bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Continuous Positive Airway Pressure on Diastolic Function in Patients With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The association of obstructive sleep apnea (OSA) and cardiac diastolic dysfunction have been
      reported, and improvement of diastolic function after continuous positive airway pressure
      (CPAP) in OSA patients was observed. However, more detailed analysis of diastolic function by
      supine bicycle exercise echocardiography is lacking. The investigators hypothesized that 3
      months of CPAP therapy in OSA patients will significantly improve diastolic functional
      parameters measured by exercise stress echocardiography. Patients with severe OSA
      (Apnea-hypopnea index > 30) will be included in this study, and randomized to CPAP versus
      sham-CPAP group by 1:1 ratio. Supine bicycle exercise echocardiography, pulse wave velocity,
      24 hours ambulatory blood pressure (BP), central BP will be checked before and after CPAP
      therapy and parameters will be compared.
    


Intervention name(s): CPAP group; sham-CPAP group
Intervention type(s): Device; Device
Intervention description(s): Enrolled patients are randomized to CPAP group or sham-CPAP group by 1:1 ratio. The patients in each group will undergo CPAP or sham-CPAP for 3 months.; Enrolled patients are randomized to CPAP group or sham-CPAP group by 1:1 ratio. The patients in each group will undergo CPAP or sham-CPAP for 3 months. Sham CPAP consists of a CPAP machine that is modified to include a large hidden leak in the exhaust port of the mask to disperse the therapeutic pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Continuous positive airway pressure; diastolic function
Pharmacokinetics of Resveratrol Comprising Products
Condition: Healthy
Study type: Interventional

Summary: 
      This study was designed to assess the pharmacokinetics of 2 doses of Red Grape Cells (RGC)
      containing resveratrol compared with a reference. RGC will be administered as single oral
      dose to fasting healthy volunteers. Plasma concentration of free resveratrol and total
      conjugates will be analyzed.
    


Intervention name(s): RGC; RGC; Resveratrol
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The equivalent of 150 mg resveratrol
Other intervention name(s): Transmax (Biotivia Ltd.)
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Oncogenous HPV DNA Integration (Intégration De l'ADN Des HPV Oncogènes)
Condition: Abnormal Cytology
Study type: Interventional

Summary: 
      High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development.
      Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical
      cancer development. The aim of this study is to validate the integration of the HPV-HR as an
      appropriate biomarker of the severity of precancerous lesions and progression of cervical
      lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular
      Combing technology, which allows direct and high-resolution visualization of the integration
      of high-risk HPV genomes.
    


Intervention name(s): all patients included in IDAHO study
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: High-risk human papillomavirus; Integration of HR-HPV DNA; biomarker of severity; biomarker of evolution
The Effect of Antihypertensive Agents Concerning With Hemodynamics and Reduction of Anaesthetics in Orthognathic Surgery
Condition: Orthognathic Surgery
Study type: Interventional

Summary: 
      For those who receive hypotensive anesthesia in orthognathic surgeries, the investigators
      premedicate with anti-hypertensive agent so that it decreases the occurence of tachycardia
      and the rebound hypertension due to hypotensive anesthesia, enabling us to compare
      hemodynamic stability and reduction of anesthetic agents during the operation.
    


Intervention name(s): b-blocker(Atenolol); ACE inhibitor(Enapril); control
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Atenolol; Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: antihypertensive agents; hemodynamic; anesthetics reduction; orthognathic surgery
Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension
Condition: Idiopathic Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional

Summary: 
      This clinical investigation is a medical device trial to examine the safety and efficacy of
      TheraSorb® Ig flex adsorber treatment (as an add-on to conventional treatment) used
      exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy
      (5 treatments) performed over 5 to 8 consecutive days in patients with Idiopathic Pulmonary
      Arterial Hypertension and WHO functional classification III.
    


Intervention name(s): TheraSorb® - Ig flex
Intervention type(s): Device
Intervention description(s): TheraSorb® Treatment with one TheraSorb® Ig flex adsorber pair, used exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy.
5 treatments performed over 5 to 8 consecutive days.
Other intervention name(s): Immunoadsorption
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Hypertension; Pulmonary Arterial Hypertension; TheraSorb; immunoadsorption
Motor Control Exercise in Osteoporotic Women
Condition: Osteoporosis; Postmenopausal
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The objective of this study was to explore the effectiveness of Motor Control Exercise on
      pain, postural alignment and spinal curvatures in women with osteoporotic vertebral
      fractures.
    

Detailed description: 
      Osteoporosis is a common metabolic bone disease that usually affects the aging population. It
      is an important public health problem, due to its association with vertebral and nonvertebral
      fractures leading to increased morbidity. Vertebral fractures are accompanied by kyphosis,
      reduced pulmonary function, loss of height, and are often associated with elevated pain while
      they may also lead to subsequent vertebral fractures. Osteoporotic individuals exhibit
      kyphosis in the erect standing position, which, in turn, is compensated by the deformation of
      other parts of the body. Improvement of postural alignment may lead to less stress on the
      spine, facilitate posture and proper body mechanics and may improve balance. The aim of the
      present study was to assess the effectiveness of Motor Control Exercise on pain, postural
      alignment and spinal curvatures in women with osteoporotic vertebral fracture against the
      results of a control group that received the basic therapies for osteoporosis.
    

Intervention name(s): Motor control exercise
Intervention type(s): Other
Intervention description(s): Participants of the exercise group were trained to consciously co-activate the transversus abdominis, pelvic floor and thoracic erector spinae muscle, relax the lumbar multifidus and use the diaphragmatic breathing pattern. They were encouraged to activate the specific muscles of the trunk regularly during daily activities, particularly in situations where they anticipated or experienced pain such as walking, twisting, lifting low-lying objects and working with the hands in sitting or standing positions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoporosis; Pain; Kyphosis; Posture; Exercise therapy
Cognitive and Psychological Disorders After Severe COVID-19 Infection
Condition: COVID 19
MeSH terms: COVID-19; Mental Disorders
Study type: Interventional

Summary: 
      As COVID-19 pandemic is still ongoing, patients follow-up begins to reveal cognitive and
      psychological disorders. There are not yet well described, neither their physiopathology.
      This study will consist in the detection and characterization of cognitive and psychological
      impairments in young patients under 65 years of age who have been hospitalized more than 72
      hours for a severe COVID-19 infection.
    

Detailed description: 
      Initial consecutive screening of patients (<65 years) hospitalized between the 01/10/2020 and
      the 01/07/2021 for more than 72 hours for COVID-19 infection in 6 hospitals of the East of
      France. If detection of cognitive complaints (QPC scale : Questionnaire of cognitive
      complaints), continuation of the study.

      Evaluation with cognitive assessments, morphological and functional imaging and EEG will be
      done at 9 ± 3 months and 2 years after initial hospitalisation. Data will be collected
      concerning social and professional outcome.

      An ancillary study will be conducted at the Nancy University Hospital. This ancillary study
      is entitled "TRAUMA-COV: Screening and therapeutic proposal of post-traumatic sequelae in the
      aftermath of a severe Covid-19 in young subjects". The main objective of this study is to
      evaluate the incidence of post-Covid-19 post-traumatic disorders (post-traumatic stress
      disorder, psychogenic and somatoform dissociative tendency, neurological dissociative
      disorder) in a longitudinal way. This optional study will be offered to all patients from the
      main study who meet the selection criteria.
    

Intervention name(s): Cognitive assessment; Imaging; Routine care; Psychiatric evaluation; Psychiatric evaluation
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Other; Other
Intervention description(s): Complete cognitive and psychological assessment; Brain MRI
Optional: Brain FDG PET (Brain positron emission tomography with F-18 fluorodeoxyglucose); Electroencephalogram (EEG)
Optional: polysomnography, lumbar puncture; Psychiatric consultation if necessary; Psychiatric consultation if necessary (before the end of their participation in the study)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: COVID 19 cognitive impairement
Tooth Extraction With Deep Sedation in Children: A Retrospective Study
Condition: Tooth Extraction Status Nos
Study type: Observational

Summary: 
      In this study it's aimed to evaluated the patients in whom dental local anesthetic attempts
      were failed due to anxiety or fear and referred to our clinic for tooth extraction with deep
      sedation. All patients dates will evaluate from their patient file retrospectively from 2011
      to 2014.
    

Detailed description: 
      Majority of dental treatments can be performed under local anesthesia. However, this is not
      always possible for pediatric non-cooperated patients with severe anxiety. In these patients,
      unpleasant dental experiences may lead to development of dental phobia when they become
      adults . Therefore, it is important to eradicate anxiety, and to prevent a possible
      psychological trauma in pediatric patients. For this purpose, psychological and medical
      methods have been applied to increase patient compliance. It has been proven that general
      anesthesia especially prevents dental phobia in elderly, and increases the quality of life
      related to oral health. In this study we aimed to evaluated the patients in whom dental local
      anesthetic attempts were failed due to anxiety or fear and referred to our clinic for tooth
      extraction with deep sedation. All patients dates will evaluate from their patient file
      retrospectively from 2011 to 2014.
    

Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        children
      
Keywords: sedation,; tooth extraction,
An fMRI Study of Opioid-related Changes in Neural Activity
Condition: Social Acceptance
Study type: Interventional

Summary: 
      The purpose of the study is to explore the effect of blocking opioids on affiliation-related
      neural activity.
    


Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Quality of Life Interventions During Cervical Cancer Treatment
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The proposed project will examine the effects of a healing touch intervention in women
      receiving chemotherapy and radiation for advanced cervical cancer.
    

Detailed description: 
      Patients receiving chemoradiation for cervical cancer are at risk for distress,
      chemoradiation-related side effects, and immunosuppression. This prospective randomized
      clinical trial proposes to examine the effects of a complementary therapy, Healing Touch
      (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular
      immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated
      toxicities and treatment delay in cervical cancer patients receiving chemoradiation.
    

Intervention name(s): Relaxation training; Therapeutic touch; Questionnaire administration; Ancillary studies
Intervention type(s): Behavioral; Behavioral; Other; Other
Intervention description(s): Muscle relaxation training; Healing Touch (HT) therapy; Subjects in all groups will give 4 blood samples during the study
Other intervention name(s): Relaxation; Healing touch; Blood draw
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized to relaxation, healing touch, or standard care arms of the study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cervical cancer; healing touch; healing touch therapy
Evaluation of Pulmonary Function in Burn Injury
Condition: Burns
MeSH terms: Burns
Study type: Observational

Summary: 
      This study evaluates the pulmonary function, respiratory muscle strength and peripheral
      muscle strength in patients with burn injury on the week that they will be discharge from the
      hospital. Healthy subjects will be evaluated for pulmonary function, respiratory muscle
      strength and peripheral muscle strength.
    

Detailed description: 
      Burn injures have adverse effect on the respiratory system.In addition to burn injury
      prolonged hospitalization may increase the ratio of respiratory complications. But, there are
      no information in the literature about pulmonary function, respiratory muscle strength and
      peripheral muscle strength in patients with burn injury. Especially, when the patients are
      discharged from the hospital, it is not known whether the patients are at the same level in
      terms of pulmonary functions respiratory muscle strength and peripheral muscle strength with
      healthy individuals. This study will assess pulmonary functions respiratory muscle strength
      and peripheral muscle strength in patients with burn injury compared to healthy subjects.
    

Intervention name(s): Respiratory function
Intervention type(s): Other
Intervention description(s): Respiratory function test evaluates the participants' pulmonary function and respiratory muscle strength
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Experimental group: Patients with burn injury Control Group: Healthy subjects
      
Keywords: Burn Injury; Pulmonary function; Respiratory muscle; Peripheral muscle
Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.
Condition: Sciatica
MeSH terms: Sciatica
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety, tolerability, and
      pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed
      schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week).

      Secondary objectives of this study in this study population are to explore the repeated-dose
      immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following
      multiple-dose administration.
    


Intervention name(s): BG00010 (Neublastin); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses, weight-based IV administration; Single dose IV matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987516)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formaulation number- SR15-62 -Z15-038).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physician Use of Non-English Language Skills in Cancer Care
Condition: Breast Cancer; Colon Cancer; Lung Cancer
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to test a method for analyzing interactions between patients and
      doctors, the Roter Interaction Analysis System (RIAS). The RIAS measures the quality of
      communication between patients and their cancer doctors.
    


Intervention name(s): survey; Audio record
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The ILR Scale, a non-English language proficiency self-assessment.; Audio record the initial visits between patients and their treating physician
Other intervention name(s): ILR Scale
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study will enroll all treating physicians of participating sites who are likely to
        treat LEP Spanish-speaking patients. All patient recruitment will be done by bilingual
        research staff who are consenting professionals with (when necessary) a volunteer
        affiliation with the collaborating study site.
      
Keywords: Communication; 15-316; Physician; Use; Non-English; Language Skills
Biomarkers in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      N-methyl-D-aspartate (NMDA)-type glutamate receptors are thought to play a pivotal role in
      neurocognitive dysfunction associated with schizophrenia. Further, several novel
      glutamate-based classes of compound are presently in development as potential novel
      treatments for persistent negative and cognitive symptoms. The study will assess
      effectiveness of a NMDA-based intervention on biomarkers related to schizophrenia as a
      mechanism for developing appropriate outcome batteries for future trials of novel compounds.
    

Detailed description: 
      16 in- or outpatients with DSM-IV-TR schizophrenia or schizoaffective disorder and prominent
      negative symptoms will be recruited for this study. This study will consist of a randomized
      trial of D-serine (60 mg/kg/d) vs. placebo using a crossover design with a 2-week baseline
      lead-in, and two 6-week intervention arms separated by a two week, placebo controlled washout
      period. Biomarkers will be assessed at baseline for each treatment arm, acutely (day 7)
      following treatment initiation, and following 6 weeks of treatment (6 biomarker sessions
      total). Primary biomarker outcome measures will include 1) amplitude of the mismatch
      negativity (MMN) waveform and 2) amplitude of the visual P1 potential. Symptomatic outcome
      measures will include PANSS and composite score of the MATRICS neuropsychological battery.
      The study will be supported from ongoing NIMH-funded Cooperative Drug Development Grant
      (CDDG) to the PI.
    

Intervention name(s): D Serine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg/kg/day; oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: biomarker; EEG; schizophrenia; NMDA; D-serine