bioihbjkbjnl/mcl2 huggingface dataset:
Procedure-to-procedure Transfer Trial
Condition: Surgery
Study type: Interventional

Summary: 
      Surgical training programs using virtual reality simulators often only use basic skills
      training and the use of procedural training is very limited. Procedural training differs from
      basic skills training by requiring integration of isolated skills and decision making and
      planning components. However, it is unknown if it is necessary to practice all procedures
      before operating on actual patients or whether it is simply a matter of learning psychomotor
      skills and if these skills are transferable between different tasks.

      The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it
      easier to reach proficiency on a different laparoscopic procedure on the simulator because
      participants have already practiced the integration of isolated skills.
    


Intervention name(s): Practice a procedural module on a simulator
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Laparoscopy; Training; Simulator
Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Observational

Summary: 
      This study will determine if the investigators can use certain tests (eustachian tube
      function tests and gas exchange tests) to predict whether or not a child who had tubes
      surgically placed in their eardrum because of middle-ear disease will redevelop the disease
      again after the tubes quit working.
    

Detailed description: 
      This study will enroll children 3-6 years of age with tympanostomy tubes inserted for otitis
      media with effusion (OME)and measure middle ear gas demand, middle ear volume and eustachian
      tube function longitudinally between the time of tube insertion and extrusion/nonfunctioning.
      The data will be used to test the hypotheses that: gas transfer across the middle ear mucosa
      decreases in phase with resolution of middle ear inflammation and effusion; gas transfer
      across the middle ear mucosa is increased by an episode of otorrhea; eustachian tube function
      is unaffected by tympanostomy tube insertion, and measurement of eustachian tube function and
      trans-middle ear mucosa gas transfer predicts disease recurrence and presentation after tube
      extrusion/nonfunctioning. The results of these studies will be used to support or refute
      tested components of existing models of middle ear pressure-regulation and to develop test
      protocols for risk assignments with respect to disease recurrence in individual ears after
      tympanostomy tube extrusion/nonfunctioning.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children 3-6 years old who underwent tympanostomy tube insertion for chronic otitis media
        with effusion within the 6 weeks prior to study enrollment
      
Biospecimen description: 
      Buccal cells obtained for DNA
    
Keywords: otitis media; tympanostomy tube; eustachian tube function; gas exchange; tympanostomy tubes
Study on the Role of Treatment With Vitamin E on Asthmatic Responses in Allergic Asthmatics
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is a common respiratory disease of unknown etiology which currently affects
      approximately 7.5 % of the adult population ( ). Asthma is an inflammatory disorder of the
      airways. Airway inflammation is evident not only in patients with fatal asthma but also in
      mild asthmatics ( ). Oxidant stress, defined as inadequately controlled generation of toxic
      reactive oxygen species (ROS) in the cells or tissues is a common feature of inflammation,
      and has also been documented in asthma ( , ). However, the current understanding of the
      relationship between the inflammation and the oxidant stress in asthmatic airways is poor.
      Does oxidant stress contribute to the expression of asthmatic phenotypes independently of
      inflammation? If so, could asthmatics benefit from supplementation of antioxidants? These
      questions have been nagging us since our laboratory provided credible evidence of oxidant
      injury in the airways of allergic asthmatics ( ). The purpose of our study is to more
      precisely determine 1/ the pathophysiologic role of oxidative stress, and 2/ usefulness of
      antioxidant therapy using vitamin E in allergic asthma.
    


Intervention name(s): Natural source d-α-tocopheryl acetate
Intervention type(s): Drug
Intervention description(s): 1500 units daily for 16 weeks
Other intervention name(s): Vitamin E
Intervention MeSH terms: Vitamin E; Tocopherols; alpha-Tocopherol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Asthma; Allergy; Atopy; Vitamin E; GSTP1; Oxidative stress
Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks
Condition: Cervical Preparation
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study the investigators plan to compare mifepristone and misoprostol use to osmotic
      dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be
      given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2
      hours prior to abortion. Osmotic dilators are the method currently used in our institution,
      and are placed 24 hours prior to abortion. The primary outcome will be the length of the
      procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure,
      participant's assessment of discomfort before mifepristone or dilators, discomfort during the
      abortion procedure, acceptability to participants, and acceptability to staff.
    


Intervention name(s): Mifepristone; osmotic dilators
Intervention type(s): Drug; Device
Intervention description(s): 200 mg po 20-24 hours prior to the procedure; osmotic dilators placed in the cervix 20-24 hours prior to the procedure
Other intervention name(s): Mifeprex; RU-486; Mifegyne; Laminaria; Dilapan-S; Dilapan
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post-prandial Glucose in Healthy Indian Subjects
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The study is designed to determine the extent to which a plant-based ingredient on different
      food formats affect blood glucose responses in healthy subjects
    


Intervention name(s): plant-based dietary supplement; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Blood glucose
Control of Pain From Braces With Patient Advice Sheets
Condition: Orthodontic Appliance Complication
Study type: Interventional

Summary: 
      To compare the analgesic property of acupressure with NSAIDs (Ibuprofen) in controlling pain
      following orthodontic treatment. This will be achieved by assessing the effectiveness of
      acupressure in controlling pain and discomfort by measuring the degree of pain relief after
      bonding of brackets to teeth and placement of initial archwire.
    

Detailed description: 
      Single centred randomised controlled trial with subjects recruited from a hospital
      orthodontic outpatient department in Dundee Dental Hospital.

      If informed consent is obtained, then the subject details will be delivered to the trial
      coordinator for randomisation to one of the groups, NSAIDs or acupressure group.

      All subjects who are eligible for inclusion will be advised of the nature and purpose of the
      trial. The total number of subjects recruited will be approximately 36 with the acupressure
      and NSAID group containing approximately 18 subjects each.

      All subjects who meet the inclusion criteria will be informed of the study and written
      consent sought for their participation. Subjects will be recruited from the new patient
      clinics and routine treatment waiting list. .

      The subjects will be asked to measure the level and duration of pain and discomfort using a
      pain diary to record their experiences using visual analogue scales (VAS). The pain diary
      will be completed from 4 hours to 7 days after treatment after the insertion of the first
      orthodontic aligning archwire.

      Intervention Groups In the acupressure group the subjects will be given an advice sheet and
      advised to use a definitive acupressure point on the back of the hand region to control
      orthodontic pain.

      In the NSAID group the subjects will be given an advice sheet and advised to take Ibuprofen
      for the orthodontic pain

      Pain scores via VAS will be analysed at 4hours, 24 hours, and 7 days after the orthodontic
      treatment. The VAS consists of a horizontal line, 100 mm in length with descriptive words at
      each end of the line which act as anchors e.g. no pain, great pain. The patient marks on the
      line the point that they feel represents their perception of their current state. The VAS
      score is determined by measuring in millimetres from the left hand end of the line to the
      point that the patient marks
    

Intervention name(s): Advice sheet
Intervention type(s): Behavioral
Intervention description(s): Advice on management of post orthodontic pain
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised parallel clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain
Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates through standard practice. Investigators assume
      that the RCT provides the reference standard treatment effect estimate and that failure to
      replicate RCT findings is indicative of the inadequacy of the healthcare claims data for
      replication for a range of possible reasons and does not provide information on the validity
      of the original RCT finding.
    

Intervention name(s): Rivaroxaban; Apixaban
Intervention type(s): Drug; Drug
Intervention description(s): Any rivaroxaban dispensing claim is used as the reference group; Any apixaban dispensing claim is used as the exposure group
Other intervention name(s): Xarelto; Eliquis
Intervention MeSH terms: Rivaroxaban; Apixaban
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, propensity score-matched, retrospective
        cohort study design comparing rivaroxaban to apixaban users. The patients will be required
        to have continuous enrollment during a baseline period of 180 days before initiation of
        rivaroxaban or apixaban (index date). Analysis is restricted to patients with non-valvular
        atrial fibrillation.
Effect of Extracorporeal Adsorption of Plasma Neutrophil Extracellular Traps (NET) in Sepsis
Condition: Sepsis; Sepsis-associated AKI
MeSH terms: Sepsis; Toxemia
Study type: Interventional

Summary: 
      This open non-randomized controlled single center study investigates to what extent the
      removal of circulating Neutrophil Extracellular Traps (NETs) from blood by NucleoCapture
      device has a positive effect on the treatment of patients with sepsis and sepsis-associated
      AKI (SA-AKI).
    

Detailed description: 
      The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's
      inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis
      and septic shock are major causes of death in intensive care units worldwide. Sepsis remains
      the most important cause of AKI in the intensive care unit (ICU) with 15%-20% of patients
      with sepsis-associated AKI (SA-AKI) prescribed RRT . In addition to association with short
      term mortality, AKI is also linked to the later development of CKD, ESRD, and long-term
      increased risk of death

      NETosis is a unique form of neutrophil cell death that is characterized by the release of
      neutrophil extracellular traps (NETs) composed of DNA web-like structures decorated with
      highly cytotoxic protein components. Release of NETs leads to bystander tissue damage
      (including the kidneys) and drives a fatal course of disease in sepsis patients.

      The plasmapheresis is a medical procedure, where pathogenic components are being removed from
      the blood by adsorbers outside the body in an extracorporeal circulation. For removal of the
      pathogenic substances the plasma is separated from the blood to pass the adsorber. The
      purified plasma is merged with the solid blood components thereafter and returned to the
      patient. The NucleoCapture device provide highly selective removal of neutrophil
      extracellular traps from human blood during plasmapheresis procedure.
    

Intervention name(s): NucleoCapture device
Intervention type(s): Device
Intervention description(s): Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm
Other intervention name(s): NucleoCapture selective DNA adsorber
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism
Condition: Autism; Asperger's Syndrome; Pervasive Developmental Disorder Not Otherwise Specified; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety Disorder; Obsessive-compulsive Disorder
MeSH terms: Anxiety Disorders; Autistic Disorder; Obsessive-Compulsive Disorder; Phobia, Social; Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Asperger Syndrome; Anxiety, Separation
Study type: Interventional

Summary: 
      Due to the considerable prevalence of anxiety in youth with autism spectrum disorders, this
      study seeks to establish the efficacy of a modified cognitive behavioral therapy protocol in
      50 adolescents versus other available treatment options.
    

Detailed description: 
      This study will further examine a treatment plan for adolescents with autism spectrum
      disorderS (ASD) and anxiety. Many children who have an autism spectrum disorder experience
      substantial anxiety that can cause impairment above that of an ASD alone. Few studies have
      examined effective treatment options for anxiety in this population. In typically developing
      youth, Cognitive Behavioral Therapy (CBT) is considered the gold standard for treating
      anxiety. But, in order to address the unique needs of children with ASD, this study utilizes
      a modified CBT treatment plan which includes social skills and parent training. In our past
      studies, this cognitive-behavioral treatment plan has been effective in kids with ASD and
      anxiety compared to kids who did not receive any treatment.The current study compares this
      modified treatment plan to other treatment options in the community. The experimental
      component of this study is being assigned to 1 of 2 groups. The first group will receive CBT
      immediately for a period of 16 weeks. The second group will have to wait 16 weeks before
      receiving CBT. During this time period, children may receive any other services in the
      community. Overall, all adolescents receive the same type of therapy; it's matter of whether
      he/she receives it immediately or after a wait period. Sixteen weekly sessions comprise CBT.
      All therapy and assessments associated with this study will be free of charge.
    

Intervention name(s): Cognitive Behavioral Therapy; Treatment as usual
Intervention type(s): Other; Other
Intervention description(s): This condition involves 16 weekly CBT sessions.; This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Asperger's Syndrome; Pervasive Developmental Disorder Not Otherwise Specified; Treatment; Cognitive-behavioral therapy; Anxiety; Children; Therapy
A Single Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the
      pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy
      Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7).
      2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral
      administration before breakfast, the other is oral administration 30 minutes after breakfast
      with high fat food.
    


Intervention name(s): Anaprazole Sodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg，fasting oral administration.; single dose, fasting oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study of Docosahexaenoic Acid (DHA) in Obese Menopausal Women
Condition: Breast Cancer; Obesity
Study type: Interventional

Summary: 
      This study aims to determine if a supplement of an omega-3-fatty acid (docosahexaenoic - DHA)
      lowers inflammation in human fat tissue thereby lowering estrogen production and the
      potential risk for breast cancer. The investigators also aim to study how this occurs to
      discover the basis for other potential treatments to lower estrogen production in fat tissue
      and decrease the risk of breast cancer.
    

Detailed description: 
      Breast cancer is one of the most frequently seen cancers in the United States. Breast cancer
      occurs at all ages but is particularly common in post menopausal women. Obesity increases the
      risk of breast cancer primarily of the type that is stimulated by the female sex hormone
      estrogen. In obesity, fat cells produce estrogen which can alter breast tissue, while
      lowering blood estrogen reduces the incidence of breast cancer. Inflammation of fat tissue,
      the coronary blood vessels and the liver are also seen with obesity. Animal experiments have
      shown the inflammation in fat tissue increases the production of estrogen, thus reducing
      inflammation in fat tissue might lower estrogen levels and the risk of breast cancer in obese
      women. A diet high in omega-3-fatty acids, such as those found in fish oil, has been shown in
      mice to reduce inflammation and aromatase expression (rate limiting enzyme for estrogen
      synthesis) in fat tissue.

      This pilot study of five obese, post-menopausal women and an additional 12 morbidly obese
      post-menopausal women will include nutritional and medical evaluations, a four day inpatient
      hospital stay on a regular diet, to measure the inflammation and the estrogen producing
      machinery of each volunteer subject. Following these baseline measurements, subjects will be
      provided DHA supplements to take daily for three months and requested to weigh themselves
      twice weekly at home with the goal of maintaining their weight. Telephone interviews will be
      performed at scheduled points to check-in with the subjects and after six weeks a return
      visit to the OPRC will be conducted to assess progress and provide additional supplements. At
      three months each subject will be readmitted to the hospital and repeat the tests performed
      before starting on the DHA supplement. If the study shows feasibility and positive results it
      will be extended to more subjects and other interventions in the future.
    

Intervention name(s): dietary intervention
Intervention type(s): Dietary Supplement
Intervention description(s): dietary intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Butylated Hydroxytoluene and BI 54903 XX Via Respimat® Soft MistTM Inhaler B in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to investigate safety, tolerability and pharmacokinetics of
      butylated hydroxytoluene (BHT) (sub-study 1) administered via Respimat® Soft MistTM Inhaler B
      (SMI B); to assess safety, tolerability and pharmacokinetics of multiple rising doses of BI
      54903 XX administered via Respimat® SMI B (main study), and to compare systemic exposure of
      single dose BI 54903 XX administered via Respimat® SMI B (sub-study 2) with single dose
      Alvesco® (ciclesonide) administered via HFA-134a propellant metered dose inhaler (MDI).
    


Intervention name(s): BHT low; BHT medium; BHT high; BI 54903 XX low; BI 54903 XX medium 1; BI 54903 XX medium 2; BI 54903 XX high; Ciclesonide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Mechanical Ventilation on the Incidence of Pneumothorax After Subclavian Vein Catheterization
Condition: Subclavian Vein Catheterization
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether mechanical ventilation influences the
      incidence of pneumothorax after subclavian venous catheterization.
    


Intervention name(s): Lungs were not mechanically ventilated during subclavian vein catheterization; Lungs were mechanically ventilated during subclavian vein catheterization
Intervention type(s): Other; Other
Intervention description(s): Control group; Ventilated group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention