bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin glulisine; insulin aspart
Intervention description: Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days; Insulin aspart (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Type 1 diabetes mellitus in children; insulin glulisine; insulin aspart; post prandial

Summary:

      To determine whether insulin glulisine decreases the breakfast post prandial glycemic
      excursion in comparison to insulin aspart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  current patient in the Helen DeVos Children's Hospital Diabetes Clinic;

          -  ages 4-11 years;

          -  prepubertal (Tanner Stage I);

          -  diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or
             presenting at time of diagnosis with positive serum or urine ketones and requiring
             insulin since diagnosis;

          -  at least six months from date of diagnosis of type 1 diabetes mellitus;

          -  TSH within reference range and negative transglutaminase IgA antibodies within nine
             months of study start;

          -  HbA1C between 6.9 and 10% within 30 days of study start; parent or guardian able and
             willing to provide written informed consent prior to enrollment;

          -  at time of study start, current insulin regimen includes multiple daily injections
             with insulin glargine as the basal insulin and insulin aspart or insulin lispro as the
             pre-meal rapid acting insulin

        Exclusion Criteria:

          -  pubertal (Tanner stage 2 or greater);

          -  concurrent Addison's disease, celiac disease or untreated hypothyroidism; - receiving
             oral, injectable or inhaled steroids or immunosuppressant medications;

          -  receiving stimulants for treatment of attention deficit disorder or attention deficit
             hyperactivity disorder;

          -  intercurrent illnesses such as a fever > 101 degrees F, infection, or gastroenteritis;

          -  use of any medication to treat diabetes other than those listed under in inclusion
             criteria;

          -  potential for lack of compliance or any other issue which, in the opinion of the
             investigator, would compromise the subject's safety or successful participation in the
             study
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
Condition: Menorrhagia
MeSH terms: Menorrhagia
Intervention: Extended treatment regimen using Her Option Cryotherapy
Intervention description: Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: Female
Minimum age: 30 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Menorrhagia; Excessive Uterine Bleeding; Cryoablation; Menstrual disorder; Endometrial ablation; Abnormal uterine bleeding; Dysfunctional uterine bleeding

Summary:

      The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used
      to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive
      menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be
      performed in a physicians office with minimal sedation.

      Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of
      a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6
      minutes with the Cryoprobe repositioned in the contralateral cornu.

      Since completion of the early studies, many physicians have experimented with varying freeze
      patterns using longer freeze durations and/or additional freezes at the fundus and the lower
      uterine segment. The results, as reported in the literature, indicate that these extended
      freeze patterns produce significantly better results than the original regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal adult women 30 years of age or older who have completed childbearing

          -  Heavy or prolonged menstrual bleeding

          -  Willing and able to complete all follow-up exams as required by protocol

        Exclusion Criteria:

          -  Known or suspected endometrial cancer or pre-malignant change of the endometrium

          -  Untreated cervical dysplasia

          -  Hereditary malformations of the uterine cavity that would prevent insertion and/or
             placement of the cryoprobe

          -  Uterine myomas > or = to 3 cm in diameter

          -  Past history of invasive treatment for abnormal uterine bleeding or uterine myomas

          -  History of classical (not low transverse incision) cesarean section

          -  Active genital or urinary tract infection or acute pelvic inflammatory disease (PID)

          -  Intrauterine device (IUD) in place

          -  Other medical conditions could be exclusionary upon evaluation for study treatment
Valganciclovir to Reduce T Cell Activation in HIV Infection
Condition: HIV Infections; Cytomegalovirus Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Cytomegalovirus Infections
Intervention: Valganciclovir; Placebo
Intervention description: 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.; Placebo designed to resemble Valganciclovir
Intervention MeSH terms: Valganciclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; CMV; T Cell activation; Valganciclovir

Summary:

      The purpose of this study is to determine whether treatment with valganciclovir decreases T
      cell activation levels among HIV-infected patients with asymptomatic cytomegalovirus (CMV)
      co-infection, potentially improving immune responses to antiretroviral therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infection with HIV >1 year in duration.

          -  Age >18

          -  Cytomegalovirus (CMV) antibody positive.

          -  All Cluster of Differentiation 4 (CD4)+ T cell counts in the last year and at
             screening <350 cells/mm3

          -  On a stable highly addictive antiretroviral therapy (HAART) regimen (DHHS definition)
             for the preceding 6 months.

               -  90% adherence to antiretroviral therapy within the preceding 30 days.

          -  Females of childbearing potential must have a negative serum pregnancy test at
             screening and all subjects must agree to use a double-barrier method of contraception
             throughout the study period.

          -  Screening %Cluster of differentiation 38 (CD38)+ Human leukocyte antigen-D-related
             (HLA-DR)+ Cluster of differentiation 8 (CD8)+ T cells >10%

        Exclusion Criteria:

          -  Patients intending to modify antiretroviral therapy in the next 16 weeks.

          -  Serious illness requiring hospitalization or parental antibiotics within preceding 3
             months.

          -  Evidence of active symptomatic CMV end-organ disease.

          -  Treatment with valganciclovir or ganciclovir in the past 30 days.

          -  Concurrent treatment with immunomodulatory drugs.

          -  Concurrent treatment with nephrotoxic drugs

          -  Screening absolute neutrophil count <1,000 cells/mm3, platelet count <100,000
             cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <50 mL/minute.

          -  Men who are considering having children will also be excluded given potential effects
             of valganciclovir on spermatogenesis.

          -  Pregnant or breastfeeding women
Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension
Condition: Prolonged Second Stage of Labor
Intervention: intravenous nitroglycerin
Intervention description: Infusion at started at time of hysterotomy and stopped at neonate delivery
Intervention MeSH terms: Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second
      stage arrest of descent to prevent or uterine extension at the hysterectomy site.
    

Eligibility criteria:

        Inclusion Criteria: women 37weeks or greater gestation diagnosed with second stage arrest
        of descent undergoing cesarean delivery -

        Exclusion Criteria: elective, active phase arrest cesarean delivery, successful operative
        vaginal delivery

        -
Repeatability in Hyperpolarized 3-Helium With MRI
Condition: Radiation Exposure
Intervention: Prone hyperpolarized 3 helium gas scan; Supine hyperpolarized 3 helium gas scan; Vitals; Pulmonary Function Tests; Initial protocol MRI scan
Intervention description: Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.; Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.; Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes; Initial scan to determine placement
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to assess and test the reproducibility and results of
      hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the
      lungs in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  must be between the ages of 18 and 90

          -  must have a Body Mass Index (BMI) of < 32 and weigh < 200 lbs.

        Exclusion Criteria:

          -  if female, must not be pregnant or breastfeeding

          -  must not have any metal objects in or on their body including body piercings that
             cannot be easily removed, bullets, metallic fragments or slivers in eyes, skin, etc.,
             pacemaker or defibrillation, aneurysm clips, cochlear implants, coronary stents, or
             neurostimulation.

          -  must not have a history of claustrophobia, panic disorders, anxiety attacks, atrial
             fibrillation, uncontrolled high blood pressure, frequent ventricular ectopic rhythm,
             hemodynamic instability, kidney dysfunction or heart disease.
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Hot Flashes
Intervention: suvorexant; placebo
Intervention description: 10-20 mg taken at bedtime for four weeks; placebo taken at bedtime for four weeks
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: insomnia; hot flashes; menopause; suvorexant; belsomra

Summary:

      The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri-
      and postmenopausal women who are experiencing sleep difficulties related to nighttime hot
      flashes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peri- or postmenopausal women

          -  DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes

          -  Some awakenings co-occur with a hot flash

          -  Score on the Insomnia Severity Index (ISI) measure ≥15

          -  Hot flashes present, including at night

        Exclusion Criteria:

          -  Diagnosis of other primary sleep disorders

          -  Shift workers

          -  Current or expected use of hypnotic medications

          -  Current major depressive episode

          -  Lifetime history of bipolar disorder, psychosis, or other serious mental health
             problem

          -  Current alcohol/substance use disorder

          -  Obesity

          -  Renal or hepatic disease

          -  Pregnancy or breastfeeding

          -  Recent malignancy

          -  Recent surgery

          -  Neurological disorder or cardiovascular disease raising safety concerns

          -  Medical instability considered to interfere with study procedures

          -  Concomitant medications with drug interaction or co-administration concerns

          -  Contraindications or allergic responses to suvorexant

          -  Recent or planned travel across time zones

          -  Excessive coffee or cigarette use
A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval
Condition: Pain
Intervention: Acetaminophen; placebo
Intervention description: Acetaminophen total dose of 1000mg; subjects randomized to this group will be given placebo tablets
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: Female
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Analgesic; Pain Control; IVF; Tylenol; Acetaminophen; Egg Retrieval; iv vitro Fertilization

Summary:

      Current standard of care is no pretreatment medications before the egg retrieval, and the
      investigators would like to evaluate if preoperative Tylenol improves procedure and post
      procedure pain control over the current practice (no pre-treatment). Specifically, this study
      will compare Tylenol with a placebo when given before retrieval procedures. The investigators
      believe that if Tylenol can offer better analgesic relief than no pretreatment medications,
      then it may reduce the amount of narcotics needed by patients during and after the procedure
      and contribute to better patient satisfaction. . This study will enroll 100 participants all
      from University of Alabama at Birmingham (UAB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  English Speaking

          -  Undergoing Transvaginal Oocyte Retrieval Procedure

        Exclusion Criteria:

          -  Acetaminophen allergy

          -  Opioid dependency
Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Intervention: Donepezil; Placebo
Intervention description: donepezil 5 mg once daily for 6 weeks; placebo or sugar pill will be taken once daily for 6 weeks
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: neuropathic pain; diabetic neuropathy; neuropathic pain after back surgery

Summary:

      Based on laboratory studies, donepezil will improve pain relief more than placebo in patients
      with chronic neuropathic pain who are currently taking gabapentin or pregabalin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of diabetic neuropathy or failed back syndrome with neuropathic symptoms

          -  Age 18-80

          -  Taking a stable dose of gabapentin or pregabalin

        Exclusion Criteria:

          -  Pregnant women or women of child-bearing potential not willing to practice a reliable
             form of birth control

          -  Allergy to donepezil or other piperidine derivatives (including fentanyl, alfentanil,
             sulfentanil, remifentanyl, demerol, tramadol, loperamide, diphenoxylate, betaprodine,
             alphaprodine, ethopropazine, anileridine, piminodine,
             1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine(MPTP),loratadine, fexofenadine

          -  Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases
             that, in the opinion of the investigator, would preclude patients from finishing the
             trial

          -  Any person with pending litigation

          -  A history of major psychosis requiring hospitalization within the last three years

          -  Non-English speaking, illiterate, unable to comprehend consent

          -  Lack of contact information

          -  Uncontrolled narrow-angle glaucoma

          -  Currently being treatment with thioridazine (Mellaril)

          -  Patients taking opioids will be excluded if they are taking a dosage that exceeds an
             equivalent of 30 mg of morphine per day

          -  Patients taking more than one regular (not rescue) medication for pain

          -  Patients taking donepezil for dementia

          -  Patients with a baseline pain score less than 2 (0-10 scale) or greater than 8 (0-10)
             will be excluded
Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
Condition: Kidney Transplantation
Intervention: mycophenolate mofetil [CellCept]; Corticosteroids; Calcineurin inhibitors; Sirolimus
Intervention description: 1.0-1.5 g oral dose twice daily; As prescribed; As prescribed; As prescribed
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Calcineurin Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 2-arm study recruited kidney transplant patients who were receiving standard care of
      calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily)
      and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was
      discontinued and replaced by sirolimus therapy (in combination with CellCept and
      corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was
      evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size
      was 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients 18-75 years of age

          -  Kidney transplant 30-180 days post-transplantation

          -  Receipt of cyclosporine or tacrolimus, CellCept, and corticosteroids for greater than
             14 days prior to study entry

          -  No known contraindications to sirolimus

        Exclusion Criteria:

          -  Multiple organ transplant recipients or secondary kidney transplant recipients

          -  Corticosteroid-resistant rejection episode within 90 days prior to study entry or
             corticosteroid-sensitive rejection episode within 30 days prior to study entry

          -  More than 1 biopsy-proven episode of acute rejection prior to study entry

          -  Treated with sirolimus before the study

          -  Organ transplant or expected organ transplant, other than kidney

          -  History of malignancy in the last 5 years (except successfully treated localized
             non-melanotic skin cancer)
Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)
Condition: Rotavirus Disease
MeSH terms: Diphtheria; Rotavirus Infections
Intervention: RotaTeq™ (V260); DTP-IPV
Intervention description: Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains; Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 11 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and
      Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260)
      in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates
      to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with
      staggered administration of RotaTeq™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese participant

          -  Age 6 weeks through <11 weeks (42 to 76 days from date of birth) at Visit 1

        Exclusion Criteria:

          -  History of hypersensitivity and/or anaphylaxis to any of the product ingredients in
             V260 or DTP-IPV

          -  Gastrointestinal disorder, growth retardation, or failure to thrive

          -  History of intussusception

          -  Untreated congenital gastrointestinal disorder (such as Meckel diverticulum)

          -  Known or suspected impairment of immunological function, including severe
             immunodeficiency (SCID)

          -  Cardiovascular, renal, liver, or blood disease

          -  History of convulsion

          -  Undergoing immunosuppressive therapy or living with a close relative with congenital
             immune deficiency

          -  Prior vaccination with rotavirus vaccine and/or DTP-IPV vaccine

          -  Live vaccine received within 28 days or inactivated vaccine received within 7 days

          -  At high risk for tuberculosis exposure