bioihbjkbjnl/mcl2 huggingface dataset:
TAP Block in Laparoscopic Cholecystectomy.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery.
      Recently, magnesium sulphate is used as adjuvant to local anesthetics.
    

Detailed description: 
      A significant pain experienced by patients after laparoscopic cholecystectomy surgery is
      required so as to block nociceptive transmission from both the abdominal wall incision, and
      visceral sites.

      Using of opioids can result in significant adverse effects, thus delaying early mobilization
      of patients.

      Ultrasound-guided transversus abdominis plane (TAP) block has been used as a satisfactory
      approach that provides postoperative analgesia. TAP block is safe; it diminishes or replaces
      the use of opioids; and it has a lower incidence of adverse effects.

      Bupivacaine is a medication used to decrease feeling in a specific area. It is used by
      injecting it into the area, around a nerve that supplies the area, or into the spinal canal's
      epidural space. Bupivacaine is indicated for local infiltration, peripheral nerve block,
      sympathetic nerve block, and epidural and caudal blocks.

      Magnesium is the fourth most plentiful cation in our body. It may be worthwhile to further
      study the role of supplemental magnesium in providing perioperative analgesia, because this
      is a relatively harmless molecule, is not expensive and also because the biological basis for
      its potential antinociceptive effect is promising.

      Magnesium sulphate (MgSO4), N-methyl-D-aspartate receptor antagonist has the potential to be
      an ideal adjuvant in TAP block.
    

Intervention name(s): Bupivacaine +magnesium sulphate; Bupivacaine only
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4; Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).
Intervention MeSH terms: Magnesium Sulfate; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure
Condition: Aortic Aneurysm, Abdominal
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Observational

Summary: 
      The development of the abdominal aorta aneurysm is multifactorial. Through use of magnetic
      resonance imaging without contrast, this study will look closely at flow, the stresses hereby
      induced, as well as signs of inflammation in the vessel wall.
    

Detailed description: 
      The etiology of the abdominal aorta aneurysm is complex and multi-factorial. Biomechanic and
      hemodynamic stress contributes to aneurysmal growth, and the relevance of inflammation is
      gaining in terms of pathological influence. The technical advances of imaging now enable one
      to utilize magnetic resonance in reconstructing aortal blood flow. Newer post-imaging
      software then enables one to perform complex data analysis, wherein shear and wall-stress can
      be calculated. The goal of this study is to analyze the aneurysms of twenty patients. Values
      will be obtained for shear and wall stress. Additionally, the utilization of short tau wave
      inversion recovery (STIR) sequences will be performed to evaluate the presence or absence of
      acute edema and inflammation of the region. It should also be noted that particular attention
      will be placed on the so-called "neck" of the aneurysm, where the aneurysm typically tapers
      into what is often regarded as normal aortic tissue. This region is important for both the
      placement of a surgical bypass prosthesis or a deployed stent graft.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Twenty patients diagnosed with an infrarenal abdominal aorta aneurysm will be selected from
        our clinical database.
      
Keywords: Abdominal Aortic Aneurysm; Wall Stress; Shear Stress; Inflammation; Magnetic Resonance Imaging
Observation of the Result After Chondron (Autologous Chondrocytes) Treatment
Condition: Articular Cartilage Defects of Knee
MeSH terms: Cartilage Diseases
Study type: Observational

Summary: 
      This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron
      transplantation by tracking subjects who had the Chondron implantation to observe
      effectiveness.
    

Detailed description: 
      Many treatment cases proved that autologous chondrocyte transplantation is a useful treatment
      method for patients with damaged articular cartilage.

      This investigator-sponsored trial attempts to evaluate the effectiveness of
      Chondron(autologous chondrocyte) transplantation by tracking subjects who had the Chondron
      implantation to observe effectiveness.
    

Intervention name(s): Autologous Chondrocyte Implantation
Intervention type(s): Procedure
Intervention description(s): Test drug: Chondron (more than 12 million chondrocytes in 0.4ml, i.e. 1 vial)
Directions and dosage:
Suspend the cells in the vial sufficiently, and implant them in the defective part, making sure that sufficient amounts are injected.
Other intervention name(s): Chondron(671500010 [ A74600011 ])
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        In this exploratory clinical trial Chondron (autologous chondrocytes) is transplanted in
        the cartilaginous defects and the effectiveness is observed through follow-up. Target
        subjects are about 5% of about 2,000 patients with Chondron implants.
      
Keywords: articular cartilage defects; ACI; Autologous Chondrocyte Implantation; Knee joint; chondron
Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale and Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients.
      Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for
      one of the most important in terms of frequency and psychosocial and educational
      consequences.

      In these conditions, our study was designed to estimate the sensitivity to changes of the
      different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will
      then optimize our methodological approach for a therapeutic trial.
    


Intervention name(s): ADHD Rating Scale-IV; ADHD Rating Scale-IV
Intervention type(s): Other; Other
Intervention description(s): ADHD Rating Scale-IV test; ADHD Rating Scale-IV test
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Epilepsy; Attention deficit; ADHD rating scale IV
Effect of HIV and/or Active Tuberculosis on the Immune Responses to Trivalent Influenza Vaccine (TIV) in Adults
Condition: Influenza; HIV; Tuberculosis
MeSH terms: Influenza, Human; Tuberculosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective, open-labelled study which will enrol 360 participants in four groups of 80
      participants including: HIV-uninfected adults without evidence of TB; HIV-infected adults
      without any evidence of TB; HIV-uninfected adults with concurrent microbiologic confirmed TB,
      HIV-infected adults with concurrent microbiologic confirmed TB.

      Participants will receive the recommended seasonal 2013 un-adjuvanted Trivalent Influenza
      Vaccine (TIV). At 3 visits, blood will be collected for determination of immune responses.

      Objective:

      • To determine the effect of HIV-infection, tuberculosis (TB) and HIV-TB co-infection on
      immune responses
    


Intervention name(s): Trivalent Inactivated Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): The study vaccine will be the seasonal 2013 un-adjuvanted TIV which is provided as a 0•5 milliliter suspension of split virus mixture of 15 micrograms each of circulating H1N1- like strain, H3N2- like strain and B - like strain.
The WHO recommended vaccine formulation for Southern Hemisphere 2013 Influenza Season contains the following influenza strains:
A/California/7/2009 (H1N1)pdm-like virus
A/Victoria/361/2011 (H3N2)-like virus
B/Wisconsin/1/2010-like virus. (Yamagata lineage)
Other intervention name(s): Vaxigrip
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Tuberculosis; HIV infection; Immune responses to Influenza vaccination
A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
Condition: Systemic Juvenile Idiopathic Arthritis; Hereditary Periodic Fevers
MeSH terms: Arthritis; Arthritis, Juvenile; Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases; Amyloidosis; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this extension protocol is to collect safety data (serious and non-serious
      adverse events) and to provide continuous canakinumab to patients in France who completed
      study CACZ885G2301E1(NCT00891046), CACZ885G2306 (NCT02296424) or CACZ885N2301 (NCT02059291)
      until a decision regarding reimbursement in France is effective for canakinumab (Ilaris®) in
      these indications.
    


Intervention name(s): canakinumab
Intervention type(s): Drug
Intervention description(s): canakinumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Juvenile Rheumatoid arthritis (JRA) chronic; systemic inflammatory disorder; painful joints; inflammation of the synovial membrane; auto-immune rheumatoid disease; reactive rheumatoid arthritis; Systemic Juvenile Rheumatoid arthritis (SJRA); Hereditary Periodic Fevers; Hereditary periodic fever syndrome(HPFS); Familial Mediterranean fever syndrome(FMFS); Hyperimmunoglobulinemia D; Tumor necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS); Muckle-Wells syndrome (MWS); Familial cold auto inflammatory syndrome
The Aim of Study is Translate and Adapt the Visual Analog Scale Foot and Ankle (VAS-FA) Instrument Into Turkish and Psycho-metrically Test Its Reliability and Validity Among Patients Who Had Foot and Ankle Disorders or Surgery
Condition: Ankle Injuries and Disorders; Foot Injuries and Disorders
MeSH terms: Wounds and Injuries; Ankle Injuries; Foot Injuries
Study type: Observational

Summary: 
      There have previously been no validated a specific foot and ankle patient-reported outcome
      measures in Turkish. The Visual Analogue Scale Foot and Ankle (VAS-FA) will translated and
      adapted into Turkish language. Thereafter, 200 patients who had foot and ankle disorders or
      surgery will complete VAS-FA questionnaire set on two separate occasions. Analyses included
      testing of ﬂoor-ceiling effect, internal consistency, reproducibility, and validity.
    


Intervention name(s): VAS-FA Turkish version
Intervention type(s): Other
Intervention description(s): Self-reported outcome questionnaires
Other intervention name(s): Foot Function Index; Short Form-36
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants must be sedentary person from Turkey and receiving treatment intervention
        between study dates for ankle or foot disorders
      
Keywords: Foot and Ankle; Disorders; Outcome Measure
Efficacy Study of School-located Influenza Vaccination Clinics to Increase Influenza Vaccination Rates in Monroe County, New York
Condition: Childhood Influenza Vaccination; School-located Influenza Vaccination
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      Children in schools in which influenza vaccination clinics are held during school hours will
      have higher rates of influenza vaccination than children in control schools (no
      school-located clinics offered)
    


Intervention name(s): School-located Influenza Vaccination Clinic
Intervention type(s): Other
Intervention description(s): Children in the intervention arm are enrolled in schools in Monroe County, NY that are offering school-located influenza vaccination clinics during school hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Influenza vaccination rates
A Study in Healthy Men to Test How Different Doses of BI 474121 Are Taken up and How They Influence the Amount of a Molecular Messenger (cGMP) in the Spinal Fluid
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are:

        -  To evaluate the effect of BI 474121 on cyclic guanosine monophosphate (cGMP) levels in
           cerebrospinal fluid (CSF)

        -  To assess the exposure of BI 474121 in CSF relative to plasma

        -  To determine the exposure effect relationship in CSF with different oral doses of BI
           474121
    


Intervention name(s): BI 474121; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 474121; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial is designed to have three parts. Part 1: single-blind, randomized, placebo-controlled. Part 2: open-label, non-randomized. Part 3: open-label, randomized.
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Enhancers and Inhibitors on Absorption From Iron Supplements
Condition: Iron-deficiency; Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Iron deficiency (ID) is a major public health problem worldwide and oral iron supplementation
      can be an effective strategy to treat and prevent ID. To maximize iron bioavailability form
      oral iron supplements the simultaneous intake of the iron absorption enhancer ascorbic acid
      (AA) is recommended, and the simultaneous intake of coffee or tea containing the iron
      absorption inhibitors polyphenols should be avoided. Also, oral iron supplements are
      recommended to be taken on an empty stomach in the morning and without a meal to avoid any
      interaction with phytic acid, another iron absorption inhibitor present in many foods.
      However, the effects of these iron absorption enhancers and inhibitors have only been shown
      on iron absorption from dietary iron (up to 10mg). Also, the effect of the diurnal hepcidin
      increase on absorption from an iron supplement given in the afternoon without a preceding
      morning dose is unclear. Whether AA also increases iron bioavailability from a supplemental
      iron dose and whether a cup of coffee, a breakfast or iron administration in the afternoon
      decreases iron bioavailability from a supplemental dose is uncertain.
    


Intervention name(s): Reference; Ascorbic acid (AA) 500 mg; Ascorbic acid (AA) 80 mg; Coffee; Breakfast; Afternoon
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes; Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 500 mg AA; Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe + 80 mg AA; Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 54Fe isotopes + 150 mL coffee; Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 57Fe isotopes + 1 bread roll (~100 g) with butter and honey + 1 cup of plain yoghurt (180 mL) + 1 cup of coffee (150 mL) + 1 glass of orange juice (250 mL); Ferrum Hausmann 100 mg + 200 mL nanopure water with 3 mg 58Fe isotopes administered in the afternoon
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: iron supplementation; women of reproductive age; iron absorption enhancers; iron absorption inhibitors; ferrous fumarate; iron deficiency
Efficacy of Pancrelipase on Postprandial Belching and Bloating.
Condition: Postprandial Bloating; Postprandial Belching; Postprandial Eructation
MeSH terms: Eructation
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis of this study is that the administration of pancrelipase with meals will
      benefit symptoms of post-prandial bloating, pain and eructation.
    

Detailed description: 
      Subjects will complete a double-blind crossover study in which, for one week periods, they
      will receive two pancrelipase tablets with each of the three major meals or a similarly
      administered identical placebo. Three times daily, subjects will rate the severity of
      belching, epigastric discomfort, epigastric fullness, bloating, and nausea.
    

Intervention name(s): Pancrelipase (Creon) 2 tablets with each meal
Intervention type(s): Drug
Intervention MeSH terms: Pancrelipase; Pancreatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pancrelipase; Abdominal bloating; Abdominal pain; Eructation
Gene Polymorphism of Taste Receptors and Circulating Endocannabinoids in Normal Weight and Obese Subjects
Condition: Nutritional Physiological Phenomena
Study type: Observational

Summary: 
      The study aims at evaluating in normal weight and obese subjects those factors such as taste
      sensitivity and circulating endocannabinoids in influencing dietary choice and thereby lipid
      and energy metabolism in order to design personalized nutritional strategies.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        White Caucasians
Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy
Condition: Disorder of Knee; Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate motor block probability throughout time and clinical
      profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a
      unilateral spinal block technique.
    

Detailed description: 
      Previous IRB approval and informed consent, 180 ASA I-II adults under ambulatory knee
      arthroscopy will be randomly allocated to receive unilateral spinal anesthesia with 7.5
      (group Levo-7.5, n=59), 9.37(group Levo-9.37, n=61) and 11.25 (group Levo-11.25, n=60) mg of
      HLBP 0.75% using a 27-gauge Whitacre needle at a rate of 0.1 ml/ seg. and lateral decubitus
      position maintained for 5 min after injection.

      An independent observer will evaluate motor (modified Bromage scale) and sensory
      (transcutaneal electrical stimulation at T10, L1, L3, and S1 dermal segments) levels and
      presence of adverse events immediately after return to supine, at the end of surgery and each
      10 min from admission to PACU until home discharge conditions.

      Trans-cutaneal electrical stimulation (TES) will be made with a PNS (Ministim® model MS- IV,
      Organon, Dublin, Irland) using 50-Hz tetanus stimuli for 5 seg. from 10 to 60 mA 3,4.
    

Intervention name(s): Hyperbaric Levobupivacaine 0.75%
Intervention type(s): Drug
Intervention description(s): Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
Other intervention name(s): Bupinest 0.75% Pesado
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Arthroscopy; Levobupivacaine; Spinal Anesthesia; Motor Block
Mindfulness Intervention For Child Abuse Survivors (MICAS)
Condition: Child Abuse Survivors
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of meditation training called
      Mindfulness-Based Stress Reduction on reducing the symptoms of psychological distress among
      adult survivors of child abuse.
    

Detailed description: 
      The specific aims of the project are:

        1. To determine whether Mindfulness- Based Stress Reduction program is associated with a
           reduction in symptoms of depression, anxiety, and psychological distress.

        2. To assess indications of efficacy, assess feasibility of enrollment and compliance among
           this patient population

        3. Provide pilot data that can be used to apply for larger grants to more fully develop
           this approach
    

Intervention name(s): Mindfulness-Based Stress Reduction program
Intervention type(s): Behavioral
Intervention description(s): Mindfulness- Based Stress Reduction comprising of 8 classes and a one-day retreat, taught over a period of 6 weeks. Intervention also includes practice at home for 20-30 minutes.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: MICAS; MBSR
Effect of Plant Stanol Esters on Blood Lipids
Condition: Elevated Blood Lipids
Study type: Interventional

Summary: 
      This study aims to measure the effect of plant stanol esters on serum total and lipoproteins
      lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood
      lipid concentrations
    

Detailed description: 
      The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular
      disease has long been recognized. Dietary plant stanol esters have been shown to effectively
      reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of
      both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL
      cholesterol levels.

      This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with
      elevated fasting blood lipid concentrations will be randomized to study groups. The groups
      consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or
      similar minidrink without plant stanol esters. After 10 weeks study period serum total and
      lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.
    

Intervention name(s): plant stanol ester
Intervention type(s): Dietary Supplement
Intervention description(s): the effect of plant stanol esters on plasma lipids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment