bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Bakery Product Enriched With Fibre and L-carnitine on Insulin Resistance in Patients With Metabolic Syndrome
Condition: Metabolic X Syndrome; Overweight; Dyslipidemias
MeSH terms: Overweight; Metabolic Syndrome; Insulin Resistance; Dyslipidemias; Syndrome
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the efficacy of a bakery product enriched with dietary
      fibre and L-carnitine on glucose homeostasis and insulin sensitivity in overweight patients
      with or without metabolic syndrome.
    

Detailed description: 
      Conceivably, different biochemical changes in insulin-mediated signalling pathways may
      contribute to an impaired insulin-mediated glucose transport and metabolism that eventually
      results in insulin resistance and the clinical features of metabolic syndrome. According to
      this, both compounds -L-carnitine and dietary fiber- interacting by different mechanism of
      action could improve glucose homeostasis and insulin sensitivity. However, the health
      beneficial effects of the combination of both compounds are not shown and confirmation of the
      functionality of such products must be accomplished by conducting the appropriate studies
      intervention nutrition.
    

Intervention name(s): dietary fibre plus L-carnitine bread; Placebo bread
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The enriched bread consisted of a mix of wheat flour, vegetable flour, rye flour, wheat gluten, soy protein, soluble and insoluble dietary fibre, inulin, guar gum, L-carnitine salt, diacetyl tartaric, enzymes, ascorbic acid, water and yeast.
Patients were recommended to consume the bread twice per day with main meals.; The placebo group received commercially available bread with a similar macronutrient composition and energy intake to that consumed by the enriched bread group but without L-carnitine and dietary fibre. Patients were recommended to consume the bread twice per day with main meals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: L-carnitine; fibre; bakery product; insulin resistance
Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?
Condition: Eye Injuries; Critically Ill
MeSH terms: Eye Injuries; Corneal Injuries; Critical Illness
Study type: Interventional

Summary: 
      The purpose of this study is to identify the incidence of scratches on the surface of the eye
      in children who cannot blink due to medication use and to identify how best to reduce the
      risk of a scratch on the surface of the eye when patients are using specific medicines.
    

Detailed description: 
      Critically ill children may require neuromuscular blockade as a treatment modality. These
      children require careful eye care to prevent corneal abrasions. However, current evidence
      does not exist to guide best practices on eye care. This research study will evaluate 2 types
      of eye care therapy. The eyes will be randomly assigned to the control or experimental eye
      care therapy group. The control eye will receive lubricating ointment every 6 hours. The
      experimental eye will receive lubricating ointment every 6 hours and have a plastic covering
      to create a moisture chamber. Using daily fluorescein staining to detect corneal abrasions,
      each child will be studied for up to 9 days. Children who develop corneal abrasions will be
      discharged from the study and the primary care team will be notified. The two groups will
      then be compared to determine the therapy associated with the lowest incidence of corneal
      abrasions.
    

Intervention name(s): plastic wrap over eye & lubrication applied q6 hrs
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pediatric critical care; neuromuscular blocking agents; corneal abrasions
A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity )
Condition: ADHD; Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of
      MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with
      ADHD.
    

Detailed description: 
      This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of
      MG01CI (1400 mg once daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults
      with ADHD. The study comprises a Screening Visit at which initial assessment will be made and
      then a Washout Period during which prospective subjects must discontinue ADHD medication for
      14 days (for psychotropic medications other than fluoxetine) or for 28 days (for fluoxetine)
      before randomization into the study. The Washout Period is 14 days, but may be extended to 28
      days for a fluoxetine washout. Subjects requiring either a 14-day or a 28-day Washout Period
      will have an Interim Visit (off drug) on or about Day -8 (Day -10 to Day -3) for CAARS-Inv
      assessment after the Washout Period. The Baseline CAARS Inv assessment will be conducted on
      Day 0. If there is a ≥25% change in the CAARS-Inv results between the Interim Visit (off
      drug) assessment and the Baseline assessment, or if the subject does not return for the
      Baseline CAARS-Inv assessment, the subject will not be randomized. For subjects not needing
      washout, if there is a ≥25% change in the CAARS-Inv results between the Screening Visit
      assessment and the Baseline assessment, or if the subject does not return for the Baseline
      CAARS-Inv assessment, the subject will not be randomized. Following the Washout Period for
      those requiring a washout, or following the Screening Visit for those subjects who do not
      require a washout, eligible subjects will undergo baseline assessments and be randomized on
      Day 0 to MG01CI 1400 mg or to matching placebo and begin the Double-blind Treatment Period.
      The Double-blind Treatment Period will be 6 weeks in duration. There will be a 2-week
      Follow-up Period after the last dose of study treatment or early termination.
    

Intervention name(s): MG01CI (1400 mg); placebo
Intervention type(s): Drug; Drug
Intervention description(s): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily; Placebo 1400 mg administered orally once daily
Other intervention name(s): Metadoxine Immediate-release/Slow-release, Bilayer Caplet; Inactive Drug
Intervention MeSH terms: Metadoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Myofascial Release With Tennis Ball on Spasticity and Motor Functions
Condition: Stroke
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional

Summary: 
      Impaired motor function and upper extremity spasticity are common concerns in patients after
      stroke. It is essential to plan therapeutic techniques to recover from the stroke. The
      objective of this study was to investigate the effects of myofascial release with the tennis
      ball on spasticity and motor functions of the upper extremity in patients with chronic
      stroke.
    

Detailed description: 
      Myofascial release is a therapeutic technique that aims to improve flexibility and sliding
      between layers of soft tissues, reduce the severity of muscle activity pain, and improve
      functional performance. A previous study included myofascial release with a tennis ball in
      the lower extremity in patients with chronic stroke and reported improved balance. Different
      other unique therapeutic interventions have been proposed over the past two decades for
      stroke management; however, myofascial release with a tennis ball has not been included in
      them. Therefore, the present study aimed to examine the effects of myofascial release with a
      tennis ball on spasticity and motor functions of the upper limb in patients with chronic
      stroke.

      Participants were equally divided into two groups viz. experimental and control, with 11
      participants in each group.
    

Intervention name(s): Myofascial release technique along with conventional physiotherapy exercises; Conventional physiotherapy exercises
Intervention type(s): Other; Other
Intervention description(s): Myofascial release technique was performed using a tennis ball along with conventional physiotherapy exercises.; Conventional physiotherapy exercises were performed including the range of motion/flexibility exercises, strength training, postural control, functional exercises, and gait training.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm parallel pre-test-post-test experimental design.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myofascial release; Chronic stroke; Motor functions; Spasticity; modified Ashworth scale; Fugl-Meyer assessment scale
Analysis of Retinal Vessel Pulsations With Electrocardiographic Gating
Condition: Vessels; Anomaly
Study type: Interventional

Summary: 
      Analysis of Retinal Vessel Analyzer (RVA) recordings of retinal vessel pulsations, and
      putting them in context of intraocular pressure (IOP) pulsations by means of
      electrocardiographic (ECG) gating, in order to determine the lead source for pulsations of
      retinal veins.
    

Detailed description: 
      Rationale / Objective is to construct the retinal vessels wall pulsation cycle using an
      electrocardiographic gating, and to analyse it in comparison with an analogue intraocular
      pressure (IOP) cycle.

      Based on the amplitude and on the phase shift of pulsations of retinal vessel wall, the goal
      is to identify a lead source of the retinal venous pulsations (IOP pulsations, or alternative
      sources, e.g. cerebrospinal fluid pulsations).

      Subjects will be recruited from the environment of the master thesis medical students,
      colleagues and friends and the informed consent will be handed to them personally. Exclusion
      criteria will be addressed. One random eye per subject will be selected. On the study day,
      first the mydriasis drops - phenylephrine + tropicamide - will be applied, then ECG
      electrodes attached; 20 minutes after the mydriasis drops, the first set of measurements will
      be performed: RVA recording with ECG gating, and Pascal Dynamic Contour Tonometry (DCT)
      recording with ECG gating. Ten minutes after this measurements, 100% oxygen 5 liters/min
      through nasal cannula will be applied for 2 minutes and then the same measurements repeated.
      Approximate time needed for the whole run - around 60 minutes per subject, including
      (dis)mounting the ECG electrodes and the mydriasis time.
    

Intervention name(s): Retinal Vessel Analyzer recordings with electrocardiographic (ECG) gating
Intervention type(s): Device
Intervention description(s): Video recordings of ocular fundus, an analysis of dynamic vessel diameters and putting them in ECG context.
Intervention model: Single Group Assignment
Intervention model description: Data driven analysis
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.
Condition: Hypertrophic Scar
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional

Summary: 
      A prospective, double blind, randomized controlled human clinical trial will be conducted by
      enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates
      will be asked to participate who have an area of extremity or truncal scar measuring
      approximately 6cmX6cm total, in one contiguous region. The study sites, will consist of four
      equally sized treatment areas (3cm x 3cm), will be randomized to be treated with PDL, CO2, a
      combination of CO2+PDL, and an untreated control for 6 treatments. The areas will be
      photographed prior to each treatment and at the final visit 4-6 months after the last
      treatment. Color, pliability and thickness will be measured using a colorimeter, cutometer
      and high frequency ultrasound respectively at each appointment. Additionally, the Patient
      Observer Scar Assessment Scale (POSAS) will be used to score the quality of the scar, using
      two trained, blinded observers. The patients will also be asked on a voluntary basis for a
      pre-trial and post-trial 3mm punch biopsy to evaluate for the presence of histological
      changes.
    


Intervention name(s): Treatment with Pulse Dye Laser; Treatment with CO2 Laser; Treatment with combination of pulse dye laser and CO2 laser.; Control
Intervention type(s): Procedure; Procedure; Procedure; Other
Intervention description(s): Pulse Dye laser treatment will be applied to one randomized area with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s.; CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.; Pulse Dye laser and CO2 treatment will be applied to one randomized area. Pulse Dye will be applied with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300Hz, 15mJ, 15% density.; One area will be randomized to receive no laser treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
M89PF in Rosacea Associated With Erythema and Sensitive Skin
Condition: Rosacea
MeSH terms: Rosacea; Erythema; Hypersensitivity
Study type: Observational

Summary: 
      Rosacea is a common facial dermatosis, with flares induced by exposome factors. M89PF
      containing Vichy mineralizing water, probiotic fractions, hyaluronic acid, niacinamide and
      tocopherol repairs the skin barrier and reinforces skin defences against exposome factors.

      This study assessed the benefit of M89PF in patients with rosacea associated with erythema
      and sensitive skin during the Covid-19 pandemic with use of protective face masks.
    

Detailed description: 
      M89PF was compared to usual skin care in a randomized, split-face study, for 30 days in
      subjects with rosacea associated with erythema and sensitive skin. Clinical evaluations
      included erythema, desquamation, skin tightness, dryness, burning sensation, itching,
      stinging, stinging test, and local tolerability. Instrument evaluations included erythema,
      skin hydration and TEWL. Subject satisfaction was also assessed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult subjects with rosacea associated with erythema and less than 3 papules or pustules
        and having sensitive skin (positive 15% lactic acid sting test)
      
Keywords: rosacea; skin barrier; exposome; M89PF; splitface; sensitive skin
AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Multinational, multicentre, non-pharmacological intervention, cross-sectional and
      longitudinal study.
    

Detailed description: 
      Large non pharmacological studies on Small Airways Disease
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        900 subjects divided into 800 asthmatic patients and 100 healthy controls will be included.
        Recruitment will be balanced, at the extent possible, in order to achieve at least > 150
        patients each for steps 1 - 4 and > 50 patients for step 5 as indicated in the
        international guidelines (GINA 2012) on the basis of their previous therapy. The 150
        healthy controls will be recruited on the basis of absence of respiratory symptoms, airway
        obstruction and hyper responsiveness.
      
Biospecimen description: 
      Optional bronchoscopy with endobronchial and trans-bronchial biopsy will be applicable in
      selected sites only in EU and US. Total number of inflammatory cells and quantification of
      specific cells including eosinophils, T cells and macrophages will be performed. Gene
      expression profiles (including RNA) will be performed at a later date for future analysis on
      the pathobiology of asthma which will be defined in future specific protocols
Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
Condition: Obesity, Severe; Cesarean Section
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to determine the optimal skin closure technique (staples versus
      subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass
      index (BMI) of >/= 40kg/m2.
    

Detailed description: 
      A. To assess the rate of wound complications with staples versus subcuticular suture closure
      in women with a BMI of ≥ 40 kg/m2 undergoing cesarean delivery (CD).

      B. No difference was observed in wound complication rates between staples and subcuticular
      suture skin closure in women with a BMI ≥ 40 kg/m2 undergoing cesarean delivery (CD).

      C. At this time, optimal skin closure method in obese women with BMI ≥ 40 kg/m2 undergoing
      cesarean delivery remains unknown. More work is needed in this area to help reduce the
      complication rate in this very high-risk population.
    

Intervention name(s): Absorbable subcuticular suture; Stainless steel staples
Intervention type(s): Device; Device
Intervention description(s): Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).; Patients will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
Other intervention name(s): 3-0 monocryl; Staples
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
Condition: HER2-Negative Breast Cancer; Triple Negative Breast Cancer; Breast Cancer; Cancer of Breast; Breast Tumors
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed as an open-label randomized parallel two-arm multicenter efficacy,
      pharmacokinetics and safety study of intravenously administered eribulin versus intravenously
      administered vinorelbine in Chinese population. Eligible female subjects will have measurable
      disease according to RECIST 1.1 with the modification that chest x-ray cannot be used for
      assessment of disease.
    


Intervention name(s): E7389 (Eribulin Mesylate); Vinorelbine injection
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Locally Recurrent or Metastatic Breast Cancer
Influence of Antiretroviral Regimen on Immune Reconstitution in the Female Genital Tract
Condition: Women's Health; HIV Infection; Genital Diseases, Female
MeSH terms: Genital Diseases; Genital Diseases, Female
Study type: Observational

Summary: 
      Increases in cluster of differentiation 4 (CD4)+ T cells in the blood is well documented in
      human immunodeficiency virus (HIV)-infected individuals after starting antiretroviral therapy
      (ART), but increases CD4+ T cells in the cervix is variable and not fully understood.
      Although the amount of HIV in the vagina declines in parallel with those in the plasma when
      antiretroviral therapy for HIV is started, HIV is still detected frequently in cervical
      samples from women with undetectable plasma viral loads, suggesting that low level viral
      replication in the female vaginal tract could lead to both inflammation and incomplete
      increases in CD4+ T cells. Two classes of HIV medications, nonnucleoside analogue reverse
      transcriptase inhibitors and protease inhibitors are substantially lower in the female
      genital tract compared to plasma, whereas concentrations of another class, nucleos(t)ide
      analogue reverse transcriptase inhibitors are similar or higher to those found in plasma.
      Thus, many widely used first-line three drug HIV therapies only achieve high concentrations
      of only two medications in the female genital tract. Importantly, with the recent development
      of raltegravir (RAL), which achieves concentrations in the female genital tract higher than
      those in plasma, ART regimens that deliver high concentrations of 3 antiretroviral drugs to
      the female genital tract are now available. The investigators hypothesize that cervical CD4+
      T cell reconstitution is better and inflammatory markers are lower in HIV-infected women on a
      HIV-therapy including tenofovir (TDF) and emtricitabine (FTC) with RAL versus ritonavir
      (RIT)-boosted atazanavir (ATZ), and that this is due to therapeutic concentrations of 3
      versus 2 antiretroviral drugs in the female genital tract.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with
        raltegravir (RAL) compared to tenofovir (TDF) and emtricitabine (FTC) and ritonavir
        (RIT)-boosted atazanavir (ATZ)
      
Biospecimen description: 
      Blood, vaginal fluid samples, cervical biopsies
    
Keywords: Immune reconstitution; CD4+ T cells
Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether recombinant human platelet-derived growth
      factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis
      elbow).
    

Detailed description: 
      Methodology: Randomized, single ascending dose, double-blinded, placebo controlled,
      multi-center study

      Study Center(s): 6

      Number of Subjects: 100

      Diagnosis and Main Inclusion Criteria: Lateral epicondylitis; male and female subjects 21 -80
      years of age

      Study Drug, Dose, Regimen:

      Dose A: sodium acetate buffer alone - placebo control Dose B: sodium acetate buffer + 0.45 mg
      rhPDGF-BB Dose C: sodium acetate buffer + 0.75 mg rhPDGF-BB Dose D: sodium acetate buffer +
      1.5 mg rhPDGF-BB Dose E: sodium acetate buffer + 3.0 mg rhPDGF-BB

      Duration and Route of Administration: Single administration dose by injection into the
      extensor carpi radialis brevis (ECRB)

      Duration of Follow-up: 24 weeks (6 months) post-operative follow-up
    

Intervention name(s): rhPDGF-BB Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection; sodium acetate buffer (0 mg rhPDGF-BB)
Intervention MeSH terms: Becaplermin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: elbow