bioihbjkbjnl/mcl2 huggingface dataset:
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This
      system for automated control of blood glucose in patients with type 1 diabetes was tested in
      the clinical research center as well as at the home of the patients. Glucose control with
      automated closed loop control was comparable to patient-managed open loop control.

      The closed loop system has been further developed and miniaturized (from backpack to
      smartphone size) in order to interfere as little as possible with daily patient life. The aim
      of this trial is to assess the efficacy of the new prototype at the home of the patient. It
      is hypothesized that the closed loop system provides better glucose control than standard
      open loop therapy.
    


Intervention name(s): Artificial Pancreas (Inreda Diabetic BV); Insulin pump therapy
Intervention type(s): Device; Device
Intervention description(s): Bi-hormonal reactive closed loop system without mealtime announcement, miniaturized prototype; Patients' own insulin pump with fast-acting insulin analog
Other intervention name(s): Continuous subcutaneous insulin infusion
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Pancrelipase
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial pancreas; Bi-hormonal closed loop; Diabetes Type 1
Fitness Training in Children
Condition: Obesity; Low Fitness
Study type: Interventional

Summary: 
      We hypothesize that improvement in cardiovascular fitness is associated with a greater
      improvement in insulin sensitivity than improvement in body composition (loss of body fat) is
      associated with insulin sensitivity. Towards that we are randomizing children who are
      overweight, or children with low fitness levels to exercise intervention 2 or three times per
      week.
    


Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): this will test the effect of exercise on insulin sensitivity, fitness and body composition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AZD9668 Relative Bioavailability
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to investigate the pharmacokinetic behaviour of the free base
      formulation of AZD9668. The study will compared the relative bioavailability of the free base
      formulation at two different dose levels compared to the tosylate salt formulation.
    


Intervention name(s): AZD9668; AZD9668
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg; 60 mg
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: COPD
Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the taste preference in children of 3 different
      flavours of the ESL oral suspension.
    

Detailed description: 
      Children between the age of 5 and <8 years who are patients of the participating
      investigators will be screened for participation in the study. This may be at a regularly
      planned visit or the investigators may invite children who would be suitable candidates.
      Children who agree to participate will be invited to come back to the clinic on a single
      Study Day and will be randomised to a particular sequence of flavours. On the Study Day, all
      children will be given 3 different flavoured samples of Eslicarbazepine acetate (ESL) oral
      suspension for tasting, in the sequence to which they were randomised, in a double-blind,
      standardized setting. Each sample will consist of 2.5 mL and is to be given with a spoon in a
      double-blind manner, and is not to be swallowed. After tasting and spitting out each sample
      the child will be asked to rate the taste on a 10 cm visual analogue scale incorporating a
      facial hedonic scale. At the end of the session, the child will also be asked which flavour
      they thought tasted the best and which tasted the worst, to assess overall taste. A follow-up
      telephone contact interview will be performed between 1 and 4 days after the Study Day to
      collect adverse event (AE) data.
    

Intervention name(s): ESL Banana taste; ESL Grape taste; ESL Tutti-Frutti taste
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.; oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.; oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
Other intervention name(s): Eslicarbazepine acetate (ESL); Eslicarbazepine acetate (ESL); Eslicarbazepine acetate (ESL)
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
LACTOPRES:Study on the Effect of Dairy Peptides on Blood Pressure in Untreated Hypertensive Subjects.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypertension is an increasingly important medical and public health issue. Literature
      suggests that there may be a role for dairy foods in the prevention and treatment of
      hypertension. Recently, it has been suggested that several peptides in milk proteins could
      have blood pressure lowering properties. LACTOPRES is a randomised, double-blind parallel
      trial to assess the blood pressure effect of an increased intake of dairy peptides in humans.
    


Intervention name(s): dairy peptides
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: hypertension; blood pressure; dairy peptides; bioactive peptides; randomized controlled trial
Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure
Condition: COVID-19; Acute Respiratory Distress Syndrome
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury
Study type: Interventional

Summary: 
      This is a research study to see how safe and effective decidual stromal cells are in treating
      patients with respiratory failure (breathing problem where not enough oxygen is passed from
      the lungs into the blood) caused by COVID-19.
    

Detailed description: 
      COVID-19 viral infectious disease that has lead to high numbers of critically ill patients or
      death due to respiratory failure.

      Decidual Stromal Cells (DSC) may be useful in the treatment of acute respiratory distress
      syndrome (ARDS) by reducing lung inflammation and then time that patients require help with
      breathing (mechanical ventilation).
    

Intervention name(s): Decidual Stromal Cells (DSC)
Intervention type(s): Biological
Intervention description(s): DSCs are involved in the immune system during pregnancy. The DSCs used in this study will come from laboratory grown allogeneic human decidual stromal cells obtained from donated placentas.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety, reactogenicity and immune responses of two
      doses of the investigational RSV vaccines (with different formulations), when administered
      intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years.

      As the investigational vaccines have not yet been tested in humans before, the study will
      first assess the safety, reactogenicity and immune responses in young adults aged 18 to 40
      years. The study will thus be conducted in 2 parts (Part A and Part B).
    


Intervention name(s): RSV Vaccine (GSK3844766A) unadjuvanted low dose; RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E; RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B; RSV Vaccine (GSK3844766A) unadjuvanted medium dose; RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E; RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B; RSV Vaccine (GSK3844766A) unadjuvanted high dose; RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E; RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B; Placebo (Saline solution)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Drug
Intervention description(s): Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Respiratory syncytial virus (RSV); Vaccine; Safety; Reactogenicity; Immunogenicity
Feasibility Study of an Innovative Medical Device for Sampling the Contents of the Small Intestine.
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      For the first time in the world, the objective of this study is to evaluate on healthy
      volunteers, an innovative medical device for the capture of intestinal liquid.This medical
      device is not yet CE marked.
    

Detailed description: 
      This medical device consists of a standard pill made of 3 capsules for the collection of
      intestinal microbiota. The pill is ingested by the volunteer and multi-omics analysis will be
      performed on intestinal fluid samples from the capsules and also on faeces.

      First in man, involving a medical device, prospective, monocentric, not randomized, not
      controlled and open-label study.
    

Intervention name(s): Innovative medical device for sampling small intestine content
Intervention type(s): Device
Intervention description(s): Ingestion of the medical device by the volunteer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Innovative medical device; Microbiota; Biochemically controlled capsule; Intestinal fluid sampling
"Remind to Move" Treatment Versus Constraint-induced Movement Therapy for Children With Hemiplegic Cerebral Palsy
Condition: Hemiplegic Cerebral Palsy; Upper Extremity Hemiplegia
MeSH terms: Cerebral Palsy; Hemiplegia
Study type: Interventional

Summary: 
      The aim of this study was to determine the effects of an innovative child-friendly
      remind-to-move treatment (RTM) treatment by comparing it with constraint-induced movement
      therapy (CIMT) on upper extremity outcomes in children with hemiplegic Cerebral Palsy. In an
      evaluator-blinded randomized controlled trial, 73 children, among of whom 20 in Manual
      Ability Classification System level I, 38 level II, and 15 level III, were recruited from 3
      special schools and randomized to receive 75-hour RTM (n=25) and CIMT (n=24) programme over
      15-weekdays, and conventional treatment (n=24). The primary outcomes were Jebsen-Taylor Hand
      Function Test (JTHFT) and Bruininks-Oseretsky Test of Motor Proficiency (BOTMP-II) Subtest 3
      for assessing the motor efficiency at baseline, posttest, and 1- and 3-month follow-up.
    


Intervention name(s): Remind-to-move; Modified constraint induced movement therapy; Conventional rehabilitation
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison of HFNC With NIV in Weaning COPD
Condition: Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      High flow nasal cannula (HFNC) has been shown to improve oxygenation and facilitate weaning
      in hypoxemia patients. Some clinical studies show the benefits of using HFNC in COPD
      patients, including reducing dead space and work of breathing. However, no clinical study has
      been to investigate the value of HFNC in weaning COPD patients from invasive ventilation.
      Thus, we proposed a randomized controlled trial to compare the use of HFNC and noninvasive
      ventilation (NIV) in weaning COPD.
    

Detailed description: 
      High flow nasal cannula (HFNC) provides high concentration oxygen in a high flow, which
      exceeds patient's inspiratory flow demand, to improve oxygenation. In a recent meta-analysis
      of seven trials with 1771 patients, HFNC was shown to improve oxygenation and avoid
      intubation in patients with severe hypoxemia. The high velocity of the gas can rinse the dead
      space of the upper airway and reduce CO2 rebreathing, reduce COPD patients' work of breathing
      and improve the dynamic compliance of respiratory system.

      Thus, we proposed a randomized controlled trial to investigate the value of high flow nasal
      cannula in weaning AECOPD patients from invasive ventilation, with comparison of noninvasive
      ventilation.
    

Intervention name(s): High flow nasal cannula; Noninvasive ventilation
Intervention type(s): Device; Device
Intervention description(s): High-flow nasal cannula (HFNC) oxygen therapy is a recent technique delivering a high flow of heated and humidified gas. HFNC is simpler to use and apply than noninvasive ventilation (NIV) and appears to be a good alternative treatment for hypoxemic acute respiratory failure (ARF). HFNC is better tolerated than NIV, delivers high fraction of inspired oxygen (FiO2), generates a low level of positive pressure and provides washout of dead space in the upper airways, thereby improving mechanical pulmonary properties and unloading inspiratory muscles during ARF.; Non-invasive ventilation (NIV) is the use of airway support administered through a face (nasal) mask instead of an endotracheal tube. Inhaled gases are given with positive end-expiratory pressure often with pressure support or with assist control ventilation at a set tidal volume and rate. Numerous studies have shown this technique to be as effective as, and better tolerated than, intubation and mechanical ventilation in patients with exacerbations of COPD
Other intervention name(s): High flow high humidity nasal cannula; Noninvasive positive pressure ventilation; Noninvasive mechanical ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weaning; Noninvasive ventilation; High flow nasal cannula
Study to Evaluate the Safety, Tolerance and Immunogenicity of Fluviral™ in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety, tolerance and immunogenicity of Fluviral™
      in healthy adults aged 18-64 years.
    

Detailed description: 
      This study was conducted by ID BioMedical which has been taken over by GlaxoSmithKline. At
      the time of conduct of this study, Fluviral was produced by ID BioMedical.
    

Intervention name(s): Fluviral™; Fluzone®
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular, single dose; Intramuscular, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
A Bioequivalence Study of Domestic (Made in China) and Imported Mizolastine Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the bioequivalence (the way in which different forms
      of the same drug are absorbed in the body) of single-dose administration of domestic (made in
      China) mizolastine tablets and imported mizolastine tablets given at the same dose in healthy
      volunteers
    

Detailed description: 
      This is a single-center, open-label (all people know the identity of the intervention),
      randomized (the study medication is assigned by chance), crossover (method used to switch
      patients from one treatment arm to another in a clinical study) study. Approximately, 24
      healthy volunteers will be enrolled in the study. Eligible volunteers will be randomly
      allocated to either Sequence A group or Sequence B group. On Day 1, volunteers from Sequence
      A group will receive imported mizolastine tablets and volunteers from Sequence B group will
      receive domestic mizolastine tablets. There will be a washout period (no treatment) of 7
      Days. On Day 8, the two sequence groups will be switched. Volunteers from Sequence A group
      will receive domestic mizolastine and volunteers from Sequence B group will receive imported
      mizolastine tablets. Safety evaluations will include assessments of adverse events, clinical
      laboratory tests, electrocardiogram, vital signs, and physical examination, which will be
      measured throughout the study. The maximum study duration for each volunteer will be
      approximately 16 days.
    

Intervention name(s): Mizolastine domestic (made in China); Mizolastine (imported)
Intervention type(s): Drug; Drug
Intervention description(s): Healthy male volunteers will receive 10 mg domestic (made in China) mizolastine tablets on Day 1 and Day 8; Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8
Intervention MeSH terms: Mizolastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Bioequivalence; Mizolastine; Domestic; Imported
Prognosis of Failure Treatment of Amebic Liver Abscess
Condition: Amebic Liver Abscess
MeSH terms: Abscess; Liver Abscess; Liver Abscess, Amebic
Study type: Observational

Summary: 
      Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually
      the factors for predicting failure in the medical treatment are not clear. We conducted trial
      for determining the clinical value of paraclinical factor in this issue.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        sequential patients with clinical, ultrasonographic and serologic diagnosis (ELISA) of
        amebic liver abscess
      
Keywords: amebic liver abscess; failure; prognosis
Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion
Condition: Breast Neoplasms; Neoplasm Metastasis; Gene Expression Profiling; Immunotherapy
MeSH terms: Neoplasms; Neoplasm Metastasis; Breast Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
Study type: Observational

Summary: 
      The investigators want to develop a gene expression profile for the prediction of
      immunotherapy response of patients with metastatic breast cancer presenting malignant pleural
      effusion.
    

Detailed description: 
      1. The patiets with malignant pleural effusion are randomizned to be treated with
           cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK)
           locally.

        2. Malignant pleural effusion from metastatic breast cancer patient is obtained through
           thoracentesis and is centrifugalized to enrich cancer cells before the therapy.

        3. The enriched cancer cells are flash frozen and stored at -80℃ until processing.

        4. The gene expression in pleural effusion is detected by microarray to screen gene markers
           that are differently expressed between groups .

        5. Statistical analysis is performed using unsupervised hierarchical cluster.
    

Intervention name(s): cytokine
Intervention type(s): Biological
Intervention description(s): interleukin 2 2 million unit every week
Other intervention name(s): interleukin 2 2 million unit every week
Intervention MeSH terms: Interleukin-2
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The breast cancer patiets present with pleural effusion and can receive chemotherapy.
      
Biospecimen description: 
      The cancer cells are taken from the malignant pleural effusion of breast cancer patiets.
    
Keywords: Metastatic Breast Neoplasms; Gene Expression Profiling; immunotherapy
Efficacy and Tolerability of a Phytotherapy Combination (Aqualibra) in Patients With Uncomplicated Cystitis
Condition: Urinary Tract Infection Lower Acute
MeSH terms: Urinary Tract Infections; Cystitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, placebo-controlled, double-blind study investigated the efficacy and safety
      of the herbal medicinal product containing a combination of extracts of restharrow root
      (Ononidis radix), Java tea (Orthosiphonis folium) and goldenrod herb (Solidaginis herba) in
      women with acute lower uUTI.
    

Detailed description: 
      This randomized, placebo-controlled, double-blind study investigated the efficacy and safety
      of the herbal medicinal product containing a combination of extracts of restharrow root
      (Ononidis radix), Java tea (Orthosiphonis folium) and goldenrod herb (Solidaginis herba) in
      the treatment of acute lower uUTI. The herbal medicinal product represent a multi-target
      therapy that includes diuretic, anti-inflammatory and antimicrobial aspects.

      Patients were randomized to one of the two treatment groups and treated with the
      phytotherapeutic agent or matching placebo for seven days.

      The primary endpoint was microbiologic response defined as reduction in bacterial urine
      culture counts by at least 10*2 CFU/ml.
    

Intervention name(s): Herbal Medicinal Product; Placebo
Intervention type(s): Combination Product; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment