bioihbjkbjnl/mcl2 huggingface dataset:
Endovascular Versus Open Repair of the Common Femoral Artery
Condition: Atherosclerotic Lesions of the Common Femoral Artery
Study type: Interventional
Phase: Phase 4

Summary: 
      Even though the indication for endovascular therapy has been enlarged, open repair of common
      femoral artery is still considered as the treatment of choice. A recent pilot study showed
      that endovascular repair of the CFA seems to be a safe technique of revascularization with
      acceptable initial results at 12 months (Azema et al, Eur J Vasc Endovasc Surg, 2011, in
      press). TECCO, a French randomized and controlled trial, has been set up to compare open and
      endovascular procedures for the treatment of CFA atherosclerotic lesions.
    


Intervention name(s): Endovascular treatment using self expandable nitinol STENTS; Open repair treatment
Intervention type(s): Device; Device
Intervention description(s): A direct stenting will be performed.; The surgeon will perform its usual technique to revascularize the common femoral artery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Maternal Emotions and Diet in Pregnancy
Condition: Pregnancy Related; Stress, Psychological; Glucose Intolerance During Pregnancy
MeSH terms: Glucose Intolerance; Stress, Psychological
Study type: Interventional

Summary: 
      This study seeks to understand how a mother's emotional state in pregnancy influences her
      biological response to food intake.
    

Detailed description: 
      The purpose of this research study is to understand how a mother's emotional state in
      pregnancy influences her biological response to food intake. Natural variation in emotional
      and mental state is frequently experienced in daily life, including during pregnancy. While
      the investigators understand that a healthy diet is important in pregnancy for maintaining
      blood sugar levels and other metabolic factors within normal ranges for optimal development
      of the baby, less consideration is given to the health effects of a mother's mental state
      during pregnancy. It may even be possible that, regardless of what a woman eats or drinks,
      the way her body responds to food may differ according to her emotional or mental state.

      This research is particularly interested in understanding how the combination of maternal
      emotional state and diet influence metabolism in pregnancy. Thus, the aim of this study is to
      test whether and how an individual's emotional response to a mental challenge of varying
      complexity during pregnancy modifies the body's metabolic response to a standard breakfast.
    

Intervention name(s): Trier Social Stress Test; Placebo Non-stress task
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Task instructions provided to subject (5mins), subject prepares speech on their strengths and weaknesses (5 mins), subject delivers speech before a stern evaluative committee while being video-taped (5 mins), subject completes a mental arithmetic challenge task before the evaluative committee with critiques if errors are made (5mins).; Subject engages in a friendly conversation about a neutral or happy topic (e.g. recent holiday, favorite past-times) for 15 minutes with a familiar research staff member.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: pregnancy; metabolism; stress; emotional state; diet; glycemic response
A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate
      the abuse liability potential of cenobamate in recreational drug users with sedative drug use
      experience.

      In the Qualification phase, subjects will receive a single dose of either alprazolam or
      placebo in a crossover design, with a wash-out period of at least 24 hours between
      treatments. Subjects who are clearly able to distinguish the positive control from placebo
      will be enrolled in the Treatment phase and will be randomized to single oral doses of
      cenobamate (2 dose levels), alprazolam (2 dose levels), and placebo in a double-blind,
      double-dummy, 5-way crossover design. Washout-periods between the 5 treatment periods in the
      Treatment phase will be at least 16 days.
    


Intervention name(s): Alprazolam Placebo; Cenobamate placebo; Alprazolam; Cenobamate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg lactose tablets; Sugar pill manufactured to mimic cenobamate 100 mg tablet; 0.5 mg and 1.0 mg alprazolam tablets; 100 mg tablet
Intervention MeSH terms: Cenobamate; Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      repeat doses of IRL201104 given to healthy volunteers.
    


Intervention name(s): IRL201104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): lyophilised powder for reconstitution for IV dosing; Matching placebo for IRL201104
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Absorption Rate of Subcutaneous Infused Fluid
Condition: Aged, 75 and Over; Aged; Hypodermoclysis; Fluid Therapy; Dehydration
MeSH terms: Dehydration
Study type: Observational

Summary: 
      The purpose of the study is to examine the rate of absorption of subcutaneous infused fluid
      in older adults when acutely ill compared to when they are not acutely ill.
    

Detailed description: 
      Dehydration is a common condition in older adults. When oral hydration is insufficient there
      is a need for parenteral hydration. Subcutaneous infused fluid or hypodermoclysis is a method
      for parenteral hydration. This method is used to treat older adults with mild to moderate
      dehydration or at risk of dehydration. Despite that, this method is used in older adults who
      are acutely ill we have a very limited understanding of the absorption time and thereby when
      the infused fluid is available in the circulatory system. This study aims to compare the
      absorption time in older adults who are acutely ill with when they are not acutely ill.
      Furthermore, this study aims to describe how fast the subcutaneous infused fluid is absorbed
      from the subcutaneous space and subsequently when it is available in the circulatory system
      where it has its effect.
    

Intervention name(s): Subcutaneous parenteral hydration
Intervention type(s): Procedure
Intervention description(s): Patients will twice receive a subcutaneous infusion of 250 ml isotonic sodium chloride (NaCl) with 30 MBq Tc-99m pertechnetate mixed in. The patients will receive the first infusion during admission to our geriatric ward (when they are acutely ill) and the second infusion approximately 8 weeks after discharge when they are no longer acutely ill. The subcutaneous access will be placed on the abdomen in the lower left or right quadrant.
Other intervention name(s): Hypodermoclysis
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to the local geriatric ward will be screened for eligibility.
      
Keywords: Dehydration; Fluid therapy; Hypodermoclysis; Geriatric; Sodium Pertechnetate Tc 99m
PUFAs and Left Ventricular Function in Heart Failure
Condition: Dilated Cardiomyopathy; Heart Failure
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the hypothesis that n-3 PUFAs improve left ventricular
      systolic function in patients with stable chronic HF secondary to nonischemic dilated
      cardiomyopathy (NICM).
    

Detailed description: 
      The results of the GISSI-HF trial indicate that in patients with chronic HF on evidence-based
      medical therapy and New York Heart Association (NYHA) functional class II-IV, long term
      treatment with n-3 PUFAs 1 g daily reduces mortality and hospitalizations for cardiovascular
      reasons. Several potential mechanisms may underlie the beneficial effects of n-3
      polyunsaturated fatty acids (PUFAs) in HF patients, including, but not limited to,
      antiarrhythmic, and hemodynamic actions. The current investigation was therefore designed to
      test the hypothesis that treatment with n-3 PUFAs improves LV systolic function expressed as
      EF in patients with stable chronic HF secondary to a nonischemic dilated cardiomyopathy
      (NICM). Additionally, we sought to determine if n-3 PUFAs also exert positive effects on LV
      diastolic function assessed by echocardiography; functional capacity assessed by
      cardiopulmonary stress testing (CPET); and New York Heart Association (NYHA) functional
      class.
    

Intervention name(s): n-3 PUFAs; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.; 1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
Other intervention name(s): OMACOR, Pronova Biopharma, Lysaker, Norway
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: n-3 PUFAs; Heart Failure; Dilated cardiomyopathy; Ejection Fraction; Exercise Capacity
Reducing the Use of Sugar by School Lunch Cooks in Public Schools
Condition: Sugar Intake
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective was to evaluate the effect of a nutritional education program for school
      lunch cooks, aiming to reduce added sugar in schools meals and in their sugar intake.
    

Detailed description: 
      Although Brazil is the largest producer and one of the world's largest consumers of sugar,
      research on sugar consumption is still a weak point among health indicators and there are no
      population studies to investigate the sugar intake in Brazilian population. Available data
      have shown reduction in the consumption of refined sugar (-37% between 1996 and 2003) but
      significant increase in consumption of soft drinks (400%), which constitute the main vehicle
      for consumption of added sugar. Moreover, studies have shown the adverse effects of excessive
      consumption of added sugar in dental caries and health, as excess energy intake hence in
      weight gain. Although several factors are associated with weight gain in adolescents, adults
      and elders, and several strategies have been released by both Brazil and International
      Agencies, as the Global Strategy, increased weight gain, particularly in adolescents, has
      been observed in several countries with large increase in Brazil, justifying specific
      projects to evaluate which messages, strategies and proposals for intervention would be
      effective.
    

Intervention name(s): Nutritional education; Control
Intervention type(s): Other; Other
Intervention description(s): A nutritional education program was carried out during seven months of one school year aiming to reduce added sugar in school meals by the school lunch cooks and in their own consumption.
All women in the intervention group participated in three sections about sugar consumption and one section on food labeling, as well as recipes competition of with reducing sugar.
Printed material and gifts, such as mugs, refrigerator magnets and small purses with the logo of the campaign were given to the participants.
All sections of education were delivered in the schools. The activities required 20 to 30 minutes and were facilitated by trained research assistants. Printed instructions and orientations on the facilitation process supported the assistants' efforts.; The control group received only three one-hour general sessions on health issues.
Other intervention name(s): Use and consumption of sugar; School lunch cooks; General sessions on health issues
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: School children; Sugar intake; Nutritional education program
Shape and Dimensions of the Upper Airway in Infants Using Computed Tomography Imaging
Condition: Child
Study type: Observational

Summary: 
      Cricoid is considered the narrowest part with the shape of airway defined as elliptical with
      the subglottis as the narrowest region.

      This study using imaging modality (2D CT images) is done to determine any differences in
      airway shape between infants and children, and to evaluate the dimensional transition between
      the subglottic area and the cricoid ring.
    

Detailed description: 
      Using imaging modalities (CT, MRI), the funnel-shape of the airway in children has been
      questioned and subglottis rather than cricoid is considered the narrowest part with the shape
      of airway defined as elliptical with the subglottis as the narrowest region.

      This is the first study using imaging modality (2D CT images) to determine the airway shape
      and dimensions in neonates and infants. The purpose of this investigation was to determine
      any differences in airway shape between infants and children, and to evaluate the dimensional
      transition between the subglottic area and the cricoid ring.
    

Intervention name(s): CT Scan
Intervention type(s): Device
Intervention description(s): CT imaging
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children less than 12 months of age
      
Keywords: Subglottis, cricoid, airway shape, CT imaging
A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of the study is to confirm if the efficacy of IM olanzapine in
      patients with schizophrenia is greater than IM placebo by comparing changes from baseline to
      2 hours post first IM injection of agitation.
    


Intervention name(s): Rapid Acting Intramuscular Olanzapine; Isotonic sodium chloride solution
Intervention type(s): Drug; Drug
Intervention description(s): 10mg/injection, IM. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).; 0.9% sodium chloride (NaCl) solution. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
Other intervention name(s): LY170053; olanzapine; RAIM
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
Condition: Staphylococcus Aureus Infection
MeSH terms: Staphylococcal Infections; Escherichia coli Infections
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is an open-label, dose-escalation pilot study with a total of 30 participants with 10
      per dosage group. The aim of the pilot study is to explore the preliminary safety of an
      experimental recombinant staphylococcus aureus vaccine.
    


Intervention name(s): Staphylococcus aureus vaccine (60µg/per protein); Staphylococcus aureus vaccine (30µg/per protein); Staphylococcus aureus vaccine (15µg/per protein)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): two doses of 60µg/0.6ml per dose; two doses of 30µg/0.6ml per dose; two doses of 15µg/0.6ml per dose
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to demonstrate a difference
      between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic
      insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.
    


Intervention name(s): biphasic insulin aspart 30; biphasic insulin aspart 50; biphasic insulin aspart 70; insulin aspart
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days; One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days; One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days; One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Correlation BIS Scores Mentally Retarded Patients
Condition: Mental Retardation
MeSH terms: Intellectual Disability
Study type: Observational

Summary: 
      The BIS monitor is a tool which assists anesthesiologists in monitoring the depth of
      anesthesia or level of anesthesia. The study doctors would like to see if it is useful tool
      for patients who are mentally challenged and require anesthesia.
    

Detailed description: 
      General endotracheal tube anesthesia (GETA) is administered for mentally retarded patients
      that need dental rehabilitation. GETA is done, in all patients, with routine monitoring of
      electrocardiography, blood pressure recording, pulse oximetry and end-tidal capnography.
      These measurements are also used indirectly to determine the depth of anesthesia and the
      anesthetic is titrated to prevent awareness during surgery and any subsequent recall (1). In
      addition, a recently introduced functional electroencephalography (EEG)-based awareness
      monitor directly analyzes the brain wave pattern during anesthetic delivery and aids the
      anesthesiologist in maintaining the ideal depth of anesthesia. The EEG based monitor serves
      to prevent awareness and recall due to light anesthesia or prolonged recovery following deep
      anesthesia (2). This instrument, named the Bispectral Index Scale (BIS) monitor, is
      non-invasive and is approved by the Food & Drug Administration. However, the BIS monitor is
      not being used routinely during the anesthetic management of mentally retarded patients due
      to a belief that such monitoring would be inaccurate in this cohort of patients (3). This
      assumption lacks scientific validation. Our trial will investigate the usefulness of BIS
      monitoring in mentally retarded patients and document any correlation between the severity of
      mental retardation and BIS scoring during various phases of anesthesia, such as awake status
      and sedation prior to anesthesia, induction and maintenance of anesthesia, and emergence and
      recovery from anesthesia. The anesthetic protocol will be standardized and the anesthetic
      management will not deviate from routine practice. The adjuvant therapies for infection
      prophylaxis and pain control will be administered in the usual fashion.
    

Intervention name(s): BIS monitor
Intervention type(s): Device
Intervention description(s): BIS monitor measures the depth of anesthesia and was used in the entire group
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        mentally retarded persons ages 12 to 65 ubdergoing dental rehabilitation
      
Keywords: general anesthesia; dental rehabilitation; mental retardation
A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, Double-blind, Randomized, Parallel-group, Single-dose, Three-Arm Study to
      Compare the Pharmacokinetics and to Evaluate the Tolerability, Safety and Immunogenicity of
      JHL1149 and Bevacizumab (Avastin) Sourced from the European Union (EU) and the Union States
      (US) in Healthy Male Volunteers
    


Intervention name(s): JHL1149; Bevacizumab; Bevacizumab
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Each patient may receive single dose of JHL1149 1mg/kg by intravenous infusion; Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion; Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Relapse Patterns in Female Cocaine Users - 4
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Observational

Summary: 
      The purpose of this study is to pilot a relapse questionnaire and examine relapse patterns in
      female cocaine users.
    

Detailed description: 
      The objectives of this study were to determine the most important antecedent factors in
      relapse episodes and difference in the use of coping skills between relapses and "close
      calls"
    

Keywords: Cocaine-Related Disorders