bioihbjkbjnl/mcl2 huggingface dataset:
Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
Condition: Metastatic Castration-resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: olaparib; enzalutamide; abiraterone acetate; abiraterone acetate; enzalutamide
Intervention description: 300 mg (2x 150 mg tablets) twice daily; 160 mg (4 x 40 mg capsules) once daily; 1,000 mg (4 x 250 mg tablets) once daily; 1,000 mg (2 x 500 mg tablets) once daily; 160 mg (4 x 40 mg tablets) once daily
Intervention MeSH terms: Olaparib; Abiraterone Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 387.0
Sex: Male
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: metastatic castration-resistant prostate cancer (mCRPC); homologous recombination repair (HRR)

Summary:

      The purpose of this study is to evaluate the efficacy and safety of olaparib versus
      enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate
      cancer who have failed prior treatment with a new hormonal agent and have homologous
      recombination repair gene mutations.
    

Eligibility criteria:

        Inclusion criteria

          1. Histologically confirmed diagnosis of prostate cancer.

          2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC).

          3. Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate
             and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .

          4. Ongoing therapy with LHRH analog or bilateral orchiectomy.

          5. Radiographic progression at study entry while on androgen deprivation therapy (or
             after bilateral orchiectomy).

          6. Qualifying HRR mutation in tumor tissue.

        Exclusion criteria

          1. Any previous treatment with PARP inhibitor, including olaparib.

          2. Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy,
             except if for non-prostate cancer indication and last dose > 5 years prior to
             randomization.

          3. Other malignancy (including MDS and MGUS) within the last 5 years except: adequately
             treated non-melanoma skin cancer or other solid tumors curatively treated with no
             evidence of disease for ≥5 years.

          4. Subjects with known brain metastases.
LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Condition: Cataract; Pain; Ocular Inflammation
MeSH terms: Cataract; Inflammation
Intervention: Loteprednol Etabonate Ophthalmic Gel dosed TID; Loteprednol Etabonate Ophthalmic Gel dosed BID; Vehicle Gel
Intervention description: Gel; Gel; Gel
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of
      Ocular Inflammation and Pain Following Cataract Surgery.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and with
             the capacity to provide voluntary informed consent.

          2. Be able to read, understand, and provide written informed consent on the Institutional
             Review Board (IRB)/Ethics Committee (EC) approved ICF and provide Health Insurance
             Portability and Accountability Act (HIPAA) authorization.

          3. Be willing and able to comply with all treatment and follow-up/study procedures.

          4. Be a candidate for routine, uncomplicated cataract surgery (phaco-emulsification with
             posterior chamber intraocular lens [IOL] implantation, not combined with any other
             surgery).

          5. In the Investigator's opinion, have potential postoperative pin-holed Snellen visual
             acuity (VA) of at least 20/200 in the study eye at Visit 1 (Screening) and at least
             20/200 in the fellow eye.

        Key Exclusion Criteria:

          1. Have a severe/serious ocular condition or history/presence of chronic generalized
             systemic disease that the Investigator feels might increase the risk to the subject or
             confound the result(s) of the study.

          2. Be a female subject who is pregnant or breastfeeding.

          3. Be monocular (fellow eye is nonfunctional or fellow eye's pinhole vision is worse than
             Snellen 20/200).

          4. Have had ocular surgery (including laser surgery) in the study eye within 3 months or
             in the fellow eye within 2 weeks prior to Visit 1 (Screening).
The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
Condition: Chronic Renal Insufficiency; Proteinuria
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Proteinuria
Intervention: Vitamin D; Placebo
Intervention description: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months; Patients randomized to this arm will receive one placebo pill once weekly.
Intervention MeSH terms: Vitamin D
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin D; CKD; proteinuria

Summary:

      A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney
      Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney
      damage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18 years

          -  Ability to provide informed consent

          -  Chronic kidney disease stage 3 and 4

          -  On ACE inhibitor or ARB for albuminuria if tolerated

          -  Assessed during eligibility screen:

          -  Albuminuria >30 mg/g creatinine

          -  25(OH) vitamin D level >12.5 and <75 nmol/L

        Exclusion Criteria:

          -  On vitamin D in past 4 weeks

          -  Plans to relocate out of New York City in the next 6 months

          -  25 (OH) Vitamin D level <12.5 nmol/L

          -  HIV infection

          -  History of hypercalcemia or kidney stones

          -  Serum phosphate >5.5 mg/dl in past 3 months

          -  Serum calcium >10.0 mg/dl in past 3 months

          -  SBP >160 DBP >100 at screening visit

          -  Transplanted organ

          -  Cancer

          -  Polycystic kidney disease

          -  Rapidly deteriorating kidney function with the expectation for initiation of dialysis
             in less than 6 months
Enhancement of Corticosteroid Efficacy in COPD
Condition: COPD
Intervention: Theophylline; Roflumilast
Intervention description: Oral; Oral
Intervention MeSH terms: Theophylline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      This is a pilot study designed to evaluate the effects of theophylline and roflumilast on
      circulating Histone deacetylase (HDAC) levels in subjects with COPD, and the bronchodilator
      effects of corticosteroids. Studies will be performed in 10 subjects with COPD nonresponsive
      to bronchodilators. Subjects will receive theophylline tablets for 1 week, followed by
      measurement of circulating HDAC and the acute effect of oral prednisone on the bronchodilator
      response to inhaled beta agonist. Roflumilast tablets will be added to the theophylline for a
      further week and the studies repeated. The study will provide preliminary data on the effects
      of theophylline and roflumilast on circulating HDAC levels and the effects of corticosteroids
      on the beta agonist bronchodilator response in COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of COPD with FEV1 <60% predicted

          -  FEV1/FVC <70% and <+15% FEV1 response to bronchodilator.

          -  Patients of both genders will be included.

          -  IRB approved written informed consent will be obtained from each subject.

        Exclusion Criteria:

          1. Recent (<1 month) exacerbation of COPD,

          2. Known hypersensitivity to beta agonists, theophylline, steroids, or roflumilast.

          3. Current or recent (<2 weeks) treatment with oral steroids, theophylline or other
             methylxanthines, or roflumlast.

          4. Diagnosis or history of asthma, uncontrolled hypertension, or congestive heart
             failure.

          5. History of Cardiac arrhythmia

          6. History of seizures.

          7. History of Liver disease

          8. Gastrointestinal disease, including history of peptic ulcer disease.

          9. Current infection or antibiotic treatment.

         10. History of depression or psychiatric disease.
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate Hydrochloride Extended Release Capsules; Placebo
Intervention description: Biphentin Methylphenidate ER Once-A-Day Capsules; Placebo capsules
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 230.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: inattention; impulsivity; hyperactivity; ADHD

Summary:

      This multi-center parallel study is designed to study the efficacy and safety of fixed doses
      of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo
      group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are
      between 6 and 18 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ages 6 up to 18

          -  ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile

          -  In need of treatment for ADHD and able to have 2-day washout from previous medication

          -  Females of child-bearing potential not pregnant and practice birth control

          -  Subject and parent/guardian willing to comply with protocol

          -  Signed consent and assent

        Exclusion Criteria:

          -  Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of
             Intelligence (WASI)

          -  Current primary psychiatric diagnosis of other listed disorders

          -  Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family
             history of sudden death, glaucoma

          -  Use of psychotropic central nervous system (CNS) meds having effect exceeding 14 days
             from screening

          -  Planned use of prohibited drugs

          -  Is pregnant or breast-feeding

          -  Significant ECG or laboratory abnormalities

          -  Experimental drug or medical device within 30 days prior to screening

          -  Hypersensitivity to methylphenidate

          -  Inability or unwillingness to comply with protocol

          -  Well controlled on current ADHD treatment

          -  Inability to take oral capsules
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab; Ipilimumab
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 533.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effects of combination treatment of Nivolumab
      with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated
      advanced Melanoma.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Potential subjects must have advanced Melanoma (stage III or IV as confirmed by
             biopsy) with spread to other sites in the body and unable to be removed by surgery.

          -  Potential subjects must be newly diagnosed with advanced melanoma and received no
             treatment for the advanced disease.

        NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1,
        anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell
        costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was
        used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs
        must be discontinued 6 months prior to study entry and the side effects related to the
        prior therapy resolved.

          -  Potential subjects (with disease spread to brain) who previously received primary
             treatment are permitted if there was no evidence of disease as confirmed by the MRI
             (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the
             first dose of the study drug). Potential subjects must not have received intravenous
             steroid treatment (>10 mg/day) intravenously for at least 2 weeks prior to study drug
             administration.

        Exclusion Criteria:

          -  Leptomenigeal metastases

          -  Subjects with autoimmune disease. Subjects with Type I diabetes mellitus,
             hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo,
             psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected
             to recur in the absence of an external trigger are permitted to enroll.

          -  All side effects from previous primary treatments other than alopecia, fatigue, or
             peripheral neuropathy must have resolved to Grade 1 or baseline before administration
             of study drug.
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: OPC-61815 injection
Intervention description: Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once
      daily for a maximum of 5 days to CHF patients with volume overload despite having received
      diuretics (injection) other than vasopressin antagonists and who have difficulty with or are
      incapable of oral intake.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients receiving loop diuretic injection at a dose equivalent to furosemide 20
             mg/day or higher

          -  CHF patients in whom lower limb edema, pulmonary congestion, and/or jugular venous
             distension due to volume overload is present

          -  Patients who are judged by the investigator or subinvestigator to have difficulty or
             be incapable of oral intake, including patients who are judged by the investigator or
             subinvestigator to require nothing by mouth(NPO) management

          -  Patients who are currently hospitalized or who are capable of being hospitalized from
             the time of informed consent until the end of the treatment period

          -  Patients who are capable of giving informed consent

        Exclusion Criteria:

          -  Patients who are on a ventricular assist device

          -  Patients who have difficulty with spontaneous respiration or who have been on tracheal
             intubation under sedative therapy

          -  Patients with severe disturbed consciousness (ie, coma or stupor)
Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children
Condition: Spinal Puncture
MeSH terms: Wounds and Injuries
Intervention: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg; Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg
Intervention description: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.; Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
Intervention MeSH terms: Remifentanil; Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Lumbar Puncture; Pediatrics; Propofol; Remifentanil; sedation; Oncology

Summary:

      The objective of this study is to compare intraoperative and recovery parameters in patients
      who receive two different dose combinations of propofol and remifentanil in patients
      undergoing a lumbar puncture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of a hemato-oncological disorder

          -  Scheduled to undergo a lumbar puncture

          -  Aged 3-12 years

          -  Unpremedicated

        Exclusion Criteria:

          -  children who are known or suspected to be difficult to ventilate by face mask

          -  children who are deemed medically unfit to receive either of the two study medications

          -  children who are obese (weight for height > 95th percentile)

          -  children who do not have an indwelling intravenous line
Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: GnRHa
Intervention description: 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.
Intervention MeSH terms: Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 345.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: GnRHa; ovarian function; anti-mullerian hormone

Summary:

      This prospective randomized controlled study is conducted to analyze the effect of Goserelin
      on ovarian function in women with breast cancer in China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women 18 to 49 years of age are eligible for enrollment

          -  Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant
             or neoadjuvant cyclophosphamide-containing chemotherapy was planned.

          -  Eligible participants had taken no estrogens, antiestrogens, selective
             estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within
             the month before enrollment.

          -  Human chorionic gonadotropin negative by urine test before entering the group.

          -  Informed consent, understanding and compliance with the requirements of the study.

          -  No significant chronic disease and any organ dysfunction.

        Exclusion Criteria:

          -  Exceptions were made for the use of hormonal contraception in women younger than 35
             years of age that was discontinued before randomization.

          -  Use of hormonal treatment for up to 2 months for the purposes of in vitro
             fertilization and cryopreservation of embryos or oocytes before randomization.

          -  Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation
             were excluded.

          -  Patients received previous adjuvant endocrine therapy for breast cancer are not
             suitable to this trial.

          -  Patients with uterine and/or adnexal diseases needing medical or surgical treatment
             are not suitable.

          -  Allergic to active or inactive excipients of GnRHa is an exclusion criterion.