bioihbjkbjnl/mcl2 huggingface dataset:
Intravitreal Aflibercept InjectiOn in Vitrectomized Eyes for Treatment of Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Observational

Summary: 
      This a non-interventional retrospective study on the efficiency and the tolerance of
      intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema
    

Detailed description: 
      Diabetic macular edema (DME) is the leading cause of blindness among people of working age.
      Treatment of DME included blood pressure and glycemic control, grid laser, intravitreal
      injection of steroids (acetonide of triamcinolone, dexamethasone implant, fluocinolone
      implant) or anti-Vascular endothelial growth factor (VEGF) therapy (Bevacizumab, Ranibizumab,
      Aflibercept) (2015). The advent of anti-VEGF therapy has revolutionized the management of
      DME. Aflibercept, one of the drugs in this group has recently been approved in France.
      However, there is no report in the efficacy and tolerance of Aflibercept in vitrectomized
      eyes in the diabetic macular oedema . In this study, in order to prove the efficiency and
      tolerance of Aflibercept, data will be collected in a anonymous way in medical records of
      patients having received a treatment by Aflibercept in the past.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetic vitrectomised patients with macular edema, treated with Aflibercept in the past
      
Keywords: DIABETIC RETINOPATHY; Intravitreal aflibercept
Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis
Condition: Alcoholic Fatty Liver Disease; Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hepatitis, Alcoholic; Fatty Liver, Alcoholic
Study type: Interventional
Phase: Phase 2

Summary: 
      The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the
      Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease
      and Alcoholic Hepatitis.
    


Intervention name(s): Placebo /bid P.O; MG-1; MG-2 : MG1000mg, Placebo /bid P.O; metadoxine
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): MG500mg,Placebo /bid P.O; placebo, metadoxine 500mg/ bid P.O
Intervention MeSH terms: Pyridoxine; Metadoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Inuniv and Working Memory
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Minimum 24 subjects aged 8-12 with a diagnosis of ADHD will be prescribed extended release
      guanfacine (Intuniv) to assess impact, if any, on working memory. Pre and post testing using
      a standardized battery of tests for effect on symptoms of ADHD and working memory will be
      administered and assessed.
    


Intervention name(s): extended release guanfacine
Intervention type(s): Drug
Intervention description(s): 1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations
Other intervention name(s): Intuniv; Serial Number 306; IND 63,551
Intervention MeSH terms: Guanfacine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ADHD, working memory
Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)
Condition: Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a extension study of CSTI571B1201 study
    


Intervention name(s): Imatinib Mesylate
Intervention type(s): Drug
Intervention description(s): once daily
Other intervention name(s): STI571
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GIST; Imatinib; STI571; Gastrointestinal Stromal Tumors
Tumor Relapsed Study of Serum Trxr Activity in Advanced Non-small Cell Lung Cancer
Condition: Advanced Non-small Cell Lung Cancer; First Line Treatment; Thioredoxin Reductase Activity; Carcinoembryonic Antigen; Progression
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      In pre-clinical study we found that the thioredoxin reductase activity of serum harbours huge
      difference between cancer patients and non-cancer patients, the enzyme activity elevated
      remarkably among cancer patients, and after any kind of treatment serum thioredoxin reductase
      activity declined remarkably, so we hypothesis that serum thioredoxin reductase activity
      could be a warning marker for early progression of first-line treatment for advanced
      non-small cell lung cancer
    

Detailed description: 
      This is a cooperative research project involving patients in Medical Oncology Department of
      Affiliated Cancer Hospital of Xiangya School of Medicine Central South University, and the
      State Key Laboratory for Natural Medicine and Biomimetic Drugs Perking University. The
      primary objective is to measure the thioredoxin reductase activity using blood in subjects
      received platinum based chemotherapy, to study the warning progression ability of thioredoxin
      reductase in blood. The secondary objective is to compare the warning progression activity of
      blood thioredoxin reductase reductase activity with carcinoembryonic antigen in subjects
      received platinum based first-line chemotherapy. Blood will be collected before chemotherapy,
      after every 2 cycles of chemotherapy, every 3 months after all first-line chemotherapy till 2
      years, then every 6 months till 3 years, or collect blood till tumor progression, evaluation
      CT results every time collecting blood samples.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with non-small lung cancer and receiving platinum based first-line
        chemotherapy in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School
        of Medicine Central South University/Hunan Province Tumor Hospital
      
Biospecimen description: 
      3-4 ml whole blood was obtained and then centrifuged and stored at -20 ℃
    
Keywords: non-small cell lung cancer; thioredoxin reductase
3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      1. To investigate the dose response of the combination therapy, Telmisartan and
           Hydrochlorothiazide for the Japanese patients with Essential Hypertension.

        2. To compare this dose response with that in the US study.
    

Detailed description: 
      This is an 8-week multicentre, randomised, double-blind, double-dummy, placebo-controlled,
      parallel group study utilizing all cells of a 3 x 3 factorial design. Following Screening
      examinations and a 4-week Placebo Run-In Period, 540 patients will be randomized to receive
      once-daily monotherapy with either telmisartan (MICARDIS), hydrochlorothiazide, placebo, or
      combination therapy with telmisartan and hydrochlorothiazide for 8 weeks (Treatment Period).

      This study includes nine cells, placebo, telmisartan (TEL) 40 mg, TEL 80 mg,
      hydrochlorothiazide (HCTZ) 6.25 mg, HCTZ 12.5 mg, TEL 40 mg/HCTZ 6.25 mg, TEL 40 mg/HCTZ 12.5
      mg, TEL 80 mg/HCTZ 6.25 mg, and TEL 80 mg/HCTZ 12.5 mg.

      Study Hypothesis:

      The hypothesis is that the dose response model for the Japanese patient with essential
      hypertension which is constructed for the change of the supine diastolic blood pressure from
      the baseline value to end of treatment with the multiple regression analysis, is similar to
      that in the US study 502.204.

      Comparison(s):

      The primary efficacy parameter will be the change from baseline in supine diastolic blood
      pressure at trough (24 hours post-dose) at the last visit during the Double-Blind Period.

      The dose response surface model will be constructed. The graphs of dose response surface will
      be generated based on the final model. The model in this study will compare with that in US
      study from the perspective of including the same terms in the model.
    

Intervention name(s): Telmisartan; Hydrochlorothiazide; Telmisartan + Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Telmisartan; Telmisartan, hydrochlorothiazide drug combination
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Optimal EGFR TKIs Treatment Strategies for Lung Adenocarcinoma Harboring EGFR Exon 19 Deletion Variants
Condition: EGFR Exon 19 Mutation; Tumor Progression
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Study type: Observational

Summary: 
      To determine the optimal EGFR TKIs treatment strategies for lung adenocarcinoma harboring
      EGFR exon 19 deletion variants
    

Detailed description: 
      RNA extraction: The investigators will extract total RNA from cell lysates by using
      Tri-reagent (Molecular Research Center, Inc., Cincinnati, Ohio) and an RNA Mini Kit (Qiagen,
      Hilden, Germany) according to the manufacturer's instruction. RNA obtained from the Mini Kit
      column will be eluted. The quantity and quality of the purified RNA will be evaluated using a
      NanoDrop ND-1000 spectrophotometer will be stored at -80 °C for further mutational analyses.

      Data acquisition: The investigators will record and follow participants' clinical
      information, including ethnicity, age, gender, smoking status, histological types, lung
      cancer stage (the TNM status), metastatic sites, ECOG score, CT/CXR imaging, chemotherapy or
      radiation treatment at the time of diagnosis of lung cancer and through the entire clinical
      courses. Specific marker such as TTF1, is used to ensure the diagnosis of primary lung tumor.
      Clinicopathologic stage assigns according to the seventh tumor-node-metastasis
      classification. The investigators assess the treatment responses according to the Response
      Evaluation Criteria in Solid Tumors (RECIST) using the unidimension method, and record the
      best response achieved per treatment. Treatment response, progression-free survival, and
      overall survival are recorded prospectively for further analysis.

      Statistical analysis: All categorical variables will be analyzed with Pearson's χ² test,
      except where a small size required the use of Fisher's exact test. The progression-free
      survival curve and overall survival will be plotted by the Kaplan-Meier method and compared
      by the log-rank test. Multivariate analysis for overall survival will be performed using the
      Cox's proportional hazards model. Two-sided p-values of less than 0.05 is considered
      significant. All analyses will be performed using SPSS software (version 16.0 for Windows;
      SPSS Inc.).
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        only citizens of Taiwan will be enrolled.
      
Biospecimen description: 
      Biopsy tissue, DNA, RNA
    
Keywords: epidermal growth factor receptor tyrosine inhibitor; lung adenocarcinoma
Evaluation of the Influence of Radiofrequency-based Toothbrush on the Accumulation of Calculus
Condition: Oral Hygiene
MeSH terms: Calculi
Study type: Interventional

Summary: 
      to evaluate the influence of radiofrequency based toothbrush (Silk'n toothwave)on the
      accumulation of the calculus
    

Detailed description: 
      Calculus is a white-brownish layer with various levels of stiffness, which accumulates on
      teeth and is formed by the mineralization of dental plaque.

      Thus, maintaining oral hygiene and adhering to maintenance programs keep low levels of plaque
      and calculus.

      The electromagnetic field is known for bone healing by lessening osteoclast activity,
      improving osteoid formation, and stimulating angiogenesis. Furthermore, the electromagnetic
      field has an antimicrobial effect.

      Electric toothbrushes have shown a statistical reduction in plaque accumulation and gingival
      inflammation.

      Previous studies have shown that Silk'n Toothwave results in less plaque accumulation and
      calculus formation, in addition to stain removal and teeth whitening.

      Study aim: to asses the effect of the electromagnetic field in a tooth brush (Silk'n
      Toothwave) on calculus accumulation and gingival parameters.
    

Intervention name(s): Silk'n Toothwave
Intervention type(s): Device
Intervention description(s): patients will receive a non-surgical treatment which will include oral hygiene instructions, calculus removal with ultrasonic and manual instruments. At the end of the meeting they will be provided with a toothbrush which is based on a radiofrequency technology.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental: Silk'n Toothwave
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Electromagnetic Fields; Oral Hygiene
Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition
Condition: Healthy Participants
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to estimate the relative bioavailability of a single 500 mg dose of
      bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact
      capsules under fed condition in adult healthy participants. The comparisons will be performed
      using the pharmacokinetic parameters that define the rate and extent of absorption, those are
      Cmax and AUC. Statistical analyses will be performed comparing these parameters calculated
      after administration of a single 500 mg dose with the intact capsule formulation (100 mg x 5)
      as the Reference treatment and the capsule contents mixed with applesauce or yogurt (100 mg x
      5) as the Test treatments.
    


Intervention name(s): Bosutinib capsule; Bosutinib capsule; Bosutinib capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500 mg dose of bosutinib capsule contents mixed with applesauce; 500 mg dose of bosutinib capsule contents mixed with yogurt; 500 mg dose of intact bosutinib capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Phase 1, open-label, randomized, single dose, 3-period, 6-sequence, crossover study in healthy participants
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; bosutinib; Maximum Observed Plasma Concentration (Cmax); Area Under the Curve (AUC)
Bladder Flap Versus Omission of Flap During Cesarean Section of Primiparous Women
Condition: Cesarean Section
Study type: Interventional

Summary: 
      Cesarean section is the most common surgical procedure performed on women. Over the years
      minor variations of each surgical step have been introduced, and cesarean sections are not
      standardized and many different techniques are employed during surgery. Creation of a bladder
      flap has been an integral surgical step of the cesarean section for many years. The role of
      the bladder flap and its usefulness in cesarean section is not known well. Further, in some
      cases the bladder flap is omitted during cesarean section. The aim of the current study is to
      compare operating time and postoperative urinary symptoms in cesarean sections using either
      bladder flap or omission of flap.
    

Detailed description: 
      Cesarean section is the most common surgical procedure performed on women. The main aspects
      of the surgical approach to low-transverse cesarean delivery have not changed much since1926.
      Over the years minor variations of each surgical step have been introduced, and cesarean
      sections are not standardized and many different techniques are employed during surgery.
      Creation of a bladder flap has been an integral surgical step of the cesarean section for
      many years. The evidence on the role of the bladder flap and its usefulness in cesarean
      section is very limited. In emergent cesarean sections where rapid delivery is the main goal,
      the bladder flap is usually omitted. Literature about the usefulness of a bladder flap is
      limited and more randomized studies are needed. Most of the study outcomes were focusing
      operating time however, the investigator in the current study additional focused on
      postoperative urinary symptoms and dynamics. The aim of the current study is to compare
      operating time and postoperative urinary symptoms in cesarean sections using either bladder
      flap or omission of flap.
    

Intervention name(s): Bladder flap
Intervention type(s): Procedure
Intervention description(s): Performing uterine incision and cesarean section with a bladder flap.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cesarean section; operating time; bladder; urinary retention
Electrical Stimulation in Women With Pelvic Organ Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      The aim of this study is to search the effects of electrical stimulation on clinical symptoms
      such as pelvic floor muscle strength, stage of POP, symptoms of pelvic floor, quality of life
      and sexual function in women with pelvic organ prolapse (POP)
    

Detailed description: 
      This study is planned as a prospective, sham radomized controlled study. Individuals who
      volunteered to participate in the study, complying with the inclusion criteria and signed the
      consent paper will be randomly allocated into ES and Sham ES groups.

      The study includes women aged 18-65 diagnosed with staged 1-2 POP by the physician.All
      patients were evaluated by the same doctor who performed the POP-Q measurement, who was
      blinded to the baseline results. The treatment of patients will be given by the same
      therapist. Measurements will be made 3 times at baseline (before treatment), interim period
      (4th week) and after treatment.
    

Intervention name(s): Experimental; Control
Intervention type(s): Device; Device
Intervention description(s): Current application will be made in the frequency range of 20-50 Hz. The Chattanooga (Intelect Neo) device with interfering current will be used for treatment, vacuum electrodes will be made in the form of 4 pole application. Two electrodes to the outside of the inguinal ligament, the other two electrodes will be placed on the upper inner part of the thigh.ES applications will be performed in the supine position with head and knee pillow supported.; The Chattanooga (Intelect Neo) device with interfering current will be used for treatment, vacuum electrodes will be made in the form of 4 pole application. Two electrodes to the outside of the inguinal ligament, the other two electrodes will be placed on the upper inner part of the thigh. The same device used in ES application to the sham group will be attached to the patients, however, active ES will not be issued from the device and only vacuum will turn on. ES applications will be performed in the supine position with head and knee pillow supported.
Other intervention name(s): Electrical Stimulation; Sham Electrical Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pelvic organ prolapse; electrical stimulation
Comparison of Factor XII Levels in Gestational Diabetic and Healthy Pregnancies
Condition: Diabetic Pregnancy; Pregnancy Related; Complement System; Disorder
MeSH terms: Pregnancy in Diabetics
Study type: Observational

Summary: 
      To compare Factor XII levels in gestational diabetic and healthy pregnancies.
    

Detailed description: 
      Thirty singleton term pregnant women with a diagnosis of Type I, Type II or gestational
      diabetes and thirty singleton uncomplicated term healthy pregnant women will be included in
      our study. Our study will be performed at Istanbul Acibadem Maslak Hospital, Turkey. Blood
      will be drawn from each patient when they are hospitalized and before they deliver either
      vaginally or by cesarean section. Blood will be drawn into two citrate tubes, each will
      contain 4 ml blood. Blood will be transferred to the lab immediately and will be centrifuged.
      The supernatant will be stored at -80°C. When the anticipated number of samples are completed
      Factor XII levels will be calculated in each sample.
    

Intervention name(s): Diabetic pregnancy; Non-diabetic pregnancy
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Blood samples will be drawn before delivery to evaluate Factor XII level.; Blood samples will be drawn before delivery to evaluate Factor XII level.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        30 Pregnant patients with a diagnosis of Type I, Type II or gestational diabetes and 30
        non-diabetic pregnant patients will be included in our trial.
      
Biospecimen description: 
      8ml of blood samples will be drawn from each participitant
    
Keywords: Diabetic pregnancies, Factor XII
Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy
Condition: Supraspinatus Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      Therapeutic management of supraspinatus tendinopathy is conflicting. There is evidence that
      eccentric exercise protocols can be effective for this condition. The inclusion of other
      therapeutic modalities could help to the management of these patients. A new therapeutic
      approach, called Electrolysis Percutaneous Therapeutic (EPTE) has been clinically developed.
      The objective of this randomized clinical trial is to determine the effectiveness of the
      inclusion of EPTE into a eccentric exercise protocol for the management of patients with
      unilateral supraspinatus tendinopathy
    


Intervention name(s): Electrolysis Percutaneous Therapeutic (EPTE); Eccentric exercise
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Supraspinatus, tendinopathy, pain, disability, EPTE
A Retrospective NIS to Evaluate the Use of Seroquel XR and IR in the Clinical Practice of Outpatients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The primary objective of this non-interventional study is to investigate how Seroquel XR and
      Seroquel IR are used in the clinical practice of outpatients with schizophrenia. This will be
      done by a retrospective review of medical records to evaluate patients treated with Seroquel
      XR or Seroquel IR as primary antipsychotic treatment.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with a diagnosis of schizophrenia who are registered at an outpatient district
        psychiatric clinic
      
Keywords: Mental disorder; Antipsychotic treatment