bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Macular Pigment by the Consumption of Corn With Strong Content in Zeaxanthine
Condition: Age Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      The Age Macular Degeneration (AMD) is the first cause of blindness in industrialized
      countries. The macular pigment (lutein and zeaxanthin) could play an important role in the
      arisen of the AMD. The food supplementation by corn with strong concentration in macular
      pigment could increase the density of the macular pigment. This could, in the future,
      represent a strategy of prevention of the AMD. The main objective of this study is to detect
      an increase of the macular pigment density after the consumption of this corn at healthy
      volunteers.
    

Detailed description: 
      The age macular degeneration represents the first cause of blindness in industrialized
      countries if it is not treated. In France, the AMD affects 600 000 persons and this figure
      should continue to increase, notably because of the increase of the life expectancy. The
      macula is responsible of the fine vision, the vision of colours and the perception of
      contrasts. The macular pigment is present only at the level of the macular area. This pigment
      is composed of three carotenoids: lutein, zeaxanthin, meso-zeaxanthin. The first two
      compounds are of strictly food origin and are not produced in an endogenous way. A change of
      the macular pigment density and/or the quality of the macular pigment is suspected to play a
      role in the appearance and the evolution of the AMD. The food supplementation by corn with
      strong concentration in macular pigment could increase the density of the macular pigment.
      This could, in the future, represent a strategy of prevention of the AMD. The main objective
      of this study is to detect an increase of the macular pigment density after the consumption
      of this corn at healthy volunteers. The treatment will consist in a daily consumption of a
      box of 125g of corn with strong zeaxanthin content during 10 weeks. This corresponds to a
      daily contribution of at least 1,2 mg of lutein and 2,2 mg de zeaxanthin. After the inclusion
      visit, the subject will be seen 5 times (after 3, 6, 8, 10, 14 weeks of treatment). In all
      these visits, measures of the macular pigment will be realized. A blood sample will be
      realized at the inclusion visit and during the visit at 6 and 10 weeks.
    

Intervention name(s): Corn zeaxanthin
Intervention type(s): Other
Intervention description(s): The treatment will consist in a daily consumption of a box of 125g of corn with strong zeaxanthin content during 10 weeks. This corresponds to a daily contribution of at least 1,2 mg of lutein and 2,2 mg de zeaxanthin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: corn; macular pigment; lutein; zeaxanthin; Age Macular Degeneration; AMD
Weaning Children From Mechanical Ventilation:Computer-driven System Versus Usual Care
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether a computer-driven system (Smartcare/PS)
      decreases weaning duration from mechanical ventilation when compared to usual care in
      children.
    

Detailed description: 
      Baseline data: All subjects included into this RCT will undergo routine examination upon
      admission to the hospital. These examinations include physical, medical/medication history
      (on the last year for medical history and the last 3 months for medication history (if
      available), vital signs, radiologic data and laboratory tests.

      Intervention: A pre-inclusion test (pressure support test) with a level of pressure support
      of ± 5 cmH2O of the P plateau, but no greater than 30 cmH2O (pressure-support level plus
      positive end-expiratory pressure), is performed to evaluate the patient's tolerance of this
      ventilation mode; the test is repeated daily until positive. The test could be stopped before
      30 minutes if the patient showed evidence of respiratory distress (respiratory rate > 40
      breaths per minute and FiO2 > 60% in order to obtain pulse oxymetry ≥ 95%). The test is
      considered positive when, after 30 minutes, the patient remained clinically stable with a
      respiratory rate lower than 40 breaths per minute and an expiratory tidal volume higher than
      6 ml per kilogram of body weight within the authorized pressure-support range, with pulse
      oxymetry no lower than 95 percent when the fraction of inspired oxygen was no greater than 60
      percent. When the pressure-support test is positive, the patient is randomized either to Arm
      1 where the intervention is weaning with the support of Smartcare/PS or to Arm 2 where the
      intervention is weaning based on usual care. Both group are ventilated with the same
      ventilator: Evita XL.
    

Intervention name(s): Smartcare/PS
Intervention type(s): Device
Intervention description(s): computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status
Other intervention name(s): Weaning from mechanical ventilation with Smartcare/PS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mechanical ventilation; automated weaning; children
Placebo-Controlled Clinical Nutrition Study of the Safety and Metabolic Effects of Two Medical Foods in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This 16 week placebo-controlled study evaluates the safety and impact of two medical food
      study products, WBF10 and WBF11, consisting of commensal microbes. The primary endpoints were
      safety, glucose AUC during meal tolerance test and C reactive protein (CRP)..
    

Detailed description: 
      Targeting the microbiome for treating metabolic syndrome has been gaining traction with
      multiple population studies demonstrating a difference between healthy individuals and
      patients with metabolic syndrome. Whole Biome has identified and created two medical food
      formulations (MFFs) aimed at improving metabolic syndrome via two mechanisms of action
      targeting the microbiome: (1) increasing butyrate production and (2) increasing mucin
      regulation.

      This randomized, parallel-group, placebo-controlled, double-blinded study assesses the safety
      and metabolic effects of 2 MFFs on glucose control and the generalized inflammatory state
      associated with Type 2 Diabetes. The microbes have been fully characterized, certified as
      Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP)
      standards. The target population was patients with Type 2 Diabetes who either had not been
      treated with antidiabetic agents or treated with metformin +/- a sulfonylurea. Subjects were
      randomized in a balanced manner to receive capsules containing placebo, WBF10 or WBF11.
    

Intervention name(s): WB-010; WB-011; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Medical food formulation; WB-011 medical food product; Placebo Capsules identical to those containing WB-010 and WB-011.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Balanced randomization across 3 arms: formulation WB-010, formulation WB-011 and placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: glucose control; inflammation; safety; microbiome
Identification of L3-L4 Interspace in Parturients
Condition: Healthy
Study type: Observational

Summary: 
      The investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4
      interspace will improve resident's long term skill to correctly identify the interspace as
      compared to palpation alone.
    

Detailed description: 
      This will be an observational education based study to improve anesthesiology resident's
      ability to correctly identify the L3-L4 interspace. Residents who agree to participate in the
      study will be trained using ultrasound to identify the L3-L4 interspace during their rotation
      on the obstetric anesthesia service. Training will include using the ultrasound to correlate
      the surface palpation with the underlying structures. This will be supplemented with teaching
      videos and literature. The training will be performed for the first three weeks of the four
      week rotation.

      After undergoing this training program, during the fourth week of the rotation, the residents
      will be asked to perform palpation identification of the L3-L4 interspace on parturients.
      Ultrasound will be used to assess the accuracy of the identified level. These assessments
      will repeated at six and 12 months to assess whether the skill has been retained.
    

Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): Educational intervention in the use of ultrasound to identify landmarks
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant female patients.
      
Keywords: Ultrasound; Palpation; Analgesia; Epidural
Prone Positioning and Regional Ventilation in Mechanically Ventilated COVID-19 Patients
Condition: Severe Acute Respiratory Syndrome Coronavirus 2; Electric Impedance; Prone Positioning
MeSH terms: Coronavirus Infections; Severe Acute Respiratory Syndrome; Syndrome
Study type: Observational

Summary: 
      The consensus therapeutic strategy implies that COVID patients with acute lung injury due to
      coronavirus are routinely placed in prone position in an attempt to improve oxygenation by
      increasing ventilation homogeneity. The purpose of the study is to quantify with the
      electrical impedance tomography (EIT) the changes in the ventilation and aeration in the
      dorsal regions of the lung when the patient is placed in prone position.
    

Detailed description: 
      Patients with acute respiratory distress syndrome (ARDS) frequently develop atelectasis in
      dorsal lung regions because of gravity and the compression by the heart and the diaphragm.
      Since lung perfusion is predominantly distributed in lower lung regions, a reduction of
      ventilation in these areas results in further ventilation-perfusion mismatch, called shunt.
      The development of atelectatic lung regions necessitate the use of higher ventilation
      pressures, which in turn results in excessive transpulmonary pressures and
      ventilation-induced lung injury in the ventral regions. Therefore it is common to promote the
      prone position in patients with ARDS in order to improve ventilation-perfusion matching and
      thus, protect the ventral regions from hyperinflation. In patients with COVID-19-related
      ARDS, the value of such therapeutic strategy based on placing in prone position has not been
      completely elucidated. The aims of the study are to determine whether prone positioning
      improves dorsal regional ventilation when compared to supine position. Moreover, another aim
      is to assess the changes in intrapulmonary shunt following patient position changes.
    

Intervention name(s): Prone positioning
Intervention type(s): Other
Intervention description(s): Change the positioning of the COVID patients who are intubated and mechanically ventilated from supine to prone
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with moderate to severe acute lung injury induced by the coronavirus necessitating
        intubation and ventilation with positioning on the ventral side.
Development & Testing of a Decision Aid for LVAD Placement
Condition: End-Stage Heart Failure; Bridge-to-Transplant LVAD Placement (BTT); Destination Therapy LVAD Placement (DT); Refusal of LVAD Placement (Decliners); LVAD Caregivers
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The goal of this project is to develop a patient-centered decision aid for decision-making
      about end-stage heart failure treatment. This study seeks to create a decision aid that
      presents outcomes, risks, projected experiences, and uncertainties about Left Ventricular
      Assist Device (LVAD) placement to help patients make values-based decisions about placement.
      The investigators propose a mixed methods design involving a literature search of clinical
      evidence, semi-structured patient interviews, and quantitative data from a multi-site trial
      of patients receiving the decision aid compared to patients not receiving the aid.
    


Intervention name(s): LVAD Decision Aid
Intervention type(s): Other
Intervention description(s): Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: End-Stage Heart Failure; Left Ventricular Assist Device; Decision Aid; Medical Decision-Making
Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis
Condition: Liver Disease
MeSH terms: Liver Diseases; Fatty Liver
Study type: Interventional
Phase: Phase 4

Summary: 
      Non-alcoholic steatohepatitis represents 10 - 15% total cases of hepatic cirrhosis. In the
      upcoming years, the economic burden of this disease will increase and will mean an important
      problem for our health system due to obesity epidemic.

      There are several treatments for non-alcoholic steatohepatitis; however, none of them have
      overcome a healthy lifestyle including diet, exercise and some drugs related with insulin
      metabolism.

      There after, using hepatoprotective drugs and antioxidants have been recommended as an
      eligible therapy to reduce the progression from fatty liver to steatohepatitis and cirrhosis.
      Being this approach not only an experimental item yet but also an unavoidable reality.

      The purpose of this randomized controlled study is explore the effects of
      siliphos-selenium-methionine-alpha lipoic acid + metformin versus metformin in patients with
      fatty liver and non-alcoholic steatohepatitis about biochemical and echosonographic
      parameters.
    


Intervention name(s): Metformin; Siliphos+ Selenium - Methionine + Alpha Lipoic Acid; Siliphos+ Selenium - Methionine + Alpha Lipoic Acid; Metformin
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): Patients with Steatohepatitis treated with diet, exercise and metformin; Patients with Steatohepatitis treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID; Patients with fatty liver treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID; Patients with fatty liver treated with diet, exercise and metformin
Intervention MeSH terms: Thioctic Acid; Selenium; Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: nafld, nash, fatty liver
Women's Health Initiative Study of Cognitive Aging
Condition: Healthy
Study type: Observational

Summary: 
      The Women's Health Initiative Study of Cognitive Aging (WHISCA) is a two-armed, randomized,
      placebo controlled, clinical trial designed to assess the efficacy of postmenopausal hormone
      therapy (HT) on age related changes in specific cognitive functions.
    

Detailed description: 
      WHISCA is an ancillary study to the Women's Health Initiative (WHI) and the WHI Memory Study
      (WHIMS) and has enrolled 2303 women aged 66 to 84 years who did not meet the criteria for
      dementia. WHISCA is investigating the effects of hormone therapy on rates of change over time
      in memory, other aspects of cognition (language, attention, spatial ability), motor function,
      and mood.

      Objectives

        -  Does HT protect against age-associated memory and cognitive longitudinal decline in
           women age 65 and older?

        -  What is the rate of change in memory and other cognitive abilities in women receiving HT
           compared to women receiving placebo?

        -  Does the addition of progesterone to HT modify the effects of estrogen on memory and
           other cognitive abilities?
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        A subset of women who were enrolled in the Women's Health Initiative Memory Study (WHIMS),
        who are at least 65 years old and not diagnosed with any type of dementia.
      
Keywords: women, dementia, cognition.; non-demented women at least age 65
Safety and Efficacy Study of NFC-1 in Subjects Aged 12-17 Years With 22q11.2DS & Associated Neuropsychiatric Conditions
Condition: 22q11.2 Deletion Syndrome
MeSH terms: DiGeorge Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 5-week, multi-center, open-label, dose optimization trial in subjects aged 12-17
      years with 22q11DS who have a diagnosis of anxiety disorder, and/or ADHD, and/or ASD.
      Approximately 12 subjects will be initiated, dose optimized, and maintained on NFC-1 over a
      period of 5 weeks.
    


Intervention name(s): NFC-1
Intervention type(s): Drug
Intervention description(s): Doses of NFC-1 will be administered as 50, 100, 200, or 400 mg twice daily as size 2, hard gelatin capsules for oral administration.
Other intervention name(s): NFC1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 22q11.2 DS
The Effect of Skin Cleansers on the Skin Surface Microbiome
Condition: Skin Health
Study type: Interventional
Phase: Phase 4

Summary: 
      This study determines the effects of a single application of different antiseptic skin
      cleansers on the composition of the skin surface microbiome using next-generation sequencing
      (NGS) techniques. Twelve healthy volunteers will receive all three test products in a
      randomized order to compare the effects of each skin cleanser.
    

Detailed description: 
      Disinfectants and oral antiseptics including PVP-I are known to kill microorganisms to a
      variable extent, at a variable range of time points. Microorganisms may be protected from
      disinfectants by production of thick masses of cells and extracellular materials, or
      biofilms. Moreover, antiseptics should not lead to dysbiosis after use. Dysbiosis is a
      negative change in the microbiome of a particular skin or mucosal region. The Human
      Microbiome project showed, that every area has a specific microbiota in which the human host
      lives with an abundance of commensal, synergistic, and potentially pathogenic microorganisms.
      Antiseptics with efficacy gaps and resistance may induce such dysbiosis, especially after
      prolonged use. It is envisaged that twelve healthy volunteers will complete the study. Each
      healthy volunteer will apply the test product according to a developed protocol, between
      established wash out periods.

      The ability of the test product (Commercially available - Betadine® 7.5% skin cleanser (PVP-I
      7.5%)) compared to the reference products (commercially available 4% chlorhexidine skin
      cleanser - Unity antiseptic hand wash (no alcohol) and Plain non antibacterial soap -
      Guardian gel hand wash (not medicated)) to reduce resident and transient microflora will be
      assessed. The hand wash products will also be assessed for their ability to maintain and/or
      restore balanced microflora.
    

Intervention name(s): 7.5% Povidone-Iodine [PVP-I]; 4% chlorhexidine skin cleanser; Plain non antibacterial soap
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Betadine® 7.5% skin cleanser (PVP-I 7.5%); Unity antiseptic hand wash (no alcohol); Guardian gel hand wash (not medicated),
Intervention MeSH terms: Chlorhexidine; Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Twelve healthy volunteers will be randomized into three arms with three different treatment sequences with four healthy volunteers in each arm. Up to fifteen healthy volunteers may be recruited with the consideration that up to three subjects may drop out.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Serum Neuroglobin and HIF-1α in Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Observational [Patient Registry]

Summary: 
      Neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia, and
      therefore has the potential to impact outcomes after acute ischemic stroke. Hypoxia inducible
      factor (HIF)-1α is neuroprotective in several models of experimental brain injury and is
      increased in brain after acute cerebral infarction in humans and experimental animals.The
      investigators sought to examine the changes in serum neuroglobin and HIF-1α concentrations in
      patients with acute ischemic stroke during the initial 96-h period after stroke and assessed
      the relation between them and the relation of them to prognosis of such patients with acute
      ischemic stroke.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patient group comprised 24 male and 16 female. Their age ranged from 42 to 76 years.
        Locations of infarct, as evidenced by radiologic and neurologic symptoms or signs, included
        the territories of the middle cerebral artery (13 cases), the posterior cerebral artery (9
        cases) the anterior cerebral artery (8 cases), vertebrobasilar area (7 cases), and
        watershed area (3 cases with cortical and subcortical low densities crossing typical
        vascular territories).
      
Keywords: Neuroglobin; HIF-α; Acute ischemic stroke; Prognosis
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics, safety, tolerability and
      immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy
      subjects.
    


Intervention name(s): SB2; EU Remicade; US Remicade
Intervention type(s): Biological; Biological; Biological
Intervention description(s): IV infusion; IV infusion; IV infusion
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Pharmacokinetics