bioihbjkbjnl/mcl2 huggingface dataset:
Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
Condition: Idiopathic Short Stature
MeSH terms: Dwarfism
Intervention: Aromatase Inhibitor; Growth Hormone; Aromatase Inhibitor and Growth Hormone
Intervention MeSH terms: Letrozole; Anastrozole; Hormones; Aromatase Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Male
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Aromatase; Growth; Letrozole; Anastrozole; GH; Children; Puberty

Summary:

      When treating very short children in puberty we are time-limited, as sex hormones cause the
      growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty,
      increase height potential, but leave children sexually infantile at a critical time in
      development. Human and animal data show that estrogen, in females and males, is a principal
      regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs),
      which block testosterone to estrogen conversion, in boys with different growth disorders, we
      have shown that AIs may have beneficial effects enhancing height potential in growth-retarded
      males, without affecting their puberty. However, no direct comparison of the effect of AIs
      alone vs. conventional GH treatment has been done to date. This study will assess the effect
      of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent
      boys with idiopathic short stature.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males: Ages: 12 - less than 18 years.

          -  Bone age less than 14 ½ years at study initiation.

          -  Presence of puberty.

          -  Idiopathic short stature will be defined as a short child equal or less than -2SD for
             height, with normal GH responses to stimuli (> or = 5ng/ml to at least 2
             secretagogues) or a normal IGF-I and BP-3, normal body proportions and no other
             identifiable growth pathology.

          -  Accurate growth data for at least 6 months at baseline is available.

        Exclusion Criteria:

          -  Chronic illnesses.

          -  Chronic use of glucocorticosteroids.

          -  Previous use of hormonal treatment with AIs, sex steroids or GH in the preceding 6
             months.

          -  Birth weight small for gestational age (SGA).
A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-659/TEZ/IVA; IVA; Placebo
Intervention description: Participants received VX-659/TEZ/IVA orally once daily in the morning.; Participants received IVA orally once daily in the evening.; Participants received placebo matched VX-659/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.
Intervention MeSH terms: Ivacaftor; VX-659
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 385.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor
      (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for
      F508del and a minimal function mutation (F/MF subjects).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Heterozygous for F508del and an MF mutation (as defined in the protocol)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
Condition: Hypercholesterolemia; Atherosclerotic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia
Intervention: bempedoic acid
Intervention description: bempedoic acid 180 mg tablets taken orally, once per day.
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1462.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlipidemia; cholesterol; heterozygous familial hypercholesterolemia; atherosclerotic cardiovascular disease; ASCVD; HeFH; LDL

Summary:

      The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated
      in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately
      controlled by their current therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed CLEAR Harmony (1002-040) parent study

        Exclusion Criteria:

          -  Experienced a treatment-related SAE that led to study drug discontinuation in the
             CLEAR Harmony (1002-040) parent study.

          -  Medical condition requires lipid measurement and/or adjustment of background
             lipid-regulating therapy.
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Condition: Lumbosacral Radicular Pain
MeSH terms: Radiculopathy
Intervention: SP-102; Placebo
Intervention description: injection; injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: lumbosacral radicular pain; sciatica; leg pain

Summary:

      This is a research study of SP-102, an experimental medication designed to relieve pain in
      patients with a specific type of leg pain. The medication is given once by your healthcare
      professional, with a possibility of a second injection as early as about 1 month after the
      first treatment.

      The purpose of the study is to measure how well a single injection of the experimental
      medication, SP-102, relieves pain. The study will also investigate the side effects of
      SP-102.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Able and willing to read, write, and understand the English language and provide
             English language written informed consent prior to beginning any study procedures.

          -  Age 18 to 70 years (inclusive) at the Screening Visit.

          -  A diagnosis of lumbosacral radicular pain (sciatica).

          -  Agrees to follow study-specific medication requirements.

          -  If sexually active and a female of child-bearing potential or a male capable of
             bearing a child, agrees to use an effective method of birth control during the study.

          -  Has reviewed all study specific materials and has, in the opinion of the Investigator,
             the abilities to understand and appropriately complete all study procedures.

        Main Exclusion Criteria:

          -  Has radiologic evidence of a condition that would compromise study outcomes.

          -  Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention
             while in the study.

          -  Has been diagnosed with insulin dependent diabetes mellitus.

          -  Presence of any other disorder, condition or circumstance (including secondary gain)
             that, in the opinion of the Investigator, has the potential to prevent study
             completion and/or to have a confounding effect on outcome assessments.

          -  Use of any investigational drug and/or device within 30 days, or is scheduled to
             receive an investigational drug other than blinded study drug during this study.

          -  Has a body mass index ≥40 kg/m2.
Video Double-Lumen Tube Prospective Randomized Study
Condition: Other Surgical Procedures
Intervention: Non-Video Double Lumen Tube (DLT); Fiberoptic Bronchoscopy (FOB); Video Double Lumen Tube (VDLT)
Intervention description: Participant receives non-video double lumen tube (DLT) placement before surgery.; Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.; Participant receives video double lumen tube (VDLT) placement before surgery.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Surgical Procedure; Fiberoptic bronchoscopy; FOB; Non-Video Double Lumen Tube; DLT; Video Double Lumen Tube; VDLT

Summary:

      The goal of this clinical research study is to learn how often a fiberoptic bronchoscopy (FOB
      -- also known as a fiberoptic scope procedure) needs to be used with a video double lumen
      tube (VDLT) during surgeries that require lung isolation. On this study, you will have one of
      2 types of commonly-used breathing tubes used, either a VDLT or a non-video double lumen tube
      (called a non-video DLT). An FOB may or may not be performed, as described below.

      The level of effectiveness of the VDLT and non-video DLT will be compared.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients need lung isolation for purposed surgery

          2. 18 years or older

          3. All patients to give written informed consent to participate

        Exclusion Criteria:

          1. Patient with known tracheobronchial anatomical anomalies

          2. Patient requiring emergency operations

          3. Patients with known difficult airways

          4. Patients where other lung isolation devices may be warranted (tracheostomy, nasal
             intubation)

          5. Patient requiring sizes not available in DLT or VDLT

          6. Patients requiring a right sided VDLT or DLT
Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Danoprevir; Ritonavir; peginterferon alfa-2a; RBV
Intervention description: Danoprevir (DNV)administered orally 100mg BID for 12 weeks;; Ritonavir administered orally 100mg BID for 12 weeks;; PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;; RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
Intervention MeSH terms: Ritonavir; Peginterferon alfa-2a; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Danoprevir; non-cirrhotic; Chinese HCV G1; SVR12

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08
      (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients
      Who Have Chronic Hepatitis Genotype 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Chronic HCV infection (≥ 6 months)

          -  Serum HCV RNA of ≥ 1 × 104 IU/mL are documented

          -  Hepatitis C virus GT1

          -  Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or
             host-targeting antivirals for HCV

          -  Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa
             during screening period, or liver biopsy determined 1 year before recruiting (Metavir
             score ˂ 3);(2) during screening period 9.6<Fibroscan indicator ≤12.9, liver biopsy
             need to confirm non-cirrhosis.

          -  Others as specified in the detailed protocol

        Exclusion Criteria:

          -  Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for
             liver cirrhosis patients

          -  Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's
             disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)

          -  History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients
             before or during screening , or imaging studies found suspicious nodules, or AFP > 50
             ng/mL

          -  Positive hepatitis A antibody，positive hepatitis B surface antigen，HIV antibody

          -  Presence or history of nervous system diseases and/or mental illness, inability to
             control oneself or express oneself.

          -  Patients with obvious cardiovascular dysfunction

          -  Pregnant or nursing female, nor unwilling to take reliable contraception

          -  Others as specified in the detailed protocol
Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: autologous hematopoietic stem cell transplantation; leukapheresis
Intervention description: Patients undergo autologous stem cell transplantation; Stem cells collected
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: noncontiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; recurrent adult diffuse large cell lymphoma

Summary:

      RATIONALE: It is not yet known which method of stem cell collection is best for patients
      undergoing an autologous stem cell transplant.

      PURPOSE: This randomized phase III trial is comparing two different methods of collecting
      stem cells in patients undergoing stem cell transplant for diffuse large cell lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of diffuse large cell lymphoma

               -  Low-grade non-Hodgkin lymphoma transformed to diffuse large cell lymphoma allowed

          -  Candidate for with autologous peripheral blood stem cell transplantation

               -  Not requiring bone marrow harvest to collect stem cells

               -  No chemotherapy with filgrastim ( G-CSF) or mobilization study drug (i.e.,
                  AMD3100) needed for mobilization of stem cells

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Cardiac and pulmonary status sufficient to undergo apheresis and stem cell
             transplantation

          -  Negative pregnancy test

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No active uncontrolled infection requiring antibiotic treatment

          -  No comorbid condition which, in view of the investigators, renders the patient at high
             risk from treatment complications

          -  Willing to provide all research blood samples as required by the protocol

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior chemotherapy (rituxan is not considered chemotherapy for
             the purpose of this study)

          -  More than 4 weeks since prior experimental therapy

          -  No concurrent enrollment on another experimental protocol during the mobilization
             phase

          -  No concurrent participation in any autologous stem cell transplantation study that is
             not using the standard conditioning regimens for lymphomas
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
Condition: Contraception
Intervention: AG200-15 (cycles 1-13); Lessina crossover to AG200-15
Intervention description: AG200-15 containing ethinyl estradiol and levonorgestrel; Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1504.0
Sex: Female
Minimum age: 17 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraceptive

Summary:

      The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal
      contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy females

          -  17(in states where the legal age of consent to receive contraceptives is 17)-40 years

          -  Regular, consistent menstrual cycles between 25 and 35 days

          -  Sexually active women requesting birth control

          -  In good general health, confirmed by medical history, physical (including gynecologic)
             examination and screening laboratory values

        Exclusion Criteria:

          -  Known or suspected pregnancy;

          -  Lactating women

          -  Significant skin reaction to transdermal preparations or sensitivity to surgical /
             medical tape

          -  Any disease that may worsen under hormonal treatment (cardiovascular, liver,
             metabolic)

          -  Use of other contraceptive methods than study medication
Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome
Condition: Genetic Disorder; Noonan Syndrome
MeSH terms: Dwarfism; Noonan Syndrome; Genetic Diseases, Inborn; Syndrome
Intervention: somatropin
Intervention description: Administered subcutaneously (s.c., under the skin) in a daily regimen for at least 104 weeks. Subject will be offered to continue treatment for another 104 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 3 Years
Maximum age: 10 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of the trial is to investigate the long-term
      efficacy and safety of two doses of NN-220 (somatropin) in short stature due to Noonan
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese children with Noonan syndrome clinically diagnosed in one of the following
             ways: 1. Clinically diagnosed by at least two medical experts using van der Burgt
             score list, 2. Clinically diagnosed by one medical expert using van der Burgt score
             list and diagnosed by result of genetic testing for Noonan syndrome, 3. Clinically
             diagnosed by one medical expert using van der Burgt score list and diagnosed by the
             same medical expert based on the results of centralised evaluation of facial change
             using van der Burgt score list

          -  Height SDS (standard deviation score): -2 SDS or below (according to the Japanese
             reference data)

          -  Age: boys 3 to below 11 years, girls 3 to below 10 years

          -  Height records must be available within the period between 40 and 64 weeks prior to
             Visit 1 (screening)

          -  Prepubertal children (definition for girls breast and pubes of Tanner stage is I, and
             none of menses, and for boys testicular volume below 4 mL, and pubes and penis of
             Tanner stage is I)

        Exclusion Criteria:

          -  Children with known or suspected hypersensitivity against human growth hormone (hGH)
             or related products (including any components of the trial products)

          -  Children with diabetic type diagnosed with the Japanese Diabetes Society
             Classification

          -  Children with history or presence of active malignancy

          -  Children who have received GH (growth hormone) treatment

          -  Children who have received systemic administration of the following medications within
             two years prior to Visit 1 (screening): Thyroid hormone (except replacement therapy),
             antithyroid hormone, androgen, oestrogen, progesterone, anabolic steroid,
             adrenocortical steroid treatment period for at least 13 weeks), derivative of
             gonadotropin releasing hormone and somatomedin C (IGF-I)