bioihbjkbjnl/mcl2 huggingface dataset:
Retrograde Application of Bone Marrow Aspirate Concentrate
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of our prospective randomised study is to assess the efficacy of the retrograde
      application of non-selected bone marrow autologous cells concentrate (BMAC) in patients with
      heart failure with reduced ejection fraction of left ventricle (HFREF) of ischemic aetiology.
      The evaluated preparation is concentrated BMAC, obtained using Harvest SmartPReP2 technology.
    

Detailed description: 
      Our assumption is that non-selected BMAC administrations will lead to improvements in the
      left ventricular ejection fraction (LV EF), the left ventricular end-systolic and
      end-diastolic diameters and volumes (measured with magnetic resonance imaging) compared to
      standard heart failure therapy.

      Furthermore, it will be associated with improved exercise tolerance in the six-minute
      corridor walk test and an improvement in the life quality of patients without increasing the
      incidence of severe ventricular arrythmias.
    

Intervention name(s): BMAC
Intervention type(s): Drug
Intervention description(s): retrograde administration on non-selected BMAC via coronary sinus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Clinical Value of Remote Ischemic Preconditioning
Condition: Heart Diseases; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Heart Diseases
Study type: Interventional

Summary: 
      Objectives: Despite utilization of available means for cardioprotection during cardiac
      surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore
      necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method.
      Laboratory research has shown promising results regarding myocardial survival during open
      heart surgery, but the clinical value of RIPC is still largely unknown. The investigators
      hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of
      postoperative atrial fibrillation (POAF).
    


Intervention name(s): RIPC
Intervention type(s): Procedure
Intervention description(s): The remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations. The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle will be performed three times in total. The entire preconditioning will therefore last for 25 minutes.
Other intervention name(s): Remote ischemic preconditioning; Ischemic preconditioning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ischemic preconditioning; Coronary artery bypass; Preoperative care; Postoperative period
Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction
Condition: Acute Coronary Syndrome
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Infarction
Study type: Interventional

Summary: 
      To assess strut coverage in patients presenting an acute myocardial infarction and treated
      either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel
      group design.
    

Detailed description: 
      Single center, simple-blind randomized controlled trial, comparing the SYNERGY stent with the
      BVS device through a parallel group design.
    

Intervention name(s): SYNERGY stent; ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)
Intervention type(s): Device; Device
Intervention description(s): Coronary angiography will assess the presence of at least one eligible coronary lesion requiring stent implantation before revascularization by angioplasty.
Stent will be implanted according to manufacturer's and competent authority recommendations.; Coronary angiography will assess the presence of at least one eligible coronary lesion requiring stent implantation before revascularization by angioplasty.
Stent will be implanted according to manufacturer's and competent authority recommendations.
Other intervention name(s): SYNERGY (Platinum chromium coronary stent); ABSORB
Intervention MeSH terms: Chromium; Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute coronary syndrome; ST (Software Test) -elevation
A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study evaluates the usefulness of a PET radioligand to estimate the binding on the mGlu4
      receptor in the brain. mGlu4 has been proposed as a therapeutic target in Parkinson's
      disease.
    


Intervention name(s): [11C]PXT012253
Intervention type(s): Drug
Intervention description(s): Single intravenous bolus injection. The injected amount will be less than 5 μg. The radioactive dose is approximately 400 MBq per 70 kg body weight.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of short ragweed pollen
      allergen extract (MK-3641, SCH 039641, RAGWITEK™) sublingual immunotherapy tablets in
      children aged 5 to 17 years with ragweed-induced allergic rhinitis/rhinoconjunctivitis with
      or without asthma. The primary hypothesis of this study is that administration of short
      ragweed pollen allergen extract sublingual immunotherapy tablets to children 5 to 17 years of
      age, compared with placebo, will result in a significant reduction in the combination of
      rhinoconjunctivitis symptoms and medication use over the peak ragweed season (RS).
    


Intervention name(s): Short ragweed pollen allergen extract; Placebo; Self-injectable epinephrine; Albuterol/Salbutamol; Loratadine; Olopatadine; Mometasone furoate monohydrate
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Drug
Intervention description(s): One sublingual tablet containing 12 units of Amb a 1-U, once daily (QD) for up to 35 weeks.; One placebo sublingual tablet, QD for up to 35 weeks.; Intramuscular (IM) injection with suggested doses of 0.15 mg for participants weighing 15-30 kg (33-66 pounds) or 0.3 mg for participants weighing ≥30 kg (≥66 pounds), as needed for severe allergic reactions. Epinephrine was only provided in countries/study sites where it was a regulatory requirement.; Inhalation of albuterol 90 mcg/puff or salbutamol 100 mcg/puff metered dose inhaler (MDI), as needed as asthma rescue medication for those participants with asthma; 5 mg (1 mg/mL syrup or 5 mg tablet) for participants 5 years old or 10 mg (1 mg/mL syrup or 10 mg tablet) for participants 6 to 17 years old, as needed for rhinoconjunctivitis symptoms; Opthalmic solution, 1 drop (0.1%) per affected eye twice daily (BID), as needed for rhinoconjunctivitis symptoms; Intranasal spray, at doses of 1 spray (50 mcg/ spray) per nostril for participants 5 to 11 years old or 2 sprays (50 mcg/spray) per nostril for participants 12 to 17 years old, as needed for rhinoconjunctivitis symptoms
Other intervention name(s): RAGWITEK™; MK-3641; EpiPen; ProAir HFA; Proventil HFA; Ventolin HFA; Claritin; Patanol; Nasonex
Intervention MeSH terms: Mometasone Furoate; Loratadine; Olopatadine Hydrochloride; Epinephrine; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneous Lirentelimab (AK002) in Adult Healthy Volunteers
Condition: Study Conducted in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center study to evaluate safety, tolerability, and bioavailability
      of subcutaneously administered lirentelimab (AK002) in adult healthy volunteers. Subjects
      will receive a single dose of intravenous AK002 or subcutaneous lirentelimab (AK002) assigned
      in a double-blind, randomized fashion.
    


Intervention name(s): lirentelimab (AK002); Placebo
Intervention type(s): Drug; Other
Intervention description(s): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
An Exploration of the Relationship Between Chronic Pain and Suicide Attempt Among Veterans
Condition: Posttraumatic Stress Disorder; Traumatic Brain Injury; Suicide Attempt
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Chronic Pain; Stress Disorders, Traumatic; Suicide; Stress Disorders, Post-Traumatic; Suicide, Attempted
Study type: Observational

Summary: 
      The purpose of this study is to explore the relationship between attempted and/or completed
      suicide and reported experience of chronic pain among an adult veteran population. Specific
      aims include a) examining the experience of chronic pain between patients who have either
      attempted and/or completed suicide, non-suicide attempt mental health patients, and
      non-mental health chronic pain patients and b) determining possible differences in reported
      experiences of chronic pain based on mental and physical diagnoses, age, gender, ethnicity,
      occupation, and patient's recorded perceptions of depression and/or quality of life. As
      articulated in the Amendment approved on June 13, 2008, additional areas of interest include
      histories of neurological disease (e.g. traumatic brain injury) and/or mental health
      diagnoses. History of both neurologic disease and mental health diagnoses will also be
      identified by chart review (per approval obtained June 13, 2008). As such this study will
      also compare differences (e.g., mental health, neurological disease) between veterans who
      have history of a suicide attempt, completion, or a lifetime history of suicidality and
      matched control veterans without a history of suicide attempts, completions, or lifetime
      history of suicide. The relationship between suicidal behavior, attempted/completed suicide,
      and reported Post Traumatic Stress Disorder (PTSD) symptoms among an adult veteran population
      is also of interest. Additionally, this data set will be used to complete a validation study
      regarding the Self-Directed Violence Classification System (SDVCS). Specifically, relevant
      information in subject chart notes regarding self-directed violence (SDV) will be used to
      categorize thoughts and behaviors according to the SDVCS.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Veterans who received care in the VA.
      
Keywords: posttraumatic stress disorder; traumatic brain injury; Suicide Attempt; Veterans
Emotional Proactive Brain Study in Adults With Autism Spectrum Condition
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      This project aims:

        -  to study behavioral and cerebral activity specificity (latency and amplitude of evoked
           potentials, time frequency maps and cerebral connectivity) in predictive process
           (top-down regulation) during visual recognition of static and dynamic stimuli in adults
           participants with autism spectrum conditions compared to typically developed
           participants.

        -  to study the relation between predictive process and autonomous response (heart activity
           and electrodermal activity)

        -  to explore potential sex differences between autistic males and females
    

Detailed description: 
      Once eligibility criteria would have been verified, information on the study will be given
      and non opposition of the participant will be collected.Then, the participant will be
      comfortably installed in order to pass the Landolt C task (visual acuity task) on a computer.
      If his vision is normal, electroencephalogram (EEG), electrocardiogram (ECG) and
      electrodermal activity (EDA) of participants, will be recorded during visual processing and
      recognition tasks. Stimuli will include emotional and non emotional pictures and films,
      filtered in coarse-to-fine versus fine-to-coarse sequences in order to stimulate or not
      predictive process described by Bar (2007).

      The participant will also have to complete an abbreviated version of the Wechsler Adult
      Intelligence Scale, IVth edition (Wechsler, 2003), and the Autism Spectrum Quotient
      (Baron-Cohen et al., 2001) if he never did it before. The aim is to pair as much as possible
      group by IQ and to verify that control participants don't present autistic traits above the
      Autism Spectrum Quotient cutoff. Groups will also be paired by age and education level.
    

Intervention name(s): EEG
Intervention type(s): Other
Intervention description(s): EEG, ECG and EDR record during a behavioral task
Other intervention name(s): ECG; EDR
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults autistic males and females without intellectual disability compared to a control
        group
      
Keywords: Autism Spectrum Condition; predictive coding; visual perception; electroencephalography; autonomous nervous system; heart rate variability; electrodermal reactivity
A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the
      safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Japanese volunteers.
      Healthy Japanese and Caucasian volunteers will be randomized to receive a single subcutaneous
      dose of either lebrikizumab or placebo.
    


Intervention name(s): lebrikizumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose-level cohorts receiving single subcutaneous dose; single dose subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      This is a post-marketing study to further assess the safety and effectiveness of the InSpace™
      in the study population in comparison to surgical RCT repair.
    

Detailed description: 
      The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick
      DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily
      living (ADL) and improvement of range of motion (ROM).
    

Intervention name(s): InSpace™ system over repair; Best Repair of torn Rotator Cuff
Intervention type(s): Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff
Study of Metabolism and Cardiovascular Disease(CVD) in Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Cardiovascular Diseases; Syndrome
Study type: Observational

Summary: 
      PCOS is the most common endocrine disorder in reproductive women. It is estimated that 5 to
      10% of women of reproductive age have PCOS. One of the major diagnostic criteria of PCOS was
      chronic anovulation which lead to irregular menstruation, amenorrhea, and infertility; the
      other diagnostic criteria was hyperandrogenism which lead to hirsutism, acne and alopecia.
      Furthermore, PCOS is thought as a metabolic disorder, the long-term consequence of PCOS were
      diabetes mellitus and cardiovascular disease, which are potentially dangerous in women
      health. Early diagnosis and prevention is very important to the PCOS patients.

      Obesity is the most potential risk of threat to health of populations. There is a major
      impact of obesity on the PCOS related disorders. Insulin resistance and distribution of
      adipose tissue were thought to be the important risk factors of cardiovascular and metabolic
      syndrome.

      To treat PCOS patients properly,Wan-Fang hospital had established a specific medical team.
      The investigators recently published in "Fertility and Sterility" about the clinical
      presentation of androgen excess in Taiwanese women. Hirsutism is much less prevalence in
      Taiwanese PCOS women than that previous reported in the Western women. It is important to
      know that some clinical presentation of PCOS might have ethic variance. Insulin resistance
      was reported as another candidate that might have ethic variance.The investigators had
      reported about 40% women in PCOS women were obese, it is similar with previous literature
      reported. Obesity is a major factor that could be controlled during the treatment of
      PCOS.Weight reduction is one of our methods in PCOS treatment. The progressive results for
      obese PCOS women would be facing the risks of diabetes and metabolic syndrome.The
      investigators thought like to evaluate the benefit of weight reduction program to the
      prognosis of obese women with PCOS. Furthermore, it is known that Endothelial progenitor
      cells (EPC) be an early marker of cardiovascular disease, the investigators would like to
      know the role of EPC to predict metabolic syndrome in women with PCOS. Wan-Fang hospital has
      a professional team in PCOS treatment and research which including gynecological
      endocrinologist, cardiologist, medical endocrinologist, specialist in weight reduction. This
      team had been working well for more that 4 years.

      The investigators hope that they can make a contribution to the study and treatment of PCOS
      in Taiwan.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Polycystic Ovary Syndrome(PCOS)
      
Keywords: PCOS,; DM,; Hypertension,; CVD
A Double Blind Crossover Trial of Levetiracetam (Keppra®) and Placebo in the Treatment of Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To define the effective dose and tolerability of levetiracetam in individuals with Restless
      Legs Syndrome (RLS). It is hypothesized that levetiracetam will be well tolerated, safe and
      effective in treating the symptoms of RLS.
    


Intervention name(s): Levetiracetam (Keppra)
Intervention type(s): Drug
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: RLS
Phase 1 Study of Anti-glycation Agent GLY-230 in Healthy Subjects
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by
      mouth.
    


Intervention name(s): GLY-230; Placebo
Intervention type(s): Drug; Other
Intervention description(s): No drug administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Mucosal-Associated Invariant T Cells in Cases of Miscarriage
Condition: Miscarriage
MeSH terms: Abortion, Spontaneous
Study type: Observational

Summary: 
      Miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to
      30%. The etiology of recurrent spontaneous miscarriage (RSM) in 40%-50% of cases cannot be
      identified. Immunological disturbances have been suggested to play an important role.

      Previous studies have focused that women with miscarriage have elevated NK cell numbers and
      activity both in the periphery and in the endometrium. Also, NK cells in women with RSM
      displayed an imbalance of Killer cell Ig-like receptors (KIRs) in favor of activating KIR
      leading to an unbalanced activation of dNK cytotoxicity and higher risk of miscarriage.
    


Intervention name(s): MAIT cells
Intervention type(s): Diagnostic Test
Intervention description(s): 1- Decidual tissues will be washed in phosphate buffer saline (PBS), and then preserved in Rosewell Park Memorial Institute (RPMI) 1640 medium supplemented with 100 U/mL penicillin, 100 mg/mL streptomycin and 5% fetal bovine serum (GIBCO BRL, Thermo Fisher Scientific, USA) until transfer to the laboratory. At the flow cytometry laboratory, the tissue samples will be minced finely and enzymatically digested by adding 3 ml collagenase enzyme type Ia and 2 ml PBS for 40 minutes at 37°C in shaking water path at 100 r.p.m. Cell suspensions obtained will be filtered, then the pellet after centrifugation will be treated with red blood cells lysing solution and washed with PBS.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All pregnant women presented with spontaneous miscarriage