bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain
Condition: Pain Management; Nerve Block; Ultrasound
Study type: Interventional

Summary: 
      Analgesia following tympanomastoid surgery is critical for the prevention of postoperative .
      There are very few regional anesthesia methods used to achieve this goal.
    

Detailed description: 
      In this study, it was aimed to investigate the effect of Ultrasound guided superficial
      cervical plexus block versus greater auricular nerve block for on postoperative
      tympanomastoid surgery analgesia.
    

Intervention name(s): IV patient-controlled analgesia (PCA) tramadol; ultrasound guided superficial cervical plexus block; ultrasound guided Great Auricular nerve block
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.; ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine; ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol
Other intervention name(s): Tramadol; superficial cervical plexus block; Great Auricular nerve block
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective,randomized,single blind
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Observational

Summary: 
      Aprepitant was approved in 2003. The drug works to lessen the amount of nausea and vomiting
      that cancer patients experience after treatment. Aprepitant has been well-studied in adults,
      but not in children. Data from adult studies has shown aprepitant to be safe. It has also
      been shown to be effective in lessening the amount of nausea and vomiting that adult patients
      experience. Because aprepitant has been shown to be safe and effective, the investigators
      have been using it in pediatric patients at this hospital as standard of care. The
      investigators will be surveying patients already receiving aprepitant for prevention of
      chemotherapy-induced nausea and vomiting to determine the amount of nausea and vomiting they
      experience. The investigators will also be surveying these patients to determine what their
      appetite is like and if they experience any disruptions in activities of daily living. The
      investigators are also going to be assessing any side effects these patients experience from
      receiving aprepitant.
    

Detailed description: 
      This will be a prospective, observational study conducted at WVU Children´s Hospital. The
      study will be conducted over a one-year period until data from 20-40 patient encounters is
      obtained. There will be no randomization and no control group. Information will be collected
      from all patients who meet the study´s inclusion criteria. Patients will be given a survey to
      complete at baseline, on all days of chemotherapy, and for five days after the conclusion of
      chemotherapy using the BARF Scale and a 4-point Likert scale. The information collected from
      the survey will include the incidence and severity of nausea and emesis, evaluation of
      appetite, activities of daily living, and rescue medications used for acute CINV. The
      specific chemotherapy regimen that each patient receives will be recorded. Any data
      identifying the patient will be de-identified after all pertinent data is collected.
      Descriptive statistics will be used to analyze data.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will include pediatric patients with an active malignancy.
      
Keywords: Aprepitant; Pediatrics; Chemotherapy-induced nausea/vomiting; Survey
A Pharmacokinetic Study of Polymyxin B in Healthy Subjects and Subjects With Renal Insufficiency
Condition: Antibiotic Toxicity
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-center, single-dose, parallel-group study to evaluate the PK
      and safety profiles of polymyxin B administered by IV infusion in healthy subjects and
      subjects with renal insufficiency.
    

Detailed description: 
      The study will enroll approximately 24 adult subjects in the following three Arms based on
      renal function. Approximately 8 subjects for each Arm are planned to be enrolled to fulfill
      the analysis of at least 6 evaluable subjects in each Arm. The subject who drops out of the
      study may be replaced at the discretion of the Sponsor.

        -  Arm 1 (normal renal function group): Subjects with CLcr ≥ 90 mL/min

        -  Arm 2 (mild renal insufficiency group): Subjects with CLcr between 60 and 89 mL/min
           (inclusive)

        -  Arm 3 (long-term IHD group): Subjects with ESRD receiving IHD therapy 3 times a week for
           at least 3 months prior to dosing of study drug; Subjects will receive a single dose of
           polymyxin B one day after his/her 3rd dialysis of the week.
    

Intervention name(s): Polymyxin B
Intervention type(s): Drug
Intervention description(s): Polymyxin B acts against gram-negative bacteria (GNB) only, via three known mechanisms of action: First, polymyxin B can electrostatically interact with the outer membranes of GNB to compete against and displace calcium and magnesium divalent cations from membrane lipids, thereby disrupting lipopolysaccharide (LPS) molecules on the outer membrane and triggering their release. This leads to changes in the permeability of the bacterial membrane and subsequently causes cell content leakage, cell lysis, and death. Second, polymyxin B can act as a surfactant, as it is amphipathic and contains both lipophilic and lipophobic groups; this allows it to penetrate cell membranes, interact with the phospholipids within, and rapidly disrupt membranes to kill bacteria. Third, polymyxin B can bind to the lipid A portion of bacterial endotoxin or LPS molecules, thus neutralizing their toxicity.
Intervention MeSH terms: Polymyxins; Polymyxin B
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Assessment of Memory in Children With Kabuki Syndrom
Condition: Kabuki Syndrome
MeSH terms: Vestibular Diseases; Hematologic Diseases; Abnormalities, Multiple; Syndrome
Study type: Interventional

Summary: 
      Mnesic function has not, at present, been evaluated in patients with Kabuki Syndrome. Some
      data from the neuroimagery suggest an impairment of memory function. The objective of our
      study is to assess the mnesic function of children with Kabuki Syndrom.
    

Detailed description: 
      Kabuki Syndrome (SK - OMIM 147920 and 300867 ORPHA: 2322) is a rare genetic disease with a
      prevalence of approximately 1/32 000 and responsible for a malformation syndrome with mild to
      moderate intellectual impairment. SK is due to mutations in the KMT2D and KDM6A genes. As
      part of a national PHRC (AOM 07-090, clinicaltrial NCT01314534, The investigators were able
      to perform psychometric tests type WISC4 and MRI type VBM). Disability in SK is characterized
      by a heterogeneous cognitive profile with strengths and weaknesses when calculating IQ. Brain
      MRI reveals small hippocampi compared to controls. These 2 data are partly contradictory
      because the strengths of the patients with SK are a working memory and a verbal comprehension
      index high compared to the other indices of the tests WISC-IV.

      The objective of the research is to better understand the mnesic function of children with
      SK.

      25 children aged 6 to 16 will be recruited. The diagnosis of SK will have been authenticated
      by the demonstration of a mutation in the KMT2D or KDM6A gene.

      The memory assessments will be conducted in one visit for each child, who will perform a
      memory assessment with a neuropsychologist, using the CMS scale.
    

Intervention name(s): No arm intervention
Intervention type(s): Other
Intervention description(s): No arm intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Kabuki Syndrome; Intellectual Profile; Memory
Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure
Condition: Rectal Prolapse
MeSH terms: Rectal Prolapse; Prolapse; Necrosis
Study type: Interventional

Summary: 
      Incarceration and necrosis of rectal prolapse is rare and often requires urgent management.
      Perineal rectosigmoidectomy (Altemeir procedure) is a reasonable technique for this
      condition. The need for a diverting stoma depends on the patient's condition and the
      experience and judgement of the surgeon. A literature review was performed to determine
      optimal management of incarcerated and necrotic rectal prolapse, and to determine the
      indication for fecal diversion.
    


Intervention name(s): perineal rectosigmoidectomy
Intervention type(s): Procedure
Intervention description(s): In an Altemeier perineal rectosigmoidectomy, a full-thickness circumferential incision is made in the prolapsed rectum about 1-2 cm from the dentate line (see the image below). The hernia sac is entered, and the prolapse is delivered. The mesentery of the prolapsed bowel is serially ligated until no further redundant bowel can be pulled down. The bowel is transected and either hand-sewn to the distal anal canal or stapled with a circular stapler. Before anastomosis, some surgeons plicate the levator ani muscles anteriorly, which may help improve continence.
Other intervention name(s): Altemeier's procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
One Week Assessment of The Phenacite Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study will investigate performance criteria over one week of daily wear to determine if
      the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms
      of subjective ratings and of visual performance.

      The study test lens was not the final optical design and the study results were not used for
      the design validation.
    

Detailed description: 
      This will be double-masked, randomized, bilateral crossover study comparing the Study Test
      lens against the comfilcon A control lens, each worn over one week of daily wear.

      The study test lens was not the final optical design and the study results were not used for
      the design validation.
    

Intervention name(s): Phenacite (Test) contact lens; comfilcon A contact lens
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Testing the Decision Aid: Supporting Patient Decisions About Upper Extremity Surgery in Cervical SCI
Condition: Cervical Spinal Cord Injury; Tetraplegia
MeSH terms: Spinal Cord Injuries; Quadriplegia
Study type: Interventional

Summary: 
      Purpose: The objective of this study is to assess a newly created decision support
      intervention (DSI) or decision aid (DA) for people with spinal cord injury (SCI) to learn
      about and consider upper extremity reconstructive surgery to help them choose a course of
      treatment that most aligns with their values.
    

Detailed description: 
      The overarching aim of this project is to define key information about improvement of upper
      extremity function after SCI (time and extent of recovery, outcome of surgical and
      non-surgical interventions and the experience thereof) and communicate this information to
      patients and clinicians to support their treatment decisions.

      This particular Aim 3 of the overall project will assess a newly developed DSI/DA tool in a
      pre-/post- pilot study of people with SCI hoping to restore upper extremity function in
      cervical SCI. Using information from prior aims of this project, a de novo tool has been
      created and will be tested. This study will measure participant knowledge of their condition
      and treatment options, and decisional conflict. Participant feedback, demographics, and
      health-literacy information will be collected to help improve and refine the DA before it is
      made widely available to the public.
    

Intervention name(s): Surveys for Research Purposes
Intervention type(s): Other
Intervention description(s): VISIT #1:
Pre-Testing:
Pre Knowledge Test
Pre SURE (decisional conflict) test
Independent DSI/DA Interaction
Post-Testing:
Post Knowledge Test
Post SURE (decisional conflict) Test
Acceptability Index
Modified Single Item Literacy Screen
Additional Demographics
VISIT #2: Check-In Call 1 week later:
After viewing the DSI/DA and completing the post-test components above, the subjects will also complete a 5 minute debrief interview about 1 week later via phone or video conference with a team member to give feedback on their experience using the DSI/DA, including its strengths and weaknesses. This will allow for further improvement and refinement of the DSI.
Intervention model: Single Group Assignment
Intervention model description: Prospective, single arm pre/post pilot study. This non-therapeutic study will provide no direct medical benefit to the research participants but will help the researchers learn more so that future generations may benefit.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Nerve Transfer Surgery; Tendon Transfer Surgery; Decision Support Intervention
Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Child Development Disorders, Pervasive
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Developmental Disabilities
Study type: Interventional

Summary: 
      This study is being carried out to learn more about the effects of Therapeutic Horseback
      Riding (THR) for children and adolescents with an autism spectrum disorder (ASD). This
      treatment is very popular and horseback riding for children and adults with disabilities has
      been used as a form of therapy in the United States for over forty years. However, very
      little research has been done to find out whether or not THR is effective as a therapy for
      children with an ASD. This study is being done to see if THR will improve the agitation
      behaviors, coordination, and communication skills of children and adolescents with an ASD.
      This study is also being done to find out if the horse is necessary for children and
      adolescents with an ASD to improve.
    

Detailed description: 
      This study expands previous preliminary equine-assisted intervention research, including the
      authors' 10-week Therapeutic horseback riding (THR) intervention pilot, by evaluating the
      effectiveness of therapeutic horseback riding (THR) on self-regulation, socialization,
      communication, adaptive, and motor behaviors in children with autism spectrum disorder (ASD).
      Method: One hundred and twenty-seven participants (ages 6-16 years) were randomized by
      nonverbal IQ standard scores (< 85 or > 85) to one of two 10-week small groups: THR
      intervention; or barn activity (BA) control group without horses. Both interventions used
      similar methods, and the fidelity of the THR intervention was monitored. Participants were
      evaluated within one month pre- and post-intervention by raters blind to intervention
      conditions and caregiver questionnaires. Weekly during the intervention, caregivers rated
      participants' behaviors during the preceding week.
    

Intervention name(s): Therapeutic horseback riding; Barn Activity Intervention
Intervention type(s): Other; Other
Intervention description(s): Inclusion of horses as part of the therapeutic experience; Equine-focused educational activities in small group setting without horses
Other intervention name(s): Equine-Assisted Activities and Therapies; Animinal-Assisted Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Therapeutic Horseback Riding
Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer
Condition: Esophageal Cancer; Squamous Cell Carcinoma
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to clarify efficacy and toxicity of daily low-dose Nedaplatin
      (CDGP) and continuous infusion of 5-FU combined with radiation in patients with esophageal
      squamous cell carcinoma.
    

Detailed description: 
      The tumor stages and disease grades were classified according to the TNM classification
      (sixth edition) of the International Union against Cancer (UICC). These were determined
      conventionally by computed tomography (CT) of the neck, chest and abdomen, bone scan,
      endoscopic ultrasonography (EUS), endoscopy and esophagography.

      Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19,
      22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26.
      Fractionated radiotherapy was performed from day 1 and a total dose of 50-60 Gy was delivered
      at the rate of 1.8-2.0 Gy per fraction. Serotonin receptor antagonist was preventively given
      as an antinauseant just before the administration of Nedaplatin.

      Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors
      (UICC, 2002). Toxicities were graded according to the Common Terminology Criteria for Adverse
      Events v3.0 (CTCAE). Survival was calculated from the start of chemoradiotherapy.
    

Intervention name(s): CDGP/5-FU combined with radiation; Radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26.; Fractionated external radiotherapy was performed from the first day of chemotherapy and a total dose of 50.4-66 Gy was delivered at the rate of 1.8-2.0 Gy per fraction.
Other intervention name(s): Nedaplatin; 5-FU; Radiation
Intervention MeSH terms: Nedaplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal cancer; Nedaplatin; 5-FU; chemotherapy; radiation; chemoradiotherapy
Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption
Condition: Fructose Malabsorption
MeSH terms: Malabsorption Syndromes; Fructose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the enzymatic product Frucosin(R) is able
      to degrade fructose in vivo in the small intestine of patients with known fructose
      malabsorption by measuring hydrogen in the expiratory air.
    

Detailed description: 
      Fructose malabsorption is a digestive disorder in which the uptake of fructose in the small
      intestine is deficient. This leads to an increase of the concentration of fructose in the
      large intestine after the intake of fructose-rich meals. The exzess fructose is then degraded
      by intestinal microbes into CO2, CH4, H2 and short chain fatty acids causing symptoms like
      bloating, diarrhea, flatulence or stomach pain.

      The clinical diagnosis requires a hydrogen breath test after challenge with fructose. After
      an oral challenge with fructose the emerging hydrogen is measured in the expiratory air. A
      fructose malabsorption is diagnosed if the hydrogen in the expiratory air reaches 20ppm or
      more.

      In the course of this study the participants will take 2 hydrogen breath tests. Before each
      of these tests the participants will take either the active treatment (Fructosin(R)) or a
      placebo. The active treatment should reduce the exhaled hydrogen indicating a reduced
      concentration of fructose in the large intestine after fructose metabolization by the verum.
    

Intervention name(s): Fructosin
Intervention type(s): Dietary Supplement
Intervention description(s): Three capsules of Fructosin before one of the hydrogen breath tests.
Other intervention name(s): Frutosin(R)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the long-term safety and tolerability of ezetimibe
      (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day)
      for up to 12 consecutive months in participants with primary hypercholesterolemia.
    

Detailed description: 
      This study is a long-term extension study of the protocol P00692 parent study.
    

Intervention name(s): Ezetimibe; Atovastatin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ezetimibe 10 mg tablets; Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg; Placebo tablets matched to ezetimibe
Other intervention name(s): SCH 58235
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Changes of the Hemodynamic Profiles on Bio Reactance Technique During TURP in Elderly Patients
Condition: Benign Prostate Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the change of the hemodynamic profiles on bio
      reactance technique during TURP in elderly patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        elderly patients undergoing transurethral resection of the prostate under spinal anesthesia
      
Keywords: Elderly patient; NICOM; TURP