bioihbjkbjnl/mcl2 huggingface dataset:
Inspiratory Muscular Training
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Objectives: To evaluate regional lung ventilation distribution in patients suffering from
      chronic heart failure (CHF) after completing inspiratory muscle training (IMT) and correlate
      it with functional capacity and quality of life among these individuals. Methods and Results:
      Nineteen CHF patients were randomly assigned to two groups: Control and IMT. Before and after
      muscle training, subjects were submitted to assessment protocol for respiratory muscles,
      digital spirometry, optoelectronic plethysmography (OEP), the six-minute walk test (6MWT) and
      a quality of life questionnaire (MLHFQ). There was no difference in lung function following
      the 12-week training period in either group. However, the IMT group showed an increase in
      actual and predicted MIP, higher MLFHQ score and greater distance walked in the 6MWT, as well
      as a reduction in the Borg scale after the 6 MWT in relation to the control. For the OEP, IMT
      group members exhibited higher values for total chest wall volume (Vcw), abdominal rib cage
      volume (Vrc,a) and abdominal volume (Vab) when compared to the control. Conclusions: For
      patients with CHF, IMT proved efficient in improving muscle strength, functional capacity and
      quality of life. The present study also analyzed the distribution behavior of lung volumes
      for the thoracoabdominal system in this population, showing that larger abdominal rib cage
      and abdomen volumes may result in more effective diaphragmatic contraction.
    


Intervention name(s): Inspiratory muscle training; Control group
Intervention type(s): Other; Other
Intervention description(s): All participants were instructed to use a Threshold® trainer for 30min a day, seven times a week over 12 consecutive weeks.10 Patients in the Control Group used a Threshold ® device without resistance, making them blind to the treatment. For the treatment group, inspiratory resistance of the Threshold® trainer was 30% of MIP, adjusted on a weekly basis to remain constant.; Patients from the control group were also assessed weekly to ensure homogenization of the learning effect for the manometer maneuver.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Heart failure; respiratory muscles; optoelectronic plethysmography
A Study in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function
Condition: Subjects With Renal Impairment; Healthy Subjects
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of
      JT001 in adult subjects with mild and moderate renal impairment compared to healthy
      mean-matched subjects.The results of this study will guide the clinical recommendation
      regarding whether or not a dose adjustment may be needed when treating patients with renal
      impairment.
    

Detailed description: 
      This study will compare the pharmacokinetics of JT001 in patients with normal, mild or
      moderate renal impairment.There are 3 periods in the study including screening(D-28~D-1 prior
      to investigation product administration) 、treatment and assessment (D1~D4 domiciled in study
      center) and telephone follow-up(D7).

      Twenty-four males and female volunteers between 18-65 years of age with BMI between 19- 28
      kg/m2 will be divided into 3 groups of 8 subjects each based on renal function as defined (8
      normal, 8 mild impairment, 8 moderate impairment).Participants in the renal impairment groups
      will be staged by their respective degree of renal function (mild or moderate) according to
      the estimated glomerular filtration rate (eGFR) determined at the screening visit. In order
      to exclude other factors that may affect the nature of PK, each renal impairment participant
      must be matched to a healthy control participant with respect to gender、age (±10 years) and
      body weight (±10kg).The subjects received a single dose of JT001 and collected blood and
      urine samples before and after administration for pharmacokinetic analysis.

      After enrollment,subjects will be confined to the study unit during the entire 4 day study
      period.On day 1, after a fast of at least 10 hours, each patient will receive a single oral
      dose 0.3g of JT001. Blood and urine samples will be collected at times sufficient to
      adequately define the pharmacokinetics of JT001 active metabolite(116N-1) in the three study
      groups. Subjects will be monitored regarding adverse effects throughout study participation.
    

Intervention name(s): Deuremidevir Hydrobromide Tablets
Intervention type(s): Drug
Intervention description(s): JT001 single dose, 0.3g
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel
Masking: None (Open Label)
Primary purpose: Other
Diagnostic Investigation of Sudden Cardiac Event Risk
Condition: Arrhythmia; Cardiovascular Diseases; Heart Failure; CVD
MeSH terms: Heart Failure; Cardiovascular Diseases; Arrhythmias, Cardiac
Study type: Observational

Summary: 
      The overall objective of the DISCERN study is to develop and validate a genomic diagnostic
      assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden
      cardiac death (SCD).
    

Detailed description: 
      This is a prospective, multi-center, observational study. The research will be performed in
      three phases, each using distinct patient cohorts:

      Phase I: Discovery - genes/biomarkers/clinical factors Phase II: Algorithm Development Phase
      III: Assay Validation

      The final algorithm (Assay) may incorporate a combination of factors including genetic
      markers, biomarker(s), and clinical factor(s). Participation in the study does not alter
      clinical care. The procedures required by the protocol are collection of a research blood
      sample (at baseline only) and interviews with the subject to collect specific clinical
      information at baseline and follow-up (6 mos, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr) after
      enrollment. All other data collected is in accordance with the participating institution's
      standard patient care.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient's with ventricular dysfunction (low ejection fraction) undergoing implantation of
        ICD or CRT-D for primary prevention. Patient's may be enrolled at time of implant or during
        follow-up in electrophysiology clinic as long as full device records are available since
        time of implant.
      
Biospecimen description: 
      whole blood, buffy coat, spun plasma, saliva
    
Keywords: Heart failure; Implanted Cardioverter Defibrillator; Biological Markers; Molecular Genetics; Coronary Heart Disease; Gene Expression; GES; CVD; CHD; Precision Medicine; Genome-wide association study; Cardiovascular Disease; CAD; GWAS; DISCERN
Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
Condition: Chronic Uveitis
MeSH terms: Uveitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to examine the efficacy of infliximab for the
      treatment of persistent uveitis in children. Participants (4-18 years of age) will be
      randomly assigned to either 5mg/kg or 10mg/kg dose of infliximab to be administered by
      intravenous infusion at four week intervals. Participant responses will be measured at at
      four to eight week intervals for up to ten months.
    

Detailed description: 
      Pediatric rheumatologists often use infliximab in the treatment of childhood uveitis, at this
      time there are no prospective studies for this use. Participants will be randomized to
      initial suggested dose of infliximab (5 mg/kg/dose vs 10 mg/kg/dose) and data will be
      collected prospectively with regard to ophthalmologic outcomes. Study participants will be
      followed for up to 10 months to determine efficacy and side effects, and an additional 30
      days for safety reports. Descriptive statistics will be gathered on participant demographics,
      uveitis characteristics, change in immunosuppressive medications, number of responders,
      ophthalmologic measures and change in corticosteroid dose during the study period. Initial to
      final dose will be examined by paired t-test. The proportion of responders in the 5 mg/kg
      initial dose group will be compared to the 10 mg/kg/dose by a Chi-square or Fisher's exact
      test, depending on numbers available. Predictors of response will be examined by logistic
      regression.
    

Intervention name(s): infliximab; infliximab
Intervention type(s): Drug; Drug
Intervention description(s): 5mg/kg/dose IV at 4 week intervals; 10mg/kg/dose IV at 4 week intervals
Other intervention name(s): Remicade; Remicade
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood; Uveitis
Enhancing Postpartum Discharge Instructions
Condition: Health Literacy; Randomized Controlled Trial; Postpartum; Cesarean Delivery Affecting Newborn
Study type: Interventional

Summary: 
      Post-cesarean delivery discharge instructions are not currently at an appropriate health
      literacy level. Enhancing discharge instructions with a visual aid did not improve scores on
      comprehension quizzes, either immediately or two-weeks post-discharge. However, participants
      preferred to have access to visual images with discharge instructions.
    

Detailed description: 
      Objective:

      To evaluate the effect of a visual aid on improving comprehension of hospital discharge
      instructions for cesarean wound care.

      Methods:

      A randomized control trial with a 1:1 allocation ratio and an intention to treat analysis was
      performed at an urban, tertiary care center from June-November 2017. Fifty English-speaking
      patients ages 18-50 who had undergone a cesarean delivery were randomized to receive either
      standard or enhanced discharge instructions regarding post-cesarean incision care. Enhanced
      instructions included a visual aid not present in the standard instructions. Participants
      completed a comprehension quiz prior to hospital discharge and again 2 weeks after discharge
      as well as the REALM literacy assessment prior to discharge.
    

Intervention name(s): Visual Aid; Standard Instructions
Intervention type(s): Other; Other
Intervention description(s): The visual aid was a one-sheet diagram with illustrations of important features of post-cesarean wound care.; Standard discharge instructions WITHOUT supplement of visual aid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Observation and Evaluation of Chewing Velocity Changes on Soft Food Chewing Efficiency
Condition: Healthy; Mastication
Study type: Observational

Summary: 
      Soft food chewing does not require strong bite force. The number of chewing strokes and
      occlusal surface area of the posterior teeth are more important. Clinically, reduction of
      occlusal surface to protect the abutments of a fixed or removable partial denture or the
      implant supported teeth is often necessary. If a certain chewing ability is maintained with
      reduced occlusal area, changing chewing velocity might help. For this hypothesis, the effect
      of chewing velocity on soft food chewing ability would be observed first. The purpose of this
      study is to evaluate the deliberately changed chewing gum chewing velocity on the chewing
      ability of healthy subjects whose dental occlusal surface area is known. Twenty dental
      students (10 men and 10 women with an age range of 20-30 years) with healthy masticatory
      systems and complete dentition will be asked to chew HA containing chewing gum with habitual
      side teeth at the cycle time of 0.5 sec, 1.0 sec and 1.5 sec for 30, 40, and 50 times. Jaw
      movement, tooth contact, and muscle activities will be observed during chewing gum chewing.
      The distribution of HA particles in the gum bolus after each chewing session will be measured
      and regarded as the chewing efficiency of that subject. Occlusal surface area of the
      maxillary posterior teeth, chewing rate, chewing time, muscle activity and jaw lateral
      displacement will be related to the chewing efficiency with multiple regression analysis. The
      effects of practice due to changing of chewing rate will also be evaluated.
    

Detailed description: 
      1. HA containing chewing gum with habitual side teeth at the cycle time

        2. The distribution of HA particles in the gum bolus after each chewing session will be
           measured and regarded as the chewing efficiency of that subject.

      National Taiwan University Hospital, National Science Council
    

Time perspective: Other
Keywords: Chewing efficiency,; Gum chewing; Chewing velocity; Occlusal surface area; EMG; Jaw movement
Effect of Maternal Body Mass Index on Labor Progress in Nulliparous Women
Condition: Labor Progress
Study type: Observational

Summary: 
      Study the rate of progress of labor among nulliparous women belonging to different body mass
      index groups, & observe how does this variation in maternal body mass index may affect the
      course of labor.
    

Detailed description: 
      For nulliparous cases presenting to the labor ward, maternal height & weight will be
      collected at the time of admission to calculate the BMI (body mass index) & further
      classified according to WHO (World Health Organization) categories. Putting into
      consideration the physiological increase in BMI related to pregnancy, the overweight
      participants whose BMI (25-29.9) will be combined with the normal range BMI (18.5-24.9)
      category. Labor characteristics of these participants will be then compared with those of the
      underweight (BMI less than 18.5) & obese (BMI 30 or higher) participants.Females are assigned
      in one of 3 groups based on their BMI; Underweight group (BMI <18.5kg/m2), Control group
      whose BMI within normal range (18.5-29.9 kg/m2),& Obese group (BMI more than or equal
      30kg/m2).

      Labor management protocols are fixed. Data on labor progression are collected, including
      cervical dilatation, cervical effacement, head station & descent. The median duration of
      labor , estimated by rate of cervical dilatation in cm, will be used as a measurement of
      labor progression in each group.

      A cesarean section for abnormal labor pattern will be documented as failure of progress.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pregnant nulliparous women, at term, during labor
      
Keywords: BMI; progress of labor; nulliparous women
Nonacog Alfa Prophylaxis And Treatment Of Bleeding Episodes In Previously Treated Patients With Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 4

Summary: 
      Nonacog alfa is indicated for the control and prevention of hemorrhagic episodes and for
      routine and surgical prophylaxis in patients with hemophilia B. The current single country,
      multi-centric, open label, non-randomized clinical trial is a post-approval study to fulfill
      the Central Drugs Standard Control Organization (CDSCO) request for supplementary information
      relating to the use of nonacog alfa in Indian subjects with hemophilia B.
    


Intervention name(s): Nonacog alfa
Intervention type(s): Biological
Intervention description(s): Nonacog alfa is indicated in India for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency).
Other intervention name(s): BeneFIX
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will look at the change in teenagers' body weight from the start to the end of the
      study. This is to compare the effect on body weight in teenagers taking semaglutide (a new
      medicine) and teenagers taking "dummy" medicine. The teenagers in the study and their parents
      will also have talks with study staff about healthy food choices, how to be more physically
      active and what they can do to help the teenagers lose weight. The teenagers will either get
      semaglutide or "dummy" medicine - which treatment is decided by chance. The teenagers will
      take 1 injection every week, on the same day of the week for about 15 months. The study
      medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.
      The teenagers will have 17 clinic visits, will have blood samples taken and will have to
      complete questionnaires and keep a diary. All this will be explained before study start.
    


Intervention name(s): Semaglutide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks; Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Safety and Immunogenicity Trial of IHV01
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized,
      placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult
      volunteers (Human Immunodeficiency Virus-1 uninfected).
    

Detailed description: 
      This is a Phase 1 randomized, placebo-controlled, modified double-blinded dose escalation
      study in 60 healthy adult volunteers who are Human Immunodeficiency Virus-1 (HIV-1)
      uninfected. Participants in the study will receive 4 injections at 0, 4, 8 and 24 weeks and
      will be followed for an additional 24 weeks. The total study duration will be 48 weeks. As
      this is a Phase 1 trial, the primary objective is to document safety of the Full Length
      Single Chain (FLSC) gp120-CD4 complex vaccine with a secondary objective to evaluate immune
      responses induced by the vaccine. This vaccine is being evaluated as it is constructed so
      that the gp120 and CD4 moieties form a stable intra-chain binding interaction that forms a
      transition state structure that presents conserved, conformational domains involved in the
      early HIV replication process. It is hypothesized that antibodies directed to these epitopes
      would be highly cross-reactive and potentially useful for HIV vaccine development.
    

Intervention name(s): 300 ug FLSC vaccine; 150 ug FLSC vaccine; 75 ug FLSC vaccine; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): FLSC vaccine 300 ug (1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168; FLSC vaccine 150 ug (0.5 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168; FLSC vaccine 75 ug (0.25 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168; Placebo sterile saline (0.25 - 1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
Other intervention name(s): Full length single chain gp120-CD4 complex vaccine; Full length single chain gp120-CD4 complex vaccine; Full length single chain gp120-CD4 complex vaccine; sterile saline
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; healthy volunteer
Sitosterolemia Metabolism
Condition: Sitosterolemia
MeSH terms: Intestinal Diseases; Lipid Metabolism, Inborn Errors; Hypercholesterolemia
Study type: Interventional

Summary: 
      Ezetimibe has become the treatment choice for patients with sitosterolemia. Ezetimibe is an
      inhibitor of cholesterol absorption from the gastrointestinal tract. The purpose of this
      study is to determine if ezetimibe improves whole body plant sterol and cholesterol
      homeostasis.
    


Intervention name(s): Ezetimibe
Intervention type(s): Drug
Intervention description(s): 10mg ezetimibe/day, at least 4 months
Intervention MeSH terms: Ezetimibe
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sitosterolemia; Ezetimibe; Plant sterol; Cholesterol
Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to assess and compare the effect of Vecam 40/300, Vecam 20/300 and
      Omeprazole 20 mg (a standard FDA approved GERD treatment) on the control of gastric pH.
    

Detailed description: 
      Eligible H. pylori negative, normal gastric acid secreting, healthy volunteers will be
      treated by the study medications in a randomized, open-label, cross-over study.Up to 60
      volunteers may be enrolled to ensure that at least 30 subjects will complete all the study
      treatments. Omeprazole 20 mg will be administered before breakfast. Vecam 40/300 and Vecam
      20/300 will be administered at bedtime w/o food. 24-hour gastric pH will be measured after
      the fifth dose (day 5).Following screening procedures, subjects will be randomly assigned to
      receive the different treatments.

      All pH measurements will be done in the study center under supervised conditions. All drug
      administrations will be supervised.

      This study is part of the Vecam clinical development plan.
    

Intervention name(s): Omeprazole; Vecam; Vecam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg capsule, orally, once daily (before breakfast) for 5 days.; 1 capsule, orally, once daily at bedtime for 5 days.; 1 capsule, orally, once daily at bedtime for 5 days.
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux; GERD; Nocturnal GERD; Heartburn; Nighttime Heartburn; Nocturnal Heartburn
Change of Lumbar Symptom After Surgical Treatment for Patients With Cervical Stenosis
Condition: Cervical Myelopathy Spondylosis; Low Back Pain
MeSH terms: Spondylosis; Spinal Cord Diseases; Low Back Pain
Study type: Observational [Patient Registry]

Summary: 
      Low back pain may be reduced after cervical spinal surgery
    

Detailed description: 
      The improved back pain score after cervical spinal surgery would be higher than that after
      non-surgical treatment.
    

Intervention name(s): Cervical spinal surgery
Intervention type(s): Procedure
Intervention description(s): Cervical laminoplasty or anterior discectomy and fusion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with cervical myelopathy and low back pain