bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Acipimox; Placebo
Intervention description: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.; Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day
Intervention MeSH terms: Acipimox
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 25 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: diabetes; insulin; blood vessel; type 1

Summary:

      Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk
      in type 1 diabetes (T1D). Non-esterified fatty acid elevation is a significant contributor to
      IR in T1D and may be a target of intervention. The hypothesis of the study is that isolated
      fatty acid lowering with acipimox will improve insulin action and blood vessel function and
      have the benefit of reducing mitochondrial oxidant generation and improving mitochondrial
      function in T1D. Targeting IR through fatty acid lowering is a novel approach to T1D
      treatment that may significantly improve current management of TID and of cardiovascular
      disease (CVD) risk in this high risk population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women, with and without type 1 diabetes between 25-59 years of age,

          2. HbA1c 6.0-9.5 (T1D only),

          3. Subjects who are willing to commit to:

               -  14 days of prescribed diet,

               -  two 44 hour inpatient stays, and

               -  two muscle biopsies.

        Exclusion Criteria:

          1. Any comorbid condition associated with inflammation, insulin resistance, or
             dyslipidemia,

          2. Tobacco use,

          3. Pregnancy,

          4. Steroid use,

          5. Scheduled physical activity >3 days a week,

          6. Angina or any other cardiovascular or pulmonary disease,

          7. History of chronic obstructive pulmonary disease or asthma,

          8. Systolic blood pressure >190 at rest or >250 with exercise, or

          9. Diastolic pressure >95 at rest, or >105 with exercise,

         10. Proteinuria (urine protein >200 mg/dl), or

         11. Creatinine > 2 mg/dl, suggestive of severe renal disease,

         12. Severe Proliferative retinopathy,

         13. Niacin treatment,

         14. History of peptic ulcers,

         15. History of hereditary angioedema, and

         16. C1 esterase deficiency.
Study of DU-176b Aged 80 Years or Older
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Du-176b; placebo
Intervention description: DU-176b orally administered at a dose of 15 mg once daily.; Placebo orally administered once daily.
Intervention MeSH terms: Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 984.0
Sex: All
Minimum age: 80 Years
Healthy volunteers: No
Keywords: anticoagulants; DU-176b; edoxaban; factor Xa; oral; prevention; atrial fibrillation

Summary:

      The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with
      non-valvular NVAF aged 80 years or older who are ineligible for available oral
      anticoagulation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are
             ineligible for available oral anticoagulation therapy

        Exclusion Criteria:

          -  Patients with active bleeding

          -  Patients who have poorly controlled hypertension

          -  Patients who have liver dysfunction accompanied with disorder of blood coagulation
Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
Condition: Allergic Rhinitis; Conjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis
Intervention: REGN5713; REGN5714; REGN5715; Placebo
Intervention description: Administered subcutaneously; Administered subcutaneously; Administered subcutaneously; Placebo that replaces REGN5713-5714-5715
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Birch Allergy

Summary:

      The primary objective is to assess the reduction of allergic symptoms as measured by combined
      symptom and medication score (CSMS) during birch pollen season after a single dose of
      REGN5713-5714-5715 versus placebo.
    

Eligibility criteria:

        Key Inclusion Criteria

          1. Documented or participant-reported history of birch pollen-triggered allergic rhinitis
             symptoms, with or without conjunctivitis, for at least 2 years

          2. Positive Skin prick test (SPT) with birch pollen extract in the screening period, as
             defined in the protocol

          3. Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the
             screening period, as defined in the protocol

          4. Willing and able to comply with clinic visits and study-related procedures

        Key Exclusion Criteria:

          1. Participation in a prior REGN5713-5714-5715 clinical trial

          2. Recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or
             due to daily contact with other allergens causing symptoms that are expected to
             coincide with birch pollen season, as assessed by the investigator

          3. Participants who anticipate major changes in allergen exposure in their home or work
             environments that are expected to coincide with the study assessments as assessed by
             the investigator

          4. Persistent chronic or recurring acute infection requiring treatment with antibiotics,
             antivirals, or antifungals, or any untreated respiratory infections (at the discretion
             of the investigator) within 4 weeks prior to screening visit. Participants may be
             re-evaluated for eligibility after symptoms resolve

          5. Documentation of active SARS-CoV-2 infection, as defined in the protocol

          6. A clinical history of asthma with 2 or more asthma exacerbations requiring
             hospitalizations or systemic corticosteroids in the previous year

          7. History of birch allergy immunotherapy as defined in the protocol

          8. Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6
             months prior to screening

        NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
The Hemophilia Inhibitor Prevention Trial
Condition: Hemophilia A Without Inhibitor
MeSH terms: Hemophilia A
Intervention: Eloctate Injectable Product; Emicizumab Injection [Hemlibra]
Intervention description: This is a factor VIII-Fc fusion protein.; This is a bispecific monoclonal antibody FVIII mimic.
Intervention MeSH terms: Antibodies, Bispecific
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase III open-label, randomized controlled trial comparing two drugs in the prevention of hemophilia inhibitor formation.
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 4 Months
Maximum age: 4 Years
Healthy volunteers: No
Keywords: hemophilia A; eloctate; Emicizumab; inhibitor

Summary:

      This is a multi-center randomized phase III clinical trial, the Inhibitor Prevention Trial,
      in which Eloctate will be compared with Emicizumab, using adaptive design, to prevent
      inhibitors in patients with severe hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male children >= 4 months and up to 4 years of age.

          2. Severe hemophilia A (FVIII < 0.01 U/ml).

          3. No evidence of an inhibitor i.e. anti-FVIII < 0.6 B.U.

          4. No more than 3 FVIII exposures (Factor VIII concentrate, cryoprecipitate, or fresh
             frozen plasma), including circumcision.

        Exclusion Criteria:

          1. Acquired hemophilia or any bleeding disorder other than hemophilia A.

          2. Treatment with clotting factor or emicizumab previously.

          3. Use of an experimental drug(s).

          4. Surgery anticipated in the next 48 weeks.

          5. Life expectancy less than 5 years.

          6. Parent/caretaker unable or unwilling to keep a personal diary of bleeding frequency
             and study drug treatment, make monthly visits and blood draws at weeks 4, 12, 24, 36,
             and 48.

          7. Other illness, condition or reason in the opinion of the investigator that would make
             the patient unsuitable for the trial.
Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
Condition: Anemia
MeSH terms: Anemia
Intervention: Venofer and stable erythropoietin (EPO) regimen; stable erythropoietin (EPO) regimen
Intervention description: Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.; Stable erythropoietin (EPO) dose and no supplemental iron.
Intervention MeSH terms: Epoetin Alfa; Ferric Oxide, Saccharated
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iron; peritoneal dialysis; anemia

Summary:

      This is a open-label, prospective study comparing intravenous (IV) iron supplementation to
      standard care in anemic patents undergoing peritoneal dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hemoglobin >= 9.5 and <= 11.5 g/dL.

          -  Ferritin <= 500 ng/ml.

          -  Serum Transferrin Saturation (TSAT) <= 25%.

          -  Stable erythropoietin (EPO) Regimen for 8 weeks.

          -  No iron for last 4 weeks before randomization.

        Exclusion Criteria:

          -  Known Sensitivity to Iron Sucrose.

          -  Suffering concomitant severe diseases of the liver & cardiovascular system.

          -  Pregnancy / Lactation.

          -  Inadequate dialysis.

          -  Current treatment for asthma.

          -  Significant blood loss.

          -  Probability of need for transfusion or transfusion within 1 week of enrollment.

          -  Anticipated major surgery.

          -  Hemochromatosis / hemosiderosis.
An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia
Condition: Familial Hypercholesterolaemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: rosuvastatin calcium; rosuvastatin calcium; rosuvastatin calcium
Intervention description: 5 mg, oral, once daily, 24 months; 10 mg, oral, once daily, 24 months; 20 mg, oral, once daily, 24 months
Intervention MeSH terms: Calcium, Dietary; Rosuvastatin Calcium; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 315.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Familial Hypercholesterolaemia; pediatric

Summary:

      This study is being carried out to see if the study medication, rosuvastatin, is effective in
      treating familial hypercholesterolaemia in children and adolescents, and to determine the
      long term (over 2 years) safety, tolerability and efficacy of the study medication in these
      patients.

      This study will also measure levels of drug in the blood and see how well it is tolerated.
      This is known as pharmacokinetic (PK) analysis.

      At baseline only a small number of patients will participate in a single dose PK phase over
      24 hours.

      In order to see if this medication works, a control group of healthy siblings will help the
      researchers to compare certain results.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children and adolescents (aged 6 to less than 18 years) with Familial
             Hypercholesterolaemia

          -  Patients aged between 6 and less than 10 years of age must not be taking a statin
             medicine

        Exclusion Criteria:

          -  History of muscle or sensitivity reactions to any statin medicines

          -  Current active liver disease or dysfunction (except a confirmed diagnosis of Gilbert's
             disease)
A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.
Condition: Healthy
Intervention: rLP2086; Placebo
Intervention description: 0.5 mL dose, given at 0, 2 and 6 months; 0.5 mL dose, given at 0, 2 and 6 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3301.0
Sex: All
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is looking at a new vaccine that might prevent meningococcal disease, and will
      study the immune response elicited by this vaccine when given to healthy young adults. The
      study will also look at the safety of the new vaccine as well as how it is tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subject aged >=18 and <26 years at the time of enrollment.

          2. Healthy subject as determined by medical history, physical examination, and judgment
             of the investigator.

          3. Negative urine pregnancy test for all female subjects.

        Exclusion Criteria:

          1. Previous vaccination with any meningococcal serogroup B vaccine.

          2. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a
             3-dose series during the period between Visit 1 and 28 days after the second
             vaccination.

          3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
             allergen immunotherapy with a licensed product and are not on stable maintenance
             doses.

          4. A known or suspected defect of the immune system that would prevent an immune response
             to the vaccine, such as subjects with congenital or acquired defects in B cell
             function, those receiving chronic systemic (oral, intravenous, or intramuscular)
             corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the
             United States with terminal complement deficiency are excluded from participation in
             this study.

          5. Significant neurological disorder or history of seizure (excluding simple febrile
             seizure).

          6. Current chronic use of systemic antibiotics.

          7. Received any investigational vaccines, drugs, or devices within 28 days before
             administration of the first study vaccination.

          8. Any neuroinflammatory or autoimmune condition, including, but not limited to,
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Transfusion of Prematures Trial
Condition: Infant, Newborn, Diseases; Infant, Extremely Low Birth Weight; Infant, Small for Gestational Age; Bronchopulmonary Dysplasia (BPD); Anemia
MeSH terms: Bronchopulmonary Dysplasia; Infant, Newborn, Diseases; Birth Weight
Intervention: Liberal Cell Transfusion; Restricted red cell transfusion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1824.0
Sex: All
Maximum age: 48 Hours
Healthy volunteers: No
Keywords: NICHD Neonatal Research Network; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW); Transfusions

Summary:

      The objective of the TOP trial is to determine whether higher hemoglobin thresholds for
      transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the
      primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months
      of age, using standardized assessments by Bayley.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Birth weight less than or equal to 1000 grams.

          -  Gestational age at least 22 weeks but less than 29 weeks

          -  Admitted to the NICU within 48 hours of life

        Exclusion Criteria:

          -  Considered nonviable by the attending neonatologist

          -  Cyanotic congenital heart disease

          -  Parents opposed to the transfusion of blood

          -  Parents with hemoglobinopathy or congenital anemia

          -  In-utero fetal transfusion

          -  Twin-to-twin transfusion syndrome

          -  Isoimmune hemolytic disease

          -  Lack of parental consent

          -  Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for
             perioperative transfusion.

          -  Prior blood transfusion on clinical grounds beyond the first 6 hours of life

          -  Infant has received erythropoietin prior to randomization, or is intended to receive
             erythropoietin through the neonatal course

          -  Congenital condition, other than premature birth, that adversely affects life
             expectancy or neurodevelopment.

          -  High probability that the family is socially disorganized to the point of being unable
             to attend follow-up at 22-26 months.
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.
Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer
Condition: Differentiated Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Selumetinib; Placebo; Radioactive Iodine Therapy
Intervention description: 3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period; 3 capsules ( to match Selumetinib capsules) orally twice a day for approximately 5 weeks treatment period; A single oral radioactive iodine dose of 100 mCI(3.7 GBq) 131I (+/-10% at the time of administration)to be administered 30 days after randomization. Additionaly, Thyrogen (Recombinant human TSH) will be used to stimulate iodine uptake according to the manufacturer's recommendation(0.9 mg intramuscular injection once a day for the 2 days prior to the dose of radioactive iodine)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Selumetinib, Differentiated Thyroid Cancer , AZD6244

Summary:

      The study is designed to evaluate the clinical efficacy, safety and tolerability of
      selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        Differentiated thyroid cancer Tumor >4 cm, or Gross extra-thyroid extension, or 1 lymph
        node >1 cm, or 5 or more lymph nodes of any size Previous thyroidectomy Must be able to
        receive radioactive iodine therapy Must be able to receive Thyroid Stimulating Hormone
        suppression

        Exclusion criteria:

        Metastaic disease Anaplastic thyroid cancer, medullary thyroid cancer or Hurthle cell
        carcinoma Presence of anti-Tg antibodies Previous treatment with any radiation Unresolved
        toxicity ≥ common terminology criteria for adverse event Grade 2