bioihbjkbjnl/mcl2 huggingface dataset:
Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The purpose of this research study is to learn about ways to help children and adults with
      sickle cell disease who are taking the medication, hydroxyurea.
    

Detailed description: 
      Sickle cell disease (SCD) is an inherited chronic multi-organ system disorder that affects
      approximately 100,000 individuals in the United States, mostly belonging to minority,
      under-served populations. SCD is associated with substantial morbidity, premature mortality,
      individual suffering, health care costs and loss of productivity. Hydroxyurea (HU) the only
      disease modifying therapy for SCD is efficacious in reducing complications such as pain
      crisis and acute chest syndrome and improving survival. It is however, vastly underutilized
      and poorly adhered to because of barriers at the health care system, provider, treatment,
      socioeconomic, and patient levels. The investigator's overarching hypothesis is that barriers
      to acceptance and adherence to HU are multi-factorial and that a structured set of
      interventions can lead to improved adherence to medication and patient centered outcomes.
    

Intervention name(s): Mobile DOT
Intervention type(s): Behavioral
Intervention description(s): Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
Other intervention name(s): Comprehensive medication adherence management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Use of Betashot in Children and Adults With Epilepsy
Condition: Nervous System Disorder
MeSH terms: Epilepsy; Nervous System Diseases
Study type: Interventional

Summary: 
      In brief, this research is a prospective, feasibility study to evaluate the use of Betashot-
      a medium chain triglyceride- based (MCT) food for special medical purposes (FSMP) in children
      and adults diagnosed with epilepsy.

      MCT is a type of dietary fat used in the ketogenic diet.
    

Detailed description: 
      This study aims to explore the use of Betashot in a group of children and adults with
      epilepsy who are consuming their normal diets, but limiting intakes of foods high in
      carbohydrate and sugars.

      The participants will be required to drink Betashot to enable the following assessment:

        1. Tolerance (side effects such as bloating or cramps)

        2. Acceptability (flavour, texture, taste)

        3. Compliance (how easy it is to use Betashot at the advised quantity, as part of their
           daily diet)
    

Intervention name(s): Betashot
Intervention type(s): Dietary Supplement
Intervention description(s): Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.
Other intervention name(s): MCT based emulsion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Application of Ultrasonic Elastography in Lung Lesions
Condition: Elastography
Study type: Observational

Summary: 
      Elastography is an imaging of tissue elasticity or stiffness and is currently emerging as a
      mainstream tool for ultrasound-based diagnosis. This compressibility property of materials,
      mathematically expressed as the change in tissue displacement as a function of its distance
      from the compressing device, is known as strain and is the parameter that is imaged in an
      elastogram.

      Elastography has currently shown promising result in differentiating viscoelastic nature of
      various organs, which is a consequence of certain underlying diseases.

      At present, there are limited literatures revealing the application and feasibility of
      ultrasonic elastography in lung lesions. This is essentially important as it may serve as an
      adjuvant to B-mode ultrasound. The investigators aimed at exploring the application and
      feasibility of ultrasonic elastography on lung lesions.
    

Detailed description: 
      Patients performed conventional B-mode ultrasound, subsequently followed by ultrasound
      elastography. The strain ration was measured and was compared between necrosis, atelectasis,
      consolidation and tumor.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with radiographic findings of consolidation, obstructive pneumonitis or tumors,
        detected on chest computed tomography (CT), who received ultrasound study with or without
        ultrasound-guided biopsy for tissue proof and UE, from December 2011 to March 2013.
The Effect of the Physiotherapy Program Applied in the Neonatal Intensive Care Unit
Condition: Premature; Infant, Light-for-dates; Neonatal Disease; Neurodevelopmental Disorders; Motor Delay
MeSH terms: Premature Birth; Infant, Newborn, Diseases; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      The aim of our study is to examine the effects of the physiotherapy program applied in the
      NICU on motor performance, behavior, transition time to full enteral feeding, and feeding
      performance in preterm infants.
    

Detailed description: 
      Preterm babies have to stay in neonatal intensive care units (NICU) because they cannot
      complete intrauterine development and have difficulty maintaining their vital functions.

      In very low birth weight babies, feeding may not be started at the desired time due to
      medical problems. Total parenteral nutrition should be started in order to prevent growth
      retardation in the baby who cannot receive adequate enteral nutrition in the first days. The
      infant who tolerates enteral feeding should also be transitioned to full enteral feeding as
      soon as possible. Early enteral nutrition and intensive early parenteral nutrition reduce
      growth retardation and improve the infant's mental developmental scores. The frequent
      occurrence of feeding intolerance in preterm infants with very low birth weight, especially
      extremely low birth weight, and the risk of NEC, which is a serious cause of mortality and
      morbidity in these infants, prevent reaching the desired nutritional goals. Therefore, the
      optimum initiation time and rate of increase of enteral feeding are still uncertain for these
      infants. The main purpose of preterm nutrition should be to minimize the problems that may
      occur in the short and long term. The aim of our study is to examine the effects of the
      physiotherapy program applied in the NICU on motor performance, behavior, transition time to
      full enteral feeding and feeding performance in preterm infants.
    

Intervention name(s): Physiotherapy application; Control Group
Intervention type(s): Other; Other
Intervention description(s): massage, oral and intraoral tactile stimuli and non-nutritive sucking will be performed to stimulate sucking, and massage applications and neurodevelopmental therapy for motor development.; standard daily applications will be performed on patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Exercise and Shoe Orthoses in Treatment of Posterior Tibial Tendon Dysfunction
Condition: Tendinopathy
MeSH terms: Tendinopathy; Posterior Tibial Tendon Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Posterior tibial tendon dysfunction (PTTD) is the most common cause of painful and
      debilitating acquired flatfoot deformity in adults. The dysfunction is often progressive and
      may result in attenuation of the PTT and eventually collapse of the plantar arch or even
      rupture of the tendon. Current therapeutic management of PTTD is multipronged and includes
      management with foot orthoses, stretching, and strengthening exercises. Evidence drawn from
      research related to the management of painful chronic Achilles tendinosis suggests that
      eccentric strengthening of the posterior tibialis may lead to superior results compared to
      concentric. The purpose of this research is to determine the effectiveness of treatment
      interventions used in the management of PTTD.
    

Detailed description: 
      All study participants receive a pair of custom made orthoses and perform daily
      calf-stretches. In addition to the orthoses two groups will perform tibialis posterior
      specific exercises; one as concentric and the second as eccentric activation. Intervention
      will last 12 weeks.
    

Intervention name(s): Orthoses and Exercise
Intervention type(s): Procedure
Intervention description(s): orthrose and exercise - daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tibialis Posterior Tendinopathy
Anal Fistula Plug, a Retrospective Study
Condition: Healing Rate; Recurrence; Complication
MeSH terms: Rectal Fistula; Recurrence; Fistula
Study type: Interventional

Summary: 
      In this study, we retrospectively reviewed clinical data of patients who were treated with an
      anal fistula plug for trans-sphincteric anal fistulas, and evaluated the long-term
      therapeutic effect of an anal fistula plug and the risk factors impacting anal fistula
      healing. In addition, we assessed the effects of post-operative changes on anal function, as
      well as the risk factors affecting anal function.
    

Detailed description: 
      Treatment of anal fistulas, especially involving signiﬁcant anal sphincters, continues to
      represent a challenge for surgeons. Surgery has been the mainstay of treatment, and the ideal
      goal of anal fistula treatment is to obliterate the fistulous tract, while preserving the
      anal sphincter and avoiding fecal incontinence. The anal fistula plug is a sphincter-sparing
      procedure that uses biological substances to close an anorectal fistula. Several studies have
      preliminarily shown that the anal fistula plug had advantages of simple and repeatable
      application, preservation of sphincter integrity, minimal patient discomfort, and subsequent
      surgical options if needed. The healing rate of anal fistula plug varied widely, which range
      from 14% to 88%, and no significant effect on anal function in the short term. Therefore,
      long-term observation and a large sample size are needed to evaluate the long-term healing
      rate of an anal fistula plug, and the effect on anal function. The aim of this study is to
      assess the long-term therapeutic effect of an anal fistula plug in patients with
      trans-sphincteric fistula-in-ano, as well as the impact on anal function.
    

Intervention name(s): Anal fistula plug procedure
Intervention type(s): Procedure
Intervention description(s): A fistula probe was used to identify fistula tracts, and internal and external openings. Gentle mechanical debridement was performed with a blunt curette to remove the necrotic tissue with care not to enlarge the track, then hydrogen peroxide and sterile saline were used to repeatedly to irrigate the fistula. The anal fistutla plug was filled into the fistula, and sutured with a figure-of-eight 2-to-0 Vicryl suture to ensure the plug was fixed in the internal opening of the fistula, avoiding the anal fistula plug being extruded. Trimming the plug at the external fistula and the external opening was left open to ensure adequate drainage.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anal fistula plug; Trans-sphincteric anal fistula; Overall healing rate; Anal function; Risk factors; Minimally invasive
Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Oral administration of Alequel, a mixture of proteins derived from the patient's bowel will
      be tested in patients with inflammatory bowel disease.
    

Detailed description: 
      Oral administration of Alequel prepared from patients biopsies will be tested in patients
      with inflammatory bowel disease to determine its anti inflammatory effect.
    

Intervention name(s): Alequel
Intervention type(s): Drug
Intervention description(s): Alequel
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence of BIBR 277 Tablet (Mannitol Based) Compared With Capsule Formulation in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277
      capsule
    


Intervention name(s): BIBR 277 tablet; BIBR 277 capsule
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Vitamin D Supplementation on Strength, Bone Density, and Injury Risk in Collegiate Athletes
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to determine whether Vitamin D supplementation improves strength
      and bone density, and reduces the risk of injury in collegiate athletes.
    

Detailed description: 
      Vitamin D is a hormone that is important for bone and muscle health. As such, not having
      enough vitamin D in your body is associated with increased risk of injury and reduced health
      and athletic performance. It is often recommended that individuals who have low levels of
      vitamin D take vitamin D supplements. However, the effects of vitamin D supplementation on
      health and strength gains in collegiate athletes are not known. The goal of this study is to
      determine whether vitamin D supplementation increases strength and bone density, while
      reducing the risk of injury in collegiate athletes. Fasting vitamin D concentrations will be
      measured and athletes will be supplemented daily with Vitamin D for 8-12 weeks. The amount of
      supplementation will depend on whether the athlete is categorized as sufficient (>30ng/ml),
      insufficient (20-35ng/ml), or deficient (<20ng/ml). Vitamin D concentrations, strength, bone
      density, and injury risk will be assessed before and after the intervention period.
    

Intervention name(s): Vitamin D 10000 UNT; Vitamin D 5000 UNT
Intervention type(s): Drug; Drug
Intervention description(s): 10000 IU Vitamin D per day; 5000 IU Vitamin D per day
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will either receive placebo, 5000IU, or 10000IU per day of Vitamin D for 8-12 weeks.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Weight Loss and Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of moderate energy restriction on the
      body adiposity, severity of OSA, blood pressure, sympathetic activity, oxidative stress,
      inflammatory biomarkers, metabolic profile and endothelial function in obese patients with
      OSA.
    

Detailed description: 
      Introduction: Nutritional intervention for weight loss is one of the treatment options for
      obstructive sleep apnea (OSA) in patients with excess body adiposity. However, the effects of
      moderate energy restriction, recommended by current guidelines for the treatment of obesity,
      on OSA are not yet known. Objective: To evaluate the effects of moderate energy restriction
      on the body adiposity; severity of OSA; blood pressure; sympathetic activity; oxidative
      stress; inflammatory biomarkers; metabolic profile and endothelial function in obese patients
      with OSA. Methods: A 16-week randomized clinical trial, involving 21 subjects with obesity
      (grade I or II), aged 20-55 years and presenting an apnea/hipopnea index (AHI) > 5 events/h.
      Participants were randomized into 2 groups: 11 in the energy restriction group (ERG) and 10
      in the control group (CG). The ERG was instructed to follow an energy-restricted diet (-800
      kcal/day) and the CG was advised not to change their food intake. At the beginning and at the
      end of the study, participants underwent evaluation of: OSA with the equipment Watch- PAT200®
      including the determination of the following parameters of OSA severity: AHI, minimum O2
      saturation, number of O2 desaturations >4%; body adiposity (weight, %body fat and
      circumferences of waist, hip and neck); blood pressure (BP); sympathetic nervous system
      activity (plasma levels of catecholamines); inflammatory biomarkers (c-reactive protein and
      adiponectin); oxidative stress (malondialdehyde); metabolism of glucose (glucose, insulin and
      HOMA-IR) and lipids (total cholesterol and fractions and triglycerides); and endothelial
      function (index of reactive hyperemia evaluated by Endo - PAT 2000® and cellular adhesion
      molecules). The statistical analysis was performed with the software STATA v. 10. The level
      of statistical significance was p < 0.05.
    

Intervention name(s): Energy Restriction
Intervention type(s): Behavioral
Intervention description(s): The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Weight loss; Obesity; Sympathetic activity; Metabolic profile; Endothelial function
Saline Challenge in Monitoring Asthma Control
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      It is generally accepted that symptoms and lung function are not sufficient ways to monitor
      asthma control. Therefore, several objective tests have been developed to help asthma control
      monitoring, each having their own shortcomings. We have developed a new test, the hypertonic
      saline cough challenge. In our previous publication this test has proven useful in diagnosing
      asthma. The present study is planned to investigate whether hypertonic saline cough challenge
      could be used to monitor asthma control. A group of steroid-naive asthmatics will be
      recruited. A treatment with inhaled budesonide is started. Asthma control is monitored at
      regular intervals utilising a validated questionnaire. At the same time points, hypertonic
      saline cough challenges will be performed. We will analyse whether changes in the
      responsiveness to the cough challenge reflects the changes in asthma control
    


Intervention name(s): budesonide
Intervention type(s): Drug
Intervention description(s): Budesonide is given via inhalation utilising a dry powder inhaler called Easyhaler. The dosage is 400 ug twice daily. The duration of the study is 12 weeks but very probably the patients continue the usage of this drug as a part of their routine clinical management.
Intervention MeSH terms: Budesonide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin
Condition: Photo-damage
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel,
      0.015% when administered for up to three consecutive days to photo-damaged skin on the face.
      The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered
      for up to three consecutive days in patients with photo-damaged skin on the face.
    


Intervention name(s): PEP005 (ingenol mebutate) Gel
Intervention type(s): Drug
Intervention description(s): 0.015%
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PEP005; Peplin; Photo-damage
Effects of a Health-At-Every-Size Approach on Weight Management in Premenopausal Overweight Women
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to measure the effects of a Health-At-Every-Size (HAES) approach
      on global health status of premenopausal overweight women preoccupied about their weight and
      who have been unsuccessful in previous weight loss attempts.
    

Detailed description: 
      Weight management is a critical issue in developed countries where the prevalence of obesity
      is increasing. Poor long-term success observed with current weight-control strategies
      stresses the relevance to explore new weight management approaches. One of these approaches,
      referred to as Health-At-Every-Size (HAES), is a new weight paradigm that focuses on a
      healthy lifestyle by promoting overall health benefits of behavioral changes related to
      dietary habits and physical activity and emphasizes self-acceptance and well-being,
      independently of body weight status. Studies on the effects of a HAES approach have shown
      significant improvements in metabolic and psychological variables.

      To our knowledge, no study has yet reported the short and long-term impacts of a HAES
      approach on a cluster of variables (psychological, morphological, metabolic, and nutritional)
      in women. The aim of this study is to measure the effects of a HAES approach on global health
      status of premenopausal overweight women preoccupied about their weight and who have been
      unsuccessful in previous weight loss attempts. In this parallel controlled trial, women will
      be randomized to one of the 3 treatment conditions: HAES group, Social support group (SS), or
      Control group. Measurements will be taken in the short term as well as in the long term (up
      to 1 year post-intervention).
    

Intervention name(s): Health-At-Every-Size (HAES)
Intervention type(s): Other
Intervention description(s): HAES group: 14 weekly sessions.
Focus on general well-being and positive ways of having a healthy and satisfying lifestyle. Supported by lectures, guided self-reflection, group discussions, as well as practical exercises, this intervention aims at enhancing awareness and knowledge about biological, psychological, and sociocultural aspects of body weight.
SS group: 14 weekly sessions.
The objective is to reproduce a structural social support provided by the group itself. Each participant offers their support to each other. Each theme discussed in the HAES group is repeated in the SS group but the health professionals in charge of the group (dietitian & psychologist) are not counselors (as in HAES group) but only facilitators.
Outcome measures: For all women under study.
Other intervention name(s): Non applicable
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight management; New weight paradigm; Overweight women; Eating behaviors; Appetite ratings; Blood lipids