bioihbjkbjnl/mcl2 huggingface dataset:
Moderate to Persistent Asthma in the Obese Subject
Condition: Asthma
MeSH terms: Asthma
Intervention: Montelukast; Sugar pill
Intervention description: 10 mg Q day; Sugar pill that looks like Montelukast that will be given Q day
Intervention MeSH terms: Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Obesity is associated with increased airway inflammation and asthma severity that results in
      suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS).
      The investigators suggested that the addition of Singular (montelukast)[LTRA] to moderate
      doses of inhaled corticosteroids will improve asthma control. This cross over study will be
      treat subjects with moderate dose ICS/LTRA for 12 weeks and high dose ICS with placebo for 12
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  moderate persistent asthma as defined daily symptoms, nocturnal awakenings >1
             time/week but not daily, daily short-acting beta agonist usage

          -  pre-bronchodilator Force expiratory volume (FEV1)>55% but <90%.

          -  Subjects must be on controller therapy for asthma with ICS for at least one month
             prior to enrollment.

          -  methacholine testing that causes a drop in the FEV1 of 20% (8mg/ml off ICS or 16mg/ml)
             on ICS within 6 months prior to entry

          -  physician diagnosis of asthma for at least one year prior to study enrollment.

          -  Obesity defined as BMI greater than 30.

          -  subjects must have an Asthma Control Questionnaire (ACQ) score >1.25 on the Juniper
             Asthma Control Questionnaire (indicating poor asthma control),

          -  require daily medications for asthma and be compliant with study related medications.

        Exclusion Criteria:

          -  Subjects must not have been intubated in the last 5 years or unstable asthma symptoms
             resulting in significant loss or work or school

          -  upper or lower respiratory tract infection within 1 month of the study

          -  use of antibiotics within 4 weeks of the study

          -  use of oral glucocorticoids within 4 weeks

          -  use of theophylline

          -  smoking history greater than 10 pack years or any cigarette use within the past two
             years

          -  significant non-asthma pulmonary disease or other medical problems

          -  Subjects planning to undergo gastric bypass surgery within 4 months of the enrollment
             date will be excluded since weight loss is a potential confounder of asthma control

          -  Pregnant women will also be excluded
Immediate Versus Delayed Insertion of the Copper Intrauterine Device (IUD) After Medication Abortion
Condition: Contraception
Intervention: CuT380A
Intervention description: Comparison of different timing of IUD insertion
Intervention MeSH terms: Copper
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IUD; Intrauterine device; Intrauterine contraception; Medication abortion; Medical abortion

Summary:

      After medication abortion, women may quickly become pregnant again and therefore need an
      effective birth control method right away. Intrauterine devices (IUDs) are very effective for
      preventing pregnancy. IUDs are usually placed more than a month after abortion. This study
      will randomly assign women having a medication abortion to two groups, either having the IUD
      inserted one week after medication abortion or having the IUD inserted more than four weeks
      later. Women will be followed for six months to compare how many return for IUD placement in
      the two groups, how many are using the IUD after six months, experience with pain, bleeding,
      and cramping, how easy or difficult it is to insert the IUD, how many IUDs are expelled or
      removed, and how many women are using any birth control six months after the abortion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing medication abortion

          -  18 or older

          -  Desires IUD as birth control method for a minimum of six months

          -  Speaks Spanish or English

          -  Has a working phone number or pager

          -  Is willing to attend visits and will be in the area for next six months

          -  Has signed informed consent

        Exclusion Criteria:

          -  Chlamydia, gonorrhea, or pelvic inflammatory disease within the past three months

          -  Known bleeding diathesis including anti-coagulation

          -  Uterine abnormality including sub-mucous myomas that significantly distort the uterine
             cavity

          -  Current cervical, uterine, or ovarian malignancy

          -  high-grade squamous intraepithelial lesion on most recent pap

          -  IUD insertion contraindicated by the World Health Organization's Medical Eligibility
             Criteria for Contraceptive Use (category 3 or 4)
Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA
Condition: Peripheral Arterial Occlusive Disease
MeSH terms: Arterial Occlusive Diseases
Intervention: VISIPAQUE 270; Isovue 250
Intervention description: VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution; ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and
      pain following intraarterial injection for peripheral DSA.
    

Eligibility criteria:

        Inclusion Criteria:

        Enroll a patient in this study if the patient meets the following inclusion criteria:

          -  Provides written Informed Consent and is willing to comply with protocol requirements;

          -  Is at least 18 years of age;

          -  Is scheduled to undergo peripheral DSA for the diagnosis and/or treatment (PTA) of
             PAOD.

        Exclusion Criteria:

        Exclude a patient from this study if the patient does not fulfill the inclusion criteria,
        or if any of the following conditions are observed:

          -  Is a pregnant or lactating female. Exclude the possibility of pregnancy:

          -  by testing on site at the institution (serum or urine βHCG) within 24 hours prior to
             the start of investigational product administration,

          -  by surgical history (e.g., tubal ligation or hysterectomy),

          -  post menopausal with a minimum 1 year without menses;

          -  Has any known allergy to one or more of the ingredients of the investigational
             products;

          -  Has a history of severe congestive heart failure [class IV in accordance with the
             classification of the New York Heart Association (NYHA)]

          -  Was previously entered into this study or received an investigational compound within
             30 days before admission into this study;

          -  Has a history of hypersensitivity to iodinated contrast agents;

          -  Has renal impairment (eGFR <60 mL/min/1.73 m2, calculated using the Modification of
             Diet in Renal Disease [MDRD] study equation , );

          -  Has any medical condition or other circumstances which would significantly decrease
             the chances of obtaining reliable data, achieving study objectives, or completing the
             study and/or postdose follow-up examinations.
Tolvaptan for Ascites in Cirrhotic Patients
Condition: Ascites; Cirrhosis
MeSH terms: Ascites
Intervention: Tolvaptan
Intervention description: Oral administration once daily Dosage will range from 15 mg to 30 mg
Intervention MeSH terms: Tolvaptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Cirrhotic; Tolvaptan; v2 receptor antagonist

Summary:

      Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites
      in liver cirrhosis. Tolvaptan will be administered in combination with current ascites
      management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with cirrhosis of liver confirmed by histology and/or combination of
             ultrasound or endoscopic examination with laboratory evidence

          -  Clinically evident ascites treated by diet and/or diuretics

          -  History of 1 or more therapeutic paracentesis in the previous 6 months.

        Exclusion Criteria:

          -  History of variceal bleeding

          -  Current or history of Gastrointestinal bleeding within 10 days of screening

          -  Ascites from another cause other than liver cirrhosis (i.e. cardiac origin, peritoneal
             infection, or peritoneal carcinoma)

          -  INR (International normalized ratio) > 3.0, neutrophils <1500 cell/μl, platelets <
             40,000/μl

          -  serum bilirubin > 3 mg/dl

          -  serum sodium < 125 meQ (milliequivalent)/L

          -  serum potassium <3.5 meQ/L
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
Condition: Renal Insufficiency; Diabetes Mellitus
MeSH terms: Renal Insufficiency
Intervention: Iodixanol 320-Arm 1; Iopamidol 300-Arm 2
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 656.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iodixanol; Iopamidol; computed tomography; Patients with pre-existing renal impairment and diabetes

Summary:

      It is well known that X-ray contrast media can affect kidney function in some patients,
      especially when administered intra-arterially, and patients who already suffer from reduced
      kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use
      low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast
      media-induced nephropathy. However, little is known about the intravenous use of X-ray
      contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose
      of this study is to evaluate and compare the effects on kidney function of two contrast
      media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney
      damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is
      expected less influence on renal function following administration of iodixanol. A standard
      hydration procedure, based on available guidelines will be given to all patients to prevent
      negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured
      before and up to 7 days after contrast media administration to evaluate the effects on renal
      function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a combination of diabetes mellitus (type I or II) and renal impairment
             who are referred for a contrast-enhanced CT examination.

        Exclusion Criteria:

          -  Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not
             permitted.

          -  Patients undergoing dialysis or kidney transplantation will not be included.
Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Biafine; Polysporin
Intervention description: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.; over the counter Polysporin ointment 3 times daily for 4 weeks to wounds
Intervention MeSH terms: Bacitracin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to evaluate the use of Biafine Cream on wounds created
      by removal of actinic keratosis using cryotherapy in a clinical setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must give written consent.

          -  Subjects must be >50 years of age, male or female.

          -  Subjects must have had cryotherapy treatment of at least one AK's on each forearm in
             the Dermatology Clinic.

        Exclusion Criteria:

          -  Subjects age <50 years of age.

          -  Subjects with known allergy or sensitivity to topical Biafine or polysporin ointment.

          -  Inability to complete all study-related visits.

          -  Introduction of any other prescription medication, topical or systemic, for AK while
             participating in the study.

          -  Subjects using other topical agent's glycolic acid products, alpha-hydroxy acid
             products, retinoids and chemical peel agents in the treatment areas while on study.
Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor
Condition: Induction of Labor
Intervention: pitocin
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: induction of labor; pitocin; foley bulb

Summary:

      The purpose of this research study is to compare induction of labor using a foley catheter
      bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of
      oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor
      induction in patients whose cervix is not significantly dilated or thinned out (effaced).
      Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's
      contractions.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a singleton pregnancy

          2. Term pregnancy (> 37 weeks gestation)

          3. Age ≥ 18 years

          4. Bishop score < 5

          5. Contractions < 6/hr

          6. Reassuring fetal heart tracing

        Exclusion Criteria:

          1. Rupture of membranes

          2. Antepartum bleeding

          3. Fetal death

          4. Placenta previa or low lying placenta

          5. Active genital herpes infection

          6. Previous use of an induction or preinduction agent during the current pregnancy

          7. EFW >4500 grams

          8. Non reassuring fetal testing

          9. Inability to pass foley through cervix

         10. Prior cesarean section
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole ointment 2%
Intervention description: Applied BID
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 3 Months
Maximum age: 23 Months
Healthy volunteers: No

Summary:

      This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of
      crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than
      24 months of age with mild-to-moderate AD.
    

Eligibility criteria:

        Inclusion Criteria:

        Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD

        Exclusion Criteria:

        Subjects with any clinically significant dermatological condition or disease (including
        active or potentially recurrent non-AD dermatological conditions that overlap with AD such
        as Netherton Syndrome)
Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Ranibizumab; Aflibercept
Intervention description: 0.5 mg intravitreal injection; 2 mg intravitreal injection
Intervention MeSH terms: Ranibizumab; Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: The reading center was masked for treatment assignment in order to ensure unbiased evaluation of the primary, secondary and exploratory objectives that were determined by SDOCT, autofluorescence imaging, and microperimetry and multifocal ERG (where available).
When communicating with the reading center study centers had to be vigilant not to unblind the reading center to the treatment.
Site staff performing the assessments of BCVA, contrast sensitivity (where possible), VFQ25 and IReST (reading speed) were also masked to the identity of the treatment.
The central laboratory used for analysis of all specimens collected for biomarker assessment were blinded to the identity of the treatment.
Enrollment: 712.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: wet age-related macular degeneration (AMD); ranibizumab; aflibercept; Best Corrected Visual Acuity (BCVA); Spectral Domain Optical Coherence Tomography (SD-OCT)

Summary:

      The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg
      aflibercept bimonthly intravitreal injections on retinal thickness stability.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Visual impairment predominantly due to neovascular AMD Active

          -  Newly diagnosed, untreated, angiographically documented choroidal neovascularization
             (CNV) lesion

        Key Exclusion Criteria:

          -  Stroke or myocardial infarction less than 3 Months prior to study entry

          -  Active injection or inflammation of either eye at the time of study entry

          -  Any type of systemic disease (or received treatment for it), including any medical
             condition (controlled or uncontrolled) that were to be expected to progress, recur, or
             change to an extent which could bias the assessment of the clinical status of the
             patient to a significant degree or put the patient at special risk
Citicoline for Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Placebo; Citicoline
Intervention description: Inactive ingredient matching the active comparator in appearance; Citicoline is an over-the-counter nutritional supplement that is used for neuroprotective effects. It is a naturally occurring neurochemical in the human body.
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: alcohol dependence; alcohol abuse

Summary:

      The purpose of this study is to determine if citicoline, as an add-on therapy, will help
      reduce alcohol use in outpatients with alcohol dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women age 18-75 years old with diagnosis of alcohol dependence

          -  Average alcohol use of at least 28 drinks per week and at least 7 heavy drinking days
             (defined as 4 or more drinks/day for women, 5 or more drinks/day for men) in the past
             28 days

          -  No alcohol use within 72 hours of randomization (maximum abstinence 7 days)

          -  CIWA-Ar (withdrawal scale) score less than or equal to 8 at randomization (consistent
             with minimal or no withdrawal symptoms and medication probably not needed)

        Exclusion Criteria:

          -  Vulnerable populations including individuals with intellectual disability or dementia,
             prison or jail inmates, pregnant or nursing women, or women of childbearing age who
             will not use acceptable forms of birth control

          -  History of arrhythmias

          -  Myocardial infarction or coronary artery bypass graft surgery in the past 6 months

          -  Active angina or blood pressure >170/105

          -  High risk for suicide (defined as suicide attempt in past 6 months, or current
             suicidal ideation with plan and intent)

          -  High risk of violence toward others (defined as assault in past 6 months, or violent
             thoughts with evidence of plan and intent)

          -  Intensive outpatient treatment for substance abuse (AA, NA meetings or weekly
             therapy/counseling for substance use for at least 28 days prior to randomization will
             be allowed)

          -  Dependence (not just abuse) on substances other than alcohol or nicotine

          -  History of delirium tremens or other sever alcohol withdrawal symptoms, history of
             cirrhosis or AST or ALT >3 times normal, or other unstable medical condition (e.g.
             uncontrolled diabetes)

          -  History of bipolar disorder or schizophrenia

          -  Current major depressive episode (past episodes and current milder depressive symptoms
             allowed) or other psychiatric disorder that should be a major focus of treatment