bioihbjkbjnl/mcl2 huggingface dataset:
Mindfulness-based Stress Reduction for Urban Youth
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests
      benefits in mental health and quality of life outcomes. To evaluate further the specific
      effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program
      compared with a health education program.
    

Detailed description: 
      A randomized controlled trial will be conducted at two urban clinic sites. HIV-positive youth
      between the ages of 14 and 22 will be recruited and randomized into either an eight-week
      (with one retreat session) Mindfulness-Based Stress Reduction (MBSR) course (intervention) or
      an eight-week (with one retreat session) Healthy Topics (HT) course (active control).
      Measures of psychological functioning, coping, and life satisfaction will take place at
      baseline, immediately post-program, and 3-months post program. Medical data, including
      Cluster of Differentiation 4 (CD4) and viral load counts, will also be collected at the three
      data collection time points.
    

Intervention name(s): Mindfulness-based stress reduction (MBSR); Healthy topics
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session.; 8 week health education program with one retreat session
Other intervention name(s): MBSR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mindfulness; meditation; urban youth; stress reduction; adolescent; Stress reduction for urban youth
Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.
Condition: Polio and Post-Polio Syndrome
MeSH terms: Postpoliomyelitis Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, blinded and controlled phase II study to evaluate the safety and
      immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600
      infants aged 2 months (60~90 days) were randomized to receive five different vaccination
      regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high,
      medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control
      groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi
      Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of
      Medical Biology), respectively, on the same schedule. Serum samples were collected before the
      1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse
      events occurring within 30 days after each dose were collected to assess the safety.
    


Intervention name(s): Three-dose regimen of high dosage investigational sIPV; Three-dose regimen of medium dosage investigational sIPV; Three-dose regimen of low dosage investigational sIPV; Three-dose regimen of commercialized sIPV; Three-dose regimen of commercialized IPV
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..; The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..; The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..; The control vaccine was manufactured by Chinese Academy of Medical Sciences.; The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Lifestyle Modification and Blood Pressure Study
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effects of 24 weeks of either a blood pressure
      education and walking program versus a yoga exercise program versus the combined intervention
      of blood pressure education and yoga on reducing mild to moderate high blood pressure in
      pre-hypertension and stage 1 hypertension subjects.
    

Detailed description: 
      The study is a non-blinded, randomized controlled trial to assess the safety and efficacy of
      24 weeks of a structured yoga exercise program (YP) versus a blood pressure education and
      walking program (BPEP) versus the combined intervention on reducing mild to moderate high
      blood pressure in adults with pre-hypertension or stage 1 hypertension. This will be done
      through a single center trial using a parallel design. All potential subjects will be
      screened first by telephone and then by 2 outpatient visits at the Clinical and Translational
      Research Center (CTRC) at the hospital of the University of Pennsylvania. Eligible subjects
      will then make 3 visits to the CTRC where they will be admitted overnight to have
      non-invasive 24-hour recordings of BP, as well as have periodic blood, urine and saliva
      collections. The entire study duration is 28 weeks (24 weeks post-randomization) and includes
      a total of 7 evaluation visits (including 2 functional magnetic resonance imaging visits) and
      a termination visit. Subjects will be randomized to YP, BPEP or the combined intervention of
      YP and BPEP.
    

Intervention name(s): Yoga exercise program; Blood pressure education/walking program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects in the yoga exercise program participate in structured bi-weekly 1.5 hour yoga classes held at a yoga studio as well as develop a weekly hour-long home practice over the 6 months of the study.; The program will consist of small group health education classes and a walking program. Subjects will be expected to attend a dietician-led nutrition class twice a month. On alternate weeks the subjects will be given either motivational talks about a variety of topics including weight loss, walking programs, and healthy lifestyle choices or they will be given educational DVDs or literature to read on the weeks that they are not attending a BPEP class. These subjects will all receive 12 nutrition classes and 12 motivational experiences. The subjects will also be expected to walk 6 days a week gradually increasing to 180 minutes of walking per week or 10,000 steps per day.
Other intervention name(s): YP; BPEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hypertension; cardiovascular disease; yoga
Testing Message Modality of Culturally Appropriate Nutrition Communication for Mexican American Women
Condition: Sugar Sweetened Beverage Consumption; Nutrition; Lifestyle-related Condition; Lifestyle Risk Reduction
Study type: Interventional

Summary: 
      A randomized controlled trial to test the effects of culturally appropriate nutrition
      communication delivered via different modalities for Mexican American women.
    

Detailed description: 
      A randomized controlled trial with pre-test and immediate post-test was employed to test the
      effects of different types of message modalities (video vs. comic book). The study was
      conducted online with Mexican American women aged 18-29 years old. Messages focused on sugary
      beverage consumption and the main outcomes are individual intention to adopt health behaviors
      which will be measured by the increased degree of individual knowledge, attitudes, subjective
      norms, self-efficacy, and intention to reduce SSB consumption, as well as social level
      behavior changes that will be measured by the improved magnitude of public health literacy,
      SSB media literacy, and empowerment. Secondary outcomes of interest include the evaluations
      on the dimension of message themselves include participants' direct reaction to messages and
      their perceived effectiveness of messages, which will be measured by transportation of
      messages, identification of characters, emotional response of scenes, perceived effectiveness
      of messages, engagement with messages, and willingness to disseminate messages.
    

Intervention name(s): Health Communication
Intervention type(s): Other
Intervention description(s): Spoken word poem set to video images performed by author. Comic book was transformed from the video that was equivalent in content to the video.
Other intervention name(s): Values based messaging about sugar sweetened beverages
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel randomized controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Values-based messages; Message modality; Health communication
The Study of the Safety and Efficacy of Ampligen in Chronic Fatigue Syndrome
Condition: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
MeSH terms: Encephalomyelitis; Fatigue Syndrome, Chronic; Myalgia; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      multi-center, double-blind, randomized, placebo-controlled study of the safety and efficacy.
    

Detailed description: 
      This study will be a prospective, double-blind, randomized, placebo-controlled, equal
      parallel groups study conducted at up to fifteen (15) centers to compare the safety and
      efficacy of Ampligen® IV versus placebo IV in 230-240 patients with CFS/ME. Patients will be
      randomized and stratified to receive either Ampligen® intravenously or placebo (normal
      saline) intravenously. Fifty percent (50%) of the patients will be treated with Ampligen® IV
      and 50% of the patients will be treated with placebo IV.

      Patients will be studied until 64 weeks (STAGES I plus II) have passed or until: 1) removed
      because of toxicity, 2) they withdraw voluntarily, 3) a change in the patient's medical
      condition makes continued participation unsafe, 4) the patient becomes non-compliant with the
      requirements of the protocol or 4) the Sponsor terminates the study.

      Official Title: A multi-center, double-blind, randomized, placebo-controlled study of the
      safety and efficacy of poly I:poly C12U (Ampligen®) 400 mg IV twice weekly versus placebo in
      patients with severely debilitating chronic fatigue syndrome (CFS)/myalgic encephalomyelitis
      (ME)

      Further Study Details

      Enrollment = 234: Study Completed
    

Intervention name(s): Ampligen
Intervention type(s): Drug
Intervention MeSH terms: poly(I).poly(c12,U)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; CFS; Ampligen; Poly I:ploy C12U
Changes of Serum Orphanin FQ in Patients With Coronary Heart Disease in Different Courses of Diabetes Mellitus
Condition: Type2 Diabetes
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      To explore the severity of diabetic patients with coronary heart disease and the change of
      serum orphanin FQ content in different diabetic courses
    

Detailed description: 
      Methods: A retrospective case-control study was conducted. The control group was a patient
      who underwent coronary angiography at the same time and was definitely diagnosed as coronary
      heart disease but not diabetes. The study group was coronary heart disease complicated with
      diabetes, which was divided into group A (≤5 years), group B (5-10 years) and group C (10-20
      years) according to the course of diabetes. (1) Review the electronic medical records and
      record the general information of the selected patients: age, sex, history of hypertension,
      history of myocardial infarction, family history of coronary heart disease, smoking history,
      chronic kidney disease; ② laboratory findings: HbA1C (glycosylated hemoglobin), SBP (systolic
      blood pressure), DBP (diastolic blood pressure), total cholesterol, HDL, LDL, triglyceride,
      BMI, creatinine and glomerular passing rate (EGFR); ③ Drug use: oral hypoglycemic agents,
      insulin, aspirin, statins, hypertension drugs, ACEI or ARB, β-blockers, CCB and diuretics.
      (ii) Taking coronary angiography as the gold standard, the grading index of severity of
      coronary heart disease was made, and the severity of coronary heart disease was evaluated by
      Gensini score.
    

Intervention name(s): Coronary angiography
Intervention type(s): Procedure
Intervention description(s): Coronary angiography was performed in patients with coronary heart disease complicated with type 2 diabetes mellitus
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Type 2 diabetes complicated with coronary heart disease
      
Biospecimen description: 
      Serum orphanin FQ,Glycosylated hemoglobin
    
Keywords: Type 2 diabetes
Cogmed for Working Memory After TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      This study will examine a cognitive rehabilitation protocol targeted at working memory
      deficits for adults and children with Traumatic Brain Injury (TBI). In this randomized
      clinical trial, the efficacy of Cogmed, a cognitive rehabilitation protocol designed to
      improve working memory, will be examined in children with TBI. Neuropsychological and daily
      life functioning will be measured. Participants will be children (N=20) and adults (N=20)
      with a documented history of TBI. Participants will be randomized to a treatment group or a
      wait list control group. The Experimental Group will receive the Cogmed working memory
      training program 30-40 minutes per day, 5 days a week for 5 weeks for a total training time
      of approximately 15 hours. The Control Group will be a wait list control group that will
      cross over into treatment after the follow-up assessment. All subjects will undergo repeat
      assessments following completion of the working memory training protocol after the 7th week
      and again at 13 weeks to document changes in working memory performance.
    


Intervention name(s): Cogmed
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Working Memory
Artificial Intelligence Enables Precision Diagnosis of Cervical Cytology Grades and Cervical Cancer
Condition: Cervical Cancer; Diagnostic Platform; Diagnosing Cervical Cytology Grades and Cancer; Artificial Intelligence
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      Cervical cancer, the fourth most common cancer globally and the fourth leading cause of
      cancer-related deaths, can be effectively prevented through early screening. Detecting
      precancerous cervical lesions and halting their progression in a timely manner is crucial.
      However, accurate screening platforms for early detection of cervical cancer are needed.
      Therefore, it is urgent to develop an Artificial Intelligence Cervical Cancer Screening
      (AICS) system for diagnosing cervical cytology grades and cancer.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Female patients who were 18 years or older with clear diagnostic results of cervical
        liquid-based cytological examination were included. All cases were collected from Sun
        Yat-Sen Memorial Hospital of Sun Yat-Sen University.
      
Biospecimen description: 
      Samples Without DNA: Samples retained, with no potential for DNA extraction from any retained
      samples (e.g., fixed tissue, plasma)
    
Keywords: Diagnostic Platform; Cervical Cytology Grade Diagnosis; Thinprep Cytologic Test; Artificial Intelligence Deep Learning Algorithm
Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players
Condition: Bone Health
Study type: Observational

Summary: 
      In a population of boys and girls high school basketball players, the primary objectives are
      to assess 1) bone mineral density and vitamin D status, and 2) energy intake and dietary
      quality.

      The secondary objectives are to assess 1) nutrients related to bone health (calcium,
      magnesium, vitamin K, protein) and 2) protein intake over the day.

      Data collection takes place pre-, mid-, and post-season.
    

Detailed description: 
      This study will assess the dietary intake male and female 14-19 year old student athletes,
      specifically energy intake and dietary quality (i.e. how closely do their diets meet
      recommendations).

      Investigators hypothesize that vitamin D status will be suboptimal in most participants
      though bone density will be normal.

      Investigators hypothesize that participants will maintain energy balance over the course of
      the season (no significant changes to body mass or body composition) but dietary quality will
      not meet recommendations.
    

Intervention name(s): Vitamin D; DXA scan; Nutrition analysis
Intervention type(s): Diagnostic Test; Diagnostic Test; Other
Intervention description(s): Finger stick capillary blood sampling using test from ZRT Laboratories, Beaverton, OR; 10 minute scan using scanner by GE Lunar, Madison, WI; Analysis of 24-h recalls will be conducted by a registered dietician using Nutritionist Pro software by Axxya Systems, Redmond, WA
Other intervention name(s): Vitamin D (25(OH)D); Dual Xray Absorptiometry
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female high school basketball players
      
Biospecimen description: 
      Vitamin D Assessment: ZRT Laboratories, Beaverton, OR. A finger stick will be used to obtain
      a capillary blood sample for assessment of Vitamin D (25(OH)D)
    
Keywords: bone health; high school; diet; basketball; vitamin D; DXA; DEXA; nutrition; diet quality; energy intake
The Effects of Mindful Eating Education on Increasing Satiety Signals
Condition: Mindfulness
Study type: Interventional

Summary: 
      The purpose of this graduate student research study is to is to examine the effects of
      mindful eating education on increasing satiety signals.

      Reasons for conducting the study: Add to the body of knowledge on the science of mindful
      eating.
    

Detailed description: 
      The procedures include:

      Visit 1:

        -  The subject will be asked to meet the student investigators at the Loma Linda Student
           Pavilion, sign an informed consent form, sign in, and provide an email address and phone
           number.

        -  After the initial briefing, the subject will be asked to eat their meal with an
           investigator present.

        -  The subject will inform the investigator verbally when they are feeling full.

        -  After the subject decides to end their meal, the subject will be asked to fill out a
           questionnaire and be reminded to bring the same meal the following week.

      Visit 2:

        -  The subject will be asked to meet the student investigators at the Loma Linda Student
           Pavilion with the same meal as the previous week.

        -  After receiving a brief education session, the subject will be asked to eat their meal
           with an investigator present.

        -  The subject must inform the investigator verbally when they are feeling full.

        -  After the subject has decided to end their meal, they will be asked to fill out a
           questionnaire and be reminded to meet the investigator at the same time the following
           week.

      Visit 3:

        -  The subject will be asked to meet the student investigators at the Loma Linda Student
           Pavilion.

        -  The subject will be asked to complete a follow-up survey on the study.
    

Intervention name(s): mindful education on eating
Intervention type(s): Other
Intervention description(s): Mindful eating education material: mindful eating handout by move.va.gov. It includes topics such as: observe your body, do not judge yourself, notice your reaction to food and savor your food.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Diltiazem on Pharmacokinetics of BMS-914392
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of
      single-dose BMS-914392 in healthy subjects.
    

Detailed description: 
      Protocol designed to evaluate the potential for a drug-drug interaction
    

Intervention name(s): BMS-914832; Diltiazem
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 30 mg, once, 1 day; Tablets, Oral, 360 mg, once daily, 10 days
Intervention MeSH terms: Diltiazem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
Condition: Inflammatory Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia
      microparticles with or without laser in the treatment of moderate to moderately-severe
      inflammatory acne vulgaris
    


Intervention name(s): Sebacia microparticles and laser; Vehicle suspension and laser; Sebacia microparticles without laser
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Electromyostimulation on Bone
Condition: Osteopenia; Sarcopenia; Falls
MeSH terms: Bone Diseases, Metabolic; Sarcopenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Although there is some evidence that whole body electromyostimulation(WB-EMS) affect bone via
      its acute and longitudinal effects on muscle mass and strength, the corresponding impact on
      bone density and falls in older adults has not been assessed yet. The investigators
      hypothesize that WB-EMS significantly affects bone parameters as assessed by DXA, and
      significantly reduce fall rate and ratio in a cohort of frail elderly women.
    


Intervention name(s): wellness control group.; whole-body electromyostimulation
Intervention type(s): Other; Device
Intervention description(s): Light physical exercise and relaxation program once a week in blocks of 10 weeks with breaks of 10 weeks between the blocks. The low-intensity, low-volume program was designed to avoid impact on our endpoints.; 3 sessions of 18 min/14 (1,5 x week)days over 12 months. 10 low-intensity/low amplitude exercises with electromyostimulation equipment with 85 Hz with periods of 6 sec of current and 4 sec of rest.
Other intervention name(s): functional gymnastic, flexibility, relaxation.; Electromusclestimulation, electrostimulation; Miha-bodytec
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; whole-body electromyostimulation; bone mineral density; falls; physical fitness; pain