bioihbjkbjnl/mcl2 huggingface dataset:
Safety of H1N1 Influenza Vaccination in Pregnant Women
Condition: Virus Diseases; Respiratory Tract Infections; Influenza; Orthomyxoviridae Infections
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Virus Diseases; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in
      population in China. However, there was little epidemiological evidence of safety when
      vaccinated in healthy pregnant women. The main objective of this study is to assess the
      safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in healthy
      pregnant women. It is a stratified and controlled clinical trial in healthy pregnant women.
      And participants were included up to 226 healthy pregnant women aged 18 -35 years old who
      have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination. The
      pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups:
      vaccinated group（122） and unvaccinated group（104）. Subjects in the vaccinated group were
      administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no
      vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And
      observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated;
      and protective effect was observed for six months.
    


Intervention name(s): split-virion, non-adjuvanted H1N1 vaccine of 15 μg
Intervention type(s): Biological
Intervention description(s): 122 participants (19 at 5-9 weeks pregnant,36 at 10-19 weeks pregnant,13 at 20-29 weeks pregnant,54 at more than 30 weeks pregnant) received split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Flu; non-adjuvanted H1N1 vaccine; Safety; pregnant women
Chewing Gum Facilitates an Earlier Return to Bowel Function in Pediatric Scoliosis Patients: A Prospective Randomized Study
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of chewing gum on reducing
      post-operative ileus and reducing post-operative gastrointestinal symptoms in pediatric
      patients undergoing surgical correction of scoliosis. This study would provide minimal risk
      to its study population, and has the opportunity to provide a benefit to patients undergoing
      scoliosis surgery. If shown to be effective, this could lead to changes and improvement of
      the post-operative course for pediatric scoliosis patients.
    


Intervention name(s): Chewing gum; Control
Intervention type(s): Other; Other
Intervention description(s): Subjective assessment - subjective assessment of abdominal pain and nausea.; No intervention will be assessed for this group.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics of Higenamine in Chinese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of
      higenamine in healthy Chinese subjects
    


Intervention name(s): higenamine
Intervention type(s): Drug
Intervention description(s): infused intravenously with higenamine at the escalating doses from 0.5 ug/kg/min through 1.0 ug/kg/min and 2.0 ug/kg/min to 4.0 ug/kg/min, each dose being given for 3 minutes
Intervention MeSH terms: Higenamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; pharmacodynamics
A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study design:

        -  Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose
           escalation study of intravenously administered HM10760A in healthy adult Caucasian and
           Japanese subjects. Up to 5 dose level cohorts are planned. In each dose level cohort,
           subjects will be randomized to receive a single dose of HM10760A or placebo.

      Primary Objective:

        -  To evaluate safety profile of single intravenous (IV) dose levels of HM10760A in healthy
           adult Caucasian and Japanese subjects.
    

Detailed description: 
      Secondary Objectives:

        -  To evaluate the dose response relationship of a single IV dose of HM10760A on
           pharmacodynamic parameters

        -  To assess the immunogenicity of a single IV dose of HM10760A.
    

Intervention name(s): HM10760A or placebo
Intervention type(s): Drug
Intervention description(s): Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Erythropoietin; Long-acting; EPO
The Effects of a Combined Exercise Training Program on Vascular Health and Metabolic Profile in Obese Adolescent Girls.
Condition: Obesity, Adolescent
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study was to examine the impact of 12 weeks of combined exercise training
      (CET) on arterial stiffness, endothelial function, inflammatory markers, insulin resistance,
      and body composition in obese adolescent girls. Thirty obese adolescent girls participated in
      this study. The girls were randomly divided into CET group (n=15) and control group (n=15).
      The CET group performed concurrent resistance training followed by aerobic training at 40-70%
      of the heart rate reserves (HRR) 3 days/week for 12 weeks. Plasma nitric oxide, endothelin-1,
      C-reactive protein, arterial stiffness, homeostasis model assessment of insulin resistance
      (HOMA-IR), glucose, insulin, and the adiponectin/leptin ratio were measured before and after
      the 12-weeks study.
    


Intervention name(s): Combined Exercise Training
Intervention type(s): Behavioral
Intervention description(s): The CET program was performed for 60 minutes with 5 minutes of warm-up and cool-down per day, 3 times a week for 12 weeks. Combined exercise consisted of 20 minutes of various resistant band exercises (Upper body: seated rows, biceps curl, shoulder flexion, elbow flexion, chest press; Lower body: hip flexion, hip extension, calf raise, leg press, squat) and 30 minutes of treadmill walking. The warm-up and cool down consisted of static stretching. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4, and to 60-70% HRR in weeks 9-12. Each training session was fully supervised by the researchers. Every subject wore a heart rate monitor during the whole training session so as to maintain the correct training intensity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Impact of Neuropsychological Alteration of Patients With Eating Disorders
Condition: Eating Disorder
MeSH terms: Feeding and Eating Disorders
Study type: Observational

Summary: 
      Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial
      model, but pathophysiology remains relatively unknown, and robust etiological models to guide
      treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability
      factors have been found in eating disorders including decision making abnormalities. The
      investigators hypothesize that decision making abnormalities are associated with a lower
      level of functioning and quality of life which could lead to social and interpersonal
      difficulties. The investigators also hypothesize that these anomalies are associated with a
      particular clinical profile (more restrictive profile, more hyperactivity, less insight on
      the disease and desire for care ...).
    

Detailed description: 
      The investigators will recruit a total of 200 patients with an eating disorder in the
      university hospital of Montpellier.

      Participation consists of a one-day visit with a multidisciplinary assessment. No action is
      specific to research. This is the usual management of patients with eating disorders
      addressed to our department.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with eating disorder
      
Keywords: Anorexia nervosa; Bulimia; Binge eating disorders; Neuropsychology; neurocognition; Daily functioning
Home-based Exercise Training During Covid-19 Pandemic in Post-bariatric
Condition: Bariatric Surgery; Obesity
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The aim of this study is to assess the effect of a home-based exercise training during social
      isolation due to covid-19 pandemic in patients who undertook bariatric surgery.
    

Detailed description: 
      Eligible patients will be invited to participate in the study by phone call. The research
      team will visit the included patients. All patients giving the written consent will perform
      the following tests before being randomly allocated into exercise training or control: 1)
      blood pressure; 2) anthropometric measures; 3) blood sampling; 4) handgrip test; 5) sit and
      stand test; 6) exercise capacity; 7) nutritional recalls and 8) health-related
      questionnaires. Patients will be randomized in a 1:1 ratio to control group (will receive
      information to keep active and eating healthy) or exercise training group (will receive a
      telemonitored exercise program through video conference, three times a week, during 3
      months). Following 3 months of intervention, the outocomes will be re-assessed.
    

Intervention name(s): Home-based exercise
Intervention type(s): Other
Intervention description(s): Home-based exercise training, supervised by videoconference.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patients With Mild Pericoronitis
Condition: Pericoronitis
MeSH terms: Pericoronitis
Study type: Observational

Summary: 
      The complications that could occur during or after the extraction of the mandibular third
      molar teeth with pericoronitis affect patient's life quality considerably. Various scales are
      used to reveal how much the life quality of patients is affected this treatment. The aim of
      this study is to identify the long term life quality of patients through the OHIP-14 TR scale
      without removing the mandibular third molar teeth with mild pericoronitis.
    

Detailed description: 
      Increasing the lenght stay in the mouth at a maximum rate and following the patient up after
      the necessary treatment and information procedures are completed. As a result of clinical and
      radiographical examinations fifty-five voluntary patients whose average age was 24 and who
      have semi or fully errupted vertical mandibular third molar teeth with the diagnosis of mild
      pericoronitis were included in the study.After the patients in the study filled out the form
      including their contact and demographic data and dental symptomsand completed OHIP-14 TR
      scale which last about 5 minutes, their curretage and operculectomy treatments were done
      under local anesthesia. The patients were invited for reexamination on seventh day after the
      treatment. Also, an active patient follow up about life quality was performed by phone at
      1,3,6 month after the treatment using the self -assessment question form and the OHIP-14 TR
      scale.
    

Intervention name(s): quality of life in the patients with mild pericoronitis
Intervention type(s): Behavioral
Intervention description(s): active surviallence by OHIP-14 TR after treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        55 patients diagnosed with pericoronitis affecting third molars
      
Keywords: quality of life; pericoronitis; third molar
Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg
      lorazepam intravenous administration in healthy Japanese adult subjects.
    


Intervention name(s): Lorazepam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single intravenous administration of 2 mg lorazepam over 1 minute; A single intravenous administration of 0.9% saline over 1 minute
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: lorazepam; intravenous; pharmacolinetics; healthy; Japanese
A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the safety, tolerability, and body weight effect of subcutaneous
      pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or
      phentermine in overweight and obese subjects.
    


Intervention name(s): pramlintide acetate; sibutramine; phentermine; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): subcutaneous injection, three times a day, 120mcg; oral tablet, once a day, 10mg; oral tablet, once a day, 37.5mg; subcutaneous injection, three times a day
Other intervention name(s): Symlin; Meridia; Adipex-P; Fastin; Obenix; Oby-Trim
Intervention MeSH terms: Pramlintide; Phentermine; Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: overweight; obesity; pramlintide; Symlin; sibutramine; Meridia; phentermine; Amylin
Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, outpatient, randomized, double-blinded (with a single-blind extension),
      placebo-controlled, dose-ranging, parallel-group study of baricitinib (LY3009104) in Japanese
      participants with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.
      Baricitinib will be orally administered once a day with background methotrexate [6 to 16
      milligrams (mg)/week] therapy for 12 weeks in the double-blind treatment period (1, 2, 4 or 8
      mg/day, or placebo), and for 52 weeks in the single-blind extension period (4 or 8 mg/day).
    


Intervention name(s): Placebo; Baricitinib; Baricitinib; Baricitinib; Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered orally as background therapy
Other intervention name(s): Sugar pill; JAK1/JAK2 inhibitor; JAK1 inhibitor; JAK2 inhibitor; NCB028050; LY3009104; JAK1/JAK2 inhibitor; JAK1 inhibitor; JAK2 inhibitor; NCB028050; LY3009104; JAK1/JAK2 inhibitor; JAK1 inhibitor; JAK2 inhibitor; NCB028050; LY3009104
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Functional Electrical Stimulation in Cardiac Patients
Condition: Coronary Disease; Heart Failure
MeSH terms: Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effects of Functional Electrical Stimulation
      (FES) on physical performance and quality of life of patients in cardiac rehabilitation.
    

Detailed description: 
      This randomized controlled trial aimed to evaluate the effects of functional electrical
      stimulation (FES) in patients with stage II and III cardiac rehabilitation (CR) on the
      variables strength, endurance and muscle tropism lower limb, functional capacity and quality
      of life. To this were invited to participate in the study cardiac patients registered in the
      database of the cardiology department of the University Hospital of Santa Maria. The sample
      included patients of both sexes undergoing coronary artery bypass grafting or valve
      replacement. The subjects were divided into two groups: placebo group (PG) or functional
      electrical stimulation group (FESG). To verify the effect of this intervention, before and
      after the protocol patients underwent the following evaluations: one repetition maximum test,
      sit-and-stand test, perimetry thighs, the six-minute walk test and evaluate the quality of
      life through The Medical questionnaire Study 36-item Short-Form Health Survey (SF-36).
    

Intervention name(s): Functional Electrical Stimulation; Functional Electrical Stimulation placebo
Intervention type(s): Device; Device
Intervention description(s): Functional electrical stimulation twice per week for eight weeks totaling sixteen sessions.; Functional electrical stimulation in the sensory threshold level, twice a week for eight weeks, totaling sixteen sessions.
Other intervention name(s): FES; FES placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thoracic Surgery; Electrical Stimulation; Rehabilitation; Quality of Life
Performance Evaluation of a Non-Invasive Glucose Monitor as Compared to CGM Data Acquired by the iPro2
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This study is for adults and adolescents with type 1 diabetes. The purpose of this study is
      to learn more about an investigational system to measure blood glucose. This system does not
      require blood to be drawn from the body, and it does not require a glucose sensor to be worn
      under the skin (subcutaneously). This device instead estimates blood glucose levels by
      shining infrared light on the skin and then using sophisticated statistical analysis on how
      the light bounces back or gets absorbed (spectral data). The researchers in this study will
      compare the accuracy of the new device to glucose measurement devices that are already
      approved by the FDA, including glucose meters and subcutaneous continuous glucose monitoring
      (CGM) sensors. Information learned from this study will be used in the development of tools
      for managing diabetes.
    

Detailed description: 
      The purpose of the study is to evaluate the utility of a novel approach to non-invasive
      glucose sensing. The testing for each patient includes fingerstick and alternate site
      capillary blood measurements taken nearly simultaneously with a series of near-infrared
      spectra collected via a novel, proprietary fiber-optic probe. Simultaneously, subjects will
      be wearing a commercial continuous glucose measuring system (Medtronic iPro 2). The spectral
      data are converted to a prediction of tissue glucose using a proprietary pre-defined
      universal algorithm. Subjects are tested every 20 minutes for up to 12 hours per day and up
      to 6 visits per patient over a period of up to 4 months.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects aged 12 through 75, previously diagnosed with type 1 diabetes mellitus, currently
        using insulin to treat their diabetes.
      
Keywords: Diabetes; Type 1; Continuous glucose monitor
Sacral Erector Spinae Plane Block Versus Caudal Block in Penile Surgeries in Pediatrics
Condition: Sacral Erector Spinae Plane Block; Caudal Block; Penile Surgeries; Pediatrics
Study type: Interventional

Summary: 
      The study will be conducted to compare the efficacy of ultrasound guided Sacral Erector
      Spinae Plane Block to caudal block on pain management in penile surgeries in pediatrics.
    

Detailed description: 
      The erector spinae plane block (ESPB) is a relatively new interfacial plane block that is
      used for postoperative analgesia in penile surgeries in pediatrics.

      The sacral ESPB is a technique known to block the posterior branches of the sacral nerves.
      Also it blocks the lumbosacral plexus especially the sacral spinal nerves (S2_S4) when
      applied to high levels.

      Caudal epidural block in children is one of the most widely administrated technique of
      regional anesthesia; it is an efficient way to offer perioperative analgesia for painful sub
      umbilical interventions. It enables early ambulation, hemodynamic stability and spontaneous
      breathing in patient groups at maximum risk of difficult airway.

      Caudal block is a known worldwide technique but with some risks such as subdural, intra
      vascular injection, infection, injury to the nerve root or local anesthesia. Therefore, we
      try a new technique as sacral ESPB.
    

Intervention name(s): Caudal block; Sacral erector spinae block
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients were received (plain bupivacaine 0.25% 1 mg/kg + 2 % lidocaine 3 mg /kg) in total volume 1ml/ kg max 20 ml via Ultrasound Guided caudal Block.; Patients were received (plain bupivacaine 0.25% 1 mg/kg + 2 % lidocaine 3 mg /kg) in total volume of 1 ml/ kg maximum 20ml divided in both sides via ultrasound guided sacral erector spinae plain block (ESPB).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare visual acuity and redness of eyes between a prototype
      contact lens and an already marketed contact lens.
    


Intervention name(s): galyfilcon A prototype lens; comfilcon A
Intervention type(s): Device; Device
Intervention description(s): silicone hydrogel contact lens; silicone hydrogel contact lens
Other intervention name(s): Biofinity® contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment