bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality
Condition: Lenses; Intraocular Sensitivity; Visual Acuity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The WHO, states that age related cataracts account for 51 percent of worldwide blindness and
      affect about 20 million people. Surgery with intraocular lens (IOL) implantation is the first
      line treatment for cataracts, thus there is an on going effort to improve IOL design and
      performance.

      It is planned to compare three different IOL designs in a psychophysical test setting. Most
      IOL testing is done in 2D scenarios such as Early Treatment Diabetic Retinopathy Study
      (ETDRS) visual acuity or contrast sensitivity testing. The use of 3D scenario would allow
      testing a more real-life situation.

      As various downsides of different IOL designs have been reported, testing of IOLs before
      surgical implantation is a promising approach to maximise patient satisfaction. Known
      deficiencies include amongst others reduced contrast sensitivity or light intensity.

      To test three different IOL designs, it is planned to have 2D healthy young subjects look
      through a stable, table mounted spectacle frame, in which the different IOLs can be inserted.
      This allows for subjective testing of IOL's in a 2D and 3D scenario.
    


Intervention name(s): Cyclopentolatehydrochloride 0,5% eye drops
Intervention type(s): Drug
Intervention description(s): 1 drop in study eye
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: IOL
"Effects of Neuromuscular Blocking Agents on End Expiratory Lung Volume During Moderate-severe ARDS"
Condition: ARDS; Neuromuscular Blockade
Study type: Observational

Summary: 
      This is a monocentric, prospective, observational study that will be conducted in the general
      ICU of San Gerardo Hospital (Monza, Italy). Study protocol will be started when NMBAs
      infusion will be stopped for clinical reason until regain of spontaneous breathing activity.

      Patients will be enrolled at the moment of NMBAs infusion interruption ("baseline" phase).
      Clinical data will be collected: hemodynamics, ventilation parameters and respiratory
      mechanics, arterial blood gas analysis, drugs used for sedation and their dosages. An EIT
      belt will be positioned around the patient's chest when clinical signs of spontaneous
      breathing activity will be detectable (unstable flow curve on the ventilator, deflection in
      airway pressure during an expiratory pause). In this phase ("NMBA interruption") same
      clinical data will be collected as at baseline. Patients will be ventilated in the same
      ventilation mode as before (Volume Controlled mechanical ventilation), but the inspiratory
      trigger on the ventilator will be turned on to reduce patient-ventilator asynchronies. When
      an EIT trace lasting at least 10 minutes will be recorded, an NMBA bolus (as prescribed by
      the treating physician) will be administered and a continuous infusion will be restarted.
      Clinical data will be collected again in this phase ("NMBA restart").
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with moderate-severe ARDS (according to Berlin definition) needing NMBAs
        administration will be included
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)
Condition: NAFLD; Alcohol-Related Disorder; Liver Fibrosis
MeSH terms: Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis; Alcohol-Related Disorders
Study type: Interventional

Summary: 
      The main objective is to determine the performance of the simple eLIFT blood test for
      advanced liver fibrosis screening in NAFLD and/or alcoholic patients in primary care.
    

Detailed description: 
      eLIFT, is a new blood fibrosis test specifically dedicated for general practitioners with
      simple parameters and easy "by head" calculation. Using the recommended cut-offs (eLIFT ≥8),
      eLIFT sensitivity was 86%. This result position eLIFT an as interesting tool for the
      screening of advanced liver fibrosis in large populations.

      As our preliminary results come from very selected patients, i.e. patients from tertiary
      centres who underwent a liver biopsy, we now need to evaluate in the real condition of
      primary care setting whether the use of eLIFT will help general practitioners to screen
      advanced liver fibrosis in their asymptomatic NAFLD and alcoholic patients.
    

Intervention name(s): e-LIFT
Intervention type(s): Diagnostic Test
Intervention description(s): Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and < 15 kPa)
Intervention model: Single Group Assignment
Intervention model description: prospective diagnostic study in primary care. Evaluation of a simple blood test (e-LIFT) for the diagnosis of advanced liver fibrosis.
Reference for advanced liver diagnosis : composite criteria :
Elastometry between 8 kPa and 15 kPa and histologic evaluation of fibrosis ≥ F3 (NASH CRN ) OR
Elastometry ≥ 15 kPa
Masking: None (Open Label)
Primary purpose: Diagnostic
A Prospective Randomized Study for Comparison of Y-Composite Grafts
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose of this study is to compare early and 1-year graft patency rates of saphenous
      vein composite grafts with those of right internal thoracic artery composite graft and
      mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass
      grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no
      touch technique and used as composite graft.
    

Detailed description: 
      The SAVERITA trial was designed as a randomized, controlled trial to recruit 224 patients who
      undergo off-pump coronary artery bypass using Y-composite graft based on the left internal
      thoracic artery. Patients were randomized by use of a randomization table. Composite conduit
      was made using saphenous vein or right internal thoracic artery according to the
      randomization result. The primary end point is to evaluate early and 1-year postoperative
      graft patency. The secondary end points are overall survival, freedom from cardiac death and
      freedom from MACCE(major adverse cardiac or cerebrovascular events). In saphenous vein group,
      20 remnant saphenous vein specimen was evaluated histologically to compare the difference
      between composite grafted vein and manually dilated saphenous vein.
    

Intervention name(s): saphenous vein composite grafting; right internal thoracic artery composite grafting
Intervention type(s): Procedure; Procedure
Intervention description(s): use saphenous vein as a composite graft connected to the left internal thoracic artery; right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery
Other intervention name(s): SAVERITA SVG; SAVERITA RITA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: coronary artery bypass; off-pump surgery; composite graft; saphenous vein; internal thoracic artery
The Use of Virtual Reality Goggles
Condition: Dental Anxiety
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate the effectiveness of virtual-reality
      audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old
      dental patients receiving routine dental care in an outpatient clinical setting.
    

Detailed description: 
      All appointments will take place at the College of Dentistry Department of Pediatric
      Dentistry. The first day's appointment will consist of clinically-indicated cleaning,
      radiographs and treatment planning. Toward the end of the first appointment, the participant
      will wear the virtual reality goggles for 5 minutes, in order to become familiar with the
      device. During these 5 minutes, fluoride varnish will be applied. The application of the
      varnish would occur whether the participant is in the research or not.

      At the second or third appointments, the goggles will be randomly used during the restorative
      treatment. Whether the participant uses the goggles at the second or third visit will be
      determined purely by chance, like flipping a coin. No nitrous oxide will be used, but local
      anesthesia will still be administered as standard. The participant will use a 1-10 scale at
      the end of each appointment to rate pain levels, and a research team member(the dental
      assistant) will assign a 1-4 scale value for behavior. The 1-10 scale will consist of the
      Wong-Baker Faces Pain Scale.
    

Intervention name(s): Virtual reality goggles
Intervention type(s): Device
Intervention description(s): Patients will act as their own control over two different dental appointments. One appointment will consist of wearing the virtual reality googles, the other appointment will be conducted without them. The goggles have a small screen inside of them along with headphones. This device will play an a movie or cartoon that will immerse the patient during treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Nab-Paclitaxel in Combination With Carboplatin as First-line Therapy in Patients With NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      This is a single-arm non-interventional study (NIS) to evaluate the effectiveness, safety and
      quality of life (QoL) in patients with advanced NSCLC receiving the combination of
      nab-paclitaxel and carboplatin as first line palliative therapy in a real life setting.
    

Detailed description: 
      The present NIS is designed to provide additional knowledge in terms of effectiveness, safety
      and quality of life in routine administration of the combination of nab-paclitaxel
      (Abraxane®) and carboplatin as first line treatment for adult patients with locally advanced
      or metastatic non-small cell lung cancer (NSCLC) who are not candidates for potentially
      curative surgery and / or radiation therapy. The combination of Abraxane® and carboplatin has
      been approved in Europe in March 2015 based on results from a pivotal randomized, open label
      phase III study with 1,052 patients.
    

Intervention name(s): Nab-Paclitaxel; Carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): Nab-Paclitaxel will be administered in accordance with the SmPC of Nab-Paclitaxel.; Carboplatin will be administered as combination partner of Nab-Paclitaxel in accordance with SmPC of Nab-Paclitaxel.
Other intervention name(s): Abraxane
Intervention MeSH terms: Paclitaxel; Carboplatin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with locally advanced / metastatic NSCLC who are not candidates for
        potentially curative surgery and / or radiation therapy
      
Keywords: metastatic; locally advanced; unresectable; NSCLC
The Dose Effect of Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The shock wave is a new and potential intervention for the reinnervation of peripheral nerve.
      The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy
      on carpal tunnel syndrome.
    

Detailed description: 
      The investigator perform a prospective randomized, single-blinded study to investigate the
      dose effect of ESWT in patients with carpal tunnel syndrome.

      The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week
      after the treatment.
    

Intervention name(s): ESWT
Intervention type(s): Device
Intervention description(s): Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is assess the safety and bioequivalence of a single oral dose of
      carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa
      combination plus a single oral dose of entacapone under fasting conditions in healthy
      volunteers.
    


Intervention name(s): ELC200 (carbidopa+levodopa+entacapone)
Intervention type(s): Drug
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone; Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; bioavailability; carbidopa; levodopa; entacapone; fasting condition; Healthy volunteers study
An 8-Week Refractory Chronic Cough Study (MK-7264-021)
Condition: Refractory Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant
      (AF-219) in participants with refractory chronic cough.
    


Intervention name(s): Gefapixant; Placebo (for gefapixant)
Intervention type(s): Drug; Drug
Intervention description(s): Gefapixant tablets administered by mouth twice daily for 8 weeks; Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks
Other intervention name(s): AF-219; MK-7264
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immune memory induced by primary and booster
      vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through
      evaluation of the immune responses following vaccination with a booster dose of pneumococcal
      conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses
      following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in
      age-matched unprimed children.

      The study also aims to assess the antibody persistence in the fourth year of life following
      primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first
      year of life.

      The study is also designed to evaluate the immunogenicity in terms of antibody response and
      the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse
      events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the
      fourth year of life.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = 00307034)
    


Intervention name(s): Pneumococcal conjugate vaccine GSK1024850A; Pneumococcal conjugate vaccine GSK1024850A
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 1 dose; Intramuscular injection, 2 doses
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal vaccine; Pneumococcal disease; Safety; Immunogenicity
A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This an initial proof of concept, phase to study to assess the safety and efficacy of
      tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary
      Disease
    


Intervention name(s): tofimilast
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Comparison of the Effect of Ondansetron and Combined Ondansetron and Betahistine on Postoperative Nausea and Vomiting After Gynecological Laparoscopy
Condition: Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      Many patients undergoing gynecologic laparoscopic surgery experience postoperative nausea and
      vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists such as
      ondansetron. Involvement of multiple types of receptors and factors may be a reason for
      inadequate control of PONV with a single agent. Betahistine, a histamine antagonist at H1
      receptor and antagonist at H3 receptor, is widely used as a treatment of dizziness. Dizziness
      is one of the cause of nausea and vomiting. This study is to compare the effects of
      ondansetron and combined ondansetron and betahistine in preventing PONV in high-risk patients
      receiving intravenous opioid-based patient-controlled analgesia (IV-PCA) after gynecological
      laparoscopic surgery.
    


Intervention name(s): ondansetron; ondansetron-betahistine
Intervention type(s): Drug; Drug
Intervention description(s): The ondansetron group is given placebo (pyridoxin) instead of betahistine.
The ondansetron group is given ondansetron 4 mg bolus at the end of surgery and ondansetron 8 mg added to the IV-PCA.; The ondansetron-betahistine group is given betahistine 18mg orally in the morning of surgery and postoperative day 1.
The ondansetron-betahistine group is given ondansetron 4 mg bolus at the end of surgery and ondansetron 8 mg added to the IV-PCA.
Intervention MeSH terms: Betahistine; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities in Free-living Conditions (eMouve2)
Condition: The Focus of the Study Was to Estimate Energy Expenditure Thanks to Accelerometry Data Collected by a Smartphone.
Study type: Interventional

Summary: 
      The aim of this study was to validate functions for estimating energy expenditure in
      free-living conditions. This method was based on accelerometry data acquired from a
      smartphone worn in a trouser pocket. The developed functions have been compared to the
      estimations provided by two research devices named Armband and Actiheart.
    

Detailed description: 
      There is a growing interest in evaluating physical activity and energy expenditure (EE) to
      provide feedback to the user. The use of mass-market sensors such as accelerometers offers a
      promising solution for the general public due to the growing smartphone market over the last
      decade.

      Thus, the proposed EE estimation function has been created using accelerometry data collected
      from 10 volunteers equipped with a smartphone and two research sensors (Armband and
      Actiheart) used to estimate EE during several controlled activities. The research sensors'
      data serves as reference during the creation and evaluation of the proposed function.

      It has been evaluated with data of 6 other volunteers in free-living conditions in the
      previous eMouve project.

      eMouve2 consists in acquiring more data from 24 new volunteers in order to validate the
      function in free-living conditions.

      This EE estimation function using the smartphone technology is dedicated to light- and
      moderate-intensity activities, and we believe it can be a new way to help people controlling
      their daily physical activity level.
    

Intervention name(s): Energy expenditure estimation
Intervention type(s): Device
Intervention description(s): Volunteers were asked to wear sensors during about 12 hours, one day. They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle
      stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f®
      RFF.
    

Detailed description: 
      Comparison of the clinical pregnancy rate in the AFOLIA group compared to the US approved
      Gonal-f® RFF Redi-ject group as the primary endpoint. Comparison of the number and size of
      follicles, the number of cycle cancellation, the hormone parameters and adverse events in the
      AFOLIA group compared to the Gonal-f® RFF group as secondary endpoints.
    

Intervention name(s): AFOLIA; Gonal-f® RFF
Intervention type(s): Drug; Drug
Intervention description(s): 225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached; 225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached
Other intervention name(s): Follitropin-alfa; Follitropin-alfa
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IVF; In vitro fertilization; Controlled ovarian stimulation; Follitropin; AFOLIA; Finox