bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS
Condition: Polycystic Ovary Syndrome; Vitamin D Deficiency
MeSH terms: Polycystic Ovary Syndrome; Vitamin D Deficiency
Intervention: Vitamin D3
Intervention description: Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: Female
Minimum age: 16 Years
Maximum age: 48 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Polycystic Ovary Syndrome; Vitamin D; Anti Mullerian Hormone; Soluble receptor for Advanced Glycation End Products

Summary:

      The purpose of this study is to investigate the mechanism that explain the beneficial
      clinical effect of vitamin D treatment in women with PCOS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Vitamin D deficient premenopausal women

        Exclusion Criteria:

          -  Pregnant women

          -  Women during their postpartum period

          -  Breastfeeding women

          -  Women taking any kind of exogenous hormones

          -  Women receiving any form of oral vitamin D replacement
The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease
Condition: Tetralogy of Fallot; Transposition of the Great Vessels With an Arterial Switch; Single Ventricle With a Fontan Palliation
MeSH terms: Heart Diseases; Heart Defects, Congenital; Univentricular Heart; Tetralogy of Fallot; Transposition of Great Vessels
Intervention: Eplerenone
Intervention MeSH terms: Eplerenone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Hypothesis:

      By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the
      great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident
      heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias
      decreased through decreases in myocardial fibrosis.

      Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6
      minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months
      without therapy, after 6 months on therapy, then finally after 12 months of eplerenone
      therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12
      months on therapy. Patients will be randomly assigned to drug free period up front versus at
      the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated
      up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at
      enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for
      monitoring.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of tetralogy of Fallot, transposition of the great vessels with
             a systemic right ventricle, or Fontan type palliation

          -  Patient followed regularly at Washington University-affiliated institution

          -  If female, willing to use 2 forms of contraception including one barrier method during
             protocol

        Exclusion Criteria:

          -  GFR <30 ml/min

          -  Potassium >5.0 mmol/L

          -  Unable or unwilling to comply with study protocol

          -  Use of potassium sparing diuretics

          -  Use of an aldosterone blocker currently or previously

          -  Known intolerance of eplerenone or aldosterone blockade

          -  Pregnant, breastfeeding, or actively trying to get pregnant
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]
Intervention description: 180 micrograms sc weekly for 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic
      hepatitis B who are either treatment-naive, or who have failed lamivudine- or
      interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c.
      weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time
      on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-70 years of age;

          -  chronic hepatitis B;

          -  Hepatitis B Virus (HBV) DNA >100,000 copies/mL.

        Exclusion Criteria:

          -  previous antiviral or interferon-based therapy for chronic hepatitis B in past 6
             months;

          -  evidence of decompensated liver disease;

          -  history or evidence of a medical condition associated with chronic liver disease other
             than viral hepatitis;

          -  coinfection with hepatitis A, C or D, or HIV.
Pioglitazone in Patients With Mood Disorders
Condition: Major Depressive Disorder; Insulin Resistance
MeSH terms: Insulin Resistance; Depressive Disorder; Depressive Disorder, Major; Mood Disorders
Intervention: Pioglitazone; Sugar Pill
Intervention description: 30mg once daily for 12 weeks; Placebo
Intervention MeSH terms: Pioglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Insulin resistance; Mood disorder

Summary:

      The purpose of this study is to see how an insulin sensitizing medication, Pioglitazone, can
      cause changes in mood in some depressed patients. Study participants receive assessment of
      their cognitive and metabolic functioning.

      If they meet criteria, they will be asked to take either Pioglitazone or a placebo for a
      90-day trial. Participants will undergo an Oral Glucose Tolerance Test to measure fasting
      insulin and glucose levels, as well as routine blood testing.

      The investigators hope to quantify the role of Pioglitazone in patients with mood disorders
      and compare the values to those previously obtained in a healthy age-matched control
      population. The investigators also hope to examine the association between IR and cognitive
      performance and clinical course of depression in patients with mood disorders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 20 and 65 years

          -  BMI between 25 and 35

          -  Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD)
             or depressive episode of bipolar disorder (Bipolar I, II or NOS)

          -  Depression severity as defined by score of < 12 on the 21-item Hamilton Rating Scale
             for Depression and no psychiatric admission within 6 months from study entry and no
             suicide attempt within the last 12 months

          -  Willingness to sign human subjects consent form

        Exclusion Criteria:

          -  Diagnosis of possible or probable cognitive impairment

          -  For women only: pregnancy, breastfeeding

          -  Personal history of Type I or Type II diabetes

          -  Unstable cardiovascular disease or other major medical condition, or history of
             myocardial infarction within the previous year

          -  Significant cerebrovascular disease, as evidenced by neurological examination,
             uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressures
             > 100)

          -  Current drug or alcohol abuse

          -  History of neurological disorder, e.g. multiple sclerosis, stroke etc

          -  Use of any drug that may significantly affect psychometric testing or the insulin
             testing
Pharmacogenomics of Antiplatelet Response - II (PARes-II)
Condition: Atherothrombosis
Intervention: Aspirin
Intervention description: 81 mg daily for 4 weeks
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Platelet Transcriptome; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Aspirin

Summary:

      This clinical trial is examining the effect of 4-week aspirin therapy on platelet
      transcriptome in persons at high-risk for myocardial infarction or stroke due to family
      history of early-onset coronary artery disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants from the GeneSTAR cohort

          -  Unaffected with no overt coronary artery disease or serious vascular event (stroke or
             peripheral vascular disease diagnosis

          -  Women who are postmenopausal.

          -  Women who use a reliable contraceptive method; a reliable contraceptive method will be
             defined as personal history of tubal ligation, ongoing use of intra-uterine device, or
             ongoing use of oral contraceptive pills.

        Exclusion Criteria:

          -  Presence of any CAD or stroke, transient ischemic attacks, peripheral arterial disease

          -  Persons taking aspirin, NSAIDS, or any anti-coagulants who are medically unable to
             stop them for a two week pre-trial

          -  A history of allergy to aspirin or clopidogrel

          -  Weight < 60kg

          -  Age < 45 and > 75 years of age

          -  A history of recent or any active bleeding

          -  Serious or current co-morbidity (AIDS, cancer)

          -  Pregnant women as determined by urine dipstick pregnancy test

          -  Any aneurysms on cranial magnetic resonance imaging/magnetic resonance angiography
             (obtained recently in the GeneSTAR participants)

          -  Blood pressure above >=159/95mmHg

          -  History of a gastric or duodenal ulcer, or significant gastrointestinal disease, like
             regional enteritis

          -  Mental incompetence to make a decision to participate (developmentally disabled, and
             persons with diagnosed psychiatric disorders-documented in primary care records).
Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% for Lower Limb Orthopaedic Surgery
Condition: Lower Limb Surgery
Intervention: Levobupivacaine; Ropivacaine
Intervention description: Comparison of Equipotent doses; Comparison of equipotent doses
Intervention MeSH terms: Ropivacaine; Levobupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Subarachnoid block; intrathecal; spinal anesthesia; isobaric; levobupivacaine; ropivacaine

Summary:

      The purpose of this study is to compare the effects of two intrathecally administered
      drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia
    

Eligibility criteria:

        Inclusion Criteria:

          1. American Society of Anesthesiologists (ASA) class I & II patients of either sex

          2. Age between 18-60 years

        Exclusion Criteria:

          1. Patient's refusal.

          2. Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs.

          3. Patients having h/o diabetes, neurological and musculoskeletal diseases.
Intranasal Midazolam in Children as a Pre-Operative Sedative
Condition: Sedation, Conscious
Intervention: Midazolam; xylocaine; saline placebo
Intervention description: Study participants will be randomly assigned to one of three treatment groups:
Group 1 - Placebo - Control patients will receive intranasal saline.
Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam.
Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.; Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.; Placebo - Control patients will receive intranasal saline.
Intervention MeSH terms: Lidocaine; Midazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Months
Maximum age: 7 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal
      midazolam makes giving the midazolam easier and more comfortable without affecting how the
      midazolam works as a sedative.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children aged 18 months-7 years, scheduled for a minor otolaryngology (ENT) surgical
             procedure requiring mask anesthesia

          2. American Society of Anesthesiologists (ASA) Class 1 or 2

          3. Parent willing and able to provide written informed consent

          4. Parent willing and able to complete the OBD VAS

        Exclusion Criteria:

          1. ASA Class 3 or greater

          2. History of allergy to midazolam or xylocaine

          3. Presence of acute respiratory infection at time of surgery

          4. Parent unwilling or unable to provide informed consent

          5. Parent unwilling or unable to complete the OBD VAS
Effect of Samples on Acne Treatment With Epiduo® Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene + benzoyl peroxide samples; Adapalene + benzoyl peroxide from standard tube
Intervention description: A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.; Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: adherence; adapalene; benzoyl peroxide; sample; topical treatment

Summary:

      The purpose of this study is to compare adherence to treatment and efficacy with Epiduo® Gel
      in patients with mild to moderate acne who receive a medication sample and instructions on
      proper application with their stock size medication tube versus patients who receive only the
      stock size medication tube.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject with mild to moderate acne, aged 12 and older, who agrees to
             participate and provides written consent.

          -  Have an Acne Global Assessment (AGA) of mild to moderate acne (an AGA score of 2 or 3)

        Exclusion Criteria:

          -  Presence of a concurrent medical condition or skin condition, which is determined by
             the investigator to potentially interfere with study outcomes or patient assessments.

          -  Subjects with known allergy or sensitivity to Epiduo® Gel (or Benzoyl Peroxide Gel) or
             components therein, including adapalene or benzoyl peroxide

          -  Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or
             willing to practice effective contraception during the study. Reliable methods of
             birth control are: abstinence (not having sex), oral contraceptives, intrauterine
             device (IUD), Depo-Provera, tubal ligation, or vasectomy of the partner (with
             confirmed negative sperm counts) in a monogamous relationship (same partner). An
             acceptable, although less reliable, method involves the careful use of condoms and
             spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant
             women and women planning to become pregnant while on study are to be excluded.
Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion
Condition: Concussion
Intervention: Progesterone; Placebo
Intervention description: Standard placebo
Intervention MeSH terms: Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: No
Keywords: Concussion

Summary:

      Concussions are a common injury among athletes in the United States. The annual incidence of
      sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8
      million, and the likelihood of an athlete in a contact sport experiencing a concussion is as
      high as 20 percent per season. Even mild traumatic brain injury, including concussion, can
      cause long-term cognitive problems that affect a person's ability to perform daily activities
      and to return to school or work. Far more concerning is the mounting body of evidence that
      concussions are not just transient injuries - but have cumulative effects. It has been well
      established in animal models that progesterone has neuroprotective benefits. Animal studies
      using progesterone for acute post-injury treatment have demonstrated reduced cerebral edema,
      reduced neuro-inflammatory markers, decreased neuronal loss, and improved behavioral
      outcomes. To date, there have been no studies to assess whether or not progesterone will be
      effective for the treatment of concussions. This double-blind placebo controlled trial will
      assess the ability of 5 days of oral micronized progesterone (Prometrium®) to shorten the
      duration of symptoms of an athlete diagnosed with concussion. The investigators hypothesize
      that athletes treated with progesterone will have faster resolution of their concussive
      symptoms. The investigators believe this study may be the first clinical trial to show an
      effective treatment for concussion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with a concussion

          -  A 18 years or older

          -  Diagnosis < 24 hours from injury

          -  Consent obtained prior to concussion

        Exclusion Criteria:

          -  Pregnant

          -  Active breast or reproductive organ cancers

          -  Allergy to peanuts

          -  History of or current thrombophlebitis or venous thromboembolic disorder

          -  Females taking birth control

          -  Known hypersensitivity or prior adverse reaction to progesterone

          -  Known liver disease
Hydrocodone For Pain Control in First Trimester Surgical Abortion
Condition: Pain
Intervention: Hydrocodone/acetaminophen; Placebo; Ibuprofen; Lorazepam; Lidocaine
Intervention description: Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.; Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.; 800 mg oral ibuprofen; 2 mg oral lorazepam; 20 ml 1% buffered lidocaine, injected
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Lidocaine; Hydrocodone; Lorazepam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 121.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain during first trimester surgical abortion

Summary:

      The purpose of this study is to determine whether preoperatively administered
      hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or older

          -  Voluntarily requesting surgical pregnancy termination

          -  Pregnancy with intrauterine gestational sac up to 10 weeks 6 days gestation, dated by
             ultrasound

          -  Eligible for suction curettage

          -  English or Spanish speaking

          -  Good general health

          -  Able and willing to give informed consent and agree to terms of the study

        Exclusion Criteria:

          -  Gestational ages 11 weeks or more

          -  Incomplete abortion

          -  Premedication with misoprostol

          -  Use of any opioid medication within the past 7 days

          -  Use of heroin within the past 7 days

          -  Requested opioids or IV sedation prior to start of the procedure

          -  Patients who refuse ibuprofen or lorazepam

          -  Contraindications or allergies to HC/APAP, lidocaine, ibuprofen, or lorazepam

          -  Significant medical problem necessitating inpatient procedure

          -  Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease

          -  Known hepatic disease