bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The primary objective of this investigation is to determine the relative percentage and rate
      of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3
      (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil supplements
      versus an encapsulated triglyceride in defined plasma lipid pools.

      The primary endpoints to be evaluated include the fatty acid composition of plasma lipids
      before and after consumption of a single dose of emulsified triglyceride based fish oil and
      triglyceride of similar n-3 compositions in capsule form. The investigators will measure
      changes in plasma phospholipid, and chylomicron fatty acids.
    


Intervention name(s): Coromega Omega-3 Squeeze; Coromega Nectar; Barleans Swirl; Nordic Omega-3 Softgel
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 660 mg EPA, 434 mg DHA; 660 mg EPA, 436 mg DHA; 660 mg EPA, 660 mg DHA; 660 mg EPA, 440 mg DHA
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Omega-3 fatty acids; Phospholipid fatty acids; chymlomicron fatty acids; Bioavailability fo fish oil supplements in healthy adults
Diabetic Care Self-Management Mobile Health Application Among Diabetes Mellitus Clients in Malaysia
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The main purpose of this study is to explore the effect of Diabetic Care Self-Management
      Mobile Health Application in behavioral modification i.e foot care behaviour and dietary
      behaviour among diabetic clients in Malaysia. Diabetic Care Self-Management Mobile Health
      Application is a mobile health (mHealth) application program aiming for primary care in
      health prevention and promotion activity. The program is developed by the researcher through
      the literature review conducted. The program is evaluated through a randomized controlled
      trial study design.
    


Intervention name(s): Diabetes Care Self-Management Mobile Health Application
Intervention type(s): Behavioral
Intervention description(s): In day 1, the participant will receive a Foot Care Kit consist of a mirror, a tube of lotion, a small towel, and a nail clipper. The participant will enrol in 3-hour workshop for general management of diabetes mellitus, diabetic foot care and dietary management. The participant will be invited to install Diabetes Care Self-Management Mobile Health Application. The mobile application is meant for sources of referral for diabetic foot care and dietary care, and for record purpose (diary) of any foot care activities carried out that participant needs to enter in the application during his/her home. The participant will be trained for the use of Diabetes Care Mobile Health Application. In addition, the participant will be invited to join a WhatsApp group for the medium of communication. The program will be lasting for 5 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Predictive Value of Prostate-specific Antigen Isoform p2psa and Its Derivates in the Diagnosis of Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      In Europe, prostate cancer (PCa) is the most common solid neoplasm, with an incidence rate of
      214 cases per 1000 men, outnumbering lung and colorectal cancer. Early detection tests have
      been developed in order to identify PCa while it is still confined to the prostate gland.

      The two most commonly used tests are digital rectal examination and serum prostate-specific
      antigen (PSA) level: however, most of cases is detected in the so called T1c stage, i.e. for
      PSA increasing only. As marker, PSA is organ-specific but not cancer-specific, and its levels
      may change as result of physical activity, sexual activity, in the presence of benign
      prostatic hyperplasia (BPH), acute and chronic prostatitis, as well as in the presence of
      PCa.

      A total serum PSA of 4.0 ng/ml has traditionally been used as threshold for considering
      prostate biopsy and large programs for the early detection of prostate cancer have shown that
      almost 70% of cancer cases can be detected using a PSA cutoff of 4.0 ng/ml. However, using a
      PSA threshold of 4.0 ng/ml 20% to 25% of prostate cancer cases are not detected
      (false-negative) and the false-positive rate is 65%. To improve the usefulness of PSA for
      identifying patients who require biopsy, the PSA threshold has been lowered at 2 ng/ml;
      moreover, the levels of free and bound PSA have been assessed, together with PSA density (the
      rate of PSA over the prostate volume) and PSA velocity (the rate of PSA increase), which seem
      to have some validity for detecting prostate cancer.

      Recent studies have shown that other new biomarkers could be used in the diagnosis of early
      prostate cancer as they showed a higher sensitivity and specificity. In the last two years,
      several investigators showed that PSA isoform [-2] proPSA (p2PSA) and its derivatives,
      namely, percentage of p2PSA to free PSA (%p2PSA) and the Prostate Health Index [PHI; (p2PSA /
      free PSA) × √tPSA)] improve the accuracy of total PSA (tPSA) and percentage of free PSA
      (%fPSA) in predicting the presence of PCa at prostate biopsy and they are also related to PCa
      aggressiveness at biopsy.

      The aim of this study is to confirm the diagnostic and prognostic predictive value of
      prostate-specific antigen isoform p2psa and its derivates, %p2psa and prostate health index
      in the detection of prostate cancer in patients with a PSA 2-10 ng/ml and/or suspicious DRE.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Urological outpatient clinics of one tertiary university high volume department of urology
      
Keywords: prostate cancer, PSA, markers, diagnosis, prognosis, pro-PSA
Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain; Breakthrough Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with
      immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid
      tolerant patients with chronic pain.
    


Intervention name(s): Fentanyl Buccal Tablet; Immediate release oxycodone
Intervention type(s): Drug; Drug
Intervention description(s): FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain.
The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets).
For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician.; Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain.
The maximum single dose would be 60 mg (4 capsules).
Other intervention name(s): CEP-25608
Intervention MeSH terms: Fentanyl; Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breakthrough Pain; Opioid-tolerant; Chronic Pain
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if amphotericin B is effective against visceral
      leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate
      which is the current approved drug used for this disease in Brazil.
    

Detailed description: 
      Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used
      for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their
      efficacy and adverse events in pediatric population are available. This study aimed to
      evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine
      antimoniate in treating pediatric VL in Brazil. This was a randomized, open-label, 2-arm and
      controlled pilot clinical trial. Treatment naïve children and adolescents with VL without
      signs of severe illness were treated with N-methylglucamine antimoniate or amphotericin B
      deoxycholate. All patients were diagnosed with positive direct examination and/or positive
      PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was
      VL cure determined after 180 days of completion of treatment. The analysis was performed
      using intention-to-treat (ITT) and per protocol (PP) analyses.
    

Intervention name(s): Meglumine antimoniate; Amphotericin B-deoxycholate
Intervention type(s): Drug; Drug
Intervention description(s): 20mg/kg/day IV for 20 days; Amphotericin B-deoxycholate 1 mg/kg/day IV for 14 days
Other intervention name(s): Glucantime; Fungizone
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B; Amphotericin B, deoxycholate drug combination; Meglumine Antimoniate; Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Visceral leishmaniasis; Amphotericin B deoxycholate; Meglumine antimoniate; Children; Brazil
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease; Central Nervous System Diseases
MeSH terms: Alzheimer Disease; Nervous System Diseases; Central Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine the safety, tolerability, and pharmacokinetics
      (PK) of three different doses of an investigational medication, EVP-6124, in individuals with
      mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI
      [acetylcholinesterase inhibitor]: either donepezil or rivastigmine). In addition, PK of AChEI
      medications will be assessed. Cognitive function will be evaluated on an exploratory basis.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, Phase 1b safety study of three dose
      levels of EVP-6124 in subjects with mild or moderate Alzheimer's disease and who are taking
      an AChEI medication (donepezil or rivastigmine).

      Study drug will be supplied as capsules and will be orally administered once daily for a
      total of 28 days. Eligible subjects will be admitted to an inpatient study unit on Day -2
      (two days before the first dose of study drug is administered) and will remain confined to
      the inpatient study unit for a total of five days. Starting on Day 4, subjects will continue
      the study in the outpatient setting, with study visits on Days 7, 14, 21, and 28. Safety
      assessments, PK sampling, and cognitive testing will be performed inpatient and at each study
      visit.
    

Intervention name(s): EVP-6124 (0.1 mg/day); EVP-6124 (0.3 mg/day); EVP-6124 (1.0 mg/day); Comparator: Placebo; Donepezil; Rivastigmine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): EVP-6124 was administered as one 0.1 mg capsule per day for 28 days.; EVP-6124 was administered as one 0.3 mg capsule every day for 28 days.; EVP-6124 was administered as one 1.0 mg capsule every day for 28 days.; Matching placebo was administered as one capsule per day for 28 days.; Concomitant therapy with donepezil at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.; Concomitant therapy with rivastigmine at a stable dose, taken daily at the same time or immediately after the assigned EVP-6124 dose. Patients must have been taking concomitant therapy for at least 3 months prior to enrollment to be eligible for the study.
Intervention MeSH terms: Rivastigmine; Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Central Nervous System Diseases; Pharmacokinetics; Cognition
Characterization and Technical Evaluation of cT1 for NASH (CATE-NASH)
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      The primary objective of this study is to evaluate to provide evidence to establish tightly
      defined cut-offs to identify patients for NASH clinical trial inclusion using cT1 and/or
      PDFF. The study will be divided into 2 sub groups comprising of cases and controls.
    

Detailed description: 
      This is a prospective, case-control, study designed to measure the mean difference in cT1 and
      PDFF in patients who have undergone liver biopsy and have confirmed NASH and fibrosis or
      'cases' (N=40) and N=20 patients with neither significant NASH nor significant fibrosis
      'controls'.

      Confirmed cases will be patients who have met the criteria for active NASH with fibrosis
      according to the NAS CRN scoring system (NAS≥4 & F2-3), 'controls' will be those who did not
      meet NASH diagnostic criteria and have evidence of fibrosis of ≤2.

      In addition, in order to investigate the variability of the biomarker investigators will
      assess the 'measurement' error in all participants by performing a repeat 'second' scan in
      the same scanning session, and , in cases only, 'biological' variability by performing a
      repeat scan in controls 2-4 weeks later.

      Suitable patients based on trial inclusion criteria will be identified by the study PI and
      clinical collaborator and invited to receive one or two MRI scans from which cT1 and PDFF
      will be derived using Perspectum's LiverMultiScan software. Baseline scan will ideally be
      performed between 3 days (to allow for recovery from the procedure and time for biopsy
      results to become available) and 6 weeks following biopsy, to minimize the likelihood that
      the patient is in a significantly different pathophysiologic state on the baseline scan day
      than on the biopsy day.

      In order to ensure that the investigators capture information on normal variability and not
      related to intervention they will also capture and record basic information at both
      measurement timepoints (e.g. body weight, waist circumference, details of lifestyle
      interventions).
    

Intervention name(s): LiverMultiscan
Intervention type(s): Device
Intervention description(s): The Livermultiscan is a quick, 15 minute contrast free MRI scan that provided metrics to quantify liver health namely fat, iron and fibro-inflammation
Other intervention name(s): LMS
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients, deemed to be suitable for inclusion into a NASH clinical trial based on their
        clinical risk factors, and who have been referred for a standard of care diagnostic liver
        biopsy on suspicion of NASH
      
Keywords: NASH; Livermultiscan; fatty liver
Coronary Care Caffeine: Influence of Coffee on Heart Rate Post Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Sudden cardiac death due to a heart rhythm disturbance after a heart attack (myocardial
      infarction) is a common cause of death. It is well documented that sudden cardiac death after
      a myocardial infarct (MI) is associated with low or poor heart rate variability (HRV). HRV is
      a measure of beat-to-beat changes in heart rate, with a greater variation associated with a
      "healthier" heart. The effect of caffeine on HRV in patients at high risk for sudden cardiac
      death is unknown. We, the investigators at the Royal Bournemouth Hospital, aim to study the
      effect of coffee or tea on HRV after MI.
    

Detailed description: 
      120 post MI patients on CCU will be studied during the first week of admission. Patients will
      be categorised using the following criteria: Infarct size and site; PMH; Co-morbidities;
      Drugs; Regular caffeine ingestion.

      Patients will be randomised to receive either caffeinated or de-caffeinated coffee or tea
      during admission. HRV will be assessed by non-invasive Holter-monitoring on the fifth day.
      Salivary caffeine concentration will be assessed concurrently to assess compliance.
    

Intervention name(s): Caffeine
Intervention type(s): Drug
Intervention MeSH terms: Caffeine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients of either gender, over 18 and under 80 years of age, admitted to the Coronary Care
        Unit following myocardial infarction.
Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate therapeutic response to MMF treatment in patients with International Society of
      Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic
      acid levels at 1-hour post dose will be monitored monthly up to 6 months.
    


Intervention name(s): Mycophenolate mofetil
Intervention type(s): Drug
Intervention description(s): Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.
Other intervention name(s): cellcept
Intervention MeSH terms: Mycophenolic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: trough level; therapeutic drug monitoring; Mycophenolate mofetil; Mycophenolic acid; lupus nephritis
Clinical Trial Comparing Standard Care Versus Prehabilitation in Patients Undergoing Cancer Surgery
Condition: Cancer of Colon; Cancer of Rectum; Liver Metastases
MeSH terms: Colonic Neoplasms; Rectal Neoplasms
Study type: Interventional

Summary: 
      To determine whether exercise and nutrition prehabilitation improves patient outcomes after
      cancer surgery
    

Detailed description: 
      Preliminary qualitative and quantitative studies suggest that there are benefits (reduced
      length of stay, improved cardiorespiratory function, reduced postoperative complications and
      improved quality of life) when prehabilitation is used with the context of cancer care. In
      2017 Macmillian Cancer Support developed a strategic 'Evidence and Insight' review on
      prehabilitation. The outcome of this was to incorporate prehabilitation into routine cancer
      care and to develop principles and guidance for prehabilitation. This study aims to support
      this vision and answer some of the questions on the patients who are most likely to benefit
      from prehabilitation and to quantify some of these benefits by investigating the molecular
      processes that influence clinical changes

      This study primarily seeks to assess the cardiovascular and biological impact of
      prehabilitation (exercise, nutrition) on patients undergoing hepatobiliary and colorectal
      cancer surgery. The investigators aim to assess whether there is an improvement in various
      cardiopulmonary exercise testing (CPET) variables such as maximum oxygen consumption and
      anaerobic threshold. The investigators also aim to study the inflammatory cytokines
      associated with cancer and how these markers respond to exercise. These inflammatory markers
      are thought to play a role in influencing some clinical outcomes such as wound infection and
      recovery.

      The study will also assess secondary outcomes including hospital stay, post operative
      complications and quality of life. The investigators aim to better understand the biological
      relationship between anti-inflammatory cytokine levels and the previously mentioned outcomes
      by measuring and analysing these mediators and performing selected muscle biopsies.
    

Intervention name(s): Prehabilitation
Intervention type(s): Other
Intervention description(s): exercise & multivitamin (nutritional/dietary advice)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 randomisation to standard care or prehabilitation
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: prehabilitation; surgery; cardiopulmonary exercise testing; cytokines
Kinematic Analysis: Posterior Stabilized, Fixed Bearing Total Knee Arthroplasty With Attune Knee System
Condition: Total Knee Arthroplasty; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      A better understanding of knee joint kinematics is important to explain the premature
      polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a
      prosthesis that most closely approximates the normal knee. Specifically, posterior
      stabilizing (PS) knees have been found to be associated with lower amounts of posterior
      femoral rollback, higher occurrence of reverse axial rotation and increased amount of
      condylar lift-off. The DePuy Synthes Joint Reconstruction's Attune PS fixed bearing (FB) knee
      system has incorporated subtle changes in its design to address restoration of kinematics
      that more closely resemble those of a normal knee. To understand if this design is able to
      effectively restore kinematics in the implanted knee, further in vivo analysis is necessary.
      This pilot study will analyze 5 subjects with the Attune PS FB 3 months post-operatively
      using the University of Tennessee's mobile fluoroscopy unit while performing three daily
      activities, level walking, ramp down and deep knee bend. Since this is a pilot study, there
      is no hypothesis.
    


Intervention name(s): DePuy Attune posterior stabilizing fixed bearing knee system
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients will have been implanted with the DePuy Attune PS FB knee system by Dr. Thomas
        Fehring of OrthoCarolina, PA in Charlotte, NC.