bioihbjkbjnl/mcl2 huggingface dataset:
Tenofovir Plus Entecavir vs. Tenofovir in Adefovir-Resistant Chronic Hepatitis B
Condition: Chronic Viral Hepatitis B Without Delta-agent
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      With the availability of potent nucloes(t)ide analogues (NA), such as tenofovir disoproxil
      fumarate (TDF) and entecavir (ETV), suppression of serum HBV DNA to undetectable levels by
      polymerase chain reaction (PCR) assays became achievable in most NA treatment-naïve patients.
      Until recently, however, many patients commenced antiviral treatment with inferior NAs prior
      to the availability of TDF or ETV, such as lamivudine (LAM) or adefovir (ADV) which has a low
      genetic barrier to resistance.

      For patients who developed genotypic resistance against ADV, the efficacy of TDF monotherapy
      is controversial. In recent studies, TDF monotherapy produced significant suppression of HBV
      replication. However, only half of patients with initial ADV resistance achieved an
      undetectable viral load (<15 IU/ml) with 48 weeks of therapy.

      On the other hand, there was a retrospective cohort study reporting that, with the
      combination of TDF and ETV, most of patients became HBV DNA undetectable after median 6
      months of treatment. Probability of reaching complete HBV DNA suppression was not decreased
      in patients with ADV or ETV resistance.

      Together, these observations indicate that there is a controversy about the efficacy of TDF
      monotherapy in patients with genotypic resistance to ADV.

      Thus, in this clinical trial, the investigators will clarify whether tenofovir monotherapy is
      effective in inducing complete virologic response compared with tenofovir plus entecavir in
      CHB patients with genotypic resistance to ADV and partial virologic response to ongoing
      treatment.
    

Detailed description: 
      A multi-center randomized active-controlled open-label trial

        -  Patients will be randomly assigned 1:1 to receive tenofovir (300 mg/day) or tenofovir
           (300 mg/day) plus entecavir (1 mg/day) for 48 weeks.

        -  Because over 98% of Korean patients with CHB have HBV genotype C, HBV genotype will not
           be determined or be regarded as a stratification factor.

        -  Patients' treatment information before randomization will be retrospectively
           collected.(DNA change, HBeAg status, HBsAg titre, ALT, and treatment duration. etc)

        -  Patients will be screened within 4 weeks before randomization to determine study
           eligibility.
    

Intervention name(s): Tenofovir; Entecavir; Tenofovir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tenofovir 300mg daily Oral; Entecavir 1 mg daily Oral; Tenofovir 300mg daily Oral
Other intervention name(s): Viread; Baraclude; Viread
Intervention MeSH terms: Tenofovir; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resistance of Adefovir
24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients
Condition: Renal Transplant
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to compare the cardiovascular profile of an everolimus and
      mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic
      acid regimen in maintenance renal transplant patients
    


Intervention name(s): Everolimus; Tacrolimus; Mycophenolic acid (MPA)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Everolimus was supplied in boxes with 60 tablets. Available tablets: 1.0 mg, 0.5 mg and 0.25 mg.; Tacrolimus was administrated as Prograf® or Advagraf®, but could not be changed during study.; Myfortic® (MFS) was given as 720-1440 mg/day or 360-1440 mg/day. Cell-Cept® (MMF) was given as 1000-2000 mg/day or 500-2000 mg/day.
Other intervention name(s): Certican®; Prograf®, Advagraf®; Myfortic®; Cell-Cept®
Intervention MeSH terms: Mycophenolic Acid; Everolimus; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal transplant, everolimus, cardiovascular profile, CNI-free immunosuppression, left ventricular hypertrophy, biopsy proved acute rejection (BPAR)
ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations
Condition: Globus; Deglutition Disorders
MeSH terms: Deglutition Disorders; Globus Sensation
Study type: Interventional

Summary: 
      Globus sensations are associated with gastroesophageal reflux disease as well as the presence
      of a gastric inlet patch. No controlled trial exists on whether ablation of the cervical
      heterotopic mucosa may lead to improvement of chronic globus sensations. The aim of this
      sham-controlled trial is to clarify whether argon-beamer-ablation of cervical heterotopic
      gastric inlet patches of the esophagus improves patients' chronic globus sensations.
    

Detailed description: 
      Some data suggest that ablation of gastric inlet patches by argon beamer therapy might lead
      to alleviation of chronic globus sensation or sore throat. Acid reflux or its treatment is
      unlikely to influence these results (Meining et al. Argon plasma ablation of gastric inlet
      patches in the cervical esophagus may alleviate globus sensation: a pilot trial. Endoscopy.
      2006 Jun;38(6):566-70). Within the present study we will perform a randomized,
      sham-controlled and blinded trial, where patients with heterotopic gastric mucosa (HGM) of
      the cervical esophagus and globus sensations (a chronic or intermittent lump in the throat
      for at least 3 months) are going to be randomized after histological verification of HGM in
      the study center (Technical University Clinic Munich). Either a beamer ablation of HGM or a
      sham-therapy will be performed after patients complete a validated questionnaire. Patients
      are blinded for 3 months, then after completing another questionnaire endoscopy is repeated.
    

Intervention name(s): Beamer Ablation (Argon Plasma Coagulation)
Intervention type(s): Radiation
Intervention description(s): APC-Beamerablation of heterotopic gastric mucosa
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Treatment
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function
Condition: Liver Dysfunction
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label, non-randomized, 1:1 parallel control and single dose
      administration study design. Healthy subjects will be matched to moderate hepatic function
      impaired (Child-Pugh B，7-9) subjects in age, gender and weight as parallel control, which
      matches healthy with normal hepatic function according to the of subjects with impaired
      hepatic function as, after enrollment of subjects with moderate impaired hepatic function
      (Child-Pugh B，7-9). Hepatic function impaired group and control group both receive orally
      single-dose of nemonoxacin malate capsule (0.5g). Collect the blood and urine samples before
      and after the administration to perform pharmacokinetic analysis and safety observation.
    

Detailed description: 
      Single dose study: evaluate safety and tolerability of oral nemonoxacin capsule 500mg.
    

Intervention name(s): Nemonoxacin
Intervention type(s): Drug
Intervention description(s): Single dose 500mg oral
Other intervention name(s): Nemonoxacin Malate Capsules
Intervention MeSH terms: Nemonoxacin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Limb Cooling in Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Observational

Summary: 
      Essential Tremor (ET) is characterized by tremors affecting the arms. The investigators will
      examine the effects of non-pharmacological limb cooling on clinical and physiological
      characteristics in patients presenting with ET at three different temperatures; and will
      measure changes in tremor amplitude after cooling of the upper limb.
    

Detailed description: 
      Once the subject has agreed to participate in the study the following assessments will be
      performed.

      Three non-pharmacological assessments will be performed at different temperature to the upper
      limbs. The first will be a baseline assessment with upper limbs maintaining a normal body
      temperature (96-98°F). The second assessment will be performed with upper limbs at a
      temperature of 59°F and the third will be performed at a temperature of 80°F for a period of
      10 minutes. At the end of 10 minutes, tremor measurements will be 15, 40, and 60 minutes.

        1. Assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery
           (HAB) and the Functional Dexterity Test (FDT).

        2. The Bagnoli and Trigno EMG systems will record surface EMG signals from muscles and
           accelerometer readings.
    

Intervention name(s): Limb Cooling Assessment of ET
Intervention type(s): Procedure
Intervention description(s): The non-pharmacological treatment assessments of limb cooling will take place for the subjects which will include the upper limbs. Both clinical and physiological recordings will be measured for a difference in tremors at three different temperatures. 1)baseline assessment maintaining a normal body temperature (96-98°F). 2) at a temperature of 59°F and 3) at a temperature of 80°F for a period of 10 minutes. The clinical assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT). In addition, the Bagnoli and Trigno EMG systems to record surface EMG signals from muscles and accelerometer readings.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators will enroll 24 subjects diagnosed with Essential Tremor (ET) and 24
        subjects with no diagnosed of ET.
Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether VPI-2690B Injection is effective in the
      treatment of diabetic nephropathy.
    


Intervention name(s): VPI-2690B low dose; VPI-2690B medium dose; Placebo to match VPI-2690B; VPI-2690B high dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Comparison of different doses of study drug; Comparison of different doses of study drug; Comparison of different doses of study drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Rotational Angiography in Cryoballoon Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      There is still unresolved question weather preprocedural imaging of left atrium and pulmonary
      veins is needed before the pulmonary vein isolation procedure for the treatment of atrial
      fibrillation. The investigators are conducting a randomized study to determine if 3D
      rotational angiography (as a mode of preprocedural imaging) performed before the cryoballoon
      ablation, facilitates the procedure and has positive impact on procedure characteristics and
      outcomes.
    

Detailed description: 
      Around 50% of cardiac electrophysiology (EP) centers are using some kind of imaging to define
      left atrium and pulmonary vein anatomy before the pulmonary vein isolation (PVI) procedure.
      Most commonly, CT or MR are performed few days/weeks before the procedure. Three dimensional
      rotational angiography is least commonly used. However it has the advantage that it can be
      performed in the EP room just before the ablation procedure. There is still no consensus if
      any kind of imaging is really needed to perform safe and effective PVI.

      The investigators want to determine if 3D rotational angiography (as a mode of preprocedural
      imaging) has positive impact on procedure safety and efficacy. Also the investigators want to
      compare the immediate procedure characteristics. The investigators are conducting a
      randomized study with 1:1 randomization and planning to enroll around 100 participants with 1
      year follow up.
    

Intervention name(s): Rotational angiography
Intervention type(s): Procedure
Intervention description(s): Preprocedural imaging before ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: preprocedural imaging; Atrial Fibrillation; Rotational angiography
Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
Condition: Peripheral Artery Disease; Peripheral Vascular Disease; Critical Limb Ischemia
MeSH terms: Vascular Diseases; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections
      for the treatment of CLI patients.
    


Intervention name(s): PLX-PAD
Intervention type(s): Biological
Intervention description(s): IM injection
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Artery Disease; Peripheral Vascular Disease; Critical limb ischemia; PAD; CLI
Effect of Exercise on Muscle Proteome Signature
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to investigate skeletal muscle proteome signature changes induced by
      exercise training in young men
    

Detailed description: 
      Advances in omics technologies have allowed for the identification of biomarkers with
      importance for the beneficial adaptations imposed by exercise training. Skeletal muscle
      exhibits remarkable plasticity to exercise training, as illustrated by pronounced alterations
      to the proteomic landscape, such as mitochondrial biogenesis. However, despite recent
      advances that have helped describe the proteomic landscape in response to a period of
      exercise training, our understanding of the processes pertaining to post-translation
      modification is scant. In this study, we aim to investigate the human acetylome and proteome
      in response to exercise training.
    

Intervention name(s): exercise training
Intervention type(s): Other
Intervention description(s): subjects complete 4-5 weeks of training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Volumetric Monitoring in Major Lung Surgery
Condition: Pneumonectomy; Acute Pulmonary Edema
MeSH terms: Pulmonary Edema; Edema
Study type: Observational

Summary: 
      The hypothesis of this observational single-center clinical study was to explore the
      volumetric hemodynamic monitoring in the perioperative period in major and risky thoracic
      intervention. The investigators monitored the changes in the volumes of blood in the central
      vessels and heart chambers as well as a volume of fluid in pulmonary tissue (i. e.
      extravascular lung water).
    

Detailed description: 
      The goal of this observational study is to investigate into changes in volumetric hemodynamic
      parameters obtained with a technique of transpulmonary indicator dilution after major
      thoracic intervention, including pneumonectomy and lobar resections. The important parameters
      of hemodynamics were monitored throughout the intervention and 48 hrs postoperatively,
      including extravascular lung water index, global end-diastolic volume index, etc.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes the patients scheduled for extended thoracic resections
        (lobar resection and pneumonectomy) due to bronchial cancer or severe destructive pulmonary
        infection (abscess and/or pneumonia).
      
Biospecimen description: 
      Blood plasma for non-specified additional retrospective tests.
    
Keywords: postpneumonectomy pulmonary edema; extravascular lung water
Protection Against Benzene Toxicity
Condition: Leukemia; Aplastic Anemia
MeSH terms: Anemia, Aplastic
Study type: Observational

Summary: 
      We are investigating the role of an enzyme (NQO1) in protection against the bone marrow
      toxicity of the occupational and environmental toxicant benzene. All of the proposed studies
      involve use of human bone marrow cells in-vitro to define mechanisms of NQO1-mediated
      protection. Cells are obtained from healthy volunteers and protocols have undergone IRB
      review and approval.
    


Time perspective: Prospective
Keywords: NQO1; DT-diaphorase; Benzene; Leukemia; Aplastic anemia
Reverse Shoulder Replacement: Age 60 or Younger Outcomes
Condition: Shoulder Arthritis
MeSH terms: Arthritis
Study type: Observational

Summary: 
      The purpose of this study is to assess the early outcomes following Reverse Shoulder
      Arthroplasty (RSA) in patients sixty years or younger for the purpose of characterizing these
      patients, evaluating their clinical outcomes and radiographic appearance.The investigators
      would like to know how quickly they are healing and returning to their baseline activities of
      daily living and ability to work. This will help when counseling patients prior to surgery as
      it will give us a better defined and study supported understanding of the post-operative
      recovery timeline in the younger population.
    

Detailed description: 
      This study is looking at patients who are sixty years or younger at the time of they undergo
      a reverse total shoulder replacement. This is an important population to look at their
      functional and clinical outcomes as they are often still employed and have more physical
      demands upon their shoulder in everyday life than the older replacement population for which
      there are more outcome data available. The investigators would like to determine how the
      younger population is healing and returning to their baseline activities of daily living and
      ability to work. This will help when counseling patients prior to surgery as it will give us
      a study supported understanding of the post-operative recovery timeline in the younger
      population. The investigators will review x-rays to evaluate healing at two years. Functional
      surveys are given pre and post operatively (1 & 2 years) and these will be reviewed as well.
      A physical exam is also performed to determine range of motion pre and post operatively (1 &
      2 years).
    

Intervention name(s): shoulder x-ray
Intervention type(s): Diagnostic Test
Intervention description(s): post operative shoulder x-ray at minimum 2 year post op
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients age 60 or younger who are will undergo or have undergone a primary reverse
        shoulder arthroplasty with a single implant system by one of our four surgeons.
      
Keywords: reverse total shoulder arthroplasty; 60 years old or younger; outcomes
Ex Vivo Effect of Surfactant Protein D on Pulmonary Cells in Patients With Asthma and Pilot Study to Assess Local Inflammation Induced by Segmental Allergen Challenge by Magnetic Resonance Imaging
Condition: Mild Intermittent Asthma (Gina 1)
MeSH terms: Asthma; Inflammation
Study type: Interventional

Summary: 
      Ex vivo effect of fragments and modified forms of surfactant protein D on pulmonary immune
      cells derived from bronchoalveolar lavage after segmental allergen challenge in patients with
      asthma and pilot study to assess local inflammation induced by segmental allergen challenge
      by magnetic resonance imaging.
    

Detailed description: 
      The effect of surfactant protein D under native and altered conditions will be investigated
      in immune cells that are derived from bronchoalveolar lavage in patients with allergic asthma
      following segmental allergen challenge. The goal of this study is to elucidate the pro-
      versus anti-inflammatory function of SP-D molecules and to identify motifs of SP-D that have
      treatment potential in allergic asthma and to assess local inflammation induced by segmental
      allergen challenge by magnetic resonance imaging.

      In addition to the patients with allergic asthma a subgroup of five healthy subjects will be
      included into the study to elucidate the specificity of the SP-D (surfactant protein-D)
      effect on the allergic inflammation in the invitro models.

      The primary objective of this study is to isolate BAL cells for different invitro experiments
      and to assess local inflammation after segmental allergen challenge by MRI in response to the
      applied allergen dose.

      Therefore, following a baseline BAL, allergen (2× individual dose, 1× one tenth of individual
      dose) and saline (1×) will be instilled into four different lung segments during a first
      bronchoscopy. After 24 hours during a second bronchoscopy BAL will be collected in these
      challenged segments to harvest invaded cells for invitro experimentation. In addition,
      bronchial biopsies and epithelial brushes will be taken to assess the degree of local
      inflammation in bronchial mucosa and to study the activation of airway epithelium following
      allergen challenge.
    

Intervention name(s): Bronchoscopy
Intervention type(s): Other
Intervention description(s): In brief, during the first bronchoscopy a baseline BAL and baseline endobronchial brush and forceps biopsies will be obtained and allergen as well as saline (control segment) will be instilled.
The subjects will undergo a second bronchoscopy in order to obtain BAL from the allergen challenged segments and the saline challenged segment, and endobronchial forceps biopsies.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science