bioihbjkbjnl/mcl2 huggingface dataset:
Latin American Multicenter Cardiovascular Magnetic Resonance Reference Study
Condition: Healthy
Study type: Observational

Summary: 
      This study was designed to investigate the physiological properties of adult heart using
      cardiovascular magnetic resonance imaging in normal volunteers in Latin America.
    

Detailed description: 
      Evaluation of myocardial mass, volumes and function is essential in the management of
      cardiovascular diseases. While 2D and 3D echocardiography play a major role in determining
      these parameters cardiovascular magnetic resonance (CMR) has become a widely accepted gold
      standard for these measurements due to its high accuracy and reproducibility.

      However, determining normal reference standards for CMR is crucial for proper use of the
      method. Previous reports have established normal ranges for both fast low angle shot
      techniques6 and the more commonly used steady state free precession methods including values
      normalized not only to body surface area but to age and gender as well. Despite these general
      references, variability in normal ranges have been reported previously when ethnicity is
      taken into account. The ongoing Multi-Ethnic Study of Atherosclerosis (MESA) trial has
      measured cardiovascular function in participants with different ethnical backgrounds,
      reporting differences in the African-American and Asian-American groups.

      Latin-American populations have generally been underrepresented in most clinical
      cardiovascular trials despite representing a growing percentage of heart disease patients in
      the world and, particularly, in the USA12-15. While the MESA trial evaluated cardiac function
      by CMR in Hispanics, data was limited to participants living in USA, within a restricted age
      group and representing only a small fraction of their entire cohort. It is thus essential to
      acquire specific data for this population regarding normal CMR values in order to permit not
      only precise clinical evaluation of Hispanic patients but also accurate assessment of
      ventricular function figures from Latin American countries in future CMR and drug trials.

      To accomplish this goal, we propose a multicenter study to collect CMR data from countries in
      Latin America in normal participants with 20-80 years of age.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Normal healthy individuals
      
Keywords: cardiovascular magnetic resonance; ventricular volumes; ventricular function; Healthy normal individuals from 20 to 80 years of age
GnRH Agonist and Intrauterine Insemination
Condition: Intrauterine Insemination
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess whether GnRH agonist administration in the luteal phase
      improves pregnancy outcome in intrauterine insemination (IUI) cycles.
    


Intervention name(s): Tryptorelin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Keywords: intrauterine insemination; GnRH agonist; implantation
Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to assess the adherence to an enhanced recovery after surgery
      (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in
      patients undergoing pancreaticoduodenectomy (PD).
    

Detailed description: 
      A specific enhanced recovery after surgery (ERAS) protocol has been applied since October
      2010 in consecutive patients undergoing pancreaticoduodenectomy (PD) in a high volume
      Institution. Patient compliance for each item has been assessed. Each ERAS patient was
      matched with a patient who received standard perioperative care. Match criteria were age,
      gender, malignant / benign disease, and PD prognostic score.
    

Intervention name(s): Enhanced recovery after surgery protocol; Standard perioperative care; PONV prophylaxis with Ondansetron + Dexamethasone; Postoperative mobilization program; Epidural analgesia with naropin + sufentanil; Pre-anesthetic medication with diazepam; Preadmission counselling; Preoperative bowel preparation with sodium phosphate
Intervention type(s): Behavioral; Procedure; Drug; Other; Drug; Drug; Behavioral; Drug
Intervention description(s): ERAS items implemented were: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV and hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, mobilization protocol, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter.; Epidural analgesia, pre-anesthetic medication with diazepam, bowel preparation with oral assumption of sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4; Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.; Patient mobilization for 2 hours on first postoperative day Patient mobilization for 4 hours on first postoperative day + assisted deambulation in the room Patient mobilization for 6 hours on first postoperative day + assisted deambulation in the ward; Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL; Premedication before general anesthesia; Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.; Preoperative bowel preparation with oral assumption of sodium phosphate
Other intervention name(s): Zofran + Decadron; Disufen; Valium; Phospho-Lax
Intervention MeSH terms: Dexamethasone; Sufentanil; Diazepam; Ondansetron; Anesthetics; Ropivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label, fixed sequence study to investigate the effect of
      multiple oral dosing of Inarigivir Soproxil and a single oral dose of Midazolam in Healthy
      Subjects
    


Intervention name(s): Midazolam; Inarigivir
Intervention type(s): Drug; Drug
Intervention description(s): Midazolam; Inarigivir
Other intervention name(s): Inarigivir Soproxil, SB 9200
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Carbon Monoxide Measurement to Screen for Sickle Cell Disease
Condition: Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO
      (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature
      conditions encountered in countries with high prevalence of SCD (Sickle Cell Disease).
    

Detailed description: 
      Increase the temperature operating range of ETCO measurements to 5 to 45°C. The signal
      output-to-CO (carbon monoxide) concentration correlation of the CO sensor is dependent on
      temperature. The new algorithm will be a different approach because the current algorithm is
      at the limits of its capability. We will establish the new specifications by determining
      performance in a bench model under simulated temperature conditions. We will then determine
      the ability of the modified device to distinguish between SCD and healthy controls. During
      this initial testing, we will examine the validity of ETCO measurements under regulated room
      temperature in the hospital setting. We will enroll 20 subjects, 10 each in the SCD arm and
      control arm to determine the mean and variance of the ETCO values.
    

Intervention name(s): End-tidal Carbon Monoxide Subjects; End-tidal Carbon Monoxide Controls
Intervention type(s): Device; Device
Intervention description(s): ETCO monitor will be used to measure CO levels in subjects and controls.; ETCO monitor will be used to measure CO levels in subjects and controls.
Intervention MeSH terms: Carbon Monoxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Sickle Cell Anemia
Augmented Reality to Reduce Pain During Botulinum Toxin Injections in Cerebral-palsied Children
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Children with cerebral palsy may benefit from treatment with botulinum toxin injections to
      decrease spasticity for improve function and quality of life. These injections cause repeated
      pain throughout childhood and may be the cause of post-traumatic stress despite drug and
      non-drug pain management. The Mini-Docs project of the French Red Cross has a module based on
      a digital device with augmented reality. Distracting the child, the use of this module on a
      tablet would reduce pain felt during botulinum toxin injections.
    

Detailed description: 
      Objective: To evaluate the effect of the use of a module with augmented reality (Mini-Docs)
      on pain during botulinum toxin injections in children with cerebral palsy aged from 3 to 8
      years

      Method: Randomized controlled trial comparing a group of children receiving the module with
      augmented reality of the Mini-Docs and drug pain management (nitrous oxide and medications),
      with a group of children receiving the usual care of pain management that combines drug pain
      management (nitrous oxide and medications) and distraction techniques. The device with the
      augmented reality module allows the child to add virtual content to the real images of the
      care. The pain will be assessed for each child 10 minutes after the injections, using a
      self-assessment scale (the Faces Pain Scale - Revised) or a heteroevaluation scale (the Face
      Legs Activity Cry Consolability scale given by the nurse). The study will be conducted in two
      centers of physical medicine and pediatric rehabilitation of the French Red Cross (Paris and
      Lyon).

      Expected Results:

        -  Decreasing children's pain during botulinum toxin injections

        -  Decreasing anxiety in children and parents during injections

        -  Increasing coping skills in children

        -  Facilitating of the achievement of the therapeutic goal during injections
    

Intervention name(s): use the module with augmented reality (Mini-Docs) on tablet during TB injection
Intervention type(s): Other
Intervention description(s): Provision of a tablet with a module using augmented reality (Mini-Docs) during TB injections in addition to the commonly used drug technology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: children; botulinum toxin; augmented reality; Pain
Regulation and Signaling of Red Blood Cell (RBC) Endothelial Nitric Oxide Synthase (eNOS) in Patients With Stable and Unstable Coronary Artery Disease
Condition: Coronary Artery Disease; Endothelial NO-synthase
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      The aim of this study is measurement of expression and activity of RBC eNOS in different
      clinical cohorts of patients with coronary artery disease and acute coronary syndrome and to
      investigate the importance of the NO-stimulated reaction cascade in terms of sGC and PKG.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        3 groups:

          -  ACS group (100 Patients)

          -  stable CAD group (100 Patients)

          -  healthy control group (100 Healthy Volunteers)
      
Biospecimen description: 
      blood samples
    
Keywords: coronary artery disease; acute coronary syndrome; angina pectoris; non-ST-segment elevation myocardial infarction; red blood cells; erythrocytes
A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects
Condition: Healthy Young Volunteers; Healthy Elderly Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose study in healthy male and female (of non-child bearing potential)
      volunteers, to assess the safety, effects on the body, and blood and urine drug levels of
      AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease
    

Detailed description: 
      A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to
      Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293
      Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers
    

Intervention name(s): AZD3293; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution; Oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: AZD3293; Healthy volunteers; Elderly volunteers; Phase 1; Single Ascending Dose Study
A Change in Diet May Decrease the Negative Consequences of Chronic Sleep Deprivation
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether or not a low calorie, low glycemic index
      diet with omega-3 fatty acid supplements can prevent some of the negative consequences of
      sleep deprivation.
    

Detailed description: 
      This pilot study included 18 medical residents at two academic medical centers in New York
      City. All residents who participated in the study were assigned to work a night shift
      schedule for two weeks, and began the study on the morning prior to their first evening
      shift. The study subjects were randomly assigned to one of two groups:

        -  Intervention diet -- consisting of 40% carbohydrates, 30% protein, and 30% fat with 2.4g
           of long chain fatty acid supplements (n=9) Total calories for males was 1600/day, and
           1200/day for females

        -  Control group -- ad lib diet.

      Main outcome measures included:

        -  weight

        -  resting metabolic rate

        -  percent body fat

        -  lipid profile

        -  CRP

        -  fasting glucose and insulin levels

        -  urinary neurotransmitter levels

        -  salivary cortisol

        -  six cognitive tests of memory, attention, and executive function.

      Subjects were tested on day 1, 7, and 14 of the study.
    

Intervention name(s): Controlled Dietary Intervention
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Diet; Chronic sleep deprivation; Weight; Cognitive impairment; Lipids; Inflammation; Resting metabolic rate; Weight Gain; Percent Body Fat; Hyperlipidemia
Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy
Condition: Mastication Disorder
MeSH terms: Sialorrhea; Cerebral Palsy
Study type: Interventional

Summary: 
      This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and
      drooling in children with cerebral palsy.
    

Detailed description: 
      Children were divided into two groups: The FuCT group and control group receiving classical
      oral motor exercises. Each group received training for 12 weeks. Oral motor assessment was
      performed. Chewing performance level was determined with the Karaduman Chewing Performance
      Scale(KCPS). Tongue thrust severity was evaluated with the Tongue Thrust Rating Scale(TTRS).
      The Drooling Severity and Frequency Scale(DSFS) was used to evaluate drooling severity and
      frequency. The evaluations were performed before and after treatment.
    

Intervention name(s): Functional Chewing Training; Classical Oral Motor Exercises
Intervention type(s): Other; Other
Intervention description(s): FuCT;
Family training
Providing optimal sitting posture for children to support oral sensorimotor functions
Positioning the food to the molar area during every meal to stimulate lateral and rotational tongue movements
Massage of the upper and lower gums through the front teeth to molar area
Chewing training to stimulate lateral and rotational tongue movements
Gradually increasing the food consistency, for 12 weeks in 5 sets (1 set = 20 min) each day; Classical Oral Motor Exercises;
Family training
passive and active lip and tongue exercises, for 12 weeks in 5 sets (1 set = 20 min) each day
Other intervention name(s): FuCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drooling; tongue thrust
Indocyanine Green Test in Bariatric Surgery
Condition: Obesity, Morbid; Surgery; Leak, Anastomotic
MeSH terms: Obesity, Morbid; Anastomotic Leak
Study type: Observational

Summary: 
      Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show
      stomach vascularity in real time
    


Intervention name(s): Indocyanine green solution; Gastric bypass
Intervention type(s): Drug; Device
Intervention description(s): Adequate perfusion was defined as "the direct and clear visualization of the fluorescence along the gastric tube, relative to the excised specimen, after an estimated time of 150-180 s after i.v. administration injection; Roux and Y Gastric bypass
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The aim of our study is to observe the preliminary results of the application of
        indocyanine green fluorescence (IGF) during laparoscopic Roux-en-Y Gastric Bypass (RYGB in
        our center and how the perfusion of the gastro-jejunal anastomosis affects the onset of
        fistula.
Discovering Laryngomalacia
Condition: Laryngomalacia
MeSH terms: Laryngomalacia
Study type: Observational

Summary: 
      Laryngomalacia is the most common congenital malformation of the larynx. It results from
      abnormal prolapse of supraglottic structures during inspiration. Symptoms usually appear
      within the first 2 weeks of life. Its severity increases in up to 6 months. 15-60% of infants
      with laryngeomalacia have synchronous airway anomalies.
    

Detailed description: 
      500 full term babies ≥37 weeks of both sexes delivered by different modes of delivery, with
      birth weights ≥2.5 kg, no history of natal or post-natal complications and from the same
      community. Mothers of these babies are from different socioeconomic standards and from the
      same community. These babies were diagnosed as having laryngomalacia. Clinical, flexible
      nasal and laryngeal scope, radiological and milk scintiscan were the tools used in our
      assessment. One thousand full term babies delivered with normal larynx, almost within the
      same period of time and from the same community were used as a control.

      Laryngomalacia was recognized with significant statistical difference in dacryostenosis,
      deviated nasal septum, adenoid hypertrophy and gastroesophageal reflux disease. No
      significant statistical difference in pectus excavatum, cleft lip or palate, congenital lobar
      emphysema fistula and choanal atresia.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Primary Care Clinic
      
Keywords: Laryngomalacia; Congenital Anomalies; Associated Health Problems
Study of Coagulation Activation Markers and Pre Eclampsia
Condition: Pre Eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Observational

Summary: 
      The primary purpose of the trial is to evaluate coagulation activator markers in patients
      with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with
      the severity of the pathology.
    

Detailed description: 
      100 pre-eclamptic patients will be compared to 200 control patients (100 control matched on
      gestational age at inclusion and 100 control matched on delivery mode (section).

      Blood and urine samples will be collected at PE diagnosis, delivery and post partum.

      Two axes will be considered:

        1. Thrombography, or kinetic measurement of thrombin generation, by studying the coagulant
           profile according to Hemker's method in CAT System (Calibrated Automated Thrombogram)
           and by thromboelastogram in ROTEM technique (delocalized coagulation analyzer), in
           parallel to specific activation markers (thrombin-antithrombin complex, fibrin
           monomers).

        2. The balance of prostacyclin/thromboxane A2 by using ELISA method for urine samples and
           genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase's promoter
           CYP8A1).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant women from two University hospitals in France
      
Biospecimen description: 
      -  Maternal blood and urine

        -  cord blood
    
Keywords: Pre eclampsia; Endogenous thrombin potential
Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying bone marrow and blood samples from patients with leukemia or lymphoma
      treated with arsenic trioxide may help doctors learn more about cancer.

      PURPOSE: This research study is assessing arsenic trioxide in young patients with recurrent
      or refractory leukemia or lymphoma who were treated on clinical trial NCI-00-C-0070J.
    

Detailed description: 
      OBJECTIVES:

        -  To assess the pharmacokinetic and pharmacodynamic profiles of arsenic trioxide in
           pediatric patients treated on protocol NCI-00-C-0070J.

      OUTLINE: Bone marrow or peripheral blood mononuclear cells collected during treatment on
      NCI-00-C-0070J are assessed for pharmacodynamics studies. Plasma cells collected during
      treatment are assessed for pharmacokinetics studies. Total arsenic (As), inorganic As forms
      (AsIII and AsV), and methylated metabolites of As are assessed.
    

Intervention name(s): pharmacological study
Intervention type(s): Other
Keywords: recurrent childhood acute myeloid leukemia; childhood acute promyelocytic leukemia (M3); recurrent childhood acute lymphoblastic leukemia; recurrent childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; recurrent childhood small noncleaved cell lymphoma; recurrent/refractory childhood Hodgkin lymphoma; childhood chronic myelogenous leukemia; atypical chronic myeloid leukemia, BCR-ABL1 negative