bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Polyunsaturated Fatty Acids on Intestinal Lipid Metabolism in Insulin-resistant Men
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin
      observed in patients with insulin-resistance is now thought to be attributable to both
      elevated intestinal production and reduced clearance of these lipoproteins. Substantial
      evidence exists indicating that elevated plasma levels of these lipoproteins are associated
      with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma
      TRL levels of intestinal origin appears to be crucial to improve CVD risk associated with
      insulin-resistance. In this regard, there is some evidence that the clinical recommendation
      to replace dietary saturated fatty acids (SFAs) by n-6 polyunsaturated fatty acids (PUFAs)
      reduces CVD risk in the general population. Although the beneficial impact of n-6 PUFAs on
      CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels,
      recent data suggest that chronic n-6 PUFA consumption may also exert beneficial effects on
      CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by n-6 PUFAs on
      postprandial lipid response may be of even greater significance in dyslipidemic patients with
      insulin-resistance among whom intestinal triglyceride-rich lipoproteins (TRLs) represent a
      large proportion of the atherogenic lipoproteins. The general objective of the proposed
      research is to investigate how dietary n-6 PUFAs in place of SFAs modify intestinal
      lipoprotein metabolism in men with dyslipidemia associated with insulin-resistance. The
      investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins
      will be lower following a diet rich in n-6 PUFAs than after consuming a diet rich in SFAs.
      The investigators also hypothesize that substitution of SFAs by n-6 PUFAs will be associated
      with significant alterations in expression of key genes and proteins involved in intestinal
      lipoprotein metabolism.
    


Intervention name(s): Polyunsaturated fatty acids diet; Saturated fatty acids diet
Intervention type(s): Other; Other
Intervention description(s): During 4 weeks, subjects eat a diet high in polyunsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 6.0% from saturated fat; 14.4% from monounsaturated fat; 12.6% from n-6 polyunsaturated fat).; During 4 weeks, subjects eat a diet high in polyunsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 13.4% from saturated fat; 15.3% from monounsaturated fat; 4.0% from n-6 polyunsaturated fat).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
tDCS Applied to the OFC: Effects on Decision-Making and Impulse Control
Condition: Impulsive Behavior; Suicidal Impulses
MeSH terms: Impulsive Behavior
Study type: Interventional

Summary: 
      In this study the investigators aim to assess whether transcranial direct current stimulation
      (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions)
      when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and
      impulse control in healthy participants.
    

Detailed description: 
      In this single-blind, three-arm and sham-controlled study, we will assess whether
      transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating
      the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is
      able to modulate decision-making and impulse control in healthy volunteers. We hypothesize
      that tDCS applied to the OFC, in comparison to sham tDCS, will significantly enhance
      decision-making and impulse control. For this study we will enroll 45 healthy individuals
      aged 18-60 years. These individuals will be assessed with a battery of computerized tasks as
      well as clinician-administered and self-reported questionnaires on depression and anxiety.
      Assessments will be carried out before and after a single 30-minute tDCS session.
    

Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Anode placed over the OFC or the DLPFC and cathode placed over the occipital region
Other intervention name(s): tDCS, Brain Polarization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Decision-making; Impulse control; Transcranial direct current stimulation; Brain stimulation; Neuromodulation; tDCS; Iowa Gambling Task; Stroop Word-Color Task
Promising Bimarker Prediction of Outcome of HELLP Syndrome.
Condition: Pre-Eclampsia, Severe; HELLP Syndrome; Microangiopathy
MeSH terms: Eclampsia; Pre-Eclampsia; HELLP Syndrome; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      HELLP syndrome is a life-threatening obstetric complication usually considered to be a
      variant or complication of pre-eclampsia. And may occasionally be confused with other
      diseases complicating pregnancy such as acute fatty liver of pregnancy, gastroenteritis,
      hepatitis, appendicitis, gallbladder disease, immune thrombocytopenia, lupus flare,
      antiphospholipid syndrome, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura,
      and nonalcoholic fatty liver disease. The distinction between thrombotic thrombocytopenic
      purpura-hemolytic uremic syndrome and severe preeclampsia is important for therapeutic and
      prognostic reasons. However, the clinical and histological features are so similar that
      establishing the correct diagnosis is often difficult; furthermore, these disorders may occur
      concurrently.
    

Detailed description: 
      When TTP/HUS does occur during pregnancy, they often are confused initially with obstetric
      diagnoses such as severe preeclampsia; hemolysis, elevated liver enzymes and low platelets
      (HELLP) syndrome; acute fatty liver of pregnancy; eclampsia, and antiphospholipid antibody
      syndrome. This might be related to the fact that the disease entity is rare and often is
      unexpected. Nevertheless, a delay in diagnosis of TTP/HUS may result in life-threatening
      maternal and fetal consequences. Aim of the current study was to compare the quantitative
      assessment of schistocytes in peripheral blood smear between women initially diagnosed as
      HELLP syndrome who showed no spontaneous resolution within 48 hrs after delivery and those
      who showed spontaneous resolution within 48 hrs after delivery which may help in decreasing
      the maternal mortality rate .
    

Intervention name(s): shistocytes percentage
Intervention type(s): Diagnostic Test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 100 women with an initial diagnosis of HELLP syndrome were recruited in the
        study.

        Blood sample taken within 12hrs peripartum and patients followed up 48hrs after delivery
        and subdivided in to 2 groups according to improvement or deterioration after 48hrs after
        delivery .
Safety and Tolerability of Bacillus Subtilis MB40 in Healthy Adult Volunteers
Condition: Healthy Participants
Study type: Observational

Summary: 
      This study is a single-blind, placebo-lead in design examining the safety and tolerability of
      a probiotic, Bacillus subtilis MB40. Subjects received a 7-day placebo BID lead-in and a
      21-day BID course of Bacillus subtilis MB40. GI questionnaires and Bristol stool charts along
      with evaluation of any medically significant changes, based on physical examination findings,
      clinical laboratory tests and vital signs assessments were used to determine the safety and
      tolerability of MB40.
    


Intervention name(s): Bacillus subtilis MB40
Intervention type(s): Dietary Supplement
Intervention description(s): 1-week placebo (maltodextrin and excipients) lead-in followed by 250 mg capsule (5 billion CFU/capsule) administered twice daily for 21 days
Other intervention name(s): OPTI-BIOME MB40
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Human volunteers meeting eligibility criteria listed above.
Treatment of Procedural Pain Associated With Turning in Patients With Mechanical Ventilation
Condition: Critical Illness; Pain
MeSH terms: Critical Illness; Pain, Procedural
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Few studies have addressed the situation of procedural pain and the use of
      preemptive analgesia for turning in patients under mechanical ventilation.

      Aim: Evaluation effect of preemptive fentanyl on the incidence of pain during turning
      maneuvers in critically ill patients under mechanical ventilation.

      Design: Single-center clinical trial, national, randomized, double-blind, with a parallel
      group, and two arms of treatment: saline placebo and fentanyl.

      Primary Endpoint: Incidence of pain during the turning procedures that are carried out by
      nurses measured by means of the Behavioral Pain Scale (BPS).

      Study Population: Critically ill patients, age > 18 years, admitted to ICU and expected to
      require mechanical ventilation for at least 24 h.

      Sample Size: 80 patients divided into the two groups (40 patients each). Statistical
      Analysis: A preliminary descriptive analysis will be carried. Later, results of primary end
      point will be comparing after the eventual corrections of corresponding variables using a
      multivariable approach. The AUC variable will be analyzed by a t-test for unpaired data. A
      second analysis using a multivariate approach will be carried out for those factors
      considered as clinically relevant in relation to pain and therefore a logistic regression
      will be used.

      Ethical Considerations: The study will be strictly conducted following the Declaration of
      Helsinki and the protocol and Standard Operating Procedures (SOPs) to ensure compliance with
      the Good Clinical Practice (GCP) standards. It is the responsibility of the researcher to
      obtain the valid informed consent from the guardian / legal representative, as the patient's
      condition will not allow to consent. Before obtaining the consent the investigator will
      explain to each guardian / legal representative the nature of the study, its purpose, the
      procedures, the estimated duration, the potential risks and benefits associated with the
      participation, as well as any inconvenience that this may involve.

      Duration of Treatment: The treatment has a maximum duration of 60 min for each patient. The
      follow-up includes visits and has duration of 6 consecutive days.

      Safety Assessment: Potential side effects of treatments will be recorded. Frequent adverse
      effects of fentanyl administration include respiratory depression, apnea, muscle rigidity,
      bradycardia and transient hypotension.
    


Intervention name(s): Fentanyl; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Pain. Analgesia. Prevention
GN Tobacco Use Survey
Condition: Smoking
Study type: Observational

Summary: 
      Smoking can contribute to many health problems for mothers and their babies. In developing
      countries, there is little information about the number of pregnant women that smoke and the
      reasons why some pregnant women choose to smoke. The purpose of this multi-site tobacco use
      survey is to obtain information on knowledge, attitudes and behaviors among pregnant women in
      diverse populations regarding tobacco products.
    

Detailed description: 
      Smoking is regarded as one of the few potentially preventable factors associated with low
      birth weight, very preterm birth and perinatal death. In an effort to determine the
      prevalence of tobacco use (smoking and smokeless tobacco) and to collect relevant data in
      support of a potential smoking prevention or cessation intervention, a multi-site tobacco use
      survey is being conducted in several countries. The survey will be used to obtain information
      on knowledge, attitudes and behaviors among pregnant women in diverse populations regarding
      tobacco products.

      The primary outcome is tobacco use status during pregnancy. Secondary outcomes include:
      knowledge and attitudes regarding tobacco products, health hazards of tobacco use and
      environmental tobacco smoke (ETS) exposure.

      Sample size of 750 per country was calculated under the assumptions that the prevalence of
      tobacco use could be as low as 0.05 with a coefficient of variation of approximately 15% and
      a prevalence of 0.10 with a CV of approximately 11%.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women 18-45
      
Keywords: Global Network; Maternal and child health; International; Women's health; Tobacco; Smoking; Africa; Latin America; South America; Guatemala; Zambia; India; Argentina; Democratic Republic of the Congo
Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function"
Condition: Heart Failure; Diabetes
MeSH terms: Heart Failure; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators wish to investigate the the short term effect of low circulating free fatty
      acids in congestive heart failure patients with type 2 diabetes.

      Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral
      muscle lipid content, improves cardiac performance and exercise capacity.
    


Intervention name(s): Metabolic substrate modulation; metabolic substrate modulation
Intervention type(s): Other; Other
Intervention description(s): for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).; low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Using Technology to Improve Eating Disorders Treatment
Condition: Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce
      eating disorder outcomes in college-age women.
    

Detailed description: 
      Colleges are faced with an elevated prevalence of eating disorders, yet less than 20% of
      students report receiving treatment. Inadequacies in mental health care delivery result in
      prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse,
      highlighting the need for improved modalities for screening and intervention. Over the past
      20 years, we have developed a comprehensive, online platform through which we identify and
      offer tailored evidence-based interventions to individuals across the eating disorder risk
      and diagnostic spectrum, using minimal person-based resources. The newest intervention in our
      suite of programs, Student Bodies-Eating Disorders (SB-ED), has not yet been tested in a
      large-scale trial or via platform delivery. The aim of this study is to conduct the first
      national deployment of our comprehensive platform and demonstrate that our transdiagnostic
      guided self-help program, SB-ED, yields measurable and significant improvements in access,
      costs, and outcomes for eating disorder treatment over referral to usual care (i.e.,
      treatment per protocol at students' corresponding college's mental health services center).

      Twenty-eight colleges will be randomly assigned to receive either SB-ED or referral to usual
      care. We will enroll at least 650 students from these campuses who screen positive for a
      DSM-5 clinical or subclinical eating disorder (excluding anorexia nervosa, which warrants
      more intensive medical monitoring). Outcomes will be measured at 6-months, 1-year, and
      2-years following the completion of the online screen.
    

Intervention name(s): StudentBodies - Eating Disorders
Intervention type(s): Behavioral
Intervention description(s): The intervention is a structured, cognitive-behavioral guided self-help program, derived from manual-based cognitive-behavioral therapy. The intervention targets the core eating disorder pathology (e.g., extreme dietary restraint, overvaluation of shape and weight, binge eating, compensatory behaviors), focusing on helping users develop regular eating patterns, self-control strategies, problem-solving skills, and relapse prevention tools for maintenance of behavior change. The program includes daily symptom checklists, journal exercises and activities, and an asynchronous moderated online discussion group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate Safety & Effectiveness of Spinal Sealant
Condition: Cerebrospinal Fluid Leakage, Subdural
MeSH terms: Subdural Effusion; Cerebrospinal Fluid Leak
Study type: Interventional

Summary: 
      To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of
      care techniques.
    

Detailed description: 
      Neurosurgical procedures in the spine often involve incision of the dura mater to access the
      spinal cord. If the dural incision is not properly repaired and watertight closure is not
      achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity.
      The most frequent complication of CSF leak is recurring headache complicated with symptoms of
      nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing
      and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak
      has also been associated with the development of cerebellar hemorrhage and subdural hematoma.
      Primary repair and watertight closure are paramount to minimizing risk and sequelae
      associated with CSF leak.
    

Intervention name(s): Spinal Sealant; Standard of Care
Intervention type(s): Device; Other
Intervention description(s): Spinal Sealant System; Standard of Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Prevention of CSF leak
Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain
Condition: Gynecologic Diseases
MeSH terms: Shoulder Pain; Genital Diseases, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this clinical trial is to evaluate the efficacy and safety of different
      recruitment maneuvers for reducing postlaparoscopic shoulder pain.
    

Detailed description: 
      Shoulder pain after laparoscopy is common and its probable mechanism is residual CO2 gas
      after surgery. The pulmonary recruitment maneuver can mechanically remove residual CO2 and
      reduce pain. In literature, there are two different recruitment maneuvers, which was manual
      inflation of the lungs with positive pressure ventilation of either 40cmH2O or 60cmH2O at the
      end of surgery. However, the higher positive pressure may be associated with more chance of
      barotrauma. Therefore, it is important to determine the lowest effective pressure for
      reducing postlaparoscopic shoulder pain. The aim of this clinical trial is to evaluate the
      efficacy and safety of different recruitment maneuvers (40cmH2O or 60cmH2O) for reducing
      postlaparoscopic shoulder pain.
    

Intervention name(s): 40 cmH2O; 60 cmH2O; Passive deflation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.; The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.; In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effectiveness of the treatment with very low
      frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated
      signs such as sensitivity disorders that affect the first three fingers and half of the
      fourth finger of the hand in patients with carpal tunnel syndrome versus the supplement (=
      Xinepa).
    


Intervention name(s): ELF; Xinepa®; Placebo Xinepa®
Intervention type(s): Other; Other; Other
Intervention description(s): Very low frequency magnetic fields (ELF) at intensity of 100 mT and a frequency of 1-80 Hz. Protocol (antiedema-antinflammatory): 12 sessions, 3 times a week for 4 consecutive weeks, each session lasted 30 minutes.; 2 tablets of Xinepa daily (morning and evening) for 1 month.; 2 tablets of Xinepa placebo daily (morning and evening) for 1 month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Magnetic Fields; Pain; Paresthesia; Visual Analogue Scale