bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
Condition: Iron Deficiency Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferumoxytol; Oral Iron
Intervention description: Experimental: Ferumoxytol; Active Comparator: Oral iron
Intervention MeSH terms: Ferrous fumarate; Ferrosoferric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia; Feraheme; ferumoxytol; CKD; pediatric; dialysis-dependent; nondialysis-dependent

Summary:

      Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral
      iron for the treatment of pediatric participants with chronic kidney disease (CKD).
    

Eligibility criteria:

        Key Inclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies
        include:

          1. Males or females 6 months to <18 years of age

          2. CKD non-dialysis participants or dialysis-dependent participants who were on
             peritoneal dialysis or stable hemodialysis prior to Screening

          3. Had iron deficiency anemia defined as: a) hemoglobin level ≤12.0 grams/deciliter
             (g/dL) and b) with either transferrin saturation level ≤40% or ferritin level <100
             nanograms/milliliter (ng/mL)

          4. Female participants of childbearing potential who were sexually active must have been
             on an effective method of birth control for at least 1 month prior to Screening and
             agreed to remain on birth control until completion of participation in the study

        Key Exclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies
        include:

          1. History of allergy to either oral or IV iron

          2. Hemoglobin level ≤7.0 g/dL

          3. Serum ferritin level >600 ng/mL

          4. Female participants who were pregnant or intended to become pregnant, or were
             breastfeeding, were within 3 months postpartum, or had a positive serum pregnancy test
A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis
Condition: Acute Pancreatitis
MeSH terms: Pancreatitis
Intervention: Indomethacin; Placebo
Intervention description: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.; Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin
Intervention MeSH terms: Indomethacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute pancreatitis; Indomethacin; Organ failure; Prevention

Summary:

      This is a randomized, double-blind, placebo-controlled pilot trial seeking to evaluate the
      efficacy of rectal indomethacin in abrogating systemic inflammation and subsequently organ
      failure and mortality in patients with AP and positive SIRS score.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients ages 18 or above admitted to UPMC with a diagnosis of AP based on at
             least 2 of the following criteria:

             (i) abdominal pain characteristic of AP (ii) serum amylase and/or lipase ≥ 3 times the
             upper limit of normal (iii) characteristic findings of AP on abdominal CT scan will be
             screened for study enrollment.

          -  Patients with SIRS (≥ 2 of the following criteria: temperature <36°C or >38°C, heart
             rate >90/min, respiratory rate >20/min OR PaCO2<32 mmHg, WBC <4,000/mm3, >12,000/mm3
             or >10% bands) upon hospital admission or who develop SIRS during their first week of
             hospitalization

        Exclusion Criteria:

          -  Presence of OF (shock defined by SBP<90mmHg, PO2<60mmHg on room air or need for
             mechanical ventilation, Cr≥2mg/dL)

          -  Presence of renal dysfunction (Cr>1.5mg/dL)

          -  Active peptic ulcer disease

          -  Pregnancy

          -  Use of daily NSAIDs within 1 week of presentation

          -  Allergy to NSAIDs.
Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
Condition: Postmenopausal Vulvovaginal Atrophy
MeSH terms: Atrophy
Intervention: WC3011 Estradiol Vaginal Cream; Vehicle
Intervention description: WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks; Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
Intervention MeSH terms: Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 722.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Postmenopausal Women, Vaginal Dryness

Summary:

      Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due
      to vulvovaginal atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal females ≥35 years with either or both ovaries removed or naturally
             menopausal with moderate to severe vaginal dryness

        Exclusion Criteria:

          -  Hypersensitivity to estrogen and/or progestin therapy

          -  Known or suspected premalignant or malignant disease (except successfully treated skin
             cancers)

          -  Manifestation of or treatment for significant cardiovascular disease, congestive heart
             failure, stroke or ischemic attacks

          -  Insulin-dependent diabetes mellitus

          -  Increased frequency or severity of headaches while on hormone or estrogen therapy

          -  Drug or alcohol addiction within last 2 years

          -  Participation in a clinical trial within 30 days

          -  Smoking ≥ 15 cigarettes daily

          -  Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥
             95 mmHg
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Exenatide; Exenatide matching placebo
Intervention description: 2 mg weekly suspension injection; Once weekly Placebo injection
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 464.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Exenatide; Diabetes drug; Treatment efficacy; Placebo; Metabolism; Cardiovascilar metabolic

Summary:

      Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel
      group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added
      to titrated basal insulin glargine with or without metformin to placebo added to titrated
      basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus
      (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added
      to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added
      to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the
      28-week treatment period.
    

Eligibility criteria:

        Inclusion criteria:

          -  Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)

          -  Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).

          -  Has fasting plasma glucose (FPG) concentration <280 mg/dL (15.6 mmol/L) at Visit 1
             (Screening)

          -  Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least
             6 weeks prior to Screening, in combination with diet and exercise alone or in
             combination with:

               1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1

               2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1
                  (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the
                  Screening visit

        Exclusion criteria:

          -  Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)

          -  History of, or currently have, acute or chronic pancreatitis, or have triglyceride
             concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1

          -  Positive serological test for hepatitis B or hepatitis C
P3 Study in Acne Comparing Once Daily SB204 and Vehicle
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: SB204 4%; Vehicle Gel
Intervention description: Once daily; Placebo comparator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1307.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel
      group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe acne

          -  Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones)
             on the face

          -  Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

        Exclusion Criteria:

          -  Women of child-bearing potential who are pregnant, nursing, considering becoming
             pregnant

          -  Any dermatologic condition that could interfere with clinical evaluations including
             severe, recalcitrant cystic acne
Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Intervention: OnabotulinumtoxinA
Intervention description: OnabotulinumtoxinA injected into the detrusor wall on Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the
      treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric
      participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and
      effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Urinary incontinence due to neurogenic detrusor overactivity

          -  Regularly using clean intermittent catheterization to empty the bladder

        Exclusion Criteria:

          -  Surgery of the spinal cord within 6 months

          -  Diagnosis of cerebral palsy

          -  Current or planned use of a baclofen pump

          -  Current or planned use of an electrostimulation/neuromodulation device for urinary
             incontinence

          -  Use of an indwelling catheter for urinary incontinence instead of using clean
             intermittent catheterization to empty the bladder

          -  Previous or current use of botulinum toxin therapy of any serotype for any urological
             condition, or treatment with botulinum toxin of any serotype within 3 months for any
             other condition or use

          -  Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-445/TEZ/IVA; IVA; Placebo
Intervention description: Participants received VX-445/TEZ/IVA orally once daily in the morning.; Participants received IVA orally once daily in the evening; Participants received placebo matched VX-445/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 405.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor
      (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for
      F508del and a minimal function mutation (F/MF subjects).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Heterozygous for the F508del mutation (F/MF)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status
Condition: Hypovitaminosis D
MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency
Intervention: 100,000 IU cholecalciferol; Placebo
Intervention description: active drug; comparator drug
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vitamin D; surgery; acute stress

Summary:

      A growing body of evidence suggests that robust postoperative immune function is associated
      with a lower risk of surgical site infections (SSIs). At the same time, vitamin D is
      increasingly recognized as a key regulator of the innate and adaptive immune systems. The
      investigators elected to conduct the current study in patients who will undergo colorectal
      surgery since these patients are historically at higher risk of developing SSIs and therefore
      would be ideal for future investigations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women;

          -  18 years or older;

          -  Scheduled for elective (non-emergent) colorectal surgery;

          -  Cleared for anesthesia; and

          -  Expected to stay overnight following surgery

        Exclusion Criteria:

          -  Scheduled for a purely laparoscopic procedure;

          -  Diagnosis of a terminal illness and/or in hospice care;

          -  Inability to sign informed consent;

          -  Inability to comply with study protocol;

          -  Intending to start vitamin D supplementation within 30 days of surgery;

          -  Intending to leave the Boston area during the follow-up period;

          -  History of renal stones or hypercalcemia;

          -  Medical conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis,
             myeloma primary hyperparathyroidism)

          -  History of hypercalcemia

          -  History of severe anemia (Hematocrit <25%)

          -  Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis
             medication); and

          -  Already enrolled or planning to enroll in a research study that would conflict with
             full participation in the current study or confound the observation or interpretation
             of the study findings
A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Rosiglitazone (BRL49653C)
Intervention description: study drug
Intervention MeSH terms: Rosiglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 149.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: rosiglitazone; Avandia; type 2 diabetes mellitus; diabetes

Summary:

      This study was designed to compare the efficacy and safety of BRL49653C versus placebo with
      concomitant use of sulfonyl urea (SU).
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients with type 2 diabetes mellitus managed by SU will be candidate for this study.
             These candidates will be checked up on their clinical laboratory data, and must have
             adequate blood, liver and kidney function.

        Exclusion criteria:

          -  Patient with serious cardiovascular disease or serious hepatic disease will not be
             eligible.
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Condition: Parkinson's Disease Psychosis
MeSH terms: Parkinson Disease; Psychotic Disorders; Mental Disorders
Intervention: Pimavanserin tartrate (ACP-103)
Intervention description: Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Intervention MeSH terms: Pimavanserin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 459.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Parkinson's Disease Psychosis

Summary:

      To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's
      disease psychosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the treatment period of a previous blinded study of pimavanserin

          -  The subject is willing and able to provide consent

          -  Caregiver is willing and able to accompany the subject to all visits

        Exclusion Criteria:

          -  Subject has current evidence of a serious and or unstable cardiovascular, respiratory,
             gastrointestinal, renal, hematologic or other medical disorder

          -  Subject is judged by the Investigator to be inappropriate for the study
Pain Reduction With Intranasal Medications for Extremity Injuries
Condition: Pain; Traumatic Limb Injury
MeSH terms: Wounds and Injuries
Intervention: Ketamine; Fentanyl
Intervention MeSH terms: Fentanyl; Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study compares the analgesic effect of intranasal sub-dissociative dosing of ketamine
      and intranasal fentanyl in children presenting to the Emergency Department with acute
      extremity injuries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  8 years to 17 years (up to the 18th birthday)

          -  Presenting to emergency department with one or more extremity injuries

          -  Visual analog scale score 35 mm or greater

          -  Parent or legal guardian present and willing to provide written consent

        Exclusion Criteria:

          -  Received narcotic pain medication prior to arrival

          -  Evidence of significant head, chest, abdomen, or spine injury

          -  Glasgow coma score less than 15 or unable to self report pain score

          -  Nasal trauma or aberrant nasal/airway anatomy

          -  Active epistaxis

          -  Allergy to ketamine, fentanyl or meperidine

          -  Non-English speaking parent and/or child

          -  History of psychosis

          -  Postmenarchal female without a urine or serum assay documenting the absence of
             pregnancy

          -  Brought in my juvenile detention center or in police custody

          -  Pregnancy
Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: recombinant human chorionic gonadotropin
Intervention description: Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions.
Intervention MeSH terms: Chorionic Gonadotropin
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: polycystic ovary syndrome; androgens; ovary; LH

Summary:

      The mechanism for increased androgen production in women with polycystic ovary syndrome
      (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by
      increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators
      hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen
      synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal
      women. To test this hypothesis, the investigators propose to conduct a dose-response study in
      which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH
      surrogate, will be assessed in PCOS and normal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal CBC (Hemoglobin must be at least 11mg/dl)

          -  Normal renal and liver function tests

          -  Normal vital signs including normal blood pressure

        Exclusion Criteria:

          -  No oral contraceptives

          -  No insulin lowering drugs

          -  No anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)

          -  No medications that will influence androgen metabolism or clearance

          -  No medications that will inhibit the cytochrome P450 enzyme system (cimetidine,
             ketoconozole, etc)

          -  No use of clomiphene citrate within 3 months prior to study