bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Comprehensive Migraine Intervention
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder
      is often not diagnosed and not appropriately treated. The goal of this proposal is to
      determine whether a migraine protocol designed for use in an emergency room can be used to
      deliver the headache care that many migraine patients never receive. This is a randomized
      trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care
      or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the
      following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational
      intervention, reading material, and headache diaries, 3) two migraine specific medications
      and 4) expedited referral to a headache specialist, if needed. Patients in the typical care
      arm will receive whatever intervention the emergency physician feels is most appropriate.
      Headache surveys will be used toll if the protocol improves migraine-related pain and
      functional disability one month after the ER visit.
    


Intervention name(s): Naproxen; Sumatriptan; Migraine education; Reenforcement of diagnosis; Typical care
Intervention type(s): Drug; Drug; Behavioral; Behavioral; Other
Intervention description(s): Naproxen 500mg PO bid prn headache; 100mg po q day prn headache; Educational program available through NIH/ national library of medicine/ X-plain; Patient advised has migraine headache and how the headache meets migraine criteria; Care to be determined by attending physician
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Concussion Active Rehabilitation
Condition: Pediatric ALL; Concussion, Mild; Concussion, Brain; Concussion, Intermediate
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      In this study, the investigator plans a randomized trial of active rehabilitation and
      standard care for acute concussion management. The investigator hypothesizes that patients
      with acute concussions managed with active rehabilitation will have decreased risk of
      prolonged concussion symptoms.
    

Detailed description: 
      Specific Aims:

      To compare the risk of prolonged concussion symptoms (PCS) between an active rehabilitation
      and a standard care cohort after an acute concussion.

      To determine if active rehabilitation compared to routine care reduces the risk of PCS for
      high-risk patients.

      This is a prospective randomized control trial of pediatric patients in the emergency
      department (ED) diagnosed with an acute concussion. Patients 8-18 years old with an acute
      concussion diagnosis will be eligible. All patients will receive pedometers to monitor their
      activity levels. If the patient is in the control group the patient will receive standard
      concussion management per the treating ED physician. Patients in the active rehabilitation
      group will receive instructions based on the latest CDC concussion management guidelines that
      specify a symptom-limited progressive return to full activities. This group will be
      instructed to take at least 10,000 steps a day for five days on their pedometers.

      One to five days after the ED concussion diagnosis a trained research coordinator will call
      all subjects to reinforce the management plan.

      28 to 32 days post ED concussion diagnosis, research assistants will contact subjects via
      email or phone call to complete the concussion symptoms inventory.
    

Intervention name(s): Active Rehabilitation Group/Case
Intervention type(s): Behavioral
Intervention description(s): If the patient is in the active rehabilitation group, the patient will receive instructions based on the latest CDC concussion management guidelines that specify a symptom-limited progressive return to full activities. This group will be instructed to take at least 10,000 steps a day for five days on their pedometers. In addition, they will also watch a two-minute video by the PI and research team reinforcing the active rehabilitation instructions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion.
The randomization plan will include randomization based on sex.
Group A: active care Group B: routine/standard care
Masking: None (Open Label)
Primary purpose: Treatment
Ablation or Surgery for Atrial Fibrillation (AF) Treatment
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this study is to compare 2 invasive strategies for Atrial Fibrillation
      treatment, Endocardial catheter ablation isolation of the Pulmonary veins versus minimally
      invasive thoracoscopic surgical epicardial isolation. Both strategies are in use for several
      years now, and have been reported as a successful strategy with success rates of 60-90%.
      However, it is not known which technique is preferable in a given patient population in terms
      of efficacy to cure AF, safety, or patient discomfort. Therefore, in the present trial a
      randomized study is proposed to provide more insight into the relative merits of both
      techniques
    

Detailed description: 
      Atrial Fibrillation is the most common cardiac arrhythmia, affecting millions of people
      around the world. It is a large burden on health care resources and may even lead to a
      shorter life expectancy. Drug treatment has been found insufficient and sometimes even
      hazardous to the pt. Traditionally, there was only one invasive approach available, being
      MAZE 3 procedure by means of full open chest cardiac surgery. This was a very invasive
      approach, limited to only a few skilled surgeons, with insufficient options to treat large pt
      volume.

      With the discovery that AF often is initiated and maintained by electrical instability inside
      and around the Pulmonary Veins, catheter ablation is now a widely accepted early invasive
      strategy to cure AF. Success rates of 60% to 90% have been reported, depending on technique
      employed and the type of AF (Resp, chronic versus paroxysmal)
    

Intervention name(s): Catheter Ablation; Surgical Ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): RF ablation with complete circumferential ablation around the right and PVs, optional additional lines between the lower and upper PVs, and towards the mitral valve ring.; Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation
Clinical Study on the Bioequivalence of Vitamin D in Healthy Adults
Condition: Bioequivalence of Vitamin D in Healthy Adults
Study type: Interventional

Summary: 
      The objective of this clinical study is to evaluate and compare the bioequivalence between a
      single oral dose of vitamin D3 gummy vitamin versus vitamin D3 tablet in healthy adults.
    

Detailed description: 
      The investigators hypothesize that the gummy and tablet preparations of vitamin D3 supplement
      will be biologically equivalent, as defined by the absence of a statistically significant
      difference in bioavailability measured as blood levels of vitamin D3 after administration of
      the same oral dose of vitamin D3 as gummy and tablet supplementation.
    

Intervention name(s): vitamin D3
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, examiner-blind, comparator-controlled crossover study
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Vitamin D
Emergence Agitation in Pediatric Strabismus Surgery
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Strabismus; Emergence Delirium
Study type: Interventional

Summary: 
      This study was performed to assess the effects of continuous remifentanil infusion and single
      bolus administration of fentanyl on the incidence of emergence agitation in pediatrics
      undergoing strabismus surgery.
    


Intervention name(s): fentanyl group; remifentanil group
Intervention type(s): Drug; Drug
Intervention description(s): fentanyl 2 μg/kg; remifentanil 0.2 μg/kg/min
Intervention MeSH terms: Fentanyl; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Emergence Agitation; fentanyl; remifentanil; children
Evaluation of Apraglutide on Gastric Emptying
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the effect of apraglutide on gastric emptying of liquids
      in healthy subjects, as measured by the PK of acetaminophen mixed with a liquid meal.
    

Detailed description: 
      This is a single-center, double-blind, randomized, multiple-dose, parallel trial with a total
      duration of up to 50 days. The trial population will consist of healthy volunteers. Eligible
      subjects will be randomized to receive either subcutaneous (SC) apraglutide or matching
      placebo. The effect of apraglutide on gastric emptying of liquids will be assessed by the
      measure of PK of acetaminophen mixed with a liquid meal.

      There will be two treatment periods, occurring according to the same sequence. In Period 1
      acetaminophen will be given on Day 1, apraglutide/placebo will be injected on Day2. In Period
      2 apraglutide/placebo will be injected on Day 9 and acetaminophen will be given on Day 10.
      This will allow to assess the PK of acetaminophen without the effect of apraglutide in Period
      1, and to assess the PK of acetaminophen at the maximum concentration of apraglutide in
      Period 2.
    

Intervention name(s): Apraglutide; Placebo; Acetaminophen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Peptide analogue of GLP-2; Matching placebo to apraglutide; Acetaminophen mixed with a liquid meal
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Gastric emptying; Pharmacokinetics of acetaminophen
Medical Abortion With Single Daily Dose of Misoprostol
Condition: Miscarriage
MeSH terms: Abortion, Spontaneous
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Medical abortion using multiple vs single daily dose of misoprostol in first trimester
      miscarriage.
    


Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): Misoprostol
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?
Condition: Adolescents With Food Insecurity
Study type: Interventional

Summary: 
      Quality nutrient intake is essential for proper development and well-being of children in all
      aspects of health, including cognitive development. Eggs are of particular interest based on
      potential cognitive and neurological benefits due in part to significant concentrations of
      choline and lutein. While overall, choline and lutein have received considerable attention in
      the literature in relation to cognition and brain function, most studies involving intake in
      young adults have had short intervention periods ranging from 90 minutes to 3 days. Food
      insecurity has been associated with decreased academic performance. Given that populations
      with food insecurity have limited resources to direct towards nutrition, identifying how a
      widely available, highly versatile and largely affordable source of nutrients (i.e. eggs) may
      have favorable impacts on cognitive function and brain function will be valuable in informing
      public health recommendations in this at-risk population. As such the investigators will
      examine whether an increased egg consumption dietary prescription can have positive effects
      on functional activity (i.e. fMRI) during an Eriksen-Flanker task, anatomical changes in the
      brain (i.e. DTI, MRI), and cognitive abilities as measured by the Stop Signal Reaction Time
      task, Operation Span task, Raven's Progressive Matrices and the Boston Naming Task.
    


Intervention name(s): Increased Egg Consumption; Typical diet
Intervention type(s): Other; Other
Intervention description(s): Subjects will be instructed to use a weekly food purchase supplement for inclusion of 2 additional eggs per day to be added to subject's typical daily diet.; Subjects will be instructed to maintain their current dietary patterns.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Pain After Laparoscopic Cholecystectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      To the investigators' knowledge, no study has looked at differences in postoperative pain
      when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and
      propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total
      intravenous anesthesia with propofol will lead to less postoperative pain in the first 24
      hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with
      isoflurane, desflurane or sevoflurane.

      PURPOSE

      To find out if maintenance of anesthesia with propofol leads to less postoperative pain after
      laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane,
      desflurane, or sevoflurane.
    


Intervention name(s): Desflurane; Sevoflurane; Isoflurane; Propofol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane; Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane; Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane; Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion
Intervention MeSH terms: Propofol; Sevoflurane; Desflurane; Isoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Quality Rating Scale for Patients in Complex Situations
Condition: Patients in Complex Situations
Study type: Observational

Summary: 
      The prevalence of multimorbid patients and complex care is increasing in France and elsewhere
      in the world. It concerns 60% of the over 65 years old. Comprehensive care, the involvement
      of the patient and his caregivers appear as the solutions for the management of these new
      care situations. The structures of multi-professional grouping, developing a coordinated
      exercise (GECO), appear as the privileged place to take care of these patients. These
      structures become the main place of exercise in France (improved working conditions for
      professionals, financial incentives, public policy, etc.); they have shown their ability to
      formulate patient care protocols, to produce coordinated exercise, to better involve the
      patient and caregivers in their care. The question of improving the quality of care arises.
      To date, there is no data on the subject apart from some evaluations mainly medico-economic.

      The patient's place in the evaluation showed his interest with the existence of a proven
      correlation between patient satisfaction in particular and his compliance and health
      outcomes.
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Completion of the questionnaire by the patient after consultation with the general practitioner
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient followed in the primary care center and being in a complex care situation,
        benefiting from a multi-professional care
      
Keywords: Multimorbidity; Exercise coordinated groups (GECO); Caregivers
Dynamic Postural Control After Exercise
Condition: Postural Control
Study type: Interventional

Summary: 
      The aim was to analyze the influence of fatigue on the dynamic postural control in one-leg
      standing and in jump landing, followed by stabilization or side jumps, and to compare
      athletes of different levels with control subjects.
    


Intervention name(s): treadmill run
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Gait Analysis Following Total Ankle Replacement and Subtalar Fusion
Condition: Ankle Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Subtalar fusion is commonly performed in post-traumatic subtalar osteoarthritis, rheumatoid
      arthritis, posterior tibial tendon dysfunction, tarsal coalition and primary subtalar
      osteoarthritis. Patients with osteoarthritis or severe dysfunction involving both the ankle
      and the subtalar joint may benefit from an tibiotalocalcaneal fusion (TTC) or an ankle
      replacement and subtalar fusion. With the development of new prosthetic designs and of
      surgical techniques, total ankle replacements (TAR) became a reasonable alternative to fusion
      with functional and quality of life improvements. A gait analysis of patients that underwent
      TAR and simultaneous subtalar fusion allows to study with precision and reliability the ankle
      range of motion (ROM). On the contrary, in healthy subjects or in patients that underwent
      isolated TAR this is not possible because the ankle ROM is influenced by the ROM of the
      subtalar joint in such a way that it is not possible to analyze the two joints separately.
      Also, excluding the role of the subtalar joint, it is possible to accurately analyze and
      compare the consequences on ankle kinematics of two different prosthetic designs.
    

Detailed description: 
      Patients who previously have underwent TAR and simultaneous subtalar fusion are
      retrospectively reviewed. Minimum follow-up after the surgery is 12 months.
    

Intervention name(s): TAR through anterior approach and subtalar fusion; TAR through lateral approach and subtalar fusion
Intervention type(s): Procedure; Procedure
Intervention description(s): Simultaneous total ankle replacement through anterior approach and subtalar fusion; Simultaneous total ankle replacement through lateral approach and subtalar fusion
Other intervention name(s): Hintegra ankle system; Zimmer TM (Trabecular Metal ) Total Ankle
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent simoultanous total ankle replacement and subtalar fusion
Vacuum Myofascial Therapy Device and Physical Activity for the Treatment of Chronic Non-specific Low Back Pain. A Single Blind Randomized Clinical Trial
Condition: Chronic Nonspecific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The term non-specific low back pain refers to the painful symptoms located in the lumbar
      region, which is delimited between the lower margin of the ribs and the lower limit of the
      buttocks
    

Detailed description: 
      This study aimed to investigate the efficacy of a vacuum myofascial therapy device (VT) for
      improving pressure pain thresholds (PPTs), functionality, range of motion (ROM), low back
      pain-related disability, pain, and quality of life in patients with non-specific low back
      pain. Methods: A randomized controlled trial in which participants with non-specific low back
      pain (NP) were randomly assigned to either an experimental (VT) or a comparison physical
      therapy program (PTP) group.
    

Intervention name(s): Vacuum myofascial therapy and physical activity program.; Physical activity program.
Intervention type(s): Procedure; Other
Intervention description(s): This group will treated five times with the analgesic program of physium therapy. Each maneuver was performed once per session by slow and progressive. The whole procedure lasted no more than 30 minutes.
Then they carried out the physical activity program; Active Comparator: Physical activity The exercise protocol would last 5 weeks, performing 3 exercise sessions per week, with an effective work time of 20 minutes per session. The exercises would be directly focused on activating the core stabilizing muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A specialist physician will be diagnosed chronic nonspecific low back pain
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: negative pressure; vacuum; low back pain; physical therapy modalities; cupping
Long-Term Olanzapine Treatment in Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will determine the short- and long-term safety and effectiveness of the drug
      olanzapine (Zyprexa®) for reducing symptoms of autism in children.
    

Detailed description: 
      Autism is a serious childhood disorder that can significantly impair functioning and
      development. Educational and psychosocial programs are standard treatments for autistic
      children, but drug therapy is often needed as well. Haloperidol is the drug most commonly
      prescribed for symptoms of autism. However, long-term administration of haloperidol has been
      associated with adverse effects such as blurred vision, constipation, and nausea. The
      investigation of alternative drug treatments is necessary. This study will determine whether
      the antipsychotic drug olanzapine may be a safe and effective alternative to haloperidol for
      treating symptoms of autism in children.

      This study will last 36 weeks and will comprise 2 phases. In Phase I, participants will be
      randomly assigned to receive either olanzapine or placebo for 12 weeks. Participants who do
      not respond to treatment will complete their participation in the study. Participants who
      respond to their assigned Phase I treatment will continue onto Phase II. All Phase II
      participants will receive olanzapine daily for 6 months. Self-report scales and checklists
      will be used to assess participants after each phase; these measures will be completed by
      participants and their parents.
    

Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention description(s): Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day
Other intervention name(s): Open Olanzapine
Intervention MeSH terms: Olanzapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Treatment; Child; Olanzapine