bioihbjkbjnl/mcl2 huggingface dataset:
Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Condition: Oximetry
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen
      desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia
      has been attained. The blood sample is analyzed for oxygen saturation with a gold standard
      bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents
      for pulse oximeter testing.
    


Intervention name(s): hypoxia
Intervention type(s): Diagnostic Test
Intervention description(s): Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluation of Histamine, CGRP and VIP as Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers
Condition: Migraine; Sinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate histamine, CGRP and VIP levels in saliva
      as biological markers for activation of trigeminal and parasympathetic nerve fibers in
      various clinical presentations of primary headaches compared to allergic rhinosinusitis and
      control populations.
    

Detailed description: 
      It has been suggested that many people with self-diagnosed or physician diagnosed "sinus"
      headache experience symptoms that fulfill diagnostic criteria for migraine or migrainous
      headache. The shared symptomatology does not differentiate these disorders."Sinus" symptoms
      as an early manifestation of migraine may be associated with elevated levels of CGRP
      suggesting peripheral trigeminal activation whereas "sinus" symptoms late in migraine may
      have associated elevations of VIP suggesting parasymptathetic activation. Subjects without
      autonomic or "sinus" symptoms will not have changes in salivatory histamine, CGRP or VIP and
      will have values similar to controls. Subjects with rhinosinusitis will have levels or
      patterns of salivatory histamine, CGRP and VIP unique from migraine subjects. If "sinus
      symptoms" are associated with parasympathetic activation, then there should be detectable
      increases in VIP early in the course of nasal symptom development and, conversely, if these
      symptoms associate with trigeminal activation, then increases in CGRP should be detected.
      Five groups of 10 subjects each will be recruited. Group A without migraine, with
      self-described "sinus" headache or symptoms of rhinosinusitis. Group B with chronic
      rhinosinusitis and no history of migraine or "sinus" headache. Group C with "sinus" headache
      with symptoms meeting IHS criteria for migraine and symptoms of rhinosinusitis preceding the
      onset of headache symptoms meeting migraine criteria. Group D with symptoms of rhinosinusitis
      that develop late in the course of migraine after criteria for IHS migraine are met. Group E
      with IHS migraine, without sinus symptoms associated with migraine.
    

Intervention name(s): almotriptan or pseudoephedrine
Intervention type(s): Drug
Intervention MeSH terms: Pseudoephedrine; Ephedrine; Almotriptan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: migraine; biological markers; rhinosinusitis; CGRP; histamine; VIP
Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis.
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This was a retrospective cohort study utilizing secondary data from IQVIA's open source
      pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for
      ofatumumab or other DMTs of interest.
    

Detailed description: 
      The date of first ofatumumab prescription claim or other DMT of interest was defined as the
      index date. No post-index requirements were imposed.

      Patients were linked to IQVIA's open source medical claims databases (Dx) to obtain patient
      clinical characteristics.

      The initial data were extracted in October 2020. The data and results were refreshed in April
      2021 and July 2021 to allow for assessment of changes in characteristics at 6 and 9 months
      post-launch.
    

Intervention name(s): Ofatunumab
Intervention type(s): Other
Intervention description(s): All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with prescription claims for ofatumumab or other DMTs of interest.
      
Keywords: Multiple sclerosis,; ofatumumab,; disease-modifying therapy,; COVID-19
How Orally Consumed 3-hydroxybuturate Alters Metabolism
Condition: Acute Ketosis
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      This study evaluate the metabolic effects of orally ingested ketone bodies. The study is
      conducted as a randomized, cross over study.
    

Detailed description: 
      Subject participate for two separate days; i) intervention, ii) placebo. Intervention:
      subjects drink ketone body solution. Tracer kinetics on glucose and lipid metabolism is
      applied. Muscle tissue and adipose tissue biopsies are taken.

      Placebo: subjects drink saline. Same sampling as on intervention day.
    

Intervention name(s): 3-hydroxybuturate; Placebo
Intervention type(s): Other; Other
Intervention description(s): Drink of ketone bodies; Drink of saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Distal Thigh Compression Garment Improves Knee Control and Safety Perceptions During Single Leg Triple Hop for Distance
Condition: Neuromuscular Control
Study type: Interventional

Summary: 
      This study measured knee frontal plane projection angle (FPPA) and sports safety and
      performance perceptions of female athletes during a single leg triple hop for distance for 3
      conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)). The
      hypothesis was that the DTCG group would display superior dynamic knee valgus FPPA compared
      to the standard knee sleeve and no device groups.
    

Detailed description: 
      Eighteen healthy college athletes participated in this prospective cohort study with a
      randomized device order. FPPA was measured during single leg triple hop for distance using
      two-dimensional biomechanical techniques to estimate dynamic knee valgus loading. A 10-cm
      visual analog scale survey collected data regarding subject perceived knee control, sports
      movement capability and overall satisfaction for each condition. Pearson correlations
      delineated knee valgus, safety and performance relationship perceptions (p < 0.05).
    

Intervention name(s): Distal Thigh Compression Garment, Knee Sleeve
Intervention type(s): Device
Intervention description(s): Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device
Intervention model: Single Group Assignment
Intervention model description: This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)).
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dynamic Knee Stability
German Lactat Clearance in Severe Sepsis
Condition: Severe Sepsis; Septic Shock
MeSH terms: Sepsis; Toxemia
Study type: Observational

Summary: 
      The aim of this study is to investigate if there is a correlation between lactate clearance
      and the course at patients with severe sepsis and septic shock at german intensive care
      units.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with severe sepsis or septic shock
Respiratory Mechanics and Pleural Effusion
Condition: Critically Ill; Acute Lung Injury; ARDS
MeSH terms: Lung Injury; Pleural Effusion; Acute Lung Injury; Critical Illness
Study type: Observational

Summary: 
      The investigators aim to compare the respiratory mechanics in acute lung injury (ALI)/acute
      respiratory diseases syndrome (ARDS) patients with and without pleural effusion.
    

Detailed description: 
      In ALI/ARDS we evaluated the respiratory mechanics (respiratory system, chest wall and lung
      elastance) at the bedside while pleural effusion was evaluated with CT scan. Thus we will be
      able to estimate any possible role of pleural effusion on the respiratory mechanics.
    

Intervention name(s): mechanical ventilation/CT Scan
Intervention type(s): Procedure
Intervention description(s): evaluation of pleural effusion and respiratory mechanics, CT scan
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ALI/ARDS patients
      
Keywords: Critically ill patients
Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized clinical trial will evaluate the efficacy of an antiresorptive osteoporosis
      drug (denosumab) in prevention of periprosthetic bone loss and in promotion of implant
      osseointegration (bone bonding) in postmenopausal women after total hip replacement. The
      investigators assume that denosumab prevents periprosthetic bone loss and enhances bone
      bonding of the hip stem in postmenopausal women.
    

Detailed description: 
      This is a randomized, double-blind and placebo-controlled trial to evaluate the efficacy of
      denosumab on the biologic incorporation of cementless hip prosthesis. The study population
      consists of sixty-eight postmenopausal female patients, who are scheduled to have cementless
      total hip replacement (THA) for primary hip osteoarthritis. The patients will be randomly
      assigned to receive a subcutaneous injection of denosumab 60 mg or placebo four weeks before
      surgery and 22 weeks after surgery. The primary hypothesis is that denosumab is effective in
      preventing periprosthetic bone loss in the proximal femur as measured by DXA. The secondary
      hypothesis is that denosumab is effective in enhancement of bone bonding (osseointegration)
      of cementless femoral stems, as measured by model-based radiostereometric analysis.
    

Intervention name(s): Denosumb; Placebo (for denosumab)
Intervention type(s): Drug; Drug
Intervention description(s): Prefilled syringe of 1 mL denosumab solution
Other intervention name(s): Brand name: Prolia; Prefilled syringe of 1 mL placebo solution
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Denosumab; Osteoporosis; Hip replacement; Osteoarthritis; Radiostereometric analysis (RSA); Dual energy X-ray absorptiometry (DXA)
Safety and Efficacy of a Single Dose of a Polyphenol-enriched Brown Seaweed Powder in Human
Condition: Glycemic Index
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary endpoint of this trial will be to evaluate the safety of a single administration
      in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a
      test meal. The secondary endpoint of this trial will be to evaluate if a single
      administration in human of a dose of 500 mg of a polyphenol-rich algal powder is able to
      reduce the rate of carbohydrate absorption as measured by following postprandial glycemia and
      insulinemia.
    


Intervention name(s): Brown seaweed powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mg (in two 250 mg capsules) taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water); Two capsules similar in aspect and weight to active product, taken with 250 ml of water 30 minutes before test meal (110g of plain white bread with 250 ml of water)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Glycemic index; Reduction of glycemic index of ingested foods
Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants
Condition: Full Term Infants; Environmental Exposures; Adiposity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life exposure
      to an adverse developmental environment, including environmental toxins, are linked to
      increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. Although the
      mechanisms underlying the fetal origins of metabolic disease are poorly understood, strong
      evidence suggests that alterations in the epigenome play a critical role in this process. The
      central hypothesis of this proposal is that intrauterine exposure to benzo[a]pyrene leads to
      epigenetic changes which will have functional consequences and may be a marker for, or may
      contribute to, increased susceptibility to adverse outcomes in childhood including increased
      adiposity and the subsequent development of obesity, metabolic syndrome or diabetes. The
      goals of this proposal are to: 1) determine benzo[a]pyrene levels in umbilical cord blood of
      newborns, 2) determine whether benzo[a]pyrene exposure during pregnancy correlates with early
      onset of obesity and metabolic disease by examining the children at 12 and 24 months of age,
      3) determine whether in utero benzo[a]pyrene exposure programs metabolic disease through
      alterations in DNA methylation and gene expression, and 4) determine the plasticity of the
      DNA methylation patterns in the same offspring at 12 months of age. The long-term goal of
      this project is to define biomarkers that identify neonates at "high-risk" for diminished
      attainment of full health potential, who can then be targeted for preventative measures.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Mother-baby pairs will be recruited.
      
Biospecimen description: 
      Maternal blood sample Cord blood sample Infant saliva Peripheral blood sample from enrolled
      patients at 12 and 24 months of age
    
Keywords: Term gestation; Environmental exposure; Benzo(a)pyrene; Polycyclic aromatic hydrocarbons; Adiposity; Cytosine methylation
Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebral Block
Condition: Rib Fracture Multiple; Anesthesia, Local
MeSH terms: Rib Fractures; Fractures, Multiple
Study type: Interventional

Summary: 
      Tracheal intubation and general anesthesia has been considered a safe and conventional
      routine methodology for thoracic surgery, include multiple rib fratcure. However,adverse
      effects such as sore throat, pain, hoarseness, and respiratory complications are common after
      that. In this study, we decide to perform surgical stabiliazation of rib fractures by
      paravertebral block surgical stabiliazation of rib fractures under awake or appropriate
      sedation without endotracheal intubation keeping spontaneous respiration to investigate its
      safety and feasibility.
    

Detailed description: 
      Rib fracture is common in the world,especially in chest trauma. Conservative treatment is
      used to it for many years but the effect is not well because of continuous pain caused by the
      dislocation of broken rib. Surgical stabiliazation of rib fractures can relieve the pain
      rapidly and help patient recover to work early. This kind of surgery is constantly conducted
      with tracheal intubation and general anesthesia. However,adverse effects such as sore throat,
      pain, hoarseness, and respiratory complications are common after that. So we think perform
      surgical stabiliazation of rib fractures under awake or appropriate sedation without
      endotracheal intubation keeping spontaneous respiration to investigate its safety and
      feasibility.
    

Intervention name(s): internal fixation of mulitiple rib fracture
Intervention type(s): Procedure
Intervention description(s): The dislocated rib fracture was anatomically reduced, and then fixed with appropriate equipment to prevent the fracture from being displaced again
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of lower dosage etoricoxib (60 mg daily) with aceclofenac (100 mg bid) for their
      efficacy and safety in the treatment of rheumatoid arthritis (RA).
    

Detailed description: 
      This was a single medical center, parallel-group, randomized controlled trial, which
      conducted for eight weeks. In this study, 40 patients of RA were randomly assigned to two
      different treatment groups (etoricoxib and aceclofenac), and 20 patients were enrolled for
      each group. In addition to baseline data collection, objective assessment tools were used to
      evaluate for efficacy and safety. The primary endpoint was American College of Rheumatology
      20% improvement criteria (ACR20) , secondary endpoints were the ACR 50,70, disease activity
      score 28 (DAS 28), European League Against Rheumatism (EULAR) response criteria, the number
      of tender and swollen joints, physician's global assessment, patient's global assessment,
      pain scores, the short form health survey (SF-36) health Questionnaire and etc. In addition,
      all adverse reactions were recorded and all the results were analyzed in the intention to
      treat (ITT) manner.
    

Intervention name(s): Etoricoxib; Aceclofenac
Intervention type(s): Drug; Drug
Intervention description(s): Etoricoxib 60 mg QD Oral; Aceclofenac 100 mg BID Oral
Other intervention name(s): Arcoxia; TONEC
Intervention MeSH terms: Etoricoxib; Aceclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: etoricoxib aceclofenac efficacy safety Taiwanese
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was an international, multicenter, randomized (2:1 active:placebo), double-blind,
      placebo-controlled study in subjects with PAH who were NOT currently receiving approved
      therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an
      additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test.
      Study procedures included routine blood tests, medical history, physical exams, disease
      evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at
      select centers - a hemodynamic substudy with a right heart catheterization at Baseline and
      Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and
      Week 12.

      Patients who completed all assessments for 12 weeks were also eligible to enter an
      open-label, extension phase study (FREEDOM - EXT).
    


Intervention name(s): Oral treprostinil (UT-15C) Sustained Release Tablets; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Sustained release oral tablet, twice daily; Placebo oral tablet twice daily
Other intervention name(s): treprostinil diethanolamine
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension
Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients
Condition: Hyperphosphatemia; End-stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Hyperphosphatemia
Study type: Interventional

Summary: 
      This study is designed to study and compare the efficacy and cost-effectiveness of
      individualized phosphate-lowering therapy in comparison with regular guideline-recommended
      therapy.
    

Detailed description: 
      Hyperphosphatemia in hemodialysis patients has been one of the most difficult conundrums for
      nephrologist for the past two decades. Elevated phosphate contributes to secondary
      hyperparathyroidism, elevated FGF23 levels, and vascular calcification, which in turn
      predispose to mortality in this population. Current guidelines recommend limiting dietary
      phosphate intake, strengthening dialysis and using phosphate binders as three therapies for
      treatment of hyperphosphatemia. Yet exact clinical implication remains ambiguous: how intense
      restricted phosphate intake should be and how dosage of phosphate binders and dialysis should
      be adjusted accordingly. Thus, treatments of hyperphosphatemia have not been effective
      enough, but appear to be refractory. In the current study, the investigators designed
      individualized phosphate-lowering therapy based on each patient's phosphate-clearing ability,
      in order to observe and compare the efficacy and cost-effectiveness of the individualized
      therapy and the regular guideline-recommended therapy.
    

Intervention name(s): enhanced individualised therapy; non-enhanced individualised therapy; regular intervention
Intervention type(s): Other; Other; Other
Intervention description(s): additional dialysis dosage, modification of medication and prescribed dietary plan; modified medication, prescribed dietary plan and regular three times/week dialysis dosage; Phosphate binders and calcitriol would be prescribed according to the guidelines. Phosphate binders included in the study are calcium acetate, calcium carbonate or sevelamer. Dosage is based on patients serum phosphate and calcium level. Calcitriol prescribed in the study is Rocaltrol and the dosage is based on PTH, serum phosphate and calcium level. Patients' diet habit will not be altered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: individualised therapy; hyperphosphatemia; hemodialysis; clinical trials; restricted phosphate diet; phosphate binders