bioihbjkbjnl/mcl2 huggingface dataset:
Unilateral Posterolateral Approach for Spondylodiskitis
Condition: Discitis
MeSH terms: Discitis
Study type: Interventional

Summary: 
      This retrospective study assess the efficacy and safety of a posterolateral unilateral
      approach for debridement and titanium cage insertion supplemented by contralateral
      transfascial screw fixation for sick patients suffering from septic thoracolumbosacral
      spondylodiskitis. Hematogenous pyogenic spondylodiskitis requires surgical intervention in
      cases of development of neurological signs, spinal instability, progressive spinal deformity
      and abscess. When operative treatment is indicated, an anterior approach by open thoracotomy
      or by a thoraco-abdominal approach or combined anterior and posterior approaches are
      recommended. In cases of severe sick patients anterior approach is associated with high
      morbidity and mortality.
    

Detailed description: 
      Twenty consecutive sick (ASA>III) patients, 14 men and 6 women, aged 64±14 years, suffering
      from single level septic thoracolumbosacral spondylodiskitis underwent an one-stage less
      invasively unilateral posterolateral decompression, insertion of titanium cage& pedicle screw
      fixation plus contralateral transfascial pedicle screw fixation.
    

Intervention name(s): Unilateral Posterolateral Approach and Debridement; Titanium cage insertion supplemented by screw fixation
Intervention type(s): Procedure; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spondylodiscitis; Titanium Cage; Posterolateral Debridement; Immunosuppressed; Less Invasive; Spine Infection
A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the
      spine. In case of progressive curve deformity, the use of spinal bracing remains the standard
      non operative treatment of moderate AIS. Most of the time, the different types of braces
      don't take into account the individual biomechanical properties of each patient's spine.
      Actually, it is essential to better understand the effect of the loads applied on the trunk
      and on the spine, and a 3D geometrical modelisation of these components is essential. Many
      studies have been publishing concerning the use of radiographs for the geometrical
      reconstruction of the spine, and more recently the EOS system. But even then, it is still
      necessary to obtain an important number of geometrical data and discretisation is still a
      long procedure.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with idiopathic scoliosis
Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Describe patient and physician assessed factors for patient well-being when treated with
      Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous
      antithrombotic treatment (switcher)
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        spanish patients with a diagnosis of non-valvular atrial fibrillation
Dose-response Effects of Soybean Oil in Salad Dressing on Carotenoid/Fat-soluble Vitamin Bioavailability in Salad Vegetables
Condition: Biological Availability
Study type: Interventional

Summary: 
      The objectives will be to evaluate the dose-response between the amount of soybean oil in
      salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in salad
      vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and
      beta-carotene.
    


Intervention name(s): Soybean oil in salad dressing
Intervention type(s): Other
Keywords: carotenoids; phylloquinone; tocopherols; vitamin A
Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial
Condition: Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial aims at preventing visual dysfunction and optic nerve degeneration
      associated with autoimmune optic neuritis by systemic i.v. administration of 33.000 IU
      erythropoietin over 3 days. The primary objective is to determine the efficacy of
      erythropoietin compared to placebo given as add-on to methylprednisolone as assessed by
      measurements of retinal nerve fibre layer thickness and low contrast visual acuity 6 months
      after acute optic neuritis.
    


Intervention name(s): Erythropoietin alfa; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Saline
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Optic neuritis; Multiple Sclerosis; Clinically isolated syndrome; Erythropoietin
Evaluation in 15 Participants of Blood Flow, Comfort and Efficiency, Using 1 vs 36 Hz Stimulation Via Textile Electrodes
Condition: Hemodynamic Instability; Pain
Study type: Interventional

Summary: 
      Muscle contractions induced by calf low-intensity neuromuscular electrical stimulation
      (C-LI-NMES) can increase venous return and may reduce venous thromboembolism. This study
      aimed to compare the effect of different C-LI-NMES frequencies and plateau times on
      hemodynamics, discomfort and energy efficiency, when applied via sock-integrated transverse
      textile electrodes.
    

Detailed description: 
      Fifteen healthy participants were stimulated via two 3x3cm transverse textile electrodes
      integrated in a sock, with ten different combinations of frequency (1Hz or 36Hz) and plateau
      times (0.5/1.5/3/5/7s), with gradually increasing NMES-intensity until plantar
      flexion-induction. At this point, popliteal peak venous velocity (PVV), time-averaged mean
      velocity (TAMV) and ejection volume (EV) were assessed by Doppler-ultrasound, discomfort by a
      numerical rating scale (NRS, 0-10) and values for current amplitude and energy were
      calculated based on the NMES-device´s intensity level. Values expressed with median
      (interquartile range), significance set to p<0.05.
    

Intervention name(s): Chattanooga Physio, DJO, neuromuscular electrical stimulation
Intervention type(s): Device
Intervention description(s): Neuromuscular electrical stimulation (NMES) was applied with a device called Chattanooga Physio (DJO), testing 10 different combinations of parameter-settings. The parameter-settings that were varied and combined were frequency (1Hz and 36Hz) and plateau times (0.5s, 1.5s, 3s, 5s, 7s). The NMES was applied to the calf of the participants via transversally placed textile electrodes (3x3 cm) integrated in a sock starting with very low current amplitude followed by gradual small increases in current amplitude until induction of ankle plantar flexion, at which time-point the outcomes where measured.
Other intervention name(s): Device name and manufacturer:
Intervention model: Sequential Assignment
Intervention model description: Repeated measures tests on on each of the 15 participants, comparing outcomes for no intervention and 10 different interventions in the form of variations in parameter-settings of neuromuscular electrical stimulation, with gradually increasing current amplitude until induction of ankle plantar flexion.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Neuromuscular electrical stimulation; Hemodynamics; Physical inactivity
Evaluation of Saccharomyces Boulardii Combined With Standard Quadruple Therapy for Eradication of Helicobacter Pylori
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      The eradication rate of standard quadruple therapy has become less successful due to low
      compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new
      treatment strategies that increase the eradication rate and reduce adverse effects. The aims
      of this prospective study is to investigate the efficacy of Saccharomyces Boulardii sachets
      for eradication of Hp, compared with standard quadruple therap.
    

Detailed description: 
      In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a
      bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days. But, eradication
      has become less successful due to low compliance and high resistance to the antibiotics.
      Therefore, it is necessary to develop new treatment strategies that increase the eradication
      rate and reduce adverse effects. Several studies previously suggested that probiotics could
      be effective for improving Hp eradication rate or reducing adverse events with PPI-based
      triple therapy. But, their effect for eradication of Hp is not yet conclusive. And the
      experiments now available about efficacy of Saccharomyces Boulardii were mainly combined with
      triple therapy. The aims of this prospective study is to investigate the efficacy of
      Saccharomyces Boulardii sachets for eradication of Hp, compared with standard quadruple
      therapy.
    

Intervention name(s): Saccharomyces boulardii; Esomeprazole; Amoxicillin; Clarithromycin; Bismuth potassium citrate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 500mg bid; 20mg bid; 1.0g bid; 0.5g bid; 0.22g bid
Other intervention name(s): Brad's yeast powder;Biocodex, Paris, France
Intervention MeSH terms: Amoxicillin; Clarithromycin; Potassium Citrate; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Saccharomyces Boulardii; Standard Quadruple Therapy
Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
Condition: End Stage Renal Disease; AV Fistula; Fistula; End Stage Kidney Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a
      less invasive means of establishing vascular access to facilitate dialysis in patients with
      end stage renal disease.
    


Intervention name(s): Ellipsys Vascular Access Catheter
Intervention type(s): Device
Intervention description(s): A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of the Catquest-9SF Questionnaire in Greek Language
Condition: Cataract; Catquest-9SF
MeSH terms: Cataract
Study type: Observational [Patient Registry]

Summary: 
      Primary objective of this study is the validation of the Catquest-9SF questionnaire in the
      Greek population.
    

Detailed description: 
      The present study aims to validate the Catquest-9SF questionnaire in the Greek population.
      The Catquest-9SF is a questionnaire for assessing the quality of vision of patients with
      cataract. It consists of 9 questions, two of which concern the subjective assessment of the
      patient's vision and the other seven the patient's ability to perform various daily
      activities.

      The Catquest-9SF questionnaire were translated into the Greek language by a translation team
      consisting of five members: one translation coordinator, two professional native
      English-speaking translators, one professional native Greek-speaking translator and one
      native Greek ophthalmologist fluent in English.

      Patients participating in the study are asked to complete a questionnaire in Greek before and
      after cataract surgery. Upon completion of the data collection, data are processed and
      analyzed through Rasch analysis to determine whether the questionnaire can be used in
      clinical practice in this translated version.

      The following clinical parameters are evaluated: age, gender, preoperative and postoperative
      monocular distance uncorrected visual acuity (UVA), distance best spectacle-corrected visual
      acuity (BSCVA) of the eye for cataract surgery, binocular distance UVA and BSCVA, refraction,
      spherical equivalent (SE), and intraocular pressure.
    

Intervention name(s): Catquest-9SF questionnaire; Demographics and clinical parameters
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Patients complete the questionnaire preoperatively and postoperatively.; The following clinical parameters are evaluated: age, gender, ocular and systemic comorbidities, educational level, preoperative and postoperative monocular distance uncorrected visual acuity (UVA), distance best spectacle-corrected visual acuity (BSCVA) of the eye for cataract surgery, binocular distance UVA and BSCVA, refraction, spherical equivalent (SE), and intraocular pressure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with cataract who will undergo cataract surgery.
      
Keywords: cataract; catquest; validation; questionnaire; Rasch Analysis
Transverse Thoracic Plane Block in the Pediatric Cardiac Patient
Condition: Pain, Acute; Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital; Acute Pain
Study type: Observational

Summary: 
      Postoperative pain after cardiothoracic surgery can be a significant problem interfering with
      recovery, yet difficult to manage due to the sedating effects of opiates. These patients
      frequently have associated postoperative pulmonary changes and are at risk of respiratory
      depression with opioid analgesia. The ultrasound-guided transversus thoracic muscle plane
      block (TTMPB) is a recently described regional anesthetic technique showing improvements in
      postoperative pain management. Further investigation is needed to establish the potential of
      the TTMPB as an analgesic modality in congenital cardiothoracic surgery in patients under the
      age of 18.
    


Intervention name(s): Transverse Thoracic Plane Block
Intervention type(s): Other
Intervention description(s): A bilateral plane block in the transverse thoracic space
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All comers int he age groups above
Emotional Fluctuations in the Flow of Daily Life. Ecological Analysis of Depressive Symptoms in the General Population.
Condition: Depression; Happiness; Personal Satisfaction
MeSH terms: Depression
Study type: Observational

Summary: 
      The aim of this study is to analyze both depressive symptomatology and psychological
      well-being fluctuation in a day-to-day basis in the general population, in order to identify
      contextual determinants of the mood and well-being changes
    

Detailed description: 
      Introduction: The Experience Sampling Method is a research tool to study what people do and
      feel in their day to day. It allows to analyse temporal relationships between variables and
      has a high ecological validity.

      Aim: To evaluate fluctuations of depressive symptoms and subjective well-being and to analyse
      the factors related to these fluctuations.

      Methodology: Longitudinal study that will follow up for two weeks a representative sample of
      the population aged 18 to 65 years living in Madrid using the Experience Sampling Method. An
      interviewer will visit the participants at their home to carry out a structured interview on
      mental health and well-being and to install a mobile app on the smart phone of participants
      in order for them to fill out information about their emotional state during the following
      two weeks. Participants will use the smart phone screen to fill out a brief questionnaire
      about their feelings, the activities they are doing and the people with whom they are
      interacting. Multilevel analysis based on lineal hierarchical models will be employed for
      data analysis as well as methods based on machine learning.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Residents of Madrid, Spain.
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
Condition: Streptococcal Infections
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at
      one dose in healthy non pregnant women and then in three different doses in healthy pregnant
      women.
    


Intervention name(s): Group B Streptococcus Trivalent Vaccine - 20/20/20 μg; Saline solution; Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg; Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg; Group B Streptococcus Trivalent Vaccine - 5/5/5 μg; saline solution
Intervention type(s): Biological; Other; Biological; Biological; Biological; Other
Intervention description(s): Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.; Subjects received two injection of saline solution.; Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.; Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.; Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.; Subjects received one injection of saline solution.
Intervention MeSH terms: Pharmaceutical Solutions; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Group B streptococcus; GBS; Vaccine; Prevention of group B streptococcus infection
Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men
      with secondary hypogonadism.
    

Detailed description: 
      This study is a phase III, open label safety study with a six month active dosing period. All
      subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be
      assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests
      and adverse event reporting.
    

Intervention name(s): Androxal
Intervention type(s): Drug
Intervention description(s): Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Other intervention name(s): Enclomiphene citrate
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs
Condition: Thoracic Surgery
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The purpose of this study is to investigate a performance of initial positioning of left
      sided double lumen endobronchial tubes using peak inspiratory pressures difference between
      two lungs.
    

Detailed description: 
      If both lungs have relatively equal volumes and the double lumen tube is in a satisfactory
      position, peak inspiratory pressure between two lungs is similar or equal when each lumen is
      sequentially clamped while ventilating each lung with the same tidal volume. We are going to
      investigate a performance of this method by fiberoptic bronchoscopy view and depth of double
      lumen tube, and compare with an conventional auscultation method.
    

Intervention name(s): Pressure difference
Intervention type(s): Procedure
Intervention description(s): Peak inspiratory pressures difference between two lungs
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Combination of Autologous MSC and HSC Infusion in Patients With Decompensated Cirrhosis
Condition: Cirrhosis, Liver
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Though the results of autologous CD34+ cell infusion and MSC in independent studies have
      shown promise, yet they are yet to reach the desired long term outcome. The possible
      postulation for this is possibly because when using autologous CD34+ cell infusion, the
      inflammatory milieu of the liver may not be conducive for sustained effects of the mobilized
      CD 34+ cells. MSC have immunomodulatory effect (ref) and may improve the liver environment
      making it more beneficial for the CD34+ cells to function and survive. In addition, MSC has
      ben shown to produce hepatocyte growth factor which is protective against liver injury and
      beneficial for liver regeneration (shown in above tables). However, it remains to be
      understood how MSCs promote liver stem stem cells to differentiate into hepatocytes or expand
      the residual hepatocyte population. MSC can also directly inhibit the activation of hepatic
      stellate cells, the main source of extracellular matrix via MSC derived IL 10 and TNF-αand
      may also induce hepatic stellate cell apoptosis. Current lacunae in cell based therapy is
      based on the poor consensus and understanding on the best type of cells to be used, the ideal
      number of cells, the most appropriate route of administration and the need for repeat dosing
      . The concept that combination of autologous hematopoietic and mesenchymal stem cells
      infusion may be more beneficial than infusing any one of them alone has been discussed in
      many scientific forums but there are no study till date to either see the safety as well as
      the efficacy of this proof of concept .

      With this above background data, we propose a study design which will be a safety study for
      combination use of autologous CD34+ and MSC
    


Intervention name(s): CD 34 and MSC infusion; Standard of care for Cirrhosis management
Intervention type(s): Combination Product; Drug
Intervention description(s): Combination of stem cells; Drugs used for Cirrhosis management such as Diuretics, Hepatoprotective agents and Lactulose
Other intervention name(s): Stem cell infusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal Stem Cell; Hematopoetic Stem cell; Autologous transfusion