bioihbjkbjnl/mcl2 huggingface dataset:
Hemodynamic Optimization During Major Urological Surgery
Condition: Hemodynamic Instability
Study type: Observational [Patient Registry]

Summary: 
      In this prospective observational study investigators aim to seek for any possible
      correlation between the venous to arterial carbon dioxide difference (pCO2 gap) at the end of
      surgery and the percentage of time spent above a predefined threshold of stroke volume (SV)
      andn mean arterial pressure (MAP).
    

Detailed description: 
      During major urological surgery (i.e. cistectomy) investigators will use a minimally invasive
      hemodynamic monitoring system (Flotrac - Vigileo, Edwards ) to guide fluid therapy and
      vasopressors administration. More specifically stroke volume target will be defined as the
      maximum SV after a series of fluid boluses, with a 10% tolerance. MAP was considered adequate
      if above 65 mmHg. After the induction of anesthesia, then each hour during surgery until the
      end of surgical procedure investigators will assess the time of adherence to the hemodynamic
      protocol (in terms of both SV and MAP) and the correspondent pCO2 gap. Investigators expect
      to find an inverse proportionality between the two parameters explored.
    

Intervention name(s): Ev1000 Clinical Platform from Edwards Lifesciences
Intervention type(s): Device
Intervention description(s): The EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for major urological surgery who met the above mentioned inclusion
        criteria will be enrolled. All patients will belong the only study group in which a
        target-based hemodynamic protocol will be applied
      
Keywords: stroke volume; goal directed therapy; major urological surgery; mean arterial pressure
High Protein Intake to Decrease Emesis and Promote Patient Satisfaction in Labor
Condition: Emesis
MeSH terms: Vomiting
Study type: Interventional

Summary: 
      The purpose of our study is to determine if the incidence of emesis can be lowered with the
      addition of a high protein drink during labor. Emesis and nausea are the leading causes of
      parturient dissatisfaction, results in a delay of returning to normal, daily living and can
      hugely impact the mother's postpartum experience. To date, no studies have been done on the
      relationship of protein intake during labor and incidence of emesis. To the best of our
      knowledge, the use of a high protein drink during labor has not been evaluated in the
      literature.
    

Detailed description: 
      The investigators plan to enroll women (n=150) who requested epidural anesthesia for labor.
      After placement of their labor epidural catheter, parturients will be randomized by a
      computer generated number table into one of two groups. Group P - high protein drink with 30
      grams of protein and ice chips PRN, or Group C - control group consisting of ice chips PRN.
      The protein drink that will be used is Premier Nutrition Protein Shake, which contains 30
      grams of protein in 11 ounces. Measured variables will include; nausea and emesis at epidural
      placement, at hourly intervals until delivery, and 1 hour post delivery. Nausea will be
      evaluated using a visual analog scale (VAS); 0 = no nausea and 10 = worst nausea ever.
      Episodes of emesis will be recorded as (yes/no). The parturient will be seen the day
      following delivery and evaluated for overall patient satisfaction. Parturients will rate
      their satisfaction level using a scale from 0-100 with 0=not satisfied and 100=very
      satisfied. The investigators believe that the incidence of emesis will be decreased in
      parturients who receive high protein intake during labor, and overall patient satisfaction
      will be increased.
    

Intervention name(s): Protein Shake
Intervention type(s): Other
Intervention description(s): Protein shake contains 30 grams of protein in 11 fluid ounces.
Other intervention name(s): Premier Nutrition Protein Shake
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: emesis; nausea
Circadian Macular Volume Changes in the Choroid
Condition: Choroid Physiology
Study type: Observational

Summary: 
      Choroidal volume measured fluctuates significantly over a 24 hour time frame.
    

Detailed description: 
      All patients undergo enhanced depth imaging (EDI) by the Spectralis SD-OCT device (Heidelberg
      Spectralis HRA2, Heidelberg Engineering, Heidelberg, Germany). SD-OCT measurements will be
      performed in both eyes after pupil dilation.

      Scanning Protocol: This studies choroidal volume measurement protocol has been previously
      published. In short, 31 high resolution B-scans centered at the fovea will be obtained by a
      single investigator. To optimize image quality each B-scan will be averaged from at least 25
      individual scans using the build in eye tracking software (TrueTrack, Heidelberg Engineering,
      Heidelberg, Germany). Scan length will be set to 9.3mm and spacing to 240µm, resulting in a
      30x25 degree area around the fovea.

      Each individual will undergo SD-OCT measurement every 3 hours within a 24 hour timeframe (at
      0, 3, 6, 9 12, 15, 18, and 21 o'clock; 8 times total). Additionally, automated blood pressure
      measurement and Goldmann applanation tonometry will be performed every 3 hours. Subject will
      be instructed to sleep in erect position from 21 to 6 o'clock, and will be awoken for
      examination at 0 and 3.

      OCT Analysis: Two retinal specialists will manually adjust the segmentation lines for
      automated choroidal volume calculation by the devices build in software. Choroidal thickness
      is defined as the layer between the outer boarder of the retinal pigment epithelium (RPE) and
      the hyper reflective layer behind the large vessels of the choroid (chorio-scleral
      interface). The devices Software thus generates a three-dimensional choroidal thickness map,
      divided according to the Early Treatment Diabetic Retinopathy Study (EDTRS) grid. In addition
      to this, subfoveal choroidal thickness will be measured manually using the SD-OCTs integrated
      caliper tool, drawing a perpendicular line to the RPE within the aforementioned bounds.

      This is considered a pilot study, so explorative data analysis will be performed.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Helathy human subjects
Visceral Somatization and Low Back Pain.
Condition: Lumbar Strain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study aims to verify the significance of the inclusion of procedures of a comprehensive
      therapeutic approach according to Eastern techniques to classical physiotherapy and to find
      out whether these Eastern techniques can contribute to the enrichment of standard
      physiotherapy. According to TCM and Ayurveda, another goal is to develop appropriate regimen
      measures to create a yoga regimen suitable for patients who have renal and bladder
      dysfunction according to TCM and whose main common symptom is chronic non-specific low back
      pain. The study is based upon comparing a four-week physiotherapy program according to the
      physician's indication and a physiotherapy program enriched with compiled regimen measures
      and yoga exercises in selected probands.
    

Detailed description: 
      Two groups of probands were used - an experimental and control group. There were 6 probands
      in each group. The four-week therapy effect, which took place twice a week for 60 minutes,
      was compared. The control group received physiotherapy, as indicated by the physician.
      According to TCM and Ayurveda, the experimental group underwent physiotherapy as indicated by
      a doctor enriched with yoga exercises and regime measures. It was asked to perform yoga
      exercises daily at home. The therapy's effect was evaluated using the Short-form-36
      Health-related Quality of Life Questionnaire (HRQoL), the VAS scale of pain intensity, the
      number of responses in the anamnestic questionnaire the author compiled the kinesiological
      analysis.
    

Intervention name(s): additional therapy; conventional physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Using conventional physiotherapy together with additional yoga exercising and regimen restriction acc to TCM.; Using conventional physiotherapy only.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Physiotherapy; low back pain; Chinese medicine; Yoga
Mechanism of Action of Transcranial Direct Current Stimulation in Neurofibromatosis Type 1
Condition: Neurofibromatosis 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Interventional

Summary: 
      Intellectual impairment, particularly working memory deficits are a significant cause of
      morbidity in children with Neurofibromatosis type (NF1) with long-term implications on
      academic and occupational functioning. Whilst significant discoveries have been made in Nf1
      animal models in trying to find treatments for these conditions, human translational studies
      have not been successful. This mechanistic experimental study will investigate the neural
      mechanisms underlying working memory deficits in NF1. In particular, we will investigate how
      individual differences in inhibitory neurotransmitter GABA relate to performance on working
      memory tests. Further, we will investigate the use of a novel, experimental intervention
      called transcranial Direct Current Stimulation (tDCS);known to modulate GABA. Using a
      randomized, crossover design in a cohort of 30 adolescents aged 11-17 years, we will apply
      real or sham tDCS to the dorsolateral prefrontal cortex (DLPFC). State-of-art real time
      imaging techniques such as Magnetic Resonance Spectroscopy (MRS) and task based functional
      MRI (fMRI) will be used to investigate the effect of tDCS on GABA concentration, changes in
      functional plasticity and working memory. We expect that results from this study will help
      elucidate the neural mechanisms underlying working memory deficits in people with NF1 and
      show biologic activity for a novel, low-cost intervention that can be used for cognitive
      remediation in NF1. This kind of focused mechanism trial method is a highly promising
      approach to understanding the complex neural system pathology in a multifactorial
      neurodevelopmental condition like NF1.
    


Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Other
Intervention description(s): tDCS is a form of non-invasive brain stimulation. tDCS is an established research tool for non-invasive modulation of neuroplasticity. It uses low-intensity DC currents to modulate spontaneous neuronal network activity by altering the resting membrane potential. Anodal tDCS has been shown to increase cortical excitability, reduce regional levels of GABA enhance LTP and synaptic plasticity.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-blind cross over experimental trial
Masking: Single (Participant)
Primary purpose: Basic Science
Docetaxel, Cisplatin (TP) + Radiation +/- Cetuximab in Larynx Carcinoma (CA)
Condition: Squamous Cell Carcinoma of the Hypopharynx; Larynx Carcinoma
MeSH terms: Carcinoma; Laryngeal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The DeLOS II trial is a multicenter randomised phase II trial investigating a
      TP/5-Fluorouracil (TPF)-chemotherapy with or without cetuximab for Patients with only by
      laryngectomy operable carcinoma of the larynx/hypopharynx. Patients were divided in responder
      or non-responder after 4 weeks. Since August 2009 Responder receive TP with or without
      Cetuximab + radiation. (Until february 2009 Responder received TPF with or without Cetuximab
      + radiation.) Planned accrual is 85 patients per treatment arm. The primary study endpoint is
      a confirmatory proof of an adequate survival rate with a functionally larynx-conserving 2
      years after randomisation.
    


Intervention name(s): Radiation; Cetuximab; Docetaxel; Cisplatin (TP); 5-Fluorouracil (TPF) (only until Feb 2009)
Intervention type(s): Radiation; Drug; Drug; Drug; Drug
Intervention description(s): Radiation start in week 11; Day 1 400mg/m2 i.v. than weekly 250 mg/m2 i.v. for 16 weeks; 75 mg/m2 i.v. day 1 3 times; 75 mg/m2 i.v. day 1 3 times; Only patients recruited until Feb 2009: 750 mg/m2 i.v. day 1-5, 3 times
Other intervention name(s): Taxotere
Intervention MeSH terms: Docetaxel; Fluorouracil; Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: by laryngectomy operable carcinoma of the larynx and the hypopharynx
Evaluation and Development of Playing Skills for Parents With Children With Special Needs
Condition: Play and Playthings
Study type: Interventional

Summary: 
      Children with special needs; experiences physical, behavioral, social, cognitive and
      emotional limitations. These limitations affect the child's play skills. They need to be
      supported and encouraged by their parents to enable them to participate in the game. Parental
      playing skills creativity, self-efficacy and active participation are important factors in
      this regard.

      In current studies, parents with special needs children; It is supported that there is a
      relationship between play, acting and parental self-efficacy. In this study, it was aimed to
      improve the skills of parents with special needs children to play games with their children
      multidimensionally and to develop these skills with individual-specific techniques.

      Detailed assessments will be carried out in order to determine the functional, cognitive and
      psychosocial skills of the parents.

      After the evaluation phase is completed, the scores of each parent will be analyzed and
      interpreted according to Occupational Therapy Models. Playing training will be given
      individually according to parameters such as strong and weak features, strong sensory system,
      personality traits, predisposition and defensive approaches.
    


Intervention name(s): Play Skills Training
Intervention type(s): Behavioral
Intervention description(s): Each parent will be provided with "play skills training" that will support them to spend effective and meaningful time with their child. While planning the educational contents, an Occupational Therapy Model suitable for the parent and the child will be used. The process will be followed by giving unique recommendations to each parent. Recommendations given based on feedback will be revised.
Intervention model: Single Group Assignment
Intervention model description: Parents with children with special needs who want to participate in the study will be determined. The assessments will be applied to parents before and after play training. These trainings aim to develop the skills of playing games with their children.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Neurodevelopmental Disorders, Autism Spectrum Disorders, Parents, Mentoring, Play and Playthings
The Effects of Family Centered Intervention Program on Preterm Infants
Condition: Infant, Premature
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Infant born preterm have an increased risk of adverse long-term developmental outcomes.The
      risk associated with preterm birth increase as gestational age decreases, and vulnerability
      remains in moderate and early preterm (<34 weeks) and late preterm (>34 weeks). There are
      many studies in the literature showed that the prevalence of developmental delay increases
      with premature birth. However, there is no study in the literature investigates effect of
      early intervention program motor performance in subgroups of preterm infants. Hence the aim
      of this study is to evaluate the differences in effects of early intervention program on
      motor development in early and moderate (<34 weeks) and late preterm infants.
    

Detailed description: 
      Fifty-two preterm infants corrected age less than 6 months included in this study. They were
      separated by their birth weeks. Babies with gestational ages between 34-36 weeks and 6 days
      (including the given days) are categorized as late preterm, while those born before 34 weeks
      are grouped as moderate and early preterm. Each group contains 26 infants.

      First, sociodemographic information and histories of babies are obtaining. Ages and contact
      information of the parents are recording. Prenatal and natal risk factors of the mothers are
      querying. Gestational ages and height, weight, and head circumferences of babies at birth are
      recording. Number of pregnancies, live births and abortions, type of delivery, multiple
      pregnancies for mothers as well as consanguinity between parents are asking.The Alberta
      Infant Motor Scale is using to evaluate spontaneous motor movements of the baby. After the
      detailed examination, intervention program set up for infants. Both groups receive 3 months
      family based intervention program.

      After the intervention program, both groups re-examined.
    

Intervention name(s): Family based early intervention program (NDT-Bobath based)
Intervention type(s): Other
Intervention description(s): Family based early intervention program is NDT - Bobath based home program. Physiotherapist teaches principles of the treatment to infants' family. Family applies the program at home.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: non-randomised clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: preterm; infant; physiotherapy
Effectiveness of Chiropractic Application for Acute Low Back Pain
Condition: Low Back Pain, Mechanical
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this project is to investigate the effectiveness of chiropractic application on
      patients who have undergone routine medication as a standard hospital treatment for
      mechanical low-back pain as described in the Clinical Practice Guidelines
    


Intervention name(s): diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM); Chiropractic Treatment
Intervention type(s): Drug; Other
Intervention description(s): Single intramuscular injection of mixture of two commercial drugs (Analgesic-anti-inflammatory and myorelaxant) at the specified dosages; High speed and low amplitude spinal manipulation techniques are applied to the case group.
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mechanical Low Back Pain; Chiropractics; Analgesic-anti-inflammatory; myorelaxant; Thiocolchicoside
Evaluation of CoolSculpt Combining Venus Legacy Technology for Enhanced Results in Fat Reduction & Laxity of the Flanks
Condition: Adipose Tissue
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect on the subject outcome using the
      combination of the Zeltiq Cryolipolysis device and the Venus Concept multipolar
      radiofrequency device with varipulse technology for the enhanced non-surgical treatment of
      skin laxity in the flank area.
    

Detailed description: 
      Commercially available as the Zeltiq CoolSculpting system, cryolipolysis is FDA cleared for
      use in the United States for an indication of fat layer reduction in the flanks, thighs, and
      abdomen through cold-assisted lipolysis. CoolSculpting has been clinically proven to
      non-surgically reduce subcutaneous fat bulges, allowing patients to achieve noticeable and
      measurable aesthetic results without the pain, expense, downtime, and risks associated with
      existing invasive and minimally-invasive procedures. The Zeltiq CoolSculpting System is a
      non-invasive device designed to cool subcutaneous fat without affecting adjacent or
      underlying structures.

      The RF device to be used in this study is a FDA cleared device used for aesthetic
      non-surgical skin tightening procedures including wrinkles, skin rhytides and cellulite in
      the face and body. The Venus Legacy utilizes a multi-polar radiofrequency system to deliver
      homogenous heating to multiple tissue depths. The Venus Legacy device also utilizes pulsed
      magnetic field technology as well as pulsed negative pressure technology.

      The flanks of Ten (10) healthy adults (male and female), 21 to 50 years of age, who desire a
      reduction in focal fat of the flanks will be recruited from the investigator's subject
      populations. Informed Consent will be obtained from each subject during a screening visit.

      The photos will be taken prior to the treatment series, one week post treatment series, at 3
      and 6 months post treatment series for the evaluation of two blinded reviewers as well as for
      the investigator to assess.
    

Intervention name(s): multipolar RF, varipulse; cryolipolysis
Intervention type(s): Device; Device
Intervention description(s): Multi-polar Radio frequency (RF) technology combining pulsed electro magnetic fields (PEMF) and mild suction stimulation (varipulse).; Cryolipolysis technology uses the sensitivity of fat cells to cold injury, causing them to freeze and undergo cellular apoptosis.
Other intervention name(s): Venus Legacy; CoolSculpt
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All participants to receive cryolipolysis treatment on one side of their body and cryolipolysis plus multipolar radiofrequency with varipulse technology treatment on the other side of their body.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment