bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Two Distraction Methods on the Level of Pain, Fear and Anxiety in Children
Condition: Pain; Anxiety; Fear; Venipuncture Site Reaction; Nursing Caries
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of watching cartoons with virtual reality
      glasses and tablets applied during the blood collection process on the level of pain, fear
      and anxiety experienced by children.
    

Detailed description: 
      Needle procedures applied to children for diagnosis and treatment cause fear, anxiety, and
      pain. In cases where children's pain and fear cannot be controlled, health professionals and
      parents may experience feelings of stress, helplessness, and guilt. Many approaches reduce
      pain and anxiety in children during painful procedures. The most commonly used of these
      approaches is the distraction technique, also known as the distraction technique, which is
      constructed with cognitive and behavioral processes. There are many methods used to divert
      attention. Some of those; watching cartoons, inflating balloons, creating balloons by blowing
      foam, directing techniques, parent coaching, using virtual reality (VR) glasses, listening to
      music, kaleidoscope, and using distraction cards. The research is a randomized controlled
      experimental study designed to determine the effects of two different methods (watching
      360-degree cartoons with virtual reality glasses and watching cartoons with a tablet) during
      the blood collection procedure in children, on the level of pain, fear, and anxiety
      experienced by children.
    

Intervention name(s): Virtual reality; Tablet
Intervention type(s): Behavioral; Device
Intervention description(s): Children will watch Ice Age in virtual reality during blood draw and the researcher will monitor their pain, anxiety and fear.; Children will watch Ice Age with a tablet during blood draw and the researcher will monitor their pain, anxiety and fear.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an experimental, parallel-group (intervention-control), randomized controlled design
Masking: None (Open Label)
Primary purpose: Supportive Care
Effect of Childhood Radioiodine Therapy on Salivary Function
Condition: Xerostomia; Hyperthyroidism; Thyroid Cancer
MeSH terms: Xerostomia; Hyperthyroidism
Study type: Observational

Summary: 
      Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in
      adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The
      investigators goals are to answer this question by measuring salivary gland function before
      and after I-131 administration in children who receive radioiodine therapy at our hospital
      for thyroid disease.
    

Detailed description: 
      Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in
      adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The
      investigators goals are to answer this question by measuring salivary gland function before
      and after I-131 administration in children who receive radioiodine therapy at our hospital
      for thyroid disease. We will use a Modified Shirmer Test to measure saliva production and a
      questionnaire to evaluation symptoms of xerostomia.
    

Intervention name(s): Radioiodine
Intervention type(s): Other
Intervention description(s): We will determine if prior radioiodine treatment in childhood impacts salivary function or symptoms. Radioiodine treatment will have been determined by the patient's medical condition and care (NOT assigned by this research study).
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who have receive I-131 therapy in childhood for thyroid disease, compared to a
        control group of patients who have never receive I-131 therapy
Postprandial Lipid Metabolism in Patients With Hypertriglyceridemia and Normo-lipidemic Controls: Medium Chain Fatty Acids (MCT) in Comparison to Long-chain, Saturated Fatty Acids (SFA) and Mono-unsaturated Fatty Acids (MUFA)
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      Postprandial lipid metabolism will be evaluated in patients with hypertriglyceridemia and
      normo-lipidemic controls; different fats will be used (saturated fatty acids, mon-unsaturated
      fatty acids and medium chain fatty acids) for the oral fat challenge.
    


Intervention name(s): MCT; SFA; MUFA
Intervention type(s): Other; Other; Other
Intervention description(s): patients will receive fat load with MCT; patients will receive fat load with SFA; patients will receive fat load with MUFA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability
      of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial
      hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.
    


Intervention name(s): Bosentan
Intervention type(s): Drug
Intervention description(s): 32-mg dispersible and breakable tablet. The body weight-adjusted dose of the dispersible tablet was dispersed in a teaspoon of water (not mixed with food) before being administered orally
Other intervention name(s): Ro 47-0203; Tracleer
Intervention MeSH terms: Bosentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bosentan; pulmonary arterial hypertension; children; FUTURE 1
Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients
Condition: Advanced Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a single-center, open, single-arm, phase II clinical trial. Eligible HCC
      patients, after signing informed consent, will receive TACE treatment. Envafolimab combined
      with Lenvatinib will be started on the day of TACE, and the subsequent TACE will be performed
      on demand. Patients will receive the treatment continuously until disease progression or
      intolerance. Tumor imaging evaluation will be performed according to RECIST V1.1 criteria
      every 6 weeks. Safety will be assessed with CTCAE 5.0. Adverse events throughout and within
      30 days of the end of the study will be recorded (severe adverse events or adverse events
      associated with Envafolimab will be recorded within 90 days after the end of
      treatment).Treatment will last for 2 years or until disease progression, withdrawal of
      informed consent, loss of visit, or death.
    


Intervention name(s): Envafolimab; TACE; Lenvatinib
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): 300mg, subcutaneous injection, q3w; The first TACE will be started on d1, and the subsequent TACE will be performed on demand.; 8mg,QD (body weight <60kg); 12mg, QD (body weight ≥ 60kg)
Intervention MeSH terms: Lenvatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Diabetes-Related Complications
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications
Study type: Interventional

Summary: 
      Type 2 diabetes is a chronic disease that affects approximately 13% of Portuguese population
      and is associated with a high cardiovascular mortality by coronary artery disease and
      cerebrovascular disease and with a serious decline on well-being. Lifestyle changes are
      widely recommended to the control of type 2 diabetes and its complications. This study aims
      to analyse the effects of different community-based lifestyle programs (exercise or exercise
      plus dietary intervention) on health and well-being in patients with type 2 diabetes.
    


Intervention name(s): Exercise; Dietary intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Community-based exercise program with 3 weekly exercise sessions; Community-based dietary intervention program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Community-based intervention; Exercise program; Dietary intervention program; Health promotion; Subjective well-being; Cardiovascular risk
Timing and Duration of Acute Hepatitis C Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Spontaneous resolution of acute hepatitis C infection cannot be predicted and the majority of
      cases persist and become chronic. This randomized trial assesses the efficacy and safety of
      peginterferon alfa-2b. The investigators hypothesize that therapy strategies could prevent
      the development of chronic hepatitis.
    

Detailed description: 
      With nearly 4 million people in the United States, and an estimated 170-200 million people
      worldwide, the hepatitis C virus (HCV) represents a clear and significant public health
      issue. Unfortunately, for most people infected with HCV (70%-85%) spontaneous resolution is
      uncommon and 60% to 80% of patients with acute hepatitis C infection develop chronic
      hepatitis. This randomized trial focuses on defining the effect of treatment of acute HCV on
      prevention of chronic hepatitis in addition to optimization of the treatment regimen, onset
      and the length of peginterferon alpha therapy in acute hepatitis C infections. This
      randomized, multi-center prospective study assesses the efficacy of peginterferon in acute
      hepatitis. We will also compare differences in sustained viral response rates in patients
      with acute hepatitis C starting treatment at 8, 12, or 24 weeks. We will also compare the
      efficacy of 8, 12 or 24 weeks therapy with PEG-IFN-alpha. All eligible patients are enrolled
      and screened for an initial observation period starting from the time of their first positive
      HCV-RNA-PCR, during which bi-weekly serum ALT and HCV-RNA subjects were performed. Patients
      who did not resolve spontaneously (loss of HCV-RNA without treatment) by the end of the
      observation period were randomly assigned to receive PEG-IFN-alpha at the assigned onset
      and/or duration. Patients who do not consent to therapy at enrollment are included as a
      non-randomized comparison group. All subjects with SVR were followed for 48 weeks after the
      follow-up at 24 weeks when SVR was determined.
    

Intervention name(s): Pegylated interferon alpha 2; Ribavirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinical trial; Randomized; Treatment; Prospective; Parallel Assignment; Efficacy Safety Study
Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to study:

        -  Effects of arzoxifene on bone fractures and bone mass.

        -  Effects of arzoxifene on getting breast cancer.

        -  Effects of arzoxifene on certain types of cardiovascular events, such as heart attack
           and stroke.

        -  Effects of arzoxifene that changes the amount of certain substances in the blood that
           are related to osteoporosis and cardiovascular health.

        -  Effects of arzoxifene on the uterus.

        -  The safety of arzoxifene and any side effects.
    


Intervention name(s): Arzoxifene; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20mg, oral, tablet, once a day for 36 months; oral, tablet, once a day for 36 months
Other intervention name(s): LY353381
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Optimization of the ex Vivo Challenge
Condition: Optimization of Laboratory Procedures
Study type: Observational

Summary: 
      The overall purpose of this research study is to collect vaginal and cervical biopsies from
      healthy HIV negative participants. These samples will enable investigators to optimize
      laboratory methods and explore implementation challenges associated with the ex vivo
      challenge model. The first objective is to assess which HIV virus is best for use in the
      model. The second objective is to determine the best endpoint for the assay.

      The primary aim of this study is to collect an adequate number of cervical and vaginal
      biopsies to support the optimization of an ex vivo challenge model. This ex vivo challenge
      model has been and will continue to be used in topical microbicide clinical trials to predict
      the efficacy of candidate drugs.
    

Detailed description: 
      The development of surrogates to predict HIV prevention product safety and efficacy is a high
      priority. An ex vivo challenge model is one such promising surrogate. Colonic tissue exposed
      to rectally applied microbicides in vivo and then challenged with HIV in the lab showed
      significant reduction in HIV replication when compared to tissue exposed to placebo gel.
      Currently, the ex vivo challenge model for ectocervical and vaginal tissue is being developed
      at the Dezzutti lab at the Magee Womens Research Institute in Pittsburgh, PA. Questions which
      need to be addressed in order to optimize the model include which HIV virus is most
      appropriate to use to challenge the tissue, is qPCR a more appropriate endpoint and marker of
      infection, and can frozen tissue perform as well as fresh tissue in the challenge model.

      In this study, we will collect vaginal and cervical biopsies to use in the optimization of
      laboratory procedures. We will obtain the sample(s) from healthy HIV negative women. Samples
      will be collected and taken to Magee-Womens Research Institute as laboratory specimens.
      Written consent will be obtained by an investigator or co-investigator prior to the
      collection of any samples.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy, non-pregnant, HIV negative women
Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance
Condition: Energy Intake; Activities of Daily Living; Quality of Life; Protein Intake; Fluid Balance; Lean Body Mass; Fat Mass; Weight
Study type: Interventional

Summary: 
      An intervention study on the effect of dietary guidance with focus on implementing
      recommended food texture, at the department of Eating and Swallowing difficulties, Region
      Midtjylland, Denmark.

      Energy- and protein intake, Weightloss, Bodymass composition, Fluid balance and Activities of
      Daily Living (ADL), will be measured by Bioimpedance spectroscopy, interviews and a
      questionnaire.
    

Detailed description: 
      It is know that people with eating- and swallowing difficulties(known as dysphagia), is prone
      to weightloss due to insufficient energy- and protein intake, and a reduction in ADL.

      ADL will in this project have its focus on the eating situation.

      The projects research questions are:

        -  Will dietary guidance with texture implementation increase energy intake in patients
           being examined on an outpatient basis for dysphagia, based on the Fiberoptic Endoscopic
           Evaluation of Swallowing (FEES) recommendation?

        -  Can a dietetic guidance with texture implementation increase quality of life and ADL in
           patients with dysphagia?

      Recruitment and data collection will take place at Hammel Neurocenter, DK.

      Each patient will be included for eight weeks, after their first FEES examination. The
      participants will be randomized to control or intervention, and strata into three groups
      based on Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) 1, 2-3 and 4.

      Within the eight weeks, participants have to show up three times to measurements, interviews
      and questionnaire, in addition to this, the intervention groups will have three follow-up
      phone meetings.
    

Intervention name(s): Dietary guidance
Intervention type(s): Other
Intervention description(s): Dietary guidance with focus on texture and energy intake, preformed by certified dietitians.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to control or intervention group, stratified on their FEDSS-score.
The study will include 34 participants - 17 in each group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Dysphagia; Dietary Guidance; Energy- and Protein intake; Food Texture; Activities of Daily Living and Quality of Life
COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses
Condition: COVID19; Mouthwash; Saliva
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Given the current lack of effective COVID-19 treatment, it is necessary to explore
      alternative methods to contain the spread of the infection, focusing in particular on its
      mode of transmission. The modes of person-to-person transmission of SARS-CoV-2 are direct
      transmission, such as sneezing, coughing, transmission through inhalation of small droplets,
      and transmission through contact, such as contact with nasal, oral and eye mucous membranes.
      SARS-CoV-2 can also be transmitted directly or indirectly through saliva. The use of
      antiviral mouthrinses may be used as adjunctive therapy.
    


Intervention name(s): mouthrinse with bêta-cyclodextrin and citrox; mouthrinse without bêta-cyclodextrin and citrox
Intervention type(s): Device; Device
Intervention description(s): 3 daily mouthrinses for 7 days; 3 daily mouthrinses for 7 days
Intervention MeSH terms: Betadex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: covid19; SARS-CoV-2; mouthrinses; antiviral; bêta-cyclodextrin; citrox
Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being performed to determine the bioavailability, or extent of absorption into
      the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to
      the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.
    


Intervention name(s): Amlodipine - reference; Amlodipine ODT - test; Amlodipine ODT - test
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg tablet, single dose, with water; 10 mg orally disintegrating tablet (ODT), single dose, with water; 10 mg orally disintegrating tablet (ODT), single dose, without water
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: biological availability; bioavailability; amlodipine; orally disintegrating tablet; ODT; tablets
Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The goal of this longitudinal study is to (1) explore the association between the gut
      microbiota and inflammatory disease activity in early onset multiple sclerosis, (2)
      investigate whether/how gut microbial composition vary when patients experience a relapse,
      and (3) to assess whether the gut microbiota shows increased similarities between affected
      pairs of first-degree relatives within the same family when compared with discordant pairs of
      first-degree relatives.
    

Detailed description: 
      Using metagenomics, as well as clinical, immunological, and radiological observations, the
      investigators will investigate if active relapsing-remitting multiple sclerosis patients have
      a more pro-inflammatory gut microbiota signature than multiple sclerosis patients with less
      active disease and matched healthy controls.

      More specifically, the investigators will investigate whether temporal variability of the gut
      microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes
      in the gut microbiota are predictive of future inflammatory disease activity in multiple
      sclerosis, and whether gut microbiota characteristics are predictive of the disease course
      after 2 years.
    

Intervention name(s): Magnetic resonance imaging (MRI)
Intervention type(s): Other
Intervention description(s): MRI scanner
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention