bioihbjkbjnl/mcl2 huggingface dataset:
CPAP Improves the Walking Capacity in Patients With COPD and OSA
Condition: Walking Capacity
Study type: Interventional

Summary: 
      We have reported that CPAP treatment improved the walking capacity of overlap syndrome
      patients.

      However, the previous study was not randomized, double blinded study. Therefore, we design a
      prospective, randomized, double blinded, controlled, cross-over trial to confirm this
      finding.
    

Detailed description: 
      inclusion criteria :

        -  COPD : FEV1/FVC < 70%, no response to bronchodilator (FEV1 change <12% and <200ml)

        -  OSA : AHI > 15/h, obstructive type predominant

      exclusion criteria :

        -  any malignancy

        -  pregnancy

        -  claustrophobia

        -  age<18

      primary outcome : exercise capacity (walking distance (meter), measured by incremental
      shuttle walking test)

      Method : For those fit in criteria. CPAP titration will be performed to determine the optimal
      pressure Baseline measurement : incremental shuttle walking test, urine catecholamine, heart
      rate variability, muscle power and other baseline characteristics Randomized those patients
      to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat
      measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement
      group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP
      treatment with optimal pressure for 1 month, repeat measurement
    

Intervention name(s): CPAP
Intervention type(s): Device
Intervention description(s): Randomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement
Other intervention name(s): continuous positive airway pressure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: walking capacity; COPD; OSA; CPAP
How to Get a Better Dry Weight in End-stage Renal Disease (ESRD) Population for Improving Blood Pressure Control
Condition: Blood Pressure; End Stage Renal Disease; Hemodialysis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      End-stage renal disease (ESRD) is a common clinical condition. In this population, the
      prevalence of systemic hypertension is high and its adequate control can determinate the
      outcome.

      The first step for a good control of blood pressure in renal patients is adjusting his/her
      dry weight. Actually, dry weight is assessed based on clinical examination and blood
      pressure.

      The electrical bioimpedance is a simple and portable device. The investigators design a
      randomized clinical trial for evaluating two ways of getting the best dry weight for
      hemodialysis patients.

      A basal 24h ABPM will be taken before the randomization. Then, 2 weeks later the dry weight
      be revised, the investigators will get a second 24h ABPM.
    

Detailed description: 
      End-stage renal disease (ESRD) is a common clinical condition over the world. In this
      population, the prevalence of systemic hypertension is high and its adequate control can
      determinate the outcome.

      The first step for a good control of blood pressure is giving a dry weight for the patient.
      We can understand dry weight or target weight as that one which the patient feels comfortable
      and there aren't clinical signals of volemic overload as edema, dyspnea, orthopnea, jugular
      turgency, hepatomegalia. Classically, the dry weight is assessed based on clinical
      examination, blood pressure and experience of hemodialysis staff.

      The electrical bioimpedance is a very simple method that possibilities access the corporal
      compartments, including the body water, using a small and not expensive portable device.

      Trying to study new forms for getting the ideal dry weight, we design a randomized clinical
      trial for evaluating two ways of getting a dry weight for hemodialysis patients.

      One group will be dry weight fixed by bioimpedance data and in another group the dry weight
      will by a clinical protocol.

      We will take a 24h ABPM basal from all patients before the randomization. Then, 2 weeks later
      the dry weight be revised, a second ABPM will be taken. The results will be compared.
    

Intervention name(s): Clinical; electrical bioimpedance
Intervention type(s): Procedure; Device
Intervention description(s): Each patient will be submitted a clinical evaluation, considering signals of overload.; From electrical bioimpedance data, will be fixed a revised dry weight for each patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dry weight; Blood Pressure; Chronic Kidney disease
Efficacy and Safety Study of MT10107 in the Treatment of Glabella Line
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This study design is a parallel, active drug controlled, double blind, randomized,
      multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus
      BOTOX® in treatment of glabella line.
    

Detailed description: 
      This study design is a parallel, active drug controlled, double blind, randomized,
      multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus
      BOTOX® in treatment of glabella line. Subjects who voluntarily signed the informed consent
      and are judged to be eligible for this study will be intramuscularly injected with the study
      drug or the comparator at a total of 20U (4U/0.1ml each) in five sites of the glabella line.
      Thereafter, follow-up visits will be made at 4 weeks, 10 weeks, 16 weeks and the efficacy and
      safety assessments will be conducted for a total of 16 weeks.
    

Intervention name(s): Botox (Botulinum toxin type A); MT10107 (Botulinum toxin type A)
Intervention type(s): Drug; Drug
Intervention description(s): 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.; 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glabella line; Glabella lines; Botulinum Toxin
Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients
Condition: Non Erosive Reflux Disease; Chronic Gastritis
MeSH terms: Gastroesophageal Reflux; Gastritis; Gastritis, Atrophic
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and
      2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis
      patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.
    

Detailed description: 
      A multicenter, randomized, open-label Phase IV study exploring symptom control rate in
      co-diagnosed NERD and chronic gastritis patients treated with 8 weeks esomeprazole treatment
      regimen and 2 weeks esomeprazole treatment regimen.
    

Intervention name(s): Esomeprazole; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment; 20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GI; Nexium; Phase IV; Co-diagnosed NERD
Study of Ulipristal Acetate in Female Patients With Moderately or Severely Impaired Renal Function, Compared With Matched Healthy Female Subjects
Condition: Renal Function
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to observe the effect of renal function on the pharmacokinetic,
      safety, and tolerability profiles of Ulipristal acetate following administration of a single
      oral dose of a 10 mg Ulipristal acetate tablet.
    


Intervention name(s): Ulipristal acetate
Intervention type(s): Drug
Intervention MeSH terms: Ulipristal acetate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Bran Size on Glycemic Responses
Condition: Potential Abnormality of Glucose Tolerance; Appetitive Behavior
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This study investigated the effects of bran's particle size on glycemic responses
    

Detailed description: 
      This study aimed at 1. to determine the GI and GL of three breads and 2. to investigate the
      effects of bran's particle size on postprandial glycemic response in healthy subjects.
    

Intervention name(s): Glucose as reference food; White bread as reference food; Bread enriched with coarse wheat bran; Bread enriched with fine wheat bran; Bread enriched with fine wheat bran and carob seed flour
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Ten subjects (male: 7, female: 3) consumed 50g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from white bread along with 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with coarse wheat bran along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) in which 10% of the flour was substituted with carob seed flour (CSFB) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: blood glucose; bran particle size; glucemic index
Lose 2 Win A Novel Method to Motivate Weight Loss Maintenance Among College Students
Condition: Overweight; Obese
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Investigators are conducting a randomized controlled trial with overweight and obese college
      students on the University of Minnesota campus. The primary outcome will be weight loss
      measured 12 months after study enrollment (corresponds to 10 months after the end of
      treatment).
    

Detailed description: 
      Approximately 30% of college students are overweight or obese. Intervening on excess weight
      early may eliminate obesity-related morbidity. Evidence supports use of monetary incentives
      to encourage weight-loss; questions remain about the efficacy of contingency management on
      weight loss maintenance.

      "Lose 2 Win" contests in which participants who achieve weight-loss goals are eligible for
      cash prizes, appear well-suited for implementation on campuses. Our objective in this
      two-phase trial is to evaluate the feasibility, acceptability and efficacy of Lose 2 Win for
      weight-loss maintenance among college students.
    

Intervention name(s): Bi-weekly in person meetings with a Registered Dietician; Financial incentives for weight loss maintenance
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the Contest Plus group had the opportunity to receive 5 in person meetings with a Registered Dietician. These meetings took place bi-weekly and gave the participants a chance to discuss food consumption, physical activity, meal planning and assessed the participant's weight at each visit.
Participants in the Contest only and Control group were not eligible to receive these meetings.; Participants in the Contest Plus and Contest Only groups were eligible for a lottery based financial incentive for maintaining their weight lost during phase 1 (Baseline to week 10) of the trial. There were three, month-long follow up assessments (weeks 16, 20 and 24) that participants were eligible for. The lottery prize was contingent upon the length of time they maintained their weight loss.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Weight loss; Weight maintenance; Contingency Management; College students; Financial incentives
A Placebo-Controlled Phase 3 Trial of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis
Condition: Alpha-Mannosidosis
MeSH terms: Mannosidase Deficiency Diseases; alpha-Mannosidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall objective of this trial is to evaluate the efficacy and safety of repeated
      Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with
      alpha-Mannosidosis
    


Intervention name(s): Lamazym; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ERT, i.v. infusions weekly; Infusions weekly
Other intervention name(s): rhLAMAN; recombinant human alpha-mannosidase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet
Condition: Cold Hypersensitivity
MeSH terms: Cryopyrin-Associated Periodic Syndromes; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      1. Objectives

             1. to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet
                in women

             2. to establish scientific evidence for the use of Korean red ginseng by investigating
                changes of infrared thermography

        2. Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity
           of hands and feet more effectively than placebo after 8 weeks administration of
           interventions- Korean red ginseng or the placebo.
    

Detailed description: 
      Design

        -  This trial is a randomized, double blind, placebo controlled trial with 80 patients.

        -  The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul,
           Korea.

        -  Participants will take Korean red ginseng or placebo for 8 weeks and will be followed up
           during 4 weeks.

        -  During the administration period, 6 capsules 2 times a day (1h after breakfast and
           dinner) of Korean red ginseng or its placebo will be provided.
    

Intervention name(s): Korean red ginseng; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Korean red ginseng is a steamed form of Panax ginseng with preserved major constituents. It has been shown to possess more biological activity than panax ginseng.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cold hypersensitivity; Korean red ginseng; Infrared thermography; Cold stress test; Distal-dorsal difference
Effect of Liking on Fruit Intake
Condition: Intake of Fruit
Study type: Interventional

Summary: 
      Increased dietary variety has been shown to increase intake in animals, as well as humans, as
      compared to a diet or meal composed of one food. While most studies investigating dietary
      variety have focused on energy-dense foods (i.e., snack foods) and have emphasized the
      negative component that variety has on intake, very little research has been conducted with
      variety to determine if this food characteristic can be used to increase consumption of
      healthy foods (i.e., fruits). We hypothesize that increasing variety of fruits provided in an
      eating bout will lead to increased intake of these foods. Therefore, the aim of this
      investigation is to test the environmental factor of variety on fruit intake in males and
      females aged 18 to 45 years.
    


Intervention name(s): variety
Intervention type(s): Behavioral
Intervention description(s): variety and nonvariety
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy
Condition: Hysterectomy (MeSH nr: E04.950.300.399)
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether spinal anesthesia combined with intrathecal
      morphine in abdominal hysterectomy on benign gynecological indications gives better outcome
      concerning duration of hospital stay and postoperative patient comfort than general
      anesthesia.
    


Intervention name(s): Bupivacain; Morphine; Propofol; Propofol; Fentanyl; Rocuronbromid; Morphine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg/mL, 4 mL intrathecally as a single dos; 0.4 mg/mL; 0.5 mL intrathecally as a single dosage; 2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery; Induction of anesthesia with 1-2 mg/kg body weight IV (intravenously). After intubation maintenance dosage of 6-10 mg/kg/hour IV during the surgery; 100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.; 0.6 mg/kg body weight IV (intravenously) at induction of anesthesia. If additional muscle relaxation is needed during surgery 5-10 mg is injected IV. The drug is given only at induction of anesthesia and during surgery; 5 mg is given IV (intravenously) before end of surgery
Other intervention name(s): Marcain spinal tung.; ATC-code: N01BB01; Morfin Special; ATC-code: N02AA01; ATC-code: N01AX10; ATC-code: N01AX10; ATC-code:N01AH01; Esmeron; ATC-code: M03AC09; ATC-code: N02AA01
Intervention MeSH terms: Fentanyl; Morphine; Bupivacaine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hospitalization; Postoperative care; Quality of Life; Health economy; Anesthesia. Spinal; Anesthesia, General
Vestibular Testing: Consistency and Effects Over Time
Condition: Dizziness
MeSH terms: Dizziness
Study type: Interventional

Summary: 
      The goal of this study is to test the consistency and repeatability of a portable goggle
      system for testing optokinetic, ocular, and reaction time. The study examines the day to day
      consistency, time of day and learning effects as well as any secondary motion sickness.
    

Detailed description: 
      The goal of this study was to test the constancy and repeatability of this test by testing it
      in different individuals and different times of day, after a variety of tasks and after
      repeated performance
    

Intervention name(s): PAS Goggle
Intervention type(s): Device
Intervention description(s): PAS goggle is a self-contained stimulus and sensing device that is designed to deliver the visual stimuli currently delivered via light projected on a wall while simultaneously recording the movement of the eyes. Each vestibular testing session last about 15 minutes.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Short-Term Effects of PT on Physical Activity
Condition: Low Back Pain; Motor Activity; Chronic Pain
MeSH terms: Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      The primary purpose is to examine the impact that physical therapy (PT) interventions,
      including manipulations, have on physical activity levels outside of the clinical environment
      in persons with low back pain (LBP) as measured both objectively with an accelerometer and
      subjectively with questionnaires.

      The secondary purpose is to determine if a relationship exists between objective physical
      activity, self-perceived disability pain catastrophizing thoughts, BMI, age, six-minute walk
      distance, lower extremity muscle endurance.

      The tertiary purpose is to assess the predictive value that a standing manual lumbar
      unloading technique has for relief of pain following manipulation
    

Detailed description: 
      At session 1: Participants are screened for eligibility. Baseline outcome measures are
      conducted (self-report questionnaires and physical performance tests). Accelerometer which is
      an instrument to measure physical activity is issued.

      At session 2 (To occur at least one-week later): Accelerometer data is retrieved and
      downloaded to a computer. Participant numerically rates low back pain level at rest and in
      most painful position. Participant receives a manual distraction procedure. Participant rates
      pain level again. Participant starts the physical therapy intervention (manipulation of the
      spine, muscular strengthening and cardiovascular exercise, education). Accelerometer is
      reissued again.

      At session 3 (At least one-week later): Accelerometer is collected and data is retrieved.
      Participant continues with the intervention (manipulation, exercise, education).
    

Intervention name(s): Physical Therapy
Intervention type(s): Procedure
Intervention description(s): Exercise, education, spinal manipulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment