bioihbjkbjnl/mcl2 huggingface dataset:
A Cafeteria Based Study of Weight Gain Prevention
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Gain
Study type: Interventional

Summary: 
      The dramatic rise in overweight and obesity during the past several decades can be explained
      by environmental changes that foster increased energy intake and decreased energy
      expenditure. There are several reasons to suggest that the most effective approach to weight
      gain prevention is the incorporate reduced-fat eating into an overall strategy of lowering
      the energy density of the diet. Our energy density manipulations will be designed to reduce
      both the fat content and the caloric density of foods served at a cafeteria, which serves as
      the "food environment" for hospital employees.
    


Intervention name(s): REDE; control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention group received the education in REDE techniques.
The intervention in this study comprised four components:
Four group education sessions to introduce the REDE principles of eating;
Approximately 10 new lower energy-dense foods were introduced in the employee cafeteria daily at lunchtime;
Food labels for all foods sold in the employee cafeteria at lunch time, which provided the energy density, calories, and macronutrient content of the prepared cafeteria foods. Prior to the intervention almost no foods had food labels.
Price reductions for lower energy density items. Both groups were exposed to the food labels and the new lower ED foods, but only the intervention group received the education sessions about how to take advantage of the new labels and cafeteria foods and only they were eligible for the price reductions.; The control group received no REDE intervention at all. Both groups were exposed to the food labels and the new lower ED foods, but the control group did not receive the education sessions.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: weight gain prevention; obesity; overweight; food environment; The intervention group received the education in REDE techniques; The control group received no intervention at all.; Both groups were exposed to the food labels and the new lower ED foods.; Only the intervention group received the education sessions and only they were eligible for the price reductions.
Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition
Condition: Kwashiorkor; Marasmus
MeSH terms: Malnutrition; Severe Acute Malnutrition; Kwashiorkor; Protein-Energy Malnutrition
Study type: Interventional

Summary: 
      The need for oral antibiotics as part of the case management of severe acute malnutrition
      (SAM) in the outpatient setting has not been studied in a prospective trial. This study will
      compare the recovery rates of children with SAM treated at home with locally-produced
      ready-to-use therapeutic food (RUTF) with and without prescribed antibiotics as part of their
      outpatient case management. The investigators hypothesize that there will be no significant
      difference in rates of recovery between children who receive and children who do not receive
      antibiotics.
    


Intervention name(s): Placebo; Amoxicillin; Cefdinir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): liquid placebo medication given twice per day for 7 days; liquid amoxicillin given twice per day for 7 days; liquid cefdinir given twice per day for 7 days
Other intervention name(s): Omnicef
Intervention MeSH terms: Amoxicillin; Cefdinir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)
Condition: Acute Myeloid Leukaemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, multinational, non-randomized, non-controlled open-label phase II
      trial to evaluate the safety and efficacy of treosulfan in a combination regimen with
      fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in
      patients with AML.

      The aim is to demonstrate a clinical benefit compared with historical data on intravenous
      busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication
      conditioning before allogeneic stem cell transplantation.
    


Intervention name(s): Treosulfan
Intervention type(s): Drug
Intervention description(s): 14 g/m²/d day -6 to -4
Other intervention name(s): Ovastat
Intervention MeSH terms: Treosulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Treosulfan; Fludarabine; ATG; AML
Novel Energy Metabolic Signaling Molecule With Therapeutic Potential
Condition: Healthy Participants
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Altogether a 25-day study. First 4 days non-blinded with water before 0-control blood samples
      (Day0). Thereafter blinded for 21 days (3 weeks). Study group was apparently healthy 50-60
      -year-old males and females (N=27).
    

Detailed description: 
      Blinded 21-day period was divided into two sub-periods (7 days and 14 days) and it included 3
      measurement days. All measurements were on the same day of each week to facilitate maximal
      comparability (Day0, Day7 and Day21). Additionally on Day0 and Day7 there were acute
      measurements 45 minutes after morning "non-acute" resting and fasting blood samples. (In a
      "non-acute" measurement last dose of Panavital or placebo was taken 12 hours before the
      "non-acute" blood sample collected next morning .)

      First week started with Day0 baseline measurements and immediately thereafter a strenuous
      VO2max test with 2 recovery days thereafter. After full recovery a 4-day blinded Panavital
      regimen. Last "non-acute" dose on Day6 was taken 12 hours before Day7 morning blood sample.
      At Day7 an acute 45 min placebo comparison was conducted.

      Thereafter a 14-day follow-up period with halved Panavital dose or Placebo. Altogether 5
      arterial blood samples were withdrawn. Three fasting and resting "non-acute" samples were
      taken in the morning before any treatments at Day0, Day7 and Day21. Two acute samples were
      collected after the VO2max (Day1) and after acute Panavital or placebo doses (Day7).

      Additionally 5 fingertip blood samples for glucose (and lactate) were taken at the same time
      as arterial samples (Day0 and Day7) and one fingertip sample was taken immediately at the end
      of VO2max.
    

Intervention name(s): Panavital; Placebo
Intervention type(s): Drug; Other
Intervention description(s): In the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water.; In the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water.
Other intervention name(s): D-glyceric acid calcium salt dehydrate
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Altogether a 25 day study with first four days non-blinded with water. There after 0-control blood samples. After the 0-control blinded treatments for 21 days (3 weeks). Study group apparently healthy 50-60 year old males and females (N=27).
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and tolerability of QAT370 compared to tiotropium in
      patients with COPD.
    


Intervention name(s): QAT370; Placebo; Tiotropium
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; pharmacokinetics; plethysmography; cycle ergometry; exercise testing; spirometry
Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety and efficacy of BG9924 in RA participants that have had an inadequate response to
      disease-modifying anti-rheumatic drug (DMARD) therapy.
    


Intervention name(s): Baminercept alfa 1; Placebo; Baminercept alfa 2; Baminercept alfa 3; Baminercept alfa 4; Baminercept alfa 5
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): experimental - one dose level; Placebo comparator; experimental - second dose level; experimental - third dose level; experimental - fourth dose level; experimental - fifth dose level
Other intervention name(s): BG9924; LT beta; BG9924; LT beta; LT beta; BG9924; BG9924; LT beta; BG9924; LT beta; LT beta; BG9924
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; RA; DMARD inadequate response; Methotrexate
Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers
Condition: Gastric Motility
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric
      volume, motor and sensory effects in healthy patients.
    


Intervention name(s): Relamorelin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Double blind RM-131 will be delivered three times by injection during the course of the study; Double blind Placebo will be delivered three times by injection during the course of the study
Other intervention name(s): RM-131
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: gastric motility
Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a randomized, open-label, active-controlled, 6-period crossover study. Target
      population will be subjects with Type 2 Diabetes Mellitus (T2DM)
    

Detailed description: 
      To assess the dose-response and dose-exposure of Dance 501 (Human Insulin Inhalation
      Solution) administered with the Dance 501 Inhaler.
    

Intervention name(s): Inhaled Human Insulin; Insulin Lispro (Humalog U-100)
Intervention type(s): Drug; Drug
Intervention description(s): Dance 501 administered using the Dance 501 Inhaler; Lispro
Other intervention name(s): Dance 501; Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Open-Label, Cross-Over design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inhaled Insulin
Impact of Chronic Air Pollution on Non-cystic Fibrosis Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis; Fibrosis
Study type: Observational [Patient Registry]

Summary: 
      We aim at investigation the impact of chronic air pollution exposure on non-cystic fibrosis
      bronchiectasis outcome.
    

Detailed description: 
      -  Patient files will be search for time of death and cause of death.

        -  Other variables will be collected: bacterial culture results, therapy, gender, age, etc.

        -  These data will be linked with pollution data: trafic load, distance to major road, etc.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a HRCT diagnosis of bronchiectasis and do not have a diagnosis of cystic
        fibrosis. They also need to have typical bronchiectatic disease (recurrent infections and
        sputum).
      
Keywords: Non-cystic fibrosis bronchiectasis
Inhibitory Receptors in Eosinophils of Atopic Subjects
Condition: Atopy; Atopic Dermatitis; Asthma; Allergic Rhinitis; Food Allergy
MeSH terms: Rhinitis; Rhinitis, Allergic; Dermatitis; Food Hypersensitivity
Study type: Observational

Summary: 
      The purpose of this study is to analyze the expression and activity of inhibitory molecules
      on eosinophils obtained from allergic subjects.
    


Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        allergy clinic
      
Biospecimen description: 
      whole blood
Effects of Parenteral Protein Concentrations in Critically Ill Patients
Condition: Hand Muscle Strain
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Sixty patients who need Parenteral nutrition for more than 48h will be assigned into two
      groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will
      receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.
    

Detailed description: 
      In this study after obtaining approval from our hospital ethics committee, a written informed
      consent will be obtained from patient's next of kin.

      Sixty patients who need PN for more than 48h will be assigned into two groups .Group A (n=30)
      patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In
      both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.

      Inclusion criteria:

      Age: from 18 to 60 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to
      have PN for> 48 hs.

      Exclusion criteria:

      Pregnant female Hepatic patients Renal patients Age <18 years

      Technique of the study :

      60 abdominal surgery/trauma ICU patients who have a contraindication or intolerance to
      enteral nutrition(EN),will be fed parenterally within 24-48 h from admission and divided
      according to the protein delivery into two groups.

      Group A , those patients will receive parenteral proteins in a dose of 1 g/kg/day.

      Group B, those patients will receive parenteral proteins in a dose of 2g/kg /day The
      nutrition will be delivered through a central line and using separate bottles technique
      ,because of the lack of a compounding unit and commercial bags in our hospital, After
      exclusion of the protein calories (will be given as 10%aa )the rest of energy requirement
      will be divided between carbohydrates (glucose25%)and lipids(SMOF20%) in a ratio of 60:40
      Serum electrolytes, blood glucose, lipid profile and serum creatinine will be monitored and
      corrected regularly in every patient

      The two groups will be compared as regarding the following :

      hand grip strength Time of staying on Icu Time of staying in hospital Ultrasound biceps
      muscle thickness Nitrogen balances
    

Intervention name(s): parenteral protein 1 g/kg; Parenteral nutrition 2 g/kg
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): patients received 1 g/ kg of protein; Patients received 2 g/ kg of protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: protein; parenteral; critical ill patient; ICU
Major Allergen in Wheat Anaphylaxis in Thai Population
Condition: Wheat Allergy; Anaphylaxis Food; Anaphylaxis Exercise
MeSH terms: Anaphylaxis; Wheat Hypersensitivity; Shock
Study type: Interventional

Summary: 
      -  To study Major allergen in Wheat anaphylaxis in Thai population

        -  To study and compare demographic data between group of wheat anaphylaxis
    

Detailed description: 
      Wheat is one of the most common causes in food-induced anaphylaxis and food dependent,
      exercised induced anaphylaxis. Gold standard for diagnose food allergy is double blind
      placebo control food challenge, but it is a high risk procedure. The accuracy of skin prick
      test and specific IgE assay showed unsatisfactory results. It might be explained by these
      tests may not detect all of the major allergens in wheat allergic patients. Previous studies
      showed that the major allergens of wheat dependent, exercised induced anaphylaxis are omega5
      gliadin, followed by high molecular weight glutenin. For IgE-mediated wheat allergy, the
      major allergens varied among studies, including omega5 gliadin, glutenin, alpha/beta/gamma
      gliadin, and the water-soluble part of wheat allergens. There is no study to direct compare
      the major allergen between patients who have low wheat specific IgE and very high wheat
      specific IgE. Also, there is no data about the major allergens of wheat anaphylaxis in Thai
      population.
    

Intervention name(s): immunoblot
Intervention type(s): Diagnostic Test
Intervention description(s): immunoblot
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy
Condition: Acute Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      This study use an observational study design from patient medical records to obtain data on
      patient demographics, nutritional status, 6MP dosing, and albumin levels of LLA child
      patients.
    

Detailed description: 
      All medical record data of LLA child patient at maintenance phase therapy, who came to Cipto
      Mangunkusumo Kiara Hospital in period 2014 - 2016. the data that are colected consist of age,
      gender, disease stratification, nutritional status, the dosage of 6-MP, albumin levels,
      hemoglobin levels, leukocyite counts, platelet counts, and absolute neutrophil counts.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in
        period of 2012 - 2014
Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection
Condition: Gastric Cancer After D2 Lymph Node Dissection
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Gastric cancer radical surgery related complications are common.Somatostatin is a
      conventional medical therapy for bleeding.This study explore the effect of Somatostatin for
      Advanced Gastric Cancer After D2 Lymph Node dissection.
    


Intervention name(s): Somatostatin
Intervention type(s): Drug
Intervention description(s): Somatostatin is a kind of traditional medicines ,which is for the treatment of intestinal fistula，upper gastrointestinal hemorrhage.
Intervention MeSH terms: Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK)
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of the study is to compare clinical outcomes from PRK and SBK using
      FDA-approved laser technology in the same patient
    

Detailed description: 
      Patients undergoing bilateral laser refractive surgery on the same day will be randomly
      assigned to have one eye treated with PRK and the fellow eye treated with SBK.
    

Intervention name(s): PRK; SBK
Intervention type(s): Procedure; Procedure
Intervention description(s): Laser refractive surgery; Laser refractive surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to establish the most effective method of increasing attendance
      to screening of type 2 Diabetes within a primary care setting within the backdrop of the NHS
      Health Check programme.
    

Detailed description: 
      The University Hospitals of Leicester and The University of Leicester have developed a
      self-assessment risk score and a practice data risk score that can be used in a variety of
      setting to detect undiagnosed diabetes and impaired glucose regulation. This is done to
      establish a simple and effective 1st stage screen to identify those people at risk of
      diabetes and engage the public to increase the number of high risk individuals attending
      screening invitations but reducing the overall number of oral glucose tolerance tests. This
      study aims to test in a pragmatic way the use of such tools in a primary care setting
      administered by primary care staff as part of the NHS Health Check programme.
    

Intervention name(s): Self Assessment; Electronic risk score
Intervention type(s): Other; Other
Intervention description(s): Self assessment used to determine current risk of diabetes and likelihood of requiring further testing; Patients current risk of diabetes is determined by a electronic risk algorithm. They are then invited to attend fof further testing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Diabetes; Screening; Risk; Self assessment