bioihbjkbjnl/mcl2 huggingface dataset:
Fructose Rich Diet and Endothelial Function
Condition: Fructose Metabolism Disorder; Fructose Rich Diet; Metabolic Disease; Aerobic Exercise
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      Cardiometabolic diseases have been associated with high consumption of sweetened beverages.
      These products are responsible for the largest portion of the total consumption of fructose
      in the diet and it is suggested that excessive intake of this monosaccharide may contribute
      to the development of risk factors for these diseases due to differences in metabolism
      relative to glucose. However, there is a lack of data in the literature demonstrating the
      deleterious effects of excessive fructose consumption on vasodilation and whether aerobic
      training may be able to prevent or mitigate these damages in humans. Therefore, the aim of
      the study will be to verify the effect of 4 weeks of high fructose diet associated with
      aerobic training on uric acid levels and its influence on markers related to oxidative stress
      and vasodilatation. Twenty-one sedentary men and women, aged between 19 and 35 years, will be
      submitted to 4 weeks of intervention. In a randomized way, subjects will be divided into 3
      groups: high fructose diet, high glucose diet and high fructose diet and exercise. Blood
      samples will be taken before, in the middle and after the intervention to verify the
      concentrations of uric acid, superoxide dismutase enzyme, thiobarbituric acid, nitrite /
      nitrate, lipid profile, glucose, insulin, C-reactive protein and endothelin-1. In addition,
      flow-mediated dilatation, insulin resistance index, pancreatic beta cell functional capacity
      index, oral glucose tolerance test, 24-hour blood pressure, heart rate variability and body
      composition will be analyzed. The comparisons will be performed through the Generalized
      Estimates of Equations, adopting the factors group and time. The Bonferroni post-hoc will be
      used to identify differences. The accepted level of significance will be 5%.
    


Intervention name(s): Fructose; Glucose; Fructose and exercise
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Consumption of 1.0g / kg of body mass / day of fructose.; Consumption of 1.0g / kg of body mass / day of glucose.; Consumption of 1.0g / kg of body mass / day of fructose + 3 weekly sessions of 60 minutes of aerobic exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
High-strength Glass-ionomer Dental Restorations
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this study is to extend our knowledge concerning the clinical performance of
      two dental filling materials in molars. The study will compare two high-strength
      glass-ionomer filling materials.

      The investigators hypothesize that after two years (1) the clinical performance of both
      filling materials shows a similar survival rate, (2) the ChemFil Rock fillings show similar
      or higher incidence of fracture than Fuji IX GP fillings.
    

Detailed description: 
      In this longitudinal prospective randomized control clinical trial, posterior restorations
      (Class II) will be placed and evaluated for their clinical performance. The study will
      compare two restorative systems currently on the market in USA: both high-strength
      glass-ionomer (GI) restorative materials. The study restorations will be monitored for a
      period of up to 2 years.
    

Intervention name(s): Chemfil ROCK Glassionomer restoration; Fuji IX GP Extra Glassionomer restoration
Intervention type(s): Device; Device
Intervention description(s): High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.; High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.
Other intervention name(s): HVGIC, HV-GIC, ART materials; Fuji Equia, HVGIC, HV-GIC, ART materials
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental caries; Proximal surfaces; Posterior teeth; Carious lesions; Tooth diseases; Dental restorations; Glass-ionomer
Cystatin SN Binds to Phytic Acid and Predicts Non-heme Iron Bioavailability
Condition: Iron-deficiency; Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Phytic acid is a known inhibitor of iron bioavailability, although long term studies have
      suggested possibly exaggerated findings compared to single meal studies, pointing to phytic
      acid adaptation over time. Salivary proline-rich proteins have been found to reduce
      tannin-iron chelation, but studies have not explored changes in salivary proteins that may
      result in phytic acid adaptation. The primary objectives of this study are: 1) To determine
      whether phytic acid impacts iron bioavailability or status when consumed over time 2) to test
      whether salivary protein production may impact iron bioavailability with phytic acid
      supplementation, and 3) to explore in vitro phytic acid salivary binding. Secondary
      objectives included assessment of the reliability of astringency as a measure of salivary
      protein production and iron absorption.

      The study was conducted in an iron absorption study of 7 women, aged 18-35 years old, to
      determine iron bioavailability with supplementation of 350 mg phytic acid before and after
      regular, three times daily supplementation for four weeks. Direct iron absorption was
      measured using area under the curve. Iron status was measured by changes in hemoglobin and
      ferritin, and was adjusted by participant c-reactive protein levels. Salivary samples were
      collected before and after supplement consumption during meal challenges, and analyzed on
      HPLC and by ELISA. Astringency testing was conducted at the end of each meal challenge. In
      vitro saliva-phytic acid modeling was explored on HPLC, MALDI-TOF, and ELISA. Iron absorption
      and status markers were analyzed by ANOVA, and mixed-modeling followed by pairwise comparison
      by least significant differences. Pearson's correlations were used to correlated salivary
      proteins and astringency with iron bioavailability.

      The present study will provide important information regarding the approximate influence of
      phytic acid consumption on iron bioavailability and storage over time in regards to salivary
      proteins. It will also give context to the role of salivary proteins with phytic acid
      consumption over time. Data will also help to delineate possible physiological mechanisms
      underlying phytic acid adaptation and possible ways to detect individuals who better adapt
      than others.
    


Intervention name(s): phytic acid
Intervention type(s): Dietary Supplement
Intervention description(s): 350 mg phytic acid (inositol hexaphosphate) three times daily for four weeks
Other intervention name(s): inositol hexaphosphate
Intervention MeSH terms: Inositol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Phytic acid; Cystatin; Salivary proline-rich protein; antinutrient
Feasibility Study of Exercise in Patients With Leg Blood Clots
Condition: Deep Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      The purpose of this pilot study is to assess the feasibility of determining the effects of a
      structured exercise program started two to four weeks after diagnosis of a first episode
      lower-extremity deep vein thrombosis (DVT) for a period of 12 weeks in reducing the incidence
      of post-thrombotic syndrome (PTS).
    

Detailed description: 
      Deep Vein Thrombosis (DVT) affects nearly 300,000 people in the U.S. each year. DVT of the
      leg results in PTS in up to 65% of patients,despite receiving appropriate medical management
      with anticoagulant therapy.

      PTS, caused by persistent venous outflow obstruction and venous valvular dysfunction, may
      result in symptoms of leg pain, swelling, heaviness and cramping especially with prolonged
      standing.

      All eligible patients with documented first-episode DVT interested in participating will
      undergo medical screening and a screening treadmill test prior to enrollment between two and
      four weeks post DVT diagnosis. All patients will be provided and asked to wear class II (30
      to 40mmHg) knee length compression hose daily during the entire trial.

      The formal exercise training includes both a supervised walking program and a home-based
      walking program for 12 weeks with follow-up at 26 weeks. Blood tests will be taken to measure
      levels of indicators of inflammation at baseline, week 4, week 12, and week 26. The primary
      outcomes will be the feasibility of the exercise program and the incidence of post-thrombotic
      syndrome at 26 weeks.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Lower extremity DVT; Clot; leg clot; Deep vein thrombosis; Thrombosis; Warfarin
The Effect of Motivational Short Interview Model in Type 2 Diabetic Patient in Primary Care in TURKEY
Condition: Lifestyle-related Condition
Study type: Interventional

Summary: 
      This study designed for primary care practionars for chronic care in primary care. A new
      model of motivational short interview used for intervention. The aim of this study is to
      develop diet and exercise regimens in type 2 diabetic patients.
    

Detailed description: 
      This is a randomized controlled trial. The pedometer for one week has given to and filling
      one day food intake form asked from all participants. The weights and the heights of the
      participants were measured and the Beck depression scale for primary care, the modify Moresby
      scale, the EQ5D, the MDDQ and the motivation scale filled face to face with all participants.
      In intervention group the steps of the motivational short interview model were; increase
      patient awareness about his/her type 2 diabetes and its difficulties, then discuss
      alternative solutions for the problems the participant has and making decisions for action,
      and the third and fourth interview includes new alternative solutions for new difficulties if
      there is and promotion of self efficacy.
    

Intervention name(s): Motivational short interview
Intervention type(s): Behavioral
Intervention description(s): New designed motivational short interview model
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: short interview, diabetes, lifestyle changes, primary care
Analysis of Medication Data With the ApoMining-Database
Condition: Delirium
MeSH terms: Delirium
Study type: Observational

Summary: 
      The primary objective of this study is to analyse medication data from the BioCog Study with
      the ApoMining-Database and to determine the positive and negative predictive value from the
      ApoMining-Database for prediction of postoperative delirium (POD).
    

Detailed description: 
      From 2014-2017 the BioCog Study (ClinicalTrials.gov Identifier: NCT02265263) collected data
      from 439 perioperative elderly patients in Campus Virchow - Klinikum, Universitätsmedizin
      Berlin. According to the study protocol, a delirium assessment was performed each day after
      operation until the 7th postoperative day. At this time, it is known which patients developed
      postoperative delirium (POD) and which did not. Additionally, from each patient data on
      long-term medication before operation and applied medication during operation and in the
      recovery room were collected. In this study, the investiagtors analyse the long-term
      medication and the perioperative medication from BioCog-Study patients with the
      ApoMining-Database (http://www.apothesen.de/index.php?id=878; ApoThesenGmbH; Bad
      Münstereifel; Germany). The ApoMining-Database is a medication database, which analyse
      tolerability and risks of medications for the elderly. The database generates a hit once a
      medication reveal a risk for delirium. Additionally, the database can calculate the
      anticholinergic burden of the medication according to the prescribing information. Whereas
      the investigators already know, which patient developed a POD, they will determine positive
      and negative predictive value from the ApoMining-Database for prediction of postoperative
      delirium.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Elderly patients undergoing elective surgery
30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30
      weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual
      monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and
      linagliptin (5 mg, administered orally once daily). In addition, durability of treatment
      effect and safety under chronic treatment conditions will be investigated.
    


Intervention name(s): Pioglitazone 15 mg; Pioglitazone 45 mg; Pioglitazone 30 mg; Linagliptin 5mg / Pioglitazone 45 mg FDC; Linagliptin 5mg / Pioglitazone 30 mg FDC; Linagliptin 5mg; Linagliptin 5mg / Pioglitazone 15 mg FDC
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks; Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks; Pioglitazone Capsules 30 mg once daily for up to 84 weeks; Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks; Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks; Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks; Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Intervention MeSH terms: Pioglitazone; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Ex Vivo Drug Sensitivity Testing and Mutation Profiling
Condition: Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Large Cell Lymphoma; Refractory Childhood Acute Lymphoblastic Leukemia; Refractory Childhood Hodgkin Lymphoma; Refractory Childhood Malignant Germ Cell Neoplasm; Recurrent Childhood Brain Tumor; Recurrent Childhood Brainstem Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Childhood Ependymoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Gliosarcoma; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
MeSH terms: Lymphoma; Leukemia; Sarcoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Rhabdomyosarcoma; Ependymoma; Gliosarcoma; Neoplasms, Germ Cell and Embryonal; Recurrence
Study type: Observational

Summary: 
      This study is a prospective, non-randomized feasibility study. Freshly isolated tumor cells
      from patients will be screened using state-of-the-art viability assay designed for ex vivo
      high-throughput drug sensitivity testing (DST). In addition, genetic information will be
      obtained from cancer and normal (germline) tissue and correlated with drug response. This
      study will provide the platform for informing treating physician about individualized
      treatment options. The main outcome of this study will be the proportions of the patients
      whose treatment was guided by the personalized medicine approach.
    

Detailed description: 
      PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of
      providing pediatric cancer patients with access to personalized treatment options and
      clinical management recommendations based on ex vivo drug sensitivity testing (DST) and
      genomic profiling.

      SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes
      (response and disease-free survival) in patients with pediatric cancers treated with
      DST-guided therapy as compared to non-DST guided (conventional) therapy.

      EXPLORATORY OBJECTIVE: To explore associations between genetic abnormalities in malignancies
      and ex vivo drug response.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chemorefractory and/or relapsed pediatric cancer patients with no alternative treatment
        options.
      
Biospecimen description: 
      Perform molecular and functional drug testing on blood, biopsy, bone marrow and tumor samples
      at relapse.
    
Keywords: ex vivo drug sensitivity assay; genomic profiling
OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions
Condition: Patients Undergoing Clean Surgery
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact layer,
      lattice shaped absorbent pad and a top film that is waterproof and a bacterial barrier and is
      coated with a water-based adhesive. The comparator is a standard care treatment regime
      comprising tape and gauze.

      This study requires 100 eligible patients which will be recruited from the patients routinely
      see by the study investigators at each study site. Eligible patients will undergo surgery
      that results in a surgical wound of 27cm or less that is expected to have low or moderate
      levels of exudate and will have received at least one randomised study treatment. The primary
      objective is to compare OPOV and tape/gauze in terms of wear time per patient.
    

Detailed description: 
      OPSITE Post-Op Visible (OPOV) is a post-operative dressing that has been developed to protect
      the wound from bacteria in the environment and absorb blood or other fluid exuding from the
      wound. The honeycomb nature of the dressing pad allows direct visibility of the wound through
      the dressing, minimising the need to expose the wound to the environment and the patient to
      the trauma of a dressing change just for the clinician to inspect the wound. OPOV is unique
      in combining these features and offers a real benefit over other standard post-operative
      dressing regimes.
    

Intervention name(s): OPSITE POST-OP VISIBLE; Tape and Gauze
Intervention type(s): Device; Device
Intervention description(s): Patient will be treated with OPSITE POST-OP VISIBLE dressing up to 14 days post surgery; Patient will be treated with tape and gauze up to 14 days post surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clean surgery
Effect of Pre-emptive Dose of Prednisone Versus Placebo in Impacted Third Molar Surgery
Condition: Facial Swelling; Tooth Position Anomalies; Tooth, Impacted; Tooth Extraction Status Nos; Tooth Avulsion
MeSH terms: Tooth, Impacted; Tooth Avulsion; Facies
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study proposes to compare the effect of a single preoperative dose of prednisone
      versus placebo in terms of facial swelling, trismus and pain after surgical removal of the
      mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.
    

Detailed description: 
      This study aims to compare the effect of a single preoperative dose of prednisone versus
      placebo in terms of facial swelling, trismus, and pain after surgical removal of M3M in a
      split-mouth randomized controlled clinical trial. Facial swelling will be evaluated using an
      innovative three-dimensional digital technique.
    

Intervention name(s): Prednisone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pre-operative drug administration before third molar surgery; Pre-operative Placebo administration before third molar surgery
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: third molar surgery; facial swelling; 3D facial swelling evaluation; tooth impacted; prednisone drug administration; corticosteroids administration
EGb 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders
Condition: Cognitive Disorders
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Study type: Observational

Summary: 
      The purpose of this study is to determine the effectiveness of EGb 761® (Tanakan®) in Russian
      patients of middle age and younger, suffering from psycho-emotional symptoms added to
      cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood
      test) score.
    


Intervention name(s): EGb761®
Intervention type(s): Drug
Other intervention name(s): Tanakan®
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Middle-age or younger patients with cognitive disorders and psycho-emotional symptoms
        (principal diagnosis).
      
Keywords: Psycho-emotional symptoms
A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy males were examined with positron emission tomography (PET) and the radioligand
      11C-AZ10419369, before and after administration of a single dose escitalopram. A change in
      the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was
      hypothesized to reflect a change in serotonin concentration.
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): 20 mg p.o.
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mechanism of Action of escitalopram