bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: DRX9000™
Intervention description: Device is designed to apply spinal decompressive forces.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot study will evaluate the effectiveness and safety of the Axiom Worldwide DRX9000
      for active treatment of chronic low back pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, greater than 18 years of age

          -  Able to understand possible risks and benefits and provide written informed consent
             (ICF) to the IRB approved clinical multimodal protocol

          -  LBP with an intensity level of greater than 4 on an eleven point numerical pain rating
             scale (VRS) of 0-10 (with 0 - no pain and 10 - worst possible pain)

          -  Completed the necessary diagnostic and medical history evaluations as described in the
             protocol to confirm the patient's diagnosis and eligibility for the study and DRX9000
             treatment protocol.

          -  Willing and able to complete a six week 20 session of DRX9000 outpatient treatments
             and a minimum of 6 months follow-up

        Exclusion Criteria:

          -  Pregnancy

          -  Evidence of neurological motor deficits on clinical examination

          -  Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or
             compression fracture

          -  Evidence of severe central stenosis with neurological deficits or nerve root
             entrapment

          -  Litigation for health-related claim (in process or pending), Worker's Compensation, or
             Personal Injury

          -  Previous spine fusion surgery, insertion of hardware or artificial disc

          -  Hemiplegia or paraplegia

          -  History of severe cardiovascular or metabolic disease, or abdominal aortic aneurysm

          -  Unwillingness to postpone other types of therapy for LBP during the 6 week treatment
             sessions

          -  Known alcohol abuse or drug abuse

          -  Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm)

          -  Body weight greater than 300 pounds (136 kg)
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Human-cl rhFVIII; Kogenate FS
Intervention description: 50 IU/kg for PK dose; 50 IU/kg for PK dose
Intervention MeSH terms: Factor VIII
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Male
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a clinical study to investigate the pharmacokinetics, efficacy, safety and
      immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant
      FVIII concentrate in previously treated patients with severe Hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A (FVIII:C <= 1%)

          -  Male subjects between 12 and 65 years of age

          -  Body weight 25 kg to 110 kg

          -  Previously treated with FVIII concentrate for at least 150 EDs

        Exclusion Criteria:

          -  Other coagulation disorder than hemophilia A

          -  Present or past FVIII inhibitor activity
Inhaled Corticosteroids Versus Observation for Patients With Decreased Lung Function Status
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Intervention: Fluticasone Propionate
Intervention description: 440 micrograms twice daily by oral inhalation.
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post-Transplant Constrictive Bronchiolitis; Bronchiolitis; Fluticasone Propionate; Inhaled Corticosteroids; Lung Condition; PTCB

Summary:

      The goal of this clinical research study is to compare lung function of patients who inhale
      steroids in the early stages of post-transplant constrictive bronchiolitis (PTCB) to patients
      who continue with standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients >/=18 years of age.

          2. Patients must be engrafted and at least 80 days post allogeneic hematopoietic stem
             cell transplantation.

          3. New onset airflow obstruction defined as decline of forced expiratory volume in 1
             second (FEV1) percent predicted >/= 15%.

          4. Total Lung Capacity (TLC) > 85% to rule out restrictive lung disease.

          5. Patient must be willing to comply with all study procedures and capable of signing
             informed consent.

        Exclusion Criteria:

          1. Patients with active pulmonary infection.

          2. Patients with known hypersensitivity to corticosteroids
B0151005 Open-Label Extension Study
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: PF-04236921; PF-04236921
Intervention description: Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.; Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease; safety; efficacy; pharmacokinetics; pharmacodynamics; Crohn's Disease Activity Index (CDAI)

Summary:

      This is a multi-center Phase 2, open label, safety extension study in subjects with moderate
      to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will
      have completed the 12-week induction period of study B0151003 and will be enrolled as either
      responders or non responders.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12
             week) induction period.

          -  Subjects who are willing and able to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

          -  Women of childbearing potential, who have sexual intercourse with a non surgically
             sterilized male partner, must agree and commit to the use highly effective methods of
             birth control from signing of the ICD through 26 weeks after the Final Study
             Evaluation or for 62 weeks from the last dose of investigational product for any
             subject who terminates early from this study.

        Exclusion Criteria:

          -  Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced
             serious event(s) related to the investigational product, an unstable medical
             condition, or any other reason, in the opinion of the investigator, would preclude
             entry or inclusion in this study.

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the subject
             inappropriate entry into this study.

          -  Received any prohibited treatment during study B0151003 that, in the opinion of the
             investigator, compromised the safety or efficacy of this study.
Efficacy and Safety of Atacicept in IgA Nephropathy
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Intervention: Placebo; Atacicept 25 mg; Atacicept 75 mg
Intervention description: Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.; Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.; Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atacicept; IgA Nephropathy; Berger´s disease; Glomerulonephritis; Proteinuria

Summary:

      This main purpose of this study was to evaluate the safety, tolerability, dose response and
      efficacy of Atacicept in participants with IgA nephropathy and persistent proteinuria. The
      study hypothesis was that treatment with Atacicept would reduce proteinuria compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than or equal to (>=)18 years of age

          -  Biopsy-proven Immunoglobulin (IgA) nephropathy

          -  Urine Protein to Creatinine Ratio (UPCR) >= 0.75 and <= 6 milligram per milligram
             (mg/mg) during screening

          -  Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or
             angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening

        Exclusion Criteria:

          -  Concomitant significant renal disease other than IgA nephropathy

          -  IgA nephropathy with significant glomerulosclerosis or cortical scarring

          -  Diagnosis of Henoch-Schonlein purpura

          -  Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement
             criteria

          -  Serum IgG below 6 grams per liter (g/L)

          -  Use of cyclophosphamide ever or use of other immunosuppressants or systemic
             corticosteroids within 4 months

          -  Active infection requiring hospitalization or treatment with parenteral
             anti-infectives within 4 weeks

          -  History, or current diagnosis, of active tuberculosis (TB), or untreated latent TB
             infection

          -  History of or positive HIV and/or positive for hepatitis B or Hepatitis C at screening

          -  History of malignancy

          -  Nursing or pregnancy

          -  Any condition, including any uncontrolled disease state other than IgA nephropathy
Early Insulin and Development of ARDS
Condition: Respiratory Distress Syndrome, Adult; Sepsis; Hyperglycemia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Hyperglycemia; Syndrome
Intervention: Insulin
Intervention description: Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) for up to 48 hours after ICU admission.
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Respiratory Distress Syndrome; Acute Lung Injury

Summary:

      Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) is a severe lung condition
      that causes respiratory failure. Symptoms usually develop within 24 to 48 hours of an
      original injury or illness, and people with ALI/ARDS typically require care in the intensive
      care unit (ICU). Little is known about how to prevent the onset of ALI/ARDS. The purpose of
      this study is to examine if early infusions of insulin, known as intensive insulin therapy
      (IIT), can help prevent ALI/ARDS in hospitalized patients with high levels of blood sugars
      and severe infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with severe sepsis, which is defined as sepsis AND one or more signs of
             organ dysfunction or hypotension

          -  Hyperglycemia (i.e., glucose level greater than 130 mg/dL on one or more tests)

        Exclusion Criteria:

          -  Diabetic ketoacidosis

          -  Severe chronic liver disease with Child-Pugh score greater than 10 (Class C)

          -  Documented episodes of blood or plasma glucose less than 60 mg/dL within 24 hours of
             study entry

          -  Lack of any available IV access for insulin infusion

          -  Pregnant

          -  Known advanced directives against intubation or aggressive ICU care

          -  Inability to be enrolled into the study in the 12 hours following admission to the ED
Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
Condition: Chronic Kidney Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Roxadustat
Intervention description: Oral capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Kidney; Chronic Kidney Disease; CKD; Renal; Anemia; Oral anemia treatment; Hemoglobin levels; Erythropoietin; Blood count; Predialysis; Pre-dialysis; Hb; Non-dialysis

Summary:

      The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the
      correction of anemia in participants with non-dialysis chronic kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 to 75 years

          2. Chronic kidney disease, not receiving dialysis

          3. Body weight 45 to 140 kg

        Exclusion Criteria:

          1. Any clinically significant infection or evidence of an underlying infection

          2. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)

          3. History of chronic liver disease

          4. New York Heart Association Class III or IV congestive heart failure

          5. Myocardial infarction or acute coronary syndrome within 12 weeks prior to
             randomization

          6. History of malignancy

          7. Chronic inflammatory disease that could impact erythropoiesis (for example, systemic
             lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in
             remission

          8. History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia

          9. History of hemosiderosis, hemochromatosis or polycystic kidney disease

         10. Active hemolysis or diagnosis of hemolytic syndrome

         11. Uncontrolled or symptomatic secondary hyperparathyroidism

         12. Seizure disorder or receiving anti-epilepsy medication

         13. Known bone marrow fibrosis

         14. Any prior or scheduled organ transplant

         15. Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase
             inhibitor

         16. History of alcohol or drug abuse
Carbidopa for the Treatment of Excessive Blood Pressure Variability
Condition: Dysautonomia, Familial; Baroreflex Failure Syndrome
MeSH terms: Primary Dysautonomias; Autonomic Nervous System Diseases; Dysautonomia, Familial
Intervention: Carbidopa Low-Dose; Placebo; Carbidopa High-Dose
Intervention description: 300 mg/day; A placebo containing an inert substance, in capsule form that does not contain an active drug ingredient.; 600 mg/day
Intervention MeSH terms: Carbidopa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 10 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Familial dysautonomia (HSAN III); Norepinephrine; Sympathetic nervous system; Autonomic nervous system; Blood pressure variability; Hypertension; Carbidopa/Lodosyn; Afferent baroreflex failure; Clinical trial

Summary:

      The overall study objectives are to determine whether carbidopa (Lodosyn®) is safe and well
      tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension
      and normalize or reduce the exaggerated blood pressure variability in patients with familial
      dysautonomia (FD, also called hereditary sensory and autonomic neuropathy type III or
      Riley-Day syndrome). Funding Source- FDA OOPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with familial dysautonomia (FD) age 10 or older

          -  Unstable blood pressure, defined as:

               -  Systolic BP standard deviation >15 mmHg

               -  Or coefficient of variation >15%

               -  Or documented episodic hypertensive peaks (>140mmHg)

          -  Confirmed diagnosis of FD (genetic testing)

          -  Providing written informed consent (or ascent) to participate in the trial

          -  Ability to comply with the requirements of the study procedures.

        Exclusion Criteria:

          -  Patients taking monoamine oxidase (MAO)-inhibitors

          -  Patients taking: metoclopramide, domperidone, risperidone or other dopamine blockers

          -  Patients taking tricyclic antidepressants

          -  Patients taking neuroleptic drugs (haloperidol and chlorpromazine)

          -  Patients with a known hypersensitivity to any component of this drug.

          -  Patients with atrial fibrillation, angina or significant ECG abnormality

          -  Patients with significant pulmonary, cardiac, liver, renal (creatinine >2.0 mg/ml)

          -  Patients who have a significant abnormality on clinical examination that may, in the
             investigator's opinion might jeopardize their healthy participating in this trial.

          -  Women who are pregnant or lactating.
Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK1247446A Group; Fluarix™
Intervention description: Low dose influenza vaccine adjuvanted with AS03 compared; GlaxoSmithKline (GSK) Biologicals' inactivated influenza split vaccine.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 150.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine; Prophylaxis Influenza vaccine

Summary:

      The purpose of this study is to evaluate the immunogenicity and the safety of the candidate
      vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and wil comply with the
             requirements of the protocol should be enrolled in the study.

          -  A male or female 60 years or older at the time of the first vaccination.

          -  Free of obvious health problems

        Exclusion Criteria:

          -  Use of non-registered products

          -  Administration of immune-modifying drugs.

          -  Administration of vaccine 30 days before enrolment in study.

          -  Immunosuppressive or immunodeficient condition.

          -  Hypersensitivity to a previous dose of influenza vaccine

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality.

          -  History of confirmed influenza infection within the last 12 Months.

          -  Acute disease at the time of enrolment/vaccination.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine
Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Poziotinib
Intervention description: 8 mg oral tablets, administered QD.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Poziotinib; Metastatic Breast Cancer; HER2-positive; Pan-HER inhibitor

Summary:

      The purpose of this study is to establish the dose regimen and evaluate the preliminary
      efficacy and the safety/tolerability of poziotinib in participants with human epidermal
      growth factor receptor 2 (HER2)-positive metastatic breast cancer who have received at least
      two prior HER2-directed treatment regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histopathologically confirmed primary breast cancer with metastatic lesions.

          2. Confirmed HER2 overexpression or gene-amplified tumor

          3. At least two prior HER2-directed therapy regimens for breast cancer, including
             trastuzumab and trastuzumab emtansine

          4. Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1
             (RECIST v1.1)

          5. Participant is at least 18, and ≤90 years of age.

          6. Adequate hematologic, hepatic, and renal function

          7. Eastern Cooperative Oncology Group (ECOG) performance status <= 2

        Exclusion Criteria:

          1. Previous treatment with poziotinib prior to study participation

          2. Brain metastases that are symptomatic or require therapy to control symptoms, as well
             as any history of radiation, surgery, or other therapy, including steroids, to control
             symptoms from brain metastases within 15 days of enrollment.

          3. Anticancer chemotherapy, biologics, immunotherapy, cure-intent radiotherapy, or
             investigational treatment within 15 days, except for hormone therapy, palliative
             therapy, or supportive therapy.

          4. History of congestive heart failure Class III/IV according to the New York Heart
             Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring
             treatment.

          5. Cardiac ejection fraction <50%

          6. History of other malignancies within the last 5 years

          7. Participant is pregnant or breast-feeding.

          8. Unable to take drugs orally