bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Involvement of the Intestinal Microbiota and Choline Deficiency in the Severity of Chronic Liver Disease Explored by Analyzing Collection of Biological Samples (MICRONACH)
Condition: Liver Disease (Alcoholic or Not)
MeSH terms: Liver Diseases; Choline Deficiency
Study type: Observational

Summary: 
      Chronic liver diseases are common and the two main causes in France are NAFLD (No Alcoholic
      Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease).

      Because of the importance of the current global obesity, NAFLD has become very common and it
      is estimated that its prevalence in the general population reaches 20-30%.

      NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease)
      includes a broad spectrum of liver damage, ranging from simple steatosis isolated
      (infiltration of fat in the liver), in hepatic inflammation, fibrosis (abnormally high
      accumulation of extracellular components in the functional liver tissue) and finally
      cirrhosis and its complications.

      Choline deficiency (essential nutrient generally classified as Class B vitamins) has been
      associated with liver damage each characterizing NAFLD and ALD. The amount of choline in the
      body depends in particular on food intake and degradation of choline by the intestinal
      microbiota.

      NAFLD and ALD are complex pathologies resulting from the interaction of environmental /
      nutritional factors and a genetic background. It therefore appears now necessary to study the
      influence of the relationship between genetic predisposition, environmental factors, and gut
      microbiota metabolism of choline on the severity of liver injury observed in NAFLD and ALD.

      If the interaction of these three elements (the host genetics - environmental factors - and
      intestinal microbiota metabolic choline) has an influence on the severity of the lesions of
      NAFLD and ALD direct application may be of bring a food supplement choline in patients at
      risk (mutation of the PEMT gene (phosphatidylethanolamine N-methyltransferase),
      postmenopausal women, microbiota profile for increased degradation of dietary choline) to
      restore the amount of choline in the body and thus to avoid a worsening of the ALD or NAFLD
      and progression to cirrhosis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in this study will be selected by the investigators of each center among
        patients for whom a liver biopsy is provided in the clinical management in their center.
Comparison of Radial and Ulnar Artery Intervention in Patients With ST Elevated Myocardial Infarction
Condition: ST Elevated Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      In the literature, there are no studies comparing these two pathways in ST elevation
      myocardial infarction (STEMI). In this patient group, it will be investigated whether
      transulnar intervention causes similar or less complications than transradial intervention,
      and whether it provides superiority or similarity in terms of outcomes.
    

Detailed description: 
      The transulnar approach is known as an alternative procedure for transradial coronary
      angiography due to its safety and applicability. For cardiologists, experienced in
      trans-ulnar access, this access zone is comfortable to use. Because less spasm is developing.
      In addition, no significant difference was found between the transradial and transulnar
      routes in terms of other complications.In the literature, there are no studies comparing
      these two pathways in ST elevation myocardial infarction (STEMI). In this patient group, it
      will be investigated whether transulnar intervention causes similar or less complications
      than transradial intervention, and whether it provides superiority or similarity in terms of
      outcomes.
    

Intervention name(s): primary percutaneous coronary intervention
Intervention type(s): Procedure
Intervention description(s): primary percutaneous coronary intervention via transulnar or transradial access
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients admitted with STEMI at the cardiology department and admitted to the catheter laboratory for primary percutaneous coronary intervention will be included in the study. There will be two groups in the study.In the first group, patients treated with transulnar access will be included. In the second group, patients using transradial access will be included. Patients will be treated by the same operator respectively. Peri-procedural data and in-hospital cardiac outcome data of patients in both groups will be recorded.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Complication; Primary Percutaneus Coronary Intervention; Radial Artery; Ulnar Artery
Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Myelodysplastic Syndrome and Acute Leukemia Related to Fanconi's Anemia
Condition: Fanconi's Anemia; Myelodysplastic Syndromes; Leukemia, Nonlymphocytic, Acute; Leukemia, Lymphocytic, Acute
MeSH terms: Leukemia; Preleukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Fanconi Syndrome; Anemia; Myelodysplastic Syndromes; Fanconi Anemia; Syndrome
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine the effectiveness of moderate dose cyclophosphamide and radiotherapy in terms of
      improving survival and reducing the morbidity following allogeneic bone marrow
      transplantation in patients with myelodysplastic syndrome and acute leukemia related to
      Fanconi's anemia.
    

Detailed description: 
      PROTOCOL OUTLINE:

      Patients receive cyclophosphamide IV over 1-2 hours on day -6 through -3 and total body
      radiotherapy on day -1. Patients undergo allogeneic bone marrow transplantation on day 0.
    

Intervention name(s): cyclophosphamide; Allogeneic Bone Marrow Transplantation
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Cyclophosphamide
Primary purpose: Treatment
Keywords: Fanconi's anemia; acute leukemia; acute lymphocytic leukemia; acute myeloid leukemia; acute undifferentiated leukemia; adult acute lymphoblastic leukemia; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia; adult acute myeloid leukemia in remission; aplastic anemia; childhood acute lymphoblastic leukemia; childhood acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia; childhood acute myeloid leukemia in remission; de novo myelodysplastic syndrome; hematologic disorders; hematopoietic/lymphoid cancer; leukemia; myelodysplastic syndrome; oncologic disorders; previously treated myelodysplastic syndrome; rare disease; secondary myelodysplastic syndrome
Study to Test GSK256073 in Patients With Dyslipidemia
Condition: Dyslipidaemias; Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two part study (Part A and Part B) that will first aim to establish the PK/PD
      relationship between exposure and lipid effects (Part A: 75 subjects), and will then confirm
      the effect using the most relevant dose(s) (Part B: ~90 subjects). Doses of 5mg, 50mg and
      150mg of GSK256073 will be administered in Part A, and the dose(s) for Part B will be based
      on the PK/PD data from Part A. Data from Part A and Part B will be combined to decrease
      overall subject numbers needed in part B. Part B of the study will include a niaspan arm for
      relative comparison of the effects of GSK256073 and niacin on lipids and flushing
    


Intervention name(s): GSK256073; GSK256073; GSK256073; Placebo; Niaspan; GSK256073; GSK256073
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg for 8 weeks; 50 mg for 8 weeks; 150 mg for 8 weeks; placebo for 8 weeks; 1500 mg for 8 weeks; x mg for 8 weeks based from data from Part A; optional dose based on data from Part A
Intervention MeSH terms: Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: lipids; HM74A
The Effect of a Vegan Alginate Product on Athletes Recovery and Performance
Condition: Athletic Performance
Study type: Interventional

Summary: 
      The feeding strategies during recovery are essential to optimize a subsequent performance.
      Carbohydrate is a major fuel source during exercise as it has been shown to maintain high
      rates of carbohydrate oxidation. Protein intake in combination with carbohydrate have been
      shown to increase Amino acid bioavailability and may alter physiologic responses during
      exercise, which may be relevant to endurance performance. The goal of this study is to assess
      the effect of a new developed vegan product on athletes recovery and subsequent performance.
    


Intervention name(s): CHO+PRO; CHO
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A vegan product containing carbohydrate and protein; containing carbohydrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
GABA-glutamate Interactions and Psychosis
Condition: Cognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates the interactions between NMDA (N-Methyl-D-aspartic acid) antagonism
      and GABA (gamma-aminobutyric acid) system as it relates to cognitive function assessed by
      ERPs (event-related potentials) in healthy volunteers.
    


Intervention name(s): iomazenil; iomazenil
Intervention type(s): Drug; Drug
Intervention description(s): Given as IV infusion; saline IV infusion
Intervention MeSH terms: Flumazenil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: GABA; glutamate; NMDA; P300; MMN
Diagnostic Challenges in IC (and Male CPPS)
Condition: Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Bacterial Prostatitis; Asymptomatic Inflammatory Prostatitis; Painful Bladder Syndrome; Cystitis, Interstitial
MeSH terms: Cystitis; Prostatitis; Cystitis, Interstitial; Syndrome; Pelvic Pain
Study type: Observational

Summary: 
      The etiology and pathogenesis of interstitial cystitis (IC) and its related condition in men,
      chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has remained elusive. This has
      hampered development of mechanistic treatment strategies for these common, chronic and
      distressing medical conditions. We believe that IC and perhaps CP/CPPS are a spectrum of
      complex but inter-related genetic and acquired diseases resulting from the interaction of
      several genes regulating immune/inflammatory and neurogenic parameters and environmental
      factors/circumstances or exposure, culminating in the combination of pain, frequency, urgency
      and sexual specific symptoms. New research has delineated the dynamic and powerful
      association of the immune and neurogenic system in pain activation. An immune-modulated
      neurogenic model of IC illuminating the action of immune derived substances and pain related
      substances might be important in discovering the determinants of pain, voiding dysfunction
      and gender specific sexual problems. This inter-related dynamic model of IC disease
      pathogenesis could be explored for potential avenues leading to novel diagnostic and
      treatment strategies. We plan to identify and evaluate the sensitivity and specificity of
      several novel nerve and inflammation related markers in the diagnosis and follow up of IC
      (and CP/CPPS). By correlating the levels of urine immune and pain related substances to
      disease mechanisms, severity and progression, we may be able to create a human disease
      specific model for diagnosis and treatment.
    


Intervention name(s): Genomic and proteomic biomarker discovery
Intervention type(s): Genetic
Intervention description(s): Discovery of novel biomarkers for CP/CPPS and PBS/IC using genomic and proteomic methods
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Tertiary university medical centers and primary care clinic
      
Biospecimen description: 
      saliva, whole blood, serum, white cells, urine, prostatic fluid, prostate/bladder tissue
    
Keywords: Chronic Prostatitis with Chronic Pelvic Pain Syndrome; Chronic Bacterial Prostatitis; Asymptomatic Inflammatory Prostatitis; Painful Bladder Syndrome; Cystitis, Interstitial
Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may
      allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

      PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in
      treating patients with metastatic kidney cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the 18-month survival rate of patients with metastatic renal cell carcinoma
           treated with allogeneic stem cell transplantation.

        -  Determine the objective rate of response of patients treated with this regimen.

        -  Determine post-transplant immunological reactions and recuperation of patients treated
           with this regimen.

        -  Determine the antitumoral activity of this regimen in these patients.

      OUTLINE: This is a non-randomized, multicenter study. Patients are assigned to 1 of 2
      treatment groups based on availability of a compatible family member for stem cell
      transplantation.

        -  Group I: Patients with a compatible family donor receive conditioning chemotherapy
           comprising cyclophosphamide IV over 2 hours on days -7 and -6 and fludarabine IV once
           daily on days -5 to -1. Patients undergo filgrastim (G-CSF)-mobilized allogeneic stem
           cell transplantation on day 0. Patients also receive immunosuppression therapy with
           cyclosporine beginning on day -2. Patients who have persistent or progressive disease,
           mixed chimerism, and no evidence of grade 2 or greater graft-vs-host disease, and have
           been off immunosuppression therapy for 1-2 weeks receive donor lymphocyte infusion on
           days 7 and 21.

        -  Group II: Patients without a compatible family donor receive treatment (immunotherapy,
           vaccination therapy, or chemotherapy) at the discretion of the treating physician.

      Patients are followed every 3 months for 5 years.

      PROJECTED ACCRUAL: A total of 170 patients (60 patients for group I and 110 patients for
      group II) will be accrued for this study within 3 years.
    

Intervention name(s): therapeutic allogeneic lymphocytes; cyclophosphamide; cyclosporine; fludarabine phosphate; allogeneic bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Cyclosporine; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Cyclosporins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent renal cell cancer; stage IV renal cell cancer
The Effect of Conservative Treatment on Perceptual and Cognitive Asymmetry in Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Adolescent idiopathic scoliosis (AIS) patients have been found to exhibit cortical asymmetry.
      This study aimed to examine the impact of conservative treatments on perceptual and cognitive
      asymmetry in the auditory system assessed by dichotic listening in AIS patients with thoracic
      major curves.
    

Detailed description: 
      Background: Adolescent idiopathic scoliosis (AIS) patients have been found to exhibit
      cortical asymmetry. This study aimed to examine the impact of conservative treatments on
      perceptual and cognitive asymmetry in the auditory system assessed by dichotic listening in
      AIS patients with thoracic major curves. Method: This study involved 30 AIS patients and 21
      healthy subjects. The intervention group used a Cheneau brace and performed 18 Schroth Best
      Practice (SBP) exercise sessions. Auditory lateralization was assessed using the Dichotic
      Listening Paradigm (DLP) in both groups before and after the intervention.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Cheneau brace and Schroth Best Practice exercise
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®
Condition: Pertussis; Tetanus; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and
      BOOSTRIX® vaccines among US adolescents.
    


Intervention name(s): ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed; BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): ADACEL®; BOOSTRIX®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tetanus; diphtheria; acellular pertussis
Thoracic Spinal Versus Epidural Anesthesia for Nephrectomy in Obstructive/Restrictive Lung Disease Patients
Condition: Nephrectomy; Lung Diseases; Anesthesia
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      Patients with respiratory disease have an increased risk of developing complications
      perioperatively. The use of regional anesthesia decreases this risk with better postoperative
      outcome. The aim of this study is to compare the safety and efficacy of thoracic spinal
      versus thoracic epidural anesthesia for open nephrectomy in patients with
      obstructive/restrictive lung disease.
    


Intervention name(s): Thoracic Spinal Anesthesia; Thoracic Epidural Anesthesia; Bupivacaine 0.5% (hyperbaric); Bupivacaine 0.5% (isobaric); Fentanyl; Dexmedetomidine
Intervention type(s): Procedure; Procedure; Drug; Drug; Drug; Drug
Intervention description(s): Spinal anesthesia will be performed for patients of the TSA group at the T7-T8 intervertebral space, using a 27 G pencil point needle with an introducer (Braun Melsungen, Melsungen, Germany).
When correct placement is confirmed by the free flow of clear CSF, 1.5 ml of hyperbaric Bupivacaine 0.5% (7.5 mg) in addition to 0.5 ml Fentanyl (25 μg) & 5 μg dexmedetomidine will be injected.; Epidural anesthesia will be performed for patients of the TEA group at the T7-T8 intervertebral space, using the "Prefix Custom Epidural Anesthesia Tray" with an 18 G Tuohy epidural needle & a 20 G epidural catheter.
Patients will initially receive 5-10 ml of a mixed preparation of 0.5% isobaric Bupivacaine with 2 μg Fentanyl per ml volume as a bolus dose via the epidural catheter, this will be followed by a continuous infusion of 5-10 ml/hr started 1 hour after the bolus dose & continued throughout the procedure.; Neuro-axially injected; Neuro-axially injected; Neuro-axially injected; Neuro-axially injected
Other intervention name(s): Heavy Marcaine; Marcaine
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Bupivacaine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Using computer & sealed envelope randomization, patients are assigned to receive either thoracic spinal anesthesia [TSA group: n=30] or thoracic epidural anesthesia [TEA group: n=30].
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Mid-thoracic spinal anesthesia; Mid-thoracic epidural anesthesia; Nephrectomy; Lung disease
Hydroxyapatite (HA) Coating Versus Plasma Porous Spray (PPS) in Press-fit Acetabular Components Early Outcomes With DEXA
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The study design comprises a randomized trial of patients undergoing primary total hip
      arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular
      plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA scanning
      will be used to measure periprosthetic bone mineral density. Clinical evaluations will be
      conducted .
    

Detailed description: 
      The study design comprises a randomized trial of patients undergoing primary total hip
      arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular
      plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA scanning
      will be used to measure periprosthetic bone mineral density preoperatively and
      post-operatively at 6 weeks, 12 weeks, 26 weeks, and 12 months for both the treated and
      contralateral hip joint. Clinical evaluations will be conducted preoperatively, and
      postoperatively at 6, 12, 26 weeks, 12 months and 24 months.
    

Intervention name(s): G7 HA Acetabular Component; G7 PPS Acetabular Component
Intervention type(s): Device; Device
Intervention description(s): G7 HA Acetabular Component; G7 PPS Acetabular Component
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors
Condition: Sleep Apnea; Sleep Disorder
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Wake Disorders
Study type: Observational [Patient Registry]

Summary: 
      In this study the feasibility of detecting sleep apnoeas with unobtrusive wearable sensors
      and sounds recorded with a smartphone is studied by making an overnight recording to patients
      with high probability of sleep apnoeas. The data acquired with the aforementioned devices is:
      ECG, acceleration, bioimpedance of thorax and processed and raw audio. In data analysis phase
      it will be studied which combinations of these signals would enable detecting sleep apnoeas
      with high enough sensitivity and specificity when compared to a night polygraphy reference
      (Nox T3 device using airflow, breathing movements, audio, position, movement, oxygen
      saturation, pulse and leg EMG).
    


Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The study group will be recruited from occupational health care patients who have been
        earlier admitted by Mehiläinen for a PG study at KNF-laboratoriot.
      
Keywords: apnea; apnoea; sleep