bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Deep Haptic Massage in Fibromyalgia : Preliminary Study
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia syndrome (FMS) is a common chronic musculoskeletal pain disorder of unknown
      etiology, characterized by generalized body pain, hyperalgesia and other functional and
      emotional comorbidities. Women are predominantly affected. Long term prognosis of FMS might
      be severe by its physical and psychological consequences. The etiology of FMS remains unknown
      but recent studies suggest a disorder of central pain modulation, neurotransmitters,
      sympatho-adrenal and hypothalamic-pituitary-adrenal system and peripheral muscles issues.
      Indeed, muscular abnormalities with a decrease of ATP and micro vascularization have been
      reported, inducing muscle weakness and local biochemical changes that participate to pain
      hyper sensitivity. Treatment of FMS is only symptomatic, often difficult, associating
      pharmacological and non-pharmacological therapies. Massages are largely used in FMS and are
      included in chronic pain management recommendations.

      Massages are recognized as haptic when the hands of the practitioner move on the skin of the
      patient; haptic massage is superficial if the pressure applied on the skin is similar to the
      weight of the hand and it's a deep haptic massage when the pressure applied is over the
      weight of the hand, allowing reaching deep muscle structure. Deep haptic massages are largely
      used for athlete to improve muscle recovery and treat tendinitis. All massages evaluate in
      FMS are superficial haptic massage; they are recognized as efficient on pain, anxiety and
      depression if they are performed at least on 5 weeks but these effects are transient et
      remain to be optimized. The efficacy of deep haptic massage has not been evaluated in
      pathological conditions. The investigators hypothesize that, in FMS patients, deep
      intramuscular maneuvers may solicit sensitive receptors, stimulating large caliber fibers A
      lemniscal conveyed by the way that bypass chronic pain information carried by the C fibers of
      the extra-lemniscal pathway: this is the "Gate Control" theory for inhibiting pain
      information.
    


Intervention name(s): Massage
Intervention type(s): Other
Intervention description(s): 6 weeks of deep haptic massage at 2 sessions of 30 minutes per week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Postprandial Glycemic and Insulinemic Response of ALLSWEET When Taken Alone or When Added to Sucrose
Condition: Blood Sugar
Study type: Interventional

Summary: 
      This study will explore the postprandial glycemic response of ALLSWEET®, a non-GMO certified
      allulose, when consumed alone or with sucrose, compared to the consuming sucrose alone. On 3
      separate days, subjects will consume in random order ALLSWEET® alone, ALLSWEET® added to
      sucrose, or sucrose alone. Blood samples for glucose and insulin analysis with be taken for 2
      hours following consumption of the beverages.
    

Detailed description: 
      Each subject will receive 3 test meals in a double blinded, randomized, crossover fashion.

        1. Test arm 1: 30g sucrose

        2. Test arm 2: 30g sucrose + 15g of ALLSWEET®

        3. Test arm 3: 15g ALLSWEET® All sweeteners will be mixed with 250ml of water.

      Eligible subjects will be studied on 3 separate days over a period of 4 weeks or less, with
      at least 1 day in between test days. A fasting fingerprick blood sample will be collected for
      glucose and insulin analysis after which the test meal will be administered. Additional
      fingerprick blood samples will be drawn over the next 2 hours (15', 30', 45', 60', 90' and
      120' after the first sip of the test drink).

      Power calculation: A sample size of 15 subjects, is sufficient to detect a 25% difference in
      incremental area under the curve between meals with 80% statistical power.

      Statistical Analysis: Incremental area under the curve values, blood glucose and insulin
      concentrations and increments at each time will be subjected to repeated-measures analysis of
      variance. After demonstration of significant heterogeneity, the significance of the
      differences between individual means will be assessed using Tukey's test to adjust for
      multiple comparisons, with the criterion for significance being two-tailed p<0.05. Means
      which differ by more than the least significant difference differ significantly.
    

Intervention name(s): ALLSWEET®; ALLSWEET® and sucrose; Sucrose
Intervention type(s): Other; Other; Other
Intervention description(s): ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be diluted in water.; ALLSWEET®, is a non-GMO certified allulose developed by the study sponsor. It will be added to sucrose (table sugar) and diluted in water.; Table sugar. It will be consumed by diluting it in water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      Subarachnoid block is the preferred method of anaesthesia for caesarean section, but is
      associated with hypotension and bradycardia, which may be deleterious to both parturient and
      baby. Animal studies suggest that in the presence of decreased blood volume, 5-HT may be an
      important factor inducing the Bezold Jarisch reflex via 5-HT3 receptors located in
      intracardiac vagal nerve endings. In this study, the investigators evaluated the effect of
      ondansetron, as a 5-HT3 receptor antagonist, on the haemodynamic response following
      subarachnoid block in parturients undergoing elective caesarean section.
    


Intervention name(s): Ondansetron; Normal saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Quantitatively Analysis of Fundus Structure Characteristics in Glaucoma Following Congenital Cataract Surgery
Condition: Glaucoma Secondary; Congenital Cataract
MeSH terms: Glaucoma; Cataract
Study type: Observational [Patient Registry]

Summary: 
      To quantitatively analyze the fundus structure and microvascular characteristics of GFCS and
      non-GFCS (NGFCS) using optical coherence tomography angiography (OCTA), to explore the
      vascular-structural association, and to assess the diagnostic abilities of structure
      parameters.
    

Detailed description: 
      A cross-sectional study. A total of 129 congenital cataract patients after congenital
      cataract extraction (40 in GFCS and 89 in NGFCS) were enrolled in this study from December
      2020 to March 2021. All participants, age range from 4 to 18 years old, completed OCT
      examinations (including macular structure parameters, optic nerve fiber layer thickness
      periphery retinal nerve fiber layer [pRNFL], and sub foveal choroidal thickness [SFCT]). All
      the NGFCS participants underwent OCTA examinations (including vessel density (VD) and
      perfusion density (PD) of macular and peripapillary area.). Linear regression models were
      used to examine the effect of various factors on different ocular parameters.
      Vascular-structural associations were assessed with Spearman correlation. Diagnostic ability
      was evaluated with area under the receiver operating curve (AUC).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study is a cross-sectional clinical study. Including children who were followed up in
        the pediatric cataract clinic of our hospital from December 1, 2020, to March 31, 2021, and
        had been diagnosed with GFCS, as well as patients diagnosed with non-congenital cataract
        extraction after surgery(NGFCS).
Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase III study to determine the sensitivity and specificity of three solutions of
      different allergen extracts for diagnosis by skin prick-test:

        -  5 Grasses pollen,

        -  Birch pollen,

        -  Dermatophagoides pteronyssinus mite
    


Intervention name(s): Skin prick-test
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Panton Valentine Leucocidin
Condition: Staphylococcus Aureus Pneumonias
MeSH terms: Pneumonia; Staphylococcal Infections; Pneumonia, Staphylococcal
Study type: Interventional

Summary: 
      Staphylococcus aureus expresses a variety of virulence factors, including Panton Valentine
      leukocidin (PVL), a cytotoxin. PVL is specifically associated with primary skin and
      soft-tissue infections and severe necrotizing pneumonia (Gillet et al. Lancet,
      2002;359:753-9). PVL-positive S. aureus pneumonia is often preceded by influenza-like
      symptoms, and is mainly characterized by hemoptysis, pleural effusion, rapid onset of acute
      respiratory distress, leukopenia and a high fatality rate (65%) (Gillet et al. Lancet,
      2002;359:753-9). Ten year after the first description of this disease and a number of
      controversies in the scientific literature, the question arise as to whether PVL remains an
      independent factor of severity in S.aureus pneumonia. In addition, numerous questions remain
      unanswered yet; these are:

        -  (i) which factors, including treatment regimen, are associated with favourable outcome?,

        -  (ii) what is the susceptibility toward antibiotics of strains associated with this
           disease ?

        -  (iii) is there any genetic susceptibility of the host to explain both the rarity, and
           the explosive presentation of the disease ? To address the above questions a prospective
           observational study at the nationwide level will be set up. All French hospitals will be
           invited to describe the clinical features of all new cases of S. aureus
           community-acquired pneumonia with severity criteria, regardless PVL production. The
           study will include an investigation of a possible innate immune dysfunction in
           collaboration with the INSERM-U550 (Génétique Humaine des Maladies Infectieuses, Faculté
           Necker, Paris). Hence, in addition to collecting clinical and biological data from all
           pneumonia cases as well as all strains of S. aureus isolated, the patients with
           PVL-positive pneumonia will be sampled for immune genetic studies (ORFeome sequencing
           and functional studied)
    


Intervention name(s): Serum and Blood samples
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PVL; Pneumonias; Staphylococcus aureus
A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the response to treatment and safety of paliperidone
      extended-release (mechanism to dissolve a drug over time in order to be released slower and
      steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with
      symptoms of emotional instability, detachment from reality, often with delusions and
      hallucinations, and withdrawal into the self).
    

Detailed description: 
      This is a non-randomized, single-arm, multi-center (conducted in more than one center) study
      to explore response to treatment and safety of flexible dose of paliperidone extended-release
      (ER) in participants with schizophrenia. During the study period, dose of paliperidone ER
      will remain within the range of 3 to 12 milligram per day and will be administered for 12
      months. Both hospitalized and non-hospitalized participants may be included in the study.
      Participants may switch to any effective dose of paliperidone ER from any oral antipsychotic
      medication without dose adjustment or if required, cross-dose adjustment may be done. Maximum
      4 weeks of switching period is allowed. Use of anticholinergic (opposing the actions of the
      acetylcholine, a neurotransmitter) drugs will not be restricted. Response to treatment will
      be evaluated primarily through total Personal and Social Performance (PSP) Scale.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Paliperidone extended-release (ER)
Intervention type(s): Drug
Intervention description(s): Paliperidone ER tablets will be administered orally once daily as flexible dose ranging from 3 to 12 milligram (mg) per day for 12 months. The recommended dose will be 6 mg once daily.
Other intervention name(s): Invega
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone; Invega
Effects of Moderate Consumption of Lean Fish on Weight Loss
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      the aim of present study is to compare the specific effects moderate consumption of lean fish
      on weight loss of healthy obese and overweight female adults, while participants follow
      energy-restricted diets also to investigate the effects of this intervention on carbohydrate
      and lipid profiles, as cardiometabolic risk factors.
    


Intervention name(s): Fish group; Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Fish group will have hypoenergetic diet in which subjects will have 3 x 150 g lean fish/ week at main meal; Control group will have hypo-energetic diet in which subjects have no seafood.
Other intervention name(s): FG; CG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: lean fish; weight loss; Diet
Single Dose of 9-cis-retinoic Acid in Hepatic Patients
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Observational

Summary: 
      To test whether patients with hepatic insufficiency can tolerate one oral dose of
      9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.
    


Intervention name(s): 9-cis-retinoic acid
Intervention type(s): Drug
Intervention description(s): Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure
Intervention MeSH terms: Tretinoin; Alitretinoin; Isotretinoin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        10 patients with hepatic disease and 10 controls
      
Biospecimen description: 
      Serum and urine
    
Keywords: Metabolisation of 9-cis-retinoic acid; hepatic patients; investigation of urine and blood samples
Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment
Condition: Type-2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients
      with mild, moderate or severe renal impairment and healthy volunteers.
    


Intervention name(s): vildagliptin
Intervention type(s): Drug
Other intervention name(s): LAF237
Intervention MeSH terms: Vildagliptin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial
Condition: Emergence Delirium; Emergence Agitation; Postoperative Delirium
MeSH terms: Delirium; Psychomotor Agitation; Emergence Delirium; Emergencies; Cognitive Dysfunction
Study type: Observational

Summary: 
      Perioperative neurocognitive disorders (PND) have been studying by clinicians, particularly
      by anesthesiologists, pretty long, however the most inspiring advancements were achieved
      during the last few decades. The most recent classification of PND which includes cognitive
      decline diagnosed before operation (described as neurocognitive disorder); any form of acute
      event (postoperative delirium) and cognitive decline diagnosed up to 30 days after the
      procedure (delayed neurocognitive recovery) and up to 12 months (postoperative neurocognitive
      disorder) was proposed in 2017. However at will one can notice at least one uncertainty that
      pertinent to the definition of delirium, emergency delirium and not mentioned in the
      classification discussed agitation.

      The objective of the study is to determine if there is a difference between emergence
      agitation and emergence delirium.
    


Intervention name(s): RASS; CAM-ICU
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Richmond Agitation-Sedation Scale; Confusion Assessment Method for the ICU
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients from 45 to 74 years old undergoing elective orthopedic surgery
      
Keywords: emergence agitation; postoperative agitation; postoperative delirium; postoperative cognitive dysfunction; emergence delirium
Prediction of Functional Disability in Subjects With Scapular Dyskinesis
Condition: Scapular Dyskinesis
MeSH terms: Dyskinesias
Study type: Observational

Summary: 
      Background: Patterns of scapular dyskinesis have unique scapular kinematics and associated
      muscular activation. The characteristics of scapular dyskinesis may be associated with
      functional disability. The investigators investigated whether the level of shoulder function
      and primary dysfunction items were different in each unique pattern of scapular dyskinesis.
      The factors associated with shoulder dysfunction in different patterns of scapular dyskinesis
      were identified.

      Methods: Participants with unilateral shoulder pain were classified as having a single
      dyskinesis pattern (inferior angle prominence, pattern I; medial border prominence, pattern
      II) or a mixed dyskinesis pattern (patterns I+II). Clinical measurements with the Flexilevel
      Scale of Shoulder Function (FLEX-SF score), shoulder range of motion, anterior/posterior
      shoulder tightness, and pectoralis minor index were recorded. These clinical measurements,
      3-D scapular kinematics (electromagnetic-based motion analysis), and associated muscular
      activation (electromyography on the upper, middle, and lower parts of the trapezius and
      serratus anterior muscles) during arm elevation were analyzed for associations with
      functional disability.
    


Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Function-related factors in patients with scapular dyskinesis. Fifty-one participants (40
        males; 11 females; mean age= 22.5±2.4 years; mean height=171.4 ± 8.0 cm; mean weight= 64.9
        ± 10.5 kg) were recruited.
      
Keywords: scapular dyskinesis; kinematics
Botox Cosmetic and the Young Patient With Glabellar Furrows
Condition: Glabellar Furrows
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if consistent treatment with Botox will lead to longer
      lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug
      Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this
      study a different dosing schedule of Botox injections will be used to see if the effects of
      the Botox treatment last longer than the effects of the standard injection regimen.
    


Intervention name(s): Botox
Intervention type(s): Drug
Intervention description(s): Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glabellar lines of moderate severity at maximum frown
Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      Antihistamines are commonly used and currently levocetirizine is most frequently prescribed
      in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems,
      especially to open tubal passage. However, the effects of these drugs on cognitive
      performance have not been investigated during diving.The objective of this study is to
      investigate the effects of levocetirizine, hydroxyzine and placebo on cognitive and
      psychomotor functioning during controlled simulated diving in a hyperbaric chamber in
      professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).It is hypothesized that
      hydroxyzine will produce significant impairment, and that the magnitude of impairment is
      related to hyperbaric pressure.
    

Detailed description: 
      This double-blind, randomized, placebo-controlled cross-over study will comprise of 1
      training day and 3 test days. Twenty-four healthy male divers from the Royal Netherlands Navy
      will participate in this study.The objective of this study is to investigate the single dose
      effects of levocetirizine (5 mg), hydroxyzine (50 mg) and placebo.

      Visit 1 is a training day, and Visit 2-4 are test days. At the test day, subjects receive one
      of the three medications. One hour after administration of the drugs, subjects will start
      with the dive in the recompression chamber. After one hour, medication has reached their peak
      plasma concentration, and effects can be expected. There will be a wash-out period of at
      least 7 days between the test days.

      Subjects will perform one simulated dive at each test day. They first descend in 2 min to a
      pressure of 4 bar (30 mt), stay for 20 min, the dive continues when they ascend to a pressure
      of 2 bar (10 mt) with another stay for 20 min. At both depths the 20 min periods are the
      measuring period to perform the test. At the end they will go to the surface according the
      decompression profile and stop for 3 min at 9 mt, 8 min at 6 mt and 23 min at 3 mt. These
      decompression stops are regular for the profile and necessary to prevent decompression
      sickness.Before and after diving, and at 2 and 4 bar, tests measuring attention, memory,
      psychomotor, concentration and comprehension ability of the participants are conducted.
    

Intervention name(s): Levocetirizine; Hydroxyzine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): a single oral dose of 5 mg; a single oral dose of 50 mg; a single oral dose
Intervention MeSH terms: Hydroxyzine; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Diving; Drugs; Antihistamines; Performance