bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
Condition: Nasopharyngeal Cancer
MeSH terms: Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
Intervention: Zometa (zoledronic acid)
Intervention description: Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic
      treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy
      variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal
      patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic
      treatment alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18, either sex

          -  Histologically confirmed stage IV nasopharyngeal cancer

          -  One bone metastasis at least confirmed by imaging

          -  without chemotherapy or radiotherapy after bone metastasis

          -  Life expectancy > 6 M

          -  ECOG <= 2

          -  Adequate bone marrow reserve (WBC > 3.5 x 109/L, Neutrophile > 1.5 x 109/L, Platelet
             100 x 109/L, Hb > 90 g/L)

          -  Serum creatinine< 2.0 mg/dL (< 1.5 times the upper limit of the normal range for the
             laboratory of the study center)

          -  Signed ICF

        Exclusion Criteria:

          -  Women who are pregnant or in lactation

          -  Patients with hyperostosis

          -  Systemic treatment for another cancer within the year prior to study entry

          -  Previous or current treatment with any other bisphosphonates, bone- protecting,
             cytotoxic or targeted therapy

          -  Initial serum creatinine >265 micromol/L and/or progressive renal disease

          -  Known hypersensitivity to any of the study drugs or to drugs with similar chemical
             structures

          -  Use of investigational agents within 28 days of the Baseline visit, or participating
             simultaneously in any other clinical studies

          -  Severe co-morbidity of any type that may interfere with assessment of the patient for
             the study
Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: Meningococcal ABCWY; Placebo
Intervention description: One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1); One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 10 Years
Maximum age: 19 Years
Healthy volunteers: No

Summary:

      This is extension of the V102_16 study (NCT02140762). V102_16E1 is designed to assess the
      effectiveness of a 3-dose vaccination series of MenABCWY, administered according to 0, 2, 6
      month schedule, against the same panel of endemic US N. meningitidis serogroup B strains, as
      measured by enc-hSBA assay. The subjects who completed the parent V102_16 study will be
      invited at the time of their last study visit to participate in this extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adolescents who completed V102_16 study and received the study vaccines as assigned in
             the protocol (either two doses of the MenABCWY or one dose each of MenACWY and
             Placebo).

        Exclusion Criteria:

          -  Serious, acute, or chronic illnesses. Previous or suspected disease caused by N.
             meningitidis.

          -  History of any meningococcal vaccine administration other than vaccination given in
             the parent V102_16 protocol.
Efficacy and Safety of Zoledronic Acid in Acute Spinal Cord Injury: Prevention of Bone Loss
Condition: Bone Loss
MeSH terms: Bone Diseases, Metabolic; Spinal Cord Injuries
Intervention: zoledronic acid; placebo
Intervention description: zoledronic acid, 5mg, iv; iv
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: spinal cord injury; osteoporosis; bone loss; zoledronic acid; bisphosphonate

Summary:

      This is a double-blind, randomized, placebo-controlled trial of zoledronic acid, 5mg, to be
      administered intravenously to people who have suffered an acute spinal cord fracture. The
      goal is to evaluate if zoledronic acid can prevent the acute bone loss seen in this
      population. Outcome measures will include bone density determinations over a one year period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women

          2. Age 18 years and older

          3. Spinal cord injury within 8 weeks of study entry

          4. ASIA AIS A or B

          5. Medically stable in the opinion of their physiatrist

          6. Able to have dexa performed

          7. Able to return for follow-up at 6 and 12 months

        Exclusion Criteria:

          1. Vitamin D deficiency

          2. Hypocalcemia

          3. Renal insufficiency (estimated creatinine clearance <30ml/min)

          4. Abnormal thyroid hormone status

          5. Abnormal mental status

          6. Osteoporosis at the hip or spine by dexa
Examining the Use of Non-Invasive Inhaled Nitric Oxide to Reduce Chronic Lung Disease in Premature Newborns
Condition: Bronchopulmonary Dysplasia
MeSH terms: Lung Diseases; Bronchopulmonary Dysplasia; Premature Birth
Intervention: Inhaled Nitric Oxide (iNO); Nitrogen (placebo)
Intervention description: iNO will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).; Nitrogen will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx).
Intervention MeSH terms: Nitric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 124.0
Sex: All
Maximum age: 72 Hours
Healthy volunteers: No
Keywords: Premature Newborns; Inhaled Nitric Oxide

Summary:

      Bronchopulmonary dysplasia (BPD) is a serious lung condition that affects premature newborns.
      The condition involves abnormal development of lung tissue and is characterized by
      inflammation and scarring in the lungs. Treatment with inhaled nitric oxide (iNO) may reduce
      the incidence of BPD and another commonly associated condition called pulmonary hypertension,
      which is high blood pressure in the vessels carrying blood to the lungs.. This study will
      determine if early treatment with low-dose iNO reduces the incidence of BPD, pulmonary
      hypertension, and death in premature newborns.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Birth weight of 500-1250 grams and gestational age of less than 34 weeks

          -  Age at enrollment is less than 72 hours

          -  Supplemental oxygen or 21% requirement by nasal cannula or NCPAP only

        Exclusion Criteria:

          -  Presence of structural heart disease (other than patent ductus arteriosus, atrial
             septal defect less than 1 cm, or muscular ventricular septal defect less than 2 mm)

          -  Presence of lethal congenital anomaly

          -  Participating in another concurrent experimental study

          -  Requires mechanical ventilation in the first 72 hours of life (patients are not
             excluded if they are intubated briefly but they must be extubated at the time of
             consent and study entry prior to 72 hours of life)
A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Erlotinib, escalating dose; Erlotinib, standard dose; Gemcitabine
Intervention description: 100mg, PO, once daily, escalating to a maximum of 250mg, PO, once daily; 100mg, PO, once daily; 1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy and safety of escalating versus standard doses to rash
      of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer.
      During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus
      gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not
      developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1
      will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2
      weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other
      dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients
      will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle.
      The anticipated time on study treatment is until disease progression, and the target sample
      size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  histologically or cytologically confirmed pancreatic cancer with measurable or
             non-measurable metastatic disease;

          -  ECOG performance status of 0-1.

        Exclusion Criteria:

          -  local, or locally advanced, pancreatic cancer;

          -  prior systemic treatment for metastatic pancreatic cancer;

          -  <=6 months since last adjuvant chemotherapy;

          -  other malignancies within last 5 years, except for adequately treated cancer in situ
             of the cervix, or basal or squamous cell skin cancer.
Trial of Sertraline to Treat Children With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Intervention: Sertraline; Placebo
Intervention description: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.; The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.
Intervention MeSH terms: Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 24 Months
Maximum age: 68 Months
Healthy volunteers: No
Keywords: Fragile X Syndrome; Pediatrics; sertraline; autism

Summary:

      This study is a control trial of sertraline (Zoloft) in fragile X syndrome children aged 2
      years to 5 years 8 months old. The trial is six months long, and each participant will
      receive a series of tests at both the beginning and end of the study. The researchers hope to
      show improvements in language and a decrease in autistic symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fragile X Syndrome

        Exclusion Criteria:

          -  Current or past SSRI treatment

          -  Current or past MAOI (monoamine oxidase inhibitor ) treatment

          -  Serious co-morbid medical disorder affecting brain function and behavior (not
             including fragile X syndrome).

          -  Uncontrolled seizure disorder or epilepsy

          -  Bipolar disorder

          -  Latex allergies
Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Panobinostat
Intervention MeSH terms: Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate; Cancer; Adenocarcinoma; Prostate-Specific Antigen; metastatic; male; HRPC; DACi

Summary:

      This Phase II single dose study was designed to characterize the safety, tolerability, and
      efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants with
      hormone refractory prostate cancer.
    

Eligibility criteria:

        Inclusion criteria:

          -  Confirmed diagnosis of adenocarcinoma of the prostate

          -  Participants with metastatic hormone refractory prostate cancer

          -  Participants that have had at least one, but not more than two prior cytotoxic
             treatments for prostate cancer

          -  Evidence of disease progression by at least one of the following:

               1. two or more lesions on bone scan

               2. progressive measurable disease

               3. two documented increases in prostate-specific antigen (PSA)

          -  Willing to use contraception throughout the study and for 12 weeks after study
             completion

        Exclusion criteria:

          -  History or clinical signs of central nervous system (CNS) disease

          -  History of other cancers not curatively treated with no evidence of disease for more
             than 5 years

          -  Prior radiotherapy within 3 weeks of starting study treatment

          -  Prior radiopharmaceuticals (strontium, samarium)

          -  Impaired cardiac function

          -  Heart disease

          -  Liver or renal disease with impaired function

        Other protocol-defined inclusion/exclusion criteria may apply.
A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: SHR0302; Placebo
Intervention description: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a Janus kinase inhibitor).; Placebo Oral Tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II
      study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe
      active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time
      needed to induce clinical response in active ulcerative colitis patients.

      This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment
      phase, will have the option to enter a blinded active arms 8-week extension phase. Early
      withdrawn subjects during the first treatment phase can not enter the extension phase. The
      total duration of the study participation, including extension and follow-up, will be
      approximately 18 weeks.

      SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal
      transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation.
      Therefore it has the potential to be a treatment for ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female subject age ≥ 18 and ≤75 years of age at randomization.

          -  Active ulcerative colitis with a 9-point modified Mayo score of 5 to 9 points and
             endoscopic subscore of 2 to 3 (The duration of the time between endoscopy and baseline
             should not exceed 10 days and allow central over read turn over before randomization).

          -  Subject should have at least three-month history of Ulcerative Colitis diagnosis at
             randomization.

        Exclusion Criteria:

          -  Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's
             disease.

          -  Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or
             less).

          -  Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure
             to treatment).
Evaluation the Treatment of Tamoxifen of Low/Intermediate Risk Bladder Tumors
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: Tamoxifen Citrate
Intervention description: Single-center, two-stage phase-II clinical trial (Simon design)
Intervention MeSH terms: Tamoxifen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Tamoxifen citrate; Bladder Cancer

Summary:

      Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors
    

Eligibility criteria:

        Inclusion Criteria:

        Males and females age 21 or older. Histologic evidence of urothelial carcinoma of the
        bladder. Low/Intermediate-risk papillary urothelial carcinoma of the bladder, at initial
        occurrence or recurrent with >6 months interval free of disease.

        Patients with multifocal tumors must have resectable lesions. Patients may be
        treatment-naïve or have failed 1 previous regimen of intravesical therapy.

        At least one endoscopically measurable tumor 6 - 10mm in diameter. Adequate hepatic and
        renal function. Patient or authorized proxy needs to have signed the informed consent form.

        -

        Exclusion Criteria:

        Patients with sessile appearing tumors, which may be invasive or high-grade. Diagnosis of
        urothelial carcinoma involving the prostatic urethra or upper urinary tract.

        Plans for pelvic radiation while participating in the study. Concurrent use of warfarin,
        heparin, or chronic use of NSAIDs, including aspirin (other than cardioprotective doses of
        80mg daily) within 30 days prior to registration or during the trial.

        Concurrent use of selective serotonin reuptake inhibitors or aromatase inhibitors.

        Chronic or acute renal or hepatic disorder or any other condition, medical or psychological
        that, in the opinion of the investigator, could jeopardize the subject's safe
        participation.

        Any other investigational drug within 30 days prior to registration and during the study.

        Women Exclusion Pregnant or lactating women. Personal history of endometrial cancer or any
        abnormal uterine bleeding. Previous or concurrent treatment with SERM and/or hormonal
        replacement therapy within 3 months of the study.

        -
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: dorzolamide-timolol-brimonidine
Intervention description: Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will received 1 drop twice a day of either formulations.
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Dorzolamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Open-angle glaucoma; Ocular hypertension; POAG; Treatment

Summary:

      To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects of either sex and any race with open-angle glaucoma or ocular
             hypertension;

          -  Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).

        Exclusion Criteria:

          -  Clinically relevant ophthalmic or systemic conditions may be excluded.