bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Training in Asthma Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of a physical training program with active
      video game in inflammatory markers, quality of life variables , clinical control and physical
      and functional respiratory assessment of asthmatic children from 5 to 11 years.
    

Detailed description: 
      The aim of the present study will be to determine whether an aerobic exercise using an active
      video game system improves asthma control, lung inflammation and functional capacity in
      children with moderate or severe asthma.
    

Intervention name(s): Video game group; Aerobic exercise group
Intervention type(s): Other; Other
Intervention description(s): The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( adventure- reflex ridge).; A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
Other intervention name(s): treadmill training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Asthma; childhood; exercise
DA Versus DAC as Postoperative Adjuvant Treatment for Early-stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Our study is a prospective, non-inferior, randomized phase II clinical trial, to compare the
      efficacy and safety profiles of DA versus DAC as adjuvant chemotherapy regimens for
      early-stage breast cancer patients.
    


Intervention name(s): Docetaxel, Doxorubicin; Docetaxel, Doxorubicin, Cyclophosphamide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigate Absorption, Metabolism, Excretion, and Mass Balance of Pacritinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, absorption, metabolism, excretion, and mass balance study of 400
      mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose to
      6 healthy male subjects following at least a 10-hour fast (not including water) on Day 1.
    

Detailed description: 
      The present study is designed to investigate the absorption, metabolism, excretion as well as
      safety/tolerability of pacritinib following the administration of a single oral dose to
      healthy male volunteers. The pacritinib dose is administered with a [14C]-labeled form to
      enable detection and quantitation of dose-related material independent of possible
      biotransformation. The study design allows detection of potential human specific metabolites
      that have not been detected in the animal species. Subjects are confined at the clinical site
      from the time of Check-in until Day 14 post-dose, but may be discharged from the clinical
      site between Day 10 and 13 post-dose if study discharge criteria are met (i.e. completion of
      sufficient radioactivity excretion). All remaining subjects will be discharged from the
      clinical site on Day 14 post-dose irrespective of the study discharge criteria. The data
      obtained in this study will be used for the further clinical development of the compound.
    

Intervention name(s): Pacritinib
Intervention type(s): Drug
Intervention description(s): 400 mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose following at least a 10-hour fast (not including water) on Day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ADME; Pacritinib
Tiotropium Efficacy Against Allergen Induced Early Asthmatic Responses
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will compare the effect of inhaled tiotropium versus placebo on allergen induced
      early asthmatic responses in individuals with atopic asthma.
    

Detailed description: 
      This is a single center, double-blind, randomized, placebo-controlled, crossover study. The
      study will consist of two one week treatment periods, one with tiotropium (two
      inhalations/5mcg/day) and one with placebo (2inhalations/day). A minimum two week washout
      period between treatments is required. Four visits over the course of approximately 4 weeks
      will be required to complete the study. Procedures at each visit are as follows:

      Visit 1:

      Participants will undergo consent procedures and if consent is provided measurements of FeNO,
      spirometry, airway responsiveness to methacholine, skin prick testing, skin titration
      endpoint testing and sputum induction will be performed. If participants meet eligibility
      criteria following these assessments, treatment 1 will be dispensed and the first dose
      administered. The participant will then self administer the treatment for the next six days
      (i.e. a total of 7 days of treatment) before returning for Visit 2.

      Visit 2:

      A final dose of treatment 1 will be administered. At 30 minutes post dose, FeNO testing,
      spirometry measurements and allergen inhalation challenge will be performed. Five hours after
      the allergen challenge, FeNO will again be measured and sputum induction will be performed.

      Visits 3 and 4:

      Visits 3 and 4 will be identical to Visit 1 and 2 except that no skin prick testing or skin
      titration endpoint testing will be required. At Visit 3 participants will be crossed over to
      treatment 2 and the first dose will be administered. Participants will self administer
      treatment 2 for the next six days before returning for Visit 4.

      The primary endpoint will be the EAR PD20, the amount of allergen required to induce an early
      asthmatic response (i.e. a fall in FEV1 post allergen inhalation of 20% or more) tiotropium
      versus placebo.
    

Intervention name(s): tiotropium bromide monohydrate (Spiriva Respimat); matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): administered daily, 2 inhalations/5mcg per dose for a total of 8 doses; administered daily, 2 inhalations per dose for a total of 8 doses
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prospectively Predict the Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy
Condition: Advanced Gastric Carcinoma; Immunotherapy
MeSH terms: Stomach Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      To vertify the function of circulating exosomal lncRNA-GC1 on predicting and monitoring
      immunotherapeutic outcomes of GC
    

Detailed description: 
      The investigator's previous work identified circulating exosomal lncRNA-GC1 as a GC-specific
      tumor burden marker and this novel biomarker showed promising efficiency in monitoring
      disease progression during treatment.

      Hence in this stuty, the investigator plan to recruit a prospective cohort to support the
      conclusions, and provide biomarkers to realize predicting and monitoring immunotherapeutic
      outcomes of GC.
    

Intervention name(s): Circulating exosomal lncRNA-GC1 detection
Intervention type(s): Device
Intervention description(s): Collect peripheral blood sample of 80 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect circulating exosomal lncRNA-GC1. Tumor response evaluation will be performed after two cycles of immunotherapy by CT/MRI based on RECIST.
Clinical data, including tumor stage, metastastic organ, regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients in this study were enrolled by the Department of General Surgery, Chinese PLA
        General Hospital for conventional therapy or clinical trials
      
Keywords: Circulating exosomal lncRNA-GC1; Advanced Gastric Carcinoma; Immunotherapy response
Prospective Outpatient Registry of Myocardial Infarction Patients
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational [Patient Registry]

Summary: 
      The investigators enrolled 160 patients who visited Moscow state outpatient clinic №9 (and
      its two branches) within six months after acute myocardial infarction. The enrollment lasted
      from 01.03.2014 to 01.07.2015. The observation period is five years. During the first year
      after enrollment in the study, patients had follow-up visits every two months, from
      second-year every six months. Analysis of the prescribed therapy and its changes was carried
      out by the cardiologist in the clinic for the entire observation period, taking into account
      the concomitant diseases /indications/contraindications. Endpoints (the death, repeated
      cardiovascular complications (AMI, stroke), emergency hospitalization due to worsening of the
      main cardiovascular disease, the appearance of clinically significant cardiac arrhythmias,
      invasive interventions) were defined during out-patient visits and telephone contact
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who have undergone AMI and applied no later than 6 months after discharge from the
        hospital to the outpatient clinic № 9 or its branches from March 1, 2014 to December 31,
        2015;
      
Keywords: myocardial infarction, registry
Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used
      since the 1960s and is regarded as the standard of care in elderly patients. We assess
      whether the addition of thalidomide to this combination or adapted high-dose chemotherapy,
      using a melphalan 100 mg/m2 -based regimen, would improve survival.
    

Detailed description: 
      Trial design This multicenter, randomized, controlled trial is conducted by the French
      Myeloma Intergroup(IFM) in elderly patients with previously untreated multiple myeloma. The
      primary objectives of the study are to compare the efficacy and safety of MP with
      MP-Thalidomide or with MEL100 (intermediate-dose melphalan 100 mg/m2 - based treatment). The
      secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100.
    

Intervention name(s): Thalidomide
Intervention type(s): Drug
Intervention MeSH terms: Thalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple myeloma; Elderly patients; Thalidomide; Autologous transplantation
Chronic Reduction of Fasting Glycaemia With Insulin Glargine Improves First and Second Phase Insulin Secretion in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Glucose-induced insulin secretion is often diminished in hyperglycaemic patients with type 2
      diabetes. The investigators examined, whether chronic basal insulin treatment with insulin
      glargine lead to improvements in glucose-induced insulin secretion.
    

Detailed description: 
      14 patients with type 2 diabetes on previous metformin therapy were examined before and after
      eight weeks of treatment with insulin glargine, aimed to normalize fasting glycaemia.
      Intravenous glucose tolerance tests were performed with and without previous adjustment of
      fasting glucose levels by means of a 3-hour intravenous insulin infusion.
    

Intervention name(s): insulin glargine
Intervention type(s): Drug
Intervention description(s): 14 patients with type 2 diabetes on previous metformin therapy were treated with insulin glargine, aimed to normalize fasting glycaemia.
Other intervention name(s): Lantus
Intervention MeSH terms: Insulin Glargine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; first phase insulin secretion; beta-cell rest; basal insulin
Musculo-scrawny Manifestation Associated With the Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The endometriosis is defined by the presence of endometriosic tissue outside of the womb and
      the prevalence is estimated to be 10% of women.Here is a project aimed to compare
      musculo-scrawny pains between patients with endometriosis and whose don't suffer of this
      pathology;
    


Intervention name(s): pain VAS evaluation
Intervention type(s): Other
Intervention description(s): each patient has to answer to a questionnaire about pain
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patient consulting in gynecologic service of GHPSJ
Impact of Heart Rate Characteristics Monitoring in Neonates
Condition: Sepsis
Study type: Interventional

Summary: 
      Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC)
      will require intubation and mechanical ventilation as a result of sepsis and sepsis-like
      illness.

      Infants will be randomly assigned to one of two groups. One group of infants will have the
      HRC index known to the physicians caring for them, and physicians will use the HRC index as
      they desire to aid in clinical management.

      Infants in the other group will have the HRC index recorded, but this information will not be
      displayed to the physicians caring for the infants.
    

Detailed description: 
      Following randomization, infants will be managed as usual practice. The treating physicians
      of the HRC-display group will be able to utilize the HRC score to assist in the care of the
      infant. The physicians of the no-display group will provide care as per standard.

      Clinical symptoms will be treated according to the medical discretion of each physician.
      Cultures will be obtained and antibiotics administered as per the medical discretion of the
      physicians.

      Clinical, culture results, antibiotic administration, ventilator use, and outcome at 120 days
      data will be collected on the infants as well as their HRC score calculated by the HeRO heart
      rate characteristics monitor.
    

Intervention name(s): HeRO heart rate characteristics monitor
Intervention type(s): Device
Intervention description(s): 24 hour continuous HRC monitoring with display
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: very low birth weight infants; heart rate characteristics
The Mechanical Properties of Burned Muscles
Condition: Burns; Muscle Loss; Viscoelastic Properties; Stiffness
Study type: Interventional

Summary: 
      The investigate of mechanical properties of muscles in burned patients.
    

Detailed description: 
      The hypermetabolic response to severe burn is characterized by muscle protein catabolism.
      Current opinion states that the hypermetabolic state resolves soon after complete wound
      closure. Clinically, we have witnessed that burned patient appear to be hypermetabolic and
      catabolic long after full healing of their wounds. Our goal in this study was to determine
      muscle mechanical properties (tone, stiffness and elasticity) after burn.
    

Intervention name(s): Myotonometric measurement
Intervention type(s): Diagnostic Test
Intervention description(s): Myotonometric assessment can predict the muscle stiffness, tone and elasticity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: Burn; muscle; myotonometer; viscoelasticity; stiffness
Use of Acetyl Salicylic Acid and Terbutalin in Assisted Reproductive Techniques (ART)
Condition: Reproductive Techniques, Assisted
Study type: Interventional

Summary: 
      This study aims to determine the possible effects of Acetyl Salicylic Acid (ASA) and
      Terbutalin on ART treatment.
    

Detailed description: 
      This study aims to determine the possible effects of ASA and Terbutalin on ART treatment.
    

Intervention name(s): Acetyl Salicylic Acid and Terbutalin
Intervention type(s): Drug
Intervention description(s): ASA 75 mg, Terbutalin 5mg
Intervention MeSH terms: Aspirin; Salicylic Acid; Salicylates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Effect of ITCA 650 on the PK/PD of Oral Contraceptive in Healthy Female Subjects
Condition: Healthy Adult Premenopausal Female Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect
      of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl
      estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal female
      subjects.
    


Intervention name(s): ITCA 650 20/60 mcg/day, ITCA placebo; ITCA placebo, ITCA 650 20/60 mcg/day
Intervention type(s): Drug; Drug
Intervention description(s): ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days, followed by ITCA osmotic mini pump delivering placebo and Levora® for 28 days; ITCA osmotic mini pump delivering placebo and Levora® for 28 days, followed by Levora® and ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the immunogenicity and safety of different formulations of the
      HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of
      Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose
      of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): HBV-MPL vaccine; Engerix™-B
Intervention type(s): Biological; Biological
Intervention description(s): 5 different formulations, 2-dose intramuscular injection; 3-dose intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; HBV-MPL; Recombinant Hepatitis B vaccine
Innovation of Audio-Visual Triage System in Combating the Spread of COVID-19 Infection and Its Efficacy: A Novel Strategy
Condition: Audio-Visual Triage System; Anxiety Levels; COVID-19 Spread; GAD-7 Score; Healthcare Professionals; Screening Strategy
MeSH terms: COVID-19
Study type: Observational

Summary: 
      During the novel coronavirus pandemic, also known as SARS-CoV-2 or COVID-19 pandemic,
      frontline healthcare professionals suffered psychological as well as pathological trauma due
      to the lack of preparation to cope with this unforeseen situation. The protocols to prevent
      the spread of this disease proved to be less effective than anticipated. In these
      circumstances, improvement of the existing triage system was felt and an AUDIO-VISUAL TRIAGE
      (AVT) system was introduced to enhance confidence as well as increase the safety of frontline
      healthcare professionals. The current analysis was performed from March 21, 2020, to April
      28, 2020, until the completion of sixty response forms, at Bahria Town International
      Hospital, Lahore. Thirty participants (Group A) deployed on visual triage and other thirty
      (Group B) on Audio-Visual triage for screening suspected cases of COVID-19 infection. Anxiety
      levels were measured by using the GAD-7 scoring system and the participants of both groups
      were periodically tested for COVID-19 infection by PCR. Independent t-test was used to
      evaluate the significance of different variables at a confidence level of 95%.
    

Detailed description: 
      A novel strategy 'Audio-Visual Triage' was introduced to boost up the confidence levels,
      lower down the anxiety levels and the most important factor is to reduce the risk of COVID-19
      infection spread. This Triage system included Audio system to communicate with patients and
      access the COVID-19 infection status at recommended distance of 6 feet. The main disturbing
      factors that were noted on Visual triage system were, 1). Close contact of healthcare
      professionals with patients and attends, 2). Fear of transmission of infection lead to higher
      levels of anxiety. To assess the efficiency of AVT Anxiety level were analyzed by using
      Spitzer et al., 2006, General Anxiety Disorder-7 (GAD-7) scoring system and outcomes were
      assessed where a score less than 5 is taken as no anxiety, 5-9 interpreted as mild anxiety,
      10-14 moderate anxiety, and ≥ 15 as severe anxiety levels.
    

Intervention name(s): Audio-Visual Triage System (AVT)
Intervention type(s): Device
Intervention description(s): Audio System was added to visual triage that resulted in an AVT. Protocols of AVT included, a medical personal sits on TRIAGE DESK (with glass barrier sheet on it) wearing personal protective equipment (PPE) at a distance of more than 6 feet from the PATIENT DESK. Both desks are connected with Non-touchable MIC SYSTEM for communication
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Asymptomatic Healthy