bioihbjkbjnl/mcl2 huggingface dataset:
Examining Heart Attacks in Young Women
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Heart disease and heart attacks pose a serious health risk to young women, and women tend to
      experience less successful recoveries after a heart attack than men do. This study will
      examine various factors that may predispose women to heart attacks and to poor recovery after
      a heart attack. The differences between men and women in the medical care that they receive
      following a heart attack will also be studied.
    

Detailed description: 
      Heart disease is one of the leading causes of death in women 55 years and younger, accounting
      for more than 8,000 deaths each year in the United States. Approximately 40,000 young women
      are hospitalized each year in the United States as a result of a heart attack. Research has
      shown that young women who have heart attacks are twice as likely to die in the hospital as
      young men who have heart attacks. While there has been an increase in awareness, little
      research has been conducted on understanding heart disease and heart attacks in young women.
      Specific biologic markers involved with inflammation, metabolic abnormalities, sex hormones,
      and genetics may indicate a predisposition to a heart attack and poor recovery. This study
      will analyze the biologic, demographic, psychosocial, environmental, and behavioral factors
      that may contribute to premature heart disease and to poor recovery after a heart attack in
      women. Researchers will examine if delays in receiving medical care following a heart attack
      can affect recovery and health outcomes for women. Gender differences in outcomes and the
      quality of medical care that is received following a heart attack will also be examined.

      This study will enroll women and men who are hospitalized following a possible heart attack.
      At study entry, participants will be interviewed to collect information about symptoms,
      functioning, quality of life, and medical care. A medical record review will also occur. At 1
      month after admission from the hospital, an interview will occur via phone and a blood sample
      will be collected when the participant returns to the hospital or alternatively be collected
      at a medical clinic convenient to the participant. Another telephone interview will occur at
      12 months. Participants' blood samples will be stored for future biologic and genetic
      studies.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        2,000 women and 1,000 men between the ages of 18 and 55 years who are hospitalized with a
        heart attack
      
Biospecimen description: 
      Blood specimens for biomarker analysis and storage for future genetic studies
    
Keywords: Acute Myocardial Infarction; Heart Attack; Gender Differences; Risk Factors; Quality of Care
Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old
Condition: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will be conducted in asthmatic children aged 5 to 11 years and is based on a
      single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI)
      fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4
      μg is compared with the free combination of licensed BDP DPI and FF DPI
    

Detailed description: 
      This is a pharmacokinetic comparison of NEXThaler 35/4 μg versus the free combination of
      Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation
      already approved in adults.
    

Intervention name(s): CHF 1535 35/4µg NEXThaler®; free comb. beclomethasone DPI and formoterol DPI
Intervention type(s): Drug; Drug
Intervention description(s): 4 (four) inhalations (total dose: BDP/FF 140/16 µg); 2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg
Intervention MeSH terms: Beclomethasone; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Crossover Study to Evaluate Relative Bioavailability of Two JNJ-54781532 Tablet Formulations in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability (the extent to which a
      drug or other substance becomes available to the body) of JNJ-54781532 formulation 2 (test)
      compared with JNJ-54781532 formulation 1 (reference) in healthy participants under fed
      conditions at a single dose of 150 milligram (mg).
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), open-label (all
      people know the identity of the intervention), 2-treatment, 2-period, 2-sequence crossover
      (participants may receive different interventions sequentially during the trial), and
      single-center study of JNJ-54781532. The duration of study will be approximately of 5 weeks
      per participant. The study consists of 3 parts: Screening (that is, 21 days before study
      commences on Day 1); Open-label Treatment (consists of 2 single-dose treatments, either
      JNJ-54781532 formulation 1 [reference] or JNJ-54781532 formulation 2 [test]), in subsequent
      2-treatment periods, each separated with washout period of 7 days); and End-of-Study (done
      upon completion of the 72-hour pharmacokinetic sampling on Day 4 of Period 2, or at the time
      of early withdrawal). All the eligible participants will be randomly assigned to 1 of the 2
      treatment sequences to ensure that they receive both of the following treatments, one in each
      period. Followed by an overnight fast of at least 10 hours participants will be administered
      with study treatment 30 minutes after high-fat, high-calorie breakfast. Participants will not
      be allowed to have food until 4 hours of drug administration. Blood samples will be collected
      for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative
      bioavailability of two formulations of JNJ-54781532 (test and reference) will be evaluated
      primarily. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Formulation 2; Formulation 1
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in one of the treatment periods.; Single-dose of JNJ-54781532 formulation 1 will be administered as 150 milligram (mg) oral tablet (5*30 mg tablet=150 mg) in one of the treatment periods.
Other intervention name(s): JNJ-54781532 Test; JNJ-54781532 Reference
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biological Availability; JNJ-39220675; Healthy; Phase 1
Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System
Condition: Functionality and Performance of Device
Study type: Observational

Summary: 
      The PharmaJet needle-free injection system is a consistent approach to delivering injectates
      into the dermal layer of the human skin for the purpose of vaccination or medication
      delivery.
    

Detailed description: 
      Up to 400 children, ages 2 months through 14 years

        1. To assess measures of injection performance, including estimates of injection
           completeness by collecting residual surface moisture with filter paper that will be
           circled with indelible ink; the volume will be compared to a reference set of moisture
           recordings.

        2. To document completeness of injections; completeness is defined as <10% of 0.1 ml volume
           remaining on the skin surface immediately after injection. Measurement of the bleb size
           following injection will recorded in millimeters.

        3. To ensure device is well received by subjects. Subject's response to the injection will
           be noted by the subject and/or family members after the procedure for up to 48 hours.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Up to 400 children, aged 2 months to 14 years
Sampling Biomarkers in Meniscus Injury to the Knee
Condition: Cartilage Diseases
MeSH terms: Cartilage Diseases
Study type: Observational

Summary: 
      The diagnosis of clinically-significant meniscal tears of the knee remains challenging, and
      it is unknown why only some injuries become painful. The limitations of diagnostic magnetic
      resonance imaging result in arthroscopy that is not always beneficial. Elucidation of
      biochemical pathways underlying pain in this condition may aid patient selection for surgery
      and provide pharmacotherapeutic targets. Cytokines may be involved in pain following meniscus
      injury and diagnostic cytokine assay may help physicians differentiate patients that may
      benefit from arthroscopy from those that may not.
    

Detailed description: 
      Lavage of the operative and contralateral knee for comparison was performed under anesthesia
      prior to arthroscopy by the infusion of sterile saline into the knee joint followed by the
      immediate withdrawal into the syringe. Sixteen asymptomatic control subjects also contributed
      knee samples. The concentrations of 17 inflammatory cytokines/chemokines were measured using
      a multiplexed immunoassay panel. Pre-operative magnetic resonance imaging findings and
      cytokine assay results were compared to "gold-standard" intraoperative findings.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        68 patients with knee pain < 6 months with either acute or insidious onset who failed
        conservative management and elected arthroscopy. Adult volunteers with no history of knee
        pain.
      
Biospecimen description: 
      saline lavage from joint space
Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess the safety and tolerability of a five-day titration schedule (using
      twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg
      daily. The study duration is two months.
    


Intervention name(s): Bifeprunox
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Titration Study; Schizophrenia; BID dosing; Pharmacokinetic
Detecting Autologous Transfusion by Measuring Alterations in the Dynamics of Red Blood Cell Maturation and Recycling
Condition: Blood Transfusion, Autologous; Blood Doping
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A total of 40 subjects will be recruited for participation in this study. 20 subjects (10
      males and 10 females) will be randomized to the active group (those receiving re-infusion of
      autologous blood) and 20 subjects (10 males and 10 females) will be randomized to the placebo
      group (receiving NS infusion).
    

Detailed description: 
      Autologous blood transfusion is a major problem in a wide range of competitive sports.
      Methods with increased sensitivity, specificity, and feasibility are needed to identify
      athletes who cheat in this manner and compromise their health and the integrity of their
      sports in general. Complete blood counts (CBC) offer routine high-resolution assessment of
      the current hematologic status of individuals, providing estimates of a number of blood
      characteristics, such as the total hemoglobin concentration in the blood (HGB) and the volume
      fraction of cells in the blood (HCT). These CBC components are homeostatically controlled by
      the carefully regulated dynamic processes of red blood cell (RBC) production in and release
      from the bone marrow, RBC maturation in the peripheral circulation over the course of the
      ~100-day RBC lifespan, and clearance and recycling of senescent cells. Any significant
      perturbation to the circulating population of RBCs, like autologous transfusion, will
      immediately trigger compensatory modulation of one or more of these dynamic processes. The
      investigators believe quantification of these underlying dynamic processes will enable us to
      detect autologous transfusion. These dynamic RBC processes cannot currently be measured
      directly, but novel mathematical modeling enables their inference from routine complete blood
      and reticulocyte counts. The investigators propose to test the ability of modeled RBC
      dynamics to identify instances of autologous blood transfusion.
    

Intervention name(s): Autologous Transfusion; Control - Normal Saline (Placebo)
Intervention type(s): Other; Other
Intervention description(s): Participants will receive autologous transfusion on Day 21; Participants will receive saline on Day 21
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Sports Medicine; Athletes; Anti-doping
Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicentre
      study of 52 weeks treatment duration. The primary objective is to evaluate the efficacy(on
      endogenous insulin secretion), safety and tolerability of weekly albiglutide (a glucagon-like
      peptide-1 receptor (GLP-1R) agonist) versus placebo when added to insulin therapy in subjects
      with new-onset type 1 diabetes mellitus (NOT1DM) and residual insulin production..
      Approximately 68 eligible subjects will be randomised in a 3:1 ratio such that 51 subjects
      receive albiglutide 30 milligram (mg) once weekly (with increase to 50 mg once weekly at Week
      6 if the 30-mg weekly dose is tolerated) added-on to insulin therapy and 17 subjects receive
      placebo once weekly added-on to insulin therapy. The total duration of a subject's
      participation will be approximately 72 weeks (up to 8 weeks of Screening, 52 weeks of
      treatment and 12 weeks of Post-treatment Follow-up)
    


Intervention name(s): Albiglutide weekly injection; Placebo weekly injection; Insulin
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Albiglutide will be provided as a fixed-dose, fully disposable pen injector system having a prefilled dual chamber glass cartridge. To be self-administered as a subcutaneous (SC) injection in the abdomen, thigh or upper arm region. The pen will deliver either 30 mg of albiglutide, 50 mg of albiglutide in a 0.5-mL injection volume. It may be administered at any time of day without regard to meals. It will be administered once a week on the same day each week; Placebo provided as a fixed-dose, fully disposable pen injector system having a prefilled dual chamber glass cartridge. To be self-administered as a SC injection in the abdomen, thigh or upper arm region. It may be administered at any time of day, once a week on the same day each week, without regard to meals.; Commercially available basal/bolus insulin regimen, self administered by the subject, in accordance to the prescription of the physician and as per the package insert
Intervention MeSH terms: rGLP-1 protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: New-onset type 1 diabetes mellitus; Albiglutide
Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy
Condition: Diabetic Nephropathies; Diabetes Mellitus, Type 2; Nephropathy, Diabetic
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect
      of APX-115 in subjects with Type 2 diabetes and nephropathy.
    


Intervention name(s): APX-115; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration of APX-115 400mg capsule once daily for 12 weeks; oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects
Condition: Periodontitis Complex; Xenograft Model
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      Papillae tunneling techniques (PTT) are a new approach toward regeneration of isolated
      intrabony defects. Compared to regular papillae preservation techniques, PTT rely on complete
      preservation of involved interdental papillae, providing optimal healing environment for
      periodontal wound. Surgical access is therefore gained either by vertical incision in
      vestibulum, or by short releasing incision on adjacent tooth. Interdental tissue is then
      carefully raised in a full thickness manner by tunneling instruments, root surface thoroughly
      cleaned by the ultrasound scaler or Gracey curettes and defect filled with the biomaterial of
      choice.

      While the success and aesthetic results of non-incised papillae techniques are well
      documented, no paper so far compared clinical results of papillae preservation techniques
      with different biomaterials.

      Therefore, the aim of our study is to compare gain of clinical attachment level (defined by
      sum of pocket probing depth and recession) to regular papillae preservation techniques, and
      to prove non-inferiority of Gel 40® (collagen matrix, loaded with micronized heterologous
      bone) to Gen-Os® (granulated cortico-cancellous heterologous bone mix).

      Secondary objectives include analysis of aesthetic parameters - differences in recession and
      tip of the papillae location before and after the treatment.
    


Intervention name(s): Xenogenic bone graft material
Intervention type(s): Device
Intervention description(s): After access to the periodontal defect via straight incision in vestibulum, at the mucogingival border or short releasing incision on adjacent tooth, Gel 40 (a mixture of collagen gel and xenogenic bone particles) or Gen-Os (pure xenogenic bone particles) will be inserted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction.
Condition: Anti Platelet Effects
Study type: Interventional

Summary: 
      This study will establish the optimal therapeutic strategy for patients with a coronary
      artery disease (CAD) and chronically treated with clopidogrel 75 mg/day requiring
      co-administration of an anti-platelet treatment with P2Y12 antagonist and a PPI for
      treatment/prevention of GI ulceration.
    


Intervention name(s): Clopidogrel; Prasugrel; Lansoprazole; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): antiplatelet agent; antiplatelet agent; proton pum inhibitor; placebo comparator similar to lansoprazole
Other intervention name(s): Lanzor; Ogast
Intervention MeSH terms: Lansoprazole; Dexlansoprazole; Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus
Condition: Hepatitis B Infection; Chronic Infection; Viremia
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis B; Viremia; Persistent Infection; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of
      the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with
      high level of HBV DNA.
    

Detailed description: 
      Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes
      serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug
      use in pregnancy will be evaluated prospectively in this study.
    

Intervention name(s): Telbivudine; Lamivudine
Intervention type(s): Drug; Drug
Intervention description(s): About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun; About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum
Intervention MeSH terms: Lamivudine; Telbivudine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
Condition: Crohn
MeSH terms: Fistula
Study type: Interventional
Phase: Phase 1

Summary: 
      Adipose-derived stem cells have properties of differentiation to various types of cells,
      immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.

      Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in
      Phase I and II study on the patients with Crohn's fistula.

      However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing
      ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and
      efficacy in patients with Crohn's fistula.
    


Intervention name(s): Allogenic human adipose-derived stem cells
Intervention type(s): Biological
Intervention description(s): ALLO-ASC 1xE7 cells/mL is injected once along the fistula. If there is no safety issue for 4 weeks, 3 more people could be enrolled who are subject to ALLO-ASC 3xE7 cells/mL.
Other intervention name(s): ALLO-ASC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's fistula