bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Lactobacillus Cultures on Iron Bioavailability.
Condition: Low Iron Stores
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of a lactic acid fermented oat gruel on
      iron absorption in the upper and lower part of the intestine, respectively.
    

Detailed description: 
      Iron deficiency and low iron stores are prevalent in infants, adolescents, and women of
      childbearing age in both Western and developing countries. One cause of iron deficiency is
      the low iron bioavailability from foods, which is partly due to inhibiting factors in the
      diet, such as phytate and phenolic compounds. A number of single meal studies with lactic
      acid fermented vegetables and cereals have shown a significant increase in iron absorption in
      humans. This is believed to be caused mainly by the lactic acid produced during the
      fermentation process, which conteracts the inhibiting effect of phytate.

      A recent study of ours indicate that the increased nonheme iron absorption from a low iron
      bioavailability meal was due not only to an effect of the lactic acid produced, but also a
      specific effect of the lactic acid bacteria. As lactic acid bacteria colonizes the entire
      intestine but mainly the colon it is of interest to determine whether these bacteria can
      increase iron absorption from the distal part of the intestine since iron absorption normally
      is believed to be absorbed from the duodenum and most proximal small intestine.

      The purpose of this study is therefore to determine the the effect of Lactobacillus plantarum
      299v in a lactic acid fermented oat gruel on iron absorption in the proximal and distal small
      intestine, respectively, in a cross-over design with 18 healthy women of childbearing age,
      served both fermented oat gruel and pasteurized, fermented oat gruel.
    

Intervention name(s): Active Lactobacillus plantarum 299v; Inactive Lactobacillus plantarum 299v
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): 10^11 cfu/meal in 2 meals on 2 consecutive days; Inactive form of the active treatment but with the fermentation products in the same concentration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Iron absorption; Organic acids; Lactobacillus; Probiotic
A Phase I Study of SHR1459 in Healthy Subjects
Condition: Health, Subjective
Study type: Interventional
Phase: Phase 1

Summary: 
      Following a 10-hour overnight fast, subjects will be administered one dose of SHR1459 orally
      with 240 mL of ambient temperature water on Day 1. D2-D3 was the cleaning period.
      Itraconazole will be administered orally 200 mg/time/day form D4 to D8 after meal. On D7
      following a 10-hour overnight fast, subjects will be administered SHR1459 and itraconazole
      200 mg with 240 mL of ambient temperature water.
    


Intervention name(s): SHR1459/Itraconazole
Intervention type(s): Drug
Intervention description(s): SHR1459 will be administered on Day 1 and Day 7. Itraconazole will be administered on Day 4 to Day 8
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine
Condition: Norwalk Gastroenteritis; Norovirus Infections
MeSH terms: Caliciviridae Infections; Gastroenteritis
Study type: Interventional
Phase: Phase 1

Summary: 
      A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years,
      6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component
      in each age group. A total of 30 people in each dose group were vaccinated with the test
      vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1.

      The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a
      time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is
      inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses
      interval of 28 days.
    

Detailed description: 
      From January to April 2020, this study was affected by the COVID-19 epidemic, which caused
      the two groups（6-17-year-old，3-5-year-old） of subjects to vaccinate beyond the window and
      deviate from the experimental plan. After communication between the researcher, the sponsor
      and the statistician, it was decided to restart the Phase I clinical trials of these two
      groups.
    

Intervention name(s): Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）; Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）; Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）; Normal saline; Aluminum adjuvant
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）administered intramuscularly according to a 0, 28，（56） day vaccination schedule; Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）administered intramuscularly according to a 0, 28，（56） day vaccination schedule; Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）administered intramuscularly according to a 0, 28，（56）day vaccination schedule; Normal saline administered intramuscularly according to a 0, 28 ，（56）day vaccination schedule; Aluminum adjuvant administered intramuscularly according to a 0, 28，（56） day vaccination schedule
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Probiotics and Allergic Diseases
Condition: Atopic Dermatitis; Asthma
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      Many studies had demonstrated that probiotics could be applied in the prevention and adjuvant
      treatment for allergic diseases. In this study, we investigate the effects of Lactobacillus
      paracasei GMNL-133(LP), Lactobacillus fermentum GM-090 (LF), and Lactobacillus paracasei
      GMNL-133(LP) with Lactobacillus fermentum GM-090 (LF) combination products used for adjuvant
      treatment of atopic dermatitis and asthma.
    

Detailed description: 
      The main purpose: To investigate if Lactobacillus paracasei GMNL-133(LP), Lactobacillus
      fermentum GM-090(LF), Lactobacillus paracasei GMNL-133 (LP) with Lactobacillus fermentum
      GM-090 (LF) combination products could be used for the adjuvant treatment of atopic
      dermatitis and asthma.

      The Secondary Objective: To investigate whether probiotics consumption improve the quality of
      life and allergic symptoms to different people with Lactobacillus paracasei GMNL-133 (LP),
      Lactobacillus fermentum GM-090 (LF) and Lactobacillus paracasei GMNL-133(LP) and
      Lactobacillus fermentum GM-090 (LF) combination products.
    

Intervention name(s): LP GMNL-133 capsule; LF GM-090 capsule; LP GMNL-133 +LF GM-090 capsule; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO; Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO; One capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Probiotics; Lactobacillus paracasei GMNL-133; Lactobacillus fermentum GM-090; Atopic dermatitis; Asthma; Lactobacillus paracasei; Lactobacillus fermentum; efficacy and safety
Extracorporeal Cardiac Shock Wave Therapy (CSWT) for Treatment of Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness of cardiac shock wave therapy
      (CSWT) for the treatment of severe coronary artery disease (CAD) in a Chinese cohort.
    

Detailed description: 
      This study was approved by the Institutional Review Board and Ethics Committee of 1st
      Hospital of Kunming Medical University, and all study subjects signed informed consent for
      participation in the study and all treatments performed. Subjects were patients who were
      hospitalized at Department of Cardiology of our hospital from December 2008 to December 2009.

      Patients were eligible to be included in the study if they met any of the following criteria:
      1) Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of
      moderate to severe coronary artery stenosis. 2) Chest tightness, onset of shortness of
      breath, and poor exercise tolerance after receiving formal drug treatment (with or without
      stent or bypass graft). 3) Hospitalized more than 2 times within 1 year due to the
      aforementioned problems. 4) CCS angina grading higher than grade II, and NYHA functional
      classification of I-III. 5) More than 1 month after acute myocardial infarction (AMI) and
      more than 2 weeks after PCI surgery. The diagnosis and treatment in all the patients was in
      accordance with the related domestic and European guidelines developed in 2007
    

Intervention name(s): cardiac shock wave therapy(CSWT)
Intervention type(s): Device
Intervention description(s): CSWT was performed with the MODULITH SLC SW therapy device (Storz Medical, Switzerland).Shock waves were triggered by the R-wave of the ECG when the instrument was activated. The shock wave energy was increased from an initial low level up 0.09 mJ/mm2 if the patient experienced no discomfort such as chest pain. Point-to-point combination treatment for the ischemic areas with 200 pulses delivered to each point was given.
Other intervention name(s): SW
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: coronary artery disease; angina pectoris; myocardial ischemia; cardiac shock wave therapy
Tranexamic Acid (TXA) in Pediatric Cardiac Surgery
Condition: Bleeding
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine tranexamic acid plasma levels in children
      undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.
    

Detailed description: 
      Tranexamic acid (TXA) is administered intravenously to prevent bleeding associated with
      cardiac surgery and by pass in adult and children. The pharmacokinetic of this product is
      unknown in the pediatric population. Only a few studies report a clinical efficacy with
      different dosages. The purpose of this study is to determine the plasma level of TXA using
      two different administrations methods: continuous versus intermittent. The second objective
      is to determine whether fibrinolysis decreased. The population consists in children weighting
      10 to 30 Kilos, undergoing cardiac surgery and at high risk of bleeding.
    

Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): Comparison of two dosage regimen of Tranexamic Acid
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: tranexamic acid in pediatric surgery; fibrinolysis and paediatric cardiac surgery
A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the
      potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or
      placebo 0.05, 0.25, 0.5, 2, 5, 12.5, 25μg/kg in Chinese healthy volunteers. 54 volunteers
      will be randomized to receive NL005 or placebo for 7 cohorts,administered iv by iv push on
      Day 1.
    

Detailed description: 
      This study is a randomized,double-blind,placebo-controlled, investigation to evaluate the
      safety, tolerability, pharmacokinetics and the potential immunological reaction of single of
      NL005 administered intravenously to healthy volunteers.

      In Phase 1A, Seven (7) cohorts of subjects (first two cohorts 2 subjects respectively, 10
      subjects per cohort for next 5 cohorts) will administered one dose of NL005 or placebo in a
      4:1 ratio. Dosing start at 0.05μg/kg and advance to 0.25, 0.5, 2, 5, 12.5, 25μg/kg.

      NL005 or placebo administered as a single dose on Day 1. Safety parameters recorded on Study
      Days 1, 2, 5, 14, and 28. Evaluation of adverse events performed throughout the study.
      Pharmacokinetic samples obtained on Study Day 1. Blood samples collected for serum antibody
      determinations at Screening , Days 14 and 28.
    

Intervention name(s): Recombinant Human Thymosin β4; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.; Five cohorts, with 10 healthy subjects , were given a single intravenous dose of Placebo. Cohorts received ascending doses of either 0.5, 2,5,12.5 or 25 ug/kg in Day1.
Other intervention name(s): rh-β4
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose Escalation for 7 Cohorts.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Recombinant human thymosin β4
UCB Therapy in Acquired Brain Injury
Condition: Acquired Brain Injury
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label trial is conducted to investigate the efficacy and safety of allogeneic
      umbilical cord blood (UCB) therapy for patients with acquired brain injury.
    

Detailed description: 
      Acquired brain injury (ABI) means brain damage caused by events after birth, rather than as
      part of a genetic or congenital disorders. Those with ABI suffer from cognitive, physical, or
      behavioral impairments limiting their activity and participation in society. ABI results from
      traumatic or non-traumatic brain injury due to internal or external source (e.g. infection,
      brain tumor, hypoxia). Preclinical studies regarding cell therapy in animal models of ABI
      showed improvements of neurological dysfunction. UCB possess various stem or progenitor cells
      and is known to secrete neurotrophic factors to repair injured brain. This clinical research
      aims to determine the safety and efficacy of allogeneic UCB for patients with ABI.
    

Intervention name(s): Umbilical cord blood therapy
Intervention type(s): Procedure
Intervention description(s): Intravascular umbilical cord blood therapy
Intervention model: Single Group Assignment
Intervention model description: UCB therapy for TBI patient
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Umbilical cord blood; Acquired brain injury
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
Condition: Hepatitis C; Liver Transplantation
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory study to evaluate the impact of eliminating steroid administration
      upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in
      patients transplanted for HCV cirrhosis.
    

Detailed description: 
      A comparison will be made between two regimens which both include tacrolimus, one utilizing
      standard steroid administration and the second with daclizumab (MAB) avoiding steroids for
      both prophylactic administration and anti-rejection treatment.
    

Intervention name(s): Tacrolimus; steroids, monoclonal anti-IL2R antibody
Intervention type(s): Drug; Drug
Intervention description(s): immunosuppression; immunosuppression
Other intervention name(s): Prograf, FK506
Intervention MeSH terms: Antibodies; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tacrolimus; Liver Transplantation; Immunosuppression; Adult; Treatment Outcome
Impact of Pandemic of Presentation to Emergency Department and Admissions
Condition: Emergencies
MeSH terms: Emergencies
Study type: Observational

Summary: 
      Observational study assessing the impact of the COVID-19 pandemic on presentations and
      admission to hospital in children and young adults.
    

Detailed description: 
      The COVID-19 pandemic has had a major impact on healthcare utilisation and delivery for
      children and young adults. This is despite these groups experiencing minimal morbidity and
      almost no mortality as a direct result of the pandemic. The immediate impact of the first
      lockdown in April 2020 has been well documented. A number of studies show a marked reduction
      in presentations of children and young adults to the emergency department.

      The question is now, are these trends continuing and are they particularly impacting on
      specific groups and on specific presentations? With these data, services can be modified to
      minimise any potential for deleterious effects. It may also be possible to target groups who
      are not utilising health services as the investigators would expect.

      The investigators will use fully anonymised routine data on presentations and admission of 0
      to 24 years olds to University Hospital Southampton NHS Foundation Trust. Data will be
      graphed to show trends in activity before and after the start of the pandemic. An interrupted
      time series regression analysis will be used to assess the significance of any changes in
      trends.
    

Intervention name(s): COVID-19 pandemic
Intervention type(s): Other
Intervention description(s): Study focuses on the impact of the COVID-19 pandemic on emergency attendances and admissions.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children and young adults aged 0 to 24 years who have presented +/- admitted to the
        emergency department at University Hospital Southampton NHS Foundation Trust between the
        1st of April 2016 and 31st of March 2021. Some children presented to paediatric assessment
        unit prior to September 2019; after that the patient pathway was merged with the emergency
        department.
      
Keywords: emergencies; children; adolescents; young adult
The Effect of DA9301 on Tablet Computer-Induced Asthenopia
Condition: Asthenopia
MeSH terms: Asthenopia
Study type: Interventional

Summary: 
      Asthenopia or eye strain describes nonspecific symptoms of an eye when it is tired from
      intensive work. Vaccinium uliginosum is a flowering plant in the genus Vaccinium. This plant
      is native to cool temperature regions of the Northern Hemisphere. Considering its
      antioxidative ingredients, the extract of Vaccinium uliginosum is expected to play a
      significant role in treating various ocular pathologies. The investigators performed a
      randomized, case-controlled study in healthy subjects and investigated the protective effect
      of Vaccinium uliginosum extract (DA-9301) on tablet computer-induced asthenopia.
    


Intervention name(s): DA9301 (Vaccinium uliginosum extract); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The PATHway system is designed to help patients remain physically active and maintain a good
      cardiovascular health. It proposes a novel approach that aims to empower patients to
      self-manage their CVD, set within a collaborative care context with health professionals.
      This will be achieved via a patient-centric holistic approach that specifically addresses the
      above barriers. It involves an internet-enabled and sensor-based home exercise platform. It
      is represented by several modules with an exercise module as the core component which will
      provide individualized rehabilitation programs that use regular, socially inclusive exercise
      sessions as the basis upon which to provide a personalized, comprehensive lifestyle
      intervention program (managing exercise, smoking, diet, stress, alcohol use etc.) to enable
      patients to both better understand and deal with their own condition and to lead a healthier
      lifestyle in general.

      The goal of this trial is to assess the acceptability, short-term effectiveness on lifestyle
      and health related physical fitness and cost-effectiveness of the PATHway intervention in
      patients with CVD in a single blind multicentre pilot randomised controlled trial (RCT).
    


Intervention name(s): PATHway
Intervention type(s): Behavioral
Intervention description(s): Patients will use the PATHway platform for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device
Condition: HIV Prevention
Study type: Interventional

Summary: 
      To assess the safety and acceptability of the non-surgical PrePex device among healthy adult
      male participants scheduled for voluntary medical male circumcision when removing the
      foreskin shortly after device placement.
    

Detailed description: 
      To assess the safety and acceptability of the non-surgical PrePex device among healthy adult
      male participants scheduled for voluntary medical male circumcision when removing the
      foreskin shortly after device placement.

      Five hundred (500) males scheduled for voluntary circumcision performed by clinicians or
      nurses using the PrePex.

      Theses clinicians and nurses have already been trained in the Prepex procedure and will
      undergo further training in the modification to the technique. Study duration per participant
      will be up to 8 weeks and will include three follow up visits and one phone call follow up.
    

Intervention name(s): PrePex
Intervention type(s): Device
Intervention description(s): Prepex is a non surgical male circumcision device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention