bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Accuracy and Reliability of Infrared Tympanic Thermometer in an Adult Emergency Department
Condition: Fever
MeSH terms: Emergencies
Study type: Observational

Summary: 
      The primary aim of this study was to determine the accuracy of an infrared thermometer
      compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to compare
      tympanic and axillary temperature measurements by evaluating agreement and correlation to
      determine whether an infrared tympanic thermometer can replace an axillary mercury
      thermometer in the emergency department.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Febrile patients defined by a cut off of 37.5°C measured by axillary mercury thermometer
        were enrolled. Patients who meet the exclusion criteria were excluded.
      
Keywords: Infrared tympanic thermometer; Axillary thermometer; Mercury glass thermometer; Adult emergency department
Scottish COmputed Tomography of the HEART Trial
Condition: Angina Pectoris; Coronary Heart Disease
MeSH terms: Heart Diseases; Angina Pectoris; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The primary objective of the study is to see if coronary artery calcium score and computed
      tomography coronary angiogram alters the proportion of patients diagnosed with angina due to
      coronary heart disease.
    

Detailed description: 
      Rapid access chest pain clinics have facilitated the early diagnosis and treatment of
      patients with coronary heart disease and angina. Despite this important service provision,
      coronary heart disease continues to be under-diagnosed and many patients are left untreated
      and at risk. Recent advances in imaging technology have now led to the widespread use of
      non-invasive computed tomography both to measure coronary artery calcium scores and undertake
      coronary angiography. However, this technology has not been robustly evaluated in any
      systematic approach. Using state-of-the-art multidetector computed tomography scanners, we
      propose to undertake a major multicentre randomized controlled trial to assess the added
      value of computed tomography imaging in over 4000 patients attending rapid access chest pain
      clinics across Scotland. This will define the most appropriate use of this emerging
      technology in the setting of diagnosing and treating patients with coronary heart disease and
      angina pectoris. This study will also lay the foundation for future studies to look at the
      potential prognostic value of this technology.
    

Intervention name(s): Computer Tomography Angiography
Intervention type(s): Procedure
Intervention description(s): Computed Tomography Angiography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Angina; Coronary Heart Disease; Computed Tomography; Angiogram; Coronary Artery Calcium Score; Chest Pain; Angina Pectoris due to Coronary Heart Disease
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17
Condition: Vaccines; Meningococcal Vaccines
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil
      (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be
      randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection
      being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and
      saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent
      children between the ages of 11 and 17 years old.
    


Intervention name(s): rLP2086 and Gardasil; rLP2086; Gardasil
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.; Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.; Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: vaccine; rLP2086; Gardasil; HPV; meningitis B; N. meningitidis serogroup B; adolescents; single-blind; Meningococcal Vaccines
Study to Evaluate the ECG Effects of Telaglenastat in Healthy Adult Subjects
Condition: Cardiac Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the effects of telaglenastat on cardiac repolarization
      (relative to placebo) in healthy adult subjects.
    

Detailed description: 
      This is a multiple-dose, randomized, double-blind (with respect to telaglenastat and
      placebo), placebo- and positive controlled, 3 way crossover thorough QT (TQT) study in
      healthy adult subjects.

      On Day 1 of Period 1, subjects will be randomized to 1 of 6 treatment sequences.

      In Treatments A and B, subjects will receive the assigned treatment on Day 1 through the
      morning of Day 4. In Treatment C, subjects will receive a single-dose administration of
      moxifloxacin in the morning of Day 4. Cardiodynamic readings will be collected for 24 hours
      on Days 1 and 4. Plasma PK samples will be collected prior to dosing (for Treatments A and B
      or Hour 0 for Treatment C) and up to 24 hours on Days 1 and 4 of all treatments.
    

Intervention name(s): telaglenastat; telaglenastat placebo; moxifloxicin
Intervention type(s): Drug; Other; Other
Intervention description(s): glutaminase inhibitor; matching placebo for telaglenastat; positive control
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double-blind (with respect to telaglenastat and placebo), placebo- and positive controlled, 3 way crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Sleep Restriction and Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Insufficient sleep may be one of the most common, and most preventable, obesity risk factors.
      The investigators wish to determine whether 14 nights of modest sleep restriction results in
      increased energy balance, thus potentially increasing the risk of obesity. The investigators
      hypothesize that sleep restriction will result in increased energy balance.
    

Detailed description: 
      Numerous studies have reported that self-reported short sleep duration is associated with
      obesity and weight gain. Insufficient sleep may be one of the most common, and most
      preventable, obesity risk factors. Given that sleep restriction is largely voluntary and
      potentially correctable, understanding the mechanisms that link insufficient sleep to
      positive energy balance and the development of obesity, particularly visceral obesity, is
      crucial to clinical applications, public health policy, and informing future studies. The
      investigators wish to determine whether 14 nights of modest sleep restriction results in
      increased energy balance, thus potentially increasing the risk of obesity. The investigators
      will combine energy balance, biomarker, and imaging data with state-of-the art sleep
      monitoring to provide unambiguous data on the effects of sleep restriction on obesity.
      Together, the investigators findings will help explain whether the reduced sleep duration in
      the general population may be contributing to the current epidemic of obesity, and suggest
      strategies to reduce this risk.
    

Intervention name(s): Sleep restriction
Intervention type(s): Behavioral
Intervention description(s): 14 days of sleep restriction, 4 hours of sleep per day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Novel Therapeutics and Endothelial Dysfunction in T1DM Patients
Condition: Endothelial Dysfunction; Diabetes Mellitus, Type 1; Biomarkers; Endothelial Progenitor Cells; SGLT 2 Inhibitors; Incretins; Glucose Excursions; FMD; FPF; Arterial Stiffness
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of study is impact of additional treatment with new antidiabetic drugs (semaglutide
      or empagliflozine) compared to control group in T1DM patients - impact on endothelial
      function measured by FMD and FPF, arterial stiffness - measured by PWV, inflammatory
      biomarkers, markers of oxidative stress and endothelial progenitor cells (CD 34+/VDRL2, CD
      133+/VDRL2) and correlation with glucovariability or time in range, measured with CGM system.
    


Intervention name(s): Semaglutide Pen Injector [Ozempic]; Empagliflozin 10 MG
Intervention type(s): Drug; Drug
Intervention description(s): GLP 1 agonist; SGLT 2 inhibitor
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 therapeutic arms - adding empagliflozin or semaglutide to basic insulin treatment and control arm in type 1 diabetic patients
Masking: None (Open Label)
Primary purpose: Treatment
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 first-in-human (FIH) study evaluating single and multiple dose
      administration of AL-034 in healthy adult participants. The aim is to examine the safety
      (including pharmacodynamic [PD] biomarker assessments), tolerability, and pharmacokinetics
      (PK) of increasing single ascending doses (SADs) (Part 1) and multiple ascending doses (MADs)
      (Part 2) of AL-034. The potential food effect will be investigated in healthy adult
      participants at one or optionally 2 single dose level(s).
    


Intervention name(s): AL-034; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single oral dose of AL-034 under fed or fasted conditions in part 1 and part 2; Participants will receive single oral dose of matching placebo (oral solution) under fed or fasted conditions in part 1 and part 2.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose Escalation
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Procyanidin B2 Enriched Cocoa Effects on Mitochondrial Biogenesis
Condition: Athletes
Study type: Interventional

Summary: 
      The purpose of this study is to test how cocoa-rich procyanidin B2 affect the mitochondrial
      exercise adaptations.
    


Intervention name(s): procyanidin B2 enriched cocoa
Intervention type(s): Dietary Supplement
Intervention description(s): Volunteers will intake 5 grams per day of dietary supplement for 10 weeks
Intervention MeSH terms: Proanthocyanidin; Procyanidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Reconsolidation and EMDR
Condition: PTSD
Study type: Interventional

Summary: 
      Blocking of reconsolidation by pharmacological or behavioral means offers the therapeutic
      possibility of weakening traumatic memories in posttraumatic stress disorder (PTSD). Two
      reconsolidation-based interventions, propranolol and extinction learning, have been shown to
      weaken fear memories in human healthy subjects. However, the success of these interventions
      seems to be limited to weak conditioned fear memories. This calls for new, potentially more
      efficacious, interventions to be tested. Bilateral eye movements seem to be a promising
      candidate intervention for blocking reconsolidation due to the compelling evidence of Eye
      Movement Desensitization and Reprocessing as effective treatment in PTSD. The investigators'
      aim is to test bilateral eye movements as an active reconsolidation-blocking intervention in
      an optimized differential fear conditioning procedure that the investigators have recently
      developed. This novel experimental assay creates stronger fear memories in healthy
      individuals.
    


Intervention name(s): Delayed Bilateral Eye Movements; Undelayed Bilateral Eye Movement
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Bilateral Eye Movements followed by a 10 min delay after reactivation of fear-memory.; Bilateral Eye Movements followed by no delay after reactivation of fear-memory. reactivation of the fear memory trace during which the reactivated memory is assumed to be in a labile state.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Reconsolidation; EMDR; PTSD
Glycemic and Insulinemic Impact of a Test Granola 2 Versus a Control Granola
Condition: Glycemic Response; Insulinemic Response; Subject Hunger Response
Study type: Interventional

Summary: 
      The objectives of this study are to examine the blood glucose and serum insulin response
      elicited by servings of Test Granola and Control Granola containing equal amounts of
      available carbohydrate over a 3 h time period. In addition, the subjective hunger response to
      these foods will be measured over 3 h.
    


Intervention name(s): Test Granola; Control Granola
Intervention type(s): Other; Other
Intervention description(s): 50.5 Test Granola; 54.3 Control Granola
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Bioavailability Study of Letrozole Tablets 2.5 mg of Dr.Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare bioavailability in healthy, post menopausal women
      subjects under fasting conditions.
    

Detailed description: 
      An Open Label, Balanced, Randomized,Two Treatment, Two Sequence, Two Period, Cross-Over,
      Single-Dose, Comparative oral bioavailability study in healthy, post menopausal women
      subjects under fasting conditions.
    

Intervention name(s): Letrozole
Intervention type(s): Drug
Intervention description(s): Letrozole Tablets 2.5 mg of Dr.Reddy's Laboratories Limited
Other intervention name(s): Femara® Tablets 2.5 mg
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolism and Pharmacokinetics of [14C] BEA 2180 BR Administered Orally Compared to [14C] BEA 2180 BR Administered Intravenously in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objectives: To determine the basic pharmacokinetics of BEA 2180 BR, its metabolites
      CD 1975 ZW and CD 1976 ZW and radioactivity including excretion mass balance, excretion
      pathways and metabolism following the oral and intravenous administration of [14C] BEA 2180
      BR

      Secondary objectives: To determine safety and tolerability following single dose oral and iv
      administration of BEA 2180 BR in healthy male volunteers.
    


Intervention name(s): BEA 2180 BR oral; BEA 2180 BR infusion
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution; Solution for infusion to be reconstituted with isotonic saline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Taste Changes With Bariatric Surgery
Condition: Taste, Altered
MeSH terms: Dysgeusia
Study type: Observational

Summary: 
      It is commonly believed that a link exists between BMI and taste perception. One group of
      researchers observed that women who are obese experience reduced taste sensitivity when
      compared to normal-weight controls. Others have compared taste sensitivity between lean and
      obese subjects and found no significant differences. The inconsistencies in these studies
      demonstrate how much variation in taste sensitivity is possible when different factors are
      applied in research. Throughout several studies, one element remains constant - bariatric
      surgery causes appetite aversions. These changes in appetite and food preference likely have
      a large influence on the overall magnitude of post-surgical weight loss. Although many
      studies have investigated the changes in taste preference after bariatric surgery, few, if
      any, have focused on changes in sweet taste perception.
    

Detailed description: 
      The overall goal of the present project is to determine how future bariatric surgery will
      affect the taste for sweet liquids. Taste perception will be assessed before surgery
      (pre-operative, pre-op) and after bariatric surgery, at approximately 1 month. Taste studies
      will be conducted with solutions prepared freshly before each test using sucrose dissolved in
      distilled water. Six concentrations of sucrose (table sugar) will be tasted in random order,
      with the most concentrated solution being roughly the sweetness of soda. The subject is
      blinded to the concentrations. It is hypothesized that there will be no significant
      difference in taste perception when pre-op and post-op values are compared. However, the
      investigators hypothesize that taste preference will identify solutions with lower
      concentrations post-op.
    

Intervention name(s): taste test
Intervention type(s): Other
Intervention description(s): All subjects will complete a procedure to determine their taste sensitivity to sweet tastants.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 21-70 will be recruited from the University of Missouri Bariatric Surgery
        Clinic.
      
Biospecimen description: 
      Before bariatric surgery, the subject will lightly scrape the inside of their cheek to
      harvest cells. These cell will be frozen for future DNA extraction and detection of taste
      receptor genes, T1R2 and T1R3.
    
Keywords: taste perception; bariatric surgery; taste preference; weight loss surgery
Effects of Whole Grain Rye on Metabolic Risk Markers and Mood
Condition: Metabolic Disorders and Cognitive Decline
MeSH terms: Metabolic Diseases; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of the study is to investigate, in healthy middle age subjects, effects of whole
      grain rye on cognitive functions, mood, and cardiovasculair risk markers
    


Intervention name(s): whole grain; reference
Intervention type(s): Other; Other
Intervention description(s): whole grain rye; white wheat bread
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen, in Healthy Subjects, Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioavailability comparison study with a cross-over desing, 2x2, open, prospective and
      longitudinal, at a single dose with two treatments, two periods, two sequences with an
      elimination (washout) period of 7 days and a number of 36 healthy subjects, of both genders,
      under fasting conditions, of reference tablets of Dexketoprofen 25 mg (Stadium®), elaborated
      by Grimann, S.A. de C.V., and capsule test drug with Dexketoprofen 25 mg- Vitamin B complex
      elaborated by Laboratorios Silanes S.A. de C.V.
    

Detailed description: 
      The study was designed to recruit 36 healthy subjects considering a 2x2 design, where each
      subject received both treatments and was its own control. The time was adjusted considering
      the half-life of the drugs to be evaluated. Healthy subjects of both genders were selected
      since no relevant pharmacokinetic differences related to gender had been reported for the
      study drug. The aim of the study was to comparatively evaluate, in the same individuals the
      plasma concentrations of Dexketoprofen 25 mg from two pharmaceutical formulations; reference
      tablets of Dexketoprofen 25 mg ( Stadium®), elaborated by Grimann, S.A. de C.V., and capsule
      test drug with Dexketoprofen 25 mg- Vitamin B complex elaborated by Laboratorios Silanes S.A.
      de C.V.
    

Intervention name(s): Dexketoprofen 25 MG; Fixed dose Dexketoprofen-Vitamin B Complex
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical Form: Tablets Dosage: 25 mg Adminstration way: Oral; Pharmaceutical Form: capsule Dosage: 25 mg of Dexketoprofen + Cyanocobalamin 500 µg, Thiamine 100 mg, Pyridoxine 50 mg. Administration way: oral
Other intervention name(s): (Stadium®); DEXK / VITB
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dexketoprofen; Trometamol; Cyanocobalamin; Thiamine; Pyridoxine; Pharmacokinetic; Bioavailability; Fixed-dose combination (FDC); Bioequivalence
A Holistic Dietary Intervention for Persons With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      People with spinal cord injury are at increased risk for overweight and obesity, type 2
      diabetes, cardiovascular disease and decreased quality of life compared With able bodied.

      This pilot aims to assess the impact of a nutrition intervention that combines several
      methods to help people change their lifestyle.

      The pilot project combines individual interviews and personal lifestyle goals (diet) with
      group classes for people with long-standing spinal cord injury.

      In addition to nutrition theory and practical exercises for diet-planning, motivational
      interviewing and mindfullness are incorporated into the course. The course is
      interdisciplinary, but is led primarily by a dietitian. Data is collected before the course
      starts and right after the 9-week course ends. The measurements involves self-perceived
      quality of life, food diary, weight, waist circumference and body composition (measured by
      BIA and DXA).
    


Intervention name(s): A holistic dietary intervention for persons with spinal cord injury
Intervention type(s): Behavioral
Intervention description(s): A lifestyle program over 9 weeks combining individual consultations with a dieatitian and interdiciplinary group sessions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients With long-standing spinal cord injury (> 2 years after injury)