bioihbjkbjnl/mcl2 huggingface dataset:
Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
Condition: Diabetes; Pregnancy
MeSH terms: Pregnancy Complications; Diabetes Mellitus
Intervention: Metformin; Placebo
Intervention description: 1000 mg twice a day; Delivered to match active drug
Intervention MeSH terms: Metformin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 831.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Metformin; Glucophage; Riomet; Glumetza; Fortamet; Glucophage XR

Summary:

      Purpose: The objective of this proposal is to study the safety and efficacy of metformin
      added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.

      Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S.
      clinical centers

      Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a
      singleton fetus will be randomized to double-blinded insulin/placebo versus
      insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant
      hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits
      monthly at clinical visits; blood draw at 24-30 weeks, newborn anthropometric measurements at
      less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Maternal age 18-45 years

          -  Singleton pregnancy with no known fetal anomalies

          -  Gestational age between 10weeks 0 days and 22 weeks 6 days by menstrual dating
             confirmed by ultrasound, or ultrasound alone

          -  Clinical diagnosis of preexisting T2DM requiring medical treatment (oral agent or
             insulin)

          -  Clinical diagnosis of diabetes diagnosed between 10 weeks and < 20 weeks 6 days
             gestation

          -  Willing to start insulin therapy and discontinue oral hypoglycemic pills other than
             study pills

          -  Able to swallow pills

        Exclusion Criteria:

          -  Clinical diagnosis of pre-existing renal disease, defined as creatinine > 1.5 mg/dL

          -  Clinical history of lactic acidosis

          -  Known allergy to metformin

          -  Participation in another study that could affect primary outcome

          -  Delivery planned at non-MOMPOD study locations

          -  Unwillingness to use insulin treatment or follow prenatal care doctor's instructions
             for insulin and blood glucose monitoring
A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Condition: Healthy
Intervention: Exendin-9,39; Saline
Intervention description: Exendin-9,39 is a competitive antagonist of GLP-1 actions at the GLP-1 receptor; Placebo comparator
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in
      the control of blood sugar level by enhancing insulin secretion from the pancreas after
      eating a meal. The purpose of this research study is to evaluate the role of GLP1R in the
      response to elevated glucagon concentrations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  20 weight-stable, non-diabetic subjects

        Exclusion Criteria:

          -  Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1
             diabetes, or the effects of age extremes in subjects with normal or impaired fasting
             glucose).

          -  HbA1c ≥5.9%

          -  Use of glucose-lowering agents.

          -  For female subjects: positive pregnancy test at the time of enrollment or study

          -  History of prior upper abdominal surgery such as adjustable gastric banding,
             pyloroplasty and vagotomy.

          -  Active systemic illness or malignancy.

          -  Symptomatic macrovascular or microvascular disease.
A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome
Condition: Guillain-Barre Syndrome
MeSH terms: Guillain-Barre Syndrome; Syndrome
Intervention: Eculizumab; Placebo
Intervention description: Eculizumab will be administered via IV infusion once a week for 4 weeks.; Placebo will be administered via IV infusion once a week for 4 weeks.
Intervention MeSH terms: Eculizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Eculizumab; Soliris; Alexion; C5 Inhibition Therapy

Summary:

      This is a Phase 3, prospective, multicenter, placebo controlled, double blind, randomized
      study to investigate the efficacy and safety of eculizumab in participants with severe GBS,
      defined using the Hughes Functional Grade (FG) scale as progressively deteriorating FG3 or
      FG4/FG5 within 2 weeks from onset of weakness due to GBS.

      This study will be conducted only at sites in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who meet the GBS criteria.

          -  Participants who were able to run prior to onset of GBS symptoms.

          -  Participants with onset of weakness due to GBS < 2 weeks before screening.

          -  Participants unable to walk unaided for ≥ 5 meters (progressively deteriorating FG3 or
             FG4 to FG5).

          -  Participants who are already on IVIg or deemed eligible for and who will start IVIg.

          -  Participants who can start their first dose of study drug before the end of the IVIg
             treatment period.

        Exclusion Criteria:

          -  Participants who have previously received or are currently receiving treatment with
             complement modulators.

          -  Participants who have been administered another investigational product within 30 days
             or 5 half-lives (whichever is longer) prior to providing consent or are currently
             participating in another interventional study.

          -  Participants who have received rituximab within 12 weeks prior to screening.

          -  Participants who are being considered for or are already on plasmapheresis.

          -  Participants who have received immunosuppressive treatment during the 4 weeks prior to
             providing consent.
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic acid; Placebo
Intervention description: intravenous infusion; intravenous infusion
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Osteoporosis, children and adolescents, zoledronic acid, chronic inflammation, Duchenne muscular dystrophy, glucocorticoids, chronic inflammatory conditions

Summary:

      This study was designed to evaluate the efficacy and safety of zoledronic acid compared to
      placebo in osteoporotic children treated with glucocorticoids
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A diagnosis of chronic rheumatologic conditions or inflammatory bowel disease or
             Duchenne muscular dystrophy requiring systemic glucocorticoids (i.v. or oral) within
             12 months prior to screening

          -  Lumbar Spine BMDZ-score of -0.5 or worse

          -  Evidence of at least at least 1 vertebral compression fracture of Genant Grade 1 or
             higher (or radiographic signs of vertebral fracture) within 1 month from Screening
             visit OR One or more, low-trauma, lower extremity long-bone fracture which occurred
             sometime within the 2 years PRECEDING enrollment in the study OR Two or more,
             low-trauma, upper extremity long-bone fractures which occurred sometime within the 2
             years PRECEDING enrollment in the study

          -  Consent/assent to study participation

        Key Exclusion Criteria:

          -  History of primary bone disease (OI, Idiopathic Juvenile Osteoporosis,
             Rickets/Osteomalacia)

          -  Any medical condition that might have interfered with the evaluation of lumbar spine
             BMD, such as severe scoliosis or spinal fusion. Patients with less than 3 evaluable
             vertebrae by Dual Energy X-ray Absorptiometry (DXA) evaluation in the region of
             interest lumbar 1 (L1) to lumbar 4 (L4),

          -  Hypocalcemia and hypophosphatemia

          -  Serum 25-hydroxy vitamin D concentrations of <20 ng/mL or <50 nmol/L

          -  estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m2

          -  serum creatinine increase between Visit 1 and Visit 2 >0.5 mg/dL (44.2 μmol/L)

          -  Uncontrolled symptoms of cardiac failure or arrhythmia

          -  Any prior use of bisphosphonates, or high dose sodium fluoride
Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)
Condition: Stroke
MeSH terms: Stroke; Embolic Stroke; Embolism
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Acetylsalicylic acid (Aspirin, BAY1019036); Rivaroxaban-Placebo; Aspirin-Placebo
Intervention description: 15 mg, once daily, orally, tablet; 100 mg, once daily, orally, tablet; Matching placebo, once daily, orally, tablet; Matching placebo, once daily, orally, tablet
Intervention MeSH terms: Aspirin; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7213.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Rivaroxaban; Xarelto; Aspirin; Acetylsalicylic acid (ASA); Oral Anticoagulant; Blood Thinner; Stroke; Ischemic Stroke; Cryptogenic Stroke; Embolic stroke of undetermined source; ESUS; Transient Ischemic Attack; Thromboembolism; Cerebrovascular Disease

Summary:

      This is a study in patients who recently had a brain attack (stroke) and in whom no clear
      cause of the stroke could be identified. These strokes are likely due to a blood clot and
      therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The
      study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban
      15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have
      fewer blood clots in the brain (stroke) or in other blood vessels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent ESUS (between 7 days and 6 months), defined as:

          -  Recent ischemic stroke (including transient ischemic attack with positive
             neuroimaging) visualized by brain imaging that is not lacunar, and

          -  Absence of cervical carotid atherosclerotic stenosis> 50% or occlusion, and

          -  No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and

          -  No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography,
             and

          -  No other specific cause of stroke (for example, arteritis, dissection,
             migraine/vasospasm, drug abuse)

        Exclusion Criteria:

          -  Severely disabling stroke (modified Rankin score ≥4)

          -  Indication for chronic anticoagulation or antiplatelet therapy

          -  Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
Condition: Post-operative Pain
MeSH terms: Toothache; Pain, Postoperative
Intervention: Ibuprofen/acetaminophen; Ibuprofen/acetaminophen (higher dose); Nurofen Plus®; Panadeine® Extra; Placebo
Intervention description: One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water; Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water; Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water; Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water; Two placebo tablets, single dose taken orally with 300 ml water
Intervention MeSH terms: Acetaminophen; Ibuprofen; Codeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 678.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Dental pain; Ibuprofen; Acetaminophen; Nurofen Plus®; Panadeine® Extra; Paracetamol

Summary:

      The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen
      plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen
      Plus® and Panadeine® Extra.
    

Eligibility criteria:

        Main Inclusion Criteria:

        Experiencing moderate to severe pain after extraction of impacted third molars

        Main Exclusion Criteria:

        Any ongoing painful condition other than that associated with the current third molar
        surgery that could significantly interfere with the subject's suitability Any condition
        that would render the subject unsuitable to receive an NSAID, acetaminophen or codeine
A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-659/TEZ/IVA; IVA
Intervention description: Fixed-dose combination tablets for oral administration qd in the morning.; IVA tablet qd in the evening.
Intervention MeSH terms: Ivacaftor; VX-659
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 484.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and tolerability of VX-659 in triple
      combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis
      (CF) who are homozygous or heterozygous for the F508del mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed study drug treatment in a parent study; or had study drug interruption(s) in
             a parent study but completed study visits up to the last scheduled visit of the
             Treatment Period in the parent study.

        Exclusion Criteria:

          -  History of drug intolerance in a parent study that would pose an additional risk to
             the subject in the opinion of the investigator.

          -  Current participation in an investigational drug trial (other than a parent study)

        Other protocol defined Inclusion/Exclusion criteria may apply.
Retapamulin as a Decolonizing Agent for MRSA
Condition: MRSA
Intervention: Retapamulin; Placebo Ointment
Intervention description: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).; The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.
Intervention MeSH terms: Retapamulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 9 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: rectal MRSA; mupirocin-resistant nasal MRSA

Summary:

      The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of
      MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin
      among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The
      sample size will include 27 subjects in each of the two arms of the study (retapamulin versus
      placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal
      colonized with MRSA will be randomized to receive either retapamulin or placebo applied
      nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at
      pre-defined time points during study duration (screening swab, swab one week after completion
      of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA
      colonization status. The colonization rates of both groups will be assessed via Fisher's
      Exact Test.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Admission to the general pediatric floor and pediatric intensive care units at NYU
             Langone Medical Center or visit to study team members at ODA clinic (Park Ave
             locations) in Williamsburg Brooklyn.

          2. Ages 9 months to 17 years

          3. Residing in the zip codes which reflect Orthodox Jewish neighborhoods where there is a
             current outbreak of this strain of MRSA.

          4. Nasal and/or rectal culture positive for mupirocin-resistant methicillin-resistant
             Staphylococcus aureus (MRSA)

        Exclusion Criteria:

        An individual who meets any of the following criteria will be excluded from participation
        in this study:

          1. Pregnant or lactating

          2. Unable to appropriately consent

          3. Open sores in either of the study sites (nares or rectum)

          4. Recent surgical procedure to either study site (nares or rectum)

          5. Concurrent use of Rifampin or Trimethoprim/Sulfamethoxazole

          6. Current active MRSA infection

          7. Immunocompromised

          8. Presence of endotracheal tube, tracheostomy tube or other foreign body in upper airway
Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone furoate nasal spray; Beclomethasone dipropionate nasal spray; Placebo nasal spray; Chlorpheniramine maleate syrup
Intervention description: intranasal administration; intranasal administration; intranasal administration; oral administration
Intervention MeSH terms: Mometasone Furoate; Chlorpheniramine; Beclomethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 679.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray
      (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages
      6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD
      were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have at least a one-year history of seasonal allergic rhinitis which previously
             required treatment for tree and/or grass pollen

          -  Have a positive skin test response to an appropriate tree and/or grass seasonal
             allergen within the last year.

          -  Must be free of any clinically significant disease other than seasonal allergic
             rhinitis.

          -  Must be pre-menarcheal.

        Exclusion Criteria:

          -  History of asthma which requires chronic use of inhaled or systemic corticosteroids.

          -  Current or history of frequent, clinically significant sinusitis or chronic purulent
             postnasal drip.

          -  History of rhinitis medicamentosa.

          -  History of clinically significant nasal candidiasis.

          -  History of multiple drug allergies or allergy/intolerance to corticosteroids or
             antihistamines.

          -  History of upper respiratory tract or sinus infection that required antibiotic therapy
             within the previous 2 weeks, or viral upper respiratory infection within 7 days prior
             to Screening.

          -  History of nasal structural abnormalities, including large nasal polyps and marked
             septal deviation, that significantly interfere with nasal air flow.

          -  History of dependence upon nasal, oral or ocular decongestants, or nasal topical
             antihistamines.

          -  History of investigational drug use in the last 30 days.

          -  History of immunotherapy (desensitizing therapy), unless on a stable maintenance
             schedule for at least one month prior to Screening.