bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Clinical Trial for Women With Vulvodynia
Condition: Vulvodynia
MeSH terms: Vulvodynia
Study type: Interventional

Summary: 
      This study will evaluate the relative effectiveness of cognitive-behavioral therapy and
      supportive psychotherapy for the treatment of women with vulvodynia.
    

Detailed description: 
      Many treatments used for women with vulvodynia are based solely upon expert opinion. This
      randomized trial aimed to test the relative efficacy of cognitive-behavioral therapy (CBT)
      and supportive psychotherapy (SPT) in women with vulvodynia. Of the 50 participants, 42 (84%)
      completed 10-week treatments and 47 (94%) completed one-year follow-up. Mixed effects
      modeling was used to make use of all available data. Participants had statistically
      significant decreases in pain severity (p's<.001) with 42% of the overall sample achieving
      clinical improvement. CBT, relative to SPT, resulted in significantly greater improvement in
      pain severity during physician examination (p=.014), and greater improvement in sexual
      function (p=.034), from pre- to post-treatment. Treatment effects were well maintained at
      one-year follow-up in both groups. Participants in the CBT condition reported significantly
      greater treatment improvement, satisfaction and credibility than participants in the SPT
      condition (p's<.05). Findings from the present study suggest that psychosocial treatments for
      vulvodynia are effective. CBT, a directed treatment approach that involves learning and
      practice of specific pain-relevant coping and self-management skills, yielded better outcomes
      and greater patient satisfaction than a less directive approach.
    

Intervention name(s): Cognitive-Behavioral Therapy; Supportive Psychotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral, cognitive, sex therapy and relaxation interventions administered to teach self-management skills for pain control.; Patient-centered talk therapy to assist participants in expressing their thoughts and feelings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vulvodynia; Vulvar pain; Dyspareunia; Sexual dysfunction; Vestibulitis
Efficiency Analysis of Wireless Vibrating Caller During Surgery
Condition: Communication
Study type: Interventional

Summary: 
      As the number of operation increases, it is important to control of the utilization rate of
      the operating room. This study is a comparative study of the benefits of different ways of
      contacting patients' family members during surgery.
    

Detailed description: 
      As the number of operation increases, it is important to control of the utilization rate of
      the operating room. When family members need to be contacted during the operation, whether
      family members in the waiting area can be notified in time will affect the overall operation
      time of the patient and the utilization rate of the operating room. The way of contact also
      indirectly affects issues such as hospital costs and patient privacy. This study is a
      comparative study of the benefits of different ways of contacting patients' family members
      during surgery.

      This study will compare the current traditional method (using radio and telephone to notify
      the patient's family to the operating room) or the wireless vibrating caller to notify the
      patient's family to the operating room, and analyze the variables generated by the two
      different methods including demand time of notification, acceptance, and patient privacy
      issues. The results of the study will use scientific data to prove which way to notify the
      patient's family is more efficient and a good way to take into account of the patient's
      privacy.
    

Intervention name(s): wireless vibrating caller
Intervention type(s): Behavioral
Intervention description(s): using the wireless vibrating caller to notify the patient's family to the operating room
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a comparative study of the benefits of different ways of contacting patients' family members during surgery.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Operating room; Telecommunication experts
Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      To allow pediatric patients with partial onset seizures an opportunity to receive (as
      follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment)
      open-label levetiracetam treatment, continue studying cognition and behavior in children, and
      continue collection of safety/efficacy data.
    


Intervention name(s): levetiracetam (LEV)
Intervention type(s): Drug
Intervention description(s): Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Partial Onset Seizures; levetiracetam; Epilepsy; Keppra
Comparison of the Leuven Protocol With the Glucommander for Postoperative Control of Blood Glucose With IV Insulin
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators are testing whether a written protocol or a computerized program can more
      effectively control blood glucose after surgery.
    

Detailed description: 
      In 2002 we adapted the protocol described by Van den Berghe et al. for use in our own
      surgical intensive care unit (SICU) with a target blood glucose range from 80 to 120mg/dL.
      After five years of implementation, we were able to achieve a mean BG of 117 mg/dL in the
      SICU. 2% of glucose values were <60 mg/dL in the SICU. Given the concern of safety while
      optimizing glycemic control, we investigated the etiologies for these hypoglycemic episodes
      and have found two frequent risk factors; the failure to consistently measure blood glucose
      every hour and in patients with end stage renal failure.

      We will investigate whether a computer-based algorithm for the titration of IV insulin will
      translate to better clinical outcomes and less hypoglycemia. Therefore, we will conduct a
      prospective randomized trial comparing the Glucommander, a computer-based algorithm with our
      Van den Berghe protocol for titration of IV insulin in patients after cardiovascular or
      transplant surgery. This computer based algorithm was invented in 1984 in Atlanta by Dr.
      Davidson and Dr. Steed who have used it in a variety of applications of IV insulin.
    

Intervention name(s): insulin regular IV infusion; IV insulin infusion
Intervention type(s): Drug; Drug
Intervention description(s): IV insulin was administered by continuous infusion and the rate changed every hour according to the blood glucose level as determined by each of the protocols being compared; IV insulin was administered by continuous infusion and the rate changed every hour according to the blood glucose level as determined by each of the protocols being compared
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postoperative blood glucose control; IV insulin infusion
The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness in Stroke Patients
Condition: Stroke, Cardiovascular
MeSH terms: Stroke; Myocardial Infarction
Study type: Interventional

Summary: 
      Background:

      Aerobic exercise training has favorable effects on quality of life, motor recovery, and
      aerobic endurance after stroke.

      Objectives: In this study, the investigators aimed to explore the effects of anti-gravity
      treadmill gait training and underwater walking therapy on cardiorespiratory fitness in stroke
      survivors.
    

Detailed description: 
      Methods: Seventy patients with a history of stroke were admitted to our center between July
      2017 and January 2018. Subjects who participated in the study were randomly assigned to
      anti-gravity treadmill training, underwater walking therapy, and control group. Investigators
      examined the aerobic capacity of participants by using the 6-minute walk test and cycle
      ergometer testing before starting the treatment along with a one-month follow-up. The
      patient's balance was examined by using the Berg Balance Scale (BBS).
    

Intervention name(s): The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients
Intervention type(s): Other
Intervention description(s): Seventy patients with history of stroke admitted to our center between July 2017 and January 2018. Subjects participated in the study were randomly assigned to anti-gravity treadmill training, underwater walking therapy and control group. We examined aerobic capacity of participants by using 6-minute walk test and cycle ergometer testing before starting the treatment along with one month follow up. Patient's balance examined by using the Berg Balance Scale (BBS).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: underwater walking theraphy; anti-gravity treadmill training
Variations of High Sensitivity Troponin T in Neonates
Condition: Newborn; Newborn, Transient
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is
      increasing, yet normal values are still to be determined for the latest generation of tests,
      such as High sensitivity cardiac troponin T test. This study is an observational study
      designed to determine biological normal values of High sensitivity cardiac troponin T test
      (troponin T -us) in newborns.
    

Detailed description: 
      -  Approximately 400 subjects will be recruited over a planned recruitment period of 2
           months. During labour, or pre natal hospitalization, information about the study will be
           given to every mothers by the midwife or the pediatrician. Absence of opposition will be
           notified in the medical file.

        -  At birth, every child born alive is possibly eligible for this study, if he doesn't meet
           the exclusion criteria.

        -  After clamping the umbilical cord, the midwife realizes the systematic sample for
           assessment of pH and lactate. If the mother did not object to the study, the midwife
           will use 200µl of this very same sample to assess Troponin T blood level. This sample
           goes to the same laboratory to be analyzed. The blood sample for troponin T measurement
           must be brought to the laboratory within 2 hours, just as pH and lactate must be. The
           midwife in charge of this patient also fills a form with informations from the patient's
           medical file. This form is anonymized for the study.

        -  Samples will not be stored, remaining swab after analysis will be destructed.

        -  Before discharge, all children undergo a medical exam by a pediatrician, whether they
           are in maternity or in neonate. The pediatrician who examines the child fills a second
           form that summarizes the noteworthy events of his hospital journey.

      Subjects have the right to withdraw from the study at any time for any reason. If one of the
      parents wishes to withdraw from the study after the first Troponin T measurement is made, we
      will ask for their permission to use the collected data.
    

Intervention name(s): Troponin T blood level
Intervention type(s): Biological
Intervention description(s): assess Troponin T blood level for every child born from the same sample of blood (after clamping the umbilical cord) used for assessment of pH and lactate.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children born in hospital René Dubos
      
Keywords: Neonatology; Troponin T; Standards
Ragweed-SPIRE Follow-On Study
Condition: Rhinoconjunctivitis; Ragweed Allergy
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the
      initial dose.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who completed at least 6 of 8 treatment visits in Study TR006
      
Keywords: Ragweed Allergy; Rhinoconjunctivitis; Immunotherapy; Ragweed-SPIRE
Microcirculation in Venoarterial Extracorporeal Membrane Oxygenation Life Support
Condition: Heart Failure; Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and
      respiratory support to patients with heart and respiratory failure. It can save time for
      these organs to recovery or for these patients to receive further management. However, many
      patients will die in spite of ECMO support. One of the key factor is whether the blood flow
      provided by the ECMO can meet the requirement of organ perfusion. The adequacy of
      macrocirculation may be determined by arterial pressure and minute blood flow of ECMO.
      However, the adequacy of microcirculation remains as a major unresolved clinical problem.
      This is a prospective observational clinical trial. The sublingual microcirculation will be
      examined with the incident dark field video microscope within 6 hours after venoarterial ECMO
      placement, and then at 24 h, 48 h, 72 h, and 96 h. The severity of multiple organ injury and
      clinical data will be recorded as well. The major parameters of microcirculation include
      total small vessel density, perfused small vessel density, and microvascular flow index. The
      sublingual microcirculation will also be examined before weaning off ECMO, within 6 hours
      after ECMO removal, and then at 24 h, 48 h, and 72 h. Serum level of endothelial cell
      specific molecule-1 at specific time points will be examined. The data of 14-day mortality,
      28-day mortality, duration of ECMO support, and intensive care unit stay will be recorded.
      This study aims primarily to investigate the relationship between microcirculation and
      prognosis of these patients. This study will also investigate the relationship among serum
      level of endothelial cell specific molecule-1, microcirculation, and prognosis of these
      patients. Wish the results of this study can be applied in further research to help to
      improve the quality of ECMO care.
    


Intervention name(s): Extra-corporeal membrane oxygenation life support
Intervention type(s): Device
Intervention description(s): venoarterial extra-corporeal membrane oxygenation life support
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support
Body Awareness in Dentistry Students and Working Dentists
Condition: Musculoskeletal Diseases; Body Image; Dentistry
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      The current study aims to comparison the body awareness and musculoskeletal problems of 1st
      dentistry students, intern students and working dentists and also investigate the factors
      affecting the body awareness over the years in dentistry profession.
    

Detailed description: 
      Dentists also have the highest prevalence among the occupational groups providing health
      services. More than 60% of dentists have pain in at least one of their body parts.Pain due to
      musculoskeletal disorders can affect body awareness of person have chronic pain. Body
      awareness is known as the capacity to distinguish body parts and has an important role in
      promoting well-coordinated movements. The current study aims to comparison the body awareness
      and musculoskeletal problems of 1st dentistry students, intern students and working dentists
      and also investigate the factors affecting the body awareness over the years in dentistry
      profession.
    

Intervention name(s): questionnaire
Intervention type(s): Other
Intervention description(s): All questionnaire were obtained via online survey system.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Dentistry students and dentists
Evaluation of Polyurethane Male Condoms
Condition: Contraception; Prevention of Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The clinical study will compare two lubricated polyurethane male condoms of different
      thickness with a marketed lubricated control male condom made of natural rubber latex. This
      crossover study will randomize 300 heterosexual couples to the sequence in which they use
      five condoms of each of the three study condom types. The clinical failure (breakage and
      slippage) rates of the two polyurethane condoms will be compared to the clinical failure
      (breakage and slippage) rate of commercial natural rubber latex control condom using a
      statistical test of non-inferiority. The study will also compare the acceptability of the two
      polyurethane condom different thickness with that of the natural rubber latex control condom
      obtained from interviews and questionnaires with subject couples.
    

Detailed description: 
      The clinical study will compare two lubricated polyurethane male condoms of different
      thickness and different sizes with a marketed lubricated control male condom made of natural
      rubber latex.

      Couples entering the study will be expected to use 5 of each type of the 3 condoms in a
      randomised order. The identity of the condoms will be masked to both the couples and the
      investigators. The aim will be to recruit 300 heterosexual with the intent of achieving a
      minimum 1,000 uses of each condom type. Couples will report condom use events using a condom
      report form. The primary information collected will relate to condom breakage and slippage of
      the penis during use.

      The total clinical failure rates (breakage and slippage) of the two polyurethane condoms will
      be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber
      latex control condom using a statistical test of non-inferiority. The study will also compare
      the acceptability of the two polyurethane condom different thickness with that of the natural
      rubber latex control condom obtained from interviews and questionnaires with subject couples.
    

Intervention name(s): Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B
Intervention type(s): Device
Intervention description(s): Condom functionality study to determine failure rates
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cognitive Training in Children With Attention Deficit/ Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of computer program C8 on specific
      cognitive functions, symptoms and functional outcome compared to treatment as usual in
      children with ADHD. Furthermore, if the effect is sustained 12 and 24 weeks after training.
      In addition, it will be investigated, whether younger children benefit more from training
      than older children.
    


Intervention name(s): Computer program C8; Treatment as usual
Intervention type(s): Other; Other
Intervention description(s): Experimental: Computer program C8 + treatment as usual: Playing a special computer program C8 40 min a day for 6 days a week for 8 weeks.; Treatment as usual at the clinic
Other intervention name(s): C8; ADHD; Cognitive training; TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
Game to Improve Hearing Health Care Outcomes
Condition: Focus of the Study is to Promote Healthy Hearing
Study type: Interventional

Summary: 
      The investigators are studying the educational potential of games, with the goal of
      developing a game to improve learning and promote healthy hearing behaviors.

      The project is looking for adolescents and young adults that play games to share their
      experience and learning from playing games.

      The investigators ask participants to fill out an enrollment form/informed consent, complete
      surveys on healthy hearing habits, and play a game provided by the project.

      This projects aims the development and evaluation of a game to educate teenagers and young
      adults about noise-induced hearing loss, enhance knowledge about hearing, and promote healthy
      hearing behaviors with the potential to improve hearing health care.
    


Intervention name(s): Noisy City information about hearing health care; Generic Game
Intervention type(s): Other; Other
Intervention description(s): Participants will play the game Noisy City, which contains information about hearing health care.; Participants will play a generic game without any particular information about hearing health care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
PERFECT Project - Part 1 - Study 3
Condition: Diabetes Prevention; Obesity Prevention
Study type: Interventional

Summary: 
      The objectives are to test the acute effects of different bagels containing pulse ingredients
      on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake
      two hours following consumption of pulse products.

      The investigators hypothesize that bagels containing pulse ingredients will lead to lower
      blood glucose, insulin, appetite and food intake responses compared to non-pulse bagels.
    


Intervention name(s): Control; Pea flour; Pea fibre; Pea protein; Pea flour + pea protein; Pea fibre + pea protein
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Non pulse ingredient bagel; Pulse ingredient bagel; Pulse ingredient bagel; Pulse ingredient bagel; Pulse ingredient bagel; Pulse ingredient bagel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention