bioihbjkbjnl/mcl2 huggingface dataset:
Hydrogen/Oxygen Mixed Gas Inhalation for Coronavirus Disease 2019 (COVID-19)
Condition: Covid-19; Hydrogen/Oxygen Mixed Gas; Dyspnea
MeSH terms: COVID-19; Dyspnea
Study type: Interventional

Summary: 
      This was a randomized, multi-center, open-label clinical trial. Eligible patients were
      recruited from seven hospitals in China. On the basis of standard-of-care, patients in
      treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by
      using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd.,
      China) until discharge. Patients in control group received standard-of-care (consisting of
      oxygen therapy) alone until discharge.
    

Detailed description: 
      This was a randomized, multi-center, open-label clinical trial. Eligible patients were
      recruited from seven hospitals in China. On the basis of standard-of-care, patients in
      treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by
      using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd.,
      China) until discharge. Patients in control group received standard-of-care (consisting of
      oxygen therapy) alone until discharge. Clinical assessments included the five-category
      ordinal scale, four-category ordinary scale of dyspnea, coughing, chest distress and chest
      pain (0: None; 1: Mild; 2: Moderate; 3: Severe; 4: Very severe) and adverse events, performed
      on admission, at enrollment, at day 2 and 3 after randomization, and the day before
      discharge. The primary endpoint was the proportion of patients with improved disease severity
      (by at least one scale). Secondary endpoints comprised the change from baseline in oxygen
      saturation and symptom scales.
    

Intervention name(s): Hydrogen Oxygen Generator with Nebulizer; Standard-of-care
Intervention type(s): Device; Other
Intervention description(s): Patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge.; Standard-of-care consisted of the supportive therapies (including oxygen therapy) recommended by the Chinese National Health Commission
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Covid-19; Hydrogen/oxygen mixed gas; Dyspnea
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, extension, Phase III study to evaluate the long-term safety and
      efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.
    


Intervention name(s): MRA(Tocilizumab)
Intervention type(s): Drug
Intervention description(s): 8mg/kg/4 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound
Condition: Treatment of Adipose Tissue in the Thighs
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and efficacy of treatment with the
      Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue
      (SAT) of the thighs.
    

Detailed description: 
      Subjects received a single treatment (Liposonix System) on one randomly assigned thigh. The
      opposite thigh was not treated and served as a control for each subject.
    

Intervention name(s): Liposonix System (Model 2)
Intervention type(s): Device
Intervention description(s): Treatment of Subcutaneous Adipose Tissue in the thighs using High Intensity Focused Ultrasound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Condition: Diabetes, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses
      of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.
    


Intervention name(s): Muraglitazar
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of Smoking Cessation Patterns in Participants Undergoing Lung Surgery
Condition: Lung Neoplasms; Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Neoplasms; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to assess the current smoking status and smoking cessation
      attempts among smokers or recent smoking quitters during the perioperative period, to
      describe postoperative pulmonary complications (PPCs) and other postoperative complications
      (PCs) following a lung surgery, and to describe the smoking cessation methods and services
      patients received from their health care professionals (HCPs) and participant's satisfaction
      among participants with lung cancer, chronic obstructive pulmonary disorder (COPD), a
      pulmonary lesion (example, nodule, or ground glass opacity) or other pulmonary conditions who
      are admitted to the thoracic surgical unit of the participating hospitals in China.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No drug will be administered as part of this study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population includes adult participant with lung cancer, chronic obstructive
        pulmonary disorder (COPD), a pulmonary lesion, or other pulmonary conditions with a
        scheduled lung surgery and their treating health care providers (HCPs) from three
        participating hospitals in China.
Prevalence and Risk Factors for Serious Birth Concerns in Unselected Population of Mothers
Condition: Serious Concerns
Study type: Observational

Summary: 
      The aim of this study is to determine the prevalence of significant concerns about childbirth
      and their impact on the course and outcome of childbirth. By identifying a group of mothers
      who have an excessive fear of childbirth, the occurrence of surgical births can be influenced
      by the right intervention.
    

Detailed description: 
      The fear of childbirth is one of the most common mental health concerns during pregnancy.
      Elevated levels of anxiety during childbirth may lead to increased risk of elective caesarean
      section or prolonged labour. About 80% of pregnant women suffer from certain kind of
      childbirth fear. The most commonly used tool for assessment and diagnosis of childbirth fear
      is Wijma Delivery Expectance Questionnaire (WDEQ). This questionnaire has been translated and
      validated into several languages. In 2020 the Slovak version of the questionnaire was
      validated. All women who completed antenatal counseling at 36 weeks of gestation were
      included in the cohort. A slovak version of questionnaire was issued to all women and the
      results were recorded in the protocol. Subsequently, demographic data, medical facts and
      childbirth outcome were added from the medical documentation. The results of the birth were
      compared with the results of the questionnaire.
    

Intervention name(s): Wijma Delivery Expectancy Questionnaire; Clinical data collection
Intervention type(s): Other; Other
Intervention description(s): Simple questionaire identifying the level of fear of childbirth in pregnancy; Collection of the standard clinical data during hospitalization
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Total 700 nullipara and multipara giving birth at 2nd Department of Obstetrics and
        Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak
        Republic in a period of two years
      
Keywords: fear of childbirth; Wijma Delivery Expectancy Questionnaire
PSV on Ventilation Inhomogeneity and Lung Function in Patients Under SB Across LMA
Condition: Respiratory Function Tests; Anesthesia, General; Patient Positioning; Ventilation
Study type: Interventional

Summary: 
      General anesthesia has been demonstrated to have a negative impact on lung function. Both
      surgery and patient position influence the perioperative lung function. Laryngeal mask airway
      (LMA) has been proved to be safe and efficient to maintain the airways patent during general
      anesthesia. Pressure support ventilation (PSV) with LMA is routinely used in clinical
      practice. The aim of the present trial is to characterize perioperative changes in lung
      volume, ventilation inhomogeneity and respiratory mechanics in patients in the lithotomy
      position and spontaneously breathing through LMA with and without PSV.
    

Detailed description: 
      This study is a randomized controlled trial. Participants for this study will be recruited
      from the Gynecological department of the University Hospitals of Geneva, scheduled for
      gynecological procedures in the lithotomy position under general anesthesia. A total of 40
      patients will be enrolled and randomly assigned into 2 groups: Group SB (spontaneously
      breathing without PSV) and Group PSV (spontaneously breathing with PSV). Measurements of
      end-expiratory lung volume (EELV) and ventilation inhomogeneity will be performed in all
      patients with a nitrogen multiple breath washout method, before and 1 hour after surgery.
      Similarly, airway resistance (Rrs) and reactance (Xrs) will be measured at the same time by
      using the Forced Oscillation Technique.

      The primary endpoint: Perioperative changes in ventilation inhomogeneity (LCI) and
      respiratory mechanics (Rrs and Xrs) of patients, positioned in lithotomy and undergoing
      general anesthesia while breathing spontaneously through LMA with or without PSV.

      The secondary endpoints: Presence of respiratory complications, oxygen need in the recovery
      room, length of stay in the recovery room and in the hospital. Correlation between duration
      of positioning and surgery with lung function and volume measurements.

      Relevance: There are no studies that addressed the value of pressure support ventilation to
      overcome the potential changes in lung function following spontaneous ventilation across a
      LMA in the lithotomy position.
    

Intervention name(s): general anesthesia across LMA; Spontaneous breathing(SB); Pressure Support Ventilation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): general anesthesia across LMA; general anesthesia across LMA under SB without PSV; general anesthesia across LMA under SB with PSV
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Respiratory Function; Patient Positioning; anesthesia
An End-to-end System for Assessment and Intervention of Frailty
Condition: Frailty
MeSH terms: Frailty
Study type: Interventional

Summary: 
      The study aims to evaluate the feasibility and effectiveness of using SAIF (an end-to-end
      System for Assessment and Intervention of Frailty) to reduce the risk and delay the progress
      of physical frailty.
    

Detailed description: 
      SAIF is a personalised, community-based system for both assessment and intervention of
      frailty. It comprises of 8 modules categorised into

        1. Interface: virtual nurse and caregiver gateway

        2. Assessment: computerised screening using Fried Frailty Phenotype (FFP) and FRAIL
           instruments, Gamified Walking While Talking to assess frailty status and predictive
           analytics to predict participant's frailty risk

        3. Intervention: Physical exercise kiosks (Cycling and Taichi) incorporated with games,
           polypharmacy management and nutrition recommendation

      A total of 105 eligible community-dwelling older adults were recruited and randomised either
      to control arm or intervention arm using a single-consent Zelen's design. Allocation
      concealment was achieved using permutated block randomisation; both research assistant and
      participant were blinded to randomisation list during enrolment.

      All participants completed baseline assessment and subsequent follow-up assessments (2-month,
      4-month and 7-month). Additionally, participants in the intervention arm began SAIF
      interaction for a period of 4 months upon completion of their baseline assessment.
    

Intervention name(s): SAIF
Intervention type(s): Other
Intervention description(s): Participants interacted with SAIF system at least 2-3 times per week; each session took up to 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Motor Control Training in Individuals With Subacromial Pain Syndrome
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The porpusose of this study is to evaluate the repercussions of a motor control exercise
      protocol in patients with subacromial pain syndrome without indication of surgical repair.
    

Detailed description: 
      Methods: This is a randomized controlled trial which will be composed of volunteers of both
      genders, aged between 35 and 60 years. All volunteers will undergo pre-assessment (Av1): pain
      sensation, pain and function, shoulder range of motion, muscle strength, electromyographic
      activity and kinematics of the shoulder complex. After the initial evaluation, the volunteers
      will be randomly divided into two groups to carry out the intervention: exercises (GE -
      conventional exercises with elastic band) and motor control (GCM - motor control training).
      The intervention protocol will last eight weeks. After four weeks, the second assessment
      (AV2), similar to AV1, will be performed and the global change perception questionnaire will
      be added. At the end of the intervention protocol, the third evaluation (AV3), similar to
      AV2, will be performed. A follow-up will be performed after 4 weeks of the end of the
      intervention protocol, with the assessment being equal to AV3.

      The project will be submitted to the Research Ethics Committee of the Federal University of
      Rio Grande do Norte through the national interface "Plataforma Brasil". The study will also
      be registered on the international clinical trial platform, ClinicalTrials.gov. The study
      will only begin after approval of the ethics and research committee. All volunteers should
      read and sign the terms of free and informed consent.
    

Intervention name(s): motor control training; The exercise group
Intervention type(s): Other; Other
Intervention description(s): The volunteers of the motor control group will initiate the exercises on a stable and rigid basis. These will be progressed with adding an unstable base as the volunteer gains motor learning (between the fourth and fifth week of the protocol). For the motor control group, two sets of 10 repetitions will be performed keeping in isometry for ten seconds each repetition.; the protocol of strengthening and will have five elastic bands with different resistances available (extra-light, light, moderate, strong and extra-strong) for elbow flexion exercises progression, medial rotation and lateral rotation of the shoulder and scapular retraction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shoulder rehabilitation; Electromyography; Posture analysis
Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A single oral dose study in subjects with hepatic impairment and healthy control subjects.
      Subjects will stay at the clinical facility where interval blood samplings will be obtained
      and examined for drug effect.
    


Intervention name(s): BMS-663068
Intervention type(s): Drug
Intervention description(s): BMS-663068
Intervention MeSH terms: Fostemsavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Lens Presentation on the Clinical Oculomotor Assessment at Near
Condition: Vision Disorders
MeSH terms: Vision Disorders
Study type: Interventional

Summary: 
      This study will compare near clinical oculomotor parameters (heterophoria, vergence ranges,
      AC/A and accommodative findings) measured when lenses and/or prisms are introduced using
      three different instruments namely: (i) a standard manual phoropter, (ii) an electronic
      phoropter and (iii) a wearable adaptive refractor (VisionFit).
    

Detailed description: 
      Previous studies have demonstrated differences in a number of near oculomotor parameters
      [e.g., heterophoria, accommodative convergence to accommodation (AC/A) ratio] when measured
      in a manual phoropter versus a trial frame. These differences may be due to variations in
      proximal vergence, differences in head and eye position and restriction of the peripheral
      visual field. Further, a number of standard clinical oculomotor procedures require the use of
      Risley rotary prisms. While prism is typically introduced in a smooth, ramp-like fashion with
      manual phoropters, step changes in prism are created with electronic phoropters. The precise
      effect of these variations on clinical measurements is unclear. Accordingly, after a routine
      refractive examination, a standard clinical near assessment (comprising near heterophoria,
      AC/A ratio, horizontal vergence ranges, amplitude of accommodation and negative and positive
      relative accommodation) will be carried out on the same individuals through: (i) a standard
      manual phoropter (American Optical model 11625), (ii) an electronic phoropter (Topcon
      CV-5000) and (iii) a wearable adaptive refractor (VisionFit). The latter resembles a trial
      frame mounted on a helmet carrier (similar to a binocular indirect ophthalmoscope headset)
      but includes adaptive lenses that can be changed electronically.
    

Intervention name(s): Phoropter
Intervention type(s): Device
Intervention description(s): Each subject will be tested on 3 separate occasions using either the manual phoropter (American Optical 11625), electronic phoropter (Topcon CV-5000) or the wearable adaptive refractor (VisionFit). Oculomotor measurements, i.e., heterophoria, vergence ranges, AC/A and accommodative findings will be measured at each session using the different devices. Each session will be separated by a minimum of 24 hours and a maximum of 14 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of Myofascial Release Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle
Condition: Woman; Primary Dysmenorrhoea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Dysmenorrhea is a series of pathological symptoms associated with menstruation that interfere
      with daily activities such as abdominal cramps and pain in the menstrual period. General
      symptoms such as nausea, vomiting, lumbago, diarrhea and headache are also common. Primary
      dysmenorrhea refers to menstrual pain that does not depend on the underlying pathology. The
      kidneys act on the fascia of the psoas muscle. If the psoas muscle does not shorten and grow
      sufficiently, the kidneys may not move for a certain period of time and may experience
      ptosis. This causes venous ponding and may cause varicocele in men and primary dysmenorrhea
      in women. Techniques to be applied directly to the fascia of the psoas muscle can reduce
      symptoms of dysmenorrhea in women. In the literature review, no studies investigating the
      effectiveness of a treatment applied directly and only on the psoas muscle on primary
      dysmenorrhea were not found. This study can set an example for future studies. In our study,
      myofascial relaxation technique will be applied in women with primary dysmenorrhoea and its
      effect on pain will be examined.
    


Intervention name(s): Myofascial relaxation technique
Intervention type(s): Other
Intervention description(s): Before the intervention, the number of days of the last menstrual cycle of all participants, the number of painful days throughout the cycle, pain intensity values according to the Visual Analogue Scale will be recorded, and the scores will be recorded in the participants.
Technique of direct relaxation of fascia of both psoas muscles to the participants in the myofascial relaxation group since the end of the last cycle, 90-120 sec. It will be applied by the physiotherapist twice a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to determine the safety and tolerability of multiple dosing
      of miravirsen in subjects infected with chronic hepatitis C.

      Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of
      miravirsen's effect on HCV viral titer.
    


Intervention name(s): miravirsen; saline
Intervention type(s): Drug; Drug
Intervention description(s): SC injection; SC injection
Other intervention name(s): SPC3649
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Antisense; miR-122 antagonist; host factor; CHC