bioihbjkbjnl/mcl2 huggingface dataset:
Low-intensity Shockwave Therapy (LiST) for the Treatment of Mild and Mild-to-moderate Vasculogenic Erectile Dysfunction
Condition: Erectile Dysfunction; Low Intensity Shockwave Therapy
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      This is a randomized, double-blind, 2 parallel arms clinical trial. All patients will be
      PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order
      to randomize 50 men with vasculogenic ED with primary objective to examine the efficacy of
      LiST using Aries2 device.
    


Intervention name(s): DornierAries2 LiST device + 5 mg Tadalafil; DornierAries2 LiST device + Placebo Pill
Intervention type(s): Other; Other
Intervention description(s): All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Tadalafil 5mg. Total treatment period = 4 weeks; All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Placebo pills. Total treatment period = 4 weeks.
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder
Condition: Anxiety
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of the research is to test the effectiveness of the social story intervention
      delivered using the iPAD application "Going to Imaging" on the anxiety, challenging child
      behaviors, child injuries and completion rates among children with ASD undergoing medical
      imaging procedures. A secondary purpose is to test the effect of this intervention on the
      anxiety levels of the parents of ASD children undergoing medical imaging procedures.

      Hypotheses:

      H1: Children with ASD who are exposed to a story book "Here the investigators go to medical
      imaging (x-ray)" to prepare for medical imaging compared with children with ASD exposed to
      treatment as usual (TAU) will have:

        1. Lower anxiety as measured by heart rate respiratory rate, and blood pressure (baseline
           compared to up to two hours later).

        2. Exhibit fewer challenging behaviors as measured by a behavior observation scale
           (developed for the study (up to 2 hours after baseline)

        3. Higher procedure completion rate.

        4. Shorter time to complete a procedure.

        5. Less child injuries.

           H2: Compared to parents of ASD children exposed to treatment as usual (TAU), parents of
           children with ASD who are exposed to a story book "Here the investigators go to medical
           imaging (x-ray)" to prepare for medical imaging will have:

        6. Lower state anxiety as measured by the State Anxiety Inventory ( baseline ).
    

Detailed description: 
      Parent state anxiety is measured at baseline with the 20-item State anxiety measure from
      www.mindgarden.com. Child anxiety is measured at baseline with vital signs (heart rate, blood
      pressure, respiratory rate). Behaviors will be observed and recorded on the behavior
      observation tool up to 2 hours after the baseline measure (during the imaging).
    

Intervention name(s): Patient teaching
Intervention type(s): Other
Intervention description(s): The Social script application is an story book on the iPAD with photos and script explaining the steps of getting a medical image such as a CAT scan from the perspective of the child.
Other intervention name(s): Going to Imaging ipad application
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: child anxiety; challenging behaviors; time; Parent anxiety
Metabolism Associated With Abdominal Fat Mass Distribution
Condition: Obese
Study type: Observational

Summary: 
      Objectives:

      The primary objective of this clinical trial is to characterize metabolic signatures
      associated with abdominal fat distribution in 40 women with different BMI 29-40 and different
      abdominal distribution of fat (visceral vs. sub-cutaneous fat).

      No intervention with a product is planned. The subjects will be given one high fat meal with
      commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to
      test the post-prandial metabolic response.
    


Sampling method: Non-Probability Sample
Study population: 
        Obese women
      
Keywords: obese women; fat mass distribution; Metabolomic profiles
Comparison of Reduced Fluence Versus Standard Photodynamic Therapy (in Combination With Intravitreal Triamcinolone Acetate)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the CNV treatment effect of PDT with verteporfin in combination with IVTA using
      reduced fluence compared to the standard fluence.
    

Detailed description: 
      Age-related macular degeneration (AMD) is by far the most common disorder in the group of
      irreversible causes of visual disability. AMD leads to dysfunction and loss of photoreceptors
      in the central retina. Neovascular AMD affects visual function early in the disease process
      and severely compromises the highly developed functions of the macula, such as perception of
      details, central fixation, color vision, and reading ability. AMD-related visual impairment
      is associated with a loss of autonomy and quality of life. Currently, laser photocoagulation,
      photodynamic therapy (PDT) with verteporfin usually combined with intravitreal triamcinolone
      acetonide (IVTA) are the only proved treatments for subfoveal choroidal neovascularisation
      (CNV). Laser photocoagulation is limited to selected cases. Photodynamic therapy using
      verteporfin provides very promising data regarding improvement of visual acuity and absence
      of fluorescein leakage. PDT was recently successfully combined with an intravitreal injection
      of the corticosteroid triamcinolone acetonide. Yet, PDT also leads to damage to surrounding
      normal choroidal vessels. A pilot trial comparing low fluence (300 mW/cm²) with standard
      fluence (600 mW/cm²) demonstrated a trend for improved outcomes using the low fluence regimen
      (VIM study). However, vascular mechanisms and choroidal damage were not examined, and the
      study group was too small to evaluate vision outcome parameters. Combined with the IVTA, the
      low fluence effects of PDT may be sufficient for CNV occlusion and the physiological choroids
      should be spared from any collateral damage. The aim of this study was to compare reduced
      fluence with standard fluence PDT using verteporfin and IVTA for CNV secondary to AMD.
    

Intervention name(s): Photodynamic therapy and intravitreal triamcinolone
Intervention type(s): Procedure
Intervention description(s): combination of photodynamic therapy and intravitreal triamcinolone combination to treat neovascular AMD
Intervention MeSH terms: Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: choroidal neovascularisation,; vision,; macula,; macular degeneration; optical coherence tomography; neovascular age related macular degeneration
Antioxidant and Immune Effects of Vitamin K2
Condition: Oxidative Stress; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The aim of the study is to obtain insight into a dose-dependent effect of vitamin K2 on
      oxidative stress and specific markers of the immune system.
    


Intervention name(s): Vitamin K2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): (K2VITAL® 1% MCT Oil); Sunflower oil
Intervention MeSH terms: Vitamin K; Vitamin K 2
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3 way crossover trial for evaluating the effect on oxidative stress markers. The first study period, is also used as a parallel study for studying the effect on immune markers.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK), and
      pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette syndrome
      (TS). The study will be conducted in approximately 18 male and female children (6 to 11 years
      of age) and approximately 18 male and female adolescents (12 to 18 years of age). Both age
      groups will be divided equally into 3 dosing cohorts with 6 subjects each. Ascending doses
      will be evaluated as part of a staggered-cohort design. Study drug will be administered in
      each cohort for 14 consecutive days.
    


Intervention name(s): NBI-98854
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of Itolizumab in COVID-19 Complications
Condition: Acute Respiratory Distress Syndrome; Cytokine Release Syndrome; Covid19
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Cytokine Release Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, Parallel Group, Active Controlled Trial
    

Detailed description: 
      This is a Multi-Centric, Open label, Two Arm Randomized, Phase 2 Study.

      All eligible patients entering into the study will be randomized in 2:1 ratio to receive the
      treatment A (Best supportive care + Itolizumab) / B (Best supportive care) respectively. Each
      patient will undergo the treatment based on their assigned treatment for a month along with
      battery of tests that includes, but not limited to, cytokines and chemokine, along with
      recording of TLC; DLC, ANC, ALC; Platelet count; S. creatinine; T.Bilirubin; morning Vitals
      -pulse, BP, RR; Temperature, PaO2/FiO2, MAP, GCS.

      As Itolizumab is an investigational drug, the benefit to COVID-19 patients experiencing
      complications such as Cytokine Release Syndrome is not known. However, findings from this
      study may be beneficial to the society at a large at the National and International Level.
    

Intervention name(s): Itolizumab IV infusion; Best supportive care (BSC)
Intervention type(s): Drug; Drug
Intervention description(s): First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.
BSC: similar to Arm B; Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Dietary Interventions on the Brain in Mild Cognitive Impairment (MCI)
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study will investigate whether dietary modification could provide positive effects on
      brain functions in elderly people with mild cognitive impairment.
    

Detailed description: 
      The age-related degradation of cognitive functions even to the point of neurodegenerative
      disorders such as Alzheimer's disease are a growing public-health concern with devastating
      effects.

      Referring to animal data, empirical studies, and pilot human trials, dietary modification
      (caloric restriction, omega-3 fatty acids and resveratrol) should improve cognitive functions
      such as learning and memory. To test this hypothesis, the researchers study general brain
      functions in elderly subjects (50-80 years old) with mild cognitive impairment.
    

Intervention name(s): caloric restriction; omega-3 supplementation; resveratrol supplementation; Placebo; 2nd step: intervention + physical / cognitive training; 2nd step: intervention + control
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 6 months of caloric restriction (15 %); 6 months of omega-3 supplementation; 6 months of resveratrol supplementation; 6 months of placebo intake; most effective dietary intervention plus physical and cognitive training; most effective dietary intervention plus control
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: memory; diet; elderly; cognition; prevention; lifestyle
Atrial Fibrillation Symptoms and Pain Sensitization
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Atrial fibrillation (AF) is the most common sustained arrhythmia and the number of patients
      with AF is expected to increase substantially in the coming decades. One third of patients
      with AF report no AF-associated symptoms, but up to one fourth report severe symptoms such as
      chest pain. It is well recognized, but unclear why patients' experience of AF-related
      symptoms, including chest pain, varies so much. Patients with chronic pain show a high degree
      of central sensitization, i.e. facilitated pain responses to repeated painful stimulation and
      impaired conditioned pain modulation, compared with controls. It is possible that patients
      with symptomatic AF may have developed pronounced pain sensitization even in the absence of
      chest pain as a symptom. No previous study has investigated pain sensitization in patients
      with AF.

      The primary objective is to assess differences in pain sensitization in patients with
      symptomatic AF compared with patients with asymptomatic AF. Secondary objectives are to study
      the association of age, sex, AF duration, comorbidities and health-related quality of life to
      pain sensitization. A total of 30 patients with permanent AF (15 symptomatic and 15
      asymptomatic) will be recruited. Patients will complete an AF-specific symptom score and a
      generic health-related quality of life questionnaire, and physicians will assess AF-related
      symptoms. Quantitative sensory testing recordings will be collected by pressure algometry.
      Assessment of temporal summation of pressure pain and conditioning pain modulation will be
      used to investigate the involvement of pain sensitization.

      This preliminary pilot study will be used to estimate sample size for a larger study in which
      both patients and control subjects will be recruited, to further investigate whether patients
      with symptomatic AF have increased pain sensitization compared with patients with
      asymptomatic AF and controls. The studies may have an impact on individualized management of
      patients with AF in the future.
    


Intervention name(s): Quantitative sensory testing
Intervention type(s): Diagnostic Test
Intervention description(s): Quantitative sensory testing recordings will be collected by pressure algometry Assessment of temporal summation of pressure pain and conditioning pain modulation will be used to investigate the involvement of pain sensitization.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Atrial Fibrillation; Symptoms; Quality of Life; Pain; Conditioning pain modulation; Temporal summation
Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      The optimal timing of surgical intervention remains controversial in asymptomatic patients
      with very severe aortic stenosis. The investigators therefore try to compare long-term
      clinical outcomes of early surgery with those of conventional treatment strategy in a
      prospective randomized trial.
    

Detailed description: 
      Management of asymptomatic patients with severe aortic stenosis (AS) remains controversial,
      and the combined risks of aortic valve surgery and late complications of aortic valve
      prosthesis need to be balanced against the possibility of preventing sudden death and
      lowering cardiac mortality. Considering that sudden cardiac death occurs at a rate of
      approximately 1% per year and that the average postoperative mortality of isolated AV
      replacement is 3.0-4.0%, the 2007 European Society of Cardiology guidelines do not recommend
      aortic valve surgery for asymptomatic patients with severe AS and the 2006 American College
      of Cardiology/American Heart Association guidelines recommend surgery as a class IIb
      indication only in patients with extremely severe AS and who are at low operative risk.
      Clinical outcomes vary widely according to the severity of stenosis in asymptomatic AS, and
      asymptomatic patients with very severe AS are often referred for aortic valve replacement in
      clinical practice despite the lack of data supporting early surgery. Rosenhek et al recently
      reported a worse prognosis with a higher event rate and a risk of rapid deterioration in very
      severe AS, and the investigators also recently reported that compared with the conventional
      treatment strategy, early surgery in patients with very severe AS is associated with an
      improved long-term survival in a prospective, observational study. However, there have been
      no prospective,randomized studies comparing early surgery with a watchful waiting strategy in
      very severe AS. We sought to compare long-term clinical outcomes of early surgery with those
      of conventional management based on current guidelines.
    

Intervention name(s): Early surgery
Intervention type(s): Procedure
Intervention description(s): Early surgery is performed within 2 months of randomization.
Other intervention name(s): Early aortic valve replacement surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: early aortic valve replacement
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aortic stenosis; surgery, survival
Enduring Happiness and Continued Self-Enhancement
Condition: Happiness
Study type: Interventional

Summary: 
      Over the past several decades, a new science of subjective well-being has produced insights
      into the factors that make people happy-from cultivating strong relationships to pursuing the
      right goals. Drawing on these empirical findings, the investigators created a comprehensive
      12-week intervention program, ENHANCE: Enduring Happiness and Continued Self-Enhancement. The
      investigators multimodal program is designed to teach people essential skills in order to
      produce sustainable changes in behavior and, as a result, long-lasting increases in
      happiness. To test the effectiveness of ENHANCE, the investigators designed a six-month
      randomized clinical trial. Participants will be assigned to an active treatment group or a
      waiting group control. They will complete baseline assessments, and follow-up assessment at
      three and six months after the start of the intervention. These assessments will contain
      measures of subjective well-being and objective measures of health, as well as a variety of
      psychological mediators (e.g., psychological needs) and moderators (e.g. personality). The
      investigators will thus be able to explore not only whether ENHANCE works to improve
      well-being, but also why and how ENHANCE works.
    


Intervention name(s): ENHANCE: Enduring Happiness and Continued Self-Enhancement
Intervention type(s): Behavioral
Intervention description(s): ENHANCE is a skill-based intervention to teach people a wide variety of strategies that have been shown to boost happiness. Each session of ENHANCE follows a similar format targeted to address three central goals. First, in each session, participants will complete an active learning module designed to educate participants about one of the ten overarching topics featured in this program (e.g., goals, close relationships). Next, participants will engage in activities that put these principles into practice. Finally, this program is designed to encourage a skill-building mindset by helping participants develop habits to integrate these principles into maintained activity in their daily lives moving forward.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Happiness; Subjective Well-Being; Psychological Flourishing; Well-Being; Health; Behavioral Change; Life Satisfaction; Affect; Emotion; Goals; Meaning in Life
Discordant Hormonal Status of Breast Cancer.
Condition: Malignant Neoplasm of Breast.
MeSH terms: Neoplasms; Breast Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to determine discordant hormonal status of primary breast tumor
      and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer
      patients.
    

Detailed description: 
      Hormonal status between primary breast tumor and axillary lymph node were analyzed.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Breast Cancer Patients Stage I,II and III.
      
Biospecimen description: 
      Paraffin embedded tissue blocks of primary breast tumor and axillary lymph nodes.