bioihbjkbjnl/mcl2 huggingface dataset:
Psychological Factors That Influence Severity of Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Observational

Summary: 
      Objective biomarker of allergic rhinitis severity is necessary for monitoring disease
      severity and response to treatment in clinical setting and for research. We believe that
      psychological factors are the missing link between patient-perceived severity of allergic
      rhinitis and objective biomarkers. In our pilot study, several psychological factors were
      studied in relation to patient reported outcomes for severity of allergic rhinitis.
    

Detailed description: 
      Monitoring allergic rhinitis (AR) severity with objective biomarkers is important for the
      clinical management of patients as well as for research purposes. The most commonly used tool
      for the assessment of AR severity is the Total Nasal Symptom Score (TNSS). Objective
      biomarkers like skin prick test size or specific IgE levels don't correlate with TNSS.

      We studied skin prick test size and specific IgE and several patient reported outcomes
      including symptom score, medication scores, combined score and Juniper mini rhinitis quality
      of life questionnaire (RQLQ). Psychometric evaluation was performed using 5 different
      psychological questionnaires that measure 13 different psychological factors.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects were selected from 185 patients managed in our outpatient clinics with a
        presumptive diagnosis of allergic rhinitis
      
Keywords: skin prick test; specific IgE; patient reported outcome; psychological factor
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain
      in subjects experiencing pain due to diabetic peripheral neuropathy.
    

Detailed description: 
      The purpose of this study is to determine the safety and efficacy of Cesamet™ in the
      symptomatic treatment of pain due to diabetic peripheral neuropathy.

      This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™
      treatment for control of pain due diabetic peripheral neuropathy. The study has two phases: a
      Pretreatment Phase and a Treatment Phase.
    

Intervention name(s): Cesamet™ (nabilone)
Intervention type(s): Drug
Intervention MeSH terms: Nabilone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Simvastatin Reduces Adiponectin Levels and Insulin Sensitivity
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Insulin Resistance
Study type: Observational

Summary: 
      We hypothesized simvastatin may reduce adiponectin levels and insulin sensitivity in
      overweight hypercholesterolemic patients.
    


Observational model: Case-Control
Time perspective: Prospective
Study population: 
        overweight hypercholesterolemic patients
      
Keywords: Lipophilic statins; Insulin resistance; hypercholesterolemic patients
Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain
Condition: Pain, Postoperative
MeSH terms: Chronic Pain; Pain, Postoperative
Study type: Interventional

Summary: 
      Up to our knowledge there is no study focused upon the incidence of post VATS chronic pain
      when dexmedetomidine is used.
    

Detailed description: 
      Most Video-Assisted Throcoscopy Surgery (VATS) procedures are considered low-risk
      interventions requiring short hospital stays or even outpatient settings. Because of these
      factors, VATS did not raise as much interest as thoracotomy in its postoperative pain
      management. However, it is a fact that pain following VATS can be severe and long-lasting
      .According to Richardson and colleagues, 38% of VATS procedures present persistent pain two
      months after surgery as a result of acute nerve damage during the surgical procedure.
    

Intervention name(s): Dexmedetomidine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg); isobaric bupivacaine 0.5% (0.3ml/kg)
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
Condition: Hepatic Impairment; Liver Disease; Pharmacokinetics
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted in order to assess the need for dose adjustment for elafibranor
      in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active
      metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe
      according to Child-Pugh categories) versus healthy participants after a single oral
      administration of elafibranor 120 mg.
    


Intervention name(s): Elafibranor
Intervention type(s): Drug
Intervention description(s): 120mg oral single dose
Other intervention name(s): GFT505
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Feasibility Study of Autologous Bone Marrow Cell Transplantation in Patients With Peripheral Arterial Occlusive Disease (PAOD)
Condition: Arterial Occlusive Diseases
MeSH terms: Arterial Occlusive Diseases; Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with peripheral artery disease, stage III or IV who are not candidates for
      interventional or operative therapy should be treated with intraarterial progenitor cell
      therapy (autologous bone marrow cells) in a randomized, placebo controlled trial.
    

Detailed description: 
      Main goal:

      Improvement of limb perfusion (Ankle brachial index).

      Secondary aims:

      Reduction of pain Reduction of Ulcer size Walking distance Improvement in tissue oxygenation
      (TCO2) Minor or major amputation
    

Intervention name(s): intraarterial stem cell therapy; Stem cells
Intervention type(s): Procedure; Other
Intervention description(s): catheter delivery of stem cells; intraarterial application of bone marrow mononuclear cells versus placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intraarterial administration of BM-MNC or placebo
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: critical limb ischemia; peripheral arterial occlusive disease; [C14.907.137]
Metabolic Effects of Short Term Sugarcane Bagasse Supplementation
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to help understand the benefits of eating food supplemented with
      fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on
      glucose metabolism and body weight.
    

Detailed description: 
      The investigators will employ a double-blind randomized controlled study design with 3 arms
      such that obese, insulin resistant adults will be randomly selected to receive food made with
      1) sugarcane bagasse, 2) non-caloric, non-fermentable fiber, or 3) a similar product with
      minimal fiber for 4 weeks. The intervention will be in the form of brownies and cookies and
      will look and taste nearly identical to each other. Caloric value will be constant with all
      three delivery systems. Subjects will have blood testing and body composition analysis before
      and after the intervention.
    

Intervention name(s): Sugarcane bagasse; Non-caloric, non-fermentable fiber; Minimal fiber
Intervention type(s): Other; Other; Other
Intervention description(s): One brownie containing 10 g of sugarcane bagasse and 2 cookies containing 3 g of sugarcane bagasse (total of 13 g of sugarcane bagasse per day); One brownie containing 10 g of fiber and 2 cookies containing 3 g of fiber (total of 13 g of non-caloric, non-fermentable fiber per day); One brownie containing 3g of fiber and two cookies containing 1g of fiber (total of 4 g of dietary fiber per day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Sugarcane bagasse, glucose tolerance, insulin resistance
INSPIRE-CF: an Alternative Physiotherapy Model for Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The primary aim of the research is to evaluate whether an alternative model of cystic
      fibrosis (CF) physiotherapy care can produce statistically significant improvements in
      clinical and patient reported outcomes, and whether this alternative model is economically
      advantageous and/or sustainable.

      Children randomised to the control group will receive 24-months of current model of CF care
      at Great Ormond Street Hospital (GOSH).

      Children randomised to the intervention group will receive 24-months of current model of CF
      care at GOSH PLUS a weekly structured, individually prescribed and personally supervised
      exercise intervention at a local fitness facility or at school. The exercise prescription
      will include aerobic, anaerobic, strength, core conditioning and stretching components.

      The main objectives of the study are:

        1. Determine differences, if any, in lung function between the two groups;

        2. Determine differences, if any, in exercise capacity between the two groups;

        3. Evaluate cost of care of alternate model of care versus current model of care.
    


Intervention name(s): Exercise Intervention
Intervention type(s): Other
Intervention description(s): The exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; physiotherapy; lung function; quality of life
ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China
Condition: Varicose Veins of Lower Limb
MeSH terms: Varicose Veins
Study type: Interventional

Summary: 
      The purpose of the RCT trial is to determine whether endovenous radiofrequency closure
      catheter and endovenous radiofrequency closure generator is not inferior to ClosureFast™ and
      ClosureRFG™ in treating varicose veins of lower extremity.
    

Detailed description: 
      This trial is a prospective, multi-center, 1:1 randomized using endovenous radiofrequency
      closure catheter and endovenous radiofrequency closure generator versus ClosureFast™ and
      ClosureRFG™ to treat varicose veins of lower extremity. And parimary endpoint is Complete
      closure rate of great saphenous vein at 6 months post-procedure.
    

Intervention name(s): ERA-C70,ERA-C30 and ERA-G5; ClosureFast™ and ClosureRFG™
Intervention type(s): Device; Device
Intervention description(s): use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) to treat varicose veins of lower extremity; use ClosureFast™ and ClosureRFG™ which has the indication of the treatment of varicose veins of lower extremity approved by NMPA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Varicose Veins of Lower Limb; radiofrequency ablation endovenous closure
Effects of Aerobic Training Program On Liver Functions
Condition: Liver Functions
Study type: Interventional

Summary: 
      The liver plays a central role in energy exchange, protein synthesis as well as the
      elimination of waste products from the body. The optimal functioning of the liver is
      essential for athletic performance. It becomes necessary to maintain the enzymes of the liver
      at an optimal level so that liver cells can be protected from inflammation or damage. This
      paper investigated the effects of a twelve-week aerobic exercise program on the liver
      function of adult athletes. A total of thirty (30) healthy male athletes aged 21 to 24 were
      recruited for this study and kept in two equal groups. The control group was kept under
      rigorous supervision and did not participate in any special activities. The experiment group
      was well-versed in their assigned training program and solely performed the experimental
      procedure for twelve (12) weeks. Evaluation of all patients in both experimental and control
      groups was carried out before and after the treatment program by measuring the levels of
      (Alkaline phosphate, AST/SGOT, ALT/SGPT, Bilirubin Total/indirect/direct, Albumin, Globulin,
      and Total protein) respectively using standard methods by collecting blood samples, 5 mls
      each of baseline into lithium heparin containers for estimation of above biochemical
      parameters at the pathology laboratory accredited by National Accreditation Board for Testing
      and Calibration Laboratories accredited (NABL, India).
    


Intervention name(s): Aerobic training
Intervention type(s): Other
Intervention description(s): Exercises on a treadmill at different speeds and inclination were performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Fatty liver; Physical activity; Treadmill; Exercises
Study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetics of the
      HCP1004 and VIMOVO 500/20mg in Healthy Korean Male
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy korean male
Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a new parent training protocol for children
      with Attention Deficit Hyperactivity Disorder (ADHD) can over perform the state of the art
      Parent Training protocol (PBT) by increasing the long term effectiveness of the treatment,
      reducing the dropout rate and reducing the comorbidities.
    


Intervention name(s): Schema Parent Behavioral Training; Parent Behavioral Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A novel protocol for parent whose children suffer from ADHD and comorbidities. The protocol combines elements from Schema Focus Therapy (SFT) and Parent Behavioral Training (PBT); A state of the art Parent Behavioral Treatment (PBT) for Children who suffer from ADHD symptoms
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ADHD
Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine
Condition: COVID-19 Vaccines; Hemodialysis Complication
Study type: Observational

Summary: 
      Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties
      to maintain a self-isolation (leading to a higher contamination than general population) and
      an increase of mortality in case of contamination (more than 20% of mortality in this
      population). However, vaccine efficiency is known to be decreased in haemodialysis patients.
      This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in
      haemodialysis patients.

      The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in
      haemodialysis patients.
    


Intervention name(s): Evaluation of the immunogenicity of the vaccine in haemodialysis patients
Intervention type(s): Biological
Intervention description(s): The immunogenicity of the vaccine will be evaluated at the peak of vaccine response (Day 7 - Day 14 after the second dose) and 6 and 12 months post vaccination, by the evaluation of humoral IgG anti-spike protein response (seroconversion rate, absolute antibody titers, affinity of antibody) and cellular anti SARS-Cov2 response (number, activation capacity, production of interferon gamma of CD4 and CD8 anti sars cov2 specific T cells)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated by chronic haemodialysis, with initiation of a vaccination by BTN162b2
        mRNA Cov-19 with classical scheme
      
Keywords: immunogenicity; haemodialysis patients; SARS-Cov2 vaccine
The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Antioxidants are potent scavengers of free radicals and serve as inhibitors of neoplastic
      processes. A large number of synthetic and natural antioxidants are known to induce
      beneficial effects on human health and disease prevention. Cardioprotective ability of grape
      seed extract polyphenols (GSEP) was studied in animals and humans. It has been suggested that
      grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury
      of free radicals after ischemia. In another study, it is suggested that proanthocyanidins,
      the major polyphenols in red wine, might trap reactive oxygen species in aqueous series such
      as plasma and interstitial fluid of the arterial wall; thereby inhibiting oxidation of
      low-density lipoprotein (LDL) and showing an antiatherosclerotic activity. The only human
      model study designed to evaluate the effect of a standardized formulation of a GSEP
      (leucoselect-phytosome [LP]) on the susceptibility of LDL to oxidation in a group of heavy
      smokers, revealed that the antioxidant potential of GSEP may be effective in oxidative stress
      (smoking); however more investigational data are needed before wider use in clinical
      settings. Based on these observations, the investigators decided to evaluate the effect of
      GSEP in reducing OX-LDL in patients diagnosed with mild hyperlipidemia.
    


Intervention name(s): Grape Seed Extract (Vitagrape); Placebo of Grape Seed Extract
Intervention type(s): Drug; Drug
Intervention description(s): Drug {Each Containing: Grape Seed Extract100 mg +...}
1 capsule twice daily for 2 months; Placebo {Each Containing: Gelatin 17mg + Cellulose Microcrystalline (Avicel) 67 mg + Dicalcium Phosphate 216mg}
1 capsule twice daily for 2 months
Other intervention name(s): Vitagrape; Iran Ministry of Health Registration Number: 5/92/43198
Intervention MeSH terms: Grape Seed Extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Grape Seed Extract; Hyperlipidemia
Influence of Severe Heart Failure to Function and Molecular Biological Parameters of Catabolism in the Human Diaphragm and Peripheral Skeletal Muscle
Condition: Heart Failure; Ischemic Myocardiopathy; Dilatative Myocardiopathy
MeSH terms: Heart Failure; Cardiomyopathies
Study type: Observational

Summary: 
      Project aim is to quantify the influence of a severe therapy-refractory heart failure caused
      by ischemic or dilative myocardiopathy on the function of the diaphragm, its molecular
      biological parameters and on the M. vastus lateralis. The control group consists of patients
      with coronary artery disease (CAD) and normal left ventricular ejection fraction indicated
      for coronary artery bypass graft surgery (CABG) Differences in the geneses of heart failure
      (ischemic vs. dilative cardiomyopathy) will be evaluated during analysis. The
      ubiquitin-proteasome signaling pathway is considered as a central issue for the mechanism of
      the analyses muscle catabolism.
    


Intervention name(s): Biopsy of the diaphragmatic muscle; Skeletal muscle biopsy
Intervention type(s): Other; Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with severe therapy-refractory heart failure
Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
Condition: Neovascular Glaucoma
MeSH terms: Glaucoma; Glaucoma, Neovascular
Study type: Interventional

Summary: 
      This 52 week study will assess the use of intravitreal aflibercept injections in patients
      with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.

      The investigators hypothesize that the neovascularization of the iris and angle present in
      neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept
      injection alone and result in increased comfort and preservation of visual field as compared
      to current standard of care utilizing pan-retinal photocoagulation. The advantages to
      intravitreal aflibercept injection use could include resolution of NVI/NVA
      (neovascularization of the iris/neovascularization of the angle) leading to quicker pain
      relief and quicker lowering of IOP (intraocular pressure).
    

Detailed description: 
      The two arms of this study will compare current common practice (initial intravitreal
      anti-VEGF (vascular endothelial growth factor) to study treatment (VEGF) injection only) for
      52 weeks.

      This single center study will consist of 20 patients with NVG. Patients will be randomized
      to:

        -  Group A: A single injection of 2mg (0.05ml) intravitreal aflibercept injection at
           baseline followed by standard of care laser with observation for a total of 52 weeks.

      or

        -  Group B: 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two
           additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52
           weeks.

      Clinical assessment will include pain assessment (Universal Pain Scale), best corrected
      visual acuity (ETDRS), ophthalmic examination, anterior segment assessment including number
      of clock-hours of NVI/NVA, gonioscopy, anterior segment photography, visual field test
      (Humphrey SITA- Standard 24-2), optic nerve OCT (Zeiss Cirrus Optic Disc Cube 200x200),
      macular OCT (Cube scan 512 x 128 and 5 Line Raster), fluorescein angiography (initial iris
      phase followed by standard retinal angiography), and concurrent medical/ocular medications.
      Qualitative assessment of neovascularization will be made by the investigator based on
      comparison to baseline angiography.
    

Intervention name(s): Aflibercept
Intervention type(s): Drug
Intervention description(s): Details covered in arm description
Other intervention name(s): Eylea
Intervention MeSH terms: Aflibercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment