bioihbjkbjnl/mcl2 huggingface dataset:
Assessment Of Peri-papillary Retinal Nerve Fiber Layer Thickness In Patients With Unilateral Branch Retinal Vein Occlusion
Condition: Branch Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Study type: Interventional

Summary: 
      Several studies have indicated a relation between the development of RVO and elevated
      intraocular pressure (IOP) and glaucoma [9]. Further investigations into the structural
      alterations in the fellow eyes of individuals with unilateral RVO have revealed that the
      pRNFL is thinner than in healthy eyes, suggesting that there may be systemic risk factors for
      both RVO and glaucoma
    


Intervention name(s): aflibercept (2mg/0.05ml)
Intervention type(s): Drug
Intervention description(s): Aflibercept is a medication used to treat and manage neovascular age-related macular degeneration, diabetic macular edema, myopic choroidal neovascularization, macular edema associated with retinal vein occlusion, and diabetic retinopathy. It is in the vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) antagonist class of medications. Aflibercept acts as a soluble protein decoy for VEGF receptors to inhibit the predominant signaling pathway responsible for angiogenesis and vascular leakage. Aflibercept and other anti-VEGF inhibitors have become the gold standard in controlling neovascular (wet) age-related macular degeneration (NVAMD). T
Intervention MeSH terms: Aflibercept
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if a single dose of AMG 282 is safe in healthy
      subjects and subjects with mild atopic asthma.
    

Detailed description: 
      A single SC or IV dose administration of AMG 282 to healthy subjects and subjects with mild
      atopic asthma will exhibit an acceptable safety and tolerability profile within the dose
      ranges studied.
    

Intervention name(s): AMG 282; AMG 282 Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose either subcutaneously or intravenously on day 1.; Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mild asthma; Atopic asthma; Healthy volunteers; First-in-human
The Physical and Psychological Benefits of Yoga and Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Breast Cancer is the most common cancer amongst Canadian women. Studies report that breast
      cancer patients are the most likely to use complementary medicine within the oncologic
      population. Yoga has become especially popular with this group as it promises to improve the
      mind, body and soul holistically. The investigators yoga program specifically focuses on
      rebuilding physical strength, increasing flexibility and reducing the pain and stress
      associated with the post-operative period. This study will examine how yoga can help improve
      the overall quality of life and its effects on the physical well-being of women with breast
      cancer. With positive statistical results, the investigators hope to implement yoga as part
      of their rehabilitation services at the Cedars Breast Clinic.
    

Detailed description: 
      Proposed Intervention:

      1-hour hatha yoga classes, once a week for a 12-week period. One class will be offered in
      French, another in English. The class will begin with approximately 10 minutes of pranayama
      (breathing exercises) and meditation, followed by 30 minutes of yoga poses and ending with 10
      minutes of sivasana (rest period.) The first couple of classes in the 12 week series will
      begin with restorative postures and will gradually progress to more gentle exercises. If
      health permits, the last couple of classes will involve some strengthening poses. A small
      portion of the class will work with the physical body in general and there will be a specific
      emphasis on the physical difficulties faced by most breast cancer patients, i.e. neck, chest,
      shoulders arms and hands.
    

Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): A 12 week yoga session will be offered to women with breast cancer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether ciliary body thickness increased in the
      presence of diabetic macular edema and whether it changed after pars plana vitrectomy.
    

Detailed description: 
      A diabetic macular edema group consisted of diabetic patients who underwent PPV for diffuse
      diabetic macular edema. A epiretinal membrane group, a surgical control group, consisted of
      non-diabetic patients with epiretinal membrane who underwent pars plana vitrectomy. A healthy
      control was also included for the comparison of preoperative ciliary body thickness. Ciliary
      body thickness was measured using ultrasound biomicroscopy, and central macular thickness was
      determined using optical coherence tomography. The visual outcome, ciliary body thickness,
      and central macular thickness were compared between groups before and 1, 2, and 4 months
      after pars plana vitrectomy and the correlations between the central macular thickness and
      ciliary body thickness and best corrected visual acuity were determined.
    

Intervention name(s): Pars Plana Vitrectomy
Intervention type(s): Procedure
Intervention description(s): 25-gauge three-port pars plana vitrectomy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diabetic Macular Edema; Ciliary Body; Ultrasound Biomicroscopy; Vitrectomy
Intraoperative Neuromonitoring Recording With a Novel SCS Paddle
Condition: Chronic Pain; Neuropathic Pain; Failed Back Surgery Syndrome; Complex Regional Pain Syndromes
MeSH terms: Neuralgia; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Chronic Pain; Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate safety and efficacy of a new spinal cord
      stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots,
      and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic
      physiological clinical research questions. It may inform future device therapy development,
      but the Study Electrode is not a product that will be marketed or sold. The Investigators
      believe the protocol is a Non-Significant Risk study answering basic physiological research
      questions, which may be performed under hospital IRB approval.
    


Intervention name(s): HD Study Electrode
Intervention type(s): Device
Intervention description(s): The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Spinal cord stimulation; chronic pain
Exercise Capacity, Cardiovascular Risk Factors and Disease-related Variables in Axial Spondyloarthritis
Condition: Exercise Capacity; Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Observational

Summary: 
      The investigators aimed to study the associations between exercise capacity and
      cardiovascular (CV) risk factors in axial spondyloarthritis (axSpA) patients and to determine
      possible relationships with disease-related variables. Thirty eight patients and 38 controls
      were recruited in our cross-sectional controlled study. Comprehensive systemic and
      musculoskeletal examinations were carried out in both of the groups. Cardiovascular risk
      profile data, ASDAS-CRP, 10-year CV event risk, physical activity levels (IPAQ) were
      recorded. A maximal treadmill exercise test by Bruce protocol was administered to all
      participants.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Thirty eight patients fulfilling the ASAS axial SpA criteria were recruited from the
        department of Gazi University Physical Medicine and Rehabilitation Rheumatology. 38 control
        subjects were randomly recruited from local hospital staff with a similar range of sex and
        age to the patients.
      
Keywords: axial spondyloarthritis; exercise capacity; cardiovascular risk factors; nonradiographic axial spondyloarthritis; cardiorespiratory fitness
Subclassification of the Syndrome of Inappropriate ADH Secretion
Condition: Hyponatremia
MeSH terms: Hyponatremia
Study type: Observational

Summary: 
      The aim of this study is to evaluate the different types of osmotic dysregulation in patients
      with Syndrome of Inappropriate ADH (SIADH) and, hence, to analyze the pathophysiology of
      SIADH.

      These types will be characterized by measurement of AVP and copeptin while performing an
      osmotic stimulation with infusion of hypertonic saline.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with chronic hyponatremia (> 3 days) due to SIADH in university hospital in
        wuerzburg

        healthy control subjects with normonatremia
      
Keywords: hyponatremia; SIADH; copeptin
Violence Against Women and Consequences During Climacteric´s Phase
Condition: Violence; Battered Women; Cognitive Behavior Therapy
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective- Analysis of the health status of women who were or are victims of domestic and
      sexual violence seeking attention at the outpatient clinic for Endocrines Gynecology and
      Climactery - University of Sao Paulo General Hospital.

      To widen the comprehension of the binomial relationship violence-pathologies by
      professionals/staff who work in health services, offering women in such situation humane,
      comprehensive and qualified attention. Specific Objectives: decreasing the rates of domestic
      and sexual violence against women employing: prevention, health education and treatment -
      within the context of health services and public policies.

      Methodology - Project Type: Research in Action A- Attention to women in a situation of
      domestic and sexual violence during climactery; B- Information/Education/Communication (IEC)
      C- Behavioral Intervention (IC) D- Institutional Development (DI). Target Populations: 1.
      Women (during the ages of 40 to 65 years) who were or are victims of domestic and/or sexual
      violence; 2. Professional/staff who work in services attending women in sexual and domestic
      violent situations (health professionals, policemen, civil society) in areas located within
      the South Regional Health Coordination - SRC. To collect information, a semi structured
      questionnaire will be employed during seven months in 2009.
    

Detailed description: 
      Trained professionals will work in the regions of: Campo Limpo, M'Boi Mirim, Santo Amaro and
      neighboring regions, neighborhood in which the Social Vulnerability Index of São Paulo (IPVS)
      shows high records.
    

Intervention name(s): Identifying experience with violence
Intervention type(s): Other
Intervention description(s): Asking about life experience with violence and Cognitive Behavior Therapy.
Other intervention name(s): Violence attention; Therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: domestic and sexual violence; menopause; professional improvement; social support network
Acute Dose Response of Korean White Ginseng in Metabolic Syndrome or Type 2 Diabetes
Condition: Type 2 Diabetes; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a Phase-I like double blind randomized placebo controlled crossover design
      trial. The objective is to assess the dose response relationship on glycemic and vascular
      effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in
      individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2
      Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria:
      as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will be
      recruited for the study.
    

Detailed description: 
      This study hypothesizes that KWG will dose dependently lower postprandial area under the
      curve compared to negative control, as well as will dose dependently decrease postprandial
      glycemia. It also assumes that use of KWG will dose dependently decrease aortic and brachial
      blood pressure, aortic augmentation index, and mean arterial pressure, and improve left
      ventricular ejection duration(ED) and subendocardial viability ratio (SEVR) compared to
      control. Finally, it expects to notice an effect on subjective satiety levels and have no
      significant adverse effects compared to control.
    

Intervention name(s): 1 gram of White Korean Ginseng; 3 grams of White Korean Ginseng; 6 grams of White Korean Ginseng; 3 grams of Wheat Bran Control; 500mg of Korean Red Ginseng
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 gram of White Korean Ginseng; 3 grams of White Korean Ginseng; 6 grams of White Korean Ginseng; 3 grams of Wheat Bran Control; 500mg of Korean Red Ginseng
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Korean White Ginseng; Type 2 diabetes; Metabolic syndrome
A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine the safety and weight loss when sibutramine is used
      in overweight and obese subjects.
    


Intervention name(s): sibutramine hydochloride monohydrate
Intervention type(s): Drug
Intervention description(s): 10 mg QD with the option to increase dose to 15 mg QD up until Week 4
Other intervention name(s): ABT-991; sibutramine; Meridia
Intervention MeSH terms: Sibutramine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sibutramine; Obesity
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      To assess and describe real-life treatment choices for rFⅧ contained regular
      prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China
      (2007-2013)
    


Intervention name(s): BAY14-2222_Kogenate-FS FVIII
Intervention type(s): Biological
Intervention description(s): Depends on Doctor's decision
Intervention MeSH terms: Factor VIII
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        About 300 at most hemophilia boys (2-<18 years) in the representative hemophilia treatment
        centers (HTCs) with available medical data record, having received rFVIII contained regular
        prophylaxis between Nov. 1st 2007 and May 31st 2013 will be enrolled from about 15 centers.
Avonex PEN Satisfaction and Patients Experience Clinical Trial
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is an open-label, multicenter, survey-based study to determine subject satisfaction with
      using the single-use autoinjector for the delivery of AVONEX PS. Enrollment will consist of
      200 subjects in a single cohort who have been prescribed AVONEX PEN in accord with its
      Product Monograph. All subjects must be experienced AVONEX PS users (i.e., using it for at
      least 12 weeks without any support person to help with the injections administered in the
      vastus lateralis) and enrolled in MS AllianceTM program (hereinafter, MS Alliance). The
      clinic nurse investigator will instruct the patient on the correct method of using AVONEX PEN
      and the first injection with Autoinjector, using the subject's own supply, will be completed
      in the clinic, with the clinic nurse investigator present. All further injections of AVONEX
      PEN will be self-administered at home. The subjects will complete the first set of
      questionnaires, including Subject Satisfaction Questionnaire, Ease of Use Grading Scale and
      the Autoinjector Instructions Grading Scale, within 10 minutes after the first injection at
      the clinic, and will be given another set of questionnaires to be completed at home within 10
      minutes following the last study injection 2 months later, provided the subjects still
      continue to self-administer their AVONEX PEN. The first set of questionnaires will be left
      with the clinic nurse investigator to be sent to the CRO by fax or e-mail, while the second
      set will need to be mailed to the CRO by study subjects using the provided self-addressed,
      postage-paid envelope.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple Sclerosis (MS) subjects between the ages of 18 and 65, inclusive, who have been
        treated with AVONEX® PS for at least 12 weeks prior to study entry.
      
Keywords: Patient Satisfaction; Multiple Sclerosis; Autoinjector; Avonex
Mechanisms of Disability in Peripheral Arterial Disease
Condition: Cardiovascular Diseases; Arterial Occlusive Diseases; Peripheral Vascular Diseases
MeSH terms: Cardiovascular Diseases; Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Arterial Occlusive Diseases
Study type: Observational

Summary: 
      To determine the mechanisms by which atherosclerotic peripheral artery disease (PAD) causes
      functional impairment and to define the degree to which peripheral artery disease associated
      pathophysiologic findings change over time.
    

Detailed description: 
      BACKGROUND:

      Research demonstrates that men and women with lower extremity peripheral arterial disease
      (PAD) have poorer functioning than men and women without PAD. Preliminary data also indicate
      that more severe PAD at baseline, as measured by the ankle brachial index (ABI), is
      associated with a greater incidence of functional loss. However, the pathophysiologic
      mechanisms in the lower extremities responsible for PAD-related functional impairment and
      functional loss are not well defined.

      DESIGN NARRATIVE:

      The study cohort will consist of 790 individuals identified from three Chicago-area medical
      centers, of whom 500 will have PAD. Participants will undergo a baseline and two annual
      follow-up visits. Pathophysiologic findings in the lower extremities refer to reduced muscle
      mass, reduced muscle quality, and reduced peripheral sensory and motor function. Quality of
      muscle tissue is defined as the ratio of muscle force to muscle mass. Muscle mass will be
      measured with Computed Tomography (CT). Peripheral nerve function will be determined using
      surface electroneurography (ENG). Lower extremity functional measures will consist of
      measures pertinent to functioning during daily living and include six minute walk distance,
      seven-day physical activity level (assessed by accelerometer), walking speed, balance tests,
      and lower extremity muscle power.

      The cross-sectional study will test the hypotheses that a) chronic lower extremity arterial
      ischemia is associated with specific pathophysiologic findings in lower extremity muscle and
      nerve and that b) these ischemia-related pathophysiologic findings are associated with lower
      extremity functional limitation.The longitudinal study will test the hypotheses that a)
      greater baseline lower extremity arterial ischemia as measured by ABI is associated with
      greater progression of pathophysiologic findings over two year follow-up and that b) greater
      ischemia-related pathophysiologic findings in the legs at baseline is associated with greater
      functional decline over two year follow up. Results will be used to develop interventions
      designed to improve lower extremity functioning and prevent functional decline in persons
      with PAD.
Diagnostic Value of Shear-Wave Elastography for Patellar Tendinopathy
Condition: Patellar Tendinopathy
MeSH terms: Tendinopathy
Study type: Observational

Summary: 
      To investigate the accuracy of shear-wave elastography (SWE) in diagnosing patellar
      tendinopathy in female volleyball and basketball players. In addition, we want to compare
      different parts of the patellar tendon and investigated the effects of different knee angles.
    


Intervention name(s): Shear-wave elastography
Intervention type(s): Diagnostic Test
Intervention description(s): Ultrasound shear-wave elastography
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        female athletes between the ages of 17-35 playing professional basketball or volleyball.
      
Keywords: Patellar tendinopathy; shear-wave elastography; ultrasound