bioihbjkbjnl/mcl2 huggingface dataset:
Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
Condition: Diabetic Macular Edema; Diabetic Retinopathy
MeSH terms: Macular Edema; Diabetic Retinopathy; Edema
Study type: Observational

Summary: 
      PURPOSE: To evaluate the efﬁcacy of switching from bevacizumab to ranibizumab (Lucentis;
      Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes
      with diabetic macular edema (DME) nonresponders to bevacizumab (Avastin; Genentech, South San
      Francisco, CA).

      METHODS: Single-center retrospective comparative study of patients with DME unresponsive to
      intravitreal bevacizumab that were switched to ranibizumab or aflibercept. Best-corrected
      visual acuity and central foveal thickness will be analysed prior to and 3 months after the
      switch. OCT biomarkers will also analyzed.

      A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS:
      Patients will improve anatomically and functionally after switch.
    


Intervention name(s): Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]; Aflibercept 40 MG/ML Intraocular Solution [EYLEA]
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ranibizumab; Aflibercept; Pharmaceutical Solutions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients followed on the ocular diabetes consultation of Centro Hospitalar
        Universitário do Porto, Portugal, with DME unresponsive or incompletly responsive to
        intravitreal bevacizumab (1,25 MG/0.05 ML).
      
Keywords: Diabetic Macular Edema; Bevacizumab; Ranibizumab; Aflibercept; BCVA; OCT
New Dual Therapy for Primary Treatment of Helicobacter Pylori Infection：a Pilot Study
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      The efficacy of traditional triple therapy has been decreased to such an unacceptable level
      as 70% in many areas. The study is based on the hypothesis: the most important factors which
      influence the effect of Helicobacter pylori (H. pylori) eradication included acid suppression
      intensity and sensitivity of antibiotics. So the investigators chose dual therapy because it
      is simple and verified to be useful. Rabeprazole, as a new proton pump inhibitor (PPI), is
      reported to be less susceptible to the influence of genetic polymorphisms for CYP2C19. So it
      has a greater and faster acid suppression effect compared to other PPIs. Amoxicillin is one
      of effective antibiotics to H. pylori with few side effects. The antibiotic resistance of
      Amoxicillin is no more than 3% in China. The purpose of our trial is to evaluate and compare
      the efficacy and safety of dual therapy regimens with different doses of Rabeprazole for
      initial treatment of H. pylori infection.
    

Detailed description: 
      The current recommended triple regimen for H. pylori treatment provides unacceptable low
      success rates because of high antibiotic resistance and poor compliance. Dual therapy had
      been used before and can be modified to get good eradication rate. The aim of our trial is to
      evaluate and compare the efficacy and safety of dual therapy regimens for initial treatment
      of H. pylori infection. A total of forty patients with non-ulcer dyspepsia and H. pylori
      infection were randomized to receive either Rabeprazole 10 mg b.i.d. and Amoxicillin 1000 mg
      t.i.d., for 14 days (R10A), or high-dose Rabeprazole 20 mg twice a day (b.i.d.) and
      Amoxicillin 1000 mg three times a day (t.i.d) (R20A) for 14 days. H. pylori strains were
      isolated and antibiotic resistance was measured by the twofold agar dilution method. H.
      pylori eradication was assessed by 13C-urea breath test at 4 weeks after treatment.
    

Intervention name(s): Rabeprazole and Amoxicillin; Amoxicillin and Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Amoxicillin (Zhuhai United Laboratories Co., Zhuhai, China) 1g t.i.d and Rabeprazole (Misato Plant of Eisai Co., Ltd. Japan) 10 mg b.i.d.for 14 days.; Amoxicillin (Zhuhai United Laboratories Co., Zhuhai, China) 1 g t.i.d and Rabeprazole (Misato Plant of Eisai Co., Ltd. Japan) 20 mg b.i.d. for 14 days
Other intervention name(s): Amoxycillin Capsules; Sodium Rabeprazole Enteric-coated Tablets; Amoxycillin Capsules; Sodium Rabeprazole Enteric-coated Tablets
Intervention MeSH terms: Amoxicillin; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: H. pylori; Dual therapy; Amoxicillin; Rabeprazole
Early Integrated Intervention in Severe Affective Disorders
Condition: Depressive Disorder; Bipolar Disorder
MeSH terms: Depressive Disorder; Bipolar Disorder; Mood Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether early integrated prophylactic combined
      medical and psychological outpatient treatment is associated with a better prognosis in
      patients with severe unipolar and bipolar affective disorders than standard treatment.
    

Detailed description: 
      Patients who have been hospitalised for unipolar or bipolar disorder have a poor prognosis
      with highly increased risk of recurrence of episodes and increased risk of psychosocial
      dysfunction. It seems as integrated prophylactic combined medical and psychological
      out-patient treatment may lead to a better long-term prognosis in patients with affective
      disorders in general. It has not been specifically investigated whether such integrated
      treatment may improve long-term outcome if the intervention is offered early in the course of
      the affective illness.

      Subjects: Patients currently discharged from first, second or third hospitalisation ever from
      psychiatric department with a diagnosis of severe single depressive episode/recurrent
      depression or with a diagnosis of manic/mixed episode or bipolar disorder.

      Comparison: Early intervention with integrated prophylactic combined medical and
      psychological outpatient treatment as offered by a clinic for affective disorders compared
      with standard outpatient treatment as offered by community psychiatric centres, private
      specialists in psychiatry or general practitioners.
    

Intervention name(s): Prophylactic combined medical and psychological treatment
Intervention type(s): Behavioral
Intervention description(s): Medical treatment is naturalistic and evidence based according to international recommendations.
Psychological treatment is either group psychoeducation or group cognitive behavioural therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prophylactic treatment; Pharmacological treatment; Psychological treatment
Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in
      patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.
    

Detailed description: 
      The first 20 patients enrolled will be evaluated by angiography and Optical Coherence
      Tomography 3 months after stent implantation. The following 20 patients will be evaluated by
      the same methods 2 months after the implantation and the last 20 patients after 30 days.

      All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index
      procedure.
    

Intervention name(s): Angiography and Optical Coherence Tomography evaluations
Intervention type(s): Device
Intervention description(s): coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stent, DES, INSPIRON, OCT, tissue repair
Transfer Modality Research Initiative - Bangladesh
Condition: Improving Pre-school Anthropometric Status; Improving Household Food Security; Improving Maternal Nutrition Knowledge
Study type: Interventional

Summary: 
      This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is
      assigned at the village level where treatments are: cash transfers (north and south); cash
      transfers + nutrition behavior communication change (north only); food transfers (north and
      south); food transfers + nutrition behavior communication change (south only); food-cash
      split (north and south); and controls (north and south). Within treatment localities, women
      living in very poor households are targeted to receive benefits for two years.
    


Intervention name(s): Cash transfer; Food transfer; Food and cash transfer; Behavior Communication Change (BCC)
Intervention type(s): Other; Other; Other; Behavioral
Intervention description(s): 1500 taka ($18.75) per household distributed monthly; 30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly; 15 kg of rice; 1 kg of lentils and 1 kg of micronutrient fortified cooking oil and 750 taka cash per household, distributed monthly; Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Emergency Curative Resection of Colorectal Cancer
Condition: Colorectal Cancer; Oncologic Complications and Emergencies
MeSH terms: Colorectal Neoplasms; Emergencies
Study type: Observational

Summary: 
      The feasibility and efficacy of emergency curative resection of complicated colorectal cancer
      is still controversial. This prospective study aim is to assess surgical and oncologic
      outcomes after emergency compared to elective curative resection of colorectal cancer
    

Detailed description: 
      60 consecutive patients presented with complicated colorectal cancer managed by emergency
      surgery were included and compared to another 155 consecutive patients admitted during the
      same period with uncomplicated colorectal cancer managed by elective surgery. Both groups
      were compared regarding curative resection rate, early postoperative mortality and morbidity,
      3-years tumor recurrence and survival rates.
    

Intervention name(s): Curative resection of colorectal cancer
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study included 60 consecutive patients presented by complicated colorectal cancer
        treated by emergency surgery at Alexandria University hospital between January 2015 and
        January 2017 (Group I). Another 155 patients with uncomplicated colorectal cancer treated
        by elective surgery during the same period were included (Group II).
      
Biospecimen description: 
      Surgical specimens after curative resection of colorectal cancer
    
Keywords: Complicated colorectal cancer; Curative resection; Surgical and oncologic outcomes
Efficacy & Safety of Nasal Influenza Immunisation in Children
Condition: Influenza Vaccines Efficacy and Safety
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The UK Departments of Health now recommend annual influenza vaccination for all children 2-7
      years of age, with children over 7 years eligible for vaccination if in certain higher risk
      clinical categories. Though data are available documenting the safety and immunogenicity of
      LAIV in this age group, there are little data to assess efficacy and immune correlates in UK
      children, and in particular atopic children. This study will enrol 200 children (and at least
      200 unvaccinated household sibling controls), many with a history of asthma or recurrent
      wheezing, and allow an assessment of efficacy, safety and immune correlates in these
      children, and how this varies with prior administration of pandemic influenza vaccine and/or
      LAIV.
    


Intervention name(s): Live attenuated influenza vaccine; Surveillance (nasal swabbing) during influenza season
Intervention type(s): Drug; Procedure
Intervention description(s): Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season
Other intervention name(s): Fluenz; Flumist
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
An Evaluation of a Psychoeducation Program in Individuals Diagnosed With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study was conducted to explore the effect on social functionality of the psychoeducation
      program organized to guide individuals diagnosed with schizophrenia to identifying and
      recognize emotions in facial expressions. half of participants were assessed the
      psychoeducation program. other half of participants were used only measurement tests.
    

Detailed description: 
      The difficulties those diagnosed with schizophrenia have with facial identification and
      identifying emotions are closely associated with the adverse symptoms of the illness. Those
      diagnosed with schizophrenia need to be helped in forming interpersonal relations so that
      they can gain the skills needed to live in society.

      ın this study the investigators prepared a psychoeducation program for individuals diagnosed
      with schizophrenia. The program titled, "Psychoeducation Program for Emotion Identification
      and Expression in Those Diagnosed with Schizophrenia" was conducted with the patients in the
      intervention groups once a week for ten weeks. On the other hand there were a control group
      which weren't be applied any intervention. The investigators applied some tests to
      intervention and control group three times ( before intervention, after intervention and
      three months after intervention). This study was conducted at three Community Mental Health
      Centers (CMHC's). The patients who met the study inclusion criterias were determined in these
      centers. Randomized psychoeducation and control groups were formed from these patients.
    

Intervention name(s): Psychoeducation Program; no intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The program titled, "Psychoeducation Program for Emotion Identification and Expression in Those Diagnosed with Schizophrenia" was conducted with the patients in the intervention groups once a week for ten weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was of quasi-experimental (pretest-posttest, with a control group) design.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cognition; facial expression; facial recognition; psychiatric nursing; psychoeducation; schizophrenia
Corneal Biomechanics and Corneal Reshaping Therapy
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of the proposed study is to investigate the predictive value of corneal biomechanical
      properties in corneal reshaping therapy and the role of these parameters in determining the
      amount of myopia reduction.
    

Detailed description: 
      Experiment 1: To evaluate changes in corneal biomechanics caused by short-term corneal
      reshaping therapy.

      Subjects will wear a conventional RGP lens in one eye, randomly selected, and an
      orthokeratology lens in the fellow eye, for 30 minutes, 60 minutes and one night,
      respectively. Corneal stiffness and tangent modulus will be measured before and after each
      wearing period.

      Experiment 2: To evaluate changes in and the recovery of corneal biomechanics effected by
      long-term corneal reshaping and to assess whether corneal biomechanics can predict the rate
      of corneal reshaping.

      Subjects will wear orthokeratology lenses for 6 months. Regular follow up visits (1 week, 1
      month, 3 months and 6 months) will be arranged to monitor the changes in corneal stiffness
      and tangent modulus.
    

Intervention name(s): Corneal reshaping therapy
Intervention type(s): Other
Intervention description(s): Reshaping the corneal curvature from wearing specific designed rigid gas permeable lenses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: corneal reshaping therapy; corneal biomechanics
A Study of a Topical Patch (AB001) in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to examine the safety, tolerability, and efficacy of
      repeated topical administration of AB001 topical patches for the treatment of chronic low
      back pain.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group study of the safety
      and efficacy of AB001 topical patches in patients with chronic low back pain. Subjects
      meeting inclusion criteria are randomized in a 1:1 ratio to receive AB001 patches or placebo
      patches. Two AB001 or placebo patches will be given topically once daily for 14 days. The
      primary end point is the change of low back pain intensity rated on a visual analog scale
      (VAS) scale on Day 15, the secondary end points include the subject global assessment (SGA)
      of low back pain, the subject global perceived effect (GPE) of study medication, the
      Roland-Morris Disability Questionnaire (RMDQ), and the pain assessment from subject diary
      (Days 1 - 3 only). Subjects' safety will be monitored throughout the study, including the
      adverse event (AE) incidence and severity, laboratory test results (hematology and clinical
      chemistry), vital signs, and physical examination.
    

Intervention name(s): AB001 patch; Placebo patch
Intervention type(s): Drug; Other
Intervention description(s): Two AB001 patches will be applied to the low back once daily for 14 days, the patches shall be removed after approximately 12 hours after daily application.; Two placebo patches will be applied to the low back once daily for 14 days, the patches shall be removed after approximately 12 hours after daily application.
Other intervention name(s): AB001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: topical patch; chronic low back pain
A Dose Escalation Study of Gefapixant (AF-219/MK-7264) in Refractory Chronic Cough (MK-7264-010)
Condition: Refractory Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, placebo-controlled, crossover, dose escalation study to assess
      the efficacy and tolerability of gefapixant (AF-219; MK-7264) in participants with refractory
      chronic cough.
    


Intervention name(s): Gefapixant; Placebo (for gefapixant)
Intervention type(s): Drug; Drug
Intervention description(s): Gefapixant 7.5 and 50mg tablets administered orally; Placebo to gefapixant 7.5 and 50mg tablets administered orally
Other intervention name(s): AF-219; MK-7264
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vertical Gingival Display Changes Associated With Upper Premolars Extraction
Condition: Gummy Smile; Orthodontic Treatment
Study type: Interventional

Summary: 
      To investigate and compare vertical gingival display (VGD) changes associated with upper
      premolars extraction during orthodontic treatment.
    

Detailed description: 
      Seventy-six subjects who met the inclusion criteria were divided into one of 3 groups
      according to their treatment modalities as follows: group 1: upper first premolars extraction
      (24 patients, aged 21.56±3.19 years); group 2: upper second premolars extraction (26
      patients, aged 22.16±3.59 years) and group 3: no orthodontic intervention was performed
      (happy with their teeth) (26 subjects, aged 20.45±3.29 years).

      Initial records (radiographs, study casts and clinical photographs) were taken for all
      subjects. The same records were taken post treatment for treated subjects only. The Pre- and
      post- treatment VGD and lip length in static and dynamic positions and the amount of upper
      teeth retractions were recorded.

      The paired t-test and ANOVA test were used to detect treatment changes and differences
      between studied groups, respectively. Factors affecting VGD were investigated using backward
      stepwise linear regression analysis.
    

Intervention name(s): Upper first premolars extractions; Upper second premolars extraction
Intervention type(s): Procedure; Procedure
Intervention description(s): Fixed orthodontic treatment with upper first premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.; Fixed orthodontic treatment with upper second premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: upper first premolars extraction (24 patients) Group 2: upper second premolars extraction (26 patients) and Group 3: no orthodontic intervention was performed (happy with their teeth) (26 subjects).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingival display; Tooth extraction; Dental esthetics; Corrective orthodontics
Cardiovascular Protective Role of Laser Acupuncture in Systemic Lupus
Condition: System; Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      Systemic lupus erythematosus is a chronic and multisystemic autoimmune disorder which
      predominantly affecting women. The most common cause of death in lupus patients affected by
      disease for more than 5 years is cardiovascular disease due to presence of some factors as
      oxidative stress, pro-inflammatory cytokines , dyslipidemia, diabetes, and hypertension.
    

Detailed description: 
      laser acupuncture (active or sham) for one month (3 days/week ) on acupoint number 14 of GV
      meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder
      meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception
      vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of
      spleen meridian, and acupoint number 5 of triple energizer meridian (laser will be applied
      for 1 min on every acupiont) in lupus females
    

Intervention name(s): laser application on acupoints
Intervention type(s): Device
Intervention description(s): laser acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention