bioihbjkbjnl/mcl2 huggingface dataset:
Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)
Condition: Obesity; Insulin Resistance; Diabetes Mellitus Type 2
MeSH terms: Insulin Resistance; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The aim of this study is to investigate serum apelin levels as well as their possible
      association with G212A polymorphism of the apelin receptor in obese children and adolescents.

      So far apelin has been reported to be involved in the pathophysiology of various heart
      diseases such as cardiomyopathies and heart failure. According to recent reports in adults
      apelin seems to be associated with impaired glucose metabolism, particularly in newly
      diagnosed diabetes type 2 patients. Obesity is associated with insulin resistance and
      compensatory hyperinsulinemia leading to diabetes mellitus type 2 even in youngsters. The
      researchers will try to investigate the role of this new adipokine in order to early detect
      and to prevent similar entities in childhood obesity.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        40 obese children 40 obese adolescents 50 lean children 50 lean adolescents
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the
      renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.
    


Intervention name(s): Dapagliflozin
Intervention type(s): Drug
Intervention description(s): Tablets, Oral, 10 mg, Once daily, 7 days
Intervention MeSH terms: Dapagliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care
Condition: Overweight/Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of a weight reduction program in adults,
      seen in a primary care setting, with overweight/obesity perceived as a health problem or with
      diseases related to overweight/obesity and ambitions to achieve weight reduction as part of
      treatment.
    

Detailed description: 
      Patients seeking advice for overweight/obesity or illness related to overweight/obesity at
      eight primary health care centers in Sweden were randomized either to intervention or control
      care groups with both dietary advice and individualized advice on increased regular physical
      activity. Main outcome measures were reduction in body weight of 5 percent or more from study
      start.
    

Intervention name(s): Intensive lifestyle counseling
Intervention type(s): Other
Intervention description(s): Both dietary advice and individualized advice on increased regular physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics
Condition: Laparoscopic Renal Surgery; Laparoscopy; Muscle Relaxation
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the current study is to compare intraoperative respiratory mechanics
      in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and
      under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative
      hemodynamics and postoperative pulmonary function between the two groups.
    


Intervention name(s): Rocuronium; Rocuronium
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.; Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.
Other intervention name(s): Esmeron®; Esmeron®
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Respiratory mechanics; Respiratory function test; Hemodynamics
Effects of Exercise and Inhibition of Dipeptidyl Peptidase-4 on Insulin Secretion in Subjects With Type 1 Diabetes
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Increasing evidence suggests pancreatic islet beta-cell regeneration occurs throughout the
      course of the disease in patients with type 1 diabetes. Therefore, decreased beta-cell mass
      in type 1 diabetes may be improved through inhibition of beta-cell destruction and
      stimulation of proliferation, even after prolonged duration of disease.

      Physical activity improves insulin secretion via unknown underlying mechanisms. We recently
      observed that Interleukin-6 induces glucagon like Peptide (GLP)-1 production and release from
      the islet alpha-cell and the intestinal L-cell. Furthermore, exercise induces release of
      Interleukin-6 from skeletal muscle resulting in elevated circulating Interleukin-6 levels.
      Therefore we hypothesize that exercise-induced Interleukin-6 promotes glucagon like peptide-1
      secretion from the islet α-cell and the intestinal L-cell, thereby providing a mechanism how
      physical activity can help maintain and improve beta-cell function in patients with type 1
      diabetes. This mechanism can be enhanced by concomitant dipeptidyl peptidase-IV inhibition.

      Physical activity is also known to enhance insulin sensitivity and to attenuate the immune
      system activity.

      Therefore by combining physical activity and dipeptidyl peptidase-IV inhibition we aim to
      allow for beta-cell regeneration in a interventional randomized open-label study.
    


Intervention name(s): Sitagliptin; Exercise
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in
      combination with leucovorin, in patients who have undergone surgery for colon cancer.
      Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21
      days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every
      28 days. The anticipated time on study treatment is 3-12 months, and the target sample size
      is 500+ individuals.
    


Intervention name(s): 5-Fluorouracil; Leucovorin; Capecitabine [Xeloda]
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 425mg/m2 iv daily from day 1 to day 5 every 28 days.; 20mg/m2 iv daily from day 1 to day 5 every 28 days.; 1250mg/m2 po bid on days 1-14 every 21 days.
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Nature Based Sounds' Intervention on Agitation and Anxiety of Patients Admitted in Intensive Care Units.
Condition: Agitated; State, Acute Reaction to Stress; Anxiety
MeSH terms: Psychomotor Agitation; Anxiety Disorders; Stress Disorders, Traumatic, Acute
Study type: Interventional

Summary: 
      Effect of nature based sounds' intervention on Agitation and Anxiety of patients admitted in
      Intensive Care Units of MMIMS&R Hospital, Mullana, Ambala
    

Detailed description: 
      INTRODUCTION: Continue stay in ICU can lead to sleep disturbances and poor stress management
      that may result in client's inability to adjust with the situations and use of medical
      support. This experience may lead to increase agitation, anxiety as well as physiological
      stress of client, decrease comfort level and increase recovery time as well as hospital stay.
      There has been great emphasis on non-pharmacological methods that decrease anxiety and stress
      since they are very appropriate and affordable.

      OBJECTIVES: The objective of the study was to assess the effect of Nature Based Sounds on
      Agitation and Anxiety of patients admitted in Intensive Care Units.

      METHODOLOGY: A Randomized Controlled Trial with pretest posttest control group design was
      used. Sixty patients from Surgical Intensive care unit and were selected conveniently and
      randomly assigned into experimental and control group using lottery method. Data was
      collected by Agitation Behavior Assessment Scale and Beck Anxiety Inventory.
    

Intervention name(s): Nature based sounds
Intervention type(s): Other
Intervention description(s): Nature based sound was administered to the experimental group with head phones for continuously 20minutes. Posttest was done by continuously 30 minute observation after administration of nature based sound with the same tools.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nature Based Sounds; Agitation; Anxiety; Patients; Intensive Care Units
Caudal Bupivacaine vs Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Children
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this prospective randomized double-blind study was to compare the analgesic
      efficacy and the side effects of two doses of dexmedetomidine (1 and 2 µg.kg-1)
      co-administered with bupivacaine with bupivacaine alone for caudal analgesia in children
      undergoing infra-umbilical surgery.
    

Detailed description: 
      -  Quality assurance plan for data validation and registry: After Data was registered, it
           was reviewed by a second person who compared it to the Data in patient data collection
           forms.

        -  Data check: carried out using Statistical Package for the Social Sciences (SPSS)
           variable definition protocols. Also data were entered in EXCEL sheets for comparisons to
           guarantee consistency.

        -  Source data verification: Paper case report forms and medical records.

        -  Standard Operating Procedures to address registry operations and analysis activities:
           Eligible patients were recruited after obtaining consent. Data was collected by
           qualified personnel rained on the process. Data was entered into Excel sheets and SPSS
           programs and compared for consistency. Analysis of Data was carried out by a qualified
           statistician. Adverse events were reported as yes/no variables. Data of patients who had
           Change in management was omitted from analysis.

        -  Sample size assessment: Sample size was calculated to detect a 65% reduction in the
           analgesic requirement during the first 24 h from 75% in the bupivacaine group with α=
           0.05 and β=0.80.

        -  Plan for missing data: Patients with missing Data were omitted from statistical
           analysis.

        -  Statistical analysis plan: carried out using International Business Machines (IBM)
           statistics 19.0 statistical package for windows. Data were compared using analysis of
           variance for continuous variables, Kruskal-Wallis test for ordinal, and chi square test
           for categorical ones. Post hoc analyses were carried out as appropriate.
    

Intervention name(s): Bupivacaine; dexmedetomidine 1μg.kg-1; dexmedetomidine 2μg.kg-1
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Caudal Bupivacaine 2 mg/kg single shot; Caudal dexmedetomidine 1μg.kg-1, single shot; Caudal dexmedetomidine 2μg.kg-1, single shot
Other intervention name(s): Broup B; Group BD1; Group BD2
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: caudal block
Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to assess the safety of a bivalent vaccine of two new 6:2 influenza virus
      reassortants in healthy adults prior to the release of the trivalent vaccine (FluMist)
      containing them.
    

Detailed description: 
      The primary study objective is to assess the safety of a bivalent vaccine of two new 6:2
      influenza virus reassortants in healthy adults prior to the release of the trivalent vaccine
      (FluMist) containing them. Safety will be demonstrated by similar fever rates (oral
      temperature ≥101°F Days 0-7) in vaccine and placebo recipients.
    

Intervention name(s): FluMist; Placebo
Intervention type(s): Biological; Other
Intervention description(s): A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0.; A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic
      stimulation (rTMS) was thus suggested in this indication.
    

Detailed description: 
      We recently demonstrated that these patients exhibit significant perfusion abnormalities in
      regions of the brain known to be involved in sensory and affective-attentional dimensions of
      pain processing. These results, in agreement with previous functional magnetic resonance
      imaging reports, confirm the hypothesis of central sensitization, which provides the
      rationale for prescription of centrally acting analgesic agents in patients with severe FM.
    

Intervention name(s): Transcranial stimulation; Transcranial stimulation
Intervention type(s): Other; Other
Intervention description(s): Stimulation to white; Repetitive transcranial magnetic stimulation (rTMS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas
Condition: High-grade Gliomas
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      Currently, the prognosis of recurrent high-grade gliomas is still dismal with no standard
      treatment protocol established. Cisplatin (CDDP), recommended by National Comprehensive
      Cancer Network (NCCN) as a chemotherapeutic agent in salvage treatment for recurrent
      high-grade gliomas, was shown to reduce O6-alkylguanine DNA-alkyl transferase (AGAT) activity
      and potentially capable of enhancing the antitumor effects of temozolomide (TMZ). Compared to
      the standard 5-day TMZ regimen, alternating weekly regimen that deliver more prolonged
      exposure of TMZ may lead to higher cumulative doses, and may deplete more O6-methylguanine
      DNA methyltransferase (MGMT), thus reducing the resistance of tumor cells to TMZ.

      The investigators therefore initiate a single-arm Phase II study to evaluate the efficacy and
      tolerability of CDDP plus alternating weekly TMZ regimen in patients with recurrent
      high-grade gliomas.
    


Intervention name(s): CDDP; Temozolomide
Intervention type(s): Drug; Drug
Intervention description(s): If hematologic and nonhematologic toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE; version 4.0) from the previous cycle had been grade 0 or 1, then TMZ dose escalation to was allowed to the maximum of 150 mg/m2. If grade 4 hematologic toxicity or grade 3 nonhematologic toxicity had occurred, then TMZ dose was reduced in 25 mg/m2 steps. If grade 4 nonhematologic toxicity occurred, patient treatment was halted. If grade 4 hematologic toxicity or grade 3 nonhematologic toxicity continued when TMZ dose was in the minimum of 75 mg/m2, patient treatment was halted.
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent high-grade gliomas; cisplatin (CDDP); temozolomide (TMZ)
Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim
Condition: Gastro-Intestinal Disorder
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to see if advanced endoscopic imaging may be helpful to
      accurately distinguish pathological tissue from normal tissue and guide therapy of
      endoscopically identified pathology.
    

Detailed description: 
      In this registry, the Fujifilm 4-LED system, which is considered non significant risk, will
      be used for routine endoscopic procedures at Mayo Clinic Florida and Rochester. Where
      indicated and based on clinical standards of care, a biopsy or tissue removal will be
      performed. Immediately prior to tissue removal, a standard set of electronic images will be
      captured including white light, BLI, BLI-bright, LCI. Each image will be stored in high
      resolution lossless format and later correlated with the final clinical and histological
      diagnosis.
    

Intervention name(s): Fuji Flim Processor VP-7000, Light Source BL-7000
Intervention type(s): Device
Intervention description(s): Fujifilm's Digital Video Processor VP-7000 and LED Light Source BL-7000 is a class II Endoscopic Video Imaging System under 21 C.F.R. 876.1500. It is the next generation of Fujifilm's VP-4440HD Digital Video Processor with Flexible-spectral Imaging Color Enhancement (FICE) and Light Source (K140149).
Intervention model: Single Group Assignment
Intervention model description: Registry of endoscopic image and pathology correlation of different pathological condition such as: inflammatory bowel disease, colon polyps
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: endoscopic image; Fujifilm; Blue light imaging
Aerosol Deposition in Asthmatic Obese Women Using Heliox
Condition: Obese; Asthma
MeSH terms: Asthma; Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      BACKGROUND: The aim of this study was to assess pulmonary deposition and distribution of
      radio-aerosol in obese and normal women, using 2-D planar scintigraphy. METHODS: after
      inhaling an aerosol of technetium labeled diethylenetriamine penteacetic acid (99mTc - DTPA)
      with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml using a
      vibrating mesh inhaler.
    

Detailed description: 
      BACKGROUND: Obese asthmatics are difficult to treat effectively, worse asthma control, and do
      not respond as well to standard therapy as lean asthmatic. Medical aerosols an important
      route of drug delivery in asthma, but narrowing in the airway cause by the obesity, can
      provoke turbulence and the effectiveness of the treatment could be compromise.

      AIM: To assess pulmonary deposition, distribution of radio-aerosol and analyze upper way
      dimension in obese and normal weight women, using 2-D planar scintigraphyand and computed
      tomography. METHODS: 20 obese women, 10 asthmatics and 10 non-asthmatics took part of the
      first part of the study. Anthropometric and clinical assessments were carried out, than lung
      function was performed. After randomization of the sequence of gas (sequence 1- oxygen and
      heliox; sequence 2-heliox and heliox) that would be used to inhale an aerosol with technetium
      labeled diethylenetriamine penteacetic acid (99mTc - DTPA) with an activity of 1 mCi in a
      total dose volume with normal saline of 2,5 ml using a vibrating mesh inhaler. All patients
      inhaled two times with one week of washout between then to eliminate risk of residual trace
      radiation and to avoid the possibility of bias.
    

Intervention name(s): nebulizing with heliox and oxygen
Intervention type(s): Other
Intervention description(s): Mesh Nebulizer with heliox and oxygen. In order to determine the sequence of the gas associated with the inhaled a randomization was performed, sequence 1- first oxygen and second heliox (80:20) or sequence 2- first heliox (80:20) and secondy oxygen.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to conduct experiments to examine subjective and reinforcing
      effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug
      abusers and preference procedures will be used to assess reinforcing effects. To examine the
      lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of
      nitrous oxide in healthy volunteers.
    


Intervention name(s): 0% N2O; 10% N2O; 20% N2O; 30% N2O; 40% N2O
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nitrous oxide; acute tolerance; subjective effects; psychomotor; analgesia; healthy volunteer