bioihbjkbjnl/mcl2 huggingface dataset:
Change of Pulmonary Function After Incentive Spirometer Training in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study was designed to examine the effect of incentive spirometry in pulmonary
      rehabilitation of children with cerebral palsy. The incentive spirometer, a device that can
      help improve breathing and strengthen inspiratory muscles. If the patient assigned to
      training group, the subjects started to respiratory muscle strengthening exercise using
      incentive spirometry. The training was performed ten sessions daily, for 4 weeks. Respiratory
      function tests including forced vital capacity, forced expiratory volume in 1 second, Peak
      cough flow, maximal phonation time were compared before interventions and at the end of
      exercise.
    


Intervention name(s): Incentive spirometer training
Intervention type(s): Behavioral
Intervention description(s): The incentive spirometer, a device that can help improve breathing and strengthen inspiratory muscles. First, the subjects exhaled normally, then placed the mouthpiece in their mouth and sealed their lips around the mouthpiece. Then they inhaled slowly and deeply with their lips sealed tightly on the mouthpiece. After they inhaled as deeply as possible, held their breath for at least 3 seconds, and then removed the mouthpiece from their mouth and breathed out normally. Subjects repeated this technique 10-15 times. When they finished 10-15 exercises, they took a deep breath and coughed. The training was performed ten sessions daily, for 4 weeks.
Other intervention name(s): exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Observational Study of Keratoconus and Post-keratoplasty Eyes
Condition: Keratoconus and Post-keratoplasty
MeSH terms: Keratoconus
Study type: Observational

Summary: 
      A prospective observational study on keratoconus and post-keratoplasty will be conducted. We
      will enroll 50 subjects in each of 3 groups: keratoconus, post-PK, and post-DSAEK. The
      Optovue anterior segment OCT prototype will be used to perform 3-D corneal scans. These scans
      will be used to measure corneal thickness (pachymetry), corneal topography (anterior and
      posterior) and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be
      used when they become available. A comprehensive eye examination, Placido-ring corneal
      topography, ultrasound pachymetry, and Scheimpflug camera imagery, will be performed for
      comparison. In some post-PK and post-DSAEK cases, vision will be primarily affected by
      regular astigmatism, myopia, or hyperopia, rather than HOA. These cases can be corrected by
      standard PRK (not OCT guided) with adjunctive mitomycin C treatment to prevent haze
      formation.107, 108 In these cases PRK will be performed according to the standard of care and
      will not be a part of the study protocol. The postoperative results will be observed at the
      3-4 month visit with UCVA, manifest refraction, BSCVA, OCT scanning, Placido topography,
      ultrasound pachymetry, and Scheimpflug camera imagery
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Post Operative surgical patients at Oregon Health & Science University for keratoconus,
        keratoplasty, DSAEK
      
Keywords: keratoconus; post-keratoplasty
Effects of Eccentric Training for Shoulder Abductors in Subjects With Shoulder Impingement Syndrome
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of the study was to evaluate the effect of eccentric strength training for shoulder
      abductors on force steadiness in subjects with subacromial impingement syndrome (SIS).
    

Detailed description: 
      Although it is known that shoulder abduction in subjects with subacromial impingement
      syndrome (SIS) presents alterations in several parameters, as for example, in scapular and
      glenohumeral kinematics, the strengthening of the shoulder abductors as an intervention
      strategy is controversial in literature.

      Strength training has been shown to be effective in reducing the fluctuations in force and
      had a positive effect on isometric steadiness in old adults and in healthy young subjects
      during bed rest. However, there are no studies that evaluated the effects of strength
      training on the force steadiness in subjects with SIS.
    

Intervention name(s): Isokinetic eccentric training
Intervention type(s): Device
Intervention description(s): The eccentric training for the shoulder abductors was performed for 6 consecutive weeks, twice a week, on alternate days.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subacromial impingement syndrome; Muscle Strength; Resistance Training
Transvaginal Ultrasonography Guided Embryo Transfer
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese
      patients undergoing in vitro fertilization.
    

Detailed description: 
      The 800 participants with body mass index more than 30kg/m2 were randomly allocated to two
      groups of equal size using an automated web-based randomization system. The first group 400
      patient undergoing the transabdominal-guided embryo transfer, the second group 400 patient
      undergoing transvaginal-guided embryo transfer.
    

Intervention name(s): transabdominal ultrasound guided embryo transfer; transvaginal ultrasound guided embryo transfer
Intervention type(s): Procedure; Procedure
Intervention description(s): 400 female with body mass index more than 30undergo transabdominal ultrasound guided embryo transfer; 400 female with body mass index more than 30 undergo transvaginal ultrasound guided embryo transfer
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; embryo transfer; invitro fertilization
AFP- L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Hepatocellular carcinoma (HCC) is one of the tumors with an increasing incidence worldwide.
      Often treatment possibilities are limited and only palliative treatment such as a
      transarterial chemoembolisation (TACE) is possible. Therapeutic response is evaluated three
      months after TACE by imaging techniques (CT, MRI). In some HCC patients the tumor marker AFP
      ( alpha-fetoprotein) is elevated, but not all patients show this elevation. In the last years
      new tumor markers such as AFP-L3 (subfraction of AFP) and des-y-carboxyprothrombin (DCP) have
      been examined. In this clinical trial the course of these markers are examined after TACE in
      order to receive hints if the patient will be a therapeutic responder.

      Furthermore the investigators are interested in the quality of life after TACE. Patients
      receive a questionnaire with regard to the quality of life before and 3 months after TACE.
    

Detailed description: 
      Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolisation are
      enrolled in this clinical trial. The aim of this trial is to evaluate the usefulness of the
      liver cancer markers AFP, AFP-L3% (subfraction of AFP) and des-y- carboxyprothrombin (DCP)
      after TACE therapy. Some authors could have shown that AFP-L3% is rising in small tumor
      nodules under 2 cm and so the markers which should decrease after TACE can give a hint for
      the therapeutic response after the intervention. So the important aim of this trial is to
      improve the early detection of tumor recurrence after TACE.

      Furthermore the quality of life measured by the EORTC QLQ C30 before and after TACE is
      evaluated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with confirmed hepatocellular carcinoma according to the AASLD criteria and who
        are treated with transarterial chemoembolisation (TACE) are included in this clinical
        trial. The patients are recruted in our primary care clinic in the department of
        gastroenterology and hepatology.
      
Biospecimen description: 
      measurement of tumor markers AFP, AFP-L3 and DCP in serum samples
    
Keywords: Hepatocellular Carcinoma; transarterial chemoembolisation; liver cancer markers: AFP, AFP-L3% and DCP
Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery
Condition: Bloodloss; Surgical Procedures, Operative
MeSH terms: Blood Loss, Surgical
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to
      Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
    


Intervention name(s): Ecallantide; Cyklokapron(R)
Intervention type(s): Drug; Drug
Intervention description(s): 2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion; 1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
Intervention MeSH terms: Ecallantide; Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Hot Footbath on the Sleep Quality
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The research title is the effect of hot footbath on the sleep quality of patients with
      chronic schizophrenia. The research was a randomized controlled trial. The setting was the
      chronic inpatient wards at a psychiatric teaching hospital in Northern Taiwan. A total of 63
      participants, 30 in the hot footbath group and 33 in the control group, were completed the
      study from November 2019 to June 2020. Participants were randomly allocated to the
      experimental group and the control group. Through this method, we explored whether the trial
      could effectively improve patients' sleep quality.
    

Detailed description: 
      The research title is the effect of hot footbath on the sleep quality of patients with
      chronic schizophrenia. The research was a randomized controlled trial. The setting was the
      chronic inpatient wards at a psychiatric teaching hospital in Northern Taiwan. A total of 63
      participants, 30 in the hot footbath group and 33 in the control group, were completed the
      study from November 2019 to June 2020. Participants were randomly allocated to the
      experimental group and the control group. The experimental group was given a hot footbath
      with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep, and this was
      repeated five times a week for four weeks; the control group was given routine care for four
      weeks. The CPSQI was used to collect the pre- and post-test data. Through this method, we
      explored whether the trial could effectively improve patients' sleep quality.
    

Intervention name(s): hot footbath
Intervention type(s): Other
Intervention description(s): The experimental group was given a hot footbath with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep
Other intervention name(s): Experimental group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The research was a randomized controlled trial. Participants were randomly allocated to the experimental group and the control group. The experimental group was given a hot footbath with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep, and this was repeated five times a week for four weeks; the control group was given routine care for four weeks. The CPSQI was used to collect the pre- and post-test data. Through this method, we explored whether the trial could effectively improve patients' sleep quality.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Footbath; Quality of sleep; Chronic schizophrenia; Patient
A Trial of SHR6508 in Secondary Hyperparathyroidism
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the tolerability, pharmacokinetics and
      pharmacodynamics of SHR6508 for Chinese patients with secondary hyperparathyroidism of
      chronic kidney disease treated by maintenance hemodialysis
    


Intervention name(s): SHR6508；Placebo; SHR6508；Placebo; SHR6508；Placebo; SHR6508；Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Group A:SHR6508 low dose; Group B:SHR6508 medium dose; Group C:SHR6508 high dose; Group D:SHR6508 high dose(single dose)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SHR6508 compared with placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Influences of Chokeberry Extract Supplementation on Handball Players
Condition: Handball Players
Study type: Interventional

Summary: 
      The study included 16 handball players, aged 16-24 years , of handball club "Novi Beograd".
      All study participants were apparently healthy, had no active sports injuries, did not use
      any medications, and were non-smokers. Standardized questionnaires conducted under the
      supervision of a trained nutritionist were used to collect general data, nutritional habits
      and use of dietary supplements. The athletes who used any dietary supplements at least a
      month before the study, were excluded. All participants (or their parents if they were under
      the age of 18) signed an informed consent document. The study was approved by the Ethical
      committee of The Military Medical Academy, Belgrade.

      The study was conducted during regular competition season, and lasted for twelve weeks. All
      participants had the same training and nutritional regime, which excluded intake of berries.
      The players received 30 mL of liquid chokeberry extract, in the morning before training, once
      per day for 12 weeks. For the preparation of chokeberry extract (liquid form) was used fruit
      (berries) of Aronia melanocarpa Elliot, Rosaceae. The extract was donated by Pharmanova
      Belgrade, Serbia. Process of extraction is performed under specific conditions which are
      subject of technical patent (producer EUHEM), for the purpose of production of extract with
      high concentration of polyphenols. The design of the product included few demands: sufficient
      daily dose of polyphenols to be dietary supplement, small volume which can be consumed as
      shot and acceptable taste for most consumers. Compliance was monitored by the trainers.
    


Intervention name(s): chokeberry extract
Intervention type(s): Dietary Supplement
Intervention description(s): The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks.
Other intervention name(s): Alixir400protect
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: oxidative stress; handball players; lipid profile; aronia; body composition
Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK
      Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.
    


Intervention name(s): Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Intervention type(s): Biological
Intervention description(s): All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Other intervention name(s): PumarixTM
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity; Safety; Pandemic Influenza
Incidence of Postoperative Neuromuscular Blockade in Post-Anesthesia Care Unit at Parkland Hospital: Does Size Matter?
Condition: Residual Neuromuscular Blockade
MeSH terms: Delayed Emergence from Anesthesia
Study type: Observational

Summary: 
      This prospective, observational study will assess 100 subjects in the post-anesthesia care
      unit (PACU) at Parkland Hospital. Upon arrival to the PACU, patients' train-of-four (TOF)
      ratio will be calculated using the StimPod NMS450 accelerometer to determine the presence of
      any residual paralysis. Any patient with a TOF ratio < 0.9 will be reassessed every 10
      minutes until the ratio is ≥0.90. The time it takes to reach a TOF ratio ≥0.9 will be
      recorded. Subjects will be classified according to BMI categories: lean as <30 kg/m2, obese
      as 30≤BMI≤39.9 kg/m2, and morbidly obese as BMI ≥40 kg/m2. This data will serve as a baseline
      to assess the incidence of residual NMB that currently occurs in our PACU so that we may use
      this pilot data to design future studies that aim to reduce the incidence of residual NMB.
    

Detailed description: 
      Upon arrival to the PACU, patients enrolled in the study will be evaluated for residual
      paralysis with train-of-four (TOF) stimulation using the StimPod NMS450 accelerometer set to
      30 mA. Any patients who have residual paralysis will be assessed Q10 minutes until the TOF
      ratio is ≥0.9. The time to achieve a TOF ratio ≥0.9 will be recorded. Any adverse events
      (e.g., hypoxia, reintubation, aspiration) that arise during the patient's PACU stay will be
      documented.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects in the post-anesthesia care unit who have undergone surgery with neuromuscular
        blockade
Establishment of Reference Values for Insulin-like Growth Factor 1 (IGF1) in the General Population
Condition: Population
Study type: Interventional

Summary: 
      Various assays can be used for IGF-I measurement in French laboratories. Unfortunately, each
      assay gives a very different result for the same sample. As IGF-I also varies with age, it is
      necessary to establish a broad population reference values of IGF1 concentration for each of
      the IGF1 assays used in clinical practice, taking into account individual variation factors
      such as age, nutritional status and possible treatments.

      The objective of this study is to establish normative data based on a large random selection
      from the general population, including representation from all age groups (around 100
      subjects for each decade age range). This will be performed for all the available assay kits.
      Subjects with medical conditions and medications that may affect the outcome will be
      excluded. Normative data will include the range (2.5 to 97.5 percentiles) in mass units and
      results will be reported as mass units but also as SD scores in order to be able, in a given
      patient, to compare its IGF-I concentration along time, even if using different assays.
    

Detailed description: 
      Healthy subjects will be recruited in 30 centers all around France. A total of 1000 healthy
      subjects are necessary. Each subject will have a clinical examination with measurement of
      height and weight. Personal medical history will be recorded and gonadal status evaluated.
      Biological standard workup will be performed and 80 ml of blood will be sampled and serum
      will be aliquoted, frozen and stored at -80°C. IGF-I level will be measured with all the
      assay methods available (sera kept in bank will be used in the future when new methods will
      be available) For each assay method and each age group (Four 3-years groups between 18 and 30
      years and six decade age groups between 30 and 89 years) IGF-I will be measured.

      Results will be expressed as mean, median, standard deviation, 2.5th and 97.5th percentiles,
      in mass units. Modelisation according to age and other factors will be performed in order to
      allow the reporting of IGF-I results for a given individual expression of IGF-I as Z-score.
    

Intervention name(s): Blood sample
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: IGF1; standards; Assays; Z-score; Healthy volunteers; Population
Life Quality Study for PFAPA Patient
Condition: PFAPA Syndrome
Study type: Observational

Summary: 
      This cohort study aims to assess the quality of life (or welfare) related to the health of
      children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall
      syndrome to compare it to children or adolescents with recurrent fever genetics of Familial
      Mediterranean fever (FMF) in order to improve their overall care.
    


Intervention name(s): Quality of life
Intervention type(s): Other
Intervention description(s): Quality of life
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with PFAPA syndrome compare to patient with FMF syndrome