bioihbjkbjnl/mcl2 huggingface dataset:
Ciprofloxacin for Prevention of BK Infection
Condition: BK Virus Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Ciprofloxacin; placebo
Intervention description: Patients will be randomized 2:1 active comparator, Cipro, to placebo comparator.; Patients will be randomized 2:1 placebo comparator to active comparator, Cipro.
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BK infection; BK viremia; BK nephropathy; polyomavirus; fluoroquinolone; ciprofloxacin

Summary:

      BK infection is an important cause of graft dysfunction and graft loss after renal
      transplantation. It has been widely accepted that emergence of BK virus correlates with the
      more potent immunosuppressive agents used to lower acute rejection rates. In contrast to
      other opportunistic infections after transplantation, for which routine prophylactic agents
      are administered, there is no effective agent for the prevention of BK infection. Some data,
      however, suggests that quinolone antibiotics such as ciprofloxacin may have activity against
      BK virus. This has led us to investigate whether routine, short-term ciprofloxacin
      administration post-transplant can lower the incidence of BK infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects over the age of 18 years

          -  Recipients of a primary or repeat renal allograft either alone (from a deceased or
             living donor) or as a dual-kidney transplant

          -  Signed informed consent form prior to any research assessment

        Exclusion Criteria:

          -  Patients with known severe allergy to ciprofloxacin

          -  History of tendon rupture or tendinitis

          -  Use of antiarrythmic drugs known to prolong the QT interval such as class IA
             antiarrhythmic drugs (e.g. quinidine, procainamide, disopyramide), class III
             antiarrhythmic drugs (e.g. amiodarone, sotalol)

          -  Patients with history of previous non-renal transplantation

          -  Recipients administered rituximab within one year prior to transplantation, or
             recipients expected to receive rituximab as part of desensitization strategy or for
             the presence of historical donor specific antibodies

          -  QTc interval interval of greater than 500 msec on admission or post-operative EKG

          -  BK nephropathy with previous transplant

          -  BK viremia on admission

          -  Any condition present during the initial transplant hospitalization that in the
             investigator's judgment would increase the risk associated with participation in the
             study
Skeletal Muscle and Adipose Tissue Study
Condition: Idiopathic Scoliosis
MeSH terms: Scoliosis
Intervention: Bolus dose of Cefazolin; Continuous Cefazolin drip; Paraspinal muscle microdialysis catheters; Subcutaneous microdialysis catheters
Intervention description: Mode of Cefazolin administration will be a intermittent bolus; Mode of Cefazolin administration will be a continuous drip; Two dialysis probes will be inserted into a paraspinal muscle; Two dialysis probes will be inserted into a paraspinal subcutaneous region
Intervention MeSH terms: Cefazolin; Dialysis Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Simple randomization will be used with each patient has probability 0.5 to be assigned in Group I or Group II. Computer program will generate a uniform random variable between 0 to 1, with subject assigned to Group I if the value is less than 0.5 and assigned to Group II if the value is greater than 0.5.
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 12 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: tissue microdialysis; spinal fusion; surgical site infection

Summary:

      The purpose of this research study is to compare the current standard of care for
      prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of
      Cefazolin during pediatric spinal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic scoliosis

          -  Planned posterior spinal fusion surgery (PSFS)

          -  Age: 12-20 years old

          -  American Society of Anesthesiology status I or II undergoing posterior spinal fusion
             for at least 6 levels

          -  No known allergy to cefazolin

        Exclusion Criteria:

          -  Known allergy to cefazolin

          -  Anatomical or other abnormalities that precluded insertion of a microdialysis catheter
             into the selected paraspinal muscle

          -  Known renal or hepatic insufficiency or failure
Comparison of Airway Clearance Therapy in Cystic Fibrosis Using the Same VEST Therapy Device But With Different Settings
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: HFCWC with higher pressure/variable-frequency settings; HFCWC with lower pressure/mid-frequency settings
Intervention description: Randomized crossover trial of airway clearance therapy comparing sine wave HFCWO with high pressures and variable frequency (pressure 10, frequencies 8,9,10 and pressure 6, frequencies 18,19,20) to low pressure and mid frequency (pressure 5, frequency 12). Subjects will have 2-day washout between airway clearance sessions. All sputum collected during sessions.; Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects will complete a questionnaire addressing the comfort of therapy upon completion of the session.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: high frequency chest wall oscillation, cystic fibrosis

Summary:

      Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher
      inflation pressures combined with both low and high oscillator frequencies will result in
      greater sputum production compared to sine waveform HFCWO with lower inflation pressures and
      mid-frequency oscillations.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of CF established by sweat chloride > 60 mmol/L.

          2. Age older than 18 years.

          3. History of chronic daily sputum production.

          4. Currently on a home therapeutic regimen that includes some form of airway clearance
             performed with a HFCWO device at least once daily that also includes concomitant use
             of an inhaled mucolytic and inhaled bronchodilator.

          5. FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10%
             variation in lung function parameters over the preceding 3 months).

          6. Evaluated at the University of Minnesota CF Center 3 or more times in the preceding 12
             months.

        Exclusion criteria:

          1. Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.

          2. Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.

          3. Chest pain requiring use of narcotic for pain control.

          4. Current participation in another clinical trial.

          5. Use of intravenous antibiotics for CF respiratory complications in the 2 months
             preceding enrollment.

          6. No prior experience using HFCWO devices for airway clearance
Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation
Condition: Major Depressive Disorder; Suicidal Ideation
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Suicidal Ideation
Intervention: paliperidone; lithium; Placebo
Intervention description: 1-5 mg daily (QD); 300-1500mg QD; 1-5 placebo capsules
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: depression; suicidality; Major Depressive Disorder, current episode, with suicidality

Summary:

      The study aims to use a combined clinical and translational approach to identify an efficient
      pharmacotherapy for the acute management of suicidality and the epigenetic regulation
      associated with the treatment.The primary objective is a clinical trial to compare the
      efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of
      care antidepressants in the acute management of suicidality in depressed subjects.

      Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still
      underway.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects who are able to provide informed consent

          2. 19-65 years of age

          3. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis
             of MDD by MINI International Neuropsychiatric Interview (MINI) and confirmed by
             psychiatric interview

          4. Currently experiencing a depressive episode with suicidality (defined as having
             current suicidal thoughts occurring at least 3 out of 7 days in a week).

          5. Montgomery-Asberg Depression Rating Scale (MADRS) must include a total score > 25 and
             a suicidal sub-score > 4.

        Exclusion Criteria:

          1. Depressed patients without suicidality, patients with severe psychotic features or
             with primary diagnoses of bipolar disorder (BD), schizophrenia, schizoaffective
             disorder, or generalized anxiety disorder (GAD), and subjects who have been taking
             lithium or an antipsychotic in the past 2 weeks

          2. Those with uncontrolled medical illnesses. Participants must be on any new medications
             for at least 30 days to be considered medically stable.

          3. For patients with panic disorder, post-traumatic stress disorder (PTSD), borderline
             personality disorder (BPD), etc. be sure that MDD is the primary diagnosis. When in
             doubt, decisions will be made on a case-by-case basis.

          4. Pregnant women.

          5. Allergic to paliperidone, to any other ingredient in paliperidone ER or paliperidone
             palmitate, or to risperidone.
Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
Condition: Dry Eye Syndromes; Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
Intervention: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD); sodium hyaluronate 0.18% (VISMED® Multi)
Intervention description: One drop in each eye three to six times daily, as needed; One drop in each eye three to six times daily, as needed
Intervention MeSH terms: Carboxymethylcellulose Sodium; Hyaluronic Acid; Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity
      in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been using artificial tears for at least 3 months prior to study inclusion

          -  Have been using preservative free artificial tears at least three times daily (TIB)
             for at least 2 weeks immediately prior to study inclusion

          -  Having moderate to severe symptoms suggestive of dry eye

        Exclusion Criteria:

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 3 months prior to entry into this study

          -  Moderate to severe blepharitis

          -  History or active signs of ocular trauma, ocular infection, or ocular inflammation
             within the last 3 months

          -  History or active signs of ocular allergic disease or ocular herpes within the last
             year

          -  History or active signs of severe or serious ocular conditions such as inflammatory
             corneal ulcers, recurrent erosions, and uveitis at any time.
Insulin Glargine "All to Target" Trial
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Insulin Glulisine; Insulin Glargine; Premixed Insulin; Insulin Glulisine
Intervention description: Subcutaneous injection up to 1 injection per day; Subcutaneous injection once-a-day; Subcutaneous injection twice-a-day.; Subcutaneous injection up to 3 injections per day.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 588.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The primary objectives were:

        -  To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra®
           (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of
           patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c] <7.0%)
           at Week 60

        -  To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection
           (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from
           Baseline to Week 60 in HbA1c
    

Eligibility criteria:

        -  Male or female patients

          -  30 to 80 years of age

          -  Body Mass Index <45 kg/m2

          -  With Type 2 diabetes mellitus for at least 2 years

          -  With an HbA1c level at screening of >7.5% and >7.0% at randomization

          -  On stable dual or triple oral therapy for at least 3 months

          -  Oral agents in 2 or 3 of the following classes: SU or repaglinide, biguanide, or TZD,
             willing and able to perform self-monitoring of BG

          -  Females of child-bearing potentially were required to be willing and able to use
             adequate contraception
Treatment of Bacterial Vaginosis (BV) With Tinidazole
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: tinidazole, metronidazole
Intervention description: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid
Intervention MeSH terms: Metronidazole; Tinidazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 593.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: bacterial vaginosis; tinidazole

Summary:

      We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than
      treatment with metronidazole
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women be at least 18 years of age

          -  Have symptoms of vaginal odor and or/discharge

          -  Meet the clinical (Amsel) criteria for BV

          -  Willing to participate in research

        Exclusion Criteria:

          -  Presence of another vaginal infection or STD

          -  Allergy to metronidazole

          -  Pregnant or nursing

          -  Use of oral or intravaginal antibiotics within the past 2 weeks

          -  HIV or other chronic disease

          -  Inability to keep return appointments
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Hydromorphone; Prochlorperazine; Diphenhydramine
Intervention MeSH terms: Diphenhydramine; Promethazine; Hydromorphone; Prochlorperazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      Opioids are commonly used to treat migraine in North American Emergency Departments. We are
      comparing efficacy and adverse events of hydromorphone, an opioid, to that of
      prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine
      will be combined with diphenhydramine to prevent adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Migraine headache (International Classification of Headache Disorders 3B criteria)

        Exclusion Criteria:

          -  Brain imaging ordered

          -  Fever

          -  Objective neurological findings

          -  Pregnancy/ breast feeding

          -  Allergy/ contraindication to investigational medication

          -  History of addiction to opioids, use of methadone, any use of opioids previous 30 days
Improving Sleep in Nursing Homes
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Intervention: Ramelteon; Placebo
Intervention description: Subjects demonstrating low sleep efficiencies and prolonged sleep latencies, will be randomly assigned to continue to receive SHI accompanied by either placebo or Ramelteon (8 mg). Matching placebo will be obtained and the medication pre-packaged and ordered based on the randomization results.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sleep hygiene; Sleep latency; Elderly sleep; Nursing Home sleep

Summary:

      Older people living in nursing homes do not sleep very well for many reasons. Sleep disorders
      such as sleep apnea (when someone briefly stops breathing during sleep), and night time
      urination, along with the problems caused by the nighttime environment of the nursing home,
      such as noise and disruptive care routines can all contribute. Poor sleep can lead to other
      health problems or make existing health problems worse.

      This study will evaluate how well a sleep hygiene intervention and a medication for sleep
      (ramelteon (Rozerem)) work to improve sleep in nursing home residents with poor sleep.
      Ramelteon is FDA approved and has been tested in older adults living in the community, but
      not in older adults living in nursing homes. We expect sleep to improve on the study drug
      along with the sleep hygiene intervention, in comparison to placebo along with the sleep
      hygiene intervention. Based on adverse events reported in previous samples of older subjects,
      we expect the study drug to cause few side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  After initial screening and consenting, subjects with a 5-night average baseline sleep
             efficiency of less than or equal to 75% will be included

        Exclusion Criteria:

          -  Less than 65 yrs old

          -  Bedbound

          -  Resided in NH for less than two months

          -  Patients on Medicare Part A skilled Benefit(anticipated short length stay) - Terminal
             Illness

          -  Unstable psychotropic drug regimen (addition, discontinuation, or change of dosage of
             any psychotropic drug in the prior two weeks) - Use of hypnotic, antihistamine, or
             benzodiazepine more than once per week during the two weeks before screening

          -  Use of drugs that could potentially inhibit the metabolism of Ramelteon (ie:
             fluvoxamine, ketoconazole, fluconazole)

          -  Use of Drugs that induce the metabolism of Ramelteon (ie: rifampin)
Prasugrel Re-load Strategies
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Prasugrel
Intervention description: Prasugrel 10mg, 30mg, or 60mg
Intervention MeSH terms: Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: coronary artery disease; percutaneous coronary revascularization; prasugrel therapy

Summary:

      A higher degree of platelet inhibition remains the goal of peri-interventional and long-term
      anti-thrombotic therapy in patients with coronary artery disease. In clinical practice,
      patients undergoing percutaneous coronary intervention with stent implantation who are
      already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior
      observations showing that higher inhibition of platelet aggregation may be achieved by giving
      a loading dose of clopidogrel in patients with coronary artery disease while on chronic
      clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet
      aggregation can be achieved by adding a prasugrel loading dose in patients on chronic
      prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel
      re-load strategy in patients on already on chronic prasugrel therapy will be useful.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with angiographically documented coronary artery disease.

          2. Age between 18 to 74 years

          3. On treatment with prasugrel 10mg/daily for at least 14 days.

        Exclusion Criteria:

          1. Blood dyscrasias or bleeding diathesis

          2. Antiplatelet treatment with clopidogrel or ticlopidine

          3. Recent antiplatelet treatment (< 14 days) with a glycoprotein IIb/IIIa antagonist

          4. Platelet count <100x106/µL

          5. Active bleeding or hemodynamic instability.

          6. Unstable angina, acute or recent (<14 days) myocardial infarction.

          7. Serum creatinine >2 mg/dL

          8. Baseline ALT >2.5 times the upper limit of normal

          9. Oral anticoagulation with a coumarin derivative

         10. History of stroke, TIA or intracranial bleeding

         11. Weight <60kg

         12. Pregnant females