bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Fructose Consumption on Intestinal Permeability in Non-alcoholic Fatty Liver Disease (NAFLD) - a Pilot Study.
Condition: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The spectrum of NAFLD as emerging epidemic ranges from steatosis to steatohepatitis (NASH),
      cirrhosis and hepatocellular carcinoma (HCC). Disease progression is poorly understood and
      treatment options are limited. Fructose overconsumption has been associated with gut
      permeability and progression of NAFLD. To unravel the mechanisms of fructose-induced
      intestinal changes, volunteers will receive a 4-week fructose challenge prior to assessment
      of intestinal permeability/translocation using endomicroscopy, sugar probes, serum markers of
      intestinal damage, inflammation, iron/copper homeostasis and histological/molecular analysis
      of intestinal biopsies. Findings in volunteers will be compared with liver patients
      undergoing study procedures without fructose challenge. Translational in vitro experiments
      will explore cellular responses to fructose and endotoxin. This project should provide novel
      insights into dietary induced alterations of the gut integrity in progression of NAFLD to
      NASH.
    


Intervention name(s): High oral Fructose challenge (150g per day for 28 days)
Intervention type(s): Dietary Supplement
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: non-alcoholic fatty liver disease; non-alcoholic steatohepatitis; NAFLD; NASH
Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells
      that remain after surgery.

      PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel
      works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected
           stage I, II, or IIIA non-small cell lung cancer.

      Secondary

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the survival patterns of patients treated with this regimen.

        -  Assess the patterns of recurrence in patients treated with this regimen.

      OUTLINE: Patients receive carboplatin IV on day 1 and docetaxel IV on day 1. Treatment
      repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 3 years.
    

Intervention name(s): carboplatin; docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25); 75 mg/m² intravenously, once, every 3 weeks
Other intervention name(s): paraplatin; Taxotere
Intervention MeSH terms: Carboplatin; Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer
Cardiorespiratory Responses to Treadmill Running at Different Slopes
Condition: Cardiorespiratory Responses; Well-trained Athletes
Study type: Interventional

Summary: 
      The purpose of this study is: i) to determine if maximal oxygen uptake in downhill running is
      significantly different versus flat or uphill running, and ii) to compare cardiorespiratory
      and muscle fatigue responses to uphill vs flat and downhill running at similar running
      velocity and similar metabolic power. The investigators hypothesized that maximal oxygen
      uptake will be lower in downhill running. The investigators also anticipate attenuated
      cardiorespiratory and muscle fatigue responses to downhill running when compared to flat or
      uphill running performed at similar velocity but not when the comparison is done at similar
      metabolic power.
    


Intervention name(s): Each participant will perform:
Intervention type(s): Other
Intervention description(s): Part 1: Maximal incremental tests will require running at fixed slopes (+15%, 0% -15%) for stages (2min duration) of increasing velocities (0.5, 1 and 1.5 km/h) Part two: submaximal running tests will require running at constant velocity (80% VO2max uphill; 80%VO2max downhill and downhill at similar velocity as uphill)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Living Experience of Hong Kong Chinese Adolescents With CHD.
Condition: Congenital Heart Disease; Psychological Well-being; Quality of Life; Adolescent; Chinese
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational [Patient Registry]

Summary: 
      This study aims to explore the impacts of CHD and its limitations on adolescents and the
      living experience of adolescents living with CHD.

      Hong Kong Chinese adolescents with CHD are having reduced psychological well-being and
      quality of life than their healthy counterparts. Qualitative study is therefore needed to
      explore how CHD may impact on the adolescents' psychological well-being and quality of life.
    

Detailed description: 
      A qualitative study was adopted. Purposive sampling of 30 adolescents with CHD were done.
      Thematic analysis was used for data analysis. The participants unfold negative impacts of CHD
      and its treatments, and the challenges they were facing with their relationship with others.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Hong Kong Chinese adolescents with CHD, aged 12 to 18, who are able to read and write
        Chinese, and are attending the outpatient clinic of Department of Pediatric Cardiology.
      
Keywords: Congenital Heart Disease, Hong Kong, Adolescent
Nerve Stimulator Versus Ultrasound-guided Interscalene Block for Shoulder Surgery
Condition: Pain
Study type: Interventional

Summary: 
      The investigators compared the postoperative analgesia of nerve stimulator-guided and
      ultrasound-guided interscalene block after shoulder surgery.
    

Detailed description: 
      Ultrasound (US)-guided peripheral nerve block has increased in popularity. It has many
      advantages such as improved success rate, faster onset time, fewer needle passes, shorter
      performance time, and reduced procedural pain and vascular puncture. However, there is no
      information about postoperative analgesia.

      Therefore, the investigators tested whether nerve stimulator (NS) - guided interscalene block
      was inferior to ultrasound-guided block in terms of duration of postoperative analgesia for
      shoulder surgery.
    

Intervention name(s): NS-guided interscalene block; US-guided interscalene block
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients received a standard single injection interscalene block using the modified lateral approach of Borgeat. The interscalene brachial plexus was identified using an insulated needle connected to a nerve stimulator. An insulated needle attached to a nerve stimulator was used to identify the brachial plexus. Placement of the needle was considered adequate if the deltoid, triceps, pectoralis, or biceps muscle motor response was still present at 0.2 - 0.5mA. Ropivacine 0.75% 20ml was used.; Interscalene block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral interscalene groove visualizing the brachial plexus located between anterior and middle scalene muscles. Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.75% ropivacaine is injected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ultrasound; nerve stimulator
PEWS Implementation in an LMIC Setting
Condition: Oncology
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      The PEWS implementation study will be undertaken with the following objectives:

        1. Assess the effectiveness of implementation of PEWS and resuscitation training to
           identify patients at risk for clinical deterioration and to impact the frequency of
           clinical interventions made by treating providers on these patients.

        2. Assess the effectiveness of implementation of PEWS and resuscitation training to impact
           time sensitive clinical interventions made on patients at risk for clinical
           deterioration.

        3. Assess the impact of implementation of PEWS and resuscitation training on length of stay
           for patients admitted to the pediatric oncology ward.
    


Intervention name(s): pediatric early warning scoring system and resuscitation curriculum
Intervention type(s): Other
Intervention description(s): teaching resuscitation to medical providers and implementing a scoring tool to help identify patients at risk for clinical deterioration in an inpatient setting
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Bilateral Versus Unilateral Lower Limb Training on Balance and Gait Parameters in Stroke Patients
Condition: Stroke, Ischemic; Balance; Distorted; Gait, Hemiplegic
MeSH terms: Stroke; Ischemic Stroke; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      To determine the effects of bilateral versus unilateral lower limb training on balance and
      gait parameters in stroke patients
    

Detailed description: 
      The aim of this study is to compare the effects of bilateral versus unilateral lower limb
      training on balance and gait parameters in stroke patients. The randomized controlled trial
      will recruit the stroke patients will be selected and randomly divided into two groups: Group
      A (unilateral training group (UTG)) and Group B (bilateral training group (BTG)).

      Patients in Group A will undergo approach-oriented training using the motor relearning
      program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the affected side,
      while those in Group B underwent strength training for the lower-limb muscles using Delorme's
      principle for the unaffected side and approach-oriented training using the MRP and PNF for
      the affected side for a period of six weeks, five days per week. A strengthening regimen will
      designed for the unaffected side, considering the frequency, intensity, time, and type
      (FITTs) principle provided by the American College of Sports Medicine (ACSM). The static and
      dynamic balance along with gait parameters will measure using the functional reach test
      (FRT), one-leg stance test (OLST), Berg balance scale (BBS) Dynamic Gait Index (DGI), gait
      parameters (stride length, gait velocity, and cadence), and Brunnstrom recovery stages (BRS)
      at the baseline and post rehabilitation.
    

Intervention name(s): Unilateral training group (UTG); Bilateral training group (BTG).
Intervention type(s): Other; Other
Intervention description(s): stroke patients will be undergone task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the hemi-paretic side; stroke patients will be undergone strength training using frequency, intensity, type, time (FITT) principle to non-hemi-paretic side and task-oriented approach using motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) to hemi-paretic side
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients will be allocated to intervention groups by randomization Patients in group A will be given MRP and PNF techniques to involve side Patients In group B will be given exercises same as above but on unaffected side.The strengthening exercises also given to this group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke, Ischemic; Balance; Distorted; Gait, Hemiplegic
Sorting and Expression Profiling of Airway Cells From Humans (The SEARCH Study)
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This will be a single site, mechanistic study of asthmatic subjects and healthy,
      non-asthmatic controls involving a baseline characterization visit and a research
      bronchoscopy visit. We will identify differences in airway epithelial epigenetic enhancer
      signatures in asthma, by analyzing freshly isolated airway epithelial cells from healthy
      controls and from well-characterized subjects with asthma.
    

Detailed description: 
      The airway epithelium is critical for normal lung function and changes in the epithelium are
      central to the development of asthma. Precise regulation of gene transcription is essential
      for airway epithelial cell differentiation and transcription changes lead to many
      abnormalities seen in asthma. Despite the dominant role of enhancers in regulating
      transcription, little is known about how these DNA regulatory elements control airway
      epithelial cell transcription or about how enhancer activity differs in asthma compared to
      health. Closing this knowledge gap will have a major impact on our understanding of normal
      epithelial development and asthma. In addition, enhancer-based approaches for reprogramming
      the airway epithelium promise to be powerful tools for dissecting mechanism that will set the
      stage for developing a new class of precisely targeted treatments for asthma. Our overall
      goals are to identify enhancers that are important in regulation of key airway epithelial
      cell genes, to determine how enhancer activity changes in asthma, and to develop approaches
      for targeting the activity of these enhancers.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy and asthmatic participants recruited from community advertising
      
Biospecimen description: 
      Bronchial brushes and lavage Sputum, induced Whole blood Urine Serum Plasma
    
Keywords: Asthma
Rocuronium Effective Dose for Laparoscopic Cholecystectomy
Condition: Muscle Relaxation
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an adaptative study where each participant's rocuronium dose will depend on the
      previous patient's response, being higher if it was not enough and lower if it was more than
      enough.
    

Detailed description: 
      Rocuronium is one of the most used neuromuscular blockers to help intubation and to relax
      abdominal wall for laparoscopic surgery.

      Rocuronium intubation dose can be enough for intubation but not last enough for excellent
      laparoscopic conditions. There is little variation in time from anesthesia induction to the
      end of the laparoscopy for cholecystectomy and avoiding excess rocuronium dose can help
      providing excellent conditions and fast track extubation.

      Dixon's up-and-down method will guide this dose-finding study for the ED50.
    

Intervention name(s): rocuronium
Intervention type(s): Drug
Intervention description(s): intravenous rocuronium infusion
Intervention MeSH terms: Rocuronium
Intervention model: Single Group Assignment
Intervention model description: Dose-finding using Dixon's up-and-down adaptative clinical trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2
Condition: Missing Teeth
MeSH terms: Tooth Loss; Anodontia
Study type: Interventional
Phase: Phase 3

Summary: 
      Since there are no clinical studies available comparing the gold standard (autogenous bone
      graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded
      with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the
      present exploratory study has been designed.

      The aim of the present study is therefore to test whether or not the application of a
      xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and
      histologically similar outcomes as the gold standard (autogenous bone block) for the
      regeneration of chronic ridge defects.

      The investigators expect that there is no difference in bone quantity and quality between the
      two methods and that the use of the test treatment will be more user and patient friendly
      according to the patient perception/acceptance since no second surgical site will be
      necessary as well as cause less complications.
    


Intervention name(s): Autogenous bone graft; InductOs; Augmentation surgery
Intervention type(s): Device; Drug; Procedure
Intervention description(s): Bone augmentation will be performed using autogenous bone from the retromolar or chin area followed by a fixation with titanium screws at the recipients site; filled with deproteinized bovine bone mineral (DBBM) particles (Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) and covered with a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland); CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane). One time application at augmentation surgery.; CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Quit and Fit: Teen Smoking Cessation
Condition: Tobacco Use Cessation
Study type: Interventional

Summary: 
      The long term goal of the study entitled "Quit & Fit" was to revise, evaluate, and
      disseminate the American Lung Association´s (ALA) teen smoking cessation program called Not
      On Tobacco (N-O-T), with an added physical activity module. The physical activity module was
      intended to encourage youth to adopt a more physically active lifestyle. Research showed that
      physical activity may increase the odds of smoking cessation. The general N-O-T program goals
      are to help adolescents quit smoking; reduce cigarette use (for participants who are unable
      to completely quit); increase healthy lifestyle behaviors; and improve life skills such as
      stress management, decision making, communication, and interpersonal skills. The primary aim
      of the current research project was to reduce smoking among West Virginia teens. A two-prong
      secondary aim was to (a) increase participants´ physical activity behavior by supplementing
      the intervention with a physical activity component and (b) assess the mediating/moderating
      impact of physical activity on cessation outcomes. If participants quit smoking, the
      likelihood that they will develop smoking-related diseases is diminished. Participating in
      this project may aid smoking cessation and therefore improve participants´ health. Research
      was conducted among 19 of the 123 West Virginia public high schools. 236 teens were recruited
      to participate in the study over 3 years. This study is a clinical behavioral trial using a
      3-group design, with subsequent random assignment.
    


Intervention name(s): Physical Activity Module; Not On Tobacco (N-O-T) Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants were provided pedometers in order to track specific "Step Goals", which were defined for male or female participants. In addition, each participant recorded other forms of physical activity in a "Challenge Log".; Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobacco Use Cessation; Youth Tobacco Use; Physical Activity; Smoking Cessation Intervention
A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of study BMX-02-001 is to evaluate the safety, tolerability and feasibility of
      orally administered BX002-A to deliver viable bacteriophages to the gut.
    

Detailed description: 
      Study BMX-02-001 is a randomized, single-blind, placebo-controlled study to evaluate the
      safety, tolerability, and feasibility of orally administered BX002-A to deliver viable phages
      that can be measured in the stool.
    

Intervention name(s): BX002-A; Placebo
Intervention type(s): Biological; Other
Intervention description(s): bacteriophage cocktail; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Intentional Pulpotomy to Preserve Hopeless Molars
Condition: Pulpitis; Dental Pulp Diseases; Tooth Diseases
MeSH terms: Pulpitis; Tooth Diseases; Dental Pulp Diseases
Study type: Interventional

Summary: 
      When proximal carious lesions of primary molars are located in close proximity to the
      cementum enamel junction (CEJ), marginal seal is challenging and extraction is recommended.
      Pulpotomy is indicated for vital primary teeth to preserve them in function. The goal of this
      study is to monitor the long-term effect of intentional bioactive cement pulpotomies and
      crown coverage performed on vital and asymptomatic carious primary molars with gingival
      margins close to or at the CEJ
    


Intervention name(s): Pulpotomy; Extraction and placement of space maintainer
Intervention type(s): Procedure; Procedure
Intervention description(s): Pulpotomy using bioactive bioceramic cement of 1.5 mm layer of a newly FDA approved calcium-based silicate cement (Nusmile NeoPutty) will be placed on the pulp chamber floor and canals' orifices for pulp and root therapy. Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health.This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, complete caries removal and then access to the pulp chamber using drills.; If during the pulpotomy procedure, hemostasis is not obtainable, or signs of advanced pulp degeneration such as dark and limited or no bleeding from canals, the pulp will be diagnosed as chronically inflamed or necrotic, and tooth will be extracted. As part of the standard of care after extractions of primary molars, space maintenance will be assessed, and a space maintainer fabricated if indicated. Extracted teeth will serve as controls, and information regarding the need or not of space maintenance.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment