bioihbjkbjnl/mcl2 huggingface dataset:
Tumor Feeding Vessels Deprivation Combined With Tyrosine Kinase Inhibitor in Liver Transplantation
Condition: Liver Transplantation
Study type: Observational

Summary: 
      To investigate the value of tumor feeding vessels deprivation combined with tyrosine kinase
      inhibitor in liver transplantation. Patients are enrolled into two groups according to the
      downstaging therapy they undergo before transplantion.
    


Intervention name(s): PVHA or TACE
Intervention type(s): Combination Product
Intervention description(s): PVHA or TACE
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        (1) age ≥18 years; (2) exceeding UCSF criteria; (3) absence of vascular invasion, nodal
        involvement, or extrahepatic metastases; (4) receiving TACE treatment or LTFVD treatment
        for downstaging purposes. Patients who underwent resection, LT, or any form of downstaging
        treatment prior to enrollment were excluded.
Gut Hormones and Bone Remodeling in Humans (KS-2)
Condition: Healthy
Study type: Interventional

Summary: 
      Effects of GLP-2 and GIP on bone remodeling in healthy young men.
    

Detailed description: 
      We will investigate acute effects of GLP-2 and GIP on bone remodeling in healthy young men.
    

Intervention name(s): GLP-2; GIP; GLP-2+GIP; Placebo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): GLP-2; GIP; GLP-2+GIP; Placebo
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
House Dust Mite Allergen Reduction in Bedding: Purotex Impregnated Covers of Bekaert Textiles
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      Product information:

      Purotex is a textile treatment that uses five 100% natural bacteria or probiotics, selected
      for their ability to clean up house dust mite allergen along with other allergen types.

      Study design:

        -  Placebo-controlled: the effect of the Purotex impregnated mattress and pillow covers
           will be compared to untreated, classical bedding covers (placebo).

        -  Cross-over design: There will be 2 'treatment' arms. One arm (Arm 1) in which the
           subjects will first use the Purotex impregnated covers (Set A=Purotex) during 2 months
           (=period A) and, after a wash out period of 1 month, the untreated covers (set
           B=placebo) during 2 months (=period B). In the second arm (Arm 2), the subjects will
           first use the untreated set (set A=placebo) and, after a wash out period the Purotex
           impregnated covers (set B=Purotex).

        -  Randomized: The subjects will be randomly assigned to one of the 2 treatment arms.

        -  Double blind: both the subjects and the investigators will not know to which treatment
           arm the subjects are assigned.

      Study hypothesis:

      We want to investigate:

        -  if there is a reduced concentration of HDM allergen in Purotex covers compared to
           untreated covers in real life

        -  if patients with allergic rhinitis to house dust mite use the Purotex covers, they
           experience an improvement of their quality of life and sleep, and an improvement of
           their allergic symptoms and global discomfort
    


Intervention name(s): use of Purotex treated bedding covers; placebo
Intervention type(s): Other; Other
Intervention description(s): Purotex is a textile treatment that uses five 100% natural bacteria or probiotics, selected for their ability to clean up house dust mite allergen along with other allergen types. The active probiotics are placed inside of millions of capsules and are introduced during the textile production. These human friendly bacteria remain non-active until friction force is created between the mattress/pillow and the sleeper's body. Under the friction force a small part of the capsules is opened and probiotics become active. They saturate the bacterial capacity of the textile and by doing so, reduce the risk of dust mite allergen development and growth of molds and harmful bacteria. The patients will apply the covers around their mattress and around their pillow. On top of these covers the patients will apply their own fitted sheet and pillowcase (which they will change every 4 weeks).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluation of the Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults
Condition: Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of the study is to extend the intended use of two BGMSs to include testing of
      arterial blood by Health Care Professionals (HCP) in a clinical setting.
    

Detailed description: 
      This trial will evaluate the performance of both Contour Next BGMS and Contour Plus Elite
      BGMS using arterial blood from adult patients hospitalized in a Critical Care Unit (medical
      and surgical intensive care units (ICUs)). The investigational BGMS will be tested by a
      Point-of-Care (POC) operator in a clinical setting using residual arterial blood samples from
      adults who underwent prescribed arterial blood tests that were deemed necessary due to their
      medical conditions.
    

Intervention name(s): Device: Contour Next and Contour Plus Elite BGMS testing of arterial blood
Intervention type(s): Device
Intervention description(s): The purpose of the study is to extend the intended use of two BGMSs to include testing of arterial blood by Health Care Professionals (HCP) in a clinical setting.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        - The subject population will consist of adults who are hospitalized in a Critical Care
        Unit, (medical and surgical intensive care units (ICUs)) at the Investigational site.
Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES)
Condition: Healthy
Study type: Observational

Summary: 
      This crossover study is designed to compare the rates of gastric emptying between two
      diagnostic radioactive meals using the gold-standard egg-white sandwich meal and Abbott
      Vital®. Healthy participants will be recruited and randomly assigned into either groups of
      Abbott Vital® and gold-standard egg-white sandwich group. The measurements will be performed
      over a 4-hour period using a gamma camera, and estimated gastric emptying rates will be
      calculated using established algorithms.
    

Detailed description: 
      The gold-standard egg-white sandwich is quite difficult and complicated for staffs to prepare
      because the food needs to be cooked first and it will take time to prepare. Besides, the
      egg-white sandwich is not suitable for those with allergies to egg and bread and also to
      vegetarian patients. This gold-standard meal is also not a common meal for Asian people so
      some of the people may not tolerate with the meal. The aim of this study is to determine
      whether Abbott Vital® is as reliable as the gold-standard egg-white sandwich by comparing the
      gastric meal retention of both meals.
    

Intervention name(s): Egg-white sandwich; Abbott Vital®
Intervention type(s): Radiation; Radiation
Intervention description(s): 1 mCi of Tc-99m sodium phytate is added into the egg-white sandwich; 1 mCi of Tc-99m sodium phytate is added into the Abbott Vital®
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Reference population is staff and students who are within the campus of Universiti Sains
        Malaysia and Hospital Universiti Sains Malaysia
      
Keywords: Gastric emptying; Single-photon emitted-computed tomography; Normative value; Egg-white sandwich; Abbott Vital®; Radiopharmaceuticals
The Evaluation of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX in Healthy Korean Male Subjects
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate pharmacokinetic/pharmacodynamic characteristics and safety of QDX after single
      oral administration in healthy Korean male subjects
    


Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention description(s): Topiramate
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy
      of a topical cream compared to a placebo cream. The study population will be those with mild
      to moderate osteoarthritis of the knee.

      The trial will also provide information about potential side effects and verify the safety of
      this composition. Blood levels will be done to assess inflammation and to determine whether
      any systemic absorption has occurred.

      Hypothesis/Purpose

        -  Pain scores after active treatment will be significantly reduced in comparison to
           placebo.

        -  There will be an improvement in stiffness and physical function as measured by the WOMAC
           using the active cream as compared to placebo.

        -  There will be a decrease in the level of inflammation assessed at baseline, end of week
           3 and end of week 6.

        -  The blood concentration of the active ingredient in the topical cream will not exceed
           the maximum daily dose that will be consumed by participants.
    


Intervention name(s): Topical Arthritis Cream
Intervention type(s): Other
Other intervention name(s): LivRelief Pharmax Rebuild
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin
Condition: Wrinkles; Ageing; Photoprotection
Study type: Interventional

Summary: 
      Objective of the study is to determine the influence of dietary supplementation with coenzyme
      Q10 (CoQ10) on skin conditions. 33 healthy female subjects will be randomly assigned to a
      placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD)
      receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with
      improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be
      used. Various skin parameters will be evaluated before the supplementation (the baseline),
      after 6 and after 12 weeks of supplementation. To evaluate the photoprotective potential of
      CoQ10 the minimal erythema dose (MED) will be determined before (the baseline) and after 12
      weeks of the supplementation.
    

Detailed description: 
      Objective of the study is to determine the influence of dietary supplementation of CoQ10 in
      form of water-soluble Q10vital® on skin conditions. 33 healthy female subjects will be
      randomly assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a
      high-dose group (HD) receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form
      of CoQ10 with improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o.,
      Slovenia) will be used. The placebo or CoQ10 will be administered in the form of a syrup; all
      subjects will consume 5 mL of syrup daily for 12 weeks. The photoprotective potential of
      CoQ10 will be evaluated with a determination of the minimal erythema dose (MED) before (the
      baseline) and after 12 weeks of the supplementation. Other skin parameters will be evaluated
      before supplementation (the baseline), after 6 and after 12 weeks of supplementation.
      Comparison will be done as the mean of the individual ratios. The differences between the
      before-after condition will be analyzed with the statistical test of analysis of variance. In
      case of failure to find homogeneity in the variances the nonparametric ANOVA, the Willcoxon
      test, will be used. The results will be expressed as mean ± standard error for each group
      with a significance level of 0.05 for all the statistical tests.
    

Intervention name(s): Placebo group; Quvital LD group; Quvital HD group
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will take 5 mL of placebo syrup (0 mg CoQ10/day) once per day for 12 weeks.; Subjects will take 5 mL of LD syrup (50 mg CoQ10/day) once per day for 12 weeks.; Subjects will take 5 mL of LD syrup (150 mg CoQ10/day) once per day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: skin rejuvenation; anti-ageing effects; minimal erythema dose; dermis structure; physiological skin condition; wrinkling; dry skin
Health Outcomes of Teens Participating in Summer Employment Immersion Programs
Condition: Pediatric Obesity; Prediabetic State
MeSH terms: Pediatric Obesity; Prediabetic State
Study type: Interventional

Summary: 
      This study is a collaboration between investigators and two community partners: a youth
      employment program and an urban farm. The community partners hire 300+ adolescents for summer
      jobs at various organizations. Approximately 120 adolescents will be employed with the urban
      farm site. As one component of their program evaluation plan, investigators will evaluate
      change in BMI of participants. The investigators hypothesize that there will be a reduction
      in BMI of those participants working at the urban farm site.
    

Detailed description: 
      The investigators will measure height/weight/BMI of all participants located at the urban
      farm site. Investigators will also collect demographic data as well as other social data
      (example: food security).
    

Intervention name(s): Measurement
Intervention type(s): Behavioral
Intervention description(s): The intervention consists of diabetes prevention education sessions focusing on increasing physical activity and decreasing the intake of sugared drinks while increasing intake of fruits and vegetables. The 2-hr sessions occur weekly for 6 weeks. Height and weight is measured for each consenting participant at baseline and after 6 weeks. Participants are also asked to complete a short questionnaire to collect demographic and knowledge data. Outcome measures include: BMI, knowledge of physical activity and dietary habits conducive to diabetes prevention, and feelings of food insecurity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Development and Validation of a Symptom Scale for Children With Chronic Graft-versus-Host Disease
Condition: Graft vs Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Study type: Observational

Summary: 
      Chronic Graft-versus-Host Disease (cGVHD) is an important cause of morbidity and mortality in
      patients undergoing allogeneic bone marrow transplantation. cGVHD usually occurs after 100
      days following transplantation and develops in 20-60% of transplant recipients. The incidence
      of cGVHD varies depending on the age of the marrow recipient, the use of sibling or unrelated
      donor bone marrow, the use of unmanipulated T cell-depleted bone marrow, and perhaps other
      factors. Clinically, cGVHD is characterized by multi-system disease, which frequently mimics
      the clinical features of autoimmune diseases. The manifestations include skin changes
      (lichenoid and sclerodermatous changes, changes in pigmentation, loss of accessory structures
      such as hair, dystrophic nails, and rash), joint contractures, severe cramping, hepatic
      dysfunctions, sicca syndrome, obstructive lung disease, esophageal dysmotility, weight loss,
      polyserositis, immunodeficiency, and autoantibodies including anti-nuclear antibody,
      anti-erythrocyte antibodies, and anti-platelet antibodies.
    

Detailed description: 
      A large number of children with cGVHD have to deal with many years of a disfiguring and
      painful chronic illness with the side effects of long term steroid use. The number of stem
      cell transplants done in children is only growing given that we are now transplanting
      patients with a variety of nonmalignant disorders and given the use of alternative donor
      sources. The broad categories of limited and extensive cGVHD are recognized by clinicians,
      but are not particularly useful in clinical practice. Since cGVHD may involve almost every
      organ system adn since cGVHD constitutes a waxing and waning nature, cGVHD makes clinical
      management very difficult and complicated. Currently, there is a symptoms scale used in the
      adult population for measuring symptom burden for adults with cGVHD. This scale is called the
      "Lee Symptoms Scale". The purpose of this project is to develop a scale that is similar in
      design to the Lee Scale, but it is specifically designed to measure the burden of cGVHD in
      the pediatric population
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cGVHD will be identified by their local physican and asked to participate in
        this research study. A total of 24 children will be asked to participate in this study. The
        parents of all of the 24 children will also be asked to participate and give us their
        feed-back on what it is like to cope with a child with cGVHD.
      
Keywords: cGVHD
Botulinum Toxin A Adult Gastrocnemius Muscle Study
Condition: Muscle Spasticity; Stroke
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between
      two different injection sites, namely at the proximal portion of the gastrocnemius(GCM)
      versus at the midbelly of the GCM.
    

Detailed description: 
      Previous studies have used the midbelly of a muscle as the position where the motor endplates
      are most densely located. The reasoning behind this method was based on the previous works
      that showed most bands of cholinesterase activity to be located in specific topographical
      patterns at the center of the muscle fiber. These results have been used as landmarks to
      place the injections. Current standard guidelines recommend that botulinum toxin be placed at
      the 4 quadrants of the midbelly portion of the gastrocnemius (GCM) muscle. However, recent
      cadaveric research studies on the distribution of the intramuscular endings of the GCM
      suggest that the highest branch density is found within the upper 20-30% length of the calf.
      Therefore, in accordance to the theory that effect of botulinum toxin are greatest at sites
      where the intramuscular endings are most dense, the location where these toxins should be
      placed would be at these proximal sites of the GCM rather than at the midbelly.

      40 recruited patients will be allocated into either the intramuscular ending targeted
      (ie.upper portion of calf) or midbelly targeted group.

      Each subject will undergo a total number of 4 assessments; prior to the injection and 2,4and
      8 weeks post injection.
    

Intervention name(s): BOTOX-A®
Intervention type(s): Drug
Intervention description(s): 200 units, single treatment only
Other intervention name(s): Generic Name: Botulinum toxin type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Muscle spasticity; Stroke; Botulinum Toxins; Lower extremity; Ankle
Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome; Dilatation, Pathologic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to provide information on feasibility and reproducibility of barostat
      assessments of colorectal sensory functions and compliance and their pharmacological
      modulation
    


Intervention name(s): SMS995; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Octreotide, Sandostatin
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Barostat; distention; IBS; irritable; bowel; syndrome; colorectal; sensation; modulation; reproducibility
Effect of Supragingival Irrigators Containing Chlorhexidine on Oral Health in Blood Dyscrasia
Condition: Severe Neutropenia; Thrombocytopenia; Chemotherapy; Blood Dyscrasia Patients
MeSH terms: Thrombocytopenia; Neutropenia; Hematologic Diseases; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      in this study , effectiveness of supragingival irrigators containing chlorhexidine is
      compared with routine oral health measures in patients with blood dyscrasia whom can not use
      effective oral health measures(e.g brushing ) due to their systemic condition(e,g,neutropenia
      ,thrombocytopenia,..)
    

Detailed description: 
      Since some patients with hematologic malignancies cannot brush effectively and are at
      increased risk of bleeding and infection due to severe neutropenia and thrombocytopenia we
      want to access whether a none invasive method ( water jet systems containing chlorhexidine )
      Can help this patients to get better oral health indexes in comparison with routine oral
      health measures in these type of patients.
    

Intervention name(s): supragingival irrigators containing chlorhexidine
Intervention type(s): Device
Intervention description(s): patients received irrigation by oxyjet supra gingival irrigators containing chlorhexidine for at least 3 minutes for all dentulous regions of jaws which was performed by researchers once daily.
Other intervention name(s): Oral-B Braun Oxyjet irrigators
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: oral irrigator; leukemia; blood dyscrasia; Oral Health Index Simplified (OHI-S); supra gingival irrigator