bioihbjkbjnl/mcl2 huggingface dataset:
Adenosine and A2A Receptors in Human Brown Adipose Tissue
Condition: Obesity
Study type: Interventional

Summary: 
      This study investigates the significance of adenosine and A2A receptors in human brown
      adipose tissue (BAT) in vivo. Using positron emission tomography (PET), perfusion and the
      density of A2A receptors will be measured in supraclavicular BAT and other tissues in healthy
      men. The investigators hypothesize, that adenosine can activate BAT, and that adenosine A2A
      receptor density changes when BAT is activated by cold exposure.

      Understanding the mechanisms of BAT activation and the role of endocannabinoids in humans is
      important and beneficial in fighting against the epidemic of obesity and diabetes.
    

Detailed description: 
      Adenosine is a purine nucleoside released locally in BAT when noradrenaline and ATP are
      released from sympathetic nerves. Recently it was found that adenosine activates murine and
      human brown adipocytes, and recruits beiging of white fat via adenosine A2A receptors (A2AR).
      Furthermore, studies with mice have shown improvements in glucose homeostasis after
      administration of A2AR agonists.

      In this study the investigators use the PET radiotracer [15O]-H2O to quantify perfusion of
      BAT, white adipose tissue (WAT) and muscle in three conditions: room temperature, cold
      exposure and intravenous infusion of adenosine. Another PET radiotracer [11C]TMSX is used to
      quantify adenosine A2A receptor density of BAT, WAT and muscle in room temperature and during
      cold exposure.
    

Intervention name(s): Adenosine; Cold exposure
Intervention type(s): Drug; Other
Intervention description(s): Intravenous infusion of adenosine (0.14 mg/kg) is administered for 5 minutes during PET/CT scan.; Controlled cold exposure is performed before and during PET/CT scan.
Other intervention name(s): Adenocor
Intervention MeSH terms: Adenosine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject participates in PET/CT scans in room temperature conditions, during cold exposure and during i.v. infusion of adenosine.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Adipose Tissue, Brown
Effect of Genetic Variation in Starch-digesting Enzymes on Digestibility and Glycemic Index of Cold and Hot Rice
Condition: Carbohydrate Intolerance
Study type: Interventional

Summary: 
      This study evaluates the effect of different methods of preparation (cooked and consumed hot
      vs cooked, cooled overnight and consumed cold) and variation in the activity of salivary
      amylase on the glycemic index and carbohydrate digestibility in healthy human subjects. The
      effect of genetic variation in small intestinal starch digesting enzymes on glycemic index
      and starch digestibility will also be assessed.
    


Intervention name(s): Glucose; Glucose plus lactulose; Hot Rice; Cold Rice
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 50g glucose dissolved in 250ml water; 50g glucose plus 10g lactulose dissolved in 250ml water; Freshly cooked polished rice containing 50g available carbohydrate (approximately 2/3 cup cooked rice) and consumed hot.; Cooked polished rice containing 50g available carbohydrate (approximately 2/3 cup cooked rice) cooled overnight in a refrigerator and consumed cold.
Intervention MeSH terms: Lactulose
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C
Condition: Bioavailability of Vitamin C
Study type: Interventional

Summary: 
      The aim of the study was to compare the profiles of vitamin C serum concentration in healthy
      volunteers after the single oral administration either in a liposomal (Liposovit-C pure) or
      traditional formulation.
    

Detailed description: 
      The randomized, double-blind, cross-over study was conducted under the supervision of
      physician on a group of 10 healthy subjects. The volunteers received 1g of vitamin C in a
      traditional formulation (powder in capsules), and after 14 days of a washout period 1 gram of
      Liposovit-C pure (liposomal formulation, powder in capsules). Venous blood was collected from
      each participant of the study immediately before the administration of a studied substance
      and 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 24 hours post
      the administration.
    

Intervention name(s): Liposomal Vitamin C (Liposovit-C); Traditional Vitamin C
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1000 mg of ascorbic acid in liposomal formulation; 1000 mg of ascorbic acid in traditional formulation
Intervention MeSH terms: Vitamins; Ascorbic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Liposovit-C; Ascorbic Acid; Liposomal Vitamin C
The Effects of Processed Whole Orange on Subjective Ratings of Satiety
Condition: Self Reported Ratings of Hunger
Study type: Interventional

Summary: 
      The study is a human dietary test meal study that is a randomized, controlled, double blind,
      cross over design with 3 intervention arms that will investigate the subjective ratings of
      satiety in response to different levels of processed whole orange compared with a
      sugar-matched isocaloric control
    


Intervention name(s): Orange flavored beverage
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Satiety, beverage, crossover
Prognostic Molecular Markers in Patients With Myelodysplastic Syndrome
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Observational

Summary: 
      In the era of hypomethylating agent in MDS treatment, the investigators aimed to investigate
      the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2)
      on the outcomes of 1st line decitabine treatment in MDS.
    

Detailed description: 
      A number of studies have tried to investigate clinical impact of mutations in spliceosomal
      machinery genes in MDS but they failed to demonstrate a consistent prognostic relevance.
      Moreover, the clinical impact of these mutations on the outcomes of hypomethylating agent
      treatment in MDS has never been explored yet. The investigators investigated the prognostic
      impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2) on the outcomes
      of 1st line decitabine treatment in MDS.
    

Intervention name(s): spliceosome
Intervention type(s): Genetic
Intervention description(s): spliceosome mutations
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        de novo MDS patients were included in the study who had received 1st line decitabine
        treatment and had adequate genomic DNA from pretreated bone marrow samples
      
Biospecimen description: 
      Genomic DNA extracted from bone marrow aspirate
    
Keywords: myelodysplastic syndrome; decitabine; spliceosome mutation
A Study of ASP4070 to Confirm Safety and Immunological Response in Patients With Pollen Allergy
Condition: Cedar Pollinosis
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen
      allergy
    

Detailed description: 
      This study consists of 2 parts: Part 1 and Part 2. [Part 1] An open-label, un-controlled
      study Examine the safety for the ASP4070 intramuscular vaccination group (high dose x 4
      times) and the ASP4070 intradermal vaccination group (high dose x 4 times).

      [Part 2] A placebo-controlled, double-blinded, randomized, parallel-group comparative study
      Assess the immunological response and safety for the ASP 4070 intramuscular vaccination group
      (high dose x 1 time and high dose x 4 times) and the ASP4070 intradermal vaccination group
      (low dose x 1 time, low x 4 times, high dose x 1 time, and high dose x 4 times) as compared
      to those for the placebo group. The study will be double-blinded within the same route of
      vaccination, and non-blinded between the routes of vaccination (between the intramuscular
      vaccination group and intradermal vaccination group).

      The first vaccination to the subjects in Part 2 will start at least 14 days after the first
      vaccination to the subjects in Part 1 (6 subjects).

      For both Part 1 and Part 2, primary study period is for 3 months starting from the last dose
      of the study drug at Day 43 (until Day 127). After the primary study period, safety
      information will be collected for 9 months (for 1 year from the last dose of the study drug)
      as the long-term safety follow-up study period. Safety information will be collected for 1
      year starting from the last vaccination of the study drug also from the patients who
      discontinued the participation in the study during the primary study period if the patients
      agree.
    

Intervention name(s): ASP4070; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intramuscular or intradermal; intramuscular or intradermal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cedar pollinosis; immunological response,; ASP4070; vaccine
Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI
Condition: Urinary Tract Infections
MeSH terms: Infections; Urinary Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2, randomised, double-blind, 2-cohort study in hospitalised adults with complicated
      urinary tract infection (cUTI), including acute pyelonephritis. All study cohorts were
      randomised in a 2:1 ratio. Treatment duration for each cohort was 7 to 10 days. Patients were
      not permitted to switch to oral therapy.

      Cohort 1: 15 patients treated with cefepime 1 g/AAI101 500 mg intravenous (i.v.) infusion
      over 2 hours once every 8 hours (q8h), and 7 patients treated with cefepime 1 g i.v. infusion
      over 2 hours q8h.

      Cohort 2: 15 patients treated with cefepime 2 g/AAI101 750 mg i.v. infusion over 2 hours q8h,
      and 8 patients treated with cefepime 2 g i.v. infusion over 2 hours q8h.
    


Intervention name(s): Cefepime 1G - 2G / AAI101 0.5G - 0.75G; cefepime 1 g or cefepime 2 g
Intervention type(s): Drug; Drug
Intervention description(s): Experimental drug; cefepime monotherapy
Other intervention name(s): cefepime/AAI101 combination; cefepime alone
Intervention MeSH terms: Cefepime; Enmetazobactam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP With Vehicle Irrigation Solution in Subjects Undergoing Meniscectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP)
      compared with vehicle irrigation solution for prevention of pain and pain relief in subjects
      undergoing meniscectomy. The pain relief is assessed based on Visual Analog Scale (VAS) Pain
      Scores in the immediate 24-hour postoperative period and for seven days postoperatively.
    


Intervention name(s): OMS103HP; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Maximum 6 bags of OMS103HP irrigation solution; Maximum of 6 bags of vehicle irrigation solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meniscectomy
Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch
Condition: or Peripheral Nerve Injury (PNI); Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
MeSH terms: Neuralgia; Neuralgia, Postherpetic; Peripheral Nerve Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is
      applied prior to the application of QUTENZA. This is a multi-center, randomized,
      assessor-blinded study which will investigate the use of an oral analgesic as an alternative
      form of pre-treatment for QUTENZA.
    

Detailed description: 
      All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one
      of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic
      (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7
      days to monitor pain scores and tolerability.
    

Intervention name(s): QUTENZA; Lidocaine; Tramadol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): topical; topical; oral
Other intervention name(s): capsaicin 8% patch
Intervention MeSH terms: Lidocaine; Tramadol; Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tramadol; QUTENZA; Pre-treatment; Tolerability
Sitting Balance in Lower Limb Amputees
Condition: Amputation; Traumatic Amputation of Lower Extremity
MeSH terms: Amputation, Traumatic
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to compare the sitting and standing postural stability of
      transfemoral individuals with healthy individuals with similar demographic characteristics.
    

Detailed description: 
      Postural stability is important for amputees to perform daily life activities and participate
      in social activities. The aim of this study is to compare the sitting and standing stability
      of transfemoral individuals with healthy individuals with similar demographic
      characteristics. A force platform was used to measure the postural stability of individuals.
      The sitting limits of stability of the participants were recorded in cm. Amputees between the
      ages of 18-50, using their prosthesis for at least 6 months, and healthy individuals with
      similar demographic characteristics were included in the study. Congenital amputees,
      individuals with bilateral lower extremity amputations, and individuals with central or
      peripheral vestibular disorders were excluded. Our study will reveal the importance of
      sitting stability limits in the evaluation and treatment of amputees.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Amputees who applied to our faculty for prosthesis construction and control, and healthy
        individuals from relatives of the researcher reached by snowball method will constitute the
        sample of the study.
      
Keywords: Limits of stability; Sitting balance; Standing balance
Effects of Gene Polymorphism After Transcranial Cranial Direct Current Stimulation on the Corticobulbar Excitability
Condition: Healthy
Study type: Observational

Summary: 
      This study aims to examine the effects of transcranial direct current stimulation at
      corticobulbar excitability in individuals with different gene polymorphism.
    

Detailed description: 
      The effects of TDCS on corticobulbar excitability of the brain after inhibitory
      pre-conditioning will be compared in patients with different BDNF phenotypes
    

Intervention name(s): tdcs
Intervention type(s): Device
Intervention description(s): application of optimised parameters of tDCS (anodal stimulation, 1.5 mA, 10 min) over the unconditioned hemisphere reverses the brain and behavioural consequences of inhibitory pre-conditioning
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy young volunteers
      
Biospecimen description: 
      DNA of gene polymorphism from the Polymorphisms in brain-derived neurotrophic factor
A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR
      DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA®
      HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg
      (TIOTROPIUM) in patients with COPD.

      SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH & Co. KG.

      ADVAIR DISKUS® are registered trademarks of the GSK group of companies.
    


Intervention name(s): Tiotropium Bromide; Fluticasone Propionate/Salmeterol
Intervention type(s): Drug; Drug
Intervention description(s): Long-acting muscarinic antagonist; Inhaled corticosteroid plus long-acting bronchodilator
Intervention MeSH terms: Fluticasone; Xhance; Bromides; Tiotropium Bromide; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Spirometry; COPD
Mobile Health Cognitive Stimulation in Heroin Users
Condition: Substance Use Disorder
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Heroin use has been related to brain dysfunction particularly in the prefrontal cortex. These
      effects are evident in neuropsychological impairments in attention, memory and executive
      functioning of heroin users. To assess these deficits and the application of a novel approach
      of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried
      out a neuropsychological intervention program with mobile health technology. Patients
      diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in
      a three-day/week basis.
    


Intervention name(s): Mobile health cognitive stimulation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid Abuse Disorder; Cognitive Therapy; Executive Function; Mobile Health; Rehabilitation
A Feasibility Study With Iressa in Resistant Cytokeratin-Positive Tumor Cells Circulating in the Blood of Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach
      with potential application in the treatment of human breast cancer. Therefore it could be
      very important and clinically relevant to know if ZD1839 is capable of eliminating occult
      tumour cells circulating in the blood of breast cancer patients
    


Intervention name(s): ZD1839
Intervention type(s): Drug
Intervention description(s): ZD1839 will be given at the dose of 250mg/day for a minimum of 3 months
Other intervention name(s): Iressa
Intervention MeSH terms: Gefitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; iressa circulating tumor cells
Home Based Computer Gaming Hand Exercise Regimen for People With Arthritis Affecting the Hands
Condition: Rheumatoid Arthritis; Osteoarthritis of Hands
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether a novel computer gaming hand exercise
      regimen would improve hand function, decrease pain/ stiffness and be feasible in people with
      Rheumatoid arthritis or Osteoarthritis affecting the hands.
    

Detailed description: 
      A novel computer gaming hand exercise regimen has been designed for people with Rheumatoid
      arthritis (RA) or Osteo arthritis (OA) affecting the hands. The design allows a broad range
      of common objects of daily life to be seamlessly transformed into 'therapeutic' input devices
      by instrumenting with a small motion sense mouse. Based on individual abilities and treatment
      needs, objects are selected to train specific fine/ gross dexterous functions. The object
      manipulations (therapeutic exercises) are then used to control and play any commercially
      available computer game, making practice challenging and engaging.

      The study is of six weeks duration comparing the computer gaming and conventional hand
      exercises in thirty people diagnosed with RA or OA affecting the hands. The investigators
      hypothesize that the game based exercises will improve hand function and reduce
      pain/stiffness and be feasible compared to the conventional hand exercises.A mixed-effect
      repeated measures analysis of variance will be conducted to test pre to post treatment
      outcomes. This will be the first study to evaluate the therapeutic effects and feasibility of
      the computer gaming hand exercise regimen in people with RA or OA.
    

Intervention name(s): Conventional hand exercise program; Computer gaming hand exercise regimen
Intervention type(s): Other; Other
Intervention description(s): Exercises targeted to improve finger range of motion and hand strength.The exercises will be performed 30 minutes,four times per week for six weeks; Computer gaming hand exercise regimen using common objects of daily life. The hand exercises are coupled with commercially available computer games and will be performed 30 minutes,four times per week for six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hand exercises; Hand function; Computer based exercises; Therapeutic gaming