bioihbjkbjnl/mcl2 huggingface dataset:
Avastin as an Adjunct to Diode Laser in the Treatment of Neovascular Glaucoma
Condition: Neovascular Glaucoma
MeSH terms: Glaucoma; Glaucoma, Neovascular
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the efficacy of Avastin as an adjunct to Diode Laser cyclophotocoagulation in the
      treatment of Neovascular Glaucoma.
    

Detailed description: 
      Design: Prospective, comparative interventional case series. Method: Patients were randomly
      assigned into Group A which were treated with Diode laser cyclophotocoagulation alone,
      whereas group B received intravitreal Avastin (One milligram = 0.04mL of 25 mg/mL) in
      conjunction with the Diode Laser. The preoperative data included etiology, mean age; follow
      up period, and a full ophthalmological examination with emphasis on mean IOP, iris
      neovascularization, pain and corneal edema.
    

Intervention name(s): Diode laser cyclophotocoagulation enhanced by intravitreal injection of Avastin
Intervention type(s): Procedure
Intervention description(s): The operative procedure involved retro-bulbar anesthesia, draping the patient in an aseptic manner, introduction of an eye speculum, 30 laser shots over 270 degrees of the circumference of the limbus. For our study we used the Iris Diode laser machine, the G-probe and we adjusted the settings for 2500 millisecond duration and the 3000 milli-joule and reduced the power progressively until just below the energy level that produced a pop.then after applying the laser, we performed a paracentesis with a 27 gauge needle to soften the globe, followed by intravitreal injection of the Avastin from a site 3.5 millimeter posterior to the limbus. The dose we administered was one milligram of bevacizumab (0.04 mL of 25 mg/mL).
Other intervention name(s): bevacizumab
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neovascular glaucoma; diode laser; cyclophotocoagulation; Avastin
Head Elevation in Prone Position
Condition: Gas Exchange; Lung Mechanics
Study type: Interventional
Phase: Phase 2

Summary: 
      Semi-recumbent position leads to improvement of gas exchange and lung mechanics in patients
      suffering from ALI or ARDS. Prone positioning leads to similar effects. To date, no data on
      the combination of these two positioning measures exist. The investigators hypothesize that
      head elevation in prone position leads to improvement in gas exchange and lung mechanics.
    


Intervention name(s): Prone position with head elevation
Intervention type(s): Procedure
Intervention description(s): Head elevation of 30° in prone position (Ant-Trendelenburg position of the whole bed)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prone position; ALI/ARDS; Head elevation
A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the efficacy, safety and tolerability of different oral dose of
      YM060, 5-HT3 receptor antagonist, in patients with d-IBS.
    


Intervention name(s): YM060
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Diarrhea; Nasea®; Irribow®; ramosetron
Treating Depression With Transcranial Direct Current Stimulation (tDCS)
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to see if transcranial direct current stimulation may improve
      the symptoms of depression.
    

Detailed description: 
      The purpose of this study is to learn about a brain stimulating procedure called transcranial
      direct current stimulation (tDCS). In tDCS therapy, two moistened sponges are applied to the
      forehead while a small amount of electric current flows between them. These electrodes are
      placed on the head so that the electricity will pass through a region in the brain that is
      believed to contribute to depression. This study is intended to test the theory that the
      electromagnetic field created by the current may affect this region of the brain in a way
      that may improve the symptoms of depression. This may affect brain activity and function.
    

Intervention name(s): transcranial direct current stimulation; transcranial direct current stimulation; transcranial direct current stimulation; iomed phoresor transcranial direct current stimulation
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Two damp sponges, one placed on the left side of the forehead, the other on the left arm. 0.1mA of current is passed for 20 minutes.; transcranial direct current stimulation delivers one milliamp of direct current, supplied by a constant current generator, the the left dorsolateral prefrontal cortex through a scalp electrode. The treatment is given for 20 minutes a day.; one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode; for the sham group the current is turned off after 10 seconds
Other intervention name(s): ioMed Phoresor; Phoresor II Auto model PM850; Phoresor II Auto model PM850; phoresor II auto model PM850
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: depression; transcranial direct current stimulation; direct current stimulation; tdcs
Feasibility Study Focusing on Fit of Made-to-measure Compression Garments in Healthy Subjects II
Condition: Product Use Issue
Study type: Interventional

Summary: 
      Fit of made-to-measure compression garments in healthy subjects will be tested on one day,
      simulating daily activities.
    

Detailed description: 
      Lower extremities of 36 healthy subjects will be measured by trained experts to collect
      measures for made-to-measure compression garments.

      Fit of made-to-measure compression garments, which are not on the market yet, among healthy
      subjects will be tested on one day, simulating daily activities. Fit will be assessed
      directly after donning and after a wearing period of maximum 7 hours at the study site by
      trained experts. Healthy subjects will give back study products at the end of the wearing
      period. AEs will be documented throughout the study.
    

Intervention name(s): Made-to-measure compression garment
Intervention type(s): Device
Intervention description(s): Subjects will wear one of two made-to-measure compression garments:
(1) JOBST® Confidence leggins (BT) and (2) JOBST® Confidence Bermuda (ET)
Intervention model: Single Group Assignment
Intervention model description: Healthy subjects will test made-to-measure compression garments. No comparator group due to explorative design.
Masking: None (Open Label)
Primary purpose: Other
Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether the supplement Methyl B12 is effective in
      treating some of the symptoms of Autism.
    

Detailed description: 
      Autism is a complex neurodevelopmental disorder with early childhood onset characterized by
      impairments in communication, social interaction, and repetitive behavior. Due to the lack of
      known treatments for autism, many parents seek complementary and alternative medical (CAM)
      therapies hoping to help their affected child. Methylcobalamin (methyl B12) is a commonly
      used CAM treatment that has anecdotal reports of remarkable clinical improvements with few
      side effects. Prior studies have found that children with autism have deficiencies in key
      metabolites and antioxidants which can be caused by methyl B12 deficiency; additional studies
      have shown that methyl B12 normalizes deficiencies in these metabolites and antioxidants.
      Based on these reports, a pilot study was conducted at UC Davis on the effect of methyl B12
      on the behavioral and metabolic measures in children with autism. The preliminary results of
      29 subjects revealed a subgroup of 9 responders to clinical behavior assessments. These
      responders also demonstrated significant improvement on the plasma measures of antioxidant
      capacity, suggesting methyl B12 improves symptoms in a subgroup of children with autism by
      increasing key antioxidants. The current study will have an 8 week double blind design with
      50 subjects, designed to evaluate improvements from methyl B12 by using behavioral
      assessments and analysis of specific metabolites in the subjects' blood. This study will
      determine whether methyl B12 will lead to benefits in any of the core features of autism, and
      will examine metabolic changes with the hope of potentially identifying a biomarker for
      treatment response in a subgroup of subjects.
    

Intervention name(s): Methyl B12; Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 75 µg/Kg subcutaneously injected once every 3 days; placebo
Other intervention name(s): Vitamin B12; methylcobalamin
Intervention MeSH terms: Vitamin B 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autism; Pervasive Developmental Disorders
Rapid and Highly Sensitive Detection of Fluorescently-labeled Troponin in Patients Admitted With Chest Pain
Condition: Chest Pain
MeSH terms: Hypersensitivity; Chest Pain
Study type: Observational

Summary: 
      Patients with chest pain may have postponed or missed diagnosis of acute coronary events due
      to relatively late detection of troponin elevation. The study will investigate a new
      diagnostic method for early detection of even minimal troponin elevation in patients admitted
      with chest pain.
    

Detailed description: 
      Patients with chest pain may have postponed or missed diagnosis of acute coronary events due
      to relatively late detection of troponin elevation. The study will investigate a new
      diagnostic method for early detection of even minimal troponin elevation in patients admitted
      with chest pain.

      A new diagnostic method will be applicated in the recent studies.
    

Intervention name(s): Blood testing in a newly described method
Intervention type(s): Other
Intervention description(s): To exploit detection strategy termed "Magnetic Modulation Biosensing", or MMB) to develop a novel, low-cost platform that can detect biomarkers, such as proteins and specific DNA sequences, rapidly and directly from real samples at very low concentrations.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Enrolled subjects will be patients admitted to Rambam health campus for the investigation
        of chest pain. Five m"l blood will be collected for troponin assay. No further intervention
        will be applied for subjects. Blood will be centrifuged and plasma separated for study
        purposes (detailed in "methods"- section 3.2.1.
Type 2 Diabetes Mellitus Prevention Ukraine
Condition: Impaired Fasting Glucose; Impaired Glucose Tolerance; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      Development, implementation and evaluation of the effectiveness of lifestyle recommendations
      for the prevention of type 2 diabetes in rural population of Ukraine
    

Detailed description: 
      An oral glucose tolerance test and anthropometric measurements were performed for 300
      randomly selected rural residents of the Kyiv region of Ukraine. Persons from impaired
      glucose regulation category (impaired fasting glucose - IFG) was enrolled to diabetes
      prevention intervention study (T2DPUA).

      Individuals in the IFG category received advice on limiting sugar intake (not more than 25 g
      per day), increasing physical activity (30 minutes daily). 30 persons from this category were
      additionally advised to consume insoluble dietary fiber 15 g per day (Vitacel wheat fiber)
      for 3 months, after which a repeat anthropometric and biochemical study. Objective control of
      physical activity and body composition is also provided.
    

Intervention name(s): Physical activity; Macronutrient modification
Intervention type(s): Other; Other
Intervention description(s): Moderate activity 150 min per week; Insoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 30 persons from this category were additionally advised to consume insoluble dietary fiber 15 g per day (Vitacel wheat fiber) for 3 months, after which a repeat anthropometric and biochemical study.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: lifestyle modification; type 2 diabetes; prevention; Ukraine; Rural
Growth Hormone and Brain Functioning After Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The current protocol aims to compare the brain-functioning (fMRI & EEG) and white matter
      structural integrity (DTI) of persons with mild to severe TBI with and without Growth Hormone
      deficiency during cognitive tasks; and to examine changes in cognitive and motor performance,
      EEG/fMRI and white matter integrity associated with growth hormone treatment for twelve
      months using an open-label design in persons with GH deficiency/insufficiency following mild
      to severe TBI. To meet this aim, we are in the process of screening 40 persons with mild to
      severe TBI, ages 18-55, who are at least six months post injury. After screening, 10 persons
      with TBI and GHD (Growth Hormone deficiency) will receive daily rhGH injections titrated to
      bring their GH levels into the normal range over the course of twelve months. Treatment will
      be initiated using rhGH (Genotropin). Subjects with TBI and GHD will be assessed at baseline,
      6 months, and 12 months with EEG, fMRI and DTI, and neuropsychological measures. 5 persons
      with TBI who do not have GHD will be assessed at baseline and at 12 months with EEG, fMRI and
      DTI, and neuropsychological measures.
    


Intervention name(s): Genotropin
Intervention type(s): Drug
Other intervention name(s): somatropin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Growth Hormone; Neuroimaging
Evaluation of NDV-3A Vaccine in Preventing S. Aureus Colonization
Condition: Staphylococcus Aureus
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed study aims to further evaluate the safety and immunogenicity of a candidate S.
      aureus vaccine NDV-3A, as well as its efficacy against acquisition of S. aureus
    

Detailed description: 
      The investigators will conduct a Phase 2 clinical trial to evaluate the safety,
      immunogenicity, and efficacy of candidate vaccine NDV-3A (NovaDigm Therapeutics, Inc.) to
      prevent incident nasal acquisition of S. aureus among a population of military recruits at
      increased risk for S. aureus colonization and disease. Colonization is a risk factor for skin
      and soft tissue infection (SSTI), and the anterior nares is an important reservoir for S.
      aureus. Use of S. aureus nasal colonization (specifically, incident nasal colonization with
      S. aureus post-vaccination) as a primary endpoint will allow the investigators to pursue a
      statistically-valid and meaningful parameter related to S. aureus SSTI. The proposed trial
      may yield evidence to warrant evaluation of NDV-3A efficacy against SSTI in a large-scale,
      Phase 2/3 trial in this high risk population.
    

Intervention name(s): NDV-3A; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single dose administered by intramuscular injection; Single dose administered by intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, placebo-controlled, randomized study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Als3; SSTI; vaccine; NDV-3A; incident nasal colonization
Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the long-term effects of levetiracetam on retention rate in subjects with
      refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant
      antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.
    


Intervention name(s): Levetiracetam; Topiramate
Intervention type(s): Drug; Drug
Intervention description(s): 250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks; 25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks
Other intervention name(s): Keppra
Intervention MeSH terms: Topiramate; Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: levetiracetam; topiramate; epilepsy; partial seizures
Evaluation of Exenatide in Patients With Diabetic Neuropathy
Condition: Type 2 Diabetes Mellitus; Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study will look at whether or not the medication exenatide improves signs and symptoms
      of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate
      diabetic peripheral neuropathy.
    

Detailed description: 
      This study will look at the effects of the medication exenatide on peripheral neuropathy in
      people with type 2 diabetes. Exenatide (trade name, BYETTA®) is an injectable medication used
      by people with type 2 diabetes to control blood sugar. Peripheral neuropathy is a
      complication of diabetes that can cause symptoms such as numbness, tingling or burning
      sensations in the feet and hands. Controlling blood sugars levels in type 2 diabetes is
      thought to prevent, delay or improve the damage to the nerve fibers that causes peripheral
      neuropathy. There is also some evidence that exenatide may have additional beneficial effects
      on the peripheral nerves, beyond the benefits of blood sugar control alone. In this study,
      about half of the participants will take exenatide by injection twice daily and the other
      half will take insulin glargine (Lantus®) by injection once daily. Both groups are expected
      to have similar improvement in blood sugar control. This study will show whether exenatide
      has beneficial effects on neuropathy beyond the benefits of better blood sugar control alone.
    

Intervention name(s): Exenatide; Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels; Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control
Other intervention name(s): Byetta; Lantus
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Neuropathy; Glucose; Control; Peripheral; Autonomic
Development of an Instrument That Monitors Behaviors Associated With OCD
Condition: OCD
Study type: Observational

Summary: 
      To support the discovery of new means for revealing the presence of Obsessive Compulsive
      Disorder (OCD), facilitating detection through new technology-based metrics, and attempt to
      automate existing diagnostic procedures allowing for more efficient diagnostic methods that
      would broaden clinical scope and outreach.
    

Detailed description: 
      Aim 1: To observe and compare childhood behaviors regarding handwashing in OCD and control
      populations

      Hypothesis 1: Control participants will spend less time washing their hands, will wash them
      less frequently, and will be less preoccupied with the sink when doing other activities.

      Aim 2: To observe and compare childhood behaviors regarding organizing a cluttered area.

      Hypothesis 2: OCD participants will be more disturbed by the presence of clutter and more
      compelled to organize the items than control participants

      Aim 3: To observe and compare childhood behaviors regarding turning on/off light switches

      Hypothesis 3: OCD children will be more likely to exhibit compulsive repetitive behaviors
      regarding the light switch than control participants
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): Observational Study: No intervention
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The investigators will recruit 20 children and adolescents with OCD aged 5-17 who present
        to the University of Minnesota Child and Adolescent Anxiety and Mood Disorders Clinic or
        who are referred from outside clinicians. Twenty healthy controls will be recruited from
        the community.
      
Keywords: OCD