bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy
Condition: Endocrine System Diseases
MeSH terms: Endocrine System Diseases
Intervention: Somatropin
Intervention description: Liquid, daily to final height Maximum Dosage: 50 µg/kg/day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 4 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      -  To evaluate the effect of increasing the growth hormone dose on the statural response

        -  To assess the value of early treatment during the course of arthritic disease by
           comparing the height acquired in the medium term by children in the two groups: treated
           from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4
           years after the diagnosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  This study will be proposed to all patients previously included in study CTN
             97-8129-016

        Exclusion Criteria:

          -  Discontinuation of corticosteroid therapy for more than a year during study CTN
             97-8129-016

          -  Patients withdrawing from the study prematurely
Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: Flutamide; Leuprolide Acetate
Intervention description: 10.8 mg intramuscularly once every 3 months for 12 months; 50 mg tablet orally daily for 12 months
Intervention MeSH terms: Leuprolide; Goserelin; Flutamide; Bicalutamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: Male
Healthy volunteers: No
Keywords: stage I prostate cancer; stage II prostate cancer

Summary:

      RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy
      using leuprolide and flutamide may fight prostate cancer by reducing the production of
      testosterone. It is not yet known whether receiving leuprolide and flutamide is more
      effective than receiving no further therapy.

      PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in
      treating patients who have stage I or stage II prostate cancer that is at high risk of
      recurrence and who have already undergone surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging

          2. Radical prostatectomy and bilateral lymph node dissection performed

          3. Pathologic assessment of surgical specimens by MDACC pathologist

          4. High risk of clinical or biochemical failure post prostatectomy (must fulfill one of
             the following criteria): pathology; a) Gleason grade sum score greater than or equal
             to 8, b) Seminal vesicle involvement, c) Extraprostatic extension with positive
             surgical margins and Gleason greater than or equal to 7

          5. Radical prostatectomy performed within 90 days of enrollment and serum PSA level <
             0.1ng/ml

          6. Written informed consent

        Exclusion Criteria:

          1. Any evidence of metastatic disease confirmed prior to enrollment

          2. Inability to confirm pathologic risk factors or inadequate prostatectomy (see item
             4.1.5).

          3. Hormonal ablation for greater than 3 months or radiotherapy for prostate cancer

          4. Failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to
             enrollment in study

          5. Elevation of liver function tests 2x normal

          6. Contraindication to the use of LH-RH agonists or antiandrogens

          7. Active secondary malignancy (other than squamous or basal cell skin cancer) within
             five years prior to enrollment in study

          8. Any concomitant medical condition that would make it undesirable for the 7patient to
             participate in the trial or jeopardize compliance with the protocol
Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy
Condition: Renal Failure
MeSH terms: Kidney Diseases
Intervention: sodium bicarbonate; saline
Intervention description: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours; hydration with saline 1ml/Kg/h for 6 hours
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: contras-induced nephropathy

Summary:

      The purpose of this study is to determine whether hydration with sodium bicarbonate is
      superior to hydration with saline to prevent contrast-induced nephropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  serum creatinine > 1.1 mg/dL

          -  glomerular filtration rate (GFR) < 50 mL/min

        Exclusion Criteria:

          -  age < 18 years

          -  use of radiographic contrast media during the last 21 days

          -  history of dialysis

          -  cardiac insufficiency class III-IV

          -  emergency procedures
Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
Condition: Colonoscopy; Endoscopy, Digestive System; Conscious Sedation
Intervention: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System); benzodiazepines and opioid sedation
Intervention description: propofol sedation per device instructions for use; per site's current standard of care
Intervention MeSH terms: Analgesics, Opioid
Phase: Phase 3
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1000.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Propofol; Diprivan; Colonoscopy; Endoscopy, Digestive System; Conscious Sedation

Summary:

      Patients routinely receive sedation during a colonoscopy or upper endoscopy
      (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during
      these procedures. The purpose of this study is to determine if this CAPS device enables a
      physician/registered nurse (RN) team to safely and effectively administer propofol sedation
      during colonoscopy or EGD procedures relative to current sedation practices.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years old

          -  Able to comprehend, sign, and date the written informed consent form

          -  English as primary language

          -  Undergoing a non-emergent EGD or colonoscopy

          -  Have taken nothing by mouth for a minimum of 6 hours prior to the study procedure

          -  American Society of Anesthesiologists (ASA) Class I, II or III

        Exclusion Criteria:

          -  Allergy or inability to tolerate study medications or components of study medications

          -  Investigator anticipates greater than 45 minute procedure time due to known anatomical
             difficulty

          -  Currently using a fentanyl patch

          -  History of diagnosed sleep apnea

          -  History of diagnosed gastroparesis

          -  Baseline oxygen saturation < 90% (room air)

          -  Pregnant or nursing females

          -  Body mass index (BMI) ≥ 35

          -  Participation in a clinical trial within the past 30 days.
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Sapacitabine; Decitabine
Intervention description: Oral sapacitabine capsules; Decitabine intravenous
Intervention MeSH terms: Decitabine; Sapacitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 482.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: AML

Summary:

      This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at
      least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the
      doctor does not recommend the use of standard intensive treatment or the patient has decided
      not to receive standard intensive treatment after being fully informed about its benefits and
      risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating
      cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug
      regimen is more likely to keep AML in check as long as possible.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed AML based on WHO (World Health Organization) classification

          -  Age 70 years or older for whom the treatment of choice is low-intensity therapy by
             investigator assessment or who has refused intensive induction therapy recommended by
             investigator

          -  ECOG (Eastern Cooperative Oncology Group) performance status 0-2

          -  Adequate renal function

          -  Adequate liver function

          -  Able to swallow capsules

          -  Agree to practice effective contraception

          -  Ability to understand and willingness to sign the informed consent form

        Exclusion Criteria:

          -  AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor
             without bone marrow involvement

          -  Having received any systemic anti-cancer therapy for AML or received treatment with
             hypomethylating agents or cytotoxic chemotherapy for preceding myelodysplastic
             syndrome (MDS) or myeloproliferative disease (MPD)

          -  Known or suspected central nervous system (CNS) involvement by leukemia

          -  Uncontrolled intercurrent illness

          -  Known hypersensitivity to decitabine

          -  Known to be HIV-positive
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
Condition: Chemotherapy-induced Neutropenia; Breast Cancer
MeSH terms: Breast Neoplasms; Neutropenia
Intervention: LA-EP2006; Neulasta®
Intervention description: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.; Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle Neulasta® is injected s.c. post chemotherapy application.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 308.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pegfilgrastim; G-CSF; neutropenia; breast cancer; myelosuppressive chemotherapy

Summary:

      The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the
      mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in
      breast cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically proven breast cancer

          -  eligible for six cycles of neoadjuvant or adjuvant chemotherapy

        Exclusion Criteria:

          -  concurrent or prior chemotherapy for breast cancer

          -  concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy,
             immunotherapy, monoclonal antibodies, and/or biological therapy

          -  concurrent prophylactic antibiotics

          -  previous therapy with any G-CSF (granulocyte-colony stimulating factor) product

        Other protocol-defined inclusion/exclusion criteria may apply.
A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; methotrexate; placebo
Intervention description: tocilizumab 8 mg IV every 4 weeks.; Approximately 15-17 mg methotrexate capsule orally once a week.; Placebo matching methotrexate capsule taken orally once a week.
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 556.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with
      methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients
      receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg
      intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv
      every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment
      adjustments (increase or decrease of treatment intensity) may be introduced at intervals,
      based on response. The anticipated time on study treatment is up to 3 years, and the target
      sample size is approximately 470 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, ≥ 18 years of age;

          -  moderate to severe active rheumatoid arthritis (Disease Activity Score (DAS28) > 4.4);

          -  inadequate response to methotrexate;

          -  on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks.

        Exclusion Criteria:

          -  prior treatment with a biologic;

          -  Rheumatoid arthritis (RA) functional class IV;

          -  known active current or history of recurrent bacterial, viral, fungal, mycobacterial
             or other infections;

          -  evidence of active malignant disease.
Efprezimod Alfa (CD24Fc, MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007)
Condition: Coronavirus Disease 2019 (COVID-19)
MeSH terms: COVID-19
Intervention: Efprezimod alfa; Placebo
Intervention description: Efprezimod alfa is given on Day 1.; Placebo is given on Day 1.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the efficacy and safety of efprezimod alfa in hospitalized adult
      participants who are diagnosed with coronavirus disease 2019 (COVID-19) and receiving oxygen
      support.

      The primary hypothesis of the study is clinical improvement in the experimental group versus
      the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with coronavirus disease 2019 (COVID-19) and confirmed severe acute
             respiratory syndrome coronavirus 2 (SARS-coV-2) viral infection

          -  Severe or critical COVID-19, or National Institute of Allergy and Infectious Diseases
             (NIAID) 8-point ordinal score 2, 3 or 4 (Scale 2: requiring invasive mechanical
             ventilation or extracorporeal membrane oxygenation (ECMO); Scale 3: non-invasive
             ventilation or high flow oxygen devices; Scale 4: supplemental oxygen support; a
             peripheral capillary oxygen saturation (SpO2) </= 94% or tachypnea (respiratory rate
             >/= 24 breaths/min). Intubation should be within 7 days

        Exclusion Criteria:

          -  Participants who are pregnant, breastfeeding, or have a positive pregnancy test result
             before enrollment

          -  Participants previously enrolled in the efprezimod alfa study

          -  Intubation for invasive mechanical ventilation is over 7 days

          -  Documented acute renal or hepatic failure

          -  The investigator believes that participating in the trial is not in the best interests
             of the participant, or the investigator considers unsuitable for enrollment (such as
             unpredictable risks or subject compliance issues)
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: E10030; ranibizumab; E10030 sham intravitreal injection
Intervention description: Pressure on the eye with a syringe with no needle
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 619.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; choroidal neovascularization; Fovista®; E10030; Lucentis®

Summary:

      The objectives of this study are to evaluate the safety and efficacy of intravitreal
      administration of Fovista® administered in combination with Lucentis® compared to Lucentis®
      monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related
      macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  Active subfoveal choroidal neovascularization (CNV) secondary to AMD

          -  Presence of sub-retinal hyper-reflective material (SD-OCT)

        Exclusion Criteria:

          -  Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral
             supplements of vitamins and minerals

          -  Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless
             of indication (including intravitreal corticosteroids)

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
             prior thermal laser in the macular region, regardless of indication

          -  Subjects with subfoveal scar or subfoveal atrophy are excluded

          -  Diabetes mellitus
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Intervention: turoctocog alfa
Intervention description: Patients will be scheduled to receive treatment with turoctocog alfa for at least 100 exposure days. In most cases, treatment will be given at home with intravenous (i.v., into the vein) self-injection by the parent/caregiver/support person.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 0 Years
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North America. The purpose of the trial is to
      evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in
      previously untreated children with haemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age below 6 years

          -  Informed consent obtained before any trial-related activities (trial-related
             activities are any procedure that would not have been performed during normal
             management of the patient)

          -  Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or
             below 1%)

          -  No prior use of purified clotting factor products (previous exposure, equal to or less
             than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted)
             including commercially available NovoEight® /Novoeight®

        Exclusion Criteria:

          -  Known or suspected allergy to hamster protein or intolerance to trial product(s) or
             related products

          -  Previous participation in this trial defined as withdrawal after administration of
             trial product

          -  Congenital or acquired coagulation disorders other than haemophilia A

          -  Any history of Factor VIII inhibitor

          -  Ongoing treatment or planned treatment during the trial with immunomodulatory agents
             (e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)