bioihbjkbjnl/mcl2 huggingface dataset:
Optical Coherence Tomography Angiography in Myopic Patients
Condition: Myopia
MeSH terms: Myopia
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to investigate the macular microvascular network alterations in high
      myopic eyes using optical coherence tomography angiography.
    

Detailed description: 
      High myopia is defined as a refractive error equal to or more than -6 D, and/or axial length
      equal to or more than 25.5 mm².Axial elongation of the globe and subsequent stretch of the
      retina leads to sight threatening complications.

      Quantitative measurements of retinal vasculature in the healthy eye have been reported using
      several in vivo and in vitro techniques, including confocal microscopy, fluorescein
      angiography (FA), and swept-source optical coherence tomography (ssOCT) angiography.

      The aim of this study is to investigate the macular microvascular network alterations in high
      myopic eyes using optical coherence tomography angiography.

      This cross-sectional prospective study included 75 eyes of 54 patients, they were recruited
      from the outpatient clinic of ophthalmology department of El-Minia university hospital.They
      were divided into two groups, group A included 25 normal eyes of 25 patients. Group B
      included 50 myopic eyes of 30 patients.

      All patients subjected to history taking and full ophthalmological examination in addition to
      axial length measurment before performing OCTA.
    

Intervention name(s): Optical coherence tomography angiography OCTA
Intervention type(s): Diagnostic Test
Intervention description(s): Macular scanning using regular structural OCT as well as microvasculature analysis using OCTA
Other intervention name(s): OCTA
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Groiup A patients were chosen when met the inclusion criteria. Group B individuals were
        chosen among healthy age-matched controls.
      
Keywords: Optical coherence tomography; Angiography; Myopia
Tibial Tunnel Widening in Anterior Cruciate Ligament (ACL) Reconstruction-Comparing Two Bioscrews
Condition: ACL
Study type: Interventional

Summary: 
      Widening of the single tibial tunnel following ACL surgery with quadrupled hamstrings
      autograft may contribute to failure of the graft and/or present technical challenges
      secondary to bone loss in a revision setting (Getelman, 1999). As such, efforts should be
      made to minimize the incidence and magnitude of tibial tunnel widening without sacrificing
      the biomechanical properties of the graft construct. The purpose of this investigation is to
      examine the tibial tunnel widening relationship between bioabsorbable interference screws
      composed of poly-L-lactic acid (PLLA) alone and composite bioabsorbable interference screws
      composed of poly-L-lactic acid embedded with beta tricalcium phosphate (PLLA+TCP) utilized as
      tibial fixation devices.

      Specifically the study has the following objectives: 1) To quantify the extent of tibial
      tunnel enlargement at 3-, 6- and 12-months post ACL reconstruction with autogenous quadrupled
      hamstring graft; 2) To determine if the incorporation of beta tricalcium phosphate to the
      bioabsorbable interference screw alters the observed magnitude of tunnel widening; 3) To
      hypothesize mechanisms for any observed differences between tibial fixation devices; and 4)
      To correlate tibial tunnel widening with clinical outcome status. It is hypothesized that the
      PLLA+TCP bioabsorbable interference screw will not be associated with a reduction in tibial
      tunnel widening around the implant but rather between the implant and articular surface,
      compared to the PLLA alone screw. It is also hypothesized that there will be no effect of
      observed tunnel widening on clinical outcomes or graft failure rates.
    


Intervention name(s): Linvatec PLLA+TCP; Linvatec PLLA
Intervention type(s): Device; Device
Intervention description(s): Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.; Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tibial tunnel widening; Interference screws
Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and docetaxel,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor
      growth in different ways. Some block the ability of tumor cells to grow and spread. Others
      find tumor cells and help kill them or carry tumor-killing substances to them. Giving
      chemotherapy and a monoclonal antibody before surgery may make the tumor smaller and reduce
      the amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying how well giving epirubicin and cyclophosphamide
      followed by docetaxel and trastuzumab works in treating women with HER2-positive stage IIIB,
      stage IIIC, or stage IV primary breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the pathological complete response in women with HER2-positive stage IIIB-IV
           breast cancer treated with neoadjuvant epirubicin hydrochloride and cyclophosphamide
           followed by docetaxel and trastuzumab (Herceptin®).

      Secondary

        -  Determine the clinical response in patients treated with this regimen.

        -  Determine the recurrence-free survival of patients treated with this regimen.

        -  Determine the overall survival of patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive epirubicin hydrochloride and cyclophosphamide in weeks 1-3. Treatment with
      epirubicin hydrochloride and cyclophosphamide repeats every 3 weeks for 4 courses. Patients
      then receive docetaxel in week 13 and trastuzumab (Herceptin®) in weeks 13-15. Treatment with
      docetaxel and trastuzumab repeats every 3 weeks for 4 courses.

      Patients then undergo appropriate surgery. After surgery, patients with hormone
      receptor-positive disease receive trastuzumab once weekly and either tamoxifen with or
      without a luteinizing hormone-releasing hormone agonist or an aromatase inhibitor. Treatment
      continues for 40 weeks.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
    

Intervention name(s): trastuzumab; cyclophosphamide; docetaxel; epirubicin hydrochloride; conventional surgery; neoadjuvant therapy
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Trastuzumab; Epirubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer
Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative
      hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine
      the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of
      post-operative pain by patients self-assessment of pain.
    


Intervention name(s): Caldolor; Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): 800 milligrams intravenous; Placebo comparator
Other intervention name(s): Ibuprofen; NS
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of Lu AA21004, once daily (QD), on
      cognitive dysfunction in patients with major depressive disorder.
    

Detailed description: 
      Lu AA21004 is under codevelopment by Takeda Global Research & Development Center, Inc. and H.
      Lundbeck A/S for the treatment of MDD.

      This study will consist of a screening period within 10 days of the Baseline Visit followed
      by an 8-week double-blind treatment period and a one-week taper down period.
    

Intervention name(s): vortioxetine (Lu AA21004); Duloxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lu AA21004 capsules; Duloxetine capsules; Placebo matching capsules
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride; Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
Sun Protection Factor Assay (SPF Assay 203/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987516
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
(Formulation Code:Z46-116)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of "Plan A"
Condition: Teen Pregnancy Prevention
Study type: Interventional

Summary: 
      The purpose of the study is to determine if exposure to the "Plan A" video influences
      viewers' uptake of LARC, reduces unprotected sexual activity, and increases receipt of STI
      testing.
    

Detailed description: 
      The Policy & Research Group (PRG) is evaluating the "Plan A" video, which was designed to
      promote effective contraceptive use, use of dual methods of protection (condom use and
      prescription birth control use), and HIV/STI testing in African/American and Latina young
      women. The video is approximately 23 minutes in length and is shown immediately prior to a
      clinical appointment at a reproductive health center. By delivering the intervention prior to
      a clinic appointment, developers hope to reach high-risk teens at a teachable moment, when
      they can ask a health care provider about what they have learned. The primary focus of the
      study is to investigate the impact of the intervention on participants': 1) LARC use; 2)
      times having sex without a condom; and 3) STI testing. Secondary outcome measures include
      assessing the impact of the intervention on participants': 1) use of dual methods of
      protection during vaginal sex; and 2) use of other effective contraceptive methods. Finally,
      the evaluation will include exploratory analysis of participants': 1) perception of risk
      and/or severity for pregnancy and HIV/STI infection; (2) intention to use LARC; (3) intention
      to use other effective contraception methods; (4) provider communication self-efficacy; (5)
      condom negotiation self-efficacy; and (6) knowledge/awareness of contraception options/LARC.

      The control (counterfactual) condition consists of a 17-minute video titled "The Toxic Life
      Cycle of a Cigarette". The control video, which discusses the effects of smoking, is shown in
      the same manner as the treatment video: immediately prior to a clinic appointment at a
      reproductive health center.

      All eligible participants who provide the proper consent are randomized and enrolled into the
      study by a study coordinator who is an employee of the reproductive health clinic. Outcomes
      will be assessed using self-reported, participant-level data gathered (by way of a
      questionnaire) at three time points: baseline (enrollment, prior to watching the video);
      3-month follow-up (3 months after baseline); and 9-month follow-up (9 months after baseline).
      The study is taking place at seven clinics within the Planned Parenthood Mar Monte system in
      California, all of which serve the target population.
    

Intervention name(s): Plan A; Toxic Life Cycle of a Cigarette
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Video
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Mindfulness Education in Adolescents
Condition: Mindfulness
Study type: Interventional

Summary: 
      Aim: It was planned to evaluate the impact of mindfulness training on interpersonal style and
      perceived social competence in adolescents.
    

Detailed description: 
      In the research, high school students will form the universe according to the education in
      the relevant institution. Based on a study with a similar design, it was decided to include
      60 people, 30 in the intervention group and 30 in the control group, according to the effect
      size.
    

Intervention name(s): Mindfulness Training
Intervention type(s): Behavioral
Intervention description(s): The application is planned as 8 sessions and one session per week. Each session corresponds to one lesson hour and is approximately 30-40 minutes. In the content of the application, the individual's attention, mind, attitude, intention, thought; It has basic concepts such as the separation and merging process of thoughts in our minds, the deep processes of awareness, staying in the moment, values, focusing process, self-compassion, integration of awareness with other situations in life, meditation practices developed with practice, and the content summarized around these concepts. It is a program that tries to enable individuals to focus on the moment they live in, within the framework of these basic concepts. The program is divided into session titles such as "Introduction to Mindfulness", "Mind Awareness", "Body Awareness", "Emotion and Behavior Awareness", "Self Compassion", "Stress Awareness", "Eating Awareness".
Other intervention name(s): Mindfulness
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mindfulness Training; Adolescent; Interpersonal Style; Perceived Social Competence; Psychiatric nursing
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with
      moderately to severely active Systemic Lupus Erythematosus (SLE).
    

Detailed description: 
      This is a Phase 2b, multinational, multicenter, randomized, double-blind, placebo controlled,
      parallel group study to evaluate the efficacy and safety of three intravenous (IV) treatment
      regimens of sifalimumab (200, 600, or 1,200 mg) in adult subjects with chronic
      moderately-to-severely active SLE with an inadequate response to standard of care (SOC) for
      SLE.
    

Intervention name(s): Sifalimumab 200 mg; Sifalimumab 600 mg; Sifalimumab 1,200 mg; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.; Sifalimumab 600 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.; Sifalimumab 1,200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.; IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks
Other intervention name(s): MEDI-545; MEDI-545; MEDI-545
Intervention MeSH terms: Sifalimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SLE; Systemic Lupus Erythematosus; Sifalimumab; MEDI-545
Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells
Condition: Influenza A Virus Infection
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Rationale:

      Classical antiviral therapies target viral proteins and are consequently subject to
      resistance. To counteract this limitation, alternative strategies have been developed that
      target cellular factors. We hypothesized that such an approach could also be useful to
      identify broad-spectrum antivirals. The influenza A virus was used as a model for its viral
      diversity and because of the need to develop therapies against unpredictable viruses as
      recently underlined by the H1N1 pandemic. Gene-expression signature-based screening
      identified broadly effective influenza A antivirals. Midodrine showed great results in
      inhibiting viral growth and was the most suited to confirm its efficacy in vivo.

      The main objective of the study is to assess the efficacy of midodrine taken at usual
      recommended dose (7.5mg/day) versus no treatment on viral replication kinetics of virus
      Influenza A.

      Secondary objectives: evaluation of the number of patients with a normalized viral load 2, 3
      5 and 7 days post-treatment; description of the anti-viral efficacy of midodrine defined as
      the delay to obtain a prolonged negativity of viral RNA; description of the tolerance of
      midodrine, evaluation of the clinical response to study treatment; evaluation of the dynamic
      of viral replication; analysis of the frequency of emergence of mutants and associated
      resistance.

      Methods:

      This is a multicenter, randomized, open-label study comparing patients aged 18 to 65 years
      infected by influenza A virus. Nasopharyngeal washing will be performed at day 0
      (randomization), 2, 3, 5 to show the viral replication evolution.

      161 patients will be randomized as follows :

        -  Arm 1 : Midodrine, 2.5 mg, 3 times a day

        -  Arm 2 : No treatment The recruitment is performed by general practitioners in the Lyon
           area.
    


Intervention name(s): Gutron® treatment
Intervention type(s): Drug
Intervention description(s): Midodrine 2.5 mg orally 3 times daily, 5 day-treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
Condition: Immunosuppression
Study type: Interventional

Summary: 
      The objective of this study is to compare the safety and efficacy of Myfortic with CellCept
      in liver transplant patients. Myfortic and CellCept are both immunosuppressive
      (anti-rejection) drugs. CellCept is commonly used after liver transplantation but
      gastrointestinal (GI) side effects are very common, sometimes necessitating in its
      discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our
      hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable
      effectiveness to CellCept.
    

Detailed description: 
      This is a prospective, randomized, double-blinded, single center, safety and efficacy study
      comparing Myfortic with CellCept used after liver transplantation. Patients with
      biopsy-proven acute cellular rejection, renal insufficiency (i.e. acute or chronic renal
      failure requiring hemodialysis or patients with creatinine clearance < 50 ml/min), or
      calcineurin inhibitor-induced neurotoxicity (defined as the presence of neurologic symptoms
      such as tremors, altered mental status, seizures, etc) will be randomized to start on either
      Myfortic (720 mg po bid) or CellCept (1 gm po bid). In those patients with
      calcineurin-induced neurotoxicity or nephrotoxicity, tacrolimus or cyclosporine doses will
      also be reduced to maintain serum trough levels of 4-8 mg/dl or 100-200 mg/dl, respectively.

      Comparison: Thirty patients will be enrolled and randomized in this two-armed, double-blinded
      study- half of the patients will receive Myfortic and the other half, CellCept.
    

Intervention name(s): Myfortic; CellCept
Intervention type(s): Drug; Drug
Intervention description(s): Myfortic 360mg or 720 mg BID for 90 days; CellCept 500mg or 1000mg BID for 90 days
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Liver transplantation; mycophenolate mofetil; gastrointestinal; adverse effects
Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Laparoscopic gastrectomy became a good option for early gastric cancer. Surgical trend is
      gradually changed to totally laparoscopic gastrectomy from laparoscopy-assisted gastrectomy
      requiring mini-laparotomy. Various types of intracorporeal anastomosis have been introduced
      for esophagojejunostomy during total gastrectomy. We invented a novel anastomosis method
      using linear stapler for total gastrectomy. Three procedures (Jejunal resection, esophageal
      resection and closure of common entry hole after anastomosis) was performed with only one
      stapler. Therefore, the novel method is simple and fast. Also, this new technique is better
      economically than previously introduced anastomosis using linear stapler because lesser
      number of stapler is required. We want to demonstrate the feasibility of novel intracorporeal
      anastomosis method during laparoscopic total gastrectomy.
    


Intervention name(s): Intracorporeal esophagojejunostomy
Intervention type(s): Procedure
Intervention description(s): Under laparoscopic view, esophagojejunostomy was pereformed with 60mm linear stapler on right side of distal esophagus like as functional end-to-end fashion before esophageal and jejunal resection. Then, three procedures of esophageal resection, common entry hole closure and jejunal resection was performed with a single use of 60mm stapler. Also, jejunojejunostomy was also performed via already made staple entry hole.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: total gastrectomy; intracorporeal; totally laparoscopic; esophagojejunostomy; anastomosis