bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Pulmozyme in Infants With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Recombinant Human DNase (Pulmozyme); Placebos
Intervention description: 2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months with 3 ml diluent placebo delivered by nebulization given daily for 6 months; 2.5 ml sterile solution (8.77 mg/ml sodium chloride, 0.15 mg/ml calcium chloride, pH 7.0 +/- 2.0) delivered daily by nebulization for 6 months, either preceding or following 6 months of Pulmozyme depending on randomization of the subject
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 1 Month
Maximum age: 30 Months
Healthy volunteers: No
Keywords: Cystic fibrosis; Infants; Children; Pulmozyme; Pulmonary function; Computed tomography

Summary:

      This is a study to find out whether Pulmozyme is effective for clearing mucus from the
      airways of children with cystic fibrosis less than 3 ½ years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 30 months

          -  Diagnosis of CF based on clinical features consistent with CF as well as 1 of the 2
             following criteria: a) two sweat chlorides >60 mEq/L (by quantitative pilocarpine
             iontophoresis), b) genotype with 2 identifiable mutations consistent with CF.

          -  Informed consent by parent or legal guardian

        Exclusion Criteria:

          -  Previous treatment with Pulmozyme

          -  Hospitalization or treatment with IV antibiotics with 14 days of initial study visit

          -  Acute intercurrent respiratory infection, defined as any of the following symptoms
             within the preceding 48 hours: 1) fever > 38 degrees C, 2) new onset of coryza or
             other upper respiratory symptoms, 3) increase in cough, wheezing, or respiratory rate

          -  History of adverse reaction to sedation

          -  Oxyhemoglobin saturation <90% on room air

          -  Severe upper airway obstruction as determined by site PI (severe laryngomalacia,
             markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea)

          -  Hemodynamically significant congenital heart disease or diagnosed arrhythmias

          -  History of hemoptysis

          -  History of previous pulmonary air leak (pneumothorax)

          -  Diagnosed seizure disorder necessitating current anticonvulsive therapy. A history of
             febrile seizures is not an exclusion criterion.

          -  Use of Investigational drug(s) within 60 days or 5 half-lives of enrollment in this
             study.

          -  Known allergy to Chinese Hamster Ovary-derived biological products or any component of
             the placebo or active drug formulations.
Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: systemic chemotherapy; axillary lymph node dissection; neoadjuvant therapy; sentinel lymph node biopsy; therapeutic conventional surgery; ultrasound imaging
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 756.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy
      before surgery may make the tumor smaller and reduce the amount of normal tissue that needs
      to be removed.

      PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and
      axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage
      IIIB breast cancer.
    

Eligibility criteria:

        Eligibility Criteria:

          1. ≥ 18 years old

          2. ECOG/Zubrod Performance Status 0-1

          3. Female. Note: Men are excluded from this study because the number of men with breast
             cancer is insufficient to provide a statistical basis for assessment of effects in
             this subpopulation of people with breast cancer.

          4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding
             inflammatory breast cancer).

          5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time
             of diagnosis and prior to preoperative chemotherapy.

          6. Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients
             enrolling on studies involving preoperative chemotherapy (through cooperative groups
             or institutional studies) may be eligible for this study, provided sentinel node
             surgery prior to preoperative chemotherapy was not required in the other studies.

          7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or
             treatment of hidradenitis.

          8. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of
             axillary status.
Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: JBT-101 (lenabasum); Placebo
Intervention description: Subjects will receive JBT-101 1 mg qd or JBT-101 5 mg qd on Days 1-28. Subjects will receive either JBT-101 20 mg q am (with placebo q pm) or JBT-101 20 mg twice a day on Days 29-84.; Subjects will receive placebo once a day on Days 1-28, placebo q pm on Days 29-84 (with JBT-101 20 mg q am), or placebo bid on Days 29-84.
Intervention MeSH terms: Lenabasum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: JBT-101, Lenabasum, Cystic Fibrosis

Summary:

      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent
             with the CF phenotype and 1 or more of the following criteria:

               1. Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine
                  iontophoresis test;

               2. Two well-characterized mutations in the CFTR gene

          -  FEV1 ≥ 40% predicted corrected

          -  Stable treatment of CF for 14 days before Visit 1

        Exclusion Criteria:

          -  Severe or unstable CF, such as:

               1. Intravenous antibiotic treatment within 14 days before Visit 1

               2. Treatment with any corticosteroids > 10 mg per day or > 20 mg every other day
                  oral prednisone or equivalent within 14 days before Visit 1

          -  Any one of the following values for laboratory tests at Screening:

               1. A positive pregnancy test (or at Visit 1);

               2. Hemoglobin < 10 g/dL

               3. Neutrophils < 1.0 x 10~9/L

               4. Platelets < 75 x 10~9/L

               5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation

               6. Serum transaminases > 2.5 x upper normal limit

               7. Total bilirubin ≥ 1.5 x upper limit of normal

          -  Any other condition that, in the opinion of the Principal Investigator, is clinically
             significant and may put the subject at greater safety risk, influence response to
             study product, or interfere with study assessments.
Robots Paired With tDCS in Stroke Recovery
Condition: Stroke
MeSH terms: Stroke
Intervention: Transcranial Direct Current Stimulation (tDCS); Placebo sham
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stroke; Cerebrovascular Accident; Cerebral Stroke; CVA; Robotic therapy; Upper extremity recovery; tDCS; Non-invasive brain stimulation

Summary:

      The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct
      Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy
      lead to a greater functional recovery in upper limb mobility after stroke than that provided
      by robotic arm therapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  First single focal unilateral lesion with diagnosis verified by brain imaging, which
             occurred at least 6 months prior

          -  Cognitive function sufficient enough to understand experiments and follow instructions

          -  Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered
             motor function in the muscles of the shoulder, elbow, and wrist)

        Exclusion Criteria:

          -  Botox treatment within 6 weeks of enrollment

          -  Fixed contraction of the affected limb

          -  Complete flaccid paralysis of the affected limb

          -  History of hemorrhagic stroke

          -  Ongoing use of CNS active medications

          -  Ongoing use of psychoactive medications

          -  Presence of additional potential tDCS/TMS risk factors including damaged skin at site
             of stimulation, presence of a magnetically/mechanically active implant, metal in the
             head, family history of epilepsy, and personal history of seizures
Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
Condition: Pain
Intervention: Lactated Ringers; Triamcinolone hexacetonide
Intervention description: Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.; 1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: facial pain; temporomandibular joint; arthrocentesis; steroid

Summary:

      The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid
      injection is more efficacious than a placebo injection based on standard pain and physical
      measures that are recorded before and after treatment.

      All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical
      care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing
      followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this
      is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc
      (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A
      pregnancy test (urine test) will be conducted on all women of child-bearing age to verify
      that the patient is not pregnant before the rinsing procedure. The patient will fill out a
      short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  18-80 years of age

          -  TMJ arthralgia

          -  Masticatory myalgia

          -  TMJ sounds

          -  History of at least 6 weeks use of occlusal appliance therapy

        Exclusion Criteria:

          -  Contraindication to sedation including pregnancy or medical history

          -  History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy

          -  History of steroidal injection into TMJ

          -  History of trauma to TMJ

          -  TMJ pain longer than 3 years

          -  History of narcotic drug use on a scheduled basis

          -  Current active infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Condition: HCV Infection
MeSH terms: Hepatitis C
Intervention: LDV/SOF; RBV
Intervention description: Tablet(s) administered orally once daily; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: genotype 1

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin
      (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have
      participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve
      sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification
      (LLOQ) 24 weeks after last dose of study drug (SVR24).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Infection with HCV genotype 1

          -  HCV RNA > LLOQ at screening

          -  Participation in a prior Gilead-sponsored study

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

          -  Must be of generally good health, with the exception of chronic HCV infection, as
             determined by the Investigator

          -  Must be able to comply with the dosing instructions for study drug administration and
             able to complete the study schedule of assessments

        Key Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Co-infection with HIV or hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation (Groups 1 and 2 only)

          -  Hepatocellular carcinoma (HCC)

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Fostamatinib; Fostamatinib; Fostamatinib; Fostamatinib; Placebo
Intervention description: Fostamatinib 100mg twice daily for 12 weeks; Fostamatinib 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12; Fostamatinib 75mg twice daily for 12 weeks; Fostamatinib 50mg twice daily for 12 weeks; Placebo twice daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of the study is to evaluate the effectiveness of four dosing regimens of
      fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking
      methotrexate but not responding. The study will last for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 and over

          -  Active rheumatoid arthritis (RA) diagnosed after the age of 16

          -  6 or more swollen joints and 6 or more tender/painful joints from certain joints in
             the hands, wrists, arms and knees

          -  At least one of: positive result for rheumatoid factor test, either in the past or
             currently (blood test); x-ray showing bone erosion within the last 12 months; presence
             of certain antibodies in the blood (blood test)

          -  Currently taking methotrexate for at least 4 months (and on a stable dose for at least
             6 weeks)

        Exclusion Criteria:

          -  Females who are pregnant or breast feeding

          -  Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue
             diseases or chronic pain disorders.

          -  Previously taken, but not responded to, certain biological treatments for rheumatoid
             arthritis

          -  High blood pressure that is not controlled by medication

          -  Low levels of neutrophils in the blood (blood test).
A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
Condition: Liposarcoma; Leiomyosarcoma
MeSH terms: Leiomyosarcoma; Liposarcoma
Intervention: Yondelis; Yondelis; Dexamethasone; Dexamethasone
Intervention description: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle.; 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle.; Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle.; Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Trabectedin; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 271.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Trabectedin; Yondelis; ET-743; Ecteinascidin; Anthracycline; Ifosfamide; Dexamethasone; Intravenous; Cancer; Malignant; Metastatic

Summary:

      The purpose of this study is to test the safety and effectiveness of an investigational
      chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or
      leiomyosarcoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)

          -  Have a pathology specimen available for centralized review

          -  Have progressive or relapsed (reappearance of) disease, received treatment with
             anthracycline and/or ifosfamide before enrollment in study, and have at least one
             measurable tumor lesion

          -  Have adequate bone marrow, liver and kidney function

          -  Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Exclusion Criteria:

          -  Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)

          -  Cancer that has metastasized (spread) to the central nervous system

          -  Active viral hepatitis or chronic liver disease

          -  Unstable cardiac (heart) condition including congestive heart failure or angina
             pectoris (heart pain), myocardial infarction (heart attack) within 1 year before
             enrollment

          -  History of another neoplastic (malignant or nonmalignant tumor) disease (except basal
             cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5
             years or more before enrollment
Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: AGN-210669; bimatoprost; bimatoprost vehicle
Intervention description: AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.; bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.; bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
Intervention MeSH terms: Bimatoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared
      with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in
      patients with primary open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye

          -  Requires bilateral treatment with an IOP-lowering medication

          -  Best corrected visual acuity of 20/100 or better in each eye

        Exclusion Criteria:

          -  Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2
             months

          -  Inability to fast for up to 10 hours

          -  Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive
             keratectomy)

          -  Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6
             months

          -  Current or anticipated use of artificial tears or any ocular medications aside from
             study medications during study

          -  Anticipated wearing of contact lenses during study