bioihbjkbjnl/mcl2 huggingface dataset:
B-cryptoxanthin and Phytosterols on Bone Remodeling and Cardiovascular Risk Factors
Condition: Postmenopausal Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      We, the investigators, aim to study, in vitro and in vivo, the bioavailability of added
      b-cryptoxanthin and phytosterols and evaluate in vivo its effect on biochemical markers of
      bone remodelling and cardiovascular risk. Specifically, we will 1) assess the stability in
      the food and the bioavailability of b-cryptoxanthin in the presence of phytosterols
      (absorption modifiers) by using a complementary approach; in vitro and in vivo studies; and
      2) we will study in post-menopausal women (target group) the biological effect (bioefficacy)
      associated with the regular consumption of modified milk-based fruit beverages (containing
      b-cryptoxanthin and phytosterols) by assessing changes in biochemical markers of bone
      turnover and cardiovascular risk.
    


Intervention name(s): b-cryptoxanthin and phytosterols
Intervention type(s): Dietary Supplement
Intervention description(s): Fruit juices containing b-cryptoxanthin (ca. 1 mg), phytosterols (ca 1.7g) or both will be consumed for 4 weeks with a 4-week washout in between.
Other intervention name(s): carotenoids, plant sterols
Intervention MeSH terms: Carotenoids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: b-cryptoxanthin; cholesterol; bone markers; Osteoporosis; cardiovascular risk; post-menopausal women
Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      To investigate whether compression of the lid margin increase microbial contamination risk of
      patients undergoing cataract surgery
    


Intervention name(s): compression and scrub of lid margin; routine preparation for cataract
Intervention type(s): Procedure; Procedure
Intervention description(s): compression and scrub of lid margin for 5 circles before cataract surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      This study will investigate the use of High-definition Transcranial Direct Current
      Stimulation (HD-tDCS) in the functional improvement of hand dexterity while performing
      music-assisted hand exercises.
    

Detailed description: 
      Stroke is a serious medical and health problem in the US, and most of the stroke patients
      suffer from upper-limb motor deficits including weakened hand dexterity. As upper-limb motor
      functions are crucial for most of the daily living activities, there is a need for effective
      intervention. The current therapeutic approaches involve intensive physical therapy training
      involving repetitive tasks which causes fatigue and lack of engagement in the patients. To
      address this issue, the investigators will investigate the combined use of individually
      targeted noninvasive brain stimulation (T-NIBS) using High-definition Transcranial Direct
      Current Stimulation (HD-tDCS) and music-assisted hand exercises using MusicGlove to modulate
      the neuroplasticity in the desired manner to observe functional changes in hand dexterity.
    

Intervention name(s): High-definition Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Stimulation sessions will be conducted on 2 different visits separated by 2-week gap. In a crossover design, Anodal HD-tDCS will be delivered either in Active/Sham mode (during the first visit) and Sham/Active during the second visit in a 4x1 ring configuration (center electrode being Anode and the surrounding 4 electrodes being cathodes) over the affected motor area.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primarily, the stroke survivors from the New Jersey/New York City area. Although not
        restricted to any primary care clinic, we encourage participants from the Kessler Institute
        for Rehabilitation.
      
Keywords: stroke; HD-tDCS; musicglove; Upper-limb rehab
Vitamin D and Vascular Health in Children
Condition: Obesity; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      In this study, we will test the central hypothesis that enhancement of vitamin D status in
      obese and overweight children will improve their vascular health and their cardiovascular
      disease (CVD) and metabolic syndrome risk profile.
    

Detailed description: 
      Our primary objective is to determine, in obese and overweight children aged 10 to 18 years
      with vitamin D deficiency (defined as serum 25-hydroxyvitamin D <20 ng/mL), the efficacy of
      enhanced vitamin D3 supplementation in improving vascular endothelial function, arterial
      stiffness, insulin sensitivity, and metabolic syndrome risk status; and to assess whether
      these effects are dose-dependent. As a secondary objective, we will examine the vitamin D
      supplementation-induced effect on adipokines and inflammatory markers relevant to CVD risk.
      In a double-masked, controlled trial, we will randomize 252 eligible children to receive
      either 600 IU (conventional supplementation), or 1000 IU or 2000 IU (enhanced
      supplementation) of vitamin D3 daily for 6 months.

      In terms of reporting of results, the following pre-specified outcomes are included in the
      primary manuscript (PubMed PMID:31950134 -- see Reference section for citation details)

        1. Waist Circumference

        2. Serum High Density Lipoprotein (HDL) Cholesterol

        3. Serum Triglycerides

        4. Inflammatory markers (Plasma TNF-alpha, high-sensitivity C-reactive protein, and IL-6)

        5. Adiopkines (Plasma Leptin and Adiponectin)

      Plasma nitric oxide metabolites were not measured.
    

Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): Tablet form
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Vitamin D Deficiency; Vascular Function; Insulin resistance; metabolic syndrome
Quality of Life and Mental Health in Children and Adolescents
Condition: Psychiatric Diagnosis; Mental Disorders
MeSH terms: Mental Disorders
Study type: Observational

Summary: 
      The purpose of this study is to investigate different aspects of Quality of Life and mental
      health in patients under treatment in a child and adolescent psychiatric outpatient clinic
      and in the normal population.
    

Detailed description: 
      Measuring and monitoring Quality of Life in children and youths continues to increase in
      importance to both researchers and decision makers. Only a limited number of well validated
      instruments that measure Quality of Life in children exists, and in Norway only few has been
      translated into Norwegian. Up to date there are no studies investigating the quality of Life
      in Norwegian child and adolescent psychiatric patients in a longitudinal perspective,
      compared to the normal population.

      Two generic Quality of Life instruments (KINDL, Bullinger & Ravens-Sieberer 2000 and the ILC,
      Matejatt & Remschmidt 1998) are introduced in Norway by this study in addition to the use of
      other well established measures like the "Child behaviour Check List" (Achenbach et al.
      2001), etc.

      Comparisons: 400 patients and their parents in a child psychiatric outpatient clinic 2000
      pupils from the normal population in the middle of Norway Repeated measures after 6 months in
      both groups. In addition a follow up study for the clinical group 3 years after referral
      started in june 2006.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients 8-10 years of age consecutively referred to the child psychiatric outpatient
        clinic in the period from 1th of June 2003 until 31th of December 2005, having a minimum of
        two direct contacts with the clinical staff. Follow up study finished in 2008.
      
Keywords: Quality of Life; Mental health; Children; Adolescents; Normal population
Efficacy of Extended Peginterferon Alpha 2a Treatment in HBeAg Positive Chronic Hepatitis B Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The most important method to slow down and stop the liver disease progression in patients
      with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response
      during treatment or obtain sustained viral response after treatment. The aim of the therapy
      with interferon is make patients obtain immune control to HBV, in clinical practice, it was
      expressed as HBeAg seroconversion, HBsAg loss and sustained viral response in HBeAg positive
      patients. However, those targets can't be get in most patients by 48 weeks of interferon
      treatment, and some patients need extended treatment to enhance the rate of HBeAg
      seroconversion and HBsAg loss. In this cohort study, the efficacies of extended therapy of
      interferon in HBeAg positive chronic hepatitis B patients will be evaluated.
    

Detailed description: 
      In this cohort study, the HBeAg positive chronic hepatitis B patients would be treated with
      peginterferon alpha 2a(PEG-IFN a-2a) for 96 week and followed 24 weeks after treatment. Serum
      HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3
      months during treatment and follow period. Parameters of liver and kidney function, and liver
      ultrasound examination will be tested with intervals 1-3 months. The rates of HBeAg
      seroconversion, HBsAg loss, and sustained viral response will be evaluated after treatment
      and follow up.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        the population in this cohort study was composed of HBeAg positive chronic hepatitis B
        patients defined as HBsAg positive, HBeAg positive, and detectable HBV DNA load with ALT
        level ≥41 U/L for more than 6 months.
      
Keywords: chronic hepatitis B; antiviral therapy; peginterferon; HBeAg seroconversion; HBsAg loss
Identification the Expression of Sox2 in Colorectal Cancer Tissues
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Sox2 has been studied in several types of human solid tumors. The investigators found that
      Sox2 had higher expression level in colorectal cancer and metastatic tissues than normal
      tissues. So the investigators assumed that whether Sox2 plays an important role in the
      progression and migration of colon cancer.
    

Detailed description: 
      In our study, we examined Sox2 expression in archived human colon cancer tissues and found
      that its Sox2 expression correlates with reduced patient survival, increased tumor grade and
      metastasis probability.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All rchived 136 tissues were obtained and pathologically confirmed from patients who
        underwent surgical resections between 2005 and 2006 at the Cancer Center of Sun Yat-sen
        University (Guangzhou, Guangdong, P. R. China)). The patients from whom the samples were
        derived underwent curative resection between 2005 and 2006. Tumor differentiation was
        characterized according to WHO classification, while the surgical pathologic stage was
        analyzed according to the TNM classification system of the International Union against
        Cancer. All samples were anonymously coded in accordance with local ethical guidelines.
      
Keywords: colorectal cancer; invasion; metastasis; IHC
Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients
Condition: Systolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Study type: Interventional

Summary: 
      Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and
      submaximal exercise performance in healthy adults. Investigation for similar effects in
      patients with heart failure has not previously been conducted.

      This was a randomized, double-blind, placebo controlled trial. Following ingestion of the
      active agent or placebo, subjects with systolic heart failure underwent submaximal steady
      state exercise with gas exchange analysis followed thirty minutes later by a six minute walk
      test. Second testing sessions were performed ten days.

      There were no significant differences in the treatment and placebo arms in average oxygen
      consumption or six minute walk distance.

      In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich
      beetroot juice concentrate, there is no significant difference with regard to oxygen
      consumption during submaximal steady state exercise or six minute walk testing distance.

      Further study is warranted to determine the true efficacy of nitrate consumption in this
      population with adjustments in acute or chronic dosing, exercise duration, or intensity.
    


Intervention name(s): nitrate-rich beetroot juice; nitrate-deplete beetroot juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 ounces of nitrate-rich beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk; 3 ounces of nitrate-deplete beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk
Other intervention name(s): Beet It Sport Stamina Shot; Beet It Sport Stamina Shot
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nitrate-rich beetroot juice; heart failure; exercise performance; oxygen consumption
Jinhua Qinggan Granules in the Treatment of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical trial is designed to be randomized, double blind, placebo controlled, to
      evaluate the effectiveness and safety of Jinhua Qinggan granules (JHQG) on mild-category
      patients of COVID-19 in Pakistani population with the age limit of 18-75 years, at10th day
      comprehensive follow-up. The informed consent form must be signed by the subjects before
      their participation in the trial.
    

Detailed description: 
      The course of treatment is 10 days, and the visit points are set on the 1st and 10th day, in
      which 10th day is follow-up. Patients will be assessed by using seven-category ordinal scale
      and clinical signs and symptoms on 1st and 10th day. If the subject recovers and checks out
      within 10 days, they will be recorded once before checking out. All effectiveness and safety
      inspection items will be done once before the trial and once at follow-up point i.e. 10th
      day. In case of any new abnormality or abnormality aggravation after the treatment, should be
      followed up until normal or stable.
    

Intervention name(s): Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine; Placebo Comparator
Intervention type(s): Combination Product; Other
Intervention description(s): Jinhua Qinggan granules: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.; Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults
Condition: Meningococcal Serogroup B
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall aim of this study is to determine if an accelerated "Bexsero® (Multicomponent
      meningococcal B vaccine)" schedule compared to a standard schedule is immunogenic, safe, and
      tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no
      formal hypothesis is tested.
    

Detailed description: 
      A pilot study to evaluate the feasibility of a rapid clinical trial at the time of a
      meningococcal B outbreak, comparing an accelerated schedule of 4CMen B (0, 3 weeks) to the 0,
      2 months schedule, to determine if the more compressed schedule is immunogenic, safe and
      tolerable. A shorter schedule offers the potential benefit of more rapid direct and indirect
      protection, and use of fewer public health resources for implementation.
    

Intervention name(s): Bexsero®; Havrix®
Intervention type(s): Biological; Biological
Intervention description(s): Multicomponent meningococcal B vaccine; Hepatitis A vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study is a randomized prospective trial with 6-month follow up. A non-inferiority
      hypothesis is tested. A new developed treatment and education programme for type 1 diabetic
      patients (PRIMAS) will be tested compared to an established treatment and education programme
      (German DTTP). Primary outcome variable is glycemic control at 6-month follow up. Secondary
      outcome variables are: diabetes knowledge, diabetes related distress, depressive symptoms,
      diabetes self-efficacy, self-care behavior, attitudes towards diabetes and insulin treatment,
      hypoglycemia awareness.
    

Detailed description: 
      Both programmes consists of 12 lessons with a length of 90 minutes. Eligible type 1 diabetic
      patients in a diabetologist practice are pooled and randomised either to the new developed
      PRIMAS programme or to an established education programme for type 1 diabetic patients (DTTP
      - Treatment and education programme for intensified insulin treatment) as an active
      comparator.
    

Intervention name(s): PRIMAS; DTTP
Intervention type(s): Behavioral; Behavioral
Intervention description(s): PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material; The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
Other intervention name(s): The German Diabetes Teaching and Treatment Programme; ZI Treatment and Education Program for intensified insulin theapy
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus, education, self management
Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This is a 10-week randomized, controlled study to investigate the effect of a Mediterranean
      diet intervention on gastrointestinal function in Parkinson's disease. After a 2-week run-in
      period, participants will be instructed to receive standard of care for constipation or
      receive standard of care + follow a Mediterranean diet for 8 weeks and answer daily and
      weekly questionnaires. Nutritional and neurological evaluations and stool samples will be
      collected at 0, 4 and 8 weeks.
    


Intervention name(s): Standard of care + Mediterranean diet (intervention); Standard of care (control)
Intervention type(s): Other; Other
Intervention description(s): Participants will receive a constipation management handout that is distributed regularly to patients who present with constipation symptoms at an outpatient neurology clinic. The handout recommends increasing fluids daily, as well as increasing physical activity and dietary fiber intake. Laxative medications and recommendations for usage are included.
Participants will be instructed to include the following in their diet: a) abundant use of olive oil for cooking and dressing dishes; b) consume ≥2 daily servings of vegetables; c) ≥2-3 daily serving of fruits; d) ≥3 weekly servings of legumes; e) ≥3 weekly servings of fish/seafood; f) ≥3 weekly serving of nuts/seeds; g) select white instead of red or processed meats; h) cook at least twice a week with sofrito. Limit consumption of cream, butter, processed meat, sugared beverages, industrial bakery products and desserts, and French fries or chips. For usual drinkers, the main source of alcohol should be wine.; Participants will receive a constipation management handout that is distributed regularly to patients who present with constipation symptoms at an outpatient neurology clinic. The handout recommends increasing fluids daily, as well as increasing physical activity and dietary fiber intake. Laxative medications and recommendations for usage are included.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blind, controlled parallel study in which participants either follow a Mediterranean diet or their habitual diet for an 8-week intervention.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mediterranean diet; Microbiome; Constipation; Inflammation