bioihbjkbjnl/mcl2 huggingface dataset:
GLP-1 Agonism Stimulates Browning of Subcutaneous White Adipose Tissue in Obesity Men
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT),
      play an essential role in regulating whole-body energy homeostasis. Excess expansion of WAT
      due to positive energy balance and defects in thermogenic gene expression in BAT are
      associated with obesity and various metabolic diseases. Until 2009 the question of whether
      adult humans had BAT and whether it could conceivably contribute to whole body energy usage
      in a meaningful way was a matter of vigorous debate. The publication of three apppers in the
      New England Journal of Medicine that demonstrated adult humans do have BAT, that it can be
      activated, and that this activation appears to be defective in obesity reframed the debate,
      and revived interest in BAT physiology. Recent studies also reveal the presence of a subset
      of cells in WAT that could be induced by environmental or hormonal factors to become
      ''brown-like'' cells, and this ''beigeing'' process has been suggested to have strong
      antiobesity and antidiabetic benefits.

      The extrapancreatic actions of glucagon-like peptide-1 (GLP-1) on endothelial cells and the
      liver have been reported. Additionally, effects of GLP-1 on adipose tissue have been
      described. Studies performed in isolated adipocytes have demonstrated that GLP-1 has the
      ability to induce both lipogenic and lipolytic mechanisms in white adipose tissue (WAT) .
      More recent study showed that GLP-1 agonism stimulates brown adipose tissue thermogenesis and
      browning through hypothalamic AMP-activated protein kinase (AMPK) in animal. However, there
      is no data clearly show that GLP-1 agonism stimulates browning of subcutaneous white adipose
      tissue (SWAT) in human obesity.
    

Detailed description: 
      Individuals were treated for 10 days. Biopsy for subcutaneous white adipose (1.5X1.5X1.5cm)
      was performed before and after 10 days treatment programme under local anesthesia. Measure
      the brown fat characteristics of biopsy samples.The sample was immediately processed in 3
      sections.One part was stored for immunohistology and western blot, the second was snap-frozen
      for estimation of biochemical markers, and the remainder was used to harvest small
      subcutaneous arteries with micro-dissection. Also, the perivascular adipose tissue (PVAT) was
      studied on the changes of morphology and possible signal pathways before and after GLP-1
      treatment.
    

Intervention name(s): Exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vaccination With Autologous Dendritic Cells Pulsed With HIV-Antigens for Treatment of Patients With Chronic HIV-Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I test of concept study: In an attempt to induce new immunity to HIV-1 during untreated
      HIV-1 infection the investigators have identified relatively immune silent immune subdominant
      HLA-A2-restricted HIV-1 CTL epitopes that fit individuals with the HLA-A2 tissue type (about
      50% of peoples in Denmark). Immunising with these conserved epitopes could induce new
      immunity and lower viral load so the patient will live longer before AIDS or Antiviral
      medicine and a lower viral load will limit spread in the population. As adjuvants the
      investigators used patients' own autologous Dendritic Cells generated from blood cells in
      vitro. 12 healthy male HIV-1 infected not in therapy individuals were used for this
      therapeutic vaccination and tested for safety and induction of new cellular CD8 and CD4
      T-cell immunity.
    


Intervention name(s): Peptides on autologous Dendritic Cells
Intervention type(s): Biological
Intervention description(s): 10 Peptides Pulsed onto 10e7 autologous macrophage-derived maturated dendritic cells administered s.c. week 0, 2, 4, 8.
Gag150 RLLNAWVKV
Gag433 FLGKIWPV
Env 67 NIWATHACV
Pol606 KLGKAGYVV
Vpu66 ALVEMGHHV
Vif101 GLADQLIHL
Vif23 SLVKHHMYV
Gag298 KRWIILGLNKIVRMY
gp41 VWGIKQLQARVLAVERYLKD
Padre AKXVAAWTLKAAA
Other intervention name(s): Dendritic Cells; HIV-1 Peptides
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; HLA-A2; Therapeutic; Vaccine; treatment vaccine; treatment naive
Effect of Dapagliflozin on IAH in T1DM
Condition: Diabetes Mellitus, Type 1; Hypoglycemia; Hypoglycemia Unawareness
MeSH terms: Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect
      hypoglycaemia, a condition referred to as impaired awareness of hypoglycaemia (IAH) that
      causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IAH is usually
      the end-result of a process of habituation to recurrent hypoglycaemia that is potentially
      reversible. Treatment with sodium glucose cotransporter (SGLT)-2 inhibitors (SGLT-2i) in
      addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type
      1 diabetes. This study will test the hypothesis that treatment with the SGLT-2 inhibitor,
      dapagliflozin, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia
      in patients with type 1 diabetes and IAH. In a randomized doubleblind placebo-controlled
      cross-over trial, patients will be treated for 8 weeks with dapagliflozin (or placebo), after
      which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a
      hyperinsulinemic hypoglycemic glucose clamp study.
    


Intervention name(s): Dapagliflozin; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): 8 weeks treatment with dapagliflozin on top of insulin treatment; 8 weeks treatment with placebo capsules on top of insulin treatment
Other intervention name(s): Forxiga
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
Condition: Peripheral Vascular Diseases; Diabetic Foot
MeSH terms: Diabetic Foot; Vascular Diseases; Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases; Peripheral Arterial Disease; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to assess the efficacy and safety of autologous transplantation of
      bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with
      non-revascularizable critical limb ischemia.
    

Detailed description: 
      Phase I/II, prospective, single-center study, with consecutive inclusion of 20 diabetic
      patients with critical limb ischemia due to bellow-the-knee extensive arterial disease.

      After the inclusion, patients are submitted to a bone-marrow aspiration (30 ml) under
      sedation. Autologous bone-marrow mononuclear cells (minimum 80 millions mononuclear cells)
      are infused intraarterially at popliteal artery by blocking antegrade perfusion during 3
      minutes.

      Clinical and angiographic follow-up will be performed at 3 months after the infusion to
      assess the efficacy of autologous mononuclear cells transplantation in terms of:

        -  Changes in below-the-knee angiography from baseline to 3 months follow-up.

        -  Changes in Ankle-Brachial pressure Index, transcutaneous oxygen pressure, and size of
           main ischemic ulcer will be also assessed at target limb.
    

Intervention name(s): Autologous Bone Marrow Mononuclear Cells
Intervention type(s): Procedure
Intervention description(s): Infusion > 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Complications; Lower limb ischemia; Adult stem cells
Drug-Drug Interaction Study in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of rifampin on the pharmacokinetics of
      K-877 in healthy adult volunteers.
    


Intervention name(s): K-877; Rifampin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Adult Volunteers
Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on,
      parallel-group study to evaluate the effect of rasagiline on cognitive function in adults
      with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).
    


Intervention name(s): Rasagiline; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Azilect® (rasagiline [N-propargyl-1-(R)-aminoindan] mesylate); TVP-1012
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Cognition; Rasagiline
Concurrent Training for Optimal Physiological and Physical Benefits
Condition: Healthy; Physical Inactivity
Study type: Interventional

Summary: 
      It is widely accepted that aerobic exercise and strengthen training are the core components
      of most workout programs. However, there is no clear consensus on whether the order in which
      the exercises are performed impacts their effectiveness. Therefore, the overarching aim of
      the study is to understand the optimal order of two types of concurrent training program for
      13 weeks by comparing the effectiveness of the training on body composition, predicated
      maximal oxygen uptake (MaxVO2), dynamic respiratory parameters, and muscle strength in
      healthy middle-aged people. Methods:Thirty-three moderately-active middle-aged and healthy
      participants were randomly assigned to the strength+aerobic group (SAG, n = 16) and
      aerobic+strength group (ASG, n = 17). Body composition, aerobic endurance, respiratory
      parameters and upper and lower strength were assessed before (pre-test) and after (post-test)
      a 13-week intervention. The chi-square test and the independent t-test will be used to
      compare sociodemographic variables between the groups. A 2 x 2 analysis of variance (ANOVA)
      with repeated measures (group x measurement) will be conducted.

      This study will enhance our understanding of the concurrent training effect on muscle
      composition and strength. These training programs allow for reducing the duration of the
      training, which can be an important factor in making adults more willing to participate in
      physical activity.
    


Intervention name(s): therapeutic Exercise
Intervention type(s): Other
Intervention description(s): The circular training method was used in the resistance training phase. During the aerobic training phase, a series of movements from moderate intensity to vigorous intensity was performed. The step loading periodization principle was taken into account in both resistance training and aerobic exercises.
The RT lasted approximately 20-25 min per session and included two sets of 8-20 repetitions, with a rest interval of 1-2 min. The RT exercises included: squat, barbell bent-over row, overhead press, plank, lateral pull down, triceps push down, barbell curl, leg extension, leg curl, lunge, barbell bench press, crunches etc.
For the aerobic training: Intensity was established between 50-65% and 80-85% of HRmax for both groups (SAG and ASG). Aerobic training includes walking and running periods and was carried out on a 400 m outdoor track. In periodization, especially 1st-4th.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anaerobic work; Endurance; Aerobic training; Concurrent Training
Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD
Condition: COPD
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, multi-center study to evaluate the accuracy, reliability and
      functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI)
      dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment
      Period.
    


Intervention name(s): Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
Intervention type(s): Drug
Intervention description(s): GFF MDI administered as 2 inhalations BID
Other intervention name(s): GFF MDI, PT003
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of AK3280 in Chinese Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, double-blind, placebo-controlled, single-center, phase I study to
      evaluate the safety, tolerability, and pharmacokinetics of AK3280 in healthy Chinese
      subjects.
    

Detailed description: 
      This phase I study is a randomized, double-blind, placebo-controlled, single-center clinical
      study in healthy subjects. The objectives of the study are to evaluate the safety,
      tolerability, and pharmacokinetics of AK3280. Approximately, 36 healthy Chinese subjects will
      be recruited and randomized to orally receive AK3280 or matching placebo. The total duration
      of the study will be approximately 25 days for each subject.
    

Intervention name(s): AK3280; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral; Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
CYP2B6 Polymorphisms in Ketamine
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This research study will determine if genetic variation in CYP2B6 affects how the body
      metabolizes ketamine.
    


Intervention name(s): ketamine
Intervention type(s): Drug
Intervention description(s): 0.4 mg/kg oral racemic ketamine
Intervention MeSH terms: Ketamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ketamine polymorphisms
Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment
Condition: Polycystic Ovary Syndrome; Infertility
MeSH terms: Polycystic Ovary Syndrome; Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to analyse the activity of myo-inositol on pregnancy rate,
      embryo development dynamics and oestradiol and progesterone concentration in blood serum and
      Superoxide Dismutase (SOD) and catalase concentration in follicular fluid of patients with
      Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI).
    


Intervention name(s): Inofolic: myo-inositol and folic acid
Intervention type(s): Dietary Supplement
Intervention description(s): 4000 mg of myo-inositol and 0,4 mg of folic acid for 3 months preceding the ICSI procedure
Intervention MeSH terms: Folic Acid; Inositol
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Infertility; Myo-inositol; Intracytoplasmic sperm injection
Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the safety and tolerability of
      ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.
    


Intervention name(s): ezetimibe (+) simvastatin
Intervention type(s): Drug
Intervention description(s): Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.
Other intervention name(s): Vytorin®; MK653A
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
Condition: Zinc Deficiency
Study type: Interventional

Summary: 
      The main objective of this clinical is to get information on pharmacokinetics of
      zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to
      two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate.
    


Intervention name(s): zinc-enriched yeast; Zinc references
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): zinc oxide; zinc gluconate
Intervention MeSH terms: Zinc; Zinc Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Zinc/pharmacokinetics
Natural History Study for Achromatopsia
Condition: Achromatopsia
MeSH terms: Color Vision Defects
Study type: Observational [Patient Registry]

Summary: 
      In preparation for human clinical trials we intend to undertake a detailed phenotypic study
      to help to identify patients who may be suitable for therapeutic intervention. In addition,
      with the recent availability of advanced imaging modalities, further detailed phenotypic
      investigations will also be valuable in helping to probe the relationship between structure
      and function and may shed light on disease mechanisms.
    


Intervention name(s): Ocular assessments
Intervention type(s): Diagnostic Test
Intervention description(s): Complete ocular examination, Axial length and corneal curvature, Optical Coherence Tomography, Visual acuity, Contrast sensitivity
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with Achromatopsia
      
Biospecimen description: 
      Blood samples for genetic screening
    
Keywords: Achromatopsia; CNGB3; CNGA3
Thrombotic Effects of Yellowstripe Scad
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional

Summary: 
      The study aimed to determine the thrombotic effects of YSS compared with salmon among healthy
      overweight subjects. It hypothesized that YSS may result significant, favorable thrombotic
      effects and the effects may be similar with salmon.
    

Detailed description: 
      The project was a randomized, two-period, crossover trial with 8-week treatment periods and
      8-week washout period. A total of 50 healthy overweight adults were recruited among staff and
      students in UPM. All the subjects were randomized into two groups. Each group was served with
      either cooked YSS (~265 g/ day) or salmon (~246 g/day) thrice per week. Blood and urine
      samples were collected for laboratory assessment.
    

Intervention name(s): YSS; Salmon
Intervention type(s): Other; Other
Intervention description(s): Intervention providing steamed whole YSS (~265 g/day, 3 days/week) for eight weeks; Intervention providing steamed salmon fillet (~246 g/day, 3 days/week) for eight weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Thrombosis; Yellowstripe scad; Salmon; Healthy overweight subjects; Randomized crossover trial
A Phase 1 Scintigraphy Study to Assess Nasal Deposition of Ciclesonide. Using a Novel Nasal Metered Dose Inhaler
Condition: Allergic Rhinitis (AR)
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open label, single dose, single site, randomized, cross over study that will
      assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide
      radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone
      furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10-14
      patients with symptomatic allergic rhinitis, aged 18-65 years.
    

Detailed description: 
      This study is an open label, single dose, single site, randomized, cross over study that will
      assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide
      radiolabeled solution via a novel nasal MDI and of a mometasone furoate monohydrate
      radiolabeled suspension via an aqueous nasal spray in approximately 10 14 patients with
      symptomatic allergic rhinitis, aged 18 65 years. In order to ensure that patients will be
      symptomatic at the time of dosing, participants will be asked to withhold their usual
      treatments for perennial or seasonal allergic rhinitis, beginning at the Screening Visit
      until after Study Visit 3.

      Each patient will be randomly assigned to one of two treatment sequences. The two treatments
      in this study are a single dose (one 37 mcg actuation per nostril) of radiolabeled solution
      of ciclesonide nasal aerosol 74 µg (Regimen A) and a single dose (two 50 mcg actuations per
      nostril) of a radiolabeled suspension of mometasone aqueous nasal spray 200 µg (Regimen B).
    

Intervention name(s): ciclesonide nasal aerosol; mometasone Aqueous (AQ) nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister; A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
Intervention MeSH terms: Mometasone Furoate; Ciclesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ciclesonide; Allergic Rhinitis
Validation of Low Dose CT for Diagnosis of Lung Nodules
Condition: Cancer; Metastasis to Lung
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      The investigators have developed an extremely low dose computed tomography (CT) protocol that
      on preliminary testing has an effective dose in the range of two chest radiographs. The
      investigators plan to test this exam in patients with known or suspected cancer undergoing
      clinically indicated chest CT.
    


Intervention name(s): Extremely Low Dose CT
Intervention type(s): Diagnostic Test
Intervention description(s): Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic