bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Medical Clowns in Children Undergoing Blood Tests
Condition: Pain; Anxiety
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The investigators hypothesized that the participation of therapeutic clowns in the pediatric
      emergency department procedure room would reduce anxiety, improve the level of cooperation
      children can provide and avoid some of the adverse effects.
    

Detailed description: 
      Research has demonstrated that cognitive psychological techniques, including distraction, can
      increase pain tolerance. Humor can be an important intervention, able to reduce stress to
      both the child and the parent. In the last decade there has been a rapid growth in the
      presence of therapeutic clowns in hospital, particularly in pediatric settings. If
      therapeutic clowns are shown to positively affect any of the parameters being measured in
      this study, they should be included as aprt of the standard of care in the pediatric
      emergency setting.
    

Intervention name(s): clown
Intervention type(s): Behavioral
Intervention description(s): a distraction technique is performed by a clown during venipuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Medical clown; Pediatric emergency medicine; Emergency procedures
Behavioral, Genetic, and Epigenetic Implications of Dietary Supplementation With Alpha-linolenic Acid in Humans
Condition: Effect of Fatty Acids on Memory Performance of Toddlers
Study type: Interventional

Summary: 
      Fatty acids or omega-3s are important in the human diet for brain development. Of the three
      main omega-3s (alpha-linolenic acid: ALA, 18:3n-3; eicosapentaenoic acid: EPA; 20:5n-3;
      docosahexaenoic acid: DHA, 22:6n-3), DHA and EPA have been studied extensively and have been
      shown to be important in brain function. Conversely, little is known about the effects of ALA
      even though the body can make DHA and EPA from it. Because the rate at which ALA makes DHA
      and EPA is very slow, ALA is not considered an important source of DHA and EPA. However, in
      the human diet, ALA is more readily available, more easily consumed, and less expensive
      relative to animal sources of DHA and EPA. So, it is very important that the investigators
      explore the effects of supplementation with ALA. It is possible that the ALA to DHA and EPA
      conversion rate can be altered by methylation, an epigenetic form of gene expression and
      regulation. In the present study, the investigators will examine memory abilities and genetic
      baselines in 16-month-olds. The investigators will then supplement their food with ALA or
      control oil for 4 months. At 20 months, the investigators will collect outcome data on
      memory, fatty acid status, genetic variations, and methylation. The investigators hypothesize
      that the ALA supplementation will result in an increase in the rate of ALA to DHA and EPA
      conversion through methylation and genetic variations and subsequently, memory abilities will
      improve. The data from this study will be used to design a larger R01 grant.
    


Intervention name(s): Flaxseed oil; corn oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Families will be asked to mix the contents of one capsule (1200 mg flaxseed oil or 1288 mg corn oil) into a cup of participants' food, twice a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Progressive Relaxation Exercise Applied to Palliative Caregivers on Coping With Stress,Anxiety
Condition: Palliative Care
Study type: Interventional

Summary: 
      It is important to consider the needs of palliative care caregivers and to plan interventions
      for psychosocial problems.
    

Detailed description: 
      Cognitive-behavioral methods, which may be applied as relaxation aids in controlling the
      anxiety levels.
    

Intervention name(s): Progressive Relaxation Exercise
Intervention type(s): Behavioral
Intervention description(s): In the progressive relaxation technique, the tension and anxiety in skeletal muscles are relatively relieved.
Other intervention name(s): Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an experimental study with pre-test and post-test control groups.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Progressive Relaxation Exercise; Coping With Stress; Anxiety
Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan.
Condition: Vitamin D Deficiency; Pre Eclampsia; Stillbirths; Low Birth Weight; Prematurity
MeSH terms: Eclampsia; Pre-Eclampsia; Stillbirth; Vitamin D Deficiency; Birth Weight
Study type: Interventional

Summary: 
      Vitamin D deficiency is wide spread in South Asian population and is contributing to burden
      of disease in this region including Pakistan. The relative importance of vitamin D
      deficiency, mutation in its receptor and maternal and child health has not been established
      in Pakistan and population based studies are required to explore and avert the maternal and
      Neonatal complications and consequences of Vitamin D deficiency

      The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and
      their Infants. It will be a double blind placebo controlled trial, which will be conducted in
      a rural district of Pakistan.
    

Detailed description: 
      The investigators are proposing a community based introduction of vitamin D supplementation
      and we intend to understand the complex relationship between vitamin D, the growth factors
      and maternal and infant anthropometric variables and hope to unravel the reasons of vitamin D
      deficiency in our population.

      The investigators expect that if vitamin D is supplemented to pregnant women and their
      newborn infants it will inevitably replenish the micronutrient stores and aid to resolve the
      maternal and neonatal morbidity due to Vitamin D deficiency.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks; Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Vitamin D; Effectiveness; Pregnant women and their neonates
Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this 2 phased, open-label study is to compare the safety and efficacy of
      etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin
      American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a
      randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that
      allows the investigator to choose continuation with the phase I treatment or the addition,
      discontinuation or titration of other DMARD therapy already being utilized for the study.
    


Intervention name(s): Phase 1: Etanercept; Phase 1: Methotrexate; Phase 2: Optional ETN, SSZ, HCQ, MTX; Phase 1: Methotrexate; Phase 1: Conventiaonal DMARD
Intervention type(s): Biological; Drug; Drug; Drug; Drug
Intervention description(s): Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24; Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.; Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128.
Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128.
Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128.
Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.; Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.; Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: enbrel; moderate arthritis; severe arthritis; rheumatoid arthritis
Effectivity of Motor Imagery and MirrorTherapy in Amputees
Condition: Amputees
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of imagery motor on phantom pain and amputation
      process
    

Detailed description: 
      The expected increase in the number of amputations in the coming decades requires special
      attention to the common effect after called phantom limb amputation. That term refers to the
      phenomena covering the sensations that occur in the affected limb and whose prevalence rate
      is an important part of amputees subjects. Developed theories about their origin focus their
      attention on the central nervous system and the peripheral nervous system. Thus, the
      imaginary movement is a complex cognitive, sensory and proprioceptive process leading to a
      mental representation of movement and it is a widely used technique in neurological
      rehabilitation and complex pain syndrome.
    

Intervention name(s): Treatment Traditional and Imaginary Motor Program; Treatment Traditional and Mirror Therapy
Intervention type(s): Other; Other
Intervention description(s): Amputees patients also conservative protocol will undergo physiotherapy techniques work Imaginary Motor. The first video will include two sequences of a harmonic gear that will allow the patient to examine, with the physiotherapist, the characteristics of the different body segments involved in locomotion and place the member in space. The second video include an analysis in five phases: a) relaxation of Benson, b) phase external imagination where cycles of normal running on a video provided by the physiotherapist, c) phase internal imagination where the patient will identify the problem discussed compared with the normal course presented in the video, d) recreation of images in the first person made an e normalized locomotion) closing his eyes, prompted the patient to mentally recreate sequences normal gait and analyzed and subsequently verbalize differences of these with respect to their own way of getting around.; Amputees patients also conservative protocol will undergo physiotherapy techniques mirror therapy work. The protocol will consist of mirror therapy sessions three days a week (25-30 minutes) for a month, where participants will move the intact limb looking in the mirror and imagining the movement of the limb with phantom sensation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Motor control Laterality; Pain Perception; Lower Extremity; Complementary Therapies; Physical Therapy Modalities
The Effects of Testosterone on Prostate Tissue (ACYP-1)
Condition: Hypogonadism; Contraception
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to understand the effects of testosterone on the
      prostate. This knowledge will be used to help in the development of a safe male hormonal
      contraceptive and may impact the development of androgen replacement therapy in older men.
    

Detailed description: 
      We will be administering two drugs: Testim (testosterone gel) and Acyline. Acyline is an
      experimental drug. We want to see their effects on levels of hormones in the blood and
      prostate. In addition, we will be examining the effects of these drugs on the expression of
      genes within the prostate.

      Acyline suppresses LH and FSH, which are hormones made by the pituitary gland, thus blocking
      the signal from the brain that causes the testes to make testosterone. Therefore, Acyline
      blocks testosterone production. In preliminary studies, a single injection of Acyline
      reversibly lowered the FSH, LH and testosterone levels in the blood for approximately 15
      days. Prolonged low levels of LH and FSH cause suppression of sperm production in normal men.
      However, men may experience some side effects from the low levels of testosterone caused by
      acyline, thus exogenous testosterone is required to sustain normal male androgen and organ
      effects without suppressing spermatogenesis. This combination of drugs is a promising male
      contraceptive regimen. In addition, millions of older men are using testosterone replacement
      to treat male "andropause"; low level testosterone associated with aging. However, the effect
      of testosterone on the prostate is unknown. Studies examining the effect of testosterone on
      the prostate are needed.
    

Intervention name(s): Testosterone gel; Acyline; Placebo acyline; Placebo Testosterone gel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Testosterone gel 100 mg daily for 4 weeks; Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks; Placebo acyline injections every two weeks (2 doses); placebo testosterone gel daily for 4 weeks
Other intervention name(s): Testim
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Acyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Male contraception; Prostate; Acyline; Androgen replacement
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily
      (QD), versus allopurinol in subjects with gout.
    

Detailed description: 
      This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects
      receiving prior urate-lowering therapy underwent a 2-week washout period prior to
      randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80
      milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or
      colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the
      washout period and the first 8 weeks of double-blind treatment.
    

Intervention name(s): Febuxostat; Febuxostat; Allopurinol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Febuxostat 80 mg, orally, once daily for up to 52 weeks.; Febuxostat 120 mg, orally, once daily for up to 52 weeks.; Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.
Other intervention name(s): TMX-67; Tei-6720; Uloric; TMX-67; Tei-6720; Uloric
Intervention MeSH terms: Allopurinol; Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: uric Acid; xanthine oxidase; tophi; Drug Therapy
Intestinal Wall Remodeling (Infliximab Therapy) in Crohn's Disease Patients Undergoing Serial Computed Tomography (CT) Enterography
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response
      and can be detected in patients undergoing serial computed tomography enterography (CTE).
    

Detailed description: 
      We will retrospectively identify Crohn's disease patients who underwent serial CTE imaging
      between 2004 and 2008. Approximately 4500 CTEs were performed over this period. We estimate a
      sample size of 50 Crohn's disease patients who have had CTE performed before and after
      infliximab therapy was initiated. We will analyze each CTE for the presence of penetrating
      disease, number of inflammatory lesion, length of each lesion, and severity of each lesion
      (degree of enhancement, wall thickness, stratification, vascular engorgement, fatty
      proliferation, and symmetry). Degree of enhancement and thickness will be graded on a 5-point
      scale. Stratification, vascular engorgement, fatty proliferation, and symmetry will be
      treated as dichotomous variables (yes/no). Only small bowel lesions will be described. A GI
      radiologist (JGF), blinded to the clinical information and previous imaging results, will
      provide the readings. Comparisons between CTEs will be performed to determine responders (all
      lesions improved), mixed responders (not all lesions improved), and refractory (no lesion
      improved). A descriptive pattern of healing will also be recorded for each lesion. Clinical
      data to be recorded include indication for CTE, time between CTE, dates of each CTE, date on
      first infliximab infusion, dose of infliximab, interval between infusions, history of
      penetrating disease, history of surgery, clinical status at imaging (remission, flare, or
      uncertain), medication usage, age, and disease duration. Clinical status at time of imaging
      will be based on the ordering clinician's global assessment at the time of repeat CTE. This
      will be determined by a review of the medical record by a gastroenterologist (DHB).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        (Retrospectively) Established Crohn's disease patients who underwent CTE imaging before and
        after initiating infliximab therapy.
A Safety, Tolerability and Pharmacokinetics Study of Topical Ointment YR001 in Adult Healthy Volunteers
Condition: Atopic Dermatitis; Psoriasis
MeSH terms: Psoriasis; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical
      ointment in healthy adult subjects.
    


Intervention name(s): YR001 Dose A on low body surface area; YR001 Dose A on middle body surface area; YR001 Dose A on high body surface area; YR001 Dose B on low body surface area; YR001 Dose B on middle body surface area; YR001 Dose B on high body surface area; Placebo on low body surface area; Placebo on middle body surface area; Placebo on high body surface area; YR001 Dose A on high body surface area twice daily; YR001 Dose B on high body surface area twice daily; Placebo on high body surface area twice daily
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Part A: Single topical dose; Part A: Single topical dose; Part A: Single topical dose; Part A: Single topical dose; Part A: Single topical dose; Part A: Single topical dose; Part A: Single topical dose; Part A: Single topical dose; Part A: Single topical dose; Part B: Multiple topical dose; Part B: Multiple topical dose; Part B: Multiple topical dose
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study includes two sequential parts of single dose and multiple dose with placebo control
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Beta 2 Adrenergic Stimulation vs Cold Exposure to Activate Human Brown Adipose Tissue
Condition: Thermogenesis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of the study is to asses brown adipose tissue activity in humans after
      intravenous administration of the selective beta-2-adrenergic agonist fenoterol as compared
      to the natural activator of brown adipose tissue, a mild cold stimulus.
    

Detailed description: 
      The activation of brown adipose tissue in response to beta-2-adrenergic stimulation as
      compared to cold exposure will be studied in an open-label, cross-over trial in healthy
      volunteers with random sequence of the two study interventions a) and b):

        1. A bolus of 25µg fenoterol will be slowly injected intravenously during 2-3 minutes
           followed by a continuous infusion of fenoterol 1µg/min over 120 minutes. The total dose
           of fenoterol per subject will thus be 145µg.

        2. During 120 minutes participants will be exposed to a mild cold stimulus water using
           cooling sleeves, covering the participant's waist, is gradually decrease body surface
           temperature to 10 degrees or to the lowest tolerable temperature without shivering.

      Energy expenditure will be measured during both interventions by indirect calorimetry and
      brown adipose tissue activity will determined by 18F-FDG-PET/CT 30 min after injection of 75
      MBq of 18F-FDG.
    

Intervention name(s): Fenoterol; Mild cold exposure
Intervention type(s): Drug; Other
Intervention description(s): Intravenous infusion; Body surface cooling
Other intervention name(s): beta2 adrenoreceptor agonist
Intervention MeSH terms: Fenoterol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, cross-over trial in healthy volunteers with random sequence of the two study interventions
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: brown adipose tissue; beta2-adrenergic agonist; cold exposure
Safety of Lumiracoxib in Patients With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This safety study evaluated the incidence of gastrointestinal adverse events and edema in
      patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator
    


Intervention name(s): lumiracoxib; rofecoxib
Intervention type(s): Device; Drug
Intervention description(s): 400 mg once daily, oral over 6 weeks; 25 mg, oral, daily over 6 weeks
Other intervention name(s): Prexige; Vioxx
Intervention MeSH terms: Rofecoxib; Lumiracoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; lumiracoxib; rofecoxib; Cox-2; Osteoarthritis (primary osteoarthritis hip, hand, knee or spine (cervical or lumbar)