bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Therapeutic Alliance and Minimal Intervention for Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of minimal intervention and therapeutic
      alliance in pain, specific and general disability, global perceived effect, empathy,
      credibility and expectation of improvement in patients with chronic non-specific low back
      pain
    

Detailed description: 
      Low back pain remains a global public health problem. The classification of patients in low
      back pain subgroups aims to optimize the health system and provide the quantity and the type
      of proper technique for each patient. Several factors may influence physical therapy. The
      therapeutic alliance may be defined as harmony or social connection between the therapist and
      the patient and may influence the treatment effect. The aim of this study is to evaluate the
      effectiveness of the addition of the therapeutic alliance to a minimum intervention for the
      treatment of chronic non-specific low back pain with low risk of psychosocial factors.
    

Intervention name(s): Positive Therapeutic Alliance; Usual care; Control group
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Intervention involving reassurance and information related to the return to daily activities, advice on dealing with the pain and clear explanation of signs and symptoms. The session will take 60 minutes and will be structured to increase the therapeutic alliance and empathy. Patients will be instructed to return in a week for further consultation to clarify doubts.; Information about low back pain based on Back Book. The therapy will be performed with limited interaction between patient and therapist and the information will be transmitted in a clear and direct way. The limited interaction between patient and therapist in this group will be established at the first session lasting 45-60 minutes. Patients will be instructed to return for a visit after a week to clarify questions.; Patients will not receive intervention in the first month in which they are enrolled. After a year, the treatment offered to the Positive Therapeutic Alliance or Usual Care group will be available for patients who are interested.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Empathy; Subgroups; Minimal intervention
Botulinum Toxin A for Emotional Stabilization in Borderline Personality Disorder (BPD)
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of the trial is to test whether a single application of botulinum toxin A
      into the glabellar region will lead to emotional stabilization in borderline personality
      disorder through paralysis of facial muscles/attenuation of negative emotions.
    

Detailed description: 
      Afferent feedback from facial muscles is believed to enhance emotional states (facial
      feedback theory). The facial expression of negative emotions involves facial muscles of the
      glabellar region. It has been shown that paralysis of facial muscles in the forehead using
      botulinum toxin A leads to the improvement of depressive symptoms. It is believed that the
      limited ability to express these emotions alleviates depressive symptoms. As Borderline
      personality disorder is characterized by negative emotions expressed via facial muscles in
      the forehead, it is hypothesized that BPD patients could profit from botulinum toxin
      treatment.
    

Intervention name(s): incobotulinumtoxin A; Acupuncture
Intervention type(s): Drug; Procedure
Intervention description(s): Application of botulinum toxin A into the forehead; Application of acupuncture into the forehead
Other intervention name(s): Botox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Surveillance of Kaletra in Korean Patients
Condition: HIV-1 Infection
MeSH terms: Infections
Study type: Observational

Summary: 
      This single-arm, multi-center, Post-Marketing Surveillance study of Kaletra
      (lopinavir/ritonavir) was conducted in accordance with the approved Korean product labeling
      in participants 2 years of age and older with human immunodeficiency virus type 1 (HIV-1)
      infection.
    

Detailed description: 
      Participants were observed for up to 48 weeks following the first dose of Kaletra. A
      follow-up visit took place 1-2 weeks after treatment initiation, and subsequent visits
      occurred at the discretion of the investigators, typically occurring every 3 months.
      Clinical/immunological/virological/laboratory status, Kaletra-containing regimen/concomitant
      medication information, and adverse event information were obtained at follow-up visits.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        general hospitals
      
Keywords: Postmarketing Drug Surveillance; HIV-1 infection; Kaletra
Energy Expenditure and Physical Activity in Preschoolers
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to calibrate the Actigraph, Respironics and CamNtech monitors,
      in a wide range of children using energy expenditure measured by respiration calorimetry.
      Energy expenditure will be predicted from the combination of heart rate and activity measured
      by accelerometry. Prediction equations for energy expenditure will be tested and validated
      against a stable isotope method called doubly labeled water for the measurement of
      free-living total energy expenditure.
    

Detailed description: 
      In this study, the investigators will apply advanced technology (fast-response room
      calorimetry, doubly labeled water (DLW), accelerometers and miniaturized HR monitors) and
      sophisticated mathematical modeling techniques (cross-sectional time series, CSTS and
      multivariate adaptive regression splines, MARS) to develop and validate prediction models
      that capture the dynamic nature of physical activity (PA) and energy expenditure (EE) in
      preschool-aged children. CSTS and MARS models for the assessment of PA based on activity
      energy expenditure (AEE) and for the prediction of minute-by-minute EE will be developed in
      100 preschool-aged children using 12-h room respiration calorimetry as the criterion method
      and validated in an independent sample (n=50) against 12-h room respiration calorimetry and
      the 7-d DLW method. In addition, the investigators will develop algorithms for the
      classification of PA levels and sleep/awake periods using statistical and machine learning
      methods and incorporate the results into our prediction models.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Child (3-5 years)
      
Keywords: Total Energy Expenditure; Physical Activity Levels; Body Mass Index; Children
Phase I Study PK Study With OXP005 and Naprosyn
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The Sponsor is developing a new form of naproxen (the study drug, OXP005), for the potential
      treatment of rheumatic and painful conditions. The study will compare the study drug to an
      already marketed formulation of prescription strength naproxen (Naprosyn® the reference
      product) by looking at how a single dose of the drug is taken up by the body. The safety and
      tolerability of the drug will also be assessed.
    


Intervention name(s): OXP005; Naprosyn®
Intervention type(s): Drug; Drug
Other intervention name(s): Naproxen; Naproxen
Intervention MeSH terms: Naproxen
Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses
      of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of
      statin therapy with or without ezetimibe.
    


Intervention name(s): CIVI 007
Intervention type(s): Drug
Intervention description(s): hypercholesterolemia agent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Compare Outcomes Between Two Acellular Dermal Matrices
Condition: Breast Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm
      Allograft Dermis (RTI Surgical®, Inc.). These are the thinnest versions of acellular dermal
      matrices (ADM) offered by both vendors and can be used for post-mastectomy breast
      reconstruction. Alloderm RTU medium has a thickness of 1.6±0.4 mm, while Cortiva 1mm
      Allograft Dermis has a thickness of 1.0±0.2 mm. In the context of breast reconstruction,
      these ADMs are used in the same manner. They may be inserted with a tissue expander
      immediately after skin- or nipple-sparing mastectomy. The investigators will examine
      breast-reconstruction associated complication rates, pre- and post-operative patient reported
      outcomes using the Breast Q, and physician reimbursement as well as direct hospital costs.
      The endpoint will be either exchange of the tissue expander for a permanent breast implant or
      autologous flap, explantation due to patient preference, development of a complication, or
      less common reasons. The investigators propose that Cortiva 1mm Allograft Dermis and Alloderm
      RTU will have equivalent complication and patient reported outcome rates as well as physician
      reimbursement, but that direct hospital cost will be less with Cortiva 1mm Allograft Dermis.
    


Intervention name(s): Alloderm RTU; Cortiva 1mm Allograft Dermis; Skin or nipple-sparing mastectomy; Breast Q; Surgery
Intervention type(s): Other; Other; Procedure; Other; Procedure
Intervention description(s): -Most commonly used acellular dermal matrices; -Tutoplast processed dermis; -Standard of care; 15 questions
10 questions in Part A asking how has the patient been feeling in past 24 hours, answers range from 0-10 with 0=none of the time and 10=all of the time
Part B has 5 questions asking patient if she has had any of the following in the last 24 hours, answers ranging from 0-10 with 0=none of the time and 10=all of the time; To address the tissue expander
Standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled
      Esketamine in participants with treatment-resistant bipolar depression (TRBD). The study is
      to determine the efficacy and dose response of three Esketamine doses, compared with placebo.
    

Detailed description: 
      This is a randomized, multiple dose, placebo-controlled, double-blind, multicentre study of
      Esketamine DPI, inhalation powder delivered via dry powder inhaler (DPI) in participants with
      TRBD. There are 3 study phases: Screening phase, a two weeks double-blind treatment phase and
      a 6-week follow-up phase. Participants are to be randomized in 1:1:1:1 ratio to receive
      placebo or one of the three doses of Esketamine DPI. Participants from each group will
      receive different dosing sequences, consider as a single dose, corresponding to low, medium,
      high Esketamine dose or placebo. Participants will undergo one cycle of treatment consisting
      of four doses of Esketamine DPI or placebo over 14-day period. Participants safety will be
      monitored throughout the study.
    

Intervention name(s): Esketamine DPI - low dose; Esketamine DPI - medium dose; Esketamine DPI - high dose; Placebo DPI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to low Esketamine dose.; Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to medium Esketamine dose.; Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to high Esketamine dose.; Placebo DPI is to be administered via dry powder inhaler.
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Uptake and Utilization of Amino Acids by Splanchnic Bed
Condition: Healthy Males
Study type: Interventional
Phase: Phase 1

Summary: 
      Splanchnic uptake and metabolism contributes significantly to the differences in flux seen
      between the intravenous and intragastric ingestion of certain indispensable amino acids.

      This is the third in a series of studies designed to increase the investigators knowledge of
      the metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed.
      In the initial two studies the investigators established the neonatal parenteral requirement
      of threonine and lysine. In the current study, the investigators will be examining the
      differences in uptake and metabolism of threonine and lysine across the splanchnic bed.
    

Detailed description: 
      We propose that we will see a smaller amount of enterally fed isotopes reach the plasma as
      compared to the amount in plasma from the parenterally delivered isotopes. We also believe
      that the amount of enterally delivered threonine isotope that reaches the plasma will be
      significantly less than the amount of enterally fed lysine isotope.
    

Intervention name(s): Threonine Experimental: Study Period 1; Lysine Experimental: Study Period 2
Intervention type(s): Other; Other
Intervention description(s): Enteral and parenteral infusion of threonine isotope; Both intravenous (iv) and intragastric (ig) Lysine isotopes.
Other intervention name(s): Tracer Isotope - L-[1-13C]threonine; Tracer isotope - L-[1-13C]lysine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: splanchnic bed; theronine and lysine metabolism uptake; isotopes; metabolism of two indispensable amino acids, threonine and lysine, by the splanchnic bed by Healthy Males
A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of topiramate monotherapy compared with
      levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or
      recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone
      mineralization, and kidney stone formation in children aged 2 to 15 years.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), open-label,
      multi-centric (conducted in more than one center) and 2-arm flexible-dose monotherapy study
      of topiramate compared with 1 another AED (levetiracetam) in pediatric participants with
      epilepsy. The total study duration will be up to of 1 year and 2 months per participant. The
      study consists of 3 parts: Screening (that is, up to 35 days before study commences on Day
      1); Treatment (1 year) and post-treatment (30 days). Safety will primarily be evaluated by
      percentage of participants with kidney stones and change from baseline in bone mineral
      density at Month 12.
    

Intervention name(s): Topiramate; Levetiracetam
Intervention type(s): Drug; Drug
Intervention description(s): Topiramate weight based dosing for participants 2 to <10 years of age not to exceed 350 mg/day, as tolerated; not to exceed 400 mg/day in participants 10-15 years of age, as tolerated.; Levetiracetam weight based dosing for all participants 2-15 years of age, not to exceed 60 mg/kg/day, as tolerated. The maximum recommended daily dosage is 3,000 mg.
Intervention MeSH terms: Topiramate; Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Epilepsy; Topiramate; Levetiracetam; Pediatric
Turn up the HEAT - Healthy Eating and Activity Time in Summer Day Camps
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The investigators long-term goal is to increase the number of Summer Day Camps (SDC) that
      meet the National Afterschool Association Healthy Eating and Physical Activity (HEPA)
      Standards. The objective is to evaluate the effectiveness of a multi-component intervention
      designed to increase children's PA levels and improve the quality of lunches and snacks
      children consume in SDCs. The HEPA intervention is designed to target children, parents,
      staff, program leaders, and the SDC environment and uses a train-the-trainer model with SDC
      leaders to train their staff to deliver and integrate the intervention into routine practice.
      In the proposed study, the investigators will evaluate these HEPA strategies, using a 4-year
      randomized controlled trial with 20 SDCs. An important feature of the study will be the
      evaluation of maintenance of the intervention after the removal of research support (e.g.,
      training, boosters) during the final year, as well as costs associated with implementation.

      The investigators hypothesize that intervention SDCs will achieve significantly greater
      increases in HEPA, compared to control SDCs. The investigators expect the study to support
      the cost-effectiveness and maintenance of our strategies for promoting HEPA that will
      facilitate SDCs meeting newly-established HEPA standards for this setting.
    

Detailed description: 
      The investigators aim to:

      Evaluate the impact of the HEPA interventions on: 1.) The proportion of children meeting the
      PA Standard (i.e., ≥60min MVPA/d) while attending summer day camp; 2.) The proportion of
      foods (e.g., fruit, vegetable, water) children and staff bring and consume at the summer day
      camp that meet the HE Standards; and 3/) Changes in children's age-sex specific BMI
      percentile from the start to end of summer

      Evaluate the cost-effectiveness of the HEPA intervention

      Evaluate the maintenance of the HEPA intervention in summer day camps
    

Intervention name(s): Healthy Eating and Physical Activity
Intervention type(s): Behavioral
Intervention description(s): The Healthy Eating and Physical Activity (HEPA) intervention aims to increase the quality of foods and beverages and physical activity opportunities in summer day camps. Through staff-level training, physical activity opportunities are modified to provide children with a substantial amount of meaningful physical activity. Through working with foods service providers, changes to the types of foods and beverages served will be made.
Other intervention name(s): HEPA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: MVPA; Healthy Eating; children; childhood obesity
Understanding How the Immune System Responds to Viruses in Peanut Allergic Children Undergoing Peanut Oral Immunotherapy
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to find out if there is a way to treat children with peanut
      allergy to help lower the risk of severe allergic reactions and also cause them to lose their
      allergy to peanuts and to understand what happens to their immune systems when they have
      viral infections while on therapy. The approach we will use to treat peanut allergy in this
      study is a process called desensitization.

      We think that children with a peanut allergy receiving peanut oral immunotherapy will be able
      to eat more peanuts without having a reaction by the end of the study than they could eat at
      the beginning. We also think that we will be able to measure changes in their immune system
      and their immune system's response to viruses while they are on therapy.
    

Detailed description: 
      Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food
      allergies it tends to be more persistent and also its prevalence seems to be rising.
      Currently there is no proven treatment other than strict avoidance. We are attempting to
      decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut
      using peanut oral immunotherapy (OIT). We are also studying the effect of viral infections on
      the immune system in children receiving peanut OIT.

      Children ages three to sixteen years of age with peanut allergy will be given peanut OIT.
      Twenty-five subjects will also be recruited as controls. These subjects will not receive any
      peanut or placebo but only have skin prick testing and lab work in addition to a history and
      physical exam. Active subjects will undergo a double-blind food challenge at entry to verify
      that they are allergic to peanuts. If allergic, they will then have modified rush
      immunotherapy on the first day and then increase the doses at least every two weeks up to a
      maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at
      home except for dose increases which will be done at Children's Medical Center. Outcome
      variables of interest include response to double-blind placebo controlled food challenge,
      skin prick testing, peanut specific IgE, and adverse events. These results will be compared
      between the start and end of peanut OIT using appropriate statistical analysis.
    

Intervention name(s): Peanut flour
Intervention type(s): Other
Intervention description(s): Peanut-allergic subjects will be given peanut flour in increasing amounts.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food Hypersensitivity; Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Peanut Hypersensitivity; Food Allergy
Effect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia
Condition: Torticollis
MeSH terms: Dystonia; Torticollis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate swallowing efficiency in patients with cervical
      dystonia following treatment with botulinum toxin Type A.
    


Intervention name(s): botulinum toxin Type A
Intervention type(s): Biological
Intervention description(s): 750 U at Visit 1
Other intervention name(s): Dysport®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment