bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation
Condition: Healthy
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine whether a probiotic can change the way
      bile is used by the body. The investigators will also look at the effect of the probiotic on
      your intestinal health.
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled crossover study. After obtaining
      informed consent, healthy, middle-aged adults with a larger waist circumference
      (n=30/probiotic cross with n=90 total/study) will be randomized to one of four groups:
      Bacillus subtilis, Lactobacillus plantarum, Bifidobacterium animalis subsp. lactis, or
      placebo. Participants will consume 1 capsule per day of probiotic or placebo for 6 weeks.
      After a 4-week washout period, participants will be crossed to the other treatment (i.e.,
      probiotic to placebo or placebo to probiotic).

      Participants will complete daily questionnaires throughout the intervention period, and one
      week before and after each intervention period. Blood samples will be collected at the
      baseline and final time points (±3 days) of each intervention. Stool samples will be
      collected during the pre-baseline and final weeks of each intervention. Dietary intake will
      be assessed weekly during each intervention period. Gastrointestinal symptoms and physical
      activity questionnaires will be completed weekly during each intervention period and also the
      weeks before and after each intervention period.
    

Intervention name(s): Probiotic: Bacillus subtilis; Lactobacillus plantarum; Bifidobacterium animalis; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Bacillus subtilis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).; Lactobacillus plantarum will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).; Bifidobacterium animalis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).; Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Other intervention name(s): Bacillus subtilis R0179; Lactobacillus plantarum HA-119; Bifidobacterium animalis subsp. lactis LAFTI B94
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: probiotics; inflammation; bile; hunger; satiety
The Reversal Intervention for Metabolic Syndrome Study
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of our study is to see if people with metabolic syndrome who attend a group education
      programme based on lifestyle changes (dietary and increased physical activity) can lessen
      their risk of having diabetes, heart disease and strokes in the future.
    

Detailed description: 
      People who have a combination of risk factors termed metabolic syndrome are at increased risk
      of developing diabetes, heart disease and strokes. Metabolic syndrome is a major public
      health concern requiring urgent action because 25% of the adult UK population fulfil the
      criteria, and this will increase as people continue to be less active and levels of
      overweight and obesity rise.

      The aim of our study is to see if people with metabolic syndrome who attend a structured
      group education programme based on lifestyle changes (dietary and increased physical
      activity) can lessen their risk of having diabetes and cardiovascular disease in the future.
      Overall, we hope to show that this type of education reduces the number of people who have
      metabolic syndrome.

      Subjects recruited with metabolic syndrome will be randomised to intervention or control
      arms. The intervention arm will receive group education and the control group will receive
      routine care.

      The results will inform primary prevention strategies in people from varied ethnic
      backgrounds who are at high risk of developing type-2 diabetes and cardiovascular disease.
    

Intervention name(s): Group lifestyle education
Intervention type(s): Behavioral
Intervention description(s): Structured group education programme based on lifestyle changes (dietary and increased physical activity)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Metabolic syndrome; Primary prevention; Diabetes; Cardiovascular disease; Patient education
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple s.c Doses HS-20004 in Healthy Chinese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in China. The aim of this trial is to assess the safety and
      tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects
    


Intervention name(s): HS-20004; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Axon - Brain Train for Pain
Condition: Chronic Pain; Depression, Anxiety; Sleep; Quality of Life
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      A mixed methods proof of concept study to ascertain the effectiveness of a home-based
      self-administered neurofeedback intervention to treat the primary and secondary symptoms of
      chronic pain.
    

Detailed description: 
      In order to address the growing problem of chronic pain management in the UK, a proof of
      concept/feasibility open label study has been devised to test a home-based self-administered
      non-pharmacological treatment utilising neurofeedback training with a headset and
      tablet-based software application.

      This study will include individuals suffering from various types of chronic pain, measuring
      changes in pain intensity alongside associated symptoms (depression, anxiety, sleep, and
      quality of life) by utilising a purpose-built software application and headset that is easy
      to use and structurally robust.

      Twenty participants will take part in pre-intervention quantitative assessments measuring the
      primary and secondary symptoms of chronic pain. This will be followed by one-to-one remote
      training where they will be provided with detailed instructions on how to self-administer the
      neurofeedback training in the comfort of their own homes. They will then take part in 4-6
      training sessions per week over an 8-week period.

      Post- intervention quantitative assessments will be conducted alongside a qualitative
      analysis of the experience of doing neurofeedback training for chronic pain. Participant
      feedback on how the protocol, equipment and research could be improved will also be recorded
      to inform further research.

      Participants will also take part in online follow-up assessments at 1, 3, and 6 months after
      the intervention. Any adjustments to pain medication will also be recorded over this period.
      It is anticipated this study will provide initial evidence of the safety, efficacy,
      reliability and validity of a low-cost non-pharmacological solution to the physical,
      psychological and social difficulties experienced by individuals with chronic pain, with a
      view to a larger subsequent multisite trial.
    

Intervention name(s): Neurofeedback training
Intervention type(s): Other
Intervention description(s): A home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks.
Intervention model: Single Group Assignment
Intervention model description: Single group assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lower Lugol's Solution Concentration on Reducing the Adverse Symptoms of Chromoendoscopy With Iodine Staining
Condition: Mucosal Irritation; Image Quality
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was to test an optimal concentration of Lugol's solution which can reduce the
      mucosal irritation and provide high image quality to ensure endoscopy examination by a
      randomized blinded controlled trial.
    

Detailed description: 
      It is widely accepted that chromoendoscopy using Lugol's solution is effective for the
      detection of early esophageal squamous neoplasia. However, this modality may cause severe
      chest pain and discomfort owing to mucosal irritation. The conventional concentration of
      Lugol's solution is in the range of 1.2% to 2.5% . Image quality can be guaranteed with this
      range of Lugol's solution. However, lead to retrosternal pain and discomfort, and can even
      induce erosion or ulceration in the esophagus and stomach. This study was to test whether a
      lower concentration of Lugol's solution, which has minimal mucosal irritation, can provide
      satisfied image quality by a randomized blinded controlled trial.
    

Intervention name(s): 1.2% Lugol's solution; 1.0% Lugol's solution; 0.8% Lugol's solution; 0.6% Lugol's solution; 0.4% Lugol's solution
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): This group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.; This group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.; This group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.; This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.; This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
Intervention MeSH terms: Lugol's solution; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: Lugol's solution; esophageal squamous cell cancer; mucosal irritation; image quality
PF-06651600 Taste Study.
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-blind, randomized, five (5)-period, cross-over study in healthy adult
      participants. A group of approximately 10 participants will assess the sensory attributes
      (taste and palatability) of 4 different formulations of an investigational product
      (PF-06651600 active pharmaceutical ingredient) and Bitrex (Registered) positive control in a
      specified sequence in 1 day.
    


Intervention name(s): PF-06651600 20 mg; Bitrex solution
Intervention type(s): Drug; Other
Intervention description(s): PF-06651600 in four (4) different oral formulations will be administered in different periods.; Bitrex solution at 0.5 ppm will be included in the treatment sequence together with the four PF-06651600 formulations.
Intervention MeSH terms: Denatonium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: PF-06651600; Palatability; Bitrex; Taste Study
Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects
      who stop the treatment with subjects who continue ortho-k lens wear and control subjects
      wearing single-vision glasses.
    

Detailed description: 
      Children wearing ortho-k have been shown to have slower rate of myopic progression than those
      wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009). Both
      studies showed that the effect of myopic control was most significant during the first six
      months of the treatment. It is unknown whether the myopic control effect would dissipate upon
      the discontinuation of the treatment or whether the myopic control effect only happened in
      the first six month of lens wear and was maintained thereafter. The current study aims at
      evaluating the effect of discontinuation of ortho-k treatment on myopic control in children
      who are currently on the treatment. This knowledge is necessary and important as
      patients/parents have concerns about the permanent dependency on ortho-k once they enrolled
      in the treatment.

      Children who have been on the treatment for two years and have recently completed the myopic
      control studies at The Hong Kong Polytechnic University, i.e. the ROMIO, TO-SEE and HM-PRO
      studies, will be invited to participate in this 14-month study. Ortho-k subjects will be
      randomly assigned to study group or the ortho-k control group. The study group subjects will
      be required to stop lens wear for 7 months at the completion of the previous study (Phase I)
      and resume lens wear for next 7 months (Phase II). The ortho-k control group subjects will be
      required to continue the current treatment for another 14 months. Control subjects in the
      existing myopic control studies will be required to continue using the same treatment, i.e.
      single-vision glasses, for another 14 months. Rate of myopic progression among the 3 groups
      and at the two study phases will be determined and compared.
    

Intervention name(s): ortho-k lenses; single-vision glasses
Intervention type(s): Device; Device
Intervention description(s): nightly wear of orthokeratology lenses to correct vision; daily wear of spectacle glasses to correct vision
Other intervention name(s): orthokeratology; corneal reshaping therapy; Menicon Z Night lenses; Menicon Z Night Toric lenses; CR-39 lenses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: children; corneal reshaping; myopia; myopia progression; orthokeratology
Changes in Ischemia and Angina Over 1 Year Among ISCHEMIA Trial Screen Failures With no Obstructive CAD on Coronary CT Angiography
Condition: Microvascular Angina; Angina Pectoris
MeSH terms: Angina Pectoris; Microvascular Angina; Ischemia
Study type: Interventional

Summary: 
      Serial assessment of angina status and ischemia on stress echo over one year among patients
      with moderate ischemia on stress imaging and non-obstructive CAD on coronary CT angiography.
    

Detailed description: 
      Some people with chest pain are found to have open arteries on angiograms instead of blocked
      arteries and many, but not all, of these people have abnormal stress tests or other tests
      showing there is not enough blood flow to the heart. Prior research has not made clear
      whether chest pain in such patients is due to heart disease or something else, in part
      because no one has found out whether chest pain and stress test results change in the same
      direction over time. This study will use two measurements of chest pain and two stress tests,
      one year apart, to find out if chest pain and abnormal stress tests are both caused by the
      same problem: not enough blood flow to the heart.The association between angina, ischemia and
      atherosclerosis severity at baseline will be examined, as will medication effects.
    

Intervention name(s): Quality of Life assessment; Stress imaging
Intervention type(s): Other; Procedure
Intervention description(s): Seattle Angina Questionnaire and other questionnaires.; Stress imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity
      of two doses of 4 different investigational MenABCWY combination vaccine when administered to
      healthy adolescents aged 11-18 years.
    


Intervention name(s): Meningococcal Vaccine
Intervention type(s): Biological
Intervention description(s): MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningococcal Disease; Vaccines; Adolescents
Functional Capacity in Institutionalized Elders
Condition: Elderly
Study type: Observational

Summary: 
      Getting old is a process of transformation of the body that occurs along the vital cycle in a
      universal and progressive way causing functional restrictions in the human being. The aim of
      this work was to identify, analyze and quantify the limitations of the functional capacity of
      the institutionalized elderly who are not provided with physiotherapic assistance.
    

Detailed description: 
      A descriptive, qualitative, quantitative and transverse field research was made, based on an
      evaluation of the activities of daily living (ADL) using the Katz Index, with 62
      institutionalized elderly people from Casa do Pobre de Maceió, Alagoas, both genders, average
      age of 77.03 years old and different levels of functions. Activities related to the self care
      were emphasized. At first, people were classified as independent, partially dependent and
      totally dependent. According to the Katz Index score, they were classified regarding their
      functional dependency, which varies from level 0 (a totally independent person) to level 6 (a
      totally dependent person in the six evaluated functions).
    

Intervention name(s): Evaluation of the functional capacity
Intervention type(s): Other
Intervention description(s): An evaluation (questionnaire) was performed by the Katz Index of individuals in this group, including personal issues (sex and age) and different levels of functional independence for the elderly in their basic activities of daily living (ABVD's) such as: bathe, dress, use the bathroom for withdrawals, transfers perform, has control of the sphincters and the food itself. Subject themselves, if capable of responding to the issues of consistency index, did. The answers were given to the auxiliary nurse responsible for care to residents.
Other intervention name(s): Elderly
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample, eder people.
      
Keywords: Physiotherapy; Aged; Functionality; Physiotherapic assistance; Functional capacity
Effect of Su-Man Formula Massage Oil Acupressure on Sleep Quality and Anxiety in Patients With Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The present study predict that Su-Man formula massage oil acupressure can improved sleep
      quality.
    

Detailed description: 
      About 7% person in general population became as insomnia every year, and that has 30% person
      due to insomnia induces other symptoms such as anxiety. In addition, the incidence of
      insomnia in the female is 50% more than in the male. Insomnia belong to the scope of bù-mèi
      in traditional Chinese Medicine (TCM). TCM consider that the cause of insomnia is due to
      unbalance between yin and yang, and acupressure can treat insomnia. Several studies report
      that aromatherapy can enhance sleepy. Therefore, the purpose of the present study was to
      assess the therapeutic effect of Su-Man formula massage oil associates with acupressure on
      sleepy quality and anxiety lysis. A total 40 patients with insomnia divided into two groups,
      each group is 20 patients as follows: 1) control group, using bergamot massage oil apply to
      GV20, GV24 SP6, HT7 and PC6 acupoints, and massage for 10 times before sleep continuously 28
      days; 2) test group, using Su-Man formula massage oil ap-ply to GV20, GV24, SP6, HT7 and PC6
      acupoints, and massage for 10 times before sleep continuously 28 days. The primary outcome
      measurement is the Chinese version of Insomnia Severity In-dex(ISI-C), Pittsburgh Sleep
      Quality Index (CPSQI), and Beck Anxiety Inventory(BAI); The secondary outcome measure is the
      changes of meridian energy.
    

Intervention name(s): Su-Man formula massage oil
Intervention type(s): Behavioral
Intervention description(s): bergamot massage oil:dilute bergamot essential oil(0.5%) with almond oil Su-Man formula massage oil: mixed 4 different essential oil include bergamot, red mandarin, petit grain bigarade, spikenard and diluted with almond oil 5%.
Other intervention name(s): bergamot massage oil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with insomnia divided into two groups, each group is 20 patients as follows: 1) control group, using sweet al mond o il apply to GV20, GV24 SP6 , HT7 and PC6 acupoints, and massage for 10 times before sleep continuously 28 days; 2) treatment group, using Su Man formula m assage oil apply to GV20, GV24 , SP6 , HT7 and PC6 acupoints, and massage for 10 times before sleep cont inu ously 28 days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Su-Man formula massage oil; Acupressure; Meridian energy; Insomnia