bioihbjkbjnl/mcl2 huggingface dataset:
Oxygen Uptake in Weaning of Patients From Prolonged Mechanical Ventilation
Condition: Ventilator Weaning
Study type: Observational

Summary: 
      1.Research hypothesis: during weaning patient from prolonged mechanical ventilation, if the
      work load caused by weaning was below the patient's AT, oxygen uptake will be constant.
      Otherwise, if the work load was above the patient's AT, the oxygen uptake will increase.

        1. Patient: who have tracheostomy tubes and with prolonged mechanical ventilation

        2. Measurement: oxygen uptake(V̇O2) and respiratory mechanics during the spontaneous
           breathing trials

        3. Outcome: Correlation between the oxygen uptake(V̇O2) and the weaning outcome

      2.Specific aims:

        1. to investigate the prognostic value of oxygen uptake in weaning patients from prolonged
           mechanical ventilation

        2. Subgroup analysis may suggest which weaning protocol potentially benefit the most for
           each population group (cardiovascular disease, chronic pulmonary disease, neuromuscular
           disease, cerebrovascular disease)
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient who have tracheostomy tubes and with prolonged mechanical ventilation
      
Keywords: oxygen uptake; prolonged mechanical ventilation; weaning
The RA PROTECTION Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      This is a prospective, multi-center, double-blind, randomized, controlled pilot study to
      assess safety and efficacy of the Vorso PROTECT System in patients who have moderately to
      severely active rheumatoid arthritis.

      Eligible participants will be randomized in a 1:1 ratio of treatment to control (non-
      therapeutic) group after it has been determined they meet all of the inclusion criteria and
      none of the exclusion criteria. Both the treatment and control group participants will be
      asked to use the VORSO System once a day while maintaining a stable dose of methotrexate
      throughout the 12-week study. Participants will return to the site at 1, 6 and 12 weeks for
      follow-up testing.
    


Intervention name(s): Vorso PROTECT System; Vorso PROTECT System - Sham (OFF)
Intervention type(s): Device; Device
Intervention description(s): The Vorso PROTECT System is designed to deliver targeted, imperceptible, non-invasive stimulation to the ear to treat the signs and symptoms (e.g., tender and swollen joints, pain, synovitis) of patients with rheumatoid arthritis.; Identical device to experimental arm, but the device will not deliver stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, randomized, sham-controlled pilot study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, cross-over study will assess the safety,
      pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects
      will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part
      2, subjects will receive a single dose of RO5508887 on two occasions, with or without food.
      Anticipated time on study is up to 12 weeks.
    


Intervention name(s): Placebo; RO5508887; RO5508887
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single ascending doses; Single ascending doses; Single doses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Phase II Randomized Pilot Study of Body Weight Support and Treadmill Training for Chronic Thoracic Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Assess the ability of patients with and without sensorimotor loss below the
      thoracic spinal cord injury to execute coordinated whole-limb synergies sufficient for
      walking with full or partial weight support.

      II. Promote weight bearing, balance, and reciprocal leg movement in these patients.

      III. Elicit synchronized motor output within and between limbs in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a controlled, prospective study. Patients pairs matched for strata
      are randomly assigned to 1 of 2 treatment groups. Patients are stratified into pairs by age,
      time since onset, Frankel grade, and Motor Score Index.

      One group receives body weight-supported treadmill training immediately after baseline
      clinical, biomechanical, and physiological measures. The second group is the control;
      baseline measures are identical but training is delayed for 3 months.

      Patients in both groups receive training 3 days/week for 3 months. Initial treadmill velocity
      is 18 meters/minute; velocity is increased in increments of 6 meters/minute until the maximum
      speed is achieved at which each patient exhibits the best locomotor capability at full weight
      bearing. Patients are trained with the minimal weight support assistance necessary for
      effective limb progression without excessive knee flexion or hyperextension. Polypropylene
      ankle-foot orthosis is allowed.

      Patients are re-tested after maximal treadmill velocity is achieved: following clonidine once
      a day for 3 days; clonidine twice a day for 3 days; cyproheptadine for 3 days; and an
      increased dose of cyproheptadine for 3 days. There is a 3-day washout between clonidine and
      cyproheptadine testing.

      Patients are not advanced if they experience adverse cardiovascular effects during therapy.
      No concurrent therapeutic exercise for the lower extremities is allowed.

      Kinematic, temporal, kinetic, spasticity, Frankel grading, Motor Index Score, metabolic, and
      functional outcome measures are evaluated at 3 and 6 months.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: environmental/toxic disorders; neurologic and psychiatric disorders; rare disease; spinal cord injury
PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma
Condition: Severe Uncontrolled Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the PK, PD and long-term safety of Benralizumab administered
      subcutaneously in 30 children aged 6 to 11 years with severe eosinophilic asthma. Up to an
      additional 3 Japanese patients aged 12 to 14 years will be enrolled to meet local regulatory
      requirements.
    


Intervention name(s): Benralizumab
Intervention type(s): Drug
Intervention description(s): Dose will be stratified by body weight at screening: Patients will receive Dose 1 or Dose 2 of Benralizumab administered by SC injection at Day 0 and Weeks 4, 8, and 16, 24, 32, and 40.
Intervention MeSH terms: Benralizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pediatric; PK; severe asthma
Logan Basic Technique Measured by Surface Electromyography (EMG)
Condition: Spinal Manipulation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this investigation is to determine the effect of Logan Basic Technique apex
      contact adjustment (LBT); on the motor recruitment pattern in the erector spinae group via
      surface EMG.
    

Detailed description: 
      LBT is a low force adjusting technique that focuses on the foundation segment of the spine,
      the sacrum, with application of contact on the sacrotuberous ligament which relieves fatigued
      and strained muscles, particularly intrinsic muscles of the back. Surface electromyography
      (EMG) is a method of analyzing the activity level of superficial muscles. It is convenient
      and advantageous when studying muscle relaxation which occurs in biofeedback studies
    

Intervention name(s): Logan Basic Technique and Surface EMG; Surface EMG; Logan Basic Technique Sham
Intervention type(s): Procedure; Other; Procedure
Intervention description(s): Participant will receive a brief Basic Technique and Surface EMG examination and Basic Technique treatment.; Surface EMG only, no intervention; Participants will receive a sham Basic Technique treatment, not indicated by examination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care
Condition: Dental Pain and Sensation Disorders
MeSH terms: Sensation Disorders; Pain, Postoperative
Study type: Interventional

Summary: 
      The main purpose of MUSANX study is to highlight analgesic effectiveness of musicotherapy in
      post-surgical periodontal and implant; and to measure its per-operative anxiolytic
      effectiveness
    

Detailed description: 
      This study will be on music use as musicotherapy "receptive " or " passive ", using hearing
      aid for listening in order to relax and reduce the anxiety and pain state of the patient.
      This care will be focused on the acute stress and pain during the dental care.

      Another major secondary purpose will consist to explore the anxiolytic effect of the
      musicotherapy on diverse stress markers such as heart rate, respiratory rate, salivary
      cortisol ratio and electro-dermal intensity (RED).
    

Intervention name(s): musicotherapy
Intervention type(s): Other
Intervention description(s): If the patient is randomized in the experimental group, he listens the Music-care® playlists and chose two closed to his musical tastes. The playlists are unique compositions create by Music-care® (french company), not known from the general public, categorized by theme (jazz, rock, world music…).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial
Condition: Depression; Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to assess the efficacy of Nepeta menthoides as an anti anxiety
      herbal remedy for depressed patients , in a 6 week randomized double-blind controlled trial.
      A total of 70 adult outpatients between 18-65 ages referring to psychiatry clinic of Shiraz
      medical university, who having depression according to Persian-language version of the Beck
      Depression Inventory-Second edition and get score above 11 according to Persian version of
      Beck Anxiety Inventory (BAI) and diagnosis is confirmed by at two psychiatrists are randomly
      allocated into two groups and assign to receive 400 mg of freeze dried powder of Nepeta
      menthoides or 50 mg of sertraline in the uniformed capsules twice daily (in the morning and
      1-2 hours before sleeping time at night). Exclusion criteria were pregnancy and lactation,
      allergy to N. menthoides and Lamiaceae family, patients with suicidal thoughts or previous
      suicidal attempt, patients with unstable cardiac, renal and hepatic diseases, seizure and
      hypothyroidism and patients who used substances or alcohol and patients who had indication
      for electroconvulsive therapy.. Severity of anxiety (by Persian version of Beck Anxiety
      Inventory (BAI)) and also common possible side effects of drugs will assess in baseline, 2nd
      week, 4th week and then two weeks after the end of the intervention (in 6th week)
    


Intervention name(s): Nepeta menthoides Boiss & Bohse freeze dried extract; Sertraline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Conduction Abnormalities With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement
Condition: Bradycardia
MeSH terms: Aortic Valve Stenosis; Bradycardia
Study type: Observational

Summary: 
      Most of the conduction abnormalities with TAVR are usually detected during the procedure or
      during the following days of observation. Little is known about the prevalence and timing of
      any conduction abnormalities that exist before (other than standard ECG) or after through
      long term cardiac monitoring.
    

Detailed description: 
      Each subject who fulfills the inclusion/exclusion criteria will be provided with Zio patch
      for 2 weeks before TAVR. Immediately after the procedure, patients will be admitted per TAVR
      protocol and will be on telemetry. Data about their ECGs and any arrhythmias will be
      collected.

      Upon discharge, patients will be provided with another Zio patch for 2 weeks. At the 2-3
      months follow up, subjects will be provided with a third Zio patch for 2 weeks
    

Intervention name(s): Ziopatch Pre discharge; Ziopatch at Discharge; Ziopatch at 2 months
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Ziopatch applied 2 weeks prior to procedure; Ziopatch applied at discharge from hospital to be worn for 2 weeks; Ziopatch applied 2 months from procedure to be worn for 2 weeks
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients to be scheduled for TAVR without preexisting Cardiac Implantable Electronic Device
        (CIED) can be screen and enrolled
Effect of a Lacidofil® STRONG in Healthy Adults Taking Antibiotic Treatment
Condition: Antibiotic Associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this study are to evaluate stool consistency and stool frequency during and
      up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg
      BID.
    

Detailed description: 
      It is hypothesized that the proportion of subjects having a diarrhea-like defecation, defined
      as a stool frequency ≥ 3 per day and/or stool consistency ≥ 5 (Bristol Stool Score) for at
      least 2 days will be lower in the group receiving Lacidofil® STRONG compared to the group
      receiving placebo and therefore mean Bristol Stool Scores will be lower in subjects receiving
      Lacidofil® STRONG compared to those receiving placebo.
    

Intervention name(s): Lacidofil® STRONG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lacidofil® STRONG capsule twice daily; Placebo capsule twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5
      inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients
    

Detailed description: 
      Data from a previous single arm study (RESPITE) indicate that transition from PDE5i to
      riociguat may be feasible, safe and beneficial in patients not adequately responding to
      PDE5i.

      REPLACE is a randomized controlled study to confirm the potential clinical benefit of
      transition from PDE5i to riociguat. Satisfactory clinical response in patients who are on a
      stable dose of phosphodiesterase-5inhibitors (PDE-5i) with or without endothelin receptor
      antagonist (ERA), but not at treatment goal will be compared between one group of patients
      randomized to maintain current treatment and another group where the PDE5i is replaced by
      riociguat.
    

Intervention name(s): Riociguat (Adempas, BAY63-2521); Sildenafil; Tadalafil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated tablets will be used in this study at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg. Tablets will be administered orally.The starting dose is 1 mg TID; the intervals between drug intakes should be 6 to 8 hours. The dosage should be increased by 0.5 mg increments in 2 week intervals to 1.5 mg, 2.0 mg, and 2.5 mg TID (maximal total daily dose).; Patients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator.; Patients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator.
Intervention MeSH terms: Sildenafil Citrate; Tadalafil; Riociguat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing the Effects of M-TAPA and TAP Block on Postoperative Analgesia in TAH
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Aim is to compare the postoperative analgesic efficacy of M-TAPA block and TAP block and
      their effect on opioid consumption in patients undergoing open total abdominal hysterectomy
      (TAH) surgery.
    

Detailed description: 
      There were three randomized groups: Group M (M-TAPA block) (n=15), Group T (TAP block) (n=15)
      and Group C (no block) (n=15). All patients had standard general anesthesia. Group M had
      bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the
      surgery. Group T patients had TAP block with 0.25% bupivacaine (total volume of 40 ml) at the
      end of the surgery. Group Control had only tramadol for postoperative pain. Numerical rating
      scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the
      surgery. Total tramadol consumption was calculated.
    

Intervention name(s): M-TAPA block; TAP block
Intervention type(s): Other; Other
Intervention description(s): Following sterile conditions for bilateral M-TAPA block application, the transducer was inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle was created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip was placed just below the chondrium and saline (5 ml) was injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. M-TAPA block with the same standard technique and drug dose was applied to the contralateral side for each group of M-TAPA patients.; After the necessary sterilization conditions were established, the linear ultrasound probe was sterilely coated and placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum were identified. As the tip of the 80 mm sonovisible needle passed through the muscular layers and fascia, a fascial click was felt and the needle was advanced with ultrasound in a controlled manner. After receiving the second click sensation (passage of the fascia of the internal oblique muscle), the location of the needle was fixed and frequently aspirated and applied to the plane so that 20 ml of 0.25% bupivacaine was applied to each side. (40 ml in total)
Other intervention name(s): Modified thoracoabdominal nerve block through perichondrial approach; Transversus abdominis plane block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: m-tapa; tap block; total abdominal hysterectomy; regional anesthesia; postoperative pain
Perioperative Hemodynamic Optimization Using the NICOM Device
Condition: Major Abdominal Surgery
Study type: Interventional

Summary: 
      In the last years, there is a growing interest in the improvement of prognosis and shortening
      of hospital length of stay in high-risk surgical patients. Several evidence-based protocols
      ("fast-track" surgery) have been developed and implemented in some hospitals for this
      purpose. Cardiovascular optimization through the so-called "goal-directed therapy" (GDT) is a
      key element in these protocols. Previous studies in the literature use invasive monitors to
      assess hemodynamics. The NICOM ™ is a non-invasive monitor validated in several clinical
      scenarios. The aim of the present randomized, international, multi-center, open-label
      clinical trial is to use a GDT protocol (including colloid boluses and vasoactive drug
      infusion) based on data obtained from the NICOM™ device (cardiac index and mean arterial
      pressure) to test the hypothesis that GDT is superior to standard practice in terms of
      reduction in the incidence of perioperative complications and length of hospital stay in
      high-risk major abdominal surgery patients (requiring ICU surveillance for, at least, 24
      hours). As secondary objectives, time to first flatus, wound infection, anastomotic leaks and
      mortality will be analysed. All patients will be followed from the day of surgery up to
      hospital discharge (determined by a specialist surgeon not involved in the study) or death.
    


Intervention name(s): Hemodynamic monitoring; Usual treatment
Intervention type(s): Device; Other
Intervention description(s): Hemodynamic monitoring based on the NICOM device; Hemodynamic monitoring based on common practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hemodynamic Monitoring; Goal-Directed Therapy