bioihbjkbjnl/mcl2 huggingface dataset:
The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy
Condition: Peanut Allergy; Milk Allergy; Egg Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity; Milk Hypersensitivity; Egg Hypersensitivity
Study type: Observational

Summary: 
      Food allergy is on the rise within the pediatric population. Having food allergy can cause
      medical, nutritional and psychological issues in those who suffer with it. Although making
      the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy
      has been a challenge. Skin prick testing and food-specific IgE testing of the blood can give
      positive results that are false. Currently, Oral Food Challenges are the best way to diagnose
      a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily
      available to suspected food allergy sufferers. This study is designed to examine the
      effectiveness of an allergy-detecting blood test called IMMULITE 2000 manufactured by the
      study sponsor, Siemens.
    


Intervention name(s): Oral food challenge
Intervention type(s): Procedure
Intervention description(s): Confirmation of allergy to egg, milk and/or peanut through an oral food challenge or documentation of a positive oral food challenge.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will be primarily obtained from the pediatric clinic at National Jewish
        Health from those suspected of egg, milk and/or peanut food allergy.
      
Keywords: Peanut allergy; Milk allergy; Egg allergy; Pediatric; Adult; Food allergy
School Based Prevention for Childhood Anxiety
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study was designed to conceptualize a school-based prevention program or childhood
      anxiety.
    

Detailed description: 
      This is a project corresponding to a career development grant. The main goal of the proposed
      research was to identify potential barriers to implementing a school-based anxiety preventive
      intervention, identify strategies to overcome these barriers, and use this information to
      test a school-based indicated intervention for child anxiety.
    

Intervention name(s): REACH for Success; Self-Study
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exposure-based cognitive behavioral with social skill training (cognitive self control, relaxation, skills for conversations and assertiveness); Books for youth about anxiety management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Deep Brain Stimulation for Patients With Dementia With Lewy Bodies
Condition: Dementia With Lewy Bodies
MeSH terms: Dementia; Lewy Body Disease
Study type: Interventional

Summary: 
      This trial aims to collect pilot data to explore whether bilateral deep brain stimulation
      (DBS) of the Nucleus Basalis of Meynert (NBM) has beneficial effects on memory and thinking
      impairments among individuals with Dementia with Lewy Bodies (DLB).
    

Detailed description: 
      We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving
      cognitive deficits in DLB patients. Six patients with DLB with moderate cognitive impairments
      (including but not restricted to deficits in attention and working memory) will have
      bilateral DBS electrodes implanted to ensure that superficial contacts lie in the motor
      Globus Pallidum interna (GPi) target, while the deepest electrical contacts lie in the NBM.
      We will place electrodes using our conventional image-guided, stereotactic frame-based
      procedure. Once the surgical wounds have healed, patients will be randomised into 2 groups in
      a crossover trial design to have 6 week periods of NBM stimulation switched on or switched
      off separated by a 2 week washout period, following which the patient will cross over to have
      the opposite condition for a further 6 weeks. Outcome measures collected at the 6 weeks and
      14 weeks timepoints will be compared according to whether each patient was ON or OFF
      stimulation at that timepoint.

      At the end of the crossover period, all patients will be invited for continued follow up with
      stimulation switched on and will have neuropsychological evaluations at 6 monthly intervals.
      Patients will be given the option of receiving additional conventional stimulation to the
      motor GPi, through the higher contacts of each electrode, at the end of the crossover period
      if required for any coexisting Parkinsonian motor complications of DLB.
    

Intervention name(s): Bilateral Nucleus Basalis Meynert DBS; Sham Nucleus Basalis Meynert DBS
Intervention type(s): Procedure; Procedure
Intervention description(s): Low frequency stimulation applied using standard Deep brain stimualtion hardware.; DBS system switched off.
Other intervention name(s): Active Deep Brain Stimulation; Sham DBS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Safety and Feasibility Study of the Eddii Mobile Application
Condition: Type-1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study is designed to measure the safety and feasibility of the Eddii mobile app for
      children living with Type-1 diabetes and using a CGM (Continuous Glucose monitor).
    

Detailed description: 
      Wearable continuous glucose monitoring (CGM) sensors have revolutionized diabetes management
      over the past decade. By providing blood glucose (BG) concentration measurements continuously
      over consecutive days, CGMs are an increasingly adopted technology. While CGM devices have
      been shown to improve the safety and effectiveness of diabetes therapy to reduce hypoglycemia
      incidents and durability and to decrease glycemic variability CGM software and tools
      available for users to feel motivated and engaged are limited. Users of CGM often use an app
      that provides an interface for them to track their BG. In most cases, this app is offered by
      their CGM device provider.

      These interfaces are considerably basic and scientific in nature, often developed by
      scientists and engineers for the everyday user. These apps are particularly dull and tiresome
      for children and adolescents living with diabetes. Current real-time CGM interfaces present
      real-time BG reading, in addition to the BG trend and a historical chart, together with
      minimal options for the user to enter lifestyle data such as medications, meals, and
      exercise. Examples of such default interfaces are ones offered by Dexcom, Medtronic Guardian
      and Freestyle Libre. While some of these apps provide patterns and health summaries to the
      user, these are provided in a separate app to the one streaming real-time BG. With the
      emergence of rtAPI (real-time Application Programming Interface) integrations with CGMs,
      there is ample opportunity to improve the dynamism, sophistication, and offerings within
      these CGM Apps , creating a platform that delights the user rather than one that makes
      diabetes management seem like a daily chore. Furthermore, it is hypothesized that creating
      additional engagement in the form of games and real-life rewards will improve glycemic
      control.
    

Intervention name(s): Eddii mobile application
Intervention type(s): Behavioral
Intervention description(s): Participants will use the Eddii mobile application in the intervention arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Toward Zero Prescribed Opioids for Outpatient General Surgery
Condition: Opioid Misuse and Addiction; Pain
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigators have created an opioid reduction "package" which includes patient education,
      non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions
      provided at discharge in an attempt to reduce the number of opioid consumption after
      outpatient general surgery.
    

Detailed description: 
      Between November 2019 and July 2021, patients undergoing elective inguinal hernia repair
      (IHR) or cholecystectomy were enrolled in the study. Patients were divided into three
      cohorts: Control, opioid sparing (OS), or zero-opioid (ZO). Control patients did not have any
      intervention; OS patients had an opioid reduction intervention protocol applied (patient
      education and perioperative multimodal analgesia) and were provided an opioid prescription at
      discharge; the ZO had the same protocol, however patients were not provided opioid
      prescriptions at discharge. Two weeks after discharge patients were interviewed to record
      opioid consumption, pain scores, and level of satisfaction since discharge.
    

Intervention name(s): Oxycodone; Zero Opioid Protocol
Intervention type(s): Drug; Behavioral
Intervention description(s): Investigators provided set opioid prescriptions for 10 pills each patient.; Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
Intervention MeSH terms: Oxycodone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Control group, opioid sparing arm, and zero opioid arm
Masking: None (Open Label)
Primary purpose: Prevention
Effective Analgesia During Routine Immunizations
Condition: Pain
Study type: Observational

Summary: 
      The purpose of this study is to observe and measure the analgesic effectiveness of the 5 S's
      (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with
      sucrose, during routine immunizations at 2 and 4 month well child visits.
    

Detailed description: 
      Study Procedure

      Infants meeting inclusion criteria were identified daily by reviewing the list of patients
      scheduled for a 2 or 4 month well child visit at the outpatient site. The parent or legal
      guardian was approached prior to vaccination by the research assistant for participation in
      the study. If the parent/guardian accepted to participate in the vaccine study, the
      consenting process was performed and patients were brought to a designated examination room.
      Infants of parents or guardians who consented were randomly assigned to one of four study
      groups using pre-sealed cards. Ten cards were assigned to each group for a total of 40 cards,
      which were recycled with each group of 40 infants enrolled into the study. The four groups of
      the study included:

        1. 2 ml of water 2 minutes prior to immunization and comfort by parent or guardian after
           Immunization (Control Group)

        2. 2 ml of 24% oral sucrose 2 minutes prior to immunization and comfort by parent or
           guardian after immunization (Sucrose Group)

        3. 2 ml of water 2 minutes prior to immunization and physical intervention using the 5 S's
           by researcher after immunization (Physical Group)

        4. 2 ml of 24% oral sucrose 2 minutes prior to immunization and physical intervention using
           the 5 S's by researcher after immunization (Physical and Sucrose Group)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients were enrolled from the General Academic Pediatric outpatient practice located
        at The Children's Hospital of The King's Daughters in Norfolk, VA. This practice serves a
        predominantly urban, Medicaid enrolled, African-American population and has approximately
        30,000 annual visits per year.
      
Keywords: infant; immunizations; pain; pain management; vaccines; analgesia
The Effect of Minimal Flow Sevoflurane Anesthesia
Condition: Anesthesia; Functional; Anesthesia Awareness
MeSH terms: Intraoperative Awareness
Study type: Interventional

Summary: 
      Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on
      hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.
    

Detailed description: 
      Introduction: Low-flow anesthesia techniques have regained popularity in recent years with
      the development of low solubility volatile agents such as sevoflurane and desflurane, and
      modern anesthesia devices. Reducing the flow of fresh gas as much as possible will reduce the
      amount of volatile agent used, thus preventing air pollution, providing lower costs, and also
      preserving heat and moisture in the respiratory tract by using rebreathing systems.
      Laparoscopic surgery is superior to open surgical techniques due to its minimally invasive
      nature, less postoperative pain, less incidence of wound infections, shortening the
      hospitalization, and allowing patients to return to their normal lives sooner after the
      operation.

      Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on
      hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

      Material and Method: Seventy patients with ASA (American Society of Anesthesiologists) class
      I-II between the ages of 18-65 undergoing elective laparoscopic cholecystectomy were included
      in the study. After the patients were randomly selected by computer, they were divided into
      two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1
      and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1. In both
      groups. Demographic data, duration of anesthesia, operation times, recovery times,
      hemodynamic parameters and arterial blood gas parameters of all patients were recorded. The
      patient data collected in both groups were compared statistically.
    

Intervention name(s): Sevoflurane inhalant product
Intervention type(s): Drug
Intervention description(s): The sevoflurane dose differed in both groups in relation to the fresh gas flow. Since the fresh gas flow is less in group M, the concentration of sevoflurane consumed by the patient at the end of the case will be less.
Other intervention name(s): Sevorane
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: they will divided into two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1 and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: minimal flow anesthesia; laparoscopic cholecystectomy
Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to establish the bioequivalence of linagliptin/
      pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and
      pioglitazone administered together.
    


Intervention name(s): Linagliptin + Pioglitazone; Linagliptin + Pioglitazone; Linagliptin/Pioglitazone; Linagliptin/Pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Medium doses, oral administration; Medium doses, oral administration; Medium dose oral administration; Medium dose oral administration
Intervention MeSH terms: Pioglitazone; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Detectability of the Bladder With an Early Prototype of the Bladder Sensor
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence
Study type: Interventional

Summary: 
      This is an explorative, monocentric, feasibility study to evaluate the detectability of the
      bladder in healthy subjects by ultrasound monitoring with the early prototype of a future
      bladder sensor, which is intended for use for an individual suffering from urinary
      incontinence.
    

Detailed description: 
      The purpose of this clinical investigation with healthy subjects (defined as subjects without
      urological problems or lower urinary tract symptoms, assured by pre-defined inclusion and
      exclusion criteria) is to collect raw measurement data of the urinary bladder region of
      volunteers with the TENA-PROTO1, in multiple postural positions to evaluate the detectability
      of the bladder in the intended users and to determine the position criteria for the (future)
      ultrasound sensor on the lower abdomen. Secondarily, this clinical investigation aims to
      collect data on the adhesive and supportive belt used to fix the transducer assembly to the
      lower abdomen by the subject. Furthermore, safety of the subjects will be continously
      documented such as adverse events (AE) and device deficiencies (DD); AEs, Adverse Device
      Events (ADE), Severe Adverse Events (SAE), Severe Adverse Device effects (SADE),
      Unanticipated Serious Adverse Device Effects (USADE) and DDs.
    

Intervention name(s): TENA-PROTO1
Intervention type(s): Device
Intervention description(s): Each volunteer will test the TENA-PROTO1 according to a standardized protocol in multiple postural positions to evaluate the detectability of the bladder by help of the investigational device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Study : LEVOBUPIVACAINE Versus Placebo
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The locoregional anaesthesia is increasingly important in surgical practice, often allowing
      to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading
      to a longer hospitalization because of the pain resulting from the surgery. The
      Levobupivacaïne (Chirocaïne) administered through catheters placed in the caesarean scars,
      showed its efficiency in post-operative analgesia.

      Method : realization of a double blind prospective randomized study, control versus placebo
      Purpose : to show that the local administration of a unique dose of analgesia reduce the
      post-operative pain with a little or non-invasive technique
    

Detailed description: 
      The study will be done at the department of Obstétric and gynecology, in the CHU of
      Saint-Etienne. It will include all patients requiring a caesarean without any
      contraindication.

      All the patients requiring a urgent or a very urgent caesarean will be excluded because a
      rapid consent can't be obtained and the product preparation can't be done.

      Inclusion after information and minimum one hour of time for consideration. Randomization :
      the teatment group will be randomized according to the patient number : control versus
      placebo : 70 patients in the group infiltration of levobupivacaïne and 70 patients in the
      group infiltration of a placebo. Every product will be prepared in a 30 ml syringe filled
      with levobupivacaïne or 0,9 % sodium chloride depending on the group of randomization. All
      patients will get their caesarean according to the same technique, then, before the cutaneous
      close, the product will be injected in the caesarean wall.

      Fllow-up : supervision of the pain (morphine consumption, VAS) and of undesirable effects.
    

Intervention name(s): chirocaine (Levobupivacaine); sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): levobupivacaine 0,5 % 30 ml infiltration (150 mg); sodium chloride : 0,9% 30 ml
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized; analgesic; caesarean scars; locoregional anaesthesia; infiltration; levobupivacaïne; Chirocaïne; caesarian; unique administration; post-caesarian analgesic
A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety
      of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing
      percutaneous coronary intervention (PCI). Patients will be randomized to receive an
      intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI.
      Follow-up will be for 4 months.
    


Intervention name(s): Percutaneous Coronary Intervention (PCI); RO4905417; RO4905417; placebo
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention description(s): at least 1 hour and up to 24 hours after completion of drug infusion; 5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI; 20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI; iv infusion, completed at least 1 hour and up to 24 hours before PCI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment