bioihbjkbjnl/mcl2 huggingface dataset:
Effects Of Dance Movement Therapy On Compassionate Flow In Nursing Students
Condition: Compassion; Educational Problems; Competence
Study type: Interventional

Summary: 
      This study aimed to investigate the differences in compassionate flow among nursing students
      both before and after an educational intervention.
    

Detailed description: 
      Background: Only a few studies have explored how compassion is taught to nursing students.

      Aim: This study aimed to investigate the differences in compassionate flow among nursing
      students both before and after an educational intervention.

      Design: This study employed a cluster randomised controlled trial design. Settings: This
      study was conducted in medical schools in Taiwan. Participants: We enrolled first- and
      second-year nursing students. Methods: The intervention group underwent dance movement
      therapy, while the control group received yoga training. Compassionate flow was assessed
      using the Compassionate Engagement and Action Scale and the Fears of Compassion Scale.
    

Intervention name(s): dance movement therapy; yoga training
Intervention type(s): Other; Other
Intervention description(s): Our DMT program was adapted from an integrated somatic dance and visual arts program previously applied to the older population (Hsu, 2023). The intervention was scheduled in the afternoon and lasted for approximately 2 h. As previously recommended, rhythmic and contralateral movements on both sides of the body were emphasized in this study to enhance coordination and stimulation between the left and right cerebral hemispheres (Phillips-Silver and Trainor, 2007). The experimental groups were then subdivided into six groups. Balloons half-filled with water were used as the game in this study to guide individual and grouping rhythms and movements. Additionally, painting was incorporated to help participants understand their bodies and psychological states (Tjasink et al., 2023). Finally, group discussions and mutual support, along with verbal sharing after the DMT exercise, were encouraged.; The yoga program included breathing exercises, Asanas, eye focus, body lock, and meditation. Participants were instructed to adjust their positioning based on their skill level to mitigate the risk of injury. The yoga intervention was scheduled at 2 pm and lasted for approximately 2 h.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Compassion; dance movement therapy; nursing competence
A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, open-label, non-randomized, one-treatment, one-period study will evaluate
      the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in
      male healthy volunteers.
    


Intervention name(s): dalcetrapib
Intervention type(s): Drug
Intervention description(s): Single oral radiolabeled dose
Intervention MeSH terms: Dalcetrapib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Reduction of Intravenous Antibiotics In Neonates
Condition: Neonatal Infection; Neonatal SEPSIS
MeSH terms: Infections; Neonatal Sepsis
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized controlled open-label non-inferiority trial comparing complete intravenous
      antibiotic treatment with a short iv. course followed by oral antibiotics in neonates (0-28
      days) with probable bacterial infection.

      Primary outcome:

      - Bacterial re-infection within 28 days after finishing of antibacterial therapy.

      Secondary outcome(s):

        -  Pharmacokinetic profile of oral amoxicillin/clavulanic acid

        -  Quality of life

        -  Cost-effectiveness

        -  Alterations in gut microbiome

        -  Use of molecular techniques for better detection of bacterial pathogens
    

Detailed description: 
      Neonates have a high antibiotic consumption because of their susceptibility for bacterial
      infections. Since the early diagnosis of bacterial infection in neonates is difficult,
      intravenous broad-spectrum antimicrobial therapy is usually started promptly after subtle
      symptoms. The majority of neonates become asymptomatic shortly after initiation; when
      infection is probable or proven by elevated inflammatory markers and/or a positive blood
      culture, intravenous antibiotics are administered for at least 7 days.

      However, for neonates blood culture has a limited sensitivity. Therefore, the majority of
      neonates with probable infection are treated for a prolonged time with intravenous
      broad-spectrum antimicrobial therapy. In older children, intravenous antibiotics are often
      changed to oral antibiotics after cessation of symptoms and decreasing inflammatory
      parameters. This is not yet widely practised in neonates because of uncertainties in
      pharmacokinetics. Two explorative small studies from France and Italy into neonatal
      antibiotic switch therapy suggest that follow-up treatment with an oral antibiotic is
      promising; but the non-inferiority and safety was not yet properly addressed. Neonatal switch
      therapy, if proven to be safe and efficacious, would have a major impact on neonatal
      well-being, mother-to-child bonding and moreover costs.
    

Intervention name(s): Amoxicillin Clavulanate; Antibiotics
Intervention type(s): Drug; Drug
Intervention description(s): Dose 75 mg/kg/day, (3dd 25 mg/kg). Concentration amoxicillin/clavulanic acid: 4:1; Intravenous antibiotic therapy following local protocol
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter prospective randomized controlled non-inferiority trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antibiotic switch therapy; Amoxicillin/clavulanic acid
Study of Eteplirsen in Young Participants With Duchenne Muscular Dystrophy (DMD) Amenable to Exon 51 Skipping
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, open-label, dose-escalation study to evaluate the safety,
      tolerability, and PK of once-weekly IV infusions of eteplirsen in approximately 12 male
      participants, ages 6 months to 48 months (inclusive), who have genotypically confirmed DMD
      with a deletion mutation amenable to exon 51 skipping.
    


Intervention name(s): Eteplirsen
Intervention type(s): Drug
Intervention description(s): Infusion for intravenous use.
Other intervention name(s): AVI-4658; EXONDYS 51®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DMD; Duchenne; Eteplirsen; dystrophy; dystrophin; exon 51
ACute and Chronic Effects of Saxagliptin
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      Glucose ACCES study will explore the acute and long term (12-week treatment) effects of
      saxagliptin in patients with impaired glucose tolerance during fasting and after a
      standardised breakfast. The investigations will be performed on:

        -  glycemic parameters

        -  on cardiovascular parameters
    

Detailed description: 
      The aim of this pilot study is to compare in patients with impaired glucose tolerance the
      effects of saxagliptin versus placebo:

      (i) on glucose metabolism (ii) on vago-sympathetic activity, arterial stiffness and
      endothelial function. A total of 36 patients will be recruited in the department of
      Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, Bondy, France.

      The measurements will be performed in the morning 1) at the time of randomisation (Acute
      ACCES study) and 2) 11-14 weeks after the beginning of saxagliptin or placebo (Chronic ACCES
      study).

      We will evaluate at fasting and each hour after a standardized breakfast:

      (i) biological and metabolic parameters. Furthermore, an oral glucose tolerance test will be
      performed at the end of the study.

      (ii) by non-invasive devices arterial stiffness (Sphygmocor®), endothelial function (ENDOPAT
      2000® ), cutaneous microcirculation (laser doppler Perimed ®.PF 5010) and cardiac autonomic
      function(task force monitor®).
    

Intervention name(s): saxagliptin; placebo pill
Intervention type(s): Drug; Other
Intervention description(s): 5mg a day for 11-14 weeks; one tablet a day for 11-14 weeks
Other intervention name(s): Onglyza
Intervention MeSH terms: Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Impaired glucose tolerance; Saxagliptin; Cardiovascular risk integrators; Vago-sympathetic activity; Arterial stiffness; Endothelial function
Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction
Condition: Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Study Design

      Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel group study
      Duration: 1 month of TID treatment Treatment Groups, Dosing, and Treatment Regimen Study
      Treatment: CBT-008 topical ophthalmic solution Control Treatment: CBT-008 vehicle
    

Detailed description: 
      Structure Multicenter, randomized, double-masked, vehicle-controlled, parallel group study.

      Duration

      1 month of TID treatment.

      Treatment Groups, Dosing, and Treatment Regimen

        1. Study Treatment CBT-008 topical ophthalmic solution CBT-008 ophthalmic solution is a
           sterile, preservative-free ophthalmic solution containing CBT-008 (2.5 and 10%), sodium
           phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide
           to adjust pH to 7.4.

        2. Control Treatment CBT-008 vehicle CBT-008 vehicle ophthalmic solution contains sodium
           phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide
           to adjust pH to 7.4.

        3. Methods for Masking Study medication will be packaged in identical kits and will be
           labeled with medication kit numbers. The central randomization system will provide the
           site with a specific medication kit number for the patient corresponding to the
           treatment group assigned.

        4. Instructions for Storage, Use, and Administration Study medication will be supplied as
           preservative free-unit dose containers, where 1 mL of CBT-008 ophthalmic solution will
           be aseptically filled into 3 mL Low Density Polyethylene (LDPE) ophthalmic dropper
           bottles. Study medication should be stored at room temperature in a secure area at
           clinical sites and dispensed only to patients enrolled into the clinical study. Patients
           will be instructed to store study medication in a cool place at room temperature at
           home. Study medication will be administered TID, one drop, to both eyes. First
           instillation of study medication on the first day will be applied by subject or care
           provider with site staff's observation for training and supervision. During the rest of
           the study treatment, patients will self-administer the medication TID for 1 month.
    

Intervention name(s): CBT-008
Intervention type(s): Drug
Intervention description(s): Cyclodextrin
Other intervention name(s): Methyl-beta-Cyclodextrin
Intervention MeSH terms: Betadex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Rituximab in Interstitial Pneumonitis
Condition: Lung Diseases, Interstitial; Pneumonitis, Interstitial
MeSH terms: Pneumonia; Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This project will address rare immune mediated inflammatory diseases (IMIDs) involving the
      lungs, i.e. interstitial pneumonitis (IP). The main objective of this study is to assess the
      effects of rituximab (RTX) as a rescue therapy for progressive IMID-IP patients. The primary
      study parameter is pulmonary function.

      The secondary objectives are to explore the application of imaging with radiolabeled RTX as
      early predictor for efficacy of RTX, to study the effects of RTX treatment on quality of
      life, and to further elucidate the pathophysiology of IMID-IP by analyzing biochemical
      markers.
    


Intervention name(s): Rituximab; Zr-89-rituximab immuno PET/CT
Intervention type(s): Drug; Radiation
Intervention description(s): 2 times 1000mg dose at 14 days interval treatment; Immuno labeled PET/CT of the lungs
Other intervention name(s): Immuno PET
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IMID; Interstitial Pneumonitis; rituximab; Immuno PET; PET/CT
Autologous Bone Marrow For Lower Extremity Ischemia Treating
Condition: Lower Extremity Ischemia
MeSH terms: Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether autologous bone marrow derived cells and
      isolated CD133+ fraction are effective in the treatment limb ischemia
    

Detailed description: 
      The number of patients with low limb obliterating atherosclerosis steadily grows and
      compounds more than 20-25 % from all kinds of a cardiovascular pathology. At conservation of
      this tendency to 2020 the amputation percentage executed due to vessel diseases, can reach 45
      %. Hemodynamics improvement in an extremity by surgery is possible at 40 - 70 % of patients
      even with the widespread and plural lesion of arteries, but results are not always
      satisfactory. The most actual is the problem of angiosurgical help to patients with distal
      forms of arterial occlusions, due to the difficulty or impossibility performing
      reconstructive interventions. In these cases the operations of an indirect revascularization
      referred on stimulation of a collateral blood flow are carried out. However, despite the
      reached successes, in some cases results of such interventions do not give desirable effect,
      search of new methods of treatment therefore is necessary. To date the most perspective
      methods of neoangiogenesis stimulation are a cellular therapy and gene-engineering
      technologies. Experimental researches on a model of local limb ischemia showed possibility of
      use of various cells for neoangiogenesis stimulation. A number of clinical researches at
      patients with obliterating limb diseases has shown efficacy of cellular therapy even at a
      critical ischemia. However randomized, the placebo-controlled researches based on principles
      of evidence based medicine while it is not enough for the convincing conclusions.
    

Intervention name(s): Bone marrow aspiration, injection of cells; Bone marrow aspiration , injection of isolated CD 133+ cells; Bone marrow aspiration, injection of saline
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Bone marrow is aspirated at patients in all arms.
Arm "TNC" receives injection of total nucleated cells into ischemic muscle; arm "CD133" receives injection of isolated CD 133+ cells; arm "placebo" receives injection of saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lower extremity ischemia; Bone marrow; Progenitor cells; Neoangiogenesis
Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a
      single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These
      particles are safe; replication, integration and reverse transcription deficient. DermaVir is
      targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with
      DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected
      cells.

      GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded,
      multicenter study to assess the safety, tolerability, immunogenicity, and preliminary
      antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with
      HIV-infection.
    

Detailed description: 
      Patients were randomized into one of the following 6 arms:

        -  Arm 1: Low dose DermaVir (0.2 mg DNA in 2 DermaPrep patches, n=9)

        -  Arm 2: Low dose Placebo (2 DermaPrep patches, n=3)

        -  Arm 3: Medium dose DermaVir (0.4 mg DNA in 4 DermaPrep patches, n=9)

        -  Arm 4: Medium dose Placebo (4 DermaPrep patches, n=3)

        -  Arm 5: High dose DermaVir (0.8 mg DNA in 8 DermaPrep patches, n=9)

        -  Arm 6: High dose Placebo (8 DermaPrep patches, n=3) DermaPrep Patch size: 80 cm2.
           DermaVir Standard Unit per patch is 0.1 mg DNA = 0.8 mL of DermaVir nanomedicine.

      The patch sites for immunization are preferably the left or right upper back and left or
      right upper ventral thigh. The same skin sites should be used for all immunizations.

      Immunization schedule (Days): 0, 42, 84, and 126.

      The total DermaVir dose:

        -  Low dose: 0.8 mg DNA

        -  Medium dose: 1.6 mg DNA

        -  High Dose: 3.2 mg DNA

      DermaVir immunizations were administered over an 18-week period Primary endpoint: 24 weeks
      Safety follow up: 234 weeks
    

Intervention name(s): DermaVir; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): glucose/dextrose
Other intervention name(s): LC002
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; Vaccine; Immune Therapy; DermaVir
Cutivate Lotion HPA Axis Pediatric Study
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate,
      0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic
      dermatitis.
    


Intervention name(s): Fluticasone propionate 0.05% lotion
Intervention type(s): Drug
Intervention description(s): Daily applications
Intervention MeSH terms: Fluticasone; Xhance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance
Condition: Autism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the current study is to determine if pre-exposure through video modeling will
      enhance testing compliance in a population of children who are receiving a diagnostic
      evaluation for Autism.
    

Detailed description: 
      The purpose of the current study is to determine if pre-exposure through video modeling will
      enhance testing compliance in a population of children who are receiving a diagnostic
      evaluation for Autism. Another purpose of this study is to determine if pre-exposure to the
      test setting can increase the compliance on individual test measures. To test the central
      hypothesis and accomplish the study objective, 2 aims guide the proposed study.

        1. Determine the extent to which pre-exposure to expectations and tasks that occur during
           the audiological evaluation will increase audiological testing compliance. Hypothesis:
           Children receiving the intervention video, which will model what they will experience
           during the audiological evaluation, will show greater compliance during the evaluation
           than children who receive the placebo video.

        2. Determine the extent to which enhanced testing compliance will increase the number of
           test measures obtained during an audiological evaluation. Hypothesis: Children who are
           more compliant during the audiological evaluation will allow the audiologist to obtain
           more test measures in a single appointment than the children who are less compliant.
    

Intervention name(s): Video Modeling Intervention; Placebo Video
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Prior to arrival of the audiological evaluation, the child and caregiver will be required to watch one of two videos created by the research personnel. One video, the intervention video, is a behavior modeling video walking through the entire audiological evaluation. It also includes tips for caregivers to practice with their child before the appointment. The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.; The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism; audiology; video modeling; testing compliance
The Guiding Significance of Pupil Monitoring in the Perioperative Period
Condition: Pupil Diameter; Pupil Contraction Rate; Pupil Light Reflection
Study type: Interventional

Summary: 
      The pupil diameter is affected by both sympathetic and parasympathetic nerves, and its
      latency and response amplitude mainly reflect the functional status of the parasympathetic
      nerve. Clinically, the diagnosis of neurological diseases can often be made based on changes
      in pupils.

      An appropriate depth of anesthesia can cause minimal damage to the body after surgery,
      thereby reducing the impact on brain function and cognitive function.

      The occurrence of postoperative delirium will have adverse effects on the prognosis of
      patients, such as prolonging the hospital stay, increasing the mortality of patients after
      surgery, and increasing early postoperative cognitive dysfunction.
    


Intervention name(s): pupil's light and pupil diameter
Intervention type(s): Procedure
Intervention description(s): It is necessary to meet the requirement that the pupil's light reflection is slightly restored to the state of entering the room, and then the tube is extubated and the pupil diameter and the light reflection are restored to the state of entering the room, leaving the recovery room
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pupil; Cognitive Dysfunction; recovery