bioihbjkbjnl/mcl2 huggingface dataset:
Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches
Condition: Colorectal Cancer Prevention
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      It has been estimated that 19,000 Colorectal Cancers (CRC) could be prevented each year in
      France by changing individual risk behaviours (sedentary lifestyle, overweight, diet,
      alcohol). The cancer screening appears to be an opportune moment for health promotion and to
      inform about CRC risk factors.

      The PRECÔTION study proposes an innovative scheme based on informative, motivational and
      community-based approaches. The objectives are to take advantage of patients' visits for
      colonoscopy to raise awareness and initiate individual prevention actions according to their
      own risk in order to modify individual risk behaviour.

      Patients who come for a colonoscopy at the Centre Léon Bérard and who are negative (80% of
      cases) will benefit from an evaluation to identify their individual risk factors, determine
      their level of risk level for CRC and their motivation to change their behaviour.

      Participants with a low level of risk will receive remote support in physical activity and
      nutrition via digital media based on a motivational approach. Participants will be proposed a
      monthly collective physical activity session, which will allow them to interact with each
      other and develop a community approach. Participants with an intermediate level of risk will
      be offered a collective health education session, in addition to the the support offered to
      participants with a low level of risk. Participants with a high level of risk will receive,
      in addition to the the support offered to participants with an intermediate level of risk, an
      individual motivational coaching and a connected watch. A logbook will also be given to all
      participants to accompany them on the different tools, especially for monitoring their goals.

      The PRECÔTION study aims to evaluate these tools as innovative means of prevention before
      evaluate their effectiveness on a larger scale.
    


Intervention name(s): Low risk; Moderate risk; High risk
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): remote support in physical activity and nutrition via digital media
monthly collective physical activity sessions
logbook; remote support in physical activity and nutrition via digital media
monthly collective physical activity sessions
one collective health education session
logbook; remote support in physical activity and nutrition via digital media
monthly collective physical activity sessions
one collective health education session
3 individual sessions of motivational coaching
connected watch
logbook
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Correlation Between NAFLD, Epicardial Adipose Tissue and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG)
Condition: Atherosclerosis; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Atherosclerosis
Study type: Observational

Summary: 
      -  Vascular inflammation is a key factor in both the pathogenesis and outcome of
           atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a
           promising tool for identifying and quantifying vascular inflammation within
           atherosclerotic plaques.

        -  Non-alcoholic fatty liver disease (NAFLD) is closely associated with many
           cardiometabolic risk factors. NAFLD can be detected by measuring liver fat accumulation
           using computed tomography (CT).

        -  Also epicardial adipose tissue (EAT) volume as determined by computed tomography (CT) is
           an independent marker of cardiovascular events in the general population.

        -  Therefore, the purpose of this investigators study is to compare the NAFLD severity and
           EAT volume with FDG uptake measured by PET/CT.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy participants who underwent a medical health check in the health promotion center in
        Korea Guro University
Phase I Trial of Clofarabine in Combo w/ HD Etoposide & Cyclophosphamide and APBSCT for Pts w/ High-Risk or Refractory NHL
Condition: Non Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I trial to determine the maximum tolerated dose (MTD) of clofarabine in a
      combination with high-dose etoposide and cyclophosphamide. This is an initial step in
      developing a novel myeloablative preparative regimen for autologous hematopoietic stem cell
      transplantation (ASCT). While this phase I trial will initially develop the regimen in
      patients with refractory disease, it is expected that it will find its best application in
      patients with less advanced disease.
    

Detailed description: 
      All patients will receive the same doses of etoposide and cyclophosphamide. The dose of
      clofarabine will be escalated in successive cohorts of patients. Using a standard dose
      escalation design, successive cohorts of 3 patients will be treated with escalating doses of
      clofarabine (see Section 5.5 below). At the MTD (or highest dose-level if the MTD is not
      reached), the cohort will be expanded to 10 patients to better investigate correlative
      studies and give some preliminary idea of efficacy.
    

Intervention name(s): clofarabine
Intervention type(s): Drug
Intervention description(s): Cohort N Clofarabine (mg/m2/day)
3-6 30
3-6 40
3-6 50
3-6 60
6-10 70
Intervention MeSH terms: Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non Hodgkin's Lymphoma; High Risk or Refractory Non Hodgkin's Lymphoma; APBSCT; clofarabine
Magnetic Resonance Spectroscopy (MRS) in Midlife Depression
Condition: Depression; Depression Bipolar
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of this study is to determine the impact of inflammation on central nervous
      system (CNS) glutamate, white matter pathology and alterations in behavior and cognition in
      middle-aged patients with major depression. Depression is associated with significant
      alterations in glutamate concentrations and white matter integrity, which has been associated
      with decreased antidepressant response, poor functional outcome, and cognitive impairment.
    

Detailed description: 
      This study involves behavioral assessments, neurocognitive testing, blood sampling and
      magnetic resonance imaging (MRI) scanning. Goals of this study are to determine the impact of
      inflammation on glutamate concentrations in the basal ganglia and on the integrity of white
      matter tracts in the basal ganglia and other subcortical regions of middle-aged depressed
      versus non-depressed individuals and to associated the impact of glutamate and white matter
      changes on behavioral symptoms among the same group of patients.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients who have a diagnosis of depression or bipolar depression and men
        and women without a diagnosis of depression or bipolar depression in the control group
      
Biospecimen description: 
      inflammatory gene expression studies, APOE4 genotyping
    
Keywords: Mid-life Depression; Bipolar Disorder; DSM-5 MDE; Inflammation; CNS Glutamate
Bioavailability of Pepper Carotenoids in Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      - list item one, Peppers

      We propose to evaluate bio absorption of pepper carotenoids in a red bell-pepper or
      non-pungent green jalapeno pepper. The pepper will be provided in a cooked dish. The specific
      aims of this study are: 1) to determine blood response kinetics of lutein following multiple
      doses of non-pungent green jalapeno pepper with meals. 2) to determine blood response
      kinetics of zeaxanthin/capsanthin following multiple doses of red bell pepper with meals. We
      will feed 16 healthy man and women (50 - 65 y, females were at least one year post
      menopause), each cooked green jalapeno pepper or red pepper for 4 days and donate blood
      samples up to 21 days to determine blood response kinetics of xanthophylls following multiple
      doses of pepper dishes.
    

Detailed description: 
      - list item one, Peppers

      Epidemiological data show that carotenoids and ß-C are health promoting when taken at
      physiologic levels in foods. However, human absorption and metabolism of carotenoids
      contained in various food matrices has not been studied well. It is important to investigate
      the characteristics of absorption and disposal kinetics after eating carotenoid rich foods in
      order to gain a basic understanding of the biological characteristics of lutein, zeaxanthin,
      and other carotenoids in food sources.

      We propose to evaluate bio absorption of pepper carotenoids in a 2-phase research study:
      phase 1 will utilize red bell-pepper and phase 2 will utilize non-pungent green jalapeno
      pepper. The pepper will be provided as a dish in a meal. We will feed 16 healthy man and
      women (50 - 70 y, females were at least one year post menopause), each with red pepper (phase
      1) and/or green jalapeno pepper (phase 2) for ~ 4 days and donate blood samples up to 21
      days. Volunteers will be randomly assigned to one of the following two phases: phase 1 and
      phase 2.

      The study will provide us the information on the bioavailability of pepper carotenoids.
    

Intervention name(s): Pepper
Intervention type(s): Dietary Supplement
Intervention description(s): pepper carotenoids as meals
Other intervention name(s): lutein; xanthaphylls
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pepper carotenoids; xanthophylls; healthy volunteers
Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults
Condition: Tobacco Products
Study type: Interventional

Summary: 
      This study involves 25 current young adult combustible tobacco cigarette (CTC) smokers who
      will complete 5 Latin square ordered, within-subject, laboratory conditions that differ by
      the tobacco product smoked:

        1. own-brand CTC (positive control),

        2. original-flavored Black & Mild (B&M) cigar,

        3. apple-flavored B&M cigar,

        4. cream-flavored B&M cigar, and

        5. wine-flavored B&M cigar.
    


Intervention name(s): Tobacco product administration and assessment
Intervention type(s): Other
Intervention description(s): two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index
Condition: Postoperative Pain; Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Balanced anesthesia needs optimization of hypnotic, relaxant, and narcotic. Administration of
      hypnotic drugs can be monitored by bispectral index score (BIS), while the dosage of muscle
      relaxants can be guided by train-of four (TOF). However, administration of narcotics lacks
      objective monitor. Overdosage of narcotic may lead to delayed awakening, while underdosage
      may lead to high degree of postoperative pain. Recently, there is a monitor, Analgesic
      Nociceptive Index (ANI) monitor, designed to guide the administration of narcotics. There are
      many descriptive studies supporting the correlation of ANI score and pain score but there are
      still very few randomized control studies which report the efficacy of ANI in clinical
      practice.
    

Detailed description: 
      Objective: To evaluate the efficacy of ANI to guide the administration of intraoperative
      fentanyl.

      Methods: Sixty female patients undergoing breast surgery with balanced anesthesia will be
      randomized into 2 groups. The first group will receive fentanyl according to standard
      practice of attending anesthesiologists. The second group will receive fentanyl according to
      ANI score protocol.

      Primary outcome: Postoperative pain numeric rating scale (NRS) score during 60 minutes in
      postanesthetic care unit (PACU).

      Secondary outcomes: Total intraoperative dose of fentanyl and postoperative nausea/vomiting
      and sedation score in PACU.
    

Intervention name(s): Standard protocol; ANI protocol
Intervention type(s): Procedure; Procedure
Intervention description(s): Give narcotic according to vital signs; ANI score 50-70 indicates optimal narcotic effect. ANI score > 70 indicated overdosage of narcotic and narcotic should be withheld.
ANI score < 50 indicates inadequate narcotic and narcotic should be given.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to assess the effect of controlled dietary lysine intake on plasma and urine
      α-aminoadipic acid (2-AAA).
    

Detailed description: 
      Diabetes is an important health concern worldwide. It is associated with significantly
      increased mortality as well as high incidence of co-morbidities. Unfortunately, treatment
      efficacy and successful disease management is highly variable among treated patients, and
      this is partly due to the fact that diabetes has multiple underlying causes most of which are
      still unknown. A newly identified biomarker, α-aminoadipic acid (2-AAA), has the potential to
      successfully predict the development of diabetes in humans, even before the development of
      other known risk markers. However, little is known about the function of 2-AAA; it is unclear
      whether 2-AAA itself causes the development of diabetes or if it is a biomarker for altered
      metabolic processes that then lead to diabetes.

      The aim of the first phase of the study was to measure plasma 2-AAA levels from healthy
      individuals from the general population to identify subjects with high or low 2-AAA. Now in
      the second phase of the study, 80 subjects with high or low 2-AAA will be invited to
      participate in a dietary lysine modification study to access the effect of controlled lysine
      intake on plasma and urine 2AAA. Participants will be asked to complete two one-week dietary
      interventions. Subjects will be screened and consented via email, online, or phone. Each
      subject will be required to come to Vanderbilt University Medical Center for four study
      visits, at which the study team will obtain a blood sample, a urine sample, stool sample,
      vital signs, waist and hip circumference, and 1-3 surveys will be completed if the subject
      did not complete them prior to the visit. Each subject that completes the entire study visit
      will be compensated $250. DNA samples will be obtained to allow for identification of genetic
      predictors of 2-AAA levels. Some individuals may be asked to return for a future follow-up
      study.
    

Intervention name(s): Lysine; Controlled Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lysine is an essential amino acid which is acquired from dietary sources.; Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors
Condition: Brainstem Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether initial local irradiation with topotecan
      and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective
      in the treatment of pediatric diffuse brainstem tumor.
    

Detailed description: 
      All pediatric patients (aged 1-16 yrs) with newly diagnosed diffuse brain stem tumor or
      inoperable thalamic tumor which infiltrate brain stem from the pediatric oncology units in
      Denmark, Finland, Iceland, Norway and Sweden will be eligible. A possible tumor biopsy with
      histologic findings is not taken into account. The diagnosis is based on MRI. The patients
      are given a conventional local radiotherapy of 54 Gy, during which the patient also receives
      topotecan as radiosensitizer. Within four weeks after completed radiotherapy, the
      investigational drugs are started. If the family for some reason refuses radiotherapy, the
      investigational therapy may still be considered. The guardians and age-appropriate patients
      are asked for written informed consent. If the family is not willing to participate in the
      trial, the patient is treated according to the currently best available therapy (meaning RT
      without topotecan as palliative therapy). The family has the right to withdraw from the
      study, whenever they so wish.

      Brain MRI at initial diagnosis, before the start of triple medication, and q 3 mo after
      initiation of triple medication, if not otherwise clinically indicated. In case it is decided
      to continue medication with progression in MRI, repeat MRIs are recommended every month. MRI
      should also be registered, if feasible, at the discontinuation of the medication.

      The clinical follow-up, as well as MRI follow-up, on clinical indications will continue also
      after discontinuation of therapy.

      PET-CT and/or MRI spectroscopy should be considered at diagnosis and at 3 mo after the start
      of triple medication.
    

Intervention name(s): Thalidomide, etoposide, celecoxib
Intervention type(s): Drug
Intervention description(s): Thalidomide p.o. 1 mg/kg/day/1; the dose is gradually escalated, the maximum dose being 6 mg/kg/day. (The individual dose is set based on adverse effects.) Celecoxib p.o. 230 mg/m2/day/1-2, or in small children at 7 mg/kg/day in 1-2 doses.
Etoposide p.o. the initial dosage 20 mg/m2/day; the dose is gradually escalated, the maxi 70 mg/m2/day.
Other intervention name(s): vepesid (etoposide); celebra (celecoxib)
Intervention MeSH terms: Thalidomide; Celecoxib; Etoposide; Etoposide phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Periodontal Treatment on Stress and Pregnancy Relationship
Condition: Pregnancy Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      There is a relationship between stress and pregnancy gingivitis. This relationship may be
      double-sided.
    

Detailed description: 
      The aim of this clinical study was to determine the effect of non-surgical mechanical
      periodontal treatment on sex steroid and stress markers at pregnancy gingivitis. A total of
      84 subjects; 22 pregnant women with gingivitis (group 1) and 25 pregnant women with
      periodontal healthy (pregnant group), group 2), 22 non-pregnant women with gingivitis (group
      3) and 15 non-pregnant women with periodontal healthy (non-pregnant group), group 4)
      participated in this study. Clinically, plaque index, gingival index, and probing pocket
      depth were measured at baseline and after therapy.
    

Intervention name(s): Non-surgical periodontal treatment; Saliva samples; GCF samples
Intervention type(s): Other; Other; Other
Intervention description(s): Non-surgical periodontal treatment was performed for pregnant and non-pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken from all patients baseline and after 8 weeks.; Saliva samples were taken from patients for the evaluation of sex steroid and stress markers baseline and after 8 weeks.; GCF samples were taken from patients for the evaluation of stress markers baseline and after 8 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Stress
Individually Tailored Web-based Multimodal Pain Rehabilitation in Primary Health Care
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional

Summary: 
      The aim is to evaluate effects of early individually tailored web-based multimodal
      rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary
      health care. The aim is also to study if this early web-based pain rehabilitation program is
      more cost-effective than only multimodal rehabilitation. Randomization will be done at each
      primary health care centre after screening to 1) Multimodal pain rehabilitation with
      web-based education and coaching support or 2) multimodal pain rehabilitation. The
      investigators suggest a clear rehabilitation chain where a web-based program is
      developed,evaluated and ready to implement if it shows positive effects on work-ability
      and/or is cost-effective. The research and implementation will be performed in a close
      cooperation with Luleå University of Technology.
    


Intervention name(s): Web-based multimodal rehabilitation based on cognitive based principles
Intervention type(s): Behavioral
Intervention description(s): The patient will be randomized to either the interventions group (multimodal pain rehabilitation with an added web-based multimodal rehabilitation with CBT-influences) or a control group (multimodal pain rehabilitation).
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: persistent neuromusculoskeletal pain; neck; shoulder; back-area; risk; longlasting; pain syndrome