bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Activity Limitation in Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Limitation of activity is one of the main item used by composites scores designed to assess
      the level of asthma control. Since this item is systematically subjectively assessed by the
      patient, the investigators would like to know if these subjective data are correlated with
      objective data.

      Aims of this study are: 1) To describe what means "limitation of activity" for asthma
      patients and how they deal with; 2) To describe the objective exercise capacity and
      characteristics of daily activity in two situations (on exacerbation, out of an
      exacerbation).
    


Intervention name(s): Assessment of activity capacities
Intervention type(s): Other
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Exacerbated asthma patients coming to the outpatient clinic of pulmonology.
Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The study objective is to compare the clinical outcomes using wavefront guided PRK with iris
      registration and conventional laser PRK using FDA-approved laser technology on the same
      patient.
    

Detailed description: 
      Patients undergoing bilateral PRK on the same day will have one eye randomly assigned to
      custom wavefront guided PRK and the fellow eye treated with conventional PRK.
    

Intervention name(s): Custom PRK with iris registration; Conventional PRK
Intervention type(s): Procedure; Procedure
Intervention description(s): PRK; PRK
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lactoferrin Prophylaxis in VLBW and Regulator T-cells
Condition: Late Onset Neonatal Sepsis; Necrotising Enterocolitis; Very Low Birth Weight Infants
MeSH terms: Sepsis; Neonatal Sepsis; Enterocolitis; Enterocolitis, Necrotizing; Birth Weight
Study type: Interventional

Summary: 
      The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin
      (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis
      and the effect of LF on regulatory T cells.
    


Intervention name(s): Lactoferrin (bovine origin)
Intervention type(s): Dietary Supplement
Intervention description(s): Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: VLBW, NEC, Late onset sepsis
Single Dose of Lu AF28996 to Healthy Young Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the
      body when given by mouth to healthy young men.
    

Detailed description: 
      Part A of the study consists of 6 groups (Cohorts 1 to 6) with 3 subjects in each, with the
      possibility of 4 additional cohorts. In cohort 1, the subjects will receive a single dose of
      Lu AF28996 by mouth. Following evaluation of data from the first dose, the subjects in the
      following cohorts are planned to receive two single increasing doses by mouth of Lu AF28996
      on 2 separate days with a wash out (day or days without dosing) in between.

      Part B is an open-label three-period crossover study in healthy young men to compare the PK
      of an oral capsule formulation with that of an oral solution formulation and to evaluate food
      effect following oral capsule administration of Lu AF28996.The subjects will be randomised to
      one of the four treatment sequences
    

Intervention name(s): Lu AF28996 solution; Lu AF28996 capsule
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution (0.1-0.2 mg/mL)
Following each cohort, a dosing conference will be held where tolerability, safety and preliminary PK results from the previous cohorts will be reviewed before deciding on the next doses; hard capsule orally QD: one dose lower than the highest dose level in part A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing the Effects of ELO Water on Diabetic Foot Ulcers
Condition: Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      This pilot study examined the effects of ELO water, a commercially-available oxygen-enriched
      drinking water, on wound healing in patients with diabetic foot ulcers over 12 weeks.
    

Detailed description: 
      As hyperbaric chamber and topical oxygen therapies have demonstrated efficacy in improving
      DFU healing, the aim of this study was to evaluate ELO water, which has been shown to
      increase arterial oxygen levels, as a novel means of increasing oxygen delivery to
      poorly-healing DFUs as an adjunct to standard care. This proof-of-concept pilot study of
      drinking oxygen-enriched ELO water to treat diabetic foot ulcers (DFUs) was conducted on 16
      adults with non-healing (for at least 30 days prior to the study) DFUs in Changi General
      Hospital in Singapore.

      ELO water was delivered to participants' homes and their water consumption recorded in
      diaries, which was checked by the research co-ordinator at 2-weekly visits for 12 weeks.
      Minimum compliance was defined to be at least 85% of the water (12/14 bottles/fortnight),
      equivalent to 9 litres/week. No changes in diabetic therapy, diet or exercise were made
      during the study period.

      All participants were seen by podiatrist for standard of care DFU treatment weekly. The ulcer
      size was captured following wound debridement each week using a standardized digital
      photographic protocol and the photos were encrypted and anonymized for confidentiality and
      data protection. All the images were assessed independently. Wound dressing was carried out
      twice per week in between visits at primary care clinics or at home.
    

Intervention name(s): ELO water
Intervention type(s): Dietary Supplement
Intervention description(s): Drinking 1.5 litres daily of ELO water for 12 weeks
Intervention model: Single Group Assignment
Intervention model description: Adults with type 2 diabetes and diabetic foot ulcer which has not healed with conventional therapy for at least 30 days prior to recruitment
Masking: None (Open Label)
Primary purpose: Treatment
MaSS - Maastricht Sarcopenia Study
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      The objective of this cross-sectional study is to obtain insight in the characteristics
      (nutritional status and level of physical activity) of sarcopenic compared to non-sarcopenic
      community-dwelling older people. There is one measurement moment and measurements will take
      place at the participant's home.
    

Detailed description: 
      -  Characterization of sarcopenic older people (demographics, nutritional status, level of
           physical activity)

        -  Prevalence rates of sarcopenia in community-dwelling older people in the Netherlands

        -  Insight in differences and/or overlap between sarcopenia versus frailty

        -  Insight in the impact of sarcopenia on economic outcomes
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Community-dwelling older people
      
Biospecimen description: 
      Blood sample.
Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells
Condition: Red Blood Cell; Peripheral Blood Mononuclear Cell; Endothelial NO-synthase
Study type: Observational

Summary: 
      The aim of this study is to investigate wether change in endothelial nitric oxid synthase of
      blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on
      development and progression of cardiovascular diseases.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        100 healthy volunteers and 100 patient with stable coronary artery disease
      
Biospecimen description: 
      Blood sample
    
Keywords: Endothelial NO-synthase; red blood cell; erythrocytes; Peripheral Blood Mononuclear Cell; cardiovascular disease
Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation
Condition: Heart Failure; Recurrent Atrial Fibrillation
MeSH terms: Heart Failure; Atrial Fibrillation; Recurrence
Study type: Interventional

Summary: 
      A streamlined AF ablation procedure done without PV mapping as a daycase is more effective
      than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial
      fibrillation.
    

Detailed description: 
      AVATAR-AF is a multicentre, randomised controlled study comparing a streamlined
      AVATAR-protocol ablation procedure to anti-arrhythmic therapy in patients with documented
      paroxysmal AF who are considered to be failing current strategy for AF. A secondary control
      arm will also compare the AVATAR-protocol to conventional AF ablation. 300 patients who are
      on no prior anti-arrhythmic, 'pill-in-pocket' or taking regular anti-arrhythmics will be
      randomised in a 1:1:1 manner to a treatment strategy of either AVATAR-protocol ablation,
      anti-arrhythmic therapy or conventional AF ablation and followed-up for 1 year.
    

Intervention name(s): AVATAR-AF ablation; Anti-Arrhythmic therapy; Conventional AF ablation
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): Experimental ablation protocol; Group 2 will be prescribed medication listed below:
Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.
You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.; Conventional ablation procedure
Other intervention name(s): Ablation method-surgical; Amiodarone; Dronaderone; Sotalol; Beta blockers; Calcium channel blockers; Flecainide; Propafenone; Ablation method-surgical
Intervention MeSH terms: Amiodarone; Flecainide; Sotalol; Propafenone; Anti-Arrhythmia Agents; Calcium Channel Blockers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure
A Phase 2a Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to compare the change in estimated glomerular
      filtration rate (eGFR) from baseline to Week 8 between placebo and GCS-100 treatment. The
      secondary objective is to determine the safety and tolerability of GCS-100 administered for 8
      weeks relative to placebo. In addition, the study will measure the effect of GCS-100 on
      circulating galectin-3 and other markers of disease activity.
    

Detailed description: 
      Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with
      adverse outcomes (de Boer et. al., 2011, Dang et. al., 2012, Fernandes Bertocchi et. al.,
      2008, Henderson et. al., 2008). Animal models with genetic knockout of galectin-3 demonstrate
      a reduction in structural and functional deficits in the kidney (Dang et. al., 2012,
      Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). GCS-100 is a galectin- 3
      antagonist that has been shown to reduce fibrosis pre-clinically. Based on the role of
      galectin-3 and fibrosis in kidney disease, the Sponsor believes GCS-100 may be effective at
      treating patients with CKD.
    

Intervention name(s): GCS-100; Placebo, Saline
Intervention type(s): Drug; Drug
Intervention description(s): The amount (in mg) of GCS-100 to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The study drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL.; The amount (in mg) of drug to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL.
Other intervention name(s): Saline solution; 0.9% Sodium Chloride Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Influence of Pramipexole on the QT Interval of the ECG in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess that pramipexole does not prolong the QT interval
      more than placebo
    


Intervention name(s): Pramipexole extended-release (ER) tablets; Pramipexole immediate-release (IR) tablets; Moxifloxacin; Pramipexole Placebo; Moxifloxacin Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin; Pramipexole; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Effect of Calcium/Vitamin D Supplementation on Body Weight and Fat Loss.
Condition: Obesity; Overweight
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to assess the effect of calcium/vitamin D supplementation (Caltrate
      600 +D®) on body weight loss during a weight-reducing program
    

Detailed description: 
      The effect of a calcium supplementation on body weight loss is inconclusive and some studies
      have suggested that adequate calcium intake can have a favourable effect on some metabolic
      variables. The objectives of this study were to evaluate the impact of (Caltrate 600 + D ®)
      on body composition and various indicators of metabolic health in overweight and obese
      females characterised by a usual low daily calcium intake, on a weight-reducing program.

      The main hypotheses of this study were:

        -  Caltrate 600 +D® increases body weight and fat mass losses of individuals on a
           weight-reducing program.

        -  Caltrate 600 +D® improves the metabolic profile of these subjects, independently of
           variations promoted by body fat loss.
    

Intervention name(s): Caltrate® 600 + D; Weight loss intervention
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Calcium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Caltrate; Lipoproteins; Glucose; Insulin; Blood pressure; Body fat; Body weight; Women; Diet; Macronutrients
Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects
Condition: Allergy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety and tolerability of single
      ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult
      subjects.
    


Intervention name(s): REGN1908-1909; placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Epigenetic and Microbiota Modifications
Condition: Diabetes type2; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In order to investigate how gut microbiota interventions are able to change gut microbiota
      population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be
      randomized to one of the three treatment groups: 1) probiotics arm, who will take a
      Lactobacillus fermentum D3 in pills daily; 2) FMT arm, who will take a lyophilized fecal
      microbiota transplant in pills; and 3) control group, who will take placebo pills. After 3
      months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will
      be assessed.
    


Intervention name(s): Lactobacillus fermentum D3; Fecal microbiota transplant (FMT); Placebo
Intervention type(s): Dietary Supplement; Biological; Drug
Intervention description(s): Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.; Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.; Placebo in a white, gelatin capsule (orally), with powder milk
Other intervention name(s): PCT/EP 2012058214
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Diabetes type2; FMT; Probiotics; Microbiota
Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of
      PF-04427429 administered intravenously to healthy adult volunteers
    


Intervention name(s): PF-04427429; PF-04427429; PF-04427429; PF-04427429; PF-04427429
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): single intravenous infusion of 10 mg PF-04427429 or placebo; single intravenous infusion of 30 mg PF-04427429 or placebo; single intravenous infusion of 100 mg PF-04427429 or placebo; single intravenous infusion of 300 mg PF-04427429 or placebo; single intravenous infusion of 1000 mg PF-04427429 or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy volunteers; PK; PD; safety and toleration
Nasal Irrigation in Infants With Bronchiolitis.
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of
      life. Most children with bronchiolitis have mild disease and are managed at home with support
      from primary care providers, while children with more severe symptoms require supportive
      therapy with oxygen and fluid administration.

      Neonates may be obligate nasal breathers until they are at least 2 months old and nasal
      obstruction may play a relevant role in respiratory resistances throughout the first months
      of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance.
      Some guidelines recommend to clear the nostrils of secretions to improve airway patency but
      no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was
      carried out.

      The aim of this randomized controlled trial is to compare normal saline and hypertonic
      solution for nasal irrigation versus simple supportive care in infants admitted to Emergency
      Department with bronchiolitis and mild desaturation.
    


Intervention name(s): Isotonic solution (NaCl 0.9%); Hypertonic solution (NaCl 3%)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchiolitis; Normal saline solution; Hypertonic solution; Nasal irrigation
Decision Support Following Genetic Testing for Breast-Ovarian Cancer Susceptibility
Condition: Breast Cancer; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional

Summary: 
      This non-therapeutic trial is for women who have received results of genetic testing for
      BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed
      decision making regarding risk management following testing to usual care. The researchers
      will test separate decision support tools for women who receive positive test results and
      women who receive negative/inconclusive test results. Among women who receive a positive test
      result, an interactive decision support intervention will be compared to a print
      intervention. Among women who receive an inconclusive result, an interactive intervention
      will be compared to usual care.
    


Intervention name(s): Enhanced Internet DA; Internet DA; Enhanced Print DA; Print DA; Inconclusive Results DA
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.; BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support. This intervention is designed to provide education regarding the available risk management options.; BRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.; BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.; Women who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Genetic counseling; genetic testing; BRCA1; BRCA2; Hereditary breast cancer; Hereditary ovarian cancer