bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients
Condition: Renal Function
Intervention: everolimus; cyclosporine A; Enteric Coated Mycophenolate Sodium (EC-MPS); corticosteroids; Basiliximab
Intervention description: Everolimus (Certican®) tablets administered orally in two divided doses (b.i.d.) at a starting dose of 4 mg/day adjusted to target a trough blood concentration between 6 and 10 ng/mL in period 2.; CsA (Sandimmun Neoral), based on C0-h levels 75-200 ng/mL or C2-h levels 700 900 ng/mL from randomization to Month 6, or C0-h levels 50-150 ng/mL or C2-h levels 600 800 ng/mL from Month 6 to Month 36, according to local method; Target dose 1440 mg in the control group, target dose 1080 in the everolimus group (higher dose in the CsA group because of interactions of CsA on gastric reabsorption of mycophenolate); For both groups: minimum corticosteroid dose of 10 mg until week 12, 5-10 mg until month 12, month 12-36 corticosteroid treatment on investigator's descretion.; Induction therapy 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg on Day 4 post-TX.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Prednisolone; Everolimus; Cyclosporins; Basiliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: De novo renal transplantation

Summary:

      This study is designed to evaluate if early conversion to everolimus from cyclosporine in de
      novo renal transplant recipients can improve long-term renal function and slow down the
      progression of chronic allograft nephropathy
    

Eligibility criteria:

        Inclusion Criteria:

          -  First or second single renal transplant from deceased or living donor

        Exclusion criteria

          -  Recipient of organs other than a renal transplant

          -  Present malignancy (within the last 2 years) other than excised basal cell or squamous
             cell carcinoma of the skin

          -  Severe liver disease

          -  At the time of randomization 7 weeks after transplantation

        In addition to the above criteria the following must be met at time of randomization:

        Inclusion Criteria:

          -  Patients maintained on a triple immunosuppressive regime consisting of cyclosporine,
             Enteric coated mycophenolate, and corticosteroids

          -  Patients completed the first 7 weeks without experiencing any rejection

        Exclusion Criteria:

          -  Graft loss

          -  Low hemoglobin value, low number of white blood cells or platelets

          -  High cholesterol values

          -  Proteinuria

          -  Wound healing problems

          -  Current severe major local or systemic infection

          -  Renal insufficiency

        Other protocol-defined inclusion/exclusion criteria may apply.
A Study in Patients With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Tadalafil; Sildenafil Citrate
Intervention description: Administered orally for 24 weeks.; Administered orally for 24 weeks.
Intervention MeSH terms: Sildenafil Citrate; Tadalafil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 770.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erectile Dysfunction

Summary:

      The purpose of this study is to investigate if treatment in erectile dysfunction with a
      long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer
      treatment adherence and better long term outcomes (over 24 weeks), compared with a
      short-acting drug (Sildenafil Citrate) taken as needed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of Erectile Dysfunction (ED) of at least 3 months duration.

          -  Anticipate having the same adult female sexual partner during the study.

          -  Agree not to use any other treatment for ED and to participate in recording responses
             to questionnaires and other instruments used in this study.

        Exclusion Criteria:

          -  Previous or current treatment with tadalafil or any other phosphodiesterase type 5
             (PDE5) inhibitor.

          -  ED caused by other primary sexual disorders, history of radical prostatectomy or other
             pelvic surgery with subsequent failure to achieve any erection, or history of penile
             implant or clinically significant penile deformity.

          -  ED caused by untreated or inadequately treated endocrine disease.

          -  Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.

          -  Severe renal or hepatic impairment, history of malignant hypertension.

          -  Presence or history of specific heart conditions.
Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD)
Condition: Critically Ill Renal Failure Requiring CVVHD and Oseltamivir; Critically Ill Requiring ECMO and Oseltamivir
MeSH terms: Critical Illness
Intervention: pharmacokinetic blood sampling; pharmacokinetic blood and dialysate sampling
Intervention description: blood samples collected to assess oseltamivir concentrations; blood and dialysate samples collected and assayed for oseltamivir concentrations
Intervention MeSH terms: Oseltamivir; Dialysis Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Healthy volunteers: No
Keywords: oseltamivir; influenza; continuous renal replacement therapy; extracorporeal membrane oxygenation; pharmacokinetics

Summary:

      Critically ill patients with flu may receive a drug called oseltamivir. They may also receive
      medical therapies to support their lung function (extracorporeal membrane oxygenation; ECMO)
      and kidney function (continuous venovenous hemodialysis; CVVHD). CVVHD and ECMO may remove
      some oseltamivir from the bloodstream. The purpose of this study is to determine how much
      oseltamivir gets removed by CVVHD or ECMO in critically ill patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  receiving Continuous Venovenous Hemodialysis (CVVHD) or Extracorporeal Membrane
             Oxygenation (ECMO)

          -  require oseltamivir treatment

          -  informed consent granted

        Exclusion Criteria:

          -  pregnant

          -  unable to complete 12 hours of CVVHD or ECMO

          -  <6 kg body weight

          -  allergy to oseltamivir
Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rasagiline; Placebo
Intervention MeSH terms: Rasagiline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 170.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Cognition; Rasagiline

Summary:

      This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on,
      parallel-group study to evaluate the effect of rasagiline on cognitive function in adults
      with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Nondemented man or woman 45 through 80 years of age with idiopathic Parkinson's
             disease (PD) based on the United Kingdom (UK) Parkinson's Disease Society Brain Bank
             Clinical Diagnostic Criteria

          2. Hoehn and Yahr stage ≥ 1 (symptoms on only 1 side of the body) with treatment and ≤ 3
             (mild-to-moderate bilateral disease; some postural instability; physically
             independent)

          3. Mild cognitive impairment in Parkinson's disease based on the Movement Disorder
             Society (MDS) Task Force Diagnostic Criteria and the Montreal Cognitive Assessment
             (MoCA) rating scale (range, 20-25, inclusive)

          4. Medically stable outpatient, based on the investigator's judgment

          5. The patient is on a stable dopaminergic medication regimen for ≥ 30 days before
             entering the study (Screening/Baseline Visit)

          6. Other inclusion criteria apply; please contact the site for more information

        Exclusion Criteria:

          1. Clinically relevant history of vascular disease (eg, stroke)

          2. History of melanoma

          3. History of deep brain stimulation (DBS)

          4. Impaired hepatic function, based on the investigator's judgment

          5. Psychosis or is receiving antipsychotic treatment

          6. Clinically significant or unstable medical or surgical condition that may preclude
             safe and complete study participation, based on the investigator's judgment

          7. Other exclusion criteria apply; please contact the site for more information
OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Intervention: onabotulinumtoxinA; Normal saline
Intervention description: OnabotulinumtoxinA (BOTOX®) injected into the detrusor.; Normal saline (placebo) injected into the detrusor.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared
      with placebo, in achieving a 100% reduction in urinary incontinence in patients with
      overactive bladder (OAB) not properly managed with an anticholinergic.
    

Eligibility criteria:

        Inclusion Criteria:

        -Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary
        incontinence for at least 6 months prior to screening.

        Exclusion Criteria:

          -  Symptoms of OAB due to a neurological reason

          -  Use of anticholinergics or other medications or therapies to treat symptoms of OAB
             within 7 days of screening

          -  Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage
             urinary incontinence

          -  Use of botulinum toxin therapy of any serotype for any urological condition

          -  Use of botulinum toxin therapy of any serotype for any non-urological condition in the
             12 weeks prior to screening

          -  History of any pelvic or urological abnormalities, bladder surgery or disease, other
             than OAB, that may affect bladder function

          -  Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral
             Sclerosis.
Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: OMACOR; Placebo oral capsule
Intervention description: 4 grammes daily, oral capsule; 4 grammes daily, oral capsule (olive oil)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: non alcoholic fatty liver disease; NAFLD; fish oil; intervention; RCT; biomarkers

Summary:

      Non alcoholic fatty liver disease (NAFLD) imposes a high and increasing burden on the NHS,
      yet there is presently no licensed treatment or validated approach to management. NAFLD
      predisposes to increased risk of type 2 diabetes, increased risk of cardiovascular disease
      and may progress to chronic irreversible liver disease.

      In NAFLD patients, the investigators will test the hypothesis that treatment with long chain
      n-3 fatty acid supplementation for 18 months favourably influences bio-markers for NAFLD and
      risk factors for cardiovascular disease and type 2 diabetes.
    

Eligibility criteria:

        Inclusion criteria:

          1. Steatohepatitis diagnosed on normal clinical grounds including in most cases liver
             biopsy and assessed by Kleiner scoring system to assess severity, with no known
             aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B &
             C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).

          2. Steatosis diagnosed by ultrasound, CT or magnetic resonance imaging who also have
             either diabetes and/or features of the metabolic syndrome, without evidence of known
             aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B &
             C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).

        Liver biopsy or liver scan will be within 3 years of recruitment to the study. Age: men &
        women >18 years. Alcohol consumption <35 units / week for women <50 units / week for men).

        Exclusion criteria:

          -  Decompensated acute or chronic liver disease, or harmful drinking (> 35 u/week in
             women > 50 u /week in men).
Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy
Condition: Diabetic Neuropathic Pain; Chronic Low Back Pain
MeSH terms: Neuralgia; Diabetic Neuropathies; Back Pain; Low Back Pain
Intervention: donepezil; duloxetine; donepezil 2.5 mg and duloxetine 30mg; placebo; gabapentin
Intervention description: Group 1: Will receive donepezil 5mg once a day; Group 2: Will receive duloxetine 30 mg twice a day; Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg; Group 4: Will receive placebo pills; Week 8: all subjects will have open label gabapentin added to their randomized study medication
Intervention MeSH terms: Gabapentin; Duloxetine Hydrochloride; Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Asymmetric Diabetic Proximal Motor Neuropathy; Diabetic Autonomic Neuropathy; Diabetic Neuralgia; Diabetic Neuropathy, Painful; Neuralgia, Diabetic; Low back pain, chronic

Summary:

      The purpose of the study is to determine whether the combination of the the three drugs
      gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic
      neuropathy or patients with failed low back syndrome (chronic back pain).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of diabetic neuropathy

          -  Age 18-80

          -  Willing to temporarily discontinue gabapentin or monoamine reuptake inhibitors upon
             entry into the study

        Exclusion Criteria:

          -  Pregnancy

          -  Allergy to study medications

          -  Uncontrolled narrow-angle glaucoma

          -  Currently being treatment with thioridazine (Mellaril)

          -  Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases

          -  Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization
Effect of Octreotide on the Colonic Motility in Pediatric Patients
Condition: Colonic Motility Index; Constipation
MeSH terms: Constipation
Intervention: Octreotide; Bisacodyl
Intervention description: Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide
Intervention MeSH terms: Octreotide; Bisacodyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The research study is designed to test how a medication called octreotide affects the
      motility (contraction or squeezing) of the colon (large intestine). Investigators are
      investigating whether octreotide can increase contraction and movement in the colon.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female and undergoing colonic manometry for a routinely accepted indication
             including: evaluation of chronic constipation, unexplained abdominal distension
             (Should have had previous diagnostic work up), recurrent fecal impaction, post
             Hirschsprung's disease repair, chronic intestinal pseudo-obstruction, or suspected
             colonic dysmotility of any other cause.

          -  Children aged 12 months or older who are undergoing colonic motility under the
             supervision of Dr. Joseph Croffie at Riley Hospital.

          -  In the investigator's judgment, parent(s)/guardian(s) is mentally competent to provide
             informed consent to participate in the study.

        Exclusion Criteria:

          -  • Subjects with known or suspected allergy to octreotide.

               -  Subjects with known prolonged corrected QT interval (QTc) Syndrome or highest
                  risk QTc-Prolonging Agents (including mifepristone).

               -  Subjects with known history of ventricular arrhythmia.

               -  Subjects with history of any organ transplant who are taking cyclosporine at the
                  time of the motility study.

               -  Subjects with history of small bowel transplant.

               -  Subjects less than 12 months old.

               -  Subjects with severe renal impairment

               -  Subjects with severe hepatic impairment

               -  Subjects taking bromocriptine, insulin, oral hypoglycemic agents, beta blockers,
                  calcium channel blockers, quinidine, terfenadine, pimozide, sildenafil,
                  tadalafil, and any agents to control fluid and electrolyte imbalance
CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial
Condition: Catheter-related Bladder Discomfort
Intervention: phenazopyridine HCl; Placebo
Intervention description: Phenazopyrdine HCl 200 mg q8h x 24; Placebo tablet administered q8 hours for 24 hours postop.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 258.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phenazopyrdine; post operative bladder catheritization; VAS scores; Bladder pain related to indwelling foley catheters.; Bladder irritaion related to indwelling foley catheters.

Summary:

      The primary aim of this randomized clinical trial is to compare the utility of
      phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the
      post-operative period in the gynecologic patient using mean VAS measurments.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Adult women undergoing gynecologic surgery who are expected to tolerate oral medication
        within 12 post-operative hours and require an indwelling catheter for a minimum of 12 post
        operative hours after start of oral medication.

        Exclusion Criteria:

          1. Hypersensitivity to phenazopyridine products (Defined as a having a previous
             anaphylaxis reaction to phenazopyridine products).

          2. Known contraindications to phenazopyridine HCl:

               -  Renal failure or insufficiency (Defined as having abnormal renal function on
                  previous laboratory testing (BUN/Cr) or as having a known renal disease).

               -  History of hepatic disease or failure (Defined as having known liver disease or
                  having elevated LFTs on previous laboratory testing. Patients who would not
                  otherwise have such testing are not required to undergo special study labs).

               -  Known glucose-6-phosphate dehydrogenase deficiency.

          3. Simultaneous suprapubic catheterization.

          4. Inability to take oral medication within 12 hours after surgery.

          5. Pregnant women.
Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
Condition: Bipolar II Disorder; Major Depressive Episode
MeSH terms: Depression; Depressive Disorder, Major
Intervention: Ziprasidone
Intervention description: Ziprasidone 20-60 mg BID, taken orally.
Intervention MeSH terms: Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bipolar II Disorder; Major Depressive Episode

Summary:

      The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the
      treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a
      major depressive episode.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one
             hypomanic episode as documented in the medical history or provided by an informant, or
             have evidence of a clear diagnosis of hypomania

          -  patients will currently be experiencing a major depressive episode of 2 or more weeks,
             but less than 12 months duration

          -  minimum score of 18 on the 17-item HAM-D at screen and baseline

        Exclusion Criteria:

          -  patients will not meet criteria for Bipolar I or Schizoaffective Disorder or
             Schizophrenia

          -  patients may have co-morbid anxiety or other Axis I disorders as long as depression
             dominates the clinical picture

          -  Suicidal ideation or history that makes participation in a clinical trial unduly risky

          -  unstable medical conditions or any abnormality in thyroid function

          -  patients with a QTc of 450msec or greater on the initial ECG

          -  patients requiring concomitant psychotropic drugs will not be eligible, although
             patients on such drugs who can undergo washout will be eligible. such patients must
             have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4
             weeks for fluoxetine and depot neuroleptics

          -  the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from
             insomnia, but cannot be taken the night before a scheduled assessment

          -  patients with dementia or substance abuse in the last 6 months

          -  pregnant or lactating women will be excluded, as will those not using adequate forms
             of contraception