bioihbjkbjnl/mcl2 huggingface dataset:
Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Atelectasis is common during and after general anaesthesia and a number of interventions have
      been suggested in order to prevent their formation. The use of Positive End Expiratory
      Pressure (PEEP) during general anaesthesia has in recent years been questioned.

      The investigators hypothesize that the use of PEEP as a single intervention improves
      oxygenation and prevents atelectasis as investigated by computed tomography compared to a
      control group with zero PEEP.
    


Intervention name(s): Positive end-expiratory pressure; Control group, zero PEEP
Intervention type(s): Procedure; Procedure
Intervention description(s): Induction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium.
As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure is set to 6 or 8 cm H20 (8 if BMI>25) in the intervention group.
Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.; Induction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Zero PEEP is used.
Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atelectasis; Positive End-Expiratory Pressure; Oxygenation; Anaesthesia; Computed tomography
A Study That Will Look at the Impact of Immunosuppression on Antibody Production in Kidney Transplant Recipients.
Condition: Kidney Transplant
Study type: Observational

Summary: 
      This study is being done to collect blood and bone marrow samples for biologic studies of
      antibody producing cells. Donor specific antibodies can cause damage to the kidneys after
      they are transplanted. The study will look at the impact of immunosuppression on antibody
      production by antibody producing cells.
    

Detailed description: 
      Bone marrow and blood samples from both non-sensitized kidney transplant recipients and
      sensitized kidney transplant recipients will be collected. The samples will be used to
      compare the effect immunosuppression has on the antibody producing cells from both of these
      kinds of transplant recipients. Bone marrow will be collected from sensitized kidney
      transplant recipients before desensitization therapy prior to transplantation and at the time
      of kidney transplant surgery. Non-sensitized patients will have bone marrow collected only at
      the time of kidney transplant surgery. Blood will be collected at the same time point that
      the marrow is collected in both kinds of patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Three groups will be studied:

          1. Non-sensitized renal allograft candidates prior to any therapy;

          2. High DSA recipients--Recipients with a positive T or B cell cytotoxicity crossmatch or
             a B cell flow cytometric crossmatch assay with a channel shift >350 at baseline
             against their living donor at baseline and

          3. Low DSA recipients-recipients with a negative T and B cell cytotoxicity assay, but a
             positive T or B cell flow cytometric crossmatch with a B cell channel shift <350.
Meal Handling of Advanced Closed Loop Insulin Delivery.
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study will Compare meal related glycemic indices following 2 types of meal announcement:

        1. Conventional assessment of carb content plus carb equivalence of proteins and fat

        2. Algorithm device optimal universal meal announce equivalent
    


Intervention name(s): Advanced hybrid closed loop system
Intervention type(s): Device
Intervention description(s): Phase 1: meals in open loop- 3 weeks Phase 2: closed loop conventional meal announcement- 3 weeks Phase 3: closed loop, pre define universal bolus- 3 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery
Condition: Nalbuphine as an Adjuvant to L. A in Peribulbar Block for Cataract Surgery
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal, epidural, caudal
      anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration
      of postoperative analgesia.The aim of this study is evaluation of the effect of nalbuphine
      when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing
      cataract surgery
    

Detailed description: 
      44 patients (22 in each group) scheduled for elective cataract surgery using peribulbar
      block. Patients of Group N received local anesthetics received 6 ml of 0.5% bupivacaine 1 ml
      hyaluronidase (75 IU), and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of
      Group C received 6 ml of 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and1 ml saline (total 8
      ml).

      Addition of nalbuphine to bupivacaine in peribulbar block is associated with reduced the time
      of onset of globe akinesia, increased the duration of globe akinesia and analgesia with
      better postoperative pain relief
    

Intervention name(s): Nalbuphine; lidocaine, bupivacaine, hyaluronidase , saline; lidocaine, bupivacaine , hyaluronidase
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Both groups received 8 ml solution for the peribulbar block, Patients of group N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)(16) and 4mg of nalbuphine in 1 ml normal saline. Patients of group C was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75 IU) and 1 ml normal saline. Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe.
If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study.
After adequate analgesia (loss of sensation to touch by a small cotton wool) and akinesia, the surgeon was allowed to start the surgery; lidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml).; 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)
Intervention MeSH terms: Lidocaine; Nalbuphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Forty-four patients were enrolled in the current study and randomly allocated into two equal groups [Group N (n=22) and Group C (n=22)]. Two patients in Group N and three patients in Group C were excluded from the study due to failure of the block to achieve satisfactory surgical condition (inadequate akinesia OMS>2) so, received additional supplementations 2-3 ml of LA mixture and were excluded from the study
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Sprint Interval Training During Rehabilitation After Spinal Cord Injury
Condition: Spinal Cord Injuries; Rehabilitation; Exercise
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Immediately following a spinal cord injury (SCI), patients are admitted to inpatient
      rehabilitation where they undergo physical reconditioning in preparation for a return to home
      setting. The current standard of practice for aerobic training is performing arm-ergometry
      for 25 mins at a frequency of three times per week. Given the move towards shortened length
      of stay during inpatient rehabilitation, performing MICT can consume a considerable amount of
      therapy time. Sprint interval training (SIT) has been shown to elicit similar improvements in
      physical capacity, despite a reduced time commitment to MICT. However, there are no
      controlled trials comparing the effects of SIT to MICT in individuals with SCI undergoing
      inpatient rehabilitation. The primary aim of this study was to investigate the efficacy of a
      five-week, thrice weekly 10 min SIT program and compare outcome measures to a traditional 25
      minute MICT program on the arm-ergometer in individuals with SCI undergoing inpatient
      clinical rehabilitation. It was hypothesized that five weeks of SIT and MICT would induce
      similar changes in maximal and sub-maximal exercise performance, self-efficacy for exercise,
      and exercise enjoyment, despite large differences in training volume and time commitment. It
      was also hypothesized that SIT would be well tolerated and elicit higher levels of
      cardiovascular strain than MICT.
    


Intervention name(s): Sprint interval training; moderate intensity continuous training
Intervention type(s): Other; Other
Intervention description(s): Participants utilized the arm ergometer for improving aerobic exercise capacity; Participants utilized the arm ergometer for improving aerobic exercise capacity
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to one of two groups: (A) sprint interval training (SIT) or (B) moderate intensity continuous training (MICT).
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Inpatient Rehabilitation; Sprint interval training; Exercise; Spinal Cord Injury
Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of our study is to show by fMRI the involvement of the motor system in the perception
      of speech, and more particularly how this implication is modulated by the degree of
      prototypicity of the stimuli.
    

Detailed description: 
      Each participant will undergo two visits:

      Phase 1: The Gipsa-Lab Laboratory's Department of Speech and Cognition. This first visit will
      make it possible to make recordings of their vowel productions and to verify that the
      participants correspond to the criteria necessary for the study (passing the Edinburgh manual
      laterality test and auditory thresholds checked using a " An audiogram). It will also be an
      opportunity to provide them with the consent documents and the fact sheet, which will give
      them time to read it before the MRI exam. The duration of this first visit will be
      approximately 1 hour.

      Phase 2: fMRI review in the 3Tesla MRI Unit at the Grenoble University Hospital Center.
      Participants will first undergo a medical examination in order to verify their absence of
      contraindication to the MRI examination. At the end of this medical examination, the consent
      of participation will be signed. The participants will then be able to carry out the MRI
      examination for a duration of about 1h15, then the behavioral judgment test of perceptual
      distance. The total duration of this second visit will be approximately 1h45.
    

Intervention name(s): MRI functional
Intervention type(s): Other
Intervention description(s): vowels records and MRI session
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: MRI, Functional
A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of single and multiple dose (once daily
      for 7 days) oral JNJ-64417184 and JNJ-53718678 on the pharmacokinetic (PK) of single and
      multiple-dose (once daily for 7 days) oral JNJ 53718678 and JNJ-64417184, respectively when
      coadministered to healthy adult participants under fed conditions.
    


Intervention name(s): JNJ-53718678; JNJ-64417184
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.; JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Inosine Energy Expenditure Study
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Investigators want to test whether the intake of the nucleoside inosine increases the human
      energy expenditure. Inosine occurs as a metabolic intermediate in the human body and is
      sometimes taken as a dietary supplement by athletes.

      For this purpose, investigators will measure the basal metabolic rate by indirect
      calorimetry. Study participants will then take inosine dissolved in water or placebo and
      energy expenditure will be assessed again.
    


Intervention name(s): Inosine; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2 grams of inosine dissolved in 250 ml water taken by mouth; 250 ml water taken by mouth
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Energy expenditure; metabolism; inosine
Quantitative Evaluation of [18F]T807 as a Potential PET Radioligand for Imaging Tau in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease (AD)
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this exploratory imaging study is to further characterize [18F]T807,
      an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker
      indicative of neurodegeneration in conditions such as AD).
    


Intervention name(s): [18F]T807
Intervention type(s): Drug
Intervention description(s): All enrolled subjects will undergo an [18F]T807 PET imaging visit. In addition, subjects with AD and aged volunteers will have one PET scan with Amyvid (florbetapir F 18 injection) as part of the screening activities to measure Aβ in the brain.
Other intervention name(s): Amyvid; [18F]florbetapir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Safety Study on an Eyelid Warming Device to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers
Condition: Eyelid Diseases
MeSH terms: Eyelid Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in
      the eyelids.

      Prospective, non comparative, open, monocentre study.

      The objectives are:

        -  To verify and establish the temperature of the eyelids and cornea for each eye before
           and after 10 minutes device application

        -  To evaluate the ocular surface, NIBUT and IOP before and after device application

        -  To determine the acceptability of healthy volunteers on the practical use of this device

      The subjects will attend 2 visits.
    


Intervention name(s): LT2420
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
Condition: Bronchiolitis; Respiratory Syncytial Virus Infections
MeSH terms: Infections; Communicable Diseases; Bronchiolitis; Respiratory Tract Infections; Respiratory Syncytial Virus Infections; Airway Obstruction
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate how two different aerosol medications may improve
      airway function in infants with respiratory illness. We are using two different medications
      and comparing the difference in lung function after each medication. We will also be taking a
      nasal wash sample for VEGF. We will be using this in comparing how infants respond to the
      aerosol medications as well. We hope to help standardize medications used for infants with
      bronchiolitis and RSV.
    

Detailed description: 
      We hypothesize that VEGF production is higher in children with RSV infection than in children
      with other viral infections and normal controls. In addition, the degree of VEGF production
      is related to severity of airway obstruction. We also hypothesize that infants with higher
      VEGF levels are more likely to improve lung function following racemic epinephrine than
      albuterol.
    

Intervention name(s): Inhaled primatene will be given as a breathing treatment; Nasal Washing
Intervention type(s): Drug; Other
Intervention description(s): While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.; 1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence
Other intervention name(s): epinephrine 0.5ml of the 2.25% concentration
Intervention MeSH terms: Epinephrine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infant; Respiratory Syncytial Virus; Bronchiolitis
Study of Mantle Cell Lymphoma Treatment by RiBVD
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and
      Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or
      refuse receive conditioning regimen followed by autograft.
    

Detailed description: 
      Demonstration of Improvement of progression-free survival (PFS) compared to literature data.
      6 months prolongation equal 24 months compared to 18 months obtained whatever the current
      regimen and in particular compared to RCHOP regimen
    

Intervention name(s): RiBVD
Intervention type(s): Drug
Intervention description(s): Every cycle:
Rituximab intravenous infusion dosage 375 mg/m² day 1 Bendamustine direct intervenous 90 mg/m² day 1 and day 2 Velcade®subcutaneous 1,3 mg/m² day 1,4, 8 and 11 dexamethasone 40 mg IVD on day 2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mantle cell lymphoma; Rituximab; bendamustine; Velcade; Dexamethasone
Enhancing Support for Women With Type 2 Diabetes: Follow-Up
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study is a 5-year continuation of "The Mediterranean Lifestyle Program." The purpose of
      this follow-up study is to determine the long-term effects from prior participation in an
      intervention promoting healthful eating, exercise, quitting smoking, stress management, and
      social support. Participants are post-menopausal women with type 2 diabetes.
    

Detailed description: 
      Coronary heart disease (CHD) is the leading cause of death and functional limitations among
      women in the U.S. Postmenopausal women with diabetes are at especially high risk of CHD, but
      CHD research with this population is very limited. This project addresses the poorly
      understood "natural history" of long-term maintenance of change in multiple behaviors (i.e.,
      dietary, physical activity, social support, smoking cessation, and stress management) related
      to CHD risk, as well as the effects of theoretically important mediating variables on relapse
      and maintenance. The study is a continuation of a research project that has already
      demonstrated significant and consistent positive effects of a lifestyle change intervention
      on reduction of behavioral CHD risk factors. This research relies on a framework that
      synthesizes social-cognitive, social-ecologic, and goal-systems theories.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants in prior study: Enhancing Support for Women With Type 2 Diabetes, "The
        Mediterranean Lifestyle Program."
      
Keywords: Type 2 Diabetes Mellitus; Coronary Disease
Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool
Condition: Down Syndrome (DS)
MeSH terms: Down Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Epigallocatechin-3-gallate (EGCG), the major catechin in green tea, is postulated to modulate
      dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and amyloid beta
      precursor protein (APP) gene overexpression in the brains of Down syndrome mouse models. The
      clinical study is aimed at demonstrating that normalization of Dyrk1A and APP functions is a
      therapeutic approach to improve cognitive performance and decelerate AD (Alzheimer's disease)
      like progression.
    


Intervention name(s): Epigallocatechin-3-gallate (EGCG)
Intervention type(s): Dietary Supplement
Intervention description(s): EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance. A daily oral dose containing 9 mg/kg (range 6.9-12.7) of EGCG is given during twelve months.
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: APP function (amyloid precursor protein, cognitive stimulation, alzheimer disease. program
Dead Space Evaluation in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional

Summary: 
      Aim of the study is to evaluate the role of chemoreceptor activity and ventilation perfusion
      mismatch on the genesis of exercise induced hyperventilation in Pulmonary hypertension
      patients. So the investigators tested the chemoreceptor response at rest, both with hypoxic
      and hypercapnic stimuli, and the ventilatory response during exercise analyzing its two
      components, alveolar and dead space ventilation.
    


Intervention name(s): cardiopulmonary exercise test,hypoxia and hypercapnia test
Intervention type(s): Other
Intervention description(s): class I and IV Pulmonary hypertension patients in stable haemodynamic status and optimized medical therapy underwent cardiopulmonary test and hypoxia and hypercapnia tests to evaluate the chemoreceptor sensitivity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic