bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Condition: Mild Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Intervention: Glyburide; Placebo
Intervention description: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.; Sham dose adjustments of the placebo will be made.
Intervention MeSH terms: Glyburide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 395.0
Sex: Female
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized prospective trial which addresses the question of whether use of an oral
      hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will
      result in achieving euglycemia in a shorter period of time and, in turn, result in less
      frequent maternal and neonatal morbidities. This study is designed to test the hypothesis
      that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling
      lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling
      alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at
             gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical
             information

          -  An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl

          -  Gestational age of less than or equal to 28 weeks and 0 days at the time of
             consent/randomization

          -  Singleton gestation

        Exclusion Criteria:

          -  Established pregestational diabetes

          -  Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation.
             Women who have a negative glucose loading test (<140mg/dl) before 24 weeks may still
             be considered for this study if they present again for glucose tolerance testing
             between 24 and 27 weeks.

          -  Multiple gestations

          -  Known major fetal anomaly or fetal demise

          -  Any renal disease with serum creatinine of >1.0

          -  Known liver disease such as hepatitis

          -  Maternal or fetal conditions likely to require imminent or very preterm delivery such
             as preeclampsia, preterm premature rupture of the membranes, preterm labor, and
             intrauterine fetal growth restriction

          -  Known hypersensitivity or allergic reaction to Glyburide
The Impact of Pain Scores on Intrauterine Lidocaine Versus Normal Saline Infusion at the Time of IUD Placement
Condition: Pain
Intervention: Lidocaine; Normal Saline
Intervention description: 1.33 cc 2% liquid lidocaine; 1.33cc normal saline
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain score; IUD placement

Summary:

      The study hypothesis is that infusion of 2% lidocaine at the time of IUD placement will
      reduce pain scores related to that procedure. In a double blinded randomized trial of 60
      women receiving either normal saline or lidocaine infused through an endometrial aspirator,
      pain scores will be obtained for each step of the IUD placement procedure and for the total
      experience.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women eligible for IUD insertion

          -  Willing to give consent

        Exclusion Criteria:

          -  Allergy to lidocaine

          -  Contraindications to IUD use
Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients
Condition: Pediatrics; Anesthesia; Vasospasm
Intervention: Papaverine; Heparin; Rescue papaverine, as needed
Intervention description: 0.12 mg/mL papaverine administered as soon as the arterial catheter is placed and secured, and 0.12 mg/mL papaverine administered one hour after initial dose; 2 units/mL heparin administered as soon as the arterial catheter is placed and secured, and 2 units/mL heparin administered one hour after initial dose; If the arterial catheter spasm/patency or waveform does not improve 10 minutes after the second papaverine plus heparin or heparin only dose, then the anesthesiology care team will consider treating clinically with 0.3 mg of papaverine.
Intervention MeSH terms: Heparin; Papaverine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Heparin; Papaverine

Summary:

      The purpose of this study is to compare intraoperative papaverine plus heparin to heparin
      alone for prevention of arterial spasm and maintenance of patency of peripheral arterial
      catheters during surgery in pediatric patients. The hypothesis is that periodic,
      intraoperative small-volume boluses of diluted papaverine plus heparin in peripheral arterial
      catheters of pediatric patients will prevent arterial spasm and help maintain patency of
      arterial catheters during general anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

        - All patients age 0-17 years who would require elective placements of arterial catheters
        based on patients clinical complexity (ex. congenital heart disease) or based on the type
        of surgery (ex. open heart surgery).

        Exclusion Criteria:

          -  Patients with a history of significant liver dysfunction.

          -  Patients undergoing liver transplants.

          -  Patients with Grade 2 or more of intraventricular hemorrhage.

          -  All preterm patients with a gestational age less than 37 weeks at the time of surgery.
Visual Function After Bilateral Implantation of AcrySof® Toric
Condition: Visual Function
Intervention: AcrySof® Toric IOL; AcrySof Natural
Intervention description: AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery; AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Visual function;; Refractive cylinder;; AcrySof® Toric;; AcrySof® Natural

Summary:

      The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof
      Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bilateral cataracts

          -  40~80 years of age

          -  4 Days - 1 Week interval between a single patient's surgery

          -  dilated pupil size (in dim light) ≥ 4.0 mm

          -  Anticipated correction with an IOL of +10 Diopters ~ +25 Diopters

          -  0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings

        Exclusion Criteria:

          -  Preoperative ocular pathology

          -  Previous intraocular or corneal surgery

          -  An increased risk for complications which could require vitreoretinal surgery

          -  Corneal irregularities

          -  Corneal opacities

          -  Current contact lens usage(within 6 months prior to first surgery)
Prunes for Gastrointestinal Function After Gynecologic Surgery
Condition: Constipation
MeSH terms: Constipation
Intervention: Prunes; Docusate Sodium
Intervention description: 12 oz of prunes daily; Oral docusate sodium twice daily
Intervention MeSH terms: Bismuth subsalicylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a prospective, randomized control trial that randomizes patients post-operatively
      into standard care versus standard care plus prunes. Patients in the control arm will take
      100 mg docusate twice per day for 3 days (standard care). Participants in the treatment arm
      will consume 4 oz prunes daily and take 100 mg docusate twice per day for 3 days. The primary
      objective is to determine the time to first bowel movement after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female patients seen in the Gynecology or Urogynecology clinics at LAC+USC Medical
             Center who are planned for surgery requiring at least 24 hour stay

          2. Age 18 or greater

          3. Able to give informed consent

          4. No contraindications to docusate or prune consumption

        Exclusion Criteria:

          1. Unable to give informed consent

          2. Unwilling to follow protocol

          3. Active malignancy

          4. Emergency surgery

          5. Diabetes mellitus

          6. Inflammatory bowel disease, gastroparesis, or other bowel disorder

          7. History of bowel resection or presence of colostomy

          8. Dependence on regular laxative use prior to surgery

          9. Baseline frequency of bowel movements less than weekly

         10. Intraoperative enterotomy or any bowel surgery performed at the time of surgery

         11. Patient unable to initiate oral intake on post op day 1 for any reason

         12. Allergy to docusate or prunes
Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
Condition: Hypophosphatasia
MeSH terms: Hypophosphatasia
Intervention: Asfotase Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Healthy volunteers: No
Keywords: HPP; Bone Disease; Soft Bones; Low Alkaline Phosphatase; Genetic Metabolic Disorder; Alkaline Phosphatase; Rickets; Osteomalacia

Summary:

      This is a multicenter study in Japan. Eleven sites which have already participated in the
      investigator-initiated clinical study (Early Access Program) will participate in this
      study.The objective of this study is to gain further information on the safety and efficacy
      of treatment with asfotase alfa.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient or parent (or legal guardian) must provide written informed consent prior to
             the performance of any study-related procedures and must be willing to comply with
             study procedures. Where appropriate and required by local regulations, patient assent
             for participation must also be obtained.

          2. Patient has completed the investigator-initiated clinical study (HPPJEAP-01) protocol
             for asfotase alfa

        Exclusion Criteria:

          1. Patient has a documented form of rickets caused by a condition other than HPP,
             including, but not limited to, rickets caused by 25(OH) vitamin D deficiency

          2. Patient has serum calcium and/or phosphorus levels below the normal range

          3. Patient is pregnant or lactating

          4. Patient received treatment with bisphosphonates within 2 years prior to the Screening
             visit

          5. Patient has a documented sensitivity to any of the components of asfotase alfa

          6. Patient is currently enrolled in any other program or clinical study involving an
             investigational new drug, device, or treatment for HPP (eg, bone marrow
             transplantation)

          7. Patient has clinically significant other disease in the opinion of the Investigator,
             defined as any other non HPP-related condition for which the patient is considered
             medically unstable.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Insulin Resistance
Intervention: peginterferon alfa-2a [Pegasys]; ribavirin [Copegus]; Pioglitazone
Intervention description: 180 micrograms subcutaneous weekly for 48 weeks; 1000-1600 mg day orally for 48 weeks.; 30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.
Intervention MeSH terms: Pioglitazone; Ribavirin; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without
      concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with
      genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to
      receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body
      weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily
      for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day +
      pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years,
      and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic hepatitis C, genotype 1;

          -  insulin resistance.

        Exclusion Criteria:

          -  other forms of liver disease;

          -  cirrhosis;

          -  previous treatment for chronic hepatitis C;

          -  insulin treatment during prior 2 weeks;

          -  type 1 diabetes.
Long Term Antihypertensive Exposure and Adverse Metabolic Effects: PEAR Follow-Up Study
Condition: Drug Induced Hyperglycemia; Secondary Hyperlipidemia
MeSH terms: Hyperglycemia; Hyperlipidemias
Intervention: Oral Glucose Tolerance Test
Intervention description: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a research study of the long term effects on blood sugar and cholesterol of blood
      pressure lowering medications. People are invited to participate in this research study if
      they participated in the Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR 1,
      NCT00246519 or PEAR 2, NCT01203852) study and are still taking a thiazide diuretic. In PEAR,
      the effects on blood pressure, blood sugar, and cholesterol of the high blood pressure drugs
      hydrochlorothiazide and atenolol over an 18 week period were evaluated. This PEAR follow-up
      study will determine the effects of thiazide diuretics on blood sugar and cholesterol, but in
      the period since the PEAR trial. The study hypothesis is that long term exposure to thiazide
      diuretics results in larger increases in blood sugar and cholesterol levels than short term
      exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  previously enrolled in PEAR study

          -  completed last PEAR study visit greater than 6 months prior

          -  receive thiazide diuretic continuously since PEAR enrollment

        Exclusion Criteria:

          -  pregnancy
Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
Condition: Autism Spectrum Disorder; Asperger Syndrome; Aspergers Syndrome
MeSH terms: Syndrome; Autistic Disorder; Autism Spectrum Disorder; Asperger Syndrome
Intervention: Milnacipran; Placebo
Intervention description: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.; Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: ASD; Autism; Autism Spectrum Disorder; Asperger Syndrome; Asperger; PDD; PDD-NOS

Summary:

      Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive
      Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders
      beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates
      suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very
      substantial costs associated with caring for patients with ASD, and ASD has the highest
      Caregiver Burden Scores of any condition. There are three core symptom domains of ASD,
      including social deficits, repetitive behaviors and language deficits. Patients can also have
      associated symptoms of attentional deficits, disruptive behaviors and intellectual
      disability. There is currently no Food and Drug administration (FDA) approved treatment for
      the core symptoms of autism, but risperidone and aripiprazole have FDA approval for
      disruptive behaviors associated with autism.

      This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults
      with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and
      normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a
      role in behavior adaptations and performance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female patients

          -  Aged 18-50 years

          -  Diagnosis of Autism Spectrum Disorder

          -  intelligence quotient greater than 70

        Exclusion Criteria:

          -  Pregnant subjects

          -  Patients deemed by comprehensive psychiatric interview to have a significant risk of
             suicide
Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
Condition: Attention Deficit Hyperactivity Disorder; Dyslexia
MeSH terms: Dyslexia; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine; Placebo
Intervention description: Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks; oral, daily, for 16 weeks
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 209.0
Sex: All
Minimum age: 10 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of atomoxetine in treating
      Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with
      ADHD and comorbid reading disability (dyslexia)
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth
             Edition (DSM-IV) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD)

          -  patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient

          -  child or adolescent patients must be 10 to 16 years old

          -  must be able to communicate in English

          -  must be able to swallow capsules

          -  be reliable to keep appointments for clinic visits and all related tests

        Exclusion Criteria:

          -  patients who weigh less than 25 Kg or greater than 70 Kg

          -  patients with a history of alcohol or drug abuse on a repeated basis within the past 3
             months

          -  patients with documented history of autism, Asperger's syndrome or pervasive
             developmental disorder

          -  females who are pregnant or breastfeeding

          -  patients with a history of severe allergy to more than one class of medications

          -  patients with documented history of bipolar I or bipolar II disorder, or psychosis
AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Testosterone gel; Placebo
Intervention description: AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.; Placebo
Intervention MeSH terms: Testosterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: Male
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      We hypothesize that AndroGel may offer some relief to subjects with low or borderline
      testosterone levels who suffer from depression and have failed to respond to a trial of a
      standard antidepressant.

      During this nine week, outpatient, double-blind study, male subjects between the ages of 30
      and 65 years with treatment-refractory depression and low or borderline low testosterone
      levels will be treated with either AndroGel or placebo. Following this nine week,
      double-blind phase, eligible subjects will have the option to continue into a six month,
      open-label phase during which time all subjects will receive the AndroGel patch.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male

          -  30-65 years old

          -  Taking at least one serotonergic antidepressant at adequate dose for at least six
             weeks but still meeting DSM-IV criteria for major depressive disorder within the past
             year

          -  HAM-D score >12

        Exclusion Criteria:

          -  Current suicidal ideation

          -  Substance abuse or dependence within the past year

          -  Current or past psychotic symptoms

          -  A history of bipolar disorder

          -  A prostate-specific antigen (PSA) level greater than 4.0 ng/ml

          -  Other clinically significant medical condition

          -  A history of failing to show any clinically significant response to two or more
             adequate trials of different antidepressants.