bioihbjkbjnl/mcl2 huggingface dataset:
Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients
Condition: Fractures
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      This studies investigates the hypothesis that bedside ultrasound is as accurate as plain
      x-rays for diagnosing clavicle fractures in children in a pediatric emergency department.
      Children with shoulder injuries are enrolled and receive both an ultrasound imaging
      (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or
      better)accuracy, with less cost, time, and radiation.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children age 1-18 years presenting to a tertiary center pediatric emergency department
        complaining of recent traumatic shoulder injury.
      
Keywords: Clavicle; Fracture; Ultrasound; Radiation
A Study for Participants With Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in
      treating adults with major depressive disorder.
    


Intervention name(s): LY2216684; Placebo; Escitalopram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3-mg and 6-mg tablets; 10-mg capsules
Other intervention name(s): Edivoxetine; Lexapro®; Cipralex®
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Echocardiographic Findings in Infants of Diabetic Mothers and Its Relation to Maternal Glycemic Control
Condition: Infant of Diabetic Mother
MeSH terms: Fetal Diseases; Pregnancy in Diabetics
Study type: Observational

Summary: 
      The aim of this work was to:

        1. Evaluate the use of echocardiography in the assessment of hemodynamic stability in
           newborns.

        2. Determine the prevalence of congenital heart diseases or any cardiac abnormalities in
           infants born to diabetic mother in relation to the glycemic control of their mothers
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study was conducted on 50 neonates admitted to the neonatal intensive care unit in
        Alexandria University Children's Hospital.

        This study included two groups:

        Group Ι: Include 25 neonates born to diabetic mother Group II: Include 25 neonates born to
        non-diabetic mothers as a control group (reference group).
Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro Compared to Twice-Daily Dosing of Ciloxan Ear Drops in Patients With Acute External Otitis
Condition: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis
MeSH terms: Otitis; Ear Diseases; Otitis Externa; Otorhinolaryngologic Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro (0.3%
      Ciprofloxacin Otic Foam), used once-daily for 7 days for the treatment of Acute Diffuse
      Otitis Externa, compared to commercial ear drops used twice daily for 7 days.
    

Detailed description: 
      Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal,
      which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common
      infections encountered by otolaryngologists, pediatricians and family physicians. Diagnosis
      of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal
      inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes
      accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C)
      diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge.
    

Intervention name(s): 0.3% Ciprofloxacin Ear Drops; FoamOtic Cipro
Intervention type(s): Drug; Drug
Intervention description(s): 4 gtt b.i.d. for 7 days.; 0.3% Ciprofloxacin Otic Foam, 1 application, q.d. for 7 days
Other intervention name(s): Ciloxan; Ciprofloxacin; Cipro; Ciprofloxacin; Cipro
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: swimmer's ear; ear drops; ear foam; otic foam; ear infection; ear pain; ear inflammation
Gut Microbiome Mediated Effects of Inulin Supplementation on Mineral and Bone Metabolism in Hemodialysis Patients
Condition: Bone Diseases, Endocrine; Nutritional and Metabolic Diseases
MeSH terms: Bone Diseases; Bone Diseases, Endocrine; Metabolic Diseases; Endocrine System Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall objective of the study is to examine the changes within the gut microbiome after
      the supplementation of inulin and its effect on markers of mineral metabolism and bone
      turnover.
    

Detailed description: 
      In this randomized controlled cross-over study, twenty HD patients (10 male/10 female, aged
      20-80) will be recruited from local dialysis clinics in Champaign-Urbana, IL. After baseline
      testing, patients will be randomized to the intervention group or placebo group
      (maltodextrin). Patients will consume inulin (females 10g/day, males 15g/day) or maltodextrin
      (females 10g/day, males 15g/day) for one month, rest for two weeks (washout period), and
      continue with the other treatment (either inulin or maltodextrin) for another month. Outcomes
      will be assessed at the beginning of each period and after a month of supplementation at both
      periods.
    

Intervention name(s): Inulin; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Females will ingest 2 doses of 5g/inulin for a total of 10g/inulin/day for four weeks Males will ingest 2 doses of 7.5g/inulin for a total of 15g/inulin/day for four weeks; Females will ingest 2 doses of 5g/maltodextrin for a total of 10g/maltodextrin/day for four weeks Males will ingest 2 doses of 7.5g/maltodextrin for a total of 15g/maltodextrin/day for four weeks
Other intervention name(s): Inulin-type fructans
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: inulin-type fructans; hemodialysis; gut microbiome; mineral and bone disorder
The Power of Hand Reflexology in Ameliorating Anxiety, Pain, and Fatigue Among Patients Undergoing Coronary Angiography
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Reflexology influences pain perception and pain-impulse transmission by releasing endorphins
      (12). Patients with a variety of medical illnesses can benefit from hand reflexology by
      lessening their physical and emotional discomfort (13, 14). Therefore, this study was done to
      investigate the power of hand reflexology in ameliorating anxiety, pain, and fatigue among
      patients undergoing coronary angiography
    


Intervention name(s): Hand Reflexology
Intervention type(s): Behavioral
Intervention description(s): Reflexology is a well-known, safe, and noninvasive alternative medicine technique. It alludes to a treatment that is applied to particular areas of the hands and feet. The compression on the hands or feet serves as a sensor linked to particular body areas. These sensors are activated by the reflexology technique to improve blood flow, energize, relax, and maintain homeostasis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
Condition: Acute Coronary Syndromes
MeSH terms: Atrial Fibrillation; Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist
      given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial
      fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in
      the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors
      (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a
      comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K
      antagonist, such as warfarin, with or without aspirin.
    

Detailed description: 
      Patients will be recruited from either inpatient coronary care or general medical units, or
      recruited from outpatient cardiology offices.

      Masking:

      Apixaban: Open label.

      VKA: Open label.

      Acetylsalicylic acid film coated tablet: Double Blinded.

      Placebo matching Acetylsalicylic acid film coated tablet: Double Blinded.
    

Intervention name(s): Apixaban; vitamin K antagonist; Acetylsalicylic acid; Acetylsalicylic acid placebo
Intervention type(s): Drug; Drug; Drug; Other
Other intervention name(s): BMS-562247; Aspirin 81 mg; aspirin placebo
Intervention MeSH terms: Aspirin; Vitamin K; Apixaban
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Icotinib is at least non-inferior to
      Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one
      or two chemotherapies.
    

Detailed description: 
      Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence
      rate increase during the past 30 years . It is the leading cause of death of cancer in man
      and 2nd in women. With the development of gefitinib and erlotinib, EGFR-TKI (epidermal growth
      factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for
      the treatment of these patients in recent years, especially for NSCLC patients in Asia
      including China. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and
      clinician. It appears to be at least as good as gefitinib in terms of efficacy and better in
      terms of safety in phase I/II trials. In this study, a randomized, double-blind, gefitinib as
      control, multi-center phase III trial was designed to evaluate the safety and efficacy of
      icotinib in the treatment of advanced NSCLC patients after failure of 1 or 2 chemotherapy.
      PFS (progress free survival) is the primary end-point with OS (overall survival), ORR
      (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point. A
      total of 400 patients will be recruited. EGFR and K-ras gene mutational analysis as well as a
      population PK study have also been proposed.
    

Intervention name(s): Icotinib; Gefitinib
Intervention type(s): Drug; Drug
Intervention description(s): 125 mg three times daily (375 mg per day) by mouth; 250 mg every 24 hours by mouth
Other intervention name(s): BPI-2009; Conmana; ZD1839; Iressa
Intervention MeSH terms: Gefitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Efficacy; Safety; EGFR-TKI; phase III; NSCLC
Polyphenols and Overfeeding
Condition: Overfeeding
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Obesity is a complex and multifactorial disease representing a major public health challenge.
      Indeed, overweight and obese people carry a major risk of developing insulin resistance and
      type 2 diabetes mellitus. It has been demonstrated that polyphenols could be used to
      counteract some of the mechanisms involved in the generation of insulin resistance. The model
      of overfeeding represents a very good study model of the metabolic complications of obesity,
      since it has been shown to induce a transient state of insulin resistance in the human.

      The purpose of this research is to study the effects of a overfeeding (+50% of daily caloric
      needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on
      insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on
      post prandial partitioning of exogenous lipids after a test meal.

      During 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola
      in addition to their usual diet and will be supplemented with 2g of grape polyphenols extract
      or with placebo.
    


Intervention name(s): 2g of grape polyphenol extract; Dietary Supplement: 2g of placebo (lactose)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding.; Men will have to consume daily 2g of placebo during the 31 days of overfeeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Overfeeding; Fat distribution; Subcutaneous and visceral adipose tissue; Insulin sensitivity; Insulin resistance; Peripheral and hepatic insulin sensitivity; Stable isotopes; Lipid oxidation; Energy expenditure; Muscle and subcutaneous adipose tissue gene expression
The Association of Ferrtin and Homocysteine Etc. With RI and MS in Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to study the association of serum ferritin and homocysteine
      levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome
      The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women
      with reproductive age. Insulin resistance and metabolic disturbance are well-known long-term
      consequence of women with PCOS. Recent evidence suggests that increased body iron might be
      involved in the pathogenesis of insulin-resistance disorders, furthermore,
      hyperhomocysteinemia is associated with an increased risk of atherosclerotic and
      thromboembolic disorder. The investigators plan to retrospectively review the medical records
      of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical
      Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Female patients who had been performed with fully PCOS-related survey Who visited the
        Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical
        University from Jan 1, 2008, to November 30, 2011.
      
Keywords: PCOS; Ferritin; Homocysteine; Insulin Resistance; Metabolic Syndrome
Survivorship of the Press Fit Condylar (P.F.C.) Sigma Fixed Bearing Knee With a Cobalt Chrome Tibial Tray
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      The study will determine the survivorship of the fixed bearing P.F.C. Sigma knee with a
      cobalt chrome tibial tray at 5 years.
    

Detailed description: 
      The primary objective of this study is to assess the survivorship of the P.F.C. fixed bearing
      knee system using a cobalt chrome tibial tray and moderately cross-linked polyethylene insert
      at 5-Years. The secondary objectives of this investigation are to evaluate additional
      clinical outcomes to provide further information on the performance of the P.F.C. fixed
      bearing knee system using a moderately cross-linked polyethylene insert and cobalt chrome
      tibial tray. These outcomes will include Radiographic assessment, American Knee Society
      Score, Oxford Knee Score and SF-12.
    

Intervention name(s): P.F.C. Sigma Knee
Intervention type(s): Device
Intervention description(s): Orthopaedic implant for primary total knee replacement with a cobalt-chrome tibial tray and a moderately cross-linked polyethylene tibial insert
Keywords: Arthroplasty, Replacement, Knee, TKR, PFC Sigma
Diagnostic Test of Choice for HELPS Syndrome
Condition: HELPS Syndrome
MeSH terms: Syndrome
Study type: Observational

Summary: 
      Our team recently described a new medical condition called HELPS
      (Hemi-Laryngo-Pharyngeal-Spasm) syndrome(1). HELPS syndrome is a condition caused by a blood
      vessel pinching the nerve rootlets of the Vagus nerve (Xth cranial nerve). It is similar to
      the well recognized hemifacial spasm syndrome but the nerve involved is the Vagus instead of
      the Facial nerve. As a result, the symptoms are episodic throat contractions and cough. The
      throat contractions become stronger and more frequent over the years and can lead to a
      terrifying inability to breath. Patients may end up intubated in the Emergency Department or
      with a tracheostomy because of inability to breath during a severe episode. Some but not all
      of our patients can tell which side of their throat (left or right) contracts during a
      choking episode. In between these choking episodes, patients feel normal. A surgical cure for
      these patients is Microvascular Decompression of the Xth nerve.
    

Detailed description: 
      The treatment of HELPS syndrome begins with the correct diagnosis. Some patients are able to
      localize the side of their symptoms in HELPS syndrome while others are unable to. The purpose
      of this study is to prospectively study which of the following is the diagnostic test of
      choice for patients who are unable to localize their HELPS: 1. CISS MRI sequences, 2.
      interictal laryngoscopy, and 3. unilateral and contralateral Botox injections separated
      3-months apart.

      Both neuroradiologist and otolaryngologist will be blinded to the outcome of surgery and be
      asked "based on your diagnostic test, which side do you believe we should perform MVD
      surgery?"
    

Intervention name(s): Pre-Operative CISS-MRI Sequences; Pre-Operative Interictal Laryngoscopy; Pre-Operative Unilateral and Contralateral Botox
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Compare pre-operative MRI diagnosis to intra-operative findings on if both are in agreement; Compare pre-operative laryngoscopy diagnosis to intra-operative findings on if both are in agreement; Compare pre-operative diagnosis using Botox to intra-operative findings on if both are in agreement
Other intervention name(s): Injections spaced 3-months apart
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HELPS (Hemi-Laryngo-Pharyngeal Spasm) Syndrome

        -Subgroup of patients who are unable to localize lateralization of throat contractions
      
Keywords: microvascular decompression, Xth nerve
Study to Investigate the Immune Response and Safety of Prophylactic Vaccines in Patients Treated for Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The aim of this study is to determine whether prophylactic vaccines recommended are effective
      and safe in patients with multiple sclerosis(MS) under MS-specific therapy.
    

Detailed description: 
      Protective vaccines against communicable diseases are of major importance in patients with
      autoimmune diseases or impaired immune response. In patients with multiple sclerosis
      bacterial or viral infections may lead to disease progression and vaccines can protect from
      these infections and prevent disease progression. Fear of possible side effects of vaccines
      have led to a general restraint regarding vaccination of patients with MS. However, previous
      studies have not shown an increased risk of disease progression following Hepatitis B
      vaccination and even a reduced progression rate in relapsing-remitting MS after
      tetanus/diphtheria vaccination.

      Various disease modifying treatments (DMT) are available for MS, most of these therapies lead
      to an impairment of the immune system affecting the immune response to vaccination.
      Additionally, live attenuated vaccines may lead to severe side-effects if used in patients
      under DMT treatment. Testing immune response after vaccination may be prudent in subjects
      undergoing DMT to assure vaccination success since only a limited number of studies have
      investigated immune response after vaccination in patients with MS undergoing DMT.
    

Intervention name(s): prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal)
Intervention type(s): Biological
Intervention description(s): Publically recommended protective vaccines in MS patients, vaccination applied according to the manufacturers description
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        relapsing remitting multiple sclerosis
      
Biospecimen description: 
      Serum sample
    
Keywords: Vaccine; Antibody response; relaps rate; expanded disability status scale
Mental Practice in Chronic, Stroke Induced Hemiparesis
Condition: Hemiparesis
MeSH terms: Paresis
Study type: Interventional

Summary: 
      Stroke is the leading cause of disability in the United States, producing motor impairments
      that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is
      particularly disabling, is the primary impairment underlying stroke-related disability, and
      the most frequent impairment treated by therapists in the United States. This study will test
      efficacy of a promising technique in reducing arm disability and increasing function, thereby
      improving outcomes and health, reducing care costs, for community dwelling patients with
      stroke-induced hemiparesis.
    


Intervention name(s): Mental Practice Group; Active Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients are administered rehabilitative therapy targeting their affected arms on 3 days/week during a ten week period. Directly after the therapy session, they participate in targeted mental practice session in which they cognitively rehearse the movement that they just physically practiced.; Individuals assigned to this group are administrated rehabilitative therapy targeting their affected arms in half four increments, occurring 3 days/week for 10 weeks. They also are administered an intervention in which they listen to a relaxation tape and/or tapes in which they receive instructions on exercises and information on stroke care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mental practice group; Active control group