bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Ultrasonographic Measurement of Inferior Vena Cava Collapsibility Index in Prediction of Hypotension Associated With Tourniquet Release in Total Knee Replacement Surgeries Under Spinal Anesthesia
Condition: Fluid Hypovolemia, Cerebrospinal
MeSH terms: Intracranial Hypotension; Hypotension; Hypovolemia
Study type: Observational

Summary: 
      Administration of intravascular fluids is one of the methods to prevent SA-induced
      hypotension, but empirical intraoperative volume repletion carries the risk of fluid overload
      during elective surgery. Over fluid resuscitation is associated with organ dysfunction and
      higher mortality rate , thus, to avoid ineffective or even harmful intravascular volume
      expansion, it is important to have tools to predict hypotension and fluid responsiveness.
    


Intervention name(s): ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Ultrasonographic measurement of Inferior Vena Cava Collapsibility Index
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Total Knee Replacement Surgeries under Spinal Anesthesia
Study of Suture Repair of Torn Meniscus in the Knee
Condition: Meniscal Tear; Meniscus Tear
MeSH terms: Lacerations; Rupture
Study type: Interventional

Summary: 
      Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used
      suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the
      repair, by assessing the re-operation rate, and by assessing improvements in knee pain and
      knee function.
    

Detailed description: 
      Potential subjects will undergo Screening for eligibility based on Inclusion/Exclusion
      criteria. Screening will include an x-ray of the injured knee and evaluation of an MRI of the
      injured knee within 6 months prior to the scheduled procedure. During the procedure, the
      meniscal tear will be evaluated by arthroscopy to determine if the tear meets study
      requirements. If the meniscal tear is determined to meet inclusion/exclusion criteria, the
      subject will be considered enrolled. If any inclusion/exclusion criteria is not met, the
      subject will be considered a screen failure and will not be enrolled. For enrolled subjects,
      specific information regarding the repair and repair technique will be collected during the
      procedure, including still and video images.

      Subjects will be contacted 7-15 days post-procedure for safety follow-up. Subjects will
      return for follow-up visits at approximately post-procedure Days 90, 185, 365 and 730.
      Identical questionnaires will be completed at each visit to assess knee pain and knee
      function. Safety information will be collected at each post-procedure visit. Additionally, an
      in-office arthroscopy of the treated knee will be performed at participating sites at Day
      185, an MRI of the treated knee will be performed at Day 365 and an X-ray of the treated knee
      will be performed at Day 730. The patient will exit the study at the Day 730 visit.
    

Intervention name(s): Suture-based meniscal repair
Intervention type(s): Device
Intervention description(s): Suture-based meniscal repair
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: meniscal; meniscus; repair; knee; arthroscopy knee; horizontal
Efficacy and Safety of Resveratrol and Carbossimetyl Beta Glucan in Treatment of Upper Airways Disease in Infancy
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 3

Summary: 
      outpatient infants (0-6 months of life), affected by symptoms of upper airways disease will
      be randomly assigned to two type of intervention:

      A: treatment group, receiving resveratrol and carbossimetyl beta glucan; B: control group,
      receiving saline solution.

      Each subject underwent clinical history, objective examination and detection of rinovirus in
      the nasal secretions at enrollment, after 48 hours and after 7 and 30 days.
    

Detailed description: 
      Consecutive outpatient infants (0 - 6 months) with common cold symptoms were enrolled and
      randomly divided into two groups: resveratrol plus carboxymethyl-β-glucan solution or saline
      isotonic solution randomized treatment (3 drops in each nasal fossa, 4 time daily for seven
      days).

      Each patient underwent clinical evaluation at enrollment, after 48 hours and after 7 and 30
      days.

      Common cold symptoms were specifically evaluated according to CARIFS Scale. Nasal swabs for
      HRV research will performed at enrollment, after 48 hours and after 7 and 30 days.
    

Intervention name(s): Resveratrol and Carbossimetyl Beta Glucan; Saline Solution
Intervention type(s): Drug; Other
Intervention description(s): Medical device based on Resveratrol and Carbossimetyl Beta Glucan. 3 drops, 4 times a day for 1 week.; Medical device based on Saline Solution. 3 drops, 4 times a day for 1 week.
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Osteoporosis Prevention in Preadolescent Girls
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test an osteoporosis prevention program aimed at preadolescent girls between
      the ages of 10 and 12 who have not yet started their menstrual periods. Girls in this age
      group are adding large amounts of new bone to their skeletons. Adding more bone at this time
      of life can reduce a person's chances of developing osteoporosis (thinning bones) in later
      years.

      We will look at how this osteoporosis prevention program affects the amount of calcium in the
      girls' diets, the amount of weight-bearing exercise they do, and their bone mass measured
      using ultrasound testing of the heel.
    

Detailed description: 
      The study's objective is to demonstrate the efficacy of a behavioral/educational intervention
      in increasing levels of dietary calcium intake and weight-bearing exercise within an at-risk
      population in a stage of rapid accrual of bone mass-specifically, premenarchal girls between
      the ages of 10 and 12. We will use cluster randomization to randomize girls to either the
      intervention or a program of education only. We will randomize eighteen groups of girls into
      each arm of the study.

      The intervention consists of six interactive sessions using various media (i.e., overhead
      transparencies, graphics, and three-dimensional demonstrations) to present instructional
      material. Topics include an explanation of osteoporosis and its modifiable and nonmodifiable
      risk factors, prevention of osteoporosis via healthy food choices (i.e., high calcium, low
      fat foods), and prevention of osteoporosis via weight-bearing exercise. Each girl monitors
      her own progress toward the goal of 1350 to 1500 milligrams of calcium per day. A similar
      method allows simple self-monitoring of weight-bearing activity. The intervention program is
      reinforced via monthly self-monitoring for 18 months. The education-only program consists of
      six generic sessions on healthy eating, physical fitness, and healthy lifestyle choices.

      The primary outcomes of interest are higher calcium intake and higher levels of
      weight-bearing exercise. A secondary outcome of interest is increased broadband ultrasound
      attenuation of the os calcis, assessed using quantitative ultrasound. In summary, the group
      of girls targeted is ideal for this intervention because they are at a stage of rapid accrual
      of bone mass.
    

Intervention name(s): Psychoeducational program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Osteoporosis prevention; Behavioral/educational intervention; Preadolescent; Calcium; Exercise; Peak bone mass; Bone density
Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics
Condition: Metabolic Control
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether nonsurgical periodontal therapy is
      effective in the metabolic control of patients with type II Diabetes mellitus.
    

Detailed description: 
      Type 2 diabetes mellitus (DM2), the most common type of diabetes, is characterized by
      hyperglycemia, hyperlipidemia, and associated complications. The classic major complications
      of diabetes are microangiopathy, nephropathy, neuropathy, macrovascular disease, delayed
      wound healing, and periodontitis. There is an interacting, complex relationship between
      diabetes and periodontitis.Many studies have shown a greater incidence and a greater severity
      of periodontitis in diabetic patients.Meanwhile, a number of studies have suggested that
      periodontitis may actually be a risk factor for diabetic complications as well. This study is
      performed to investigate the effects of non-surgical periodontal therapy on metabolic control
      in DM2 patients.
    

Intervention name(s): Scaling and Rootplaning
Intervention type(s): Procedure
Intervention description(s): All patients in the test group receive scaling and rootplaning under local anesthesia
Other intervention name(s): test group; control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: metabolic control; fasting plasma glucose; glycated hemoglobin
Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma
Condition: Hodgkin's Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Observational

Summary: 
      The aim of the proposed study is to assess endothelial function and IMT, as correlates of
      cardiovascular disease (CVD), in young adult Hodgkin's disease (HD) survivors, and to relate
      endothelial function to other risk factors including obesity, dyslipidemia, hyperinsulinemia
      and fasting glucose.
    

Detailed description: 
      Disease free survival of Hodgkin's disease (HD) patients has improved dramatically over the
      past few decades. With the dramatic advance in patient's survival, the prevention and
      treatment of long-term adverse effects of chemotherapy and radiotherapy has become a major
      focus of interest. HD survivors have excess mortality compared with the age-matched general
      population, even after excluding disease relapse. A considerable proportion of the excess
      mortality is due to cardiovascular disease (CVD), principally ischemic heart disease and
      stroke.

      The proposed study will assess endothelial function in HD survivors, using the non-invasive
      technique of brachial artery flow-mediated dilation (FMD), by high-resolution
      ultrasonography. We will also assess IMT. The results of these tests are independent
      predictors of atherosclerosis disease progression and cardiovascular event rates. This is a
      prospective study comprising 40 young-adult (aged 18-30 years) . The study will comprise 40
      survivors of HD: 20 patients treated with chemotherapy and radiotherapy to the chest and 20
      patients treated with chemotherapy alone. The patients will be compared to age and
      sex-matched patients from the data base of the endothelial function laboratory at the heart
      institute of the Sheba Medical Center. In addition to brachial artery endothelial function
      assessment, the patients will also undergo a physical examination including anthropometric
      measurements (height, weight, waist and hip circumference), and blood pressure. The
      evaluation will also include blood tests for glucose, lipid profile, CRP, AST, ALT and
      insulin. A medical history including smoking history and family history of CVD and
      dyslipidemia will be obtained.

      Patients treated with radiotherapy to the chest will be compared to patients treated with
      chemotherapy alone and both patients will be compared to healthy controls. The patients will
      be characterized by age, risk factors for coronary heart disease and endothelial function as
      assessed by brachial artery FMD. We will establish the rate of endothelial function
      abnormalities in survivors of HD and its correlation with the other risk factors.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young-adult survivors of Hodgkin's disease
      
Keywords: Hodgkin's lymphoma; cardiovascular disease; radiation therapy; Brachial artery flow-mediated dilation (FMD)
Psychological Pain Treatment in Endometriosis
Condition: Endometriosis; Pelvic Pain; Chronic Pain
MeSH terms: Endometriosis; Chronic Pain; Pelvic Pain
Study type: Interventional

Summary: 
      This study evaluates the effects of psychological treatment on pain, quality of life and work
      ability among women with endometriosis related chronic pelvic pain in a three-armed,
      randomised study. One group will receive mindfulness-based psychological treatment, the
      second group will receive a non-specific general psychological treatment (a psychological
      placebo) and the third group will be a waiting list control (treatment as usual).
    


Intervention name(s): Mindfulness-based psychological treatment; Non-specific psychological treatment
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic
Study type: Interventional
Phase: Phase 1

Summary: 
      Mavacamten is a small-molecule allosteric inhibitor of cardiac myosin that reversibly
      inhibits its binding to cardiac actin, thereby relieving systolic hypercontractility and
      improving ventricular compliance. This is an open-label, parallel-group, single-center Phase
      1 clinical study. Healthy adult Chinese subjects with different genotypes will be included
      and administered with a single fasted oral dose of mavacamten to evaluate its PK profile. Up
      to 44 subjects will be enrolled in this study.
    

Detailed description: 
      Approximately 44 healthy adult Chinese subjects are expected to be enrolled in this study
      according to their genotypes into 4 cohorts.

      The doses administered include: 15 mg for cohort 1; 25 mg for Cohort 2; 15 mg for Cohort 3;
      15 mg for Cohort 4. Blood samples will be collected from subjects at scheduled time points
      for PK testing. Series of safety assessments (including but not limited to AEs, laboratory
      tests, vital signs, and ECGs) will be performed during the whole study at specified time
      points.

      This study will consist of the following 5 periods:

        -  Pre-screening period and Screening period (Day -43 to Day -2, up to 42 days)

        -  In-house period (Day -1 to Day 3, total 4 days)

        -  Outpatient period (Day 4 to Day 75, total 72 days):

        -  End of study visit (Day 75)
    

Intervention name(s): Mavacamten
Intervention type(s): Drug
Intervention description(s): Single fasted oral dose of Mavacamten 15/25 mg on Day 1
Other intervention name(s): Mavacamten capsule
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mavacamten
Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism
Condition: Rheumatoid Arthritis; Spondyloarthritis
MeSH terms: Spondylitis; Rheumatic Fever; Spondylarthritis; Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      The hypothesis is that group interaction associated with individual interviews intensify the
      acquisition of safety skills compared to individual interviews alone in patients with CIR
      treated by subcutaneous biotherapies.
    

Detailed description: 
      Selection and inclusion of patients will be done by principal investigator of Rheumatology
      Department. After verification of inclusion and non-inclusion criteria by principal
      investigator and signature of consent, patients will be randomized by 1: 1 randomization
      (centralized randomization by statistician into 2 groups at M0) :

        1. Experimental group (individual and group therapeutic education )

             -  M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous
                injection education" and "biotherapy management".

             -  M3 (group with 3 to 10 patients) Intensification Biotherapy Education: Workshops :
                "Subcutaneous injection education" and "biotherapy management".

             -  M6 (individual presential or by phone) Assessment of security skills and
                questionnaires.

             -  M12 (individual presential or by phone) Assessment of security skills and
                questionnaires.

        2. Control group (individual therapeutic education alone ) :

             -  M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous
                injection education" and "biotherapy management".

             -  M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection
                education" and "biotherapy management".

             -  M6 (individual présential or by phone) Assessment of security skills and
                questionnaires.

             -  M12 (individual présential or by phone) Assessment of security skills and
                questionnaires. Group session proposed.
    

Intervention name(s): Therapeutic education
Intervention type(s): Other
Intervention description(s): Individual and group therapeutic education sessions will consist of :
acquisition by patient of self-care skills such as performing subcutaneous injection,
acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ...
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic inflammatory rheumatism; biotherapies; therapeutic education; safety skills
A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with
      ascites despite having received conventional diuretic therapy. Based on the change in body
      weight, on Day 7 it will be decided whether to continue administration at the same dose or to
      increase the dose, and then OPC-41061 will be orally administered for an additional 7 days at
      either 7.5 mg/day or, if diuretic effect for the initial 7-day administration is
      insufficient, at an increased dose of 15 mg/day. Plasma drug level, efficacy, and safety of
      OPC-41061 by 14-day repeated administration will be investigated.
    


Intervention name(s): OPC-41061
Intervention type(s): Drug
Intervention description(s): OPC-41061 tablets will be orally administered once daily after breakfast at 7.5 mg on Day 1 to 7 and at either 7.5 or 15 mg on Day 8 to 14.
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cirrhosis; ascites; Tolvaptan; OPC-41061
Three-dimensional Airway Suction Model
Condition: Satisfaction, Personal
Study type: Interventional

Summary: 
      The main purpose of this study is to use 3D printing technology to high-fidelity simulation
      respiratory models Furthermore, the results of this study will extent to medical school and
      hospital.
    

Detailed description: 
      Background：

      Most clinical teaching materials are expensive and inaccessible. To promote the accessibility
      of anatomy models and student learning effects in our medical school and hospital, we use 3D
      printing technology to print high-fidelity simulation respiratory models and apply them in
      medical education.

      Study Design：

      This is a single-site prospective study of medical education. Participants who are students
      of the School of respiratory therapy will be randomly divided into to control group and
      experimental group. Both groups will receive the same teaching program. The traditional
      education model will be used in the control group, and the 3D printed model will be used in
      the experimental group.

      Methods：

      The 3D scanning technology will be applied to create drawing files of high-fidelity
      simulation respiratory models, which are drawn by professional 3D drawing staff. Then, we
      print out the models with 3D printing technology. The output material will be close to the
      softness of the human models. The medical education of this study will be divided into two
      parts. The first part is the teaching of realistic airway suction; the second part is the
      simulation of advanced mechanical ventilation.

      Effect：

      We expect benefits that the use of 3D printing high-fidelity simulation respiratory models in
      medical education. For example, it can reduce the cost of education models and enhance
      efficacy in medical education. The experience and outcome will be shared with the medical
      school and hospital.

      Keywords：

      3D printing; medical education model; high-fidelity simulation; respiratory care.
    

Intervention name(s): 3D printed educational model; Tranditional model education
Intervention type(s): Other; Other
Intervention description(s): Slide-based presention plus 3D printed airway suction model; Slide-based presention plus tranditional model
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: 3D printed; airway suction; respiratory therapy; medical education
The Effect of Sprouting of Wheat on Postprandial Glycemic and Satiety Responses of Wheat Bread Products
Condition: Blood Sugar
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effect of inclusion of 50% sprouted wheat
      wholemeal in a bread recipe on the postprandial glycemic and satiety responses, as well as on
      appetite-related sensations and acceptability of the developed products relative to a product
      made with a similar unsprouted wheat recipe.
    

Detailed description: 
      This study is a randomized crossover trial involving three different bread products. At each
      study visit, capillary blood glucose will be measured at fasting, and then 15, 30, 45, 60,
      90, and 120 minutes following the start of ingestion of the study food. Visual analogue
      scales will be used to assess appetite and fullness sensations at fasting, and then 30, 60,
      90 and 120 minutes.
    

Intervention name(s): Bread
Intervention type(s): Other
Intervention description(s): Bread portions of 50 gram available carbohydrates.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other