bioihbjkbjnl/mcl2 huggingface dataset:
Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Female patients treated with radiation for left-sided breast malignancy will undergo
      alternate fractions of Active Breathing Coordinator (ABC)-assisted and VisionRT-assisted Deep
      Inspiration Breath-Hold (DIBH).
    

Detailed description: 
      Female patients treated with radiation for left-sided breast malignancy will undergo
      alternate fractions of ABC-assisted and VisionRT-assisted DIBH. Residual motion during
      breath-hold will be quantitatively assessed using MV fluoroscopy from the treatment beam
      itself (i.e., no additional radiation dose). The dosimetric impact of residual motion on
      organs at risk (heart and lung) will be assessed by applying rigid and/or deformable
      displacements to the planning CT images, computing the 3D dose map and comparing with the
      original planned dose map.
    

Intervention name(s): Active Breathing Coordinator (ABC); VisionRT
Intervention type(s): Device; Device
Intervention description(s): The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH; A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH.
Other intervention name(s): AlignRT system
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Double Burden of Malnutrition Among Adolescents in Low-income and Middle-income Countries
Condition: Stunting; Thinness; Obese
MeSH terms: Malnutrition; Thinness
Study type: Observational

Summary: 
      Individual-participant data analysis of the Global School-Based Student Health Survey and
      Health Behaviour in School-Aged Children surveys in 57 LMICs between 2003-2013.
    

Detailed description: 
      We used the most recent Global School-Based Student Health Surveys (GSHS) and Health
      Behaviour in School-Aged Children (HSBC) surveys, with data available on height and weight.
      The GSHS is a World Health Organisation (WHO) initiative, designed to assess health
      behaviours of adolescents through cross-sectional school-based surveys, across several
      countries using similar standardised procedures. The HSBC study are WHO sponsored
      cross-sectional school-based surveys that uses similar standardised procedures to the GSHS to
      examine the physical and mental health of adolescents in the WHO European Region and North
      America.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Adolescents aged 12-15 years from the Global School-Based Student Health Surveys (GSHS) and
        Health Behaviour in School-Aged Children (HSBC) surveys.
Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-R
Condition: Apetite Stimulants
Study type: Interventional
Phase: Phase 1

Summary: 
      A bioequivalence study to compare and evaluate the pharmacokinetic characteristics and the
      safety after administration of DW5221 and DW5221-R in healthy adult m ale volunteers
    


Intervention name(s): DW5221; DW5221-R
Intervention type(s): Drug; Drug
Intervention description(s): megestrol acetate; megestrol acetate
Other intervention name(s): Test; Reference
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Ankle Splinting on Vascular Function in Aging
Condition: Aging
Study type: Interventional

Summary: 
      Endothelial function of the skeletal muscle vasculature declines with advancing age. Although
      aerobic exercise training is commonly prescribed to combat loss of endothelial function in
      the elderly, the rate of compliance to training programs is low. Contrary to aerobic exercise
      training, stretching exercise is widely performed in elderly patients to increase muscle
      flexibility and to prevent muscle atrophy induced by immobilization. However, it remains
      unknown as to whether regular stretching of the calf muscles using ankle dorsiflexion
      splinting improves muscle blood flow. The purpose of the proposed work is to test the
      hypothesis that performance of ankle dorsiflexion splinting improves endothelial function and
      lower leg muscle blood flow in older adults. Ankle dorsiflexion splinting will be performed
      on the randomized leg for 30 minutes, 5 times per week for 4 weeks. Leg vascular measures
      will be performed on the splinted and non-splinted legs prior to and at the end of the 4-week
      intervention.
    

Detailed description: 
      Older adults will be recruited in this study. Vascular function will be assessed before and
      after the 4-week ankle splinting intervention. To examine the acute effects of splinting,
      vascular measures will also be obtained before and immediately following 30 min of ankle
      splinting. All procedures will be performed at the Integrative Cardiovascular Physiology
      Laboratory at the University of Florida.

      Participants will have one leg randomly assigned to using a splint to stretch the calf
      muscles 30 min per day, 5 days per week for 4 weeks, while the contralateral non-splinted leg
      will serve as an internal control.
    

Intervention name(s): Ankle splinting
Intervention type(s): Other
Intervention description(s): Ankle dorsiflexion splinting will be performed 30 minutes per day, 5 days per week for 4 weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fed Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this single-dose, open-label, randomized, two-period crossover study was to
      compare the rate of absorption and oral bioavailability of a test formulation of morphine
      sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division
      Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x
      100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered
      under fed conditions.
    


Intervention name(s): morphine sulfate sustained-release capsules; KADIAN
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 200 mg, single-dose capsule; 2 x 100 mg, single-dose capsule
Other intervention name(s): Treatment A; Test Product; Treatment B; Reference Product
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability; KADIAN; 200 mg; morphine sulfate sustained release capsules; 100 mg; fed conditions
Mobile CBT for Negative Symptoms
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This randomized controlled clinical trial will test a combined group contact plus mobile
      CBT-informed skills training intervention targeting defeatist attitudes in consumers with
      schizophrenia in comparison to a supportive contact control group in order to change
      motivational negative symptoms linked to defeatist attitudes.
    

Detailed description: 
      The primary purpose of this project is to determine if mCBTn at the optimal dose from the R61
      produces greater reduction in severity of defeatist attitudes than a supportive contact
      control group in consumers with schizophrenia spectrum disorders with persistent
      moderate-to-severe experiential negative symptoms. A second aim is to determine whether
      reduction in defeatist attitudes mediates improvement in experiential negative symptoms and
      psychosocial functioning in mCBTn. The third aim is to determine whether mCBTn increases
      pupil dilation and whether changes in pupil dilation (an objective psychophysiological
      biomarker of effort) are associated with changes in defeatist attitudes and negative
      symptoms. The final aim is to explore predictors of response to mCBTn, including device use
      and group session adherence, demographics, neurocognitive impairment, and negative and other
      symptom severity at baseline.
    

Intervention name(s): Mobile-assisted CBT-informed Skills Training; Supportive Contact
Intervention type(s): Behavioral; Behavioral
Intervention description(s): mCBTn combines the CBT-informed components that target defeatist attitudes from Cognitive Behavioral Social Skills Training (CBSST) group skills training and mobile smartphone interventions from our prior clinical trials research.; The SC intervention will provide the same amount of group and mobile device contact as the mCBTn condition. Participants will be carrying a phone but will not have access to the CBT-informed app. Group contact sessions will be semi-structured and consist of trouble-shooting device use and check-in about symptoms and potential crisis management, followed by a flexible discussion involving psychoeducation, instructions for accessing community crisis lines and related community resources, empathy, and non-directive reinforcement of health, coping, and symptom management behaviors that grow out of group discussions, with only minimal group leader guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; CBT; Mobile CBT; Negative Symptoms
Polso SpO2 Accuracy Validation Study
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso
      Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to
      arterial blood samples assessed by CO-Oximetry for SpO2 validation
    

Detailed description: 
      The purpose of this study is to validate the SpO2 accuracy and performance of the Polso
      Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to
      arterial blood samples assessed by CO-Oximetry for SpO2 validation. It is expected that the
      Accuracy Root Mean Square (Arms) performance of the Polso Monitoring System will meet a
      specification of 3.5% or less in non-motion conditions for the range of 70-100% SaO2 thereby
      demonstrating an acceptable SpO2 accuracy performance specification.

      The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation
      levels real time throughout the study for subject safety and to target stable plateaus. This
      device is used to assess the stability of the data.

      A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining
      the functional SaO2 value from arterial blood samples obtained during the study.

      A minimum of 10 healthy adult subjects, ranging in pigmentation from light to dark, will be
      enrolled in the study to meet the study design requirements defined by ISO 80601-2-61:2011
      and by the FDA's Guidance for Pulse Oximeters. The subjects will have an arterial catheter
      placed in the radial artery to allow for simultaneous blood samples during stable plateaus of
      induced hypoxic levels.

      The study population will include 10-15 healthy non-smoking (or has refrained from smoking
      for 2 days) competent adults 18-50 years of age. The subject selection will be an equitable
      distribution of males and females of any race with varying skin tones including at least 2
      darkly pigmented subjects or 15% of the subject pool, whichever is larger. Data collection
      will occur over a 2-5 day period for this study population.
    

Intervention name(s): Diagnostic test of SPO2
Intervention type(s): Device
Intervention description(s): The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Randomized Cross-over Trial of Comparison Between Robotic and Laparoscopic Suturing for Gastric Defect by Novices
Condition: Surgical Suturing for Closure of Gastrotomy; Laparoscopic Suturing; Robotic Surgical Suturing
Study type: Observational

Summary: 
      To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and
      conventional Laparoscopic surgical suturing among novice
    

Detailed description: 
      Background Da Vinci® Robotic Surgical System (DVRSS) has been widely applied to perform
      complex minimally invasive surgical procedures across different specialties. This study aimed
      to investigate the impact of DVRSS on surgical proficiencies among inexperience novice
      surgeons and compared to conventional laparoscopic surgery.

      Methods Twenty medical students (n=20) without surgical experience were enrolled. After a
      constructive training for basic surgical techniques, participants were randomly allocated
      into DVR or laparoscopy group. Participants were asked to close five cases (also named five
      tasks) of a 2cm long incision on pig stomach by using DVR or laparoscopy. Surgical time,
      successful closure rate and pneumatic bursting pressure of gastric incision withstanding were
      recorded. In addition, participant performance and workload were quantified by using
      performance score, scales of Global Rating Scale Assessment (GSA) and NASA-Task Load Index
      (NASATLI).
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Medical students with no prior experience in surgery
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair
Condition: Postoperative Pain; Hernia; Surgery
MeSH terms: Hernia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study testing SABER-Bupivacaine (an experimental pain-relieving
      medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common
      local anesthetic, for a few days in order to treat local post-surgical pain. This study is
      testing SABER-Bupivacaine in people having surgery to repair a hernia.

      The purpose of the study is to measure and compare the safety (side effects), tolerability
      (ability to tolerate), and efficacy (how well it works) of two different volumes of
      SABER-Bupivacaine with SABER-Placebo.
    


Intervention name(s): SABER-Bupivacaine; SABER-Bupivacaine; SABER-Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once; Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once; Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once
Other intervention name(s): POSIMIR® bupivacaine solution
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post-operative pain; hernia surgery; opioid
Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment
Condition: Vogt Koyanagi Harada Disease
MeSH terms: Uveomeningoencephalitic Syndrome; Retinal Detachment
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate
      targeted therapeutic delivery to the choroidal and retinal structures than intravitreal
      injection
    

Detailed description: 
      Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate
      targeted therapeutic delivery to the choroidal and retinal structures than intravitreal
      injection. Yielding high levels of corticosteroid in the retinal and choroidal layers which
      was detectable for more than 3 months with limited exposure in the anterior segment.
      Triamcinolone acetonide is a synthetic corticosteroid formulated as an injectable suspension
      and has been evaluated in a number of trials to be 7.5 fold more potent anti-inflammatory
      than cortisone. Triamcinolone acetonide enhance tight junctions between endothelial cells
      thus reducing vessel leakage. It also has an angiostatic action by inhibition of vascular
      endothelial growth factor and has a useful effect on many inflammatory retinal diseases. The
      recommended dose of Triamcinolone acetonide injection is 4 mg/0.1 mL which was administrated
      in this study. The aim of this study was to assess the efficacy of suprachoroidal
      Triamcinolone acetonide injection (SCTA) as adjunctive therapy in the management of
      Vogt-Koyanagi Harada's (VKH) multiple serous retinal detachment (RD) and evaluate best
      corrected visual acuity (BCVA), intraocular pressure(IOP) and central foveal thickness (CFT)
      by Optical Coherence Tomography (OCT) in patients diagnosed as VKH at ophthalmology clinic,
      Benha University, EGYPT and Ebsar eye center, Benha, EGYPT.
    

Intervention name(s): Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease
Intervention type(s): Drug
Intervention description(s): Suprachoroidal steroid injection for management of serous retinal detachment in VKH disease
Other intervention name(s): SCTA for Exudative RD in VKH disease
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vogt-koyanagi Harada, Suprachoroidal injection
Comparison of Different Methods for the Analysis of Gut Microbiome Composition
Condition: Healthy
Study type: Observational

Summary: 
      The human gastrointestinal tract shelters a complex and dynamic population of microorganisms,
      the gut microbiota, which plays an important role in immune and metabolic homeostasis. In
      recent years several major diseases were linked with alterations in the gut microbiome
      composition.

      There are known factors which can influence gut microbiata composition. For example diet is
      known to play a fundamental role in determining the composition of the intestinal microbiota
      over time. However, there are very few studies evaluating how collection and DNA isolation
      methods affect microbiome composition.
    

Detailed description: 
      An observational clinical study with 28 healthy subjects is planned to assess how different
      commercially available stool sampling kits and fecal DNA extraction kits influence the
      apparent composition of the gut microbiome. Participants will be instructed to collect stool
      samples at two time points separated by one week using six different methods (naïve and Zymo
      DNA/RNA Shield kit on dry ice as well as OMNIgene GUT, RNALater, 95% EtOH, Zymo DNA/RNA
      Shield at room temperature). DNA extraction from all samples will be performed using QIAamp
      Power Fecal (Qiagen, N. V) and ZymoBIOMICS (Zymo Research, CA.).
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects
      
Biospecimen description: 
      Stool (stool DNA), Blood Serum and Blood Plasma
Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial
Condition: Dry Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry
      age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of
      therapeutic apheresis using the methodology of double filtration plasmapheresis to treat
      microcirculatory disorders.
    


Intervention name(s): Rheopheresis / double filtration plasmapheresis
Intervention type(s): Device
Intervention description(s): Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.
Other intervention name(s): Rheopheresis; Double filtration plasmapheresis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheopheresis; Dry Age Related Macular Degeneration; AMD; apheresis; microcirculation
Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test an insulin management system ("Control-to-Range (CTR)
      system") in an inpatient setting to see if the system is safe and effective enough to test in
      a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose
      Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines
      how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the
      insulin.

      The study will include two hospital stays consisting of meals and exercise scenarios. Both
      hospital stays will be for 24+ hours during the day and night. The study will include about
      50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.
    

Detailed description: 
      Clinical Research Center (CRC) Session Detail (closed-loop control active for all elements)

      Day 1 (24+ hours):

        1. Admission at 7:00 AM

        2. Standardized breakfast with normal bolus at 9:00 AM

        3. Lunch with normal bolus at 1:00 PM

        4. Dinner with normal bolus at 7:00 PM

        5. Overnight sleep

        6. Breakfast with missed meal bolus followed by user alert and correction bolus

        7. Discharge

      Day 2 (24+ hours):

        1. Admission at 7:00 AM

        2. Standardized breakfast with normal bolus at 9:00 AM

        3. Lunch with normal bolus at 1:00 PM

        4. Exercise

        5. Dinner with normal bolus at 7:00 PM

        6. Overnight sleep

        7. Breakfast with overbolus at 7:00 AM

        8. Discharge

      Meal boluses will be semi-automated, with manual meal announcement by the physician/nurse,
      automated bolus recommendation by the system, and automated delivery of the bolus following
      confirmation of the recommendation. Between-meal insulin dosing will be fully automated;
      bolus confirmation by the physician/nurse will be requested by the closed-loop controller
      only when it determines that carbohydrates may be necessary to avoid hypoglycemia following
      the bolus.
    

Intervention name(s): Control-to-Range Automated Insulin Management System
Intervention type(s): Device
Intervention description(s): The devices that will be used in the Closed-Loop Control System are standardized across all study sites and include the DexCom Seven Plus Continuous Glucose Monitor (CGM), the OmniPod insulin pump, and the FreeStyle blood glucose meter. The Closed-Loop Control System will be used during all 3 admission visits.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment