bioihbjkbjnl/mcl2 huggingface dataset:
Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study
Condition: Sports Nutritional Sciences
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      Abnormal opioid system have been identified in addictive behavior and activity of the opioid
      system has also shown a strong link with the nutritional balance. A significant increase in
      endorphin levels was noticed after exercise, proportional to the duration and intensity of
      this activity. One brain imaging study showed an increase in opioid activity in athletes
      after endurance training. However , a decrease in opioid tone related to receptor
      desensitization in the brain has been raised in the sport and it is possible to feel like ,
      the subject must perform physical exercise more frequently . Consequently, in order to deepen
      the hypothesis of addiction in high-level sport , the brain opioid activity should be
      assessed pre- training compared to a group of sedentary control subjects .

      Preliminary results of a previous study the investigators are conducting on anorexia nervosa
      (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and
      the regulation of gonadal function. However, the relation of cause and effect between these
      anomalies and undernutrition remains to be determined . Given the addictive component in the
      endurance sport and the variability of the nutritional status of its practitioners ,
      evaluation of brain activity in these subjects could provide additional answers.
    


Intervention name(s): [11C]diprenorphine
Intervention type(s): Other
Intervention description(s): 3 micrograms [11C]diprenorphine - intravenous use - 1 time
Other intervention name(s): radiopharmacentical precursor solution
Intervention MeSH terms: Diprenorphine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: endurance sportswomen; addiction; undernutrition; [11C]diprenorphine Pet; pituitary region
Food Matrix and Genetic Variability as Determinants of Bioavailability and Biological Effects of Beta-cryptoxanthin and Phytosterols
Condition: Hypercholesterolemia; Osteoporosis
MeSH terms: Osteoporosis; Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Regular consumption of a beverage containing β-cryptoxanthin (b-Cx) and plant sterols (Ps)
      has been shown to exert a synergic effect in reducing cardiovascular risk and bone remodeling
      markers (formation and resorption). The present project aims to assess the influence of
      technological treatment and genetic variability on the bioavailability and the health effects
      of the added components (Ps, b-Cx), in particular to their potential role in prevalent
      disorders.In vitro and in vivo studies will be carried out to this effect. In vitro and in
      vivo studies (human intervention study) will be performed and cardiovascular, bone turnover
      and inflammation markers will be evaluated. Additionally, an in vitro colonic fermentation
      model and cell cultures will be used to explore anticarcinogenic effects and potential
      cytotoxicity.
    


Intervention name(s): b-cryptoxanthin plus phytosterols
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: b-cryptoxanthin; plant sterols; serum Cholesterol; bone turnover markers
Single Ascending Dose Study of CM326 in Healthy Volunteers
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics,
      pharmacodynamics and immunogenicity of CM326 in healthy volunteers.
    


Intervention name(s): CM326; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
Condition: Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant
      treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of
      imatinib to convert a tumor from inoperable to operable.
    


Intervention name(s): imatinib mesylate
Intervention type(s): Drug
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastrointestinal,; stromal,; neoadjuvant,; imatinib,; mesylate,; pre-operatory
Teaching Children With Asthma and Who Live in a Rural Setting How to Self-Manage Their Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if teaching rural children with asthma and their parents about appropriate
      medication use, asthma triggers unique to a rural setting and increasing access to medical
      care will result in a decrease in emergency department visits.
    

Detailed description: 
      Many self-management asthma interventions have demonstrated increase in asthma knowledge,
      reduced emergency department visits, increased self-efficacy and quality of life. The type of
      self-management interventions, specifically individualized and interactive educational
      interventions, have been suggested to have the strongest effect on asthma morbidity. Few
      studies have tested asthma self-management educational interventions in increasing knowledge,
      self-efficacy and quality of life in rural pediatric populations. The goal of this study was
      to test the effectiveness of an asthma educational intervention in improving asthma knowledge
      in rural children and their parent/caregivers. We hypothesized that an interactive asthma
      educational intervention would increase parent/caregiver and child asthma knowledge resulting
      in decreased emergency room visits in rural families of children with asthma.
    

Intervention name(s): Nurse asthma education intervention; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Asthma Education; Asthma Education
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study Evaluating the Effects of AIR645 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy of inhaled AIR645 in the suppression of the Asthmatic Responses in
      subjects with mild asthma inhaling an allergen.
    


Intervention name(s): AIR645; Physiologic saline solution
Intervention type(s): Drug; Drug
Intervention description(s): AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.; Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypersensitivity; Lung Diseases, Obstructive; Immune System Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases; Hypersensitivity, Immediate; Asthma; Respiratory Hypersensitivity
Postural Assessment by Photogrammetry
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      This study aimed to measure the degree of thoracic kyphosis in elderly women with those
      affected by osteoporosis in the spine, through photogrammetry computer and check the
      difference between the values obtained with the assumption of greater thoracic kyphosis in
      osteoporotic women.
    

Detailed description: 
      The decrease in bone density of vertebrae leads to a reduction of the anterior vertebral
      bodies, resulting in compression and collapse of vertebrae, with narrowing of intervertebral
      disc spaces and, determining a number of deformities in the spine and postural changes, among
      which can highlight the increase in thoracic kyphosis. This becomes significantly higher with
      age and after menopause, defined as an increase in curvature in the sagittal plane of the
      thoracic spine.

      Radiographic images have been used for the measurement of thoracic kyphosis, but with some
      drawbacks of this method such as radiation exposure, radiographic image quality
      unsatisfactory hampering its analysis and the lack of equipment in the physical environment
      to monitor clinical evolution of the treatment, causing thus the search for noninvasive
      methods for evaluating the curves of the spine, including the photogrammetry computed.

      According to the American Society of Photogrammetry, the computed photogrammetry is "the art,
      science and technology of information on physical objects and environment through processes
      of recording, measuring and interpreting photographic images and patterns of electromagnetic
      radiant energy and other sources." It is a widely used tool for assessment by quantifying the
      postural changes through the application of photogrammetric principles to photographic images
      obtained in body movements, adding to the diagnostic evaluation for physical therapy in
      different areas.
    

Sampling method: Non-Probability Sample
Study population: 
        The investigators evaluated 12 women with mean age of 68.5 years (range 65 to 74 years),
        divided into two groups. Group 1 consists of six women with a densitometric diagnosis of
        osteoporosis in column (SD: -2.70 to -4.97) and group 2 consists of six women with a
        densitometric diagnosis of osteopenia in column (DP: 1.07 to -2 , 09), both compared with
        young adults.
      
Biospecimen description: 
      The two groups were photographed in the sagittal plane with right column markers fixed on two
      anatomical points. The selected images were quantified by computerized photogrametry, using
      the program Autocad-2006
    
Keywords: Osteoporosis; kyphosis; photogrammetry
Pharmacokinetics and Safety of ALA in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics and safety of ALA in patients with moderate and
      severe acne vulgaris after single dose in different dosages.
    


Intervention name(s): ALA 5%; ALA 10%
Intervention type(s): Drug; Drug
Intervention description(s): prepare 5% ALA solution, apply topically to the affected area for 1.5 hours, single dose; prepare 10% ALA solution, apply topically to the affected area for 3 hours, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne vulgaris
Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute
      treatment of migraine.
    

Detailed description: 
      Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment
      of migraine.
    

Intervention name(s): Ketorolac tromethamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride); Intranasal (IN) placebo
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine; Ketorolac
Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
Condition: Idiopathic Pulmonary Arterial Hypertension; Cardiomyopathy
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Cardiomyopathies
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to compare the number of participants with reversible
      pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as
      compared to 100% oxygen.
    


Intervention name(s): Nitric Oxide for inhalation; Oxygen; Nitric Oxide plus Oxygen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system; 100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system; Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
Other intervention name(s): INOmax®; Inhaled Nitric Oxide, Oxygen
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pulmonary Vasculature; Nitric Oxide; INOmax®; Acute Lung Injury; Pulmonary Vasodilator Testing; Idiopathic Pulmonary Arterial Hypertension; Congenital Heart Disease; reversible pulmonary hypertension; vasoreactivity; Congenital Heart Disease with Pulmonary Hypertension
Oral and Jaw Health in Bipolar Patients
Condition: Bipolar Disorders; Oral Health
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      The assessment of oral health, jaw health and related problems in bipolar patients is
      important to provide a holistic approach to patients in terms of physical, mental and
      psychosocial aspects and to improve quality of life. In this study, oral health,
      temporomandibular dysfunction (TMD) and oropharyngeal dysphagia (OD) were investigated in
      patients with Bipolar Disorder (BD).
    

Detailed description: 
      During the remission period, 70 individuals aged 20-60 years with BD were divided into two
      groups according to the duration of diagnosis as under ten years (Group 1=33) and over ten
      years (Group 2=37). Oral and dental health-related quality of life was assessed with the Oral
      Health Impact Profile-14 (OHIP-14), TMJ pain was assessed with the Numeric Pain Scale (NPS),
      the presence of TMJ discomfort was assessed with the Fonseca Anamnestic Questionnaire (FAQ),
      chewing functionality was assessed with the Jaw Function Limitation Scale-8 (JFLS-8), and
      oropharyngeal dysphagia was assessed with the Eating Assessment Tool (EAT-10).
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with bipolar disorder in remission
      
Keywords: Bipolar disorders; Oral health; Temporomandibular disorders
Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effect of a 1-year administration of the vitamin D analog
      2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density
      (BMD), safety, and tolerability.
    

Detailed description: 
      DP001 is a vitamin D analog that has been shown to stimulate bone formation in pre-clinical
      studies. In a Phase 1B study of postmenopausal women, an increase in the bone formation
      marker, osteocalcin, was evident without an increase in serum calcium. The aim of this study
      is to determine if 1-year administration of DP001 to postmenopausal women with osteopenia
      results in a significant increase in BMD at doses that are safe and well tolerated.
    

Intervention name(s): Placebo; DP001
Intervention type(s): Drug; Drug
Intervention description(s): oral, once daily; oral, once daily
Other intervention name(s): 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3; 2MD
Intervention MeSH terms: Dihydroxycholecalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis; 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3; Vitamin D; Bone Density Conservation Agents; Bone Regeneration
Clinical Features of Severe Patients With COVID-19
Condition: SARS-CoV2
MeSH terms: COVID-19
Study type: Observational

Summary: 
      As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit
      (ICU) community must prepare for the challenges associated with this pandemic. Providing an
      efficient care to the patients of the most severely affected category - intensive care unit
      (ICU) patients - has become one of the serious problems appearing in the COVID-19 pandemics.
      A typical patient's clinical portrait in ICU of COVID centers is very similar in different
      countries, however, the key to improve the treatment results for critically ill patients has
      not yet been found. Data on predictors of severe course in COVID-19 is limited. Knowledge of
      predictors of severe course of disease can lead to different selection of therapeutic
      strategy, determine the group of risk of patients for severe course of disease, and improve
      outcomes.
    

Detailed description: 
      The clinical disease (COVID-19) results in critical illness in about 5% of patients. The aim
      of the study is to identify predictors of the severe pneumonia caused by the SARS-CoV-2
      virus, and to describe the clinical features of patients admitted to an ICU of the
      COVID-center of the Federal Research Clinical Center of Federal Medical & Biological Agency
      on the first day and in dynamics till discharge from the ICU or death.

      The demographic and clinical data will be collected. Laboratory data (hemoglobin,
      lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, IL-6, procalcitonin, glucose
      level, high-sensitive troponin Т, vitamin D level, signs of the presence of a secondary
      bacterial infection, immunogram and Instrumental data (CT-scan, Electrocardiography,
      echocardiography, arterial and venous ultrasound investigation) will be analysed.

      This study is singlecentral observational trial.
    

Intervention name(s): The demographic, clinical, laboratory, and instrumental data
Intervention type(s): Diagnostic Test
Intervention description(s): Measurement of the demographic, clinical data, laboratory data, and instrumental data
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with COVID-19 requiring respiratory support
      
Keywords: SARS pneumonia; COVID-19; severe disease; risk factors
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA; Nephrosis, Lipoid
Study type: Interventional

Summary: 
      This is a single center,prospective,no-controlled clinical trial
    

Detailed description: 
      1. The complete remission of enough steroids as inducement therapy in adult minimal change
           disease-like IgA nephropathy patients

        2. The safety of enough steroids as inducement therapy in adult minimal change disease-like
           IgA nephropathy patients
    

Intervention name(s): Prednisone or Prednisolone
Intervention type(s): Drug
Intervention description(s): daily single dose of 1mg/kg (maximum 80mg) or alternate day single dose of 2mg/kg (maximum 120mg),maintained for a minimum period of 6 weeks and maximum period of 12 weeks. After achieving complete remission., corticosteroids should be tapered slowly, 10mg every two weeks tapered to reach 0.15mg/kg/d, then 2.5mg every two to four weeks tapered to reach the minimum dosage 10mg/ alternate day
Other intervention name(s): Prednisone, prednisolone, corticosteroids
Intervention MeSH terms: Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: enough steroids; MCD; efficacy
Effect of Dosing Time and Meal on IN-105 (Insulin Tregopil) PK and PD
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the PK and PD of oral IN-105 (Insulin Tregopil) w.r.t. time of dosing
      prior to meal, duration between meals and type of meal .
    

Detailed description: 
      A Phase 1, Randomized, Placebo Controlled, Crossover Trial in Type 2 Diabetes Patients to
      evaluate the effect of pre-meal dosing time, inter-meal interval and meal composition on the
      PK and PD of IN-105 (Insulin Tregopil), an oral insulin; conducted in 3 sequential cohorts in
      an adaptive manner .
    

Intervention name(s): IN-105 (Insulin Tregopil); Placebo comparator
Intervention type(s): Drug; Other
Intervention description(s): 15 mg strength tablets for oral use used at a dose of 30 mg; Placebo tablet for oral use
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3 Cohorts Cohort 1: 5 periods, 4 treatments and 5 sequences with a partial replicate crossover design Cohort 2: 6 periods, 6 treatments and 6 sequences in a cross-over design Cohort 3: 6 periods, 6 treatments and 6 sequences in a cross over design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral insulin; Dosing time; Insulin concentration; Prandial insulin; Post Prandial Glucose (PPG)