bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of L-arabinose on Intestinal Sucrase Activity in Man
Condition: Blood Glucose
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of L-arabinose in a sugar-rich meal on
      intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and
      insulin, and selected intestinal hormonal responses to increasing doses of L-arabinose.
    

Detailed description: 
      Background:

      The intake of common table sugar (sucrose) in the industrialised countries is relatively
      high. In Denmark the daily intake of sugar is in the range of 30-40 g/d exclusive the intake
      of sugar containing drinks. The health consequences of this relatively high sugar intake are
      heavily debated in the media. One of the arguments is that a high sugar intake may be one of
      the factors involved in the development of the metabolic syndrome, including overweight,
      increased blood glucose and insulin levels as well as impaired insulin action.

      L-arabinose is widely distributed in plants and is a common component in plant cell walls in
      maize, wheat, rye, rice, plant gums etc. The isolated 5-carbon sugar has been shown to
      suppress the increase of blood glucose and plasma insulin after ingestion of sucrose in rats
      by inhibition of sucrase activity. In vitro studies on Caco-2 cells indicate that L-arabinose
      is a potent inhibitor on sucrase activity, possibly in a non-competitive way.

      Potential nutritional advantages of consuming L-arabinose in combination with sucrose may
      therefore be a delayed digestion of sucrose and a lower absorption of glucose, resulting in
      both lower blood glucose and insulin levels. A delayed digestion of sucrose will reduce the
      energy utilisation with the potential of reducing weight gain in human subjects.

      Methods:

      This dose-response study with 14 healthy male volunteers has a randomised cross-over design
      based on four single "meals" separated by one week wash-out periods. Sugar rich drinks
      supplemented with different doses of L-arabinose will be tested with respect to postprandial
      blood glucose, insulin, triglyceride, glucose-dependent insulinotropic peptide (GIP) and
      glucagon-like peptide-1 (GLP-1). Postprandial blood samples will be taken every 15 to 30 min
      for 180 min. Appetite sensations will be measured every 30 min during the experiment. After
      180 minutes a lunch will be served and energy intake (EI) will be registered.
    

Intervention name(s): L-arabinose
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Blood glucose; Insulin; Triglyceride; GIP; GLP-1; L-arabinose; Appetite; Energy intake
To Study And Compare Bioavailability And Safety Of Four Different Formulations Of The Study Drug
Condition: Healthy Subjects
Study type: Observational

Summary: 
      SB-742510 is a semi-synthetic pleuromutilin antibiotic that is being developed for treatment
      of respiratory infections.

      The purpose of this study is to estimate the bioavailability of four different formulations
      and to evaluate the safety of each of the four formulations
    


Time perspective: Prospective
Keywords: healthy volunteer,; Bioavailability,; safety; Phase I,
Clinical Evaluation Study for Assessing the Visual Performance of Hanita Lenses Trifocal IOL
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm
      single-center, open-label study.
    

Detailed description: 
      Device: Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL). Indication studied: The
      Hanita Lenses Trifocal IOL is intended for implantation in the capsular bag in the posterior
      chamber in order to replace the crystalline lens of the eye to attain visual correction of
      aphakia in adult patients in whom a cataractous lens has been removed, who desire improved
      uncorrected vision, useful near and intermediate visual functions, and reduced spectacle
      dependence.

      Study description: This study is a prospective, single-arm single-center, open-label study.
    

Intervention name(s): cataract surgery and intraocular lens implantation - both eyes
Intervention type(s): Device
Intervention description(s): cataract surgery and intraocular lens implantation for both eyes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Covid-19 in Lupus Patients
Condition: Systemic Lupus Erythematosus; Covid-19
MeSH terms: COVID-19; Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      The Covid-19 pandemic is a major public health issue. Potential treatments are essential to
      control the infection. Hydroxychlorquine is currently tested in several clinical trials to
      evaluate its efficiency.The objective of this study was to evaluate the symptoms related to
      COVID-19 occuring in patients with systemic lupus erythematosus (SLE)
    

Detailed description: 
      Introduction:The Covid-19 pandemic has had a major impact on many countries on the sanitary
      and economic level. Finding an efficient cure is paramount in order to reduce its severity
      and mortality. Several medications are currently under investigation. Among them,
      hydroxychloroquine can prevent viral replication at several sites and has been shown
      efficient in vitro. Several clinical trials are in progress to evaluate its efficiency in
      vivo. However, no study so far has evaluated the covid-19 infection in patients with SLE.

      Objectives and methods: The primary objective was to describe the prevalence and the severity
      of Covid-19 infection in patients wih systemic lupus erythematosus. The secondary objective
      was to compare these parameters in patients treated by hydroxychloroquine and those not
      treated by hydroxychloroquine. This observational study of a historical-prospective cohort
      focuses on all adult lupus patients seen during the last year in the departments of
      rheumatology and nephrology in CHU Montpellier. It will collect information concerning the
      patient's condition, treatments and main comorbidities (cardio-vascular, respiratory, hepatic
      and immune depression), as well as symptoms suggesting covid-19 infection, its confirmation
      and its course and severity.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All adult patients with systemic lupus erythematosus followed by the departments of
        rheumatology and nephrology, seen during the last year
      
Keywords: Systemic lupus erythematosus; Hydroxychloroquine
Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional

Summary: 
      Urinary tract infections affect more than 130 million people worldwide each year. Almost 50%
      of women will have at least one urinary tract infection during their lifetime, usually
      cystitis. Half of them will have recurrent cystitis. Antibiotics are the first-line treatment
      for cystitis, but their effectiveness is decreasing due to the rapid spread of
      multi-resistant uro-pathogenic bacteria. The objective of this study is to identify blood
      biomarkers associated with a high risk of recurrent cystitis. Immune system cells, and more
      specifically innate immunity cells, play a key role in controlling urinary tract infections.
      In addition, clinical studies have shown that there is a high inter-individual variability in
      the ability of innate immune cells to respond to different stimuli. We therefore hypothesized
      that there was an association between the risk of recurrent cystitis and a deficiency of
      certain immune cell types in producing certain pro-inflammatory cytokines, including TNF-α,
      in response to one or more bacterial stimuli, particularly flagellin.
    


Intervention name(s): Collection of blood samples; Collection of fecal samples; Collection of urine samples; Collection of vaginal swaps
Intervention type(s): Procedure; Other; Other; Other
Intervention description(s): 23 mL of blood will be collected during the inclusion visit; Fecal sample self-collected after the inclusion visit; 10 mL of urine will be collected during the inclusion visit; Sample of vaginal microbiota collected during the inclusion visit
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Different Concentrations of Xylitol and Erythritol on Gut Peptide Release and Gastric Emptying in Humans
Condition: Physiological Satiation Mechanisms
Study type: Interventional

Summary: 
      Xylitol and erythritol have become increasingly popular as sugar substitutes in the food
      industry. Both substances are freely available. While glucose ingestion stimulates satiation
      hormone secretion in the gut and slows down gastric emptying, artificial sweeteners such as
      aspartame, sucralose and acesulfame-K have no such effect. However, acute intake of 50g
      xylitol or 75g erythritol in 300mL tap water leads to a marked increase in the satiation
      hormones and induces a significant retardation in gastric emptying. The concentrations used
      to Show this effect were rather high (50g xylitol and 75g erythritol) and led to bloating and
      diarrhea in 60-70% of all subjects two hours after administration. The aim of the present
      study is to find an effective concentration of xylitol and erythritol still stimulating
      satiation hormone release without any gastrointestinal adverse events.
    


Intervention name(s): Xylitol 7g; Erythritol 10g; Xylitol 17g; Xylitol 35g; Erythritol 25g; Erythritol 50g
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Xylitol 7g in 300mL tap water; Erythritol 10g in 300mL tap water; Xylitol 17g in 300mL tap water; Xylitol 35g in 300mL tap water; Erythritol 25g in 300mL tap water; Erythritol 50g in 300mL tap water
Other intervention name(s): E967-Xylitol; E968-Erythritol; E967-Xylitol; E967-Xylitol; E968-Erythritol; E968-Erythritol
Intervention MeSH terms: Erythritol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Parallel assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Computer Based Training in Cognitive Behavioral Therapy Web-based
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators are conducting a randomized clinical trial of our new web-based version of
      the CBT4CBT program to evaluate its effectiveness relative to standard outpatient counseling
      at SATU. The computer-based training program (CBT4CBT) focuses on teaching basic coping
      skills, presenting examples of effective use of coping skills in a number of realistic
      situations in video form, and providing opportunities for patients to practice and review new
      skills while receiving substance abuse treatment.
    

Detailed description: 
      One hundred eighty drug-using individuals seeking treatment at the Substance Abuse Treatment
      Unit (SATU) of the Connecticut Mental Health Center will be randomized to (1) standard
      outpatient counseling at SATU (typically consisting of weekly group counseling), (2)
      individual clinician delivered CBT, or (3) web-based CBT4CBT. Treatments will be delivered
      over a 12-week period with a six-month follow-up after termination of the study treatments.
      The primary outcome measures will be reduction in substance use (frequency of drug use by
      time, confirmed by urine toxicology screens). Secondary outcomes will include treatment
      utilization and cost, several measures intended to detect whether web-based CBT4CBT retains
      key characteristics of traditional clinician-administered CBT (e.g., acquisition of coping
      skills, use of change strategies), participant characteristics which will be evaluated as
      potential moderators of outcome, as well as participant satisfaction and treatment
      credibility.
    

Intervention name(s): Standard Treatment As Usual (TAU); Individual clinician-provided CBT; CBT4CBT
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Treatment normally offered at this clinic which could include individual or group drug counseling sessions one time per week last one hour each time.; Individual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session.; Subjects work with a computerized program that teaches skills for stopping drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive behavior therapy; computer assisted instruction; drug abuse therapy; educational resource design and development
A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to evaluate the safety and efficacy of LY3009104 in participants
      with Rheumatoid Arthritis (RA).
    

Detailed description: 
      This study consists of the following:

        -  Screening period: 4 to 28-days

        -  Part A: a 12-week blinded, placebo controlled treatment period

        -  Part B: a 12-week blinded extension period

        -  Part C: an optional 52-week open-label extension period

        -  Part D: an additional optional 52-week open-label extension period

        -  Follow up period: 28 days
    

Intervention name(s): LY3009104; Placebo; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally as background therapy
Other intervention name(s): Janus Kinase (JAK)1/JAK2 Inhibitor; JAK1/2 Inhibitor; INCB028050; baricitinib
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; RA
Risk Factors Associated With Infection After Spine Surgery
Condition: Deep Surgical Site Infection; Spine Surgery
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Study type: Observational

Summary: 
      Surgical site infection (SSI), particularly deep SSI, is one of the most serious
      complications after spinal surgery. evaluating the risk of SSI and, correspondingly,
      prescription of prophylactic measures are extremely important to prevent SSI and avoid
      potentially devastating consequences. A retrospective study was conducted aiming to develop a
      point-based prediction model of deep surgical site infection in patients receiving open
      posterior instrumented thoracolumbar surgery.
    

Detailed description: 
      Data of 3,419 patients in 4 hospitals from Jan 1, 2012 to Dec 30, 2021 were retrospectively
      collected and were evaluated aiming to develop a point-based prediction model of deep
      surgical site infection in patients receiving open posterior instrumented thoracolumbar
      surgery. Clinical knowledge-driven, data-driven and decision tree model was used to identify
      predictive variables of deep SSI. Internal validation was performed by using bootstrapping
      methods.
    

Intervention name(s): open posterior instrumented thoracolumbar surgery
Intervention type(s): Procedure
Intervention description(s): Both group previously received open posterior instrumented thoracolumbar surgery in 4 centers
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study population included patients who previously receceived open posterior instrumented
        thoracolumbar surgery due to spine disease (except that spine infection or revision
        surgery)
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
Condition: Kidney Transplant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate how well adolescent kidney transplant patients
      tolerate a single dose of belatacept they receive at least 6 months after transplant surgery,
      and how their body handles the drug.
    


Intervention name(s): Belatacept
Intervention type(s): Drug
Intervention description(s): Single intravenous infusion of belatacept, 7.5 mg/kg
Other intervention name(s): BMS-224818
Intervention MeSH terms: Abatacept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cardiopulmonary Fitness, Lung Function, Muscular Oxygen Saturation, and Quality of Life in T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this study is to compare the differences of

        1. cardiopulmonary fitness

        2. lung function

        3. muscular oxygen saturation

        4. quality of life between type 1 diabetes mellitus and healthy adults.
    

Detailed description: 
      This study is also to investigate the relationships between cardiopulmonary fitness, lung
      function, muscular oxygen saturation, glycemic control, and quality of life in patients with
      type 1 diabetes mellitus.
    

Intervention name(s): exercise testing with near-infrared spectroscopy; lung function testing; quality of life
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): subjects will sit on the ergometer, resting heart rate and BP will be measured for at least 2 minutes. Before testing, each participant will be informed to perform cycling with 0 watt for 2 minutes. Then, exercise testing will be started at 30 watt, and increase 15 watt in male and 10 watt in female every minute until the termination criteria achieved.; spirometry testing: Each participant will then place mouthpiece in mouth and close lips around the mouthpiece. Participants will inhale completely and rapidly and then exhale maximally until no more air could be expelled while maintaining an upright position. Values of FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) will be calculated immediately after the exhalation.
single-breath carbon monoxide diffusing capacity: Participants will sit on a firm and nose clips will then be attached and mouthpiece be placed in mouth. After participants perform several stable breathes, testing starts with a complete exhalation. Each participant will be instructed to inhale rapidly and completely and then hold for 10 seconds.; assessing quality of life using short-forum 36 (questionnaire)
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        outpatient department
      
Keywords: diabetes mellitus; cardiopulmonary fitness; lung function; muscular oxygenation
Teriparatide for Improved Knee Prosthesis Fixation
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators will study how well knee joint prostheses become fixed to the bone when
      patients get teriparatide, compared to placebo. Measurements will use high resolution 3D
      radiography (radiostereometry, RSA).
    


Intervention name(s): teriparatide
Intervention type(s): Drug
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® Extend
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetic profiles of experimental formulations of
      paracetamol.
    


Intervention name(s): Marketed paracetamol; Experimental paracetamol formulation
Intervention type(s): Drug; Drug
Intervention description(s): marketed formulation; Experimental formulation
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: paracetamol; pharmacokinetics
Neutrophil/Lymphocyte (N/L) Ratio and Long Term Follow-up in ST-elevation Myocardial Infarction
Condition: ST Elevated Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Although the pre-procedural neutrophil to lymphocyte ratio (N/L) has been associated with
      adverse outcomes among patients with coronary artery disease, its role during the acute phase
      of ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. This
      study sought to investigate the association of the pre-procedural N/L ratio within-hospital
      and long-term outcomes among STEMI patients undergoing primary percutaneous coronary
      intervention (PCI).
    

Detailed description: 
      Inflammation plays a role in the initiation and progression of the atherosclerotic process.
      Due to a growing recognition of its role, recent studies have focused on inflammatory markers
      and their association with outcomes in patients with ST-segment elevation myocardial
      infarction (STEMI). Recently, our single center study demonstrated that preprocedural
      neutrophil/lymphocyte (N/L) ratio is an independent predictor of impaired coronary flow after
      primary percutaneous coronary intervention (PCI) and of in-hospital major advanced cardiac
      events (MACE) in patients with STEMI.Several previous studies also evaluated the role of N/L
      ratio in long-term outcomes among patients with STEMI; however, they evaluated the
      association between long-term mortality and in-hospital N/L ratio, they were single-center
      studies and they evaluated a relatively small study population.

      In the present multicenter experience, the investigators aimed to investigate the association
      of the preprocedural N/L ratio with the in-hospital and long-term outcomes in patients with
      STEMI undergoing primary PCI.
    

Intervention name(s): primary percutaneous coronary intervention, each groups
Intervention type(s): Procedure
Intervention description(s): All primary PCI procedures were performed using the standard femoral approach with a 7-French guiding catheter for each patients. After administration of 5,000 IU of intravenous heparin (70 U/Kg) and a 300 mg loading dose of clopidogrel, direct stenting was performed whenever possible, and in the remaining cases, balloon pre-dilatation was performed. The operator determined the choice of stents (bare metal or drug-eluting stent).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        STEMI patients who were admitted within 6 hours from symptom onset and who underwent
        primary PCI were prospectively included in this study
      
Biospecimen description: 
      serum and plasma of blood
    
Keywords: N/L ratio, STEMI, primary PCI, Long-term mortality