bioihbjkbjnl/mcl2 huggingface dataset:
Hyperpolarized Xenon MRI in Cystic Fibrosis Pulmonary Exacerbations
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The investigators aim to assess whether pulmonary MRI (hyperpolarised 129Xe ventilation
      imaging [Xe-MRI]) can detect changes in ventilation defects in patients with CF before and
      after treatment for a pulmonary exacerbation. The investigators will determine whether
      changes seen using pulmonary Xe-MRI are associated with changes in pulmonary function
      (spirometry, lung volumes, lung clearance index [LCI]) in patients with CF before and after
      pulmonary exacerbation.
    

Detailed description: 
      Cystic fibrosis (CF) is one of the most common genetic diseases affecting children and young
      adults [1]. Lung disease is the primary cause of morbidity and mortality in these patients
      and sensitive markers of lung disease in CF are important for directing therapy in these
      patients.

      LCI, measured by multiple breath washout (MBW), has been shown to be more sensitive than
      traditional pulmonary function tests (PFTs) for assessing the treatment effect of novel
      therapies in CF patients [2,3]. However, LCI provides no information regarding the spatial
      distribution of ventilation inhomogeneity within the lungs and improvements in mucus plugging
      of poorly ventilated regions can paradoxically worsen the LCI [4,5]. Thus an imaging
      technique that can capture regional changes in the distribution of ventilation might be
      better suited than LCI to detect treatment effects and could also help to better define the
      utility of LCI as a clinical tool.

      Xe-MRI is a safe, non-ionizing modality for imaging the lungs, providing an accurate spatial
      representation of ventilation inhomogeneity [6]. Xe-MRI has been shown to be effective in
      imaging of adult patients with chronic obstructive pulmonary disease (COPD) and CF [6]
      however, there are no published studies using Xe-MRI in children.

      The hypothesis of this study is that Xe-MRI and LCI will provide complimentary information
      when quantifying ventilation inhomogeneity in CF lung disease and that Xe-MRI will be able to
      define patients in whom LCI fails to capture positive effects of treatment. The ultimate goal
      is to develop more sensitive tools for longitudinal monitoring to direct the clinical care of
      CF patients in the future.

      To accomplish this, the investigators will compare the ability of Xe-MRI and LCI to detect
      changes in ventilation inhomogeneity in patients with CF before and after treatment for a
      pulmonary exacerbation, a common pulmonary complication of CF.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 8-18 with cystic fibrosis admitted for inpatient treatment with a clinical
        diagnosis of pulmonary exacerbation
      
Keywords: CF; Exacerbation; Hyerpolarized xenon MRI; Pediatrics; Lung Clearance Index
Calorie Restriction With Leucine Supplementation
Condition: Obesity; Menopause; Osteoporosis; Sarcopenia
MeSH terms: Osteoporosis; Sarcopenia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether consuming additional leucine during calorie
      restriction induced weight loss has beneficial or harmful effects on multi-organ (liver,
      muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut
      microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal
      women.
    


Intervention name(s): Weight loss with normal protein and leucine intake; Weight loss with protein/leucine supplementation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day).; Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day) with the additional protein given in the form of whey protein, which has a high leucine content.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pink and Dude Chef
Condition: Child Nutrition; Fruit and Vegetable Intake; Healthy Food Choice; Healthy Food Preparation
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate an afterschool program to teach nutrition through
      basic cooking skills. This after school extracurricular program increases the students'
      confidence, knowledge, and skills for cooking as one of the first steps for dietary
      improvement. In addition to the life lessons students learn during this class, they gain
      self-confidence and become self-sufficient culinary experts that are capable of educating
      their siblings, parents, and social circles. This research project will test the impact this
      program has on nutritional knowledge, culinary efficacy, and nutritional choices made in and
      out of the home. The Pink and Dude Chef Afterschool Cooking Program was developed through
      STRIDE (Science through Translational Research in Diet and Exercise at California Polytechnic
      state University (Cal Poly) in San Luis Obispo, CA.

      Hypothesis: Middle school students participating in the Pink and Dude Chef afterschool
      cooking program will increase nutritional knowledge, culinary efficacy, motivation to eat
      fruits and vegetables, and fruit and vegetable intake compared to an attention control group.
    


Intervention name(s): Pink and Dude Chef Afterschool Cooking Program
Intervention type(s): Behavioral
Intervention description(s): 12 educational cooking classes: two classes per week for six weeks (2 hours each)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Child; Nutrition; resonance Raman spectroscopy; Fruit & Vegetable; Children Cooking
Lesinurad Tablet Bioequivalence
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the bioequivalence of lesinurad tablets manufactured at two different
      sites.
    

Detailed description: 
      This study is intended to evaluate the clinical comparability of lesinurad tablets
      manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK)
      parameters.
    

Intervention name(s): Lesinurad 400 mg (manufactured at Site 1); Lesinurad 400 mg (manufactured at Site 2)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lesinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Gait Parameters and Balance in Patients With Obstructive Lung Diseases
Condition: Gait Disorder, Sensorimotor
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Gait Disorders, Neurologic
Study type: Observational

Summary: 
      In the literature, most of the studies examining the gait characteristics and balance
      separately or examining the relationship between them are on patients with COPD.

      No study examining gait parameters in other obstructive pulmonary patients such as
      bronchiectasis and asthma was found.A convincing link between gait disturbances and falls in
      COPD patients is still unknown and further research is needed. Therefore, the purpose of our
      study; gait parameters and balance in individuals with obstructive pulmonary disease. We will
      also examine the relationship between gait parameters and extrapulmonary clinical indicators
      of these individuals.
    

Detailed description: 
      Patients with COPD call walking as one of the most problematic activities in daily life.
      Patients with COPD walk less in daily life than their healthy peers. Gait characteristics of
      extrapulmonary comorbidities that probably affect the musculoskeletal and cardiovascular
      system vary. The gait assessment gives an idea about the biomechanical factors associated
      with a reduction in walking distance in COPD patients. In patients with COPD, after the onset
      of shortness of breath or leg fatigue, a decrease in cadence during walking, shortened stride
      length, an increase in the time spent in the double support period, an increase in the peak
      ankle dorsi flexion moment is observed. During gait, there is an increase in balance
      disorders in the mediolateral direction. In addition, patients with COPD walk on a constant
      speed treadmill with more stride time and less step width variability. Studies have shown
      that patients with COPD have increased temporal walking characteristics, decreased step and
      stride length, and increased walking variability.

      In the literature, most of the studies that examine gait characteristics and balance
      separately or examine the relationship between them are on patients with COPD. No study
      examining gait parameters in other obstructive pulmonary patients such as bronchiectasis and
      asthma has been found. A persuasive link between walking disorders and falls in COPD patients
      is still unknown and further research is needed. This study will contribute to clarifying the
      mechanisms of why the balance studied in patients with COPD is adversely affected.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The obstructive lung diseases from every subgroups: COPD, asthma and bronchiectasis
        patients
      
Keywords: balance; chronic obstructive diseases
Pharmacokinetics of BPDO-1603 or BPDO-16031 and BPDO-16033 Administration in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetics and safety of BPDO-1603 or BPDO-16031 and BPDO-16033 administration in
      healthy adults. Randomized, open-label, single-dose, cross-over, Phase 1 study
    


Intervention name(s): BPDO-1603
Intervention type(s): Drug
Intervention description(s): donepezil/mematine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease, Dementia
pK of a Novel 200 mg Ibuprofen Medicated Plaster
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study of the pharmacokinetics of a novel 200 mg Ibuprofen Medicated
      Plaster. The study will be conducted as a monocentric, open, randomised, single and
      multiple-dose, two-period, crossover trial in healthy volunteers. A total of 16 healthy
      volunteers will be randomised.

      A wash-out period of 3 days is planned between the two periods. Each of the volunteers will
      be randomly assigned to one of 2 possible administration sequences.
    


Intervention name(s): Ibuprofen 200 mg TEPI Medicated Plaster; Aktren® 200 mg überzogene Tabletten (Ibuprofen)
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen 200mg TEPI medicated plaster applied to the upper back daily for 24 hours for 5 days; one dose of Aktren® 200 mg überzogene Tabletten (Ibuprofen tablet)
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      The Feeling Hot studies focus on the proof-of-principle of using temperature sensing as a
      tool to detect nocturnal erections. In the Feeling Hot 2 study the penile skin temperature is
      investigated during nocturnal erections during overnight ambulatory measurements.
      Simultaneous measurements with the RigiScan will be performed to detect the nocturnal
      erections and validate the principle of temperature measurements for erectile dysfunction
      diagnostics.
    

Detailed description: 
      Differentiation in nature of erectile dysfunction (ED) is currently made by nocturnal
      erection detection with the RigiScan. The RigiScan uses outdated software, measurements are
      user unfriendly and system components are out of stock. In the search of modernizing erectile
      dysfunction diagnostics, the question has arisen whether temperature measurements can
      function as a tool for nocturnal erection detection. With the absence of a pressure
      component, the patient experience should improve. Literature and mathematical modelling
      studies have shown that the penile temperature increases significantly during erection.
      However, no studies have used penile skin temperature measurements to detect nocturnal
      erections. The Feeling Hot 2 study explores the validity of this measurement set-up for
      overnight ambulatory measurements of nocturnal erections in the search of modernizing
      erectile dysfunction diagnostics.
    

Intervention name(s): Feeling Hot sensor system
Intervention type(s): Device
Intervention description(s): The Feeling Hot sensor system consists of two temperature probes placed on the penis and the outer thigh of the test subject to measure skin temperature during erection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Erectile Dysfunction; RigiScan; Nocturnal erection; Penile temperature
Video-based Teach-to-goal Intervention on Inhaler Technique on Jordanian Adults With Asthma and COPD
Condition: COPD; Asthma; Inhaled Steroid Dependent Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study was an interventional educational study that was intended to find out the effect
      of a video based inhaler technique education on improving inhaler technique mastery, disease
      control, medication adherence and patient quality of life in comparison to verbal education
      among adults with asthma or COPD.
    


Intervention name(s): Verbal teach to goal education; Video based teach to goal education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants were showed how to use correctly their inhalers and then asked again to show the technique. For each incorrect step, the patients were corrected and asked to repeat the steps until they mastered the technique. This process was repeated a maximum of three times.; Participants were educated by the a video-based teach to goal method. using a smartphone, an educational video illustrating the correct technique for each of the inhalers used by the patient was displayed. After watching the video, the patients were asked to show again how to use their inhaler and for each wrong step the video was displayed again until mastering the correct technique a maximum of three times. At the end of the interview participants in the intervention group received a copy of the video via WhatsApp and were all invited to watch the video whenever needed.
Other intervention name(s): verbal TTG; video-based TTG
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients diagnosed with asthma or COPD, who were started on any inhaler for a minimum of one month and will continue using them chronically were met in the JUH respiratory clinic and invited to participate.
Patients at high risk for infection, or those presenting with a very severe clinical presentation were excluded.
Taking into account the non-invasive nature of the educational intervention, and the need to reduce the risk of spread of COVID19 virus (sharing pens or papers), a verbal consent was obtained.
Enrolled participants were randomized using simple randomization into two groups; odd numbers for the control group (received a verbal TTG education on their inhaler technique) and even numbers for the intervention group ( received a video based TTG education). The primary and secondary outcomes of the study were inhaler technique mastery, amelioration of disease control, disease related quality of life and medication adherence at follow-up (after 3 months).
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Video-Based; Teach To Goal Education; Chronic Obstructive Pulmonary Disease; Asthma; Randomized Controlled Trial; Patient Education; Quality of Life; Medication adherence; Inhaler technique
Feasibility of a Mobile Application to Support Reflection and Dialog About Strengths in People With Chronic Illness
Condition: Chronic Disease; Rheumatic Diseases
MeSH terms: Rheumatic Diseases; Collagen Diseases; Chronic Disease
Study type: Interventional

Summary: 
      Self-management of chronic illness can be highly demanding and people need to mobilize their
      personal strengths in order to live well with their condition. A mobile application was
      designed in collaboration with people with chronic illness and health care providers with the
      aims to support awareness of patients' strengths and patient-provider dialogues that include
      strengths. The aim of the present study is to evaluate with mixed methods the perceived
      usefulness and usability of the application and potential effects of the application on
      patients.
    

Detailed description: 
      In this pre-post design pilot study participants will be recruited from self-management
      courses for people with rheumatic diseases. Before using the application participants will be
      asked to report their strengths in a written format. After using the mobile application to
      reflect on their strengths the participants will be interviewed about their experience of
      using the application and on the task of reflecting on their strengths. They will also be
      asked to fill out a questionnaire on perceived usefulness and user-friendliness. Before and
      after using the application the participants fill out questionnaires on emotions (Positive
      and Negative Affective Scale) and self-efficacy (The Arthritis Self-efficacy Scale). All
      interviews will be audio-taped and analyzed with a qualitative approach. Descriptive analysis
      will be applied for quantitative data.
    

Intervention name(s): Mobile application
Intervention type(s): Device
Intervention description(s): Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.
Intervention model: Single Group Assignment
Intervention model description: Participants will be recruited to a pre-post design study.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: self-management; health assets; Strengths; mHealth; Feasibility
Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients
Condition: Limbal Stem Cell Deficiency
MeSH terms: Limbal Stem Cell Deficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex
      vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface
      reconstruction in cases of partial and sever limbal stem cell deficiency.
    

Detailed description: 
      Ocular surface is composed of corneal and conjunctival epithelial cells. Normal cornea is
      essential for normal vision. Defects in renewal and repair of ocular surface as a result of
      limbal stem cell deficiency are now known to cause varying ocular surface morbidity including
      persistent photophobia, repeated and persistent surface breakdown and overt
      conjunctivalisation of the cornea. Restoring ocular health in these eyes has traditionally
      been frustrating. Ex vivo cultured limbal epithelial stem cells have been used successfully
      to treat limbal stem cell deficiency. Ex-vivo limbal stem cell allograft transplantation is
      achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives
      or cadaveric donors). The donor stem cells are obtained by excising a small area of the
      conjunctiva at the limbus and are a minor procedure. The tissue so obtained is then grown in
      tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted
      on to the affected eye(s), backed with an amniotic membrane. The surgery is undertaken under
      either local or general anesthesia.
    

Intervention name(s): Cultured limbal stem cells Transplantation
Intervention type(s): Procedure
Intervention description(s): Transplantation of cultivated limbal epithelium on amniotic membrane
Other intervention name(s): Transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: limbal stem cell deficiency
Safety and Efficacy of CD10367 in Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory, single-centre, investigator blinded, randomized, controlled,
      intra-individual study, involving subjects with psoriasis vulgaris.

      The objective is to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the
      safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once
      daily application.
    

Detailed description: 
      Study drugs will be applied in each subject once daily, 5 days a week during the first 2
      weeks and for 4 days the third week on 6 mini-zones located on at least 2 psoriatic plaques
      as described below:

        -  on 2 mini-zones pretreated by a keratolytic product, will be tested:

             -  CD10367 3% solution

             -  CD10367 solution placebo

        -  on 4 mini-zones non-pretreated, will be tested:

             -  CD10367 3% solution

             -  CD10367 1% solution

             -  CD10367 solution placebo

             -  Betneval 0.1% ointment
    

Intervention name(s): CD10367 3% Solution - Non-desquamated zone; CD10367 1% Solution - Non-desquamated zone; CD10367 solution placebo - Non-desquamated zone; Betneval ointment - Non-desquamated zone; CD10367 3% Solution - Desquamated zone; CD10367 solution placebo - Desquamated zone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Once daily application for 3 weeks; Once daily application for 3 weeks; Once daily application for 3 weeks; Once daily application for 3 weeks; Once daily application for 3 weeks; Once daily application for 3 weeks
Other intervention name(s): Betamethasone Valerate
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment