bioihbjkbjnl/mcl2 huggingface dataset:
Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Observational

Summary: 
      The study is a case-controlled observational trial. Forty patients will be divided into 2
      groups (good or poor sleepers) depending on their first postoperative night Bispectral index
      data. Firstly, this study aims to characterise the lung microbiota in patients treated with
      thyroid surgery. Secondly, it aims to evaluate microbiota and its influence on plasma
      kynurenine.
    

Detailed description: 
      The study is a case-controlled observational trial. Forty patients will be divided into 2
      groups (good or poor sleepers) depending on their first postoperative night Bispectral index
      data. Firstly, this study aims to characterise the lung microbiota in patients treated with
      thyroid surgery. Secondly, it aims to evaluate microbiota and its influence on plasma
      kynurenine.
    

Intervention name(s): General anesthesia
Intervention type(s): Drug
Intervention description(s): For maintenance of propofol anesthesia, total intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml. Remifentanil (0.2-0.5 μg/kg/min) was given to all patients during the operation.
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study is a case-controlled observational trial. Forty patients will be divided into 2
        groups (good or poor sleepers) depending on their first postoperative night Bispectral
        index data. Firstly, this study aims to characterise the lung microbiota in patients
        treated with thyroid surgery. Secondly, it aims to evaluate microbiota and its influence on
        plasma kynurenine.
An Open Label, Phase 1b, Ascending Dose Study of DM199
Condition: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1B study to assess the safety, tolerability and pharmacokinetics of DM199 in
      healthy volunteers. The study will be consist of two parts: Part A will focus on intravenous
      dosing and Part B will directly compare intravenous dosing with subcutaneous dosing.
    


Intervention name(s): Recombinant human tissue kallikrein
Intervention type(s): Drug
Intervention description(s): Intravenous DM199
Other intervention name(s): DM199
Intervention MeSH terms: Kallikreins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines
Condition: Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the potential for co-administration of the first
      dose of CYD Dengue vaccine with childhood vaccination.

      Primary Objectives:

        -  To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or
           coadministered with childhood vaccines.

      Secondary Objectives:

        -  To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given
           alone or co-administered with childhood vaccines.
    

Detailed description: 
      Participants will be enrolled in a 3-step enrollment and randomized to 1 of 4 treatment
      groups. Groups 1 and 2 will receive 5 vaccinations, and Groups 3 and 4 will received 6
      vaccinations (childhood vaccines or placebo co-administered with the first dose of CYD Dengue
      vaccine in 2 separate arms). All toddlers will receive a pentavalent acellular pertussis
      combination vaccine or Combo (PENTAXIM®), planned approximately 10 months after enrollment.
    

Intervention name(s): Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus; OKAVAX®:Attenuated live varicella-zoster virus and AVAXIM® 80U: Hepatitis A virus Vaccines; Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and Childhood vaccines; Live, attenuated, recombinant dengue serotypes 1, 2, 3 and 4 virus and NaCl (Placebo)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous and 0.5 mL, Intravascular; 0.5 mL, Subcutaneous and 0.5 mL, Subcutaneous; 0.5 mL Subcutaneous and 0.5 mL Subcutaneous
Other intervention name(s): CYD Dengue Vaccine; OKAVAX®; AVAXIM® 80U; CYD Dengue Vaccine; TRIMOVAX®; CYD Dengue Vaccine; NaCl 0.9% (Placebo)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Fever; Dengue Hemorrhagic Fever; CYD Dengue Vaccine; Toddlers
Comparative Evaluation of CTG With and Without rhPDGF- BB Using Modified Coronally Advanced Tunnel for Root Coverage
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The present study is a human, prospective, single centre, single blind, comparative
      controlled randomized clinical trial for the treatment of Miller's Class I, II or combination
      of class I and II mandibular recession and comparing the clinical outcomes prior to and 6
      months after treatment. The trial is in accordance to the Consolidated Standards of Reporting
      Trials (CONSORT) criteria, 2010.
    

Detailed description: 
      24 recession defects were selected in patients who were systemically and periodontally
      healthy, satisfying the determined inclusion criteria. Patients with at least two or more
      teeth having Miller's class I , II or combination of class I and II mandibular recession
      defects were included in the study. A detailed, thorough medical and dental history was
      obtained and each patient was subjected to comprehensive clinical and radiological
      examination. All patients were informed about the nature of the study, surgical procedure
      involved, potential benefits and risks associated with the surgical procedure and a written
      informed consent was obtained from all patients.

      The patients were assigned into two treatment groups (test and control). The test group was
      treated with recombinant human Platelet Derived Growth Factor-BB and Modified Coronally
      Advanced Tunnel +Connective Tissue Graft whereas the control group was treated by Modified
      Coronally Advanced Tunnel +Connective Tissue Graft alone.
    

Intervention name(s): root coverage
Intervention type(s): Procedure
Intervention description(s): recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB for Experimental: Test group and without recombinant human platelet derived growth factor- BB for Active Comparator: Control group
Other intervention name(s): root coverage with/without growth factor
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients were assigned into two treatment groups (test and control). The test group was treated with recombinant human Platelet Derived Growth Factor-BB and Modified Coronally Advanced Tunnel +Connective Tissue Graft whereas the control group was treated by Modified Coronally Advanced Tunnel +Connective Tissue Graft alone.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Gait Training With Auditory Stimuli on Balance, Gait & Funtional Independence in Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      To determine the effect of gait training with auditory stimuli on dynamic balance, gait and
      functional independence on chronic stroke.
    

Detailed description: 
      The purpose of this study is to find the effect of gait training with auditory stimuli using
      a smart phone metronome application on dynamic balance, gait and functional abilities of
      chronic stroke patients.
    

Intervention name(s): conventional gait training
Intervention type(s): Other
Intervention description(s): The experimental group received circuit gait training with auditory stimuli using a smartphone metronome application. The training program consisted of eight different activities i.e. tandem walk, one-leg standing, military march, sitting up and forward walk, lateral walk, kicking a ball towards the wall, walking on a set pattern and obstacle walk .Patient will practice each task for 3-4 mints and three times per week.
Other intervention name(s): Gait training with auditory stimuli
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Testing the Efficacy and Safety of the WEI Nasal Jet
Condition: Complication of Surgical Procedure
Study type: Observational [Patient Registry]

Summary: 
      Testing the efficacy and safety of the WEI Nasal Jet.
    

Detailed description: 
      This is only initial thought and suggestions from the inventor Dr. Huafeng Wei. Principal
      investigator from each medical center interested in testing this new device should design
      their own clinical trials based on patient population and their own ideas for clinical
      trials. Just remind you that patient safety is number one and try all efforts to minimize
      patient risks during your clinical study.
    

Intervention name(s): Experimental group and control groupl
Intervention type(s): Device
Intervention description(s): JET
Other intervention name(s): WEI; Control
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Suggested patient inclusion criteria:

        Patients receiving various types of surgeries under sedation, especially for procedures of
        colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde
        cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in
        the study.
      
Biospecimen description: 
      •Patients receiving various types of surgeries under sedation, especially for procedures of
      colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography
      (ERCP) cystoscopy and other brief surgeries you are interested in the study.
    
Keywords: Wei JET
The Effect of Manual Therapy and Exercise in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Identification of the effects of spinal stabilization exercises and manual therapy methods on
      pain, function and quality of life in individuals with low back pain.
    

Detailed description: 
      113 patients participating in the study were divided into two groups. The patients in the
      physiotherapy group were instructed to perform special spinal stabilization exercises, while
      the patients in the manual therapy group were instructed to perform soft tissue
      mobilizations, muscle-energy techniques, joint mobilizations and/or manipulation methods
      depending on the nature of their lower back pain problems. Both groups were offered
      stabilization, strengthening, stretching, balance and exercise trainings as well as
      recommendations as to the daily life activities in line with the requirements of each
      individual. The severity of the pain suffered by the individuals was evaluated through a
      Visual Analog Scale. Oswestry Disability Index and Short Form-36 (SF-36) Scale were made
      respectively with respect to the functional condition and life quality. Assessments were
      repeated before and after the treatment.
    

Intervention name(s): manual technics; Exercise
Intervention type(s): Other; Other
Intervention description(s): soft tissue technics, joint mobilization and muscle energy technics were applied three sessions per week, totally six week.; spinal stabilization exercise applied three sessions per week, totally six week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers
Condition: Drug Use
Study type: Interventional

Summary: 
      This study was conducted to investigate whether 100 mg/5 mL cefixime trihydrate dry syrup
      manufactured by PT. Bernofarm, Indonesia was bioequivalent to its reference product, 100 mg/5
      mL Suprax® dry syrup manufactured by Odan Laboratories Ltd., Canada registered trademark of
      Astellas Pharma Inc., Japan.
    

Detailed description: 
      Twenty two healty subjects were given a single dose of 100 mg/5 mL cefixime trihydrate dry
      syrup or or 100 mg/5 mL Suprax® dry syrup with 240 mL of water. Then the blood samples for
      cefixime trihydrate was drawn and analyzed using HPLC. All subjects sample plasma were
      analyzed for pharmacokinetic evaluation.
    

Intervention name(s): Cefixime Trihydrate 100 mg/5 mL Dry Syrup; Suprax 100 MG in 5 mL Oral Suspension
Intervention type(s): Drug; Drug
Intervention description(s): Participants received a single dose of 5 mL of cefixime dry syrup with 240 mL of water; Participants received a single dose of 5 mL of Suprax with 240 mL of water
Other intervention name(s): Cefixime Trihydrate 100 mg/5 mL Dry Syrup
Intervention MeSH terms: Cefixime
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, single-blind, two-period, single dose, cross-over design in 22 healthy subjects under fasting condition.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: bioequivalence study; cefixime trihydrate; dry syrup; Indonesia
Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea
Condition: Bile Acid Malabsorption
MeSH terms: Malabsorption Syndromes; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to validate a possible diagnostic test for bile acid diarrhoea prospectively
      compared to the SeHCAT scintigraphy. Fasting participants are given a standard meal and 1,250
      mg chenodeoxycholic acid. The investigators measure fasting FGF19, bile acids species
      including 7-alpha-CHO and serial blood samples after the stimulation.
    


Intervention name(s): Oral chenodeoxycholic acid stimulation
Intervention type(s): Drug
Intervention description(s): oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor
Other intervention name(s): Chenodeoxycolic acid
Intervention MeSH terms: Chenodeoxycholic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Roles of Intraluminal Pressure and the Dilation of Tunica Media in the Development of Aortic Dissection
Condition: Aortic Dissection
MeSH terms: Aortic Dissection
Study type: Observational

Summary: 
      Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why
      some aortic dissection are limited in extent while other aortic dissection extend
      extensively. The investigators hypothesize that the medial layers are separated as a result
      of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis
      is ture, dilation is necessary to the development of aortic dissection. In this study, an in
      vitro experiment was performed to test whether dilation is essential to the development of
      aortic dissection.

      Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart
      Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation.
      Firstly, the dissected aortic wall is sampled for routine pathological examination. Secondly,
      the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on the inner
      surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly, the tissue
      sheet is used to seal a hole in a syringe with the incision faced inside, and tissue sheet of
      the experimental group was bound by a band to restrict its dilation in the next step.
      Fourthly, the syringe is filled with blue stain, and a mechanical test is performed. Fifthly,
      for the experimental group, the band is removed, and the syringe is filled with red stain.
      The mechanical test is performed again. Finally, the tissue sheet is released and cut into
      several parts to show whether the inner and outer media layers are separated by the blue
      stain or the red stain.
    

Detailed description: 
      The mechanical test: the syringe's pressure will increase gradually to a target level, and
      then decrease gradually to 0 Mpa, and this process is repeated for about 60 times.
    

Intervention name(s): the aortic delamination test
Intervention type(s): Diagnostic Test
Intervention description(s): The aortic delamination test will be performed in the dissected tissue of all patient. The processes of this test has been descripted in the summary.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chinese adult patients with aortic repair surgery
A Prospective Study to Assess Metabolic Changes in Children and Adolescents Treated With Atypical Antipsychotics
Condition: Adverse Effects
Study type: Observational

Summary: 
      The purpose of this study is to observe patients aged 6-18 with various psychiatric diagnosis
      being treated with drugs called atypical antipsychotics to determine the effects of the drugs
      on growth, weight gain, and laboratory tests.
    

Detailed description: 
      Introduction: Antipsychotics have been used for many years to treat serious mental illnesses
      like schizophrenia and bipolar illness (manic depression). These older drugs carry a higher
      risk of side effects like shaking, stiffness, restlessness or uncontrolled movements. They
      may occur when the drugs are first taken, or later, after years of use. Newer drugs called
      atypical antipsychotics (ATA's) are much less likely to cause these problems. Their lack of
      these side effects and greater safety have led doctors to use them for other diseases in both
      adults and younger patients. They have proved to be helpful in aggression, impulsiveness,
      anxiety and mood swings. Unfortunately, a number of other side effects, such as weight gain,
      increased rates of diabetes and increases in cholesterol have also been identified. While a
      lot of current research into these side effects has been done in adults, there have been few
      studies with younger patients. The research so far has been brief and involved small numbers.
      This is especially important in this young and potentially vulnerable group of patients.

      Study Methods: This research will study children and teens aged 6 to 18 who are being treated
      with the newer drugs for the first time. If agreeable to the patients and their parents or
      guardians, their doctors will prescribe one of the newer drugs and will measure the effects,
      if any, on weight, blood sugar, cholesterol as well as the improvement in their condition.
      Weight, height, and blood work will be done before the drug is started, and 6 and 12 months
      after they have been on it, comparing the results with their original values. The doctor, the
      patient and the parent or guardian will rate the patients' condition at these times, as well,
      to evaluate their improvement.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample of youth 6-18 where treatment with atypical antipsychotic medication is
        being initiated
      
Keywords: child; adolescent; weight gain; endocrine disruptors
Whole Body Vibration Therapy in Boys With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      Whole-body vibration therapy (WBVT) is a novel, non-pharmacological intervention aimed at
      improving muscle strength and endurance as well as bone density. It holds promise for
      children with neuromuscular disorders such as Duchenne muscular dystrophy (DMD) since muscle
      weakness results not only from muscle breakdown but also physical inactivity and muscle
      disuse atrophy. Weak DMD patients may increasingly limit their physical activity due to fear
      of falling or loss of independence (e.g. difficulty rising to stand without assistance).
      Prolonging the length of time boys with DMD are ambulatory is important for delaying
      complications of this disease (lung hypoventilation, scoliosis) as well as maintaining bone
      health. We propose to conduct a pilot study of WBVT in young boys with Duchenne muscular
      dystrophy (DMD). The primary outcome will be to document safety and feasibility of WBVT in
      this patient population. The secondary outcomes will evaluate changes in muscle strength and
      endurance. Bone health will also be examined as part of routine clinical care. The study will
      include 20 ambulatory boys with DMD; patients will be randomized (1:1 allocation) into 2
      groups: WBVT treatment or no WBVT treatment (controls). Treatment groups will consist of 10
      boys undergoing daily WBVT in an 8-week, open-label trial.
    

Detailed description: 
      Post-Study Completion Note: Given competition for enrollment in other DMD trials and burden
      from daily home WBVT training, it was not feasible to study WBVT in the trial setting, nor is
      it likely to be a feasible modality for optimizing musculoskeletal health in routine care.
    

Intervention name(s): Whole Body Vibration Therapy
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Whole body vibration therapy, muscle strength testing, bone health, ambulatory, endurance.