bioihbjkbjnl/mcl2 huggingface dataset:
Examining the Impact of Tampon Use on the Vaginal Microbiota
Condition: Vaginal Microbiota
Intervention: Tampon A; Tampon B
Intervention description: 24 Tampax Pearl Regular Tampons for use during a single menstrual period.; 24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for one of the first two menstrual cycles during the study. Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the other of the first two menstrual cycle during the study. Subjects used tampons A and B in a randomly assigned order. Subjects then used tampons of their choosing for the third menstrual cycle of the study.
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tampon; menstruation; menstrual period

Summary:

      The vaginal microbiota is the community of bacteria in the vagina. The composition of the
      vaginal microbiota (which bacteria are present and how many of each are present) is known to
      affect vaginal health and contribute to the development of bacterial vaginosis (the largest
      cause of vaginal discharge and malodor, and the most common vaginal disorder). It is also
      known that the composition of the vaginal microbiota changes across a menstrual cycle with
      the largest changes happening during a woman's period. However, it is not know how tampon use
      affects vaginal microbiota composition. This study is being done to learn what effect tampon
      use has on vaginal microbiota composition during a woman's period and between periods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  regular menstrual cycles lasting 21-35 days

          -  menses lasting for at least 4 days

          -  current tampon user

          -  good self-reported general health

          -  good self-reported vaginal health

        Exclusion Criteria:

          -  currently pregnant

          -  planning to become pregnant in 4 months following enrollment

          -  difficulty using tampons

          -  current toxic shock syndrome

          -  history of toxic shock syndrome

          -  current sexually transmitted infection

          -  current urinary tract infection

          -  currently using antibiotics

          -  antibiotic use in 4 weeks prior to enrollment

          -  current antifungal use

          -  antifungal use in 4 weeks prior to enrollment

          -  autoimmune condition
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Placebo; Tobi Podhaler
Intervention description: One dose (4 capsules) of placebo; The placebo capsule has to be released from the blister card and inserted into the Podhaler device. The device is then actuated and the study drug is inhaled according to the instructions for use
Intervention MeSH terms: Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: CF, Human Factors, TOBI® Podhaler™, user interface, IFU

Summary:

      The purpose of this study is to validate the user interface of TOBI Podhaler by establishing
      that the product can support safe and effective use for the intended users
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent or, parent/guardian consent and where applicable pediatric
             assent, must be obtained before any assessment is performed

          -  Male and female subjects aged 6 years and older

          -  Confirmed diagnosis of CF by one or more of the following tests for CF as documented
             in the patient's medical history : (1) quantitative pilocarpine iontophoresis sweat
             chloride test of > 60 mmol/L or 60 mEq/L, (2) genotype with identifiable CF-causing
             mutations on both chromosomes, (3) an abnormal nasal transepithelial potential
             difference characteristic of CF

          -  FEV1 value must be at least 25% of normal predicted values for age, sex, and height as
             documented in the patient's medical history (historical values within 3 months can be
             used for this criterion).

          -  Able to comply with all protocol requirements

          -  Clinically stable in the opinion of the investigator

        Exclusion Criteria:

          -  Subjects currently enrolled in studies that are not considered as observational
             non-investigational studies

          -  Subjects or caregivers who have used the Podhaler device previously

          -  Hemoptysis more than approximately 60 mL at any time within 30 days prior to
             enrollment

          -  History of hypersensitivity to the inhaled placebo dry powder (DSPC and/or calcium
             chloride powder)

          -  Signs and symptoms of acute pulmonary disease, e.g. pneumonia, pneumothorax,
             bronchospasm, acute respiratory infection

          -  Clinically significant conditions or findings at enrollment that might interfere with
             the accurate and valid assessment of this study

          -  Subjects or caregivers who are considered potentially unreliable or considered
             unlikely to be compliant within the trial

          -  Pregnant women
Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy
Condition: Nonproliferative Diabetic Retinopathy
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy
Intervention: Lucentis
Intervention description: Local anesthesia with T-caine with Saline irrigation. Routine eye drap was done by potadine-cotton ball. Lucentis injected to vitreous cavity, finally dressing.
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Nonproliferative diabetic retinopathy, Microaneurysms

Summary:

      Title of study:

      Effects of Ranibizumab to delay or regression non-proliferative diabetic retinopathy(NPDR)
      with DME assessed by microaneurysm changes: A pilot study Objectives Diabetic retinopathy
      (DR) is a major cause of visual impairment. Anti-vascular endothelial growth factors have
      demonstrated therapeutic benefits in diabetic macular edema (DME). We aimed to prospectively
      analyze the effects of early intensive treatment using intravitreal ranibizumab (IVR)
      injections in nonproliferative diabetic retinopathy patients with macular edema.

      Primary objective:

      To investigate other efficacy endpoints including other visual acuity, anatomical change in
      mild-to-moderate NPDR with DME after intravitreal Ranibizumab injection from baseline through
      6 months after treatment.

      Secondary objectives:

      To compare microvascular changes assessed by microaneurysm counts and perifoveal
      non-perfusion area changes and safty in eyes of mild-to-moderate NPDR with DME after
      intravitreal Ranibizumab injection from baseline through 6 months after treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients (Male & female) ≥40 years of age

          -  Type 2 DM

          -  Best corrected visual acuity ≥ 20/200 (Snellen equivalent using Early Treatment
             Diabetic Retinopathy Study chart)

          -  central retinal thickness of ≥300 µm on optical coherence tomography

          -  nonproliferative diabetic retinopathy (NPDR) with diabetic macular edema

        Exclusion Criteria:

          -  proliferative diabetic retinopathy

          -  Vitreous hemorrhage

          -  previous history of vitreoretinal surgery, post-cataract operation status (≤4 months
             before participation in this study)

          -  prior treatment with anti-VEGF drugs, intraocular corticosteroids, and/or retinal
             laser application

          -  Uncontrolled hypertension.

          -  Uncontrolled glaucoma.

          -  If both eyes met the study inclusion criteria, the more severely affected eye was
             selected
Adrenocorticotropic Hormone in Membranous Nephropathy
Condition: Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Intervention: ACTHar
Intervention description: for 6 months
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Membranous nephropathy; adrenocorticotropic hormone; ACTH; proteinuria; glomerulonephritis

Summary:

      The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH,
      Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous
      nephropathy. Acthar is a hormone that stimulates steroid production from small glands above
      the kidneys. It has direct protective effects on the kidney and is currently approved by the
      FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of
      action are not entirely understood and will be studied in the present trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 70 years

          -  Free of immunosuppression for at least 3 months

          -  Capability of understanding the purpose of the study

          -  Written informed consent

        Exclusion Criteria:

          -  Epidermal growth factor receptor (eGFR) < 30ml/min/1.73m2

          -  Kidney Transplant

          -  Secondary MN (defined on the basis of clinical criteria)

          -  Type 1 or Type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus
             is not an exclusion)

          -  History of previous use of Acthar for treatment of nephrotic syndrome

          -  Prior sensitivity to Acthar or other porcine protein products

          -  Contraindication to Acthar per Prescribing Information

          -  Planned treatment with live or live attenuated vaccines once enrolled in the study

          -  More than three previous treatment regiments

          -  Participation to other clinical trials over the previous 12 months

          -  History of cancer, except carcinoma in situ and treated basal and squamous cell
             carcinomas

          -  Pregnancy

          -  Lactation

          -  Current substance abuse

          -  Any clinically relevant condition that might affect study participation and/or study
             results
Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Exenatide; Placebo
Intervention description: Exenatide SQ 2mg/week for 24 weeks.; Placebo SQ 1x/week for 24 weeks.
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a 24-week, randomized, double-blind, placebo-controlled trial of exenatide weekly
      injection (2mg per dose) as an adjunctive therapy in 70 schizophrenia subjects to examine
      exenatide's effects on negative symptoms and cognition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-65 years

          -  diagnosis of schizophrenia or schizoaffective disorder

          -  stable dose of the current antipsychotic drug for at least one month

          -  well established compliance with outpatient treatment per treating clinician's
             judgment

          -  able to complete the cognitive assessment battery (must be English speaking)

          -  Female subjects will be eligible to participate in the study if they are of
             non-childbearing potential or of child-bearing potential and willing to practice
             appropriate birth control methods during the study

        Exclusion Criteria:

          -  inability to provide informed consent

          -  current substance abuse

          -  psychiatrically unstable per treating clinician's judgment

          -  significant medical illnesses including uncontrolled hypertension, diabetes, seizure
             disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases

          -  currently on anti-inflammatory or immunosuppressant medication including oral steroids

          -  currently on sulfonylurea drugs (e.g. glyburide)

          -  history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy,
             organ transplantation, blood dyscrasia, central nervous system demyelinating disorder,
             and any other known autoimmune or inflammatory condition

          -  pregnant or breastfeeding

          -  prisoners
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Condition: Intervertebral Disc Degeneration
MeSH terms: Intervertebral Disc Degeneration
Intervention: Duloxetine; Placebo
Intervention description: duloxetine 60 mg; placebo
Intervention MeSH terms: Duloxetine Hydrochloride
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: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation
      with fentanyl demand controlled by the patient. The primary objective is to evaluate the
      efficacy of duloxetine in fentanyl consumption during the postoperative period of patients
      undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints
      were pain scores and the presence or absence of adverse effects such as headache, nausea,
      vomiting, itching, dizziness and drowsiness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients were included, of both genders, aged between 18 and 70 years and American
             Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study

        Exclusion Criteria:

          -  Patients allergics to duloxetine, ketoralac or fentanyl, pre-existing history of use
             of illegal substances or alcohol in an abusive manner and abnormal kidney or liver
             function tests.
Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
Condition: Cystic Fibrosis; Dysbiosis
MeSH terms: Cystic Fibrosis; Fibrosis; Dysbiosis
Intervention: Vitamin D3; Placebo vitamin D3; Inulin; Placebo Inulin
Intervention description: High-dose vitamin D3 50,000 IU /week for 12 weeks; Matching to Vitamin D3 placebo capsules for 12 weeks; Chicory-derived prebiotic inulin 12 g/day for 12 weeks; Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Gastrointestinal Dysbiosis; Vitamin D; Prebiotic; Inulin; Gut microbiome; Intestinal inflammation; Intestinal absorption

Summary:

      The study will assess if administration of high-dose vitamin D and a commonly used prebiotic
      (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal
      functions in Cystic Fibrosis with the additive or synergistic effects of the combination of
      vitamin D + inulin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. male and female patients (age > 18 years) with confirmed CF by genetic mutation and/or
             sweat chloride testing,

          2. not currently on oral or systemic antibiotics for pulmonary exacerbation,

          3. vitamin D deficient/insufficient (25(OH)D, 6 - 30 ng/mL) with most recent 25(OH)D in
             the past 12 months,

          4. use of CFTR modulator therapy is allowed

        Exclusion Criteria:

          1. severe vitamin D deficiency 25(OH)D ≤ 5 ng/mL or hypocalcemia or hypercalcemia,

          2. active GI disease, abdominal pain and/or diarrhea,

          3. chronic kidney disease worse than stage 3 (eGFR < ml/min per 1.73 m2),

          4. any vitamin D supplement use >2,000 IU or vitamin D analogue (patients who are taking
             more than 2,000 IU of vitamin D must agree to stop the vitamin D for 6 weeks and take
             less than 2,000 IU of vitamin D during the study),

          5. use of immunosuppressants or history of organ transplantation,

          6. current use of probiotics or prebiotics
Management of Sub-Clinical Bacteriuria in Pregnancy
Condition: Cystitis; Cystitis;Puerperium; Pyelonephritis
MeSH terms: Bacteriuria; Cystitis; Pyelonephritis
Intervention: Antibiotic; Standard Prenatal Care
Intervention description: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.; Continued surveillance of urinary cultures
Intervention MeSH terms: Anti-Bacterial Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if treatment of pregnant women with urine cultures
      with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease
      adverse pregnancy outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women who seek prenatal care within the University of Texas Health System
             with UT Physicians.

          -  Urine culture of less than 100,000 CFU

        Exclusion Criteria:

          -  Less than 18 years of age

          -  Risk factors to complicated UTI (including but not limited to: diverticula,
             urolithiasis, renal cysts, indwelling catheter, intermittent catheterization, stent
             placements, nephrostomy tubes, neurogenic bladder, cystocele, vesicoureteral reflux,
             ileal conduit)

          -  Use of immunosuppressant drugs

          -  Abnormalities of the urinary tract (including but not limited to: known ureteric or
             urethral strictures, tumors of the urinary tract, pelvicalyceal obstruction,
             congenital anomalies, history of urological procedures)

          -  History of renal disease including renal failure and transplants

          -  Urine culture > 100,000 CFU of any organism
Octylseal Surgical Adhesive in General Surgery
Condition: Wounds
Intervention: Cyanoacrylate (Octylseal )
Intervention description: surgical adhesive
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No
Keywords: wounds

Summary:

      The purpose of this study is to evaluate how surgical adhesive is used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Candidate for use of a topical surgical skin adhesive

        Exclusion Criteria:

          -  Subjects with know sensitivity to topical surgical tissue adhesive products or
             degrading products (cyanoacrylates or formaldehyde)

          -  Subjects with a history of keloid formation, hypotension, insulin dependent diabetes
             mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy
             history

          -  Subjects who present with a contraindications for product usage as per labeling

          -  A wound with evidence of active infection or gangrene or wounds of decubitus etiology

          -  Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to
             bodily fluids or with dense natural hair

          -  Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Hydromorphone; Prochlorperazine; Diphenhydramine
Intervention MeSH terms: Diphenhydramine; Promethazine; Hydromorphone; Prochlorperazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      Opioids are commonly used to treat migraine in North American Emergency Departments. We are
      comparing efficacy and adverse events of hydromorphone, an opioid, to that of
      prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine
      will be combined with diphenhydramine to prevent adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Migraine headache (International Classification of Headache Disorders 3B criteria)

        Exclusion Criteria:

          -  Brain imaging ordered

          -  Fever

          -  Objective neurological findings

          -  Pregnancy/ breast feeding

          -  Allergy/ contraindication to investigational medication

          -  History of addiction to opioids, use of methadone, any use of opioids previous 30 days