bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Fats and oils play important roles in maintaining human nutrition and health through
      providing energy, essential fatty acids, and acting as modulators of many biological
      processes (signal transduction, immunity and inflammation). Due to differences in the fatty
      acid composition and content of antioxidants of individual cooking oils, the degree of
      oxidative and thermolytic reactions may vary oil by oil. It is lack of human feeding study to
      investigate the molecular mechanisms on how and which deep-fried oil exerts its adverse
      effects. The investigators are also lack of biomarkers for monitoring deep-fried oil
      exposure. Therefore, the purpose of this study is to compare how human body responds
      differently to several popular uncooked and deep-fried oils with varied fatty acid
      compositions with respect of oxylipin profile, inflammatory markers, non-targeted
      metabolomics, and transcriptomics. The investigators will recruit 20 volunteers, provided
      them once a week the milk shakes prepared from 60g of olive oil, soybean oil, palm oil,
      camellia oil, tallow (butter), and deep-fried oils of the last 4, respectively; in comparison
      with a no-fat milk shake control. The experiments lasted for 10 weeks.。Each time; serum,
      plasma, whole blood and urine samples were collected at baseline, after 2 hours, and after 4
      hours. The investigators anticipate to find biomarker(s) for deep-frying, and contribute to
      the understanding of molecular mechanisms on how deep-fried oils exert adverse effects toward
      health through integrative omics or so-called system biology approaches.
    


Intervention name(s): Fat-free milkshake; Olive oil; Soybean oil; Fried soybean oil; Palm oil; Fried palm oil; Camellia oil; Fried camellia oil; Tallow; Fried tallow
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): participants drinks a fat-free milk shakes; participants drinks the milk shakes prepared from 60g of olive oil; participants drinks the milk shakes prepared from 60g of soybean oil; participants drinks the milk shakes prepared from 60g of fried soybean oil; participants drinks the milk shakes prepared from 60g of palm oil; participants drinks the milk shakes prepared from 60g of fried palm oil; participants drinks the milk shakes prepared from 60g of camellia oil; participants drinks the milk shakes prepared from 60g of fried camellia oil; participants drinks the milk shakes prepared from 60g of tallow; participants drinks the milk shakes prepared from 60g of fried tallow
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and
      one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.
    

Detailed description: 
      Five period cross-over study in which subjects received a single day of dosing in each
      period. Dosing was either QD or BID with one of two T esters (T-enanthate (TE) or
      T-undecanoate (TU)). Dosing was within 5 minutes of meals (breakfast and for BID dosing
      dinner). There was a minimum of a 5-day washout between periods. Subjects were hypogonadal
      men.
    

Intervention name(s): Testosterone undecanoate; Testosterone enanthate
Intervention type(s): Drug; Drug
Intervention description(s): Single-day dose as QD or BID for 3 of 5 crossover periods; Single-day dose for 2 of 5 crossover periods
Other intervention name(s): TU; TE
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: testosterone; male hypogonadism; low testosterone
Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion
Condition: Hypoosmolality; Hyperosmolality; Renal Failure
MeSH terms: Renal Insufficiency; Diabetes Insipidus
Study type: Observational

Summary: 
      The are 2 principal goals in this study:

        1. To measure plasma copeptin levels in healthy subjects and to correlate them with plasma
           AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states.

        2. To measure plasma copeptin concentrations in patients with chronic renal failure under
           the same conditions described above, in order to characterize the impact of renal
           function on circulating copeptin levels in correlation to plasma AVP and urine
           osmolality.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers; patients with chronic renal failure
      
Keywords: Hypoosmolality; Hyperosmolality; Copeptin; Vasopressin
Assessment of PCSO-524 Relative to a Comparator Product
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A marine lipid oil extract isolated from the New Zealand Greenshell® Mussel, Perna
      canaliculus (P. canaliculus), contains a unique synergistic blend of marine fatty acids.

      The objective of the this study is to evaluate the acute (5-hour) and chronic (21-day)
      bioavailability of a fixed dose of PCSO-524 compared to a fish oil product in a population of
      healthy adult participants.
    


Intervention name(s): Fish Oil; PCSO-524
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Source of omega-3 fatty acids.; Extract of Greenshell Mussel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Fish Oil; EPA; DHA; Omega-Score; Omega-3 Fatty Acids; Green-Lipped Mussel; Omega-score < 5.2%
A Comparison of Peripheral Nerve Catheter Securement Techniques at the Insertion Site in Healthy Volunteers
Condition: Regional Anesthesia Morbidity
Study type: Interventional

Summary: 
      Continuous peripheral nerve block catheters are used for prolonged analgesia, but are often
      associated with complications such as catheter failure or dislodgement. This is a single
      center, prospective study to compare peripheral nerve catheter securement techniques at the
      insertion site in healthy volunteers.
    

Detailed description: 
      This study will involve the placement of subcutaneous peripheral nerve catheters in healthy
      volunteers utilizing 6 different securement techniques. The primary outcome is the force
      required to dislodge the peripheral nerve catheter by 1 centimeter as measured by a
      dynamometer in Newtons. The secondary endpoint will be the force required to disrupt the
      catheter dressing.
    

Intervention name(s): Dressing; Dressing + adhesive; Experimental: Dressing + adhesive + strips (parallel); Experimental: Dressing + adhesive + strips (perpend); Experimental: Dressing + adhesive + strips + benzoin; Experimental: Dressing + adhesive + strips + spray
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone; Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM Devon, UK) at insertion site; Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed parallel to long axis of catheter; Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed perpendicular to long axis of catheter; Transparent film dressing + topical skin adhesive + skin closure strips + topical benzoin (Compound Tincture of Benzoin USP 10%, Professional Disposables International, Inc., Orangeburg, NY, USA) spread in a 12 centimeter by 14 centimeter area around the insertion site; Transparent film dressing + topical skin adhesive + skin closure strips + medical adhesive spray (AdaptTM Medical Adhesive, Hollister Incorporated, Libertyville, IL, USA) in a 12 centimeter by 14 centimeter area around the insertion site
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Pharmacokinetics of Quinidine Alone and in Combination With Dabigatran Etexilate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, two-way crossover design with a quinidine sulfate run-in period followed by a
      randomised sequence of dabigatran etexilate plus quinidine sulfate or dabigatran etexilate
      alone to evaluate the safety of co-administration of dabigatran etexilate and quinidine. and
      the pharmacokinetic interaction between quinidine and dabigatran etexilate.
    


Intervention name(s): dabigatran etexilate; quinidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Quinidine; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gait Analysis in Children With Clubfoot Treated With Tibialis Anterior Tendon Transfer
Condition: Clubfoot
MeSH terms: Clubfoot; Talipes; Equinus Deformity
Study type: Observational

Summary: 
      Patients with clubfoot treated with the Ponseti method and undergoing Tibialis Anterior
      tendon transfer from a prospective database are evaluated using gait analysis including the
      Oxford foot model and compared to a group of healthy children.
    

Detailed description: 
      Children with dynamic clubfoot recurrence after initial Ponseti treatment who underwent TATT
      between 2014 and 2017 are considered for this study. Exclusion criteria are neurological
      disease, split transfer of the tendon, additional bone or joint invasive surgery, and initial
      treatment abroad.

      Gait analysis, including the Oxford foot model, will be conducted, and the kinematic and
      kinetic data of the lower extremity will be compared with a group of age-matched healthy
      children. To comprise a control group for the purpose of collecting gait analysis data of
      healthy children, employees of our hospital are asked to allow their children to participate
      in this study.

      Patients will undergo gait analysis, including video recordings with a Vicon motion capture
      system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced
      Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of
      Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the
      foot) models.
    

Intervention name(s): Gait analysis
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with dynamic clubfoot recurrence with a minimum age of three years from a
        prospective, consecutive database of patients with clubfoot treated with the Ponseti method
      
Keywords: Tibialis anterior tendon transfer; Oxford foot model; gait analysis
Lumefantrine in Venous Plasma Versus Dried Capillary Blood Spot
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      Measurement of the concentration of antimalarials in the blood of the general population
      helps estimating the overall drug pressure and is used in efficacy studies. The current
      sampling standard for drug measurement is plasma obtained by venous puncture. The use of a
      Dried Blood Spots (DBS) sampling strategy can make some aspects of field trials conditions
      easier, but concordance with usual venous sampling is not yet established.

      The current work will allow validating the concentrations of lumefantrine measured in the DBS
      samples collected during the field trials and validate the use of DBS for future studies. In
      addition, bearing in mind the substantial deployment of artemether-lumefantrine combinations
      supplies throughout most malaria endemic countries, this study may improve our understanding
      of lumefantrine and artemether distribution in the blood compartments and generate knowledge
      for further developing analytical methods for drug measurement.

      The overall purpose of this study is to validate the dried blood spots as a sampling method
      for the analysis of lumefantrine.

      The primary objective is to assess the concordance between lumefantrine plasma and dried
      blood spots (DBS) concentrations.

      The investigators also aim at describing lumefantrine's distribution in the different blood
      compartments: binding to plasma proteins, total in plasma, inside the red blood cells, total
      in whole blood.
    

Detailed description: 
      (Details available on request)
    

Intervention name(s): Artemether + lumefantrine
Intervention type(s): Drug
Intervention description(s): A single adult dose of artemether-lumefantrine will be administered on a unique occasion together with food. Venous and capillary blood samples will be collected at 6 to 10 time points, as defined before drug administration with each volunteer.
Other intervention name(s): (Riamet)
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: antimalarials; blood samples; drug concentrations; pharmacokinetics; lumefantrine; healthy volunteers
The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the bio-clinical effects of sacubitril/valsartan
      combination in treatment of patients with Congestive heart failure. Moreover, the
      investigators aim to evaluate side effects of this combination.

      - The following parameters were determined at baseline and at end of the study at 6 months of
      the beginning.

        1. New York Heart Association (NYHA) Class.

        2. Frequency of hospitalization by acute exacerbation of CHF

        3. NT-ProBNP

        4. Left ventricular systolic function by Echocardiography

      Moreover, the side effects of the drugs used during study was assessed by

        1. Renal function (Serum creatinine) was performed every month till the end of the study.

        2. Serum electrolytes (Potassium and Sodium) was performed every month till the end of the
           study.
    


Intervention name(s): Sacubitril-Valsartan; Valsartan
Intervention type(s): Drug; Drug
Intervention description(s): 30 patients initially received Sacubitril/Valsartan at 24/26 mg twice daily orally then dose was doubled as tolerated every 2-4 weeks to reach the target maintenance dose 97 mg/103 mg twice daily; 30 patients received valsartan, starting at a dose of 40 mg/day orally. The dose was then doubled every 1-2 weeks on the basis of their blood pressure to reach a dose of 160 mg once daily according to guideline-directed medical therapy.
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation Of Striatal Glucose Metabolism With Positron Emission Tomography Following PF-02545920 In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain
      called the striatum.
    


Intervention name(s): PF-02545920; placebo; PF-02545920; PF-02545920; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 and 5 mg tablets, 6 mg single dose; matching placebo tablets, single dose; 1 mg tablets, 3 mg single dose; 5 mg tablets, 15 mg single dose; matching placebo tablets, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: FDG-PET; regional cerebral glucose metabolism; striatum; PDE10 inhibitor
A Study of LY2409021 in Participants With Different Levels of Kidney Function
Condition: Kidney Failure, Chronic; Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to measure how much of the study drug, LY2409021, gets into the
      blood stream and how long it takes the body to get rid of it when given to participants with
      different levels of kidney function. There were five study groups. Each participant only
      enrolled in one group. Participants in groups 1 through 4 were healthy or have mild,
      moderate, or severe kidney disease. They completed one study period lasting about 29 days.
      Study group 5 enrolled participants with kidney disease who were on dialysis. They have
      completed two study periods which together last about 59 days. Screening was required within
      21 days prior to the start of the study for all participants.
    


Intervention name(s): LY2409021
Intervention type(s): Drug
Intervention description(s): Administered orally
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the
      treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.
    

Detailed description: 
      This was a randomized, observer-blind, multinational, comparator and placebo-controlled
      parallel group, (3:3:1 ratio) study to compare the efficacy and safety of BF-200 ALA with the
      comparator Metvix® (methyl-[5-amino-4-oxopentanoate]) and placebo, for the treatment of AK
      with PDT.
    

Intervention name(s): BF-200 ALA; MAL Cream; Vehicle
Intervention type(s): Drug; Drug; Drug
Intervention description(s): topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.; topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.; topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.
Other intervention name(s): Ameluz; Metvix; Metvixia; matched placebo to BF-200 ALA gel
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR
      in an initial dosing period, followed by the addition of a ULT to test the efficacy and
      safety of the combination and prophylaxis of gout flares during ULT.
    

Detailed description: 
      AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed
      potential dual effects in both reducing serum uric acid (sUA) and gout flares. The mechanism
      of action of AC-201 includes the inhibition of the production and activity of caspase-1 and
      interleukin-1β (IL-1β), and selective inhibition of re-absorption transporters in the kidney.
      The goal of gout treatment is to reduce serum uric acid (sUA) concentrations below the urate
      solubility limit while avoiding acute gout flares. However, the initiation of urate-lowering
      therapy (ULT) increases the occurrence of acute gouty arthritis flares. IL-1β plays a key
      role in mediating this inflammatory response.
    

Intervention name(s): Placebo; AC-201; Febuxostat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo twice daily from Day 1 to Week 12; AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12; Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL
Other intervention name(s): PBO; AC-201 CR tablet; ULT
Intervention MeSH terms: Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
BEYOND Pilot Study
Condition: Multiple Sclerosis; Relapsing-Remitting
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to valuate safety and tolerability of Betaseron.
    


Intervention name(s): Betaseron (Interferon beta-1b, BAY86-5046); Betaseron (Interferon beta-1b, BAY86-5046)
Intervention type(s): Drug; Drug
Intervention description(s): 250 mcg; 500 mcg
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment