bioihbjkbjnl/mcl2 huggingface dataset:
Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19
Condition: COVID-19
MeSH terms: COVID-19; Metabolic Diseases
Study type: Observational

Summary: 
      Objective of the study: to investigate the effect of meglumine succinate solution on the
      dynamics of metabolic blood parameters and respiratory function of the lungs in intensive
      care patients with new coronavirus infection. An observational prospective study included 105
      patients with a severe course of novel coronavirus infection
    


Intervention name(s): Reamberin; Ringer's solution
Intervention type(s): Drug; Drug
Intervention description(s): the balanced succinate-containing crystalloid solution Reamberin (meglumine sodium succinate); Ringer's solution at an average daily dose of 8.1 ml/kg/day
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with severe novel coronavirus infection COVID-19 (NCI) who were treated at the
        intensive care unit (ICU)
      
Keywords: COVID-19; METABOLIC DISORDERS; Respiratory function of the lungs
Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will test the ability of the topical cream WR 279,396 to treat the skin lesions
      caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that
      contains paromomycin + gentamicin. This cream will be compared to the effect of a topical
      cream containing paromomycin alone and to a placebo cream that contains no antibiotics.
      Therefore, this study will have three groups of patients, and they will be assigned to one of
      these treatments randomly. The study will be carried out without the patient or the physician
      knowing which cream is being used for which patient. The goal is to determine if WR 279,396
      cream or the paromomycin cream is better than placebo, and if WR 279,396 is better than
      paromomycin alone.
    

Detailed description: 
      This is an efficacy study to test the ability of WR 279,396 topical cream to treat
      uncomplicated cutaneous leishmaniasis caused primarily by Leishmania major in adults and
      children in Tunisia where the disease in endemic. A total of 375 volunteers will be
      randomized to the three arms described above to determine product efficacy. Safety data in
      all three arms will also be collected.
    

Intervention name(s): WR 279,396 topical cream; Paromomycin Alone topical cream; Vehicle placebo cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.; The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.; Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
Intervention MeSH terms: Paromomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cutaneous leishmaniasis, topical treatment, Tunisia
National Validation and Sensitivity to Change of the SAQ
Condition: Asthma; Severe Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      DESIGN A multi-centre mixed methods study of a new asthma specific quality of life
      questionnaire including limited clinic data.

      AIMS To collect further quantitative data to validate a new asthma quality of life scale, the
      Severe Asthma Questionnaire (SAQ).

      To determine the Minimum Clinically Important Difference (MCID) of the SAQ

      OUTCOME MEASURES

      Questionnaires:

        1. The Severe Asthma Questionnaire (SAQ)

        2. The Mini Asthma Quality of Life Questionnaire (MiniAQLQ)

        3. The EQ-5D-5L

        4. The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ)

        5. Global Rating of Change Questionnaire (GRCQ)

           Clinical data comprises:

        6. Spirometry

        7. BMI

        8. Asthma severity

        9. Health care utilisation: ED attendance in the last 12 months, Hospital admissions in the
           last 12 months;

       10. Number of exacerbations in the last 12 months requiring OCS Prednisolone dose mg/day (if
           oral steroid dependent).

      POPULATION All patients aged 16 years or over, who have attended one of three participating
      UK specialist asthma centres for the validation study and with data also collected from
      Derriford Hospital's Chest Clinic (DHCC) for use in determining Minimum clinically Important
      difference.

      ELIGIBILITY Over 16 years of age Diagnosis of Severe Asthma

      DURATION 18 months
    


Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All patients must have a diagnosis of severe asthma, be taking high dose inhaled
        corticosteroids (GINA step 4 & 5), and be aged 16 years or over.
      
Keywords: Quality of Life; Patient Reported Outcomes
Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
Condition: Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      Cortisol is a stress hormone that can be measured in saliva. This has provided a convenient
      way to evaluate the biological impact of day-to-day stressors that people encounter as they
      go about their lives, since saliva is so easy to collect. However, the biological meaning of
      saliva cortisol measures has never been carefully examined. The goal of this study is to
      collect saliva from a large group of people as they go about their every-day lives, to
      measure their cortisol levels, and then study them in the laboratory where Investigators can
      learn more about how their stress response system (which produces cortisol) is really
      functioning. Investigators can then determine much more precisely what saliva cortisol levels
      really mean in terms of stress system biology. This will allow investigators to obtain much
      more useful information from the next decade of research on naturalistic stress and its
      biological impact using saliva cortisol measures, helping investigators to understand how
      stress undermines health and how to combat this effect.
    


Intervention name(s): Metyrapone; Dexamethasone; Cortrosyn; Corticorelin ovine triflutate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 750 mcg, oral, administered twice, 3.5 hours apart; Administered twice:
1.5 mg, oral, at 11 pm And 0.25 mg, oral, at bedtime at least one week before or after other administration.; 250 mcg, IV, bolus, in the afternoon.; 100 mcg, IV, over 30 seconds, in the afternoon.
Other intervention name(s): Metopirone; Decadron; Cosyntropin; Acthrel; Corticotropin-Releasing Hormone
Intervention MeSH terms: Dexamethasone; Adrenocorticotropic Hormone; Cosyntropin; Corticotropin-Releasing Hormone; Metyrapone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: stress biology; cortisol; adrenocorticotropin; salivary biomarkers
Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis
Condition: Shoulder Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      A prospective randomized controlled study among 60 consecutive adhesive capsulitis to compare
      between the ultrasound-guided anterior hydrodilatation in rotator interval and the posterior
      approach.
    

Detailed description: 
      patients was randomized into two equal groups. Group I received ultrasound-guided
      hydrodilatation with corticosteroid, saline, and local anesthetic via posterior
      intra-articular approach; group II received the same ultrasound-guided hydrodilatation via
      anterior rotator interval approach.

      Both groups received guided stretching exercises for 3 months after injection. Baseline and 3
      months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index
      (SPADI), and range of motion (ROM) had been recorded for all patients.

      A statistical power analysis was performed after sample size estimation, based on data from
      the current study (N = 60), comparing group I to group II.

      Qualitative data was expressed as numbers and percentages, and Chi-squared test, Quantitative
      data were expressed as mean and standard deviation.
    

Intervention name(s): ultrasound-guided posterior hydrodilatation; corticosteroid, saline, and local anesthetic; guided stretching and strengthening exercise program
Intervention type(s): Procedure; Drug; Other
Intervention description(s): Group I was treated through posterior approach; The injection needle is introduced at the skin surface just lateral to the transducer and in an oblique lateral to medial direction. Group II was treated through anterior rotator interval approach. A 21-gauge needle is introduced into the rotator interval using an oblique path within the imaging plane of the transducer; from lateral to medial, the needle tip is imaged in real time throughout its passage from superficial to deep and is positioned in the biceps tendon sheath between the coracohumeral ligament above and biceps tendon below. Both groups were given the same guided stretching and strengthening exercise program; corticosteroid, saline, and local anesthetic; guided stretching and strengthening exercise program
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Is Music the Food of Anesthesia in Children?
Condition: Music
Study type: Interventional

Summary: 
      The patients were randomly separated into three groups. Group M (n=35) applied CD player and
      Group S (n=35) received the independent anesthesiologist placed earplugs into the patients'
      ears. Group N (n=35) exposed to the ambient operating room noise.
    

Detailed description: 
      Hundred and five pediatric patients who scheduled for abdominal surgery in ASA I-II risk
      groups were enrolled in the study. The patients were randomly separated into three groups.
      Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist
      placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room
      noise. The preoperative children's anxiety levels were assessed with the M-YPAS in the
      operating room. Heart rate (HR) and mid-arterial pressure (MAP) were recorded at 30-minute
      intervals until the completion of surgery, end of surgery and postoperative. During each
      measurement, noise level recordings were performed using sonometre. Pediatric Anesthesia
      Emergence Delirium Score (PEAD) was assessed after extubation, postoperative.
    

Intervention name(s): CD player; CEL-480 Sound Level Meter Sonometre; Earplug; Ambient operating room noise
Intervention type(s): Device; Device; Device; Procedure
Intervention description(s): CD player opened during anesthesia induction and continued until postoperative 15 minute; Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.; the independent anesthesiologist placed earplug into the patients' ears during anesthesia induction and the ear plug were removed immediately before tracheal tube extubation.; patients were exposed to the ambient operating room noise.
Other intervention name(s): player; Sonometre
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: music, anesthesia, surgery
Effects of Dihydrocapsiate on Adaptive and Diet-Induced Thermogenesis With a High Protein Very Low Calorie Diet
Condition: Healthy
Study type: Interventional

Summary: 
      The study is designed to determine the effects of a non-pungent supplement from sweet chilli
      pepper on resting metabolic rate and diet-induced thermogenesis (DIT) after a period of very
      low calorie intake over 4 weeks.
    

Detailed description: 
      Thirty-six subjects will be recruited by public advertisement. Postmenopausal women and men
      over age 30 with a body mass index (BMI) between 27 to 35 kg/m2,and in good health by
      history, physical examination, and basic laboratory screening (complete blood count, serum
      chemistries, liver panel, and lipid panel) will be selected for study. Subjects with type 2
      diabetes or glucose intolerance will be excluded as will individuals who regularly drink more
      than one alcoholic beverage daily. Thirty-six men and women who meet the selection criteria
      below will be randomly assigned to one of three arms providing CH-19 at two dose levels per
      day vs. placebo capsules.

      This will be a prospectively randomized double blind study in which neither the subjects nor
      the clinical research personnel will be aware of whether the subjects will be assigned to
      placebo or dihydrocapsiate at two different doses. A total of 36 subjects will be divided
      among three groups.

      To keep the number of capsules taken by each subject constant, all subjects will take three
      capsules three times per day containing the appropriate number of active or placebo capsules
      and will be randomized after screening to one of three groups:

        -  Group 1: Dihydrocapsiate 1 capsule and 2 placebo capsules three times a day within 30
           minutes before breakfast, lunch and dinner.

        -  Group 2: Dihydrocapsiate 3 capsules three times per day within 30 minutes before
           breakfast, lunch and dinner

        -  Group 3: Placebo 3 capsules three times per day within 30 minutes before breakfast,
           lunch and dinner
    

Intervention name(s): dihydrocapsiate capsule
Intervention type(s): Dietary Supplement
Intervention description(s): Group 1: 1 dihydrocapsiate capsule and 2 placebo capsules three times a day within 30 minutes before breakfast, lunch and dinner.
Group 2: 3 dihydrocapsiate capsules three times per day within 30 minutes before breakfast, lunch and dinner
Group 3: Placebo 3 capsules three times per day within 30 minutes before breakfast, lunch and dinner
Other intervention name(s): chili pepper
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Resting energy expenditure (REE); metabolic rate
Determination of the Optimal Size of Oropharyngeal Airway; Correlation With External Body Measurements
Condition: Ear,Nose and Throat Surgery
Study type: Interventional

Summary: 
      There are several studies that have measured various oropharyngeal airway space distances
      using radiological method. However, direct confirmation of optimal size of oropharyneal
      airways (OPAs) in individual using fiberoptic bronchoscope (FOB) is lacking as now. The
      purposes of this study were to directly determinate the proper size of OPA in individual by
      FOB via different sizes of OPA in adults under general anestheisia. Additionally, we examine
      the relationships among the size of OPA, straight length from the incisors to the tip of the
      epiglottis by laryngoscopy, patient height, and external facial measurements.
    


Intervention name(s): Guedel type color-coded OPAs
Intervention type(s): Device
Intervention description(s): The OPAs was used four different sizes as No. 8 (80 mm, green), 9 (90 mm, yellow), 10 (100 mm, red), and 11 (110 mm, orange) in regular sequence. The curvilinear distance from the incisors to the tip of the epiglottis was measured by FOB (Olympus LF-GP; Olympus Optical Co., Tokyo, Japan) with tape marking via each size of OPAs. The distance from the distal end of OPA to the tip of the epiglottis was calculated by the difference between measured distance from the incisors to the tip of the epiglottis via each OPA by FOB and typical distance from the flange to distal end of each OPA via inside tube of OPA. When the size of OPAs was longer than distance from the incisors to the tip of the epiglottis, OPAs were partly withdrawn and repositioned the distal end of OPAs is placed just above the tip of epiglottis. Then, the length from the incisors to the flange of OPAs was measured. .
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
"Fit For Kids"-Copenhagen
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of a 40- week multifactorial intervention against
      overweight, obesity and physical inactivity in Danish children.

      The investigators wish to examine 40 children before and after the "Fit for Kids"
      intervention with basic anthropometric measures such as body mass indexi (BMI), waist/hip
      ratio, systolic- and diastolic blood pressure, level of physical fitness and Total Body fat
      mass.

      Furthermore the investigators wish to examine the more specific inflammatory, metabolic and
      hormonal effect of the intervention with a more extensive examination programme.

      The tests include a DXA-scan, cardio-respiratory fitness, accelerometer monitoring, pedometer
      monitoring, cognitive testing, Continuous Glucose Monitoring System, different metabolic and
      inflammatory markers and an oral glucose tolerance test. The study will take place at Centre
      of Inflammation and Metabolism, Rigshospitalet, Copenhagen.

      The study is a randomised controlled trial with a gradual rollout. The 40 children will be
      randomised. Twenty children will start the intervention at baseline and 20 children will
      start after the first 20 weeks of intervention, thus providing a control group.

      The investigators expect to find a significant reduction in BMI, total body fat mass and
      systolic blood pressure after the intervention. As for the more extensive tests, the data
      approach is explorative, as the investigators look at more statistical dependent variables.
      The contribution of this project is a further description on the effect of intervention
      against overweight and physical inactivity on the metabolic and inflammatory response.
    


Intervention name(s): Physical activity, dietary counseling, coaching
Intervention type(s): Behavioral
Intervention description(s): Physical activity, dietary counseling, coaching
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Diabetes; Physical activity
Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies
Condition: Malignant Female Reproductive System Neoplasm
MeSH terms: Genital Neoplasms, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone
      works in improving pain control during the first 24 hours after surgery in patients with
      gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely
      infiltrated into the skin surrounding the abdominal incision, and is effective in providing
      good relief of incisional pain. Hydromorphone is also a type of pain medication that may
      provide better management of deep abdominal pain. It is not yet known if giving liposomal
      bupivacaine with or without hydromorphone will work better in improving pain in patients with
      gynecological malignancies during the first 24 hours after surgery.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Evaluate if no additional intervention is noninferior to intrathecal analgesia (ITA) for
      postoperative pain experience 24 hours after surgery after laparotomy for gynecological
      malignancy within an established enhanced recovery pathway which includes incisional
      liposomal bupivacaine (ILB).

      II. Evaluate the effect of intrathecal analgesia on patient satisfaction with postoperative
      analgesia after laparotomy for gynecological malignancy.

      III. Report the impact of ITA use on cost. IV. Validate the Quality of Recovery (QOR)-15 in
      our population.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine.

      ARM II: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine
      and hydromorphone intrathecally (IT).
    

Intervention name(s): Hydromorphone; Laparotomy; Liposomal Bupivacaine; Questionnaire Administration
Intervention type(s): Drug; Procedure; Drug; Other
Intervention description(s): Given IT; Undergo laparotomy; Drug; Ancillary studies
Other intervention name(s): (-)-Hydromorphone; Dihydromorphinone; Hydromorphon; Bupivacaine Liposome Injectable Suspension; Exparel
Intervention MeSH terms: Hydromorphone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Internal Versus External Tocodynamometry and Labor Outcome
Condition: Dystocia; Contractions
MeSH terms: Dystocia
Study type: Interventional

Summary: 
      In this study, parturients will be randomized to either internal or external tocodynamometry
      contractions' follow up. Investigators recruit primiparous, those who try to have vaginal
      birth after cesarean section and multiparous, who need oxytocin during labor. Primary
      endpoint is the number of operative labors in each group. Secondary endpoints are the
      duration of labor, the use of oxytocin and the condition of the newborn.
    


Intervention name(s): Intrauterine pressure catheter; External tocodynamometry
Intervention type(s): Device; Device
Other intervention name(s): Internal tocodynamometry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: internal tocodynamometry, external tocodynamometry, cesarean section, labor, newborn, vacuum extraction, dystocia