bioihbjkbjnl/mcl2 huggingface dataset:
What is the Impact of Early Life Exposures on the Cardiovascular System in Young Adulthood?
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to investigate whether early life exposures such as premature
      birth or exposure to preeclampsia before you are born results in long-term alterations in the
      cardiovascular system that increase risk of cardiovascular disease development.
    

Detailed description: 
      While the incidence of cardiovascular disease has reduced dramatically, coinciding with
      favourable changes in risk factors, cardiovascular disease remains the single largest cause
      of mortality and premature mortality in the United Kingdom. Identification of novel
      biological pathways that underlie disease susceptibility raises the potential for new early
      primary prevention strategies to complement classical management. There is particular
      interest in the role of early environment in 'programming' risk of cardiovascular disease in
      later life and growing evidence that various early life exposures impact cardiovascular
      health in the longer term.

      We have thus designed the Early Vascular Study to investigate the long-term impact of early
      life exposures, with a particular focus on the impact of preterm birth, in the presence or
      absence of pregnancy-induced hypertension in the mother, on the cardiovascular system in
      young adulthood. This study also allows investigation of the long term impact of perinatal
      interventions used in this cohort. Comprehensive multi-modality non-invasive imaging measures
      of cardiovascular structure and function allow precise quantification of cardiovascular
      phenotype. This is combined with blood sample collection to study changes in molecular and
      metabolic markers and pathways.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm-born Cohort: A cohort of preterm-born young adults who were enrolled, at birth,
        from five centres in England between 1982 and 1985 into a randomised trial of milk feeding
        regimes to study the influence of early diet on later cognitive function and cardiovascular
        disease.

        Term-born Cohort: A cohort of controls born at term with normal birthweight now aged
        between 20 and 40 years to provide age stratified normal ranges for the outcome measures.
      
Biospecimen description: 
      whole blood, serum, plasma, immortalised cell lines
Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      GTx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen
      receptor modulator (SARM) that has demonstrated androgenic and anabolic activity and is
      currently being evaluated as a potential treatment for stress urinary incontinence (SUI) in
      postmenopausal women. Urinary incontinence and pelvic floor disorders are major health
      problems for women, especially as they age. Pelvic floor muscle relaxation has been found to
      correlate with lower urinary tract symptoms including SUI. Muscles of the pelvic floor and
      lower urinary tract are crucial for supporting the pelvic organs and micturition; however,
      damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic
      organ prolapse and urinary incontinence. Although anabolic steroids may increase muscle mass
      and strength, lack of oral bioavailability and known potential risks have limited their use.
      Nonsteroidal SARMs have potential to achieve benefits of anabolic steroid therapy (improved
      muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with
      fewer adverse effects, such as hirsutism and acne, in women. Both nonclinical and clinical
      data suggest that SARMs may provide a new therapeutic option for pelvic floor and lower
      urinary tract disorders, as both testosterone and its more potent metabolite,
      dihydrotestosterone, have anabolic effects on muscle.
    


Intervention name(s): GTx 024; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.; Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
Other intervention name(s): Enobosarm
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled, parallel design, randomized, multicenter, Phase 2 study consisting of the following periods: screening period, treatment period, and follow-up period.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
Condition: Decrease in Night Vision; Disturbance; Vision, Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are:

        -  To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the
           four endpoints:

             1. Contrast sensitivity

             2. Low contrast visual acuity

             3. Wavefront aberrometry

             4. Subjective questionnaire

        -  To assess the safety of ophthalmic phentolamine mesylate
    

Detailed description: 
      Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing
      severe night vision difficulties to evaluate ocular and systemic safety and efficacy
      following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.
    

Intervention name(s): Phentolamine Mesylate Ophthalmic Solution 1%; Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)
Intervention type(s): Drug; Other
Intervention description(s): Topical Sterile Ophthalmic Solution; Topical Sterile Ophthalmic Solution
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Night Vision Disturbances; NVD; Glare; Halos; Starbursts; Nyxol
Outcomes of the Use of CO2 (Carbon Dioxide) Laser in the Treatment of Chronic Anal Fissure
Condition: Chronic Anal Fissure
MeSH terms: Fissure in Ano
Study type: Interventional

Summary: 
      Outcomes of using CO2 (Carbon Dioxide) laser in the management of chronic anal fissure as an
      alternative to conventional methods
    

Detailed description: 
      The use of CO2 laser in management of chronic anal fissure as a new alternative technique.
      Interventional study of 236 patients. Comparison to other techniques was made with respect to
      pain scores and healing time.
    

Intervention name(s): Laser surgery
Intervention type(s): Device
Intervention description(s): Use of CO2 laser to perform surgeries to treat chronic anal fissure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine
Condition: Pneumococcal Infections
MeSH terms: Tetanus; Diphtheria; Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination
      ("tetanus shot") before giving pneumococcal vaccine makes the pneumococcal vaccine more
      effective without causing too many side effects.
    

Detailed description: 
      The only vaccine licensed in the United States for protecting adults against pneumococcal
      disease (PPV23) protects against invasive disease in observational studies but has generally
      been poorly effective against pneumonia or all-cause mortality in randomized clinical trials.
      Another vaccine containing seven polysaccharide antigens conjugated to diphtheria toxoid
      (PCV7) is licensed for children and under investigation in adults.

      In this pilot study, we are comparing the safety and immunogenicity of three immunization
      schedules in adults:

        -  Td vaccine, 2-week interval, PCV7, 4-month interval, PPV23

        -  PCV7, 4-month interval, PPV23

        -  PPV23

      We aim to:

        -  compare the safety profiles of pneumococcal vaccines given on each of the three
           schedules

        -  compare serotype-specific ELISA antibody response to pneumococcal antigens given on each
           of the three schedules

        -  compare functional serotype-specific antibody responses to pneumococcal antigens given
           on each of the three schedules

        -  study the influence of diphtheria antibody levels at the time of pneumococcal conjugate
           vaccine administration on the magnitude of the immune response to pneumococcal antigens
    

Intervention name(s): Tetanus-diphtheria toxoids (Td); 7-valent pneumococcal conjugate vaccine; 23-valent polysaccharide vaccine
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diptheria-Tetanus vaccine; Pneumococcal vaccine; Adverse events following vaccination; Immunization; Immunogenicity
Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This research was carried out with the objective of verifying the possibility of intervention
      through cognitive training protocols to assist in the stimulation of neurons and to delay the
      degradation resulting from Alzheimer's disease in its initial phase. The specific objective
      of this research was to develop and validate a virtual environment of games (called
      SorrisoTur) that allows the intervention of cognitive training.
    

Detailed description: 
      SorrisoTur encompasses cognitive training concepts and protocols in playful situations, which
      were coded in the form of 2D mini-games that are run on a computer connected to the Web, and
      designed to stimulate cognitive domains, such as memory, executive functions, spatial-visual
      skills, language (expression, comprehension, reading, and writing) and personality/behavior.
      For the comparison of results, three groups were created; one group of elderly people with
      Alzheimer's disease at an early stage, one group formed by healthy elderly, and another group
      with young people and applied Mini-Mental State Examination (MMSE) and Wechsler Intelligence
      Scale for Adults (WAIS-III) before and after of interventions with the games.
    

Intervention name(s): Virtual Environment
Intervention type(s): Other
Intervention description(s): The Virtual Environment was called SorrisoTur and consists of 10 mini-games with difficulty levels in a limited number of cities and mini-games distributed in a thematic scenario of the map of Brazil. The virtual environment consists of the cognitive training mini-games within a theme for all screens, mini-games, and information. The interventions with the Virtual Environment were administered in periods of one hour, twice a week, for a month.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Naloxone for Optimizing Hypoxemia Of Lung Donors
Condition: Brain Death; Organ Donors; Lung Transplantation
MeSH terms: Brain Death
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Brain-dead patients who provide authorization for organ donation will be randomized to
      naloxone or placebo if baseline arterial blood gas (ABG) after initiation of OPO (Organ
      Procurement Organization) management reveals hypoxemia, as defined by the ratio of partial
      pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2) below 300
      mm Hg, unless they have already been ruled-out for lung recovery. Investigators aim to assess
      whether naloxone improves oxygenation prior to organ recovery more than placebo.
    

Detailed description: 
      Naloxone has been used by many OPOs for decades to improve the pulmonary status of brain-dead
      organ donors (based on anecdotal evidence and small uncontrolled studies). Its efficacy in
      this population has never been assessed in a controlled clinical trial. The rationale for its
      use appears to be that it blocks the increase in capillary permeability that occurs with
      herniation and brain death (as demonstrated in a single sheep study of herniation).
      Investigators aim to rigorously test this hypothesis in a randomized placebo-controlled trial
      in brain-dead organ donors who have baseline hypoxemia. The primary outcome will be the acute
      change in oxygenation (on first follow-up ABG after naloxone as well as the final ABG prior
      to organ recovery). Investigators will also assess whether treatment results in more lungs
      being recovered and transplanted, after correcting for baseline variables such as age, blood
      group, smoking history, and cause of death. This study will be performed under the auspices
      of the Organ Donation Research Consortium and be carried out by multiple OPOs across the
      country. Naloxone or blinded placebo (identical syringe filled with saline) will be given
      after the baseline ABG shows hypoxemia (PFR - PaO2 divided by FiO2, on positive
      end-expiratory pressure [PEEP] of 5 and usually 100% FiO2). Naloxone and placebo will both be
      co-administered with a neuromuscular blocking agent (e.g. vecuronium, per center protocol) to
      obviate any increase in spinal reflex movements that may be potentiated by naloxone
      treatment. All other protocols for organ donor management should be maintained at each OPO
      and no other study interventions are required. Transplant centers will be informed (through
      DonorNet) that the organ donor being considered for lung recovery has been enrolled in this
      blinded clinical trial.
    

Intervention name(s): Naloxone; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Naloxone 8-mg IV bolus
Other intervention name(s): Narcan; saline
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Carfilzomib + Elotuzumab + Dexamethasone for Relapsed Multiple Myeloma After 1-3 Prior Treatment Lines
Condition: Multiple Myeloma in Relapse
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The main aim of this study is to assess the ORR with a new drug combination, carfilzomib
      (CAR) + elotuzumab (ELO) + dexamethasone (CAR-ELO-Dex).
    

Detailed description: 
      This Nordic Myeloma Study Group study is a phase 2 study for advanced multiple myeloma (MM)
      patients below 75 years of age. The main aim of this study is to assess the overall response
      rate (ORR) with a new drug combination, carfilzomib + elotuzumab + dexamethasone
      (CAR-ELO-Dex). Even if this is not a randomized study rough comparisons can be done with
      earlier reports of different regimens in the same clinical situation. In addition, safety
      assessment is of critical importance for a new regimen. A modern concept is to study the
      depth of complete responses (CR) with a sensitive multiparameter flow cytometry (MFC) method
      for minimal residual disease (MRD) assessment - an endpoint that is mostly lacking in
      previous studies for this patient population. We assume that treatment with this new
      combination of CAR + ELO + Dex will produce at least as good responses as the most efficient
      regimens so far used in this clinical situation, and there will be a substantial proportion
      of CR responses with MRD-negativity which can be regarded as an indicator of high-level
      treatment efficacy and which gives a good basis for comparisons of treatment efficacy between
      different study regimens in future.

      The target population of the study is the patients who have relapsed or progressed after 1 to
      3 prior treatment lines in which PI (bortezomib and/or ixazomib) and/or lenalidomide have
      been included. The primary endpoint is overall response rate while the secondary endpoints
      include complete remission, duration of response, assessment of the depth (quality) of CR
      with MRD measurement by flow cytometry, estimation of progression free survival (PFS) and
      time to next treatment, and evaluation of adverse events and safety.
    

Intervention name(s): Carfilzomib for Inj 60 milligram (MG); Elotuzumab 400 MG; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone; All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone; All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
Other intervention name(s): Proteasome inhibitor; Monoclonal antibody; Steroid
Intervention MeSH terms: Dexamethasone; Elotuzumab; Proteasome Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SHAPES: Supporting Multimorbid Older People
Condition: Heart Failure; Diabetes; Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The Smart & Healthy Ageing through People Engaging in Supportive Systems (SHAPES) Innovation
      Action is a Horizon 2020, EU-wide project looking at how technology can enable the older
      population to live healthier lives at home. It involves the development, piloting and
      deployment of a large scale, EU-standardised open platform. This platform will integrate with
      a wide-range of technological, organisational, clinical, educational and societal solutions
      seeking to facilitate long-term healthy and active aging.

      Within this project are 7 pilot themes investigating various potential uses of the platform,
      in Northern Ireland we are leading on medicines control and optimisation.

      This pilot is focused on identifying, managing and improving deficiencies in adherence to
      medicines and treatments of older individuals living with permanent or temporary reduced
      functions or capabilities due to chronic, age-related illnesses and living at home. Digital
      Solutions (including blood pressure monitors, pulse oximeters, weight scales and glucometers)
      will be used to enable self-monitoring of the individual's physiological parameters. Data
      will also be used to develop an algorithm to help predict decompensations in participants
      with heart failure and dynamic personal ranges will also be developed. In the future this may
      enable early opportunities to adjust medicines and treatments so as to deliver safer and more
      effective use of medicines in-home, however, in this pilot there will be no changes to
      treatment.

      The target population is composed of older individuals (+65 years) living at home with heart
      failure and/or diabetes. We aim to recruit 30 people (for 3 months) to our pilot in Northern
      Ireland. We are working closely with colleagues in Spain, Czech Republic, Cyprus and Germany
      to run similar pilots within their healthcare systems.
    


Intervention name(s): SHAPES app
Intervention type(s): Device
Intervention description(s): Participants will be asked to use the app and connected devices daily for 3 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Developing Effective Response Inhibition Training for Symptom Relief in OCD and Trichotillomania
Condition: Obsessive Compulsive Disorder; Trichotillomania
MeSH terms: Obsessive-Compulsive Disorder; Trichotillomania
Study type: Interventional

Summary: 
      Obsessive-compulsive disorder (OCD) and its related disorders (e.g., trichotillomania) are
      characterized by the marked difficulty in inhibiting unwanted or inappropriate responses.
      There is compelling evidence that poor response inhibition is a core cognitive feature of OCD
      and its related disorders, but no effective intervention exists that directly attempts to
      address this problematic cognitive deficiency. This study will examine the feasibility and
      clinical utility of a computerized cognitive training program designed to improve response
      inhibition among individuals diagnosed with OCD or trichotillomania.This training program
      offers systematic practice of response inhibition in the form of a 40-level computer game.
      Individuals with these conditions will be randomized to either 8 sessions of (a) computerized
      response inhibition training (RIT) or (b) placebo computer training (PLT). We hypothesize
      that RIT will outperform PLT in improving response inhibition capabilities and reducing
      relevant clinical symptoms. In sum, this project is expected to generate important knowledge
      to guide the development of effective computer-based treatment approaches that may help
      reduce critical problems of existing treatments such as suboptimal patient retention and
      treatment under-utilization, thereby improving overall treatment response rates among
      individuals suffering from OCD and related conditions.
    


Intervention name(s): Response inhibition training; Placebo Control Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance; This placebo control training looks very similar to the response inhibition training program in its appearance. However, it does not offer any practice related to response inhibition capabilities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OCD; Trichotillomania; Response inhibition; Cognitive training