bioihbjkbjnl/mcl2 huggingface dataset:
Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia
Condition: Dystonia, Primary
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      Cortical excitability depends on inhibitory mechanisms efficiency among which long latency
      intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic
      stimulation (TMS). Some recent evidences suggest that LICI may be one of the mechanisms by
      which the motor comment is adapted to the ongoing motor task with LICI strength being
      dependent on task complexity. In writer cramp and musician cramp, two forms of dystonia, the
      cortical excitability is not correctly modulated in some complex gestures. the hypothesis is
      that this task dependent perturbation of excitability in writer cramp could be due to a lack
      of LICI efficiency.
    


Intervention name(s): LICI
Intervention type(s): Other
Intervention description(s): Paired pulse TMS to measure LICI and late cortical disinhibition
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 10 patient with dystonia and 10 healthy subject paired by sex and age.
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Family-Professional Collaboration on Functional Goals Achievement of Children With Cerebral Palsy and Caregivers' Quality of Life and Burden
Condition: Cerebral Palsy; Collaborative Intervention Process; Functional Goals Achievement
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of implanting the family-professional
      collaboration practice model on the functional goals achievement of children with CP and
      their caregivers' quality of life and burden. The children will be treated by physical
      therapists who will be assigned to two groups (control and experimental).
    

Detailed description: 
      A randomized, single-blinded control study involved 28 physical therapists and 44 pairs of
      children with CP aged 2-12 years old and their caregivers will be assigned randomly into
      experimental and control groups. Physical therapists in the experimental group will receive
      two instructional sessions (3 hours each) to implement collaboration during the therapy
      sessions and physical therapists in the control group will receive no instructions. Children
      will receive 45- 60 minutes therapy sessions (5 sessions/week) for six weeks. Goal Attainment
      Scaling (GAS) to measure the children's goals achievement change rate, the Arabic version of
      the World Health Organization Quality of Life Brief (WHOQOL- Brief) to examine the
      caregivers' quality of life, and the Zarit Burden Interview Arabic Abridged version (ZBI-A)
      to evaluate the caregivers' burden will be used.
    

Intervention name(s): family-professional collaboration practice model
Intervention type(s): Other
Intervention description(s): Online instructional sessions will be conducted in two sessions for six hours (3 hours per session) for the physical therapists in the experimental group. The instructional session focus on explaining the specific strategies and process to implement the Family-professional Collaboration (four step process) Model as ( Step 1: Mutually agreed-upon goals, Step 2: Shared planning, Step 3: Shared implementation and Step 4: Shared evaluation of child and family outcomes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Family-professional collaboration; partnerships; children's performance; quality of life; burden; caregivers; physical therapists
Efficacy of the PARI LC Sprint Sp Nebulizer for Acute Asthma Attack in Hospitalized Children Less Than 36 Months of Age
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The main objective of this study is to determine whether the use of the PARI LC Sprint Sp
      nebulizer in the treatment of asthma in children under 36 months reduces the duration of
      hospitalization.
    

Detailed description: 
      The secondary objectives of this study are to evaluate whether the use of the LC Sprint Sp
      Nebulizer results in:

      A-shortened duration of oxygen-dependence.

      B-reduced side effects by assessing the patient's heart rate before and 30 minutes after the
      first aerosol and noting the occurrence of desaturation <90% during the nebulisation
      sessions.

      C-increased acceptance of the aerosol, measured via a questionnaire given to the patient's
      parents at the end of hospitalization (a single questionnaire will be completed by either
      parent or both parents).

      D-shortened length of stay based on the following discharge criteria: observation of a
      respiratory severity score ≤ 2 (Clinical Asthma Score (CAS)) for at least 12 consecutive
      hours and a transcutaneous oxygen saturation (SpO2)> 94% when awake or > 91% during sleep.
    

Intervention name(s): Standard nebulizer; PARI LC Sprint Sp nebulizer
Intervention type(s): Device; Device
Intervention description(s): Nebulizer sessions for the patients will be administerd using our "standard" nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical.; Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer.
Manufacturer: PARI GmbH Germany
Other intervention name(s): Micro Mist Nebulizer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nebulizer; PARI LC Spring SP
The Effects of Lentil-containing Food Products on Satiety and Food Intake
Condition: Appetite; Satiety; Food Intake
Study type: Interventional

Summary: 
      The Lentil Satiety study will examine the effects of replacing wheat and rice with two types
      of lentils within food products (muffins and chilies) on satiety and food intake in healthy
      adults.
    

Detailed description: 
      The Lentil Satiety study will examine the effects of replacing wheat and rice with two types
      of lentils (small green Eston and red split) within food products (muffins and chilies) on
      satiety and food intake in healthy adults, for a total of 6 study treatments. A total of 3 to
      6 study visits (corresponding to consuming all muffins and/or all chilies) will take place
      where participants will consume one of the study treatments and subsequently complete satiety
      questionnaires over 180 minutes to measure satiety as subjective appetite sensations (hunger,
      fullness, desire to eat, and prospective food consumption). At 180 minutes, participants will
      receive ad libitum pizza and bottled water to consume until they are comfortably full for a
      measure of weighed food intake. At the end of each study visit, participants will be given a
      food scale and instructed to weigh and record all food and drink consumed for the remainder
      of the day for a measure of 24-hour energy intake.
    

Intervention name(s): Small Green Lentil Muffin; Split Red Lentil Muffin; Wheat Muffin; Small Green Lentil Chili; Split Red Lentil Chili; Rice Chili
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Consumption of small green lentil muffin; consumption of ad libitum pizza test meal after 180 minutes; Consumption of split red lentil muffin; consumption of ad libitum pizza test meal after 180 minutes; Consumption of wheat muffin; consumption of ad libitum pizza test meal after 180 minutes; Consumption of small green lentil chili; consumption of ad libitum pizza test meal after 180 minutes; Consumption of split red lentil chili; consumption of ad libitum pizza test meal after 180 minutes; Consumption of rice chili; consumption of ad libitum pizza test meal after 180 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: lentils; satiety; appetite; food intake; 24-hour energy intake
Consistency Lots Vaccine Study (V260-009)
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evaluate consistency in the antibody response to three
      manufactured lots of an investigational Rotavirus Vaccine.
    


Intervention name(s): rotavirus vaccine, live, oral, pentavalent; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Three oral doses (~8.81 X 10^7 IU/Dose for Lot 1; ~8.01 X 10^7 IU/Dose for Lot 2; and ~6.91 X 10^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination; Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10
weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
Other intervention name(s): V260; RotaTeq™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery
Condition: Opioid Free Anaesthesia
Study type: Interventional

Summary: 
      This study has been planned to compare the effect of opioid free anaesthesia using
      dexmedetomidine and ketamine with opioid based anaesthesia using fentanyl in maintaining the
      intraoperative hemodynamic stability and recovery characteristics in patients undergoing
      Transsphenoidal surgery of pituitary tumors.
    

Detailed description: 
      Opioid Free Anesthesia (OFA) is a technique where no intraoperative opioid is administered
      during the anesthetic management. Opioid free anesthesia is usually achieved through
      sympatholysis, analgesia, and anesthesia with dexmedetomidine and analgesia with low dose
      ketamine. In addition paracetamol and other non-steroidal anti inflammatory drugs (NSAIDS)
      may be used as adjuncts to the multi-modal pain regimen.

      Dexmedetomidine, a highly selective agonist of the alpha2 adrenergic receptor, has many
      clinical benefits, such as sedation, analgesia, preventing unwanted stress responses and low
      risk of respiratory depression. Because of concern that opioids might cause perioperative
      respiratory depression, substitution with dexmedetomidine will be helpful with its analgesic
      and sympatholytic properties. Dexmedetomidine has shown to reduce minimum alveolar
      concentration (MAC) of inhalational anesthetics and the requirement of perioperative opioid
      by 30-50%. In neurosurgical patients, dexmedetomidine is helpful in maintaining intracranial
      pressure (ICP) and intraoperative hemodynamic stability, especially during intubation and
      extubation. It can allow for faster awakening and thus an earlier neurological examination by
      decreasing necessary volatile agent and opioid doses.

      Ketamine, an N-methyl-d-aspartate(NMDA) antagonist, blunts central pain sensitization at
      sub-anesthetic doses (0.5 mg/kg or less) and has been studied extensively as an adjunct for
      perioperative analgesia. Sub-anesthetic ketamine improves pain scores and reduces
      perioperative opioid consumption in a broad range of surgical procedures.Recent literature
      has suggested that adjuvant ketamine administration in mechanically ventilated patients has
      no cerebrovascular effects.

      The present study has been planned to compare the effect of opioid free anesthesia using
      dexmedetomidine and ketamine with opioid based anesthesia using fentanyl in maintaining the
      intraoperative hemodynamic stability and recovery characteristics in patients undergoing TSS
      of pituitary tumors.
    

Intervention name(s): Dexmedetomidine; Ketamine; Fentanyl; Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): o.9% normal saline will be used instead of ketamine
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      Carboxymethylcellulose (CMC), a common component in artificial tears, has been shown to
      modify the gut microbiome. The study is examining its effects on the eye microbiome, which
      may have implications on ocular disease and artificial tear choice. The study will administer
      artificial tears containing CMC to the treatment group and artificial tears without CMC to
      the control group. Surveys and conjunctival swabs will be collected before and after
      treatment for bacterial genome sequencing and analyzed by R statistical packages.
    


Intervention name(s): Carboxymethylcellulose (CMC) Artificial Tears; Preservative-free, CMC-free Artificial Tears (control)
Intervention type(s): Drug; Drug
Intervention description(s): A pack of 21 vials of artificial tears containing carboxymethylcellulose 0.5% will be given to subjects in the treatment group.; A pack of 21 vials of artificial tears containing 0.4% polyethylene glycol 400 and 0.3% propylene glycol will be given to subjects in the control group.
Other intervention name(s): Refresh Plus; Systane Ultra PF
Intervention MeSH terms: Carboxymethylcellulose Sodium; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lung Ultrasound Score and Weaning Outcome
Condition: Lung Ultrasound Score; Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Objectives: Failure of extubation of patients on mechanical ventilation is one of the common
      problems in the ICU.

      Aim of work: To evaluate the validity of lung ultrasound score in prediction of weaning
      outcomes and post-extubation distress.
    

Detailed description: 
      Methods: A prospective observational study of 50 patients planned for extubation who passed a
      spontaneous breathing trial, lung ultrasound score and serum level of NT-PRO BNP were done to
      all patients at end of spontaneous breathing trial, and all patients were followed after
      extubation and monitored for oxygenation, re-intubation rate, ICU stay, and ICU mortality.
    

Intervention name(s): lung ultrasound
Intervention type(s): Other
Intervention description(s): Lung ultrasound score was done at the end of SBT using curved array ultrasound probe 2-5 MHz, Siemens X300, Korea
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee
Condition: Pain; Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and effectiveness of the investigational
      ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance)
      for the treatment of pain caused by osteoarthritis.
    

Detailed description: 
      Proof-of-concept study, multicenter, randomized, double-blind, parallel-group,
      placebo-controlled study designed to evaluate the safety and efficacy of a transdermal
      ketoprofen patch with CHADD heat versus a placebo patch with dummy heat in patients with mild
      to moderate pain associated with osteoarthritis of the knee. After screening, patients
      discontinue all analgesic medication (except ≤325 mg aspirin daily for cardioprotective
      purposes). Patients selected a target knee (right or left), and all efficacy evaluations were
      completed with respect to this target knee. After discontinuing analgesics for at least 48
      hours, and when the average pain intensity over the previous 24 hours for the target knee was
      ≥40 mm using a 100 mm visual analog scale (VAS), patients were randomized in a 1:1 fashion to
      receive treatment with either the transdermal ketoprofen patch with CHADD heat or the placebo
      patch with dummy heat. Patients treated the target knee each night for 12 hours (± 1 hour)
      for 4 weeks. Patients returned to the study site every 7 days (± 1 day) for study
      evaluations. Throughout the study, patients were allowed to take up to 2000 mg acetaminophen
      per day as rescue medication; however, rescue medication was not allowed within the 48 hours
      prior to efficacy evaluations.
    

Intervention name(s): Transdermal Ketoprofen Patch with CHADD; Placebo transdermal patch
Intervention type(s): Drug; Drug
Intervention description(s): 12 hours patch application for 28 days; 12 hours application for 28 days
Other intervention name(s): Matrix Transdermal Ketoprofen/CHADD Sytem; Placebo patch with dummy heating unit
Intervention MeSH terms: Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Osteoarthritis; OA; Mild to Moderate Osteoarthritis (OA) Pain of the Knee
The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
Condition: Aneurysms
MeSH terms: Aneurysm
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent
      System to facilitate endovascular coil embolization of wide neck saccular intracranial
      aneurysms.

      Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck,
      intracranial, saccular aneurysms arising from a parent vessel
    

Detailed description: 
      This is a multi-center, prospective, non-randomized feasibility study including 30 subjects.
      Subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy
      follow-up evaluation at 6 months (+ four weeks).
    

Intervention name(s): Cordis Self Expanding Stent
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intracranial; Wide-neck; Saccular; Aneurysms
A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit.
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study to verify the same effectiveness and safety profile for the test
      product, Nicorette Strongmint lozenge, as for an already approved product, NiQuitin® Minimint
      lozenge (reference product), in a standardized mode. This verification is done in a so-called
      bioequivalence study, which means that the same amount of the same active substance
      (nicotine), in the same dosage form, for the same route of administration, and meeting the
      same or comparable standards is performed.

      During the study visits, blood samples will be drawn to measure the level of the substance in
      the blood to verify that the two products are comparable. Tolerability of the treatments will
      be evaluated based on reported and observed adverse events.
    

Detailed description: 
      This is a single-dose, two-period crossover, randomized, fasting, open-label, bioequivalence
      study.

      244 male and female volunteers with a smoking history of minimum 3 months and aged between 18
      and 45 years, inclusive, and motivated to quit will be included. The treatment administration
      order will be randomized with an equal number of subjects in each treatment sequence.

      Single doses of 4 mg Nicorette Strongmint Lozenge (i.e. test product) and 4 mg NiQuitin®
      Minimint Lozenge (i.e. reference product) will be administered in a standardized mode, on two
      separate treatment visits. A washout period of minimum 48 hours will separate the treatment
      administrations.

      An abstinence period of 12 hours including an overnight stay at the clinic is required at
      both treatment occasions.

      Blood for pharmacokinetic analyses will be drawn pre-dose (i.e. within 5 minutes before drug
      administration) and at 10, 15, 20, 30, 40, 50, and 60 minutes, as well as 1.25, 1.5, 2, 3, 4,
      6, 8, 10, and 12 hours after start of drug administration. Thus, 17 samples will be collected
      per treatment visit.

      Subjects will be monitored to capture any adverse events that may occur.
    

Intervention name(s): Nicorette Strongmint lozenge 4 mg; Niquitin MiniMint lozenge 4 mg
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of one Nicorette lozenge 4mg lozenge administrated orally to slowly dissolve in the mouth.; A single dose of one Niquitin Minimint lozenge 4mg administrated orally to slowly dissolve in the mouth.
Other intervention name(s): Nicorette lozenge 4 mg; Niquitin lozenge 4 mg
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence
Impulse Control Disorders in Parkinson's Patients Treated With Pramipexole and Other Agents (DOMINION Study)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders
Study type: Observational

Summary: 
      The purpose is to explore the frequency of impulse control disorders in Parkinson's patients
      treated with different Parkinson's medications.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Parkinson's patients treated with various medications