bioihbjkbjnl/mcl2 huggingface dataset:
Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast
      cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen
      of letrozole is more effective in postmenopausal women who have received hormone therapy for
      early-stage breast cancer.

      PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in
      preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for
      hormone receptor-positive, lymph node-positive, early-stage breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the disease-free survival (DFS) of postmenopausal women treated with continuous
           letrozole for 5 years vs intermittent letrozole over a 5-year period.

      Secondary

        -  Compare overall survival of patients treated with these two regimens.

        -  Compare distant DFS of these patients.

        -  Compare breast cancer-free interval of these patients.

        -  Compare sites of first DFS failure in these patients.

        -  Compare second (nonbreast) malignancies in these patients.

        -  Compare deaths without prior cancer events in these patients.

        -  Compare adverse events resulting from these two regimens.

      OUTLINE: This is a multicenter study. Patients are stratified according to treatment center
      and type of prior endocrine therapy (selective estrogen receptor modulators [SERMs] alone vs
      aromatase inhibitors [AIs] alone vs both SERMs and AIs each for at least 1 month). Patients
      are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral letrozole daily for 5 years.

        -  Arm II: Patients receive oral letrozole daily for the first 9 months of years 1 through
           4, followed by 12 months in year 5.

      After completion of study therapy, patients are followed annually.
    

Intervention name(s): Letrozole; Letrozole
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously; Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -> 36 mo) plus 1 x 12 mo in yr 5 -> 48 months
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer
Preheating of Femur Component in Hybrid Total Hip Arthroplasty
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 2

Summary: 
      Background

        -  Recently published studies confirm that preheating of femoral component enhances shear
           strength of implant-cement interface. Both Iesaka et al 2003 and Jafri et al 2004 showed
           reduction in cement porosity on cement-implant interface with preheated femur
           components. We will use the radiostereometry analysis (RSA) to investigate how the
           preheating of femur component influence on prosthesis survivorship. There are no
           clinical controlled studies performed to the date.

      The aim of the study

        -  Comparison of the migration rates between preheated and non-preheated femur components,
           analyzed with RSA.

      Methods

        -  Randomization of 80 patients into 2 groups with 40 in each. All patients will undergo
           standard hybrid total hip replacement. In group one the femur component (Bi-Metric,
           Interlock Biomet) will be preheated to 40 degrees of Celsius before cementation. In
           group two: the control group, the femur component will be of room temperature. We will
           measure the temperature at cement bone interface during the operation with use of
           thermocouple electrodes inserted through separate drill hole in the femur. The
           measurements will be recorded every 10 seconds. The patients will follow the standard
           postoperative rehabilitation program.

        -  The RSA analysis will be performed the first day after the operation and at 3, 12, 24
           months postoperatively.

        -  The Dual-energy X-ray absorptiometry scanning (DEXA) of the femur will be performed at
           the first week after the operation and at 12 and 24 months postoperatively.

        -  The patients will be followed both clinically and radiologically at 1 and 2 years after
           the operation (Harris Hip Score).

        -  The results will be expressed as mean + SD (in mm). ANOVA statistical analysis will be
           used to confirm the differences between the groups.
    


Intervention name(s): Total hip replacement (Preheating of femur stem)
Intervention type(s): Procedure
Intervention description(s): Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Arthroplasty,; Hip,; Pre-heating,; Radiostereometric analysis,; Dual-Energy Radiographic Absorptiometry,
Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin
Condition: Glabellar Lines
Study type: Observational

Summary: 
      This is a prospective, longitudinal, non-interventional, multi-center study to collect
      subject and physician satisfaction, and treatment experience with Dysport in real clinical
      practice in subjects of Chinese origin.
    

Detailed description: 
      Approximately 250 subjects are planned to be included in the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male and female adult subjects up to 65 years of age with moderate to severe glabellar
        lines (GL)
Diabetes and Sports: Evaluation of a Diabetes Education Module
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly
      developed treatment and education module will be tested compared to a waiting-list control
      group. The module covers the topic "diabetes and sports". Primary outcome variable is
      diabetes-specific empowerment regarding diabetes and sports. Secondary outcome variables are:
      diabetes-related distress, health-related quality of life, depressive symptoms, self-care
      behavior, and glycemic control.
    

Detailed description: 
      The module consists of one lesson (duration: 90 minutes). The module is derived from the
      empowerment approach and is based on the previously evaluated education and treatment program
      for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by
      a trained diabetes educator. Patients are randomized either to the immediate participation in
      the module or to the control group. Control group is a waiting-list control group. Patients
      in this waiting-list control group get the education after the completion of the 6-month
      follow-up.
    

Intervention name(s): Education - Diabetes and Sports
Intervention type(s): Behavioral
Intervention description(s): Based on the treatment and education programme PRIMAS a problem-specific education module regarding "Diabetes and Sports" was created. The module covers specific and detailed aspects of the topic "sports" such as insulin reduction, hypoglycemia awareness during physical activity, and blood glucose values prior to physical activity. With this module, a more comprehensive education of patients with specific interest is possible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; education; randomized; prospective
Acceptability of Hepatitis B Vaccination in General Population
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Observational

Summary: 
      The present study is conducted in order to assess the acceptability of Hepatitis B
      vaccination in French general population before and after reimbursement of the paediatric
      vaccine InfanrixHexa. Four measurements are planned, first before reimbursement and the
      others at year 1, 2 and 3 after reimbursement.
    

Detailed description: 
      The present study aims to evaluate the changes in Hepatitis B immunization coverage and the
      acceptability thereof among parents, in the general population. This is a national,
      prospective, epidemiological study, comprising four measurement time-points over a three-year
      period, (T1 in 2009, T2 in 2010, T3 in 2011, and T4 in 2012) in order to cover the period
      prior to the introduction of InfanrixHexa® reimbursement, the transition period, and the
      period following reimbursement of the vaccine. The periods between each data collection
      time-point will be identical, lasting a year. Two age groups will be investigated at each
      data collection time-point: 12-15 months and 24-27 months, thus providing measurements
      before/after reimbursement.
    

Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): Poll and questionnaire-based methodology completed by face-to-face interviews, with possible additional follow-up offered to households.
Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population will consist of parents (with infants) agreeing to take part in a
        personal interview.
      
Keywords: Vaccination; Acceptability; General population; Hepatitis B; Vaccine coverage
Multiple Dose BE Study With Nevirapine 400mg PR Tablets
Condition: HIV-1
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this steady state pivotal study is to compare the rate and extent of
      absorption and to evaluate Bioequivalence of test drug compared to the approved reference
      product in HIV infected individuals
    


Intervention name(s): Nevirapine; Viramune®
Intervention type(s): Drug; Drug
Intervention description(s): Nevirapine 400mg PR tablet; Viramune® 400 mg Retardtabletten
Intervention MeSH terms: Nevirapine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence
Colloid Improves Organs Function in Resuscitation of Extensive Burn Patients
Condition: Burn
MeSH terms: Burns
Study type: Observational [Patient Registry]

Summary: 
      The present study was to evaluate the effectiveness of colloid compared with crystalloids for
      fluid resuscitation in critical burn patients with total burn surface area ≥50%.
    

Detailed description: 
      Extensive burn patients are some of the most challenging critically ill patients who may have
      multiple-system organ failure with life-threatening complications.Over time, several
      resuscitation formulae have been proposed to guide burn resuscitation and the best known ones
      are Parkland and Evans formulae. The main controversy between the two formulae also focuses
      on whether to infuse the colloid in the first 24 h.Controversy continues and the conflicting
      results left many clinicians unsure about the effect of colloids on fluid resuscitation in
      extensive burn patients who suffer higher risk of hypovolaemia, abdominal compartment
      syndrome (ACS), multiple organs dysfunction and mortality. To address this uncertainty, we
      conducted a prospective, randomized, controlled clinical trial to compare fluid resuscitation
      in extensive burns guided by Parkland formulae with TMMU formulae as a modified Evans formula
      routinely used in China.
    

Intervention name(s): colloids
Intervention type(s): Drug
Intervention description(s): TMMU group allows for administration of colloids early,while Parkland group infuse colloids 24 h after burn injury.
Other intervention name(s): frozen fresh plasma
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study was performed in the Department of Burn Intensive Care of the Tangdu Hospital,
        an academic hospital of the Fourth Military Medical University of Xi'an. populaitons were
        extensive burns who admitted to our hospital within 4 h since burn injury.
      
Keywords: fluid resuscitation; burn; colloid,; multiple organ dysfunction; intra-abdominal pressure
Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises
      with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial
      stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances
      such as nitric oxide.

      The present study assess the vascular properties of carotid and brachial arteries in children
      with SCD compared with a control group without cardiovascular risk factors.
    


Intervention name(s): Echocardiography
Intervention type(s): Procedure
Intervention description(s): Measures by Doppler and study of endothelial function
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: endothelial function; flow-mediated dilation; vascular elastic properties
Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group
      comparison study in subjects with severe acne vulgaris on the face.
    


Intervention name(s): Epiduo/Tactuo; vehicle gel; doxycycline 200mg; Isotretinoin
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): topical to the face, once daily in the evening; topical to the face, once daily in the evening; oral, 2 capsules once daily in the morning with aglass of water and with food; oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
Intervention MeSH terms: Doxycycline; Isotretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Healthy Aging Through Dietary Intervention
Condition: Aging, Healthy
Study type: Interventional

Summary: 
      To test the impact of flavanol supplementation of cardiac and vascular function and
      subsequently on exercise capacity in elderly individuals
    


Intervention name(s): Flavanol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Assessement, supplementation for 30 days with either Placebo or Flavanols, Re-assessment; Assessement, supplementation placebo for 30 days with either Placebo or Flavanols, Re-assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of VentriGel in Post-MI Patients
Condition: Myocardial Infarction; Heart Failure; Left Ventricular Remodeling
MeSH terms: Myocardial Infarction; Infarction; Ventricular Remodeling
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I, open label, study will investigate the effects of VentriGel injection in
      patients who have experienced a first, large ST elevation myocardial infarction (STEMI)
      treated by PCI within the past 3 years and have evidence of left ventricular remodeling.
    

Detailed description: 
      Evaluate the safety and feasibility of VentriGel delivered trans-endocardially to subjects
      with left ventricular ejection fraction (LVEF) 25 to 45% secondary to MI. Secondary endpoints
      will look at efficacy variables of ESV, EDV, EF, scar mass.
    

Intervention name(s): VentriGel
Intervention type(s): Biological
Intervention description(s): VentriGel will be injected via MyoStar catheter after NOGA mapping
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extracellular matrix
System to Evaluate the Risk of Lymph Node Metastasis Preoperatively in Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Lymphatic Metastasis
Study type: Observational

Summary: 
      The lymph node status is difficult to be assessed preoperatively, this study aimed to develop
      a scoring system for predicting the risk of LNM in cervical cancer patients before operation.
    

Detailed description: 
      Lymph nodes metastasis (LNM) was proved to be a critical risk factor related to the survival
      to cervical cancer survival. However, preoperative pelvic magnetic resonance imaging (MR) or
      computed tomography (CT) tests are less sensitive to assess the risk of lymph node
      metastasis. PET-CT is too expensive and radiative to be widely used in clinical practice. A
      model was constructed based on clinical indicators to predict lymph node metastasis
      preoperatively, providing a reference for clinical treatment.
    

Intervention name(s): surgery
Intervention type(s): Procedure
Intervention description(s): Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 426 patients with cervical cancer who underwent radical resection in China were
        recruited
Effectiveness of Aerobic Exercises and Laughter Yoga Compared With Yoga in Anxiety/Depression Levels in Breast Cancer
Condition: Breast Cancer Survivors
MeSH terms: Breast Neoplasms; Depression
Study type: Interventional

Summary: 
      90% of breast cancer survivors experience cancer-related fatigue which decreases the physical
      activity. Moreover, due to the cancer treatments depression and anxiety will be happened.
      Previous studies showed the effect of physical activity on reduction of depression and
      anxiety; therefore the aim of this study is to evaluate the effectiveness of aerobic
      exercises and laughter yoga compared with yoga in anxiety and depression levels in breast
      cancer survivors.
    

Detailed description: 
      204 breast cancer survivors will be randomized to each of these three groups: Group 1, 12
      weeks aerobic exercises; Group 2, 12 weeks of laughter yoga; and Group 3, 12 weeks of yoga.

      To assess the effectiveness of these exercises in depression and anxiety levels, patients
      will complete the hospital anxiety and depression scale (HADS) questionnaire before and after
      the 3-month exercise.

      For secondary outcomes, patients will complete the following questionnaires before and after
      the 3-month exercise: 36-item short-form survey (SF-36), Minnesota Living with Heart Failure
      Questionnaire (MLHFQ), Insomnia Severity Index, Beck's depression inventory-Ⅱ (BDI-Ⅱ),
      Chalder's chronic fatigue syndrome, and five facet mindfulness questionnaire (FFMQ).

      The effectiveness of the mentioned exercises in primary and secondary outcomes will be
      assessed using ANOVA/ANCOVA analysis by adjusting the baseline assessment. Mean difference
      (MD) and standardized mean difference (SMD) with their 95% confidence interval (CI) will be
      reported to show the effectiveness of aerobic exercises and laughter yoga compared with yoga
      in different outcomes.
    

Intervention name(s): Online exercise
Intervention type(s): Other
Intervention description(s): Patients in each group will be added to the specific group on Whatsapp, and the schedule and information about the exercise will be explained there. Furthermore, patients will be joined to particular pages on Instagram, and exercises will be performed through Live on that pages. All the patients will exercise for 12 weeks, two or three times every week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Aerobic exercises; Laughter yoga; Yoga; Depression; Anxiety
The Effect of Self and Peer Assesment Education Given to Nursing Students: Stoma Care Skill Example
Condition: Assessment, Self; Stoma Colostomy; Achievement
Study type: Interventional

Summary: 
      Self- and peer-assessment is one of the important methods among student-centered assessment
      methods. The ability of the student to evaluate himself and his peers provides many
      contributions to him in his education and professional life.Nursing education aims to gain
      many psychomotor skills.Aim is to examine the effects of self and peer assessment training on
      the success of stoma care skills.
    

Detailed description: 
      There are different results regarding the effects of self-assessment and peer assessment on
      psychomotor skill achievement. It is thought that the reason for this difference in results
      may be student-related reasons or may be related to the effectiveness of the education.

      The aim is to measure the stoma care skill success of the students who are given self and
      peer assessment training through the rating scale.
    

Intervention name(s): education of self and peer assesment
Intervention type(s): Other
Intervention description(s): Stoma care skill achievement is expected to be higher in the group that received self- and peer-assessment training compared to the group that did not receive training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: stoma care; peer assesment; self assesment