bioihbjkbjnl/mcl2 huggingface dataset:
Circulating Tumor Cell Detection in Hepatocellular Carcinoma
Condition: Circulating Tumor Cell
MeSH terms: Carcinoma, Hepatocellular; Neoplastic Cells, Circulating
Study type: Observational

Summary: 
      The investigators examined circulating tumor cells (CTC) in the perioperative peripheral
      blood of hundreds of HCC patients undergoing liver cancer surgery using CellSearch technology
      between 2013 and 2016. Although the investigators have done a preliminary study of the above
      data and published some results, the previous study was only a basic analysis. Now the
      investigators plan to carry out further in-depth analysis of these data, including
      hospitalization data, follow-up results, surgical tumors and blood specimens, and make full
      use of biostatistics, molecular biology, pathology and other related techniques to elucidate
      the association between the levels of CTC or CTC clusters and patients' disease during the
      perioperative period, and to explore the molecular basis of CTC production in hepatocellular
      carcinoma.
    

Detailed description: 
      From 2013 to 2016, CellSearch technology was used to detect the number of circulating tumor
      cells (CTC) in peripheral blood of hundreds of HCC patients undergoing liver cancer surgery
      during perioperative period. The analysis results confirmed that the level of CTC before and
      after surgery were significantly correlated with overall survival (OS) and disease-free
      survival (DFS) of patients. CTC level changed before and after surgery, but there was no
      statistical difference. Preoperative CTC was more correlated with patients' disease-related
      clinical parameters, while postoperative CTC was an independent prognostic indicator of
      patients after surgery. In addition, the investigators' study found that CTC clusters level
      can be a new marker of tumor progression in HCC patients.

      Based on the above data, the investigators will perform retrospective analysis to compare the
      relationship between CTC level and clinical indicators of HCC patients. Participants were
      divided into groups according to pathological type, differentiation degree, clinical stage,
      invasion degree, recurrence and metastasis of tumors. Combined with immunohistochemistry and
      quantitative PCR results, the correlation of CTC in tumor genesis, pathological model, degree
      of differentiation, tumor stage, invasion, metastasis and expression of other tumor markers
      was studied.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Perioperative patients with hepatocellular carcinoma who underwent CTC detection of
        peripheral blood
      
Biospecimen description: 
      blood
The Effect of Final Exam Preparation on Anxiety Level, Self-Perception, Ocular Symptoms, Accommodation and Vergence in Myopia
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      To evaluate the effects of exam preparation on anxiety level, self perception, ocular
      symptoms and oculomotor responses in myopes
    

Detailed description: 
      Twenty two first year optometry students were evaluated towards the end of their first
      academic year on a battery of Oculomotor and Survey tests. This occurred during two sessions,
      one Low Stress session and one High Stress session. Sessions were separated by one month.

      Low Stress Session (LS), No Exams or Minor Exams High Stress Session (HS), Final Exam
      Preparation week

      Battery of Surveys:

      Adult Manifest Anxiety Scale for College Students (AMAS-C):

      36 items which probe 4 types of anxiety

        -  Worry/Oversensitivity

        -  Test Anxiety

        -  Physiological Anxiety (Somatic responses to anxiety)

        -  Social Concerns

      Self Perception Profile (SPP):

      45 items which probe 9 domains

        -  Scholastic Competence

        -  Social Acceptance

        -  Athletic Competence

        -  Physical Appearance

        -  Job Competence

        -  Romantic Appeal

        -  Behavioral Conduct

        -  Close Friendship

        -  Global Self-worth

      CI Symptom Survey (CISS-15):

      15 items which probe ocular and aesthenopic signs and symptoms

      Students also reported Hours of daily near work (NWhrs).

      Battery of Oculomotor Tests:

      (20/30 ETDRS target used for all) Vergence Tests

        -  Phorias Near and Far (Neutralized Alternate Cover Test)

        -  Vergence Ranges Near and Far (Prism Bar)

        -  Vergence Facility Near and Far (3BI/12BO)

        -  Near Point of Convergence

      Objective Accommodative Tests (SRW-5000autorefractor)

      Monocular Accommodative Responses to:

        -  Near Target (33cm)

        -  Minus Lens (-3D) while viewing distant (6m) target

      Subjective Accommodative Tests:

      Monocular Accommodative Responses to:

        -  Donder's Push Up Amplitude test

        -  Near Accommodative Facility (+/-2.00, five practice trials)

        -  Distant Accommodative Facility (plano/-2.00, five practice trials)
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: stress; anxiety; myopia progression; accommodation; vergence
Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      This prospective double blinded study will be conducted over 60 pediatric patients ASA
      (American Association of Anesthesiologists) I and II between the age of 1-7 years old, who
      will be scheduled for unilateral groin surgery. Patients will be randomly allocated into 3
      study groups: Control group that only received local anesthetics ( bupivacaine) Group II
      bupivacaine with the dexmetedomidine ( 0,5mcg/kg ) and group III bupivacaine with the
      dexmedetomidine (1mcg/kg).Patients in all groups will receive quadratus lumborum block.

      Bradycardia, hypotension, atropine, and bolus fluid infusion requirements will be recorded.
      When there was up to a 30% decrease in basal mean blood pressure, a crystalloid infusion
      bolus will be given at 10 ml/kg. When bradycardia occurred , atropine will be given at a dose
      of 0.02 mg/kg. Patients will be followed up in the postoperative recovery unit for the first
      2 hours, and then in the ward. The RAMSEY sedation scale and WATCHA agitation scale were
      evaluated at 5, 15, 30, and 60 minutes in the postoperative recovery unit. Nausea, vomiting,
      and other side effects were recorded if present.

      Time to first analgesic requirement ( primary outcome) , FLACC Scale scores will be recorded
      within 24h postoperatively, total dose of analgesic consumption, incidence of postoperative
      complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression will
      be recorded.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pediatric patient children aged 1-7 years
      
Keywords: dexmedetomidine; bupivacaine; quadratus lumborum block; postoperative pain; regional anesthesia; pediatric anesthesia
BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study designed to determine the safety and tolerability of a single dose of BIIB023
      administered intravenously versus placebo to subjects with RA.
    


Intervention name(s): BIIB023; Placebo (sterile normal saline)
Intervention type(s): Drug; Other
Intervention description(s): Single IV doses of BIIB023 in dose-escalating cohorts; Single IV dose of Placebo
Other intervention name(s): Human glycosylated IgG1 monoclonal antibody
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Scavenging of Reactive Carbonyl Species by Apple Polyphenols in Human
Condition: Human Health; Polyphenols; Pharmacokinetics
Study type: Interventional

Summary: 
      This is an interventional study to investigate formation and pharmacokinetics of reactive
      carbonyl species adducts of apple polyphenols in human after a single dose of apple
      consumption.
    

Detailed description: 
      A crossover design was used. Twelve healthy volunteers were recruited and asked to avoid the
      consumption of any apple products starting 1 week before intervention and continuing
      throughout the entire study for a total of 3 weeks.

      On week 2, each of six participants received 600 g apple blends (seeds removal) in a single
      dose, and afterwards, urine and blood samples at different timepoints over 24 h, and fecal
      sample at different timepoints over 48 h were collected. Meanwhile, other six participants
      received breakfast (without any apple products) only, and urine and blood samples at
      different timepoints over 24 h, and fecal sample at different timepoints over 48 h were
      collected.

      On the contrary, on week 3, six participants who received apple blends on week 2 received
      breakfast only, and six participants who were used as control on week 2 received apple
      blends. And urine and blood samples at different timepoints over 24 h, and fecal sample at
      different timepoints over 48 h for both groups were collected.

      Samples will be analyzed by LC-MS/MS. Pharmacokinetics of conjugates will be investigated.
    

Intervention name(s): Apple consumption; Control group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Apple blends (600 g) One single dose; Breakfast without any apple-related products
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: endogenous reactive carbonyl species; apple consumption; formation of carbonyl species adducts of apple polyphenols; pharmacokinetics of adducts in human; intervention
Quality of Life in Juvenile Patients With Uveitis
Condition: Uveitis
MeSH terms: Uveitis
Study type: Observational

Summary: 
      Data about psychodynamics in uveitis patients are scare. A negative impact of disease is
      described not only in adult patients with active, but also with quiescent disease. During
      adolescence even less is known about psychodynamics although this is an especially sensible
      and challenging stage of life. Given the assumption that juvenile patients with quiescent
      disease still could suffer from emotional distress, this would require special attention.

      In this study the investigators evaluate the impact of juvenile uveitis on HRQoL and
      attempted to identify clinical and demographic factors contributing to an impaired health
      status. The investigators limit the study to patients with quiescent uveitis and good visual
      function in at least one eye to exclude additional negative stressors. As there are no
      validated uveitis-specific psychometric questionnaires evaluating QoL available yet, the
      investigators use age-appropriate generic instruments. This should allow obtaining an
      overview about the adolescents' general Health-related Quality of Life (HRQoL) and whether
      psychological interventions should be offered to this sensitive patient group.
    


Intervention name(s): Filling in a psychometric questionnaire
Intervention type(s): Other
Intervention description(s): Juvenile patients attending the uveitis are asked to fill in a psychometric questionnaire
Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Patients with uveitis, aged 11-18 years
      
Keywords: childhood uveitis; health-related quality of life; gender
Effect of Rebound Exercise in Individuals With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effect of rebound exercise (mini trampoline
      jumping) on metabolic outcomes and quality of life in patients with Type 2 Diabetes.
    

Detailed description: 
      The exercise involved jumping on the mini trampoline with feet slightly apart. Participants
      stood on the mid portion of the trampoline bed and made repeated up-and-down bouncy
      movements. Each foot strike equals one step or bounce. With each landing, the mat of the
      trampoline underwent deformation and the springs released the energy stored in them such that
      the participant was made to bounce off the mat. Exercise was administered for between 10 - 15
      minutes after which a 5-minute period of rest was allowed. A heart rate monitor was used to
      guide the intensity of the exercise in the moderate range. Each participant accumulated
      between 20 and 30 minutes of rebound exercise (bouncing on a mini trampoline) per session,
      administered three times per week for 12 weeks. All data were captured at baseline and at the
      end of the 12-week intervention period.
    

Intervention name(s): Rebound exercise
Intervention type(s): Other
Intervention description(s): Repeated jumping on a mini trampoline was administered
Other intervention name(s): Mini trampoline rebounding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer is the most frequently observed cancer in women in France.The mortality rate is
      still decreasing with a decrease of 1.6% per year between 2010 and 2018, explained by the
      improvement in available treatments.For patients with breast cancer expressing hormone
      receptors, treatment with Tamoxifen or anti-aromatase can have the risk of the cancer coming
      back.However, these treatments have many side effects, including the risk of osteoporosis and
      metabolic disorders with anti-aromatases; and arterial and thromboembolic accidents with
      Tamoxifen.These effects have been well studied while taking hormone therapy.However, very few
      studies have analyzed the impact of these treatments after stopping them in women who have
      had non-metastatic hormone-sensitive breast cancer and uncertainties persist on the evolution
      of the health risk after initial treatment.
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): A questionnaire will be given to patients who will ask them about their possible fractures, their bone and oncological follow-ups and their possible cardiovascular events since the end of treatment with hormone therapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
18F-FDG-PET Guided Dose-Painting With Intensity Modulated Radiotherapy in Oropharyngeal Tumours
Condition: Oropharyngeal Cancer
MeSH terms: Oropharyngeal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Treatment of cancers of the head and neck, including oropharyngeal tumours, usually consist
      of a combination of radiotherapy and chemotherapy, although surgery may also play a part.
      Radiotherapy works by using the high energy x-rays to destroy cancer cells. Head and neck
      cancers often respond well to radiotherapy in the first instance and a proportion of patients
      will be cured by this treatment. However, not all of the cancer cells are destroyed by the
      combination of radiotherapy and chemotherapy and, in some patients, the cancer does come
      back.

      Studies have suggested that more efficient killing of cancer cells, and therefore, better
      cure rates, can be achieved by increasing the radiotherapy dose. However, in the past, this
      was not possible due to side effects. Intensity Modulated Radiotherapy (IMRT) is a new
      radiotherapy delivery technique that allows better shaping of the dose to the areas that need
      irradiating with the potential for fewer side effects. If the investigators use IMRT to
      deliver an intentionally higher dose of radiation (called a boost) to small selected areas
      whilst, at the same time giving standard treatment doses to the remaining areas, this
      approach is called IMRT dose-painting. These selected areas can be identified by a scan
      called 18F-FDG-PET (18F-fluorodeoxyglucose-positron emission tomography, also known as a
      'PET' scan) which is a type of scan that can give information about the activity of a cancer.

      The purpose of this study is to find out whether the investigators can use IMRT dose-painting
      to boost the dose to the region inside a tumour which appears most active on 18F-FDG-PET. If
      this study shows that this approach is well-tolerated, then the investigators may be able to
      improve cure rates with this treatment. This would need to be tested in a subsequent study.
    


Intervention name(s): FDG-PET guided radiation dose escalation
Intervention type(s): Radiation
Intervention description(s): Selective dose escalation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of the Therapy With BRAINMAX® Using fMRI for the Treatment of Patients With Asthenia After COVID-19
Condition: Asthenia; COVID-19; Functional MRI; Cognitive Impairment
MeSH terms: COVID-19; Asthenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      to assess executive network using resting-state fMRI and patterns of brain activation using
      task fMRI with a cognitive paradigm, against the background of taking the drug in comparison
      with placebo in patients with post-COVID asthenic syndrome.
    

Detailed description: 
      A prospective, randomized, double-blind, placebo-controlled trial to evaluate the
      effectiveness of therapy using functional MRI of the brain in the setting of neuroprotective
      therapy for the treatment of patients with chronic fatigue syndrome after COVID-19. The study
      included 30 patients matched by sex and age with confirmed coronavirus infection. All
      patients were examined with MFI-20, MoCa, FAS-10 scales, MRI using a Siemens MAGNETOM Prisma
      3T scanner before and after a course of therapy with EMHPS-M or placebo (15 patients each)
      using resting state fMRI and with cognitive paradigm. First group received intramuscularly
      with the dosage regimen of 5 mL of solution (500 mg of ethyl methyl hydroxypyridine succinate
      + 500 mg of meldonium) once per day for 10 days. Second group received Placebo in the same
      way.
    

Intervention name(s): Structural and functional MRI; Ethyl methyl hydroxypyridine succinate + Meldonium; Placebo
Intervention type(s): Other; Drug; Drug
Intervention description(s): MRI using a Siemens MAGNETOM Prisma 3T scanner before and after a course of therapy, using resting state fMRI and with cognitive paradigm.; Ethyl methyl hydroxypyridine succinate 100.0 mg/mL, meldonium dihydrate - 100.0 mg/mL (Solution for intravenous and intramuscular administration); Placebo was used in the same way
Other intervention name(s): fMRI; BRAINMAX®
Intervention MeSH terms: 3-(2,2,2-trimethylhydrazine)propionate
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Asthenia; COVID-19; Chronic fatigue syndrome; Functional MRI; Cognitive impairment; Brain fog; BRAINMAX
ZD6474 in Treating Patients With Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: ZD6474 may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth. ZD6474 may also stop the growth of small cell lung cancer by blocking blood
      flow to the tumor.

      PURPOSE: This randomized phase II trial is studying how well ZD6474 works compared to placebo
      in treating patients with small cell lung cancer that has responded to previous chemotherapy
      with or without radiation therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the progression-free survival of patients with previously treated small cell
           lung cancer (SCLC) treated with ZD6474 vs placebo.

        -  Compare the response rate of patients treated with these regimens (only patients who had
           measurable disease outside a prior radiation field at study entry).

        -  Compare the toxicity and tolerability of these regimens in these patients.

        -  Compare the pharmacokinetics of these regimens in these patients.

        -  Correlate outcome and response with vascular endothelial growth factor expression and
           microvessel density in patients treated with these regimens.

        -  Compare the quality of life of patients treated with these regimens.

        -  Provide a comprehensive tumor, plasma, and urine bank linked to a clinical database for
           further study of molecular markers in SCLC.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to participating center, timing of prior radiotherapy (early [before
      day 1, course 4 of chemotherapy] vs late vs no prior radiotherapy), stage of disease at
      diagnosis (limited vs extensive), and response at study entry (complete vs partial). Patients
      are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral ZD6474 daily.

        -  Arm II: Patients receive oral placebo daily. In both arms, courses repeat every 28 days
           for up to 2 years in the absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline, every 4 weeks while on therapy, and then every 8
      weeks until disease progression.

      Patients are followed every 8 weeks until disease progression and then every 6 months
      thereafter.

      PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): vandetanib; adjuvant therapy
Intervention type(s): Drug; Procedure
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: extensive stage small cell lung cancer; limited stage small cell lung cancer