bioihbjkbjnl/mcl2 huggingface dataset:
The Visualization of Uncertainty in Clinical Diagnostic Reasoning for Pulmonary Embolism
Condition: Pulmonary Embolism; Diagnostic Uncertainty; Clinical Reasoning; Evidence Based Medicine; Visualization of Uncertainty
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional

Summary: 
      Medical reasoning is a form of inquiry that examines the thought processes involved in making
      medical decisions. When physicians are faced with patients' symptoms or signs, their thought
      processes follow either direct shortcuts to suspect a diagnosis or go into a deeper and more
      analytic process to reach a diagnosis. The second pathway is less prone to biases and errors.
      This study explores whether the use of an interactive visual display of probabilities of
      pulmonary embolism generated from positive or negative test results will increase the
      adherence to evidence based guidelines in the diagnosis of pulmonary embolism.
    


Intervention name(s): Visualized pulmonary embolism computer task model; Didactic review lecture
Intervention type(s): Other; Other
Intervention description(s): This group of participants was presented and trained to use a visual representation of diagnostic pathway for pulmonary embolism. The design of this visual representation is based on Bayes theorem and cognition enhancing visual design principles.; This group of participants was presented with a didactic lecture covering the diagnostic approach of pulmonary embolism.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: randomized controlled study
Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      FlowMet study is a "sub-study" of the PregMet study (registered in 2005).

      The aim of the FlowMet study is to register the possible effect of metformin on the blood
      flow of the uterine artery in pregnant PCOS women. The participants will be examined with
      ultrasound Doppler in gestational week 10-13:

        1. before and 3h after the first tablet intake of metformin/placebo

        2. and 10-14 days after inclusion in the trial

        3. blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.; Placebo 2 tablets x 2 daily. Orally from Weifa
Other intervention name(s): metformin 500mg tablets from Weifa; Placebo tablets from Weifa
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: PCOS; pregnancy; metformin; blood flow; Pulsatility index
Cytokine Profile in Children With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Celiac disease (CD) is an immune-mediated systemic disease that is elicited by consumption of
      gluten and related prolamines in genetically susceptible individuals. Not only genetic but
      also environmental factors play an important role in CD pathogenesis. CD patients have
      imbalance in the gut microbiota, they have reduced number of Bididobacterium species in feces
      and biopsies.

      Up till now, only effective treatment for CD is life long adherence to gluten free diet. If
      gluten free diet is not strict that leads over the years to complications of disease, such as
      autoimmune diseases, psychiatric diseases, osteoporosis etc. That may be caused by continuous
      recirculation of activated immune cells between the inflamed organ and the periphery. To
      avoid complications of disease in long term the investigators want to test specific probiotic
      bacteria from Bifidobacteria genus, that has has been in vitro studies recognized as
      anti-inflammatory.

      Hypothesis

        1. Children with celiac disease on gluten free diet have a higher level of pro-inflammatory
           cytokine (TNF-alpha) and anti-inflammatory cytokine (IL-10) in comparison with healthy
           controls.

        2. 3 months after daily probiotic consumption TNF-alpha level decrease and IL-10 level
           increase.

      In the investigators research will be selected 70 children, age from 2 to 18 years, divided
      in different groups:

        1. Group: 25 children with celiac disease on GFD for at least 3 months and will receive
           probiotic for 3 months.

        2. Group: 25 children with celiac disease on GFD for at least 3 months and will receive
           placebo for 3 months.

        3. Group: 20 healthy children
    


Intervention name(s): Bifidobacterium breve; Placebo (for Bifidobacterium breve)
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Retrospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
Condition: Refractive Errors
MeSH terms: Refractive Errors
Study type: Observational

Summary: 
      The purpose of this study is to examine the long term effect of ultra-violet filtering
      contact lenses on macular pigment density (MPOD) and accommodative function.
    


Intervention name(s): No Intervention
Intervention type(s): Device
Intervention description(s): No Intervention
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subject selection is based on a history of wearing one of two types of contact lenses for
        at least five years. Age-matching subjects into 4 age-brackets will be attempted with a
        target of five subjects in each age bracket among the two types of lenses.
Neuropeptides and Venous Pelvic Pain
Condition: Pelvic Pain; Varicose Veins Pelvic; Pelvic Congestion Syndrome
MeSH terms: Varicose Veins; Pelvic Pain
Study type: Observational

Summary: 
      Mechanisms of the development of pain in chronic venous diseases (CVD), including pelvic
      congestion syndrome (PCS), are studied incompletely. The existing hypotheses of the
      occurrence of venous pelvic pain (VVP) do not allow to answer the question why some patients
      have no pain syndrome while others have very pronounced pain despite the same
      morphofunctional changes in the pelvic veins? The investigators are planning to carry out a
      study aimed at studying the content of calcitonin gene-related peptide (CGRP) and substance P
      (SP) in the serum of patients with pelvic veins and pelvic pain, and to study the
      relationship between the values of CGRP and SP in these patients.
    

Detailed description: 
      The first phase of the study includes a set of 3 patient groups: the first is patients with
      pelvic vein dilation and blood reflux through them in combination with venous pelvic pain;
      the second is patients with pelvic vein dilatation without venous pelvic pain. The third,
      control group will include healthy female volunteers without pelvic veins and any chronic
      pain syndromes.

      At the second stage of the study, a study will be made of the levels of calcitonin
      gene-related peptide (CGRP) and the substance P (SP) in the serum using an ELISA method. In
      addition, after studying the content of the CGRP and SP in the serum of volunteers, the
      investigators expect to obtain the reference values of these neuropeptides. In this phase of
      the study, a statistical analysis of the data obtained will be carried out, a correlation
      analysis between venous pelvic pain and the level of the CGRP and CP.

      The data for each patient will be entered into a specially designed patient questionnaire. It
      will include clinical and ultrasound data, results of ELISA.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 18-45 years
      
Keywords: venous pelvic pain; pelvic congestion syndrome; calcitonin gene-related peptide; substance P
Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain
Condition: Moderate to Severe Acute Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter
      study to evaluate the safety and efficacy of SP-103 in subjects with moderate to severe acute
      lower back pain.
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter
      study to evaluate the safety and efficacy of SP-103 in subjects with moderate to severe acute
      lower back pain. Three to 7 days after the Screening Visit, subjects will return for a
      Baseline visit to verify electronic Diary compliance, collect urine samples for a drug screen
      and pregnancy test (for women of child-bearing potential), and complete baseline clinical
      rating scales.

      If subjects meet all the study inclusion criteria and none of the exclusion criteria,
      subjects will be randomized into the study. Subjects are expected to apply investigational
      product for 12 hours per study day) study days 1 through 28 and to record the time of
      investigational product applications and removals an electronic diary.

      Subjects will capture daily numeric pain rating scores and topical adhesions assessments in
      the electronic diary each evening prior the removal of investigational product.

      On day 28, subjects will return to the study site to complete the End of Study visit.
    

Intervention name(s): SP-103; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SP-103 topical system is worn daily for 12 hours per day for 28 days; Placebo topical system is worn daily for 12 hours per day, for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lbp; lower back pain; lidocaine; topical system; patch
Incretin and CRTd.
Condition: Type 2 Diabetes Mellitus; Heart Failure
MeSH terms: Heart Failure; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Incretin therapy is a treatment for type 2 diabetes (T2DM) affected by heart failure (HF). In
      this study the investigators will recruit T2DM patients affected by HF with depressed
      ejection fraction and treated by Cardiac resynchronization therapy (CRT). These patients will
      randomly be treated by incretin v/s conventional hypoglicemic drugs. In this patients
      investigators will report at follow up CRT-d responders rate, mortality, and hospital
      admission for HF worsening. Incretin may reduce hospital admissions for HF in T2DM v/s
      conventional hypoglicemic drugs.
    


Intervention name(s): Incretin Effect; Cardiac Resynchronization therapy defibrillator device
Intervention type(s): Drug; Device
Intervention description(s): The patients will receive incretins therapy.; The patients will receive a Cardiac Resynchronization therapy defibrillator device
Intervention MeSH terms: Incretins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers
Condition: Iron-refractory, Iron-deficiency Anemia (IRIDA)
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered
      orally in healthy adult volunteers. It is a randomized multiple treatments, single dose
      study.
    

Detailed description: 
      This is a Phase 1/2, randomized multiple treatments, single dose study assessing the
      pharmacokinetics (PK) and absolute bioavailability of Fer-In-Sol ( Ferrous Sulfate) and
      Triferic (ferric pyrophosphate citrate, or FPC) administered orally with Shohl's solution in
      healthy volunteers.

      Total participation in the study is approximately six weeks and is comprised of a screening
      visit, 6 treatment periods, and a follow-up visit.

      The study will be conducted over a 13 day period:

      Day 1 will used to determine the baseline serum iron profile for each subject.

      Each subject will subsequently receive in a randomized sequence between Day 2 and 10:

        1. A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).

        2. A single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed after
           10 minutes by Fer-In-Sol at 3 mg Fe/kg bw

        3. a single oral dose of Triferic PO at 3 mg Fe/kg bw

        4. a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10
           minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.

        5. a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed
           immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.

      All subjects will receive a single dose of 6.6 mg Triferic as a 4 hour IV infusion (to mimic
      the 4 hour iron tolerance test) on Day 12.

      Blood samples will be obtained at various times to analyze for serum iron parameters and for
      safety.
    

Intervention name(s): Triferic; Fer-In-Sol; Shohl's solution
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): ferric pyrophosphate citrate; FPC; Ferrous Sulfate; Oracit
Intervention MeSH terms: Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; healthy adult volunteer
Assessing the Accuracy of the RevK Sensor
Condition: Patients Undergoing Spine Surgery
Study type: Observational

Summary: 
      Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version
      is RevK.
    

Detailed description: 
      Evaluation of a new generation of sensors for monitoring blood hemoglobin with the Masimo
      non-invasive hemoglobin monitor. The newest sensor version is RevK.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing spine surgery
Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Live in Patients With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to
      establish the effect on patient's quality of life scores.
    


Intervention name(s): Low dose of telmisartan; High dose of telmisartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Online Cognitive Control Training on Rumination and Depressive Symptoms
Condition: Depression; Rumination - Thoughts
MeSH terms: Rumination Syndrome; Feeding and Eating Disorders of Childhood
Study type: Interventional

Summary: 
      The present study examines whether a computerized cognitive control training as compared to a
      placebo (fake) training will reduce the frequency of depressive rumination in depressed
      individuals. Rumination has been identified as a major risk factor for the onset and
      recurrence of depressive episodes and it has been suggested that it is linked to deficits in
      cognitive control functions. It is thus expected that training cognitive control will reduce
      the frequency of rumination as well as ameliorate its detrimental effect on negative mood
      states.
    

Detailed description: 
      Rumination has been shown to intensify dysphoric mood and is one of the best researched risk
      factors for the onset and recurrence of depressive episodes. Accumulating evidence suggests
      that the tendency to ruminate is linked to impairments in cognitive control functions,
      especially to problems discarding no longer relevant negative material from working memory
      (=working memory updating).

      The aim of the present study is to examine whether training to update emotional material in
      working memory will have an effect on the frequency of using rumination as well as on the
      impact of rumination on mood in the daily lives of clinically depressed participants.
      Participants will be randomly assigned to 10 sessions of either online cognitive control
      training or an online placebo condition. The ability to update emotional material in working
      memory will be assessed pre and post training by two computer tasks (close and far transfer
      tasks). The effects of the training on daily rumination and the dynamics between daily mood
      and rumination will be assessed pre- and post-training, as well as at 3-months follow-up
      using ambulatory assessment (via smartphone app). It is expected that individuals in the
      training as compared to the placebo group will show a greater reduction in rumination
      frequency as well as a reduction in the negative impact of rumination on mood.
    

Intervention name(s): Adaptive emotional cognitive control training; Adaptive non-emotional feature match task
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Is supposed to train ability to continuously update emotional material in working memory.; Does not train updating of working memory content; may train reaction time speed, visual search, or concentration abilities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
PREVALENCE STUDY OF PNH CLONES IN PATIENTS WITH NEOPLASIES
Condition: Myeloproliferative Neoplasm
MeSH terms: Myeloproliferative Disorders
Study type: Observational

Summary: 
      Multicenter prevalence study of the PNH clone (paroxysmal hemoglobinuria nocturnal) in SMP
      Ph-. This multicenter, prospective study aims to evaluate the presence of an PNH clone in
      patients with a confirmed diagnosis of myeloproliferative neoplasia Phcon or without
      mutations in the 3 main genes involved in this disease (JAK2, MPL, and Cal-R),but showing
      signs of ongoing hemolysis or particular clinical conditions.

      To this end, a multicolor flow cytometric test will be used to evaluate the presence of
      deficient GPI molecules in granulocytic, monocytic and other cells erythrocyte (flow
      cytometric test, based on the use of the FLAER reagent in peripheral blood samples).

      The study will be conducted at clinical hematology centers in the wider area of the Romagna
      and at other Italian hematology clinical centers, where and analyzed the peripheral blood
      samples and clinical data to be included in the study.

      The participating centers will carry out the flow cytometric diagnostic test at i own
      reference laboratories, while the biological material for subsequent studies
      genetic-molecular type (next generation sequencing) will be analyzed centrally at the
      Biosciences laboratory of the IRST IRCCS only for cases testing positive for the presence of
      the PNH clone. Clinical information will be collected for each patient enrolled in the study
      necessary for the classification of the case and all the laboratory data necessary for
      achievement of the objectives of the study. The main objective of the study is to evaluate
      the prevalence of PNH clones in patients with a confirmed diagnosis of myeloproliferative
      neoplasm Ph- with or without mutations affecting the 3 main genes involved in this disease
      (JAK2, MPL, e Cal-R), but showing signs of ongoing hemolysis or particular clinical
      conditions.

      Secondary objectives of the study are:

      - correlate the characteristics of the PNH clone with the clinical characteristics and
      laboratory of myeloproliferative neoplasms Ph- (the presence of phenomena thrombotics, the
      disease state, the DIPSS prognostic score index, and the state mutational).

      · characterize the genomic architecture of the cases using NGS technology positive results
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Diagnosis of one of the following Ph-negative myeloproliferative neoplasms:

        polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis, according to i WHO
        2016 criteria
Phytosterols and Oxyphytosterol Concentrations
Condition: Normocholesterolemic
Study type: Interventional

Summary: 
      Plant sterols and stanols (also called phytosterols and phytostanols) are structurally
      related to cholesterol, but absorbed to a much lesser extent. Due to this structural
      similarity, plant sterols and stanols inhibit intestinal cholesterol absorption and lower
      serum LDL cholesterol concentrations by about 10% at daily intakes of 2.5 g. Plant sterol-
      and stanol-enriched food products are therefore widely available on the market to lower the
      risk for coronary heart disease. Plant sterols can undergo oxidation, which results in the
      formation of oxyphytosterols. Animal studies have now suggested that oxyphytosterols are
      atherogenic. Although oxyphytosterols have been identified in human serum samples, the effect
      of an increased intake of plant sterols on serum oxyphytosterol concentrations in humans is
      not known. On the other hand, plant stanols cannot be oxidized and lower not only cholesterol
      absorption, but also plant sterol absorption.

      The major objective of the present study is to examine the effects of dietary plant sterols
      and stanols on fasting serum concentrations of oxyphytosterols. The minor objective is to
      investigate the effects of these products on postprandial serum oxyphytosterol
      concentrations.
    


Intervention name(s): Plant sterol-enriched margarine; Plant stanol-enriched margarine; Control margarine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily consumption of 20 gram of a plant sterol-enriched margarine (providing daily 3.0 gram of plant sterols), for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the plant sterol-enriched margarine is consumed together with a high-fat milkshake; Daily consumption of 20 gram of a plant stanol-enriched margarine (providing daily 3.0 gram of plant stanols), for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the plant stanol-enriched margarine is consumed together with a high-fat milkshake; Daily consumption of 20 gram of a control margarine, for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the control margarine is consumed together with a high-fat milkshake
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Plant sterols; Plant stanols; Oxyphytosterols; Cardiovascular Disease