bioihbjkbjnl/mcl2 huggingface dataset:
Daprodustat Bioequivalence and Food Effect Study
Condition: Anaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is two-way crossover study to compare pharmacokinetic (PK) of daprodustat 2 milligram
      (mg) versus 4 mg tablets and food effect on the PK of daprodustat following single oral doses
      in healthy Japanese male subjects. This study will be conducted in two parts. Part 1 is the
      bioequivalence part in which subjects will receive single dose of 2 tablets of 2 mg
      daprodustat and single dose of 1 tablet of 4 mg daprodustat in crossover manner. Part 2 is
      Food effect part. In this part, subjects will receive single dose of 4 mg daprodustat tablet
      in fasting and fed state in a crossover manner. There will 5-day wash-out period between each
      intervention period. There will be approximately 52 subjects in Part 1 and 12 subjects in
      Part 2. The study will last for 6 weeks.
    


Intervention name(s): Daprodustat 2 mg tablet; Daprodustat 4 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): Daprodustat is available as 2 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 2 tablets of 2 mg daprodustat will be administered in a fasted state during Part 1 of the study.; Daprodustat is available as 4 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 4 mg daprodustat will be administered in a fasted state during Part 1 and in fed and fasted state in Part 2 of the study.
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study will be conducted in two parts. Part 1 is the bioequivalence part in which subjects will receive single dose of 2 tablets of 2 mg daprodustat and single dose of 1 tablet of 4 mg daprodustat in crossover manner. Part 2 is Food effect part. In this part, subjects will receive single dose of 4 mg daprodustat tablet in fasting and fed state in a crossover manner.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Japan; Crossover; Daprodustat; Bioequivalence; Pharmacokinetics
In-vitro and In-vivo Comparative Evaluation of Rotary Fanta and Zunba Files in Root Canal Preparation of Infected Primary Molars
Condition: Root Canal Preparation of Infected Primary Molars
Study type: Interventional

Summary: 
      Adequate shaping and cleaning, followed by a good coronal seal, are prerequisites for a
      favorable outcome. The goal of root canal preparation is to create optimized canal geometry
      to allow effective irrigation and obturation with preservation of the original canal
      morphology.

      The aim of current study is to evaluate the effectiveness of Fanta and Zunba rotatory
      instruments in cleaning of infected root canal of primary molars to those instrumented with
      manual K-files.
    


Intervention name(s): root canal preparation
Intervention type(s): Procedure
Intervention description(s): root canal preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
Condition: Influenza; Orthomyxoviruses; Myxovirus Infection
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To describe the immune response to a single administration of 2 formulations of the
      investigational cell-based influenza vaccines in healthy adult subjects.

      Secondary Objective:

      To describe the safety following a single administration of 2 formulations of the
      investigational cell-based influenza vaccines in healthy adult subjects.
    

Detailed description: 
      This is a multi-center study in healthy adult subjects. All subjects will receive a single
      dose of one of the influenza vaccine formulations and will provide blood samples for
      immunogenicity assessment.
    

Intervention name(s): Influenza virus vaccine - cell based (2007-2008 Formulation); Influenza virus vaccine - cell-based (2007-2008 Formulation); Influenza virus vaccine (2007-2008 Formulation)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 1.0 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Fluzone® (2007-2008 formulation)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Orthomyxoviruses; Split-virion inactivated influenza vaccine; cell-based vaccine; Adults
Efficacy Comparative Study Between Tears Again®, Opticol® and Optive®
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Observational

Summary: 
      Primary Purpose:

        -  To compare the efficacy in treating dry eye syndrome in contact lens wearers or computer
           users of Tears Again® versus Opticol® versus Optive®

      Secondary Purpose:

        -  Subjective evaluation of symptomatology

        -  Evaluation of preference in different kind of administration - spray versus monodoses
           versus multi-doses
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Administrative staff of the hospital with more than 4 hours/day computer use and contact
        lens wearers
Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      Subjects with gas-related complaints exhibit impaired handling of intestinal gas loads and we
      hypothesized that inulin would have a beneficial effect. Aim: to determine the effect of a
      prebiotic chicory-derived inulin-type fructan on the tolerance of intestinal gas. Methods.
      Placebo-controlled, parallel, randomized and double-blind trial study. Subjects with
      abdominal symptoms and reduced tolerance of intestinal gas (selected by a pre-test) will
      receive either inulin (8 g/d, n=18) or maltodextrin as a placebo (8 g/d, n=18) for 4 wk. A
      gas challenge test (4 h jejunal gas infusion at 12 mL/min while measuring abdominal symptoms
      and gas retention for 3 h) will be performed before and at the end of the intervention phase.
      Gastrointestinal symptoms and bowel habits (using daily questionnaires for 1 wk) and fecal
      bifidobacteria counts will be measured before and at the end of the intervention.
    


Intervention name(s): Inulin; Maltodextrine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period; Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intestinal gas; functional gut symptoms; intestinal sensitivity; intestinal motility
The Neurobiology of Expectancy and Pain Perception
Condition: Pain
Study type: Interventional

Summary: 
      This study will use using fMRI (functional Magnetic Resonance Imaging) to elucidate how
      contextual learning/expectation relieves or aggravates pain experience in the same cohort of
      subjects and the same study session.
    


Intervention name(s): Heat pain applied using TSA or CHEPS
Intervention type(s): Device
Intervention description(s): TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age
Condition: Foetal Growth Problem; Small for Gestational Age
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height
      gain during 12 months of growth hormone treatment in children born small for gestational age
      due to intrauterine growth retardation.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the OsciPulse Rapid Cycling Compression Device Effects on Venous Blood Flow
Condition: Venous Thromboses; Venous Stasis
MeSH terms: Thrombosis; Venous Thrombosis; Varicose Ulcer
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will evaluate the effects on venous blood flow of the investigational device,
      OsciPulse system, which is an external intermittent limb compression device. The study will
      enroll healthy human subjects who will have their deep venous blood flow measured by vascular
      ultrasound during immobility, use of the OsciPulse system, and use of two reference vascular
      compression devices. Our hypothesis is that the OsciPulse system will create distinct
      patterns of venous flow, specifically at the site of venous valves, in comparison to the
      reference compression devices.
    

Detailed description: 
      Enrolled healthy subjects will undergo and initial vascular ultrasound imaging procedure to
      locate a deep venous valve in either the sapheno-femoral junction or femoral trifurcation
      sites. Once the imaging valve is identified the baseline level of venous flow will be
      collected in 30 s video clips of 2D color Doppler videos and spectral Doppler. Next, either
      the OsciPulse device, or one of the two reference therapy devices, will be applied by study
      personnel according to the device's specific instructions. The subject will wear the device
      during the capture of 1 spectral Doppler clip and three 30 s 2D color Doppler ultrasound
      clips on both the left and right leg. Next, the remaining two devices will be applied based
      on instructions, and vascular ultrasound clips captured for each. Completion of this visit
      protocol will be the end of the study.
    

Intervention name(s): OsciPulse system; Reference Therapy 1; Refence Therapy 2
Intervention type(s): Device; Device; Device
Intervention description(s): The OsciPulse system is an intermittent pneumatic limb compression system. The OsciPulse sleeves that are applied to the top portion of the user's calves and are periodically inflated with rapid bursts of compressed air to create frequent pulses of venous return.; The Venaflow Elite is a sequential compression device that uses compressed air to inflate sleeves worn on the calf of the user to stimulate venous return. The Venaflow system sleeves cover the entire calf region of the user and contain two bladders that are inflated sequentially to induce venous return.; The Kendall SCD device is a sequential compression device that uses compressed air to inflate sleeves worn on the calf of the user to stimulate venous return. The Kendall SCD sleeves cover the entire calf region of the user and contain three bladders that are inflated sequentially to induce venous return.
Other intervention name(s): Venaflow Elite Vascular System; Kendall 700 Series SCD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Venous compression; Intermittent pneumatic compression
A Study Using Functional Magnetic Resonance Imaging (fMRI) to Assess the Effects of Naltrexone SR/ Bupropion SR Therapy in Overweight or Obese Subjects
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the effect of naltrexone SR/bupropion SR (NB) on
      brain function in response to food cues using functional magnetic resonance imaging in
      overweight or obese subjects.
    


Intervention name(s): Naltrexone SR 32 mg/bupropion SR 360 mg/day; Placebo; fMRI scan
Intervention type(s): Drug; Drug; Other
Intervention description(s): fMRI to assess the effects of the drug/placebo on areas of the brain
Other intervention name(s): functional magnetic resonance imaging to assess the effects of the drug/placebo on areas of the brain
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: obesity; overweight; magnetic resonance imaging; naltrexone; bupropion
BIIB014 Cardiovascular Monitoring Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will examine the effects of a single dose of BIIB014 on blood pressure and
      haemodynamic variables in healthy volunteers over 24 hours.
    


Intervention name(s): Placebo; BIIB014 50mg; BIIB014 100mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose oral capsule placebo comparator; Single dose oral capsule 50mg BIIB014; Single dose oral capsule 100mg BIIB014
Intervention MeSH terms: 3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy subjects
DNA Changes in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Collecting and storing samples of blood from patients and their brothers with
      cancer to study in the laboratory may help doctors learn more about changes that may occur in
      DNA and identify biomarkers related to cancer.

      PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers
      with prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the frequency of single nucleotide polymorphism (SNP) genotypes in patients
           with prostate cancer, their affected siblings, and an unaffected healthy population
           (control).

        -  Determine the age of onset of prostate cancer in affected probands and affected
           siblings.

        -  Determine the penetrance or likelihood that given SNPs will result in disease in
           affected siblings based upon Mendelian genetics.

        -  Determine the odds ratio of developing prostate cancer in the presence of SNPs.

        -  Determine SNP genotypes in patients enrolled on ECOG-E3805, a prostate phase III study
           enrolling men with D2 prostate cancer treated with androgen-ablation therapy alone or
           androgen-ablation therapy with chemotherapy, and correlate them with disease progression
           (i.e., androgen independence).

      OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
      ethnicity, age at diagnosis, and Gleason score.

      Patients, their affected siblings, and healthy participants (controls) undergo collection of
      blood samples. Genomic DNA is extracted from whole blood and sequenced for single nucleotide
      polymorphisms (SNPs) in Akt and mdm-2 genes. SNP data is correlated with clinical and
      biographical data.

      PROJECTED ACCRUAL: A total of 500 patients (250 probands and 250 siblings) and 146 healthy
      participants (controls) will be accrued for this study.
    

Intervention name(s): polymorphism analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Other
Observational model: Other
Time perspective: Retrospective
Keywords: recurrent prostate cancer; stage IV prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer
Phase I/II, Randomized, Double-Blind, Study of the Progenitor Cell Mobilizing Effects of Imprime PGG™ Injection Administered at Varied Dosing Regimens With G-CSF Versus G-CSF Alone
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a randomized, placebo-controlled, dose-escalation, single-center study
      evaluating two different doses of Imprime PGG, each in 7 different dosing regimes. A total of
      66 subjects will be enrolled into 2 cohorts and, within each cohort, randomized to 1 of 7
      treatment groups receiving Imprime PGG or placebo in varied dosing regimens with
      granulocyte-colony stimulating factor (G-CSF).
    


Intervention name(s): Imprime PGG TM for Injection
Intervention type(s): Biological
Intervention description(s): Doses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Healthy Subjects
The Efficacy of Fycompa (Perampanel) in Children With Epilepsy
Condition: Neurologic Disorder
MeSH terms: Nervous System Diseases
Study type: Observational

Summary: 
      Fycompa (Perampanel), a new anti-epileptic drug that uses a new mechanism-AMPA receptor
      antagonist. Its initial indication is for local or generalized epilepsy in children and
      adults over 12 years old, but its effectiveness in the treatment of epilepsy in children At
      present, more evidence is still needed. We will study the effectiveness of Fycompa
      (Perampanel) in the treatment of epilepsy in children under the age of 18. It is expected
      that the clinical use of Fycompa (Parampanel) in Taiwan will be able to analyze and study the
      effectiveness of the clinical use of Fycompa (Parampanel) in the treatment of epilepsy in
      children, and compare it with foreign reports.
    


Intervention name(s): Perampanel
Intervention type(s): Drug
Intervention description(s): Efficacy of epilepsy drugs
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients suffering from epilepsy
Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a
      high eradication rate for clarithromycin-resistant strains, and have a great potential to
      replace bismuth quadruple therapy in the treatment of H. pylori infection.
    

Detailed description: 
      Bismuth quadruple therapy has been recommended as a choice of the first-line treatment for H.
      pylori infection in several important international consensuses. However, it is associated
      with a high frequency of adverse events. Both hybrid and high-dose dual therapies developed
      by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant
      strains, and have a great potential to replace bismuth quadruple therapy in the treatment of
      H. pylori infection. In the second-line treatment, tetracycline-levofloxacin quadruple
      therapy developed by our study group can achieve a higher eradication rate than levofloxacin
      triple therapy for salvage treatment of hybrid therapy. However, whether the new therapy can
      be a promising rescue treatment for bismuth quadruple or high-dose dual therapy remains
      unanswered.
    

Intervention name(s): 10d bismuth quadruple therapy; 14d hybrid therapy; 14D high-dose dual therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): rabeprazole 20 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days; a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days; rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days
Other intervention name(s): rabeprazole 20 mg bid; tripotassium dicitrate bismuthate 300mg qid; tetracycline 500 mg qid; metronidazole 250 mg qid; rabeprazole 20 mg bid; amoxicillin 1 g bid; clarithromycin 500 mg bid; metronidazole 500 mg bid; rabeprazole 20 mg qid; amoxicillin 750 mg qid
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Tetracycline; Rabeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Eradication rate
PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10,
      Rituxan and MabThera in Patients with Rheumatoid Arthritis.
    


Intervention name(s): CT-P10; Rituxan; MabThera
Intervention type(s): Biological; Drug; Drug
Intervention description(s): 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion; US-licensed reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion; EU-approved reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
Other intervention name(s): rituximab; rituximab; rituximab
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Pletaal SR Capsule (Cilostazol) in Subjects With Peripheral Arterial Disease Symptom Due to Chronic Occlusive Arterial Disease
Condition: Chronic Occlusive Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Arterial Occlusive Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate symptomatic changes and safety before and after the administration
      of Pletaal® SR Capsules based on Peripheral Artery Questionnaire (PAQ) in subjects with
      peripheral arterial disease symptom due to chronic occlusive arterial disease (COAD).
    

Detailed description: 
      This is a multinational, single-arm, therapeutic used clinical trial. After screening in
      subjects with peripheral arterial disease symptom due to chronic occlusive arterial disease,
      the eligible subjects will be enrolled, followed by the administration of the study drug (two
      capsules qd of Pletaal SR 100mg Capsules) for 12 weeks.
    

Intervention name(s): Pletaal SR capsule
Intervention type(s): Drug
Intervention description(s): two capsules once a day of Pletaal SR 100mg Capsules
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment