bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
Condition: Delirium
MeSH terms: Delirium
Study type: Interventional

Summary: 
      The main objective is to evaluate the impact of the "bundle of actions" on the delirium's
      incidence in resuscitation patients during their stay in the service, compared to a
      conventional treatment.

      The investigators therefore hypothesize that a set of coordinated paramedical actions in the
      prevention of delirium would reduce its incidence by 15% compared to conventional care.
    

Detailed description: 
      The "Bundle of Actions" is a coordinated and specific action plan, which has already been
      validated, focusing on the coordination of wake-up and respiration, the management of
      delirium, as well as the early mobility of the patient. Innovation consists of simple,
      reproducible nursing care that reduces triggers of delirium; as well as the use of two new
      approaches in reanimation: conversational hypnosis and early and comprehensive re-empowerment
      of the patient in the management of his pain and well-being.
    

Intervention name(s): Bundle; Standard Paramedical and Medical practices
Intervention type(s): Other; Other
Intervention description(s): Awakening and Breathing Coordination Delirium monitoring and management (detection and management of delirium) Early mobility
Factors of environment:
thirst
noise
pain and well-being
sleep
isolation; The current recommendations recommend the following scheme:
Identification and correction of an organic cause / factors (sepsis, metabolic disorders, withdrawal syndrome, pain)
Use of non-pharmacological means (early mobilization, correction of sensory deficits, temporo-spatial reorientation strategies)
Use of reference antipsychotic pharmacological means
Other intervention name(s): ABCDE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Delirium; Reanimation; Conversational hypnosis
Serious Game Therapy in Neglect Patients
Condition: Stroke; Unilateral Spatial Neglect
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The growing field of new technologies offers new perspectives for neurorehabilitation.
      Serious games are a promising solution in the rehabilitation of cognitive impairments, and
      they may be useful in the rehabilitation of unilateral spatial neglect. Investigators
      developed a rehabilitation program for visual exploration training with a serious game and
      investigated its efficiency. Twelve patients with unilateral spatial neglect after a right
      hemispheric stroke were recruited. Six patients assigned to a group received both serious
      game training and conventional rehabilitation, and after only conventional rehabilitation;
      and six patients assigned to another group received first conventional rehabilitation and
      then serious game training and conventional rehabilitation. The investigators compared the
      two groups after rehabilitation.
    


Intervention name(s): serious game rehabilitation
Intervention type(s): Behavioral
Intervention description(s): The SG rehabilitation was proposed to be played four times per week for three weeks, for a total of 12 sessions, with 15 min per session (= 60 minutes per week). Conventional rehabilitation comprised five sessions of 45 min of neuropsychological rehabilitation using classical exploration training (= 225 minutes per week).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each patient was assigned to a group who received 2 rehabilitations for 3 weeks, 1) both serious game training and a conventional rehabilitation first and then conventional rehabilitation alone (group 1, G1), or 2) a conventional rehabilitation first and then both serious game training and a conventional rehabilitation (group 2, G2).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; new technology; unilateral spatial neglect
Clinical Value of Metagenomic Sequencing in Neonatal Sepsis
Condition: Neonatal Sepsis
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Observational

Summary: 
      This study aimed to enroll 2000 neonatal patients with suspected sepsis or clinical diagnosed
      sepsis. These patients will undergo both conventional methods and metagenomics sequencing to
      detect the pathogenic microorganisms of sepsis. The purpose of this study was to assess the
      clinical value of metagenomics sequencing for the diagnosis and treatment of neonatal sepsis.
    

Detailed description: 
      Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and
      accurate diagnosis of infectious diseases in children is important for developing an
      effective treatment and management strategy. However, the current diagnosis of infectious
      agents mainly depends on culture and molecular testing. Both of the methods either has long
      turnaround times or narrow detection range. Metagenome next generation sequencing (mNGS) has
      been applied to the diagnosis of central nervous system infection, lower respiratory tract
      infection and sepsis, which showed high positive rate, short turnaround time. As a
      multi-center prospective observational clinical study, the study intends to enroll 2000
      suspected neonatal sepsis cases from multiple centers. Culture, classical PCR and mNGS were
      performed simultaneously. This study is one of the few multi-center studies in China to
      evaluate the value of mNGS in the diagnosis and treatment of neonatal sepsis, and will
      provide representative data for the distribution characteristics of pathogen spectrum of
      children in the real world and the clinical diagnosis and treatment value of mNGS.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study focuses on neonates with primary clinical diagnosis of sepsis.
      
Biospecimen description: 
      At the same time of sending conventional blood culture or cerebrospinal fluid culture, 2ml of
      blood and 1ml of cerebrospinal fluid were collected additionally.
    
Keywords: Neonatal Sepsis; Metagenomics; High-Throughput Nucleotide Sequencing
Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or
      menopause following treatment with 3 mg of eszopiclone.
    

Detailed description: 
      A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of
      eszopiclone 3 mg in women with insomnia secondary to perimenopause or menopause. Eligible
      subjects will be randomized to either eszopiclone 3 mg or placebo nightly for four weeks.
      This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired
      by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to
      Sunovion Pharmaceuticals Inc.
    

Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): eszopiclone 3 mg; placebo tablet
Other intervention name(s): Lunesta; S-zopiclone
Intervention MeSH terms: Eszopiclone; Zopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopause; Perimenopause
Freeze All Strategy Versus Fresh Embryo Transfer After GnRH Analogue Trigger
Condition: Ovarian Hyperstimulation Syndrome; Pregnancy Related
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Observational

Summary: 
      Ovarian hyperstimulation syndrome (OHSS) is one of the most dangerous complications of
      assisted reproduction technology (ART), described in approximatively 3 to 10% of stimulation
      cycles although an underestimation of the real incidence has been suggested.

      The use in clinical practice of GnRH antagonist has made it possible to perform the trigger
      with GnRH analogues, with the advantage of considerably reducing the risk of OHSS.
    

Detailed description: 
      The main concerns about the trigger with analogue are about obstetric outcomes, since it may
      increase the Abortion Rate (AR) and reduce the Ongoing Pregnancy Rate (OPR) due to luteal
      phase deficiency, and on the other hand about oocyte quality and competence.

      While in order to maximize the chance of pregnancy at fresh embryo transfer after GnRHa
      trigger, several studies have focused on the importance of luteal phase support, other
      authors suggest that the best strategy is freeze-all: cryopreservation of all the obtained
      embryos and subsequent single embryo transfers.

      However, data about oocyte quality, retrieval rate, pregnancy rate and reduced occurrence of
      complications such as OHSS, especially on the very first embryo transfer, are still scarce.
    

Intervention name(s): obstetric outcomes after fresh versus cryopreserved embryo transfer
Intervention type(s): Behavioral
Intervention description(s): measure of ongoing pregnancy rate, delivery rate, abortion rate, ectopic pregnancy rate, multiple birth rate, ovarian hyperstimulation syndrome incidence, drop out rate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study database includes all Oocyte Retrievals (OR) performed between 01/01/2012 and
        31/12/2020 at Humanitas Fertility Center after antagonist protocol stimulation and trigger
        with GnRH agonist.
Adjunctive Pregnenolone in Veterans With Mild TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      Mild traumatic brain injury (TBI) is common among veterans who have served in OEF/OIF
      (Operation Enduring Freedom in Afghanistan/Operation Iraqi Freedom) and other theatres.
      Delayed symptoms may occur following TBI, including cognitive symptoms (impaired attention,
      processing speed, executive functioning), as well as behavioral symptoms such as anxiety,
      depression, and irritability (Fann et al. 2004; Holsinger et al. 2002). Neuroactive steroids
      have neuroprotective effects in rodent models of TBI (Djebaili et al. 2005; Djebaili et al.
      2004; He et al. 2004; Pettus et al. 2005; Roof et al. 1997) and the neuroactive steroid
      pregnenolone and its sulfated derivative also markedly enhance learning and memory in rats
      (Akwa et al. 2001; Flood et al. 1992; Flood et al. 1995; Vallee et al. 1997; Vallee et al.
      2003). In humans, reductions in pregnenolone (George et al. 1994) and its GABAergic
      metabolite allopregnanolone (Uzunova et al. 1998) have been associated with depressive
      symptoms. Pharmacological intervention with the neuroactive steroid pregnenolone could
      therefore result in a multi-targeted treatment approach, potentially improving cognitive
      deficits as well as anxiety and depression symptoms following TBI.
    

Detailed description: 
      See brief summary
    

Intervention name(s): Pregnenolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo for two weeks (during placebo lead-in), then:
Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID); Placebo for two weeks (placebo lead in), then:
Placebo equivalent to Pregnenolone arm: 100 mg in divided doses (50 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 300 mg in divided doses (150 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 500 mg in divided doses (250 mg, PO, BID)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TBI; Pregnenolone; Cognition
Thermic & Lipemic Properties of Dietary Carbohydrates
Condition: Exogenous Obesity; Dietary Modification
Study type: Interventional

Summary: 
      The purpose of this study is to determine if consumption of meals containing carbohydrates
      with different glycemic index (a high glycemic index meal and a low glycemic index meal)have
      different effects on energy expenditure, type of metabolic fuels used for energy, blood
      lipids and lipoproteins, and sensations of hunger, fullness, and the hormones related to
      satiety.
    

Detailed description: 
      Little is known about the metabolic effects of chronic dieting and weight cycling in humans,
      but limited evidence suggests that fatty acid oxidation may be depressed leading to periodic
      elevation of circulating lipids associated with meal ingestion and preferential storage of
      fat in adipose tissue. With the traditional approach of restrictive dieting failing to result
      in permanent weight loss and, possibly producing abnormalities in lipid metabolism, it is
      important to evaluate alternative approaches to achieve a healthy body weight through
      improved metabolism. In this study the investigators will test the postprandial metabolic
      effects of standard mixed meals containing carbohydrates with high glycemic index and compare
      these effects to responses obtained with standard mixed meals, matched for protein and fat
      content but containing carbohydrates with low glycemic index.
    

Intervention name(s): High Glycemic Index meals; Low Glycemic Index meals
Intervention type(s): Other; Other
Intervention description(s): Dietary intervention with meals containing high glycemic index carbohydrates. All foods provided to meet the individual's energy needs. Standardized test meal (breakfast)also contained only high glycemic index carbohydrates and energy content was adjusted for each individual, providing 40% of daily energy needs.; Dietary intervention with meals containing low glycemic index carbohydrates. All foods provided to meet the individual's energy needs. Standardized test meal (breakfast)also contained only low glycemic index carbohydrates and energy content was adjusted for each individual, providing 40% of daily energy needs.
Other intervention name(s): Low Fiber Meals; High fiber meals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: energy metabolism; lipids; lipoproteins; satiety; glycemic load; insulin
Intravitreal Injection of MSCs in Retinitis Pigmentosa
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the feasibility and safety of adult human bone
      marrow-derived mesenchymal stem cells by intravitreal injection in patients with retinitis
      pigmentosa.
    

Detailed description: 
      Retinitis pigmentosa (RP) is an inherited disorder of the photoreceptor cells in the retina.
      Patients may lose vision since they were young or later in life. Currently, there are more
      than 60 genes identified as the cause of this condition, one of which, RPE65, has been
      studied in several gene therapy trials for Leber congenital amaurosis with promising results.
      Another treatment approach for RP is stem cell therapy. Studies in animal models of RP have
      shown that subretinal injection of bone marrow-derived mesenchymal stem cells may delay
      degenerative changes of photoreceptor cells.
    

Intervention name(s): BM-MSC
Intervention type(s): Other
Intervention description(s): Bone marrow-derived mesenchymal stem cells 1 million cells in balanced salt solution 100 microlitres will be injected into the vitreous cavity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Retinitis pigmentosa; Bone marrow-derived mesenchymal stem cells; Intravitreal injection
Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections; Gastroenteritis
Study type: Observational

Summary: 
      The main aim of this study is to investigate cases of rotavirus gastroenteritis in Belgian
      children with opportunity to receive Rotarix™ to monitor the potential occurrence of genetic
      drifts (point mutations) in the vaccine strain and the occurrence of genetic shifts
      (re-assortments) between vaccine and naturally circulating wild-type strains in Belgium
      population after the introduction of Rotarix™. The study will also detect if there is any
      alteration in rotavirus pathogenicity conferred by re-assortment and if the mutated vaccine
      strain is still efficacious in preventing rotavirus gastroenteritis.
    

Detailed description: 
      This study is conducted in two phases: Phase I and Phase II. Phase I will be retrospective
      and consist of re-using the data collected in RotaBel (EPI-ROTA-111426) study. Phase II will
      be prospective and consist of maintaining the active surveillance system to identify
      rotavirus cases in several hospitals in Belgium.
    

Intervention name(s): Stool samples
Intervention type(s): Procedure
Intervention description(s): Stool samples collected and checked for the presence of rotavirus
Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        Children confirmed with G1 and/or P[8] cases from the RotaBel study, children between 14
        weeks and <5 years of age, hospitalized for severe gastroenteritis in the study hospitals
        and who are tested positive for rotavirus
      
Biospecimen description: 
      Stool samples
    
Keywords: Observational; Rotarix™; post-marketing
The Effectiveness of Health Promotion Programs on the Pre-frail Individuals
Condition: Older Adults
Study type: Interventional

Summary: 
      This pilot study aimed to examine the efficacy of a home-based multicomponent exercise
      training program in older community- dwellers during to the Coronavirus Disease 2019.
    

Detailed description: 
      This pilot study aimed to examine the efficacy of a home-based multicomponent exercise
      training program in older community- dwellers during to the Coronavirus Disease 2019.

      Design: A two-arm parallel cluster randomized controlled trial. Older adults ≥60 years old
      were recruited from eight community units in northern Taiwan. One-hundred and sixty-seven
      eligible subjects consented to participate in the study. Community units were randomly
      assigned to either an intervention arm (n=82) or a control arm (n=87). The intervention
      consisted of one 60-minutes group exercise session once a week in first 8 weeks, and
      self-management in next 8 weeks. The control arm received an education leaflet. Assessments
      were performed at baseline and 16 weeks for physical activity, physical performance, and
      pre-frailty rate. Analysis of covariance or chi-square test adjusted for pretest evaluated
      the differences between the two study arms.
    

Intervention name(s): multicomponent exercise training program
Intervention type(s): Behavioral
Intervention description(s): One supervised 60 minutes training sessions per week were organized combining warm-up, speed-walking, resistance exercise, static and dynamic balance. Supervised walking sessions were for 10-20 minutes at a target intensity of 13-15 on the Borg scale. Thereafter, 10 resistance exercises targeting lower body, trunk and upper body muscles were performed with elastic band. In addition, participants were instructed to accumulate 150 minutes per week of moderate intensity aerobic activity in bouts of at least 10 minutes, and at least 2-3 days all major muscle groups training.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. The control arm received an education leaflet.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: multicomponent exercise training; older adults; physical activity; physical performance; Pre-frailty; Coronavirus Disease 2019 pandemic
Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Obesity is associated with difficult intubation rate of 30%, and this study was performed to
      compare the use of McCoy laryngoscope and C-MAC D-blade video laryngoscope for intubation in
      obese patients. A total 104 patients with body mass index (BMI) ≥ 35kg/m² scheduled for
      general anesthesia were randomly assigned to be intubated with McCoy laryngoscope or C-MAC
      D-blade video laryngoscope. The primary outcome was intubation time, and secondary outcomes
      were mask ventilation scale, intubation difficulty scale (IDS), percentage of glottis opening
      (POGO) score, and hemodynamic variables including mean arterial pressure, heart rate and
      saturation.
    


Intervention name(s): McCoy laryngoscope; C-MAC D-blade video laryngoscope
Intervention type(s): Device; Device
Intervention description(s): Patients scheduled for general anesthesia were intubated with McCoy laryngoscope.; Patients scheduled for general anesthesia were intubated with C-MAC D-blade video laryngoscope.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: obesity; intubation; laryngoscopes
Time-Dependent Mobilization of Circulating Progenitor Cells During Strenuous Exercise in Healthy Individuals
Condition: Healthy Men
Study type: Interventional

Summary: 
      Only few data are available on the influence of strenuous exercise on the content of
      circulating progenitor cells and especially the timeframe of their release. The aim of the
      present study was to investigate the potential influence of 4 hours of cycling on the
      time-dependent release of progenitor cells.
    

Detailed description: 
      1. What is the response of hematopoietic and endothelial progenitor cells after a
           standardized prolonged endurance exercise?

        2. What is the kinetic of cell mobilization during this standardized exercise?
    

Intervention name(s): Exercise
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
AZD9668 Relative Bioavailability
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will aid future formulation development and optimisation of AZD9668
      tablets by evaluating possible effects of minor changes to the formulation and process on the
      rate and extent of absorption.
    


Intervention name(s): AZD9668; AZD9668; AZD9668
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 x 30 mg batch DLE494; 2 x 30 mg batch DLF497; 2 x 30 mg tablet variant 1
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: COPD