bioihbjkbjnl/mcl2 huggingface dataset:
Sleep and Breathing in the General Population - Chemical Stimuli
Condition: Sleep-disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      Central sleep apnea (CSA) is a common condition and its treatment remains elusive. The focus
      of this proposal is to identify the role of the physiologic path involving cortical arousals
      in CSA by decreasing arousal frequency using the pharmacological agent zolpidem. The goal is
      to identify the acute effects of administering zolpidem on sleep and respiratory outcomes,
      and subsequently, its effect on the severity of CSA and propensity to develop CSA. This study
      will shed light on the mechanisms underlying CSA that involve cortical arousals and will
      guide future therapeutic interventions for CSA.
    

Detailed description: 
      The literature suggests that zolpidem may be effective in the treatment of central sleep
      apnea (CSA). However, evidence regarding the efficacy of zolpidem and the underlying
      mechanisms involved in its effect on CSA are not well-studied. Furthermore,
      respiratory-related arousals are hypothesized to contribute CSA symptoms and severity. The
      aim of the study is to determine the effect of decreasing respiratory-related arousals on the
      propensity to develop central apnea. The investigators hypothesize that administration of the
      nonbenzodiazepine hypnotic zolpidem will decrease the frequency of respiratory-related
      arousals, lower the central apnea-hypopnea index, and widen the CO2 reserve during sleep in
      patients with CSA compared to no treatment. Participants will complete a night study on a low
      dose of zolpidem and another night study without zolpidem in a crossover manner. The order of
      night studies is randomized. The results will help unveil the role of arousals in CSA and the
      acute effect of zolpidem on CSA severity and the propensity to CSA.
    

Intervention name(s): Zolpidem; No Treatment
Intervention type(s): Drug; Other
Intervention description(s): A nonbenzodiazepine hypnotic; The Control condition in which participants do not receive medication.
Other intervention name(s): Ambien
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: After an initial assessment to determine eligibility, participant complete two in-lab night studies in a randomized manner including one night with the administration of zolpidem and another without zolpidem.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep-disordered Breathing; central sleep apnea
Myocardial Infarction Genes (MI-GENES) Study
Condition: Coronary Artery Disease; Myocardial Infarction; Genomic Risk Communication
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      This study is being done to better understand how genetic information might improve
      assessment of heart attack risk.
    

Detailed description: 
      This study aims to randomize patients to 2 arms. The first arm will receive the conventional
      Framingham risk score for coronary heart disease while the intervention arm will receive the
      genetics-informed risk for coronary artery disease.

      The investigators will assess baseline blood lipid levels and follow the 2 arms up to 6
      months after randomization. Primary endpoint is change in LDL levels between the 2 arms.
      Secondary outcomes include blood pressure control, weight, smoking cessation, and other
      lifestyle modifications.

      This trial will help us understand whether coronary artery disease risk derived from genetic
      information would have a significant impact on patients' perception of coronary artery
      disease risk and motivate healthy lifestyle modifications that reduce their long term risk.
    

Intervention name(s): Genetic Risk Score
Intervention type(s): Other
Intervention description(s): Patients in this arm will receive their genetic-informed risk for having a heart attack.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Coronary Artery Disease; Myocardial Infarction; Genomic Risk Communication; Risk Stratification
Validation of the CLAD Score Ifor Renal Colic Pain
Condition: Renal Colic
MeSH terms: Colic; Renal Colic
Study type: Interventional

Summary: 
      Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room
      admissions.

      This study would validate the performance of the CLAD score in predicting the need for
      surgical management within 7 days of patients admitted to the emergency department for renal
      colic pain.
    

Detailed description: 
      Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room
      admissions. It results clinically in a lumbo-abdominal pain syndrome radiating into the
      genitals. The origin of this pain is the tensioning of the urinary tract, most frequently by
      a lithiasis creating a transient obstruction

      Toulouse medical team has developed the "Complicated uroLithiasis and Alternative Diagnosis"
      (CLAD) score, which predicts the risk of requiring surgery within 7 days of admission of
      patients to the emergency room for renal colic

      The aim of this study is to validate this CLAD-V score by collecting the elements of the CLAD
      score and the clinician's intuition is made available to practitioners in the emergency
      department.

      All patients presenting to the emergency room for renal colic pain are eligible. The doctor
      in charge of the patient will have to examine him and take care of him according to the
      service protocol. The doctor must then complete the questionnaire provided.

      A reminder of the patient on D7 is carried out to collect information on the need for surgery
      after the emergency or not.

      Each center ensures inclusions and reminders on D7 and will only transmit the database
    

Intervention name(s): CLAD-V SCORE
Intervention type(s): Other
Intervention description(s): the CLAD-V score is measured by the doctor during the emergency take care. After 7 days the patient will be call back to compare the prediction of CLAD-V score and the reality of surgical intervention or no.
Intervention model: Single Group Assignment
Intervention model description: The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. He will also completed the CLAD-V score and gives his intuition on the surgical outcome of the patient
Masking: None (Open Label)
Primary purpose: Prevention
Single Low-Dose of Supplement Amino Acid
Condition: Growth Hormone; Amino Acid
Study type: Interventional

Summary: 
      The purpose of the study is to confirm the results of a prior study that demonstrated pills
      containing two amino acids which are in foods increased growth hormone and insulin-like
      growth factor-1.
    

Detailed description: 
      Oral supplementation with a key combination of derivatives that has been shown to increase
      human growth hormone in healthy volunteers peaking at 90 minutes and IGF-1 at 8 hours
      post-administration.
    

Intervention name(s): Amino acid supplement; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): An orally administered supplement of the proprietary amino acid derivative; A non-active orally administered supplement of the proprietary amino acid derivative
Other intervention name(s): SeroVital™; non-active
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: growth hormone
Stress Sensitivity and Reward Responsivity in Depression
Condition: Depressed
MeSH terms: Depression
Study type: Observational

Summary: 
      The goal of this project is to learn more about the different ways in which people process
      information that is stressful and rewarding, and how abnormalities in these two processes are
      related to depression.
    

Detailed description: 
      Participants will participate in two 3-hour sessions separated by a week at Providence Care,
      Mental Health Services, and a third, 1.5-hour session at the Queen's MRI Facility. At the
      first session participants will complete a packet of questionnaires about their mood and take
      part in an interview about their mood, medications, drug use, and any other symptoms, as well
      as an interview about their relationships with their parents and any experiences of abuse. At
      the second session participants will participate in a stress test, which involves giving a
      speech to a panel. The investigators will also collect saliva samples to look at stress
      hormones. Participants will also complete a task on the computer that involves looking at
      cartoon faces and making decisions about them. At the third session, the investigators take
      images of of participant's brain using a magnetic resonance scanner.

      Participants are invited to participate in a 6-month follow-up for this study, which would
      involve the same procedure as outline above.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      Saliva is collected at eight points across the second session in 5mL vials. Saliva samples
      are assayed for neuroendocrine hormones (e.g., cortisol). Whole blood is collected in EDTA
      tubes at the first session. Whole blood is currently being banked. No assays are being
      conducted at this time.
Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Although prior dose-finding studies have investigated the optimal bolus dose of oxytocin to
      initiate adequate uterine tone, it is unclear what oxytocin infusion regimen is required to
      maintain adequate uterine tone after delivery. The study investigators aim to compare two
      different infusion rates of oxytocin to assess the optimal infusion regimen for reducing
      blood loss in women undergoing elective Cesarean delivery.
    

Detailed description: 
      Oxytocin (pitocin) is a drug commonly used in obstetric practice, and the drug effect is to
      increase the muscular tone of the uterus to reduce uterine bleeding after neonatal delivery.
      Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin
      after delivery of the baby. Post-delivery, oxytocin is commonly administered as an IV bolus
      and/or infusion. No previous studies have accurately assessed differences in oxytocin
      infusions after delivery in patients undergoing elective cesarean delivery. Thus the study
      aim is to investigate which infusion rate can optimally provide adequate maintenance of
      uterine tone during Cesarean delivery while being associated with minimal or no maternal
      side-effects.
    

Intervention name(s): Oxytocin Infusion
Intervention type(s): Drug
Intervention description(s): Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
Other intervention name(s): Oxytocin; Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oxytocin; blood loss; Cesarean delivery
Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME)
Condition: Glioblastoma, Adult
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most
      widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma
      cells through a metabolic abnormality and thus helps in defining tumoral edges through a
      modified microscope. A multicentric, randomized study comparing 5ala guided surgery with
      conventional procedures showed that this technique doubles the rate of complete removal on
      post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free
      survival. More recently, fluorescein appeared as an interesting alternative fluorophore for
      glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its
      use remains scarcely studied and its clinical benefit unsure. In that context, the
      investigators propose a randomized trial comparing conventional " white light " surgery with
      fluorescein-guided resection of glioblastomas, in order to assess the relevance of this
      technique in glioblastomas removal.
    


Intervention name(s): Fluorescéine Sodique Faure; White-light surgery
Intervention type(s): Drug; Procedure
Intervention description(s): Fluorescéine Sodique Faure given intravenously during the induction of the anesthesia, at the dose of 3mg/kg, diluted in 50mL of physiological serum, in 10 minutes.; The surgery will be performed under classical conditions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: surgery - glioblastoma - fluorescein
Written Self-disclosure for Youth Abdominal Pain
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aims are to evaluate: (1) the effectiveness of written self-disclosure (WSD) on health
      status of youth ages 12-18 with functional recurrent abdominal pain (RAP); (2) whether
      effectiveness of WSD is similar for younger (12-14) and older (15-18) youth with functional
      RAP; and (3) the feasibility and acceptability of WSD when extended to the pediatric health
      care setting.We will implement a randomized, controlled trial (RCT) designed to compare
      health status in 140 youths (ages 12-18) with functional RAP assigned either to standard
      medical care (SMC) or WSD provided in the health care setting in addition to SMC. Health
      status will be measured at Baseline and 3- and 6-months thereafter. Primary measures of
      health status are symptom severity and episode frequency, consistent with the definition of
      RAP. Secondary measures of health are functional health, psychological distress,
      health-related quality of life, and health care utilization. Total use and diagnostic tests
      will index health care utilization, collected for the 6-mos prior to and following Baseline.
      Mixed model ANOVA or MANOVA will be used to test directional hypotheses corresponding to the
      specific aims.
    


Intervention name(s): Written self-disclosure
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Abdominal
Predictive Factors of Intestinal Infraction in Acute Mesenteric Ischemia
Condition: Mesenteric Ischemia
MeSH terms: Mesenteric Ischemia; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to identify several factors that can accurately predict the incident of
      intestinal infraction in patients with mesenteric vascular occlusion or ischemia.
    

Detailed description: 
      The study aims to identify several clinical, laboratory, and radiologic factors that can
      accurately predict the occurrence of intestinal infraction in patients with mesenteric
      vascular occlusion or ischemia in order to prevent unnecessary surgical intervention in
      patients with just intestinal ischemia and to hasten intervention in patients with actual
      intestinal gangrene.
    

Intervention name(s): Heparin injection
Intervention type(s): Drug
Intervention description(s): Intravenous heparin injection in patients with acute mesenteric ischemia and evaluating their response within 24 hours
Other intervention name(s): Low molecular weight heparin injection
Intervention MeSH terms: Heparin; Calcium heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
TachoComb S Versus Standard Surgical Treatment in Surgical Resection of Renal Tumour (TC-015-IN)
Condition: Surgical Resection of Superficial Renal Tumour
MeSH terms: Kidney Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall objective is to compare efficacy and safety of TachoComb S and standard surgical
      treatment for the control of local bleeding in patients undergoing surgical resection of
      renal tumours. Specific objectives include the comparison between test treatments of
      intra-operative haemostatic efficacy as well as post-operative blood loss, haematoma
      formation, and surgeon's rating of usefulness of test treatment.
    


Intervention name(s): Fibrinogen (human) + thrombin (human) (TachoSil)
Intervention type(s): Procedure
Intervention MeSH terms: Thrombin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Correlation of Visual and Motor Deficits in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This is a prospective study of patients with stroke with accompanying motor and visual
      deficits. There will be patients' evaluations at 2 time points at the acute and subacute
      period after the stroke. Statistical correlation of the improvement of their deficits will be
      conducted
    


Intervention name(s): Physiotherapy and speech therapy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: course of motor and visual rehabilitation; improvement of deficits; stroke patients
Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function
Condition: Healthy; Attention
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to determine if 8-week dietary treatment with the omega-3 fatty
      acid docosahexaenoic acid (DHA) improves attention performance and associated cortical
      activity and metabolism in 8 - 10 year old males that were not breast-fed during infancy.
    


Intervention name(s): docosahexaenoic acid
Intervention type(s): Dietary Supplement
Intervention description(s): DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio
Other intervention name(s): DHA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DHA; fMRI
Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      To determine if an asthma navigator is helpful in improving communication between care
      providers and improving patient adherence to asthma medications after an asthma exacerbation.
    

Detailed description: 
      This study will aim to use technology to evaluate the effectiveness of a patient navigator
      for childhood asthma. The Investigators will place adherence monitoring devices on patient
      inhalers, and track use of patient asthma medicines. The Investigators will also utilize an
      asthma navigator who will discuss adherence with families and help to address any barriers to
      adherence that families identify. Additionally, the navigator will communicate patient
      specific adherence information to the patient's primary care physician (PCP) and school
      nurse. The adherence monitor will monitor communications between these providers.
    

Intervention name(s): Propeller Health device + asthma navigator
Intervention type(s): Device
Intervention description(s): The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetic study comparing Salmeterol/fluticasone Easyhaler products and Seretide Diskus
      50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in
      healthy subjects
    


Intervention name(s): Salmeterol/fluticasone Easyhaler; Salmeterol/fluticasone Easyhaler with charcoal; Seretide Diskus; Seretide Diskus with charcoal
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multisensorial Information's Treatment in Autism Spectrum Disorder
Condition: Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Introduction:

      Autism spectrum disorder is characterized by deficits in three functional domains: language
      and communication, social reciprocity, and the presence of restricted interests/repetitive
      behaviors. There's also deficits in social cognition. When having a face-to-face
      conversation, a listener not only hears what a speaker is saying, but also sees the
      articulatory gestures that accompany those sounds. Speech signals needs then a multisensory
      processing. Impairments in multisensory perceptual binding may be particularly relevant in
      ASD, given that hallmark features of the disorder include difficulties in speech,
      communication, and social interactions.

      Objectives:

      The investigator suggest that atypical multisensory processing in ASD may have an impact on
      speech perception and social processing.

      Aims:

      Methods:

      This pilot study measures free recall scores in 3 lists of words presentation after 30
      minutes. In the first condition (CI) words are only listening. In the second condition (CII)
      words are associated with a picture of a mans face. In the third condition (CIII) words are
      associated with a video of a man speaking. Three lists are homogeneous form words
      characteristics (lexical frequency, emotional valence norm, imageability). Participants were
      7- to 13-year-olds typically developing children (TD) (N = 19) and ASD children (N = 19).

      The investigator would create some new tools for exploring the treatment of a social
      information. These tools should be the closest of a ecological social interaction.
    


Intervention name(s): memory test
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science