bioihbjkbjnl/mcl2 huggingface dataset:
An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
Condition: Meibomian Gland Dysfunction (MGD); Contact Lens Discomfort (CLD)
MeSH terms: Meibomian Gland Dysfunction
Intervention: AZR-MD-001 Vehicle; AZR-MD-001 Active Dose
Intervention description: AZR-MD-001 is an ophthalmic ointment; AZR-MD-001 is an ophthalmic ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      SOVS2019-070 is a single-center study of AZR-MD-001 ointment and AZR-MD-001 vehicle in
      patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  MGD Patients:

               -  Evidence of meibomian gland obstruction (based on a meibomian gland secretion
                  (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline
                  visit

               -  Reported dry eye signs and symptoms within the past 3 months

               -  TBUT < 10 seconds in both eyes

          -  CLD Patients:

               -  Evidence of meibomian gland obstruction (based on a meibomian gland secretion
                  (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline
                  visit

               -  A history of wearing soft contact lenses for at least 6 months

               -  Wearing of the soft contact lenses for at least 3 weeks before the baseline visit
                  and wore or attempted to wear lenses at least 4 times a week before the baseline
                  visit.

               -  Symptomatic as defined by an answer of "No" at baseline to the question, "Are you
                  able to comfortably wear your lenses as long as you want?"

               -  Self-reported history of contact lens dryness/intolerance in the 6 months
                  preceding the baseline visit.

               -  Baseline CLDEQ-8 score >12

               -  Contact lens may be use during the study as long as they are removed 15 minutes
                  before dosing and not reinserted until at least 15 minutes after dosing.

        Exclusion Criteria:

          -  Uncontrolled ocular disease (except for MGD or CLD) or uncontrolled systemic disease

          -  Patient has glaucoma or ocular hypertension

          -  Corneal abnormality or disorder that impacts normal spreading of the tear film or
             corneal integrity

          -  BCVA worse than 20/40 in either eye at the baseline visit
Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa
Condition: Anorexia Nervosa; Osteoporosis
MeSH terms: Osteoporosis; Anorexia; Anorexia Nervosa
Intervention: estradiol 0.045 mg/levonorgestrel 0.015mg
Intervention MeSH terms: Levonorgestrel; Estradiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 25 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Anorexia Nervosa; Osteoporosis; Eating Disorder; Disordered Eating; Estrogen; Bone

Summary:

      Decreased bone strength is a common and serious medical problem present in many women with
      anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones
      than women with normal bone strength.

      This study will investigate whether the use of transdermal estrogen can improve bone mineral
      density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when
      used for 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female; ages 25-50 years

          -  Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) psychiatric
             criteria for AN, including <85% of ideal body weight as defined by the 1983
             Metropolitan Life Insurance Height and Weight Tables, and amenorrhea

          -  T-score of < -1.5 at spine or hip

          -  Treatment team or treatment professional in place for clinical treatment/monitoring
             during the study

        Exclusion Criteria:

          -  Diseases known to affect bone metabolism, including untreated thyroid dysfunction,
             vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency

          -  Personal history of venous or arterial clot

          -  History of stroke or myocardial infarction

          -  History of migraine headaches

          -  History of hypercoagulable disorder

          -  Personal history or history of a first-degree relative with breast cancer

          -  History of hereditary angioedema

          -  Any medication known to affect bone metabolism, including systemic glucocorticoids
             within three months of the baseline visit, depot medroxyprogesterone within 6 months
             of the baseline visit, oral bisphosphonates within one year of the baseline visit or
             intravenous (IV) bisphosphonates within three years of the baseline visit

          -  Bone fracture within the prior 12 months

          -  Serum potassium < 3.0 meq/L or serum alanine aminotransferase (ALT) > 3 times the
             upper limit of normal

          -  Fasting serum triglyceride level > 150 mg/dL

          -  Pregnant or breastfeeding

          -  Active substance abuse
A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera/Rituxan]; Methotrexate
Intervention description: 1000mg iv on days 1 and 15; 10-25mg po weekly
Intervention MeSH terms: Rituximab; Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This single arm study will investigate the pattern of B cell depletion in synovial tissue and
      peripheral blood of patients with active RA, after MabThera (1000mg iv x 2 on days 1 and 15)
      + methotrexate (10-25mg/week po) treatment. The clinical efficacy and pharmacokinetic profile
      of MabThera after treatment and retreatment will also be investigated. The anticipated time
      on study treatment is 2+ years, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients 18-80 years of age;

          -  RA for >=3 months;

          -  receiving outpatient treatment;

          -  failed treatment with >=1 DMARD (but not anti TNF or other biologic therapy);

          -  inadequate response to methotrexate, having taken and tolerated it for >=12 weeks,
             with a stable dose for >=4 weeks.

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than RA, or significant systemic involvement
             secondary to RA;

          -  history of, or current, inflammatory joint disease other than RA, or other systemic
             autoimmune disorder;

          -  diagnosis of RA before the age of 16;

          -  bone/joint surgery within 12 weeks of study;

          -  prior use of anti-TNF or other biologic therapy, an anti-alpha 4 integrin, or any
             cell-depleting therapies.
Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.
Condition: Kaposi Sarcoma; Human Immunodeficiency Virus; Immune Reconstitution Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Sarcoma, Kaposi; Sarcoma; Immune Reconstitution Inflammatory Syndrome
Intervention: Valganciclovir; Antiretroviral Combinations
Intervention description: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.; Patients will receive standard antiretroviral treatment as recommended
Intervention MeSH terms: Anti-Retroviral Agents; Valganciclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Kaposi sarcoma (KS) has an unpredictable course, patients with disseminated KS starting
      combined Antiretroviral Therapy can develop Immune Reconstitution Syndrome (IRIS), with a
      severe clinical presentation and high mortality (severe-IRIS-KS). The objective of this study
      is to evaluate the presence of Severe IRIS-KS and it´s attributable mortality in patients
      with AIDS and disseminated KS with the use of valganciclovir prior to the initiation of cART
      compared with the standard management of immediate cART initiation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be included with AIDS naïve to antiretroviral therapy and severe KS, who
             accept to participate and who sign the letter of informed consent.

          -  The following are the KS severity criteria: pulmonary compromise, and/or digestive
             tract compromise, and/or disseminated cutaneous, and/or lymphadenopathic compromise
             with generalized lymphedema.

        Exclusion Criteria:

          -  Patients with another synchronic malignant neoplasm

          -  Patients receiving corticosteroids

          -  Patients with active hepatitis B and/or hepatitis C

          -  Patients with KS limited to skin with less than 30 lesions.

          -  Patients with APACHE II score ≥15 points.
PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
Condition: Carcinoma, Non Small Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: PF-00299804; PF-00299804
Intervention description: PF-00299804 orally at 45 mg daily, on continuous schedule; PF-00299804 orally at 45 mg daily, on continuous schedule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: non-small cell lung cancer; advanced; previously treated

Summary:

      To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804
      taken daily, as single agent in patients with advanced NSCLC who failed at least one
      chemotherapy + erlotinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced Non-Small Cell Lung Cancer (NSCLC)

          -  Prior treatment with and failure of at least one regimen of chemotherapy and
             erlotinib.

          -  Prior treatment with no more than two chemotherapy regimens, including adjuvant or
             combined modality treatment.

          -  Measurable disease .

          -  Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

          -  Tissue available for KRAS/ EGFR testing

          -  Creatinine clearance > 40 cc/min or serum creat < 1.5 x ULN

        Exclusion Criteria:

          -  Chemotherapy

          -  Radiotherapy

          -  Biological or investigational agents within 4 weeks of baseline disease assessment.

          -  Patients who lack of tolerance of erlotinib therapy.
Strategies To Prevent Pneumonia 2 (SToPP2)
Condition: Infections, Hospital; Ventilator-Associated Pneumonia; Mechanical Ventilation Complication
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Cross Infection
Intervention: Pre-intubation CHX; Control
Intervention description: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.; No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nosocomial (Hospital-Acquired) Infections; Ventilator-Associated Pneumonia; Mechanical ventilation; Endotracheal intubation

Summary:

      Ventilator-associated pneumonia (VAP) is a serious complication in mechanically ventilated
      critically ill patients. The intervention tested in this project (swabbing the mouth with
      chlorhexidine before the endotracheal tube is inserted) could reduce the risk of
      ventilator-associated pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Need for intubation

        Exclusion Criteria:

          -  Pneumonia at the time of intubation
The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain
Condition: Pulmonary Hypertension; Pulmonary Arterial Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: Qutenza (8% capsaicin)
Intervention description: We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
Intervention MeSH terms: Capsaicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 15 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Qutenza; Capsaicin; Remodulin; Treprostinil

Summary:

      Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial
      hypertension, a life threatening disease of the lung blood vessels. Unfortunately,
      treprostinil is irritating to the skin and many patients experience intense pain at the
      infusion site for the first 7-10 days after placing a new subcutaneous infusion site.

      Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of
      post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that
      pretreatment of an area of skin with Qutenza would decrease the pain associated with a new
      treprostinil infusion site. The investigators hope that Qutenza will decrease both the
      intensity of the pain and the duration of the pain after patients place a new treprostinil
      infusion site.

      In this initial study, the investigators will provide Qutenza in open-label, unblinded
      fashion and ask patients to rate their pain using a diary tool with which they are already
      comfortable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pulmonary Hypertension

          -  Using subcutaneous treprostinil

          -  Already participating as a subject in our prospective study of infusion site pain

          -  Has documented debilitating pain (6/10 or greater) in the study after a site change

        Exclusion Criteria:

          -  Uncontrolled hypertension

          -  Recent stroke or myocardial infarction
Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection
Condition: HIV Infections
MeSH terms: Infections
Intervention: EVG; RTV; ARV regimen
Intervention description: Elvitegravir (EVG) tablet administered orally once daily with food; Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food; The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).
Intervention MeSH terms: Elvitegravir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Healthy volunteers: No
Keywords: Phase 2; Open-label; Rollover; Integrase Inhibitor; Antiretroviral Agents; Highly Active Antiretroviral Activity; HAART; HIV, HIV-1, AIDS virus, Human Immunodeficiency Virus; Acquired Immune Deficiency Syndrome Virus; treatment experienced

Summary:

      The main objective of this study is to observe the long-term safety of elvitegravir (EVG)
      boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in
      participants who have completed a prior EVG+RTV treatment study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of a prior EVG+RTV treatment study without treatment-limiting toxicity.

          -  Males and females of childbearing potential must agree to utilize effective
             contraception methods.

          -  Ability to understand and sign a written informed consent form.

        Exclusion Criteria:

          -  Females who are pregnant or breastfeeding.

          -  Participation in any other clinical trial without prior approval from the Sponsor.

          -  Any other clinical condition or prior therapy that, in the opinion of the
             investigator, would make the subject unsuitable for the study.

          -  Subjects receiving ongoing therapy with contraindicated drugs.
16-Week Repeat Oral Dose Study of AKB-6548 for Anemia in Participants With End Stage Renal Disease (ESRD) Requiring Chronic Hemodialysis
Condition: Anemia; End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Anemia
Intervention: AKB-6548; AKB-6548; AKB-6548
Intervention description: Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.; Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.; Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.
Intervention MeSH terms: Glycine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: anemia; end stage renal disease; chronic kidney disease; CKD; dialysis; chronic renal insufficiency; renal impairment; erythropoietin; kidney; oral anemia treatment; hemoglobin; hypoxia-inducible factor; HIF; hypoxia-inducible factor propyl-hydroxylase inhibitor; HIF-PHI; pharmacokinetics

Summary:

      The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and
      tolerability of orally administered AKB-6548 in participants with end stage renal disease
      undergoing chronic hemodialysis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 to 79 years inclusive

          -  Chronic Kidney Disease (CKD) Stage 5 on chronic hemodialysis for at least 3 months

          -  Anemia secondary to CKD treated with erythropoiesis stimulating agent and intravenous
             iron

        Key Exclusion Criteria:

          -  Body mass index >44.0 kilograms per meter squared (kg/m^2)

          -  Transfusion within 8 weeks prior to Screening

          -  Alanine transaminase or total bilirubin >1.25x ULN

          -  Uncontrolled hypertension

          -  Class III or IV congestive heart failure

          -  Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack
             within 6 months prior to Screening
Effects of Methylphenidate on Cellular Abnormalities in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Congenital Abnormalities; Attention Deficit Disorder with Hyperactivity
Intervention: Extended Release Methylphenidate (Ritalin LA ) plus Behavior Therapy; Behavior Therapy
Intervention MeSH terms: Methylphenidate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder,; ADHD; Cytogenetic abnormalities,; extended-release methylphenidate,

Summary:

      This study will assess the frequency of chromosomal abnormalities measured in circulating
      lymphocytes in treatment-naive children with Attention Deficit Hyperactivity Disorder (ADHD)
      treated for 3 months with either extended release methylphenidate or behavioral therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children of both genders, 6-12 years old

          -  Written informed consent by the parent and the patient (over 7)

          -  Diagnosis of ADHD

          -  Age-appropriate cognitive functioning

          -  All patients who had at least one post-baseline cytogenetic assessment in the core
             study can enter the observation phase.

        Exclusion Criteria:

          -  History of malignant neoplasm

          -  History of seizures (except childhood febrile seizures)

          -  Hyperthyroidism

          -  Concurrent medical condition which may interfere with study

        Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Dexamethasone; Sham injection; Laser Photocoagulation
Intervention description: Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.; Initial sham injection with up to 1 additional treatment based on re-treatment criteria.; Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone
      with laser treatment vs. laser treatment alone in patients with diabetic macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older with diabetic macular edema

          -  Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or
             worse)

          -  Visual acuity in other eye no worse than 20/200

        Exclusion Criteria:

          -  Known anticipated need for ocular surgery within next 12 months

          -  History of glaucoma or current high eye pressure requiring more than 1 medication

          -  Uncontrolled systemic disease

          -  Known steroid-responder

          -  Use of systemic steroids - Use of Warfarin/Heparin