bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Observational

Summary: 
      In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN
      study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs
      level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test
      every year from the second year to the fifth year after the ending of peginterferon alfa
      treatment, and long-term benefit of interferon treatment will be evaluated.
    


Intervention name(s): Peginterferon Alfa-2B; Peginterferon Alfa-2A
Intervention type(s): Drug; Drug
Intervention description(s): pre-received standard peginterferon alfa-2b therapy; pre-received standard peginterferon alfa-2a therapy
Other intervention name(s): pegberon; pegasys
Intervention MeSH terms: Peginterferon alfa-2a; Peginterferon alfa-2b
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic hepatitis B who previously participated in TB1211IFN study.
      
Biospecimen description: 
      plasma, hemocyte
    
Keywords: peginterferon alpha; HBeAg seroconversion; immune control
Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, single dose, randomized, parallel group study in healthy adult
      subjects to assess the comparability of bococizumab administered in a prefilled syringe vs.
      prefilled pen and comparability between drug substance manufactured at Pfizer Andover vs.
      Boehringer Ingelheim Pharma.
    


Intervention name(s): bococizumab PFS:Pfizer; bococizumab PFS: BIP; bococizumab PFP
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Pfizer Andover; 150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma.; 150 mg bococizumab administered SC in a prefilled pen using drug substance manufactured at Pfizer Andover
Intervention MeSH terms: Bococizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PK, bococizumab, comparability, LDL-C
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads
      to greater improvement in insulin secretion as compared with placebo infusion. Insulin
      secretion will be assessed using mixed meal-stimulated C-peptide.

      Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3
      otelixizumab, 1/3 placebo). These study agents will be administered as an addition to
      insulin, diet, and other physician determined standard of care treatments.

      DEFEND-1 is now closed to enrollment.

      DEFEND-2 will begin early in 2010. It is very similar to DEFEND-1 and will again require
      subjects with new onset type 1 diabetes. Please check back here for more details.

      In the meantime, established and new onset type 1 diabetes patients in North America are
      welcome to consider the TTEDD study:

      http://www.clinicaltrials.gov/ct2/show/NCT00451321?term=TTEDD&rank=1
    

Detailed description: 
      The following visits are required:

        -  Screening Visits: 2 to 3 appointments will be conducted to determine eligibility. At 2
           of these visits participants will drink a liquid meal and have blood tests done over the
           post-meal period.

        -  Dosing Visits: 8 outpatient visits on consecutive days, each lasting about 4-6 hours.

        -  Follow-up Visits: weekly for the first month, then every 2 weeks for 3 months, followed
           by monthly visits through 1 year. There will be 3 visits in the second year.

        -  The total duration of the study is 2 years.

        -  Glucose test strips, glucose monitors and PDAs to record insulin will be provided to all
           study subjects for the duration fo the study. Frequent glycemic monitoring will occur
           through lab testing and blood glucose self-monitoring to help facilitate tight glycemic
           control in all subjects.
    

Intervention name(s): otelixizumab infusion plus physician determined standard of care; placebo infusion plus physician determined standard of care
Intervention type(s): Biological; Biological
Intervention description(s): infusion; infusion
Other intervention name(s): monoclonal antibody; ChAglyCD3; anti-CD3; TRX4
Intervention MeSH terms: Muromonab-CD3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 1 diabetes; new onset type 1 diabetes; T1DM; Type l diabetes; juvenile diabetes
Anti-Inflammatory Activities of Grapes in Humans at Risk for Cardiovascular Disease
Condition: Obesity; Inflammation
MeSH terms: Cardiovascular Diseases; Inflammation
Study type: Interventional

Summary: 
      The goal of the study is to determine whether grape consumption can reduce the risk of
      cardiovascular disease by reducing the presence of inflammatory molecules and positively
      altering cholesterol levels, lipid profiles, and immune cell responses.
    

Detailed description: 
      Obese individuals are at high risk for the development of hypertension and cardiovascular
      disease. Adipose tissue is a major source of pro-inflammatory molecules which can promote the
      development of atherosclerosis. Development of atherosclerotic plaques are mediated by
      oxidized or otherwise modified LDL cholesterol and infiltration of activated immune cells
      into the atherosclerotic lesions. Grapes contain high levels of polyphenols, a class of
      compounds known to possess antioxidant and anti-inflammatory properties. The overall goal of
      this proposal is to determine whether grape consumption can reduce the risk of cardiovascular
      disease by reducing the presence of inflammatory molecules and positively altering
      cholesterol levels, lipid profiles, and immune cell responses. Using a randomized cross-over
      design, twenty obese subjects will consume beverages containing either four servings of grape
      powder per day or the caloric equivalent without grape powder (placebo control) for a total
      of three weeks. After a two week washout period, the beverages will be switched for a further
      three weeks. Blood will be taken from each person at six intervals to determine lipid
      profiles, measure inflammatory markers in plasma, and analyze immune cell responsiveness.
    

Intervention name(s): Grape powder, followed by placebo powder; Placebo powder followed by grape powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): For three weeks, twice per day, volunteers will consume one packet of freeze-dried grape powder containing the equivalent of approximately 2 servings of fresh grapes (46 grams of powder) stirred into water. Following a two week washout, volunteers will consume one packet of placebo powder twice per day for three weeks.; For three weeks, twice per day, volunteers will consume one packet of placebo powder stirred into water. Following a two week washout, volunteers will consume one packet of freeze-dried grape powder containing the equivalent of approximately 2 servings of fresh grapes (46 grams of powder) twice per day for three weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluation of SVV From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery
Condition: Fluid Responsiveness; Prone Position; Non Invasive Cardiac Output Monitoring
Study type: Observational

Summary: 
      NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices
      derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the
      previous studies. However, its usefulness in prone positioning has not been investigated.
      Thus, the aim of this prospective observational study is to evaluate the usefulness of stroke
      volume variation (SVV) derived from NICOM® to predict fluid responsiveness in prone patients
      undergoing spine surgery.
    


Intervention name(s): Fluid loading to evaluate fluid responsiveness
Intervention type(s): Other
Intervention description(s): loading of hydroxyethyl starch 6ml/kg over 10-15min to all patients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing spine surgery under general anesthesia in prone position
      
Keywords: Fluid responsiveness; NICOM; Prone Position; Stroke Volume Variation
Multiple Ascending Doses of SY-009 in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase Ib placebo-controlled study to assess safety, tolerability, pharmacokinetics
      and pharmacodynamics of SY-009 after Multiple Ascending Doses in patients with Type 2
      Diabetes Mellitus (T2DM).
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, dose-increasing,
      multiple oral administration clinical trial. The planned dose escalation levels were 1, 2, 3
      and 4 mg daily (6 dose groups).

      After the completion of the test and safety evaluation of the initial dose of 1mg daily dose
      in two groups (0.5mg bid and 1mg QD), the main researchers of the team leader and the sponsor
      jointly determine whether to enter the 2mg daily dose study.

      After the completion of the test and safety evaluation of two groups (1mg bid and 2mg QD) of
      2mg daily dose, the main researchers of the group leader and the sponsor jointly determine
      whether to enter the 4mg daily dose study.

      If the test and safety assessment of 4mg daily dose group (2mg bid) are completed and the
      dose termination standard is not met, the test will be terminated; if the safety assessment
      during or after the test reaches the dose termination standard, the study of 3mg daily dose
      group (1.5mg bid) will be carried out, and then the test will be terminated.
    

Intervention name(s): SY-009; SY-009 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): The subjects were admitted to the clinical trial center two days before the administration period (D-2), fasted for 10 hours overnight on the day before the Administration (D-1), and banned water for 1 hour before the administration. Take sy-009 test drug or placebo immediately before meal (QD is before breakfast, bid is before breakfast and dinner) in the morning of the first day of administration, and deliver it with not more than 200ml warm boiled water. From the day 2 (D2) to the day 7 (D7) before dinner, the oral cavity of the subjects was checked for residual drugs after each administration.; SY-009 matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Forteo Alendronate Comparator Trial
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to evaluate the effects of teriparatide with those of
      alendronate on spine bone mineral density (BMD) and other osteoporosis factors in
      postmenopausal women with osteoporosis.
    


Intervention name(s): Teriparatide; Alendronate; Calcium; Vitamin D; Placebo-Oral; Placebo-SC
Intervention type(s): Drug; Drug; Dietary Supplement; Dietary Supplement; Drug; Drug
Intervention description(s): Administered SC; Administered orally; Administered orally; Administered orally; Administered orally; Administered SC
Other intervention name(s): LY333334; Forteo; Forsteo
Intervention MeSH terms: Vitamin D; Alendronate; Teriparatide; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
      It may also help doctors predict how well patients respond to treatment.

      PURPOSE: This laboratory study is looking at tissue samples from patients with acute myeloid
      leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine gene expression, genome integrity, cytosine methylation, and chromatin
           structure in patients with normal cytogenetics leukemia (NCL) acute myeloid leukemia.

        -  Determine whether NCL can be deconstructed into specific disease entities by analysis of
           the integrated genomic and epigenomic datasets using supervised and unsupervised methods
           in these patients.

        -  Identify the gene pathways that define NCL subtypes and molecular targets for validation
           in preclinical and clinical trials for these patients.

        -  Determine whether integrated analysis provides markers of prognostic and therapeutic
           response that accurately predicts clinical outcome and can be used to select patients
           for risk-stratified therapeutic trials.

      OUTLINE: This is a pilot, multicenter study.

      Samples are analyzed to assess array comparative genomic hybridization using polymerase chain
      reaction (PCR) and fluorescent in situ hybridization; chromatin immunoprecipitations (chip)
      using PCR; Hpa II tiny fragment enrichment by ligation-mediated PCR (HELP) using DNA
      methylation analysis; and gene expression profiling.

      PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
    

Intervention name(s): DNA methylation analysis; comparative genomic hybridization; fluorescence in situ hybridization; microarray analysis; polymerase chain reaction; diagnostic laboratory biomarker analysis; immunologic technique
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Keywords: adult acute myeloid leukemia in remission; recurrent adult acute myeloid leukemia; untreated adult acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22)
Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion
Condition: Gram-Negative Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent
      dosage regimen has shown observable outcomes. Our objective is to assess whether continuous
      infusion of piperacillin/tazobactam is superior in terms of efficacy, safety and cost to the
      intermittent regimen to treat suspected or proved infections due to gram negative bacteria.
      The setting is Critical Care Medicine Department at Cairo University Hospitals. Methods A
      prospective randomized comparative study.
    

Detailed description: 
      A total of 56 patients were recruited from ICU- Cairo University Hospitals. All adult
      critically ill patients admitted to Critical Care Medicine Department with suspected or
      confirmed bacterial infections on admission or during their ICU stay were assessed for
      inclusion into the study. All patients were subjected to the following: A. Patient's full
      history: Age, sex ,medical history ,concurrent diseases, concurrent medications

      B. Patient evaluation and assessment:

      The following were evaluated at baseline and periodically thereafter until day of stopping
      antibiotic, discharge and/or death :

        1. Kidney functions (Serum creatinine, blood urea nitrogen)

        2. Liver functions (ALT, AST, Bil D, Bil T, Albumin)

        3. Complete blood count

        4. Microbiological Evaluation: Cultures and sensitivity tests from suspected site of
           infection

        5. Clinical signs and symptoms of infection documented by the attending physician on
           patient's medical record

        6. APACHE II Variables
    

Intervention name(s): Piperacillin/Tazobactam Continuous infusion; Piperacillin/Tazobactam Intermittent infusion
Intervention type(s): Drug; Drug
Intervention description(s): Continuous infusion; Intermittent infusion
Other intervention name(s): Piprataz injection; Piprataz injection
Intervention MeSH terms: Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotics; Beta-lactams; Continuous administration
Long-term Effect of The Mother Infant Transaction Program (MITP)
Condition: Premature Births
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to investigate if a cost and time effective intervention in a
      previous RCT for preterm infants and their parents can reduce the parents experience of
      concern and stress, and improve the childrens development in various aspects at three years
      of corrected age.

      Hypothesis 1: The preterm born children of parents who were enrolled in the earlier RCT have
      a higher developmental level then preterm children of parents who received the usual
      treatment.

      Hypothesis 2: Parents who who were enrolled in the earlier RCT will have a lower level of
      stress and concern then parents who received treatment as usual.
    

Detailed description: 
      A previous RCT by Ravn (NCT00245843) investigated if the MITP could sensitize the mothers
      toward the babies signals and thereby increase the quality of joint attention. The study
      followed the children for 1 year.

      This study is a follow-up to the above mentioned RCT. It investigates whether the effect of
      the RCT is present at three years corrected age.

      The research questions are:

        1. Can a psychoeducative program like the MITP influence the childrens' development in
           various aspects?

        2. How did the MITP influence the parents experience of concern and stress three years
           later?

        3. Were there any differences by the groups? a) Preterm intervention group b)Preterm
           control group c) Full term control group

      The questionnaires to be used in this observational study are:

      Ages and Stages
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        The cohort is 42 preterm infants in the intervention group, 40 preterm and 40 full term in
        control groups.
      
Keywords: Premature babies; Social interaction; Psychoeducative intervention; Mother Infant Transaction Program; Three years follow-up; Late preterm; Cognitive development; Social development; Emotional development; Motor development; Children born preterm and their parents
Randomized Trial of EUS Neurolysis in Pancreas Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a clinical trial to determine more effective methods of controlling the pain in
      pancreatic cancer. Although narcotic pain medication are effective, they have many side
      effects and are underutilized due to social stigma and fear of addiction. Celiac plexus
      neurolysis is a nerve block procedure that has been shown to be effective in uncontrolled
      clinical trials. We hypothesized that celiac plexus neurolysis plus pain medication will be
      more effective and have fewer side effects than pain medication alone. We are evaluating the
      effectiveness of this standard pain medications with or without celiac plexus neurolysis in a
      randomized controlled trial. One half of the participants will receive pain medications only
      and the other half will receive pain medications plus neurolysis, delivered via an endoscopic
      ultrasound device placed in the stomach.
    

Detailed description: 
      This is a phase III randomized blinded sham controlled trial of endoscopic ultrasound guided
      celiac plexus neurolysis. Patients with pancreatic cancer who are unresectable and who have
      significant pain (> 3 on 0-10 scale) will be enrolled. At the time of a staging endoscopic
      ultrasound, patients will be randomized to celiac neurolysis or sham (injection of same
      medication into lumen of stomach). Neurolysis will be performed using standard bupivicaine
      and ethanol. Patients will be followed for at least 3 months for pain, quality of life and
      narcotic usage.
    

Intervention name(s): Celiac Plexus Neurolysis
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pancreatic neoplasm
HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial Substrate
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Aim of the present prospective, single-centre study is to determine the outcome after pure
      PVI using HeartLight™ in 100 patients with different extents of LA-LVA.

      The latter will be assessed by an electro-anatomical voltage map using a commercial 3D
      mapping system (CARTO, Biosense Webster).
    

Detailed description: 
      The ablation strategy for patients with atrial fibrillation (AF) and concomitant atrial
      substrate (e.g. low-voltage areas; LVA) is a matter of controversy.

      Results of studies investigating the impact of LVA may have been confounded by
      PV-to-left-atrial (LA) reconnection due to non-durable ablation. Therefore, the true
      contribution of LA-LVA to AF recurrences remains unknown.

      Meanwhile, new ablation technologies such as the HeartLight™ laser balloon (LB) ablation
      system providing near complete chronic PVI rates have been developed.

      Aim of the present prospective, single-centre study is to determine the outcome after pure
      PVI using HeartLight™ in 100 patients with different extents of LA-LVA.

      The latter will be assessed by an electro-anatomical voltage map using a commercial 3D
      mapping system (CARTO, Biosense Webster).
    

Intervention name(s): PVI with HeartLight
Intervention type(s): Device
Intervention description(s): Catheter ablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment