bioihbjkbjnl/mcl2 huggingface dataset:
Critical Respiratory Diseases in Ex-preterm Infants in PICU
Condition: Infant, Premature, Diseases; Respiratory Disease; Respiratory Failure; Premature Birth
MeSH terms: Respiratory Insufficiency; Respiratory Tract Diseases; Respiration Disorders; Premature Birth; Infant, Premature, Diseases
Study type: Observational

Summary: 
      Premature birth is the leading cause of death in children younger than 5 years old worldwide,
      especially in low- and middle-income countries. Premature infants who survive are at greater
      risk of a range of short-term and long-term health consequences. Common long-term health
      morbidities among children who are born prematurely include cerebral palsy, infections
      (particularly respiratory infections), bronchopulmonary dysplasia, feeding difficulties,
      hypoxic-ischemic encephalopathy, visual and hearing problems. Re-hospitalization occurs
      frequently during first few years of life among ex-premature infants with respiratory
      illness. This leads to increased financial burden for health care system and families. The
      impact of prematurity on the health care system, especially on pediatric intensive care units
      (PICUs) has mainly been evaluated in high income countries. Little is known about long term
      health outcomes of ex-premature infants and their impact on the cost to health care system in
      low- and middle-income countries. This pilot, single institution, observational study aims to
      determine the prevalence, course of the diseases, and outcomes of ex-premature infants with
      respiratory illnesses who are admitted to a PICU of a tertiary children's hospital in
      Vietnam. Investigators will determine the epidemiology of respiratory illness, and the
      resource utilization for these children in the PICU. To achieve these aims, the investigators
      will prospectively screen and recruit all children aged less than 2 years old admitted to the
      PICU with respiratory illness/failure and collect pertinent clinical data. The study
      participants will be follow-up until PICU discharge.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients aged ≤ 2 year olds with respiratory diseases
      
Keywords: Respiratory Diseases, ex-prematurity; Respiratory Failure; Pediatric Intensive Care
Analysis of a New Mask for Positive Airway Pressure (PAP) Device Users
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      BACKGROUND AND AIMS Continuous positive airway pressure (CPAP) is an effective therapy to
      treat sleep apnea. Sleep apnea is a condition where the airways collapse when the patient is
      asleep. CPAP treats sleep apnea by delivering an air pressure to the airways, splinting the
      airways open. CPAP is a device that sits besides the bed and is applied to the patient using
      a face mask.

      The development of new CPAP masks is an on-going focus at ResMed Ltd in a bid to improve
      comfort and user compliance. ResMed are developing a new mask and investigations are required
      to evaluate mask performance over time.

      ResMed Ltd design and manufacturer CPAP masks. The revision and development of masks is an
      on-going focus of the company in a bid to improve usability and patient compliance while
      maintaining optimum treatment. ResMed is developing a new mask. Investigations are therefore
      required to determine how much matter is built-up on the mask over time and to evaluate mask
      performance (including comfort and seal) and efficacy.

      AIMS

      The aims of the study are:

        1. To measure and compare the change in the abundance of microbes on the new mask over a
           period of 8 weeks

        2. To measure and compare the change in comfort, seal, stability, efficacy, leak and user
           compliance of this new mask over a period of 8 weeks

        3. To measure and compare the change in comfort, seal, stability, efficacy, leak and user
           compliance of this new mask versus an available mask

      It is hypothesised that:

        1. The new mask acquires microbes from the user but there is no difference in the abundance
           of microorganisms between 2 and 8 weeks.

        2. The new mask maintains the same degree of comfort, seal, stability, efficacy, leak and
           compliance between 2 and 8 weeks.

        3. Compared to the existing mask, the new mask provides a higher degree of comfort, seal
           and stability and improves user compliance. The new mask also maintains efficacy, and
           maintains or reduces leak compared to the current masks.
    


Intervention name(s): CPAP mask - prototype
Intervention type(s): Device
Intervention description(s): prototype mask, wore for all sleeps for 4 and 8 weeks (as randomly selected). Mask to be used in conjunction with participant's usual prescribed CPAP settings.
Other intervention name(s): PAP mask
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: CPAP; mask; microorganisms
Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment of women with stress urinary incontinence using injection of autologous
      adipose-derived mesenchymal stem cells mixed with collagen gel
    

Detailed description: 
      During the implementation of the project, method for the treatment of women stress urinary
      incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with
      collagen was developed.

      Effectiveness of MSCs is due to the following:

        -  the ability of MSCs to stimulate tissue regeneration

        -  positive results of preclinical studies of the method of treatment of stress urinary
           incontinence (SUI) in animals (female rats).

      After gynecological examination, diagnosis of SUI, MSCs were isolated from adipose tissue,
      cultured and then transplanted back to directly under mucosa of urethra by three point
      injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the
      paraurethral area.

      Injected volume was 3 ml per patient. For injection MSCs (6*10^6 cells) were mixed with
      collagen solution (3,5% w|w).

      Follow up patients monitoring was mperformed at 2, 4, 6 and 12 months after injection.
    

Intervention name(s): Autologous adipose-derived mesenchymal stem cells; Standard treatment according to the Clinical protocols
Intervention type(s): Biological; Other
Intervention description(s): Autologous adipose-derived mesenchymal stem cells mixed with collagen solution; Standard treatment according to the Clinical protocols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress Urinary Incontinence; Mesenchymal stem cells
Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974 (0974-042)
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will demonstrate the definitive bioequivalence of a solid dose formulation of
      MK0974 to the liquid filled capsule formulation of MK0974.
    


Intervention name(s): MK0974 tablet; Comparator: MK0974 liquid filled capsule
Intervention type(s): Drug; Drug
Intervention description(s): MK0974 280 mg tablet in one of two treatment periods; MK0974 300 mg liquid filled capsule in one of two treatment periods
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This is a clinical study for adult subjects with Post Traumatic Stress Disorder.
    

Detailed description: 
      Open label clinical study to evaluate the efficacy of PRX-03140 in reducing PTSD symptoms
    

Intervention name(s): PRX-03140
Intervention type(s): Drug
Intervention description(s): 50 mg PRX-03140 capsules once daily for 2 weeks. After 2 weeks, the dose will increase to 100mg PRX-03140 once daily for 10 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; Post Traumatic Stress Disorder
Evaluation of a Lifestyle Intervention for Employees With Prediabetes
Condition: Prediabetes; Overweight; Obese
MeSH terms: Overweight; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for
      diabetes prevention among employees with prediabetes.
    

Detailed description: 
      The lifestyle intervention includes a 16-week group-based program which targets weight
      reduction through the adoption of a lower fat diet and greater physical activity.
    

Intervention name(s): Lifestyle counseling
Intervention type(s): Behavioral
Intervention description(s): 16-week nutrition, physical activity and behavioral intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: lifestyle risk reduction
A Trial of One-week on/One-week Off Temozolomide Versus Continuous Dose-Intense Temozolomide in Patients With Glioblastoma Multiforme at First Relapse
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the clinical benefit and safety of two different
      Dose-Intense temozolomide regimens（one-week on/one-week off regimen versus continuous
      dose-intense regimen）in patients with glioblastoma at first relapse.
    


Intervention name(s): Temozolomide
Intervention type(s): Drug
Other intervention name(s): Temodal
Intervention MeSH terms: Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioblastoma; relapse; Temozolomide; glioblastoma at first relapse
Impact of Hesperetin in Combination With Sucrose on Energy Metabolism
Condition: Blood Glucose Fluctuations; Hunger
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this cross-over intervention study is to investigate the influence of the
      sweet-modulating substance hesperetin in combination with sucrose in comparison to an equally
      sweet-tasting sucrose-only solution on markers of energy metabolism.
    

Detailed description: 
      The study is designed as a randomised cross-over intervention study with two arms. The aim is
      to investigate the influence of a 10% sucrose solution, corresponding to the sugar content of
      a conventional soft drink, compared to an equally sweet-tasting 7% sucrose solution in
      combination with 50 mg/L of the polyphenol hesperetin, on time-dependent blood glucose
      fluctuations and ad libitum energy intake in metabolically healthy male volunteers.

      To investigate the underlying mechanisms, the individual appetite score, metabolic and
      hormonal responses to the interventions and circulating extracellular vesicles and their
      miRNA composition will be measured. In addition, the participants' individual thresholds for
      sweet taste, preference and consumption for sweet-tasting foods such as sugar and sweeteners,
      and their body composition will be recorded as potential influencing factors.
    

Intervention name(s): Sucrose; Hesperetin
Intervention type(s): Other; Drug
Intervention description(s): 10% sucrose corresponding to a regular soft drink; increases sweetness of 7% sucrose solution to match sweetness of 10% sucrose solution
Other intervention name(s): table sugar; (2S)-3',5,7-Trihydroxy-4'-methoxyflavan-4-one; CAS number 520-33-2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy and Safety of 1-week Triple Therapy With Ilaprazole for the Eradication of Helicobacter Pylori
Condition: Helicobacter Pylori Eradication
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compared efficacy and safety of Ilaprazole based triple regimen therapy including
      Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first
      line eradication treatment of H.pylori
    

Detailed description: 
      Participants are defined as persons who have endoscopically confirmed on gastric or duodenal
      ulcer(including scar stage) ,gastritis and dyspepsia confirmed to be H.pylori positive
      patients in the biopsy and UBT test. For 7 days, Participants treated as Esoprazole based
      triple regimen therapy therapy including Esoprazole 20mg，Clarithromycin 500mg and Amoxicillin
      Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test
      and Biopsy at 49±5days from the first day dosing
    

Intervention name(s): Ilaprazole; Esoprazole
Intervention type(s): Drug; Drug
Other intervention name(s): Ilaprazole and amoxicillin 1000mg bid, clarithromycin 500mg bid; Esoprazole and Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid
Intervention MeSH terms: Amoxicillin; Clarithromycin; Potassium Citrate; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, positive drug parallel-group controlled
      clinical study in China to evaluate efficacy, safety, tolerability and immunogenicity of
      HLX03 and adalimumab (Humira) in subjects with moderate to severe plaque psoriasis. This
      study will recruit 216 subjects (18-75 years old, male and female) with moderate to severe
      plaque psoriasis. The 216 subjects will be randomly assigned per 1:1 ratio into the following
      two treatment groups (HLX03 OR Adalimumab). The study will be conducted in three periods,
      including the screening period, treatment period and follow-up period. For each participating
      subjects, the maximal length of the study will be 56 weeks (including up to four weeks of
      screening time).
    


Intervention name(s): HLX03; adalimumab
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.; 80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study has been designed to evaluate the change in serum BDNF level with
      oxcarbazepine monotherapy in bipolar disorder and to explore the possibility of its
      neuroprotective effect.
    

Detailed description: 
      Bipolar disorder (BD) is a chronic psychiatric illness of partially unknown pathophysiology.
      BD likely involves, at a molecular and cellular level, dysfunctions of critical neurotrophic,
      cellular plasticity and resilience pathways and neuroprotective processes. Abnormalities of
      neurotrophins (NTs) and other trophic factors orchestrate important alterations which could
      be implicated in the etiology of BD. As consistently reported in post-mortem studies, these
      modifications are generally associated with the disruption of distinct subregions and
      functions of the brain, one of which is the deregulation of neurotrophins.

      NTs are capable of signaling neurons, glial cells and other cellular systems to enable
      survival, differentiation and growth. BDNF is one of the most studied and abundant NTs in the
      brain, which plays an important role in a variety of neural processes during the development
      of both animals and humans. Initially, BDNF is important for neurogenesis, neuronal survival,
      and normal maturation of neural development pathways. In the adult, BDNF is not only
      important for synaptic plasticity and dendritic growth, but also for long-term memory
      consolidation. Several studies have proved that BDNF is significantly reduced in manic,
      hypomanic or depressive stages of BD, whereas euthymic patients exhibit BDNF levels similar
      to healthy controls.

      Rafael T. de Sousa et al have observed a significant increase in serum BDNF levels after 28
      days of lithium monotherapy in patients with BD and suggested neuroprotective role of lithium
      due to its direct regulatory effect on BDNF. Oxcarbazepine is a commonly used mood stabilizer
      which has demonstrated comparable efficacy to divalproate sodium and better tolerability
      profile but till date there is no study on its effect on BDNF. The aim of the present study
      is to evaluate the change in serum BDNF level with oxcarbazepine monotherapy in bipolar
      disorder and to explore the possibility of its neuroprotective effect.
    

Intervention name(s): Oxcarbazepine
Intervention type(s): Drug
Intervention description(s): After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks).
Intervention MeSH terms: Oxcarbazepine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxcarbazepine; Brain Derived Neurotrophic Factor; Bipolar disorder; Neuroprotection
Low Dose IL2 Immunotherapy in AD
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Neuroinflammation is a significant component of Alzheimer disease (AD). Our data demonstrated
      compromised regulatory T cells (Tregs) phenotype and suppressive function in AD patients,
      skewing the immune system toward a proinflammatory status and potentially contributing in
      disease progression. Low dose interleukin-2 (IL-2) is now viewed as a very promising
      immunoregulatory drug having the capacity to selectively expand and restore functional Tregs.
      This study is a phase I open-label study to assess subcutaneous interleukin-2 (IL2) safety
      and potential efficacy as a Treg inducer in AD. 8 Alzheimer dementia patients with mild
      clinical dementia will be recruited into the study. The baseline cognitive status will be
      evaluated in these patients. Monthly five-day-courses of subcutaneous IL2 (1MUI/day) will be
      administered for a total of 4 months. Changes in Tregs from pre to post injections will be
      measured during the study period. The expected time participants will be in the study is 6
      months.
    


Intervention name(s): Aldesleukin
Intervention type(s): Drug
Intervention description(s): Low dose Interleukin-2 (Aldesleukin) administration to expand Regulatory T cells
Intervention MeSH terms: Aldesleukin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acceptability of HPV-self Sampling
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      This trial aimed at evaluating the acceptability of HPV self-sampling among french women
      eligible for cervical cancer screening (25 - 65 years old) in the region of Occitanie, in the
      south of France. Acceptability will be evaluated using an anonymous questionnaire and the
      main outcome of the study will be the response acceptability " yes " or " no " for HPV
      self-sampling. Secondary outcome will be analysis of socioeconomic determinants for the
      acceptability of HPV self-sampling.

      These data will help to propose new strategies for cervical cancer screening in France,
      particularly to taget non-attenting populations
    

Detailed description: 
      Women will be recruted in 8 centers located in 2 departments , Aude and Herault (in the
      Region of Occitanie in the south of France).The questionnaire will be proposed to the women
      attending one of these eight centers by an investigator, who will verify the inclusion and
      exclusion criteria. The same person will collect the filled questionnaire.

      The questionnaire is anonymous and is composed of 15 questions evaluating the acceptability
      of HPV self-sampling and socio-economic determinants.

      These questionnaires will be collected and statistical analysis will be performed using
      appropriate tools.

      This study will bring informations on the acceptibility of HPV self sampling among french
      women eligible for cervical cancer screening in 2 Departements of the South of France.
      Self-sampling acceptability will be linked to socio-economic determinants.

      These data will be important to propose and evaluate new strategies to improve screening
      coverage, particularly of the context of the organized cervical cancer screening that will
      take place in France in 2018.
    

Intervention name(s): questionnaire
Intervention type(s): Other
Intervention description(s): The questionnaire will be distributed and collected by the same investigator in one of the eight centers involved in the study. The investigator will verify the inclusion criteria and the absence of exclusion criteria.
Other intervention name(s): Distribution of an anonymous questionnaire
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women attending 8 centers of the Departments of Hearault and Aude : social medical cares,
        Department of gynecology in the hospitals of Montpellier and Carcassonne ; mid-wifes
        consultations.
      
Keywords: Women; 25-65 years
Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This research study is evaluating a six-session online program designed to help insomnia
      (difficulty falling or staying asleep) in adolescent and young adult cancer survivors.
    

Detailed description: 
      The purpose of this study is to learn whether an adapted version of SHUTi (Sleep Healthy
      Using the Internet), a six-session online program which has been found to be effective in
      other groups of people, will be useful in treating insomnia in adolescent and young adult
      cancer survivors.
    

Intervention name(s): SHUTi
Intervention type(s): Behavioral
Intervention description(s): Sleep Healthy Using the Internet (SHUTi) is a publicly available insomnia intervention program. It focuses on 5 treatment components that form the core of CBT-I: sleep restriction, stimulus control, cognitive restructuring, sleep behaviors, and relapse prevention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Insomnia