bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition
Condition: Child Nutrition Disorders
MeSH terms: Malnutrition; Nutrition Disorders; Child Nutrition Disorders
Study type: Interventional

Summary: 
      Supplementary feeding programs for children with moderate acute malnutrition have been
      implemented in developing countries using treatment foods with minimal or no evidence of
      their effectiveness. Fortified peanut paste is a popular new treatment food for children with
      severe and moderate malnutrition.

      Objectives: To investigate the relative effectiveness of two non-identical therapeutic foods
      in children with moderate malnutrition by comparing differences in performance indicators
      (i.e. recovery rates), recovery times, and change in weight-for-height z-scores in each
      group.

      This proposed research project will evaluate the relative effectiveness of two non-identical
      treatment foods for the treatment of moderate acute malnutrition in children
    

Detailed description: 
      This research protocol will be embedded as a component of the UN World Food Programme (WFP)
      -supported Supplementary Feeding programmes in Ethiopia. The proposed study is a prospective
      cluster-randomized equivalence trial that will compare the relative effectiveness of two
      feeding interventions in four woredas (districts). Research will be implemented in two
      comparable woredas (one with CSB and one with RUSF), in two different areas in Sidama zone
      that represent different livelihood zones, main source of crop income, and level of food
      insecurity
    

Intervention name(s): Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.; RUSF (ready-to-use supplementary foods) Supplementary Plumpy®
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A daily ration equivalent of 300g CSB and 32g vegetable oil Bi-weekly distribution of premix of 4.2kg CSB with 0.5L vegetable oil. Estimated 1413 kcal, 47g protein; Peanut-based fortified supplement
One 92g sachet eaten throughout the day Bi-weekly distributions of 14 sachets 500 kcal and 13g protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: United Nations World Food Programme; blended food (CSB); ready-to-use supplementary foods (RUSF); Plumpy®
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess the single-dose relative bioavailability study of 1
      mg risperidone orally disintegrating tablets and (Risperdal M-TAB) under fed conditions.
    

Detailed description: 
      Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr Reddy's
      Laboratories Ltd. and Janssen Pharmaceutica Products, LP. (Risperdal M-TAB) 1 mg Risperidone
      Orally Disintegrating Tablets in Healthy Adult Male Volunteers under Fed Conditions
    

Intervention name(s): Risperidone Orally Disintegrating Tablets
Intervention type(s): Drug
Intervention description(s): Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited
Other intervention name(s): (Risperdal M-TAB) tablets of Janssen Pharmaceutica Products
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Crossover; Risperidone
Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy
Condition: Overdose
MeSH terms: Drug Overdose
Study type: Interventional
Phase: Phase 4

Summary: 
      Activated charcoal (AC) is an established, effective means of gastrointestinal
      decontamination. Providers give it to patients who have ingested something that is thought to
      be potentially poisonous to prevent it from being absorbed. However, one limitation to its
      use is palatability of the AC for the patient, potentially limiting how much, if any, is
      taken.

      Other studies have suggested that mixing AC with various substances improves the rating on
      various scales (taste, etc). An important question is whether mixing the AC with other
      substance effects the ability of the AC to bind to xenobiotic in the gut. This small study
      investigates whether mixed cola with charcoal affected its ability to prevent the absorption
      of acetaminophen. It also performs a survery to see if participants preferred the AC-cola
      mixture. The investigators hypothesize that the AC will be equally as effective with cola as
      without. The investigators also hypothesize that participants will prefer the AC-cola
      mixture.
    


Intervention name(s): Activated Charcoal; Activated Charcoal
Intervention type(s): Drug; Drug
Intervention description(s): Activated charcoal alone; Activated charcoal mixed with cola
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Changes of Dorsalis Pedis Artery Flow Pattern After Caudal Block in Children: Observational Study Using a Duplex Sonography
Condition: Anesthesia, Caudal
Study type: Observational

Summary: 
      The purpose of this study is to determine the changes of Dorsalis Pedis Artery Flow Pattern
      after Caudal Block in Children: Observational Study Using a Duplex Sonography.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children patients who visit Severance hospital
      
Keywords: Twenty (ASA status I) unpremedicated children, ages 1 to 5 yr old
To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product
Condition: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm equivalent bronchodilator efficacy of the test
      product compared to the reference product.
    


Intervention name(s): Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh; Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh; Symbicort Turbuhaler 320/9 ug/inhalation 4 inh; Symbicort Turbuhaler 320/9 ug/inhalation 1inh; Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh; Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh; Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh; Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
Condition: Gallbladder Neoplasms
MeSH terms: Gallbladder Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective Primary:

      Determine the objective response rate in patients with advanced gallbladder treated with new
      Chemotherapy regimen

      Secondary:

      Determine time to progression-free survival and overall survival of patients treated with
      this regimen.

      Determine quality of life of patients treated with this regimen. Determine the toxicity of
      new chemotherapy regimen
    

Detailed description: 
      Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment,
      Safety/Efficacy Study

      Chemotherapy regimen:

      Group A: Conventional chemotherapy regimen Group B: New chemotherapy regimen: conventional
      regimen plus SST（somatostatin） Cycles repeat every 4 weeks and 6 cycles in total

      Patients: A total of 260 patients (130 per group) will be accrued for this study.

      Patients distribution:

      10patients per center are enrolled in the study and 30 centers (hospitals) in total which
      meet the total number of patients in trial.

      Clinical Outcome Assessments:

      Primary: the objective response rate (response evaluation criteria in solid tumors ,RECIST
      criteria) Secondary: progression-free survival, overall survival, quality of life，the adverse
      event

      Safety Assessments:

      Physical exam, laboratory test, probably occurred adverse event.
    

Intervention name(s): Somatostatin; epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）
Intervention type(s): Drug; Drug
Intervention description(s): Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h
Intervention MeSH terms: Leucovorin; Fluorouracil; Epirubicin; Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gallbladder neoplasmas; Gallbladder Neoplasms,Advanced Stage,Chemotherapy,Somatostatin
Acute Pediatric Fracture Analgesia Study
Condition: Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      A clinical trial comparing ibuprofen and acetaminophen with codeine for children after
      discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more
      effective analgesia compared to acetaminophen with codeine in children with uncomplicated
      forearm fractures.
    

Detailed description: 
      A clinical trial comparing ibuprofen and acetaminophen with codeine for children after
      discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more
      effective analgesia compared to acetaminophen with codeine in children with uncomplicated
      forearm fractures. A random table will be used to generate an assignment of the participants
      to either ibuprofen or acetaminophen with codeine. Assessment of the child's pain severity,
      pain medication use, functional limitations and parental satisfaction will allow for
      identification of a difference in the management of pain in the first 72 hours after a
      forearm fracture. Descriptive statistics will be used to analyze demographic data.
    

Intervention name(s): ibuprofen; acetamin w codeine
Intervention type(s): Drug; Drug
Other intervention name(s): motrin; advil; tylenol with codeine, T3
Intervention MeSH terms: Ibuprofen; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fracture
Glucose-stimulated Gut Lipid Release
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      During dietary fat absorption, the gut packages the majority of the fats into lipid particles
      that are secreted into blood circulation. The gut is also capable of storing a considerable
      amount of fats that can be released at a later time upon receiving certain stimulus signals.
      One of the signals is glucose ingestion. This protocol examines how glucose ingestion
      releases gut lipid store. Participants drink a fatty formula and 5-9 hours later drink either
      a glucose solution or water (as control). One hour later, duodenal biopsy specimen are taken
      for analysis of lipid stores in the gut cells.
    

Detailed description: 
      Participants undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical
      indications are recruited after obtaining informed consent. They first have a high fat liquid
      formula. 5 to 9 hours later, half of the participants drink 50 grams of glucose in 50 ml of
      water. The other half drink 50 ml of water. 1 hour later, duodenal biopsy specimen are
      collected and stored for analysis of lipid stores in the gut using electron microscopy and
      proteins using proteomics.
    

Intervention name(s): Glucose; Water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): glucose drink; control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients
Condition: Covid19; Asymptomatic Condition
MeSH terms: COVID-19; Asymptomatic Diseases
Study type: Observational

Summary: 
      Coronavirus disease 2019 (Covid-19) has been declared global emergency with immediate safety,
      preventative and curative measures to control the spread of virus. Confirmed cases are
      treated with clinical management as they are diagnosed but so far, there is no effective
      treatment or vaccine yet for Covid-19.

      With recommended guidelines of AYUSH Ministry, India, the use of Ayurveda for Covid-19 has
      increased; however, its efficacy and safety in Covid-19 confirmed patients remain unclear.

      Present study examined the efficacy and safety of one of the recommended Ayurveda drug
      (Guduchi Ghan Vati) compared with standard care for patients with asymptomatic Covid-19
      patients.
    


Intervention name(s): Guduchi Ghan Vati
Intervention type(s): Drug
Intervention description(s): Guduchi Ghan Vati is an Ayuvedic classical preparation which is prepared from aqueous of extract of Tinospora cordifolia.
Other intervention name(s): Giloy Ghan Vati
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Covid-19 Confirmed Asymptomatic patients
      
Keywords: Ayurveda; Guduchi Ghan Vati
The Assessment of Airway Resistance and Airtrapping in Elderly COPD Patients by Forced Oscillation Technique (FOT)
Condition: COPD
Study type: Observational

Summary: 
      The study hypothesize that parameters of new function machine---'forced oscillation
      technique' (FOT) can correlate well with the conventional lung function data for measurement
      of airway resistance and airtrapping in elderly COPD patients.
    

Detailed description: 
      INTRODUCTION:

      Forced oscillation technique (FOT) may be a good supplementary tool to assess lung function
      in elderly since it is a simple and fast tool requiring minimal patients' cooperation.

      AIMS:

      To investigate the accuracy of forced oscillation test FOT in assessment of airway resistance
      and airtrapping in elderly COPD patients by comparing FOT parameters to various conventional
      lung function parameters including FEV1, FEF 25-75, RV/TLC ratio, IC etc. The best FOT
      parameter for airway resistance and airtrapping is also determined.

      STUDY DESIGN:

      A cross-sectional study conducted in Kwong Wah Hospital, Hong Kong, SAR

      METHODS:

      COPD patients were recruited from 1st Jan, 2010 to 31st Dec 2011. Both of the lung function
      tests (forced oscillation technique (FOT) and conventional lung function test) were
      performed. Parameters of FOT (FRes FDep, RAvr, XAvr, were compared with conventional lung
      function test for assessment of both airway resistance and airtrapping in COPD subjects.
      Adjusted FOT parameters (FResRatio and FDep) were also compared with %FEV1 and different GOLD
      stages.

      Statistics:

      Comparison between FOT parameters and spirometric parameters was done by correlation test and
      expressed as Spearman coefficient. ANOVA test is used to compare FOT parameters among
      different groups of GOLD stages (stage 1 to 4) and groups with various degree of airtrapping
      (stage 1 to 3). Post hoc analysis was estimated by Bonferroni test.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        COPD patients from both 'in-patient' and 'outpatient clinic' in Kwong Wah Hospital, Hong
        Kong, China
      
Keywords: forced oscillation technique; COPD; elderly; airway resistance; airtrapping
Evaluation of Metabolomic Analysis in Early Diagnosis of ALS
Condition: ALS
MeSH terms: Disease
Study type: Interventional

Summary: 
      This project is expected to answer the question of interest assays of metabolites in the CSF
      as a tool for early diagnosis and should show whether it is possible or not to use such
      markers in the blood or urine. These studies should also help shed light on the
      pathophysiological original early clinical disease. While ALS appears to be more a clinical
      syndrome that pathophysiological entity unique metabolic abnormalities identified could help
      identify mechanisms disrupted in which therapeutic interventions will be possible.
    

Detailed description: 
      A blood test that would allow the diagnosis

        1. to reduce the time between the first signs and diagnosis in ALS patients for therapeutic
           treatment earlier and

        2. to exclude rapidly non ALS in their avoiding unnecessary investigations and anxiety of
           being infected with a terrible prognosis disease. It is currently accepted that
           neurodegenerative diseases such as ALS begin before the first clinical signs and the
           patient could benefit from a more efficient care if it was early.

      Conduct a prospective study with 400 patients.

      The secondary objectives are:

        1. attempt to improve the predictive power of markers assays by adding new parameters

        2. to check whether the assayed molecules in other environments more accessible (blood,
           urine) would provide equivalent diagnostic power of those assayed in the CSF

        3. identify metabolic pathways disrupted early that could be related to the pathogenesis of
           neurodegeneration.
    

Intervention name(s): lumbar puncture
Intervention type(s): Procedure
Intervention description(s): lumbar puncture at enrollment in study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ALS; Spinal Cerebrospinal Fluid; Urine; SERUM; Diagnosis
CHO-loading Before and High Intermittent CHO-intake During Physical Exercise in T1D
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Prolonged physical exercise (PE) is a challenge in type 1 diabetes with an increased
      incidence of both hypoglycemia and hyperglycemia.

      The purpose was to evaluate the impact of two consecutive days of carbohydrate (CHO) loading,
      followed by high intermittent CHO-intake during prolonged PE, facilitated by a proactive use
      of Real-Time Continuous Glucose Monitoring (rtCGM), on glucose control in individuals with
      type 1 diabetes.

      Ten physically active individuals with type 1 diabetes were invited to participate in a 3-day
      long sports camp with the objective to evaluate CHO-loading and high intermittent CHO-intake
      during prolonged PE. 1.5 months later the same procedure was evaluated during a 90 km
      cross-country skiing race. Participants were instructed to act proactively using rtCGM with
      predictive alerts set for high and low glucose values to maintain sensor glucose values
      within target range, defined as 72-180 mg/dl (4-10 mmol/l).
    

Detailed description: 
      This is a descriptive, single arm, non-randomized interventional study. The intervention
      consisted of carbohydrate loading prior to and intermittent high carbohydrate intake during
      physical exercise and a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM) to
      achieve and maintain glucose control.

      Central Contact Person Stig A Mattsson, dietician PhD student Phone: +46702047759 E-mail:
      stigmattsson@live.com

      IPD Sharing Statement No: There is not a plan to make IPD available.
    

Intervention name(s): Carbohydrate loading and high intermittent carbohydrate intake during physical exercise
Intervention type(s): Other
Intervention description(s): The intervention consisted of carbohydrate loading prior to and intermittent high carbohydrate intake during PE and a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM) to achieve and maintain glucose control
Intervention model: Single Group Assignment
Intervention model description: This is a descriptive, single arm, non-randomized interventional study. The intervention consisted of carbohydrate loading prior to and intermittent high carbohydrate intake during physical exercise and a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM) to achieve and maintain glucose control.
Masking: None (Open Label)
Primary purpose: Other
Combination of Dasatinib and Peg-Interferon Alpha 2b in First Line for Chronic Myeloid Leukemia in Chronic Phase
Condition: Chronic Phase of Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 2

Summary: 
      Interferon alpha was a therapy used in Chronic Myeloid Leukemia in Chronic phase prior to the
      advent of tyrosine kinase inhibitors. Synergistic effect of the combination of Peg-IFNα2a
      with Imatinib was demonstrated in the clinical SPIRIT trial. In this study, the investigators
      address the question of the efficacy and safety of dasatinib in combination with low dose of
      Peg-IFNα-2b as frontline therapy for patients with newly diagnosed Chronic Myeloid Leukemia
      in Chronic phase.
    


Intervention name(s): Dasatinib; Peg-Interferon alpha2b
Intervention type(s): Drug; Drug
Intervention description(s): Dasatinib 100mg daily starting at inclusion
If ANC ≤ 1.5.109/L, platelets ≤ 100.0.109/L or lymphocytes > 4.0.109/L at 3 months, dasatinib will be continued alone, and patients will be still followed in the study; 30 µg weekly starting month 4- month 21
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Dasatinib