bioihbjkbjnl/mcl2 huggingface dataset:
Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
Condition: Infection
Study type: Interventional

Summary: 
      The study team will determine whether a decreased feeding tube dwell time will reduce feeding
      tube contamination
    

Detailed description: 
      Contaminated feeding tubes can occur in the neonatal intensive care unit (NICU) and have been
      associated with significant morbidity. Due to an immature immunologic systems, premature
      infants are at significant risk of complications related to contaminated feeding tubes.
      Feeding tube dwell time may affect the level of contamination. This study will determine if a
      maximum feeding tube dwell time of 48 hours reduces contamination compared to a maximum
      feeding tube dwell time of 7 days, thereby improving neonatal health outcomes.
    

Intervention name(s): Feeding tube dwell time of 48 hours; Feeding tube dwell time of 7 day
Intervention type(s): Device; Device
Intervention description(s): Feeding tube dwell time of 48 hours for first 4 weeks of life.; Feeding tube dwell time of 7 days for first 4 weeks of life.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: neonatal intensive care unit (NICU); feeding tube contamination
Kinesio-taping Versus Pelvic Floor Exercise for Post Colonoscopy Coccydynia
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional

Summary: 
      Forty-two patients, with coccydynia following colonoscopy were selected from Kasr El-Aini
      teaching Hospital, with age ranged from 25-45 years. Patients were randomly assigned to the
      control or experimental groups. The patients in the three groups completed 3-weeks 3 sessions
      per week for traditional physical therapy treatment consisting of stretching exercise for the
      piriformis and iliopsoas muscles, clamshell exercise, seat cushioning and seat kitz.
      Experimental group I received kinsiotaping techniques in addition to the traditional physical
      therapy. While experimental group II received pelvic floor exercise in the form of reverse
      kegel exercise or pelvic pulges, in addition to conventional therapies. pain intensity were
      evaluated by numerical rating scale as a primary out come measure, and Oswestry disability
      index was used as a secondary out come measure.
    


Intervention name(s): kinesio-taping techniques.; Pelvic floor exercise; traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pelvic floor exercise; coccydynia
Comparative Study of Fixation or Fusion of Calcaneal Fractures
Condition: Fractures, Comminuted; Fracture Fixation, Internal
MeSH terms: Fractures, Bone; Fractures, Comminuted; Intra-Articular Fractures
Study type: Interventional

Summary: 
      A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres
      across Canada. It will compare patients who receive open reduction, internal fixation for
      Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same
      type of fracture. Patients will be followed up for a period of two years from the time of
      operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12
      months, and 24 months.
    


Intervention name(s): Open reduction internal fixation; Fusion
Intervention type(s): Procedure; Procedure
Intervention description(s): Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).; Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Calcaneus; Intra-articular fracture; open reduction internal fixation; primary subtalar fusion
Cardiac Pathologies in Standard Thoracic CT Imaging
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      Modern high-end CT scanners with faster scan acquisition times now allow for routine
      assessment of cardiac pathologies, which could result in numerous incidental cardiac findings
      on standard thoracic CT angiography (CTA) scans. The CaPaCT-study aims to assesses the
      presence, management and possible clinical impact of incidental cardiac pathologies which are
      becoming visible on standard thoracic CT scans performed on new high-end scanners.
    

Detailed description: 
      A known disadvantage of constantly improving diagnostic imaging is the detection of
      incidental findings. Computed Tomography (CT) scanner technology is ever improving in both
      temporal and spatial resolution. Recently developed advanced reconstruction algorithms and
      dedicated post-processing software reduce image noise thereby improving image quality.
      Equipped with these advancements, modern CT scanners accomplish well defined imaging of
      cardiovascular structures. These technical improvements have enabled cardiac assessment on
      routine standard (non-ECG triggered) thoracic CT scans.

      If thoracic radiologists are able to assess the heart and coronary arteries on a standard
      thoracic CT, this could result in an extensive amount of incidental cardiac findings. Herein
      lies the potential for large scale reporting of incidental cardiac findings and,
      consequently, a huge influx of new 'patients' for downstream testing and potential
      (over-)treatment.

      Coronary Artery Disease (CAD) is a known comorbidity for multiple diseases, for example
      presence of CAD could require a different treatment strategy in lung cancer and worsen
      prognosis [Khakoo et al]. In patients with diabetes mellitus (DM), the incidence of CAD is
      four times higher compared with the general population, and the risk of a cardiovascular
      event is two- to four-fold higher [Kannel et al. + Aktas et al.]. Therefore, the discussion
      on management and treatment of these patients with incidental cardiac findings on chest CT
      evidently is important. Unfortunately, to date no consensus has been reached on the
      management and reporting of these findings. The CaPaCT study (cardiac pathologies on standard
      thoracic CT) has been developed to evaluate the visibility and management of incidental
      cardiac pathologies on a ultra-high pitch thoracic CT-scan with help of the CAD-RADS
      classification.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All consecutive patients referred for thoracic CT-scanning.
      
Keywords: Multidetector Computed Tomography; Incidental cardiac findings; Thoracic high-pitch Computed Tomography; Management guidelines
Rehabilitative Management of Mastication
Condition: Surgery; Malocclusion
MeSH terms: Malocclusion
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to verify the effectiveness of a systematic rehabilitative
      program for mastication in patients submitted to orthognathic surgery.
    

Detailed description: 
      Orthognathic surgery can produce complications during the postoperative period - i.e.
      situations of acute pain and inflammation - as a consequence of fractures and incisions in
      the mucosa. The inadequate management of soft tissue and prolonged surgical time could be the
      causes of acute facial oedema, hematoma and ecchymosis in the face and neck, as well as
      functional disorders involving swallowing and breathing, which can affect patients'
      integrity.

      Despite the fact that decreased muscular extensibility and strength, increased muscular
      fatigability, hipomobility, and alteration of the biomechanical efficiency and length of the
      masticatory muscles are documented clinical consequences, no systematic method of obviating
      such problems through muscular rehabilitation has yet been published
    

Intervention name(s): orofacial myofunctional treatment protocol; counseling; Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): Once a week for six weeks, the experimental group received a forty minutes session of orofacial myofunctional treatment. A home exercise program was prescribed during each session. The protocol implies in continuous and daily practices - participants were asked to perform exercises at least three times a day. After the first six weeks, the experimental group underwent four sessions for maintenance purposes (two sessions twice a month and two sessions once a month). The total treatment duration was of five months.; The instruction group underwent two supervised forty minutes therapy sessions along the six weeks following surgery. These sessions involved the perception of the stomatognathic system, especially in terms of adequate performance during mastication. Specific exercises were not given and patients were instructed to try to reproduce the adequate pattern of mastication at all meals (i.e. alternated bilateral, with lip closure; with coordination activity of the tongue and mandible).; As the sEMG test-retest is a critical issue, participants of CG were also tested in two distinct moments (testing occurred with 1 year interval) in order to verify possible changes in the sEMG measurements as a result of retesting.
Other intervention name(s): rehabilitative orofacial myofunctional protocol; supervised instruction; healthy individuals; no intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: clinical evaluation; controlled clinical trial; electromyography; exercise program; motor control
Insulin Resistance and Substrate Metabolism After Acute Erythropoietin (EPO) Administration
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      Recently EPO receptors have been found in human muscle tissue, but what is still not known is
      the physiological role of these receptors. In this study the researchers want to investigate
      if there is any effect of a acute administration of EPO on insulin resistance and/or
      substrate metabolism in muscle tissue.
    

Detailed description: 
      Recently EPO receptors have been found in human muscle tissue, but what is still not known is
      what the physiological role of these receptors are. It has previously been shown that Growth
      Hormone mediate insulin resistance. The GH receptor and EPO receptor belong to the same
      family of cytokine receptors, and thereby share many of the same signalling pathways. In this
      study we want to investigate if there is a similar effect on insulin resistance and/or
      substrate metabolism after acute administration of EPO in human muscle tissue. Different
      signalling pathways are investigated på western blotting, and insulin sensitivity are
      measured be a hyperinsulinemic euglycemic clamp, and substrate metabolism is measured by the
      forearm model.
    

Intervention name(s): erythropoietin; placebo (saline)
Intervention type(s): Drug; Drug
Intervention description(s): bolus of 400 IU/kg; i.v
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Erythropoietin; human muscle tissue; insulin sensitivity; substrate metabolism
A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole
Condition: Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in
      healthy male volunteers.
    

Detailed description: 
      This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic
      characteristics of AD-206 compared with administration of Esomeprazole in healthy male
      subjects.
    

Intervention name(s): AD-206 20mg; Esomeprazole 20mg; AD-206 40mg; Esomeprazole 40mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet administered before the breakfast during 7 days; 1 tablet administered before the breakfast during 7 days; 1 tablet administered before the breakfast during 7 days; 1 tablet administered before the breakfast during 7 days
Other intervention name(s): Test drug; Reference Drug; Test drug; Reference Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination for Retinopathy of Prematurity
Condition: Investigate the Efficacy of Sucrose During Eye Examination
Study type: Interventional

Summary: 
      Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The
      purpose of this study was to determine the effectiveness of local anesthetic eye drops and a
      pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye
      examinations for retinopathy of prematurity.
    

Detailed description: 
      Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants.
      Administration of oral sucrose with and without non-nutritive sucking is the most frequently
      studied non-pharmacological intervention for procedural pain relief in neonates.The purpose
      of this study was to determine the effectiveness of local anesthetic eye drops and a
      pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye
      examinations for retinopathy of prematurity.
    

Intervention name(s): Oral sucrose solution; Steril water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral sucrose solution plus topical anesthetics; steril water plus topical anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: eye examination, oral sucrose, premature infant pain scale
A Phase II Study of Anlotinib in MTC Patients
Condition: Tumor
Study type: Interventional
Phase: Phase 2

Summary: 
      Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug
      Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,
      Ltd. ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for
      VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis. The trial is to explore
      ALTN for the effectiveness of advanced medullary thyroid carcinoma and security.
    


Intervention name(s): Anlotinib
Intervention type(s): Drug
Other intervention name(s): ALTN
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is
      effective in the treatment of postoperative inflammation.
    

Detailed description: 
      The objective is to assess the efficacy and safety of 0.002% and 0.05% difluprednate
      ophthalmic emulsions in patients with postoperative inflammation after cataract surgery
      (implantation of intraocular lens). In addition, the evaluation system for a future
      dose-finding phase III study of difluprednate ophthalmic emulsion will be established.
    

Intervention name(s): Difluprednate Ophthalmic Emulsion
Intervention type(s): Drug
Intervention MeSH terms: Difluprednate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Use of a 3D Printer to Make Custom Sleep Masks for Positive Airway Pressure Treatment
Condition: Sleep Apnea; Pediatric Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      This is a small pilot study to look at the feasibility of creating a customized sleep mask
      for use with Continuous Positive Airway Pressure (CPAP) or other similar treatments for sleep
      apnea. The participant will have three dimensional (3D) pictures of the face taken by special
      cameras. The pictures will be sent to a 3D printer and a mask will be created based on the
      participant's face contours. The participant will use the mask for about 6 months. The study
      will measure the amount it is used during sleep and if there is an increase in reported
      comfort.
    

Detailed description: 
      The aim of this study is to improve adherence and effectiveness of noninvasive ventilation by
      decreasing the side effects commonly seen with noninvasive ventilation. Studies have shown
      that even though noninvasive ventilation (NIV) with positive airway pressure (PAP) is
      successful at treating obstructive sleep apnea and hypoventilation, individuals have poor
      compliance with therapy. The reasons for poor compliance are numerous, but one significant
      and continually reported reason is poor mask fit. A poor mask fit is not only uncomfortable,
      but frequently causes side effects such as dry eyes, congestion, skin irritation and
      breakdown, and ineffective ventilation from inadequate pressures due to air leaking around
      the mask. Pediatric patients tend to be especially difficult to fit with conventional masks
      because of their smaller facial features and the lack of masks developed for pediatric use.

      In this study, patients will be fitted with a custom made NIV mask following facial imaging
      with a 3D camera (Artec 3D Scanner). The facial image will be used to construct an NIV mask
      model using computer design software that will then be created by using a 3D printer.
    

Intervention name(s): 3D printed NIV mask
Intervention type(s): Device
Intervention description(s): use of 3D printed mask
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CPAP; Noninvasive Ventilation Mask
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
Condition: Osteoporosis; Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid
      hormone-related peptide, is effective in preventing fractures in postmenopausal women with
      severe osteoporosis who are at risk of fractures.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, comparative Phase 3, multicenter
      international study to evaluate the efficacy and safety of BA058 (abaloparatide) 80 µg in the
      prevention of fracture in otherwise healthy ambulatory postmenopausal women with severe
      osteoporosis.
    

Intervention name(s): Placebo; BA058 80 mcg; teriparatide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo 0 mcg subcutaneous daily; BA058 80 mcg subcutaneous daily; teriparatide 20 mcg subcutaneous daily
Other intervention name(s): abaloparatide, Abaloparatide-SC; Forteo; Forsteo
Intervention MeSH terms: Teriparatide; Abaloparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BA058; abaloparatide; Abaloparatide-SC; osteoporosis; postmenopausal; bone loss; ACTIVE; fracture
Bioavailability of Dabigatran With or Without Clarithromycin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate whether and to what extent the reported potent P-gp inhibitor clarithromycin
      affects pharmacokinetic parameters (area under the curve (AUC) and maximal concentration
      (Cmax)) of dabigatran.
    


Intervention name(s): Dabigatran etexilate; Clarithromycin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clarithromycin; Dabigatran
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Deep Brain Stimulation in Patients With Dystonia
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of deep brain
      stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia.
    

Detailed description: 
      Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing
      twisting, writhing movements and abnormal postures. It is associated with abnormal electrical
      activity in two groups of nerve cells in the brain called the globus pallidus internus (GPi)
      and the subthalamic nucleus (STN). Deep brain stimulation (DBS) has been shown to be an
      effective treatment in patients with medically refractory dystonia and is currently approved
      for both the GPi and STN targets under a humanitarian device exemption (HDE) for use in
      segmental and generalized primary dystonia as well as focal cervical dystonia. GPi DBS
      appears to be effective for medication-refractory focal and segmental dystonia affecting the
      cranial and cervical regions in open-label series, but recently GPi stimulation has been
      associated with subtle motor disturbances in previously non-dystonic body regions (i.e., arms
      and legs) in this population of patients. DBS of the STN has also been reported to be
      effective for treating generalized and cervical dystonia in small open label trials. STN DBS
      for cranial and cervical regions may provide similar efficacy in the treatment of dystonia as
      GPi DBS, but without unwanted stimulation-induced motor effects. Objectives of this study are
      to evaluate the safety and efficacy of STN DBS for dystonia. Up to twenty-five patients will
      be screened, consented, and enrolled in this study. All patients will undergo bilateral STN
      DBS for dystonia. Participants will be evaluated pre- and postoperatively with standard
      dystonia rating scale Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), and a
      patient questionnaire will be administered postoperatively to determine if patients are
      experiencing stimulation-induced motor adverse effects and will be logged for safety
      monitoring. This pilot study will provide preliminary open label efficacy outcomes for STN
      DBS in the treatment of primary dystonia and will help determine if this target should be
      compared to GPi DBS in a larger double-blind trial.
    

Intervention name(s): Medtronic implantable deep brain stimulation (DBS) system
Intervention type(s): Device
Intervention description(s): surgical placement of deep brain stimulation system for treatment of dystonia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blepharospasm; Deep brain Stimulation; cervical dystonia; cranial dystonia; generalized dystonia; subthalamic nucleus; DBS