bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of NMES Associated to Vascular Occlusion in Functional Performance and Muscle Hypertrophy in Athlete's
Condition: Electric Stimulation Therapy; Muscle Strength
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      This study evaluates the effect of training with neuromuscular electrical stimulation (NMES)
      associated with vascular occlusion of the lower limbs, for increased strength and hypertrophy
      of the quadriceps muscle of professional basketball athletes.
    

Detailed description: 
      The pre-season preparation is seen as vital to maximize sports performance. However, there
      has been much debate on what the best strategy to prepare for use. Basketball is a sports
      activity of high intensity and volume of jumps, which are generally likely to cause injuries
      resulting from muscle imbalance and dynamic overload. Primarily in activities with eccentric
      contraction of the knee extensor muscles. A means of preventing injuries and optimization of
      sports performance is through strength training. Neuromuscular electrical stimulation (NMES)
      has been a physical therapy effective in increasing the recruitment of muscle fibers and
      strength. Another method that has been shown effective in increasing strength and muscle
      hypertrophy is the association of low intensity training and peripheral vascular occlusion.
      Therefore, the purpose of this study is to evaluate the effectiveness of neuromuscular
      electrical stimulation associated to vascular occlusion of lower limb muscle recruitment,
      strength and muscle hypertrophy. This will be met recruited basketball athletes of high
      performance, the males, aged between 18 and 30 years and BMI between 20 and 24 Kg/m2. The
      athletes will be randomized into four groups: group control (n = 15), group electrotherapy (n
      = 15) and group electrotherapy + vascular occlusion (n = 15). Will be carried out 12 sessions
      of treatment during the pre-season, and the volunteers evaluated before and after the
      pre-season and in middle the season, through the following instruments: Isokinetic
      Dynamometer, Surface Electromyography, Force Platform, Cross Section Area of Muscle, Vertical
      Jump, Functional Evaluation (Jump, Agility and Balance), Infrared Thermography and Numeric
      Scale of Pain Evaluation. For data analysis, normality test is used to verify the data
      distribution and consistent statistical test for the appropriate comparisons within and
      between groups, and thus considered two factors in the comparisons, time and group. Will
      adopt a significance level of 5%.
    

Intervention name(s): NMES; Vascular Occlusion
Intervention type(s): Device; Device
Intervention description(s): Neuromuscular Electrical Stimulation; Restriction of sanguine flow to the lower limbs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Physical Therapy; Rehabilitation; Neuromuscular Electrical Stimulation; Muscle Strength
Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five
      treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The
      overall objective is to demonstrate that the combination of budesonide (BD; PT008) and
      formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides
      benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.
    


Intervention name(s): BFF MDI 320/9.6 μg; BFF MDI 160/9.6 μg; BFF MDI 80/9.6 μg; BD MDI 320 μg; FF MDI 9.6 μg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID); Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID); Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID); Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID); Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Budesonide and formoterol inhalation aerosol
To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy Study in Male and Female
      with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period.
    


Intervention name(s): HMI-115
Intervention type(s): Drug
Intervention description(s): Once Every 2 weeks, subcutaneously injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 3, 2011
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate markers, mechanisms and define general predictors for
      immunological health by comparing influenza vaccine responses in monozygotic and dizygotic
      twins.
    

Detailed description: 
      The investigators plan to study the response to influenza vaccines much more broadly and
      deeply across different age groups and with different vaccine formulations and to probe the
      influence of genetics on these responses using monozygotic and dizygotic twins. On an
      investigational basis, investigators plan to compare various immunological responses,
      identify age-specific biomarkers or clusters of markers, quantify the frequency of
      influenza-specific T-cells pre- and post-vaccination, and determine the effective breadth of
      T-cell repertoire to an influenza vaccine within an individual as a function of age and to
      what degree this is genetically determined.

      Twin Groups B-E will receive a single administration of the 2011-2012 formulation of seasonal
      trivalent inactivated influenza vaccine (TIV). Group F, elderly monozygotic twin
      participants, will be randomly assigned to receive a single dose of inactivated vaccine,
      either the usual dose or the High-Dose TIV. Blood samples to conduct the assays described
      will be taken at pre-immunization, Days 7-10 and 28 post-immunization. The number of
      individual participants, not the number of twin pairs is being reported in all the modules.
    

Intervention name(s): TIV; High-Dose TIV
Intervention type(s): Biological; Biological
Intervention description(s): Influenza Virus Vaccine Suspension for Intramuscular Injection; High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for intramuscular injection
Other intervention name(s): Fluzone® TIV; High-Dose Fluzone® TIV
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Trivalent, inactivated influenza vaccine; High-Dose trivalent, inactivated influenza vaccine; Adult and elderly identical twins; Adult fraternal twins
Sildenafil and Exercise Capacity in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Hypertension (persistently elevated blood pressure) is a major risk factor for heart disease
      and stroke. Hypertensive individuals show a reduced exercise capacity, which is present from
      a very early stage and contributes to their increased cardiovascular risk. Sildenafil belongs
      to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, and it works by
      enhancing the effects of nitric oxide, a substance that dilates blood vessels and increases
      blood flow. We hypothesize that sildenafil, because of its effect on nitric oxide and blood
      flow, will improve exercise capacity in hypertensive patients. Therefore, the main aim of the
      study is to investigate the effects of PDE5 inhibition on exercise capacity and vascular
      function in hypertension, and to compare these effects in hypertensive patients and healthy
      controls.
    


Intervention name(s): sildenafil; hydralazine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50mg 3 times daily for 7 days; 25mg 3 times daily for 7 days; 3 times daily for 7 days
Other intervention name(s): Viagra
Intervention MeSH terms: Hydralazine; Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Hypertension; Exercise capacity; PDE5 inhibitors
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of
      infants undergoing Lumbar Puncture (spinal tap).
    

Detailed description: 
      Pain of infants will be measured using the Neonatal Facial Coding System by videotaping the
      infant's face while they undergo the procedure. A comparison between the group that received
      active drug and the group that received placebo will allow a measurement of the difference,
      if any, of the pain experienced during the procedure of the infants.
    

Intervention name(s): Lidocaine Cream 4%; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure; inactive placebo without LMX4
Other intervention name(s): LMX4
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pain; lumbar puncture; neonates; infants; emergency department; topical anesthesia; LMX4
Patient Perceptions and Willingness to Enroll in Clinical Trials
Condition: Cancer, Clinical Trials
Study type: Observational

Summary: 
      The objective of our study is to determine which factors affect willingness to participate in
      gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will
      be approached to complete a survey assessing willingness to participate in clinical trials.
      The validated Attitudes and Randomized Trials Questionnaire (ARTQ) will be used to assess
      willingness to participate.
    


Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Attitudes and Randomized Trial Questionnaire (ARTQ), Hospital Anxiety and Depression Scale, Perception Survey
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All women presenting to the gynecologic oncology clinic meeting the inclusion/exclusion
        criteria will be approached to participate in this study.
Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness
      and safety of non-hormonal medical device versus sham device to treat VVA in post-menopausal
      women.
    

Detailed description: 
      After screening and baseline assessment, participants, ages 21 to 65 years of age, will be
      randomized and followed for a 12-week intervention period. After the primary endpoint
      evaluation at week 12, each participant in both arms will immediately commence an open label
      period using an Active device for week 13 to 1 year to collect further effectiveness and
      safety data.
    

Intervention name(s): Non-hormonal vaginal device therapy; Sham vaginal device therapy
Intervention type(s): Device; Device
Intervention description(s): Experimental Active Therapy; Sham Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Balance Training in Diabetic Neuropathy
Condition: Diabetic Neuropathy With Neurologic Complication
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      This study evaluates the efficacy of balance training in Diabetic Neuropathy. Control group
      will receive general exercises while Eperimental/ Interventional group will receive Balance
      exercises along with general exercises.
    


Intervention name(s): Balance Training; General Exercises
Intervention type(s): Other; Other
Intervention description(s): Balance enhancing exercises; General Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes Mellitus type 2; Diabetic neuropathy; Rehabilitation; Balance exercises; Berg Balance Scale
Effect of the Use of a Visual Feedback Device in RCP Trainings
Condition: Simulation Training
Study type: Interventional

Summary: 
      To verify the efficacy of manikins with feedback in the training of physicians and nurses in
      the courses of Advanced Cardiac Life Support (ACLS) authorized by the American Heart
      Association (AHA) when compared to the traditional training form.
    

Detailed description: 
      Introduction: The Cardiopulmonary Arrest (CRP) is the largest medical emergency, training is
      fundamental for a good performance in Cardiopulmonary Resuscitation (CPR). In a realistic
      simulation scenario, the results tend to improve with the use of feedback manikins that
      evaluate the quality parameters in CPR and show in real time what the rescuer needs to
      improve in order to be successful in training and increase the probability of success in
      future real care. Objective: To verify the efficacy of the manikins with feedback in the
      training of physicians and nurses in the courses of Advanced Cardiac Life Support (ACLS)
      authorized by the American Heart Association (AHA). Methods: Comparison of CPR performance of
      ACLS students. The intervention group will be submitted to the real-time feedback of the
      manikins, the control group will receive feedback from the instructor. Statistical analysis
      will consist of inter-group comparisons and will cover mean, standard deviation, and
      parametric tests such as Student's T test. The results will be related to the characteristics
      of the sample, including anthropometric profile, profession, training time, practice area,
      previous training with a focus on CPR and physical exercise practice.
    

Intervention name(s): Feedback mannequim
Intervention type(s): Device
Intervention description(s): The intervention group received rcp training with their performance being evaluated in real time so that they could correct themselves
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cardiopulmonary ressuscitattion; education medical continuing; emergency medical services; simulation training; feedback dummy
Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of topical pimecrolimus on the immune
      system by assessing the levels of antimicrobial peptides in the skin of patients with eczema.
      It is hypothesized that pimecrolimus applied topically will repair the body's immune system
      in patients with eczema by increasing antimicrobial peptides.
    

Detailed description: 
      Patients with atopic dermatitis (AD) have higher rates of skin infections from viruses and
      bacteria. They also have an impaired innate immune system. Antimicrobial peptides are a
      component of the innate immune system which are decreased in atopics. In vitro, pimecrolimus
      has demonstrated its ability to increase antimicrobial peptides. This study will examine the
      ability of pimecrolimus to increase antimicrobial peptides in vivo in AD patients. Thus, the
      study will yield a better understanding of the role of pimecrolimus in regulating the immune
      system in atopics.
    

Intervention name(s): Pimecrolimus; Vehicle cream
Intervention type(s): Drug; Other
Intervention description(s): 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).; 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1.
Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
Other intervention name(s): Elidel; CASM 981
Intervention MeSH terms: Pimecrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: atopic dermatitis; elidel; pimecrolimus; CASM981; immunity; cathelicidin; antimicrobial peptide; eczema
Motivation to Change, Coping, and Self-Esteem in Adolescent Anorexia Nervosa
Condition: Personality Features in Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      By use of several questionaires, this study aimed at an investigation of the changes in
      motivation, symptoms, self-esteem and coping style in adolescent patients with anorexia
      nervosa.. The psychometric properties of the Anorexia Nervosa Stages of Change Questionnaire
      (ANSOCQ) and its relation to coping style and self-esteem were assessed. After a treatment
      period of nine months, clinical AN diagnosis and the body mass index (BMI) were re-assessed.
      Besides construct validity of the ANSOCQ, its predictive validity in terms of predicting the
      outcome of AN was assessed.
    

Detailed description: 
      N=92 adolescents referred to an eating disorders clinic meeting criteria for anorexia nervosa
      (AN) gave written informed consent to participate in this study and completed the ANSOCQ, the
      Eating Disorder Inventory (EDI-2), the Eating Attitudes Test (EAT), the Body Image
      Questionnaire (BIQ), two questionnaires measuring Self-Related Cognitions (SRC) and the
      Coping Across Situations Questionnaire (CASQ). After a treatment period of nine months,
      clinical AN diagnosis and the body mass index (BMI) were re-assessed. Exploratory factor
      analysis and logistic regressions were performed.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        N=92 adolescents referred to our eating disorders clinic meeting criteria for anorexia
        nervosa (AN).
      
Keywords: eating disorders; ANSOCQ; anorexia nervosa
Pilot Study on Shear-induced Platelet Aggregation in Acute Coronary Syndromes
Condition: Angina, Unstable
MeSH terms: Acute Coronary Syndrome; Angina, Unstable
Study type: Observational

Summary: 
      The purpose of this study is to determine whether shear-induced platelet aggregation is able
      to discriminate first acute coronary syndrome (ACS) from recurrent ACS
    

Detailed description: 
      Predictive factors of recurrence of ACS are not well determined. Platelet aggregation and
      leucocyte activation seem to be involved in the pathogenesis. The aim of our study is to
      compare SIPA, platelet activation and platelet-leucocytes aggregates on the onset of the ACS
      and 3 months later in 2 groups of patients scheduled for a first episode of ACS or recurrent
      ACS .
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients admitted in the intensive care unit with acute coronary syndrome
      
Biospecimen description: 
      serum, plasma, urines
    
Keywords: SIPA; acute coronary syndrome
Effect of Exercise and Protein Supplementation on Muscle Function in Patients With Hemodialysis
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Sarcopenia can be easily observed in patients with hemodialysis. However, there were few
      studies on the precise concept and diagnostic criteria for sarcopenia in patients with
      hemodialysis. The investigators have already recognized the sarcopenia-associated mortality
      and morbidity in patients with hemodialysis. However, intervention studies on hemodialysis
      patients with sarcopenia have not been conducted until now. Here, The investigators aim a
      pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention
      for sarcopenia in patients with hemodialysis.

      This is a prospective study with 60 patients with hemodialysis who were diagnosed as
      sarcopenia or frailty in our previous cohort study. Combined intervention will consist of
      resistance exercise and nutritional supplementation for 12 weeks. The primary outcome of this
      study is muscle mass and handgrip strength after 12 weeks' intervention. All functional
      outcomes will be measured at 0, 12, and 24 weeks after intervention. The data will be
      analysed using the intention-to-treat principle.
    

Detailed description: 
      While feasible, inexpensive, and non radiation-exposed tools such as bioimpedance analysis
      have been used to measure appendicular skeletal muscle mass. In addition, isokinetic strength
      will be measured by a dynamometer for hand grip strength to evaluate sarcopenia. The main two
      axes of treatment of conventional sarcopenia are muscle resistance exercises and protein
      supplementation including branched chain amino acids. Therefore, it is necessary to confirm
      the clinical effect by intervention for resistance exercise and nutritional supplementation
      in patients with hemodialysis.
    

Intervention name(s): exercise and nutritional support
Intervention type(s): Other
Intervention description(s): resistance exercise and protein supplementation including branched chain amino acids for 12 weeks
Other: Combined exercise and nutrition intervention resistance exercise and nutritional supplementation for 12 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment