bioihbjkbjnl/mcl2 huggingface dataset:
BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test
      product to the reference product in adult patient with Asthma
    

Detailed description: 
      This study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the
      reference product in terms of FEV1 measures at different timepoints in adult patient with
      Asthma.
    

Intervention name(s): Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg; Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhalation aerosol, 2 actuations orally inhaled twice daily; Inhalation aerosol, 2 actuations orally inhaled twice daily; Inhalation aerosol, 2 actuations orally inhaled twice daily
Other intervention name(s): Test product; RLD; Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Malt-derived Ingredients and Their Prolactinotrophic Effects
Condition: Acute Response to Food Ingredient Consumption
Study type: Interventional

Summary: 
      This proof-of-concept study aims to investigate whether malt-derived ingredients have acute
      prolactinotrophic effects in healthy women of child-bearing age.
    


Intervention name(s): Malt ingredient; Non-alcoholic beer solids
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Solution with malt-derived ingredient; Solution with non-alcoholic beer solids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Tart Cherries and Melatonin Content
Condition: Sleep
Study type: Interventional

Summary: 
      The aim of this investigation was to examine the effects of tart Montmorency cherry juice on
      urinary 6-sulfatoxymelatonin and sleep quality using a double-blind, placebo-controlled,
      cross-over design.
    

Detailed description: 
      The aim of the study is to examine the efficacy of tart cherry juice on sleep quality,
      quantity, and timing. Naturally circulating melatonin is instrumental in regulating
      sleep/wake schedules. Tart Montmorency cherries (Prunus Cerasus) contain high levels of
      melatonin and may be a useful intervention to supplement for realignment of circadian phase
      and by increasing the robustness of circadian amplitude. In normal healthy adults, with
      experimentally induced phase advanced circadian misalignment, the administration of a 3mg
      supplement of melatonin significantly increased sleep architecture characteristics. In this
      study we want to examine the efficacy of tart cherry juice in increasing urinary levels of
      melatonin and the subsequent impact this will have on sleep parameters.
    

Intervention name(s): Cherry juice; Fruit juice cordial
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 30 mLs preceding morning meal and 30 mLs preceding evening meal each day for 7 days.; fruit flavoured juice concentrate
Other intervention name(s): CherryActive concentrate; Apple and blackcurrent squash (0164 9338). Sainsbry's Supermarkets Ltd.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep, circadian cycle, melatonin
Effects of a Moisturizing Product on Dry Eye and Skin
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      Dry eye is a common syndrome associated with symptoms of dryness, burning, itching and
      grittiness of eyes. The objective of this study is to investigate the effects of a
      moisturizing product in liquid formula on symptoms and signs of dry eye and on skin around
      the eyes.
    


Intervention name(s): Moisturizing Eye Product in Liquid Formula
Intervention type(s): Device
Intervention description(s): Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy
Condition: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This purpose of the study is to investigate the bronchodilating effects of 3 different
      dosages of formoterol given in combination with budesonide as Symbicort pMDI.
    

Detailed description: 
      A Phase 2, randomized, blinded, 5-period cross-over, placebo and active controlled,
      multicenter, dose-finding study comparing single doses of formoterol 2.25 µg, 4.5 µg, and 9
      µg delivered via Symbicort pMDI and Foradil® 12 µg evaluating the relative bronchodilating
      effects and safety in children.
    

Intervention name(s): 80/2.25 μg Symbicort pMDI; 80/4.5 μg Symbicort pMDI; Foradil Aerolizer 12 μg; 40 μg budesonide HFA pMDI; placebo HFA pMDI
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): inhalation; inhalation; inhalation; inhalation; inhalation
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthmatic children; Symbicort; Foradil
A Study to Compare Genetic Variations of IGF-I and IGF-II
Condition: Dementia
MeSH terms: Dementia
Study type: Observational

Summary: 
      The purpose of this study is to determine if insulin-like growth factors (IGF) play a role in
      the development of dementia, specifically Alzheimer's disease (AD). The study will compare
      results from genetic testing between patients with AD and two other groups: younger
      biological family members of the AD patients and individuals without AD matched by age to the
      AD patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        There are three groups of participants for this research study: one group will consist of
        individuals diagnosed with dementia; another group will consist of younger biological
        family members of the patients with dementia; and the third group will consist of
        individuals without dementia who are matched in age to the patients with dementia.
      
Biospecimen description: 
      saliva and blood
    
Keywords: Dementia; Insulin-like growth factor; IGF; APO E4; Genetics
Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis
Condition: IGA Glomerulonephritis
MeSH terms: Glomerulonephritis; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates prospectively the effects of an anti-angiotensin II regimen on renal
      outcome in patients with mesangioproliferative glomerulonephritis followed-up for 10 years.
    

Detailed description: 
      After signing informed consent, enrolled patients started treatment with ACEi. We decided to
      prescribe to all patients the same drug (ramipril) at the same dosage (5 mg/day). All
      patients were examined every 2 months during the first year of follow-up and every 6 months
      thereafter. At each visit, they underwent a complete physical examination. If the target
      blood pressure of <140/90 mmHg was not achieved with ramipril monotherapy, addition of other
      antihypertensive drug(s) was allowed. Patients complaining adverse side effects attributed to
      ramipril were switched to losartan (50 mg/day). The patients were also prescribed a normal
      protein (1 gram/kg/day) and moderately salt-restricted (6-8 grams/day) diet throughout the
      study.
    

Intervention name(s): Ramipril or losartan
Intervention type(s): Drug
Intervention description(s): Ramipril (5 mg/day) was started soon after the enrollment and continued throughout the follow-up, having Losartan (50 mg/day) as alternative.
Other intervention name(s): renin-angiotensin system (RAS) inhibitors
Intervention MeSH terms: Losartan; Ramipril
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of HPV Vaccine On The Prevalence Of HPV In Norway
Condition: Cervical Intraepithelial Neoplasia; Cervical Cancer; Oropharyngeal Cancer
MeSH terms: Uterine Cervical Dysplasia; Oropharyngeal Neoplasms
Study type: Observational

Summary: 
      The overall aim of the study is to assess the effect of school-based Human Papillomavirus
      (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and
      non-vaccinated women born in 1997. Women born in 1997, residence to Norway in 2009 (the year
      of vaccine initiation of the 1997-cohort) are invited to participate in the study.
    

Detailed description: 
      This cohort is amongst the first that was offered HPV vaccine in an organized vaccination
      programme globally. The women will be recruited through Facebook ads. The study will enable
      us to measure differences in the prevalence of HPV types in vagina and the mouth between
      vaccinated and non-vaccinated young women in Norway.

      The womens vaccination status will be validated by linkage to the Norwegian Immunisation
      Registry (SYSVAK) and their residence status will be validated through linkage to the
      Norwegian Population Registry.
    

Intervention name(s): Self sample from vagina; Self sample from the oral cavity; Questionnaire
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): Self sample using The Rover's Evalyn Brush; Self sample using COPAN FloqSwab; Questionnaire about vaccination status and sexual behaviour
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women resident to Norway in 2009
      
Biospecimen description: 
      Self samples from vagina and the oral cavity
    
Keywords: HPV vaccines; HPV-6; HPV-11; HPV-16; HPV-18; Gardasil
PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis
Condition: Allergic Rhinitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the present study is to characterize the dose-response relationship of
      PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms
      of clinical efficacy and safety.

      For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due
      to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of
      treatment and at the end of the study patients will be subjected to a nasal provocation test.
    


Intervention name(s): Placebo; PURETHAL Mites 6,667 AU/ml; PURETHAL Mites 20,000 AU/ml; PURETHAL Mites 50,000 AU/ml; PURETHAL Mites 100,000 AU/ml
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Increasing volumes of placebo, will be administered by subcutaneous injection (starting with 0.05 ml) at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of placebo, are given at 4-weekly intervals.; Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.; Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.; Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.; Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: non-seasonal allergy; house dust mite; immunotherapy; dose response
Study of Erythropoietin (EPO) Administration Schedule
Condition: Chronic Renal Failure; Anaemia
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the hemoglobin and hematocrit variability between
      once and three times weekly erythropoietin therapy for the anemia in patients with
      maintenance dialysis.
    


Intervention name(s): recomon (Epoetin Beta); recomon (Epoetin Beta)
Intervention type(s): Drug; Drug
Intervention description(s): administer once weekly; administer three times weekly
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic renal failure; Anaemia
Reliability of the 4 Metre Gait Speed in Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This study is investigating the reliability of the 4 metre gait speed test (4MGS) in patients
      with a lung disease called Idiopathic Pulmonary Fibrosis (IPF).
    

Detailed description: 
      This observational study is investigating a simple test of walking speed, measured using the
      4 metre gait speed test (4MGS), in patients with a lung disease called Idiopathic Pulmonary
      Fibrosis (IPF). Drug development for this disease is slow in part because there is a lack of
      reliable measurements that can assess effectiveness of treatment. Slow walking speed has been
      shown to relate to poor outcomes in older adults and people with another lung disease called
      Chronic Obstructive Pulmonary Disease (COPD. The investigators are interested to see whether
      usual walking speed is a reliable measure in patients with IPF as this will help inform us of
      its potential use as an outcome measure. To do this, participants who consent to taking part
      in the study will be timed walking at their usual walking speed over a distance of 4 metres
      (13.12 feet). Participants will be asked to do this twice with a rest in between if required.
      One week later, participants will be asked to repeat the walking tests again.
    

Intervention name(s): 4MGS
Intervention type(s): Other
Intervention description(s): Measurement of usual gait speed over 4 metres (metres/second)
Other intervention name(s): 4 metre gait speed test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with IPF according to NICE guidelines
      
Keywords: Gait speed; Functional outcome measure
Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in
      the laboratory may help doctors learn how patients respond to treatment.

      PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving
      imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the
      tumor tissue.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy, of imatinib mesylate, in terms of achieving a therapeutic
           tumor:plasma concentration ratio, in patients with primary malignant glioma.

      Secondary

        -  Correlate tumor grade (low vs high) and/or tumor enhancement on MRI with tumor
           concentration of this drug in these patients.,

      OUTLINE: Patients receive oral imatinib mesylate once daily for 7-12 days. Patients then
      undergo surgical resection.

      Blood and tissue samples are collected at the time of surgery and analyzed for imatinib
      mesylate concentration.

      After completion of study treatment, patients are followed for 7 days.

      PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
    

Intervention name(s): imatinib mesylate; pharmacological study; conventional surgery
Intervention type(s): Drug; Other; Procedure
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult anaplastic oligodendroglioma; adult oligodendroglioma; adult anaplastic astrocytoma; adult giant cell glioblastoma; adult gliosarcoma; recurrent adult brain tumor; adult brain stem glioma; adult mixed glioma; adult glioblastoma; adult pilocytic astrocytoma; adult diffuse astrocytoma; adult anaplastic ependymoma; adult ependymoma; adult myxopapillary ependymoma; adult subependymoma; adult pineal gland astrocytoma; adult subependymal giant cell astrocytoma
Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be
      effective treatment for myelodysplastic syndrome. It is not yet known whether
      immunosuppressive therapy is more effective than supportive care in treating myelodysplastic
      syndrome.

      PURPOSE: Randomized phase II trial to compare the effectiveness of antithymocyte globulin
      with that of supportive care in treating patients who have myelodysplastic syndrome.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the clinical response rate of patients with early myelodysplastic syndrome
           treated with rabbit anti-thymocyte globulin vs standard supportive care.

        -  Evaluate the safety of anti-thymocyte globulin in these patients.

        -  Compare the time to and duration of clinical response, rates of partial response and
           therapy failure, and rate of disease progression in patients treated with these
           regimens.

        -  Compare the ECOG performance score, number of transfusions and/or growth factor use, and
           maximum time between transfusions in patients treated with these regimens.

        -  Compare the infection risk, use of medical resources, and quality of clinical response
           in patients treated with these regimens.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to myelodysplastic syndrome (MDS) subtype (refractory anemia (RA) vs RA with excess
      blasts or hypocellular MDS). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive rabbit anti-thymocyte globulin (ATG) IV over at least 8-12 hours
           on days 1-4.

        -  Arm II: Patients receive standard supportive therapy for 6 months. At the end of 6
           months, patients may receive ATG as in arm I.

      Patients are followed for 6 months.

      PROJECTED ACCRUAL: A total of 72 patients (48 in arm I and 24 in arm II) will be accrued
      within a minimum of 6 months.
    

Intervention name(s): anti-thymocyte globulin
Intervention type(s): Biological
Intervention MeSH terms: Antilymphocyte Serum
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory anemia; refractory anemia with excess blasts; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes
Two Way Bioequivalence Study Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg
      with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study
      participants under fed conditions.

      The purpose is to monitor clinical status, adverse events, laboratory investigations and to
      assess relative safety and tolerance of ondansetron formulations under fed conditions.
    

Detailed description: 
      An open-label randomized, single oral dose, two way crossover bioequivalence study to compare
      ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets
      [ODT® (Containing Ondansetron 8 mg)] in 48 healthy, adult, human study participants under fed
      conditions. Volunteers who signed the consent form and showed their willingness to
      participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion
      criteria and found to be healthy on physical examination with laboratory investigation values
      within reference limits were considered eligible to be admitted into the study. Study
      participants were fasted for 10 hours prior to dosing in both periods. Dosing was conducted
      as per the randomization schedule in each period under fed conditions.A washout period of 7
      days was observed between the two periods.
    

Intervention name(s): Ondansetron (ODFS); Ondansetron (ODT)
Intervention type(s): Drug; Drug
Intervention description(s): Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS); Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)
Other intervention name(s): Zuplenz; Zofran
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment