bioihbjkbjnl/mcl2 huggingface dataset:
Central Versus Peripheral Air Injection for DALK (Deep Anterior Lamellar Keratoplasty)
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      Different techniques of deep anterior lamellar keratoplasty (DALK) have been introduced to
      create a uniform recipient bed, thereby reducing complications, such as interface
      irregularity and opacification encountered with conventional lamellar keratoplasty. The
      big-bubble technique provides a planned, safe, quick and consistent baring of Descemet
      membrane (DM) by injection of air deep into the stroma. Nevertheless, this technique has a
      long learning curve with a low success rate of big-bubble formation and a high rate of DM
      perforation when performed by surgeons in training. Different modifications to the original
      technique using intraoperative instruments such as corneal pachymetry, anterior segment
      optical coherence tomography (OCT), and femtosecond laser, have been used to increase the
      chances of achieving a successful DM detachment from the deep stroma by air injection. Even
      with these innovations, the rate of successful big-bubble formation did not reach 100%.
      Recently, the investigators described a modification to the original big-bubble DALK in which
      a 27-gauge needle was inserted into the stroma peripherally from the trephination site
      towards the limbus. The investigators found that air injection peripheral to the trephination
      can effectively and reproducibly separate the corneal stroma from the Descemet membrane (DM).
      This study was aimed to compare the success rate and complications of big-bubble DALK using
      central versus peripheral air injection performed by senior cornea fellows under the
      supervision of an experienced faculty member in an academic hospital.
    


Intervention name(s): Central air injection; Peripheral air injection
Intervention type(s): Procedure; Procedure
Intervention description(s): Air was injected inside the trephination site in the central injection group.; Air was injected at the corneal periphery outside the trephination site.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: deep anterior lamellar keratoplasty; big-bubble technique; peripheral air injection; keratoconus
Study of NXN 188 for the Treatment of Migraine With Aura
Condition: Migraine With Aura
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Interventional
Phase: Phase 2

Summary: 
      NXN-188 Dihydrochloride is being developed as an immediate release oral product for the
      treatment of acute migraine. This study is being conducted to evaluate NXN-188 in subjects
      with a migraine history of aura.
    

Detailed description: 
      This was a multicenter, double-blind, parallel group, active and placebo-controlled, three
      arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache with
      aura.

      After study eligibility was confirmed, subjects were randomized to NXN-188 600 mg,
      sumatriptan 100 mg, or placebo in a 1:1:1 ratio. Subjects left the clinic to self-administer
      the treatment at home at the onset of moderate to severe headache in a suitable dosing
      environment.

      Treatment was not to exceed 42 days from Randomization. If the subject did not have a
      headache within 42 days of randomization (s)he did not take the study medication and returned
      it to the site. If the subject experienced a qualifying headache (s)he recorded the symptoms
      in a diary, dosed with the study drug, and called the IVRS to record assessments all adverse
      events and to report dosing. If the study drug provided insufficient relief 2 hours post
      dosing (s)he was permitted to use non-triptan rescue medication recommended by the
      investigator.
    

Intervention name(s): NXN-188; placebo; sumatriptan succinate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NXN-188 hard gelatin capsules, 600 mg administered as three 200 mg capsules; administered as 3 placebo hard gelatin capsules; administered in a hard gelatin capsule with 2 capsules of placebo
Other intervention name(s): NXN-188 dihydrochloride; placebo capsules
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine; aura
Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317)
Condition: Chikungunya
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 parallel-group age- and gender-matched open label study in healthy adults
      18-65 years of age to assess the safety and immunogenicity of an alum-adjuvanted chikungunya
      virus-like particle vaccine (PXVX0317) in prior recipients of other alphavirus vaccines
      versus alphavirus naïve controls.
    

Detailed description: 
      It is currently unknown whether prior exposure to heterologous alphaviruses will enhance or
      interfere with immune responses to chikungunya virus (CHIKV) exposure or vaccination. The
      objective of this study is to evaluate the safety and immunogenicity of the chikungunya
      vaccine candidate PXVX0317 when administered to prior recipients of experimental alphavirus
      vaccines versus alphavirus naïve gender- and age-matched controls.
    

Intervention name(s): Chikungunya
Intervention type(s): Biological
Intervention description(s): Virus Like Particle
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open Label Safety and Immunogenicity
Masking: None (Open Label)
Primary purpose: Prevention
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
Condition: Epilepsy; Dravet Syndrome; Lennox-Gastaut Syndrome
MeSH terms: Epilepsy; Brain Diseases; Epilepsies, Myoclonic; Lennox Gastaut Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect on the frequency of all seizures
      (convulsive and drop) in participants treated with TAK-935 compared to placebo.
    

Detailed description: 
      The drug being tested in this study is called TAK-935 (OV935). This randomized, double-blind
      study will assess the effects of TAK-935 (OV935), compared to placebo, on efficacy, safety,
      and tolerability in pediatric participants with Dravet syndrome (DS) or Lennox Gastaut
      syndrome (LGS). This multi-center trial will be conducted worldwide and will enroll
      approximately 126 participants.

      Participants will be randomized based on their diagnosis in 2 categories; DS or LGS. The
      study will consist of 2 periods: Screening Period and Treatment Period. The overall duration
      of Treatment Period is up to 20 weeks including 8-week Dose Optimization Period and 12-week
      Maintenance Period. The overall time to participants in this study is approximately 30 weeks.

      Participants completing this study will have an option to enroll in the open-label extension
      study, under a separate protocol.
    

Intervention name(s): TAK-935; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-935 tablets or mini-tablets.; TAK-935 placebo-matching tablets or mini-tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy; Brain Diseases; Central Nervous System Diseases; Tuberous Sclerosis; CDKL5 deficiency disorder; Dup15Q syndrome; Anoxic brain injury; Infantile spams; West syndrome; Cortical dysplasia; SCN1A; OV-935; Cholesterol 24S-hydroxylase inhibitor; Seizure; Anti-epileptic drug; Anticonvulsants; Nervous System Diseases; Drop seizure; Atonic seizure
Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Condition: Moderate or Severe Submental Fullness
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the safety and potential efficacy of deoxycholic acid injection compared to
      placebo for the reduction of submental fat (fat below the chin).
    

Detailed description: 
      The trial included an initial cohort (3 participants in each arm) to evaluate safety followed
      by expansion to a second, larger cohort if adequate safety was determined in the initial
      cohort. Data from both cohorts was pooled for analysis.
    

Intervention name(s): Deoxycholic Acid Injection; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): ATX-101
Intervention MeSH terms: Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease
Condition: IBD
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the efficacy, safety and tolerability of
      lactulose in bowel preparation in IBD patients. The main question it aims to answer is: Does
      lactulose have better efficacy, safety and tolerability than 3L-PEG? Participants will be
      divided into PEG group or Lactulose group at a 1:1 ratio by a random number method. Each
      patient will get a leaflet provided by hospital introducing bowel preparation methods and
      diet restriction before bowel preparation. They will have bowel preparation with different
      drugs according to group. The grade of bowel cleansing will be assessed through the Boston
      Bowel Preparation Scale (BBPS). The tolerability, satisfaction and safety of the two bowel
      preparation methods will be assessed through the patients self-administered questionnaires.
    


Intervention name(s): 3 bottles of Lactulose oral solution; 3L-polyethylene glycol
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take lactulose for bowel preparation.; Patients will take 3L-polyethylene glycol for bowel preparation.
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: colonoscopy; polyethylene glycol; IBD; bowel preparation; lactulose
Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study is designed to evaluate the reactogenicity and immunogenicity of one or two
      booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults
      aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate
      vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634)
      will be recruited. 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 (NCT00309634)
    

Detailed description: 
      The present study is designed to evaluate the reactogenicity and immunogenicity of one or two
      booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults
      aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate
      vaccine. The persistence of antibodies will be analysed at 6, 12, 18 and 24 months.
    

Intervention name(s): Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose; Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Intervention type(s): Biological; Biological
Intervention description(s): A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.; Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Open Label Extension Study of Bifeprunox
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A one year extension study using flexible doses, 20 or 30 mg daily, of open-label bifeprunox.
    


Intervention name(s): Bifeprunox
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia
Correlation Between Montreal Cognitive Assessment and Voice Therapy Outcomes in the Aging Treatment- Seeking Population
Condition: Cognitive Impairment; Voice Disorders; Voicebox Disorders; Cognitive Decline; Swallowing Disorder
MeSH terms: Deglutition Disorders; Voice Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study will investigate if the performance on the Montreal Cognitive Assessment (MoCA) is
      associated or predictive of the outcomes in voice, swallowing or upper airway therapy in the
      older laryngology treatment seeking patients. The relationship between the scores of MoCA and
      parameters in therapy will be analyzed. The outcomes of this study could potentially impact
      how investigators determine candidacy for therapy and develop patient treatment plans to meet
      their needs. This is a collaborative study with Emory Voice Center and the NYU Voice Center.
    


Intervention name(s): Speech Therapy; Swallowing Therapy; Upper Airway Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Training with a Speech Language Pathologists for voice disorders. This is typically done with an initial visit done jointly with an MD physician. Then there are 4 subsequent therapy visits in addition to home practice exercises. Finally there will be another joint post-treatment evaluation to determine progress and next steps.; Training with a Speech Language Pathologists for swallowing disorders. This is typically done with an initial visit done jointly with an MD physician. Then there are 4 subsequent therapy visits in addition to home practice exercises. Finally there will be another joint post-treatment evaluation to determine progress and next steps.; Training with a Speech Language Pathologists for upper airway disorders. This is typically done with an initial visit done jointly with an MD physician. Then there are 4 subsequent therapy visits in addition to home practice exercises. Finally there will be another joint post-treatment evaluation to determine progress and next steps.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: voice therapy; cough therapy; swallowing therapy
Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm
Condition: Diabetes, Type I
Study type: Interventional

Summary: 
      An open interventional data collection study in order to build a database to close the loop
      between glucose sensor and insulin pump.

      background: The ultimate goal in diabetes treatment is to develop an autonomous insulin
      delivery system (artificial pancreas) capable of continuous glucose sensing, thereby
      mimicking the physiologic function of the islet beta cells and freeing the patient from the
      need for constant calculations of daily insulin and carbohydrates. Several prototypes of
      closed-loop system have been developed in recent years, based on different types of control
      algorithms, to establish the connection between the sensor and the insulin pump. Current
      research in the formulation of this type of subcutaneous closed-loop system still faces major
      challenges, therefore, there is a need for further study and evaluation.

      Objectives:

        1. To evaluate the lag time of the effect of subcutaneous insulin infusion on blood glucose
           levels by using continuous glucose sensor

        2. To measure the insulin sensitivity as expressed by changes in blood glucose levels after
           s.c insulin infusion .

        3. To evaluate real time sensor calibration algorithms based on the measured lag times

        4. Collecting clinical data in order to develop and evaluate mathematical models which will
           serve a base to simulators.

        5. Developing and accessing advanced learning and control algorithms as a step towards
           developing an artificial pancreas
    


Intervention name(s): continuous glucose sensors and insulin pump
Intervention type(s): Device
Intervention description(s): continuous glucose sensors and insulin pump
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Artificial pancreas; Insulin Pump
Characterizing Ankle Function During Sloped Locomotion for Prosthesis Development
Condition: Traumatic Amputation of Lower Extremity
MeSH terms: Amputation, Traumatic
Study type: Observational

Summary: 
      The proposed study aims to characterize biological ankle joint function during walking and
      running on slopes in order to further develop advanced powered ankle-foot prostheses. Ankle
      joint torque and angle data will be collected from non-amputees while walking and running at
      multiple speeds and slopes. This data will be used to develop control parameters for a
      powered ankle-foot prosthesis. Then, these parameters will be implemented and tested in a
      powered prosthesis worn by people with below the knee amputations.
    


Intervention name(s): Powered ankle-foot prosthesis
Intervention type(s): Device
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Study 1: Non-amputee Study 2: Unilateral transtibial amputee Study 3: Unilateral
        transtibial amputee Study 4: Non-amputee Study 5: Unilateral transtibial amputee
BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery
Condition: Ventilation
Study type: Observational [Patient Registry]

Summary: 
      The BASKA mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel
      supraglottic airway device. It has many of the features of other supraglottic airways, with a
      number of innovations. These include; A non-inflatable cuff, that it is continuous with the
      central channel of the device. As the pressure increases with positive pressure ventilation,
      the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation
      more efficient.
    

Detailed description: 
      The BASKA mask incorporates an inlet that fits into the upper esophagus, and the dorsal
      surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and
      towards the side channels to which suction can be attached to facilitate aspiration of this
      space (Fig.1c). These features may reduce the risk of pulmonary aspiration of secretions or
      gastric contents that accumulate in the supraglottic area.

      Compared with previous versions, these modifications have made BASKA mask airway a fairly
      safe and effective airway device in low-risk patients undergoing gynecologic laparoscopic
      surgeries
    

Intervention name(s): BASKA MASK; Endotracheal tube
Intervention type(s): Device; Device
Intervention description(s): Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant; Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube.
Other intervention name(s): BASKA; ETT
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Female patients scheduled for elective gynecological laparoscopic surgery.
Safety, Pharmacokinetics, and Efficacy Study of NB-001 to Treat Recurrent Herpes Labialis
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose of this study is to determine the safety and efficacy of topical applications of
      NB-001 as compared to placebo for the treatment of recurrent herpes labialis.
    


Intervention name(s): NB-001
Intervention type(s): Drug
Intervention MeSH terms: 5-((2-(6-Amino-9H-purin-9-yl) ethyl) amino)-1-pentanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cold sore
Effect of Warmed Irrigation in Hip Arthroscopy Undergoing Hip Arthroscopy
Condition: Femoro Acetabular Impingement; Pain, Postoperative
MeSH terms: Femoracetabular Impingement; Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to determine if pre-warming of arthroscopic fluid reduces
      immediate post-surgical pain in hip arthroscopy patients. The investigators hypothesize there
      will be a significant decrease in the Visual Analog Score (VAS) measured 30 minutes
      post-operatively in the warmed fluid group compared to the control group. Secondary outcome
      measures to be collected will include VAS scores 60 minutes after surgery and on
      post-operative day (POD) one. Additionally, the investigators will collect post-operative
      temperature measured 30 and 60 minutes post-operatively as well as morphine equivalent dosing
      in PACU and at the two-week follow up visit.
    

Detailed description: 
      In the last two decades, hip arthroscopy for the treatment of femoral acetabular impingement
      has increased rapidly. Currently, over 30k hip scopes are performed annually in the United
      States (incidence 1.06 per 10K). Due to anatomical differences, hip arthroscopy procedures
      have the potential for significant fluid extravasation when compared to knee arthroscopy. A
      2011 study on hip arthroscopy showed on average 9.68 liters of fluid were used for a standard
      hip procedure; of that 1.13 liters absorbed into the surrounding soft tissues. A recent
      systematic review and meta-analysis showed warming of arthroscopic fluids significantly
      decreased the risk of hypothermia during hip arthroscopy. Additionally, active warming has
      been shown to decrease the rate of surgical site infection during numerous procedures. In
      total knee arthroplasty patients, a forced air warming gown significantly reduced narcotic
      pain consumption compared to standard care. However, the benefits of active warming for
      decreasing post-operative pain has not been studied in hip arthroscopy patients.
      Specifically, the investigators were interested in the roll the pre-warming arthroscopic
      fluid plays in post-operative pain after hip arthroscopy. The purpose of this study is to see
      if pre-warming of arthroscopic fluid reduces immediate post-surgical pain and narcotic
      consumption in hip arthroscopy patients.
    

Intervention name(s): Warmed Arthroscopic Fluids; Room Temperature Arthroscopic Fluids
Intervention type(s): Procedure; Procedure
Intervention description(s): Warmed Arthroscopic Fluids; Room Temperature Arthroscopic Fluids
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective Randomized Controlled Trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hip Arthroscopy; Warmed Fluids