bioihbjkbjnl/mcl2 huggingface dataset:
Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II
Condition: Respiratory Syncytial Virus, Bronchiolitis
MeSH terms: Bronchiolitis; Respiratory Sounds
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The main objective of the APW-RSV II clinical trial is to evaluate if the addition of
      azithromycin to routine bronchiolitis care, among infants hospitalized with RSV
      bronchiolitis, reduces the occurrence of recurrent wheeze during the preschool years.
    

Detailed description: 
      The APW-RSV II clinical trial is a double blind, placebo-controlled, parallel-group,
      randomized trial, including otherwise healthy 188 participants, ages 1-18 months, who are
      hospitalized due to RSV bronchiolitis. The study includes active treatment phase with
      azithromycin or placebo for 2 weeks, and an observational phase for up to 48 months.

      The main objective of the APW-RSV II clinical trial is to evaluate if the addition of
      azithromycin to routine bronchiolitis care, among infants hospitalized with RSV
      bronchiolitis, reduces the occurrence of recurrent wheeze (RW) during the preschool years.

      Study participants will be enrolled during 3 consecutive RSV seasons beginning in Fall 2016.
      Study participants will be randomized to receive PO azithromycin 10 mg/kg/day for 7 days
      followed by 5mg/kg/day for additional 7 days, or matched placebo. The primary clinical
      outcome is the time to the occurrence of a third episode of wheezing. The duration of follow
      up is 18-48 months, which is determined based on the year in which the participants is
      recruited: first year recruits will be followed for up to 48 months, while the 3rd year
      recruits will be followed for at least 18 months.
    

Intervention name(s): Oral azithromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days; Placebo suspension
Other intervention name(s): Azithromycin suspension
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to look at how tucatinib might affect the way another drug
      (metformin) works. It will look at healthy volunteers and how tucatinib affects how the body
      absorbs metformin. This will help us find out whether tucatinib is safe to give together with
      metformin. The study will also look at how tucatinib affects how the kidneys work.
    

Detailed description: 
      This is a single center, fixed-sequence, drug-drug interaction study to assess the effects of
      multiple oral doses of tucatinib on the pharmacokinetics of a single oral dose of metformin
      in healthy subjects. The primary objective of the study is to assess the effects of tucatinib
      on the single-dose PK of metformin. Secondary objectives of the study are to (1) assess the
      safety and tolerability of metformin when coadministered with tucatinib and (2) assess the
      effects of tucatinib on renal function using iohexol as glomerular filtration rate (GFR)
      marker.
    

Intervention name(s): Tucatinib; Metformin; Iohexol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150mg administered orally twice daily; 850mg administered orally; 1500 mg administered intravenously (IV)
Intervention MeSH terms: Metformin; Tucatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Instrumented Wobble Board to Present the Distribution and Center of Pressure in Dynamic Balance
Condition: Balancing Interference
Study type: Interventional

Summary: 
      This study quantified the displacement of the center of pressure in the computer in real time
      and record this data for future analyzes
    

Detailed description: 
      The wobble board is an unstable equilibrium platform, constant training on this platform
      generates an improvement in balance and strengthens the muscles, it is ideal for
      rehabilitation exercises and balance conditioning. However, these platforms do not provide
      quantitative data on exercises performed on it. And the force platform that provide this
      quantitative data is static, offering no difficulty in maintaining balance. In this way, a
      sensor board wobble board was developed using a conventional wobble board with a plate
      attached to it, between the plate and the platform are eight strain gauges sensors that are
      activated according to the position of the force applied on the platform, the values of the
      sensors are collected by software that demonstrates the point of greatest pressure on the
      disk and its displacement during the exercises, with this data it is possible to determine
      the stability of the user and observe their behavior during the exercises.
    

Intervention name(s): With feedback; Without feedback
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): To evaluate the displacement of the center of pressure on the disc during the equilibration with feedback.; To evaluate the displacement of the center of pressure on the disc during the equilibration without feedback.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Wobble board; center of pressure; dynamic balance; force platform
Randomised, Double-blind, Placebo-controlled Study of Topical Clobetasone Butyrate 0.05% Cream in Subjects With Eczema for Two Weeks to Evaluate the Efficacy and Safety
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a multicenter, randomised, double-blind, two treatment arms, vehicle (cream base)
      -controlled, parallel-group study in subjects with moderate to severe eczema (defined by
      investigators global assessment (IGA) score greater than or equal to 3).

      Subjects were screened within 3 days prior to randomization. At the screen visit, subjects
      gave informed consent and were then assessed for health status and eligibility for inclusion
      in the study. At the baseline visit, subject eligibility was assessed for randomization (Day
      0). Eligible subjects were randomised to Clobetasone Butyrate 0.05% Cream group or vehicle
      (cream base) group at the rate of 1:1. During the treatment phase, subjects returned to the
      sites in day 7 post-baseline visit for assessment of their disease status and eligibility to
      continue on the study. During the final visit, 14 days after the baseline, subjects returned
      to the study sites for assessment of their disease status before completing the study. In
      addition, the safety and tolerability of Clobetasone Butyrate 0.05% cream were also assessed
      through the whole trial.
    


Intervention name(s): Clobetasone Butyrate 0.05% Cream; Vehicle (base cream)
Intervention type(s): Drug; Drug
Intervention description(s): Clobetasone Butyrate 0.05% Cream; Vehicle (base cream)
Intervention MeSH terms: Clobetasone butyrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: eczematous; dermatitis
Efficacy and Safety of Elobixibat in Combination With Cholestyramine for Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective is to evaluate the efficacy and safety of once-daily oral doses of 10 mg
      elobixibat in combination with 9g cholestyramine powder (cholestyramine 4g) in patients with
      nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).
    

Detailed description: 
      This is a placebo-controlled, randomized, double-blind, parallel group, comparative study,
      when patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis
      (NASH), are administered elobixibat at 10 mg and cholestyramine powder at 9g( cholestyramine
      4g) once daily for 16 weeks.
    

Intervention name(s): Elobixibat 10mg + cholestyramine powder 9g (cholestyramine 4g); Elobixibat 10mg + cholestyramine powder placebo; Elobixibat placebo + cholestyramine powder 9g (cholestyramine 4g); Elobixibat placebo + cholestyramine powder placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients with nonalcoholic fatty liver disease are administered Elobixibat 10mg + cholestyramine powder 9g (cholestyramine 4g) for 16 weeks; Patients with nonalcoholic fatty liver disease are administered Elobixibat 10mg+ cholestyramine powder placebo for 16 weeks; Patients with nonalcoholic fatty liver disease are administered Elobixibat placebo+ cholestyramine powder 9g (cholestyramine 4g) for 16 weeks; Patients with nonalcoholic fatty liver disease are administered Elobixibat placebo+ cholestyramine powder placebo for 16 weeks
Other intervention name(s): AJG533 10 mg + CTM27 9 g; AJG533 10 mg + CTM27 placebo; AJG533 placebo + CTM27 9g; AJG533 placebo + CTM27 placebo
Intervention MeSH terms: Cholestyramine Resin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elobixibat; Cholestyramine; Nonalcoholic fatty liver disease; Nonalcoholic steatohepatitis; phase 2 trial; Combination therapy
LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children
Condition: Children
Study type: Observational

Summary: 
      The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the
      current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.
    

Detailed description: 
      The goal for this randomized, non-crossover investigation is to compare a disposable version
      of the standard LMA, LMA Unique TM,with the air-Q ILA-SP in pediatric patients. Oropharyngeal
      leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible
      fiberoptic bronchoscope examination is often employed to assess proper placement of airway
      devices. We hypothesize that airway leak pressures with the ILA-SP will be superior to the
      LMA upon initial device placement, and ten minutes after device placement. Airway leak
      pressures will be measured by recording the circuit pressure at which equilibrium is reached.
      Ease of placement, fiberoptic grade of laryngeal view, and complications (airway related,
      gastric insufflation, trauma) will also be assessed.
    

Intervention name(s): Laryngeal Mask Airway; air-QTM Intubating Laryngeal Airway
Intervention type(s): Device; Device
Intervention description(s): Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.; Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.
Other intervention name(s): Laryngeal Mask AirwayTM (Laryngeal Mask Airway North America; San Diego, CA USA); air-QTM Intubating Laryngeal Airway Mercury Medical;Clearwater, Fl USA
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children weighing 20 to 30 kg undergoing surgery requiring a supraglottic airway device
      
Keywords: Supraglottic airway devices
A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
Condition: Gastric Cancer; Helicobacter Pylori Infection; Bismuth
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      To observe the eradication rate of H. pylori infection, symptom improvement and the incidence
      of adverse effects in patients using a bismuth colloidal pectin granules quadruple therapy.
    

Detailed description: 
      The study will include three phases: screening, treatment and follow-up. Screening: Patients
      who have been screened to meet the criteria for naval platooning will be enrolled after
      signing an informed consent form.

      Treatment: Subjects will receive 14 days of eradication treatment. With the exception of
      colloidal bismuth pectin granules, which will be limited, proton pump inhibitors (PPI) and 2
      antibiotics will be selected on the basis of the physician's experience.

      Follow-up: Includes two visits. approximately 14 days of treatment and 28 days after the end
      of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
    

Intervention name(s): Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
Intervention type(s): Drug
Intervention description(s): Standard dose of proton pump inhibitor, bismuth , and 2 antibiotics, 14 days course.
Standard doses of proton pump inhibitors are esomeprazole 20mg, rabeprazole 10mg (or 20mg).
Omeprazole 20mg, lansoprazole 30mg, pantoprazole 40mg, alprazole 5mg, any one of these.
Bismuth is colloidal bismuth pellets, 150mg, 2 times/d.
Antibiotic Program:
Scheme 1 Amoxicillin 1000 mg, 2 times/d; Clarithromycin 500mg, 2 times per day Scheme 2 Amoxicillin 1000 mg, 2 times/d; Levofloxacin 5001 times/2 times Scheme 3 Amoxicillin 1000 mg, 2 times/d; Furazolidone 100mg, 2 times/d. Scheme 4 Amoxicillin 1000 mg, 2 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 5 Amoxicillin 1000 mg, 2 times/d; Tetracycline 500mg, 3 times/d or 4 times/d Scheme 6 Tetracycline 500mg, 3 times/d or 4 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 7 Tetracycline 500mg, 3 times/d or 4 times/d; Furazolidone 100mg, 2 times/d.
Intervention MeSH terms: Bismuth
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      BPH is very common in elderly men, it is a stromal as well as epithelial invasion of the
      prostatic gland. Due to an imbalance between growth and apoptosis cellular mechanisms that
      are not fully elucidated. It is the same for symptomatology and urodynamic obstruction
      without clear identification of the part which is due to static phenomena (volume increase)
      and dynamic reports (α 1-receptor action). That explains the multiplicity of treatments and
      the difficulty of therapeutic indications between monitoring, medical treatment, and surgical
      operation. Experimental studies of BONT-A intra prostatic injection on animal and human
      models, have shown efficacy in BPH cell apoptosis, decrease in cell growth and decline in the
      number of adrenergic α1 receptors.

      Many studies in humans show therapeutic efficacy leading to a possible use of BONT-A as mini
      invasive treatment of symptomatic BPH, as an alternative to medical or surgical treatment.

      PROTOX study proposes to evaluate tolerance and effectiveness of the intra-prostatique BONT-A
      injection in the treatment of symptomatic BPH.
    


Intervention name(s): BONT-A intra-prostatic injection; Optimized medical BPH treatment
Intervention type(s): Drug; Drug
Intervention description(s): • Intra prostatic injection of 200 IU of BONT-A (2 x 100 IU to dilute in 10 cc salted serum), divided into 4 injections, 2 in each prostate lobe for a volume intra injected 2.5 cc per site.
Interruption of the medical therapy 1 month after the injection;; Optimization of the medical therapy according to recent guidelines
Intervention MeSH terms: incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sore Throat Prevention Following Intubation
Condition: Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this interventional study is to find out the incidence of sore throat among
      intubated patients in Jordan university hospital and to find out which is preventive and
      effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as
      lubricant versus dexamethasone 8 mg intravenously or both.
    

Detailed description: 
      Three groups were divided into: first group received xylocaine gel as endotracheal cuff
      lubricant,second group received dexamethasone 8 mg intravenously and third group received
      both( xylocaine and dexamethasone).

      The investigator compared between the three groups regarding sore throat in intubated
      patients and followed them up to 48 hours.
    

Intervention name(s): xylocaine; Dexamethasone; Xylocaine and Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): First group were given xylocaine; Second group were given Dexamethasone; Third group were given both Xylocaine and Dexamethasone
Other intervention name(s): X; D; XD
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lidocaine; BB 1101
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Sore Throat; Intubation; Xylocaine; Dexamethasone
Effect of Thoracic Manual Therapy in Hemiplegic Patients
Condition: Stroke
Study type: Interventional

Summary: 
      Neurological problems both lead to many respiratory problems primarily and events secondary
      to neurological diseases or symptoms can be the cause of respiratory failure. The addition of
      respiratory failure will adversely affect the course of the neurological picture, making
      treatment more difficult.

      The cardiopulmonary functions of hemiplegia patients decrease due to the decrease in the
      expansion of the thoracic part on the hemiplegic side and insufficient respiratory muscles.
      In addition, common symptoms in stroke patients, including limited use of ankylosis and
      muscle movements, cause oxygen deficiency and increased metabolic demands. After stroke,
      thoracic expansion is reduced upon paralysis of the diaphragm and respiratory muscles.
      Continuation of this condition can lead to muscle fibrosis. As a result, the level of
      thoracic expansion decreases during breathing.

      A decrease in thoracic spine mobility correlates with a decrease in forced vital capacity
      (FVC) and forced expiratory volume in the first second (FEV1). The increase in the rigidity
      of the chest wall affects the ventilator pumping mechanism, reducing the level of rigidity
      (increasing the mobility of the chest wall) is recommended as a way to improve lung function.
    


Intervention name(s): Manuel Therapy
Intervention type(s): Other
Intervention description(s): The manual therapy protocol will consist of 45-60 minutes and the following techniques;
suboccipital decompression
cervical mobilization (in the posterior-anterior direction)
sternocleidomastoid release
scalene release
trapezoidal release
scalene release
pectoralis tractus
sternoclavicular joint mobilization
sternum mobilization
parasternal circumference intercostal and paravertebral release
diaphragm release
rib reasing
scapulothoracic joint mobilization
thoracic vertebra mobilization
Myofascial release techniques will be applied for 3-5 minutes each.
Mobilization techniques were applied in each joint for 30 seconds and 5 times.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: pulmonary function; manual therapy; respiratory function test
Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method
Condition: Subcutaneous Adipose Tissue
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment
      with the Liposonix System (Model 2)using a single pass technique.
    


Intervention name(s): Liposonix System (Model 2)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial
Condition: Complication of Surgical Procedure; Leak; Blood
Study type: Interventional

Summary: 
      The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative
      complications. Staple line reinforcement (SLR) is strongly advocated.
    

Detailed description: 
      The aim of this study was to prospectively and randomly compare three different techniques of
      SLR during LSG: oversewing (group A), buttressed transection with a polyglycolide acid and
      trimethylene carbonate (group B) and staple-line roofing with a gelatin fibrin matrix (group
      C).
    

Intervention name(s): Bariatric surgery
Intervention type(s): Procedure
Intervention description(s): Staple line reinforcement during sleeve gastrectomy
Other intervention name(s): bariatric surgical procedure; gastric resection; steaple line reinforcement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Real-time and Computerized Sonographic Reporting System in Predicting Malignant Cervical Lymphadenopathy
Condition: Lymphadenopathy
MeSH terms: Lymphadenopathy
Study type: Observational

Summary: 
      The investigaotors want to establish a real-time and computerized score reporting system
      based on the significant predictors of the measured sonographic parameters and demographic
      data.
    

Detailed description: 
      One hundred eight patients with neck lymphadenopathy, receiving ultrasonography and
      ultrasound-guided fine-needle aspiration (US-FNA), were used to construct a predictive model.
      This model was validated by another independent patient cohort.
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with previously untreated neck masses were referred for sonographic evaluation and
        subsequent US-FNA after informed consent was obtained. Demographic data, including age and
        sex, side, site, and number of lymphadenopathy was collected as well.
      
Keywords: age; lymphadenopathy; fine needle aspiration; sonography