bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
Condition: Skin Neoplasms; Kidney Transplantation
MeSH terms: Skin Neoplasms
Intervention: sirolimus; cyclosporine or tacrolimus
Intervention MeSH terms: Cyclosporine; Sirolimus; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney; Transplant; Skin Cancer

Summary:

      The purpose of this study is to determine the effect of sirolimus on the prevention of new
      non-melanoma skin cancer (NMSC) in kidney transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplant at least 1 year prior

          -  Subjects with a functioning renal allograft with calculated glomerular filtration rate
             (GFR) ≥40mL/min (Nankivell method) and proteinuria ≤500mg/day.

          -  Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen

          -  History of NMSC within last 3 years

        Exclusion Criteria:

          -  History of other cancer within last 3 years

          -  NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months

          -  Multiple organ transplant
Knee Arthroplasty Performed With Conventional and Customized Instrumentation
Condition: Knee Arthritis
MeSH terms: Arthritis
Intervention: Customized Patient Instrumentation; Traditional Instrumentation
Intervention description: Custom cutting guides based on computed tomography (CT) images of the patient's leg are used to make the bone cuts and select the implant size.; Traditional surgical instruments will be used to make bone cuts and size the components in this control group.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Healthy volunteers: No
Keywords: Total Knee Arthroplasty; Instrumentation

Summary:

      The main purpose of this study is to determine whether the surgical time required for primary
      total knee arthroplasty is significantly less when performed with Customized Patient
      Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by
      video camera, in order to time the length of surgery and each surgical step. The number of
      surgical trays required for each case will be recorded. As an additional endpoint, the
      investigators will measure limb and component alignment on x-rays to determine if these two
      methods achieve equivalent alignment results. The thickness of bone cuts will be compared to
      the surgical plan and to each other.

      The primary hypothesis is that the use of customized patient instrumentation will reduce the
      operative time required for total knee arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient requires unilateral primary total knee arthroplasty

        Exclusion Criteria:

          -  Body mass index greater than 41

          -  Previous ipsilateral hip or ankle replacement

          -  Knee flexion contracture greater than 20 degrees
Efficacy of Pregabalin in Patients With Radicular Pain
Condition: Neuropathy; Radicular, Lumbar, Lumbosacral; Failed Back Surgery Syndrome; Spinal Stenosis; Herniated Disc
MeSH terms: Spinal Stenosis; Intervertebral Disc Displacement; Radiculopathy; Failed Back Surgery Syndrome
Intervention: Pregabalin; Sugar Pill
Intervention description: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.; One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Pregabalin; Radicular pain; Failed back surgery; Of greater than 3 months duration

Summary:

      The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain
      in patients who present with radicular pain due to a herniated disc, spinal stenosis or
      failed back surgery syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with pain in dermatomal distribution, in either cervical or lumbar region.

          2. History of pain for more than 3 months.

          3. History of herniated disc, spinal stenosis or failed back surgery.

          4. A series of epidural steroid injections within the past 6 months.

          5. Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia,
             allodynia, dysesthesia) in the affected dermatomes.

          6. Patients must be cognitively capable of completing the pain questionnaires.

        Exclusion Criteria:

          1. Patients below 18 or over 65 years of age.

          2. Patients with mostly axial spinal pain.

          3. Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.

          4. Workmen's compensation or disability issues.

          5. Patients with chronic depression and on depression medications.

          6. Addiction and/or substance abuse issues.

          7. Patients using gabapentin or failure to respond to previous gabapentin use.

          8. Patients with known peripheral neuropathy (e.g. DPN, PHN etc.).

          9. Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing).

         10. History of angioedema with pregabalin use.

         11. Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac
             conduction abnormalities, and/or thrombocytopenia.

         12. Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®,
             Actos®).

         13. Pregnant patients.
Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Valsartan/amlodipine 80/5 mg tablets; Amlodipine 5 mg capsules; Amlodipine 10 mg capsules; Atenolol 50 mg tablets; Atenolol 100 mg tablets
Intervention MeSH terms: Atenolol; Amlodipine; Valsartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 393.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination
      amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than
      an atenolol/amlodipine combination based regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients 18 years of age or older

          -  Hypertension defined by MSDBP > 90 and or MSSBP > 140 mmHg, MSDBP > 80 mmHg, or/and
             MSSBP > 130 mmHg if diabetes or chronic renal impairment uncontrolled under their
             previous therapy, or untreated , or experiencing unacceptable side effects

          -  Written informed consent to participate in the study prior to any study procedures

        Exclusion Criteria:

          -  Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP > 180
             mmHg)

          -  Evidence of a secondary form of hypertension

          -  Type 1 diabetes mellitus

          -  History of congestive heart failure, unstable coronary insufficiency, life threatening
             arrhythmia, significant valvular disease, second or third degree heart block etc.
Efficacy of Fish Oil in Lupus Patients
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Omega-3; flow-mediated dilation of the brachial artery; corn starch
Intervention description: Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks; flow-mediated dilation of the brachial artery measurement at baseline and after 12 weeks; 3 capsules qd for 12weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE; atherosclerosis; omega-3

Summary:

      The investigators hypothesize that low-dose dietary supplementation with omega-3 fish oil
      will improve disease activity and endothelial function in Systemic Lupus Erythematosus (SLE)
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a clinical diagnosis of SLE are eligible.

          -  Patients must be 18 years of age or older and able to give informed consent.

        Exclusion Criteria:

          -  SLE patients who are allergic to fish oil or any omega 3 product.

          -  Patients who are pregnant or are planning to become pregnant or are nursing.

          -  Omega-3 use within the previous 6 weeks of enrollment.

          -  Use of warfarin or heparin.

          -  Patients who have coronary artery disease.
BLIS - Breastfeeding Levonorgestrel IUD Study
Condition: Contraception
Intervention: Levonorgestrel IUD
Intervention description: Timing of IUD insertion
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 285.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Contraception; Birth Control; Levonorgestrel IUD; Mirena IUD

Summary:

      We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth
      on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish
      to breastfeed, and are willing to participate in the study will be randomly assigned to
      either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks
      later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery
      between those who get the IUD placed early or later.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, 18-40 year old pregnant women

          -  Intend to breastfeed

          -  Desire the LNG IUD as their method of contraception

          -  Agree to be randomized to early versus standard postpartum insertion

          -  Have delivered a healthy term infant (37 weeks gestation)

          -  Willing to complete all study related procedures, visits and questionnaires

        Exclusion Criteria:

          -  Chorioamnionitis

          -  Obstetric complications including transfusion

          -  Severe pregnancy induced hypertension

          -  Prolonged hospitalization

          -  Coagulopathy

          -  Liver disease

          -  Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion
             (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or
             history of breast cancer, or hypersensitivity to any of the components in the LNG
             IUD).
Steroids in Bilateral Total Knee Replacement
Condition: Postoperative Inflammatory Response
Intervention: Hydrocortisone; Saline
Intervention description: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times; Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Intervention MeSH terms: Hydrocortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Bilateral total knee replacement; cytokine; desmosine

Summary:

      Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a
      major marker of inflammation is known to increase during total joint replacement surgery. IL6
      has been found to be elevated postoperatively in patients with hip fractures and has been
      linked to mental status changes and possibly other complications. It is known to lead to
      shock and participate in the inflammatory state seen in sepsis. High levels have further been
      linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress
      syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low
      dose steroids given in two doses in the initial perioperative period decreased the amount of
      IL6 released compared to placebo, but this was not sustained past 24 hours.

      Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in
      urine samples. It is considered to be a marker of lung injury and is found to be elevated in
      patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the
      investigators have found that urine desmosine levels rise with bilateral total knee
      replacement compared to unilateral total knee replacement indicating possible lung injury.

      Therefore the investigators hypothesize:

      Continued low dose steroids given three times over a 24 hour period will:

        1. Significantly decrease peak IL6 cytokine release during bilateral total knee replacement
           and maintaining this reduction in IL6 beyond 24 hours.

        2. Decrease urinary desmosine levels, and hence be protective of lung injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for bilateral total knee replacement

          -  Between 50-90 years of age

        Exclusion Criteria:

          -  Patients on steroid therapy

          -  Patients that require stress-dose steroid pre-operatively

          -  Patients that smoke

          -  Patients that are diabetic

          -  Patients younger than 50 or older than 90 years
Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Continued Paroxetine CR; Quetiapine; Placebo
Intervention MeSH terms: Quetiapine Fumarate; Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 72 Years
Healthy volunteers: No
Keywords: generalized anxiety disorder; pharmacotherapy; treatment refractory; double-blind

Summary:

      The purpose of this study is to examine the safety and efficacy of quetiapine for generalized
      anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients, age 18-72.

          -  Primary diagnosis of generalized anxiety disorder.

          -  Patients on concurrent benzodiazepines will be entered into the trial if they remain
             symptomatic despite stable doses for at least one month

        Exclusion Criteria:

          -  Pregnant or lactating women or other women of child bearing potential not using
             acceptable means of birth control

          -  Patients with a primary diagnosis of major depression, dysthymia, panic disorder or
             social phobia.

          -  Patients with current or history of bipolar disorder, schizophrenia or other psychotic
             conditions

          -  Patients with post-traumatic stress disorder or obsessive-compulsive disorder current
             in the past 6 months.

          -  Patients with a history of alcohol or substance abuse or dependence within the last
             six months.

          -  Patients with significant unstable medical illness.

          -  Ongoing psychotherapy directed toward the treatment of generalized anxiety disorder.

          -  History of hypersensitivity to paroxetine CR, paroxetine or quetiapine.

          -  History of cataracts.

          -  Concurrent use of psychotropic medications including buspirone and antidepressants.
             Patients must have discontinued buspirone or antidepressant therapy at least two weeks
             prior to study entry, and fluoxetine at least four weeks prior, but no patient will be
             taken off effective medication.

          -  Concomitant use of herbs and dietary supplements with known psychotropic properties,
             including St John's Wort, Kava, Valerian, Gingko, Ginseng, ephedra and weight loss
             supplements. Other than such agents with known psychotropic properties, no over the
             counter medications are exclusionary.
PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]; Copegus
Intervention description: 135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks; 400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of
      prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to
      initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection.
      The anticipated time on study treatment was 3-12 months, and the target sample size was
      100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients at least 18 years of age

          -  Positive hepatitis C virus RNA at pre-transplantation

          -  Primary, single-organ recipient (cadaveric donor)

          -  Liver transplant between 10 and 16 weeks before treatment initiation

        Exclusion Criteria:

          -  Multi-organ or re-transplant recipient

          -  Evidence of current hepatitis B infection

          -  Seropositive for human immunodeficiency (HIV) infection
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic
Condition: Trigger Finger
MeSH terms: Trigger Finger Disorder
Intervention: Corticosteroid with lidocaine with epinephrine; Corticosteroid with normal saline
Intervention description: Trigger finger injection; Trigger finger injection
Intervention MeSH terms: Lidocaine; Epinephrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Steroid injection is the first line treatment for trigger finger. Steroid injection is
      sometimes mixed with a local anesthetic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old with trigger finger

        Exclusion Criteria:

          -  Preference for open trigger finger release

          -  Not a candidate for corticosteroid injection

          -  Contraindication to lidocaine with epinephrine
Relapse Prevention to Reduce HIV Among Women Prisoners
Condition: Opioid Dependence; HIV
MeSH terms: Opioid-Related Disorders
Intervention: Placebo; Buprenorphine
Intervention description: Placebo to match buprenorphine administered for 3 months; Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
Intervention MeSH terms: Buprenorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: Female
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: opiates; HIV

Summary:

      This study is a feasibility and acceptability study assessing whether providing buprenorphine
      for women under criminal justice supervision leaving a controlled environment and returning
      to the community would prevent opioid relapse and reduce HIV risk behaviors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female,

          -  history of opioid dependence,

          -  released back to the community from a controlled environment,

          -  criminal justice involvement.

        Exclusion Criteria:

          -  under age 19,

          -  medical contraindications,

          -  major psychiatric problems.