bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients
Condition: End-stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Peritoneal dialysis (PD) is an important model of renal replacement therapy for end-stage
      renal disease (ESRD) patients. Thus far, evidence for the initiation dosage of PD treatment
      is lacking, most patients begin their PD with four 2 L exchanges per day. However, many
      patients have their residual renal function at the initiation of PD, an 8 L dialysate per day
      will enhance the toxicity of bioincompatible dialysate and increase the economic burden
      compared with that of 6 L dialysate per day. Thus, the investigators perform a prospective,
      randomized, controlled, multi-center clinical study. The patients initiation of PD treatment
      within 6 months are randomized to be assigned to two groups: 6 L of dialysate per day and 8 L
      of dialysate per day, follow up will be regularly performed until 96 weeks. Clinical outcomes
      such as mortality, complications and life quality between the two groups will be
      investigated.
    

Detailed description: 
      To investigate the effect, feasibility and safety of 6L of dialysate per day after initiation
      of peritoneal dialysis (PD), we perform a prospective, randomized, controlled, multi-center
      clinical study. The patients initiation of PD treatment within 6 months are randomized to be
      assigned to two groups: 6L of dialysate per day and 8L of dialysate per day, follow up will
      be regularly performed at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks,
      60 weeks, 72 weeks, 84 weeks and 96 weeks. Serum biochemical parameters, Kt/V, residual renal
      function (RRF), life quality and cardiovascular test will be regularly recorded. Clinical
      outcomes such as mortality, technique failure, complications and life quality between the two
      groups will be investigated.
    

Intervention name(s): 6 L dialysate; 8 L dialysate
Intervention type(s): Drug; Drug
Intervention description(s): 6 L peritoneal dialysis solution; 8 L peritoneal dialysis solution
Intervention MeSH terms: Dialysis Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Replacement Therapy; Peritoneal dialysis
To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200
      and IBU and ISO combinations (200 +20) given in single dose.

      This study is being conducted to support the submission for new indication in treatment of
      the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular
      dystrophy.
    

Detailed description: 
      This trial is designed to define drug interactions following the combined administration of
      Isosorbide Dinitrate, a NO donor, and ibuprofen, NSAID, a through pharmacokinetics approach.

      Both ibuprofen and Isosorbide Dinitrate were licensed worldwide. Ibuprofen is approved for
      use in adults and children; Isosorbide is approved for use in adults. Ibuprofen is currently
      used in pediatric patients as a first line anti-inflammatory and antipyretic agent. Consensus
      exists that among NSAIDs ibuprofen is the one endowed with less adverse effects (see note 66
      of the Italian Drug Agency AIFA and MEA). No specific studies concerning safety and
      tolerability of ISDN in pediatric patients have been reported.
    

Intervention name(s): Isosorbide Dinitrate; Ibuprofen; Ibuprofen and Isosorbide Dinitrate combination
Intervention type(s): Drug; Drug; Other
Intervention description(s): Isosorbide Dinitrate 10 mgx2, daily, capsules; Ibuprofen 200 mg daily, capsules; Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose
Other intervention name(s): Diniket 10 mg; Antalgil 200 mg; Antalgil 200 mg and Diniket 10 mg
Intervention MeSH terms: Ibuprofen; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DMD; Duchenne; Muscular Dystrophy
CB-PRP in Retinitis Pigmentosa and Dry Age-related Macular Degeneration
Condition: Retinitis Pigmentosa; Dry Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Retinitis; Retinitis Pigmentosa
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will provides the enrollment of patients with genetic retinal dystrophies with
      primary rod impairment and dry age-related macular degeneration (Geographic type) A
      subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) will be performed
      only in one eye, the other eye will be considered as a control group.

      A complete morpho-functional ophthalmological evaluation will be performed in all patients at
      each control.
    

Detailed description: 
      All patients underwent genetic evaluation and they reported different types of mutations that
      induce anatomic-functional impairment of the rods.

      Patients affected by bilateral dry age-related macular degeneration (Geographic type) will be
      recruited as well.

      After selecting the patients to be enrolled, the study will proceed with the vitrectomy
      surgery and subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP)
      provided by the Umbilical Cord Bank according to the procedures provided for by the current
      legislation on blood components for non-transfusion use.

      A complete ophthalmological examination will be performed at 1, 3, 6, and 12 months. They
      will include:

        -  Anterior segment biomicroscopy

        -  direct and indirect ophthalmoscopy

        -  ETDRS visual acuity assessment

        -  intraocular pressure measurement

        -  optical coherence tomography (OCT)

        -  OCT Angiography (OCTA)

      The following assessments will be performed at baseline and at 6 and 12 months.

        -  Microperimetry

        -  Electroretinogram (ERG)

        -  Visually evoked potential (VEP)

        -  contrast sensitivity (MARS tables)

        -  Goldmann perimetry

      Some morpho-functional data will also be collected in the contralateral eye and used as the
      control group.

      To ensure the best safety for the patient, the first 5 eyes will be separated by a minimum of
      20 days in order to observe the post-surgical evolution.
    

Intervention name(s): Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP)
Intervention type(s): Biological
Intervention description(s): A subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) will be performed only in one eye, the other eye will be considered as a control group.
A complete morpho-functional ophthalmological evaluation will be performed in all patient at each control.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cord blood platelet-rich plasma; Retinitis pigmentosa; Dry Age-related Macular degeneration; Macular Geographic Atrophy
The Natural History of Injury-Related Disuse Osteopenia
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Observational

Summary: 
      Determine the severity and time course (natural history) of disuse osteopenia that occurs in
      the lower extremity(ies) and lumbar spine of patients sustaining lower extremity injuries
      that require the patient to maintain restricted weight bearing status (12 weeks) following
      the surgical fixation of the patient's injuries.

      The investigators hypothesize that there will be a significant decrease in the bone mineral
      density in the lower limbs of patients undergoing restricted weight bearing for
      peri-articular injuries of the lower extremity. This loss of bone mineral density is often
      prolonged in its duration and may lower subsequent fracture threshold and prolong the time to
      recovery and return to activities.
    

Detailed description: 
      It is well documented that restricted weight bearing even for relatively short periods (12
      weeks) associated with the surgical treatment of peri-articular injuries of the lower
      extremity (ie acetabulum, distal femur, tibial plateau, pilon, talus, calcaneus) can lead to
      a measurable decrease in bone density in the injured limb. Furthermore, this osteopenia can
      persist for extended periods of time - much longer than the original period of restricted
      weight bearing. This relative osteopenia can delay recovery from injury, lower fracture
      threshold for subsequent injury and potentially delay return to active duty in the case of a
      wounded warrior. There exists a significant body of research in the modulation of the
      osteopenia associated with restricted weight bearing as it pertains to long term space flight
      (microgravity).
    

Intervention name(s): dual energy x-ray absorptiometry
Intervention type(s): Diagnostic Test
Intervention description(s): DXA scan
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -Patients with one or more of the following lower extremity peri-articular fractures with
        restricted weight bearing for 12 weeks: (OTA types A,B,C). Injuries may be unilateral or
        bilateral.

          1. Acetabulum fracture

          2. Distal Femur fracture

          3. Tibial plateau fracture

          4. Pilon fracture

          5. Talus fracture

          6. Calcaneus fracture
The Rewire Study (Mindfulness Mobile App to Reduce Adolescent Substance Use)
Condition: Adolescent Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The current proposal is aimed at developing a substance use cessation app (Rewire) for high
      risk adolescents who are involved in the juvenile justice system. The Rewire app will be
      based on the primary substance use cessation components tested in our previous work with
      juvenile justice-involved adolescents and on intervention components shown to be central to
      smoking cessation.
    

Detailed description: 
      The Rewire Study will recruit 60 youth (30 boys and 30 girls) who have had contact with the
      Department of Youth Services in the last year. Consent will be obtained from parents or
      guardians for the youths' participation. The participating teens will come to Oregon Research
      Institute for a baseline assessment. During this visit, the teens will complete an assent
      form and spend spent 20-30 minutes completing an online survey with an assessor; topics
      covered in the survey include emotion regulation and drug and alcohol use. Teens will have
      the app loaded onto their phones and be provided with instructions for its use during this
      visit. Participants are asked to use the app over the next 2 weeks, completing 4 modules and
      spending 5-10 minutes each day answering questions about recent emotions and substance use.
      Teens will be contacted via email for follow up assessments at 2 weeks and 2 months
      post-baseline. These emails will contain links to the follow-up survey which also asks about
      emotion regulation and drug and alcohol use; surveys should take 20-30 minutes to complete.
    

Intervention name(s): Rewire App
Intervention type(s): Behavioral
Intervention description(s): A prototype Rewire app will be designed and created; the first four modules will be evaluated by 60 high-risk adolescents. The teens are asked to complete each module and spend a few minutes each day for two weeks using the practice exercises.
Intervention model: Single Group Assignment
Intervention model description: All 60 teens in The Rewire Study will complete the first 4 modules of the Rewire app. Prior to using the app, they will complete a baseline assessment. Follow up surveys will be completed at 2 weeks and 8 weeks post-baseline. Survey topics include drug and alcohol use, emotion regulation, mindfulness and stress, app usability and participant satisfaction.
Masking: None (Open Label)
Primary purpose: Treatment
Infants With Down Syndrome on a Different Surface
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study included infants with Down syndrome who applied to the Faculty of Physical Therapy
      and Rehabilitation, Developmental and Early Physiotherapy Unit of Hacettepe University. The
      project is characterized to investigate whether there is any differences on different surface
      between infants with Down syndrome and typically infants who are in the same conditions.
    

Detailed description: 
      Down syndrome is the most common chromosomal abnormality among the new-borns and
      characterized by the cognitive deficits, hypotonia, motor developmental and sensory function
      problems. The somatosensory system disorder such as touch, proprioception, pain and
      temperature may be seen in these infants and children. There is a delayed peripheral
      conduction of the stimulus and delayed cerebral processing may cause the abnormal tactile
      perception response. In the earliest period of life General Movements (GMs), a gestalt-based
      observation method is one of the most reliable and valid predictors of neurological
      dysfunction, and it is widely used. GMs occur in age-specific patterns and are described as
      fidgety movements between from 3 to 5 months in the post-term age. We did the GMs assessment
      on two different surfaces in the infants with DS and typically infants on the same day, and
      therefore assumed that determining the fidgety movements and the concurrent movement would
      enable to us observe the effect of extroceptive stimulation on the fidgety movements and the
      concurrent movement.

      The aim of this study was to investigate the following questions: (i) are fidgety movements
      and the concurrent motor repertoire of infants with DS depending on different surfaces?, (ii)
      do fidgety movements and the concurrent motor repertoire change in neurotypical infants
      depending on the different surface?, and (iii), what are the differences between infants with
      DS and neurotypical infants?.
    

Intervention name(s): General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day
Intervention type(s): Other
Intervention description(s): Different surface
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Down Syndrome; Different Surface; Fidgety Movements; General Movements
Adequacy of Anaesthesia for Colonoscopic Procedures
Condition: Colonic Diseases, Functional
MeSH terms: Colonic Diseases; Colonic Diseases, Functional
Study type: Interventional

Summary: 
      The aim of this randomized prospective trial is to assess the utility of Adequacy of
      Anaesthesia technique (Response Entropy and Surgical Pleth Index) for monitoring pain
      perception intraoperatively and its influence on postoperative pain perception, both
      patients' and operators' satisfaction in patients undergoing colonoscopic procedures under
      intravenous sedation using propofol and fentanyl.
    

Detailed description: 
      Surgical Pleth Index (SPI) is reported to properly reflect nociception-antinociception
      balance in patients undergoing surgical procedures, where a value of 100 corresponds to a
      high stress level and a value of 0 to a low stress level; values near 50 or increase in value
      > delta 10 correspond to the stress level which is known to reflect requirement for rescue
      analgesia.

      The applicability of SPI- guided deep sedation regimen in colonoscopic procedures has not
      been previously studied. Additionally, depth of sedation markedly influences the
      nociception-antinociception balance so its monitoring also proved useful in procedures
      performed under deep sedation.

      Therefore, we aim to investigate if both SPI-guided fentanyl administration alongside with
      State Entropy guided propofol aministration (Adequacy of Anaesthesia monitoring) versus State
      Entropy guided propofol aministration alongside with fentanyl titration based on haemodynamic
      parametres versus fentanyl titration based on haemodynamic parametres only influence both
      patients' or operator's satisfaction from anaesthetic management.
    

Intervention name(s): rescue fentanyl; rescue propofol
Intervention type(s): Drug; Drug
Intervention description(s): a rescue dose of fentanyl 0,5 mcg per kilogram of body; propofol in a single dose of 0,5 mg/kg of body weight
Other intervention name(s): rescue analgesia; rescue sedation
Intervention MeSH terms: Fentanyl; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: Surgical Pleth Index (SPI); Adequacy of Anaesthesia (AoA); State Entropy (SE); Postoperative nausea and vomitting (PONV); Colonoscopy
Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations
Condition: Relative Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution
      Formulations of BLD-0409 in Healthy Volunteers
    

Detailed description: 
      The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics
      (PD) of two oral formulations of BLD-0409, tablet and solution, in healthy volunteers (HV).

      The study consists of two parts:

      Part 1: A randomized, open-label, 3-period, 6-sequence, complete crossover study with at
      least 3-day washout between treatment periods comparing oral solution formulation to tablet
      formulation.

      Part 2: A randomized, open-label, 4-period, 4-sequence, complete crossover study with at
      least 3-day washout between treatment periods evaluating single ascending doses of tablet
      formulation.
    

Intervention name(s): BLD-0409
Intervention type(s): Drug
Intervention description(s): Randomized to active product.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuroregenerative Potential of Intravenous G-CSF and Autologous Peripheral Blood Stem Cells
Condition: Neurodegeneration; G-CSF; Peripheral Blood Mononuclear Cells; Cerebral Palsy
MeSH terms: Cerebral Palsy; Nerve Degeneration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The current study describes a randomized, double-blind, cross-over study of intravenous G-CSF
      followed by infusion with autologous mobilized peripheral blood mononuclear cells (mPBMCs) in
      children with cerebral palsy (CP) to determine the safety and feasibility of the procedure,
      as well as the potential efficacy for improving neurological impairment.
    

Detailed description: 
      We hypothesized that mobilized peripheral blood mononuclear cells (mPBMCs) would be a better
      source of cell therapy for children with CP, if these cells had a similar neuroregenerative
      potential to bone marrow/cord blood mononuclear cells (MNCs). Multipotent precursor cells
      exist in peripheral blood, and a fraction of elutriated blood cells from normal individuals
      contains MNCs that have the potential to be MSCs. There are several advantages to using
      mPBMCs for cell therapy in children with CP: the G-CSF that is used to mPBMCs has
      neuroregenerative potential; the collection and fractionation of stem cells can be repeated;
      and, the therapy is suitable for most children with CP.
    

Intervention name(s): Peripheral blood mononuclear cells (mPBMC); G-CSF; Placebo
Intervention type(s): Biological; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuroregeneration; G-CSF; Peripheral blood mononuclear cells; Cerebral palsy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
Condition: Healthy Study Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of a single subcutaneous (SC) dose of rozanolixizumab administered to
      healthy participants by manual push (MP) versus (vs) syringe driver.
    


Intervention name(s): rozanolixizumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.; Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.
Other intervention name(s): RLZ; PBO
Intervention MeSH terms: Rozanolixizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy Study Participants; Phase 1; rozanolixizumab; manual push; syringe driver