bioihbjkbjnl/mcl2 huggingface dataset:
Endotracheal Intubation Using Three Laryngoscopes in Maternal Cardiac Arrest: a Manikin Simulation Study
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      European Resuscitation Council (ERC) Guidelines for Resuscitation 2010 emphasize high quality
      chest compressions .They propose minor changes for pregnant women: manual left deviation of
      the uterus or a left-lateral incline of 15-30to alleviate pressure on the inferior vena cava.
      We will examine the performance of the Glidescope (GVL), the Pentax-AWS Airwayscope(AWS) and
      Macintosh laryngoscope (McL) for airway management during chest compressions on 15 and 30
      degree left-lateral tilt (15 &30 LLT) custom-made hard wedges.
    

Detailed description: 
      Materials

        1. Sim Mom manikin (Laerdal, Stavanger, Norway)

        2. Stryker ST104-747(Transport stretcher®, 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo,
           Michigan, US)

        3. LUCAS Chest Compression System( LUCAS Chest Compression System, Physio-Control/Jolife
           AB)

        4. Backboard(450 ×600 ×10 mm, 3 kg Lifeline Plastic, Sung Shim Medical Co., Bucheon, Korea)
    

Intervention name(s): 15 degree left-lateral tilt wedges; 30 degree left-lateral tilt wedges
Intervention type(s): Device; Device
Intervention description(s): The wedges are made of aluminium; The wedges are made of aluminium
Other intervention name(s): Custom-made hard wedges; Custom-made hard wedges
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Endotracheal intubation; Left lateral tilt wedge; Maternal Cardiopulmonary Resuscitation; Manikin Study
Comprehensive Investigation of Opiates, Neuropeptides, Barrier Function, Scratching and Sleep Physiology
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      The purpose of this research is to study the sleep patterns of people with moderate to severe
      atopic dermatitis and how itching affects those patterns. This study will also measure your
      body's activity during sleep using non-invasive tests described below.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult men and women between 18 and 50 years of age with atopic dermatitis
      
Biospecimen description: 
      Blood, dermal microdialysate
Evaluation of Wear Experience With a Water Surface Daily Disposable Contact Lens
Condition: Contact Lens
Study type: Interventional

Summary: 
      The purpose of this study is to assess the wear experience of existing wearers of a monthly
      replacement contact lens after they have been fit with a daily disposable contact lens that
      has water surface treatment.
    


Intervention name(s): Comfilcon A Toric contact lenses; Verofilcon A for Astigmatism Daily Disposable contact lenses
Intervention type(s): Device; Device
Intervention description(s): Monthly replacement contact lenses; Daily disposable contact lenses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Linguistically-Tailored Mobile Intervention for the Improvement of Follow Up for Abnormal Pap Test Results
Condition: Cervical Carcinoma
Study type: Interventional

Summary: 
      This clinical trial evaluates the feasibility of a linguistically-tailored mobile
      intervention, called CervixChat in improving the follow-up of patients with abnormal
      Papanicolaou (pap) test results. A text messaging program, such as CervixChat may support
      patients who need a colposcopy.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To evaluate the feasibility of CervixChat intervention in a mix method design, through
      participants consent rate and the study completion rate.

      SECONDARY OBJECTIVE:

      I. To evaluate the acceptability of CervixChat intervention using a validated Likert-scale
      participant satisfaction questionnaire, as well as participant's interview data.

      EXPLORATORY OBJECTIVE:

      I. To evaluate the preliminary impact of CervixChat intervention, by comparing the colposcopy
      appointment adherence rate in the study cohort against a 1:1 matched control sample selected
      based on matching age, race and ethnicity, from participants at Jefferson Obstetrics and
      Gynecology (Ob-Gyn) department scheduled for a colposcopy in 2019.

      OUTLINE:

      Patients receive text messages for 1-2 months before scheduled appointment. Patients also
      complete a survey at baseline and after standard of care colposcopy and an interview after
      standard of care colposcopy.

      After completion of study, patients are followed up periodically.
    

Intervention name(s): Health Promotion and Education; Survey Administration; Interview
Intervention type(s): Other; Other; Other
Intervention description(s): Receive messages; Complete survey; Participate in an interview
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness
Condition: Brain Injuries; Disorder of Consciousness; Stroke; Spasticity as Sequela of Stroke; Contracture; Hypertonic Disorder; Central Nervous System Diseases; Pathologic Processes; Craniocerebral Trauma; Trauma, Nervous System; Neurocognitive Disorders
MeSH terms: Contracture; Stroke; Brain Injuries; Nervous System Diseases; Central Nervous System Diseases; Consciousness Disorders; Craniocerebral Trauma; Trauma, Nervous System; Pathologic Processes; Wounds and Injuries; Neurocognitive Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects on upper limb spasticity of soft splints
      worn during three weeks three hours a day by patients with stroke or disorders of
      consciousness.
    

Detailed description: 
      Patients with stroke or disorders of consciousness (DOC) are likely to suffer from major
      muscular troubles such as spasticity. This spasticity may induce pain, loss in range of
      motion and permanent joint deformities. The aim of this study is to investigate the effects
      of soft splinting on the hand spasticity in both patients with stroke and patients with
      disorders of consciousness. The investigators plan to include 100 patients (50 stroke - 50
      with DOC) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm
      diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1
      cm diameter).

      Skin condition will be followed by the nursing team during the three weeks. Spasticity, pain
      and consciousness assessments will be performed at baseline (week 0), after 1 week of
      treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later
      (week 6) and three months later (week 12).
    

Intervention name(s): Real soft splint (6 cm); Placebo soft splint (1 cm)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Treatment of Proximal Humeral Fractures
Condition: Humeral Fractures, Proximal
MeSH terms: Fractures, Bone; Humeral Fractures; Shoulder Fractures
Study type: Interventional

Summary: 
      This trial is designed to compare head-to-head conservative with operative treatment in 2
      stratum. Stratum 1: In 2 part fractures the comparison is between conservative treatment and
      operative treatment with plate fixation with Philos. Stratum 2: In multi-fragmented fractures
      (MFF) meaning 3 and 4 part fractures, the comparison is between conservative treatment,
      operative treatment with Philos plate and operative treatment with Epoca prosthesis. Subgroup
      analysis will be performed in an effort to obtain limit values for specific treatment of
      different age and fracture groups. A cost-effectiveness analysis and comparison between
      different treatment modalities will be carried out. The primary outcome measure will be the
      DASH score and the secondary outcome measure the EQ-5D value. Recruitment period is 3 years
      and follow-up 2 years.
    


Intervention name(s): Philos; Epoca; Control group
Intervention type(s): Device; Device; Other
Intervention description(s): Conservative treatment versus Philos locking plate in 2 part fracture group.
Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group.; Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group; Conservative control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Proximal humerus fracture; conservative; locking plate; Philos; Hemiprosthesis
Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload
Condition: Transfusion-dependent Anemia
MeSH terms: Iron Overload
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment
      compliance and change in serum ferritin of a deferasirox granule formulation and a
      deferasirox DT formulation in children and adolescents aged ≥ 2 and < 18 years at enrollment
      with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to
      demonstrate the effect of improved compliance on iron burden.

      Randomization will be stratified by age groups (2 to <10 years, 10 to <18 years) and prior
      iron chelation therapy (Yes/ No). There will be two study phases which include a 1 year core
      phase where patients will be randomized to a 48 week treatment period to either Deferasirox
      DT or granules, and an optional extension phase where all patients will receive the granules
      up to 5 years. Patients who demonstrated benefit to granules or DT in the core phase, and/or
      express the wish to continue in the optional extension phase on granules, will be offered
      this possibility until there is local access to the new formulation (granules or FCT) or up
      to 5 years, whichever occurs first.
    


Intervention name(s): Deferasirox granule formulation; Deferasirox DT formulation
Intervention type(s): Drug; Drug
Intervention description(s): Deferasirox granules will be provided as stick packs containing 90 mg, 180 mg and 360 mg granules for oral use.; Deferasirox DT will be provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use
Other intervention name(s): ICL670; ICL670
Intervention MeSH terms: Deferasirox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: New formulation; deferasirox; chelation; iron overload; compliance; satisfaction; palatability; PRO; PK; safety; PK/PD; ICL670
Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis
Condition: Coronary Artery Disease; Refractory Angina
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether transendocardial injections of autologous
      endothelial progenitor cells CD 133 is safe and feasible in patients with refractory angina.
    

Detailed description: 
      The PROGENITOR trial is a randomized, double-blinded, multicenter controlled trial including
      patients with Canadian cardiovascular society angina classification (CCS): II-IV and ischemic
      zones by SPECT but without any option for revascularization. Primary endpoint was to assess
      the safety and feasibility of transendocardial injection of selected CD133+cells. All
      patients were treated for 4-days with granulocyte colony-stimulating factor and underwent
      apheresis. CD133+ cells were selected with CliniMacs system and were injected
      transendocardially guided by the NOGA XP system.
    

Intervention name(s): Selected CD 133+ cells
Intervention type(s): Biological
Intervention description(s): Endothelial progenitor cell CD 133
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Refractory angina
Mental Health Engagement Network (MHEN)
Condition: Mood Disorder; Psychotic Disorder
MeSH terms: Mental Disorders; Psychotic Disorders; Mood Disorders
Study type: Interventional

Summary: 
      Patients with mood disorder or psychotic disorder will be given handheld devices with
      personal health records to educate, monitor and deliver customizable healthcare tools based
      on their personal needs. The use of technology has great potential to deliver care more
      effectively and efficiently. No actual information is on the handheld device - it is accessed
      from a secure site behind hospital firewalls.
    


Intervention name(s): Access to TELUS Health Space and Smart Phone
Intervention type(s): Behavioral
Intervention description(s): Participants will be given their own TELUS Health Space and Smart Phone in order to have access to their personal health records. Specific procedures using the smart phone will depend on the individual care plan for each participant. Prompts and assessments will vary depending on participant needs.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Mental Health; Smart Technology; Mood disorder; Psychotic disorder
Effects of the Atkins Diet Versus a Low Fat Diet on Inflammation
Condition: Cardiovascular Health; Obesity
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research is to assess the effects of a low-carbohydrate (modified Atkins)
      diet versus a low fat (Heart Healthy) diet on cardiovascular health.
    

Detailed description: 
      The purpose of this study is to compare the effects of a modified Atkins diet (low
      carbohydrate and low calorie) and a traditional heart healthy diet (low fat and low calorie)
      on biochemical markers of inflammation and metabolism, anthropometric measurements, vascular
      studies of endothelial function, adipose tissue composition, and patient compliance and
      satisfaction over a twelve week period in healthy men and women. Patients will be recruited
      from the Nutrition and Weight Management Center at Boston Medical Center. Enrolled subjects
      will be randomly assigned to a reduced calorie diet (either the Atkins diet or a traditional
      heart healthy diet), and will be counseled by a dietitian and a physician throughout the
      study period. The patients will have physical exams, labs, vascular studies of endothelial
      function, and adipose tissue biopsies at baseline and at twelve weeks to assess progress.
      Participants dietary compliance will be assessed using food journals and 24 hour recall.

      The Atkins diet appears to have potential to reverse the epidemic of obesity-linked
      cardiovascular disease (CVD) in the United States. Obesity is in effect an inflammatory state
      in which adipose (fat) tissue releases adipokines- small, inflammatory proteins. High
      adipokine levels in the blood lead to an inflammatory response, ultimately damaging the
      endothelial cells which line the blood vessels and increases the risk of vascular disease.
      Ultimately the effects of these two different diets will be analyzed to help determine if a
      low carbohydrate, low calorie diet is more beneficial than a traditional heart healthy diet
      (low fat, low calorie) at reducing the systemic inflammatory response by using physical exam
      measures, inflammatory blood markers, vascular ultrasound studies, and adipose tissue
      biopsies.
    

Intervention name(s): Low-Carbohydrate (Modified Atkins) Diet; Low-Fat (Heart Healthy) Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Low-Carbohydrate (Modified Atkins) Diet; Low-Fat (Heart Healthy) Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The PK/PD Study of A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects
Condition: Hypercholesteremia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Single Center, Randomized, Double-blind, Dose Escalation, Placebo Parallel
      Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics,
      Pharmacodynamics with A Single Subcutaneous Injection of SHR-1209 in Healthy Subjects.

      The primary objective of this study is to investigate the safety and tolerability of a range
      of subcutaneous SHR-1209 in healthy subjects. Secondary objectives are to determine the
      pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1209 in healthy subjects
      including assessment of immunogenicity.
    

Detailed description: 
      32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two
      subjects in the lowest dose group, all of whom received the SHR-1209 without placebo control.
      The other three groups have 10 subjects in each group, 8 administered SHR-1209 and 2
      administered placebo. The primary endpoint is the Safety and Tolerability : adverse events,
      vital signs, physical examination, laboratory examination, 12 lead electrocardiogram,
      injection site reactions, etc.
    

Intervention name(s): SHR-1209; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous; Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SHR-1209 Phase 1
Neovascular Age-related Macular Degeneration
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Observational

Summary: 
      Age-related macular degeneration (AMD) is the leading cause of blindness in non-Hispanic
      white Americans. Neovascular AMD is an advanced form of macular degeneration that
      historically has accounted for the majority of vision loss related to AMD. The presence of
      choroidal neovascular membrane (CNV) formation is the hallmark feature of neovascular AMD.
      Choroidal neovascular membranes consist of buds of neovascular tissue and accompanying
      fibroblasts from the choroid perforating Bruch's membrane with extension either above or
      below the retinal pigment epithelium. These neovascular complexes are associated with
      hemorrhage, fluid exudation and fibrosis formation resulting in photoreceptor damage and
      vision loss. Treatment of neovascular AMD consists of injecting inhibitors of vascular
      endothelial growth factor (VEGF) into the vitreous cavity to interfere with proliferation of
      choroidal neovascularization and to reduce vascular permeability.

      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal
      and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,
      except that OCT measures the intensity of reflected light rather than acoustical waves.

      This observational study will use OCT technology to study and compare the retinal and
      choroidal anatomy and blood flow in two groups of patients with neovascular AMD: treatment
      naïve group and active treatment group.

      The purpose of this study is to assess the utility of OCT angiography in the evaluation of
      NVAMD.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults older than age 50 with clinical findings of neovascular AMD with clinical evidence
        of active choroidal neovascular membrane
      
Keywords: Wet AMD; Age-related macular degeneration; Optical coherenece tomography; Imaging; Blood flow
Safety Study of Single Oral Doses of VBY-036 in Healthy Volunteers (VBY036P1A)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      VBY-036 may treat or prevent nerve pain. This study aims to find the highest safe and
      tolerable single dose of VBY-036 in healthy volunteers. Volunteers are randomly selected to
      receive one dose of either a placebo or VBY-036 (10, 30, 100, 300, 600 or 900 mg).
    

Detailed description: 
      Detailed description is noted in Brief Summary.
    

Intervention name(s): VBY-036; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study drug VBY-036; Placebo
Other intervention name(s): Cathepsin S inhibitor
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Subjects; Safety; Tolerability; VBY-036; Maximum; Pharmacodynamic; Pharmacokinetic