bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This purpose of this study is to compare the effect of exenatide to that of sitagliptin on
      2-hour postprandial glucose in subjects with type 2 diabetes mellitus.
    


Intervention name(s): exenatide; sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection (5mcg or 10mcg), twice a day; oral administration (100mg), once a day in the morning
Other intervention name(s): Byetta; Januvia
Intervention MeSH terms: Sitagliptin Phosphate; Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; exenatide; sitagliptin; Amylin; Lilly
Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Study type: Observational

Summary: 
      This research study will be completed by enrolling a prospective, observational cohort study
      to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This
      investigation will compare quality of life outcomes between each treatment type, as well as
      measure cellular and molecular markers of inflammation in the sinus mucosa, to create models
      that predict improvement in quality of life following treatment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients who have failed intial medical management for chronic sinusitis and have
        presented to a tertiary care clinic for continued treatment.
      
Biospecimen description: 
      Sinonasal mucosal tissue specimens
A Study to Investigate the Effect of 7-Keto on Resting Metabolic Rate in Overweight Adults
Condition: Resting Metabolic Rate; Overweight Subjects
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the effect of two different doses of 7-Keto compared to placebo
      on resting metabolic rate. One third of subjects will be given the lower 7-Keto dose, one
      third will be given the higher 7-Keto dose and one third will be given the placebo.
    


Intervention name(s): 7-Keto 50mg; 7-Keto 25mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Resting Metabolic Rate; 7-Keto-DHEA; Efficacy; Overweight Adults; Obese Adults
Translating Adoption of Improved Varieties Into Nutritional Impact
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The purposes of this study are (1) to determine whether child nutrition-focused adoption
      encouragement messages focused on Quality Protein Maize (QPM) and the availability of small
      quantities of QPM seed can be effective at increasing QPM adoption and health outcomes for
      young children, and (2) to determine whether consumption encouragement messages and
      techniques (e.g., containers for earmarking) can be effective at increasing QPM targeting to
      and health outcomes for young children.
    


Intervention name(s): Adoption Encouragement Treatment; Consumption Encouragement Treatment
Intervention type(s): Other; Other
Intervention description(s): Households in the Adoption Encouragement Treatment received child nutrition focused guidance on the nutritional and agronomic benefits of Quality Protein Maize (QPM) adoption, and the opportunity to order up to 6 kg of QPM seed to plant in their own fields.; Households in the Consumption Encouragement Treatment received the same guidance as households in the Adoption Encouragement Treatment, as well as additional guidance on the importance of specifically targeting foods made with QPM to young children and tools to help households keep the grain separate and remember to feed QPM-based foods to the young children.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Biomarkers; Child Nutrition Sciences; Economics, Behavioral
GRASSP: Gralise® for Spine Surgery Pain
Condition: Post-laminectomy Pain Syndrome
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)
    


Intervention name(s): Gralise®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®).; 14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo).
Other intervention name(s): Gralise: Gabapentin ER; Placebo: inactive pill manufactured to mimic gralise.
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: post laminectomy pain syndrome, failed back surgery syndrome
Effect of Sensory Integration Therapy on Balance and Functional Mobility
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Purpose: to investigate the effect of sensory integration therapy on balance and functional
      mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic
      cerebral palsy, the children were assigned to a control group and a study group. Balance was
      assessed using the Biodex balance system and functional mobility was assessed using the Timed
      Up and Go test.
    

Detailed description: 
      Purpose: to investigate the effect of sensory integration therapy on balance and functional
      mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic
      cerebral palsy, the children were assigned to a control group and a study group. Balance was
      assessed using the Biodex balance system and functional mobility was assessed using the Timed
      Up and Go test. The control group received selected physical therapy, while the study group
      received the previously mentioned selected physical therapy program modified to increase
      sensory input. Treatment sessions for both groups were conducted for both groups for 1 hour
      once a day, three times per week for two successive months.
    

Intervention name(s): Selected physical therapy program; Modified physical therapy program to increase sensory input
Intervention type(s): Procedure; Procedure
Intervention description(s): Gait training and balance training; Gait training and balance training using sensory stimulating matts
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: study group and control group
Masking: None (Open Label)
Primary purpose: Treatment
Rotigotine Restless Legs Syndrome Dose Finding Trial
Condition: Idiopathic Restless Leg Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial is to demonstrate clinical efficacy of four different dosages of
      SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15
      cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936)
      will be more effective than placebo. The tolerability and safety of rotigotine will be
      assessed.
    


Intervention name(s): SPM 936
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement (IUPC) Measurement in Pregnant Women
Condition: Pregnancy - Labor Monitoring
Study type: Observational

Summary: 
      This measurement study was designed to evaluate the performance of SureCALL® EMG Labor
      Monitor® (SureCALL®) to the predicate Tocodynamometer device (TOCO) using the performance of
      an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
    

Detailed description: 
      The SureCALL® EMG Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor
      intended to measure intrapartum uterine activity. It is intended for use on term pregnant
      women who are in labor, with singleton pregnancies, using surface electrodes on the maternal
      abdomen. The device is intended for use by healthcare professionals in a clinical setting.

      This measurement study was designed to evaluate the performance of SureCALL® to the predicate
      Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter
      device (IUPC) as the "gold standard".

      This study involved 20 women at term, in labor, at three clinical sites. Each study subject
      was instrumented with three technologies for measuring uterine activity:

        1. a tocodynamometer attached to the maternal abdomen

        2. a set of abdominal surface electrodes for uterine electromyography, and

        3. an intrauterine pressure catheter.

      Using IUPC as the "gold standard", this study methodology allowed a three way comparison for
      evaluating how well the SureCALL® system performed compared to the TOCO technology.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women in labor with uncomplicated singleton pregnancies and IUPC indicated with membranes
        ruptured and sufficient cervical dilation.
Investigation of Myotonometer Reliability in Evaluation of Plantar Fascia Biomechanical Properties
Condition: Diabetes; Diabetes Mellitus; Plantar Fascia
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The study aims to examine the intra-rater, inter-rater, and inter-session reliability of
      MyotonPRO in measuring plantar fascia mechanical properties in adults with diabetes.
    

Detailed description: 
      Therefore, changes occur in standing weight-bearing points, loading zones, and gait
      biomechanics. The thickened plantar fascia increases the risk of developing diabetic foot
      with increased peak-plantar pressure, and therefore, plantar fasciitis is more common in
      individuals with diabetes than in healthy individuals. The myotonometer studies showed that
      chronic diabetes history increases dynamic stiffness, which is one of the mechanical
      properties of the plantar fascia, and that as the severity of the disease increases, fascial
      stiffness also increases. The aim of the study is to examine the intra-rater, inter-rater,
      and inter-session reliability of MyotonPRO in measuring plantar fascia mechanical properties
      in adults with diabetes.
    

Intervention name(s): Myotonometric measurement
Intervention type(s): Other
Intervention description(s): MyotonPRO is a non-invasive myotonometer used to evaluate the viscoelastic properties of soft tissues. Data collection will be carried out by three researchers experienced in the use of myotonometer. Before the evaluations, participant and repeated measurement information for both researchers will be recorded on the device. All assessments will be made bilaterally. The first researcher will perform two measurements 30 minutes apart from the measurement point standardized with MyotonPRO to evaluate the plantar mechanical properties. Then, the second researcher will take two measurements with MyotonPRO from the same point with 30 minutes intervals. One day later, the first researcher will measure again from the same reference point once.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults between 18-35 years old diagnosed with Type 2 Diabetes
      
Keywords: Diabetes
Remediation of Impaired Self-Regulation in Patients With Mild TBI
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      The ability to regulate impulses enables us to plan for the future, to maintain focus in the
      face of distractions (i.e. to encode memories), and to manage emotions. This self regulation
      can be compromised in individuals who have a history of mild traumatic brain injury and
      co-occurring disorders. In this study the investigators are using functional MRI scanning to
      understand how memory and self regulation are expressed in the brains of people with a
      history of mild traumatic brain injury. The investigators are also testing whether the
      medication tolcapone may improve memory and self regulation.
    

Detailed description: 
      In this randomized, double-blind, placebo-controlled, crossover cognitive neuroscience study,
      the investigators are evaluating whether the COMT inhibitor tolcapone impacts memory and self
      regulation, as measured both behaviorally (via cognitive testing) and neurophysiologically
      (via functional MRI). A new study arm that does not include use of tolcapone, nominally
      equivalent to the placebo arm only, is now also included to address performance on cognitive
      testing alone.
    

Intervention name(s): Tolcapone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): COMT Inhibitor; A pill that contains no active ingredient
Other intervention name(s): Tasmar
Intervention MeSH terms: Tolcapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: concussion; traumatic brain injury; MRI; memory; tolcapone
Micronized dHACM Injectable for the Treatment of Plantar Fasciitis
Condition: Fasciitis, Plantar
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Prospective, single-blinded, randomized controlled trial of the micronized dHACM injection as
      compared to the saline placebo injection in the treatment of plantar fasciitis
    

Detailed description: 
      Approximately 146 patients will be enrolled in this study. Each patient will receive 1
      injection and be evaluated for efficacy and safety during a 12-month observation period. The
      study is expected to be completed within 36 months, inclusive of enrollment and follow-up of
      all subjects.
    

Intervention name(s): AmnioFix® Injectable; Saline Injection
Intervention type(s): Other; Drug
Intervention description(s): 1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM); Injection of 1mL 0.9% Sodium Chloride Injection, USP
Other intervention name(s): dHACM; 0.9% NaCl; Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic plantar fasciitis; Heel pain
Effect of Reconditioning Exercise on Older Adults With Urinary Tract Cancer Following Curative Surgery
Condition: Rehabilitation
MeSH terms: Urologic Neoplasms
Study type: Interventional

Summary: 
      As population ages, geriatric patients with urinary tract cancer suffer from more
      complications and functional decline that alter treatment plan despite advance in cancer
      surgery. It was found that these urinary tract cancer survivors required a longer time to
      recover to the state before the treatment, and some may be even unable to recover to the
      state before the treatment. Exercise intervention has been found to be beneficial to improve
      functional capacity for cancer survivors, such as breast cancer. However, it is unclear
      whether exercise intervention could also improve functional recovery and mobility in patients
      with urinary tract cancer following curative surgery, especially in older adults. The purpose
      of this study is to investigate the effect of reconditioning exercise on morbidity,
      oncological outcomes, and functional recovery in older adults with urinary tract cancer
      following curative surgery.

      Patients aged over 65 years old and after having undergone curative surgery for confirmed
      urinary tract cancer will be recruited. The participants will be assigned into two groups
      using blocked randomization design. One group will receive reconditioning exercise training
      for five consecutive days, and the other group will receive exercise education. Structured
      questionnaire for comprehensive geriatric assessment and functional mobility, such as walking
      performance, will be used to assess the training effect. Outcome measures are assessed
      including major complication after surgeries, changes in functional status, tumor
      progression, and length of survival. Physical function measurement will include hand grip,
      muscle strength of lower extremities, and gait performance.
    


Intervention name(s): Rehabilitation; Health education
Intervention type(s): Other; Other
Intervention description(s): Progressive resistance exercise and graded aerobic exercise will be provided for those in the experimental group.; Health education and gross joint range of motion exercise for bilateral upper and lower extremities will be provided for those in the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fondaparinux in Critically Ill Patients With Renal Failure
Condition: Venous Thromboembolism
MeSH terms: Renal Insufficiency; Thromboembolism; Venous Thromboembolism; Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine whether a dose-adjusted prophylaxis
      fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours
      (hr) in patients with renal failure achieves peak and trough levels similar to patients with
      normal renal function, and protects patients from developing venous thromboembolism (VTE).
      Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing
      interval from q24 to q48 hr, in patients with estimated creatinine clearance of < 30 ml/min,
      will be safe and effective.
    

Detailed description: 
      We will be studying fondaparinux 2.5 mg subcutaneously every 48 hr in three distinct patient
      groups: 1) Acute kidney failure without hemodialysis, 2) Acute kidney failure (AKI) with
      intermittent hemodialysis (IHD) and 3) Acute renal failure with continuous renal replacement
      therapy (CRRT). All patients will be assessed for efficacy of the dose. Efficacy will be
      assessed by following clinically for any evidence of VTE, either deep venous thrombosis (DVT)
      or pulmonary embolism. In addition, lower extremity duplex studies will be performed at
      baseline and at the end of the study period to assess for DVT.

      Secondary objectives will be safety and accumulation. Safety will be determined by assessment
      of clinically significant bleeding, defined as a drop in Hgb of > 2 grams (gm) in 24 hr, or
      the need for red blood cell transfusion related to bleeding. Accumulation may occur in renal
      failure and will be studied throughout the intensive care unit (ICU) stay through
      reevaluation of levels over time.
    

Intervention name(s): Fondaparinux
Intervention type(s): Drug
Intervention description(s): 2.5 mg every 48 hours
Other intervention name(s): Arixtra
Intervention MeSH terms: PENTA; Fondaparinux
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fondaparinux; Renal Failure; Critically Ill
Efficacy of Epidural Steroid for Controlling Pain After Primary TKA
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine efficacy of epidural steroid for postoperative pain
      control after TKA
    

Detailed description: 
      Epidural triamsinolone can reduce postoperative pain and longer duration of pain control
      after TKA
    

Intervention name(s): epidural triamsinolone; epidural lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): add drugs into catheter at 48 hr after surgery; add into catheter at 48 hr after surgery
Other intervention name(s): epidural steroid; epidural xylocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post-operative pain control; total knee arthroplasty; epidural steroid injection
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      We hypothesize that simvastatin in combination with ICS might have synergistic
      anti-inflammatory effects on airway inflammation in asthmatic patients
    

Detailed description: 
      To determine the additive effect of simvastatin on airway inflammation in ICS-treated
      patients with persistent asthma by measuring eosinophil counts in induced sputum
    

Intervention name(s): simvastatin; B1-6-12
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg per oral once daily for 8 weeks; 1 table per day for 8 weeks
Other intervention name(s): zocor; vitamin B1-6-12
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation
Condition: Lung Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Everolimus is effective in the treatment
      and prevention of chronic graft dysfunction and chronic graft rejection after lung
      transplantation.
    


Intervention name(s): Everolimus; Mycophenolatmofetil
Intervention type(s): Drug; Drug
Intervention description(s): Initial dosage 2 x 0.75 mg/d; Initial dosage 2 x 500 mg/d intravenous
Other intervention name(s): Certican; Cellcept
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung Transplantation; Immunosuppression; Mortality; Graft rejection; Bronchiolitis obliterans; Opportunistic infections; Nephrotoxicity