bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months
Condition: Hand, Foot and Mouth Disease; Herpangina; Other EV71-associated Diseases
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Herpangina; Mouth Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of
      epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a
      small proportion of cases. There has been a significant increase in EV71 epidemic activity
      throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region have heen
      associated with a severe from of brainstem encephalitis associated with pulmonary oedema and
      high case-fatality rates.

      The data from the phase 1 and 2 trials suggested that the inactivated EV71 vaccine had a
      clinically acceptable safety and good immunogenicity for healthy Chinese children and
      infants. According to the immunogenicity and safety results, the 320U with adjuvant with
      immunizing schedule of two doses (per 28 day) will be applied in phase 3 clinical trial.
    


Intervention name(s): inactivated vaccine (Vero Cell) against EV71; 0/0.5ml placebo
Intervention type(s): Biological; Biological
Intervention description(s): inactivated vaccine (vero cell) against EV71, 320U /0.5ml, two doses, on day0, 28; 0/0.5ml placebo, two doses, on day0, 28
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: efficacy; safety; inactivated vaccine (Vero Cell) against EV71; EV71-associated diseases
A Case Series Study of Negative Pressure Platform Wound Device
Condition: Incisions, Surgical
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      This primary case series study will demonstrate the safety and feasibility of the NP-PWD
      technology and treatment protocol to promote healing of surgical incision healing. In a first
      use in humans of the NP-PWD's capability to deliver negative pressure wound treatment (NPWT),
      this project will gather data from patients with elective surgical incisions, with the
      intention to evaluate the NPWT capability for future use in more tenuous situations of wound
      closure.
    

Detailed description: 
      A case series study of 10 subjects will be conducted by enrolling patients who are scheduled
      for elective surgical incisions. Patients will be screened for inclusion criteria and asked
      to consent to participate in the study for single application treatment with the NP-PWD for
      3-6 days. Initial evaluation of the incision would occur on Day 0, including screening,
      pre-procedure evaluation, measurement and photography of the closed surgical incision. Follow
      up data is then gathered Day 3-6 with removal of the NP-PWD, surgical incision assessment and
      photography, and assessment for adverse effects. Day 9-14 follow up include the same
      assessments of progression of wound closure. Gathered clinical data of the 10 subjects will
      be used to evaluate the safety in using the NPWT device for effective wound healing.
    

Intervention name(s): NP-PWD
Intervention type(s): Device
Intervention description(s): Application of NP-PWD device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will attempt to find out if the addition of an intravenous form of a drug that is
      already used for treating asthma in children will help resolve asthma attacks faster than
      using the current standard care alone.
    

Detailed description: 
      The duration of treatment is a one time dose.
    

Intervention name(s): montelukast sodium; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration; Pbo for a study approximately 120 minutes in duration
Other intervention name(s): MK0476; SINGULAIR®
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth
      of cancer cells and slow the growth of chronic lymphocytic leukemia.

      PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating
      patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the complete and partial response rate in patients with fludarabine-refractory
           B-cell chronic lymphocytic leukemia treated with denileukin diftitox.

      Secondary

        -  Determine the toxicity profile of this drug in these patients.

        -  Determine the response rate in patients (regardless of CD25 receptor density) treated
           with this drug.

        -  Determine the progression-free survival and overall survival of patients treated with
           this drug.

      OUTLINE: This is a multicenter study.

      Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 21
      days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

      Patients achieving a complete response after 8 courses proceed to follow-up. Patients
      achieving a partial response or stable disease after 8 courses may continue treatment at the
      discretion of the investigator.

      Patients are followed every 3 months for 1 year and then annually until relapse.

      PROJECTED ACCRUAL: A total of 12-44 patients will be accrued for this study within 1 year.
    

Intervention name(s): denileukin diftitox
Intervention type(s): Biological
Intervention MeSH terms: Denileukin diftitox
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell chronic lymphocytic leukemia; refractory chronic lymphocytic leukemia
Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to confirm the mechanism of reduced response to DPP-4 inhibitor
      in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-4
      inhibitor
    

Detailed description: 
      Sitagliptin, a DPP-4 inhibitor was used as an incretin enhancer in clinical practice first.
      In clinical trials, sitagliptin showed effective control of blood glucose level in type 2
      diabetes and 100 mg once daily with metformin was similar to sulfonylurea (glipizide) with
      metformin in lowering HbA1c. Mostly in practice, stable blood glucose levels were maintained
      after change of sulfonylurea to sitagliptin in type 2 diabetes treatment. However, in some
      cases, there were abrupt severe hyperglycemia and uncontrolled blood glucose level after drug
      change to sitagliptin.

      Several mechanism could be considered for reduced response to DPP-4 inhibitor in some type 2
      diabetes patients. Firstly, significantly reduced secretion of glucagon-like peptide 1
      (GLP-1) more than expected in diabetes or functional defect of GLP-1 activity could be the
      mechanism of loss of GLP-1 effect irrespective of DPP-4. Secondly, mutation or functional
      defect of DPP-4 enzyme could not be inhibited by DPP-4 inhibitor. Thirdly, GLP-1 receptor
      mutation or other defect in β-cell responsiveness to GLP-1 leads to reduction of response to
      DPP-4 inhibitor.
    

Intervention name(s): Sitagliptin
Intervention type(s): Drug
Intervention description(s): Sitagliptin (100mg, per oral) once a day.
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Dipeptidyl peptidase IV inhibitors; Glucagon-like peptide 1
Effects Exercise Training in Patients With Pituitary Adenoma
Condition: Pituitary Adenoma
MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases
Study type: Interventional

Summary: 
      This study planned to investigate the effects of aerobic training combined with strengthening
      training and yoga on biochemical factors, physical performance and quality of life in people
      with pituitary adenoma. The hypotheses are; H1: Aerobic training combined with strengthening
      training is effective on biochemical factors in people with pituitary adenoma.

      H2: Aerobic training combined with strengthening training is effective on physical
      performance in people with pituitary adenoma.

      H3: Aerobic training combined with strengthening training is effective on quality of life in
      people with pituitary adenoma.

      H4: Yoga is effective on biochemical factors in people with pituitary adenoma. H5: Yoga is
      effective on physical performance in people with pituitary adenoma. H6: Yoga is effective on
      quality of life in people with pituitary adenoma. H7: Aerobic training combined with
      strengthening training and yoga is effective on biochemical factors, physical performance and
      quality of life in people with pituitary adenoma.
    


Intervention name(s): Aerobic exercise combined with strength training; Yoga
Intervention type(s): Other; Other
Intervention description(s): 30 minute aerobic exercise training with warm-up and cool down followed by 30 minute strength training for specific muscles.; 60 minute yoga intervention including different asanas, breath control and meditation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
Condition: Alzheimer Disease; Genetic Predisposition to Disease
MeSH terms: Alzheimer Disease; Genetic Predisposition to Disease
Study type: Interventional

Summary: 
      The purpose of this study is to compare two methods for remote genetic counseling (telephone
      and two-way videoconferencing) for patients who are receiving disclosure of their APOE
      (apolipoprotein E) genotype. The target population will consist of males and females in the
      age range of 60-75 years who, as potential participants in a study (Generation Study), will
      need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing
      to receive genetic counseling and disclosure remotely. Subjects must be willing to be
      randomized to either telephone arm or videoconference arm.
    


Intervention name(s): Two-way videoconference remote genetic counseling; Telephone remote genetic counseling
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Telemedicine; Counseling, Genetic
Clinical Audit on the Managment in Assiut University Children Hospital
Condition: Rheumatic Fever
MeSH terms: Rheumatic Fever; Rheumatic Diseases; Fever
Study type: Observational

Summary: 
      clinical audit on the Managment of rheumatic fever in assiut university children hospital.
    

Detailed description: 
      Acute rheumatic fever,an auto immune response to Group A streptococcus infection of the upper
      respiratory tract,may result in carditis.when the inflammation leads to permenant damage of
      the valves the individual has rheumatic heart disease.

      Recurrences of rheumatic fever are likely in the absence of preventive measures and may cause
      further cardiac valve and muscle damage,leading to heart failure,stroke and premature
      death.bacterial endocarditis is also a complication.
    

Intervention name(s): C reactive protein, anti streptolysin o antibody test ,erythrocyte sedimentation rate
Intervention type(s): Diagnostic Test
Intervention description(s): Throat culture to detect the causative organism
Other intervention name(s): Throat culture
Intervention MeSH terms: Antibodies; Antistreptolysin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Clinical audit on the managment of rheumatic fever in assiut university children hospital
The Impact of the Biopsy of 1-2 Cells in a PGD Program for Anueploidy Screening
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the impact of the biopsy of one or two cells in a
      preimplantatation genetic diagnosis program (PGD) for the screening of aneuploidies. This
      prospective and randomized study will be performed at the Instituto Valenciano de
      Infertilidad in Valencia (Spain) in those patientes included in our clinical program. Our
      purpose is to optimize the methodology employed in our laboratory in order to guarantee
      optimal implantation and pregnancy rates without a detrimental effect on the accuracy and
      efficiency of the cytogenetic analysis. Patients will undergo and IVF cycle, embryo biopsy
      will be performed on day 3 embryos in two fashions: in some patients only one cell per embryo
      will be retrieved whereas in others, 2 cells will be retrieved in good morphology embryos and
      only 1 in the slowl ones. In all cases aneuploidy screening will be performed by FISH for
      chromosomes 13, 16, 18, 21, 22, X and Y. Embryo developmente will be checked every 24 hours
      and chormosomally normal embryos will be replaced into the uterus on day 5 of development.
    


Intervention name(s): Biopsy of Day 3 Embryo; · day embryo biopsy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Pregnancy and implantation rates; Efficiency and accuracy of the genetic testing
Validation of the Stayhealthy BC1 Body Comp Analyzer
Condition: Body Composition
Study type: Interventional

Summary: 
      The purpose of this study was to validate the Stayhealthy BC1 bioelectrical impedance
      analyzer to assess percent body fat in children and adults. The BC1 was compared to
      dual-energy x-ray absorptiometry assessment of body fat for adults and to hydrostatic
      weighing assessment of body fat for children. We hypothesized that the BC1 would provide
      similar measures of body fat between devices with acceptable limits of agreement.
    

Detailed description: 
      The BC1 body composition analyzer is manufactured by Stayhealthy. It is a handheld,
      noninvasive bioelectrical impedance device. When held, the BC1 sends an electrical impulse
      through the body to determine body fat, muscle mass, and body hydration. Bio-impedance
      devices measure the change in electrical resistance in body tissues by using a detectable
      electrical signal that passes through the body. The method is based on the principle that
      lean body mass contains virtually all the water and conducting electrolytes in the body and
      provides a good electrical pathway. In contrast, fat or fat-containing tissues produce a poor
      electrical pathway. By inducing a low-energy, high -frequency signal, a measurement of the
      baseline resistance to flow of electrical current can be assessed. The resistance measurement
      relates directly to the volume of the conductor. Through repeated measurements and
      identifying other parameters (i.e. gender, weight, age and height) proprietary equations were
      developed that determine total body water, fat free body mass, and total body fat.
    

Intervention name(s): BC1
Intervention type(s): Device
Intervention description(s): Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing.
Other intervention name(s): BIA, underwater weighing, DEXA scanning, BC1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Percent body fat; Body Composition; Stayhealthy
A Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI)
      esomeprazole on the single-dose PK of orally administered TAK-906.
    

Detailed description: 
      The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy
      participants to evaluate the effect of a PPI esomeprazole on the PK of TAK-906.

      The study will enroll approximately 12 participants. Participants will be assigned to the
      following treatment sequence:

      • TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg

      All participants will be given an oral dose of TAK-906 and Esomeprazole.

      This single center trial will be conducted in the United States. The overall duration to
      participate in this study is 52 days. Participants will make visit to the clinic during
      Period 1 and Period 2 in addition to approximately 10 to 14 days after receiving their last
      dose of TAK-906 for a follow up assessment.
    

Intervention name(s): TAK-906; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): TAK-906 capsules.; Esomeprazole capsules.
Other intervention name(s): TAK-906 maleate; Nexium
Intervention MeSH terms: Esomeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The AGIL study was designed to evaluate the effectiveness and safety of adalimumab over 5
      years in routine daily clinical practice in Germany, with a focus on the impact of therapy on
      employment-related outcomes.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample: Patients with rheumatoid arthritis
      
Keywords: Work Productivity; Long-term Observation; Humira; Quality of Life; Rheumatoid Arthritis
Clinical & MRI Finding of TMJ Disk Perforation
Condition: TMJ Disc Disorder
Study type: Observational

Summary: 
      the study aimed to evaluate the clinical and MRI finding of TMJ with disk perforation with
      predication of the risk factors.
    

Detailed description: 
      The retrospective study included patients seeking treatment for TMD at Al-Azhar University
      Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University.
      The sample originally included patients who provided consent to participate in this study and
      who ultimately underwent treatment for TMJD between 2008 and 2019.

      Exclusion Inclusion criteria: Patients were included if they were older than 18 years and
      diagnosed with TMJD. criteria for this study included systemic diseases (the presence of
      polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal
      or medical devices, claustrophobia), the presence of neurologic disorders, head and neck
      cancer, oral submucous ﬁbrosis, a history of TMJ surgery, a history of previous nonsurgical
      treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma
      patients with subcondylar fracture and patients with congenital and developmental disorders
      of the TMJ were also excluded from the study.

      the study included 2 groups group 1: normal TMJ patients group 2: patients with TMJ internal
      derangement
    

Intervention name(s): MRI
Intervention type(s): Diagnostic Test
Intervention description(s): MRI OF TMJ
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The sample originally included patients who provided consent to participate in this study
        and who ultimately underwent treatment for TMJD between 2008 and 2019.
Magnetic Resonance Elastography (MRE) as a Predictor of HCC Recurrence After Radiofrequency Ablation (RFA)
Condition: Hepatic Fibrosis; Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis; Fibrosis; Recurrence
Study type: Interventional

Summary: 
      The purpose of this study is to determine:

        -  The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA
           treatment

        -  The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the
           gold-standard histology score predicting hepatic fibrosis
    

Detailed description: 
      To evaluate whether MRE score reflecting hepatic fibrosis can predict the recurrence of HCC
      within 2 years after RFA treatment

        -  Local recurrence/intrahepatic distant recurrence

        -  Multivariable analysis including several related factors to find whether MRE score is an
           independent predictor of HCC recurrence even after adjusting other factors (etiology of
           liver disease, size of HCC, vessel invasion, HBsAg titer, etc.)

      To find the efficacy of each indicator (MRE score, non-invasive serum markers) compared to
      the gold-standard histology score predicting hepatic fibrosis.
    

Intervention name(s): Magnetic resonance elastography
Intervention type(s): Procedure
Intervention description(s): Magnetic resonance elastography before RFA and Liver biopsy of 2 HCC tissue and 2 non tumor liver parenchyma tissue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hepatic fibrosis; Magnetic resonance elastography; Hepatocellular carcinoma; Recurrence