bioihbjkbjnl/mcl2 huggingface dataset:
Status Asthmaticus on the PICU; Intravenous Salbutamol
Condition: Childhood Asthma With Status Asthmaticus
MeSH terms: Asthma; Status Asthmaticus
Study type: Interventional
Phase: Phase 4

Summary: 
      Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data
      are scarce. To date, there is an insufficient evidence base to guide initial and subsequent
      dosing recommendation for its IV use in children. Especially the need for a loading dose
      needs to be addressed. Therefore, pharmacodynamic and kinetic data are needed to guide
      initial dosing strategies of IV salbutamol in children. To assess the efficacy of a loading
      dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or
      severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1
      hour after administration of the loading dose, compared to placebo.
    


Intervention name(s): Salbutamol; Sodium Chloride 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous Salbutamol loading dose; 10 ml of Sodium Chloride 0.9% in 10 minutes intravenous
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pediatric FN Definition 2012 Bern
Condition: Cancer in Children/Adolescents; Fever in Neutropenia
MeSH terms: Neutropenia; Fever
Study type: Observational

Summary: 
      STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values,
      emergency calls and consultations for fever, and on hospitalizations for FN in children and
      adolescents with cancer

        -  to describe the frequency of episodes of FN, and of other clinically relevant FN-related
           measures

        -  to compare these frequencies and measures in reality vs. applying Bernese standard
           limits for defining fever (ear temperature ≥39.0°C)

        -  to compare these frequencies and measures applying the Bernese standard limit of ≥39.0°C
           (LimitStandard) vs. a range of hypothetically lower limits defining fever (LimitLow)

        -  to determine if it would be useful to perform an interventional study on the question of
           different fever limits, powered to study both efficacy (frequency of FN) and safety (AE
           in delayed FN diagnosis)

        -  to use the platform of this prospective study to explore if the serum level of cortisol
           is associated with adverse events in FN

      HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions
      of fever from ear temperature 39.0°C to lower limits would

        -  increase the rate of FN episodes diagnosed during chemotherapy (primary endpoint).

        -  increase the rate of other clinically important FN-related measures related to
           chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related
           measures during treatment of FN episodes diagnosed in reality (secondary endpoints
           4,5,6).

        -  not relevantly decrease the proportion of FN with AE (secondary endpoint 7).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients diagnosed with cancer requiring chemotherapy, treated at the Division of
        Pediatric Hematology/Oncology, Department of Pediatric, University of Bern / Inselspital,
        CH-3010 Bern, Switzerland
      
Biospecimen description: 
      1 mL serum, kept refrigerated until the end of study, then analyed as batch for cortisol,
      then discarded.
Clopidogrel And Ticagrelor in Healthy Subjects
Condition: Pharmacodynamics
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers
      compared with standard Clopidogrel agent.
    

Detailed description: 
      Consist with previous study Ticagrelor had greater, faster and more the platelet inhibition
      effect than Clopidogrel in both healthy subjects and stable coronary artery disease patients.
      Moreover, Asian subjects exposed higher active metabolite and stronger pharmacodynamics
      response than European subjects with same oral dose of antiplatelet agent. However, previous
      report comparing the efficacy and safety of Ticagrelor and Clopidogrel in healthy Asian
      ethnicity is lacking. Therefore, the aim of this study is to evaluate the pharmacodynamic
      responses of a lower Ticagrelor dose using laboratory platelet function tests in healthy
      Korean volunteers.
    

Intervention name(s): Ticagrelor 90 mg; Clopidogrel 600 mg
Intervention type(s): Drug; Drug
Intervention description(s): The subjects administer Ticagrelor 90 mg as loading dose (LD) follow by 90 mg/day as maintenance dose (MD) for 5 days, following a 2-week washout period, to receive the alternate thienopyridine (Clopidogrel 600 mg as LD follow by 75 mg/day as MD for 5 days).; The subjects administer Clopidogrel 600 as loading dose (LD) follow by 75 mg/day as maintenance dose (MD) for 5 days, following a 2-week washout period, to receive the alternate thienopyridine (Ticagrelor 90 mg/day as LD, follow by 90 mg/day as MD for 5 days).
Other intervention name(s): Brilinta 90 mg; Plavix 600 mg
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Ticagrelor; Clopidogrel; Platelet function test
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the safety of an investigational meningitis vaccine in toddlers and their
      immune response to it.
    


Intervention name(s): MnB vaccine rLP8026; MnB vaccine rLP8026; MnB vaccine rLP8026
Intervention type(s): Biological; Biological; Biological
Intervention description(s): MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively); MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively); MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Toddlers; Vaccine; Safety
Magnetic Resonance Spectroscopy to Evaluate Tourette s Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Observational

Summary: 
      This study will use magnetic resonance imaging (MRI) and magnetic resonance spectroscopy
      (MRS) of the brain to try to gain a better understanding of the disease process in Tourette s
      syndrome, a neuropsychiatric disorder characterized by motor and vocal tics. Tourette s
      syndrome is also associated with behavioral and emotional disturbances, including symptoms of
      attention deficit hyperactivity disorder (ADHD) and obsessive-compulsive disorder (OCD). MRI
      and MRS show chemical substances in the brain. Findings in normal volunteers will be compared
      with those of patients.

      Healthy volunteers and patients with Tourette s syndrome 14 years of age and older may be
      eligible for this study. Volunteers will be screened with a medical history and physical and
      neurological examinations. Patients will be screened through NINDS protocol 93-N-0202.

      Participants will undergo MRI and MRS. MRI uses a strong magnetic field and radio waves to
      visualize brain anatomy and chemistry. For this study, the subject lies on a stretcher, which
      is moved into a strong magnetic field (the MRI scanner). Earplugs are worn to muffle loud
      thumping noises caused by the electrical switching of the radio frequency circuits. During
      the study, the subject lies still during each scan, for 1 to 8 minutes at a time. Total
      scanning time varies from 20 minutes to 2 hours, with most examinations lasting between 45
      and 90 minutes. The subject can speak through an intercom with the staff member performing
      the study at all times during the procedure. Up to 5 studies may be performed.
    

Detailed description: 
      OBJECTIVE

      The purpose of this study is to obtain a better understanding of the pathophysiology of
      Tourette's Syndrome (TS) with nuclear magnetic spectroscopic imaging. The basal ganglia have
      been implicated in the origin of tics, and we plan to use spectroscopy to determine whether
      there is any neuronal degeneration or a decrease in aminobutyric acid (GABA) within the basal
      ganglia, thalamus, or frontal cortex of patients with TS when compared to normal individuals.

      STUDY POPULATION

      This research will be conducted using patients with TS and normal volunteers.

      DESIGN

      Patients and normal volunteers will be scanned with 3 Tesla General Electric (GE) magnetic
      resonance imager using magnetic resonance spectroscopy (MRS) to measure N-acetylaspartate,
      choline, creatine, lactate and GABA.

      OUTCOME MEASURES

      Concentrations of metabolites will be compared between two groups.
    

Keywords: Tourette's Syndrome; GABA; NAA; Choline; Creatine; Tourette Syndrome; Healthy Volunteer; HV; Normal Control
Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients
Condition: Infertility, Female; Reproductive Sterility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      In assisted reproductive treatment (ART), it is necessary to follow closely the stimulation
      cycles of patients undergoing these treatments in order to monitor the number and size of
      developing follicles. Oestradiol (E2) and progesterone (P) are products of steroidogenesis
      and the concentrations of both hormones increase with the diameter of the growing follicle
      and accurate and reliable methods to measure E2 and P are essential to assess treatment
      response and support clinical decision. Measurement of both hormones, as well as monitoring
      of follicle growth through ultrasound measurements, is an important part of ovarian
      stimulation, requiring patients to undergo multiple blood draws. It is often a physically and
      emotionally painful process and the most convenient solution to this problem is the
      measurement of hormone concentration in other biological fluids. Salivary diagnostic tests
      are a less invasive, inexpensive and stress-free alternative to measurements of hormone
      concentration in other biological fluids. The current study pretends to evaluate the
      correlation between salivary ELISA assays and serum determination of progesterone and
      oestradiol concentrations IVF patients. In addition, secondary objectives include the
      measurement of diurnal variability of salivary hormone levels and patient experience with
      saliva collection as users.
    


Intervention name(s): Determination of progesterone and oestradiol
Intervention type(s): Diagnostic Test
Intervention description(s): Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.
Intervention MeSH terms: Estradiol; Progesterone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective unicentric study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ELISA; Saliva; Progesterone; Oestradiol; Early follicular phase; Mild follicular phase; Late follicular phase
Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy
Condition: Pain; Shoulder Arthroscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain
      after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a
      corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The
      addition of higher doses of dexamethasone to nerve blocks, which are injections of local
      anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce
      pain. However, it is unclear whether the advantage of longer pain relief outweighs patient
      dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have
      shown that systemic, intravenously administered dexamethasone may similarly reduce pain
      levels when compared with dexamethasone in the block. In our study, the investigators propose
      to examine the effect of low-dose IV versus block dexamethasone on interscalene block
      duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more.
      One study suggests that 1 mg may have the same effect as larger doses. Our aims are to
      determine whether the addition of low-dose dexamethasone to a local anesthetic in the block
      can prolong its duration, and whether there are differences in postoperative pain,
      consumption of painkillers, side effects, and satisfaction in patients who received IV or
      block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or
      block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block
      duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and
      7-10 days after surgery. Results from this study will reveal whether patients prefer the
      longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.
    


Intervention name(s): Bupivacaine; Perineural dexamethasone; Intravenous dexamethasone; Intravenous saline; Perineural saline
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dexamethasone in nerve block; Saline in nerve block
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This study is to determine if non-invasive electrical stimulation of the spinal cord can be
      used to: 1) assess spared function following a spinal cord injury; and 2) be use for
      rehabilitation.
    

Detailed description: 
      This study is to determine if non-invasive electrical stimulation of the spinal cord can be
      used to: 1) assess spared function following a spinal cord injury; and 2) be use for
      rehabilitation.

      The investigators hypothesize that this type of stimulation can be used to locate and
      determine if any spinal (nerve) pathways or connections were spared following a spinal cord
      injury. We also hypothesize the same stimulation can help revive or recover function to
      muscles connected to these spared spinal (nerve) pathways in individuals who are clinically
      paralyzed. Our research has demonstrated that modifying the activation state of the spinal
      cord after an injury, or awakening the spinal cord, can benefit people with paralysis years
      after a spinal cord injury. This method and device have not yet been approved by the FDA for
      the treatment of paralysis and are under investigation. This study if successful will help
      provide further evidence that could be use to one day to gain FDA approval.
    

Intervention name(s): Transcutaneous Electrical Spinal Cord Stimulation
Intervention type(s): Device
Intervention description(s): A prototype device that non-invasively delivers electrical stimulation to the spinal cord will be used to assess and rehabilitate spared spinal cord function.
Other intervention name(s): Prototype Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Spinal cord injury; Paralysis; Rehabilitation; Assessment; Theranostics
rTMS Treatment of Primary Progressive Aphasia
Condition: Primary Progressive Aphasia; Repetitive Transcranical Magnetic Stimulation
MeSH terms: Aphasia; Aphasia, Primary Progressive; Pick Disease of the Brain; Frontotemporal Dementia
Study type: Interventional

Summary: 
      Primary Progressive Aphasia (PPA) is a neurodegenerative disease in which language function
      is gradually and progressively impaired. Patients will eventually be disabled in
      communication and have cognition deficits, which put a heavy burden not only on their
      families but also on the whole society. However, no effective treatment for PPA has been
      explored so far. The current clinical randomized trial is to study the safety and efficacy of
      repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of PPA. Also,
      multi-modality of neuroimaging techniques, such as functional MRI and PET will be used to
      investigate brain network changing in this procedure.
    


Intervention name(s): Magstim rTMS
Intervention type(s): Device
Intervention description(s): The device is made in London,UK
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
CVN058 Effect on Mismatch Negativity in Schizophrenics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, double-blind, placebo-controlled, 3 period cross-over study to evaluate
      CVN058 target engagement by measuring auditory evoked potential mismatch negativity (MMN)
      downstream to 5-hydroxytryptamine receptor 3 (5-HT3) as a pharmacodynamic (PD) marker.
    

Detailed description: 
      Male and female subjects with schizophrenia, age 18 to 50 years old, inclusive, will be
      randomized to 1 of 6 treatment sequences (Table 2.a) to receive 1 of 3 dose regimens in each
      period: a single oral administration of CVN058 (15 mg or 150 mg) or matching placebo. The
      sequence will determine the order in which a subject will take each of the 3 regimens.
      Discontinued subjects may be replaced at the discretion of the sponsor so that approximately
      20 completed subjects are available for analysis.

      The study includes three 1-day treatment periods, with a minimum of 7-day washout, maximum 10
      day washout (2 total washouts, after Periods 1 and 2) between periods, and a 7-10 day
      follow-up call post dosing of the last period. Subjects may be inpatients or outpatients at
      the discretion of the Investigator.
    

Intervention name(s): CVN058; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 3-way crossover; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Male and female subjects with schizophrenia, age 18 to 50 years old, inclusive, will be randomized to 1 of 6 treatment sequences to receive 1 of 3 dose regimens in each period; a single oral administration of CVN058, or a matching placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MMN; EEG; P50; gamma power; P300; auditory gating
Iron Bioavailability From Biofortified Orange-fleshed Sweet Potato
Condition: Iron-deficiency; Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based
      solutions have to be implemented to serve populations, not only individuals. One solution is
      the introduction of iron biofortified staple crops on market level. Before market level
      introduction, the bioavailability of iron in the new biofortified Orange Fleshed Sweet Potato
      (OFSP) breed needs to be assessed. In this study the investigator compares the fractional and
      total iron absorption after extrinsic stable isotope labelling of the new biofortified high
      iron OFSP variety and a normal market level OFSP variety. The study is conducted in Malawian
      women of reproductive age with marginal iron status.
    

Detailed description: 
      The 25 women enrolled will consume test meals consisting of 400g steamed and mashed high iron
      sweet potatoes labelled with Fe-58 daily for a period of 10 days and will then switch to the
      test meals consisting of 400g steamed and mashed control sweet potatoes labelled with Fe-57
      for a period of 10 days. The order of test meal type is random. A baseline blood sample will
      be taken on the first meal feeding day prior to consumption of any test meals, on study day
      26 (14 days after completion of the first test meal period) and on Day 40 (14 days after
      completion of the second test meal period). Erythrocyte incorporation of the stable isotope
      labels will be measured in these blood samples using an ICPMS and will be used to calculate
      fractional and total iron absorption from the two different type of test meals.
    

Intervention name(s): High Fe OFSP meal labelled with Fe-58; Control OFSP meal labelled with Fe-57
Intervention type(s): Other; Other
Intervention description(s): 400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days; 400 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each woman consumes both Orange Fleshed Sweet Potato varieties
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Biofortification; Orange fleshed sweet potato; Stable isotope studies
Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions
Condition: Intestinal Diseases
MeSH terms: Intestinal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to compare two formulations of Albendazole of the same dose in
      healthy adult participants. Researchers will compare the extent and rate to which the drug is
      absorbed.
    


Intervention name(s): Albendazole IP 400 mg; Albendazole 400 mg
Intervention type(s): Drug; Drug
Intervention description(s): Albendazole IP 400 mg tablets will be administered under fed conditions; Albendazole 400 mg tablets will be administered under fed conditions
Intervention MeSH terms: Albendazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Albendazole; Bioequivalence