bioihbjkbjnl/mcl2 huggingface dataset:
My Scrivener® - Measuring Effectiveness and Dose Response in Children
Condition: Asperger's Syndrome; Dyslexia; Cerebral Palsy; Attention Deficit Disorder; ADHD; Traumatic Brain Injury; Stroke
MeSH terms: Brain Injuries; Cerebral Palsy; Brain Injuries, Traumatic; Dyslexia; Attention Deficit Disorder with Hyperactivity; Asperger Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess whether a computer haptic peripheral device programmed to provide
      repetitive motion training is as effective as the same repetitive motion training provided by
      a human being.
    

Detailed description: 
      This study builds on a large body of neurological research that uses robot-guided repetitive
      motion training to induce neuroplasticity and improvements in upper extremity motor skills in
      adults and children. This research study is looking at handwriting, a fine-motor task that is
      used daily.

      In our study, we want to see if 3-dimensional robotic-assisted repetitive motion training can
      be a safe and effective intervention for school-age children with fine motor deficits arising
      from several different impairment origins. Our research construct is: Legible handwriting =
      function of (tactile feedback, visual feedback, duration, and fine-motor control).

      Independent variables:

        -  Tactile feedback is a continuous variable of force-feedback measured in pounds of force.

        -  Duration is a continuous variable measured in seconds and number of repetitions.

        -  Visual feedback is the letter scribed on the paper.

      Dependent variable:

        -  Legible handwriting will be measured by scoring on the Test of Handwriting Skills and
           the Print Tool™ evaluation.

        -  Fine motor deficit/control will be measured directly and objectively by quantifying the
           error between the desired scribing task and the actual scribing task.

      The robotic device is an affordable (<$200) computer haptic (the Falcon(R)) that currently is
      approved by the FCC for home and office. It is *not* approved for medical use. This is an
      investigational, nonsignificant risk device.
    

Intervention name(s): My Scrivener(R)
Intervention type(s): Device
Intervention description(s): Twenty 20-minute sessions of the Handwriting Without Tears(R) instructional handwriting program, with substitution of hand-over-hand or self-generated repetitive motion writing by computer guided repetitive motion.
Other intervention name(s): My Scrivener; Falcon, by Novint Technologies; Handwriting Without Tears
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: haptic; rehabilitation; fine-motor skill; handwriting
Hemodialysis Access Surveillance Evaluation Study
Condition: Hemodialysis Access; Thrombosis
MeSH terms: Thrombosis
Study type: Interventional

Summary: 
      The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis
      treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the
      development of dialysis access thrombosis (clotting).

      Investigators would like to study if monitoring with a specific technique called ultrasound
      dilution technique can help prevent problems with access when compared to what is the current
      standard of care for patients.
    


Intervention name(s): Transonic
Intervention type(s): Device
Intervention description(s): Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).
Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines
Recirculation, access flow will be performed according to HD03 Manual.
Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Surveillance
Study in Subjects Undergoing Complete Abdominoplasty
Condition: Postsurgical Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study
      of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia
      supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.
    

Detailed description: 
      This is a Phase 2, single-center, randomized, double-blind, placebo-controlled, parallel
      design study evaluating up to 4 ascending dose level cohorts, each evaluating a single dose
      of CA-008 vs. placebo injected/instilled during an elective C-ABD. Up to 72 subjects may be
      randomized in 4 cohorts.

      For each subject, postsurgical assessments will be conducted in two parts:

        -  Inpatient period: starts with completion of study treatment injection (T0) and continues
           through 96 hours (T96h).

        -  Outpatient period: begins on discharge from the inpatient unit through various follow up
           visits to day 29 (D29)/week 4 (W4) after surgery. Note that additional follow up visits
           may occur at any time or even after D29/W4 to follow adverse events (AEs) to resolution
           or establishment of a new baseline.
    

Intervention name(s): CA-008 5 mg; Placebo; Bupivacaine Hydrochloride; Hydromorphone; Fentanyl; Acetaminophen; Oxycodone; CA-008 10 mg; CA-008 15 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg CA-008 reconstituted in saline.; Each cohort will use placebo reconstituted in saline.; 0.25% administered pre-surgery; 0.02 mg/kg IV administered intraoperatively; 100 mcg IV administered intraoperatively; 1000 mg IV administered intraoperatively; 5-10 mg PO administered post-surgery; 10 mg CA-008 reconstituted in saline.; 15 mg CA-008 reconstituted in saline.
Other intervention name(s): Vocacapsaicin; Vocacapsaicin; Vocacapsaicin
Intervention MeSH terms: Acetaminophen; Fentanyl; Oxycodone; Hydromorphone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Respiratory Muscle Strength, Exercise Capacity and Physical Activity Levels in Children Primary Ciliary Dyskinesia
Condition: Primary Ciliary Dyskinesia
MeSH terms: Ciliary Motility Disorders; Dyskinesias
Study type: Observational

Summary: 
      Primary ciliary dyskinesia is an autosomal recessive disorder characterized by abnormal
      ciliary movement and disrupted mucociliary clearance. In uncleaned airways, microorganisms
      and respiratory irritants cause inflammation and infection. Permanent rhinitis and chronic
      sputum cough are typical features in primary ciliary dyskinesia patients. Primary ciliary
      dyskinesia is a disease that threatens lung function from pre-school age. One of the main
      causes of respiratory muscle weakness in chronic lung diseases diseases is worsening of lung
      function. Such a weakness causes alveolar hypoventilation, microatelectasis, reduction of the
      cough strength .The cough strength is important for airway cleaning.

      Exercise capacity is affected in chronic lung diseases. Assessment of exercise capacity in
      chronic lung diseases is prognostically important. Reduced exercise capacity and pulmonary
      function in PCD cause decrease in physical activity level. PCD patients have low quality of
      life and early recognition has been found to affect the quality of life positively. Children
      with chronic illness have higher level of depression than healthy children.

      In literature, no study investigated respiratory muscle strength, exercise capacity and
      physical activity PCD patients. Therefore, the investigators aimed to compare aforementioned
      outcomes in PCD patients and healthy controls.
    

Detailed description: 
      According to sample size calculation 26 diagnosed primary ciliary dyskinesia patients and 26
      healthy individuals will be included. Respiratory muscle strength, anaerobic and aerobic
      exercise capacity, physical activity, pulmonary functions, peripheral muscle strength, cough
      strength, respiratory muscle endurance, activity dyspnea perception, quality of life and
      depression will be evaluated. Primary outcome measurements are respiratory muscle strength,
      exercise capacity, physical activity; secondary outcomes are pulmonary functions, peripheral
      muscle strength, cough strength, respiratory muscle endurance, activity dyspnea perception,
      quality of life and depression.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Out- patients and healthy volunteers
      
Keywords: Exercise capacity; Respiratory muscle strength; Physical inactivity; Quality of life
Use of Google Translate to Enhance Patient Pain and Nausea Assessment and Satisfaction After General Anesthesia
Condition: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      This study investigates the use of Google Translate "Conversation Mode" translation service
      to improve communication about pain and nausea with Spanish-speaking patients who are
      recovering after surgery. The Google Translate "Conversation Mode" translation application is
      designed to provide translation from one language to another and used to allow the nurse or
      study doctor to communicate with patients in Spanish by asking pre-prepared questions through
      an electronic device such as an iPad or iPhone. Google Translate "Conversation Mode" may
      facilitate assessment of pain and nausea after surgery in Spanish speaking patients.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To determine the feasibility of Google Translate "Conversation Mode" use to assess
      postoperative surgical pain presence, location and intensity, and nausea presence and
      intensity in Spanish speaking patients in the post-anesthesia care unit (PACU).

      SECONDARY OBJECTIVES:

      I. To evaluate the length of stay in PACU. II. To assess patient satisfaction with regards to
      pain/nausea experienced in PACU.

      III. To determine nursing satisfaction with regards to the use of Google Translate
      "Conversation Mode".

      OUTLINE:

      Patients use Google Translate "Conversation Mode" translation application before and after
      surgery. Patients also complete survey over 10 minutes.
    

Intervention name(s): Medical Device Usage and Evaluation; Survey Administration
Intervention type(s): Other; Other
Intervention description(s): Use Google Translate "Conversation Mode" translation application.; Complete survey
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with scheduled surgery under general anesthesia and will require translation
        services as part of standard care
Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy
Condition: Bladder Exstrophy
MeSH terms: Bladder Exstrophy
Study type: Observational

Summary: 
      The purpose of this study is to determine whether patients who have undergone exstrophy
      closure may be at risk for long-term orthopedic issues manifest by gait abnormalities. This
      study is a descriptive analysis of the study cohort's gait patterns and pelvic structure.

      Specific Aim 1: to determine whether patients with classic bladder exstrophy who underwent
      closure demonstrate gait abnormalities.

      Hypothesis 1: Patients undergoing closure of bladder exstrophy (with or without pelvic
      osteotomy) demonstrate gait abnormalities compared with a reference population.

      Hypothesis 2: Patients undergoing closure of bladder exstrophy (with or without pelvic
      osteotomy) will have below normal functional survey scores.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Bladder exstrophy patients receiving follow-up services at Connecticutcmc Urology clinic.
      
Keywords: Bladder exstrophy; Abnormal gait; anatomy; urinary bladder disease; urogenital abnormalities
A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate safety and toleration of multiple inhaled doses
      as well as the time course of PF-03526299 concentration in the blood following dosing by dry
      powder inhaler.
    


Intervention name(s): PF-03526299; PF-03526299
Intervention type(s): Drug; Drug
Intervention description(s): dry powder for inhalation, 1.396 mg, BID for 14 days; dry powder for inhalation, 4 mg, BID for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Short-term Prednisone to Treat STA Study(SPTSS)
Condition: Subacute Thyroiditis
MeSH terms: Thyroiditis; Thyroiditis, Subacute
Study type: Interventional
Phase: Phase 4

Summary: 
      Efficiency and Safety Study of Short-term Prednisone to Treat Moderate and Severe Subacute
      Thyroiditis

      The investigators hypothesize that less adverse reactions will be observed, comparing with
      the guidelines recommend. The recurrence rate, adrenal insufficiency, temporary and permanent
      hypothyroidism aren't significant difference.
    

Detailed description: 
      Comparing with the guidelines recommend, short-term (one week)prednisone and nsaids following
      up next week to treat moderate and severe subacute thyroiditis will be assessed.

      The patients in wards will be assessed from temperature,erythrocyte sedimentation
      rate,C-reactive protein,local pain and goiter.The random treatment will be executed in
      moderate and severe SAT after informed consent be signed.

      Subjects will be monitored once every 2 weeks.If patients complained of pain in their neck or
      if the erythrocyte sedimentation rate is still high,after discontinuation of prednisone,
      prednisone treatment will be resumed in moderate and severe subject and non-steroidal
      anti-inflammatory drugs will be used in mild subject.Anti-ulcer drugs will be administered to
      all patients.

      The endpoint of the study are efficiency and safety of short-term prednisone treating. The
      investigators will assess adrenal insufficiency (such as anorexia, nausea, vomiting,
      abdominal pain),steroid withdrawal syndrome, recurrence rate and hypothyroidism. The
      investigators will observe erythrocyte sedimentation rate,pain,steroid level and thyroid
      function.
    

Intervention name(s): Prednisone 1 week; Prednisone 6 weeks
Intervention type(s): Drug; Drug
Intervention description(s): Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.; Guidelines recommend
Other intervention name(s): Glucocorticoid; Glucocorticoid
Intervention MeSH terms: Prednisone; Glucocorticoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Efficacy; safety; short; term; subacute thyroiditis
A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It
      will be used to treat two migraine attacks in subjects who have a history of skin sensitivity
      associated with their headaches.This skin sensitivity is called cutaneous allodynia
      (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a
      non-noxious stimulus is applied to normal skin. It has been noted in several studies that in
      subjects with migraine, seventy nine percent of the subjects experienced allodynia on the
      facial skin on the same side as the headache. It has also been shown that that once allodynia
      develops, other migraine medicines that would normally be very effective for migraine pain,
      become much less effective or ineffective. This study will compare the differences,if any, in
      attacks treated early with this study drug and treated later with the same study drug. It is
      hoped that that this trial will provide information on the use of DHE-45 in subjects who have
      cutaneous allodynia. Understanding more about allodynia may help us understand how the pain
      system works in migraine.
    


Intervention name(s): dihydroergotamine mesylate
Intervention type(s): Drug
Intervention description(s): 1.0 mg. intramuscularly
Other intervention name(s): DHE-45
Intervention MeSH terms: Dihydroergotamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: migraine; cutaneous allodynia
Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Condition: Gastroenteritis
MeSH terms: Gastroenteritis; Emergencies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators will study the efficacy and side effect profile of LGG, a probiotic, in
      pediatric patients with acute gastroenteritis.
    

Detailed description: 
      Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to
      the Emergency Department with acute gastroenteritis.
    

Intervention name(s): LGG; micro-crystalline cellulose
Intervention type(s): Drug; Drug
Intervention description(s): LGG 10^10 cfu PO BID X 5 days; 1 capsule PO bid x 5 days
Other intervention name(s): Lactobacillus GG ATCC 53103; Lactobacillus rhamnosus; culturelle; placebo micro-crystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lactobacillus rhamnosus GG; LGG; Probiotic; Gastroenteritis; acute gastroenteritis; child; pediatric; RCT
Rifaximin as a Modulator of Microbial Translocation and Immune Activation
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to see whether rifaximin, an antibiotic that works in the
      intestines, can lower the amount of germs in the intestines of HIV infected persons. It is
      possible that when the amount of these germs is lowered, an HIV-infected person's immune
      system will become less active and will have a better chance of recovering. Also, the study
      will evaluate the safety of using rifaximin in HIV-infected subjects.
    

Detailed description: 
      A5286 is a randomized, open-label, two-arm, pilot (phase II) study that evaluated whether 4
      weeks of treatment with rifaximin, a non-absorbable antibiotic, decreases markers of immune
      activation and levels of translocated gut microbial products in HIV-1 infected subjects
      virally suppressed on ART with CD4+ T-cells < 350 cells/mm^3. Rifaximin were admistered to
      subjects for 3 weeks. Follow-up continued to week 12. The total sample size was 73 subjects.
      Subjects were randomized at a 2:1 ratio (rifaximin: no study treatment), using permuted
      blocks, without institutional balancing.

      Subjects were seen through week 12 for clinical and laboratory evaluations, including plasma
      HIV-1 RNA, CD4+ T-cell count, and safety laboratories. Subjects had 2 baseline visits -- at
      pre-entry and entry. Study visits were scheduled at weeks 2, 4, 8, and 12. CD4+ T-cell counts
      and HIV-1 RNA were measured at all weeks; measures of activations, gut-homing markers, and
      soluble biomarkers were also performed at all weeks.
    

Intervention name(s): Rifaximin
Intervention type(s): Drug
Intervention description(s): Participant were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds
Condition: Measles; Varicella; Mumps; Rubella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is undertaken to generate clinical data on GSK Biologicals' combined
      measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from
      newly established working seed viruses which are one passage further than the current working
      seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current
      working seed viruses will serve as comparator.

      A seed lot system is a system according to which successive batches of a vaccine are derived
      from the same master seed virus. For routine production, a working seed lot is prepared from
      the master seed virus.
    


Intervention name(s): Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine); GSK Biologicals' 208136, new formulation
Intervention type(s): Biological; Biological
Intervention description(s): Vaccine will be administered subcutaneously in the left upper arm (deltoid region); Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Working seed virus; Rubella; Mumps; Varicella; Combined measles-mumps-rubella-varicella vaccine; Pediatric immunization; Measles
Chocolate Meal Study
Condition: Impact of Food Composition on Gastric Emptying
Study type: Interventional

Summary: 
      This comparative pilot study is designed to compare the rates of gastric emptying and by
      inference rates of digestion of challenge meals. Two types of meal will be compared,
      chocolate mousse style dessert and chocolate bars. The information from this study will then
      be compared to the elicitation times for both objective and subjective symptoms in the
      allergic patients who have been challenged in a different study using the same two meals.
    


Intervention name(s): Food type
Intervention type(s): Other
Intervention description(s): 1ml, 1ml, 5ml, 50ml, 6ml, 20ml, 60ml and 200ml of chocolate dessert or 1 g, 1 segment (5 segments to a bar) repeated 6 times, 2 bars repeated twice of chocolate bars
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)