bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child
Condition: Cerebral Palsy; Muscle Hypertonia
MeSH terms: Cerebral Palsy; Muscle Hypertonia
Study type: Observational

Summary: 
      In children requiring botulinum toxin injections, improving supervisory procedures of
      injection sessions to reduce pain and improve the experience of this invasive procedure is
      needed. The intervention of medical clowns seems very interesting in this goal, but its
      effectiveness has not been proven within the botulinum toxin injections. The objective of the
      study is to evaluate in terms of profit the presence or absence of clowns during a session of
      botulinum toxins by determining their impact on pain and anxiety felt among children and
      their carers
    

Detailed description: 
      In the literature, the presence of clowns allows a major reduction of pain and anxiety in
      children and their accompanying in various medical and hospital surgical settings. A previous
      study on a population of 60 children was conducted to assess the impact of the presence of
      clowns during the production of botulinum toxin injection in children but not confirming the
      benefit of their participation in carrying this medical procedure. The results of this study
      are opposed to current scientific data. Their impact clown assessment criteria seem however
      insufficient to actually support the conclusion as to the ineffectiveness of distractibility
      clowns in this specific medical procedure iterative injection of botulinum toxin.

      The objective of the study is to evaluate the pain and anxiety before and after the botulinum
      toxin injection session in children and hetero-assessment of pain and anxiety by accompanying
      depending on the presence or not of clown. The second objectives are the evaluation of the
      course of the session by the injector doctor, the accompanying of the child and to evaluated
      the effect of distraction during the toxin of the clown or the usual distraction (music,
      movie...)
    

Intervention name(s): distraction
Intervention type(s): Behavioral
Intervention description(s): Children will all benefit toxin injections with the same protocol. Only the distraction will be different during the session: either the children will have a distraction realized by the team of clowns / or children will benefit a classic distraction (TV, music, ...)
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children receiving botulinum toxin in local pediatric day hospital
      
Keywords: botulinum toxin; anxiety reduction; pain reduction; medical clowns; distraction
Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      During acute coronary syndromes (ACS), the generation of inflammatory mediators negatively
      influences arterial wall remodeling and the endothelium-dependent vasomotor function in the
      coronary and systemic arterial systems. In fact, the intensity of the inflammatory
      upregulation is strongly related to the incidence of recurrent coronary events. The
      investigators previously demonstrated that high dose potent statins can rapidly reduce plasma
      levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. In
      addition, such statin treatment attenuates the post-discharge endothelial dysfunction of
      these patients. By inference, it is plausible to hypothesize that these beneficial effects
      during ACS may be intensified by an additive lowering of plasma cholesterol through the
      treatment with ezetimibe. So far, data is unavailable to verify this assumption. In parallel,
      data from animal models have suggested that both statins and ezetimibe may reduce insulin
      sensitivity by their effect on cholesterol content and, by this way, on insulin signaling in
      liver cells. In this context, the present study aims to investigate the role of the addition
      of ezetimibe upon statin treatment on stress-induced insulin resistance and on the
      time-course of the inflammatory response during the acute phase of myocardial infarction and
      its late effect on endothelium-dependent arterial dilation.
    


Intervention name(s): Simvastatin; Ezetimibe-Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Simvastatin 40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation; Ezetimibe-Simvastatin 10-40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation
Other intervention name(s): Statin; Zocor; Vytorin
Intervention MeSH terms: Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: myocardial infarction; systemic inflammatory activity; endothelial function
Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery
Condition: Posterior Capsule Opacification; Postoperative Complications
MeSH terms: Cataract; Capsule Opacification; Postoperative Complications
Study type: Interventional

Summary: 
      This prospective, randomized, clinical trial looks to compare children undergoing congenital
      cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration
      as well as postoperative complications such as glaucoma, inflammation and IOL centration when
      IOL fixation is performed using two different techniques : 1) conventional in the bag IOL
      implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the
      posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to
      receiving IOL implantation using one of the two techniques will be followed up until 12
      months postoperatively.
    

Detailed description: 
      This prospective, randomized, controlled, clinical trial compares visual axis obscuration as
      well as intra and postoperative complications in children undergoing cataract surgery with
      IOL implantation using one of two techniques :

        1. in the bag IOL with limbal anterior vitrectomy

        2. posterior optic capture of IOL optic through the posterior capsulorhexis without any
           vitrectomy.

      The aim is to evaluate whether avoiding anterior vitrectomy is a feasible option,
      particularly younger children, where anterior vitrectomy has become an integral part of the
      routine surgical strategy.

      All children will be evaluated at 1 month, 3 months, 6 months and 12 months postoperatively.
    

Intervention name(s): cataract surgery; Intraocular lens implantation
Intervention type(s): Procedure; Procedure
Intervention description(s): cataract surgery in children; intraocular lens implantation in the capsular bag or optic capture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Reducing UV Exposure to Prevent Skin Cancer: Message Development & Testing
Condition: Behavior, Health
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      Phase 3b of the research will be a laboratory experiment that uses an experimental and
      analytic design that is parallel to that used in Phase 3a, the online experiment. The primary
      objective of Phase 3b is to assess physiological response (i.e., eye tracking) to different
      message appeals of the audio-visual messages used in Phase 3a on respondents' behavioral
      intentions and UV-related behavioral choices post-exposure. Including time for preparation,
      viewing, and removal of the monitoring equipment, the message viewing session will take about
      45 minutes per session.
    


Intervention name(s): Outdoor Sun Behavior; Indoor Tanning Behavior
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will provide informed consent and complete a short background questionnaire about usual sun exposure and protection behaviors and demographics. Next, each participant will be seated in a room to view the audio-visual media messages. Eye-tracking equipment running Paradigm (Perception Research Systems Incorporated) for stimuli presentation will be calibrated to the participant. Subjects will be seated at a desk in front of a computer monitor, keyboard and mouse setup. Each participant will view messages with different emotional appeals related to outdoor sun exposure (seeking shade, covering up, using sunscreen, and multiple behaviors). Messages will be shown in random order, with each message interspersed by a 30 second baseline screen consisting of black background and white, centered plus sign. The last 10 seconds of each preceding the 30-second baseline screen will be used to establish physiologic baseline to minimize carry-over effects of the preceding message.; Upon arrival, participants will provide informed consent and complete a short background questionnaire about usual indoor tanning, sun exposure and protection behaviors, and demographics. Next, each participant will be seated in a room to view the audio-visual media messages. Eye-tracking equipment running Paradigm (Perception Research Systems Incorporated) for stimuli presentation will be calibrated to the participant. Subjects will be seated at a desk in front of a typical computer monitor, keyboard and mouse setup. Each participant will view messages with each type of target behavior (freedom, health risk, appearance)). Messages will be shown in random order, with each message interspersed by a 30 second baseline screen consisting of black background and white, centered plus sign. The last 10 seconds of each preceding the 30-second baseline screen will be used to establish physiologic baseline to minimize carry-over effects of the preceding message.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)
Condition: Rhinitis; Urticaria
MeSH terms: Rhinitis; Rhinitis, Allergic; Urticaria; Chronic Urticaria
Study type: Observational

Summary: 
      The objective of this non-interventional study is to evaluate the safety of Aerius syrup in
      pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria.
      The patients will receive 2.5 ml (1.25 mg) once daily.
    

Detailed description: 
      Pediatric patients aged 1-5 years
    

Intervention name(s): Desloratadine
Intervention type(s): Drug
Intervention description(s): 2.5 ml (1.25 mg) once daily
Other intervention name(s): Aerius; SCH 034117
Intervention MeSH terms: Desloratadine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric clinics around Hungary.
A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in
      subjects with ALS.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study of NP001 in subjects with ALS
      conducted in multiple centers. Drug or placebo will be given intravenously. Approximately 105
      subjects will be enrolled. Subjects will be allocated (1:1:1) to placebo and 2 dose levels of
      NP001.
    

Intervention name(s): NP001; NP001; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Low dose of NP001; High dose of NP001; normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ALS
Yellow Fever Immune Response at Single Cell Resolution
Condition: Healthy
MeSH terms: Yellow Fever
Study type: Observational

Summary: 
      The immune system is composed of diverse cell types with different functions that act
      together in order to defend against infection. This pilot study will test a new technology
      for studying these many different cell types at very large numbers at the level of individual
      cells. This method will then be used to identify the cell types and functions important for
      the immune response to the highly protective yellow fever vaccine, which will improve our
      understanding of effective vaccine features.
    

Detailed description: 
      Vaccines have had monumental impact in reducing the mortality and morbidity of infectious
      disease. However, the underlying immune mechanisms that contribute to their effectiveness are
      incompletely understood. Transcriptomics (methods that measure the activity of thousands of
      genes) studies have identified key features of responses to vaccination(see references) and
      infection(see references). However, these experiments are typically performed on
      heterogeneous cell mixtures such as peripheral blood mononuclear cells (PBMC which include
      certain types of white blood cells) and therefore provide an aggregate measure of gene
      expression from the many different immune cells and their respective activities in the
      mixture. Such results can obscure important biological information, particularly in minor
      subsets of active cells. Establishing a method for immune transcriptomics at single cell
      resolution would be a highly significant advance and enable more informative and functionally
      relevant systems immunology studies with commonly used sample types (i.e. PBMC). Applying
      this high-resolution approach to Yellow Fever Vaccine (YFV), an exceptionally effective
      vaccine, is likely to identify unappreciated mechanisms that contribute to protective
      immunity.
    

Intervention name(s): Yellow Fever Vaccine
Intervention type(s): Drug
Intervention description(s): Yellow Fever Vaccine .5 ml
Other intervention name(s): YF-Vax
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers
      
Biospecimen description: 
      Research Bloods
    
Keywords: yellow fever vaccine; immune response; droplet microfluidics single cell ("inDrop") RNA-Seq
Extension, Carbidopa-levodopa in Neovascular AMD
Condition: Macula; Degeneration; Retina
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol is an extension of protocol 0002, Proof of Concept and Dose Ranging Study of
      carbidopa-levodopa in Neovascular AMD. that is a 3 month study of escalating doses of
      carbidopa-levodopa in neovascular AMD. This trial is a 9 month extension for patients who
      successfully complete protocol 0002 and wish to continue carbidopa-levodopa therapy. It will
      use the two higher dose regimens of protocol 0002. these will be assigned according to how
      well the higher dose was tolerated in protocol 0002.
    

Detailed description: 
      This extension will employ the same medications, measurements, guidelines for anti-VEGF
      injections and safeguards as in protocol 0002. In combination with protocol 0002, it will
      provide a total of 12 months of therapy with carbidopa-levodopa.
    

Intervention name(s): carbidopa-levodopa 25-100 mg
Intervention type(s): Drug
Intervention description(s): High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients who complete 3 months of escalation dose carbidopa-levodopa, will receive 9 additional months of therapy with the highest dose used in protocol 0002, carbidopa-levodopa 25-100 mg 2 tablets TID. If that dose was not well tolerated in study 0002, the patient will receive the intermediate dose, carbidopa-levodopa 25-100 mg, 1 tablet TID.
Masking: None (Open Label)
Primary purpose: Treatment
Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      Given the established role of high dose cytarabine (HiDAC) combined with rituximab, along
      with recent data showing the encouraging efficacy of bendamustine, the investigators seek to
      integrate the synergistic effects of these medicines in alternating cycles as induction
      therapy prior to autologous stem cell transplant (ASCT). Based on prior experience with
      bendamustine and rituximab (BR) based induction therapy, the investigators seek to evaluate
      the efficacy and safety of stem cell mobilization in this pilot study
    


Intervention name(s): Bendamustine; Rituximab; Cytarabine; Pegfilgrastim; Leukapheresis; Filgrastim; Autologous stem cell transplant
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Drug; Procedure
Other intervention name(s): Bendamustine Hydrochloride; Treanda; Rituxan; Cytosar-U; Tarabine PFS; Neulasta; G-CSF; Neupogen
Intervention MeSH terms: Cytarabine; Rituximab; Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PTSD and Risk Behavior in HIV Positive Female Adolescents
Condition: PTSD; Sexual Abuse; HIV Infections
MeSH terms: HIV Seropositivity
Study type: Observational

Summary: 
      This is a qualitative study using a purposive sampling methodology to interview HIV-positive
      female adolescents who have experienced physical and/or sexual abuse. An open-ended, in-depth
      interview, occurring over one to two sessions, will be conducted with each participant.
    

Detailed description: 
      This study is expected to take approximately 12 months to accrue participants and complete
      all the interviews. The interview will be conducted in one or two sessions and will be up to
      two hours in duration per session.

      The study will initially be conducted at three ATN clinical sites with approximately 20
      females recruited per site for a total of 60 participants. Other ATN clinical sites may be
      allowed to participate in the future if the study is slow to accrue.

      The participants consist of English speaking women, ages 18-24 years, who acquired HIV
      through heterosexual intercourse or injection drug use after the age of 9 years, reported a
      history of sexual and/or physical abuse prior to age 18, and engaged in vaginal or anal
      intercourse in the 4 months prior to screening.

      Approximately half of the participants will report a recent history of substance use as
      defined by study criteria and approximately half of the participants will report no such
      history.

      Eligible patients will be identified and screened by the ATN research staff at the
      participating sites. The Protocol Chair and trained Research Assistant will conduct the
      open-ended qualitative interviews using an open-ended script. The interview will be
      audio-taped and transcribed. Prior to the open-ended script interview, participants will be
      asked about Posttraumatic Stress Disorder symptoms, abuse history, substance use, sexual
      behavior, and demographics. Responses to these questions will not be audio-taped and will be
      entered into the ATN 053 database by the ATN site staff.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        English speaking women, 18-24 years old with behaviorally- acquired HIV through
        heterosexual intercourse or injection drug use after the age of 9 years, who report a
        history of sexual and/or physical abuse prior to age 18, and who have engaged in vaginal or
        anal intercourse in the 4 months prior to screening.
      
Keywords: Adolescent Females; HIV positive; PTSD; Sexual Abuse
A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of CoFactor in healthy
      subjects.
    


Intervention name(s): CoFactor; Leucovorin
Intervention type(s): Drug; Drug
Other intervention name(s): ANX-510
Intervention MeSH terms: Leucovorin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CoFactor; ANX-510
Effect of Amino Acids and Sugar Alcohols on Satiation Peptides and Activation of Specific Brain Regions
Condition: Endocrine System Diseases
MeSH terms: Endocrine System Diseases
Study type: Interventional

Summary: 
      With this study the investigators investigate the effects of amino acids (tryptophan, leucin)
      and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation.
    


Intervention name(s): 1.56 g L-Tryptophan; 1.56 g L-Leucine; 50 g Xylitol; 75 g Erythritol; 75 g Glucose; Tap water; Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate); Nasogastric Tube
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Device
Intervention MeSH terms: Erythritol; Tryptophan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention