bioihbjkbjnl/mcl2 huggingface dataset:
Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway
Condition: Paralysis
MeSH terms: Paralysis
Study type: Interventional

Summary: 
      The LMA Supreme is a new extraglottic airway device which brings together features of the LMA
      ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal
      leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA
      ProSeal and the LMA Supreme in paralyzed anesthetized patients
    

Detailed description: 
      The LMA Supreme is a new extraglottic airway device which brings together features of both
      the LMA ProSeal (high seal cuff, gastric access and bite block - to facilitate ventilation,
      airway protection and airway obstruction, respectively), the LMA Fastrach (fixed cuve tube
      and guiding handle - to facilitate insertion and fixation) and the LMA Unique (single use -
      prevention of disease transmission). The new features are that the airway tube incorporates a
      drain tube within its lumen to shorten and straighten its path, it is oval-shaped to match
      the shape of the mouth and to reduce rotation in the pharynx, the inner cuff has been
      strengthened to prevent airway obstruction from infolding and epiglottic fins have been added
      to prevent airway obstruction from epiglottic downfolding. In the following randomized,
      crossover study, we test the hypothesis that ease of insertion, oropharyngeal leak pressure,
      fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the
      LMA Supreme in paralyzed, anesthetized patients
    

Intervention name(s): LMA Supreme; LMA ProSeal
Intervention type(s): Device; Device
Intervention description(s): Extraglottic airway devices
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: LMA Supreme; LMA ProSeal; Laryngeal mask airway; Ventilation
Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)
Condition: Ulcerative Colitis Chronic Moderate
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The PROCTO trial is a double-blind randomized, placebo-controlled, 24-week, comparative,
      exploratory phase II proof of concept trial. The trial will be conducted with 2 treatment
      groups as a parallel group comparison and will serve to compare a 7500 TSO regimen vs.
      placebo for achieving clinically meaningful responses in Ulcerative Colitis.
    


Intervention name(s): Trichuris suis ova; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Eggs from the pig whipworm; Solution without TSO
Other intervention name(s): TSO
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind randomised, placebo-controlled, 24 weeks, comparative, exploratory phase II proof of concept trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; Trichuris suis; Trichuris suis ova; Probiotic; IBD; Inflammatory bowel diseases; Anti inflammatory; Hygiene Hypothesis; Helminths; Microbiome; MAYO
Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen
Condition: Sepsis; Bacteremia
MeSH terms: Bacteremia
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous
      infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in
      Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate
      of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and
      rates of relapse after 28 days.

      Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or
      microbiological cure greater than the intermittent administration.
    


Intervention name(s): cefepime; cefepime
Intervention type(s): Drug; Drug
Intervention description(s): Administration of cefepime in continuous infusion (3 Gr over 24 hours) for 7-14 days at the discretion of the investigator. Administration of saline solution 0.9%, 50-100 mL over 30 minutes every 8 hours.; Administration of cefepime in intermittent infusion (1 Gr over 30 minutes every 8 hours) for 7-14 days at the discretion of the investigator.Administration of saline solution 0.9%, 50-250 mL over 24 hours
Other intervention name(s): maxipime; Maxipime
Intervention MeSH terms: Cefepime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sepsis; Bacteremia; Intravenous infusions; cefepime
The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion
Condition: Mental Health Wellness 1
Study type: Interventional

Summary: 
      The aims of the study are to determine the effectiveness of Mindfulness-Based Interventionas
      a workplace health promotion program on psychological distress, prolonged fatigue, job strain
      (job control and job demand), and perceived stress and to explore the influences of personal
      characteristics (including gender, age, education, and occupation) on the outcomes of the
      intervention with time.
    

Detailed description: 
      This study was one component of the Taiwan Workplace Mental Health Promotion Scheme. The
      study adopted a study design of a randomized controlled trial. Two large-scale manufacturing
      factories were chosen for this study. All of the factories' 3270 full-time employees were
      requested to fill in a questionnaire comprising questions regarding mental health and job
      strain. Of these employees, 2849 individuals were willing to complete the questionnaire. A
      total of 431 employees (15.13%) were found to be in psychological distress with job strain.
      The screening procedure was carried out between June and July in 2011. A letter of invitation
      with an introduction to MBI was sent to these employees. Of these 431 employees, only 144
      responded that they would be willing to take part voluntarily in the study. These 144 workers
      were allocated randomly into the intervention group (Group I, n=72) or the waiting-list
      control group (Group C, n=72).

      All the participants were measured five times with an interval of four weeks between
      measurements. These measurements were taken at pre-intervention (T1), at mid-intervention
      (T2), at the completion of intervention (T3), four weeks after intervention (T4), and eight
      weeks after intervention (T5). The data related with the effectiveness of the intervention
      were obtained between August and December in 2011.
    

Intervention name(s): mindulness-based intervention
Intervention type(s): Behavioral
Intervention description(s): A number of mindfulness techniques, including both "formal" and "informal" practices with integration in the context of Mind/Body meditation, were explored in order to cultivate moment-by-moment present awareness with non-judgmental acceptance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness meditation; mental health promotion; worker
A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy Europeans Children Aged 6 to 35 Months
Condition: Influenza; Swine-origin A/H1N1 Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to generate data on immunogenicity and safety of the monovalent
      H1N1 vaccine in support of the development and registration.

      Primary objectives:

        -  To describe the immune response to vaccines 21 days after each vaccination in all
           participants.

        -  To describe the antibody persistence eight months after the first vaccine administration
           using hemagglutination inhibition (HAI) method in a subset of participants who received
           two half-doses of either formulation 1 or 2.

        -  To describe the immune response against the A/H1N1 strain using the HAI method 21 days
           after last vaccination with the 2010-2011 NH seasonal Trivalent Influenza Vaccine (TIV)
           administered 13 months after the first vaccination in a subset of subjects who received
           two half-doses of either t either formulation 1 or 2 of the A/H1N1 influenza vaccines as
           primary series.

        -  To describe the safety profile of each vaccine in all participants.
    

Detailed description: 
      All participants will receive two injections of their randomized vaccine on Day 0 and Day 21,
      respectively.

      A subset of the participants eligible who received two half-doses of either formulation 1 or
      2 will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent
      Influenza Vaccine (TIV) 13 months after the first vaccination as Follows:

        -  Subjects less than 36 months at the time of TIV injection will receive two half-doses
           and additional sampling for immunogenicity assessment (one before the first TIV
           vaccination and one 21 days after last TIV vaccination).

        -  Subjects aged more than 36 months at the time of TIV injection will receive a full TIV
           dose and additional sampling for immunogenicity assessment (one before TIV vaccination
           and one 21 days after TIV vaccination).
    

Intervention name(s): Swine A/H1N1 influenza vaccine (split virion, inactivated); Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant); Swine A/H1N1 influenza vaccine (split virion, inactivated + adjuvant)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).; 0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset); 0.5 mL, Intramuscular on Day 0 and Day 21
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Pandemic Flu; Swine-origin A/H1N1 Influenza; Swine-origin Influenza Virus; Infants
Evaluation of New Specifications (38mm) of FirehawkTM in the Treatment of Coronary Heart Disease
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to evalute the clinical safety and effectiveness of released
      specification (38mm) of FirehawkTM Sirolimus target-eluting coronary stent system.
    


Intervention name(s): Rapamycin target-eluting coronary stent systems (38mm)
Intervention type(s): Device
Other intervention name(s): Firehawk-38
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Intervention model description: all patients implanted Firehawk stent of new specification (38mm long)
Masking: None (Open Label)
Primary purpose: Treatment
Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH
Condition: Subarachnoid Hemorrhage
MeSH terms: Seizures; Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Our primary objective is to compare two treatment options for prevention of seizures
      following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam
      is as efficacious in the prevention of in-hospital seizures when compared to an extended
      course.
    

Detailed description: 
      This is a prospective, single-center, randomized, controlled trial. Patients admitted with
      spontaneous SAH (and meet enrollment criteria) will be randomized to either levetiracetam
      1000 mg twice daily for 3 days or levetiracetam 1000mg twice daily until hospital discharge.
    

Intervention name(s): Brief LEV; Extended LEV
Intervention type(s): Other; Other
Intervention description(s): Levetiracetam 1000mg BID x 3 days for prophylaxis; Levetiracetam 1000mg BID for length of hospital stay for prophylaxis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Subarachnoid Hemorrhage; Seizure Prophylaxis; Levetiracetam
An Open-Label Preference Evaluation of BLI800
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate patient experience ratings of BLI800 in adult
      patients undergoing colonoscopy.
    

Detailed description: 
      The objective of this study is to evaluate the patient satisfaction and preference of BLI800
      in adult patients undergoing colonoscopy.
    

Intervention name(s): BLI800
Intervention type(s): Drug
Intervention description(s): BLI800 Bowel Preparation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimal Duration of Stretching Exercise in Patients With Chronic Mechanical Neck Pain
Condition: Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      controversy remains about the stretching parameters needed to achieve a particular goal or
      treatment outcome. In clinical practice, multiple stretching techniques are used;
      nevertheless, there is no evidence-based agreement on the most effective parameters. One of
      these parameters, that might be affecting the treatment outcome the most, is the stretching
      duration, thus far there is a little agreement on the optimal stretching duration.

      This non agreement in exact stretching parameters is obvious between authors and researchers
      in the field of muscle energy techniques (MET) as well as those who have used and advocate
      various durations for the passive stretch that follows the contraction phase in MET.
    

Detailed description: 
      comparison and subsequent conclusions about appropriate stretching times are mainly based on
      mechanical factors such as range of motion and flexibility, while ignoring the neural
      adversative mechanical tension that may be created during stretching exercises. According to
      the literature , stretching induced neural tension may adversely affect the central nervous
      system and nerve root function due to the absence of the perineurium, which is the primary
      load carrying structure. Thus, safe or unsafe limits of nerve elongation are not well
      established, despite several basic scientific and clinical studies.. Consequently, in the
      present study, the current study aimed to answer the question: Is it theoretically possible,
      that increased longitudinal strain and stress on the spinal cord and nerve root from
      continuous stretching exercises may subtly impair the neural function? Our hypothesis is that
      a duration threshold exists where, once reached, adverse neural function will be apparent
      resulting in a reduction of either or both latency and amplitudes of evoked potentials.
    

Intervention name(s): Stretching exercises
Intervention type(s): Other
Intervention description(s): Post-facilitation stretch is a technique involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a static stretch.
Other intervention name(s): muscle energy technique
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, double blinded, parallel-group, randomized clinical trial was conducted at one of our university's research departments,
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized controlled trial; muscle energy technique; Stretching exercises
Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      - To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily
      (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma
      glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after
      a standardized breakfast at the end of a 8-week treatment period in participants with type 2
      diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin).

      Secondary Objectives:

        -  To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8
           mg QD after an 8-week treatment period in participants with T2DM not adequately
           controlled with insulin glargine (± metformin) on:

             -  Post-prandial C-peptide, glucagon and appetite perceptions after a standardized
                breakfast,

             -  Appetite perceptions after standardized dinner,

             -  Gastric emptying after a standardized labelled test meal,

             -  Fasting plasma glucose, 24-hour plasma glucose profile,

             -  Glycosylated hemoglobin (HbA1c),

             -  Insulin glargine dose,

             -  7-point self monitored plasma glucose (SMPG),

             -  Body weight and waist circumference,

             -  24-hour heart rate and blood pressure,

        -  To assess lixisenatide and liraglutide safety and tolerability as add on treatment to
           insulin glargine (± metformin).
    

Detailed description: 
      Up to 2-week screening period

        -  A run-in period of 12 weeks at maximum including a forced titration with insulin
           glargine up to 11 weeks and 1 baseline pharmacodynamic assessment week

        -  A 8-week treatment(s) period(s) up to Day 57

        -  Follow-up: 7 ±2 days after the last treatment day

        -  Total study duration approximately 14 weeks up to 23 weeks
    

Intervention name(s): Lixisenatide (AVE0010); Liraglutide; Insulin Glargine; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection self-administered with a pen-like injector (OptiClik®).
Route of administration: subcutaneous; Pharmaceutical form:solution for injection
Route of administration: subcutaneous; Doses to be adjusted to maintain a fasting self-measured plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL); If previously taken metformin to be continued at stable dose throughout the study
Other intervention name(s): Victoza®; Lantus® SoloSTAR®
Intervention MeSH terms: Metformin; Insulin Glargine; Liraglutide; Lixisenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study was to evaluate the efficacy and safety of 611 in chinese
      adults with moderate to severe atopic dermatitis.
    

Detailed description: 
      The maximum study duration was 28 weeks per participants, including a screening period of up
      to 4 weeks, a 16-week randomized treatment period, and a 8-week follow-up period.
    

Intervention name(s): 611 Q2W; 611 Q4W; Matching placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): subcutaneous injection, 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 2 to Week 14, 7 cycles); subcutaneous injection, 600mg (loading dose, Day1) + 300mg Q4W (maintenance dose, on week 4, 8, 12) + placebo Q4W (on week 2, 6, 10, 14); subcutaneous injection, Q2W, from Week 2 to Week 14, 7 cycles
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Scapular Stabilization Exercises on the Clavicular Movement
Condition: Clavicle
Study type: Interventional

Summary: 
      This study was planned to indicate efficiacy of the scapular stabilization exercises on the
      clavicula movements.
    

Detailed description: 
      All subjects in the study were evaluated for range of motion (Goniometer), muscle strength
      (Manuel Muscle Strength Test), angular displacements of clavicula during abduction and
      skapular plan elevation of arm (Video Analysis Method), disability of the arm (Quıck Dash
      Turkish). The study was applied in two groups for three times per week during 8 weeeks.
    

Intervention name(s): scapular stabilization exercises
Intervention type(s): Other
Intervention description(s): the effect of the scapular stabilization exercise on the clavicular motion on the adolescent girls
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: adolescent,; clavicula,; scapula,; exercise
Postoperative Pain After the Use of Different Root Canal Sealers
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study evaluated the postoperative pain after the endodontic treatment using AH Plus,
      Endoseal MTA and EndoSequence BC sealers in root canal obturation.
    


Intervention name(s): Root Canal Filling Sealers
Intervention type(s): Other
Intervention description(s): Root Canal Obturation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: postoperative pain; Endoseal MTA; Endosequence BC; AH Plus; Root canal filling; endodontic treatment
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects
      with focal epilepsy.
    


Intervention name(s): Seletracetam (UCB44212)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: oral capsules
Concentration: 2, 10 and 50 mg
Route of administration: oral administration
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Partial Onset Seizures; Seletracetam; Levetiracetam