bioihbjkbjnl/mcl2 huggingface dataset:
A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
Condition: HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The
      purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine
      and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.
    


Intervention name(s): Clevudine; Adefovir dipivoxil
Intervention type(s): Drug; Drug
Intervention description(s): 30mg for 48 weeks; 10mg for 48 weeks
Other intervention name(s): Levovir; Hepsera
Intervention MeSH terms: Adefovir; Adefovir dipivoxil; Clevudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine
Condition: Cervical Cancer; Genital Warts
MeSH terms: Condylomata Acuminata
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective is to determine if antibody responses to HPV types 16 & 18 are non-inferior
      after a 2-dose paediatric regimen as compared to a 3-dose adult regimen of Q-HPV vaccination,
      with responses measured at Month 7.
    

Detailed description: 
      Human Papillomavirus (HPV) infection is a cause of cervical cancer. Immunogenicity, safety
      and efficacy in the prevention of persistent infection from HPV 16 and 18 has been proven
      using a 3-dose regimen in adolescent and adult females using the Quadrivalent Human
      Papillomavirus (Q-HPV) vaccine. The intensity of the immune response is inversely
      proportional to age. Immunogenicity in adolescents 9-15 years of age is 1.7 - 2 times greater
      than in 16-26 year old vaccine recipients. Paediatric dosing studies are necessary and
      prudent given limited provincial funding for new biologics acquisition and programme service
      delivery. A reduction from an adult 3-dose HPV vaccine regimen to a pediatric 2-dose regimen
      will result in increased compliance to the full vaccine series and in significant savings to
      the health care system both in the cost of biologics and of program delivery and
      administration.
    

Intervention name(s): HPV (Human Papillomavirus) Vaccine
Intervention type(s): Biological
Intervention description(s): HPV (Human Papillomavirus) Vaccine received by all participants in groups 1, 2 and 3 according to the arm
Other intervention name(s): Gardasil; Q-HPV; HPV Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HPV; HPV vaccine; Gardasil; Human Papillomavirus; vaccine; 2 dose versus 3
Anti-Inflammatory Effect of Statins in the Human Endotoxin Model
Condition: Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of HMG-CoA reductase inhibitor
      pretreatment on inflammation and coagulation activation in human endotoxemia.
    

Detailed description: 
      The beneficial effect of lipid lowering in cardiovascular disease is well established. Statin
      potently reduce elevated cholesterol levels but also exert pleiotropic other effects such as
      improvement of inflammation-induced vascular dysfunction, upregulation of endothelial nitric
      oxide synthase, yield antiinflammatory and antioxidant properties and lower tissue factor
      (TF) expression on peripheral blood mononuclear cells (PB-MNC) in vivo. The mechanism of
      action for these effects remains unclear, but is already seen after short term treatment and
      was independent of cholesterol reduction. Following endotoxin administration to healthy
      humans, the systemic response includes the activation of inflammation by cytokines, mainly
      IL-1, IL-6, THF-α and INF-γ, activation of the clotting system with enhanced thrombin
      generation, and vascular dysfunction, as demonstrable by an impaired response to
      vasoconstrictors. Low dose endotoxemia therefore serves as an adequate model for acute
      inflammation and the interaction of the three systems.

      The goal of this study is to determine the effect of HMG-CoA reductase inhibitor pretreatment
      on inflammation and coagulation activation in human endotoxemia and to investigate if
      anti-inflammatory effects are similar between two different statins. Further, we plan to
      study genome-wide effects on the leukocyte transcriptome induced by (i) statin pretreatment,
      (ii) low-dose endotoxemia, and (iii) the anti-inflammatory effects if the statins.

      The study will be carried out as a randomized placebo controlled double-blind threeway
      crossover three period study. Subjects will receive three treatment periods (Day 1 - Day 5)
      in randomized order consisting of 5 days oral Simvastatin (80 mg/day), 5 days oral
      Rosuvastatin (40 mg/day) and 5 days adequate placebo. On Day 5 of each study period, subjects
      will receive LPS (2 ng/kg i.v.). Inflammatory protein expression and coagulation activation
      will be assessed on Day 1 and Day 5 of each period. Washout-time between treatment periods
      will be ≥6 weeks.
    

Intervention name(s): LPS 2ng/kg intravenous bolus; Simvastatin 80mg; administered daily p.o. over 5 days; Rosuvastatin 40mg; administered daily p.o. over 5 days
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: LPS; Statins; leukocyte mRNA expression profiles
Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      An observational study of the effect of femoral nerve block in addition to an adductor canal
      block for pain following total knee arthroplasty.
    

Detailed description: 
      Subjects undergoing total knee arthroplasty will receive a preoperative adductor canal block
      with continuous catheter. Following a standardized general anesthetic for the procedure,
      subjects will be asked to rate their pain using the NRS-11 pain scale in the recovery room.
      Once the pain is reported at a 5/10 or above, a femoral nerve block will be performed using
      either 2% chloroprocaine or saline placebo (randomized). Pain scores are then evaluated over
      the next 30 minutes by a blinded investigator to determine if the femoral block adds any
      additional analgesic benefit over an adductor canal block.
    

Intervention name(s): Active comparator: chloroprocaine; Sham comparator: saline
Intervention type(s): Procedure; Procedure
Intervention description(s): 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.; 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
Other intervention name(s): femoral nerve block with chloroprocaine; femoral nerve block with normal saline
Intervention MeSH terms: Chloroprocaine; Procaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, blinded observational study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: femoral nerve block; adductor canal block; analgesia
Non Invasive Continuous Blood Pressure Sensor
Condition: Blood Pressure; Arterial Line; Anesthesia
Study type: Observational

Summary: 
      The primary objective of this study is to collect training data in order to establish a
      method for correlating arterial blood pressure with voltage output signals from a
      non-invasive piezoelectric array sensor placed on the skin superficial to the radial artery.
    

Detailed description: 
      The primary objective of this study is to collect training data in order to establish a
      method for correlating arterial blood pressure with voltage output signals from a
      non-invasive piezoelectric array sensor placed on the skin superficial to the radial artery.
      The development of this sensor could allow for non-invasive continuous measurement of
      arterial blood pressure.

      The key hypothesis is: if the piezoelectric array sensor can detect pulsatile pressure waves
      when placed on a near surface artery and pulse wave analysis has been shown to allow for
      accurate beat-to-beat estimation of blood pressure, then the device placed superficial to a
      near surface artery should allow for the non-invasive estimation of continuous blood
      pressure.

      Secondary objectives include identification of any significant ergonomic and motion artifact
      issues that could affect sensor utilization in future applications.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients undergoing elective surgery with planned utilization of invasive arterial
        pressure monitoring.
      
Keywords: Piezoelectric; Array Sensor; Blood Pressure; Monitoring; Arterial Line; Non-invasive
Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment,
      2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of
      adolescents with atopic dermatitis (AD)
    


Intervention name(s): AN2728 Topical Ointment, 2% QD; AN2728 Topical Ointment, 0.5% QD; AN2728 Topical Ointment, 2% BID; AN2728 Topical Ointment, 0.5% BID
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): AN2728 Topical Ointment, 2% QD; AN2728 Topical Ointment, 0.5% QD; AN2728 Topical Ointment, 2% BID; AN2728 Topical Ointment, 0.5% BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atopic dermatitis
Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention
Condition: Obesity
Study type: Interventional

Summary: 
      In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an
      abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal
      to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in
      Protocol #1). They will be randomly assigned to either lifestyle intervention (diet/exercise)
      or diet/exercise plus metformin for 6 months. After the 6 month evaluation the subjects will
      cross over the treatment arms, i.e., those that were doing diet/exercise intervention only
      will add metformin, those that were doing the diet/exercise plus metformin will discontinue
      the metformin and continue with diet/exercise changes only. Intrahepatic fat contents will be
      measured as well.

      The investigators hypothesize that obese children in these age groups will have increased
      cardiovascular risk related to their obese state before reaching the currently defined
      criteria of metabolic syndrome.

      The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle
      and drug interventions.
    


Intervention name(s): Metformin; Dietary modification with caloric restriction; Establishment of exercise protocol
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Metformin, 250mg by mouth twice a day with meals will be started and if tolerated increased to 500mg twice a day in 3 days in those less than 12 years old and titrated further to 1000mg twice a day if tolerated.; The life style intervention changes will include a hypocaloric diet representing at least a 500 kcal/day reduction based on their dietary histories and Resting Energy Expenditure (REE) determined by the initial calorimetry.; Participants will attend the Fitness Center 3 times per week and supervised by an exercise technician or exercise specialist. Exercise will be individually prescribed for each participant based on their functional abilities. Exercise will consist of 5-10 minutes for warm up and stretching, followed by 15-30 minutes of cardiovascular exercise (i.e. treadmill, bicycle ergometer, rower, nustep, etc), 10-20 minutes of strength training (supervised using weight stack equipment), and 5-10 minutes of cool down and stretching. As children typically do not need an exercise prescription based on heart rate, we will familiarize them with perceived exertion scales and monitor that they are exercising in the moderate to hard range of perception of effort. Participants will be started at 15 minutes of cardiovascular exercise and 10 minutes of strength training exercise, progressing by 2-3 minutes every week until 30 and 20 minutes is achieved for each respectively.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the usability of the ultrasound devices and common
      pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and
      functionality as measured by NRS scale and the Western Ontario and McMaster Universities
      Arthritis Index (WOMAC) will be evaluated.
    


Intervention name(s): Sustained Acoustic Device with 2.5% Diclofenac Patch; 1% Diclofenac Topical Gel
Intervention type(s): Device; Drug
Intervention description(s): Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.; Topical pain-relief gel
Other intervention name(s): ZetrOZ Ultrasound Device; Wearable Ultrasound Device; Long Duration Ultrasound; LITUS Device; Long Duration Low-Intensity Device; Voltaren
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-Steroidal Anti-Inflammatory Drugs; Sustained Acoustic Medication; Low-Intensity Continuous Ultrasound
Evaluation of Clinical and Functional Results After Operative Correction of Lesser Toe Deformities
Condition: Plantar Plate Tear; Metatarsalgia; Lesser Metatarsophalangeal Joint Instability; Hammer Toe; Surgery; Plantar Plate Repair
MeSH terms: Joint Instability; Metatarsalgia; Hammer Toe Syndrome
Study type: Observational

Summary: 
      The plantar plate is an important static stabilizer of lesser metatarsophalangeal joints, and
      disruptions of the plantar plate can lead to significant instability and lesser toe
      deformities.Our study proposes an inexpensive and versatile method for plantar plate repair
    

Detailed description: 
      A torn plantar plate is small and difficult to access using regular instruments in a
      restricted operative field. A unique method for plantar plate repairs was used to repair
      various configurations of plantar plate tears with standard operative instruments that is
      available in most operating rooms. A retrospective study was performed on patients who
      underwent operations for lesser MTPJ instability between September 2015 and December 2019.
      The outcome analysis included the Lesser Metatarsophalangeal-Interphalangeal Scale from the
      American Orthopedic Foot and Ankle Society (AOFAS) forefoot score, the Visual Analogue Scale
      score for pain and satisfaction, and answering the question "Would you recommend this
      procedure to other patients?"
    

Intervention name(s): plantar plate repair
Intervention type(s): Procedure
Intervention description(s): surgical repair via dorsal approach of lesser metatarsophalangeal joint general anesthesia
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent operations for lesser metatarsophalangeal joint instability between
        September 2015 and December 2019.
A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled study will assess the efficacy, safety,
      tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2
      diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously
      once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current
      stable doses of metformin.
    


Intervention name(s): RO5095932; RO5095932; metformin; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): cohorts receiving multiple ascending doses, sc once weekly for 4 weeks; dose titration to target dose, sc once weekly for 6 weeks; stable dose; sc once weekly for 4 weeks
Intervention MeSH terms: Metformin
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Does the "TOOKIE Vest" Reduce Line Fall Out Rate in Children?
Condition: Childhood Cancer
MeSH terms: Syncope
Study type: Interventional

Summary: 
      The objective of the trial is to assess whether the TOOKIE vest is an effective intervention
      in reducing line fall out. All oncology patients with a tunneled central line will be
      approached to participate in this study. Following informed consent they will be issued with
      a TOOKIE vest.
    

Detailed description: 
      All oncology patients with a tunneled central line will be approached to participate in this
      study. Following informed consent they will be issued with a TOOKIE vest. Lines will be
      studied for the duration they are in situ. This will vary depending on the underlying
      diagnosis and treatment regime. One hundred central line insertions for oncology patients
      will be prospectively identified and be given the "TOOKIE Vest" to wear. Data will be
      collated for each group regarding age, gender, diagnosis, type of central access inserted,
      duration of line, reason for removal, in cases of infection the infected organism will be
      documented, date of each fall out.
    

Intervention name(s): Tookie Vest
Intervention type(s): Device
Intervention description(s): Tookie Vest
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Evaluation of the Effect of Fasting and Exercise on Uptake of Tc-99m Sestamibi in Breast Tissue
Condition: Molecular Imaging
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine if exercise, fasting, or eating prior to
      the molecular breast imaging study will have an effect on the uptake of the tracer in the
      breast tissue.
    

Detailed description: 
      The primary objective of this study is to determine if exercise, fasting, or eating prior to
      a molecular breast imaging study will have an effect on the uptake of the radiotracer Tc-99m
      sestamibi in the breast tissue.

      Tc-99m sestamibi is primarily extracted by the liver. Changes in hepatic blood flow may
      therefore influence the amount of radiotracer available for uptake in the breast tissue.
    

Intervention name(s): Meal; Exercise; Sestamibi; Caffeine Tablet; External Heating
Intervention type(s): Dietary Supplement; Other; Radiation; Drug; Other
Intervention description(s): effect of meal; effect of exercise; reduce radiation dose; effect of caffeine; Heating Pad and warm blanket robe
Other intervention name(s): Ensure; Tc-99m; 200 mg Vivarin Tablet
Intervention MeSH terms: Caffeine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Normal subjects; Female; Molecular Breast Imaging; Fasting; Exercise; Tracer Uptake; Tc-99m Sestamibi; Prandial status; metabolic status; negative mammogram; Caffeine; External Warming
Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase I, open label trial to determine the Maximum Tolerated Dose (MTD),
      safety, pharmacokinetics, and efficacy of BIBW 2992 (an epidermal growth factor
      receptor(EGFR)inhibitor) to be used in combination with:

        -  radiotherapy alone (in patients with an unmethylated (functioning) MGMT gene regulator)
           or

        -  radiotherapy and Temozolomide (in patients with a methylated (silenced)
           O6-methylguanine-DNA methyltransferase gene (MGMT) to treat newly diagnosed patients
           with Grade IV Glioblastoma (primary brain cancer).
    


Intervention name(s): Temozolomide; Radiotherapy; BIBW2992; Radiotherapy; BIBW2992
Intervention type(s): Drug; Procedure; Drug; Procedure; Drug
Intervention description(s): During RT: 75 mg/m2 daily , 4 weeks after RT: given days 1 to 5 of 28 day cycles (150 mg/m2 in cycle 1, 200 mg/m2 in cycle 2 up to cycle 6); Day 1 to day 42; Escalating dose cohorts during Radiotherapy(RT) period, fixed dose after RT; Day 1 to day 42; Escalating dose cohorts during Radiotherapy(RT) period , fixed dose after RT
Intervention MeSH terms: Temozolomide; Afatinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment