bioihbjkbjnl/mcl2 huggingface dataset:
Studying the Effect of Capsinoids on Brown Fat Using Infrared Thermal Imaging.
Condition: Obesity; Diabetes; Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The primary hypothesis of this study is that consumption of capsinoids increases brown
      adipose tissue activity, detectable by infrared thermal imaging.

      The secondary hypothesis is that consumption of capsinoids can affect an individual's
      glycaemic response.
    

Detailed description: 
      It has been recently established that brown adipose tissue (BAT) exists in adult humans. BAT
      is a thermogenic tissue which dissipates energy as heat. The primary objective of this study
      is to use thermal imaging to assess the effect of capsinoids on BAT activity in adult humans,
      and whether there is a relationship between the increase in energy expenditure and BAT
      activity after capsinoids intake. The secondary objective is to investigate whether
      capsinoids will have an effect on an individual's glycaemic response. Lean, healthy male
      volunteers will be recruited. There will be two test sessions which are randomized, where
      subjects will consume either capsinoids or placebo capsules, and a standardized amount of
      white rice (equivalent to 50g carbohydrates). Indirect calorimetry will be used to assess
      energy expenditure before and after consumption of the test meal. Thermal imaging of
      supraclavicular BAT, the primary BAT depot in humans, will be undertaken using an infrared
      thermal camera to assess changes in BAT temperature. Blood glucose levels will be monitored
      by finger prick blood sampling method. This study aims to investigate whether capsinoids
      consumption leads to changes in BAT temperatures detectable by the infrared thermal camera,
      to confirm the feasibility of using thermal imaging as a rapid, noninvasive, and reproducible
      way of studying BAT activity thus providing a platform to advance research in this emerging
      field of human BAT.
    

Intervention name(s): Capsinoid/placebo and rice
Intervention type(s): Dietary Supplement
Intervention description(s): The subject will ingest six capsinoid/placebo capsules and a standardized amount of white rice (equivalent to 50g carbohydrates). Each capsule consists 1.5mg of capsinoids, making a total dose of 9mg capsinoids.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Comparison of Two Spinal Manipulation Treatments in Patients With Chronic Mechanical Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      There is enough evidence to suggest that the spinal manipulation of the upper cervical spine
      and cervicothoracic spine are effective in decreasing neck pain. Therefore, the purpose of
      this randomized controlled trial is to compare the effects of an isolated application of
      upper cervical spine thrust joint manipulation with the application of a full combination of
      cervical, cervico-thoracic and thoracic spine thrust joint manipulation on neck pain,
      disability and cervical range of motion in individuals with chronic mechanical neck pain.
    


Intervention name(s): Spinal manipulation
Intervention type(s): Other
Intervention description(s): Application of upper cervical spine thrust joint manipulation or application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comminuted Fractures of the Midshaft of the Tibia; (Interlocking Nail +/- Blocking Screws or Locked Plating With Predicted Distribution of Locking Screws) Choice Based on Finite Element Analysis Correlated With Clinical Outcome and Union.
Condition: Comminuted Fracture Tibia
MeSH terms: Fractures, Bone; Fractures, Comminuted
Study type: Observational [Patient Registry]

Summary: 
      study is to assess the clinical and radiological results of Comminuted fractures of the
      midshaft of the tibia; treated with interlocking nail +/- blocking screws or locked plating
      with predicted distribution of locking screws, choice based on finite element analysis
      correlated with clinical outcome and union.
    

Detailed description: 
      FE analyses will be performed using the finite element code COSMOS/M. The three-dimensional
      "lower leg" FE model (LL FE model) will be used included the tibia and the fibula. The bony
      structures will be generated by segmentation of a data set of computed tomographies from the
      Visible Human Project.

      Analysis of data regarding clinical outcomes and radiological assessment of healing rate and
      union
    

Intervention name(s): Finite element analysis
Intervention type(s): Other
Intervention description(s): Biomechanical study to describe micromotion
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient with comminuted fractures of the midshaft of the tibia.
      
Keywords: Comminuted fracture, Finite element analysis, Tibia
Microbial Composition of Breast Milk Collected From Healthy Turkish Women
Condition: Microbial Community in Breast Milk
Study type: Observational

Summary: 
      Breast milk is an optimal source of nutrients for newborns as well as a potential source of
      bacteria for the intestinal microbiota. However, there are limited number of studies
      evaluating the relationship between maternal nutrition, breast milk and neonatal intestinal
      microbiota.
    

Detailed description: 
      The study was conducted on a total of 20 healthy women following at Obstetrics and Gynecology
      Department of Gülhane Education and Research Hospital in Ankara Health Sciences University.
      Sociodemographic characteristics, anthropometric measurements, breastfeeding characteristics
      were evaluated in the third trimester of the women who underwent routine prenatal care.
      Breast milk samples were obtained at 16.day postpartum during lactation.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        20 healthy women who were at 16. day postpartum
      
Biospecimen description: 
      Breast Milk
    
Keywords: breast milk; microbiota
Combined Single / Multiple Dose Escalation Study in Patients With Renal Anemia Due to CKD (Chronic Kidney Disease)
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The drug that is under investigation during this study is BAY85-3934 which is intended to be
      used as a treatment for patients suffering from renal anemia due to chronic kidney disease
      (stage 3 and 4).

      The purpose of this study is to provide safety and tolerability information on the drug.
      Other objectives of the study are to investigate the effect of the drug on the body
      (pharmacodynamics) as well as the absorption, breakdown, metabolism, distribution and
      excretion (pharmacokinetics) by measuring the concentration in blood and urine.

      The study will be conducted in one study center in the United Kingdom and several centers in
      Germany. 84 (of which 36 are optional) patients who meet the inclusion criteria will
      participate in the study. BAY 85-3934 will be given following a combined single / multiple
      dose escalation design in seven (of which three are optional) dose steps.
    


Intervention name(s): BAY85-3934; BAY85-3934; BAY85-3934; BAY85-3934; BAY85-3934; BAY85-3934
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects received an oral single dose of placebo tablet matched to the molidustat dose (BAY85-3934) on Day 1 followed by a washout day and once daily multipledose over 12 days (from Day 3 to Day 14).; Subjects received an oral single dose of 5 mg of molidustat IR tablet on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).; Subjects received an oral single dose of 10 mg of molidustat ( 2x 5mg IR tablets) on Day 1 followed by a washout day and once daily multipledose over 12 days (from Day 3 to Day 14).; Subjects received an oral single dose of 25 mg of molidustat (1 x 20 mg IR tablet and 1 x 5 mg IR tablet) on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).; Subjects received an oral single dose of 50 mg) of molidustat (2 x 20 mg IR tablets and 2 x 5 mg IR tablets) on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).; Subjects received an oral single dose of 75 mg of molidustat (3 x 20 mg IR tablets and 3 x 5 mg IR tablets) on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Anemia
Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg
      Apixaban in subjects with normal renal function and subjects with end stage renal disease
      (ESRD) maintained with hemodialysis.
    

Detailed description: 
      Primary Purpose : To provide a clear understanding of the pharmacokinetics of Apixaban in
      subjects with ESRD and to determine the effect of hemodialysis on Apixaban pharmacokinetics .
    

Intervention name(s): Apixaban; Apixaban
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 5 mg, Once, 4 days; Tablets, Oral, 5 mg, Twice, 15 days
Intervention MeSH terms: Apixaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: PHARMACOKINETIC; NOS
Ulmus Macrocarpa Hance Extract and Lipid Profile
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The investigators conduct a randomized, double-blind, placebo-controlled study to investigate
      the effects of the Ulmus Macrocarpa Hance extract on lipid profile in adults with
      dyslipidemia for 12 weeks.
    

Detailed description: 
      Previous another our study have indicated that Ulmus Macrocarpa Hance extract (UMH) may have
      the ability to decrease blood cholesterol. Therefore, the investigators conduct a randomized,
      double-blind, placebo-controlled study to investigate the effects of the UMH on lipid profile
      in adults with dyslipidemia; the safety of the compound are also evaluate. The Investigators
      examine total cholesterol, HDL-cholesterol, triglyceridemia, LDL-cholesterol, and other
      biochemical parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty
      adults were administered either 500 mg of UMH or a placebo each day for 12 weeks;
    

Intervention name(s): UMH extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Schisandra chinensis extract 500 mg/day for 12 weeks; Starch placebo 500 mg/day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis
Condition: Nephritis; Systemic Lupus Erythematosus
MeSH terms: Nephritis; Glomerulonephritis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose
      escalation study, enrolling approximately 48 subjects. Part A of the study will enroll
      subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3
      cohorts. Part B of the study will enroll SLE subjects with GN into 3 cohorts. The purpose of
      the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and
      pharmacokinetics.
    

Detailed description: 
      Part A of the study will enroll SLE without GN (non-renal) subjects into 3 cohorts (6 AMG
      811: 2 placebo). All subjects will receive a dose of AMG 811 or placebo every 4 weeks
      beginning with Day 1 (D1) for a total of 3 injections. Subjects will be followed through to
      study day 197, 5 months from the last dose of study medication.

      Part B of the study will enroll SLE subjects with GN into Cohorts 4, 5, and 6 (6 AMG 811: 2
      placebo). Similar to Part A, subjects in Cohorts 4, 5, and 6 will be dosed every 4 weeks with
      AMG 811 or placebo for a total of 3 injections followed by a 5 month follow-up period. For
      Cohort 6, subjects will be followed by a 6 month follow-up period.
    

Intervention name(s): AMG 811
Intervention type(s): Drug
Intervention description(s): Part A of the study will enroll SLE without GN (non-renal) subjects into 3 cohorts (6 AMG 811: 2 placebo). All subjects will receive a dose of AMG 811 or placebo every 4 weeks beginning with day 1 (D1) for a total of 3 injections. Subjects will be followed through to study day 197, 5 months from the last dose of study medication. Part B of the study will enroll SLE subjects with GN into Cohorts 4, 5 and 6 (6 AMG 811: 2 placebo). Similar to Part A, subjects in Cohorts 4, 5 and 6 will be dosed every 4 weeks with AMG 811 or placebo for a total of 3 injections followed by a 5 month follow-up period. For Cohort 6, subjects will be followed by a 6 month follow-up period.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lupus; Nephritis
Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effects of canagliflozin and phentermine to those
      of placebo to promote on a change in body weight over a 26 week period.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), double-blind (neither
      physician nor participant knows the identity of the assigned treatment), placebo-controlled
      (an inactive substance that is compared with a medication to test whether the medication has
      a real effect), parallel-group, multicenter study of the effects of canagliflozin and
      phentermine co-administration in non-diabetic overweight or obese participants. The study
      will be conducted for about 33 weeks, approximately 344 participants will be randomly
      assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of
      canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All
      participants will be also provided with diet and exercise counseling for weight loss
      (standardized non-pharmacological therapy).
    

Intervention name(s): Canagliflozin; Phentermine; Matching Placebo to Canagliflozin; Matching Placebo to Phentermine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 300 mg capsule, taken once daily, orally for 26 weeks.; 15 mg capsule, taken once daily, orally for 26 weeks.; Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.; Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
Other intervention name(s): INVOKANA
Intervention MeSH terms: Canagliflozin; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Canagliflozin; Phentermine; INVOKANA®
The Practice of Providing Palliative Care in the Situation of the COVID-19 (Coronavirus Disease 2019) Pandemic in Czech Republic
Condition: Covid19; Distress, Emotional
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Pandemic of coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus 2) causing
      the disease COVID-19 (Coronavirus Disease 2019) overwhelmed healthcare and brought new
      challenges and stressful situations.
    

Detailed description: 
      In a short time, the capacities of intensive care units (ICU) were filled in many countries
      and regions. Due to the need for an excessive number of patients requiring intensive care,
      physicians and nurses who do not routinely provide care to critically ill patients or do not
      have the appropriate training (non-ICU clinician) were involved in the care of COVID-19
      (Coronavirus Disease 2019) patients. In this context, ICU directly dedicated to the care of
      patients with COVID-19 ARDS (Acute Respiratory Distress Syndrome) were also opened. Non-ICU
      clinicians were more or less involved together with the standard ICU staff in palliative
      care, including End-of-Life decision (EOLD) making, even in a situation of limited scarce
      resources (equipment or personnel). New workplace and scope of work, which did not correspond
      to the standard activity or education, most likely led to an increased stress load. EOLD can
      also be one of the factors leading to increased stress levels. The aim of the project is to
      describe the practice of palliative care for patients with COVID-19 in a situation of
      pandemic COVID-19 and to identify factors leading to possible moral distress related with
      EOLD.
    

Intervention name(s): Questionnaire Survey
Intervention type(s): Other
Intervention description(s): Physicians providing care to patients with COVID-19 admitted at ICU in period of COVID-19 pandemic will be questioned by electronic web-based survey within Masaryk University information system.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthcare providers (physicians and nurses) providing care to patients with COVID-19
        admitted at ICU in period of COVID-19 pandemic.
      
Keywords: Palliative Care; Compassionate Care; End-of-life decisions; Moral distress
Antibiotic Education for Children in an Emergency Care Unit
Condition: Otorhinolaryngologic Diseases; Respiratory Tract Infections; Pyelonephritis; Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Pyelonephritis; Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a patient education in acute condition about the
      intake of oral solution antibiotic in children under 6 year-old are effective to improve the
      satisfaction about the therapeutic education, the knowledge about antibiotics among the
      patients' families and thereby decrease the misuses of antibiotics.
    

Detailed description: 
      Adherence to antibiotic regimen for common childhood illnesses, such as otitis media and
      streptococcal pharyngitis, is related to a variety of outcomes such as illness' remission,
      prevention of recurrent infections, maintaining of cost-effectiveness, and prevention of the
      growth of antibiotic-resistance. A patient and family 's therapeutic education about the
      intake of an oral solution of antibiotic should decrease the misuses of antibiotic, improve
      the family 's knowledge and the satisfaction of the patient and his family. Those factors are
      related to the understanding and adherence to the antibiotic prescription.
    

Intervention name(s): antibiotic education for children in an emergency care unit; antibiotic education for children in an emergency care unit
Intervention type(s): Other; Other
Intervention description(s): Educational, Behavioral, and Organizational intervention to improve the use of oral antibiotics in children under 6 years; Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years.
Other intervention name(s): antibiotic education for children an emergency care unit
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Patient education; Antibiotic; Child; Respiratory tract infection; Patient satisfaction; Parental knowledge; Adherence
Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery
Condition: Cancer of Liver; Pancreatic Cancer; Biliary Tract Cancer
MeSH terms: Biliary Tract Neoplasms; Liver Neoplasms
Study type: Observational

Summary: 
      The collection of data regarding patient outcomes after surgical intervention creates
      imperative knowledge to include surgeon performance, cost analysis, base for surgical
      research and publication, which in turn assist surgeons to improve the standard of care
      utilizing evidence-based practice.
    

Detailed description: 
      The concept of disease management stems from a logical evolution in the field of outcomes
      applications by healthcare provides is the concept of disease management. The basic premise
      of disease management is that there is a more optimal way to manage patients in order to
      reduce costs and improve health outcomes. The data collected from patient-reported outcomes
      allows the physician and staff to screen for specific health conditions, monitor patients
      individually, evaluate outcomes for specific groups, assess quality of care, determine impact
      of intervention and predict outcomes. Most of the follow-up results from this study will be
      obtained directly from the patient during follow-up visits, but other information may be
      obtained from medical records.

      Evaluation of the surgical database Application will identify both patient and procedural
      variables that can predict adverse outcomes.
    

Intervention name(s): HPB Surgery
Intervention type(s): Procedure
Intervention description(s): Hepatopancreatico Biliary Surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hepatopancreatico Biliary surgical patients.
CEDM as a Screening Tool for Breast Cancer in Higher-risk Women: A Prospective Study
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      To evaluate the effectiveness of Contrast-enhanced digital mammography (CEDM) in detecting
      breast cancer in women at higher risk.
    

Detailed description: 
      The aim of this study was to evaluate the effectiveness of different imaging techniques for
      detecting breast cancer in women with a higher risk due to personal or family history of the
      disease.
    

Intervention name(s): CEDM
Intervention type(s): Device
Intervention description(s): Women underwent CEDM screening
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women underwent CEDM screening at Kaohsiung Veterans General Hospital from January 2019 to
        December 2021
      
Keywords: breast cancer; Contrast-enhanced digital mammography