bioihbjkbjnl/mcl2 huggingface dataset:
Patient Satiety as an Indicator of Stomach Contents and Fluid Volume
Condition: Fasting; Hunger
Study type: Observational

Summary: 
      This research proposal aims to investigate the correlation between a) the hunger feeling as
      measured by a ten point scale and b) total gastric fluid volumes and content as measured with
      gastric PoCUS in fasted, healthy subjects > 18 of age, scheduled for elective surgery.
    

Detailed description: 
      An ultrasound exam will be performed before induction of anaesthesia. GUS results from
      selected patients will be systematically acquired and assessed following an algorithm
      (Appendix Ia). The ultrasound results will be collected on a standardized form (Appendix
      IIa). The technique is performed in the supine and right lateral decubitus position (Appendix
      Ib) and only by anesthesiologists with sufficient experience with ultrasound and the
      technique. The patient will be asked to indicate his/her satiety on a predetermined ten-point
      scale. Patient data and satiety score will be collected on a standardized form (Appendix
      IIb). The scanning anaesthesiologist is blinded to the result of the questionnaire.
    

Intervention name(s): Gastric ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): An ultrasound exam will be performed before induction of anaesthesia. GUS results from selected patients will be systematically acquired and assessed following an algorithm (Appendix Ia). The ultrasound results will be collected on a standardized form (Appendix IIa). The technique is performed in the supine and right lateral decubitus position (Appendix Ib) and only by anesthesiologists with sufficient experience with ultrasound and the technique. The patient will be asked to indicate his/her satiety on a predetermined ten-point scale.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy adult patients scheduled for elective surgery that fit inclusion criteria
      
Keywords: Ultrasonography; Gastric ultrasound
Prediction of 3D Effect of Brace in Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
Condition: Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      In this study, the accuracy of a new numerical method is evaluated for predicting the 3D
      effect of brace on idiopathic scoliosis. This method results from the combination of several
      innovative technologies: the EOS imaging system and the anatomical transfer developed by
      Anatoscope. This is an essential step in validating a digital tool that can be used in
      routine clinical practice.
    

Detailed description: 
      The whole process of brace production remains unchanged. In this study, the simulation
      software will not be used to influence the medical decision or the manufacture of the brace.
      In parallel with conventional production, anatomical transfer will be used in the deformed
      digital model of the trunk to simulate the effect of conventional brace on the spine. This
      modeling will be used to compare the correction of the conventional brace observed on the
      spine with EOS imaging system, with that simulated by the software.

      EOS Tranfert study is a observationnal, prospective, monocentric, unrandomized and controlled
      study. This research doesn't modify care of the patient
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children or adolescent idiopathic scoliosis patient
      
Keywords: 3D analysis; Brace; EOS imagind system; Anatomical transfer
The Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of the present study was to conduct a preliminary evaluation the feasibility and
      impact of a risk-targeted behavioral activation intervention for work-disabled individuals
      with co-morbid pain and depression.
    

Detailed description: 
      The design of the study was a single arm non-randomized trial. The sample consisted of 66
      work-disabled individuals with co-morbid pain and depression. The treatment program consisted
      of a 10-week standardized behavioral activation intervention supplemented by techniques to
      target two psychosocial risk-factors for delayed recovery, namely, catastrophic thinking and
      perceptions of injustice.
    

Intervention name(s): Risk-Targeted Behavioral Activation
Intervention type(s): Behavioral
Intervention description(s): The behavioral activation component of the treatment program focused on goal setting, structuring and scheduling activities, increasing success and achievement experiences, and problem-solving. In order to maximize the impact of behavioral activation on disability reduction, goal setting and scheduling of activities focused primarily on resumption of discontinued activities as opposed to focusing on the scheduling of pleasant activities. One objective of goal setting and activity scheduling was to reduce the discrepancy between the client's pre-injury activity repertoire and the client's current activity repertoire.
Behavioral activation was supplemented by a collection of techniques designed to reduce catastrophic thinking and perceptions of injustice, two psychosocial risk factors that have been shown to contribute to prolonged work-absence.
Intervention model: Single Group Assignment
Intervention model description: Single arm.
Masking: None (Open Label)
Primary purpose: Treatment
Therapeutic Hypothermia With IntraVascular Temperature Management (IVTM) in Post-Cardiogenic Cardiac Arrest and Post-Return of Spontaneous Circulation Patients in Japan
Condition: Cardiac Arrest
MeSH terms: Heart Arrest; Hypothermia
Study type: Interventional

Summary: 
      A multicenter, single-arm, prospective, interventional trial to evaluate therapeutic
      hypothermia with intravascular temperature management (IVTM) in post-cardiogenic cardiac
      arrest, post-return of spontaneous circulation (ROSC) patients in Japan.

      The objective of this study is to verify that therapeutic hypothermia performed by
      intravascular cooling using the investigational device (IVTM) can control body temperature
      appropriately in post-cardiogenic cardiac arrest, post-ROSC patients.
    


Intervention name(s): ZOLL Intravascular Temperature Management System (IVTM)
Intervention type(s): Device
Intervention description(s): Induced therapeutic hypothermia post cardiac arrest
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiac arrest; Return of Spontaneous Circulation (ROSC); IntraVascular Temperature Management (IVTM); Therapeutic Hypothermia; Japan
n3 PUFA and Muscle-disuse Atrophy in Young Women
Condition: Muscle Atrophy
MeSH terms: Muscular Disorders, Atrophic; Muscular Atrophy; Atrophy
Study type: Interventional

Summary: 
      This study will examine the influence of n3 PUFA supplementation on the rate of muscle
      atrophy in women undergoing 2 weeks of unilateral limb immobilization. Assessments in
      skeletal muscle strength and skeletal muscle volume will also me made before, after and in
      recovery from immobilization.
    

Detailed description: 
      Biological aging is associated with the loss of skeletal muscle mass and strength resulting
      in compromised metabolic function and mobility. Throughout life, individuals will also
      experience periods of reduced physical activity/muscle disuse that independently lower muscle
      mass and strength accelerating the aging process. The losses in muscle mass with aging and
      disuse are underpinned by feeding-induced declines in rates of muscle protein synthesis.
      Thus, strategies to enhance muscle protein synthesis could have clinical implications for
      those who wish to maintain metabolic health and function during times of muscle disuse.

      Supplementation with n3 PUFA-enriched fish oil has been shown to potentiate rates of muscle
      protein synthesis in response to simulated feeding in both younger and older adults. Fish oil
      supplementation also has been efficacious in enhancing skeletal muscle strength during a
      period of resistance exercise training. However, no study has examined the impact of fish oil
      supplementation to enhance muscle protein synthesis and offset declines in muscle
      mass/strength during a period of immobilization.
    

Intervention name(s): n3 PUFA-enriched fish oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day; Organic Sunflower Oil 5000mg per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: n3 PUFA
The Relationship Among rSO2, MAP, et al by Near-Infrared Spectroscopy in Endovascular Neurosurgery
Condition: Near-Infrared Spectroscopy in Endovascular Neurosurgery
Study type: Observational

Summary: 
      record,describe and discuss the relationship among rSO2, MAP,CAM value, vital organ
      disfunction and the outcome of patients after operation by Near-Infrared Spectroscopy in
      Endovascular Neurosurgery
    

Detailed description: 
      record,describe and discuss the relationship among rSO2, MAP,CAM value, vital organ
      disfunction and the outcome of patients after operation using Near-Infrared Spectroscopy in
      Endovascular Neurosurgery meanwhile detect the Brain oxygen supply and function monitoring
      using noninvasive Near-Infrared Spectroscopy in Endovascular Neurosurgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Scheduled to undergoing Endovascular Neurosurgery
      
Keywords: Near-Infrared Spectroscopy
Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride
      (HCl) ophthalmic solution (AGN-190584) when administered bilaterally, once daily for 30 days
      in participants with presbyopia.
    


Intervention name(s): Vehicle; Pilocarpine HCl Ophthalmic Solution
Intervention type(s): Other; Drug
Intervention description(s): Vehicle, one drop in each eye, once daily, for up to 30 days.; Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
Other intervention name(s): AGN-190584; VUITY
Intervention MeSH terms: Ophthalmic Solutions; Pilocarpine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      investigational vaccine GSK1557482A.
    


Intervention name(s): GSK investigational vaccine GSK1557482A; Fluzone®
Intervention type(s): Biological; Biological
Intervention description(s): One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects; One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: GSK Biologicals influenza vaccine GSK1557482A; influenza infection
Stellate Ganglion Blockade in COVID-19 Positive Patients
Condition: COVID 19; ARDS
MeSH terms: COVID-19; Ganglion Cysts
Study type: Interventional

Summary: 
      This study will establish the safety and efficacy of using stellate ganglion blocks in
      patients with ARDS due to COVID-19 disease.
    

Detailed description: 
      The attending proceduralist will perform the SGB in the ICU. Nurse will provide patient
      monitoring and assistance during the procedure. Standard monitors and ACLS resuscitative
      equipment will be immediately available. A norepinephrine solution will be at bedside to
      treat potential hypotension associated with SGB. The SGB perineural catheter will be placed
      using standard sterile technique. Initial perineural bolus injection - clonidine 100 mcg,
      Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered. An OnQ perineural infusion 0.2%
      bupivacaine will be initiated at 2ml/hr for 5 days. Acute pain service will discontinue
      infusion and remove the catheter after 5 days.
    

Intervention name(s): Stellate Ganglion Block
Intervention type(s): Procedure
Intervention description(s): An injection of local anesthetic into the front of the neck. Medication used for the block include- clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered.
Intervention model: Single Group Assignment
Intervention model description: Open-label use of stellate ganglion block.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stellate ganglion; perineural block
Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Recently a clinical prediction rule (CPR) has been developed and validated that accurately
      identifies patients with low back pain that are likely to benefit from a lumbo-pelvic
      manipulation. The studies that developed and validated the rule used the identical
      manipulation procedure. However, recent evidence suggests that different manual therapy
      techniques may result in the same outcome.Purpose: The purpose of this study is to
      investigate the effectiveness of three different manual therapy techniques in a subgroup of
      patient with low back pain that satisfy the CPR.
    


Intervention name(s): Mobilization
Intervention type(s): Procedure
Intervention description(s): manualtherapy techniques
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Shock Waves on Dental Parameters
Condition: Tooth Stability; Blood Flow
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This randomized clinical trial investigates the effect of the extracorporeal shockwave
      therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically
      approved non invasive method to influence bone turnover and tissue regeneration. The
      hypotheses of this trial are that ESWT increases the periodontal stability of orthodontically
      aligned teeth as well as increase the blood flow. Increasing the periodontal stability would
      reduce the retention phase, relapse risk and accelerate the rehabilitation of the surrounding
      tissues.
    


Intervention name(s): Extracorporeal shockwave therapy; No extracorporeal shockwave
Intervention type(s): Device; Device
Intervention description(s): 1000 impulses; 0 impulses, acoustic effect
Other intervention name(s): Orthogold 100 MTS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tooth mobility; periodontal status; irregularity index; pulpal blood flow
Carotid Plaque-Burden Scale and Outcomes. A Real Life Study
Condition: Atheroscleroses, Cerebral; Carotid Plaque
MeSH terms: Intracranial Arteriosclerosis; Atherosclerosis
Study type: Observational

Summary: 
      Carotid ultrasonography has been proposed as a tool for prediction of future cardiovascular
      disease (CVD). Nevertheless, its role in clinical practice remains controversial.

      Methods: The investigators analyse the incidence of CVD and mortality in a cohort of 1004
      participants without preexisting CVD according to a simple plaque scale recorded in different
      segments of the carotid artery assess by ultrasound. A prognostic tool for CV events was
      development adding Carotid Plaque-Burden (CPB) scale to the Systematic COronary Risk
      Evaluation (SCORE2) table (CPB- SCORE2 scale).
    

Detailed description: 
      Based in number of plaques and stenosis a simple plaque scale was recorded in different
      segments of carotid artery, involving a cohort of 1004 participants with vascular risk
      factors. Outcomes were recorded during 14 years. A prognostic tool for CV events was
      development adding simple Carotid Plaque-Burden (CPB) scale to the SCORE2 table (CPB- SCORE2
      scale).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a major vascular risk factor, hypertension, diabetes or hypercholesterolemia,
        from vascular risk office at the Hospital Universitario San Pedro de Alcántara, Cáceres,
        Spain
      
Keywords: carotid ultrasound.; Carotid plaque-burden; atheroscleroses events prediction
Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as
      triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation
      therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide
      together with radiation therapy may be an effective treatment for prostate cancer. It is not
      yet known whether giving triptorelin and flutamide together with external-beam radiation
      therapy is more effective than external-beam radiation therapy alone in treating prostate
      cancer.

      PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and
      external-beam radiation therapy to see how well they work compared to external-beam radiation
      therapy alone in treating patients with stage II or stage III prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and
           flutamide followed by conformal external beam radiotherapy and continued androgen
           blockage therapy vs conformal external beam radiotherapy alone in patients with stage II
           or III prostate cancer.

        -  Compare the survival rate, in terms of 5-year clinical or biological remission, in
           patients treated with these regimens.

        -  Compare overall survival in patients treated with these regimens.

        -  Compare acute and late toxicity of these regimens in these patients.

        -  Compare quality of life of patients treated with these regimens.

        -  Determine the value and time-delay to obtain prostate-specific antigen nadir in patients
           treated with external beam radiotherapy alone.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients undergo conformal external beam radiotherapy.

        -  Arm II: Patients receive androgen blockade therapy comprising triptorelin subcutaneously
           every 4 weeks and oral flutamide once daily. Androgen blockade therapy continues for a
           total of 4 months. Two months after initiation of androgen blockade therapy, patients
           undergo conformal external beam radiotherapy.

      Quality of life is assessed.

      PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
    

Intervention name(s): flutamide; triptorelin; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Triptorelin Pamoate; Flutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer
The Pharmacokinetic Study of the Combination of Digoxin and Polythylene Glycol Loxenatide Injection in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic study of the combination of
      digoxin and polythylene glycol loxenatide injection (PEX168) in healthy adults，and to provide
      scientific basis for clinical combination of PEX168 and drugs.This study is also to evaluate
      the safety and tolerability of mono-digoxin or digoxin plus PEX168.
    

Detailed description: 
      This will be an open-label, single-arm, sequential, single-center clinical trial. 16 healthy
      males will be admitted to the clinical facility on Day -1, the day prior to the start of
      dosing. The subjects will be observed in clinic twice: Day -1 to 8 and Day 37 to 44. Subjects
      will receive a single dose of digoxin on Day 1 followed by 5 weekly subcutaneously injected
      doses of PEX168 and a second single dose of digoxin on Day 38. To determine the
      pharmacokinetic parameters of digoxin after drug administration alone and after multiple
      doses of PEX168, blood and urine samples will be collected after each dose of digoxin and
      tested by the laboratory.The subjects will be discharged on Day 8 and Day 44. Approximately
      28 days after the last discharge, the subjects will be called for a post study visit.
    

Intervention name(s): Digoxin; PEX168
Intervention type(s): Drug; Drug
Intervention description(s): Digoxin 0.5mg tablet by mouth on Day 1 and Day 38; PEX168 in subcutaneous injection on Day8，15，22，29 and Day 36
Other intervention name(s): Digoxine; Digoxinum; Lanoxin; Vanoxin; Polythylene Glycol Loxenatide Injection
Intervention MeSH terms: Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kyrgyz Asthma Rehabilitation at High Altitude
Condition: Effect of High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma
      rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and
      asthma control.
    

Detailed description: 
      Low altitude baseline measurements will be performed in Bishkek. Participants will then
      either be assigned to a rehabilitation program in Bishkek (760m) or in Tuja Ashu (3200m).

      The rehabilitation programs in high or low altitude will be identically performed and will
      comprise

        -  asthma education and awareness

        -  instruction on inhaled therapies

        -  smoking cessation counseling

        -  respiratory and skeletal muscle training in groups

        -  guided walks / cycle ergometer training

        -  questionnaires on asthma control, quality of life

        -  spirometry and peak flow measurements

        -  echocardiography

      Measurement on study subjects will be performed at baseline (Bishkek), during the
      rehabilitation program, after completion of the rehabilitation program and during a follow-up
      at week 15.
    

Intervention name(s): altitude rehabilitation program; rehabilitation program
Intervention type(s): Other; Other
Intervention description(s): altitude exposure; Rehabilitation at low altitude
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention