bioihbjkbjnl/mcl2 huggingface dataset:
Craving and Lifestyle Management Through Mindfulness Pilot Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether an innovative program that combines
      mindfulness-based stress reduction and mindful eating practices with diet and exercise
      guidelines (CALMM+ intervention) will lead to greater weight loss and more favorable body fat
      distribution than a conventional weight-loss program(Diet-Ex intervention).
    

Detailed description: 
      Obesity is an important growing epidemic, with about 65% of Americans overweight (Flegal,
      Carroll et al. 2002). Psychological stress is widely cited anecdotally as a factor that
      causes people to engage in overeating, and studies provide strong evidence that stress can
      promote obesity. Stress induces selective preference of sweet, high-fat food and increases
      visceral fat depots. Chronic stress has also been shown to impair immune responses, including
      decreasing immune responses to vaccination. The proposed study will pilot test an innovative
      program that combines stress reduction and mindful eating practices with diet and exercise,
      Craving and Lifestyle Management through Mindfulness (CALMM+). This program will be compared
      with diet and exercise intervention alone (Diet-Ex). Approximately 20 persons will be
      randomized to the two groups, which will meet weekly for 16 weeks. Key outcome measures are
      weight, fat distribution (as measured by waist/hip ratio), perceived stress, and mood. These
      measures will be assessed in visits performed at baseline, 3 months, and 6 months. Data from
      this study are intended to provide pilot data for use in planning a larger randomized,
      controlled trial that will compare the effects of the CALMM+ and Diet-Ex interventions on the
      metabolic and psychological processes assessed in this pilot study.
    

Intervention name(s): Craving and Lifestyle Management through Mindfulness(CALMM+)
Intervention type(s): Behavioral
Intervention description(s): MBSR is a program that provides systematic training in mindfulness meditation and gentle yoga as a self-regulation approach to reduce stress and improve medical and psychological symptoms. In this randomized controlled pilot study, we aim to test a 16-week intervention that further integrates diet and exercise into the CALMM program (CALMM+). This novel program, which includes elements drawn from MBSR, will be actively compared with the conventional diet and exercise group(TLC). Both groups will receive about 7 hours of in-class and out-of-class activities per week. The activities includes exercise, keeping dietary records, and stress reduction practices (if they are assigned to the intervention group).
Other intervention name(s): CALMM2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; mindfulness based stress reduction; diet and exercise; mindful eating; stress
Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster Dose
Condition: Encephalitis, Japanese
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to understand the persistence of the Japanese encephalitis (JE) antibody
      response in previously vaccinated children. The proposed study will enrol Bangladeshi
      children who had previously participated in a lot to lot consistency study (JEV05;
      NCT01567865) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).
    

Detailed description: 
      Study participants previously immunized with CD-JEV (Clinical Trials identifier: NCT01567865,
      JEV05) will have serum collected three and four years after initial vaccination to assess
      long-term immunogenicity. Four years after receiving the initial dose of CD-JEV, eligible
      participants will be vaccinated with a second subcutaneous dose of CD-JEV to assess the
      antibody response.

      Participants will be monitored for safety for 28 days following receipt of the booster dose.
    

Intervention name(s): Live Attenuated Japanese Encephalitis SA-14-14-2 Vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL subcutaneous injection
Other intervention name(s): CD-JEV; CD.JEVAX®; RS.JEV®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Japanese Encephalitis Vaccines; Flavivirus Infections
KiVa Anti-bullying Program in Chile: Evaluation of Effectiveness With and Without the Digital Game Component
Condition: Bullying
MeSH terms: Bullying
Study type: Interventional

Summary: 
      Bullying is a major problem worldwide and, with no exception, in Chile. Bullying is defined
      as a systematic aggressive behavior against a victim who cannot defend himself or herself.
      Victims suffer many consequences such as social isolation, psychological maladjustment, and
      self-injury behavior. Additionally, bullies have a higher risk for conduct problems and
      substance use disorders. These problems appear to last in time, affecting mental health even
      years later since the experience of bullying.

      There are few studies in Chile aiming to determine the prevalence of bullying. In one of such
      studies, 47% of the students reported having been bullied during the last month before the
      application of the questionnaire. Even though there are many initiatives and guidelines in
      Chile supported by the government to help schools in order to deal with bullying, there is no
      any cluster randomized controlled trial (RCT) aiming to assess the effectiveness of an
      anti-bullying program.

      KiVa anti-bullying prevention program contains universal and indicated actions. Main
      universal actions for 5 to 6 graders consist of 10 two-hours lessons given during a year and
      an online game, which have the aim to raise awareness of the role of the group in bullying,
      increase empathy and promote strategies to support victims. Indicated actions consist of a
      set of discussion groups with the victims and with the bullies with proper follow-up.

      The aims of this study are: 1) To develop a culturally appropriate version of the Kiva
      material, and 2) to test its effectiveness of KiVa program with and without the online game,
      to reduce bullying behavior among low-income primary schools in Santiago using a cluster RCT
      design with three arms: i) KiVa full program group, ii) KiVa without online game program
      group, and iii) Control group.
    


Intervention name(s): KiVa program
Intervention type(s): Other
Intervention description(s): KiVa program is an anti-bullying intervention developed in University of Turku, Finland. It is based on the participant role model, where bullying is seen as a group process focused on the bystanders' reactions to the bullying. This program includes universal and indicated actions. Universal actions include ten students lessons given by teachers where pupils learn the role of bystanders in the bullying process, how to increase empathy towards the victim, and safe strategies to supports victims. Indicated actions are delivered by a school team of three staff members, who handle acute cases of bullying.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bullying; KiVa program; Primary school students
Percutaneous Irreversible Electroportion for Unresectable Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This trial is studying how well Irreversible Electroportion (IRE) therapy works in treating
      patients with breast cancer. IRE kills tumor cells by Electrical impulses creating nano-pore
      on the cell membrane and inducing target cell death.This may be an effective treatment for
      patients with unresectable breast cancer.
    

Detailed description: 
      This is a phase I/II non-randomized exploratory study. All fully eligible and registered
      patients will undergo imaging by mammography, ultrasound, and breast MRI. The primary and
      secondary objectives of the study are described below.

      OBJECTIVES

      Primary

      Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors
      (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.

      secondary

      Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.

      To describe the adverse events associated with IRE To prospectively gather pain assessment
      data on cryoablation and surgical resection Explore technical variables that may affect the
      success of IRE
    

Intervention name(s): NanoKnife LEDC System
Intervention type(s): Device
Intervention description(s): Irreversible electroporation (IRE) is a method to induce irreversible disruption of cell membrane integrity (loss of cell homeostasis) resulting in cell death without the need for additional pharmacological injury. Because IRE is a non-thermal technique, changes associated with perfusion-mediated tissue cooling (or heating) are not relevant. While cells in the ablation region are destroyed, the underlying extracellular matrix is not damaged thus allowing tissues in the ablation zone to heal normally.
Other intervention name(s): NanoKnife
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Pain Characteristics After Total Laparoscopic Hysterectomy
Condition: Myoma of Uterus
Study type: Interventional

Summary: 
      Laparoscopic operative procedures have revolutionized gynecological surgery. These have
      several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter
      postoperative stay, which cuts down on hospital costs. However, postoperative pain continues
      to be one complication, which results in an unpleasant experience for the patient and at
      times causes a delayed discharge. There are few studies about pain characteristics as one of
      laparoscopic hysterectomy complications. The purpose of this study is to investigate the
      prevalence and characteristics of shoulder pain, headache, abdominal pain, and back pain in
      patients undergoing total laparoscopic hysterectomy.
    


Intervention name(s): classic LMA insertion
Intervention type(s): Device
Intervention description(s): Classic LMA (cLMA) will be inserted when no response is obtained in the train-of-four stimulation. The fiberoptic view through the LMA, intraoperative complications of the cLMA, any complication during anesthesia emergence will be recorded. The device is examined and noted for the presence of visible blood.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain; total laparoscopic hysterectomy
Effect of a Fermented Soy Product on Cognition, Immune Status and Vaccine
Condition: Cognitive Change; Inflammation; Immune Response
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The research study will test the effects of Q CAN PLUS powder on the immune, inflammatory and
      cognitive functions.
    

Detailed description: 
      The purpose of this study is to determine the effects of a fermented soy product (Q-CAN),
      compared to placebo, on the immune, inflammatory and cognitive functions of elderly
      individuals. The study intervention will be four months in length. sixty two participants ,
      65 years or older will be randomized to participate in the study.
    

Intervention name(s): Q CAN PLUS; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Active powder with fermented soy, 2 pouches per day, each pouch contains 12-15 gms of fermented soy; Maltodextrin powder with Whey protein and flavor (provided by BESO Biological Research, Inc.)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a free-living prospective, randomized, double-blind, parallel study design with 31 subjects in free-living conditions. subjects will be randomized to receive either Q CAN powder or placebo powder for 12 weeks.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fermented Soy; Cognition; Inflammation; Immunity
An Observational Study to Evaluate The Relationship of Nasal Mucus Properties and Symptoms
Condition: Acute Rhinosinusitis; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      This is a study to learn more about the common cold from studying the nasal secretions
      produced during a cold or episode of allergic rhinitis.
    

Detailed description: 
      This study involves collecting and analyzing nasal mucus to see if there are changes in mucus
      properties during the course of a cold or episode of allergic rhinitis. Outcome measures
      include SNOT20 questionnaire, nasal secretion collection, acoustic rhinometry on the fifth
      and fourteenth day of symptoms. The investigators will also collect SNOT20 questionnaires on
      the tenth and twenty-eighth day.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinics and Community
      
Biospecimen description: 
      Nasal Secretions
    
Keywords: Cold; Acute Rhinosinusitis; Allergic Rhinitis
A Study to Assess the Bioavailability of ASP015K
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess the bioavailability of ASP015K within the
      gastrointestinal tract.
    

Detailed description: 
      Each subject will participate in four separate study periods. In each period, subjects will
      be admitted to the clinical unit approximately seven hours on the day prior to being given
      study drug. Subjects will remain at the clinical research unit for the next 24 hours after
      they have received study drug. Subjects will return to the clinical research unit at 36 and
      48 hours after they have received study drug to give blood samples. There will be a minimum
      of a four day "washout" period, between each study period.

      Under certain circumstances, subjects may be asked to return to the clinical research unit
      for an additional study period.
    

Intervention name(s): ASP015K; ASP015K
Intervention type(s): Drug; Drug
Intervention description(s): oral tablet; solution via oral capsule
Intervention MeSH terms: Niacinamide; Peficitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP015K; Healthy subjects; Pharmacokinetics of ASP015K
Raloxifene on Coagulation System in the Postmenopausal Women
Condition: Raloxifene; Postmenopausal Women
Study type: Observational [Patient Registry]

Summary: 
      Objective: The aim of this study is to assess the effects of raloxifene HCl on coagulation
      parameters in healthy postmenopausal women.

      Material and method: 80 healthy postmenopausal women were evaluated at Karadeniz Technical
      University Hospital at gynecology out-patient clinic from December 2005 to December 2006.
      Local institutional ethics committee approved our study protocol and written informed consent
      was obtained from all participants before enrollment. All patients received daily 600
      milligrams of calcium and 400 international units of vitamin D (Cal-D-VİTA, Roche
      Switzerland,). 60 milligrams of raloxifene HCI, which is a selective estrogen receptor
      modulator (SERM), was added to treatment protocol if patients required hormonal therapy.
      Patients receiving raloxifene therapy in addition to calcium and vitamin D therapy formed the
      study group(n=50). Control group (n=30) was made up of the patients only receiving calcium
      and vitamin D. Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III and
      fibrinogen levels were measured in all patients before treatment. These measurements were
      repeated at three and twelve months after treatment. Comparisons were performed with Student
      t test or Mann Whitney test between the two groups and two-way ANOVA within the groups.
      Proportions were compared with Fisher exact or Chi-square tests. Statistically analysis was
      done with SPSS packet program (SPSS 11; SPSS Inc.) All p values were two-tailed and p<0.05
      was considered statistically significant.
    


Intervention name(s): coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.
Intervention type(s): Diagnostic Test
Intervention MeSH terms: Protein C; Antithrombins; Antithrombin III; Protein S
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who applied to Menopause outpatient clinic with the approval of Karadeniz
        Technical University Faculty of Medicine Ethics Committee numbered 2005/47 were evaluated
        within the scope of the prospective study. Working time was determined as 12 months.
      
Keywords: raloxifene; coagulation system; von Willebrand factor; Factor 8; vitamin D; protein C; protein S; antithrombin- III; fibrinogen
Repeatability of OCT and IV-US in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional

Summary: 
      To assess the correlation between pulmonary IV-OCT and pulmonary IV-US measurements and
      standard PAH clinical measures of disease progression and the relative sensitivity of the
      techniques to change.
    


Intervention name(s): Patients with Pulmonary Arterial Hypertension
Intervention type(s): Procedure
Intervention description(s): 2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of co-administration of activated
      charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.
    


Intervention name(s): Mavacamten; Activated Charcoal with Sorbitol
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Sorbitol; Charcoal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mavacamten; Sorbitol; Activated Charcoal
Replace Glycemic Load and Satiety Study
Condition: Glucose Blood; Glycemic Index
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to examine the effect of four diets differing in glycemic index and amount of
      carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.
    

Detailed description: 
      The extent to which a food raises blood sugar after its consumption is ranked using the
      Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in
      blood sugar while those with a low GI produce small fluctuations in blood sugar. It is
      believed that low GI foods are advantageous for health since the swings in blood sugar and
      insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you
      less hungry and that this may play an important role in body weight regulation.
    

Intervention name(s): High GL 107; Medium GL 76; Medium GL 68; Low GL 48
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Three meals a day; Three meals a day; Three meals a day; Three meals a day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: glycemic Index
Effect of Different Left Lateral Table Tilt for Elective Cesarean Delivery Under Spinal Anesthesia
Condition: Elective Cesarean Section; Spinal Anesthesia
Study type: Interventional

Summary: 
      The recommended position of the mother under caesarean section after spinal anesthesia is 15
      degrees left. However, recent research has challenged the basic principles and practicality
      of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly
      prove that in the supine position, the position of the full-left 30 degrees of the full-term
      pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the
      left-angle of 15 degrees did not. Therefore, there are more and more controversies about the
      choice of cesarean section position. This experiment aims to explore effects of different
      positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on
      lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.
    

Detailed description: 
      When the pregnant woman in the third trimester is in the supine position, the enlarged uterus
      may oppress the inferior vena cava, thereby reducing the amount of blood and heart output of
      the pregnant woman. This affects the mother mainly, such as dizziness, nausea and vomiting,
      chills, and severe irritability，difficulty breathing or even cardiac arrest, the impact on
      the fetus is mainly the reduction of blood flow in the placenta, affecting the blood exchange
      of the uterus placenta, causing neonatal respiratory distress, acidosis and even death. The
      recommended position of the mother under caesarean section after spinal anesthesia is 15
      degrees left. However, recent research has challenged the basic principles and practicality
      of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly
      prove that in the supine position, the position of the full-left 30 degrees of the full-term
      pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the
      left-angle of 15 degrees did not. Therefore, there are more and more controversies about the
      choice of cesarean section position. This experiment aims to explore effects of different
      positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on
      lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.
    

Intervention name(s): 15° and 30° wedge sponges
Intervention type(s): Device
Intervention description(s): After the spinal anesthesia is completed, the wedge sponge is placed between the patient's pelvis and ribs and the wedge is removed before the skin is cut.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Position