bioihbjkbjnl/mcl2 huggingface dataset:
Stroke Volume Variations and Pulse Pressure Variations Undergoing Artificial Pneumothorax Surgery
Condition: Artificial; Complications, Heart
MeSH terms: Pneumothorax
Study type: Interventional

Summary: 
      Stroke volume variation (SVV) and pulse pressure variation (PPV) have been thought to be
      sensitive predictors of fluid responsiveness in mechanically ventilated participants. In this
      paper, the investigators reported a special group of people to use SVV and PPV during their
      operation. The maintenance of hemodynamic stability and the critical organ perfusion is
      crucial to the treatment for patients with artificial Pneumothorax during esophageal surgery,
      because artificial pneumothorax causes incomplete ventilation of one lung. In addition,
      artificial pneumothorax may seriously affect theparticipant's heart and lung function, brings
      more challenges to the intraoperative anesthetic management, expecially in volume management.
      Little information is available about the accuracy of SVV and PPV to predict fluid
      responsiveness in participants with artificial Pneumothorax during esophageal surgery. It is
      unclear whether it will affect the accuracy of SVV and PPV, and whether it will cause the
      change of their threshold values. The investigators will discuss it in the passage and the
      investigators will give an preliminary mechanism to explain the results.
    

Detailed description: 
      Backgroud: This study aims to evaluate the ability of stroke volume variation (SVV) and pulse
      pressure variation (PPV) to predict fluid responsiveness in mechanically ventilated
      participants with artificial Pneumothorax during esophageal surgery.

      Methods: 40 participants, diagnosed with esophageal cancer, undergoing thoracoscopic radical
      resection of esophageal cancer were studied. All the participants used Vigileo/FloTrac system
      for analysis. Haemodynamic data such as MAP, HR, SV, SVI, CO, CI, SVV, PPV were recorded
      before and after volume expansion (VE). Fluid responsiveness was defined as an increase in
      SVI≥10%(△SVI≥10%). Participants were divided into Responders and Non-responders by changes in
      △SVI ≥10% and < 10%. Nonparametric Wilcoxon rank sum test was used to compare the hemodynamic
      parameters of Responders and Non-responders before and after VE. Pearson correlation analysis
      was used to analyze the values of SVV, PPV and △SVI. The receiver operating characteristic
      (ROC) curve of each hemodynamic index was drawn to determine its accuracy and threshold.
    

Intervention name(s): FloTrac Vigileo
Intervention type(s): Diagnostic Test
Intervention description(s): A dedicated transducer (FloTrac TM, Edwards Lifesciences, LLC, Irvine, CA, USA) was connected to the radial arterial line on one side and to the Vigileo System (Vigileo TM Edwards Lifesciences, LLC, Irvine, CA, USA) on the other side
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
Condition: Warming Systems During Surgery
Study type: Interventional

Summary: 
      Recently, a novel posterior heating system has been developed that provides enhanced pressure
      relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this
      FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal
      surgery. The investigators therefore propose to test the hypothesis that intraoperative
      distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body
      forced-air warming in patients undergoing open major abdominal surgery under general
      anesthesia.

      Secondary hypotheses include that:

        1. intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air
           warming

        2. final intraoperative core temperature is non-inferior with PerfecTemp than upper-body
           forced-air warming

        3. final intraoperative core temperature is superior with PerfecTemp than upper-body
           forced-air warming.
    


Intervention name(s): heated blanket; heated pad
Intervention type(s): Device; Device
Intervention description(s): heated blanket; patients will be warmed with a heated pad during surgery.
Other intervention name(s): Bair Hugger; LMA PerfecTemp system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: heated blanket; heated pad
Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT
Condition: Spasticity; Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with
      cerebral palsy, having a significantly effect on their mobility and quality of life. There is
      much controversy about what is the most appropriate treatment of spasticity The objective of
      the present study is to evaluate the effects of radial extracorporeal shock wave therapy
      (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with
      cerebral palsy

      The number needed of patients is 70 (35 per group). Leaving a period of washout between one
      therapy and the other
    

Detailed description: 
      Outcome Measures:

      The primary outcome will be to measure spasticity with passive range of motion of the foot
      (pROM) by muscular extensibility and its traction reflex using goniometryIt will be assessed
      at baseline before the treatment, as well as after 3 weeks, 2 months, 3 months, after the
      washout period (3months), 3 months and 3 weeks, 5 months and 6 months, when the end the
      intervention.

      Secondary outcome includes: 1) Pain will be assessed with Visual Analog Scale (VAS) after the
      first application of each therapy. 2) Ascertain if the type of Gross Motor Functional
      Classification System (GMFCS) has an influence on the improvement of these two treatments; 3)
      Assess whether infiltration of Botulinum Toxin in other muscle groups have influence on the
      results of study; and 4) Undergo a qualitative registration to know the perception and
      experience that patient/family will have during this study, through a satisfaction
      questionnaire.
    

Intervention name(s): shock waves; Botulinum Toxin Type A
Intervention type(s): Device; Drug
Intervention description(s): Swiss dolorclast smart EMS Registration: EN-60601-1 Type BF IP40. 93/42 CEE; Botulinum toxin type A Botox
Other intervention name(s): Type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: shockwaves; Physiotherapy; Botulinum toxin
A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous
      injection when administered in combination with Lucentis® against a control of Lucentis®
      alone in subjects with subfoveal choroidal neovascularization secondary to age-related
      macular degeneration (AMD).
    

Detailed description: 
      Subjects will be randomized in a 1:1:1 ratio to the following dose groups:

        -  E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye

        -  E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye

        -  E10030 sham + Lucentis® 0. 5 mg/eye

      Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at
      Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

      Primary Efficacy Endpoint:

      The primary efficacy endpoint is mean change in visual acuity from baseline at the Week 24
      visit

      Safety Endpoints:

      Safety endpoints include adverse events, vital signs, ophthalmic variables [visual acuity,
      intraocular pressure (IOP), ophthalmic examination, color fundus photography, fluorescein
      angiograms (FA), optical coherence tomography (OCT)], and laboratory variables.

      Approximately 444 subjects will be randomized into one of the three treatment cohorts
      (approximately 148 patients per dose group).
    

Intervention name(s): E10030 plus Lucentis; Lucentis
Intervention type(s): Drug; Drug
Intervention description(s): once a month intravitreal injection; 10 mg/mL intravitreal injection monthly
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Proof-of-Concept Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Hemophilic Arthropathy
Condition: Hemophilic Arthropathy
MeSH terms: Joint Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Repeated joint bleeding leads to hemophilic arthropathy (HA), which manifests with chronic
      synovitis, cartilage damage and bony destruction. Currently available treatments of HA,
      including analgesics, NSAIDs, and hyaluronic acid, are predominantly directed toward the
      symptomatic relief of pain and inflammation, with no or little effect on joint cartilage
      degeneration. AC201CR, a control released formulation of AC-201, demonstrates
      anti-inflammatory effects by reducing NLRP3 inflammasome assembly. AC-201 is also unique in
      that it influences both the anabolism and catabolism of chondrocytes in vitro and has shown
      cartilage-sparing properties in animal studies. The study is designed to evaluate the joint
      structure-modifying and symptom-relieving effects, safety, and tolerability of AC-201CR in
      subjects with HA.
    


Intervention name(s): Placebo; AC-201CR
Intervention type(s): Drug; Drug
Intervention description(s): Placebo-only control study medication is the same formulation as active treatment without active ingredient; The investigational product is formulated as controlled-release (CR) tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
Condition: Chronic Low Back Pain; Opioid-induced Hyperalgesia
MeSH terms: Hyperalgesia; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Opiates such as morphine are the cornerstone medications for the treatment of moderate to
      severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become
      more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that
      analgesic tolerance to opioids (habituation) develops during chronic use even though this
      phenomenon has never been prospectively studied. Our specific aims propose to prospectively
      test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent
      tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and
      hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced
      hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance
      and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study
      will be the first quantitative and prospective study of tolerance and hyperalgesia in pain
      patients and will have important implications for the rational use of opioids in the
      treatment of chronic pain.
    


Intervention name(s): Morphine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.; Patients will receive placebo tablets.
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Study type: Interventional
Phase: Phase 2

Summary: 
      Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment
      option. Treatment is often available in private practice offices, where a prescribing
      physician may offer a non-FDA approved treatment on an individualized basis. The situation is
      different in many hospital and academic settings, such as our own for example, where the
      formulary is defined through a FDA-approved indication. The absence of an indication
      precludes its addition to many hospital formularies, thus limiting the options available to a
      prescribing physician and denying patient access to a treatment offered in the private
      practice setting. An indication and formulary status require controlled clinical trials on
      the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this
      commercially-viable cantharidin formulation has a comparable safety and efficacy profile as
      formulations previously studied under conditions which most closely match the what has been
      historically done in the clinic.
    


Intervention name(s): Cantharidin
Intervention type(s): Drug
Intervention description(s): Application of topical cantharidin
Intervention MeSH terms: Cantharidin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity
Condition: Child Obesity
MeSH terms: Obesity; Obesity, Morbid; Pediatric Obesity
Study type: Interventional

Summary: 
      This internal pilot study will determine whether a highly promising primary care based
      intervention that combines group based parenting skills training and public health nurse home
      visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight
      status in 1 to 5 year old children with severe obesity.

      Children with severe obesity will be identified through the obesity management clinical
      program at The Hospital for Sick Children called STOMP (SickKids Team Obesity Management
      Program). The STOMP Early Years Program is a unique and intensive, paediatric obesity
      management program designed for 1 to 5 year-olds with severe obesity and their families.
      Families who participate in this study will be randomly assigned (having an equal chance of
      being in either group) to one of the two study groups that will run for 6 months:

      Group A: Ten weeks of group parenting education sessions with 2-4 public health nurse home
      visits and four one-on-one check-ins with an interdisciplinary team at STOMP.

      Group B: Wait listed to receive parenting education sessions; receive one-on-one checks with
      an interdisciplinary team at STOMP.

      In addition to the measures collected as part of STOMP, families will complete the following
      questionnaires before the start of the trial, and after 6 months:

      Parenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21),
      Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ).
    


Intervention name(s): Parenting education sessions
Intervention type(s): Behavioral
Intervention description(s): If assigned to the parenting education session group, families will start with the 10-week group parenting education sessions and 2-4 home visits immediately after being enrolled. During this time, they will also come in for four one-on-one check-ins with the STOMP team. Each check-in will be approximately 1 hour. At least one parent/caregiver will attend weekly parenting sessions which will take place at SickKids. The Toronto Public Health Nurse will arrange 2-4 home visits with the family during the 6 month period of the study. The home visits will focus on helping to apply the messages and skills from the group sessions in their homes, and making connections in the neighbourhood to recreational or nutrition programs or other supports for the family.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parenting; Home visiting; Childhood obesity treatment
Short-term Oral Steriods for Acute Tinnitus
Condition: Tinnitus, Subjective; Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Tinnitus; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      The goal of this clinical trial is to learn about the efficacy of oral steroids in the acute
      tinnitus population. Participants will receive appropriate dosages of prednisone and/or oral
      Ginkgo Biloba tablets.
    

Detailed description: 
      Researchers will compare the intervention group and control group to see whether short-term
      systemic steroid therapy is effective for acute tinnitus.
    

Intervention name(s): Prednisone tablet; Ginkgo Biloba Extract
Intervention type(s): Drug; Drug
Intervention description(s): The dose selection of oral prednisone is the maximum daily dose for 5 days, followed by a taper every 2 days; Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus
Other intervention name(s): prednisone; ginkgo biloba
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Food Effect Study of CTP-656 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Three way crossover study to assess the bioavailability of 656 under fed and fasted
      conditions.
    

Detailed description: 
      This study will assess in healthy male subjects a solid oral dose formulation of CTP-656
      under fasted and fed conditions.

      Primary:

      • To characterize the relative bioavailability and pharmacokinetic profile of a single 150 mg
      solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed
      moderate-fat conditions.

      Secondary:

        -  To characterize the pharmacokinetic profile of metabolites of CTP-656 following a single
           150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and
           fed moderate-fat conditions.

        -  To assess the safety and tolerability following a single 150 mg solid oral dose of
           CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.
    

Intervention name(s): CTP-656
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Safety, Bioavailability and Pharmacokinetics
Using Spices and Herbs to Increase Vegetable Intake Among Urban High School Students
Condition: Poor Nutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      A two-phase, school-based intervention will be conducted at a high school in Baltimore to
      evaluate whether the addition of spices and herbs to vegetable dishes in the National School
      Lunch Program (NSLP) can increase vegetable intake among students in an urban and
      predominantly African-American high school.
    

Detailed description: 
      The proposed research will be conducted at Cristo Rey Jesuit High School in Baltimore,
      Maryland. In this two-phase intervention, the research team will work in Phase I with
      stakeholders throughout the high school community to identify the barriers to vegetable
      intake in the NSLP in this student population and to determine how spices and herbs might
      help overcome these barriers. The stakeholders with whom we will collaborate will include
      students, school administration, and cafeteria staff.

      Phase II will focus on the direct measurement of vegetable intake among students both before
      and after spices and herbs are added to the vegetables in the NSLP. The spiced vegetable
      recipes that received the most favorable student rankings in the taste tests of Phase I will
      be offered.

      The vegetable recipes flavored with spices and herbs will meet all NSLP requirements for fat,
      sugar, total calories, and all other guidelines.

      Student vegetable intake will be assessed through two outcomes: 1.) plate waste, and 2.)
      production waste.
    

Intervention name(s): Adding spices and herbs to school lunch vegetables
Intervention type(s): Other
Intervention description(s): Direct measurement of school lunch vegetable intake among students both before and after spices and herbs are added.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Spices; Herbs; Vegetables; National School Lunch Program; High school
To Evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and
      Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.
    


Intervention name(s): Viaject 7; LISPRO
Intervention type(s): Drug; Drug
Intervention description(s): 100IU/mL administered subcutaneously; 100IU/mL administered subcutaneously
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment