bioihbjkbjnl/mcl2 huggingface dataset:
Inspiratory Muscle Training (EMI) on Inspiratory Muscle Strength, Pulmonary Capacity and Performance in Soccer Players
Condition: Breathing Exercises: Inspiratory Muscle Training
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The training of the respiratory muscles seems to be fundamental in people who require a high
      physical demand. There is abundant scientific evidence that relates the respiratory variables
      and the limitation to exercise. The published studies are athletics and cycling, however it
      is scarce in football. Objective. To assess the effects of inspiratory muscle training on
      lung function and sports performance in soccer players.
    

Detailed description: 
      Objective. To assess the effects of inspiratory muscle training (IMT) on lung function,
      inspiratory muscle strength and athletic performance in soccer players.

      Method. Participants will be randomized into two groups: experimental and sham . The two
      groups will perform a protocol of 8 weeks of training (6 days / week) with the PowerBreathe
      device. The EG will use progressive resistance loads up to 80% of the MIP, while the SG will
      use the device with a minimum load (20% PImax) during the 8 weeks. All participants will have
      the following tests before and after the intervention and 3 months after the end of the
      program: spirometry (FVC, FEV1), PImax, biophotogrammetry, and fit 30/15 test. For the
      statistical analysis, a 2-factor variance analysis will be performed for repeated measures
      and Pearson's correlations. The statistical significance will be set with a value of p <0.05.
      The effect size will be calculated using the partial eta-square.
    

Intervention name(s): Inspiratory muscle training
Intervention type(s): Device
Intervention description(s): The inspiratory muscle training program will be of the "strength and endurance" type, using the POWERbreathe® device and composed of: daily sessions (3 sets of 15 repetitions -inspiration), 6 days a week for 8 weeks. Participants will begin training breathing with a resistance of 20% of their PImax during the first week. After the first week, the resistance will increase between 5% and 10% in each session until reaching 80% of the PImax, which will be maintained during the first month. Upon completion, the PImax value will be re-evaluated and the player will train 80% of this new value during the second month. At the end of the second month, the PImax is evaluated and the player will train the third month with a resistance of 80% of this new value.
Other intervention name(s): G-IMT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized into two groups: experimental (G-IMT) and sham (Gn-IMT). The two groups will perform a protocol of 8 weeks of training (6 days / week) with the PowerBreath
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery
Condition: Polyp of Large Intestine; Colorectal Neoplasms; Crohn Disease
MeSH terms: Colorectal Neoplasms; Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether hemodynamic optimization with
      photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery
      could decrease the incidence of perioperative complications.
    

Detailed description: 
      All patients received the photoplethysmography monitoring, but the monitor was blinded in the
      control group.
    

Intervention name(s): Photoplethysmography
Intervention type(s): Device
Intervention description(s): Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and Young Adults: Links With Subjective Symptoms and Recovery
Condition: Sports-related Concussion
Study type: Observational

Summary: 
      Concussion in sports ("Sports-Related Concussion" or "SRC") are a public health issue. The
      management of these injuries is evolving rapidly and decisions to return to play are based on
      clinical judgment. It is now recognized that the assessment of cognitive function must be one
      of the components of the assessment, in particular, in the protocol used to decide if a
      patient can resume practice. The available scales include only a brief cognitive assessment
      but do not provide an understanding of the level of deficit treatment. The use of
      computerized TAP (Test of Attentionnal Performance) tests, including finer measures of
      reaction time and apprehending the different attention and executive components (alertnes,
      orientation, flexibility, inhibition, updating), would allow a better understanding of the
      nature of the disorder and link it to subjective symptoms, and recovery.
    


Intervention name(s): Inclusion Questionnaires; Questionnaires at inclusion, M1 and M3
Intervention type(s): Other; Other
Intervention description(s): During the inclusion visit, neuropsychologist tests the scales: SCAT3 (Sport Concussion Assessment Test 3ème version), Trail-making test (TMT), Wechsler Adult Intelligence Scale (WAIS) TAP, HAS (Hospital Anxiety and Depression scale) ; PSQI (Pittsburg Sleep Quality Scale) ; RPQ (Rivermead Post concussion symptoms Questionnaire) ; and RHFUQ (Rivermead head injury follow-up questionnaire); During the inclusion visit, the 1-month visit and the 3-month visit; neuropsychologist grading of the scales: SCAT3 (Sport Concussion Assessment Test 3ème version), Trail-making test (TMT), Wechsler Adult Intelligence Scale (WAIS) TAP, HAS (Hospital Anxiety and Depression scale) ; PSQI (Pittsburg Sleep Quality Index) ; RPQ (Rivermead Post concussion symptoms Questionnaire) ; and RHFUQ (Rivermead head injury follow-up questionnaire)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients consulting at the CMRR of the CHU Dijon Bourgogne
Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety
Condition: Diphtheria; Acellular Pertussis; Tetanus
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 2

Summary: 
      The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals'
      combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when
      administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years
      when co-administered with MMR vaccine in subjects who had previously received four doses of
      Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.
    


Intervention name(s): Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Erythrocyte Glutamine Level Relation to Pulmonary Hypertension Risk in Beta Thalassemia Major Children
Condition: Thalassemia in Children; Pulmonary Hypertension; Hemolysis
MeSH terms: Hypertension, Pulmonary; Hypertension; Thalassemia; beta-Thalassemia; Hemolysis
Study type: Observational

Summary: 
      The study will investigate the relation between erythrocyte glutamine/glutamate ratio and
      pulmonary hypertension risk in Egyptian thalassemic children in Assiut University Children
      Hospital
    


Intervention name(s): blood sample; Tricuspid regurge velocity
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): blood sample for measuring liver and kidney function, CBC, ferritin level and erythrocyte glutamine level; Tricuspid regurge velocity will be measured by doppler echocardiography denoting the pulmonary hypertension risk in children
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Upper Egypt thalassemic children aged 10-18 years old attending Assiut University Children
        Hospital.
      
Biospecimen description: 
      Plasma sample
    
Keywords: Thalassemia; Glutamine/glutamate ratio; Pulmonary hypertension
Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a non-randomized, three-armed, open-label, parallel-group, non-inferiority trial
      designed to compare the immunogenicity and safety of the SpikoGen COVID-19 vaccine in
      children aged 5 to <12 years and 12 to <18 years with adults aged 18 to 40 years. Children
      aged 12 to <18 years and adults received 25 µg of the recombinant protein together with 15 mg
      of Advax-SM. Children aged 5 to <12 years received a half-dose of the adjuvanted vaccine. The
      injection was given in two doses with a 21-day interval in the deltoid muscle of the
      non-dominant arm. The vaccine immunogenicity was evaluated at 14 days after the second dose.
      Solicited adverse events were recorded for 7 days after each vaccination. Unsolicited adverse
      events were collected through one month after the second dose. Safety monitoring was
      continued through six months after the second dose in children aged 5 to <12 years and 12 to
      <18 years.
    


Intervention name(s): Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant; SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Intervention type(s): Biological; Biological
Intervention description(s): SARS-CoV-2 recombinant spike protein (12.5 µg) with Advax-SM adjuvant (7.5 mg) in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm; SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm
Intervention MeSH terms: Myeloma Proteins; Paraproteins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: COVID-19; SARS-CoV-2; Recombinant protein; Spike; Advax-SM; Advax; Vaccine; Adjuvant
Aligning With Schools To Help Manage Asthma (Project ASTHMA)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Project ASTHMA is a school-based health center intervention program that institutes
      guideline-based chronic asthma care and provides supervised administration with daily
      preventive asthma medications to improve asthma symptoms and lung function, reduce emergency
      visits, and decrease missed days of school among children from communities with health
      disparities.
    

Detailed description: 
      Project ASTHMA in schools is a 7 month randomized control intervention pilot trial. Forty
      students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities
      frequently for their asthma, will be recruited from 3 urban SBHCs in the fall of 2018. All
      students will receive NHLBI guideline-based asthma assessments to determine eligibility and
      proper dosing of preventive medication. The asthma assessment will include spirometry
      testing. All enrolled students and parents will receive asthma education at the time of
      enrollment. Eligible students will be randomized to an intervention or usual care group using
      permuted block randomization stratified by SBHCs. In collaboration with the student's PCP,
      the SBHCs' mid-level providers will prescribe the preventive medication to the students in
      the intervention group. These students will receive the morning dose of their preventive
      medication from the school nurse each school day for the remainder of the school year.
      Students and their parents will be responsible to administer the evening and non-school day
      doses. Students randomized to the usual care group will be referred back to their PCP for
      further asthma management. All participants will be re-evaluated at 1, 3 and 7 months after
      enrollment, and medication dose adjustments will be made in the intervention group as needed.
    

Intervention name(s): Asthma Assessment & Management; Asthma Education; Controller medication at school
Intervention type(s): Other; Other; Other
Intervention description(s): Asthma Assessment & Management based on NAEPP-EPR3 guidelines; Asthma education on medications; Students will receive the morning dose of their daily preventive asthma medication at school on school days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group will receive the morning dose of their daily preventive asthma medication at school. The student & family will be responsible to administer the evening dose & both doses on non-school days.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pediatric; School Based Health Center
Effects of Smoking State on Decision Making
Condition: Behavior
Study type: Interventional

Summary: 
      Adult smokers will be tested using behavioral and neuroimaging measures after smoking as
      usual and after overnight abstinence.
    


Intervention name(s): smoking abstinence; smoking satiety
Intervention type(s): Other; Other
Intervention description(s): participants will be asked to not smoke for at least 12 hours; participants will be asked to smoke as usual
Intervention model: Single Group Assignment
Intervention model description: Participants will be instructed to smoke as usual before one fMRI study visit (satiated state) and to abstain from using all tobacco/nicotine for 12 hours before the other fMRI study visit (abstinence and/or withdrawn state). The order of the satiated and abstinence/withdrawn study visits will be randomized and counterbalanced across participants.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Decision making
The Effects of Mixed Grain on Blood Glucose and Insulin in Healthy Male
Condition: Healthy People; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study was an open, 4-treatment, 5-sequence, 5-day cross-over randomized design clinical
      trial to evaluate the efficacy of mixed grain on blood glucose, insulin and Glycemic
      index(GI) in healthy males.
    

Detailed description: 
      After a 12-hour fast, oral glucose or meal tolerance test was performed with blood samples
      drawn at time 0, 15, 30, 45, 90, 120, 150, and 180 min.

        1. Serum levels of glucose, insulin, and C-peptide were analyzed by biochemical
           autoanalyzer. The area under the curve (AUC) changes in blood glucose were computed by
           the trapezoidal method.

        2. Glycemic index(GI): the area under the glucose response curve after consumption of a
           test food divided by the area under the curve after consumption of a control food
           containing the same amount of carbohydrate and calculated using 50 g glucose as the
           reference.
    

Intervention name(s): Mixed grain 1; Mixed grain 2; White rice; Glucose solution
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.; All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.; All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.; All test foods contained 50 g available carbohydrate from the test food products.
Other intervention name(s): Mixed grain 1 (Giant embryonic brown rice) diet; Mixed grain 2 (Giant embryonic rice) diet; control diet; Reference diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mixed grains; Glycemic index; Giant embryonic brown rice; Giant embryonic rice; diabetes
OR PathTrac (Tracking Intra-operative Bacterial Transmission)
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Observational

Summary: 
      Healthcare-associated infections occur frequently and are associated with patient harm. These
      infections are becoming more difficult to treat due to antibiotic resistance. It is important
      that healthcare facilities take the steps necessary to prevent the spread of resistant
      bacteria between patients.
    

Detailed description: 
      Two patients undergoing sedation in a randomly selected operating room will be evaluated in a
      serial manner in order to detect transmission of pathogenic bacteria. Patient care will not
      change due to their participation in this study; the patients will undergo sedation and
      surgery according to usual practice. This study involves taking microbiology cultures from
      various places in the operating room before and after each procedure. Cultures will also be
      taken from the two patients after they are asleep and from their intravenous tubing. From
      both patients anesthesiologist, surgeon and their surgical team, cRNA, and nursing staff will
      also have cultures obtained. Each cultures will be de-identified and given a study ID number
      before transport to the research laboratory for microbiological assay. The patient's medical
      record will be reviewed for 30 days after surgery to surveil for documentation of a potential
      hospital acquired infection.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be surgical patients requiring peripheral intravenous and/or
        central venous catheter access and undergoing gynecology/oncology, colorectal, open
        vascular, total joint or cardiovascular procedures.
      
Biospecimen description: 
      The bacterial cultures can be kept and analyzed at a later date to determine how they have
      transformed into antibiotic resistant organisms.
Conventional and Molecular Diagnostic Method for Patients With Suspected UTI
Condition: Urinary Tract Infections-UTI
MeSH terms: Infections; Urinary Tract Infections
Study type: Interventional

Summary: 
      In this protocol, the investigators are examining the use of a novel pathogen testing
      technology and method of identification of antibiotic susceptibility against the conventional
      C & S testing for patients with both complicated and uncomplicated UTIs. The investigators
      will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic
      accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3)
      quality of life as defined by particularly symptomology and "bothersomeness" of the symptoms;
      and 4) overall cost.
    


Intervention name(s): culture versus Molecular diagnostics
Intervention type(s): Other
Intervention description(s): Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laser Tongue Debridement for Oral Malodor
Condition: Halitosis
MeSH terms: Halitosis
Study type: Interventional

Summary: 
      Malodor is a multifactorial condition with oral pathology representing the main culprit and
      the tongue being the first to second contributor to the malodor. Bacterial load can represent
      a quantifiable measure regardless of the original pathology. It is hypothesized that
      reduction in malodor can be represented by tongue changes both in appearance, bacterial and
      biofilm load reduction (measured by CFU and volatile gases measurement), organoleptic
      measurement and subjective improvement.

      Methods: A randomized controlled prospective study under IRB approval. Diagnostic criteria
      for enrollment and follow up were organoleptic test by 2 judges, halimeter reading, tongue
      colores changes HALT questionnaire and direct aerobic and anaerobic tongue cultures measured
      by CFU. Patients were treated with laser tongue debridement (LTD) with an Er,Cr:YSGG solid
      state laser has been shown to be effective in biofilm reduction.
    


Intervention name(s): Waterlase Express Laser System; Tongue scraper
Intervention type(s): Device; Device
Intervention description(s): 10-minute treatment with the Waterlase Express (Biolase, Irvine CA). The dorso-posterior surface of the tongue is treated with the laser in 10 passes of 60 seconds each with 10 seconds of rest in between. Laser settings were 60μs pulse width, 4W, 40Hz, 10% air and 5% water irrigation. An MC12 sapphire laser tip (Biolase, Irvine CA) is held 3mm away from the tongue in a constant sweeping motion during treatment with passes overlapping passes in alternate direction, side to side motion and front to back motion with laser fluence on the tongue surface calculated at 3J/cm2. The settings were non ablative and non thermal.; mechanical scraping of the dorso-posterior surface of the tongue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT
      chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.
    

Detailed description: 
      Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several
      prospective randomized trials have demonstrated that concurrent chemoradiotherapy was
      superior to radiotherapy alone in the treatment of locoregionally advanced NPC.
      Cisplatin-based chemotherapy has been shown to have higher response rates in NPC than
      noncisplatin regimens. However, the patients' compliance was unsatisfactory because the
      obvious gastrointestinal toxicity of cisplatin. Nedaplatin is the new second generation
      platinum and it has slight gastrointestinal reaction. Our trial is in order to study the
      effectiveness of nedaplatin or cisplatin with intensity-modulated radiation therapy (IMRT)
      chemoradiotherapy in treating patients with locoregionally advanced NPC.
    

Intervention name(s): Nedaplatin; Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT; Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
Other intervention name(s): NDP; DDP
Intervention MeSH terms: Nedaplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment