bioihbjkbjnl/mcl2 huggingface dataset:
Predictive Factors of PTSD in Adults Admitted to an Emergency Service
Condition: Post Traumatic Stress Disorder; Psychiatric Issue
MeSH terms: Emergencies; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      After trauma or stress factor like death exposition, serious injuries or sexual violence,
      some patients may develop stress reaction characterized by the presence of various symptoms
      among different categories (reviviscence, negative humor, dissociates symptoms, occasion,
      hypervigilance). In the month following trauma, the investigators speak of acute stress
      reaction (ASR) when symptoms are present during at least three days. If symptoms are present
      one month after trauma, then it is a post-traumatic stress disorder (PTSD).

      Among patients visiting emergency after latest trauma, quite a few is in acute stress
      reaction. However, this reaction is often incorrectly identified by healthcare team, due to
      lack of oriented medical examination, patients visiting about other complaints (pain,
      insomnia) and not expressing clearly the trauma context. Yet, it is know that acute stress
      reaction occurrence and existence of dissociate symptoms after trauma confrontation is
      considerably predictive of the eventual post-traumatic stress disorder occurrence.

      The identification of risk population of post-traumatic stress disorder is not the subject of
      any particular structured procedure in emergency services while early care of these patients
      may allow limiting post-traumatic stress disorder occurrence and associate consequences.
      Previous works on the subject having exclusively targeted some trauma subgroups or some
      predictive factors subtypes, investigators propose here biopsychosocial global approach that
      can weight the impact of each parameters.

      In this study, investigators aim at determining predictive biopsychosocial factors of the
      post-traumatic stress disorder occurrence at 3 months in patients visiting emergency after
      latest trauma (less than one month old) and identified as "high-risk" to develop
      post-traumatic stress disorder (moderate or high).
    


Intervention name(s): Filling questionnaires
Intervention type(s): Other
Intervention description(s): Questionnaires will be submitted to patients during their visit to emergency service and 3 months later to evaluate the prevalence of Post Traumatic Stress Disorder and to identify predictive biopsychosocial factors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Make my Day - Primary Prevention of Stroke
Condition: Non-Communicable Diseases; Stroke; Cardiovascular Risk Factor
MeSH terms: Stroke; Noncommunicable Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility of a digital, person-centered stroke
      prevention program with a focus on primary prevention. The program is aiming to enable
      lifestyle change and to promote healthy activity patterns to decrease risk factors for stroke
      and in that way prevent future stroke.
    

Detailed description: 
      The study is a randomized controlled pilot trial evaluating the feasibility of a digitally
      augmented person-centered stroke prevention program with a focus on primary prevention. The
      program is aiming to enable lifestyle change and to promote healthy activity patterns to
      decrease risk factors for stroke and in that way prevent future stroke. With activity
      patterns (individual actions and behaviour) in everyday life we mean a persons overall
      lifestyle that may or may not contribute to health.

      The prevention program is a theoretically grounded, complex intervention tested against a
      control-group that are receiving usual care. The prevention program is based on activities in
      people's everyday lives and integrates health and well-being with what people do, as well as
      with what they want or need to do, in order to thrive and live well. Lifestyle change refers
      to a conscious change of behaviour and everyday activities in order to promote health. The
      process of changing behaviour results from an interaction between the person (eg,
      self-efficacy), the environment (support and material) and the action. In the project, the
      key behavioural change technique is incorporating engaging everyday activities (EEAs) that
      contribute to a healthy lifestyle. This might include changing the form of current EEAs or
      finding new health-promoting EEAs.
    

Intervention name(s): Prevention program for stroke
Intervention type(s): Behavioral
Intervention description(s): The prevention program include individual and group intervention sessions supported by a digital platform. The program will be personally tailored in relation to what the person needs and what to change and the individuals rediness for change. The digital platform will support the person during and in between sessions by prompting goals and goal-fulfilment, logging activities, step counts and provide a forum for sharing and reflection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Life style; Primary prevention; Modifiable risk factors; mHealth; Engaging occupation
Single and Multiple Oral Administration Study of ASP015K in Healthy Nonelderly Volunteers
Condition: Pharmacokinetics of ASP015K; Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the safety, tolerability and PK profiles of single and multiple doses of
      ASP015K in healthy nonelderly men.
    

Detailed description: 
      This study consists of two parts; single and multiple administration parts. In single
      administration part, multiple dose levels of ASP015K or placebo are administered to Japanese
      and Caucasian men to evaluate whether there is ethnic differences in the pharmacokinetics and
      pharmacodynamics of ASK015K. In multiple administration part, drugs are administered only to
      Japanese volunteers.
    

Intervention name(s): peficitinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ASP015K
Intervention MeSH terms: Peficitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ASP015K; Ethnic difference
Effects of Ramelteon on Driving Ability
Condition: Insomnia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate the effects of bedtime administration of
      a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road
      driving performance. In addition, the drugs' effects on balance are evaluated during the
      night, and the next morning residual effects on memory and psychomotor performance.
    


Intervention name(s): Ramelteon 8 mg; Zopiclone 7.5 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: ramelteon; zopiclone; driving; memory; balance; psychomotor
Methylselenocysteine Effects on Circadian Rhythm
Condition: Breast Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The primary objective of this study is to determine if vitamin supplementation with a
      naturally occurring dietary amino acid called organic selenium (i.e., methylselenocysteine)
      can restore disruption of circadian rhythm in shift workers.
    

Detailed description: 
      All living cells have a circadian (daily) rhythm which controls a variety of bodily functions
      that change throughout the day, including body temperature, sleep, hunger, activity, hormone
      levels, etc. The circadian rhythm of the body is controlled by the amount of light that
      enters our eyes, so on our planet the length of the rhythm is 24 hours long. It is therefore
      reasonable to suspect that upsetting the timing of the rhythm would lead to changes in body
      function (as commonly experienced in "jet lag") and that prolonged changes might even lead to
      alterations in bodily functions and contribute to disease. This suggests that people whose
      service to the community that requires that they often work at night (nurses, doctors,
      police, hospital staff, firefighters, airline crews, factory workers, etc), might be at
      elevated risk of developing diseases. Studies have shown that women who do shift work have an
      elevated risk of breast cancer, probably as a result of altered hormone levels and cycling.
      Other studies have shown that vitamin supplementation with a naturally occurring dietary
      amino acid called organic selenium (i.e., methylselenocysteine) can restore this disrupted
      rhythm and possibly decrease this disease risk. Thus, the purpose of this study is to
      investigate whether taking daily selenium (i.e., methylselenocysteine) will restore the
      disrupted circadian rhythm in shift workers.
    

Intervention name(s): Methylselenocysteine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Methylselenocysteine capsule given daily; Placebo capsule given daily
Intervention MeSH terms: Selenomethylselenocysteine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Minoxidil 5% / Botanical Hair Regimen in Men With Thinning Hair and Male Pattern Hair Loss/Androgenic Alopecia
Condition: Male Pattern of Hair Loss, Androgenic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The purpose of this study is to characterize the effect of Minoxidil 5% Foam and Botanical
      Hair Solution Regimen in men with thinning hair and male pattern hair loss/androgenic
      alopecia (Norwood III & IV).
    


Intervention name(s): Treatment: Minoxidil 5% / Botanical Hair Solution for Men
Intervention type(s): Drug
Intervention MeSH terms: Minoxidil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Levels of Pain, Discomfort, and Functional Impairment With Two Techniques of Retraction
Condition: Class II Malocclusion
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      Thirty-eight patients requiring extraction of maxillary first premolars will participate in
      the study. They will be divided randomly into two groups: an en-masse retraction group and a
      two-step group. In each group, anterior teeth retraction will be initiated after completion
      of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of
      force per side, Mini-implants will be used as an anchor unit in the en-masse retraction
      group, and TPA in the two-step's retraction group.

      The levels of pain, discomfort, and functional impairments will be self-reported using a
      validated questionnaire with a 4-points Likert scale.
    

Detailed description: 
      Pain associated with orthodontic treatment is one of the undesirable complications, which
      negatively affects the patient's cooperation. Pain may occur due to the pressure on the
      periodontal ligaments induced by orthodontic forces. The perception of pain is affected by
      many factors related to the patient, such as age, gender, and any previous treatment
      experiences, which are negatively or positively reflected in the patient's cooperation. As
      for the factors related to the type of orthodontic treatment provided.

      The levels of pain and discomfort vary with the different anchorage systems used during
      orthodontic treatment.

      Several methods have been proposed to assure good anchorages, such as headgear, transpalatal
      arch (TPA) with or without a Nance button, lingual arches, bonding of second molars, or
      intermaxillary elastics, and recently mini-implants.

      The use of mini-implants has recently become more common. The mini-implants have been used to
      secure absolute anchorage in en-mass retraction, canine retraction, total arch distalization,
      and anterior teeth intrusion. The most common usage is en-mass retraction of anterior teeth.
    

Intervention name(s): Mini-implants; Transpalatal arche (TPA)
Intervention type(s): Device; Device
Intervention description(s): En masse retraction of upper anterior teeth will be applied where mini-implants will be used as an anchor unit. Anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side.; Two-step retraction of upper anterior teeth will be applied where transpalatal arches (TPAs) will be used as an anchor unit. Teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Biomarkers in Patients With Stage III or Stage IV Follicular Lymphoma Treated on Clinical Trial E-1496
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors identify and learn more about biomarkers related to cancer. It may also help doctors
      predict how patients respond to treatment.

      PURPOSE: This laboratory study is looking at biomarkers in patients with stage III or stage
      IV follicular lymphoma treated on clinical trial E-1496.
    

Detailed description: 
      OBJECTIVES:

        -  Correlate gene expression profiles with progression-free survival (PFS) of patients with
           stage III or IV follicular lymphoma treated with cyclophosphamide, vincristine, and
           prednisone with or without rituximab on clinical trial E-1496.

        -  Determine if immunoglobulin Fc-gamma receptor polymorphisms are predictive of PFS in
           these patients.

        -  Assess the significance of the microenvironment by constructing tissue microarrays of
           follicular lymphoma and immunostaining with relevant biomarkers.

        -  Correlate relevant biomarkers with clinical features, response, and PFS.

      OUTLINE: This is a multicenter study.

      Tissue samples are analyzed by gene expression profiling, microarrays to predict gene
      expression, immunohistochemistry, and immunoglobulin Fc-gamma receptor polymorphism analysis
      for biological markers.

      PROJECTED ACCRUAL: A total of 175 samples will be accrued for this study.
    

Intervention name(s): gene expression analysis; microarray analysis; polymorphism analysis; diagnostic laboratory biomarker analysis; immunohistochemistry staining method; immunologic technique
Intervention type(s): Genetic; Genetic; Genetic; Other; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E1496
      
Keywords: stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma
Sequencing Treatments for Mothers With ADHD and Their At - Risk Children
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesize that successfully treating maternal Attention Deficit Hyperactivity Disorder
      (ADHD) will have a beneficial effect that extends to the child. We believe that
      multi-component interventions combining maternal stimulant medication, Lisdexamfetamine
      (LDX), and Behavioral Parent Training (BPT) will improve parenting, maternal, and child
      outcomes. In terms of improved parenting, we hypothesize that some mothers may respond well
      to LDX or BPT alone and therefore may not require multi-modal treatment, whereas others may
      benefit most from multi-modal treatment
    

Detailed description: 
      The overarching goal of this study is to construct and evaluate an adaptive intervention
      (i.e., an individualized treatment protocol that is adjusted based on the child-mother dyad's
      initial response to treatment) to improve the trajectory of ADHD outcomes in at-risk
      children. Our primary outcome measure for the child will be whether child ADHD symptoms on
      the Conners Parent and Teacher Rating Scales decreased at the completion of the study. Our
      secondary outcome measure will be whether there was a need for medication for the child over
      the course of the study. The primary outcome for the mother will be the Conners Adult ADHD
      Rating Scale (CAARS) Attention Scale and the Clinical Global Impression-Severity scale
      (CGI-S).
    

Intervention name(s): Vyvanse (lisdexamphetamine); Behavior Parent Training
Intervention type(s): Drug; Behavioral
Intervention description(s): Active ADHD drug, Vyvanse, is administered to mother.; Mother is given 8 weeks of individual sessions of behavioral parent training
Other intervention name(s): Lisdexamfetamine; BPT
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mothers; ADHD; Treatment; Child
CalFitness Smartphone-Delivered Physical Activity Intervention
Condition: Sedentary Lifestyle; Physical Activity
Study type: Interventional

Summary: 
      The overall goal of this study is to test personalized mobile phone-based physical activity
      interventions among staff members at the University of California, Berkeley. Most physical
      fitness applications for smartphones and activity trackers use a constant goal for the number
      of steps each day. However, if the step goals are dynamically adjusted according to past
      behavior, then the corresponding goals may encourage individuals to increase their physical
      activity level. This study consists of a randomized controlled trial in which we are
      assessing the efficacy of two different algorithms for calculating personalized goals for the
      number of steps each day.
    


Intervention name(s): Step Goal Delivery by Smartphone
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Secondary Intervention and Surveillance After EVAR
Condition: Abdominal Aortic Aneurysm Without Rupture
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Rupture
Study type: Observational

Summary: 
      This is a retrospective cohort study of consecutive patients submitted to elective EVAR,
      between February/2009 and May/2019 in a single institution. Symptomatic or ruptured AAA,
      mycotic aneurysms, isolated iliac aneurysms and complex abdominal aortic repairs were
      excluded. The primary outcomes were freedom from secondary intervention and compliance with
      follow-up, defined as surveillance imaging performed within a periodicity no longer than 18
      months.
    


Intervention name(s): EVAR
Intervention type(s): Procedure
Intervention description(s): Endovascular repair of abdominal aortic aneurysms
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients submitted to elective EVAR in a university center.
Pulse Oximeter Motion Study
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three
      motions compared to non-motion control at three arterial oxygen saturation target plateaus.
    

Detailed description: 
      Evaluate the performance of 4 pulse oximeters (Masimo Radical-7, Nihon-Koden OxyPal Neo,
      Nellcor N-600, and Philips Intellivue MP5) in 10 healthy adult volunteers. Three motions will
      be evaluated: tapping, pseudorandom, and volunteer-generated rubbing, adjusted to produce
      photoplethsmogram disturbance similar to arterial pulsation amplitude. During motion,
      inspired gases will be adjusted to achieve stable target plateaus of arterial oxygen
      saturation (SaO2) at 75%, 88%, and 100%. Pulse oximeter readings (SpO2) will be compared with
      SaO2 from simultaneous arterial blood samples
    

Intervention name(s): Motion
Intervention type(s): Other
Intervention description(s): Volunteer has motion on right hand while with continuous pulse oximetry during three oxygenation plateaus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Lipolytic Effects of GH in Hypopituitary Patients in Vivo
Condition: Hypopituitarism; Insulin Resistance; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Pituitary Diseases; Brain Diseases
MeSH terms: Pituitary Diseases; Brain Diseases; Hypopituitarism; Insulin Resistance; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases
Study type: Interventional

Summary: 
      Growth hormone (GH) is essential for longitudinal bone growth and somatic development. These
      protein anabolic effects require sufficient nutritional supply. During fasting and caloric
      restriction GH predominantly promotes fat metabolism.

      GH counteracts the effect of insulin in many tissues, of which insulin-stimulated glucose
      uptake in skeletal muscle has been most extensively studied. Substrate competition between
      elevated free fatty acids and glucose is suggested as a mechanism, and this hypothesis can be
      tested mechanistically by means of acipimox, which is a nicotinic acid that suppresses the
      fat metabolizing effects of GH.

      The hypothesis is, that the suppressive effect of GH on insulin-stimulated glucose uptake in
      skeletal muscle is obviated by acipimox-induced inhibition of fat metabolism.

      In order to investigate this, eight adult hypopituitary patients with documented
      GH-deficiency will be studied in the presence and absence of GH and acipimox, respectively,
      and biopsies from skeletal muscle and subcutaneous adipose tissue will be analyzed.

      Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in
      long-sight have great importance for the understanding of growth disorders from overweight
      and type 2 diabetes to malnutrition and eating disorders.
    


Intervention name(s): Acipimox; Placebo; GH substitution; GH pause
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Acipimox is administered 4 times previous to and during the investigation day. Acipimox is used to suppress the lipolytic effect of GH.; Placebo is administered 4 times previous to and during the investigation day.; GH substitution as usually; GH substitution pause two days prior to the experimental day
Other intervention name(s): Olbetam
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science