bioihbjkbjnl/mcl2 huggingface dataset:
Videolaryngoscopy vs. Direct Laryngoscopy for Elective Airway Management in Pediatric Anesthesia
Condition: Tracheal Intubation Morbidity
Study type: Interventional

Summary: 
      Videolaryngoscopy can lead to superior airway conditions and to the possible higher success
      compared to standard direct laryngoscopy. Patient will be randomized to the interventional
      group (videolaryngoscopy) and control group (direct laryngoscopy). The first attempt success
      rate, time to first end-tidal CO2 (ETCO2) wave, overall success rate, incidence of
      aspiration, bradycardia, desaturation a overall complications will be monitored.
    

Detailed description: 
      Videolaryngoscopy is specialized equipment for airway management, where a camera located at
      the tip of the laryngoscope blade can visualize also structures that can´t be seen on direct
      laryngoscopy, co the operator can obtain superior view of aditus laryngis during intubation.
      Currently videolaryngoscopy is not routinely used for intubation and it is reserved for
      patients with difficult airway. The aim of the trial is to compare the elective use of
      videolaryngoscopy versus direct laryngoscopy for elective airway management (tracheal
      intubation). Patients after informed consent approval will be randomized to the
      interventional group (videolaryngoscopy) and control group (laryngoscopy). The randomization
      will be managed by the Institute of Biostatistics and Analyses by the Faculty of medicine,
      Masaryk university. The primary aim will be the first intubation attempt success rate, the
      secondary aims will be time to successful intubation (time to first ETCO2 wave), overall
      success rate, number of intubation attempts, incidence of aspiration, desaturation and
      incidence of overall complications in all operators, in trainees, residents (5-10 years of
      practice), consultants (10-15 years of clinical practice) and consultants with over 15 years
      of clinical practice.
    

Intervention name(s): Videolaryngoscopy; Direct laryngoscopy
Intervention type(s): Device; Device
Intervention description(s): In experimental group (interventional group), patients will be intubated with the videolaryngoscope; In control group (active comparator group), patients will be intubated with the direct laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Videolaryngoscopy; Laryngoscopy; Tracheal intubation; Success rate
Efficacy of Infliximab as a Rescue Therapy in Pediatric Acute Severe Colitis
Condition: Pediatric Acute Severe Colitis
MeSH terms: Colitis
Study type: Observational

Summary: 
      Background and aims: Acute severe ulcerative colitis (ASC) is a potentially life-threatening
      event. Poor pediatric data are available about the success rates of Infliximab (IFX) as a
      second line therapy. This study was performed in consecutively observed pediatric patients
      with ASC, treated according to the 2011 European Crohn's colitis Organization (ECCO)-
      European Society for Pediatric Gastroenterology, Hepatology and nutrition (ESPGHAN)
      guidelines on pediatric ASC¹ and aim to assess the long-term efficacy of IFX and clinical
      predictors of poor outcome.

      Methods: Children hospitalized for an episode of ASC, defined as a Pediatric Ulcerative
      Colitis Activity Index (PUCAI) of at least 65 points, were enrolled. Clinical assessment
      through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein,
      hemoglobin, albumin, hematocrit, ferritin) was recorded at admission and at day 3 and 5. All
      patients were treated according to the above mentioned guidelines for ASC and received
      intravenous (iv) corticosteroids (CS) as first-line therapy. IFX was administered as
      second-line therapy in CS-refractory patients. In a 2-year follow up the overall colectomy
      rate and the efficacy of IFX in avoiding colectomy were evaluated.
    


Intervention name(s): Clinical and laboratory assessment
Intervention type(s): Other
Intervention description(s): Clinical assessment through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein, hemoglobin, albumin, hematocrit, ferritin) were recorded at admission and at day 3 and 5. All patients were treated according to the 2011 ECCO-ESPGHAN guidelines for ASC: all patients received intravenous (iv) corticosteroids (methylprednisolone 1.5-2 mg/Kg/day) for 5 days. Patients not responding to corticosteroids (i.e. PUCAI>65 at day 5) started Infliximab (IFX, 5 mg/Kg 0,2,6 then every 8 weeks) as second-line therapy. All therapies were decided at the discretion of the referral gastroenterologist and recorded on standardized case report forms
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive children hospitalized for an episode of ASC, defined as a PUCAI>65
      
Keywords: Acute severe colitis; Children; Infliximab; colectomy
Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
Condition: Premature Infant
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The main purpose of this study is to identify and to determine the involvement of
      cardio-respiratory coordination mechanisms during SSC between the preterm infant and his
      (her) parent.
    

Detailed description: 
      The skin to skin care (SSC) is a technique that proceeds by laying the neonate ventrally on
      the parent's chest. Many positive effects are recognized as due to SSC i.e, maintaining the
      infant's body temperature, better sleep organization, neurocognitive development and
      cardio-respiratory stability, more strength in parent-infant affective relations, reduction
      in neonatal and parental stress, more success in feeding with breast milk. Nowadays, SSC is
      generalized in modern Neonatal Intensive Care Units as part of developmental care. However,
      the mechanisms involved in SSC are not totally understood. The hypothesis in this study is
      that the cardio-respiratory stability results partially from the intervention of the
      coordination between cardiac and respiratory activities. These suppose the involvement of
      complex mechanisms of cardio-respiratory coordination including neuro-autonomous loops with
      chemoreceptors and baroreceptors, bulbar vasomotor and respiratory regulatory centers,
      ortho-parasympathetic neuronal and chemical pathways and cardiac, vascular and lung
      effectors. In this study the identification of these characteristics will be performed by
      processing signals of ECG, SaO2 (arterial oxygen saturation), respiratory movements,
      perfusion index, cutaneous and ambient temperature extracted from the clinical monitoring
      systems. Each preterm infant included in the study will be explored twice, 5-10 days apart.
      The explorations will be carried out on 3 steps: before (at least 30 minutes), during (at
      least 60 minutes) and after (≥ 60 minutes) the SSC session. Each patient will participate in
      the study for 10 days at maximum. Inclusions in the study will last for a total period of 18
      months and 10 days. The cardio-respiratory coordination will be assessed using coordigram
      technique, corresponding to the proportion of time with > 0.7 amplitude on spectral density.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age
Preemptive Oral Gabapentin 600 mg in Reducing Morphine Requirement After Non Obstetric Lower Abdominal Surgery
Condition: Non-obstetric Lower Abdominal Surgery
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aimed to get the information about the effectiveness of preemptive oral gabapentin
      600 mg in reducing morphine requirement after non obstetric lower abdominal surgery
    

Detailed description: 
      Seventy-two subjects were given informed consent before enrolling the study and randomized
      into two groups; gabapentin and placebo. Two hours before the incision, patients were given
      preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor,
      electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room.
      General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal
      tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant.
      Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were
      extubated until fully conscious. Patients will be transported to recovery room
      postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient
      controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory
      delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement,
      interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine
      requirement, mean visual analogue scale, and time interval after surgery to the first
      administration of morphine will be assessed in this study.
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral Gabapentin 600 mg; Oral NaCl 500 mg
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: preemptive analgesia; gabapentin; morphine; lower abdominal surgery
Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies
Condition: Hematologic Malignancies; Relapse; Graft-Versus-Host Disease
MeSH terms: Neoplasms; Hematologic Neoplasms; Graft vs Host Disease; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators hypothesize that adding carfilzomib to standard conditioning regimen for
      allo-HCT for advanced or high-risk hematologic malignancies will decrease post-transplant
      relapse and treatment-related mortality by decreasing severe GVHD, leading to overall
      improvement in transplant outcomes.
    


Intervention name(s): Carfilzomib; Tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Carfilzomib will be administered starting at dose level 1 (20 mg/m2 IV) on day +1, +2, +6 and +7.
Dose escalation will be performed on the day +6 and day +7 doses only in each dose level. Day +1 and day+2 doses will be fixed at 20 mg/m2 IV in all dose levels.; Tacrolimus will be administered at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
Other intervention name(s): Kyprolis®
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogeneic Transplantation; Carfilzomib; Relapse; Graft-Versus-Host Disease; Multiple Myeloma; Lymphoma; Leukemia
Pre-oxygenation Methods in Bariatric Patients
Condition: Obesity; Anesthesia; Bariatric Surgery Candidate
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the study is to compare effectiveness of different methods of achieving
      pre-oxygenation in bariatric patients. The investigators intend to compare facemask
      pre-oxygenation with a high-flow humidified nasal oxygen.

      The primary outcome measure of interest is time to desaturation to 92% or 18 minutes of
      apnoea.
    

Detailed description: 
      General anaesthesia involves giving patients anaesthetic and muscle relaxant medications to
      allow transition to sleep and airway relaxation to permit laryngoscopy, respectively. During
      laryngoscopy, a breathing tube is placed to 'secure' the airway. There is therefore a length
      of time from administration of these medications to when the breathing tube is placed, when
      the patient is not breathing and the airway is not secured. This time is known as apnoea
      time. In a patient who is not breathing, blood oxygen levels fall to dangerously-low levels,
      within 1-2 minutes. In order to prevent this, patients breathe 100% oxygen before induction
      of anaesthesia as part of a process known as pre-oxygenation. There are different ways of
      delivering pre-oxygenation, but the common aim is to increase the oxygen reservoir within the
      lungs to give the anaesthetist more time to place the breathing tube. With good
      pre-oxygenation, apnoea times of up to 7 minutes are possible.

      Apnoea time is a potentially hazardous period during induction of anaesthesia and it is
      particularly so in patients with severe obesity. On the one hand, obesity makes the upper
      airway anatomy difficult, and on the other hand, lung collapse (atelectasis) caused by
      abdominal contents compressing the base of the lungs reduces the amount of oxygen available
      within the lungs. Apnoea time can be as short of 30 seconds. Identifying the most effective
      method of pre-oxygenating bariatric patients can therefore significantly improve the safety
      of delivering general anaesthesia to these patients.
    

Intervention name(s): Optiflow and THRIVE technique; Standard anaesthetic face mask
Intervention type(s): Device; Device
Intervention description(s): Nasal high flow humidified oxygen; Oxygen delivery via an anaesthetic facemask
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Bariatric Surgery
Uptake of an Omega-3 Oil in Healthy Adults
Condition: Absorption; Pharmacokinetics
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the uptake of two different omega-3 fatty acid
      preparations in healthy adults. The main question it aims to answer is whether the two
      different preparations have the same uptake after single dose supplementation.
    

Detailed description: 
      Participants will be asked to take capsules of the new "phospholipids+" (PL+) omega-3 product
      (a combination product of krill oil and fish oil) in the morning with a low-fat breakfast.
      This product contains around 1250 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid
      (DHA).

      Researchers will compare this group with another group that takes standard fish oil (FO)
      ethyl esters (EE, with the same amount of EPA+DHA) to see if there are differences in
      pharmacokinetic parameters, including incremental area under the curve (iAUC), the maximum
      concentration of (Cmax) and the time it takes for EPA, DHA and EPA+DHA to reach the maximum
      concentration (Tmax) in plasma.
    

Intervention name(s): PL+ omega 3 fatty acids; FO EE fatty acids
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): PL+ omega 3 fatty acids is a food supplement that combines krill oil and FO EE. The dose will be around 1250 mg EPA+DHA.; A conventional fish oil food supplement containing EPA and DHA in the EE form. The dose will be 1250 mg EPA+DHA.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, two-way cross-over study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Omega 3 fatty acids; EPA; DHA
Absorbable Screws to Treat Anterior-Superior Iliac Spine Avulsion Fractures
Condition: Fractures, Bone; Pediatrics
MeSH terms: Fractures, Bone; Fractures, Avulsion
Study type: Observational

Summary: 
      There is some debate over the best treatment for anterior-superior iliac spine (ASIS)
      avulsion fractures although conservative treatment can be applied when there are no
      neurological symptoms. Open reduction and internal fixation can be performed for dislocations
      exceeding 1.5 cm, or in patients requiring a short period of convalescence, although a second
      operation is subsequently required to extract osteosynthetic material. In this paper, we
      introduce the use of absorbable screws as a new fixation material for the second round of
      surgery.
    

Detailed description: 
      To investigate the feasibility of absorbable screws as a new fixation material for the
      treatment of ASIS avulsion fractures in children and adolescents.The investigator plan to
      retrospectively analyzed 59 patients diagnosed with ASIS avulsion fractures in our hospital
      between Jan 2009 and Dec 2016. These patients were divided into two groups: group A
      (conservative group) and group B (absorbable screws). Group A received conservative therapy
      involving bed rest with the affected lower extremity positioned with the hip and knee in
      flexion to ensure minimal tension of the muscles attached to the ASIS avulsion fracture.
      Group B received open reduction and internal fixation with fixation by absorbable screws. Six
      weeks and three months after treatment, all patients were assessed for range of motion (ROM)
      and by X-ray as they returned to activity. One week after treatment, the American Academy of
      Orthopaedic Surgeons (AAOS) lower limb and hip score was used to evaluate hip function; the
      same scores were also determined during follow-up at 1, 3, 6 and 12 months postoperatively.
    

Intervention name(s): open reduction and internal fixation with fixation by absorbable screws
Intervention type(s): Procedure
Intervention description(s): Group A received conservative therapy involving bed rest with the affected lower extremity positioned with the hip and knee in flexion to ensure minimal tension of the muscles attached to the ASIS avulsion fracture. Group B received open reduction and internal fixation with fixation by absorbable screws.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study was a retrospective review of one center's experience of treating avulsion
        fractures of the ASIS in children and adolescents. All patients were evaluated and treated
        in the same hospital.
The Difference in Preoperative Evaluation That is Given by a Senior Physician, a Specialist, and a Computer Program
Condition: Surgery
Study type: Observational

Summary: 
      There is an increasing need and interest in being able to empirically estimate customized,
      patient-specific risks for virtually all surgical operations in a user-friendly format.

      The ACS (American College of Surgeons) surgical risk calculator is a decision-support tool
      based on reliable multi institutional clinical data, which can be used to estimate the risks
      of most operations.1 The aim of this study is to compare the assessment provided by the The
      ACS Surgical Risk Calculator with the assessment provided by a senior and a resident
      anesthesiologist, and by that comparison to establish the need for the ACS calculator
    

Detailed description: 
      Understanding the risks of surgery is clearly important for both patients and surgeons in the
      shared decision making process. Informed consent requires that patients have a thorough
      understanding of the potential risks of surgery. Moreover, clinicians and patients also need
      information regarding surgical risks in order to make decisions on the type of operation or
      whether surgery should be performed at all.

      Therefore, there is a need to discuss the risks derived empirically with a specific patient
      before any action to guide both surgical decision-making and informed consent.

      However, predicting postoperative risks and identifying patients at a higher risk of adverse
      events have traditionally been based on individual surgeon experience and augmented by
      published rates in the literature, either from single institution studies or clinical trials.
      Unfortunately, these estimates are typically not specific to an individual Patient's risk
      factors. The ACS (American College of Surgeons) Surgical Risk Calculator estimates the chance
      of an unfavorable outcome (such as a complication or death) after surgery. The risk is
      estimated based upon information the patient gives to the healthcare provider about prior
      health history. The estimates are calculated using data from a large number of patients who
      had a surgical procedure similar to the one the patient may have.
    

Intervention name(s): Patients who are scheduled for any surgical procedure
Intervention type(s): Other
Intervention description(s): looking for correlation for estimating the complications between the anesthesiologists and the computerized method.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who are scheduled for any surgical procedure will be recruited for the study
MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions
      (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with
      acceptable toxicity.
    

Detailed description: 
      Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to
      distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5
      treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated
      good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning
      and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a
      selective boost of additional 0.5, 1.0, 1.5, or 2 Gy per fraction for a total dose of 37.5,
      40, 42.5 or 45 Gy to biopsy-proven lesions, defined using MRI.

      Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk
      prostate nodules and deliver a higher radiation dose, to achieve maximal local control
      without increasing treatment toxicity
    

Intervention name(s): SIBRT
Intervention type(s): Radiation
Intervention description(s): Patients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
Intervention model: Single Group Assignment
Intervention model description: Male patients with a histologically confirmed diagnosis of non-metastatic prostate adenocarcinoma, meeting the inclusion and exclusion criteria below, and electing to undergo definitive radiation treatment with SBRT, will be eligible for participation in this study. Patients will receive 35 Gy in five fractions, also, patients will receive a simultaneous integrated boost from 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. Gastrointestinal/genitourinary toxicities will be assessed at every visit, including quality of life questionnaires and EPIC scores will be assessed at the one month follow up visits.
Masking: None (Open Label)
Primary purpose: Treatment