bioihbjkbjnl/mcl2 huggingface dataset:
Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose: : This study was performed to compare the accuracy of non-cycloplegic
      photorefraction with cycloplegic refraction in detection of refractive amblyopia risk factors
      and determine some corresponding beneficial cut points.

      Method: In this diagnostic accuracy study, right eyes of 185 children (1 to 14 years)
      underwent first non-cycloplegic photorefraction (with PlusOptix SO4 photoscreener) and then
      cycloplegic refraction from October 2009 to August 2010. Based on the cycloplegic refraction
      results, hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D)
      were set as criteria based on AAPOS guidelines. The difference in detection of refractive
      amblyopia risk factors between the two methods was the main outcome measure.
    


Intervention name(s): photorefraction
Intervention type(s): Device
Intervention description(s): photorefraction is a name of device.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Non-cycloplegic photorefraction; cycloplegic refraction,; Amblyopia
The Zeaxanthin and Visual Function Study
Condition: Age Related Macular Degeneration; Cognition Disorders
MeSH terms: Macular Degeneration; Cognition Disorders
Study type: Interventional

Summary: 
      To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to
      patients with early and moderate Atrophic Age Related Macular Degeneration.
    

Detailed description: 
      To evaluate whether or not zeaxanthin supplementation raises macular pigment optical density
      (MPOD). Previous research has shown MPOD to mirror visual benefits for patients with age
      related atrophic macular degeneration (AMD) having visual symptoms (decreased visual acuity,
      contrast sensitivity, photostress glare recovery and National Eye Institute Visual Function
      Questionnaire 25 scores), but lower risk National Eye Institute (NEI) / Age Related Eye
      Disease Study (AREDS) characteristics.
    

Intervention name(s): 3R 3'R Zeaxanthin; Lutein; Lutein and Zeaxanthin
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): 8 mg per day during 12 months; 9 mg of Lutein during 12 months; 8 mg of lutein and 8 mg of Zeaxanthin administered during 12 months
Other intervention name(s): EZEyes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Macular Pigment Optical Density; Skin Carotenoids; Lipofuscin; Photostress (Glare Recovery); Visual Field Progression; Contrast Sensitivity; Color Vision; Cognitive Function
S0415 Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Biological therapies such as cetuximab may stop the growth of tumor cells by
      blocking the enzymes necessary for their growth.

      PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with
      metastatic esophageal cancer or gastroesophageal junction cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the 6-month overall survival of patients with metastatic adenocarcinoma of the
           esophagus or gastroesophageal junction treated with cetuximab as second-line therapy.

        -  Determine the response rate (confirmed and unconfirmed, complete and partial), time to
           progression, and time to treatment failure in patients treated with this drug.

        -  Determine the toxicity of this drug in these patients.

        -  Correlate, preliminarily, gene expression and germline polymorphism of enzymes and genes
           involved in the epidermal growth factor receptor pathway, DNA repair, and angiogenesis
           with time to progression, response, overall survival, toxic effects, and time to
           treatment failure in patients treated with this drug.

      OUTLINE: This is a multicenter study.

      Patients receive cetuximab IV over 1-2 hours on day 1. Treatment repeats once weekly in the
      absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months for 1 year and then every 6 months until 3 years from
      the date of study registration.

      PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 6-14
      months.
    

Intervention name(s): cetuximab
Intervention type(s): Biological
Intervention description(s): 1 time Cetuximab 400mg/m2 IV over 120 minutes followed by weekly Cetuximab 250mg/m2 IV over 60 minutes.
Other intervention name(s): Erbitux
Intervention MeSH terms: Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the esophagus; recurrent esophageal cancer; stage IV esophageal cancer
TREating Pediatric Obesity
Condition: Infant Obesity; Hepatic Steatosis; Metabolic Syndrome; Insulin Resistance; Dyslipidemias
MeSH terms: Fatty Liver; Obesity; Metabolic Syndrome; Insulin Resistance; Dyslipidemias; Pediatric Obesity
Study type: Interventional

Summary: 
      The main aim of the study is to collect preliminary information on the feasibility and
      efficacy of a time restricted eating intervention in Spanish children and adolescents with
      obesity and metabolic comorbidities. Two 8-week interventions will performed in a randomized
      crossover controlled design: a) reduction of the habitual eating window; b) standard care.
      Different measurements of body composition and cardiometabolic health markers will be
      performed along those weeks.
    


Intervention name(s): Standard Care; Time restricted eating
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive nutritional education sessions and will be instructed to maintain an intake window of at least 13 hours a day, preferably every day of the week and in any case at least 6 days a week.; A personalized progression will be established to progressively reduce the intake window during the first 10 days of intervention. After these first 10 days, the participants will be prescribed to limit food intake to a maximum of 10 hours a day, at least 5 days a week. Participant can freely select the time of day to place the intake window. However, it will be recommended to avoid making the last intake in the 3 hours before going to bed. After 4 weeks of intervention, the dietitian will invite them to reduce the intake window to 9 or 8 hours, if they consider it feasible, maintaining this new intake window during the last 4 weeks of intervention. The intake window can be maintained at 10 hours until the end of the study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study is primarily investigating the effectiveness of Autologous Conditioned Plasma
      (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.
    

Detailed description: 
      This study is a prospective, multi center randomized double blind, two arm study.

      90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma
      Intra-articular or the control.
    

Intervention name(s): ACP; Placebo
Intervention type(s): Device; Other
Intervention description(s): Autologous Conditioned Plasma; Three Normal Saline IA injections of 3-8 mL at 1-week intervals.
Other intervention name(s): Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SCOSI-M: Preventing Prescription Drug Problems
Condition: Prescription Drug Problems
Study type: Interventional

Summary: 
      Brandeis University and University of South Carolina (USC) have joined together to develop
      the South Carolina Opioid Safety Initiative - Military (SCOSI-M), to develop an academic
      detailing (medical education) intervention for physicians and evaluate its effectiveness in a
      pilot study. The goal of the intervention is to increase the use of safe prescribing and
      prescription monitoring practices among primary care physicians. The research team will
      design and pilot an educational intervention for physicians who treat military personnel,
      veterans, and their families with prescription opioids. The overall aim of SCOSI-M is to
      prevent the onset or progression of prescription drug problems among Iraq and Afghanistan
      veterans, military members, and their families who are at high risk for developing problems
      if their treatment involves long-term use of an opioid.
    


Intervention name(s): Educational Intervention
Intervention type(s): Other
Intervention description(s): The design is primarily a pre-post, non-equivalent comparison group test of program effectiveness. If final sample size permits, we will examine program effects for each practice environment separately. For measures that require interview data there will be no comparison group data.
We will construct matched comparison groups of physicians for each environment for which only secondary data analysis will be conducted. The matched comparison group will be constructed using prescription data from the DoD's pharmacy data transaction system (MACH and DORN VAMC) and from SCRIPTS (community-based physicians and VA prescribers).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a study on genetic pathology, obtaining of pure
      cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for
      diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or
      less. Recently, confocal laser endomicroscopy has been introduced for real-time
      histopathologic diagnosis in various cancers. The investigators aim to evaluate that biopsy
      using probe-based confocal laser endomicroscopy will increase the percentage of cancer cells
      in biopsy samples.
    


Intervention name(s): Probe-based confocal laser endomicroscopy; White light endoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): In this arm1, an investigator observes a cancerous lesion using white light endoscopy. In addition, contrast dye for confocal laser endomicorscopy (fluorescein sodium 0.1mL/kg) is administered. Then, the cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy would be done 5 times at the most suspcious parts of the cancerous lesion.; In this arm2, an invesigator observes a cancerous lesion using white light endoscopy. The biopsy would be done 5 times at the most suspicious parts of the cancerous lesion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy
Condition: Pancreaticoduodenectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      Up to now, the studies concerning nutritional assessment after pancreatic resection were
      rare. The low-dose pancreatic enzyme treatment after pancreatectomy showed no significant
      benefit in terms of nutritional status. This study is a multicenter randomized phase IV study
      by using high-dose Norzyme® (40,000 IU) to evaluate quality of life and nutritional status
      after pancreaticoduodenectomy.
    

Detailed description: 
      There are not enough studies evaluating nutritional parameters in patients with pancreatic
      resection. After pancreatic surgery, there are several ways to improve patient condition in
      terms of quality of life including nutrition.

      In the investigators previous study, pancreatic enzyme supplement through the administration
      of Norzyme® 25000 IU containing lipase 25000 IU, amylase 22500 IU, and protease 1250 IU after
      various type of pancreatectomy to improve quality of life and nutritional status failed to
      prove its effectiveness. After administration of low-dose Norzyme® (25000 IU), some patients
      showed weight gain, but statistically significant conclusions were not obtained mainly
      because of various types of pancreatectomy and low supplementary dosage of pancreatic enzyme.

      Therefore, the investigators design this study to find out the effect of high-dose Norzyme®
      (40000 IU) on weight gain, quality of life, stool habit change, and nutritional status in
      patients with pancreaticoduodenectomy. The investigators will evaluate the effectiveness and
      adequacy of high-dose pancreatic supplementary treatment through a randomized, placebo-using,
      single-blinded, and multicenter study.
    

Intervention name(s): Norzyme® 40000 IU; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A kind of pancreatic enzyme supplement containing lipase: 40,000 FIP, amylase: 25,000 FIP, and protease: 1,500 FIP Single capsule of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal; Single capsule of placebo drug with the same appearance of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal.
Other intervention name(s): Norzyme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Pancreaticoduodenectomy; Nutritional Status; Quality of Life; Biochemical Marker
Single Dose CHG Pharmacokinetic Study
Condition: Surgical Skin Preparation
Study type: Interventional
Phase: Phase 1

Summary: 
      A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen
      (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment
      where the same procedure as Treatment-1 and -2 was performed, but without the topical
      application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar
      days.
    


Intervention name(s): Chlorhexidine Gluconate
Intervention type(s): Drug
Intervention description(s): 2% CHG
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Thulium Contact Laser of Laryngotracheal Stenosis
Condition: Laryngeal Carcinoma; Bilateral Vocal Cord Paresis; Subglottic Stenosis
MeSH terms: Vocal Cord Paralysis; Paresis; Constriction, Pathologic
Study type: Interventional

Summary: 
      The purpose of the study is to compare results of the treatment of tumorous and non-tumorous
      laryngotracheal stenosis using thulium contact laser versus carbon dioxide laser used in the
      past.
    

Detailed description: 
      Laryngotracheal stenosis is a serious disease significantly worsening the quality of life.
      Impaired breathing often leads to tracheotomy, deterioration of the voice leads to
      communication problems with others and swallowing problems are often present, as well The
      main causes of laryngotracheal stenosis are post intubation and post tracheostomy conditions,
      inflammatory process (often autoimmune), tumors (mainly squamous cell carcinoma and
      chondroma) and trauma. Within the last years there is substantial shift in the treatment
      strategy from open surgery to endoscopic techniques. However, surgical treatment is often
      difficult due to demanding exposure of tumor and problematic margins control.

      In recent years there has been a development of particular techniques of endoscopic resection
      of tumors and non-malignant laryngeal glottic and subglottic stenosis using a carbon dioxide
      (CO2) laser with promising improvement of treatment results.

      However, CO2 laser has some limitations, particularly in the treatment of tumors spreading
      into anterior commissure, because CO2 laser beam cannot get "around the corner". Moreover,
      subglottic area is also difficult to be reached by CO2 laser beam. Therefore, contact laser
      with adjustable manipulators with possibility to bend tip of manipulator according to the
      actual need seems to be of some advantage.
    

Intervention name(s): laryngeal carcinoma; bilateral vocal cord paralysis; subglottic stenosis
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): treatment of laryngeal carcinoma using thulium contact laser; treatment of bilateral vocal cord paralysis using thulium contact laser; treatment of subglottic stenosis using thulium contact laser
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laryngeal carcinoma; bilateral vocal cord paralysis; laryngotracheal stenosis; laser treatment; decannulation; voice; swallowing
Bioequivalence of Telmisartan as Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination Tablet or as Two Telmisartan 40 mg Tablets in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish bioequivalence of telmisartan orally administrated in two different ways: either
      with a telmisartan 80 mg/hydrochlorothiazide (HCTZ) 12.5 mg fixed-dose combination tablet or
      with two telmisartan 40 mg tablets
    


Intervention name(s): Telmisartan/HCTZ combination; Telmisartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
Condition: Hypercholesterolemia; Hyperlipidemia, Familial Combined
MeSH terms: Hyperlipidemia, Familial Combined; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to compare the effect of Welchol in combination with
      TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients
      with high cholesterol.
    


Intervention name(s): colesevelam HCl tablets and fenofibrate tablets; fenofibrate tablets and Welchol placebo tablets; fenofibrate tablets and Welchol placebo tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day; fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day; fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day
Intervention MeSH terms: Fenofibrate; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Mixed hyperlipidemia
The Efficacy of Thread Embedding Acupuncture on Pain Score, Neck Disability Index, and Pressure Pain Threshold for Myofascial Pain Therapy in the Upper Trapezius Muscle
Condition: Myofascial Pain of Upper Trapezius Muscle
MeSH terms: Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Myofascial pain is characterized by myofascial trigger points, considered as a major cause of
      neck and shoulder pain in the working population. Thread-embedding acupuncture is a new
      acupuncture modality that can provide long-term stimulation aimed at prolonging its
      therapeutic effect that is similar to conventional acupuncture, such as analgesic effects.
      The goal of this randomized controlled trial is to evaluate and compare the effects of
      thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for
      myofascial pain in the upper trapezius muscle. The primary aim of this study is to
      investigate whether thread-embedding acupuncture therapy gives better and last longer results
      for myofascial pain of the upper trapezius muscle than sham thread-embedding acupuncture.
    

Detailed description: 
      This is a clinical trial study to evaluate and compare the effects of thread-embedding
      acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the
      upper trapezius muscle. The subjects are 44 males/female with myofascial pain in the upper
      trapezius muscle and will be randomly assigned to 2 groups: (1) thread-embedding acupuncture
      and (2) Sham thread-embedding acupuncture. The subjects will receive a single treatment. The
      outcome will be assessed before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks
      after treatment. Patients and the outcome assessors will be blinded to the group allocation.
    

Intervention name(s): Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture
Intervention type(s): Procedure
Intervention description(s): Thread-Embedding Acupuncture: using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread Sham Thread-Embedding Acupuncture: using a 29-gauge TEA needle but thread-removed, just needle alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05234)
Condition: Rhinitis, Allergic; Conjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH
      39641/MK-3641/Amb a 1-U) compared with placebo in participants with ragweed-induced
      rhinoconjunctivitis over a one-year period. It is expected that ragweed allergic participants
      on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis
      symptoms and require less allergy rescue medications during ragweed pollen season.
    


Intervention name(s): Ambrosia artemisiifolia allergen extract (Amb a 1-U); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Rapidly dissolving tablet administered sublingually once daily, at a dose of 1.5, 6 or 12 units.; Placebo matching Ambrosia artemisiifolia allergen extract rapidly dissolving tablet, administered sublingually once daily
Other intervention name(s): SCH 39641; MK-3641
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment