bioihbjkbjnl/mcl2 huggingface dataset:
Serum Fibroblast Growth Factor-21 Levels During Prolonged Fasting
Condition: Fibroblast Growth Factor-21; Fasting
Study type: Observational

Summary: 
      The investigators hypothesized that serum FGF21 levels would increase with prolongation of
      the fasting period. The investigators also hypothesized that food intake and body composition
      would change. The study was conducted with 12 healthy male adults. A questionnaire was
      administered at the beginning of the study. Anthropometric measurements, dietary intake and
      physical activities were recorded and blood samples were taken before, during and after
      Ramadan.
    

Detailed description: 
      The aim of this study was to determine the effects of hunger on serum Fibroblast Growth
      Factor 21 (FGF21) levels, nutritional status and anthropometric measurements of adult males
      during fasting. FGF21 is a significant protein in the process of adaption to fasting due to
      its effects on liver, adipose tissue, and brain. A total of 12 healthy individuals with
      normal body mass index, between the ages of 18 to 35 participated to this cross-sectional
      study. All participants provided written informed consent. Sample size determined with power
      analysis. A questionnaire was administered in order to determine individuals' general
      characteristics, nutrition habits, and smoking and alcohol habits. Anthropometric
      measurements, 24 hours dietary recall and physical activities were recorded and blood samples
      were taken four times in following periods; before Ramadan, first week of Ramadan, third week
      of Ramadan and two weeks after Ramadan. Serum FGF21 levels were determined by ELISA
      (Enzyme-Linked Immunosorbent Assay). Mean energy and nutrient intake were calculated by BEBIS
      (Nutrition Information System) and results were compared with Recommended Dietary Allowances
      (RDA). Paired samples t-test and Wilcoxon-signed rank test were used to explore differences.
      The study was approved by Hacettepe University Non-Interventional Clinical Research Ethics
      Board.
    

Intervention name(s): 12 hour fasting for 29 days
Intervention type(s): Behavioral
Intervention description(s): This study aims to determine the effects of fasting on serum FGF21 levels. For this reason, male adults who fasted during the Ramadan were included in the study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals were recruited through social media announcements. Individuals residing in
        Ankara, where Hacettepe University is located, were recruited.
      
Biospecimen description: 
      Blood samples were collected.
    
Keywords: FGF-21; Fasting; Ramadan
Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment
Condition: Urea Cycle Disorders
MeSH terms: Urea Cycle Disorders, Inborn
Study type: Interventional

Summary: 
      In this short-term study a method for the evaluation of the metabolic competency of the urea
      cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for
      patients with urea cycle disorders and to monitor the severity of the disease, a reliable and
      safe quantitative method for the measurement of the urea cycle flux is required.

      Urea synthesis will be evaluated by administering sodium [1-13C]-acetate and measuring
      subsequent incorporation of [13C] label from Na-acetate into urea in healthy volunteers and
      asymptomatic subjects genetically disposed to urea cycle disorders.
    


Intervention name(s): sodium [1-13C] acetate
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: isotope ratio measurement; urea cycle; 13C acetate; Healthy adults
Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function
Condition: Cognitive Function
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on
      improvement of Memory Function. The investigators measured decrement of improvement of Memory
      Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood
      pressure.
    


Intervention name(s): Eriobotyra Japonica Lindley Extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Eriobotyra Japonica Lindley Extract (1.5g/day); Placebo (1.5g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
High-intensity Interval Training Enhances Mobilization/Functionality of Endothelial Progenitor Cells and Depressed Shedding of Vascular Endothelial Cells Undergoing Hypoxia
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Exercise training improves endothelium-dependent vasodilation, whereas hypoxic stress causes
      vascular endothelial dysfunction. Monocyte- derived endothelial progenitor cells (Mon-EPCs)
      contribute to vascular repair process by differentiating into endothelial cells. This study
      investigates how high-intensity interval (HIT) and moderate intensity-continuous (MCT)
      exercise training affect circulating Mon-EPC levels and EPC functionality under hypoxic
      condition. Sixty healthy sedentary males were randomized to engage either HIT (3-minute
      intervals at 40% and 80%VO2max , n=20) or MCT (sustained 60%VO2max , n=20) for 30
      minutes/day, 5 days/week for 6 weeks, or to a control group that did not received exercise
      intervention (n=20). Mon-EPC characteristics and EPC functionality under hypoxic exercise
      (HE, 100W under 12%O 2 ) were determined before and after various interventions.
    


Intervention name(s): HIT; MCT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3-minute intervals at 40% and 80%VO 2max; sustained 60%VO 2max
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: endothelial progenitor cell; hemodynamic; Exercise; HIIT
The Effects of OC000459 on Nasal Mediators
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is the first proof of concept study for OC000459 and is undertaken to assess the effects
      of the compound on the development of inflammatory cytokines in a model (nasal allergen
      challenge model) that is validated and clinically safe and easy to conduct. OC000459 will be
      compared with placebo in the study.

      The study will be a randomised, double blind, placebo controlled, crossover evaluation of the
      effect of OC000459 on cytokine secretion induced by nasal allergen challenge. Male subjects
      with a known history of allergic rhinitis and screening positive to allergen will be
      included. After dosing with OC000459 or placebo, nasal allergen challenge will be performed
      and measurements made in the nasal fluids. Nasal symptom scores will also be recorded. Safety
      parameters will be monitored throughout.
    


Intervention name(s): Oxagen OC000459
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Nasal Allergen Challenge Study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic rhinitis
The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants
Condition: Healthy
Study type: Interventional

Summary: 
      This is a randomized, open-label, prospective study to evaluate the nutritive effects of an
      a2 infant formula on growth and tolerance in healthy term infants. A total of 280 healthy,
      term, mixed-fed infants between 60 and 120 days of age were enrolled at Shanghai. The
      participants were randomly assigned to one of the two study groups: the a2 infant formula
      group and the conventional A1/A2 infant formula group. Each group contained 140 infants. The
      study duration was 56 days.
    

Detailed description: 
      Primary objective:

      To compare the growth measurements of the infants fed with the a2 infant formula with those
      fed with conventional A1/A2 infant formula during the study period.

      Secondary objectives:

      To compare the two study groups in

        1. Dermatitis quality of life

        2. Formula tolerability and acceptability

        3. All medically confirmed adverse events

      The study included four visits at day 0 (baseline), day 14, day 28 and day 56. Information of
      efficacy outcomes were collected at each visit. Subject diary was used to record tolerance
      data and daily formula feeding amount during the study. The parents of the participants were
      also required evaluate their satisfaction with the study formula at the last visit.
    

Intervention name(s): a2 Platinum Premium Infant Formula Stage 1; Frisolac Infant Formula Stage 1 (Dutch Edition)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral intake of a2 Platinum Premium Infant Formula Stage 1 milk powder (dissolved in water); Oral intake of Frisolac Infant Formula Step 1 (Dutch Edition) milk power (dissolved in water)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
e-GAB: Electronic Geriatric Assessment Bundle: Development of an Arabic Self-administered Android CGA Application
Condition: Health Services for the Aged; Frailty; Cognitive Impairment; Depression; Disability Physical; Urinary Incontinence; Malnutrition
MeSH terms: Urinary Incontinence; Malnutrition; Frailty
Study type: Observational

Summary: 
      The aim of this study is to design and assess the accuracy of administering the electronic
      Geriatric Assessment Bundle (e-GAB) compared to geriatrician performed comprehensive
      geriatric assessment (CGA) in a group of Egyptian elderly. The development of an Arabic
      software platform for CGA can improve the clinical practice by providing a valid user
      friendly tool to collect and analyze data for geriatric patients attending non- Geriatric
      health care service.
    

Detailed description: 
      Modern geriatric care is based primarily on the concept of multidisciplinary approach of
      elderly care. This could be achieved by integrating CGA in different disciplines dealing with
      the older patient. CGA is different from that of the standard medical evaluation; it is a
      systematic evaluation of frail older adults. It uses combinations of validated geriatric
      tools to formulate an inventory of health problems, and develop an individualized geriatric
      intervention plan.

      The software platform for CGA has been widely used in western countries; however, tools that
      can fit patients with different backgrounds should be implemented..

      From the initial pool of 3 potential subtests, four experienced geriatricians developed a
      bundle of 15 subtests, to evaluate cognition, mood, vision, hearing, urinary continence,
      nutrition, functional capacity, fall risk and balance impairment, frailty, polypharmacy,
      sleep, pain, home safety, and social problems. Moreover, a rapid survey of medical and
      surgical conditions was obtained.

      Initial evaluation of these subsets compared to the reference standard CGA was done. Each
      patient completed the bundle then underwent CGA by an experienced geriatrician blinded to the
      result of e-GAB
    

Intervention name(s): e-GAB; standard physician performed CGA
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): android application for comprehensive geriatric assessment; CGA by an experienced geriatrician blinded to the result of e-GAB
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        50 elderly patients completed the bundle then underwent CGA by an experienced geriatrician
        blinded to the result of e-GAB
      
Keywords: comprehensive geriatric assessment; telemedicine; multidisciplinary approach of elderly care; electronic geriatric assessment bundle
Treatment Study: Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC)
Condition: Heroin Dependence; Opioid-Related Disorders; Cocaine Abuse or Dependence
MeSH terms: Opioid-Related Disorders; Cocaine-Related Disorders; Heroin Dependence
Study type: Observational

Summary: 
      This research study takes place at Wayne State University and will take about 11 weeks to
      complete. This is a treatment research study for individuals who currently have cocaine abuse
      or dependence, and who may also have heroin dependence. The purpose of this study is to test
      whether oral sustained release d-amphetamine (SR-AMP) is safe and more effective than placebo
      for preventing relapse to cocaine use for individuals who abuse or are dependent upon
      cocaine. We are also interested whether, for patients who are dependent on cocaine and
      heroin, whether SR-AMP is safe and effective for preventing cocaine relapse in combination
      with buprenorphine.
    

Detailed description: 
      Cocaine dependence, particularly in combination with heroin dependence, poses serious and
      substantial public health, social, and economic problems (e.g., high medical costs, crime,
      lost productivity). Cocaine and heroin use disorders often co-occur, and this conjunction is
      associated with higher rates of medical and psychiatric problems and worse drug abuse
      treatment outcome.

      Many medications have been tested, but have failed, for treating cocaine dependence alone or
      in cocaine abusers who also use heroin.

      This clinical trial will test whether SR-AMP is more effective than placebo for preventing
      relapse to cocaine use, using SR-AMP for patients with only cocaine dependence, or in
      combination with buprenorphine (for those patients who are also dependent on heroin).

      Participants will first be an outpatient and must come to the Jefferson Avenue Research
      Program three times per week (e.g. Monday, Wednesday, Friday) to measure drug use and
      drug-related symptoms. This phase will last at least 2 weeks.

      Next, participants will live on an inpatient research unit for seven (7) consecutive nights.
      During the weeklong inpatient stay, in addition to receiving SR-AMP or placebo capsules,
      participants will begin counseling treatment to help prepare to avoid relapse after they are
      discharged from the inpatient unit.

      After the inpatient stay, participants will then be an outpatient and come to the Jefferson
      Ave. Research Program daily for eight (8) weeks. Throughout all eight weeks, three urine
      samples will be collected each week to assess illicit drug use, and questionnaires related to
      drug symptoms and to assess mood and risk behaviors will be given.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Heroin dependent and Cocaine abuse or dependent research volunteers.
      
Keywords: Opioid; Cocaine
A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the
      safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of
      MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell
      carcinoma of the head and neck.
    


Intervention name(s): MEDI4736; tremelimumab
Intervention type(s): Biological; Biological
Intervention description(s): MEDI4736 will be administered by IV infusion in combination with tremelimumab.; Tremelimumab will be administered by IV infusion in combination with MEDI4736.
Intervention MeSH terms: Durvalumab; Tremelimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effectiveness and safety of denosumab in treating women with
      Postmenopausal Osteoporosis.
    


Intervention name(s): placebo; Denosumab
Intervention type(s): Drug; Drug
Intervention description(s): Placebo administered by subcutaneous injection; Denosumab 60 mg administered by subcutaneous injection
Other intervention name(s): AMG 162; Prolia®
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postmenopausal Osteoporosis
EFFORT Asthma: Effects of Diet and Exercise in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This project aims to study the effects of lifestyle changes on asthma and systemic
      inflammation in a randomized clinical trial of diet and exercise. The project is a
      multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred
      on improving asthma control in non-obese sedentary asthmatics via simple means.
    

Detailed description: 
      After screening and enrollment, a total of 200 Danish sedentary, non-obese asthma patients
      will be randomized to one of four groups: 1) control group (no intervention), 2) physical
      exercise intervention, 3) diet intervention (a diet with an overall high content of protein
      and a low glycemic index) or 4) exercise plus diet intervention.

      Asthma is defined as respiratory symptoms and at least one positive asthma test. Patients
      will continue their regular doses of anti-asthma treatment unchanged throughout the study
      period. Type of anti-inflammatory medicine will be recorded and the adherence to the therapy
      will be assessed before the intervention period and at follow-up using questionnaires
    

Intervention name(s): Exercise; Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Aerobe exercise 3 times a week in 8 weeks; Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Drug Interaction and Safety Between Pitavastatin and Valsartan (CWP-PTV-101)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate a pharmacokinetic drug interaction and safety between
      Pitavastatin and Valsartan in healthy male subjects
    


Intervention name(s): Multiple Oral Dose of; Multiple Oral Dose of
Intervention type(s): Drug; Drug
Intervention description(s): Pitavastatin 4mg; Valsartan 320mg
Other intervention name(s): Livalo®; Diovan®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: healthy volunteers
A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions
Condition: Lung Cancer
Study type: Interventional
Phase: Phase 4

Summary: 
      Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

        -  ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and

        -  Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada)
           afterasingle-doseinhealthysubjectsunderfastingconditions.
    

Detailed description: 
      This is a blinded,single-dose,randomized,two-period,two-sequence,two-treatment,cross over
      study, designed to evaluate the comparative bioavailability of two formulations of erlotinib
      HCl 150mg tablets administered to healthy male and female subjects under fasting conditions.

      • SubjectswererandomlyassignedtooneofthetwodosingsequencesABorBA underfasting conditions.
    

Intervention name(s): Erlotinib HCl 150 mg; Tarceva®
Intervention type(s): Drug; Drug
Intervention description(s): Concentrations of erlotinib were measured from the samples collected over a 72 hour interval after receiving either Erotinib generic or Tarceva original. Later, after 14 days, a crossover was took place with the same measures.
dosing in each period.; Tarceva® 150 mg
Intervention MeSH terms: Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Based on the log-transformed parameters, the following criteria were used to evaluate the bioequivalence between the test and reference products:
The 90% confidence interval of the relative mean AUCt of the test to reference products should be between80% and125%.
TherelativemeanCmaxofthetesttoreferenceproductsshouldbebetween80% and125%
Masking: None (Open Label)
Primary purpose: Other
Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effects of teriparatide on skeleton images in
      postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that
      stimulates the production of new bone in the skeleton. This process of bone formation can be
      studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This
      trial will test whether bone scans will identify areas of the skeleton that are forming new
      bone during teriparatide therapy. It also will study what these areas look like after therapy
      is stopped.
    


Intervention name(s): teriparatide
Intervention type(s): Drug
Intervention description(s): Subcutaneous, 20 microgram (mcg)/day, 18 months
Other intervention name(s): LY333334; Forteo; Forsteo
Intervention MeSH terms: Teriparatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment