bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients
Condition: Anemia, Iron-Deficiency; Kidney Failure, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Sodium Ferric Gluconate Complex in Sucrose Injection; Ferrous sulfate tablets
Intervention description: Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks; ferrous sulfate, 325 mg oral, three times daily for 6 weeks
Intervention MeSH terms: Ferric gluconate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron deficiency; Anemia; Chronic kidney disease; Sodium Ferric Gluconate; Anemia, Iron-Deficiency/drug therapy/etiology; Kidney Failure, Chronic/blood/complications/therapy

Summary:

      This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate
      (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease
      patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow
      to make more red blood cells).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe anemia

          -  Iron deficiency

          -  Moderate to severe chronic kidney disease

        Exclusion Criteria:

          -  Receiving dialysis

          -  Known sensitivity to Ferrlecit® or any of its components

          -  Receiving therapy with erythropoietic agent

          -  Clinically unstable
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
Condition: High Triglycerides; Hypercholesterolemia; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Hypercholesterolemia; Hypertriglyceridemia; Schizophrenia; Bipolar Disorder; Psychotic Disorders
Intervention: Lovaza
Intervention description: 4 grams per day
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in
      subjects who have been on an atypical (second-generation) antipsychotic medication. The
      investigators hypotheses are that patients who receive Lovaza will experience a significant
      decrease in triglycerides from baseline. Secondary hypotheses include: Patients will
      experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female or male patients, 18-75 years of age.

          2. Serum triglycerides >200 mg/dl or high cholesterol >250 mg/dl

          3. Current use of an atypical (second-generation) antipsychotic medication - including
             clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole
             (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega) - for at
             least three months

        Exclusion Criteria:

          1. Current use of triglyceride or cholesterol-lowering medication other than a statin

          2. Current use of omega-3 fatty acid supplement

          3. Intake of fish more than twice per week

          4. Currently pregnant, or breastfeeding

          5. Known hypersensitivity or allergy to omega-3 fatty acids (or any fish allergies)

          6. Current use of anticoagulant medication, except for 1 baby aspirin/day - 81mg
             (coumadin, heparin, Plavix. etc).

          7. Consumption of alcohol greater than two drinks per day or active substance abuse

          8. Any medical condition that would make participation in the study unsafe, as determined
             by investigator
Nesiritide and Renal Function After the Total Artificial Heart
Condition: Congestive Heart Failure; Cardiorenal Syndrome
MeSH terms: Cardio-Renal Syndrome; Heart Failure
Intervention: nesiritide; placebo
Intervention description: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours.; placebo bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours.
Intervention MeSH terms: Natriuretic Peptide, Brain
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Total Artificial Heart; Left Ventricular Assist Device; Natriuretic peptides; Heart Failure; Cardiorenal Syndrome

Summary:

      The prevalence of renal dysfunction after implantation of the artificial heart is high. The
      infusion of exogenous B-type natriuretic peptide (BNP) after implantation of the total
      artificial heart (TAH) improves renal function in a sustained manner. The renal protective
      and hormone-modulating effects of nesiritide may be enhanced with ventriculectomy compared to
      heart failure surgery that leaves the native myocardium intact. The goal of this project is
      to determine the renal protective effects of nesiritide after implantation of a mechanical
      device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Implanted with a total artificial heart (CardioWest) or Left ventricular assist device
             (HeartMate II)

          -  Age > 18 years

        Exclusion Criteria:

          -  Previous calcineurin inhibitor (CNI) exposure

          -  Hemodialysis prior to device implant
Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care
Condition: Alzheimers Disease; Postoperative Delirium; Post Operative Cognitive Dysfunction
MeSH terms: Alzheimer Disease; Delirium; Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction
Intervention: Total intravenous anesthesia with propofol; General anesthesia with isoflurane
Intervention MeSH terms: Anesthetics; Propofol; Isoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 191.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: isoflurane; propofol; total intravenous anesthesia; inhaled anesthetic; volatile anesthetic; anesthesia; delirium; Post Operative Cognitive Dysfunction; Alzheimer's Disease; Mild Cognitive Impairment

Summary:

      This study will examine the hypothesis that changes in the cognition (i.e. thinking and
      memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers
      Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF),
      and/or changes in brain connectivity. The investigators will also examine whether different
      types of anesthesia have different effects on these CSF markers of Alzheimers disease, or
      different effects on thinking and memory after anesthesia and surgery, or differential
      effects on the correlation between cognitive changes and CSF marker changes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Surgical patients 60 years of age or older

          -  Surgery scheduled to last at least 2 hours (including time for anesthesia induction,
             etc)

          -  English speaking ability.

          -  Ability to give informed consent

        Exclusion Criteria:

          -  Inmate of a correctional facility (i.e. prisoners).

          -  Pregnancy

          -  Documented or suspected family or personal history of malignant hyperthermia.

          -  Patient unable to receive either propofol or isoflurane due to allergy or other
             specific contraindication.
A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Condition: Acute Bacterial Skin and Skin Structure Infection
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial
Intervention: Oritavancin; Warfarin
Intervention description: Administered intravenously; Administered as a concomitant medication at a standard dose and dosing schedule
Intervention MeSH terms: Oritavancin; Warfarin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: skin infection

Summary:

      This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV
      infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin
      and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive
      pathogens.

      An additional group of participants with ABSSSI, who were not on concomitant warfarin
      therapy, were also enrolled to obtain additional information following a single dose of
      oritavancin administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ABSSSI (wound infection, cellulitis/erysipelas, or cutaneous abscess)
             suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy

          -  Must be currently being treated with chronic warfarin therapy* *Participants in the
             non-warfarin group are not required to be on chronic warfarin therapy.

        Exclusion Criteria:

          -  Known or suspected bacteremia, sepsis or refractory shock

          -  Participants who are likely to need treatment with IV heparin within 48 hours

          -  Significant or life-threatening condition

          -  Women who are pregnant or nursing

          -  Receiving chronic systemic immunosuppressive therapy such as chemotherapy or
             prednisone

          -  CD4 count <200 cells/mm^3 in participants with known human immunodeficiency virus or
             acquired immune deficiency syndrome

          -  Neutropenia
Impact of Hot Flashes on Sleep and Mood Disturbance
Condition: Menopause; Depression; Hot Flashes
MeSH terms: Hot Flashes
Intervention: leuprolide
Intervention description: Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hot Flashes; Sleep disturbance; Lupron; Menopause

Summary:

      We plan to enroll premenopausal women in a trial investigating the impact of hot flashes
      developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa),
      leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to
      mimic the menopause transition. We will collect data on sleep disruption and mood changes to
      assess their relationship to the development of hot flashes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18-45 years old

          -  Premenopausal

          -  Willingness to use barrier methods of contraception during study and after completion
             of study until menses resume

          -  Good general health

        Exclusion Criteria:

          -  Pregnancy or currently breastfeeding

          -  Hot flushes

          -  Mid-luteal phase progesterone <3ng/mL

          -  Clinically significant abnormalities in screening blood tests

          -  BMI > 35 kg/m2

          -  Previously diagnosed osteoporosis or osteopenia

          -  Clinically significant depressive symptoms

          -  Psychiatric illness

          -  Sleep apnea or periodic limb movement of sleep (PLMS)

          -  Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists

          -  Current or recent use of centrally active medications

          -  Current or recent use of systemic hormone medications

          -  Night shift workers

          -  Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep,
             or mood

          -  Abnormal vaginal bleeding

          -  History of any medical diseases that may put subject at risk when treated with study
             medication.
Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients
Condition: Poor Quality Sleep
Intervention: Lunesta
Intervention description: Both groups receive eszopiclone. Group 1 receives Lunesta (eszopiclone) in intervention weeks 1 and 2 followed by placebo in weeks 3 and 4.
Group 2 receives placebo in intervention weeks one and two followed by Lunesta (eszopiclone) in weeks 3 and 4.
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Aging; Sleep; Nursing Home; Sleep in nursing homes

Summary:

      The purpose of this study is to examine the effects of the sleep aid Lunesta (Eszopiclone),
      on older adults who reside in a nursing home and have poor sleep as determined by wrist
      actigraphy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nursing Home Patients

          -  Age 65 and above

        Exclusion Criteria:

          -  Under age 65

          -  Anticipated short stay (short term or hospice)

          -  Severe behavioral disturbance

          -  Unstable drug regimen in prior 2 weeks

          -  Use of a hypnotic, antihistamine, benzodiazepine, narcotic or antipsychotic

               -  once per week in prior 2 weeks

          -  Use of a potent inhibitor of CYP3A4

          -  Parkinson's with uncontrolled tremor

          -  Severe Dementia

          -  Severe Sleep Apnea

          -  Inability to tolerate wrist Actigraphy

          -  Sleep Efficiency >75%

          -  Sleep apnea

          -  Sleep efficiency of greater than 75% during the night.
Sevoflurane as an Anesthetic During Dilation and Evacuation Procedures
Condition: Blood Loss; Anesthesia
MeSH terms: Hemorrhage
Intervention: Sevoflurane; No Sevoflurane
Intervention description: Subject receives Sevoflurane in addition to other standard of care drug regimens for anesthesia with this procedure.; Subject only standard of care drug regimens for anesthesia with this procedure.
Intervention MeSH terms: Sevoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 160.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sevoflurane; anesthesia; abortion; blood loss

Summary:

      Sevoflurane is an FDA-approved anesthetic drug commonly used for anesthesia during second
      trimester abortion procedures. It has a few advantages, including ease of use by the
      anesthesia provider. However, the literature suggests that when used in doses higher than
      those used at Oregon Health & Science University (OHSU) and Lovejoy, it is associated with an
      increase in the risk of bleeding. The investigators study aims to test whether the lower dose
      used at OHSU and Lovejoy during second trimester abortion procedures causes any difference in
      blood loss, when compared to similar abortion procedures for which this drug is not used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily requesting pregnancy termination

          -  Estimated gestational age of 18 weeks - 23 weeks, 6 days gestational age as calculated
             by fetal biparietal diameter on clinic ultrasound.

          -  Be able and willing to sign an informed consent and agree to terms of the study

        Exclusion Criteria:

          -  Known severe maternal respiratory disease or upper respiratory infection or sinus
             blockage

          -  Anticoagulation use: within 24 hours if Lovenox, or within 12 hours if heparin, (Must
             have a documented normal international normalized ratio (INR) prior to procedure if on
             anticoagulation)

          -  Multiple pregnancy

          -  Fetal demise, if more than 2 weeks difference exists between known gestational age (by
             previous US dating) and gestational size on current ultrasound.

          -  Known allergy/sensitivity to sevoflurane or any other inhaled anesthetic agents
Changing in Skin Physiology After Microdroplet Placement of Stabilized Hyaluronic Acid in Aging Faces
Condition: Aging
Intervention: Restylane Vital
Intervention description: stabilized hyaluronic acid (HA)-based gel of nonanimal origin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      IMPORTANCE Skin rejuvenation can be achieved effectively and safely by injection of a
      stabilized hyaluronic acid (HA)-based gel of nonanimal origin (NASHA) injection using a
      stamp-type electronic multineedle injector.

      OBJECTIVE To determine the efficacy and safety of NASHA using a stamp-type electronic
      multineedle injector, and if changes in skin physiology occur earlier than in previous
      trials.

      DESIGN, SETTING, AND PARTICIPANTS Twenty-five patients were recruited to this single-center,
      evaluator-blinded, prospective, balanced (1:1), split-face randomized clinical trial.One
      dermatologist who was blinded as to the treatment side evaluated the skin hydration, melanin
      content, erythema, and elasticity of both cheeks using a corneometer, a mexameter, and a
      reviscometer, respectively, at each follow-up visit (0, 1, 2, 4, 8, and 12 weeks
      postinjection). The subjects and two independent investigators assessed the clinical
      improvement using the Global Aesthetic Improvement Scale (GAIS) at the every visit.
      Twenty-four participants completed the study, and no participants withdrew due to adverse
      effects.

      INTERVENTIONS Each participant submitted to a single treatment with a NASHA injection to one
      side of the lower cheek. The cheek side to which the treatment was applied was chosen
      randomly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy people older than 25 years

        Exclusion Criteria:

          -  known hypersensitivity to HA, an active skin disease, any autoimmune disorder, or
             significant renal, hepatic, or other medical diseases
Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
Condition: Pain
MeSH terms: Acute Pain
Intervention: Zipsor®
Intervention description: Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treament. Drug taken by mouth.
Intervention MeSH terms: Diclofenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: pain; NSAID; moderate pain; mild pain; acute pain; mild acute pain; moderate acute pain; mild or moderate acute pain

Summary:

      As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is
      to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between 12-17 years of age.

          -  Subjects must be post-op, having mild or moderate acute pain.

        Other inclusions apply.

        Exclusion Criteria:

          -  Subject has a known history of allergic reaction, hypersensitivity to diclofenac,
             aspirin, acetaminophen, or reaction to the non-active ingredients of the study
             medication.

          -  Subject has been taking analgesic for 48-72 hours prior to Screening.

          -  Subject has a history of any GI event greater than 6 months before Screening.

          -  Subject is currently receiving any medication that is contraindicated for use
             concomitantly with diclofenac or acetaminophen.

          -  Subject has previously participated in another clinical study of Zipsor or taking
             Zipsor for any other indication.

          -  Subject is requiring treatment for pre-existing hypertension.

        Other exclusions apply.