bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      The main objective is to evaluate the effect of therapeutic exercise program on blood glucose
      regulation in women with gestational diabetes mellitus (GDM) who are assigned to
      diet-and-exercise, compared to diet only (usual treatment). The primary outcome is the need
      for insulin treatment in the two groups.
    

Detailed description: 
      In women with gestational diabetes, light to moderate daily physical activity may a useful
      therapeutic approach to improve the control of glycaemia and decrease the need for
      prescription of insulin. Increased physical activity in pregnant women with gestational
      diabetes is expected to decrease the mother and child morbidity associated with gestational
      diabetes, but also to improve the general health status of the mother and the child.

      The objectives of this randomized trial are:

        -  To evaluate the effect of therapeutic exercise program on blood glucose regulation in
           women with GDM who are assigned to diet-and-exercise protocol.

        -  To demonstrate the feasibility of the therapeutic exercise treatment and the possibility
           of using the exercise program as an optional therapeutic approach for women with GDM.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Once per week, participants will be enrolled in supervised group exercise intervention. They will be encouraged in walking 45 minutes per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD
Condition: COPD
Study type: Interventional

Summary: 
      It is a prospective, multi-institutional clinical study and targets patients diagnosed with
      chronic obstructive pulmonary disease. About 120 subjects (35 at Ilsan Paik Hospital, 35 at
      Severance Hospital, and 50 at Asan Medical Center in Seoul) will be subject to a random
      allocation of 1:1. The arbitration group implements living rules for responding to fine dust,
      supports air purifiers, and only general guidance is implemented in the non-property group.
      Patients are recruited from Asan Medical Center in Seoul (Songpa-gu, Seoul), Severance
      Hospital ( Seodaemun-gu, Seoul), and Ilsan Paik Medical Center (Goyang, Gyeonggi-do) for 12
      months. During outpatient visits, lung function tests and airway resistance tests shall be
      conducted, and surveys presented in the research plan shall be conducted.
    

Detailed description: 
      It is a prospective and multi-institutional clinical study targeting patients with chronic
      obstructive pulmonary disease in general.

      A total of 120 COPD patients will be recruited from three institutions: Asan Medical Center,
      Severance Hospital, and Ilsan Paik Hospital. (60/30/30 expected) A panel of COPD patients is
      established to conduct prospective studies, and measures to mediate recurrence and
      deterioration of adult chronic respiratory diseases due to exposure to fine dust are
      presented. Improvement of the lifestyle of the arbitration forces. Detailed research methods
      such as air purifier support are presented in the research plan.

      In addition, a fine dust measurement researcher visits each household to measure indoor fine
      dust concentration. The measurement method of fine dust concentration will be using the
      process test method, IoT-based sensors, and direct-to-read measuring devices to measure Air
      Korea's air pollution. Detailed visit timing and methods are carried out in the manner
      specified in the research plan.

      We collect sputum at every visit and blood at the last visit.
    

Intervention name(s): Five active practices of living rules for responding to fine dust.
Intervention type(s): Behavioral
Intervention description(s): Check the fine dust weather forecast
Check the operation time and filter of the air purifier
Window ventilation
Inhalant is used or not
Bad fine dust: Refrain from going out
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: COPD without intervention group , with intervention group
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Perminova Respiratory Effort Accuracy Validation 09-12-2013-Rev 2
Condition: Respiratory Rate Accuracy Test
Study type: Observational

Summary: 
      The purpose of this study is to validate the accuracy of the Perminova N4 Monitoring system
      Respiration Rate technology.
    

Detailed description: 
      After IRB Approval, eighteen volunteer test subjects will be entered into an accuracy study
      that is designed to validate accuracy of the respiratory rate technology of the Perminova N4
      Monitoring system (Device Under Test). The subjects will be selected to represent a range of
      body types including small, average, muscular, and large with a range of BMI's.

      A range of stable respiratory rates will be elicited from each volunteer test subject. The
      rates will be approximately 5, 10, 15, 20, 25, 30, 35 and 40 breaths per minute; with some
      natural variation from these exact numbers.

      Each subject will be instrumented with an open system mask that allows for measurement of the
      end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be
      used as the Accuracy Reference Device (Reference) in this study. Performance of the currently
      released ECG Impedance Respiratory Rate monitor (Acceptance Standard) will be used to
      establish the acceptance criteria in this study by comparing to Reference.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy Male or female, ages 18-45
      
Keywords: Respiratory Rate
Wearable Noninvasive Positive Pressure Ventilation Device in COPD
Condition: Non-Invasive Ventilation
Study type: Interventional

Summary: 
      The objective is to assess the impact of a wearable Noninvasive Positive Pressure
      Ventilation, on physical activity and quality of life in patients with severe COPD,
      complaining of dyspnea.
    

Detailed description: 
      In order to avoid the occurrence of uncomfortable dyspnea, patients with Chronic Obstructive
      Pulmonary Disease (COPD) are locked in a vicious circle of inactivity and social isolation
      which profoundly affects their quality of life and prognosis. A new wearable non invasive
      positive pressure ventilation device has been recently proposed; it can be used by
      intermittence during or after physical activities for reducing dyspnea or for shortening
      dyspnea- recovery time. The investigators hypothesize that this system, in reducing the
      inconvenience caused by dyspnea, would stimulate a more active lifestyle and improve quality
      of life. Their objective is to assess the impact of this device on physical activity and
      quality of life in patients with severe COPD, complaining of dyspnea.

      In this open study with no control group, participants will use the device at their
      convenience, according to their needs in daily life and for 4 weeks.
    

Intervention name(s): Non-Invasive Ventilation
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
MRI and Cardio-Pulmonary Exercise Testing in Evaluating Exercise Intolerance in Patients With Stage I-III Breast Cancer After Chemotherapy Treatment
Condition: Healthy Subject; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This pilot research trial studies magnetic resonance imaging (MRI) and cardio
      (heart)-pulmonary (lung) exercise testing in evaluating exercise intolerance in patients with
      stage I-III breast cancer after treatment with chemotherapy drugs called anthracyclines.
      Anthracyclines are related with heart problems, cardiac abnormalities, bone and muscle
      dysfunction. Patients with breast cancer who are exposed to anthracycline drugs may also
      experience progressive fatigue and exercise intolerance which may limit daily activities and
      is an important barrier for patients returning to work. Using MRI and cardio-pulmonary
      exercise testing (CPET) may help doctors understand the causes of fatigue and exercise
      intolerance in patients receiving anthracycline chemotherapy and this may also allow doctors
      to plan better treatments to protect patients' heart, cardiovascular system, bone and muscle
      function.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the feasibility of performing upright treadmill cardio-pulmonary exercise
      stress testing utilizing magnetic resonance imaging.

      II. To determine the reproducibility of measures of peak oxygen uptake (V02) and cardiac
      output as well as arterio-venous oxygen difference (A-V02) difference in survivors of breast
      cancer treatment and control participants.

      OUTLINE:

      Patients undergo CPET using a one-way breathing mask in 2 separate days 1-2 weeks apart.
      Patients also undergo MRI before and within 60 seconds after exercising.
    

Intervention name(s): Cardiopulmonary Exercise Testing; Magnetic Resonance Imaging
Intervention type(s): Other; Device
Intervention description(s): Undergo CPET; Undergo MRI
Other intervention name(s): CPET; CPX; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MRI; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult women with breast cancer or age-matched control
Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors
Condition: Gastric Tumor; Helicobacter Pylori; Endoscopic Resection; Metachronous Neoplasms
MeSH terms: Stomach Neoplasms; Neoplasms, Second Primary
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Helicobacter pylori eradication could
      reduce the new tumor development after endoscopic resection of gastric tumor.
    

Detailed description: 
      The association between Helicobacter pylori infection and development of gastric cancer has
      been established by epidemiologic studies. Conversely, eradication of H. pylori showed no
      significant reduction of the incidence of gastric cancer in a large-scale, double-blind,
      randomized controlled trial. Eradication of H. pylori to prevent cancer was only effective in
      the subgroup without precancerous lesions (i,e, dysplasia, intestinal metaplasia, and
      atrophy). In contrast, randomized prospective study in Japan showed that H. pylori
      eradication after endoscopic resection of early gastric cancer significantly reduced
      metachronous gastric cancer. To solve this conflicting issue is critical because gastric
      cancer is the second leading cancer incidence worldwide, particularly Korea, Japan, and China
      have highest cancer incidence, and its incidence might decrease by H. pylori eradication
      treatment.

      With respect to therapeutic modality, endoscopic resection for early gastric cancer is
      currently the established treatment of choice in Korea and Japan because it has been proven
      to be both minimally invasive and effective in the curative treatment of early gastric
      cancer.

      Endoscopic resection has also been performed in the gastric dysplasia because dysplasia has
      to some extent malignant potential although firm evidence is lacking. In comparison with
      surgical resection, endoscopic resection conserves remnant stomach. Accordingly, patients
      treated with endoscopic resection have higher possibility for metachronous gastric cancer
      than those treated with surgical resection.

      So far, it has not yet been clearly established whether H pylori eradication for gastric
      tumors (early gastric cancer and gastric dysplasia) could reduce metachronous cancer. We
      performed randomized controlled, open-label trial on the effect of new cancer development
      after H pylori eradication for gastric tumors.
    

Intervention name(s): eradication treatment of Helicobacter pylori infection
Intervention type(s): Drug
Intervention description(s): Eradication group receive Omeprazole sodium 20mg, amoxicillin 1g, clarithromycin 500mg orally at the same time twice daily for 7 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric tumor; Helicobacter pylori; endoscopic resection; metachronous neoplasms
The Incidence of Difficult Intubation in Obese Versus Non-obese Patients
Condition: Airway Obstruction
MeSH terms: Airway Obstruction
Study type: Observational

Summary: 
      The aim of our study is to identify the incidence of difficult endotracheal intubation in
      patients with normal BMI undergoing surgery under general anaesthesia in our hospital and
      compare it to that of obese patients.
    


Intervention name(s): ET Tube
Intervention type(s): Other
Intervention description(s): Patients with a BMI of greater than 30 or less than who are presenting to the hospital for any surgical procedure requiring general anesthesia
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Heterogeneous group representing the general population of Muharraq
Beneficial Effects of Music on Cognition and Consciousness Level
Condition: Coma
MeSH terms: Coma
Study type: Interventional

Summary: 
      Exposure to music improves cognitive function in 'healthy' participants and in brain-damaged
      patients. However, it is still difficult to understand what precisely in music causes a
      positive effect : are they emotional components, familiarity or preference which improve
      cognition or is there any specific effect of music? Moreover, it is not yet possible to
      characterize the neural and functional links between the brain systems solicited by music and
      those associated with other cognitive functions enhanced by music.

      Finally, researches on brain-damaged patients have not exploited the potential effect of
      music on the level of alert and perceptual awareness, while this type of stimulation could be
      a valuable tool to improve cognition in patients with a disturbance of consciousness and
      alertness.

      The main objective is to describe the impact of music on the brain's response to
      self-referential or neutral stimuli in brain-damaged patients with persistent consciousness
      disorder after a coma and in healthy participants.
    


Intervention name(s): Electroencephalography (EEG)
Intervention type(s): Other
Intervention description(s): EEG will be performed to assess brain activity in response to sounds of different nature, including music and the given name of the registered person
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Brain-damaged; Disorders of consciousness; Post-coma; consciousness; coma; vegetative state; minimally conscious state; music; P300
A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase 2 randomized study is to evaluate the efficacy and safety of
      treatment with a regimen of VELCADE, dexamethasone, and thalidomide (VDT) or VELCADE,
      dexamethasone, thalidomide, and cyclophosphamide (VDTC) in subjects with newly diagnosed
      symptomatic multiple myeloma who have received no prior treatment and are candidates to
      receive high-dose therapy and autologous bone marrow/stem cell transplantation.
    


Intervention name(s): bortezomib, dexamethasone, and thalidomide; bortezomib, dexamethasone, thalidomide, and cyclophosphamide
Intervention type(s): Drug; Drug
Intervention description(s): VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21)
Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles.
Thalidomide will be given by mouth (p.o.)every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime).; VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy(HDT)and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m2 as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21).
Dexamethasone 40 mg/day will be given by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles.
Thalidomide will be given by mouth (p.o.) every day, starting on Day 1 of Cycle 1 (e.g., the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime).
Cyclophosphamide will be given as an intravenous (i.v.) dose of 400 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for a total of 4 cycles.
Intervention MeSH terms: Thalidomide; Dexamethasone; Dexamethasone acetate; Cyclophosphamide; Bortezomib; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Branched-chain Amino Acids in the Development of Insulin Resistance
Condition: Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to clarify the role of the branched-chain amino acids in the
      development of Insulin resistance in patients with diabetes
    

Detailed description: 
      The proposed project aims to elucidate the role of the BCAA in the development of insulin
      resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease
      of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin
      resistance and diabetes progression.

      The specific aims are to elucidate the effect of the diet induced decrease of BCAAs
      concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat
      distribution (III) energy metabolism (IV) metabolic and inflammatory status
    

Intervention name(s): Branched-chain amino acids reduced intake
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Myopic Control for High Myopes Using Orthokeratology
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the eyeball elongation in high myopic
      children using partial correction orthokeratology and single-vision spectacles.
    

Detailed description: 
      Orthokeratology (ortho-k) has been shown to have strong potential for retardation of myopic
      progression in low myopes. To date, clinical experience has shown the technique to be less
      effective in achieving full myopic reduction in high myopes. Would myopic control be possible
      for high myopes undergoing partial correction ortho-k treatment?

      A randomized, longitudinal study is designed to investigate the efficacy of partial
      correction ortho-k in retardation of myopic progression in high myopic children. Eye growth
      in terms of axial length elongation in children wearing ortho-k and over-spectacles (to
      correct residual refractive errors) (study group) and those wearing single-vision spectacles
      (control group) will be evaluated and compared.
    

Intervention name(s): Orthokeratology lenses; Single-vision spectacle lenses
Intervention type(s): Device; Device
Intervention description(s): Nightly use of orthokeratology to correct the refractive error and over-specs for a period of two years; Daily use of spectacles to correct the refractive error for a period of two years
Other intervention name(s): Corneal reshaping therapy; Glasses; Spectacles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: children; corneal reshaping; myopia; myopia control; orthokeratology
A Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Postmenopausal Women
Condition: Amino Acid; Body Weight Changes; Skin Manifestations; Obesity; Postmenopausal Disorder
MeSH terms: Overweight; Body Weight; Body Weight Changes; Skin Manifestations
Study type: Interventional

Summary: 
      The use of dietary amino acids has been explored for therapeutic and safety intervention of
      obesity and obesity-induced dysfunction. In particular, 3 molecules have been shown to be
      effective both in the animal model and in humans, in promoting the loss of fat mass,
      specifically visceral adipose tissue, and in maintaining free fat mass: arginine, glutamine
      and leucine (and its metabolite beta hydroxy methyl butyrate, HMB). The aim of this study was
      to evaluate the efficacy in terms of fat mass, in particular Visceral Adipose Tissue
      reduction, as primary end point, in obese patients following the administration of specific
      food for special medical purposes (FSMP) for muscle recovery, consisting of arginine,
      glutamine and HMB. The secondary end point is the evaluation of skin state, by a validate
      self-reported questionnaire survey to assess skin, after 4- weeks intake of this FSMP.
    


Intervention name(s): L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate; Placebo
Intervention type(s): Dietary Supplement; Combination Product
Intervention description(s): 2 daily sachets (mid morning and mid afternoon) of an oral dietary supplement with L-glutamine and L-arginine and calcium beta-hydroxy-beta-methylbutyrate; Isocaloric formula
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Children's Health Study Diet and Air Pollution
Condition: Diet Habit; Pollution; Exposure; Child Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      This study is built upon the existing data in the Children's Health Study to examine the
      longitudinal association between childhood exposure to air pollutants and changes in diet
      among adolescents.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children from 12 Southern California communities were enrolled into the study in 4th and
        7th grades (1993-1994) and were followed annually until high school graduation (1998-2001).