bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of an Animal-assisted Activity on the Stress Level of Hospitalized Children
Condition: Hospitalization in Children
Study type: Interventional

Summary: 
      The aim of this research is to study the effect of an animal-assisted activity (AAA) on the
      stress level of hospitalized children.
    

Detailed description: 
      A hospitalization is a major stressor in a child's life, which can have negative effects on
      recovery. It is assumed that animal-assisted interventions can have a positive effect on the
      level of stress, but this has not yet been sufficiently researched. This study aims to
      measure a possible effect. Children who are hospitalized will receive an animal-assisted
      activity. A normal afternoon in their hospital room counts as a control activity. The stress
      level is measured through saliva cortisol, blood pressure, heart rhythm variability and a
      visual analogue stress scale.
    

Intervention name(s): Animal-assisted activity; Control intervention
Intervention type(s): Behavioral; Other
Intervention description(s): The intervention is an animal-assisted activity consisting of a visit to Villa Samson (a place on the campus of the hospital specifically intended for patients to meet pets), where the child will work with a therapy dog for 1 hour. Under supervision, the animal is stroked and combed by the child, they play games together, the child feeds the animal, etc.; The control intervention reenacts a normal stay in the hospital, so the child spends one hour in the hospital room where the child can play, watch tv, etc.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized clinical trial.
Masking: None (Open Label)
Primary purpose: Supportive Care
GSK1349572 Relative Bioavailability Study
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, two part, open-label, crossover study in healthy adult
      subjects. Part A will evaluate the relative bioavailability of two new tablet formulations
      compared to the current tablet formulation of GSK1349572 at 50 mg administered as single
      doses each comprising of two 25 mg tablets. Pharmacokinetic samples from Part A will be
      analyzed and, if at least one of the new formulations meets appropriate criteria and is
      selected, Part B will be a single-sequence design conducted to evaluate food effect of the
      selected new tablet formulation at one dose level. A subset of subjects enrolled in Part A
      will continue in Part B. Safety evaluations and serial PK samples will be collected during
      each treatment period. A follow-up visit will occur 7-28 days after the last dose of study
      drug.
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship.
    

Intervention name(s): GSK1349572 formulation AP; GSK1349572 formulation AW; GSK1349572 formulation AX
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK1349572 50 mg single dose fasted.; GSK1349572 formulation AW 50 mg single dose in Part A and 75 to 200 mg fasted or with moderate or high fat meal in Part B.; GSK1349572 formulation AX 50 mg in Part A and 75-200 mg fasted or with a moderate or high fat meal in Part B
Intervention MeSH terms: Dolutegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; healthy; GSK1349572
Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)
Condition: Focus Groups
Study type: Observational

Summary: 
      Collect DNA from well-characterized healthy volunteers.
    

Detailed description: 
      DNA and plasma will be used to identify and determine allele frequencies of genetic variants
      in membrane transporters and other genes relevant to human disease or drug response,
      including drug metabolizing enzymes, collagen, race/ethnicity, neurovascular disease,
      asthma/allergy/lung disease, and cardiovascular disease. This phase of the study will serve
      as the hypothesis-generating phase for future studies by identifying genetic variants and
      determining allele frequencies among an ethnically diverse cohort of healthy volunteers.
      Future investigations (separate IRB applications) will attempt to correlate genotypes to
      phenotypes among this cohort of volunteers. The allele identification and frequency data from
      this group of healthy volunteers will also be used to design association studies in relevant
      disease populations.

      Determine if identified sequence variants are associated with gain or loss of in vitro
      biologic function using lymphocytes obtained from patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy participants that are willing to be called back for subsequent genotype to
        phenotype studies.
      
Biospecimen description: 
      40 mL of blood for DNA extraction
    
Keywords: Healthy Cohort
Spine Deformities in Juvenile Idiopathic Arthritis
Condition: Scoliosis; Juvenile Idiopathic Arthritis; Awareness
MeSH terms: Arthritis; Scoliosis; Arthritis, Juvenile
Study type: Observational

Summary: 
      Juvenile Idiopathic Arthritis (JIA)is the most common chronic rheumatic disease in childhood.
      While JIA usually affects the ankle and knee joints, it can also affect hip, cervical spine
      and shoulder involvement. Secondary problems such as spine involvement or lack of weight
      transfer may lead to scoliosis. The aim of this study was to perform scoliosis screening in
      children with JIA and to evaluate families' awareness of scoliosis.
    

Detailed description: 
      Juvenile Idiopathic Arthritis (JIA)is the most common chronic rheumatic disease in childhood.
      While JIA usually affects the ankle and knee joints, it can also affect hip, cervical spine
      and shoulder involvement. Secondary problems such as spine involvement or lack of weight
      transfer may lead to scoliosis. The aim of this study was to perform scoliosis screening in
      children with JIA and to evaluate families' awareness of scoliosis. aged 4-16 years will
      include in the study. Trunk rotation measure with scoliometer by applying forward bending
      test. Children with more than 5 rotations will send to the X-ray. 28 questions will asked,
      which evaluate the demographic characteristics of children, their educational status, their
      participation in sports activities, and the physical appearance of families about their
      children. These questions will asked if the parents had heard of scoliosis before, where they
      heard it, and whether anyone had scoliosis in the family. Families who complained of posture
      disorder will asked which shoulder is high without looking at their children and whether they
      see any height when they leaned forward and the pain situation in their children. Statistical
      analysis of the data using the SPSS 24.0 (Statistical Package for Social Sciences) program.
      In all analyzes, p≤0.05 consider statistically significant.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children with juvenile idiopathic arthritis
      
Keywords: scoliosis; Juvenile idiopathic arthritis; Awareness; spine
Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization
Condition: Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The primary purpose of this study was to investigate the effects of slider and tensioner
      techniques on pain, hip and knee ROM in lumbosacral radiculopathy patients with peripheral
      sensitization. A secondary purpose was to evaluate the correlation between these outcomes
      measurements.
    

Detailed description: 
      Study design: Double-blind case-control trial. Methods: Fifty-one male lumbosacral
      radiculopathy patients with peripheral sensitization, were divided into one of the three
      groups: slider, tensioner, and control. The primary outcome measurements were visual analog
      scale (VAS) for pain, hip range of motion (ROM) during SLR test, and knee flexion ROM during
      slump test. The measurements were taken at baseline, after 1st, 3rd, and 6th session.

      Statistical Analysis: A two-way mixed design analysis of variance (MANOVA) with post-hoc
      (Bonferonni Correction) was used to calculate the differences with Time (baseline,
      1st,3rd,6th sessions) as a within-group factor and Group (control, slider, and tensioner) as
      a between-group factor. The effect size was calculated with Cohen's d. Pearson's correlation
      was used for correlation analysis.
    

Intervention name(s): Neural mobilization exercises -Tensioner technique; Neural mobilization exercises -Slider technique; Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention type(s): Other; Other; Other
Intervention description(s): Exercise aiming to lengthen the neural structure using more than one joint.; Exercise aiming to slide/glide the neural structure using more than one joint.; Electrotherapy device aiming to decrease patient's symptoms.
Other intervention name(s): Control
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lumbosacral radiculopathy; peripheral sensitization; Neural mobilization; radicular LBP; slider; tensioner
Efficacy of Dexpanthenol in Thermic Erythema
Condition: Erythema
MeSH terms: Erythema
Study type: Interventional
Phase: Phase 2

Summary: 
      The study focuses to prove the equivalent efficacy of two different Dexpanthenol
      formulations.
    


Intervention name(s): Dexpanthenol foam spray, new formulation; Dexpanthenol foam spray, old formulation
Intervention type(s): Drug; Drug
Intervention description(s): 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter; 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
Intervention MeSH terms: Pantothenic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Thermal Erythema; Dexpanthenol; Erythema; Efficacy
DPBRN Peri-operative Pain and Root Canal Therapy
Condition: Post-operative Tooth Pain; Root Canal Therapy
MeSH terms: Toothache
Study type: Observational

Summary: 
      The purpose of this study is to identify pre-operative factors that put patients at greater
      risk of developing severe tooth pain following root canal therapy, thereby providing evidence
      that will allow dentists to act preventively to lessen this risk, improve pain control,
      increase their patients' quality of life, and decrease the number of dental emergency
      interactions.

      A parallel goal of this study is to assess the feasibility of recruiting dentists that
      provide root canal therapy and patients using the DPBRN.
    

Detailed description: 
      Goals for this study is to:

        -  Assess the frequency and intensity of pre-operative pain

        -  Evaluate the occurence and intensity of intra-operative pain

        -  Evaluate the occurence and intensity of post-operative pain

        -  Assess the interference of persistent tooth pain with daily life

        -  Identify a limited set of risk factors related to the development of post-operative
           pain.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants directly involved in this study are patients who have sought dental
        treatment in the practitioner-investigators' practices. The practitioner-investigators will
        be endodontists and general dentists.
      
Keywords: Post-operative pain; intra-operative pain; root canal therapy; feasibility; post-surgical persistent pain
Is Lymphocyte Subtype Important for Acute Pancreatitis Severity?
Condition: Pancreatitis; Lymphocytic Infiltrate; Immune System Diseases
MeSH terms: Pancreatitis; Immune System Diseases
Study type: Observational

Summary: 
      Pancreatitis is a common complication especially in patients with gallbladder stones, most
      patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20%
      of patients, the disease is severe and mortality rates of up to 30% are detected in these
      patients. In the evaluation of acute biliary pancreatitis, many scoring systems have been
      established (Atlanta, Ranson, APACHE, BISAP etc.) from past to present to determine morbidity
      and mortality of the disease.

      In this study, the investigators aimed to evaluate the correlation between morbidity and
      mortality of acute biliary pancreatitis and lymphocyte subtypes with Flow-cytometry.
    

Detailed description: 
      Pancreatitis is a common complication especially in patients with gallbladder stones, most
      patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20%
      of patients, the disease is severe and mortality rates of up to 30% are detected in these
      patients. In patients with severe pancreatitis, aggressive fluid replacement, organ damage
      follow-up, appropriate antibiotherapy, and endoscopic sphincterotomy and radiological
      interventions may be of great benefit. In the evaluation of acute biliary pancreatitis, many
      scoring systems have been established (Atlanta, Ranson, APACHE, BISAP etc.) from past to
      present to determine morbidity and mortality of the disease. There are limited number of
      studies in the literature about the immune parameters in the evaluation of acute
      pancreatitis. In a studies, serum inflammatory markers such as IL-1, IL-6 and CD4, CD8 T
      lymphocyte and Treg population were evaluated.Treg cells are reported to be an independent
      prognostic factor in determining the severity of acute pancreatitis. In patients diagnosed
      with acute biliary pancreatitis, determination of the course of the disease at the time of
      diagnosis is extremely important for treatment and survival.

      In this study, the investigators aimed to evaluate the correlation between morbidity and
      mortality of acute biliary pancreatitis with lymphocyte subtypes via Flow-cytometry.
    

Intervention name(s): Flow Cytometric analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Blood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine lymphocyte subgroups
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute pancreatitis
      
Keywords: pancreatitis; lymphocyte; Flow-cytometry
Relative Bioavailability and Food Effect Study of IX-01 Capsules in Healthy Men
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the absorption and blood levels of IX-01 when given
      as a capsule compared to liquid form, and how food affects the absorption in healthy men.
    


Intervention name(s): IX-01
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial of Community Health Worker-led Decision Coaching
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Black men are disproportionately affected by prostate cancer, the most common non-cutaneous
      malignancy among men in the U.S. This randomized trial will evaluate the efficacy of a
      Community Health Worker-led decision coaching program to facilitate Shared Decision Making
      (SDM) and Prostate Specific Antigen (PSA) screening among Black men with regards to decision
      quality, the decision making process, patient-provider communication and PSA utilization for
      Black men in the primary care setting.
    


Intervention name(s): Education Counseling Session for PSA Screening; General Health Counseling Coaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): counseling from extensively trained CHW; coaching using an educational tool focused on dietary and lifestyle modification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Screening
Two Contrasting Interventions for Sleep Management
Condition: Primary Insomnia; Secondary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is
      more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also
      investigate whether MBB is additionally beneficial for co-morbid conditions such as stress,
      PTSD, depression, etc, compared with that of Zolpidem.
    

Detailed description: 
      Sleep disturbance in active duty military personnel is highly prevalent and contributes to
      reduced performance of military duties. Under extreme conditions, army personnel could
      endanger themselves and their comrades. Increasingly, non-pharmacological treatments for
      insomnia are showing promise as complementary and alternative medicine treatments. Many of
      these awareness training programs (ATPs) perform as well as, or even better than,
      medications. This study will determine whether Mind-Body Bridging (MBB), an ATP that teaches
      awareness/mindfulness and cognitive skills, is more effective than a common sleep medication,
      Zolpidem. The study will also determine whether MBB exhibits additional benefits in co-morbid
      mental health conditions, including, stress, PTSD, depression, etc, compared with that of
      Zolpidem. This will offer soldiers additional treatment options for insomnia in the hope that
      it will improve both sleep and other common comorbidities.
    

Intervention name(s): Zolpidem; Mind-Body Bridging
Intervention type(s): Drug; Behavioral
Intervention description(s): Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed.; An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Other intervention name(s): Ambien; Awareness Training
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
Condition: Abnormal Uterine Bleeding
MeSH terms: Uterine Hemorrhage
Study type: Interventional

Summary: 
      The investigators have developed a novel instrument for taking endometrial biopsies at no
      touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with
      speculums and tenaculums, and also avoids the possible need for cervical dilatation. The
      investigators wish to study the ease of use and efficacy of the new device compared with
      traditional techniques of endometrial sampling at hysteroscopy.
    

Detailed description: 
      We have developed a novel instrument for taking endometrial biopsies at no touch
      (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and
      tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the
      ease of use and efficacy of the new device compared with traditional techniques of
      endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a
      biopsy and patient experience.
    

Intervention name(s): Endometrial biopsy
Intervention type(s): Procedure
Intervention description(s): Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy
Other intervention name(s): Pipelle; H Pipelle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Menorrhagia; Uterine fibroids; Endometrial polyps; Endometrial cancer
Quantifying Airway Inflammation With Radiologic Tests
Condition: Lung Inflammation
MeSH terms: Pneumonia; Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In this randomized, double-blind, placebo controlled trial we used positron emission
      tomography to determine if lovastatin or recombinant human activated protein C exhibit
      anti-inflammatory effects in humans following intrabronchial installation of
      lipopolysaccharide (LPS or endotoxin).
    

Detailed description: 
      Quantitative, noninvasive biomarkers for lung-specific inflammation have yet to be developed
      but can potentially contribute significantly to the development of therapies to treat lung
      inflammation. The purpose of this study was to demonstrate that positron emission tomographic
      (PET) imaging with [18F}fluorodeoxyglucose (FDG-PET) can be used to quantify the change in
      lung inflammation in healthy volunteers.
    

Intervention name(s): placebo pill and placebo IV; Lovastatin pill and placebo IV; placebo pill and recombinant human activated protein C IV; Endotoxin
Intervention type(s): Drug; Drug; Drug; Biological
Intervention description(s): Placebo pill every four hours, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS; lovastatin pill every four hours, total of 80 milligrams a day, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS; placebo pill every four hours, total of 80 milligrams a day, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
recombinant human activated protein C IV 24 micrograms per kg per hour starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS; Endotoxin 4 ng/kg instilled bronchoscopically in all volunteers 12 hours after starting lovastatin treatment and 2 hours after starting recombinant human activated protein C treatment.
Other intervention name(s): Mevacor; Xigris; Reference Endotoxin (E. Coli O113:H10K); lipopolysaccharide
Intervention MeSH terms: Drotrecogin alfa activated; Protein C; Lovastatin; L 647318; Dihydromevinolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized; positron emission tomography; lung inflammation; lovastatin; recombinant human activated protein C; endotoxin; fluorodeoxyglucose