bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA）
      for simple female stress urinary incontinence.
    

Detailed description: 
      Stress urinary incontinence (SUI) is a common disease of female. The inconvenience caused by
      SUI affects the patients' quality of life and health seriously. To date, there has not
      specific therapy on SUI. Former research showed acupuncture may work for SUI. This
      multi-center randomized controlled clinical trial of acupuncture for simple female stress
      urinary incontinence is designed to confirm the efficacy and safety of EA. This project is
      conducted by Chinese researchers, supported by the Chinese Government. The research result is
      expected to provide high quality evidence of EA for simple female stress urinary
      incontinence.
    

Intervention name(s): electroacupuncture group; sham electroacupuncture group
Intervention type(s): Device; Device
Intervention description(s): Procedure: electro-acupuncture;Points: Bilateral Zhongliao (BL33) Huiyang(BL35).Specially-made pad is stick on pierced acupoints. Bilateral BL33 are given acupuncture of 50～60mm with 30～45°angle to inward and downward by 75mm filiform needle. Bilateral BL35 are given acupuncture of 50～60mm to outward and upward by 75mm filiform needle. Twirl, lift and thrust for 3 times, until local sour and heavy feeling coming.The electric stimulator is applied to bilateral BL33 and BL35, with continuous wave,50 Hz and electric current 1- 5mA.Every session lasts for 30 min per day.The participants are treated continuously for 6 weeks for 3 sessions a week, 18 sessions for each patient in all. The treatment is designed based on recent literature research in 10 years, former result and expert consensus.; Procedure: sham electroacupuncture;Points: Bilateral sham Zhongliao (BL33) sham Huiyang(BL35).Specially-made pad is stick on pierced acupoints. Both sham BL33 and BL35 are given non-penetrating needling with blunt needle. Twirl, lift and thrust for 3 times. The sham electric stimulator is applied to bilateral sham BL33 and sham BL35. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.
Other intervention name(s): SDA-V electroacupuncture apparatus(Huatuo,made in China); Sham SDZ-V electroacupuncture apparatus(Huatuo,China)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: efficacy; safety; electroacupuncture; simple female stress urinary incontinence
Diagnostic Performance of Shear Wave Dispersive Imaging in Breast Lesions: Comparison With Shear Wave Elastography
Condition: Breast Diseases
MeSH terms: Breast Diseases
Study type: Observational

Summary: 
      Human soft tissue such as breast tissue has viscoelasticity property. However, most
      ultrasound has only been measured for elasticity and viscosity has been neglected. Shear wave
      elastography (SWE) is a ultrasound technique that quantifies tissue elasticity. Shear wave
      dispersion (SWD) imaging is a newly developed ultrasound technique that evaluates the
      dispersion slope of shear waves, which is related to the viscosity of biological tissues. The
      goal of this retrospective study was to compare diagnostic performance between SWE and SWD to
      distinguish benign from malignant breast masses and to investigate additional role of SWD.
      Using histological diagnosis of breast lesions as a standard reference, quantitative indices
      of SWE and SWD were evaluated to diagnose breast cancer, and the diagnostic performance of
      SWE and SWD was compared.
    

Detailed description: 
      This retrospective study was approved by our institutional review board, which waved the
      requrement for informed consent. The investigators obtained quantitative parameters of SWE
      and SWD of solid breast lesions before biopsy. The investigators measured average tumor
      elasticity and tumor-to-fat elasticity ratio on SWE and average tumor dispersion and
      tumor-to-fat ratio and on SWD from each breast lesion. Diagnostic performance of SWE and SWD
      was compared using the area under the curve (AUC), sensitivity, specificity, and accuracy.
    

Intervention name(s): ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Shear-wave elastography and shear-wave dispersion ultrasound to evaluate the diagnostic performance of solid breast lesions for the diagnosis of breast cancer
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study population should fulfill the following criteria as follows:(a) histologically
        confirmed breast lesions and (b) shear wave elastography and dispersion ultrasound
        performed before biopsy
Yoga-Pilates Exercise & the Effects on Urethral Rhabdosphincter Morphology and Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This is a prospective interventional study conducted at Oregon Health & Science University
      that will measure the pre- and post-intervention characteristics of women with stress urinary
      incontinence undergoing an 8-week home yoga-Pilates intervention. The investigators plan to
      deliver this method of exercise to patients through a web-based video in order to increase
      accessibility and compliance and decrease patient costs. The investigators will assess
      changes using a pre- and post-treatment 1-day voiding diary, answers to questionnaires
      International Consultation on Incontinence Questionnaire-Short Form and Patient Global
      Impression of Improvement questionnaire), transperineal ultrasound, and physical exam.
    

Detailed description: 
      Stress urinary incontinence (SUI) affects up to 1/3 of women and negatively impacts multiple
      aspects of a woman's life. Pelvic floor physical therapy has been shown to improve stress
      incontinence through multiple mechanisms, including rhabdosphincter hypertrophy. Yoga and
      Pilates have also been shown to improve stress incontinence but there is a key gap in
      understanding how yoga-Pilates impacts urethral function and if these exercises represent a
      viable option for treating SUI.

      To fill this gap a new exercise is proposed: a web-based 8-week yoga-Pilates pelvic floor
      workout. The investigators plan to enroll women with SUI and compare urethral rhabdosphincter
      cross-sectional area in a pre-post intervention study. The investigators will also administer
      validated quality of life and severity measures for SUI to evaluate the potential efficacy of
      yoga-Pilates. The overarching goal of this project is to determine how yoga-Pilates impact
      urethral function and if these exercises decrease SUI symptoms.
    

Intervention name(s): Yoga-Pilates
Intervention type(s): Behavioral
Intervention description(s): As above
Intervention model: Single Group Assignment
Intervention model description: Pre/Post
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Yoga; Pilates; Rhabdosphincter
A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in
      patients with treatment-resistant hypertension.
    


Intervention name(s): ROX COUPLER
Intervention type(s): Device
Intervention description(s): The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Blood Pressure; Hypertension; Resistant Hypertension
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in
      pregnant women with twins and a short cervical length at 18-22 weeks scan.
    

Detailed description: 
      This trial includes pregnant women with twins undergoing routine ultrasound examination at
      18.0 to 22.6 weeks of gestation.
    

Intervention name(s): Silicon ring (Arabin Cervical Pessary)
Intervention type(s): Device
Intervention description(s): Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
Intervention MeSH terms: Silicon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Short cervix; Preterm birth; Cervical pessary; Twins
Arkansas Active Kids! -Objective 3
Condition: Physical Activity; Child
Study type: Observational

Summary: 
      This is a cross-sectional study aiming to identify how daily activities affect children's
      body fitness and general health. Also, the study will address how specific behaviors (such as
      diet and sleep) as well as neighborhood and home environment affect children's metabolic
      health and fitness level.
    

Detailed description: 
      The purpose of this study is to determine how daily activities, home, neighborhood and school
      environments affect Arkansas children's health. Children from Central Arkansas ages 7-10
      years will be recruited to participate in a variety of physical activity tests including
      strength, flexibility, balance and endurance. During these tests, participants will perform
      tasks such as cycling on a stationary bike and extending and flexing their knees on a special
      type of chair. Body composition will be measured and blood, saliva, urine and stool samples
      collected. Participants and parents will be asked to complete questionnaires on physical
      activity, home and neighborhood environment as well as sleeping habits. Finally, participants
      will wear an accelerometer based monitor that will track their physical activity and sleeping
      patterns. One in person visit will take place at Arkansas Children's Nutrition Center (Little
      Rock, AR) and will last up to 8 hours. Reimbursement will be provided.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Up to 300 pre-pubertal children ages 7 to 10 years old, both boys and girls, will be
        recruited from Central Arkansas.
      
Biospecimen description: 
      Whole blood, serum, stool, saliva, urine
    
Keywords: Exercise; Children; Arkansas; Physical activity; Sedentary
AVACEN Treatment Method and Postprandial Blood Glucose
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN
      device on postprandial blood glucose. The AVACEN device creates negative pressure around the
      hand while heating the palm. Two sham devices, one providing heat but no vacuum and one
      providing neither heat nor vacuum were also used. Each subject will use each of these three
      devices during the first hour of a 2-hour oral glucose tolerance test on separate visits.
      Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood
      pressure, tympanic temperature, and subjective thermal ratings were measured before and
      throughout the 2-hour oral glucose tolerance test.
    


Intervention name(s): AVACEN 100; AVACEN 100 heat only; AVACEN 100 sham
Intervention type(s): Device; Device; Device
Intervention description(s): The AVACEN 100 pulls a -30mmHg vacuum around the hand from the wrist down and applies heat (108 Fahrenheit) to the palm; The AVACEN 100 applies heat (108 Fahrenheit) to the palm; The AVACEN 100 does not provide heat or vacuum
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will determine the magnitude and duration (time to resolution i.e., returning to
      normal ranges) of elevations in the following coagulation test results after a single 1200 mg
      dose of oritavancin: Prothrombin Time/International Normalized Ratio (PT/INR), Activated
      clotting time (ACT), Activated Partial Thromboplastin Time (APTT), Chromogenic Factor Xa
      Assay, D-dimer, Silica Clot Time and Dilute Russell's Viper Venom Time (DRVVT).
    

Detailed description: 
      Oritavancin has been approved in the United States for the treatment of adult patients with
      acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused
      by susceptible isolates of designated Gram-positive microorganisms.

      Antibiotics of this class (lipoglycopeptide and lipopeptide antibiotics) artificially prolong
      phospholipid-dependent coagulation tests such as prothrombin time (PT) and activated partial
      thromboplastin time (aPTT) by binding to and preventing the action of the phospholipid
      reagents needed to activate coagulation.

      Because precipitation of oritavancin has been shown to occur in human plasma at
      concentrations as low as 50 μg/mL in vitro, a relevant approach to further elucidate the full
      range of effects of oritavancin plasma concentrations on coagulation testing would be to
      conduct a clinical study in healthy volunteers in which coagulation tests are monitored
      following a single 3 hour infusion of 1200 mg oritavancin. The data from this study will help
      inform physicians about how to manage patients who require coagulation monitoring in the
      setting of treatment with oritavancin.
    

Intervention name(s): Oritavancin
Intervention type(s): Drug
Intervention MeSH terms: Oritavancin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Effects on coagulation tests in healthy volunteers
Internet-Delivered Cognitive Behavior Therapy for Anxiety and Depression Amongst French Canadians
Condition: Major Depression; Anxiety Disorders
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This study represents Phase II of a research program involving an international collaboration
      with Macquarie University (Sydney, Australia) to implement an Internet-based cognitive
      behavior therapy for the treatment of anxiety and depression in French-speaking Canadians
      from the Atlantic Provinces.

      The primary objective is to establish the clinical efficacy of a French-Canadian self-guided
      format version of the Wellbeing Course by conducting a randomized-control trial where an
      experimental group will be compared to a waitlist control group. A secondary objective is to
      demonstrate the course's acceptability through participants' satisfaction with the course.
    


Intervention name(s): The Wellbeing Course
Intervention type(s): Behavioral
Intervention description(s): The Wellbeing Course (Titov et al., 2011) includes five online lessons:
Lesson 1 presents information on the prevalence of anxiety disorders and depression as well as on how they may interfere with life goals. This lesson also discusses how cognitive, behavioral and physical symptoms can contribute to poor emotional health.
Lesson 2 presents different strategies to generate realistic cognitions.
Lesson 3 describes strategies for physical de-arousal and for re-engaging in reinforcing activities.
Lesson 4 describes avoidance and safety behaviors in relation with anxiety and depression along with graded exposure.
Lesson 5 is about problem solving, relapse prevention and staying well.
For each lesson, a "Do It Yourself" guide is included as well vignettes and additional material.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neonatal Resuscitation - Sustained Inflations
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study compares a fifteen second sustained inflation (SI) to five repeated two - three
      second 'inflation breaths' during resuscitation at delivery of infants born prematurely.
    

Detailed description: 
      Around 10% of newborns will require some form of assistance after delivery, with babies born
      more prematurely more likely to require resuscitation

      Current UK guidelines advise initial resuscitation with the delivery of five 'inflation
      breaths' lasting 2-3 seconds with peak inflation pressure of 30cmH2O (20-25cm H2O in
      premature neonates). Previous studies have shown that despite resuscitation training,
      clinicians in both simulated and real resuscitation scenarios do not deliver the recommended
      duration of inflation breaths. This, combined with leaks around the facemask often being as
      large as 50% or greater, contributes to low expired tidal volumes during resuscitation, thus
      increasing the likelihood of hypoxia and delay in establishing effective respiration.

      The use of sustained inflations (up to 15 seconds), rather than intermittent shorter
      inflation breaths, has shown promising results, with reduction in the need for intubation,
      and the need for and duration of mechanical ventilation. Around 30% of units in Germany use
      sustained inflations as first line delivery room management, as do many other hospitals
      around the world. Resuscitation guidelines from the USA, UK and Europe suggest that sustained
      inflations should be researched further.

      Several studies have shown that for several lengths of inflation breaths, the expired tidal
      volume achieved is higher if the baby makes respiratory effort during the inflation (active
      inflation) and that stimulation of spontaneous respiratory effort is a key part in
      establishing an FRC, enabling spontaneous breathing, and increasing the likelihood of
      successful resuscitation.

      To date, there are no studies directly comparing whether prolonged inflations are more
      successful at provoking an inspiration than other methods of resuscitation. We therefore aim
      to compare a 15 second sustained inflation to repeated shorter inflations to determine which
      is more effective.
    

Intervention name(s): Inflation Breaths; Sustained Inflation
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Leptin Replacement in Children
Condition: Obesity; Metabolic Syndrome; Diabetes
MeSH terms: Metabolic Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the endocrine and immune effects of leptin replacement in leptin-deficient
      children, from a consanguineous family. The hypothesis is that leptin replacement will have
      significant effects on endocrine function.
    

Detailed description: 
      The proposed study of the treatment of a child with congenital leptin deficiency will permit
      to elucidate key aspects of human endocrine function, and will give new insights on the role
      of leptin in human endocrine regulation.
    

Intervention name(s): Recombinant methionyl human leptin
Intervention type(s): Drug
Intervention description(s): Recombinant methionyl human leptin, subcutaneous, once a day, 0.02 to 0.04 mg/kg (adjusted according to weight loss), indeterminate duration.
Other intervention name(s): Metreleptin; r-metHuLeptin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Congenital leptin deficiency; Obesity; Metabolic Syndrome; Diabetes
Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether correction of low nighttime oxygen (O2)
      levels and/ or high carbon dioxide levels in patients with cystic fibrosis improves their
      quality of life. The treatments being used overnight are (1)O2 (2)pressurised air which
      assists breathing (non-invasive positive pressure ventilation, NIPPV)
    

Detailed description: 
      Cystic fibrosis is the commonest life-limiting genetic disorder in the Caucasian population
      with a median survival of 31 years. Lung disease is responsible for the majority of morbidity
      and mortality and correlates with declining quality of life. Respiratory failure is the
      primary cause of death. Daytime respiratory failure (hypoxia with pO2<55 and/or hypercapnia
      with pCO2>50) is associated with a worse prognosis with a 2-year survival of 50%. Nocturnal
      respiratory failure (greater than 5% of the night spent with SpO2<90% and/or rise in
      PtcCO2>10mmHg overnight) is a precursor to the development of daytime respiratory failure. It
      has been postulated that earlier treatment of respiratory failure may improve outcome and
      quality of life.

      Intervention: Nocturnal O2 and bilevel NIPPV in CF patients with nocturnal respiratory
      failure, compared to nocturnal placebo (air). Crossover trial utilising patients as their own
      control.

      Aims: (1) To assess the effects of non-invasive ventilation (NIV) and oxygen (O2) therapy on
      quality of life, hospital admission rate, sleep quality and exercise tolerance in CF patients
      with NRF (2) To identify a level of severity of NRF where treatment with NIV is effective
    

Intervention name(s): Nocturnal oxygen , nocturnal bi-level positive pressure ventilation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: cystic fibrosis; hypoxia; oxygen; noninvasive ventilation; quality of life