bioihbjkbjnl/mcl2 huggingface dataset:
Ciprofloxacin/Celecoxib Combination in Patients With ALS
Condition: ALS (Amyotrophic Lateral Sclerosis)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, off label study, to provide interested ALS patients with
      Ciprofloxacin/Celecoxib fixed dose combination, while assessing safety and tolerability,
      routine disease progression measures (ALSFRS-R and Vital Capacity).
    

Detailed description: 
      Patients will be prescribed a fixed dose combination of Ciprofloxacin and Celecoxib to be
      taken twice daily, and will be monitored for safety and tolerability. Additionally, routine
      progression measures will be assessed.
    

Intervention name(s): Fixed dose combination Ciprofloxacin/Celecoxib
Intervention type(s): Drug
Intervention description(s): Fixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day
Other intervention name(s): PrimeC
Intervention MeSH terms: Ciprofloxacin; Celecoxib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility, Safety and Efficacy of Remote Ischemic Preconditioning for Symptomatic Intracranial Arterial Stenosis in Octogenarians
Condition: Bilateral Limb Ischemic Preconditioning; Intracranial Arterial Stenosis
MeSH terms: Ischemia; Constriction, Pathologic
Study type: Interventional
Phase: Phase 1

Summary: 
      Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the
      heart. This study aims to evaluate the feasibility, safety and initial efficacy of using
      briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in
      octogenarians with symptomatic intracranial arterial stenosis.
    


Intervention name(s): bilateral limb ischemic preconditioning (Doctormate, IPC-906X)
Intervention type(s): Device
Intervention description(s): Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X, produced by Beijing Renqiao Institute of Neuroscience)five cycles of 5 minutes bilateral upper limb ischemia-reperfusion performed by inflating tourniquets to 200 mmHg, twice daily for 180 consecutive days, along with conventional medical treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: remote ischemic preconditioning; octogenarian; intracranial arterial stenosis; stroke recurrence
Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial
Condition: Chronic Plaque Psoriasis; Obesity
MeSH terms: Psoriasis; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The study hypothesis is to investigate whether a moderate weight loss (i.e. a weight
      reduction of at least 5%) could improve the response rate to a suboptimal dose of
      cyclosporine in patients with severe psoriasis.
    


Intervention name(s): low calorie diet
Intervention type(s): Other
Intervention description(s): Low calorie diet was designed to achieve a loss of 5-10% of initial weight. All enrolled patients received a balanced diet scheme, based on a caloric intake reduction related to BMI and sex (range 1200-1500 Kcal/day for women, 1300-1600 Kcal/day for men). Calorie intake consisted approximately of 60% carbohydrates, 25% fat, 15% protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose
      of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza
      virus infection. It is also performed to assess immunogenicity and pharmacokinetics
      (shedding).
    

Detailed description: 
      GHB16L2 intends to provide a novel vaccination for influenza virus infection. 80 healthy
      volunteers will be included at a ratio of 1:1 for GHB16L2 or placebo. GHB16L2 will be
      administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.
    

Intervention name(s): GHB16L2; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants; SPGNH buffer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: live attenuated flu vaccines; influenza A (H1N1); intranasal application; replication-deficient influenza virus
H5N1 Mix and Match With AS03
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old,
      inclusive, will be enrolled over a 5-month period into this multicenter, randomized,
      double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study
      and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted
      vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular
      subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given
      with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2
      doses separated by approximately 21 days.
    

Detailed description: 
      This is a randomized, double-blinded, controlled, Phase I study in healthy male and
      non-pregnant female subjects, 18 to 49 years old, inclusive, designed to assess the safety,
      reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent
      influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by sanofi pasteur
      administered at different dosage levels (3.75, 7.5 or 15 mcg) given with the AS03 adjuvant
      manufactured by GSK or PBS diluent.
    

Intervention name(s): AS03 Adjuvant; Phosphate Buffered Saline (PBS) diluent; Sanofi H5N1 Antigen
Intervention type(s): Drug; Other; Biological
Intervention description(s): Adjuvant/diluent manufactured by GlaxoSmithKline (GSK); Placebo/diluent provided by sanofi pasteur; Subvirion inactivated monovalent influenza A/H5N1 (Hemagglutinin (HA) of A/Indonesia/05/2005) virus vaccine manufactured by sanofi pasteur, at 2 doses levels 21 days apart, administered at 3.75, 7.5, or 15mcg, with either AS03 adjuvant or PBS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: influenza, vaccine, H5N1
Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in
      Korean healthy children aged 12~23 months
    

Detailed description: 
      To compare the Vero cell-derived inactivated Japanese encephalitis(JE) vaccine
      'KD-287(JEIMMUGEN INJ.)' with the mouse brain-derived inactivated JE vaccine in terms of the
      immunogenicity and safety, in Korean healthy children aged 12~23 months
    

Intervention name(s): JE vaccine
Intervention type(s): Biological
Intervention description(s): 3 times, IM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: JEV; vero cell
Effect of EITC on Biological Markers of Aging, Health and Mortality
Condition: Poverty; Tax Policy
Study type: Interventional

Summary: 
      Paycheck Plus (PP) is a randomized controlled experiment (RCT) that explores the health and
      longevity effects associated with increasing the Earned Income Tax Credit (EITC). EITC is a
      national program that provides tax credits to low-income, disproportionately minority workers
      who file taxes. EITC is politically popular, having received bipartisan support. The EITC,
      along with state supplemental programs, have 7 million American families out of poverty. The
      investigators' preliminary data analyses show that the EITC has had large population health
      impacts, reversing declines in self rated health and survival among the poorest Americans.
    

Detailed description: 
      Poverty disproportionately impacts minority and rural populations and is very strongly
      correlated with poor health over the life cycle, and has been hypothesized to lead to a
      shorter, less healthy aging process. Poverty is associated with a greater burden of disease
      than smoking and obesity combined and accounts for the bulk of health disparities by race. It
      is widely believed that an antipoverty policy, such as Earned Income Tax Credit (EITC), could
      improve healthy aging among working-age low-income adults over the life cycle. It does so by
      increasing material hardship and psychological stress, two risk factors that are strongly
      correlated with biological markers of premature aging (e.g., shorter telomeres, higher
      cholesterol levels, and higher blood pressure).
    

Intervention name(s): Paycheck Plus
Intervention type(s): Other
Intervention description(s): A four-fold increase in the Earned Income Tax Credit
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Earned Income Tax Credit (EITC); Tax Credit; Paycheck Plus
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in
      approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening
      diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce
      the development and progression of diabetic retinopathy, intensive control of glucose is
      usually not achieved in clinical practice.
    


Intervention name(s): Octreotide Acetate in Microspheres 20 mg; Octreotide Acetate in Microspheres; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic retinopathy,Octreotide Acetate in Microspheres
MyPad - Intelligent Bladder Pre-void Alerting System
Condition: Enuresis, Nocturnal; Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional

Summary: 
      Development a 'dry alarm' that can help children and adolescents become dry at night.
    

Detailed description: 
      Enuresis / Bedwetting is a common problem causing much emotional distress. Most children are
      dry by the age of 5 years, but a significant number of older children still wet their bed.
      This can be very distressing for child and family. There is also an associated cost due to
      extra laundry and impact of lost sleep.

      Programmes to help children become dry at night often include the use of a moisture alarm.
      The alarms sound when the child begins to wet the bed, waking them up to go to the toilet
      instead. Most alarms work by detecting wetness, sounding the alarm when the child starts to
      pass urine. As such, they still need to change pyjamas and bed sheets.

      The investigators aim to develop a 'dry alarm' that can help children and adolescents become
      dry at night. The alarm will sound when the bladder is full, before the child passes urine.
      This would avoid wet beds. The investigators have engineered parts for this alarm, but need
      to work on making it ready for use. This device will enable children to have dry nights
      whilst learning bladder control.

      This study has several phases. The alarm will consist of a small box worn over the abdomen.
      The aim is to test this overnight, and adjust it for comfort and ease. The device uses a mini
      ultrasound machine, which measures how much urine is in the bladder. There will be a series
      of tests to calibrate the device compared to a clinical ultrasound device. Then children with
      enuresis/ bed wetting will wear it overnight. It will be linked to an alarm which will sound
      once the bladder is full.

      This particular study will determine the feasibility of the product, to confirm the design
      and specifications, including a comfort trial, calibration and comparison with clinical
      scans, and operating process prior to a future clinical trial.

      The total number of participants is 25 - however this will be split over the different phases
      of the trial.

      Comfort Trial - 5 Calibration trial 3 month testing phase - 10
    

Intervention name(s): MyPad
Intervention type(s): Device
Intervention description(s): Ultrasound bed wetting alarm
Intervention model: Single Group Assignment
Intervention model description: Cohort
Masking: None (Open Label)
Primary purpose: Device Feasibility
Gut Microbiota in Chronic Noncommunicable Diseases
Condition: Arterial Hypertension; Atherosclerosis Occlusive Disease; Heart Failure With Preserved Ejection Fraction; Heart Failure With Reduced Ejection Fraction; Diabetes Mellitus, Type 2; Obstructive Pulmonary Disease; Asthma; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Lung Diseases, Obstructive; Heart Failure; Atherosclerosis; Diabetes Mellitus, Type 2; Noncommunicable Diseases
Study type: Observational

Summary: 
      It is an observational study in patients with chronic noncommunicable diseases (i.e.
      cardiovascular diseases, diabetes mellitus, non-alcoholic fatty liver disease, chronic
      obstructive pulmonary disease and asthma ) and control group with no signs of these
      conditions. The study has a prospective part planned for 2021 and a retrospective part which
      includes the patients enrolled between 2018-2020. The aim of the study is to investigate gut
      microbiota composition, its metabolites, levels of inflammatory and other markers of the
      disease in prospective groups (arterial hypertension, type 2 diabetes mellitus, chronic
      obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease and control
      patients) as well as in retrospective groups (chronic heart failure with preserved and
      reduced ejection fraction, obstructive atherosclerosis of any vascular bed, arterial
      hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma,
      non-alcoholic fatty liver disease, and control patients). Also we are planning to investigate
      the association between gut microbiota composition and its metabolites, levels of
      inflammatory and other markers of the disease in retrospective and prospective groups.
    


Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic noncommunicable diseases including cardiovascular diseases, type 2
        diabetes mellitus, nonalcoholic fatty liver disease, chronic obstructive pulmonary disease,
        asthma and control group
      
Biospecimen description: 
      Serum, plasma, stool samples
    
Keywords: chronic noncommunicable diseases; gut permeability; inflammation; gut microbiota
Early Detection of Second Lung Cancer in Patients With Stage I Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Using new methods to examine sputum samples for the presence of cancer cells may
      detect lung cancer earlier.

      PURPOSE: Screening trial to study the effectiveness of new methods of examining sputum
      samples to detect second primary lung cancer in patients with resected stage I non-small cell
      lung cancer.
    

Detailed description: 
      OBJECTIVES: I. Evaluate whether immunostaining of induced sputum specimens improves the
      sensitivity and specificity of routine morphologic sputum surveillance to detect second
      primary lung cancer in patients with previously resected nonsmall cell lung cancer. II.
      Evaluate which patients are at risk of developing a second primary lung cancer by
      immunostaining specimens from patients with no morphologic atypia on routine Papanicolaou
      cytology. III. Make available archived sputum samples and bronchial washings for further
      analysis of new antibodies and techniques. IV. Evaluate whether analysis of elevations of
      relevant growth factors in bronchial lavage fluid from patients with positive immunostaining
      or morphologic atypia increases the accuracy of early detection. V. Evaluate whether
      quantitation of shed antigens in sputum increases the accuracy of early detection. VI.
      Evaluate whether the extent of airway obstruction, as measured by the forced expiratory
      volume, can predict an increased risk of developing lung cancer.

      OUTLINE: Screening for Second Primary Lung Cancer. Annual sputum induction for Papanicolaou
      cytology and immunostaining (using monoclonal antibodies 624H12 and 703D4), with optional
      pulmonary function tests and fiberoptic bronchoscopy with bronchial washings.

      PROJECTED ACCRUAL: 1,100 patients will be entered over 3 years. The sample size will be
      adjusted based on the rate of positive staining in the first 100 patients. Patients followed
      at uncertified centers are analyzed separately.
    

Intervention name(s): cytology specimen collection procedure; immunoenzyme technique; study of high risk factors
Intervention type(s): Other; Other; Procedure
Primary purpose: Screening
Keywords: stage I non-small cell lung cancer
Seroprevalence of SARS-Cov-2 Antibodies in Children
Condition: COVID; Corona Virus Infection; Multisystem Inflammatory Syndrome in Children
MeSH terms: Coronavirus Infections
Study type: Observational

Summary: 
      It is unknown what proportion of healthy children have been exposed to SARS-Cov-2 and how
      many have antibodies. The aim of this study is to follow a cohort of healthy children over
      six months and measure their antibodies to SARS-CoV-2.
    

Detailed description: 
      Coronaviruses are non-segmented positive-stranded RNA viruses with a roughly 30 kb genome.
      The majority of coronaviruses cause disease in a specific host species but some have infected
      humans by cross-species transmission. This process has led to a number of severe outbreaks of
      human disease including severe acute respiratory syndrome (SARS) in 2003 and Middle East
      respiratory syndrome (MERS) in 2012.

      From December 2019 a novel infection "severe acute respiratory syndrome coronavirus 2"
      (SARS-CoV-2) was identified in the Wuhan region of China. The infection was identified as the
      causal factor in a growing number of severe cases of pneumonia. This disease was subsequently
      named coronavirus disease 2019 (COVID-19) by World Health Organisation (WHO). SARS-CoV-2 has
      been shown to cause severe disease similar to the previous SARS coronavirus from 2003. Severe
      disease is associated with pneumonia and damage to vital organs including lung, heart, liver,
      and kidney.

      Fortunately SARS-CoV-2 appears to cause only mild, or no, symptoms in children.

      The social distancing measures in the United Kingdom include the closure of schools and the
      cancelling of routine paediatric clinics. These drastic, but necessary, steps are likely to
      have a profound effect on the well-being of children.

      This study is required to determine what proportion of children have been exposed to
      SARS-Cov-2 and how many, if any, have neutralizing antibodies. The findings from this study
      could be used to inform public health decisions regarding the re-opening of schools and other
      services vital to the well-being of children.

      In addition the study will recruit children with paediatric multi-system inflammatory
      syndrome admitted to the Royal Belfast Hospital for Sick Children along with matched controls
      with other infections.
    

Intervention name(s): Covid-19 Antibody testing (IgG and IgM); Blood Storage
Intervention type(s): Diagnostic Test; Other
Intervention description(s): Antibody testing for previous exposure to Covid-19; Storage of blood for multi-omics analysis
Intervention MeSH terms: Antibodies
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged from 0 to 15 who are resident in the United Kingdom
      
Biospecimen description: 
      Plasma
    
Keywords: antibodies
A Bioequivalence Study of Rabeprazole From Idiazole 20mg DR Tabs (GSK, Egypt) and PARIET 20 mg DR Tabs (JANSSEN, EGYPT)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, two-way crossover open-label study to determine the
      bioequivalence of Rabeprazole from Idiazole 20mg DR tabs (GSK, Egypt)and PARIET 20 mg DR tabs
      (JANSSEN, EGYPT) after a single oral dose administration of each to healthy adults under
      fasting conditions.
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically
      transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Idiazole 20mg DR tabs; PARIET 20 mg DR tabs
Intervention type(s): Drug; Drug
Intervention description(s): Delayed release tablets containing 20 mg of rabeprazole; Orally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)