bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: levocetirizine dihydrochloride; placebo
Intervention description: 5 mg daily (oral tablet) for 14 days; 0 mg daily (matching oral tablet) for 14 days
Intervention MeSH terms: Levocetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 580.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: levocetirizine; Xyzal; Seasonal Allergic Rhinitis; total symptom score; quality of life

Summary:

      The study objective is to investigate the efficacy of levocetirizine in reducing symptoms
      associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a history of SAR symptoms

          -  A positive skin prick test at least one grass allergen

          -  Moderate - severe SAR symptoms at baseline

          -  Women of childbearing potential must use a medically acceptable form of contraception

          -  80% compliance on run in study medication and 80% compliance on completing the diary

        Exclusion Criteria:

          -  The presence of any clinically significant comorbid disease which may interfere with
             the study assessments

          -  The presence of renal disease

          -  Pregnant or breastfeeding

          -  Subject is currently participating in another clinical trial

          -  Known hypersensitivity to piperazines or any of the excipients

          -  Intake of medications prohibited before the start of the trial

          -  Subjects who started or changed the dose of immunotherapy

          -  Rhinitis medicamentosa

          -  Subjects with a recent history (within the last 2 years) of drug or alcohol abuse
Treatment of Acute Hepatitis C Virus in HIV Co-Infection
Condition: Hepatitis C; Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; HIV Infections; Acquired Immunodeficiency Syndrome; Coinfection; Hepatitis
Intervention: Pegylated interferon alfa-2a + Ribavirin
Intervention description: Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C virus; Acute hepatitis C infection; HIV; HCV

Summary:

      This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV)
      infection during the first 6 months after acquiring HCV among people who already have
      pre-existing HIV infection will result in improved responses to HCV therapy with a shorter
      duration of infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly acquired HCV infection of 6 months or less duration

          -  Detectable HCV RNA at study entry

          -  HIV infection, any CD4 count

        Exclusion Criteria:

          -  Pregnant or intent to become pregnant within 24 weeks of study completion

          -  Uncontrolled depression

          -  Other serious liver disease

          -  Other safety parameters must be met
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Palbociclib; Letrozole
Intervention description: 125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles; 2.5 mg/d tablets orally on a continuous regimen
Intervention MeSH terms: Letrozole; Palbociclib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 252.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hormone receptor positive advanced breast cancer

Summary:

      A study of palbociclib in combination with letrozole as treatment of post-menopausal women
      with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole
      therapy is deemed appropriate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-menopausal women (>=18 years of age) with proven diagnosis of advanced carcinoma
             of the breast (ER(+) and/or PgR(+) and HER2(-)) who are appropriate for letrozole
             therapy (in the first-line advanced/metastatic disease setting).

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  Adequate bone marrow, liver, and renal function.

        Exclusion Criteria:

          -  Prior treatment with any CDK inhibitor .

          -  QTc >480 msec; history of QT syndrome, Brugada syndrome or known history of QTc
             prolongation, or Torsade de Pointes.

          -  High cardiovascular risk, including, but not limited to myocardial infarction,
             severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary
             embolism in the past 6 months of enrollment.
Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)
Condition: Osteoporosis; Bone Loss; Spinal Cord Injury
MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries
Intervention: teriparatide; weight-bearing
Intervention description: teriparatide 20ug daily sc for 6 months; device assisted walking
Intervention MeSH terms: Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Individuals with spinal cord injury sustain significant loss of bone mass in their lower
      extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two
      interventions that build bone, to increase bone mass in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-75 years

          2. Complete SCI - total loss of motor function below level of lesion

          3. Capable of positioning to have DEXA performed

          4. Capable of undertaking the weight-bearing exercise regime

          5. Capable of reading and understanding informed consent document

          6. Able to self-administer PTH or have someone in the family who can do so

          7. T score <-2.5 or Z score <-1.5 on evaluation of total hip BMD

          8. No known endocrinopathies

          9. Normal TSH levels

         10. Normal 25-OH vitamin D levels

         11. Normal calcium levels

         12. Normal renal function (creatinine <2.0mg/dl)

         13. Able to return for all follow-up visits

        Exclusion Criteria:

          1. Surgical or other intervention resulting in metal or anatomy precluding obtaining DEXA
             and/or MRI measurements

          2. Other medical conditions that in the opinion of the investigator would preclude the
             subject from completing the study

          3. History of malignancy

          4. History of radiation therapy

          5. Unable to self-administer PTH or have it administered

          6. Elevated liver function tests >2x normal

          7. For males, significantly abnormal free testosterone levels

          8. Currently being prescribed anti-convulsants

          9. Currently being prescribed glucocorticoids, other than inhaled glucocorticoids

         10. Currently being prescribed any bone-active agents, including any bisphosphonate,
             raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or
             strontium-containing compounds.

         11. No previous history of bisphosphonate use

         12. No previous use of other bone-specific agents during past 2 years
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
Condition: Hyperphosphatemia; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Hyperphosphatemia
Intervention: Tenapanor; Sevelamer Carbonate
Intervention description: NHE3 Inhibitor; Phosphate binder
Intervention MeSH terms: Sevelamer
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Healthy volunteers: No

Summary:

      The study is designed to evaluate the ability of tenapanor alone or in combination with
      sevelamer to achieve serum phosphorus concentration (sP) within the population reference
      range (sP >2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis
      with hyperphosphatemia (>4.5 mg/dL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must complete TEN-02-301 (PHREEDOM)

        Exclusion Criteria:

          1. Schedlued for kidney transplant

          2. Life expectancy <12 months
One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
Condition: Schizophrenia and Disorders With Psychotic Features
MeSH terms: Metabolic Syndrome; Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Intervention: Ziprasidone HCL (oral)
Intervention description: Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40 to 160 mg total daily dose) for up to 1 year.
Intervention MeSH terms: Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ziprasidone; metabolic syndrome; risk factors; schizophrenia; psychotic disorders.

Summary:

      The purpose of this study is to explore the impact of ziprasidone on the distribution of
      metabolic syndrome risk factors in a population of patients presenting with glucose
      intolerance, dyslipidemia and/or elevated waist circumference associated with their current
      antipsychotic medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must present at least 2 of the following risk factors of MS at screening:
             Elevated waist circumference: >102 cm in men and >88 cm in women; Elevated
             triglycerides (TGs): ≥1.7 mmol/L (≥150 mg/dL); Reduced HDL-Cholesterol: <1.03 mmol/L
             (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; Elevated fasting glucose: ≥
             5.6 mmol/L.

          -  According to the clinical judgment of the investigator, the risk factors for MS have
             developed in close temporal relationship to starting an antipsychotic medication.

          -  Substitution to a less metabolically disruptive antipsychotic medication is
             considered.

        Exclusion Criteria:

          -  Subjects with contraindication(s) to the use of Ziprasidone according to Canadian
             prescribing information.

          -  Subjects with a history of treatment resistance.

          -  Subjects with any medical condition (e.g. pre-existing diabetes, pre-existing
             dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate
             or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that
             may confound the evaluation of the study drug.

          -  Body mass index ≥ 40 at baseline.
GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Celecoxib; Any commercially available NSAID with the indication for osteoarthritis
Intervention description: open-label; dosing as per USPI label related to the chosen commercially marketed NSAID
Intervention MeSH terms: Celecoxib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8067.0
Sex: All
Minimum age: 55 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: GI events in patients with moderate GI risk treated with NSAIDS

Summary:

      This study investigates if Celebrex has a lower incident of Gastrointestinal Events than
      other NSAIDS in subjects with osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients of at least 55 years of age with a clinical diagnosis of OA
             who are expected to require daily prescription anti-inflammatory analgesic therapy for
             arthritis symptom management and for whom either celecoxib or a nsNSAID is an
             appropriate treatment option.

        Exclusion Criteria:

          -  GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening
             visit.

          -  Patients with a history of myocardial infarction, unstable angina, ischemic or
             hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to
             coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.
Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles
Condition: Peri-oral Wrinkles
Intervention: Restylane and Perlane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Correction of peri-oral wrinkles

Summary:

      This is an open-label study to assess safety using Restylane and Perlane in the correction of
      facial wrinkles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Same Wrinkle Severity (either both Moderate [3] or both Severe [4]) of marionette
             lines and upper peri-oral rhytids

        Exclusion Criteria:

          -  Active or chronic skin disease, inflammation or related conditions, near or on the
             Nasolabial Folds

          -  Subjects who had undergone procedures based on active dermal response (e.g., laser or
             chemical peeling procedures) within 6 months prior to study entry

          -  Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic
             facial surgical therapy within 9 months prior to study entry

          -  Permanent implant placed in the Nasolabial Fold area
Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
Condition: Paget's Disease of the Bone
MeSH terms: Bone Diseases; Osteitis Deformans
Intervention: Zoledronic Acid
Intervention description: Zoledronic acid 5 mg intravenous infusion once
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Healthy volunteers: No
Keywords: Paget's Disease; Zoledronic acid; Reclast®/Aclasta®; Infusion; Re-treatment; Re-lapse

Summary:

      The purpose of this study was to demonstrate that participants with Paget's disease of the
      bone who had responded to zoledronic acid treatment as participants in the core registration
      studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully
      treated with a 5 milligram (mg) infusion of zoledronic acid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written Informed Consent

          -  Participants with Paget's disease randomized to the zoledronic acid arm from the
             CZOL446K2304 and CZOL446K2305 core studies and who were responders by 6 months

          -  Confirmed relapse of Paget's disease of bone (i.e., serum alkaline phosphatase (SAP)
             above upper limit of normal (ULN), bone scan, worsening clinical symptoms)

        Exclusion Criteria:

          -  A participant previously treated with zoledronic acid who relapsed and was retreated
             with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months

          -  Bisphosphonate Hypersensitivity

          -  Participants with suspected/proven metastases at re-treatment

          -  Calculated creatinine clearance <35 milliliter/minute (mL/min) at screening

          -  Serum calcium level <2.07 millimole/liter (mmol/L) at screening

          -  Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or
             hypothyroidism

        Other protocol-defined inclusion/exclusion criteria may apply.
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders
Intervention: Eszopiclone; Placebo
Intervention description: eszopiclone 2 to 3 mg po at bedtime; placebo 2 to 3 mg po at bedtime
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: pain; fatigue; sleep; bone marrow transplant; cancer

Summary:

      To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and
      who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:

        -  improve sleep thereby decreasing need for opiates via PCA

        -  improve sleep thereby decreasing pain by self report

        -  improve sleep thereby decreasing fatigue by self report
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients hospitalized for chemotherapy or blood/bone marrow transplant.

          2. Age 20 - 75

          3. Not currently regularly taking any prescribed sleeping pill more often than 4x/week.

          4. Can tolerate oral medication.

        Exclusion Criteria:

          1. Patients with a current history of substance abuse

          2. Patients with a history of allergic response to Lunesta.

          3. Patient who require additional oral or parenteral opioids after starting PCA opioid
             treatment.
The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation
Intervention: Linagliptin; Placebo
Intervention description: 5 mg daily oral tablets of linagliptin; matching placebo giving orally daily
Intervention MeSH terms: Linagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a single center, prospective randomized double blind, parallel and placebo controlled
      study to evaluate oxidative stress and inflammation before and after treatment with
      linagliptin for 12 weeks. We will also, testing whether Linagliptin is an insulin sensitizer.
    

Eligibility criteria:

        Inclusion Criteria:

        Age 20-80 years inclusive. Type 2 diabetes BMI ≥30 kg/m2 Subjects on statins, ACE
        inhibitors, thiazolidinediones and antioxidants will be allowed as long as they are on
        stable doses of these compounds and the dosage in not changed during the course of study.

        HbA1c ≤ 8.0%

        Exclusion Criteria:

        - Use of GLP-1 agonists or DPP-IV therapy in the last 3 months. History of Pancreatitis.
        Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and
        hypertriglyceridemia.

        Subjects who are taking antiplatelet or anticoagulant medications will be excluded from the
        fat biopsy portion of the study.

        Coronary event or procedure (myocardial infarction, unstable angina, coronary artery
        bypass, surgery or coronary angioplasty) in the previous four weeks Hepatic disease (liver
        function tests more than 3 times the upper limit of normal) Renal impairment (serum eGFR
        <30 ml/min) Any other life-threatening, non-cardiac disease Uncontrolled hypertension (BP >
        160/100 mm of Hg) Congestive Heart Failure class III or IV. Use of an investigational agent
        or therapeutic regimen within 30 days of study Participation in any other concurrent
        clinical trial
Treatment of Tracheostomy Granulomas
Condition: Granuloma; Tracheostomy
MeSH terms: Granuloma
Intervention: Betadine; Silver Nitrate; Hydrocortisone Butyrate Cream, 1.0%
Intervention description: Apply locally as needed.; Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated.; Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.
Intervention MeSH terms: Povidone-Iodine; Silver Nitrate; Hydrocortisone; Hydrocortisone-17-butyrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 31 Days
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study plans to learn more about the different ways used to treat tracheostomy
      granulomas. Investigators want to see which standard of care method (steroid application,
      silver nitrate, or betadine) is more successful in treating tracheostomy granulomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children's Hospital Colorado inpatient or outpatient

          -  31 days to 17 years (inclusive)

          -  Needs treatment for a tracheostomy granuloma

        Exclusion Criteria:

          -  Tracheostomy granuloma has been treated in the last two weeks