bioihbjkbjnl/mcl2 huggingface dataset:
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
Condition: Locally Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: Durvalumab; Cisplatin; Carboplatin; external beam radiation therapy (EBRT) + brachytherapy
Intervention description: IV infusion every 4 weeks; Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy; For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy; Radiation therapy per standard of care
Intervention MeSH terms: Carboplatin; Durvalumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 770.0
Sex: Female
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Durvalumab; Chemoradiotherapy; Locally Advanced Cervical Cancer

Summary:

      This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study
      to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus
      Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer
    

Eligibility criteria:

        Inclusion Criteria:

        For inclusion in the study, patients should fulfill the following criteria:

          1. Female

          2. Aged at least 18 years

          3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009)
             Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node

          4. No prior chemotherapy or radiotherapy for cervical cancer

          5. WHO/ECOG performance status of 0-1

          6. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target
             Lesion at baseline.

        Exclusion Criteria:

        Patients should not enter the study if any of the following exclusion criteria are
        fulfilled:

          1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical
             cancer

          2. Intent to administer a fertility-sparing treatment regimen

          3. Undergone a previous hysterectomy

          4. Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short
             axis) above the L1 cephalad body, in the inguinal region or outside the planned
             radiation field.

          5. History of allogeneic organ transplantation

          6. Active or prior documented autoimmune or inflammatory disorders

          7. Uncontrolled intercurrent illness

          8. History of another primary malignancy and active primary immunodeficiency
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Condition: Relapsing Multiple Sclerosis (RMS)
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ublituximab; Teriflunomide; Oral Placebo; IV Placebo
Intervention description: Administered as an IV infusion.; Film coated tablets administered orally.; Administered orally.; Administered as an IV Infusion.
Intervention MeSH terms: Teriflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, multi-center, double-blinded, active-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded, active-controlled study
Enrollment: 545.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96
      weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral
      placebo compared to 14 mg oral teriflunomide/IV placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsing multiple sclerosis (RMS) (McDonald Criteria 2010)

          -  Active disease

          -  Expanded disability status scale (EDSS) 0 - 5.5 (inclusive) at screening

        Exclusion Criteria:

          -  Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed
             treatment

          -  Treatment with the following therapies at any time prior to randomization:
             alemtuzumab, natalizumab, teriflunomide, leflunomide and Stem cell transplantation

          -  Diagnosed with primary progressive multiple sclerosis (PPMS)

          -  Pregnant or nursing
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
Condition: Anemia; Chronic Kidney Disease (CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: HX575 epoetin alfa; US-licensed epoetin alfa
Intervention description: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.; Solution for subcutaneous injection.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 435.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: erythropoietin alfa; CKD 5d

Summary:

      The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed
      reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to
      generate data supporting that the efficacy and safety under treatment with HX575 and
      Epogen®/Procrit® are comparable.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous
             maintenance therapy with Epogen® or Procrit® at least once per week

          -  Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period

          -  Adequate iron substitution

        Exclusion Criteria:

          -  Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy

          -  History of Pure Red Cell Aplasia (PRCA), or anti-erythropoietin (EPO) antibodies

          -  Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection

          -  Hepatitis C infection on an active treatment

          -  Symptomatic congestive heart failure (New York Heart Association [NYHA] class III and
             IV)

          -  Unstable angina pectoris, or cardiac infarction during the last 6 months prior to
             randomization

          -  Percutaneous coronary intervention, or coronary artery bypass grafting during the last
             6 months prior to randomization

          -  History of malignancy of any organ system

          -  Systemic lupus erythematous

          -  Immunocompromized patients

        Other In-/Exclusion criteria may apply
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: TRI102; Placebo
Intervention description: formulation containing active moiety (amphetamine); formulation without active moiety
Intervention MeSH terms: Amphetamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether TRI102 is effective in the treatment of
      Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this
             condition

        Exclusion Criteria:

          -  Other serious illnesses or conditions that would put the patient at particular risk
             for safety events or would interfere with treatment/assessment of ADHD
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.
Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Intervention: oral levofloxacin; nebulized levofloxacin
Intervention MeSH terms: Levofloxacin; Ofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis
      (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms
      and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral
      antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily
      intranasal antibiotic irrigations. The two treatments will be compared to see if there is any
      difference in patient outcomes. This will help guide treatment strategies for patients with
      CRS in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults (age ≥ 18).

          2. Diagnosis of CRS.

          3. Worsening sinonasal symptoms.

          4. Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and
             anterior ethmoidectomy).

          5. English speaking.

          6. Open sinuses (open middle meatus bilaterally; determined on endoscopy).

          7. Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen
             antibiotic regimens.

        Exclusion Criteria:

          1. Patients < 18 years of age.

          2. Treatment with systemic or topical antibiotics within the last 1 month.

          3. Pregnant women.

          4. Non-English speaking persons.

          5. Systemically ill at initial visit necessitating treatment prior to culture data.

          6. Allergies to chosen susceptible antibiotics.

          7. Sinonasal culture with less than 1+ growth.

          8. Multiple organisms grown on culture that are not sensitive to a single antibiotic.

          9. Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome,
             ciliary dyskinesia).

         10. Patients with immunodeficiencies.
Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
Condition: Cholestasis of Parenteral Nutrition
MeSH terms: Cholestasis
Intervention: Smoflipid 20% Lipid Emulsion for Injection; Intralipid, 20% Intravenous Emulsion; Intralipid, 20% Intravenous Emulsion
Intervention description: Intravenous lipid containing soy, MCT, olive, and fish oils at goal doses of 3 g/kg/day; Intravenous lipid emulsion of 20% soy oil at goal doses of 1 g/kg/day; Intravenous lipid emulsion of 20% soy oil at goal doses of 2-3 g/kg/day
Intervention MeSH terms: Soybean oil, phospholipid emulsion; SMOFlipid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective patients will be randomized to one of the two treatment arms, either composite lipid containing fish oil (Smoflipid) or soy-based lipid reduction. A third arm will include retrospective patients who will act as controls and received soy-based lipid at standard dosing.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Healthy volunteers: No

Summary:

      Intestinal failure associated liver disease is a cholestatic liver disease associated with
      prolonged need for parenteral nutrition that can lead to such significant complications as
      liver failure. In the neonatal population, infants with history of intestinal resection and
      short bowel syndrome are at increased risk for this disease. The investigators plan to
      compare two possible lipid dosing preventative strategies including a composite, fish oil
      lipid and soy-based lipid reduction.
    

Eligibility criteria:

        Inclusion Criteria: Neonates with anticipated need for parenteral nutrition (based on
        primary physicians opinion) for greater than or equal to four weeks and one of the
        following diagnoses:

          -  Anatomic: Neonate with intestinal atresia, omphalocele, gastroschisis, or volvulus
             with or without intestinal resection.

          -  Ischemic/perforation: Neonates with spontaneous intestinal perforation or necrotizing
             enterocolitis requiring surgical intervention.

        Exclusion Criteria:

          -  Current weight less than 750 grams

          -  AST or ALT greater than 5 times the upper limit of normal within 2 weeks of enrollment

          -  Direct bilirubin greater than 2 mg/dL on any consecutive measurements 5 - 7 days apart
             within 2 weeks of enrollment

          -  Severe coagulopathy with INR greater than 95th percentile for age (>1.7 at less than 5
             days of age, > 1.5 older than five days of age)

          -  Culture confirmed sepsis with positive blood, urine, or CSF culture within 2 weeks of
             enrollment

          -  Renal failure requiring dialysis

          -  Cyanotic heart disease requiring prostaglandin therapy

          -  Hypertriglyceridemia (greater than 250mg/dL) at time of enrollment
Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Aspirin 650mg Oral Capsule; Acetaminophen Tablet 650mg; Placebo
Intervention description: A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.; A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.; A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Intervention MeSH terms: Aspirin; Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a within-subject design double-blind RCT in which each participant receives 1 of 3 treatments at 3 timepoints (i.e., 3 separate days separated by 1-week washout periods).
Masking: Single (Outcomes Assessor)
Masking description: Study biostatistician will derive the randomization schedule. Study pharmacy will make assignments and maintain blinding until data analysis is complete for the full sample.
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: exercise; aspirin; cooling; antipyretic

Summary:

      This study investigates the use of aspirin as an exercise pre-treatment to reduce overheating
      and exhaustion, which may potentially allow many more people with multiple sclerosis to
      participate in and benefit from exercise. The design is double-blind, within-subject, with
      three arms: participants will receive one of three treatments at three separate study visits:
      aspirin, acetaminophen, and placebo, followed by completion of a maximal exercise test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsing-remitting MS

          -  self-reported heat-sensitivity to exercise

          -  Expanded Disability Status Scale (EDSS) total score ≤ 6.0

          -  exacerbation-free (and no use of corticosteroids) for 6 weeks prior

          -  BMI ≤ 40

        Exclusion Criteria:

          -  prior history of significant head injury, stroke, or other neurological
             disease/disorder

          -  current daily use of antipyretics or pain medication

          -  currently in a major depressive episode

          -  vascular disease of the legs, uncontrolled high blood pressure

          -  uncontrolled diabetes mellitus or problem with blood sugar levels

          -  contraindications to aspirin use (history of confirmed peptic ulcer, gastrointestinal
             or severe gynecological bleeding)

          -  tarry stool or known fecal occult blood

          -  uncontrolled syndrome of asthma, rhinitis, or nasal polyps

          -  contraindications to acetaminophen use (severe active hepatic disease, Hepatitis C
             Virus)
P3 Long Term Safety Study of Once Daily SB204 in Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: SB204 4%
Intervention description: Open label, topical SB204 4%
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 601.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a multi-center, open label long-term safety (LTS) study to be conducted in
      approximately 600 subjects with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed 12 weeks of treatment in NI-AC301 or NI-AC302

        Exclusion Criteria:

          -  Terminated early from an SB204 Phase 3 pivotal study for any reason

          -  Have an on-going adverse event at Week 12 visit for NI-AC301 or NI-AC302 that warrants
             stopping study drug application

          -  Have used medications or vitamins during the 12 weeks immediately preceding this study
             which were reported to exacerbate acne.
Efficacy Study of Patient Preoperative Preps In-vivo
Condition: Surgical Skin Preparation
Intervention: CHG/IPA Surgical skin preparation; Normal saline
Intervention description: Apply topically to the inguinal region for 2 minutes; Apply topically to the inguinal region for 2 minutes
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the antimicrobial efficacy of an investigational
      CHG/IPA prep on skin flora of the inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good health

          -  Minimum skin flora baseline requirements on inguinal region

        Exclusion Criteria:

          -  Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin
             disorders (including acne) on the applicable test area

          -  Topical antimicrobial exposure within 14 days prior to screening and treatment days

          -  Use of systemic or topical antibiotics, steroid medications, or any other products
             known to affect the normal microbial flora of the skin within 14 days prior to
             screening and treatment days