bioihbjkbjnl/mcl2 huggingface dataset:
Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya
Condition: Multiple Sclerosis-Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Sclerosis; Disease Progression
Study type: Observational

Summary: 
      This study will determine whether in RRMS patients receiving Gilenya there is a link between
      disease progression and biologic markers.
    

Detailed description: 
      The biologic basis that determines disease progression in multiple sclerosis (MS) patients
      remains to be defined. We propose that a long term study of patients where inflammatory
      activity of the disease is expected to be controlled on treatment, will identify patients
      into cohorts of those whose disease is deemed to be stable with those patients whose disease
      has been deemed to progress. Once the two groups have been identified, it will then be
      possible to assess whether there are differences in biologic markers between the two groups.
      These markers would then have the potential to be used to monitor disease progression or be
      predictors for patient response to drug treatment.
    

Intervention name(s): Gilenya
Intervention type(s): Drug
Intervention description(s): All patients will receive Gilenya
Other intervention name(s): fingolimod
Intervention MeSH terms: Fingolimod Hydrochloride
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with relapsing-remitting multiple sclerosis deemed by their treating physician to
        be a suitable candidate for Gilenya therapy
      
Biospecimen description: 
      serum, peripheral blood mononuclear cells, DNA
    
Keywords: Multiple Sclerosis, Relapsing-Remitting; Gilenya; Fingolimod
Effect Aerobic Training on Women With Breast Cancer After Chemotherapy
Condition: Cancer; Exercise; Hemoglobins
Study type: Interventional
Phase: Phase 1

Summary: 
      Introduction: The purpose of this study was to determine the effect of twelve weeks of
      aerobic exercise program on erythrocyte levels in women with breast cancer after
      chemotherapy.

      Methods: Thirty women with breast cancer after chemotherapy of Sydalshhda hospital (aged
      between 47-65 years) volunteered for this study, and then randomly selected an exercise (n =
      15) and control (n = 15) groups. Exercise group completed a twelve-week aerobic exercise
      training program consisted of three sessions per week, each session lasting 30 to 60 minutes
      50 to 75 percent of their maximum heart rate reserve, while the control group were followed.
      Blood samples including red blood cell counts (RBC), hematocrit (HCT), hemoglobin (HB), peak
      oxygen consumption before and after 12 weeks of aerobic exercise were measured. For analysis
      of data, repeated-measures analysis of variance (ANOVA) was used.
    


Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): twelve-week aerobic exercise training program consisted of three sessions per week, each session lasting 30 to 60 minutes 50 to 75 percent of their maximum heart rate reserve
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Childhood Asthma Management in Primary Care: Implementation Of Exhaled Nitric Oxide and Spirometry Testing
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      What are the capacity and training needs in general practice to implement routine spirometry
      and eNO testing in children aged 5-16 years?

      Asthma is the commonest long-term disease of childhood in the United Kingdom (UK).
      Under-diagnosis and under-treatment of childhood asthma in general practice (GP) have been
      reported from several European countries including the UK. This can result in poor symptom
      control and increased risk of asthma related deaths.

      It has been suggested that both under- and over- diagnosis of childhood asthma in general
      practice could be improved by routinely using objective lung function testing for diagnosis
      and monitoring.

      The proposed objective lung function tests (spirometry and exhaled nitric oxide measurements
      - eNO) are already used routinely in UK hospitals, but are not usually available in general
      practice where most children are cared for.

      Why is it important? - Availability of these tests will help health professionals in general
      practice to look after children with asthma better, and hopefully improve asthma control.

      What will this study achieve? - Though it is believed that providing spirometry and eNO in
      general practice would be beneficial, there is little data on how this can be achieved. This
      study will employ both qualitative and quantitative measures in order to evaluate the
      resources required to implement routine spirometry and eNO testing for children in primary
      care; and to investigate the impact this would have on diagnosis in children with suspected
      asthma.

      How? - The investigators will work with general practices in and around Leicestershire, UK.
      Firstly, to identify what the barriers are to implementing these tests, and secondly to train
      the practices to perform and interpret spirometry and eNO independently in children.

      Children with suspected or previously diagnosed asthma will be invited for review and lung
      function testing. The investigators will record the time it takes to train general practices
      to perform and interpret spirometry and eNO independently, and the additional clinic capacity
      required to provide these tests.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients registered to participating general practices in Leicestershire and
        Northamptonshire
      
Keywords: Spirometry; Exhaled Nitric Oxide; Primary Care
Study to Evaluate SYN115 in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory study to evaluate if SYN115 has an effect on Parkinson's disease as
      measured by clinical symptoms and brain images using magnetic resonance imaging (MRI) when a
      function test is administered.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, two-way crossover study in which each
      patient will act as their own control. Each patient enrolled will receive both SYN115 (20 mg
      or 60 mg) and placebo separated by a minimum of one week washout between periods. An adaptive
      design will be used to determine if SYN115 elicits effects relevant to PD in the fewest
      number of patients by performing interim analyses in successive cohorts of patients receiving
      60 or 20 mg.
    

Intervention name(s): Placebo; Tozadenant
Intervention type(s): Drug; Drug
Intervention description(s): Placebo oral capsules
Placebo for 7 days; 20 mg oral capsules with a daily dosage of either 20 mg BID or 60 mg BID
Other intervention name(s): A2a antagonist; SYN115
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
Condition: Nasal Congestion and Inflammations; Rhinitis
MeSH terms: Rhinitis; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter clinical trial, phase III, non-inferiority, controlled by active
      medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation
      upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and
      a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel
      groups, and will receive the medicines of study, according of the randomization.
    

Detailed description: 
      This study evaluate the efficacy and safety of experimental drug The study was designed to
      evaluate the efficacy and safety of fixed combinations Decongex® Plus Syrup and Decongex®
      Plus Oral Solution (consisting of brompheniramine maleate and phenylephrine hydrochloride)
      compared to Resfenol® Oral Solution (paracetamol, maleate chlorpheniramine and phenylephrine
      hydrochloride) in the treatment of nasal congestion and rhinorrhea present in acute attacks
      of viral rhinitis (common cold) and allergic. This study population will consist in
      participants of both sexes, aged between 6 to 11 years old with acute inflammatory condition
      of the upper airways, defined as nasal congestion and runny nose, with no less than 24
      (twenty four) hours and a maximum of 48 (forty-eight) hours prior to inclusion.
    

Intervention name(s): brompheniramine + phenylephrine; Brompheniramine + pseudoephedrine
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution: brompheniramine (2mg/mL) and phenylephrine (2,5 mg/mL), t.i.d., according weight of patient.
OR Syrup: brompheniramine (2mg/5mL) and phenylephrine(5 mg/5mL), t.i.d., according weight of patient.; Elixir: Brompheniramine (0,2mg/mL) and pseudoephedrine (3,0 mg/mL), t.i.d., according weight of patient
Other intervention name(s): Group 1; Group 2
Intervention MeSH terms: Brompheniramine; Phenylephrine; Oxymetazoline; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rhinitis; common cold; nasal symptoms; children
Safety and Efficacy Study of Famitinib in Patients With Advanced Colorectal Adenocarcinoma（FACT）
Condition: Colorectal Cancer Metastatic; Colorectal Cancer Recurrent
MeSH terms: Colorectal Neoplasms; Adenocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and
      Flt3, whose anti-tumor and anti-angiogenesis effects have been validated in preclinical
      tests. In PhaseⅡb study, a significantly improved Progression Free Survival (PFS) was found
      in patients with advanced colorectal cancer treated with Famitinib compared to placebo. On
      the other hand, the toxicity of Famitinib was manageable in both PhaseⅠand Ⅱb studies.

      The purpose of this study is to determine whether Famitinib can improve Overall Survival (OS)
      compared with placebo in total 540 patients with advanced colorectal cancer who have failed
      in previously received at least two lines of standard chemotherapy.
    


Intervention name(s): Famitinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg p.o. qd; 25 mg p.o. qd
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colorectal Cancer; Famitinib
Genetic and Risk Factors in Exfoliation Glaucoma Patients
Condition: Glaucoma Capsulare; Genetic Predisposition to Disease; Risk Reduction
MeSH terms: Glaucoma; Exfoliation Syndrome; Genetic Predisposition to Disease
Study type: Observational

Summary: 
      Prospective non-randomised cohort study enrolling patients with exfoliation glaucoma. All
      patients were ophthalmological examined at inclusion. Blood samples were taken for genetic
      analysis.
    

Detailed description: 
      Patients & examinations In this prospective non-randomised cohort study, the investigators
      enrolled patients with exfoliation glaucoma at the Ophthalmology Department of the
      Skaraborg's Hospital, Skövde, and Sahlgrenska University Hospital, Gothenburg, from 1st
      January, 2014, to 31st December, 2017. All patients were followed-up for three years ± three
      months. Informed consent was obtained from all patients. The study protocol was granted
      ethical approval by the University of Gothenburg (DN:119-12). The study was performed in
      accordance with the tenets of the Declaration of Helsinki.

      At the recruiting visit, an ophthalmic nurse checked the visual acuity of patients with a
      Snellen's chart and performed a visual field test. Humphrey Field Analysis was performed
      using the software threshold 24-2. Subsequently, an ophthalmologist measured the intracoular
      pressure (IOP) with a Goldmann applanation tonometer and performed slit-lamp biomicroscopy,
      including gonioscopy. Pupils were then dilated with 2.5% phenylephrine and 0.5% tropicamide.
      After 20 min, the presence of exfoliation was confirmed, and the optic nerve was assessed
      using a 90-D lens. Subsequently, the central corneal thickness (CCT) was measured using an
      ultrasound device. The average value of seven measurements was automatically calculated. At
      the end of the visit, blood samples were collected. The number of medicines was registered as
      the number of compounds and not the number of bottles used.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In this prospective non-randomised cohort study, the investigators enrolled patients with
        exfoliation glaucoma at the Ophthalmology Department of the Skaraborg's Hospital, Skövde,
        and Sahlgrenska University Hospital, Gothenburg.
      
Biospecimen description: 
      Blood samples.
    
Keywords: Glaucoma; Exfoliation; Risk factors; Genetics
Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke
Condition: Acute Ischemic Stroke (AIS)
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to assess the safety, tolerability and local tolerance, and
      to investigate the plasma levels and terminal elimination half life of MCI-186, and to review
      the routine clinical and neurological assessments data of MCI-186 in subjects with acute
      ischemic stroke.
    


Intervention name(s): MCI-186; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1: Edaravone: circa 1000 mg / 72-hour infusion
Cohort 2: Edaravone: circa 2000 mg / 72-hour infusion; Cohort1:circa 1000mg / 72-hour infusion matching placebo
Cohort2:circa 2000mg / 72-hour infusion matching placebo
Other intervention name(s): Edaravone
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Aldosterone and the Metabolic Syndrome
Condition: Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders
MeSH terms: Metabolic Syndrome; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of mineralocorticoid receptor (MR)
      antagonism and renin inhibition on glucose metabolism in humans.
    

Detailed description: 
      The purpose of this study is to determine the effects of mineralocorticoid receptor (MR)
      antagonism and renin inhibition on fasting blood glucose and glucose-stimulated insulin
      secretion in humans.
    

Intervention name(s): Hydrochlorothiazide (HCTZ); Aliskiren 150 mg (ALI 150); Spironolactone (SPL 25); Aliskiren 300 mg (ALI 300); Spironolactone 50 mg (SPL 50)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): HCTZ 12.5mg daily; Aliskiren 150mg daily; spironolactone 25mg daily; Aliskiren 300mg daily; Spironolactone 50 mg daily
Other intervention name(s): HCTZ; Tekturna; Aldactone; Tekturna; Aldactone
Intervention MeSH terms: Hydrochlorothiazide; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Glucose; Insulin
A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the research study is (1) to rate the taste, texture, appearance, and
      mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored
      Tang, (2) rank the importance of the taste, texture, appearance, and mixability when rating
      cholestyramine and Tang to determine the accuracy and usefulness of a taste test
      questionnaire.
    

Detailed description: 
      The primary objective of this study is to evaluate patient acceptability of 2 doses of
      orange-flavored generic Questran (cholestyramine) versus orange-flavored Tang Drink Mix (a
      commercial powdered orange drink without cholestyramine) via 2 BASA scales. A second
      objective is to assess the 2 different versions of the BASA scale. One version will be
      unweighted with the score based upon the aggregate score of each acceptability component. A
      second version will be weighted based upon subjectively-reported importance of the
      acceptability components. The one main study objective or focus is to determine which version
      of a BASA scale best differentiates patient acceptability of a bile acid sequestrant
      (cholestyramine) versus a placebo control powder (containing no bile acid sequestrant)
      thereby determining which BASA scale is the best validated instrument for future studies in
      assessing and comparing patient acceptability of bile acid sequestrants.
    

Intervention name(s): Cholestyramine; Cholestyramine; Tang
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cholestyramine 4 grams one time dose; Cholestyramine 12 grams one dose, one day; Tang one dose one day
Other intervention name(s): Questran; Questran
Intervention MeSH terms: Cholestyramine Resin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bile acid sequestrant; Resin; Cholesterol; Diabetes mellitus; Lipids; Glucose; Bile Acid Sequestrant Acceptability Scale (BASA)validation study
To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esophageal Cancer Patients Undergoing Chemoradiotherapy
Condition: Esophageal Squamous Cell Carcinoma; Chemoradiotherapy; Enteral Nutrition
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Observational

Summary: 
      This study prospectively recruited esophageal squamous-cell carcinoma patients who received
      nasogastric tube (NG), gastrostomy feeding and oral intake to compare the changes in
      nutritional status and quality of life during chemoradiation therapy (CRT).
    


Intervention name(s): Dietary guidance
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with esophageal squamous cell carcinoma who received concurrent chemoradiotherapy
        voluntarily chose different nutritional treatment paths according to the degree of
        dysphagia.
Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured
      by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein
      (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).

      Secondary Objectives:

      To assess the effects of SC doses of alirocumab on:

        -  Various parameters of the metabolism and turnover in plasma of different lipoproteins

        -  Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol
           (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB,
           lipoprotein(a) (Lp(a))

        -  Lipoprotein particle size profile

        -  PCSK9 (free and total) concentrations in serum To assess safety and tolerability of
           alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum
           alirocumab concentrations.
    

Detailed description: 
      Total duration of the study per subject is 26 weeks, including a screening period of ≤ 4
      weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a
      follow up period of 8 weeks.
    

Intervention name(s): alirocumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:Solution for injection
Route of administration: Subcutaneous; Pharmaceutical form:Solution for injection
Route of administration: Subcutaneous
Other intervention name(s): SAR236553; REGN727; Praluent
Intervention MeSH terms: Alirocumab
Intervention model: Crossover Assignment
Intervention model description: Single-sequence crossover
Masking: Single (Participant)
Primary purpose: Basic Science
Acute Whole Body Vibration Change the Glycemic and Lactate Levels
Condition: Diabetes
Study type: Interventional

Summary: 
      The type II diabetes is characterized by high levels of blood glucose followed by excessive
      insulin release so that the target cells become less sensitive and develop insulin
      resistance, maintaining hyperglycemic levels. The Whole body vibration session may improve
      the glucose metabolism in diabetic patients by reducing the peripheral blood sugar. Ten
      healthy elderly women and eight diabetic elderly women were allocated into two groups, and
      have made an acute whole body session.
    


Intervention name(s): whole body vibration
Intervention type(s): Device
Intervention description(s): whole body vibration training on a vibrating platform with healthy elderly and diabetic elderly
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research