bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Laughter Yoga on Tex Anxiety and Educational Stress
Condition: Laughter Therapy; Anxiety; Stress, Exam
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The primary purpose of this study is to examine the effects of laughter therapy on tex
      anxiety and educational stress in 8th-grade students.
    


Intervention name(s): laughter yoga
Intervention type(s): Behavioral
Intervention description(s): laughter yoga
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Function of Implanted Glucose Sensor 2
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to verify safety and assess tolerance of a long-term, implanted
      glucose monitoring sensor. The study will also provide data to characterize the response
      properties and calibration of the implanted sensor and determine if such properties vary with
      implant duration.
    


Intervention name(s): Model 100 Sensor
Intervention type(s): Device
Intervention description(s): One Model 100 Sensor to be implanted per subject.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: diabetes mellitus requiring insulin
Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to learn about the effects of a medication called
      Vyvanse on the heart (cardiovascular system). The U.S. Food and Drug Administration (FDA) has
      approved Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). People
      who have ADHD have trouble paying attention, organizing, and planning; these symptoms can
      cause problems at work, socially and at home.

      Vyvanse (also known as Lisdexamfetamine) is a stimulant class medication. There have been
      reports of serious cardiovascular effects in children and adults treated with stimulants.
      While there is no definite evidence that these events were related to the use of stimulants,
      the deaths have raised questions about the cardiovascular safety of stimulants.

      The study will involve in-depth cardiovascular tests, namely echocardiograph (ultrasound of
      the heart) and cardiopulmonary exercise test (also called stress test; subjects exercise on a
      bicycle while measuring their heart activity and breathing is monitored by cardiologists).

      The investigators predict to see changes in blood pressure and heart rate as shown in
      previous clinical studies, and that the in-depth cardiovascular tests will provide new
      insights into the cardiovascular impact of stimulants.
    


Intervention name(s): Lisdexamfetamine
Intervention type(s): Drug
Intervention description(s): Lisdexamfetamine daily until the completion of participation in the clinical trial (up to Week 11 or final study visit). Subjects will start on 30 mg of LDX per day for the first week of treatment. The dose will be increased weekly in 20 mg increments, up to a 70 mg daily (maximum). If significant adverse effects (AE) occur, the daily dose may be reduced by 20 mg. At subsequent visits, a higher dose may be resumed if tolerated. Both cohorts of the study will follow the same treatment plan.
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: cardiovascular testing; home blood pressure monitoring; office home blood pressure monitoring; cardiopulmonary exercise testing; transthoracic echocardiography; Lisdexamfetamine; Vyvanse; normotensive and hypertensive adults with ADHD; ADHD medication.
Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children
Condition: Covid19
Study type: Interventional

Summary: 
      In children with Covid-19, the diagnosis of Kawasaki Disease (KD) and pneumonia should be
      made very quickly. However, the regional hospitals surrounding Paris don't have the required
      expertise. The use of MELODY allows the paediatric team to quickly carry out the necessary
      examinations while avoiding the movement of patients and the risk of contamination.

      The MELODY remote system developed by the company AdEchoTech is a CE marking telemedicine
      technique, allowing an expert to perform an ultrasound scan on a distant patient (several
      hundred/thousands of kms). The Melody system makes it possible to optimize ultrasound
      expertise resources wherever they are located (all specialties combined) The feasibility of
      the clinical use of telerobotic sonography has been demonstrated in adults for abdominal,
      cardiac and prenatal exam. Thus, the aim of this study is to assess the feasibility of this
      system in children.
    


Intervention name(s): Ultrasound using the telerobotic Melody system
Intervention type(s): Device
Intervention description(s): The children will first have a telerobotic ultrasound abdominal, pulmonary or cardiac followed by a classical ultrasound.
Intervention model: Single Group Assignment
Intervention model description: Children will be initially scanned with a telerobotic ultrasound system. Within 3 hours after the telerobotic examination, patients will be scanned by a different sonographer with similar experience and qualifications using the conventional ultrasound, who will be blinded to the findings of the telerobotic examination.
Masking: None (Open Label)
Primary purpose: Diagnostic
Montelukast Back to School Asthma Study (0476-340)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study, in children with chronic asthma, evaluates the number of days of worsening asthma
      during 8 weeks of treatment with montelukast after treatment is started for the first day of
      school.
    


Intervention name(s): montelukast; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): montelukast 5 mg tablet Once a day (QD) for 8 weeks; Placebo to montelukast QD for 8 weeks
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Sensitivity of a Transdermal Device to Monitor the Sweat Alcohol Concentration
Condition: The Sweat Alcohol Concentration
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine
      the presence of vapor of alcohol in insensible perspiration.

      One of possible application would be a continuous and non invasive monitoring of drinking
      behavior. To investigate the validity of this method, it's necessary to compare Transdermal
      Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations
      and breath Alcohol Concentrations provided by reference methods.

      The purpose of this study is to identify the kinetic of alcohol concentration in blood,
      exhaled air and sweat after alcohol ingestion.
    


Intervention name(s): oral dose of alcohol; alcotest; blood samples; Transdermal monitor
Intervention type(s): Other; Device; Biological; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
Condition: Sleep Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652
      given once daily to people with excessive daytime sleepiness. Subjects will be randomized to
      either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.
    


Intervention name(s): ABT-652; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See arm description for details; See arm description for details
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sleep disorder
Histopathological Diagnosis of Adenomyosis
Condition: Adenomyosis
MeSH terms: Adenomyosis
Study type: Interventional

Summary: 
      The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy
      for diagnosing adenomyosis.
    


Intervention name(s): hysteroscopic endo-myometrial biopsy; ultrasound
Intervention type(s): Procedure; Device
Intervention description(s): two dimensional trans-vaginal ultrasonography
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: adenomyosis
The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis
Condition: Bronchiolitis, Viral
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare a single dose of oral dexamethasone to placebo in a multicenter,
      randomized, double blind trial of infants aged 2 to 12 months with first-time bronchiolitis
      (defined as wheezing within 7 days of onset). This is given as additional therapy beyond any
      other routine therapy used at that center. No current standard therapy is withheld, and no
      additional tests or other treatments are part of the study.The primary hypothesis is that
      dexamethasone will be more effective than placebo in preventing hospital admission. The
      secondary hypotheses are that dexamethasone will decrease respiratory scores and possibly the
      duration of the disease when compared to placebo, and that dexamethasone will be as safe and
      as well tolerated as placebo.
    

Detailed description: 
      Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory
      condition leading to the most hospital admissions in young children. It is also probably the
      most common serious illness of childhood lacking evidence-based treatment. Evidence both for
      and against the effectiveness of corticosteroids such as dexamethasone has been published.
      Editorials, expert reviews, and a recent report from the Agency for Healthcare Research and
      Quality recommend a study such as this one.

      Patients will be drawn from the emergency departments at participating medical centers in the
      Pediatric Emergency Care Applied Research Network, created by the Emergency Medical Services
      for Children program and the Maternal and Child Health Bureau of the Health Resources and
      Services Administration to study health problems of high acuity and high incidence in
      children.

      Comparisons: The primary outcome (hospital admission after 4 hours of ED observation) and
      secondary outcomes will be compared between treatment and placebo groups.
    

Intervention name(s): dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1mg/kg dexamethasone; 1mg/kg placebo
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: randomized clinical trial; placebo-controlled; double-blind; double-masked; infant; dexamethasone; wheezing
Wet Cupping (AlHijamah); Double Versus Single Cupping Technique
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Randomized clinical trial to compare the effectiveness and safety of double (traditional)
      versus single (Asian) cupping techniques in chronic low back pain.
    

Detailed description: 
      Chronic Low Back Pain is a very common pain disorder in the primary care. As in many chronic
      pain conditions, patients are usually asking for alternative options, especially local
      traditional and therapies including wet cupping, to replace the long-term use of painkillers.
      The majority of the wet cupping trials conducted abroad used different techniques, which is
      different from our local traditional wet cupping technique. This study can identify the
      technique that is more efficacious in reducing pain, prolonging the pain relieve period, and
      decrease patient dependence on painkillers in chronic low back pain.The aim of this study is
      to compare the effectiveness and safety of double (traditional) versus single (Asian) cupping
      techniques in chronic low back pain. This a randomized comparative effectiveness pilot
      clinical trial. After taking written informed consent, patient with chronic low back pain
      will be randomized into two groups, one group to receive wet cupping therapy with the
      Traditional double technique, the other group to receive it with the Asian single technique.
      Numeric Rating Scale, Present Pain Intensity and Oswestry Disability Questionnaire will be
      used to measure the outcome before and after the intervention, one week after the
      intervention, then two weeks after. Wilcoxon rank sum test for the continuous dependent data
      analysis and the analysis of covariance ANCOVA, to compare both groups mean scores will be
      used. The outcome baseline for each score will be used as the covariate. Chi square or
      Fisher's exact test will be used to compare categorical data with Minimal Clinical
      Improvement Difference within and between the two groups.
    

Intervention name(s): wet cupping
Intervention type(s): Procedure
Intervention description(s): In double cupping (traditional technique): Cupping (suction) then scarification then cupping (suction).
In single cupping (Asian): puncture using auto lancet then cupping (suction). In both techniques 4 out of 6 acupoints (BL23, BL24, BL25 bilateral) will be selected.
Other intervention name(s): Hijamah; wet cupping device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: wet cupping Saudi Arabia
Evaluation of the Bioavailability of Dexamethasone in Healthy Subjects
Condition: Dexamethasone Administration; Intranasal Administration; Inflammation; Intravenous Drug Usage; Healthy Subjects
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The most important property of a dosage of a drug administration is its ability to deliver
      the active ingredient to the site of action in a quantity sufficient to exert the expected
      pharmacological effect. This ability is known as bioavailability. Dexamethasone is a drug
      with wide clinical use in patients with inflammatory pathologies (infectious or
      non-infectious). The main routes of administration are oral and intravenous. The intranasal
      route could be one more effective, less invasive that would allow to obtain a faster
      therapeutic concentration and in greater concentration in the lungs and in the central
      nervous system than the intravenous route, maintaining very similar systemic concentrations
      to those achieved intravenously. For these reasons, it is important to know the
      bioavailability of dexamethasone administered by this route in order to establish the best
      dosing regimen. The pilot study is of an exploratory nature (descriptive, comparative or
      informative), whose objective is to know the pharmacokinetic characteristics of a new route
      of administration of a drug in the study population to establish the pharmacokinetic
      parameters, and the comparison between the intranasal bioavailability against the intravenous
      administration by determining confidence intervals and calculating one-sided double t of
      Scuirmann.

      Objetive: To evaluate the Absolute Bioavailability (for information purposes) of
      Dexamethasone 8 mg/2 ml Injectable Solution (Intranasal Route 6 mg/ 1.5 ml Vs Intravenous
      Route 6 mg/ 1.5 ml), according to the specific evaluation parameters and general under
      fasting conditions.
    


Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): The nominal doses were similar, volunteers were randomly assigned to receive a single dose of DXM by IV bolus of 1.5 mL (equivalent to 6 mg of dexamethasone) or the same dose intranasally by using a Mucosal Atomization Device (MAD Nasal). allowing direct pharmacokinetic comparison without dose normalization. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 2 PERIODS, 2 TREATMENTS, 2 SEQUENCES, CROSSOVER 2X2.
Masking: None (Open Label)
Primary purpose: Other
Keywords: dexamethasone; intranasal; pharmacokinetics; Bioavailability
Personalized Drinking Feedback Interventions
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The objective of this research is to better understand how to reduce hazardous drinking among
      OEF/OIF veterans by assessing the effectiveness of a low-cost, computer-delivered
      preventative program.
    

Detailed description: 
      Excessive drinking among OEF/OIF veterans represents an important public health problem for
      both the veterans themselves and those with whom they interact. The objective of this
      research is to better understand how to reduce hazardous drinking among this group by
      assessing the effectiveness of a low-cost, computer-delivered preventative program. It is
      hypothesized that an intervention that provides personalized feedback about drinking
      behaviors will be more effective than an education-only control condition at reducing alcohol
      use and negative alcohol-related consequences.
    

Intervention name(s): Personalized Drinking Feedback; Education-Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Personalized feedback about one's drinking habits; Educational information about alcohol use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Alcohol; Brief Intervention; Personalized Feedback; Veterans
Brain Imaging of Intranasal Oxytocin Treatment in Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 4 part study:

      Phase 1a. -functional magnetic resonance imaging (fMRI) ( with oxytocin 24 IU vs. placebo =
      oxytocin 0 IU) - funded by grant #U54 HD079124-01, Phase 1b-eye-tracking(oxytocin 24 IU vs.
      placebo = oxytocin 0 IU), Phase 2a. fMRI (oxytocin 8 IU vs. oxytocin 40IU), Phase 2b.
      -eye-tracking (oxytocin 8IU vs. oxytocin 40IU). Time course of effect will also be assessed
      within session.
    

Detailed description: 
      We hypothesize that intranasal oxytocin treatment (OT) of individuals with an autism spectrum
      disorder (ASD) will:

      Hypothesis 1a. will produce greater increases in Ventral Tegmental Area (VTA) and Nucleus
      Accumbens (NAc) activation during social reward anticipation compared to placebo, providing
      evidence that OT increases activation in brain regions critical for social motivation. (NICHD
      funding for this section/aim- Dr. Joe Piven -U54 HD079124-01)

      Hypothesis 1b. will spend proportionally more time attending to the social image on a screen
      vs. the non-social image compared to placebo.

      Hypothesis 2a. will produce differential effects in VTA and NAc activation during social
      reward anticipation compared with the oxytocin 8 IU vs. oxytocin 40 IU dose, providing
      evidence that OT dose-dependently increases activation in brain regions critical for social
      motivation.

      Hypothesis 2b. will differentially attend to the social image on a screen vs. the non-social
      image compared in the oxytocin 8 IU vs. oxytocin 40 IU dose, providing evidence that OT
      dose-dependently changes the value of social stimuli.
    

Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention description(s): For Phase I, subjects will be randomized to receive either 24IU (6 sprays) of active oxytocin or 6 sprays of placebo (3 sprays per nostril)
For Phase II, subjects will be randomized to receive either 8 IU or 40 IU of oxytocin.
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: autism; brain; functional magnetic resonance imaging; oxytocin
URMC Related Haplo-identical Donor BMT
Condition: Hematological Disease; Immune Deficiencies; Solid Tumors; Myelofibrosis; Multiple Myeloma; Lymphoma
MeSH terms: Multiple Myeloma; Hematologic Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a single-center treatment protocol, designed to validate the process of
      related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant
      Unit.
    

Detailed description: 
      This study will be a single-center treatment protocol with five possible preparative
      regimens, designed to validate the process of related donor haploidentical-SCT at the Wilmot
      Cancer Institute Blood and Marrow Transplant Unit. Enrolled patients will receive
      chemotherapy +/- radiation as a pre-transplant conditioning regimen. Patients will then
      receive haploidentical stem cells, either bone marrow or mobilized peripheral blood, followed
      by GvHD prophylaxis that will include cyclophosphamide. Multiple data points will be
      collected prior to, during, and following transplantation to ensure safety of the process and
      to evaluate the stated objectives.
    

Intervention name(s): Total Body Irradiation 1200 cGy; Fludarabine; Pre-Stem Cell Infusion Cyclophosphamide; Pre-Stem Cell Infusion Mesna; Busulfan; Melphalan; Stem Cell Infusion; Post-Stem Cell Infusion Cyclophosphamide; Post-Stem Cell Infusion Mesna; Thiotepa
Intervention type(s): Radiation; Drug; Drug; Drug; Drug; Drug; Procedure; Drug; Drug; Drug
Intervention description(s): 1200 cGy TBI in 8 fractions; Fludarabine; Cyclophosphamide given prior to the stem cell infusion; Mesna given prior to the stem cell infusion; Busulfan; Melphalan; Stem cell infusion; Cyclophosphamide given after the stem cell infusion; Mesna given after the Stem Cell Infusion; Thiotepa
Other intervention name(s): TBI
Intervention MeSH terms: Cyclophosphamide; Melphalan; Busulfan; Thiotepa; Fludarabine; Mesna
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment