bioihbjkbjnl/mcl2 huggingface dataset:
Eating Peanuts for Health
Condition: Obesity; Overweight; Hyperlipidemia
MeSH terms: Overweight; Hyperlipidemias
Study type: Interventional

Summary: 
      Evidence is accumulating that peanut consumption confers health benefits, such as reduction
      of cardiovascular disease risk and possibly diabetes risk (Jenkins et al., 2008; Mattes et
      al., 2008). However, peanuts are a high fat, energy dense food and concerns about weight gain
      are widespread. Although research indicates that other characteristics of peanuts offset
      these properties, and that peanuts may be incorporated into diets without posing a threat to
      weight gain (Mattes et al., 2008), concern remains among policymakers, healthcare providers,
      and consumers. Furthermore, worry exists that eating salted peanuts may elevate blood
      pressure and that eating honey-roasted peanuts make elevate blood sugar. These fears create
      substantial obstacles to increased peanut consumption.

      Recommendations to increase peanut consumption may be made, but if they are not followed,
      there will be no impact on health. Additional knowledge is needed on: (1) the acceptability
      of peanuts consumed on a chronic basis, (2) the chronic intake of moderate levels of peanuts
      and body weight, and 3) the effects of peanuts on blood pressure and blood sugar. The
      proposed research will examine the acceptability of long-term inclusion of a single form
      versus varied forms of peanuts in the diet. It is expected that responses will be varied
      among individuals with different personality characteristics (e.g., prefer sweet versus
      savory foods, hedonic versus non-hedonic eaters). A better understanding of how different
      segments of the population choose to include peanuts in their diet and how to optimize
      long-term consumption should provide insights for better marketing and improved health.
      Furthermore, it is anticipated that eating salty peanuts will not raise blood pressure and
      that eating honey-roasted peanuts will not raise blood sugar. Documenting this will add
      credibility to the evidence that peanuts do not cause weight gain, as well as reinforce
      recommendations to increase peanut consumption for their health benefits.
    


Intervention name(s): Consumption of 42 grams of peanuts daily
Intervention type(s): Other
Intervention description(s): Consumption of the given 42 grams of peanuts daily without instructions for use (i.e. with/without meals, etc.)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; energy balance; variety; nut intake
Decision Support Workshop for Breast Reconstruction
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of a pre-consultation decision
      support workshop for breast reconstruction after breast cancer, in facilitating the
      decision-making process, compared to routine pre-surgical education.
    

Detailed description: 
      Postmastectomy breast reconstruction is becoming increasingly utilized in breast cancer
      patients to provide surgical restoration of the breast mounds. The breast reconstruction
      discussions can be highly complex, as there are many different techniques, timing, and
      complications that are unique to each procedure. However ¼ of women report being dissatisfied
      with some component of their cancer or reconstructive care. Failure of the physician to
      provide adequate information about treatment options is the most frequent source of cancer
      patient dissatisfaction and breast reconstruction patients have expressed a need for further
      information regarding the complex decision to pursue breast reconstruction. In such scenarios
      of complex medical decision-making, decision support techniques may be an effective solution
      to information provision and shared decision-making. As a result, the investigators developed
      a pre-consultation educational group intervention delivered in a group setting for women
      considering breast reconstruction, with the aims to fill an existing information-gap, promote
      high-quality decision-making and enhance decision self-efficacy and other decision measures.
      This pilot study will be the first step in the evaluation of the educational group
      intervention and the results will be used to determine the feasibility and inform the optimal
      design for a definitive randomized controlled trial. This study will first examine the
      feasibility and acceptability of the intervention through implementation in a pilot,
      mixed-methods, 1:1 allocation parallel-arm randomized controlled trial.
    

Intervention name(s): Decision Support Workshop
Intervention type(s): Other
Intervention description(s): Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
Social worker (30 mins): values clarification exercise
Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer; breast reconstruction; shared decision making; decision support intervention
Remote Use of the Asthma Control Test (ACT) to Improve Care of Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study will assess whether adaption of the Asthma Control Test (ACT) and childhood Asthma
      Control Test (cACT) for mobile devices improves rate of completion and improves control of
      asthma in children and adolescents
    

Detailed description: 
      Asthma is the most prevalent chronic disease of childhood with an overall prevalence of 10%.
      While effective therapies exist to control symptoms and prevent exacerbations, many asthma
      patients experience significant morbidity including limitations on daily activities as well
      as asthma exacerbations that lead to missed school (and work for care givers) and necessitate
      emergency department visits and hospitalizations. Among children from lower socioeconomic
      statues and in black and Hispanic families, asthma incidence and severity are even greater.
      Reasons for this disparity included decreased access to effective asthma care, increased
      exposure to tobacco smoke and environmental allergens, and underutilization of controller
      medicines. These groups have significantly increased resource utilization due to emergency
      department visits and hospitalizations. Optimal care for asthma patients, especially those
      with at highest risk, will therefore require new strategies for evaluating ongoing control
      and providing direct feedback to patients.

      We propose to transform the way asthma care is provided through the use of an innovative
      patient centered technology -Trivox Asthma - to improve quality of care and outcomes for
      asthma patients while reducing the cost of care. Specifically we will extend Trivox Health to
      facilitate closer monitoring of patients with asthma through the existing web platform and a
      new mobile interface. This will allow asthma patients, their parents and school nurses to
      remotely input data on asthma control through smartphones and/or tablets. We will use the
      ACT+, an expansion of a validated measure currently utilized in both primary care and
      specialty clinics, to measure both asthma control and risk.

      Effectiveness of this intervention will be measured by examining resource utilization and
      ongoing asthma control.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with asthma seen in one of the clinics caring for patients with asthma at Boston
        Children's Hospital Age 4-21
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia III
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      A dual-arm prospective, interventional clinical trial to evaluate the safety and performance
      of obtaining hemostasis with catheters along with the use or absence of a hemostatic agent
      following treatment with the AQUABEAM System.
    

Detailed description: 
      PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet
      resection system that utilizes a high-pressure saline stream to resect and remove prostate
      tissue in males suffering from LUTS due to BPH. The primary objective of this study is to
      evaluate the safety and performance of obtaining hemostasis using balloon catheters with and
      without hemostatic agents following prostate resection using AQUABEAM for the treatment of
      LUTS resulting from BPH. Up to 50 participants will be included in the trial at one clinical
      study site. All patients will be followed up for 3 months for safety assessment prior to
      study exit. The trial is a dual-arm prospective, interventional clinical trial.
    

Intervention name(s): AQUABEAM System followed by catheter without hemostatic agent; AQUABEAM System followed by catheter with hemostatic agent
Intervention type(s): Device; Device
Intervention description(s): The AquaBeam system delivers a high-pressure saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The physician will use balloon catheter to achieve hemostasis post-Aquablation procedure.; The AquaBeam system delivers a high-pressure saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The physician will use balloon catheter with hemostatic agent to achieve hemostasis post-Aquablation procedure.
Intervention MeSH terms: Hemostatics
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Image-guided; BPH; Aquablation; AQUABEAM; LUTS; Tissue resection; Robotics
Effect of Low Level Laser Therapy on the Temporomandibular Joint During Treatment of Skeletal Class II Malocclusion
Condition: Malocclusion Class II
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      to evaluate effect of low-level laser therapy (LLLT) on mandibular condylar volume and
      position after treatment of Class II malocclusion with Twin Block (TB) functional therapy via
      cone beam computed tomography (CBCT).

      Materials and methods: Twenty eight growing patients, 14 boys and 14 girls ranged in age 9-12
      years, were randomly divided into control group (mean initial age 10.64±1.36 years) and laser
      group (mean initial age 10.55 1.45 years). All patients treated with TB appliance where
      Gallium aluminum arsenide diode laser applied in one group weekly around TMJ region for 12
      sessions in three months with set parameters: continuous 635 nm, 50 mW, 4.5J/cm2, 45 seconds/
      point, total dose per side 11.25J. CBCT were obtained before and immediately after TB
      therapy, in addition to routine orthodontic records. Changes in TMJ and skeletal variables
      were analyzed and compared within and between both groups.
    

Detailed description: 
      to evaluate the effect of low-level laser therapy (LLLT) on mandibular condylar volume and
      position after treatment of Class II malocclusion with Twin Block (TB) functional therapy via
      cone-beam computed tomography (CBCT).

      Materials and methods: Twenty-eight growing patients, 14 boys, and 14 girls ranged in age
      9-12 years, were randomly divided into control group (mean initial age 10.64±1.36 years), and
      laser group (mean initial age 10.55 1.45 years). All patients treated with TB appliance where
      Gallium aluminum arsenide diode laser applied in one group weekly around TMJ region for 12
      sessions in three months with set parameters: continuous 635 nm, 50 mW, 4.5J/cm2, 45 seconds/
      point, total dose per side 11.25J. CBCT were obtained before and immediately after TB
      therapy, in addition to routine orthodontic records. Changes in TMJ and skeletal variables
      were analyzed and compared within and between both groups.
    

Intervention name(s): low level laser therapy
Intervention type(s): Radiation
Intervention description(s): In the laser group, patients received LLLT from a semiconductor Gallium Aluminum Arsenide diode laser (SMARTMPRO, LASOTRONIX, Poland) with the following set parameters; 635 nm wavelength in continuous-wave mode, 50 mw power output, 4.5 J/cm2 energy density, 11.25 J total dose per side, 45 seconds/ point, and 8 mm fiber optic tip diameter. Laser was applied (Fig.2) at five points located within TMJ region on both right and left sides in contact with skin as follows: lateral, superior, anterior, posterior, and posterior- inferior points.
Other intervention name(s): photobiomodulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: laser group and control group
Masking: None (Open Label)
Primary purpose: Treatment
Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver: Case-control Study (NoFlic Study)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      The main objective of this study is to identify direct carcinogenic factors in the absence of
      cirrhosis, and the carcinogenesis pathways involved on nonfibrotic liver (NfCHC).
    

Detailed description: 
      Most hepatocellular carcinoma (HCC) complicates cirrhosis, which is often caused by infection
      with hepatitis B or C viruses, alcohol, obesity, exposure to aflatoxin B1 (AFB1) or
      hemochromatosis. Nevertheless, 10 to 40% of HCCs can develop on non-cirrhotic terrain and
      about 5% on nonfibrotic liver (NfHCC). In 20 to 40% of these NfHCCs, no classical HCC risk
      factor is identified. Some cases could be the result of a transformation of an adenoma.
      Others may be associated with yet non-formally identified toxins and / or a specific genetic
      predisposition. While there is a lot of data on alterations of signaling pathways (ß-catenin,
      AKT / mTOR, Ras / pERK, etc.) in "classical" HCCs, altered pathways remain unknown in most
      NfHCCs, even in some cases, activation of β-catenin, inactivating mutations of HNF1 or
      activators of gp130 have been shown. A specific study of NfHCCs, rather rare cancers,
      represents an opportunity to look for directly carcinogenic factors in the absence of
      cirrhosis, and to dissect the involved carcinogenesis pathways.
    

Intervention name(s): Blood test and self-administrated questionnaires
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        CASES: patients with a diagnosis of NfHCC with anatomopathological examination and showing
        a HCC according to standard histopathological criteria and an absence of significant
        fibrosis in non-tumoral tissues with the METAVIR system score or equivalent (F0 or F1) or
        the Kleiner et al stage of ASH and NASH (≤stade 2)

        - CONTROLS: patients without NfHCC at baseline
      
Keywords: hepatocellular carcinoma; Non-cirrhotic liver; Risk factors
Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Risk behaviors and their associated adverse health outcomes are becoming increasingly
      problematic among HIV-infected youth. This study is being conducted to test whether a brief
      motivational enhancement (ME) intervention will help reduce health risk behaviors (drug and
      alcohol use, sexual risk behavior, poor adherence to medications) among HIV+ youth.
    

Detailed description: 
      Healthy Choices is a randomized clinical trial examining the efficacy of motivational
      enhancement in reducing risk and promoting healthy behaviors. This study will use a sample of
      225 youth (180 after attrition), ages 16-24, of whom 90 will receive the intervention,
      referral, and standard care, and 90 will receive referral plus standard care. The sample will
      be drawn from five study sites. Using parallel screening, recruitment will target 100 youth
      with an adherence problem, 100 youth with a substance use problem, and 25 youth with a sexual
      risk problem. A repeated measures design will be used for the proposed study. Primary outcome
      measures are drug and alcohol use, condom use, and HIV medication adherence. Youth will
      complete an initial data collection session (baseline) during which questionnaire and
      interview measures will be administered. Blood specimens for viral load and CD4+ count will
      also be obtained.

      Randomization procedures will take place after completion of the baseline assessment.
      Participants who are randomized to the intervention group will participate in four sessions
      for approximately 3 months and will also receive standard care plus individualized referrals.
      The control group will receive standard care and individualized referrals. All five sites
      offer comprehensive, multidisciplinary care including social work and case management
      services and access to mental health services. Participants will receive a three-month
      post-test designed to coincide with ME completion. Subsequent post-tests will occur at 6, 9,
      12, and 15 months after baseline data collection (3, 6, 9, and 12 months after ME
      completion).
    

Intervention name(s): Healthy Choices - Motivational Enhancement Intervention; Standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants who are randomized to the intervention group will participate in four sessions (over approximately 3 months) of Healthy Choices; a motivational enhancement intervention specifically designed to target multiple risk behaviors in HIV+ youth. Participants will receive individualized referrals at the fourth session.; Participants will receive standard care plus referrals at three months post-baseline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motivational enhancement; health behaviors; risk behaviors
Effects of MDMA and Methylphenidate on Social Cognition
Condition: Social Cognition
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to assess and compare the effects of a single dose of
      3,4-methylenedioxymethamphetamine (MDMA)and methylphenidate (MPH) on emotional and social
      cognition in healthy subjects. The investigators hypothesize that MDMA enhances affective
      perception for positive and impairs perception for negative emotional stimuli compared to
      placebo or MPH.
    


Intervention name(s): 3,4-Methylenedioxymethamphetamine; Methylphenidate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 75 mg per os, single dose; 40 mg per os, single dose; capsules identical to MDMA or methylphenidate but containing no active drug
Other intervention name(s): - MDMA; - ecstasy; - Ritalin; - Concerta
Intervention MeSH terms: Methylphenidate; N-Methyl-3,4-methylenedioxyamphetamine
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Effects of psychostimulants on emotion recognition and empathy
Pharmacokinetics Study of Asciminib in Subjects With Impaired Renal Function Compared to Matched Healthy Volunteers
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetics (PK) and safety profile of
      asciminib following a single oral dose in adult subjects with renal impairment compared to a
      matched group of healthy subjects with normal renal function.

      The results will determine whether or not a dose adjustment should be recommended when
      treating patients with asciminib who have impaired renal function.
    


Intervention name(s): Asciminib
Intervention type(s): Drug
Intervention description(s): 40 mg single dose
Other intervention name(s): ABL001
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ABL001; asciminib; impaired renal function; pharmacokinetics
Effect of 10-day Overnight Hypoxia Treatment on Whole Body Insulin Sensitivity (SLEEP HIGH Study)
Condition: Insulin Resistance
MeSH terms: Insulin Resistance; Hypersensitivity; Hypoxia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to look at how a reduction in oxygen levels (hypoxia) influences
      insulin sensitivity and carbohydrate metabolism. It is expected that 10 nights of exposure to
      moderate hypoxia (~ 15% O2, similar to conditions at an altitude of ~7500 feet) will improve
      glucose metabolism.
    


Intervention name(s): Hypoxia Exposure
Intervention type(s): Other
Intervention description(s): Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at ~ 15% O2 (ca. 2400 m elevation).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; hypoxia; insulin sensitivity; altitude