bioihbjkbjnl/mcl2 huggingface dataset:
Mushroom Ingestion Study
Condition: Diet, Healthy
Study type: Interventional

Summary: 
      The investigators propose to determine the effect of consuming 0, 1 or 2 servings of white
      button (Agaricus bisporus; most popular, lower ergothioneine) or yellow oyster (Pleurotus
      citrinopileatus; higher ergothioneine) mushrooms on postprandial changes in plasma levels and
      urinary excretions of mushroom-specific compounds.
    

Detailed description: 
      The investigators hypothesize that consuming different mushroom varieties will elicit
      distinct postprandial nutrimetabolomic profiles in the plasma and urine and that the amount
      of metabolites present will increase with the servings of mushrooms. Measuring ergothioneine
      in the plasma will provide a quantitative outcome to document the postprandial responses to
      consuming the test meals. The nutrimetabolomic related outcomes are exploratory and have not
      been documented in human research.
    

Intervention name(s): Yellow Oyster -- 84 g; Yellow Oyster -- 168 g; White button -- 84 g; White button -- 168 g; Control
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Participants will consume the standardized test day salad plus 84 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served; Participants will consume the standardized test day salad plus 168 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served; Participants will consume the standardized test day salad plus 84 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served; Participants will consume the standardized test day salad plus 168 g (raw weight) mushrooms. Mushrooms will be cooked prior to being served; Participants will consume the standardized test day salad only
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: For this randomized crossover study, subjects will consume 5 test meals varying in mushroom content, each separated by a minimum of 10 days (Figure 1). For 3 days prior to each testing day participants will be provided with and instructed to exclusively consume a low-antioxidant "run-in" diet (low fruit, vegetable, and spice diet) to minimize background concentrations of potential test food-derived compounds of interest. On test days, participants will consume a standardized mixed-macronutrient meal (500 kcal, 75g CHO, 15g Protein, 15g Fat) containing 1) no mushrooms (control), 2) 84 g of raw white button mushrooms served cooked; 3) 168 g of raw white button mushrooms served cooked; 4) 84 g of raw yellow oyster mushrooms served cooked; or 5) 168 g of raw yellow oyster mushrooms served cooked. Between each run-in diet/testing period, participants will consume their usual, unrestricted self-selected diets for a minimum of 7 days.
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Mediterranean; Mushrooms; Metabolomics
PECS Block in Breast Surgery: an Observational Multicenter Study
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      We will enroll patients submitted to breast surgery (in and outsettings) with regional
      anesthesia.

      The blinded observers, in the first 48 hours post-operative, will evaluate (telephone
      interview in outsetting) the pain intensity through the Numeric Rating Scale ( 0= no pain, 10
      = worst possible pain) thereby recording the treatment procedures in accordance with usual
      clinical practice. At the same time we will evaluate the presence of intraoperative or
      postoperative complications related to regional anesthesia, the PONV rate (post-operative
      nausea and vomiting) and the analgesic/antiemetic therapy.
    


Intervention name(s): regional anesthesia in breast surgery
Intervention type(s): Other
Intervention description(s): In the Hospitals involved in this study are performed routinely wall blocks (PECS I-II blocks and serratus block) during breast surgery
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients submitted to breast surgery
      
Keywords: breast surgery
Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical
      Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during
      non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse
      Oximeter.

      The study is observational in nature which quantifies device performance and accuracy in
      compassion to a Reference Pulse Oximeter.
    

Detailed description: 
      The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical
      Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during
      non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse
      Oximeter. The end goal is to show the SpO2 accuracy performance of the Oxitone 1000 and if
      needed, use the data to make improvements prior to an arterial blood hypoxia study.

      A Clinimark 3900 Reference Pulse Oximeter or Nellcor N-600x will be used for the SpO2
      calibration. There are no risks or adverse device effects to be assessed. There are no
      contraindications for use in the proposed study / study population

      The Control Pulse Oximeter, GE Healthcare (Datex-Ohmeda) 3900, an FDA cleared device, is used
      to monitor the oxygen saturation levels real time throughout the study for subject safety and
      to target stable plateaus. This device is used to assess the stability of the data.
    

Intervention name(s): Pulse Oximeter
Intervention type(s): Device
Intervention description(s): Measurement of physiological parameters
Other intervention name(s): Blood Pressure; Respiratory Rate; Respiratory Gassess; Temperature
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Residents of the Denver metropolitan area
      
Keywords: Pulse Oximetry; Temperature; Respiratory Rate; Respiratory Gases; This study determines the measurement accuracy of the physiological parameters
Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the safety, tolerability, and pharmacokinetics of
      PF-04447943 after single and multiple-dose administration to healthy young adult and elderly
      Japanese subjects, respectively.
    


Intervention name(s): PF-04447943; PF-04447943; PF-04447943; Placebo; PF-04447943; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3 mg solution, oral single dose.; 10 mg solution, oral single dose.; 25 mg solution, oral single dose.; Solution, oral single dose.; 25 mg solution, oral twice daily for 7 days.; Solution, oral twice daily for 7 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase 1; Pharmacokinetics; Healthy Young Adult; Japanese; Healthy Elderly; Alzheimer disease
Dynamic Infrared Thermography as an Alternative to CT Angiography
Condition: Breast Cancer
Study type: Observational

Summary: 
      Dynamic infrared thermography (DIRT) is an imaging method that does not require ionizing
      radiation or contrast injection. The study evaluates if DIRT can be an alternative to
      computed tomographic angiography (CTA) in perforator mapping. DIRT findings are compared with
      hand-held Doppler, CTA and intraoperative findings.
    

Detailed description: 
      In deep inferior epigastric perforator flap (DIEP) breast reconstruction the blood supply to
      the DIEP flap is reestablished by anastomosing the perforator to the internal mammary
      vessels. The selected perforator is crucial for flap survival as it is the only source of
      blood supply to the flap. CTA allows for precise anatomical description of the origin of
      perforators, their intramuscular course and point of fascia penetration but expose the
      patient to ionizing radiation and an intravenous contrast medium.

      DIRT is an imaging method that does not require ionizing radiation or contrast injection. The
      study evaluates if DIRT can be an alternative to CTA in perforator mapping. The study is
      performed in a hospital where DIRT and CTA have been established preoperative imaging methods
      that have been used for several years as routine examinations for all DIEP breast
      reconstruction patients.

      25 patients scheduled for secondary breast reconstruction with a DIEP flap are included.
      Preoperatively, the lower abdomen is examined with hand-held Doppler, DIRT and CTA. Arterial
      Doppler sound locations are marked on the skin.

      DIRT examination involves rewarming of the abdominal skin after a mild cold challenge. The
      locations of hot spots on DIRT are compared with the arterial Doppler sound locations. The
      rate and pattern of rewarming of the hot spots are analyzed. Multiplanar CT reconstructions
      are used to see if hot spots are related to perforators on CTA and intraoperative findings.

      When intraoperative findings confirm that a useful perforator is located at the same
      localization as indicated with DIRT, this perforator is used for DIEP breast reconstruction.
      Postoperatively the surgical outcome and possible complications related to the selected
      perforator are evaluated.
    

Intervention name(s): DIRT
Intervention type(s): Procedure
Intervention description(s): An infrared camera is used to capture video sequences of thermal images before, during and after exposure of the lower abdomen to a cold challenge.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women scheduled for DIEP breast reconstruction after mastectomy
      
Keywords: DIEP; Computed Tomography; Doppler; Thermography
Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn
Condition: Burn
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2

Summary: 
      Different medical treatments are available for treatment of skin burns such as skin grafts
      and silver sulfadiazine ointment. These treatments are used for second degree burn as routine
      technique in burns units. Cell therapy is a new approach for treatment of skin disease.In
      this study we use autologous epidermal cell suspension to achieve better cosmetic and
      functional results in treatment of second degree burn.
    

Detailed description: 
      In this study 20 patients in Burn Department of Sina Hospital Tabriz, with at least 2 areas
      of second degree burn randomly choose. First skin samples are taken from normal skin by 4mm
      punch and send to the laboratory for preparation of epidermal cell suspension and this
      suspension is transferred to the one area of second degree burn in each patient and the other
      area in the same patient dresses by silver sulfadiazine ointment. The dressing changes are
      followed up for 12h for first assessment of therapy until 10th day after intervention. In the
      days of 5, 10, 15 and 20 the percentage of re-epithelization for each treatment will be
      measured. After 2 months, patients are visited and any complications check for scar
      formation, pain, post inflammatory hyper-pigmentation.
    

Intervention name(s): Autologous epidermal cell suspension; Silver sulfadiazine ointment
Intervention type(s): Biological; Drug
Intervention description(s): First skin samples taken from normal skin by 4mm punch will be send to laboratory for preparation of epidermal cell suspension and this suspension transfer to one area of second degree burn; the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day
Intervention MeSH terms: Sulfadiazine; Silver Sulfadiazine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Burn; Epidermal cell suspension
Clinical Trial to Evaluate Safety and Efficacy of a Facial and Lip Moisturizer in Adult Subjects Undergoing a Facial Dermatologic Procedure With Fractional CO2 Laser
Condition: Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser
MeSH terms: Facies
Study type: Interventional

Summary: 
      This is study aims to evaluate the topical safety (tolerability/acceptability) and efficacy
      of TH Facial Moisturizer and TH Lip Moisturizer Investigational products after 21 ± 2 days of
      use under normal conditions on the half-face by adult participants who underwent
      dermatological facial procedure with fractional CO2 Laser under the supervision of a
      dermatologist. For these investigational products, safety parameters, clinical efficacy,
      instrumental efficacy (skin hydration, skin barrier integrity and facial imaging) and
      perceived efficacy through subjective perception questionnaires will be evaluated. Subjects
      will receive the product to use it at home for 21 +/- 2 days.
    


Intervention name(s): TH Facial Moisturizer; TH Lip Moisturizer; Facial Moisturizer B (Control); Sunscreen; Facial wash
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.; All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.; All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.; Auxiliary product; Auxiliary product.
Other intervention name(s): The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.; The lip lotion product is a moisturizing formulation intended for topical use on the lips. It will be applied at least twice daily.; The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.; It will be used all over the face whenever there is the intention of sun exposure.; It will be used to wash the face at least once daily.
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: All participants will receive the same study regimen consisting of 5 products: a facial moisturizer, a facial moisturizer (control), a lip moisturizer, a sunscreen and a facial wash.The facial moisturizers will be applied on the half face. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge.
Masking: None (Open Label)
Primary purpose: Basic Science
A New Designed Balance Platform for Children
Condition: Child Development
Study type: Observational

Summary: 
      People always come across with different floors which gradually affect dynamic balance.
      Dynamic balance is important in activities of daily life of all people. There are various
      reliable and valid tests for both children and adults, but no test design which includes
      different floor materials has been developed. Thus, this study aimed to describe a new
      designed balance test platform and investigate its reliability and validity in 3-5 years old
      children.
    

Detailed description: 
      Children whose families signed consent form will be included. Height and weight will be
      measured. Then they will be taken to the balance measurements. Design will firstly be shown
      to child and one trial will be permitted before starting the test. Timed-up and Go test will
      also be used as a reliable and valid test for dynamic balance in this age group. Single leg
      standing will also be used to investigate the discrimination feature of the dynamic balance
      tested by new design platform.

      All tests will be done without socks and shoes. Timing will be the only results for all
      tests. Calibrated chronometers will be used for this aim. After all measurements complete,
      statistical analysis will be conducted.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children who have a typical development will be recruited from various kindergartens in
        Cyprus.
      
Keywords: Balance
A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
Condition: Smoking
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety
      of a single dose of CVT-301 in smoking and non-smoking adults.
    


Intervention name(s): CVT-301; Carbidopa
Intervention type(s): Drug; Drug
Intervention description(s): Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.; Administered orally according to the carbidopa dosing schedule.
Other intervention name(s): Lodosyn ®
Intervention MeSH terms: Carbidopa
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adults
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Condition: Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial
      in 25,875 U.S. men and women investigating whether taking daily dietary supplements of
      vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of
      developing cancer, heart disease, and stroke in people who do not have a prior history of
      these illnesses. This ancillary study is being conducted among participants in VITAL and will
      examine whether vitamin D or fish oil is associated with cognitive decline in 3000 older
      participants of VITAL.
    

Detailed description: 
      Primary aim of annual rate of cognitive decline. Secondary aims will be addressed in sub-set
      of participants: 1) among participants, African-American race (African-Americans have high
      risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on cognitive
      decline; 2) among a subset of participants, baseline plasma levels of vitamin D and omega-3
      fatty acids modify agent effects.
    

Intervention name(s): vitamin D3; omega-3 fatty acids (fish oil); Vitamin D3 placebo; Fish oil placebo
Intervention type(s): Dietary Supplement; Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin D3 (cholecalciferol), 2000 IU per day; Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).; Vitamin D placebo; Fish oil placebo
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT
Condition: Hepatocellular Carcinoma; Cholangiocarcinoma; Metastases; Stereotactic Body Radiotherapy
MeSH terms: Cholangiocarcinoma
Study type: Observational

Summary: 
      Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the
      galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique
      provides volumetric mapping of liver function and it allows quantisation of liver function.
      The method may be used for selection of patients for stereotactic radiotherapy of liver
      tumors, for determination of radiation induced liver dysfunction and may be included into the
      treatment planning process of stereotactic radiotherapy.
    


Intervention name(s): Measuring liver function by PET/CT
Intervention type(s): Other
Intervention description(s): Measuring liver function by use of FDGal and PET/CT before, 1 month and 3 months after stereotactic radiotherapy for liver tumors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with liver tumors reffered for stereotactic body radiation therapy
      
Keywords: liver function; galactose; 18-F-deoxy-galactose; PET/CT; stereotactic body radiation therapy; SBRT
Optimization of Asthma Treatment Through Exhaled NO for Increased Asthma-Related Quality of Life (NOAK)
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to
      regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in
      patients with allergic asthma
    


Intervention name(s): Single corticosteroid inhalers and Singulair
Intervention type(s): Drug
Intervention description(s): Treatment steps according to preset algorithm
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Allergy; Cytokines; Glucocorticoids; Inflammation; Nitric Oxide (NO); Quality of Life; Self-Rated Health; Stress