bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Music Therapy on Nurses
Condition: Music Therapy
Study type: Interventional

Summary: 
      This study was planned to examine the effect of music therapy on the comfort levels of
      nurses. In the study, data will be collected by using Descriptive Characteristics Information
      Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria will be in
      the intervention or control group will be determined by simple randomization. Music
      intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20
      minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the
      participants again.
    

Detailed description: 
      This study was planned to examine the effect of music therapy on the comfort levels of
      nurses. This study will be conducted as a randomized controlled experimental study. In the
      sample calculation, it was determined that for Power = 0.8 (beta = 0.2), alpha = 0.05 and
      effect size = 0.7, the sample size should be 66, 33 for the intervention group and 33 for the
      control group. In the study, data will be collected by using Descriptive Characteristics
      Information Form and Nurse Comfort Scale. Whether the nurses who meet the inclusion criteria
      will be in the intervention or control group will be determined by simple randomization.
      Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week,
      20 minutes per session. After 5 weeks, the Nurse Comfort Scale will be applied to the
      participants again. Research data will be analyzed in SPSS-25 package program.
    

Intervention name(s): music therapy
Intervention type(s): Other
Intervention description(s): Music intervention sessions will be applied to each participant for 5 weeks, 3 days a week, 20 minutes per session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: nurse; comfort; music therapy
Ergospirometric Values and WBV in Elderly
Condition: Aging
Study type: Interventional

Summary: 
      this study aims evaluate the ergospirometric values after 03 months of training with WBV in
      elderly health people. The hypothesis is increases of ergospirometric values.
    


Intervention name(s): WBV and Resistance; resistance & sham WBV; WBV & resistance sham
Intervention type(s): Device; Device; Device
Intervention description(s): use of WBV and resistance device during 03 months in elderly health people. The WBV used progressive increases of time and amplitude and the resistance training improves the weight.
For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction.
For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min.; used only resistance
For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction.
For WBV: used MY3 platform (Power Plate®, MY3, UK)off.; used really the WBV, but sham for resistance training
For Resistance: performed similar movments in upper and lower limbs in weight machine Mega II Movement®, without using weights.
For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: VO2; VCO2; VE/VO2; heart rate
A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based
      chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV
      NSCLC.
    


Intervention name(s): platinum-based chemotherapy alone (up to six cycles); platinum-based chemotherapy followed by maintenance therapy with gefitinib
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Omega-3 Supplementation Combined With Endurance Training Improve Running Economy in Recreational Runners.
Condition: Effect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue Functions
Study type: Interventional
Phase: Phase 3

Summary: 
      Recreational male runners participated in 12 weeks training and omega-3 supplementation
      programme. Before starting and at the end of the 12-week cycle, the runners performed an
      increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.
    

Detailed description: 
      40 healthy, recreational male runners participated in 12 weeks training and supplementation
      programme. The training protocol was built based on undulatory load manipulation 3:1, which
      was suggested to be effective to prevent overtraining and stress due to oscillations between
      volume/intensity. Throughout the study all participants took 4 identical-looking capsules per
      day (2 in the morning and 2 in the evening) containing either omega-3 fatty acids or medium
      chain triglycerides as placebo in total amount of 4g of fat per day. Before starting and at
      the end of the 12-week cycle, the runners performed an increasing intensity treadmill test
      where oxygen uptake and VO2 peak were assessed. Additionally, blood was collected to
      determine the concentrations of selected proteins (including eNOS, irisin, adiponectin) that
      may be associated with potential changes in participants' oxygen uptake during the treadmill
      test.
    

Intervention name(s): Omega-3 supplementation in recreational runners
Intervention type(s): Dietary Supplement
Intervention description(s): Male recreational runners participated in 12 weeks of endurance training combined with omega-3 fatty acids supplementation. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: omega-3; supplementation; endurance training; running
Brain Neoplasms, Leukemia and Petrochemical Exposures
Condition: Leukemia; Brain Neoplasm
MeSH terms: Leukemia; Neoplasms; Brain Neoplasms
Study type: Observational

Summary: 
      The aim of this study is to examine the association of exposure to air contaminants (PAH &
      VOC) emitted from the petrochemical industries, specific genetic polymorphisms (P4501A1 (MspI
      & exon 7) and GSTM1 & T1) of study subjects and their parents, and the risks of brain tumors
      and leukemia among children and youths in metropolitan Kaohsiung, southern Taiwan.
    

Detailed description: 
      Brain tumors and leukemia are the most common malignancies among children and adolescents in
      the U.S. Adequate information on the role of inherited genetic susceptibility and
      environmental exposures in the development of neoplasms in children and adolescents is
      lacking. In Taiwan, four large petrochemical industries are located in the Kaohsiung
      metropolitan area. These facilities are proximal to residential areas because of the high
      population density in the region. Data have shown that the concentrations of ambient
      polycyclic aromatic hydrocarbons (PAH) and volatile organic compounds (VOC) around the
      petrochemical industries are at least 10 and 2 times, respectively, higher than those in U.S.
      industrialized communities. Our preliminary case-control study in metropolitan Kaohsiung
      showed that young residents (under age 30) living within 3 kilometers of the vicinity of
      petrochemical industries have a 6.0 fold increase in brain neoplasms and a 2.9 fold increase
      in leukemia. The purpose of this proposal is to examine the association of exposure to air
      contaminants (PAH and VOC) emitted from the petrochemical industries, specific genetic
      polymorphisms (P4501A1 (MspI & exon 7) and GSTM1 &T1) from study subjects and their parents,
      and the risks of brain tumors and leukemia among children and youths in metropolitan
      Kaohsiung. Our hypothesis is that there is an increased risk of brain tumors and leukemia in
      patients with high cumulative exposure to these hazards, and that heritable polymorphisms in
      several genes modify this association. In addition to an independent association of
      environmental and genetic factors with brain neoplasms and leukemia, we hypothesize that
      there is greater risk associated with the presence of combined environmental exposure and the
      high risk genotype. Also, we will assess the role of parental genetic polymorphisms in the
      development of cancer in their siblings. This proposed study uses an environmental molecular
      epidemiologic approach, utilizing prospective enrollment of a cohort of brain tumor and
      leukemia subjects in a population-based case-control design. This proposal is responsive to
      the recommendation of the National Research Council that risk assessment and public health
      policy pay special attention to the protection of children.
    

Observational model: Case-Control
Keywords: Neoplasm; Petrochemical; Leukemia; Taiwan
Theory-Based Obesity Intervention Program for Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of education and counseling given to women
      according to the Theory of Planned Behavior on weight management. This study will be
      conducted as a single-blind randomized controlled study consisting of intervention and
      control groups. A total of 78 overweight and obese women included in the study. The
      participants assigned to either of the groups by the block randomization method. A training
      program consisting of a total of five sessions applied to the intervention group, and
      counseling will be provided for 6 months. The data will be analyzed with Statistical Package
      for Social Sciences (SPSS) 22.0 package program.
    


Intervention name(s): Application of The Theory of Planned Behaviour For Weight Control
Intervention type(s): Behavioral
Intervention description(s): The training to be imparted to the participants was applied online in groups of 5-6 people via the Google Meet program. Obesity training consisting of a total of five sessions. Each session lasted for approximately 30 minutes. After the training given to intervention group, the women will be followed-up for 6 months. The women in the intervention group will be given counseling service by the researchers, and their status will be evaluated every month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: obesity; women; health behaviors; Theory of Planned Behavior
Comparison of Photorefraction With Cycloautorefraction and Cycloretinoscopy at Emam Hosein Medical Centre in 2008-2009
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Screening of refractory defect is one of major reason for amblyopy. Photorefraction is a new
      method with some advantages in treatment of this problem. In this study the investigators are
      going to compare the results of this surgery in children between 1 to 10 years old with
      cycloautorefraction in children above 3 years old.
    


Intervention name(s): photorefraction,cycloautorefraction,cycloretinoscopy
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: children between 1 to 10 years old; amblyopy
A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare four different semaglutide versions and different injection tools.
      The study aims to show similar levels of semaglutide in the blood using different versions of
      semaglutide. The researchers also want to look at how well the injection tools work.
      Participants will get two versions of semaglutide at two separate dosing visits. One of them
      is a version that doctors already can prescribe and the other will be one of the new
      versions. Which version participants get first is decided by chance. Participants will get
      semaglutide as an injection under the skin. The time between injections is 7 to 8 weeks. The
      study will last for about 16 weeks. Participants will have 27 study visits with the study
      doctor. For two of the visits, participants will stay at the clinic for 4 days and 3 nights.
    


Intervention name(s): Semaglutide, 0.5 mg/mL; Semaglutide, 1.0 mg/mL; Semaglutide, 1.34 mg/mL; Semaglutide, 2.0 mg/mL; DV3372, 0.5 mg/mL; DV3372, 1.0 mg/mL; PDS290; NovoPen®4
Intervention type(s): Drug; Drug; Drug; Drug; Device; Device; Device; Device
Intervention description(s): A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.; A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.; A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.; A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.; DV3372 device will be used for administration of semaglutide 0.5 mg/mL.; DV3372 device will be used for administration of semaglutide 1.0 mg/mL.; PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.; NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Emulsion Droplet Physical State on Postprandial Lipemia and Satiety
Condition: Postprandial Lipemia; Satiety
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The purpose of this study is to compare the changes in blood lipids and feelings of satiety
      after consumption of oil-in-water emulsions in which the droplets are in either the liquid or
      solid (i.e. crystalline) states.
    

Detailed description: 
      A double blinded randomized cross-over acute meal study will be carried out in which 15
      healthy male participants will attend two study visits, separated by at least one week. On
      each study visit, fasted participants will consume either the solid or the liquid emulsion,
      in a randomized order. Both emulsions tested will have the exact same composition only
      differing in the physical state of the lipid emulsions, in order to isolate the impact of
      physical state, specifically, on metabolic response. Postprandial lipemia and satiety will be
      measured for 6 hours after consumption of the test beverage. The study meals will include
      crushed acetominophen, the appearance of which will be measured in plasma as a measure of
      liquid content gastric emptying. Participants will be asked to maintain their usual lifestyle
      habits throughout the study, with some changes in the 48 hour period leading up to each of
      the two visits.
    

Intervention name(s): Emulsion with solid droplets; Emulsion with liquid droplets
Intervention type(s): Other; Other
Intervention description(s): This will be a 500 mL beverage emulsion in which the droplets are crystalline. It will have identical composition to the other intervention, i.e. in one the lipid droplets are solid (i.e. crystallized) and the other in which they remain liquid will be introduced at least 7 days apart. The differences in physical state will be achieved simply by changing the temperatures the emulsions are held at. The emulsion will contain 10 % of the lipid palm stearin with 0.4% of the emulsifier sorbitan monostearate (Span60).; This will be a 500 mL beverage emulsion in which the droplets are liquid. It will have identical composition to the other intervention, i.e. in one the lipid droplets are solid (i.e. crystallized) and the other in which they remain liquid will be introduced at least 7 days apart. The differences in physical state will be achieved simply by changing the temperatures the emulsions are held at. The emulsion will contain 10 % of the lipid palm stearin with 0.4% of the emulsifier sorbitan monostearate (Span60).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Effectiveness of OBG vs.a Bandage Contact Lens for Large Corneal Epithelial Defects in Patients Post-PRK.
Condition: Corneal Epithelial Wound
Study type: Interventional

Summary: 
      This is a prospective, randomized (Reading Center), masked, controlled study in up to 45
      subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm
      well or trephine at the time of surgery to ensure consistency of the size of the ablation
      area.
    

Detailed description: 
      This is a prospective, randomized (Reading Center), masked, controlled study in up to 45
      subjects who have undergone bilateral PRK with epithelial removal using alcohol in a 9.0 mm
      well or trephine at the time of surgery to ensure consistency of the size of the ablation
      area. Subjects will be assigned to one of three treatment arms on Day 0.
    

Intervention name(s): Acuvue Oasys; Ocular Bandage Gel
Intervention type(s): Device; Device
Intervention description(s): Bandage Contact Lens; 0.75% crosslinked HA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Photorefractive Keratectomy, Corneal Defect
Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      To asssess efficacy of airway clearance provided by Vest therapy (HFCWO) in the reduction of
      respiratory exacerbations requiring hospitalization or antibiotic utilization in patients
      with muscle weakness and restrictive lung disease.
    

Detailed description: 
      This non-randomized home based pre-post intervention study. The study will compare the
      efficacy of Vest® therapy (HFCWO) for mucus secretion clearance in a population of patients
      with muscle weakness and restrictive lung disease with frequent pulmonary exacerbations.
      Enrolled subjects with a tracheostomy will be evaluated for microbial load and inflammatory
      status as a pilot evaluation of microbial load and inflammatory status outcomes.

      The total number of evaluable subjects to be recruited is estimated at 40. Subjects will be
      considered evaluable if they have completed at least 6 months of follow up.
    

Intervention name(s): Vest Treatment (high frequency chest wall oscillation)
Intervention type(s): Device
Intervention description(s): twice daily for 15-20 minutes
Other intervention name(s): HFCWO
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: High Frequency Chest Wall Oscillation; Cerebral Palsy; Restrictive lung disease
Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
Condition: Amino Acid Absorption
Study type: Interventional

Summary: 
      The purpose of this study is to examine the pharmacokinetic pattern of amino acid absorption
      after a two-week pattern of milk protein supplementation with and without the addition of
      Bacillus coagulans GBI-30, 6086.
    

Detailed description: 
      The study will be conducted using a randomized, double-blind, crossover study design. 30
      healthy men and women between the ages of 18 - 55 years of age will be recruited to
      participate in this study. Prior to beginning the study, all participants will sign an
      IRB-approved informed consent document and complete a healthy history questionnaire to
      determine study eligibility. Two supplementation protocols that each span two weeks will be
      completed and separated with a washout period of three weeks. For each study visit, all
      participants will report to the laboratory between 0600 - 1000 hours after observing an 8 -
      10-hour fast. For two weeks prior to each study visit, participants will be assigned in a
      randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk
      protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans
      GBI-30, 6086. Upon arrival for each study visit, participants will have their resting heart
      rate, blood pressure, body mass, height, and body composition measured using bioelectrical
      impedance analysis (BIA). Upon ingestion of their final assigned supplementation dose,
      standard multiple sample phlebotomy approaches will used to collect approximately 10mL of
      venous blood from a forearm vein before (0 min), 30, 60, 90, 120, 180, and 240 minutes after
      ingestion of their final assigned supplementation dose for that period in the study protocol.
      Participants will be provided 200 mL of cold water to ingest after each blood collection.
      Upon processing, all blood samples will be stored at -80 C. All samples will o be discarded
      according to Institutional Review Board-stipulated guidelines. Study participants will be
      provided an additional two-week supply of the alternative treatment to begin after observing
      a three-week washout. After two weeks of supplementation, study participants will return to
      the laboratory for their remaining testing visit. All subsequent study visits will be
      completed in a randomized fashion to minimize any order effects from testing.
    

Intervention name(s): Milk protein + GBI-30; Milk protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Both conditions matched flavor, color, and serving size; Both conditions matched flavor, color, and serving size
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other