bioihbjkbjnl/mcl2 huggingface dataset:
Objective Markers of Pain Perception in Pediatric Emergency
Condition: Suffering, Physical
MeSH terms: Emergencies; Pain
Study type: Interventional

Summary: 
      Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief
      rests on the oral communication of the young patient, who does not always able to it
      (difficult to verbalize, fear of the hospital, problem mental development ...). There is no
      way in which pain can be apprehended objectively, immediately and effectively. To advance our
      knowledge of this problem, several approaches have been studied as from functional magnetic
      resonance imaging (fMRI), electroencephalography (EEG), or from autonomic parameters.
      However, all these approaches have their limitations: although fMRI presents interesting
      performances, it allows only a retrospective analysis, and cannot adapt to the clinical
      context of the young patient for example. EEG-based approaches and autonomic parameters show
      interesting results but suffer from perfectible sensitivity to muscle activation for EEG
      whereas the vegetative parameters to stress. In this context, our working hypothesis
      considers that the search for markers of painful perception must be based on a
      neurophysiological approach, based on the combined analysis of the EEG and autonomic
      responses in real time. The aim of this work is to study (1) the cortical (EEG) and autonomic
      (cardiovascular, skin, pupillary) responses induced by sutures in children who can
      communicate their pain according to whether they cause pain or not.
    


Intervention name(s): electroencephalography helmet; dermal electrode; blood pressure sensors; Pupillometry glasses; Holter
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): electroencephalography helmet with twelve electrodes will be performed during surgical gesture to determine the pain of child.; dermal electrode on the back of the hand will be performed during surgical gesture to determine the pain of child.; blood pressure sensors on the finger will be performed during surgical gesture to determine the pain of child.; Pupillometry glasses will be performed during surgical gesture to determine the pain of child.; Three electrodes electrocardiography on the chest will be performed during surgical gesture to determine the heart rate variability.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pain; children; emergency; electroencephalography; heart rate; skin conductance; pupillary diameter
The Effect of Olive Leaf Extract on Blood Pressure in Overweight Prehypertensives
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is the leading cause of death in New Zealand (40% of all
      deaths). 37% of New Zealanders suffer from high blood pressure (World Health Organisation
      2008 figures), a well established modifiable risk factor for CVD. Above 115/75 mmHg, CVD risk
      doubles for each increment of 20/10 mmHg that blood pressure is raised. An increase in BMI
      and waist circumference has been associated with an increase in blood pressure. The leaves of
      the olive plant are rich in plant compounds known as polyphenols. This particular group of
      polyphenols are known secoiridoids, which are also present in olive oil and olives though at
      lower concentrations, are only found in this family of plants. Diets high in polyphenols have
      been found to reduce the risk of chronic diseases. Studies have shown that consumption of
      phenolic-rich olive leaf extract (OLE) can significantly reduce blood pressure in individuals
      suffering from high blood pressure (hypertension), with the magnitude of effect being
      comparable to a commonly used antihypertensive drug. In such trials OLE also resulted in an
      improved blood lipid (a reduction in total and LDL cholesterol and triacylglycerides) which
      also reduces CVD risk. One study testing the effect of OLE on individuals with mild or
      prehypertension (i.e. those with systolic blood pressure in the range 121-139 mmHg and
      diastolic blood pressure in the range 81-89 mmHg but not taking antihypertensive medication)
      also found these same improvements. OLE has been indicated to have the potential to improve
      other cardiovascular risk markers such as vascular function, inflammation, platelet
      aggregation, oxidation of LDL and glucose tolerance however much of this evidence is derived
      from animal, in vitro and ex vivo studies and so well designed and controlled human studies
      are required to verify that these findings are applicable to humans. Therefore OLE
      supplementation may be a useful dietary strategy for reducing CVD risk in a cohort of
      overweight prehypertensive individuals.

      The aim of the study is to determine the effect of OLE intake on blood pressure and other CVD
      risk markers in overweight subjects with mild hypertension and to link any study outcomes
      with the presence of OLE phenolics in urine
    


Intervention name(s): Olive leaf extract liquid
Intervention type(s): Dietary Supplement
Intervention description(s): Commercially available polyphenol-rich olive leaf extract liquid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Pre-operative Focused Transthoracic Echocardiography for Prediction of Post-operative Cardiac Complications
Condition: Diastolic Dysfunction
Study type: Observational

Summary: 
      The extent focused transthoracic echocardiography when done pre-operatively to patients
      admitted for elective surgery and suspected to be at risk of cardiac disease specially the
      geriatric population can affect perioperative anesthetic management of these patients.
    


Intervention name(s): TRANSTHORACIC ECHOCARDIOGRAPY
Intervention type(s): Diagnostic Test
Intervention description(s): TTE (Vivid I echocardiography machine General Electric Healthcare, Milwaukee, WI, USA) with a 3S-RS (1.5-3.6 MHz) transthoracic probe). was done by professional anesthesiologist following the :Hemodynamic Echocardiography Assessment in Real Time ( HEART) protocol. According to the clinical findings of TTE patients may be either free or have one or more of the following haemodynamic states normal, empty, vasodilated ,left ventricular systolic or diastolic failure, left ventricular systolic and diastolic failure, and right ventricular failure, valve stenosis or regurgitation of at least moderate severity
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Eligibility for participating in the study was assessed before assignment by the attending
        physician in the anesthesia clinic . Patients above 60 years of age ASAI and ASA II were
        included in the study unless history of cardiac disease, history of previous postoperative
        cardiac complications and symptoms or signs of cardiac diseases were found as theses
        patients were excluded from the study.
A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
Condition: Keratoconjunctivitis Sicca
MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      R348 eye drops in patients with dry eye disease.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled single and multiple ascending dose
      study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered
      in patients with mild to moderate keratoconjunctivitis sicca (KCS).
    

Intervention name(s): R348 Ophthalmic Solution, 0.2%; R348 Ophthalmic Solution, 0.5%; R348 Ophthalmic Solution, 1.0%; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): R348 Ophthalmic Solution, 0.2% single and multiple ascending dose; R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose; R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose; Placebo, single and multiple ascending dose
Other intervention name(s): R932348; R932348; R932348
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Pilates Method in the Range of Ballerina's Turnout
Condition: Dancing
Study type: Interventional

Summary: 
      A high degree of turnout is desired by many dancers, because enables an efficient weight
      transfer; provides an excellent extension and control; and reduces the risk of injury when
      used properly. The dancer's body conditioning is worked and acquired through various types of
      training, among which stands out the Pilates Method. Thus, the aim of the study is to
      determine the effect of a training program of Pilates Method in the range of ballerinas'
      turnout. The study will be conducted with young dancers, between 10 and 14 years, who
      practice classical dance twice a week. They will be randomly divided into two groups:
      intervention and control, but only the intervention group will do Pilates classes. To verify
      the extent of the turnout, tests will be applied in both groups, before the start of Pilates
      classes (pre-test) and after 24 sessions (post-test). In the evaluation protocol will be
      collected kinematic data, while performing the movements of demi plié and elevé.
      Anthropometric variables of height and body mass will be obtained; and also the extent of the
      passive and active turnout in dancers.
    


Intervention name(s): Pilates Mat Classes; Ballet Classes
Intervention type(s): Other; Other
Intervention description(s): The intervention, the exercises, and their progressions were systematized based on protocol proposed by Siler (2008).; The intervention is ballet classes three times a week, 1 hour and 30 min. The ballet classes consists in barre work and center work with specific ballet exercises.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: dance; ballet; Exercise Movement Techniques; turnout
Study to Assess Adverse Events (AEs) When Oral Atogepant Tablet is Given to Adult Chinese Participants Who Completed Study 3101-303-002 to Prevent Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Migraine is characterized by attacks of throbbing, moderate or severe headache, associated
      with nausea, vomiting, and/or sensitivity to light and sound. The main objective of the study
      is to evaluate how safe and effective the atogepant is in preventing chronic migraine in
      adult Chinese participants who completed study 3101-303-002. Adverse events will be
      monitored.

      Atogepant is an investigational drug being developed to prevent chronic migraine. All
      participants will receive the same treatment. Approximately 120 adult participants who
      completed study 3101-303-002 will be enrolled at approximately 25 centers in China.

      All participants will receive atogepant oral tablet once daily for 12 weeks.

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the study at a hospital or
      clinic. The effect of the treatment will be checked by medical assessments, blood tests,
      checking for side effects and completing questionnaires.
    


Intervention name(s): Atogepant
Intervention type(s): Drug
Intervention description(s): Oral Tablet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chronic Migraine; Migraine; Atogepant; AGN-241689
FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.
Condition: Chronic Kidney Disease; Acute Kidney Injury
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury
Study type: Interventional

Summary: 
      This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult
      volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with
      acute kidney injury (AKI).
    

Detailed description: 
      A rapid and accurate measurement of glomerular filtration rate (GFR) is important in acute
      kidney injury (AKI) and chronic kidney disease (CKD) for assessment of impairment, diagnosis,
      and prompt treatment. FAST BioMedical is an emerging technology company whose mission is to
      quantify clinically meaning ful physiological parameters that have been difficult or
      impossible to measure. GFR is the most clinically relevant metric for understanding renal
      function, as it is the rate by which the kidney is able to filter waste products in the
      bloodstream. The FAST mGFR is for direct measurement of GFR that relies on reading the ratio
      of fluorescent markers attached to different size dextran molecules introduced into the
      bloodstream. The test is intended as an adjunct to current methods utilized to assess kidney
      function.
    

Intervention name(s): 75 mg / 6 mL VFI™
Intervention type(s): Device
Intervention description(s): Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This pilot study was a prospective, open-label, single site study designed to evaluate the safety of the FAST mGFR Test™ in healthy adult volunteers, patients with varying degrees of renal impairment and hemodynamically stable AKI.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Chronic Kidney Disease; Acute Kidney Injury; AKI; CKD; Plasma Volume; GFR; Glomerular Filtration Rate; Blood volume; mGFR; measured GFR; kidney biomarker; renal disease; renal biomarker; Renal function; kidney function; organ function; kidney monitor; kidney device
A Study of KHK4827 in Subjects With Palmoplantar Pustulosis
Condition: Palmoplantar Pustulosis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of efficacy and safety of KHK4827 in Subjects with Palmoplantar Pustulosis
    


Intervention name(s): KHK4827; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): brodalumab 210mg Q2W, SC; Q2W, SC
Intervention MeSH terms: Brodalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Palmoplantar Pustulosis; brodalumab; KHK4827
A Study of Brivaracetam in Subjects With Partial Onset Seizures
Condition: Epilepsy, Focal
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150
      mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy
    


Intervention name(s): Placebo; Brivaracetam; Brivaracetam
Intervention type(s): Other; Drug; Drug
Intervention description(s): Daily oral dose of two equal intakes, morning and evening, of placebo in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period); Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period); Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period)
Intervention MeSH terms: Brivaracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; Focal Epilepsy; Partial Onset Seizures; Brivaracetam
Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
Condition: Hypertension in Pregnancy; Preeclampsia
MeSH terms: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive
      regimens for women with severe hypertension in pregnancy. Women presenting with severe
      hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of
      three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the
      efficacy, safety and side effects of these three oral regimens for management of hypertension
      in pregnant women. The investigators hypothesize that nifedipine treatment of severe
      hypertensive parturient women is more effective than treatment with labetalol or methyldopa
      in controlling high blood pressure within six hours.
    

Detailed description: 
      This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive
      regimens for women with severe hypertension in pregnancy. Women presenting with severe
      hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of
      three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the
      efficacy, safety and side effects of these three oral regimens for management of hypertension
      in pregnant women. The investigators hypothesize that nifedipine treatment of severe
      hypertensive parturient women is more effective than treatment with labetalol or methyldopa
      in controlling high blood pressure within six hours.
    

Intervention name(s): Nifedipine; Labetalol; Methyldopa
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Labetalol; Methyldopa; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension in pregnancy; preeclampsia; anti-hypertension; labetalol; nifedipine; methyldopa
Feeling Hot 1: Environmental Influences of Overnight Measurement on Skin Temperature of the Erectile Penis
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      The Feeling Hot studies focus on the proof-of-principle of using temperature sensing as a
      tool to detect nocturnal erections. In the Feeling Hot 1 study the influence of environmental
      factors of overnight measurements are studied in a controlled setting. Healthy individuals
      will have visually aroused erections in different circumstances (naked, clothing, blankets)
      to determine the feasibility of this new measurement method for nocturnal erection detection
      in the search to modernize erectile dysfunction diagnostics.
    

Detailed description: 
      Differentiation in nature of erectile dysfunction (ED) is currently made by nocturnal
      erection detection with the RigiScan. The RigiScan uses outdated software, measurements are
      user unfriendly and system components are out of stock. In the search of modernizing erectile
      dysfunctions diagnostics, the question has arisen whether temperature measurements can
      function as a tool for nocturnal erection detection. With the absence of a pressure
      component, the patient experience should improve. Literature and mathematical modelling
      studies have shown that the penile temperature increases significantly during erection.
      However, it is unclear what the influence of environmental factors such as blankets and
      clothing is on the increase in penile temperature during erection. The Feeling Hot 1 study
      explores the effects of these environmental factors in a controlled setting to gain insight
      into the possibility of using temperature sensing to detect nocturnal erections.
    

Intervention name(s): Feeling Hot sensor system
Intervention type(s): Device
Intervention description(s): The Feeling Hot sensor system consists of two temperature probes placed on the penis and outer thigh of the test subject to measure skin temperature during erection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Erectile Dysfunction; RigiScan; Nocturnal erection; Penile temperature
Prasugrel/Clopidogrel Maintenance Dose Washout Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to describe the cumulative proportion of participants
      who return to baseline platelet P2Y12 receptor function over time (up to 12 days post last
      maintenance dose) following discontinuation of prasugrel 10 mg daily x 7 days assessed by
      Accumetrics VerifyNow P2Y12 reaction units (PRU) and described by Kaplan Meier curves. The
      primary analysis is descriptive and is intended to provide information relating to the return
      of baseline platelet function following discontinuation of maintenance therapy with either
      prasugrel or clopidogrel.
    


Intervention name(s): Prasugrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 10mg tablet administered once daily for 7 days.
After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria.; Clopidogrel 75 mg tablet administered once daily for 7 days.
After a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria.
Other intervention name(s): Effient; Plavix
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: thienopyridine; pharmacologic action; prasugrel; clopidogrel