bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
Condition: Developmental and Epileptic Encephalopathy; Dravet Syndrome; Lennox Gastaut Syndrome
MeSH terms: Brain Diseases; Epilepsy; Epilepsies, Myoclonic; Lennox Gastaut Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to assess the safety, tolerability, efficacy, and
      pharmacokinetics of adjunctive therapy of LP352 in adults and adolescents with developmental
      and epileptic encephalopathies.
    

Detailed description: 
      This is a randomized, double-blind, parallel-group, dose-escalation, placebo-controlled study
      of LP352 in adults and adolescents with developmental and epileptic encephalopathies (DEE)
      with an average of ≥ 4 observed/countable motor seizures per 4-week period during the 12
      weeks before screening while on stable antiseizure medicine (ASM).

      Subjects will be randomized 4:1 to LP352 or placebo. The study will have a baseline period of
      28 days, followed by a 15 day up-titration period during which time subjects will titrate up
      to their highest tolerated doses, and a 60-day maintenance period. After Day 75, subjects
      will be tapered down over a period of up to 15 days, with a follow-up visit 30 days after
      last dose. Enrolled subjects will be allowed to continue treatment with up to 4 concomitant
      ASMs at a stable dose.
    

Intervention name(s): LP352; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LP352 administered three times daily, orally or through G-tube; Matching placebo for LP352 administered three times daily, orally or through G-tube
Other intervention name(s): Placebo Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CDKL5 deficiency disorder; developmental and epileptic encephalopathy; Dravet Syndrome; epilepsy; Lennox-Gastaut Syndrome; treatment resistant epilepsy; tuberous sclerosis complex
Erector Spina Plane Block and Radiofrequency Treatmen
Condition: Back Pain; Block; Pain, Muscle
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      ESP is the deepest back muscle originating from the transverse processes of the vertebrae.
      Blocks applied to this region are effective for a longer time and in the broader area than
      those applied to superficial muscles. Recently, pulsed radiofrequency treatments have also
      been performed in myofascial pain, and successful results have been obtained. The
      investigators aim to investigate whether there is a difference between these two applications
      in terms of treatment efficacy.
    

Detailed description: 
      Trigger point injections and erector spina planus muscle (ESP) blocks are used to treat back
      pain related to myofascial pain syndrome. ESP is the deepest back muscle originating from the
      transverse processes of the vertebrae. Blocks applied to this region are effective for a
      longer time and in the broader area than those applied to superficial muscles. Recently,
      pulsed radiofrequency treatments have also been performed in myofascial pain, and successful
      results have been obtained.

      Deep and superficial back muscles, transverse processes of the vertebrae, costume, and
      pleural movement are identified by ultrasonographic examination. The investigators perform
      the intervention through the transverse processes. The investigators give 20 ccs of fluid
      (bupivacaine, steroids, saline). The patients to whom The investigators apply pulsed
      radiofrequency complete the procedure by giving 20 ccs of fluid after the radiofrequency
      application on the transverse processes and during the procedure, using 10 cm, 21 gauge
      radiofrequency needles with an active tip of 10 mm. The radiofrequency wave is applied at 2
      Hz, ten milliseconds, and 55 volts for 5+5 for 10 minutes.

      The investigators aim to investigate whether there is a difference between these two
      applications in terms of treatment efficacy. For this reason, the Visual Pain Scale of each
      patient will be recorded before the procedure, the second week after the procedure, and the
      first month. The Centrality of Pain Scale will be applied to these patients at the controls.
      The correlation between the results of this scale, which evaluates the emotional and physical
      state of the patients, and the post-treatment pain scales will be evaluated.
    

Intervention name(s): Erector spina plane block; Erector spina bale block and pulsed radiofrequency
Intervention type(s): Procedure; Procedure
Intervention description(s): The transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection; The transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection and pulsed radiofrequency treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Integrated Analysis in Recovery After Exercise With and Without Hydration.
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to evaluate post-exercise recovery in healthy young men submitted to a
      prolonged exercise protocol of submaximal intensity with or without water intake, from the
      integrated analysis of autonomic (heart rate variability indices), cardiovascular outcomes
      (systolic blood pressure, diastolic blood pressure and heart rate) and respiratory (oxygen
      saturation and respiratory frequency). In addition, it will also be evaluated whether the
      proposed model is able to estimate the number of individuals undergoing hydration that have
      better recovery.
    


Intervention name(s): Control protocol; Hydration protocol
Intervention type(s): Other; Other
Intervention description(s): I.10 minutes of initial rest in the supine position; II. 90 minutes of treadmill aerobic exercise at an intensity of 60% of the vo2 peak; IV. 60 minutes of passive recovery in the supine position.; I.10 minutes of initial rest in the supine position; II. 90 minutes of treadmill aerobic exercise at an intensity of 60% of the vo2 peak; IV. 60 minutes of passive recovery in the supine position. V. Water ingestion distributed in 10 equal portions, administered at regular intervals of 15 minutes from the 15th minute of exercise until the end of the recovery period.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The prevalence of autism spectrum disorders (ASD) has increased dramatically in the last
      decade. The increasing occurrence of ASD creates an imperative need to test the effectiveness
      and efficacy mechanisms of appropriate interventions. Hippotherapy (HPOT) is a treatment
      option that has been show beneficial for children with ASD as well as other children with
      developmental disorders. The current projects focuses on understanding the mechanisms of HPOT
      efficacy and evaluating a short-term HPOT program for children with ASD.
    

Detailed description: 
      The incidence of autism spectrum disorders (ASD) has increased dramatically in the last
      decade. The latest report from the Centers for Disease Control and Prevention state that 1 in
      59 children are being diagnosed with ASD and it is four times more prevalent in boys than
      girls. Common treatments for children with ASD are applied behavioral therapy, occupational
      and speech therapy, which are used solely or in combination. Hippotherapy (HPOT) is another
      treatment option that has been shown to positively impact various aspects of behavior. This
      pilot project aims to determine the effects of a 6-week HPOT program on movement and social
      behavior of children with ASD and to investigate the underlying mechanisms of why HPOT is
      successful for ASD through the coupling of physiological and temperamental responses between
      horse and rider. The approach involves examining these skills pre, during, and post HPOT
      intervention in children diagnosed with ASD. A group of aged matched children with typical
      development will serve as the control group. Innovative measures of physiological coupling
      and temperament between horse and rider as well as objective and quantitative measures of
      movement and social behavior and caregiver perception will be collected. The investigators
      anticipate that following completion of the proposed study, they will provide the necessary
      foundation to understand the mechanisms of HPOT, and thus provide a new framework to test
      clinical trials of HPOT and human-animal interaction, and ultimately improve the lives of
      those diagnosed with ASD and their families.
    

Intervention name(s): Hippotherapy
Intervention type(s): Behavioral
Intervention description(s): The hippotherapy involves occupational therapy while being on a horse.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Randomized Pilot Trial of the Impact of Bedside Delivery of Discharge Medications to Pediatric Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This randomized pilot study proposes to field-test key logistical aspects of studying an
      intervention already available to patients on the pediatric ward, namely a discharge
      medication delivery service, called "Meds-in-Hand," which has been refined via a quality
      improvement process, but not rigorously studied nor fully implemented.
    

Detailed description: 
      At this time, Meds-in-Hand is not currently utilized for approximately 40% of patients
      admitted to the pediatric ward at Boston Medical Center. Currently patients do not receive
      their discharge medications via the delivery service for a variety of reasons, however they
      continue to receive the usual care standard employed by most hospitals, where prescriptions
      are sent to their home pharmacy for pickup after discharge. This study does not change the
      actual medications patients receive, but how and when they get them. Rigorous study of the
      relationship between Meds-in-Hand and patient satisfaction and clinical outcomes has not been
      performed to date, so there is equipoise about the value of the intervention, however
      observational data in the population in question, namely children admitted for an asthma
      exacerbation, suggest that patients who receive Meds-in-Hand prior to discharge have a
      reduced likelihood of a return visit to the Emergency Department in 30 days. The study will
      focus on parent-patient dyads admitted with an asthma exacerbation where the child is aged
      2-17 years, however parents will be the exclusive study subjects. Parents of the patients
      will be asked a baseline, in-hospital survey as well as participate in phone follow-up
      interviews to report on the patient experience and parent-reported child health outcomes at
      approximately 3 and 30 days after leaving the hospital. 60 total parents will be enrolled, 30
      in each arm of the study. This pilot study will also obtain empiric estimates of key study
      parameters to inform future study design and begin to examine trends between the groups of
      patients who are randomized to the Meds-in-Hand intervention and those randomized to usual
      care.
    

Intervention name(s): Discharge Medication Delivery Service
Intervention type(s): Other
Intervention description(s): hospital-owned outpatient pharmacy fills and delivers discharge medications to patients in their rooms prior to discharge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Pure Autonomic Failure; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Elevations of plasma cortisol, a stress hormone, during prior episodes of low blood sugar
      (hypoglycemia) appear to be responsible for the deficient responses during subsequent
      hypoglycemia. Our specific aim is to determine if dehydroepiandrosterone (DHEA), a hormone
      with anti-corticosteroid actions, can prevent hypoglycemia associated autonomic failure in
      type 1 diabetic volunteers.
    

Detailed description: 
      DHEA is the acronym for dehydroepiandrosterone, a steroid hormone produced naturally from
      cholesterol in the adrenal glands of males and females. It is also sold as an
      over-the-counter dietary supplement, and seems to have anticorticosteroid effects. DHEA
      antagonizes the effects of corticosterone on hippocampal function in rats and reduces
      responses to neural stress in mice. In our lab we have found that administration of the DHEA
      to rats during antecedent hypoglycemia, preserves counter-regulatory responses to subsequent
      hypoglycemia. The purpose of this study is to determine if the same response occurs in
      humans.
    

Intervention name(s): Dehydroepiandrosterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo tablets or tablets containing DHEA will be given orally before each hyperinsulinemic clamps on day 1 (x 2). Placebo tablets or tablets containing DHEA will be given orally before Day 2 hyperinsulinemic hypoglycemic clamp x 1.; Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.
Other intervention name(s): DHEA
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: hypoglycemia; dehydroepiandrosterone
Combined Intrathecal Morphine and Dexmedetomidine Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The current study investigated the effect of adding dexmedetomidine to intrathecal morphine
      for postoperative analgesia in cancer patients undergoing major abdominal surgery.
    

Detailed description: 
      Opioids, administered intrathecal or epidural, are widely used for postoperative, and chronic
      nociceptive pain secondary to cancers. Intrathecal injection of morphine to provide
      postoperative analgesia during the initial 24 h after operation is a widely used
      technique.The Human studies on the antinociceptive effects of co-administrated intrathecal
      morphine and dexmedetomidine in postoperative pain are still lacking. In this study, the
      investigators aimed to compare the synergistic interaction and side-effects of combined
      intrathecal morphine and dexmedetomidine with either drug alone for postoperative analgesia
      in cancer patients undergoing major abdominal surgery. Patients were randomly allocated into
      three groups of 30 patients each to receive either; hyperbaric bupivacaine 0.5% (Group
      I/Bupivacaine Group), bupivacaine and 0.5 mg morphine (Group II/Morphine Group), bupivacaine
      and 0.5 mg morphine plus 5 µg of dexmedetomidine (Group III/Morphine-DEX Group). The assigned
      drugs were dissolved in 1ml physiological saline and administered intrathecal with
      bupivacaine before induction of general anesthesia.
    

Intervention name(s): Dexmedetomidine (Precedex); Bupivacaine; Morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intrathecal administration; intrathecal 10 mg bupivacaine; intrathecal 0.5mg morphine
Other intervention name(s): Precedex; Buvicaine; morphine sulphate
Intervention MeSH terms: Dexmedetomidine; Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesia; intrathecal; opioids; morphine; dexmedetomidine
Biomarkers for the Early Identification of Sepsis in the Emergency Department
Condition: Sepsis
MeSH terms: Sepsis; Toxemia; Emergencies
Study type: Observational

Summary: 
      Monocentric prospective study on consecutive patients attending the emergency department and
      suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of
      interest in sepsis.
    

Detailed description: 
      The management of patients admitted to the emergency department (ED) requires investigative
      biological parameters that help clinicians to make the right diagnosis.

      Sepsis concerns patients with infection associated with a systemic inflammatory response.
      While this inflammatory profile is observed in many clinical situations in the ED, the
      challenge is to characterize in these patients suspected of sepsis those who have a real
      infection.

      Currently, no individual biomarker of sepsis is sufficiently discriminant. The objective of
      this study is to measure in patients suspected of sepsis in the emergency department, a
      combination of biomarkers (covering several distinct pathophysiological pathways) that could
      provide high specificity and sensitivity for the diagnostic and prognostic. The originality
      of this study is that compared with patients admitted to intensive care units, patients
      investigated for suspected sepsis in the ED are seen earlier in their medical history and
      usually before any therapeutic intervention (intravenous fluids, antibiotics, catecholamines)
      interfering with several biomarkers of interest.
    

Intervention name(s): blood sampling
Intervention type(s): Biological
Intervention description(s): during the usual blood sampling performed in the ED in patients suspected of sepsis, two additional tubes will be sampled for a panel of biomarkers measurement
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients attending the ED and suspected to have sepsis
      
Biospecimen description: 
      plasma and sera
    
Keywords: sepsis; biomarker; prognostic; emergency department; diagnosis
A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) 100 mg
      taken without or with water and the Glucobay standard tablet 100 mg taken with water.
    


Intervention name(s): Acarbose (Glucobay ODT, BAYG5421); Acarbose (Glucobay, BAYG5421)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acarbose
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Acarbose; ODT
Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment,
      crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose
      levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS
      MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo
      MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90
      μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study
      design utilizes 10 treatment sequences.
    

Detailed description: 
      This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a
      single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5,
      and 6), with a 3- to 7-day Washout Period between Treatment Visits.
    

Intervention name(s): AS MDI 90 μg; AS MDI 180 µg; Placebo MDI; Proventil 90 μg; Proventil 180 μg
Intervention type(s): Drug; Drug; Other; Drug; Drug
Intervention description(s): AS MDI 90 μg (2 actuations of 45 μg/actuation); AS MDI 180 μg (2 actuations of 90 μg/actuation); Placebo MDI (2 actuations); Proventil 90 μg (1 actuation of 90 μg/actuation); Proventil 180 μg (2 actuations of 90 μg/actuation)
Other intervention name(s): AS MDI; AS MDI; Proventil; Proventil
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Noise Reduction Preferences in Teenagers and Pre-teens
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Noise reduction preferences and blue tooth access to hearing aid streaming features will be
      evaluated in experienced hearing aid users age 10-17.
    

Detailed description: 
      The purpose of this study is to evaluate the preferences for hearing aid noise reduction
      settings in users age 10 -17, as well as to evaluate preferences for accessing the hearing
      aid Bluetooth streaming programs for this population. Subjective preferences will be obtained
      by having the participants listen to a noisy scene with different levels of noise reduction,
      to which they are blinded, and rate their preference. Blinded objective speech performance
      testing will be completed by a) finding the signal-to-noise ratio at which participant can
      correctly repeat back 50% of the target words, and b) measuring the percent of words
      correctly repeated during a noisy listening task. These tasks will be done using different
      levels of noise reduction. Subjective preferences for accessing Bluetooth streaming will also
      be obtained by asking participants which method they prefer (phone, hearing aid, or touch
      control).

      .
    

Intervention name(s): Phonak Hearing Aid
Intervention type(s): Device
Intervention description(s): Commercially available hearing aid with various noise reduction strengths
Intervention model: Single Group Assignment
Intervention model description: All participants will be fit with hearing aids with the same noise reduction feature. This feature has distinct, discrete levels of noise reduction which will be evaluated by the participants.
Masking: None (Open Label)
Primary purpose: Treatment