bioihbjkbjnl/mcl2 huggingface dataset:
Venous Thromboembolism in Pregnant and Puerperal Women in Denmark 1995-2005
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      The purpose of this study is to describe the incidence of thromboembolic events in relation
      to pregnancy and when in pregnancy and the puerperal period.
    

Detailed description: 
      Venous thromboembolism (VTE) still causes maternal death in the western world. The purpose of
      this study is to estimate the relative and absolute risk of VTE at different gestational ages
      in pregnant women compared to non-pregnant women.

      All Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of
      previous VTE and current use of oral contraceptives are included.Non-pregnant women are
      controls.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Danish Women 15 to 49 years old in the period January 1995 through December 2005, free of
        previous VTE and current use of oral contraceptives.
      
Keywords: Thromboembolic event
A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-Label Study in Healthy Male and Female Subjects to Identify the Concentration that
      Provides Optimal Bioavailability of Levodopa Infused Subcutaneously via a Pump System; and to
      Compare the Bioavailability of Levodopa/Carbidopa Solution to that of Levodopa/Carbidopa
      Intestinal Gel (LCIG), Infused via a Naso-Jejunal Tube
    

Detailed description: 
      Part 1: This is a single centre, open-label design with 2 study arms (ND0612H and ND0612L),
      in 24 subjects that will receive the ND0612L or ND0612H regimens. Part of the subjects will
      also participate in Part 2 of the study. Within each study arm, subjects will receive 3 doses
      of the investigational LD/CD solution for subcutaneous (SC) infusion. Study drug will be
      administered for 24 -30 hours as a subcutaneous (SC) infusion to the lower abdomen. Then
      subjects will be readmitted for Part 2. Part 2: This is a single centre, open-label design
      with 3 treatment arms to which 15 subjects who completed the ND0612H arm of Part 1
      ND0612-005a will be allocated in a randomised manner. Within each treatment arm subjects will
      receive 2 out of 3 doses of LCIG infused for 16 hours directly to the jejunum. Subjects will
      be discharged from the clinic 24 hours after the end of the last infusion
    

Intervention name(s): ND0612; LCIG
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous solution; Intrajejunal Gel
Other intervention name(s): (Levodopa-Carbidopa solution); (Levodopa-Carbidopa Intestinal Gel)
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Cash Transfers on Severe Acute Malnutrition
Condition: Severe Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      Cash transfer, aims to strengthen food security for vulnerable households by giving families
      enough purchasing power to consume an adequate and balanced diet, maintain a good standard of
      hygiene, access health services, and invest in their own means of food production in addition
      to their children's growth and development.

      While cash transfer to vulnerable households has shown a long-term positive impact on growth
      and on malnutrition-related mortality in children aged 0-5 years, there is little conclusive
      evidence their effectiveness in Sub-Saharan Africa that cash transfer has a direct effect on
      the Community-based Management of Acute Malnutrition (CMAM). Here, the investigators will
      perform a cluster-randomized trial to investigate during 6 months the effects of
      unconditional cash transfers on the management of severe acute malnutrition (SAM) in children
      from 6 to 59 months according to the national protocol in the Democratic Republic of Congo.
    


Intervention name(s): Outpatient therapeutic program, counseling and cash transfer; Outpatient therapeutic program and counseling
Intervention type(s): Other; Other
Intervention description(s): Each household will receive an unconditional cash transfer of $40 value every month during a 6 months' period.
The amount of cash per household per month was defined according to the results of the Household Economy Approach survey. This amount represents 70% of supplement to the monthly average household income characterized as very poor to meet their basic needs. This threshold corresponds to the total of food and income necessary to cover 100% of energy needs food (2100 kcal per day per person), the costs associated with the preparation and consumption of food (e.g. salt, soap, kerosene and / or firewood for cooking and basic lighting) and finally all expenses for access to water for human consumption.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Malnutrition; Severe Acute Malnutrition; Cash Transfer; Democratic Republic of Congo; Cluster randomize trial
Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis
Condition: Congenital Heart Disease; Fibrinolysis; Rotational Thromboelastometry
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are
      antifibrinolytic agents routinely administered in children undergoing different surgeries
      associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries).
      Although there is a growing literature regarding the pharmacokinetic characteristics of these
      drugs in children, the plasmatic concentration required to completely inhibit fibrinolysis
      remains to be determined. In this in vitro study, the investigators will use an experimental
      model of fibrinolysis designed for rotational thromboelastometry (ROTEM®) to determine the
      minimal concentration inhibiting fibrinolysis for both TXA and EACA. In addition, this study
      will be used to create and validate a new experimental assay to measure fibrinolysis and the
      effect of antifibrinolytic agents.
    


Intervention name(s): Intraoperative Blood Sample
Intervention type(s): Other
Intervention description(s): Blood sample will be run using rotational thromboelastometry to determine the minimal concentration of TXA and EACA need to inhibit fibrinolysis
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective in vitro study being performed on whole blood obtained from two
        groups of infants. The first group will include infants with congenital heart disease (CHD)
        who are scheduled to undergo an elective cardiac catheterization lab procedure at Boston
        Children's Hospital. The second group will include infants who do not have congenital heart
        disease (No-CHD) and are scheduled to undergo a non-cardiac surgery (such as craniofacial
        surgery, neurosurgery, or orthopedic surgery) in the operating room at Boston Children's
        Hospital.
      
Biospecimen description: 
      The doctor will obtain one 13.6 mL blood sample from the arterial catheter or intravenous
      catheter at the beginning of the procedure after the patient has been anesthetized.
A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effectiveness of basal insulin analog and insulin
      analog mid mixture in Chinese participants with type 2 diabetes mellitus.
    


Intervention name(s): Insulin Analog Mid Mixture; Basal Insulin Analog
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mid mixture insulin analog; basal insulin analog
Collaborative Study of 1,3 Butadiene Biomarkers
Condition: Cancer
Study type: Observational

Summary: 
      Butadiene is a suspect human carcinogen to which most people are exposed daily. Exposures are
      difficult to measure by air sampling. This study examines the relationship between air levels
      and several biomarkers of exposure. Biomarkers are substances analyzed in human tissues or
      waste products. Adducts are materials formed when a chemical reacts with a biological
      material. In this study we are looking at biomarkers in the blood: hemoglobin and DNA
      adducts, and urinary metabolites. If a strong relationship is found then the amounts of
      biomarkers in a person's blood or urine can tell us how much they have been exposed. The
      tests are being conducted on petrochemical workers who have a wide range of exposures to
      butadiene. An international group of investigators is conducting the study.
    


Time perspective: Prospective
Keywords: biomarkers; exposure; adducts; metabolites; butadiene
Inhaled Ondansetron & Dyspnea
Condition: Dyspnea
MeSH terms: Dyspnea
Study type: Interventional
Phase: Early Phase 1

Summary: 
      "Dyspnea" refers to the awareness of breathing discomfort that is typically experienced
      during exercise in health and disease. In various participant populations, dyspnea is a
      predictor of disability and death; and contributes to exercise intolerance and an adverse
      health-related quality-of-life. It follows that alleviating dyspnea and improving exercise
      tolerance are among the principal goals of disease management. Nevertheless, the effective
      management of dyspnea and activity-limitation remains an elusive goal for many healthcare
      providers and current strategies aimed at reversing the underlying chronic disease are only
      partially successful in this regard. Thus, research aimed at identifying dyspnea-specific
      medications to complement existing therapies for the management of exertional symptoms is
      timely and clinically relevant. The purpose of this study is to test the hypothesis that
      single-dose inhalation of nebulized ondansetron (a serotonin 5-HT3 receptor antagonist) will
      improve the perception of dyspnea during strenuous exercise in health, young men. To this
      end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled
      ondansetron (8 mg) on detailed assessments of neural respiratory drive (diaphragm EMG),
      ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory
      muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective
      responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing
      in healthy, men aged 20-40 years.
    


Intervention name(s): Ondansetron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.9% saline
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ondansetron; Exercise
Health Education Provided to Primary School Students
Condition: Nurse's Role; Health Behavior
Study type: Interventional

Summary: 
      This study was conducted in a primary school in turkey.It was aimed to examine the effects of
      health education given to children in primary school period.As a result, it has been seen
      that education can be effective.
    

Detailed description: 
      Investigation of the Effects of Health Education Provided to Saraçoğlu Toki Mustafa Çetin
      Primary School Students on Health Screening Results The aim of this study is to find the
      effect of health education given to primary school students on health screening results.

      The research is a pre-test and post-test quasi-experimental model with a single subject
      group. Saracoglu Toki Mustafa Cetin Primary School is that located in Turkey; It was held
      between September 2019 and March 2020. It was aimed to reach the entire universe, not
      choosing the sample. The pre-test screening was completed with 460 students and the post-test
      screening with 400 students. An Introductory Information Form and Screening Test Application
      Form were used to collect data. After the health education was given by the researchers using
      visual, auditory materials and drama technique, the results were evaluated.
    

Intervention name(s): Health Education
Intervention type(s): Behavioral
Intervention description(s): All students who attended the school were provided training by the researchers to improve oral and dental health and general hygiene. These trainings were made using slide shows and various entertaining materials. In addition, education was transformed into a drama with a theater show, and the importance of hand washing, hair and toilet hygiene was explained.
In addition to hygiene, students were given training on correct eating patterns for a day so that they could develop healthy.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Health screening was done to the experimental group with one group. Surveys were conducted. Later, health education was given to this group. Six months later, the same group was screened for health again and a questionnaire was applied.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
The Risk Stratification of Papillary Thyroid Cancer With AUS/FLUS by FNA
Condition: Thyroid Cancer; Atypia of Undetermined Significance; FLUS
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Thyroid Diseases
Study type: Observational

Summary: 
      Purpose: To investigate the clinical characteristics of papillary thyroid cancer (PTC) with
      Bethesda category III (AUS/FLUS) by fine needle aspiration (FNA) and to assisted the
      precision treatment.

      Methods:A total of 290 patients who underwent thyroidectomies or thyroid lobectomies from
      August 2015 to September 2020, following a diagnosis of Bethesda category III (AUS/FLUS) from
      preoperative thyroid FNA were investigated.

      Groups: In order to investigate the clinopathologic characteristics, the patients, were
      grouped according to Cytology,Gender, Tumor size.
    

Detailed description: 
      Purpose: To investigate the clinical characteristics of papillary thyroid cancer (PTC) with
      Bethesda category III (AUS/FLUS) by fine needle aspiration (FNA) and to assisted the
      precision treatment.

      Methods:A total of 1739 cases diagnosed with Bethesda category III (AUS/FLUS) by FNA from
      August 2015 to September 2020 were reviewed, and 523 patients received thyroidectomy or
      lobectomy. 290 patients were diagnosed with PTC and investigated retrospectively.

      Groups: In order to investigate the clinopathologic characteristics, the patients, were
      grouped according to Cytology,Gender, Tumor size.as follows:AUS and FLUS&AUS/FLUS;male and
      female; tumor size≤1cm and>1cm.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The clinical database for patients undergoing thyroidectomies or thyroid lobectomies at the
        university hospital from August 2015 to September 2020 was revisited, and the thyroid
        pathology reports were screened and reviewed to analyse the comparison analysis of thyroid
        cancer with Bethesda category III (AUS/FLUS) by fine-needle aspiration cytology.
Establishing Guidelines for Manual Lymphatic Drainage
Condition: Lymphedema of Leg
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in
      participants with lower extremity lymphedema.
    

Detailed description: 
      To determine if there is a difference in L-Dex Score and Segmental Limb Volume in
      participants with lower extremity lymphedema as measured in liters by the SOZO machine
      between participants who receive Manual Lymphatic Drainage (MLD) techniques utilizing light
      tactile pressure with 5-10 mmHg without skin stretch versus medium tactile pressure of 11-20
      mmHg and medium skin stretch with therapist in a stationary position, versus firm tactile
      pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift.
    

Intervention name(s): Pressure
Intervention type(s): Procedure
Intervention description(s): Subjects are randomized to one of three treatment groups
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment Group 1 Treatment Group 2 Treatment Group 3
Masking: None (Open Label)
Primary purpose: Treatment
Transcultural Validation of Activities Scale for Kids (ASK)
Condition: Cerebral Palsy and Healthy Individuals
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      The Activities Scale for Kids performance (ASKp) is one of the few self-assessment
      questionnaires in pediatric rehabilitation that measures child perception in performance of
      daily routine activities. ASKp is composed of 30 questions designed to explore activities and
      participation in children and teenagers with musculoskeletal disorders. Scores assess level
      of physical ability, identify appropriate treatment and monitor changes over time. We
      recently undertook the cross-cultural validation to achieve a culturally adapted Italian
      version of ASKp: the Italian version is now to be tested on Italian children.
    

Detailed description: 
      The purpose of the study isto test the psychometric properties of the Italian version of the
      ASKp assessment scale, in a representative sample of individuals with PCI.

      ASK p will be administered on a sample of individuals belonging to the population of children
      and / or adolescents with diplegia and hemiplegia as a consequence of PCI. We will perform
      comprehensive descriptive analysis of the data collected as well as the measurement of the
      degree of reliability of the Italian version of the scale. The aim is to obtain an estimate
      of ASKp reliability obtained through transcultural validation.

      Additionally, we will submit the ASKp on a control group of typical development children in
      order to test its ability to discriminate between different skill levels.
    

Intervention name(s): ASKp
Intervention type(s): Diagnostic Test
Intervention description(s): 30 items questionnaire
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy children or adolescents and children or adolescents with cerebral palsy
      
Keywords: Cross-cultural comparison; Disability evaluation; Self-assessment; Child; Adolescent
Protein-Prebiotic Wellbeing Study
Condition: Digestive Health; Quality of Life
Study type: Interventional

Summary: 
      Healthy participants with self-reported GI complaints will consume the protein supplement
      that they normally use for recovery purposes after exercise during a 3-week baseline period,
      followed by a 3-week intervention period in which they maintain usage of their product, but
      replace a part of this product with a fermented dairy protein with prebiotic fiber. In
      addition, a group of healthy participants without self-reported GI complaints will serve as a
      reference group by consuming the protein supplement that they normally use for recovery
      purposes after exercise during a 3-week period.
    

Detailed description: 
      A substantial number of athletes suffer from gastro-intestinal problems, which may impair
      performance and/or subsequent recovery. Also, gut barrier integrity is impaired with
      high-intensity training. Emerging studies are showing a positive correlation between the gut
      microbiome and muscle function, athletic performance, body composition, and natural energy
      levels. This study will perform an exploratory analysis of the well-being and digestive
      health of well-trained athletes, and assess the potential effect of fermented dairy protein
      with prebiotic fiber on these parameters.

      Question 1: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber
      affect the self-reported digestive comfort compared to a 3-week baseline period? And
      additionally, will the quality of life (self-reported general well-being and states of mood)
      change with the use of this type of product?

      Question 2: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber
      show an alteration in gut microbiota in comparison to a 3-week baseline period, while dietary
      intake remains unaffected?

      Question 3: How is the 3-week supplementation of a fermented dairy protein with prebiotic
      fiber experienced by the participants (taste and concept liking)?

      Question 4: Is there a difference in baseline gut microbiota between athletes with and
      athletes without self-reported GI complaints.
    

Intervention name(s): fermented dairy protein with prebiotic fiber
Intervention type(s): Other
Intervention description(s): During the intervention period, the participant will consume a new product and will reduce the amount of protein in their normal diet reflecting the protein content of the new product.
Intervention model: Single Group Assignment
Intervention model description: Modifying diet by adding a fermented dairy protein with prebiotic fiber
Masking: None (Open Label)
Primary purpose: Other
Keywords: Participants; Healthy subjects; Athlete; Women; Men; Fermented Dairy; Prebiotics; Gut microbiota; Self-reported; GI tract; Diet; Sleep
Pedicle Screw Placement With XVS
Condition: Spine Fusion
Study type: Interventional

Summary: 
      Open label, prospective, single arm, multi-center study. Pedicle screws placement in
      sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2)
      different surgeons, using the XVISION SPINE system.

      Pedicle screw placement accuracy will be assessed by two independent, experienced
      radiologists, using the Gertzbein score.

      Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model
      rendering and XVISION SPINE system registration.

      Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of
      pedicle screw placement using the Gertzbein score.

      Surgeons performing the procedures will be requested to fill in usability questionnaires at
      the end of the procedure
    


Intervention name(s): xvision Spine sytem
Intervention type(s): Device
Intervention description(s): pedicle screw placement will be performed using the XVS navigation system
Other intervention name(s): XVS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment