bioihbjkbjnl/mcl2 huggingface dataset:
Restoring Emotion Regulation Networks in Depression Vulnerability
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Selective biases in attention can be modified by a simple computerized technique: The
      Attention Bias Modification Task (ABM) pioneered by MacLeod et al. Cognitive biases may be
      one reason depression recurs, and altering these biases should reduce risk of recurrence.
      Recently, evidence has supported this hypothesis . The mechanisms by which ABM works are not
      well understood. More research is needed to explore how altering an implicit attentional bias
      can lead to changes in subjective mood. One possible explanation is that positive attentional
      biases are an important component of explicit methods of emotion regulation. The ability to
      effectively regulate one's emotions is a fundamental component of mental health and this
      ability is impaired in depression. It has also been shown that recovered depressed people
      spontaneously show a more dysfunctional pattern of emotion regulation as compared to never
      depressed controls. Supporting this, growing evidence implicates dysregulation of a
      medial/orbitofrontal circuit in mood disorders. This circuit includes the orbitofrontal
      cortex and anterior cingulate cortex, the ventral striatum, the ventral pallidum and medial
      thalamus. Components of this circuit are reciprocally connected with the amygdala, which is
      implicated in emotional processing in the healthy brain and dysregulated in depression.
      Negative emotion processing biases depend on both enhanced "bottom-up" responses to
      emotionally salient stimuli and reduces "top-down" cognitive control mechanisms, required to
      suppress responses to emotionally salient but task irrelevant information. Cognitive
      reappraisal and distancing are common strategies to down- or upregulate emotional responses.
      Reappraisal is an emotion regulation strategy that involves reinterpretation and changing the
      way one thinks about an event or stimulus with the goal of changing its affective impact.
      Distancing is a type of reappraisal that involves creating mental space between oneself and
      the emotional event in order to see things from a different, less self-focused perspective.
      It has been shown that distancing is a strategy that people can improve at over time compared
      to reinterpretation. The neural systems which support the explicit regulation of emotion have
      previously been characterized and include both lateral- and prefrontal cortex. This frontal
      activity is predicted to downregulate limbic circuitry involving the amygdala during passive
      viewing of emotional salient stimuli.
    


Intervention name(s): Attentional Bias Modification; Sham Comparator
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Computerized; Computerized
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional

Summary: 
      The objective of this study was to assess bioequivalence of a potential generic 750 mg
      balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg
      balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting
      conditions.
    


Intervention name(s): Balsalazide
Intervention type(s): Drug
Intervention MeSH terms: Balsalazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Efficacy and Safety of Intravenous vs Oral Acetaminophen for Treatment of Fever in Healthy Adult Males
Condition: Fever
MeSH terms: Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the rapidity of onset of antipyretic effect and the efficacy and safety of a single
      dose of IV acetaminophen (IV APAP) versus oral (PO) acetaminophen in the treatment of fever
      induced by a standard dose of endotoxin
    

Detailed description: 
      A Phase III, Randomized, Double-Blind, Double-Dummy, Single-Dose Study of the Efficacy and
      Safety of Intravenous Acetaminophen Versus Oral Acetaminophen for the Treatment of
      Endotoxin-Induced Fever in Healthy Adult Males
    

Intervention name(s): Intravenous acetaminophen plus oral placebo; Oral acetaminophen plus IV placebo; Reference standard endotoxin (RSE)
Intervention type(s): Drug; Drug; Biological
Intervention description(s): Single dose of 1 gm IV acetaminophen; Single dose of 1 g PO APAP; To subjects in both study arms: Administration of a 1 ng/kg body weight test dose of RSE to induce fever and test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever.
Other intervention name(s): IV APAP; IV APAP; RSE
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if there is a difference in outcomes between
      liberal transfusion (transfusing when hemoglobin drops below a set higher value number) and
      conservative transfusion (transfusing when hemoglobin drops below a set lower value number).
    

Detailed description: 
      Transfusion of Orthopaedic trauma patients is routinely done in asymptomatic individuals as
      there is no accepted national standard or recommendations from the American Academy of
      Orthopaedic Surgeons or the Orthopaedic Trauma Association for what level of anemia is
      appropriate in an asymptomatic patient. Individual practitioners typically make this decision
      based on anecdotal experiences and expert opinion. No prospective study has been performed to
      date to answer this question in this patient population.

      The null hypothesis of this proposed pilot study is that no difference will be seen with a
      liberal transfusion strategy to keep a patient's hemoglobin above 7 g/dL versus a
      conservative strategy to keep the patient's hemoglobin above 5.5 g/dL in patients
      asymptomatic at rest. The primary outcome of this pilot study will be infection; defined as
      postoperative wound infection (superficial or deep) or other perioperative infection but not
      surgical site (urinary tract infection or pneumonia). Deep infection is defined as the need
      for intravenous antibiotics or a return to surgery for debridement. Superficial infection is
      defined as the use of oral antibiotics only successfully treat a surgical site infection.
      Secondary outcomes will include pulmonary embolism, deep venous thrombosis, acute renal
      failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve
      palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death, and the
      musculoskeletal functional assessment.
    

Intervention name(s): Blood and blood products for transfusion
Intervention type(s): Biological
Intervention description(s): Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb >7 g/dL. If the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL. If the patient's Hgb does not drop below 7.0 g/dL, randomization will not be done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of AL721 in HIV-Infected Patients With Swollen Lymph Nodes
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the tolerance and safety of increasing doses of AL-721 in patients with persistent
      generalized lymphadenopathy (PGL) and symptomatic HIV infection, and to obtain preliminary
      information on the effectiveness of AL-721 against the human immunodeficiency virus (HIV) in
      HIV-infected persons with PGL and symptomatic HIV infection. Although zidovudine (AZT)
      prolongs life in certain AIDS patients, it is not a cure for AIDS and it also has toxic
      effects in many patients. Therefore, it is necessary to test other drugs in HIV-infected
      patients. AL-721 is a mixture of lipids (fats) extracted from egg yolks. Laboratory tests
      suggest that it might inhibit the infectivity of the HIV. AL-721 has been tried so far in a
      few patients for short periods of time and has been found to be well tolerated.
    

Detailed description: 
      Although zidovudine (AZT) prolongs life in certain AIDS patients, it is not a cure for AIDS
      and it also has toxic effects in many patients. Therefore, it is necessary to test other
      drugs in HIV-infected patients. AL-721 is a mixture of lipids (fats) extracted from egg
      yolks. Laboratory tests suggest that it might inhibit the infectivity of the HIV. AL-721 has
      been tried so far in a few patients for short periods of time and has been found to be well
      tolerated.

      Patients receive AL-721 twice daily. The first dose is taken on an empty stomach 1 hour
      before a fat-free breakfast, with specific instructions given on foods that are allowed; the
      second dose is taken at least 3 hours after the evening meal. No snacks are permitted after
      the evening meal or after the evening dose of study medication. The study is scheduled to
      last for 16 weeks of treatment and 4 weeks of follow-up. Throughout the study, frequent blood
      samples will be taken from an arm vein. The blood samples are studied to evaluate any changes
      in the patient's immune system, any toxic effects that might be detected in the blood, and
      any changes in the presence of the HIV in the blood.
    

Intervention name(s): AL 721
Intervention type(s): Drug
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virus Replication; T-Lymphocytes; Dose-Response Relationship, Drug; Drug Evaluation; Acquired Immunodeficiency Syndrome; AL 721; AIDS-Related Complex; Antiviral Agents
Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis
Condition: Ascites; Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial compares a combination of two drugs that constrict blood vessels
      (Octreotide LAR and Midodrine) to albumin after large volume paracentesis. Subjects have
      cirrhosis and ascites.
    

Detailed description: 
      This prospective, placebo-controlled, randomized, clinical trial compares the effect of a
      combination of vasoconstrictors (octreotide plus midodrine) to albumin on the time to
      recurrence of ascites in patients with refractory ascites treated with large volume
      paracentesis. The treatment allocation ratio for the two treatment arms is 1:1 using a
      stratified random permuted block design. Subjects are patients 18-80 years old with cirrhosis
      and ascites who are stratified according to the presence or absence of renal dysfunction at
      the time of randomization. Measurements include blood pressure, weight, girth, abdominal
      ultrasound, forearm blood flow, plasma renin activity, angiotensin, and aldosterone, repeated
      during a 6 month period.
    

Intervention name(s): Albumin; Intravenous Saline Infusion (Albumin placebo); Midodrine; Oral tablet (Midodrine placebo); Octreotide LAR; Saline injection (Octreotide LAR placebo); Large Volume Paracentesis
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed; Intravenous saline Infusion (Albumin placebo); Midodrine oral tablet at 10 mg three times a day.; Oral tablet (Midodrine placebo) three times a day; Octreotide LAR 20 mg intramuscular injection every 30 days; Saline intramuscular injection 5 cc every 30 days.; Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.
Other intervention name(s): LVP
Intervention MeSH terms: Octreotide; Midodrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: albumin; ascites; paracentesis
Recurrence of Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Recurrence
Study type: Observational

Summary: 
      analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular
      carcinoma within 1 year after radiofrequency ablation.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with hepatocellular carcinoma (HCC) who underwent radiofrequency ablation (RFA)
        from 1/2006 till 12/2010in Tropical medicine department and hepatocellular carcinoma
        clinic, Ain Shams university
      
Keywords: Hepatocellular cacinoma; Radiofrequancy ablation; Intrahepatic recurrence
Does Fluid Requirement Decrease With the Use of Pneumatic Compression Device on Lower Limbs
Condition: Fluid Overload
Study type: Interventional

Summary: 
      Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis
      a vis on fluid requirement during general anaesthesia and surgery.
    

Detailed description: 
      Induction of general anaesthesia is associated with cardiac depression and peripheral
      vasodilatation resulting in hypotension .This hypotension can be corrected by giving
      intravenous fluid, or the vasoconstrictor. While optimum fluid balances in the perioperative
      period is of vital importance in overnight fasting patients to correct the fluid deficit, any
      fluid overload is not only counterproductive to the heart function but is associated with
      fluid retention in body and edema in postoperative period.

      Peristaltic pneumatic compression device, a variant of intermittent sequential compression of
      legs, uses higher pressure and longer compression cycles to avoid venous stasis in
      immobilized patients. Sequential compression devices have sleeves with pockets of inflation,
      which works to squeeze on the appendage in a milking action .The most distal areas will
      inflate initially, and the subsequent pockets will follow in the same manner. The primary aim
      of the device is to squeeze blood from the underlying deep veins to proximal side. When the
      inflatable sleeves deflate, the veins will replenish with blood. The intermittent
      compressions of the sleeves will ensure the movement of venous blood . Peristaltic Pneumatic
      Compression of the legs significantly reduces fluid demand and enhances stability during
      minor ear, nose, and throat surgery. Peristaltic Pneumatic Compression has the potential to
      support fluid restriction regimens during surgery .
    

Intervention name(s): HUNTLEIGH FLOWTRON ACS900
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: About 60 patients of age group 25 to 50 belonging to American Society of Anesthesiologists (ASA) grade 1 and 2 were allocated to either control or sequential pneumatic compression device group .Allocation was done by sealed envelop technique.In the operating room,in the control group,the device was placed on operating table and was placed next to the patients calves.in the intervention group,the device was placed over calves and inflated during induction of General Anaesthesia (GA) and maintenance.legs were draped in both the groups.Femoral vein velocities were assessed using ultrasound in preoperative period , intraoperatively 15 minutes after induction of anaesthesia and in post-operative period.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Platelet REactivity in Sepsis Syndrome (PRESS)
Condition: Sepsis Syndrome
MeSH terms: Sepsis; Toxemia; Syndrome; Systemic Inflammatory Response Syndrome
Study type: Observational

Summary: 
      Activation of blood platelets is a typical finding in patients with systemic inflammation and
      sepsis.They seem to mediate key pro-inflammatory mediator secretion, immune-cell activation
      while their adhesion to the endothelium enhances the pro-coagulatory activity of endothelial
      cells impairing microcirculation thus, may lead to multiple organ dysfunction. However, the
      exact effects of bacterial products on platelet function have not been found to be consistent
      and may vary according to the species, the timing of the study, and the pathogenesis of
      sepsis. Data vary, including both increased and decreased platelet reactivity and aggregation
      among patients with sepsis compared to healthy controls. Defining platelet's behaviour during
      sepsis is particularly important in view of recent findings revealing potential association
      between antiplatelet therapy and reduction in short term mortality, incidence of acute lung
      injury and intensive care unit admission in critically ill patients.This study aims to
      measure P2Y12 mediated platelet reactivity, -using the point-of-care P2Y12 VerifyNow assay,
      in platelet reactivity units (PRU)- along different stages of sepsis, including
      bacteremia/uncomplicated infection, sepsis, severe sepsis and septic shock. Subgroup follow
      up of patients going along different stages will also be performed. At the end of this study
      analysis of clinical and laboratory findings in correlation with platelet reactivity will be
      performed to assess platelet aggregation during sepsis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Within 0-8 hours of presentation in emergency department patients will be assessed and
        assigned upon their health status in four distinct groups of uncomplicated
        infection/bacteraemia , sepsis, severe sepsis/septic shock as this is defined by
        International Sepsis Definitions Conference. Thirty five healthy volunteers will serve as a
        control group.
      
Keywords: sepsis; platelet; platelet reactivity; P2Y12
Vitamin D, Genes and Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The aim of this study is to investigate the interaction between intake of vitamin D and
      polymorphisms in GC and CYP2R1 in relation to risk of colorectal cancer in a Danish
      prospective cohort study.
    

Detailed description: 
      The association between vitamin D and incidence of colorectal cancer (CRC) has been
      thoroughly investigated in both observational and experimental studies, but the results are
      conflicting. Genetic epidemiology is an advantageous alternative to randomized, clinical
      trials for ethical and economic reasons.

      The aim of this study is to investigate whether polymorphisms in GC and CYP2R1 that predicts
      25-hydroxycholecalciferol (25(OH)D) concentrations after both ultraviolet B radiation and
      consumption of vitamin D3-fortified bread and milk in Danes are associated with risk of CRC;
      and further, to examine whether intake of vitamin D through diet and supplementation alter
      the risk of CRC.

      Data are retrieved from the Danish prospective "Diet, Cancer and Health" study encompassing
      57,053 persons which were recruited between 1993 to 1997. Between 1994 and 31th December
      2009, 1038 CRC cases has been diagnosed. A sub-cohort of 1857 persons has been randomly
      selected within the full cohort at time of entry into the cohort. The study design is a
      nested case-cohort study.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The Diet, Cancer and Health study is an ongoing Danish cohort study designed to investigate
        the relation between diet, lifestyle and cancer risk. The cohort consists of 57,053
        persons, recruited between December 1993 and May 1997. All the subjects were born in
        Denmark, and the individuals were 50 to 64 years of age and had no previous cancers at
        study entry. Blood samples, anthropometric measures and questionnaire data on diet and
        lifestyle were collected at study entry.

        The present study uses a nested case-cohort design. Follow-up is based on population-based
        cancer registries. Between 1994 and 31th December 2009, 1038 CRC cases were diagnosed. A
        sub-cohort of 1857 persons has randomly been selected within the full cohort at time of
        entry into the cohort.
      
Biospecimen description: 
      DNA extracted from buffy coeats
    
Keywords: Vitamin D; GC; CYP2R1; Gene-environment interaction; prospective case-cohort study; single nucleotide polymorphisms; colorectal cancer
Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer
Condition: Lymphocele
MeSH terms: Lymphocele
Study type: Interventional
Phase: Phase 3

Summary: 
      Injection the day before surgery of 90 mg of Lanreotide LP sub-cutaneously or placebo.
      Evaluation of the lymphorrhea in the 2 arms of the study
    

Detailed description: 
      Patients will be recruited among patient refered to our department for a breast cancer and
      needing an axillary dissection. Enrolled patients will have an injection of Lanreotide or
      placebo the day before surgery when they arrive in their room. The quantity of lymph in
      axillary drain will by daily noted until day 4. The patient will be evaluated at D15, D30 and
      M6 for pain, lymphocele and adverse events.

      Data will be compared in the 2 groups.
    

Intervention name(s): Lanreotide LP 90; Placebo lanreotide
Intervention type(s): Drug; Drug
Intervention description(s): Lanreotide LP 90; Placebo
Intervention MeSH terms: Lanreotide; Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Axillary lymphocele breast cancer
Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin Hormone Secretion in Healthy Volunteers
Condition: Healthy Volunteers Recruited From the General Population
Study type: Interventional

Summary: 
      To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin
      hormone secretion in healthy volunteers
    

Detailed description: 
      A mixed meal (524 kcal) is ingested rapidly (within 5 min) or slowly (10-15 min) and changes
      in insulin, glucagon, GIP and GLP-1 levels are followed for subsequent 300 min
    

Intervention name(s): Mixed meal
Intervention type(s): Other
Intervention description(s): Ingestion of mixed meal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: mixed meal¨; insulin; glucagon; GIP; GLP-1