bioihbjkbjnl/mcl2 huggingface dataset:
Neurodevelopmental Outcomes and Fluconazole Prophylaxis
Condition: Neurodevelopmental Outcomes
Study type: Observational

Summary: 
      The purpose of this study is to compare the neurodevelopmental outcome and quality of life
      between the fluconazole-treated and the placebo-treated patients that were enrolled in a
      fluconazole prophylaxis study that occurred in the investigators' neonatal intensive care
      unit (NICU) between 1998-2000.
    

Detailed description: 
      Invasive fungal infections in preterm infants is associated with significant morbidity and
      mortality. Mortality in infected infants < 1000 grams is between 26-66% and
      neurodevelopmental impairment occurs in 57%.1-13 Between 1998-2000 we conducted a randomized
      placebo controlled trial of fluconazole prophylaxis in 100 infants <1000 grams at
      birth(IRB-HSR #9389). Invasive fungal infections occurred in none of the fluconazole-treated
      patients compared to 20% of the placebo group. Following this study the efficacy has been
      confirmed in a multicenter randomized controlled trial and 7 retrospective studies. One major
      issue that has remained is whether the fluconazole-treated infants have better
      neurodevelopmental outcomes as well as if it is safe without an increase in
      neurodevelopmental impairment.

      Neurodevelopmental outcomes can be assessed by testing and examinations or by parental and
      child questionnaires. In addition, quality of life is an important context of outcomes.
      Recent conceptualizations of quality of life recognize the multidimensional nature of quality
      of life, including psychological and social functioning, consistent with the World Health
      Organization's definition of health as "not only the absence of disease and infirmity, but
      the presence of physical, mental, and social well-being." The World Health Organization
      subsequently emphasized the growing consensus that quality of life is a subjective
      experience, defined as "individuals' perceptions of their position in life in the context of
      the culture and value systems in which they live, and in relation to their goals,
      expectations, standards, and concerns."

      To address these issues, we aim to study and compare the neurodevelopmental outcome and
      quality of life between our fluconazole-treated and placebo-treated patients in our initial
      study
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Parents of subjects were interviewed and two surveys were obtained, the Child Health Questionnaire and the Vineland-II.
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects were born <1000 grams, treated in our NICU, and are now 7 to 10 years of age.
      
Keywords: fluconazole prophylaxis; fungal colonization; fungal infection; preterm infants; long term outcomes; quality of life
Clinical Evaluation of the OrthoPAT Advance System
Condition: Transmission, Blood, Recipient/Donor
Study type: Observational

Summary: 
      This study is intended to provide additional performance data of the OrthoPAT Advance in
      routine orthopedic surgery.
    

Detailed description: 
      The OrthoPAT Advance system is being developed by Haemonetics to change the user interface,
      especially for adding calculations for Estimating Blood Loss- (EBL). The OrthoPAT® serves as
      the predicate device. The following items will be changed in the OrthoPAT Advance system
      compared to OrthoPAT:

        -  Software & User Interface - ability to enter irrigant and anti-coagulant volumes and
           allow Estimated Blood Loss (EBL) calculation to be made by OrthoPAT Advance.

        -  Hardware -

             -  Redesign of reservoir and filter to process blood earlier by reducing hold-up
                volume and improve fluid visualization in reservoir.

             -  Extended battery life.

      It is not intended to validate the major changes in the OrthoPAT Advance device (reservoir /
      filter and EBL), which will be conducted as lab based tests. The correct functioning of the
      reservoir / filter and EBL changes will be confirmed in the clinical setting in this study.
      However the most rigorous challenge to the filter will be by presenting the worst case media
      and this can only be controlled in the laboratory.
    

Intervention name(s): OrthoPat Advance
Intervention type(s): Device
Intervention description(s): The device will be used initially in hysterectomy procedures. After a confirmation of product quality, the device will be used in routine orthopedic procedures.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects scheduled for hysterectomy or orthopediac procedures.
Dance Therapy and Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Title:

      The effect of dance-therapy on the functional capacity, body image and quality of life of
      patients with advanced obesity

      Project duration:

      33 months (August 2010 to June 2013)

      Clinical context:

      Obesity has reached epidemic proportions. The gait and balance problems in obese people and
      the associated decreased functional capacity and risk of falling highlight the need to
      evaluate the benefits of specific treatments on these problems. Attention should be paid not
      only to metabolic management but also to the physical rehabilitation required in cases of
      advanced obesity.

      Objectives:

      The aim of this study is to evaluate the efficacy of dance-therapy on functional capacity
      (walking ability, postural control and physical activity level), body image and quality of
      life of patients with advanced obesity.
    


Intervention name(s): Dance Therapy; patient education
Intervention type(s): Other; Other
Intervention description(s): overweight individuals participating in a patient education program for obese people combined with specific dance-therapy; overweight individuals participating in a patient education program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; dance; gait; balance; posture; dance therapy
Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in
      subjects with Type 2 diabetes taking liraglutide and metformin.
    


Intervention name(s): ITCA 650 Osmotic Mini Pump 20/60 mcg/day; ITCA 650 Osmotic Mini Pump 60 mcg/day; Metformin; Liraglutide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day; ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day; Stable dose for at least 3 months (at least 1000 mg/day); Stable dose for at least 3 months (at least 1.2 mg/day)
Intervention MeSH terms: Metformin; Liraglutide; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation Study on Corneal Lens for Vision Correction
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens,
      made of silicone commonly used in the contact lens industry, on healthy eye with or without
      astigmatism.
    


Intervention name(s): Astigmatic Correction Lens (Nexis ACCL lenses); Toric Soft Contact Lenses
Intervention type(s): Device; Device
Intervention description(s): Astigmatic refractive error correction; astigmatism correction using toric optics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Risk Factors Associated to Difficult-to-control Asthma
Condition: ASTHMA
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Several studies have demonstrated the efficacy of asthma treatment but despite being
      correctly diagnosed, conveniently prescribed and adherent to the therapeutics, 5% to 10% of
      asthmatics do not reach disease control.

      The aim of this study is to measure asthma control, evaluate inflammatory and functional
      characteristics, describe comorbidities and aggravating factors and phenotypes derived from
      the characteristics of a severe asthmatic population followed at an outpatient university
      service in Sao Paolo, Brazil.
    

Detailed description: 
      Study design: interventional

      Patients selection:

      Seventy-four severe asthma patients, aged between 18 and 65 years old were recruited from the
      outpatient clinics of the Pulmonary Division of the University of São Paolo Hospital.

      Severe asthma were defined according to GINA. Intervention: after 2 weeks screening period
      patients were treated with high inhaled corticosteroid dose plus long acting beta 2 agonist
      during 12 weeks plus oral corticosteroid ( prednisone 40 mg/day) during 2 weeks.

      Procedures ( baseline, after 2 weeks and 12 weeks): asthma control questionnaire (ACQ),
      asthma control (ACT) test, lung function test, quality of life questionnaire (SGRQ and
      SF-36), exhaled nitric oxide (FeNO), induced sputum (IS). After 12 weeks patients underwent
      the following evaluation: Upper Digestive Endoscopy, Esophageal 24hs pHmetry, High Resolution
      Chest Tomography, Nasoscope exam,Bronchofibroscopy with endobronchial biopsy.
    

Intervention name(s): inhaled corticosteroid plus LABA plus oral corticosteroid
Intervention type(s): Drug
Intervention description(s): formoterol plus budesonide 12/400mcg 2times/day and 6/200 mcg as needed and prednisone 40 mcg
Other intervention name(s): inhaled corticosteroid; LABA; oral corticosteroid
Intervention model: Single Group Assignment
Intervention model description: Retrospective analysis after treatment outcome (controlled vs. non controlled) based on the primary outcome; and post hoc analysis after oral steroid treatment based on pulmonary function reversibility
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SEVERE ASTHMA; RISK FACTORS; CHARACTERIZATION; CLINICAL CONTROL; INFLAMMATORY MARKERS; SEVERE; CONTROL
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
Condition: Uterine Fibroids; Abnormal Uterine Bleeding; Pelvic Pain; Adenomyosis
MeSH terms: Leiomyoma; Uterine Hemorrhage; Adenomyosis; Pelvic Pain
Study type: Interventional

Summary: 
      The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal
      cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice
      laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial
      comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by
      residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be
      randomized to either 2D versus 3D.
    

Detailed description: 
      This is a randomized single blinded controlled trial investigating 3D laparoscopy in the
      clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of
      novice surgeons in the simulation lab, there has been no reports to date investigating the
      role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D
      laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a
      scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D
      laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will
      compare the time to close the vaginal cuff comparing both systems.
    

Intervention name(s): Storz 3D Laparoscopy System; 2D Laparoscopy
Intervention type(s): Device; Device
Intervention description(s): The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.; The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Laparoscopy; 3D Visual System; Total Hysterectomy
Breast Study to Determine the Ability of Non-Invasive Optical Transillumination Spectroscopy to Predict Breast Density.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to learn more about the application of transillumination
      measurements in the determination of breast cancer risk. The goal is to demonstrate a
      correlation between non-invasive optical transillumination spectroscopy and parenchymal
      density pattern.
    

Detailed description: 
      X-ray generated images, such as mammograms, rely on the density of tissue within the breast.
      Tissue density are believed to be associated with proliferation of stroma and/or epithelium,
      which result in an increase in water associated light absorption and a decrease in lipid
      associated light absorption. The amount of density of the breast tissue has been shown to be
      an indicator of cancer risk. Thus, assessing this breast tissue density is also an important
      tool in determining breast cancer risk.

      Optical transillumination has been shown to give information about tissue composition and
      tissue density. Unlike x-ray mammography which uses ionizing radiation, optical
      transillumination uses normal white light and is deemed safe to be used frequently for women
      of all ages and therefore can be used for those situations where mammography is not an
      option.

      Normal white light is shone into the tissue and the light that leaves the breast on the other
      side from the source is detected and analyzed. Since the same physiological conditions that
      contribute to dense breast tissue, as seen in mammography, also will have unique optical
      signatures.

      We will compare the amount of this dense tissue from the mammogram, taken with 12 months, to
      the density measurements found through the optical procedure. The goal is to be able to
      duplicate the information from the mammogram using the transillumination technique. All
      measurements are non-invasive and no blood samples or biopsies are required.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Cohort recruited from the Marvelle Koffler Centre at Mount Sinai Hospital (Toronto,
        Ontario, Canada)
      
Keywords: Optical Transillumination Spectroscopy; Transillumination Breast Spectroscopy; Breast Cancer Risk
A Pilot Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
Condition: Bioequivalence
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study between two inhaler products of fixed dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder
    

Detailed description: 
      A bioequivalence study of a single dose of the fixed-dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder administered from Fluticasone
      propionate 250 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent
      Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 250/50 mcg inhalation powder/GSK
      (reference-R) in healthy volunteers under fasting conditions. The study will be one-center
      crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
    

Intervention name(s): Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent; ADVAIR DISKUS® 250/50
Intervention type(s): Drug; Drug
Intervention description(s): 2 inhalations of Test and Reference product in each study period; 2 inhalations of Test and Reference product in each study period
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: bioequivalence; fluticasone propionate; salmeterol xinafoate; ADVAIR
The Foot and Ankle Ability Measure (FAAM) is Translated From English to Turkish and Assess the Validity and Reliability in Athletic Population Who Have Foot and Ankle Disorders.
Condition: Ankle; Injury, Superficial, Multiple (With Foot)
MeSH terms: Ankle Injuries
Study type: Observational

Summary: 
      Sport activity induces a relevant risk for lower extremities especially ankle and foot
      structures. Athletes who participate in basketball, volleyball and soccer are predisposed.
      Self-reported outcome instruments have been used by clinicians to assess the treatment
      interventions effectiveness directed at patients with pathologies and identify impairments,
      disabilities and quality of life. The assessment of musculoskeletal injuries can be problem
      without clinical, radiological examination and on scores from patient-based questionnaires.
      The information from these questionnaires provides us good evidence if there is not
      interpretation of obtained scores. The Foot and Ankle Ability Measure (FAAM) is a
      self-reported outcome instrument for patients with foot and ankle disorders available in
      English, German, and French. The FAAM has a sports subscale and activity of daily living
      (ADL) subscale that can assess the activities that requires higher level. The aim of this
      study is to translate the FAAM into Turkish language, perform a cross-cultural adaptation,
      and investigate the reliability, validity of the translated version in athletic population
    


Intervention name(s): Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaire
Intervention type(s): Other
Intervention description(s): Self reported outcome instrument
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The professional Turkish-speaking athletes who foot and ankle disorders participate in this
        study.
      
Keywords: Self-reported outcome instrument; Sport; Ankle and foot; Injury
Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders
Condition: Personality Disorder, Borderline; Avoidant Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      This study intends to compare the effectiveness of schema therapy with standard psychiatric
      outpatient care for patients with borderline or avoidant personality disorder.
    


Intervention name(s): Schema Therapy; standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): group based schema therapy; standard psychiatric out-patient care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Is Effective Preoxygenation in Elderly Patients Related to Position?
Condition: Anesthesia Intubation Complication
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of the head-up position of 20 and 30
      degrees on the ETO2 reaching time of 85% and the desaturation time of 92% after intubation in
      elderly patients compared to the supine position.
    

Detailed description: 
      Patients will be randomized into 3 groups. The patients will lay in the supine position, in
      the control group and 20 and 30 degrees head up position in other two groups. Each patient
      will be preoxygenated with well fitting anaesthesia face mask with FiO2 of 100% at least 6L
      of flow until the ETO2 reaches concentration of 85%. The angle (20 or 30 degrees) formed by
      the patients' bodies (hips and feet parallel to the ground, lifting the back from the ground
      plane) with the ground will be measured with a spirit level, angle meter, and confirmed with
      a smartphone application. The time to reach ETO2 85% by starting preoxygenation in patients
      will be measured and recorded with a stopwatch. When the target is reached, anesthesia
      induction will be performed and the patients will be intubated. After the start of the
      intubation attempt, the stopwatch will be started again, after intubation, the patient will
      be ventilated with a balloon once and the location of the tube will be confirmed, the circuit
      will be separated and SpO2 will be expected to go down to the level of 92 % and recorded
      during this time.
    

Intervention name(s): Head up positioning during preoxygenation
Intervention type(s): Procedure
Intervention description(s): patients will be preoxygenated in head up position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: preoxygenation, elderly
Virtual Rehabilitation and PNF in the Recovery of the Motor Function Post Stroke
Condition: Stroke; Cerebrovascular Disorders
MeSH terms: Stroke; Cerebrovascular Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of use the Nintendo Wii® (NW) and
      therapeutic exercises by the method Proprioceptive Neuromuscular Facilitation (PNF) in the
      recovery of the motor function of poststroke hemiparesis patients.
    

Detailed description: 
      Randomised clinical trial (RCT) will be held in following the recommendations of the CONSORT
      (Consolidated Standards of Reporting Trials). This RCT have longitudinal and prospective
      feature, held at the Neurosciences Clinic located at the Clinic Professor Francisco Magalhães
      Neto the HUPES Complex / Federal University of Bahia from June 2015 until June 2016.

      In the initial evaluation were obtained by a trained examiner and blinded to the allocation
      of participants, all personal data of all patients, as well as evaluations of balance and
      quality of life through specific validated scales:

      1. Fugl Meyer scale (FMS);

      The investigators employ an experimental program of therapeutic exercises for the PNF method
      and virtual rehabilitation with NW, for a period of two months, with sessions two times a
      week for 50 minutes (a total of 16 sessions).
    

Intervention name(s): Virtual Rehabilitation; PNF Method; Virtual Rehabilitation and PNF Method
Intervention type(s): Other; Other; Other
Intervention description(s): It is the use of the NW games for rehabilitation of balance in post-stroke patients.; It is the use of the therapeutic exercises based on the PNF diagonals for rehabilitation of balance in post-stroke patients.; It is the use of the exercises based on the PNF diagonals and of the NW for rehabilitation of balance in post-stroke patients.
Other intervention name(s): NW Wii-rehabilitation Commercial Game; Kabat method Diagonals of PNF; Kabat method Wii-rehabilitation Commercial Game Diagonals of PNF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment