bioihbjkbjnl/mcl2 huggingface dataset:
Effect of ASEA on Energy Expenditure and Fat Oxidation in Humans
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      To test the effect of ASEA consumption on 24-hour resting energy expenditure. Hypothesis:
      consumption of 8-oz of ASEA water (4-oz before breakfast and 4-oz before bedtime) will
      significantly elevate 24-h resting energy expenditure as compared to consumption of a placebo
      control (salt water, same dietary intake).
    

Detailed description: 
      The ASEA beverage is a special oral formulation produced from a pure saline solution
      containing 123 mg sodium and 129 mg chloride per 4 oz. serving. A proprietary electrolytic
      and catalytic process rearranges the salt water solution to mimic the redox signaling
      molecular composition of the native salt-water compounds found in and around human cells.
      Data obtained thus far, suggests the possibility that consumption of the ASEA beverage may
      increase energy expenditure and thus be beneficial for the treatment of obesity, however,
      this has not been assessed in human clinical studies. To this end, we will measure the
      effects of ASEA consumption on energy expenditure by indirect calorimetry using the indirect
      room calorimeter at the University of North Carolina (UNC) Nutrition Research Institute.

      The primary outcome measures will be the change in 24-h energy expenditure and respiratory
      quotient in response to ASEA consumption. The secondary outcome variables will include
      changes in relevant peptide hormones, and norepinephrine/epinephrine and their relationship
      to changes in energy expenditure in response to consumption of ASEA.
    

Intervention name(s): Salt Water; ASEA water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects to arrive fasted and will spend two 24-h periods inside the metabolic chamber (ASEA or salt water) with a one week interval between visits. Blood will be drawn at 9 am prior to consumption of salt water or breakfast, and at 11 am after consumption of salt water and breakfast. Subjects will receive a second portion of salt water at 10:15 pm just prior to bedtime. The energy content of meals will be identical at each visit.; Subjects to arrive fasted and will spend two 24-h periods inside the metabolic chamber (ASEA or salt water) with a one week interval between visits. Blood will be drawn at 9 am prior to consumption of ASEA water or breakfast, and at 11 am after consumption of ASEA water and breakfast. Subjects will receive a second portion of ASEA water at 10:15 pm just prior to bedtime. The energy content of meals will be identical at each visit.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Over nutrition; nutrition disorders; energy expenditure; metabolic rate
Combined Resistance and Aerobic Exercise Training on Obesity in Adolescent Girls
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the study was to observe therapeutic effects of combined resistance and
      aerobic exercise training (CRAE) on hyperinsulemia in obese adolescent girls. Forty obese
      adolescent girls (14±1 years) participated in this study. The participants were randomly
      separated into two groups; no-exercise group (n=20) and exercise group (n=20). The exercise
      group performed 12 weeks of CRAE.
    


Intervention name(s): Combined Exercise Training
Intervention type(s): Behavioral
Intervention description(s): The combined exercise training were consisted with 5 minutes of warm-up, 20 minutes of resistant band exercises (Upper: seated rows, biceps curl, shoulder flexion, elbow flexion, pushup; Lower: hip flexion, hip extension, calf raise, leg press, squat), 30 minutes of treadmill walking, and 5 minutes of cool-down. Intensity of the training was gradually increased from 40-50% heart rate reserve in 1-4 weeks to 60-70% HRR in 9-12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Venous Lactate in Progression to Overt Septic Shock and Mortality in Non-elderly Sepsis Patients in Emergency Department
Condition: Sepsis; Disease Progression; Septic Shock; Fatal Outcome
MeSH terms: Sepsis; Toxemia; Shock, Septic; Emergencies; Shock; Disease Progression
Study type: Observational [Patient Registry]

Summary: 
      To investigate the role of initial venous lactate in predicting the severity progression to
      overt septic shock and 30-day mortality in non-elderly patients without hemodynamic shock who
      suspected to have acute infections.
    

Detailed description: 
      Blood lactate is one of the markers that can predict the organ failures and mortality in
      emergency department (ED) patients with sepsis. Regarding its predictive role in the clinical
      deterioration in normotensive sepsis patients, a recent prospective observational study of
      the patients with moderately-high serum lactate (2.0-3.9 mmol/L) showed that one-forth of the
      patients eventually developed progressive organ dysfunctions or required vasopressor or
      mechanical ventilator. Unfortunately, low serum lactate (< 2.5 mmol/L) was still found up to
      50% of overt septic shock patients, even in vasopressor-dependent cases. For the prognostic
      role on mortality, numbers of articles showed that blood lactate can also predict death in
      sepsis patients, especially in those who are elderly and critically-ill. However, no previous
      study was done in younger patients since lactate kinetics in the body may differ among the
      age groups. The primary aim of our study is to investigate the role of initial venous lactate
      levels in predicting the chance of severity progression to overt septic shock especially in
      non-elderly patients who suspected to have acute infections and without hemodynamic shock in
      ED. The secondary outcomes are to evaluate its prognostic role on hospital length of stay and
      30-day mortality of this target population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Emergency department patients of King Chulalongkorn Memorial Hospital (a 1500-bed,
        tertiary-care, university-affiliated urban hospital)
      
Biospecimen description: 
      Venous blood lactate obtained by standard venipuncture together with other essential blood
      works before giving antibiotics or intravenous fluid, if required. Lactate level is measured
      by Epoc® point-of-care blood analyzer (Epocal Inc., Ottawa, ON, Canada) within 5 minutes
      after obtaining the venous sample without any preservative.
    
Keywords: Lactate; Sepsis; Septic shock; Disease progression; Prognosis
Cocoa Ileostomy Study
Condition: Ileostomy - Stoma
Study type: Interventional

Summary: 
      There is substantial interest in the potential role of chocolate and its primary bioactive
      component; flavan-3-ol, (-)-epicatechin, in both the prevention and management of
      cardiovascular disease (CVD). Numerous observational studies have found the association
      between high cocoa intake and a reduced CVD risk and mortality, yet the impact of these
      mechanisms in vivo is unclear. In order to have a beneficial effect, these cocoa flavan-3-ols
      must be absorbed in the body in a forms, while still maintaining its advantageous
      characteristics. Consumption studies with ileostomists who have had their colon
      removed,provide information regarding the bioavailability and bioactivity of (-)-epicatechin
      and flavan-3-ols from cocoa, therefore the aim of this study is to determine the impact of
      methylaxanthines (including theobromine) on bioavailability of cocoa flavan-3-ols prior to
      entering the colon.

      This study has a randomised double blinded crossover control design, being applied to
      ileostomy patients who are aged 18-65 years, N=10, 5 per group. The study is divided into two
      phases. During the first phase, subjects will partake in a 2-day restriction diet (No
      phenolic foods) and an overnight fast prior to sampling. Ileal fluid (0hr) is obtained from
      participants. They will then be asked to consume the cocoa flavanol beverage dissolved in
      310g 1% milk. After this urine and ieal fluid is collected every 4 hours at 3 more time
      points and blood every hour at 8 time points. A 24 hr urine and ieal fluid sample is
      collected the following day. There will be a 1-week wash out period between each phase.
      Procedure is repeated again for phase 2.
    


Intervention name(s): Cocoa Flavanol beverage mix; De-xanthinated Cocoa Flavanol beverage mix
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.; Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised double-blinded crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cocoa Flavan-3-ols; methylaxanthin; theobromine; Ileostomists; bioavailability; randomised controlled trial
Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)
Condition: Cold Urticaria
MeSH terms: Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the efficacy of dupilumab in adult and adolescent participants with primary
      acquired chronic inducible cold urticaria (ColdU) who remain symptomatic despite the use of
      an H1-antihistamine

      Secondary Objectives:

      To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease
      control To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU
      local signs and symptoms (hives/wheals, itch, burning sensation and pain) after provocation
      test To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU
      disease activity To demonstrate improvement in health-related quality-of-life and overall
      disease status and severity To evaluate the ability of dupilumab in reducing the proportion
      of participants who require rescue therapy To evaluate the proportion of participants with
      cold exposure triggered urticaria To evaluate safety outcome measures To evaluate
      immunogenicity of dupilumab
    

Detailed description: 
      The duration of study for each participant will include 2-4 weeks of screening period, 24
      weeks of treatment period and 12 weeks of post treatment period.
    

Intervention name(s): Dupilumab SAR231893; Placebo; Non sedating H1-antihistamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:Injection solution Route of administration: Subcutaneous; Pharmaceutical form:Injection solution Route of administration: Subcutaneous; Pharmaceutical form:Tablet Route of administration: Oral
Intervention MeSH terms: Histamine Antagonists; Histamine H1 Antagonists; Histamine H1 Antagonists, Non-Sedating
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II study to test in first line the VAD (Vincristine Adriablastine Dexamethasone) + C
      (Chlorambucil ) regimen associated to rituximab ( R-VAD + C ) in a cohort of young patients
      under 66 years with a mantle cell lymphoma and also the test the role of an in vivo marrow
      purge with rituximab before an autologous stem cell transplantation for the consolidation of
      the patients which fulfilled a response to 4 cycles of (R VAD + C) regimen.
    

Detailed description: 
      All patients at diagnosis with a stage II, III or IV an arbor disease are treated with 4
      cycles of (R VAD +C) .

      The responders more than RP > 50% received 2 other cycles before to be intensified with
      alkeran 140 mg/ m2 and a 8 grays TBI over 4 days before an autologous PBSCT.The stem cell
      collection is realised after a mobilisation with HD Cyclophosphamide (4 mg/m2) after the four
      R-(VAD + C) cycles and purged by a rituximab injection 10 days before the collection.

      There is an clinical and molecular evaluation of the strategy
    

Intervention name(s): Adriblastin; dexamethasone; Chlorambucil; rituximab; cyclophosphamide; alkeran; Total body irradiation (8Gy/4fr); vincristine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Drug
Intervention description(s): 0,4 mg/day day 1 to day 4
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Melphalan; Chlorambucil; Rituximab; Vincristine; Doxorubicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mantle cell lymphoma; Chemotherapy; Autologous PBSCT; Molecular evaluation
Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm the efficacy of CJ-12420, Once daily (QD), compared
      to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA)
      classification grades A to D at Week 8.
    

Detailed description: 
      This is a double blind, randomized, active controlled, phase 3 study. Subjects will be
      randomly assigned to one of the three treatment groups (CJ-12420 50mg, CJ-12420 100mg,
      esomeprazole 40mg).

      All subjects will be asked to take three tablets at the same time each day throughout the
      study, and also all subjects will be asked to record daytime and nighttime symptom in a
      subject diary on a daily basis.
    

Intervention name(s): CJ-12420 100mg QD; Esomeprazole 40mg; CJ-12420 50mg QD
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CJ-12420 100mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100mg.; Esomeprazole 40mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40mg.; CJ-12420 50mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 50mg.
Other intervention name(s): Tegoprazan Tab.; Nexium Tab.; Tegoprazan Tab.
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935
Condition: Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H)
      enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron
      emission tomography (PET) ligand [18F]MNI-792 and PET imaging and to determine the
      relationship of occupancy to TAK-935 exposure.
    

Detailed description: 
      The drug being tested in this study is called TAK-935. TAK-935 is being tested to examine the
      degree and duration of brain CH24H enzyme occupancy/target engagement as a function of
      TAK-935 plasma concentration in order to guide dosing and schedule for future clinical trials
      with TAK-935. This study will utilize the PET ligand [18F]MNI-792 to evaluate the brain CH24H
      occupancy of TAK-935 after single dose oral administration in healthy adult participants. The
      study will evaluate up to 16 participants. The first 2 participants will take TAK-935 600 mg
      oral solution and undergo PET imaging using tracer [18F]MNI-792 up to 5 mcg (up to 370 MBq),
      injection, intravenously prior to each PET scan at Baseline, 45 minutes and 10 hours
      post-TAK-935 dose. TAK-935 dose and timing of post-dose scans for subsequent participants
      will be based on the data from the previous participants. This single-center trial will be
      conducted in the United States. The overall time to participate in this study is up to 55
      days. Participants will make 4 visits to the clinic, including 2 confinement periods to the
      clinic for PET imaging. Participants will be contacted by phone on Day 28 for follow-up
      safety assessments.
    

Intervention name(s): TAK-935; [18F]MNI-792 (tracer)
Intervention type(s): Drug; Drug
Intervention description(s): TAK-935 oral solution.; [18F]MNI-792 injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy, Positron Emission Tomography, Brain enzyme occupancy, Cholesterol 24S-hydroxylase, CH24H
The Prednisone-sparing Effect of Anti-IL-5 Antibody (SB-240563)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if treatment with anti-IL-5 antibody has a
      prednisone-sparing effect in patients with symptomatic eosinophilic bronchitis (with or
      without asthma).
    

Detailed description: 
      Eosinophilic bronchitis, which is identified by quantitative sputum cell counts (eosinophils
      greater than 2%) is responsive to corticosteroid treatment. It occurs alone or in association
      with asthma or in some patients with chronic obstructive pulmonary disease (COPD). In most
      patients the eosinophilic bronchitis responds to treatment with inhaled steroids but in some
      it requires a minimum dose of prednisone to keep it controlled. At present, there is no
      outstanding drug which can have a prednisone-sparing effect.

      Interleukin (IL)-5 is a cytokine specifically focused on the development, differentiation,
      recruitment, activation and survival of the eosinophil. The specificity of IL-5 has raised
      the possibility that blocking it's activity, using humanized monoclonal antibodies, may be
      useful therapy for eosinophilic bronchitis. Such an antibody (SB-240563) has been introduced
      for clinical trial. The investigators will compare its effect versus placebo in patients with
      prednisone-dependant symptomatic eosinophilic bronchitis (with or without asthma) before and
      after a reduction in prednisone dose to identify if it has a prednisone-sparing effect.

      The study is divided into 3 sequential study periods. Period 1: symptomatic eosinophilic
      bronchitis (with or without asthma) on the same dose of prednisone for 6-weeks or more.
      Period 2: standardized prednisone reduction (and inhaled steroid if prednisone is
      discontinued during the study treatment) at intervals of 4-weeks until there is a clinical
      and eosinophilic exacerbation or bothersome steroid withdrawl effects. Period 3: washout.

      The patients will be seen every 2 weeks. Intravenous injections of SB-240563 750mg or placebo
      will be given at weeks 2,6,10,14 and 18. Doses of prednisone will be reduced in a standard
      way.
    

Intervention name(s): SB-240563 (Mepolizumab)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: 1. Eosinophilic bronchitis, 2. Asthma, 3. Steroid dependent asthma, 4. Sputum eosinophils, 5. SB-240563 (Mepolizumab)
The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy
Condition: Gastrointestinal Dysfunction; Alteration of Cognitive Function
Study type: Interventional
Phase: Phase 4

Summary: 
      There are different sedation regimes for lower gastrointestinal system endoscopy which can be
      administered by anesthesiologists and non-anesthesiologists. This study aims to compare the
      effects of propofol/remifentanil combination and midazolam/meperidine combination on early
      cognitive function following lower gastrointestinal system endoscopies.
    

Detailed description: 
      Sedation for lower gastrointestinal system endoscopies can be administered by
      anesthesiologists or endoscopists and cognitive dysfunction after this procedure has not been
      fully investigated. The aim of this study was to investigate the effect of different sedation
      regimes applied by anesthesiologists or endoscopists on early cognitive dysfunction.
      Following ethics committee approval and written informed consent, 100 patients were randomly
      divided into two groups. In Group MM where drug regime was solely determined by endoscopists,
      2 mg midazolam and 20mg meperidine was given intravenously and additional 1-2mg midazolam and
      20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) was given when
      facial pain scale (FPS) was greater than 3. In Group RP where drug regime was solely
      determined by anesthesiologists, 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil
      bolus was administered and additional 0,5 mcg/kg remifentanil bolus was given when FPS was
      greater than 3. Bispectral index (BIS) and hemodynamic monitorization was carried out
      throughout the procedure and BIS 60-80 with FPS<3 was targeted. The time to Observer
      Assessment of Alertness/Sedation Scale (OAAS) score to reach 3 was measured after the
      procedure and Trieger Dot Test (TDT) and Digit Symbol Substitution Test (DSST) was repeated
      at 5th, 15th and 30th minutes.
    

Intervention name(s): Midazolam; Meperidine; Remifentanil; Propofol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dosage adjustment; Dosage adjustment; Dosage adjustment; Dosage adjustment
Other intervention name(s): Versed; Demerol; Ultiva; Diprivan
Intervention MeSH terms: Midazolam; Meperidine; Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Cognitive dysfunction; Colonoscopy; Sedation