bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of a Yoga Program in Schools
Condition: Adolescent Development
Study type: Interventional

Summary: 
      The purpose of this preliminary study is to evaluate the effects of a yoga-based program on
      high school students' psychological health. Results will be used to generate specific
      hypotheses of how yoga may improve adolescent mental health.
    

Detailed description: 
      Specific Aims:

        1. To evaluate the hypothesis that 12 weeks of yoga during physical education will be
           acceptable by and feasible with high school students. To test Specific Aim 1, outcomes
           assessed at both Monument Mountain Regional High School and Waltham High School include:
           feasibility and acceptance.

        2. To evaluate the hypothesis that yoga will improve self-and parent-reported psychosocial
           well-being including affect, mood, stress and anxiety in high school students, relative
           to control students taking regular physical education. To test Specific Aim 2, both
           primary outcomes (affect and mood) will be assessed at both schools. Additional
           psychosocial well-being outcomes assessed at Monument Mountain Regional High School
           include: life purpose/satisfaction and self-confidence during stress; self-esteem;
           parent-reported psychological difficulties; perceived stress; and sleep quality.
           Additional psychosocial well-being outcomes assessed at Waltham High School include:
           self-esteem; parent-reported psychological difficulties; and sleep quality.

        3. To evaluate the hypothesis that yoga will improve self- and parent-reported
           self-regulatory skills including resilience, mindfulness, emotion regulation, anger
           expression, self-esteem and self-confidence relative to physical education controls.
           Self-regulation outcomes assessed at Monument Mountain Regional High School include:
           resilience; mindfulness; emotion regulation; control of anger expression; bullying;
           health behaviors; substance use risk factors; and attention. Self-regulation outcomes
           assessed at Waltham High School include: resilience; mindfulness; emotion regulation;
           control of anger expression; substance use risk factors; and attention.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention description(s): 12 to 16 weeks of group yoga classes (approximately 32 classes per student), 30-45 minutes per class, 2-3 times per week, during physical education class. Yoga program includes physical postures and movement, breathing exercises, partner/group games, deep relaxation and meditative techniques.
Other intervention name(s): Kripalu Yoga In The Schools
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mental health; Education; Mind Body Therapies
Effects of Power Ball on Grip Strength in Children With Developmental Delay.
Condition: Developmental Delay
Study type: Interventional

Summary: 
      Developmental delay refers to the child who does not perform the normal milestones as other
      children accomplish in the same age within time or somehow late but can achieve them. While
      if the delay is found in two or more than two areas of the developmental skill it is known as
      Global Developmental Delay (GDD). It is divided into mild, moderate and severe developmental
      delay contributed by many other causes like prenatal, perinatal, postnatal and socioeconomic
      factors. The objective of the study is to determine the effects of power ball on grip
      strengthening children with developmental delay. In this study, we will randomly assigned 28
      children into two groups, One group will be control group getting the conventional treatment
      (isometric hand grip training exercises) and other will be experimental group getting the
      power ball training with conventional treatment. During the sessions hand held dynamometer is
      use to check the grip strength. By using power ball grip strength in children with
      Developmental Delay can be improved.
    


Intervention name(s): Power ball; isometric hand grip strengthening exercises
Intervention type(s): Other; Other
Intervention description(s): experimental group getting the power ball training with conventional treatment.; conventional treatment (isometric hand grip training exercises)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: power ball; Strengthening exercises; Hand grip; Developmental delay; Dynamometer
Efficacy and Safety of Clostridium Botulinum Toxin Type A to Improve Appearance of Moderate to Severe Glabellar Lines
Condition: Moderate to Severe Glabellar Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to demonstrate the safety and the efficacy of a single
      treatment of an injectable liquid form of Clostridium botulinum toxin type A haemagglutinin
      complex (BTX-A-HAC; hereafter referred to as BTX-A-HAC Next Generation (BTX-A-HAC NG)), used
      for the improvement in the appearance of moderate to severe glabellar lines (the lines
      between the eyebrows).
    

Detailed description: 
      At the Baseline Visit (Day 1), subjects were randomised in a ratio of 2:1 to receive either
      BTX-A-HAC NG solution (50 U) or placebo. Randomisation was stratified according to gender and
      severity of glabellar lines at maximum frown (moderate to severe) at Baseline. A single dose
      of BTX-A-HAC NG solution 50 U or placebo was injected on Day 1. Subjects were then monitored
      at the study centre for 30 minutes. On Day 4, subjects were contacted by telephone for
      adverse event monitoring and to record concomitant medications and treatments.

      Subjects attended follow-up visits at the study centre on Days 8, 15, 29, 57, 85, 113, 148
      and 183. The Day 183 follow-up visit was the end of study visit; all subjects who had
      completed the Day 183 Visit were considered to have completed the study.
    

Intervention name(s): Botulinum toxin type A; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): A solution containing 50 U in 0.25 mL (200 U/mL). Each vial contained 0.625 mL of deliverable volume of solution. A volume of 0.25 mL, containing 50 U of BTX-A-HAC NG (i.e. 10 U/0.05 mL) was withdrawn from the vial into a syringe for administration. The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection), each of which was to be administered into predefined sites across the glabellar region (two injections into each corrugator muscle and one injection into the procerus muscle).; A solution containing only the excipients of BTX-A-HAC NG (identical in appearance to the active product). Each vial contained 0.625 mL of deliverable volume of solution. A volume of 0.25 mL was withdrawn from the vial into a syringe for administration. The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection), each of which was to be administered into predefined sites across the glabellar region (two injections into each corrugator muscle and one injection into the procerus muscle).
Other intervention name(s): BTX-A-HAC NG
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moderate to Severe
An in Vivo Bioequivalence Study of 2 Loxoprofen Sodium Products in Vietnamese Healthy Male Volunteers
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate whether FABALOFEN 60 is bioequivalent to JAPROLOX® TABLETS
      after a single oral administration of each loxoprofen formulation in healthy subjects by
      assessing of pharmacokinetic properties including AUC, Tmax and Cmax and to evaluate the
      safety of test drug FABALOFEN 60 and reference drug JAPROLOX® TABLETS during drug
      administration.
    

Detailed description: 
      This study is a randomized, single-dose, 2-sequence, 2-period, 2-treatment crossover study in
      24 fed healthy subjects with an at-least-6-day washout period. The drug level in serum is
      detected by High-performance Liquid Chromatography (HPLC) to determine Cmax, AUC0-t and Tmax.
      Safety are evaluated during drug administration, blood sampling time, washout period and 1
      week after the end of blood sampling for any adverse drug reactions.
    

Intervention name(s): FABALOFEN 60; JAPROLOX TABLET
Intervention type(s): Drug; Drug
Intervention description(s): Dosage: Single dose of one tablet of test product in each period. Administration: 30 minutes before administration, subjects will receive a test meal (high-fat and high-calorie) and finish this meal in 30 minutes or less. Take 1 tablet of test product with 240 mL of water. Lying position or strenuous activities are not allowed within 2 hours post dose; Dosage: Single dose of one tablet of reference product in each period. Administration: 30 minutes before administration, subjects will receive a test meal (high-fat and high-calorie) and finish this meal in 30 minutes or less. Take 1 tablet of reference product with 240 mL of water. Lying position or strenuous activities are not allowed within 2 hours post dose
Other intervention name(s): Loxoprofen sodium 60mg/tablet; Loxoprofen sodium 60mg/tablet
Intervention MeSH terms: Loxoprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, single-dose, 2-sequence, 2-period, 2-treatment crossover study
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Cold Water Immersion With Different Dosages (Duration and Temperature Variations) on Heart Rate Variability Post-exercise Recovery
Condition: Cryotherapy Effect
Study type: Interventional

Summary: 
      The aim of the present study was to investigate the effects of cold water immersion (CWI)
      during post-exercise recovery with different durations and temperatures on heart rate
      variability (HRV) indices. 100 participants performed a protocol of jumps and a Wingate test,
      and immediately afterwards were immersed in cold water, according to the characteristics of
      each group (CG: control; G1: 5' at 9±1°C; G2: 5' at 14±1°C; G3: 15' at 9±1°C; G4: 15' at
      14±1°C). Analyses were performed at baseline, during the recuperative technique (TRec) by CWI
      and 20, 30, 40, 50 and 60 minutes post-exercise. The HRV indices average of all RR intervals
      in each analysis period (Mean RR), standard deviation of normal R-R intervals (SDNN), square
      root of the mean of the sum of the squares of differences between adjacent R-R intervals
      (RMSSD), spectral components of very low frequency (VLF), low frequency (LF) and high
      frequency (HF), scatter of points perpendicular to the line of identity of the Poincaré Plot
      (SD1) and scatter points along the line of identity (SD2) were assessed. Comparisons between
      groups and moments were performed using the technique of analysis of variance for repeated
      measures in two scheme factors. A significance level of p<0.05 was considered.
    


Intervention name(s): immersion cold water
Intervention type(s): Other
Intervention description(s): immersion cold water at different temperatures and exposure times
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Recovery of function; Autonomic nervous system; Heart rate variability; Cryotherapy; Immersion
A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression
Condition: Depression; Depression Secondary to Other Disease
MeSH terms: Disease; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is:

        1. to find out the structural or functional effects of selective serotonin reuptake
           inhibitors (SSRI) in major depressive disorder (MDD);

        2. find special abnormalities in depression secondary to other disease, e.g., autoimmune
           disease like systemic lupus erythematosus (SLE).

        3. find the relationship between the efficacy of antidepressant and the change of
           neuroimaging in MDD

        4. to find possible predispose to MDD

        5. to explore the DNA methylation status in depression;
    

Detailed description: 
      1. to explore the pathology of depression

        2. to identify the difference between MDD and depression secondary to other disease
           ,especially autoimmune disease

        3. to explore the effect of gene-environment interaction on the epigenetic regulation of
           the depression
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): A,1: Escitalopram, oral, 20 mg/day, 8 weeks
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Alcohol Exposure and Airway Hyperresponsiveness
Condition: Healthy
MeSH terms: Respiratory Hypersensitivity
Study type: Interventional

Summary: 
      Alcohol has consequences including increased risk for upper respiratory tract infections,
      pneumonia, acute respiratory distress syndrome (ARDS), and alcohol-induced asthma. The
      investigators have established that airways are specifically impacted by alcohol exposure
      because the airways are heavily exposed to the vapor phase of alcohol during drinking. These
      preliminary studies demonstrate that brief alcohol administration significantly attenuates
      airway hyperresponsiveness (AHR) in a mouse model leading to the hypothesis that alcohol
      exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism.
    

Detailed description: 
      Alcohol has well-established consequences in the lung including increased risk for upper
      respiratory tract infections, pneumonia and acute respiratory distress syndrome (ARDS). There
      have even been a few reports of alcohol-induced asthma. Data from the investigators'
      laboratory have established that the airways are specifically impacted by alcohol exposure.
      Because the airways are heavily exposed to the vapor phase of alcohol during drinking and
      airway motor tone is modulated by cAMP, the investigators speculated that airway bronchial
      motor function would be altered in mice fed alcohol. The investigators' preliminary studies
      demonstrate that brief alcohol administration significantly attenuates airway
      hyperresponsiveness (AHR) in a mouse model. This novel finding has led us to hypothesize
      that:

      Alcohol exposure modifies airway hyperresponsiveness through a cAMP/NO- dependent mechanism.
    

Intervention name(s): ethanol
Intervention type(s): Other
Intervention description(s): subjects will ingest 3 ounces of vodka mixed with fruit juice within 30 min.
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Musicotherapy in the Reduction of Fatigue in Women With Breast or Gynecological Cancer Under Radiotherapy
Condition: Breast Cancer; Uterine Cancer; Ovarian Cancer
MeSH terms: Uterine Neoplasms; Fatigue
Study type: Interventional

Summary: 
      OBJETIVE: To study the influence of musicotherapy in reduction of fatigue related to cancer
      in patients with breast's or gynecology's cancer, during the radiotherapy treatment.
    

Detailed description: 
      METHODS: This is a randomized controled study (Control Group - CG e musicotherapy Group -
      MTG) wich values fatigue, life's quality, anxiety, depression by using evaluative instruments
      Functional Assessment of Cancer Therapy: Fatigue (FACT-F), Beck Depression Inventory (BDI),
      Beck Anxiety Inventory (BAI) in three different moments (during first week of radiotherapy,
      in the intermediate phase's week and during the last week of radiotherapy) for patients of
      both groups. Women allocated in MTG, in addition to the scales described above, answered the
      musicotherapy Questionary (MQ), and the Subjective Impression of the Subject's Questionary in
      last meeting. Musicotherapy sessions were individual and lasted an average of 40 minutes.
      Music therapeutic techniques used were Musical Audition (MA) and Therapeutic Musical Audition
      (TMA).
    

Intervention name(s): Music therapy
Intervention type(s): Behavioral
Intervention description(s): Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days
Other intervention name(s): musictherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: breast cancer; gynecological cancer; radiotherapy; fatigue; musicotherapy
Aversive Therapy for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The purpose of this research study is to test a new way to help people quit smoking. The PI
      will test acceptability and feasibility of a new device called Pavlok wearable wrist band.
      Participants will be smokers who are highly motivated to quit. Participants will be
      randomized into intervention and control groups.
    

Detailed description: 
      The participants will be evaluated after 1 week and assessed for their ongoing participation
      and commitment to the study. Those still interested and eligible will be randomized to two
      groups described below and will continue the study for 3 more weeks. There will be follow up
      surveys at various time points while wearing the wristband (1 week, 2 week, 3 weeks) and a
      final survey at T=3 months.

      The intervention group will continue to wear the wristband and the wristband will deliver a
      slight electric stimulus every time it is pressed.

      The placebo group will wear continue to press the button on the wristband but it will not
      give a slight electric stimulus when pressed. Both groups will wear the device for a total of
      4 weeks.
    

Intervention name(s): Pavlok wristband with electric stimulus; Pavlok wristband without electric stimulus
Intervention type(s): Other; Other
Intervention description(s): it is a device for various behavior modifications in the form of wristband which participants will wear on the wrist. Device has maximum voltage of 0-500 volts, delivers a electric stimulus for a maximum of 1 sec and average duration of 0.2 secs; it is a device for various behavior modifications in the form of wristband which participants will wear on the wrist. Participants will not receive any electric stimulus since this feature will be turned off.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: aversive therapy
Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
Condition: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.

      PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients with
      myelodysplastic syndrome.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety, tolerance, and maximum tolerated dose of subcutaneous
           interleukin-2 (aldesleukin; IL-2) in patients with myelodysplastic syndrome (MDS).

        -  Evaluate the hematologic effects of subcutaneous IL-2 in MDS.

      OUTLINE: IL-2 will be administered in cycles of twice daily subcutaneous injections 7 days a
      week for 4 consecutive weeks. After each cycle the patient will be evaluated for response.
      The patient could continue IL-2 therapy for up to 12 cycles. There are 4 dose levels of IL-2.
      At each dose level 3 patients will be accrued sequentially.

      Treatment with IL-2 should be continued until grade III toxicity or any side effects
      requiring hospitalization occurs. After the patient returns to baseline pretherapy values or
      grade I toxicity, the subject will resume IL-2 at 50% of the initial dose. If the patient
      again goes into grade III toxicity or is in need of hospitalization, IL-2 will be
      discontinued.

      PROJECTED ACCRUAL: Between 12-24 patients will be accrued.
    

Intervention name(s): aldesleukin
Intervention type(s): Biological
Intervention MeSH terms: Aldesleukin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; atypical chronic myeloid leukemia, BCR-ABL1 negative; myelodysplastic/myeloproliferative neoplasm, unclassifiable; childhood myelodysplastic syndromes