untreated brain metastases, spinal cord compression or primary brain tumours;

          -  Pregnant or lactating women;

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to study start;

          -  Treatment with any investigational drug, or participation in another investigational
             study, within 30 days prior to enrollment.
Guanfacine to Improve Substance Use Outcomes in Women
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Intervention: Guanfacine; Behavioral Counseling
Intervention description: Guanfacine 3mg/day Versus Placebo; placebo
Intervention MeSH terms: Guanfacine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized double blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blind
Enrollment: 74.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Hypothesis: Guanfacine (GUA) (3mg/day) will reduce drug craving, improve cognitive
      flexibility and result in associated lower drug use in women with substance use disorder
      (SUD) in an outpatient clinical setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  100 treatment seeking women

          -  Ages 18-70 years

          -  Body mass index (BMI) of 18-35

          -  Meet current DSM-V criteria for co-occurring SUDs, with primary DSM-V cocaine or
             primary DSM-V opioid use disorder AND co-occurring cannabis or alcohol or nicotine use
             disorders;

          -  Positive drug urine toxicology screens for primary addictive disorder during a 2-week
             intake assessment period

          -  Good health as verified by screening examination

          -  Able to read English and complete study evaluations

          -  Able to provide informed written and verbal consent

        Exclusion Criteria:

          -  Meet criteria for physiological dependence on alcohol requiring medical detoxification

          -  Regular use of anti-hypertensives, anti-arrythmics, antiretroviral medications, and
             medications that would interact with Guanfacine and be contraindicated as per study
             physician;

          -  Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal,
             current mania)

          -  Significant underlying medical conditions which in the opinion of study physician
             would preclude patient from fully cooperating or be of potential harm during the
             course of the study; Specifically hepatic and renal impairment as per liver enzymes at
             3X the normal limit, or BUN>50mg or BUN:Cr > 10:1.

          -  Hypotensive women with sitting blood pressure below 100/50 mmHG

          -  Women who are pregnant, nursing or refuse to use a reliable form of birth control

          -  EKG evidence at baseline screening of any clinically significant conduction
             abnormalities, including a Bazlett's QT c>470 msec for women.
Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates
Condition: Kidney Failure
MeSH terms: Renal Insufficiency
Intervention: IVIg and rituximab
Intervention description: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.
If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA).
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Some patients who need kidney transplants have high levels of antibodies that make them
      incompatible with most potential deceased donor kidney offers. These patients are considered
      highly-sensitized and are very difficult to transplant because the likelihood that they will
      receive a compatible organ is very low. There are some medications and procedures that can
      decrease the antibody levels and this can increase the chance of finding a compatible donor
      for these patients. In this study the investigators will give two medications (IVIg and
      Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor
      kidney transplant. After the investigators administer these medications, the investigators
      will continue to check for compatibility as organ offers are received. If a compatible organ
      offer is received, the investigators will perform the transplant using that organ. The
      investigators hypothesize that these medications will lower antibody levels and increase the
      chance that a these patients are able to receive a compatible kidney transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-75

          -  End-stage renal disease on dialysis

          -  Panel Reactive Antibody (PRA) > 60%

          -  Have been evaluated for and are currently listed for deceased donor renal
             transplantation

        Exclusion Criteria:

          -  Have contraindication to transplantation

          -  Have contraindication to receiving IVIG

          -  Have allergy to IVIG

          -  Have received IVIG for desensitization previously without effect

          -  Pregnant women or those intending to become pregnant
Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: T2345; Prostaglandin
Intervention description: One drop at 8.00pm.; One drop at 8.00pm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345
      versus an active comparator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Untreated bilateral newly diagnosed patients with primary open angle glaucoma

        Exclusion Criteria:

          -  Any ocular hypertension other than chronic open angle glaucoma
Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Intervention: PF-00299804
Intervention description: 45 mg by continuous oral dosing
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: recurrent or metastatic squamous cell cancer of the Head and Neck; no prior systemic therapy for recurrence

Summary:

      This study will investigate the safety and efficacy of oral PF-00299804 in patients who have
      not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck
      squamous cell cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent or metastatic Squamous Cell Cancer of the Head and Neck;

          -  Measurable disease;

          -  Eastern Cooperative Oncology Group (ECOG) 0-1 in Stage 1 = first 23 patients;

          -  Eastern Cooperative Oncology Group (ECOG) 0-2 in Stage 2 = 33 patients;

        Exclusion Criteria:

          -  prior therapy for recurrence;

          -  platelets < 75,000;

          -  prior Epidermal Growth Factor Receptor (EGFR) therapy;

          -  interstitial lung disease;

          -  primary of nasopharynx