bioihbjkbjnl/mcl2 huggingface dataset:
Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Neurobehavioral Manifestations; Sclerosis
Intervention: Fingolimod; Interferon beta 1b
Intervention description: 0.5 mg in capsules for oral administration once daily; 250 μg injected s.c. every other day
Intervention MeSH terms: Interferons; Interferon-beta; Fingolimod Hydrochloride; Interferon beta-1b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; cognitive symptoms; relapsing-remitting multiple sclerosis (RRMS); fingolimod; Magnetic resonance imaging (MRI)

Summary:

      The purpose of this pilot study is to evaluate, by means of a specific cognitive test battery
      (Brief Repeatable Battery and Delis-Kaplan Executive Function System scale), the
      slowing/reduction of cognitive dysfunction progression in RRMS patients after 18 months of
      treatment with fingolimod in comparison with interferon beta 1b treatment, and to evaluate
      which test of the battery is the most sensitive in detecting differences between treatment
      groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with relapsing-remitting forms of MS defined by 2005 revised McDonald
             criteria.

          -  Patients with active disease, defined as at least one clinical relapse in the last
             year, or two clinical relapses in the last two years if there are signs of disease
             activity at one brain MRI scan performed in the last six months.

          -  Patients with cognitive impairment at screening, defined as at least one test of the
             Rao's Brief Repeatable Battery with scores falling outside the 90th percentile of the
             normative data.

        Exclusion Criteria:

          -  Patients who had already been treated with multiweekly interferon (interferon beta 1b,
             or beta 1a multiweekly) and had an unsatisfactory response according to the judgment
             of the investigator.

          -  Patients with hyperactive forms of the MS disease according to the judgment of the
             investigator.

          -  Patients with an EDSS score higher than 5.

          -  Patients with a prior or current diagnosis of Major Depression according to DSM-IV.

          -  Patients with a history of chronic disease of the immune system other than MS such as
             known immunodeficiency syndrome.

        Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
Condition: Hiv
Intervention: TDF-FTC; Counselling on PrEP in antenatal and postnatal care
Intervention description: We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.; Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: Open label cohort study
Masking: None (Open Label)
Enrollment: 200.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pre-exposure prophylaxis; PrEP; pregnancy; prevention of mother to child transmission; PMTCT

Summary:

      The overarching goal of this proposal is to evaluate the feasibility and acceptability of
      integrating PrEP into antenatal and postnatal care, to describe the cascade in women
      initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP
      cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1)
      Evaluate the feasibility and acceptability of integrating PrEP into antenatal and
      postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and
      adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate
      attrition and associated factors across the PrEP cascade.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Documented HIV-negative according to two fingerpick rapid tests (per routine antenatal
             care protocol in this setting), confirmed with a 4th generation antigen HIV test at
             study enrollment

          2. No previous exposure triple-drug antiretroviral therapy

          3. Age 18 years or older

          4. Lives within 20 kilometers of a clinic

          5. Without psychiatric or medical contraindications to PrEP use

          6. Able to provide informed consent for research

        Exclusion Criteria:

        Failure to meet any of the inclusion criteria
Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Gabapentin; Placebo
Intervention description: Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.; Patient will receive placebo tab less than 1 hour before surgery
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 112.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: laparoscopy; postoperative pain; gynecology; gabapentin

Summary:

      The purpose of this study is to prospectively determine the influence of immediate
      pre-operative gabapentin administration on acute postoperative pain. The investigators
      hypothesize that immediate post-operative pain will be improved with pre-operative
      administration of gabapentin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient must be female and planning to have a laparoscopic or robotic assisted
             procedure for benign gynecologic indications.

          2. Patients must be treated in the department of Obstetrics and Gynecology in the
             division of Minimally Invasive Gynecologic Surgery.

          3. The patient must be in the age range of 18-80 years, in general good health and able
             to comply with study procedures.

        Exclusion Criteria:

          1. Male patients will be excluded from this study.

          2. Patients under 18 years old will be excluded from this study.

          3. Pregnant patients. All patients will have a routine pre-operative urine HCG to exclude
             pregnancy.

          4. Patients having abdominal, vaginal or hysteroscopic procedures

          5. Allergy to gabapentin

          6. Chronic use of gabapentin (greater than 6 months)
Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Intervention: Carboxymethylcellulose (CMC) Artificial Tears; Preservative-free, CMC-free Artificial Tears (control)
Intervention description: A pack of 21 vials of artificial tears containing carboxymethylcellulose 0.5% will be given to subjects in the treatment group.; A pack of 21 vials of artificial tears containing 0.4% polyethylene glycol 400 and 0.3% propylene glycol will be given to subjects in the control group.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Carboxymethylcellulose (CMC), a common component in artificial tears, has been shown to
      modify the gut microbiome. The study is examining its effects on the eye microbiome, which
      may have implications on ocular disease and artificial tear choice. The study will administer
      artificial tears containing CMC to the treatment group and artificial tears without CMC to
      the control group. Surveys and conjunctival swabs will be collected before and after
      treatment for bacterial genome sequencing and analyzed by R statistical packages.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults above age 18 of either sex who can self-administer artificial tears and return
             for follow-up at the UF Oaks Eye Clinic.

        Exclusion Criteria:

          -  Individuals with active eye infections or have prosthetic eyes.

          -  Are immunocompromised, or are diagnosed with autoimmune diseases or malignant
             neoplasms about the eye.

          -  Individuals who take immunomodulatory therapy, steroids, antibiotics, medicated
             eyedrops, or are already using CMC eyedrops within 1 week of the study will also be
             excluded.
Treatment of Post-dural Puncture Headache in Postpartum Patients: Sphenopalatine Ganglion Block to Epidural Blood Patch.
Condition: Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Intervention: Sphenopalatine ganglion Block; Epidural blood patch
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to compare the effectiveness of a sphenopalatine
      ganglion block to an epidural blood patch for post-dural puncture headache relief in
      randomized postpartum parturients over a 48 hour period.
    

Eligibility criteria:

        Inclusion Criteria

          1. Age 18 years or age or greater

          2. Postpartum obstetric parturient who was previously admitted to UCH.

          3. Diagnosis of post-dural puncture headache based on the International Classification of
             Headache Disorders:

               1. Dural puncture has been performed

               2. Headache has developed within 5 days of the dural puncture

               3. Not better accounted for by another ICHD-3 diagnosis.

               4. Occurring immediately or within seconds of assuming an upright position and
                  resolving quickly (within 1 minute) after lying horizontally.

        Exclusion Criteria

          1. Refusal to participate in the study

          2. Placement of an EBP within the past 5 days

          3. Allergy and/or intolerance to any the study materials

          4. Contraindications to an EBP

          5. Plan for therapeutic anticoagulation post-partum
Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial
Condition: Cardiovascular Disease; HIV Infection
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Cardiovascular Diseases
Intervention: Lovaza; Placebo
Intervention description: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.; 2 capsules given twice daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV; cardiovascular risk; atherogenic lipid profile; brachial artery reactivity; omega three fatty acids

Summary:

      The purpose of this study is to determine whether fish oil supplementation with Lovaza,
      formally known as Omacor will result in a significant reduction in serum triglyceride (TG),
      an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-infected men and women at least 18 years of age

          -  On stable HAART for previous three months and without anticipated changes in their
             HAART regimen throughout the duration of the study

          -  Fasting triglycerides > 150 mg/dl and < 1,500 mg/dl

          -  Participants may be on lipid lowering therapy; if on lipid lowering therapy, therapy
             must be stable for 8 weeks and cannot be changes during the course of the study

          -  Participants may be on beta blockers (e.g., Atenolol, Metoprolol, Propranolol),
             Estrogens (e.g.,Estinyl;Estrace;Estraderm) and Thiazides (water pills), however
             therapy with these agents must be stable for 8 weeks before starting the study and
             cannot be altered while on the study unless deemed medically necessary by the
             participant's medical provider and approved by Dr. Wanke

          -  Female participants of reproductive age must not be pregnant (negative test) or
             lactating at screening and throughout the trial and agree to use 2 methods of barrier
             contraception for the course of the trial and 2 months after the trial unless they are
             surgically sterilized (tubal ligation or hysterectomy), or post-menopausal with no
             menses for > 1 year

          -  Ability to provide consent

        Exclusion Criteria:

          -  Plasma HIV-1 RNA > 10,000

          -  Previous history of atherosclerotic disease or diabetes mellitus

          -  Change in HAART regimen over three months prior to study entry

          -  Change in lipid lowering therapy within 2 months

          -  On chronic anticoagulants such as heparin or coumadin

          -  On fish oil, omega 3 supplements, or Omacor currently or during the past month
Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
Condition: Lumbar Spondylosis; Lumbar Spondylolisthesis; Adult Degenerative Lumbar Scoliosis
MeSH terms: Scoliosis; Spondylolisthesis; Spondylosis
Intervention: teriparatide; Placebo
Intervention description: Teriparatide 20 ug subcutaneous injection daily for 12 weeks; Saline solution
Intervention MeSH terms: Teriparatide; Parathyroid Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 60 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effects of 12 weeks of daily treatment with
      teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral
      spine fusion surgery for degenerative conditions of the lumbar spine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 60-90 years with lumbar spondylosis, spondylolithesis, or adult
             degenerative scoliosis, including disc pathology, stenosis, deformity, instability, or
             postdecompression revision, who are scheduled to undergo three-level or greater
             posterolateral lumbar spinal fusion.

          -  Willing and able to use a pen-type delivery system to administer daily subcutaneous
             injections.

        Exclusion Criteria:

          -  Use of bone morphogenic protein (BMP) posterolaterally during the fusion procedure.

          -  Previous spinal fusion at the intended fusion levels.

          -  Prior use of Forteo (teriparatide).

          -  Use of digoxin.

          -  Paget's Disease of bone.

          -  History of primary skeletal malignancy, presence of bone metastases, or previous
             skeletal exposure to therapeutic irradiation.

          -  Elevated serum calcium, serum PTH >70 pg/ml, 25-hydroxyvitamin D <12 ng/mL, or active
             liver disease.

          -  History of symptomatic nephro- or urolithiasis in the past two years.

          -  History of malignant neoplasm in the past five years, except for superficial basal
             cell carcinoma or squamous cell carcinoma.

          -  Carcinoma in situ of the uterine cervix treated in the past year.
Safety and Efficacy of Vilazodone in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vilazodone; Placebo to citalopram; Placebo to vilazodone; Citalopram
Intervention description: Vilazodone was supplied as film-coated tablets.; Placebo to citalopram was supplied as a capsule.; Placebo to vilazodone was supplied as film-coated tablets.; Citalopram was supplied as encapsulated tablets.
Intervention MeSH terms: Dexetimide; Citalopram; Vilazodone Hydrochloride; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1162.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Depression

Summary:

      The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed
      dose levels of vilazodone compared to placebo in patients with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-70 years of age.

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.

          -  The patient's current major depressive episode must be at least 8 weeks and no longer
             than 12 months in duration.

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women of
             childbearing potential who are not practicing a reliable method of birth control.

          -  Patients with a history of meeting DSM-IV-TR criteria for:

               -  Any manic, hypomanic or mixed episode, including bipolar disorder and
                  substance-induced manic, hypomanic, or mixed episode

               -  Any depressive episode with psychotic or catatonic features

               -  Panic disorder with or without agoraphobia

               -  Obsessive-compulsive disorder

               -  Schizophrenia, schizoaffective, or other psychotic disorder

               -  Bulimia or anorexia nervosa

               -  Presence of borderline personality disorder or antisocial personality disorder

               -  Mental retardation, dementia, amnesia, or other cognitive disorders.

          -  Patients who are considered a suicide risk.
Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; Chemotherapy
Intervention description: 150 mg oral dose of erlotinib given once daily; Cisplatin (75 mg/m^2 intravenously [IV]) on Day 1 and gemcitabine (1250 mg/m^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)
Intervention MeSH terms: Cisplatin; Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small-cell lung cancer (NSCLC)

Summary:

      This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin
      combination chemotherapy as the first-line treatment for patients with non-small-cell lung
      cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.

      This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a
      second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients
      previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease
      progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will
      be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles
      until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant in ENSURE trial

          -  Disease progression during first-line treatment

        Exclusion Criteria:

          -  N/A
Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Atorvastatin; Atorvastatin
Intervention description: A single 80 mg dose of marketed 80 mg atorvastatin tablets; A single dose of new formulation of 80 mg atorvastatin tablets
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioqeuivalence, Pharmacokinetics, Atorvastatin

Summary:

      To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial
      atorvastatin tablets (Lipitor®).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects between the ages of 18 and 55 years.

          -  Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
             allergies at time of dosing) disease or clinical findings at screening.

          -  Treatment with an investigational drug within 30 days or 5 half lives preceding the
             first dose of study medication.