bioihbjkbjnl/mcl2 huggingface dataset:
Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)
Condition: Pleural Empyema
MeSH terms: Empyema; Empyema, Pleural
Study type: Interventional
Phase: Phase 3

Summary: 
      Bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural
      empyema) around the lungs in children. The incidence of pleural empyema in children has
      increased significantly in the last 10 years.

      Short term morbidity for this condition is substantial, but unlike in adults, the long term
      outcome of this condition for children in developed countries is favourable. Inserting a
      chest drain and then adding a medicine (tissue plasminogen activator - tPA) to break down
      organized pus has been shown to be an effective therapy for reducing the duration of illness.
      However, this treatment is still suboptimal and prolonged hospitalization is common. Recent
      data from adults suggests that adding an additional medicine (DNase) to decrease the
      viscosity (thickness) of the fluid improves drainage and leads to better patient outcomes;
      however, there are no published studies on children.

      This is a multi-centre randomized controlled trial comparing the time to discharge from
      hospital after chest drain insertion in previously well children who present with pleural
      empyema, treated with intrapleural DNase and tissue plasminogen activator (tPA) by chest
      drain for three doses over 48 hours compared with three doses over 48 hours of tPA alone.
      Other outcomes related to effectiveness, safety and cost will be assessed as well.
    


Intervention name(s): TPA (Tissue Plasminogen Activator); DNase; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Intrapleural administration of tPA 4 mg in 10 ml (≤10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days; Intrapleural administration of DNase 5 mg diluted to 10 ml (≤10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days; Intrapleural administration of normal saline 10 ml (≤10 kg) or 20 ml (>10 kg)
Other intervention name(s): Cathflo (alteplase, recombinant); Pulmozyme (Dornase alfa); Normal saline
Intervention MeSH terms: Tissue Plasminogen Activator; Plasminogen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized controlled trial; Pleural Empyema; tPA; DNase
The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects
Condition: Healthy; Obese
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      During this project the effect of modified wheat bran on colon health and systemic health
      will be evaluated in a long-term intervention study in healthy and obese subjects.
    


Intervention name(s): Wheat bran; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 20 g each day; 20 g each day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Strength and Coordination Training on Biomechanics and Injury in New Runners
Condition: Injuries; Patellofemoral Pain Syndrome; Iliotibial Band Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Wounds and Injuries; Iliotibial Band Syndrome
Study type: Interventional

Summary: 
      The investigators hypothesize that new runners participating in an 8 week strength and
      coordination training program prior to beginning to run will 1) display different
      coordination patterns , and 2) experience fewer injuries, compared to new runners who do not
      perform strength or coordination training prior to running.
    

Detailed description: 
      The study will investigate the effect of a sequenced training program - beginning with
      strength training, followed by running-specific coordination exercises, and finally a gradual
      introduction to running - on strength, coordination and injury incidence in a group of novice
      runners. he investigators hypothesize that runners who perform strength and coordination
      training prior to beginning to run will 1) demonstrate greater lower extremity strength, 2)
      demonstrate alters coordination patterns and 3) experience fewer injuries, when compared to a
      control group of novice runners who perform no physical preparation prior to a gradual
      introduction to running. The possible long-term benefits of this study include reduced burden
      of running-related injuries, increased participation in the sport of running, improved
      cardiovascular and metabolic health characteristics, and reduced incidence of disease such as
      cardiovascular events and cancer.
    

Intervention name(s): Strength and Coordination Training; Walking
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Perform training exercises 3/week. Weeks 1-2: general strength (isolated muscle groups) Weeks 3-4: running-specific strength (multi-joint, upright) Weeks 5-6: power/coordination I (low amplitude/intensity) Weeks 7-8: power/coordination II (higher amplitude/intensity) Weeks 9-16: Run training. Each training session will start with a 10 minute strength & coordination warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run.; Perform training exercises 3/week. Weeks 1-2: 30 minute walk Weeks 3-4: 35 minute walk Weeks 5-6: 40 minute walk Weeks 7-8: 45 minute walk Weeks 9-16: Run training. Each training session will start with a 10 minute walking warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: running related injuries
Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently
      the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo
      myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is
      performed, and has advantage over surgery because it is performed endoscopically, thus is
      less invasive. One potential disadvantage in respect to surgery may be that it may determine
      higher rates of post-operative reflux. The purpose of this study is to prospectively assess
      the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3
      and 12 months.

      This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of
      achalasia, without megaesophagus or colonic esophagus, will be included for the POEM
      procedure.

      This study will last about 2 years. The aim is the feasibility, security and success rate of
      POEM for achalasia. Patients will be followed for at least one year.
    


Intervention name(s): Hybrid Knife
Intervention type(s): Device
Intervention description(s): POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: achalasia; per oral endoscopic myotoymy; endoscopy
Dalfampridine for Imbalance in Multiple Sclerosis
Condition: Multiple Sclerosis; Fatigue
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in
      people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages
      the myelin insulation around nerves which slows conduction of messages from the brain to the
      leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin.
      Recent research indicates that imbalance in MS is in large part caused by poor conduction by
      the nerves that transmit information about the position of the legs to the brain. It is
      therefore likely that, by improving nerve conduction, dalfampridine will also improve
      imbalance in people with MS. Dalfampridine will be administered in this study by the same
      route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve
      walking speed in people with MS. The proposed pilot study will examine the effects of
      dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This
      small pilot study will help to show if dalfampridine improves imbalance in MS and will guide
      the design and implementation of a larger full scale study to definitively determine if
      dalfampridine improves balance and prevents falls in people with MS.
    


Intervention name(s): Dalfampridine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg, bid, pill taken by mouth for 12 weeks; placebo pill, bid for 12 weeks
Other intervention name(s): Ampyra
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; postural balance; gait; fatigue
Evaluation of the Safety and Effectiveness of Stomaphyx for Transoral Incisionless Reduction of the Enlarged Gastric Pouch and Stoma
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 2

Summary: 
      Executive Summary

      Aims and Hypotheses of the Study:

      The aim of the study will be to evaluate the safety, effectiveness and early outcome of the
      StomaphyX procedure for reducing the enlarged gastric pouch and stoma in post-bariatric
      patients. The study will test a hypothesis that the StomaphyX procedure will be effective in
      promoting the loss of regained weight, reducing the risk for comorbidities and improving
      patients' quality of life.

      Type of Study: Prospective non-randomized Study Duration: 12 months Number of Patients: 20

      Inclusion Criteria:

      18-70 years of age, BMI ≥ 35, ≥ 2 years after primary Roux-en-Y gastric bypass with evidence
      of enlarged gastric pouch volume or enlarged stoma diameter of ≥ 20 mm via endoscopy or
      fluoroscopy. Pts also demonstrate a weight regain of 15% of excess body weight loss.

      Exclusion Criteria:

      Esophageal stricture, or any anatomic conditions that preclude passage of transoral
      endoluminal instruments, has another causal factor for weight regain other than stoma or
      pouch dilatation, portal hypertension, coagulation disorders or chronic use of
      anticoagulants, any active medical condition that would preclude the patient from completing
      the study or would result in an unreasonable risk to the patient.

      Intervention Treatment: Creation of multiple full-thickness plications within the gastric
      pouch using the StomaphyX device (EndoGastric Solutions, Inc., Redmond, WA, USA)

      Evaluation Criteria Primary Outcome: Change in body weight at 6 and 12 months Secondary
      Outcome: Gastric pouch volume assessment, stoma diameter determination, quality of life
      scores, waist circumference, co-morbidity resolution Effectiveness and Safety Assessment
      Clinical: Weight, height, waist circumference quality of life questionnaires (Impact of
      Weight QOL-Lite, Eating and Weight Patterns, Three-factor Eating, Emotional Eating Scale, GI
      QoL, GSRS and/or PGWB) Anatomical: Upper GI endoscopy, computed tomography or barium
      radiography Biochemical: Blood and urine tests (glucose, cholesterol, triglyceride, HDL, LDL,
      uric acid) Safety: Adverse events, complications, co-morbidities, hospital stay
    


Intervention name(s): StomaphyX
Intervention type(s): Device
Intervention description(s): StomaphyX with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA) is a transoral incisionless fastening device that allows for GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enlarged gastric pouch and stoma; Post bariatric surgery
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK
      Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through
      25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK
      134612 vaccine.
    


Intervention name(s): Meningococcal vaccine GSK 134612; Menactra®
Intervention type(s): Biological; Biological
Intervention description(s): One intramuscular injection; One intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Neisseria meningitidis; Adult; Adolescent; Safety; Vaccines, conjugate; Meningococcal vaccines; Immunogenicity
Clinical Performance of Masimo Rad-GT
Condition: Healthy
Study type: Interventional

Summary: 
      The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy
      of temperature measurements.
    

Detailed description: 
      Individual sites are only representative of a subset of the overall population, per ISO
      80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic
      safety and essential performance of clinical thermometers for body temperature measurement),
      and therefore clinical bias and limits of agreement should not be evaluated for the subsets.
      Publication of results should include repeatability from individual sites and the combined
      clinical bias and limits of agreement (NCT05779397, NCT05787782, and NCT05674344).
    

Intervention name(s): Masimo RAD-GT
Intervention type(s): Device
Intervention description(s): Non-contact infrared thermometry device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Relationship Between Serotonin and Brain Response to Social Dominance and Emotion Perception.
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Previous studies have already revealed the involvement of the serotoninergic system in the
      social behavior process. For example, more serotonin (5HT) was found in dominant male adult
      monkeys. Little is known about the serotoninergic implication in human's social behavior. The
      project aims to clarify the role of the serotoninergic system in social behavior in relation
      to the process of social hierarchical information. In order to determine how serotoninergic
      system is involved, the investigator will use a new technic TEP-fMRI. This technic allows us
      to measure the brain activity and the serotoninergic transporter occupancy (using the
      [C11]-DASB) at the same time. The current study aims to investigate whether serotonin
      transporter (5-HTT) activity correlates with the neural response (BOLD) during the detection
      of social dominance in facial expressions or other measures of social information processing.
      Blood sample, SLC6A4 (allele coding for the 5HT transporter) genotyping and
      neuropsychological questionnaires will give at the investigator more information and allow to
      investigate whether performance on social information processing is modulated by personality
      trait and genotype.
    


Intervention name(s): PET-fMRI scan
Intervention type(s): Device
Intervention description(s): fMRI scan include MR sequences: BOLD and fMRI. The PET acquisition will be carried out in dynamic for 90 consecutive minutes following intravenous administration of 4 MBq / kg dose of [11C]DASB bolus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PET-fMRI; dominance; 5HT transporter
Head to Head Study Epi proColon and FIT
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The study aims to show non-inferiority in the clinical performance of the investigational
      assay, Epi proColon, to FIT using matched blood and stool specimens from screening-guideline
      eligible subjects.
    

Detailed description: 
      There is strong evidence supporting the use of FOBT in CRC screening, with the earliest
      randomized controlled trials demonstrating a reduction in CRC incidence and mortality from
      CRC screening. Despite the implementation and incremental improvements in gFOBT- and
      FIT-based tests, they continue to represent a small percentage of CRC screening and currently
      remain largely the province of large, integrated healthcare delivery systems. Reasons for the
      limited adoption of stool-based testing are complicated, but include lack of physician
      recommendation, patient preferences, and cultural barriers.

      Availability of a blood-based test may overcome the adoption challenges presently facing
      stool-based CRC screening and facilitate better compliance with CRC screening guidelines.
      However, there are currently no FDA-approved in vitro diagnostic tests for detection of CRC
      in a blood sample. As such, a high through-put blood-based test with performance
      characteristics similar to fecal testing could satisfy this clinical need.

      This study is designed to prospectively collect matched blood and stool specimens and
      clinical data from screening guideline-eligible subjects found to have invasive colorectal
      cancer (CRC) at colonoscopy, i.e. AJCC/UICC stages I, II, III, and IV, with collection of
      specimens and testing after colonoscopy and from screening guideline-eligible subjects with
      blood and stool specimens collected before colonoscopy. A completed subject will have a FIT
      result, an Epi proColon result, and a medical diagnosis/colonoscopy determined clinical
      status (CRC, non-CRC). Demographic and baseline covariates will be reported for each
      individual.
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Subjects are recruited from gastroenterology clinics and surgical centers in the United
        States.
      
Biospecimen description: 
      Plasma
Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia
Condition: Fibromyalgia; Obesity
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Research has shown that weight problems are very common in fibromyalgia. Research also
      suggests that overweight and obesity may contribute to worsening of fibromyalgia symptoms and
      biochemical vulnerability associated with fibromyalgia. Effective weight management may be
      important in not only improving general health but also better management of fibromyalgia
      symptoms. Research has indicated that nutrition and coping education is important aspects of
      successful weight management. In this study, the investigators are evaluating the effect of
      nutrition and coping education on weight and symptom management of fibromyalgia among
      overweight and obese patients.
    


Intervention name(s): Lifestyle Modification; Supportive education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 16 hours of motivational, lifestyle management session, 8 hours nutritional education.; 16 hours general fibromyalgia education, 8 hours of nutritional education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Rehabilitation Coordinators in Orthopedic Care
Condition: Back Problems or Pain; Foot Problems or Pain; Shoulder Problems or Pain
Study type: Interventional

Summary: 
      REKO-O is a study that addressed women and men on sick leave in Uppsala County. Participants
      which are enrolled in orthopedic care clinic.
    

Detailed description: 
      REKO-O is a randomized controlled intervention study that addressed women and men on sick
      leave in Uppsala County. Participants which are enrolled in orthopedic care clinic
    

Intervention name(s): Intervention with rehabilitation coordinator
Intervention type(s): Behavioral
Intervention description(s): Intervention with rehabilitation coordinator in orthopedic care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Back pain
Efficacy and Safety of Intranasal Fentanyl in the Treatment of Breakthrough Pain (FT-018-IM)
Condition: Cancer
MeSH terms: Breakthrough Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objectives:

        -  To confirm the efficacy of intranasal fentanyl titrated to doses 50, 100 or 200 µg for
           treatment of breakthrough pain (BTP) in cancer patients

        -  To establish long-term safety of treatment with intranasal fentanyl

      Secondary objectives:

      - To explore the relationship between dose of background opioid treatment and titrated
      fentanyl dose
    


Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cancer pain with breakthrough pain episodes
A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides.
Condition: Pediculosis
MeSH terms: Lice Infestations
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Objective

      To compare the cure rates (defined as the complete absence of live lice, adults or nymphs, as
      diagnosed by wet-combing of three Australian approved head lice products for the treatment of
      primary school children with head lice infestation. The study design will be randomised and
      assessor-blind using three comparative parallel treatment groups.

      The study population will consist of Queensland state primary school children (up to Year 7)
      with live head lice (adults or nymphs) on the hair or scalp who have not used any head lice
      product in the four weeks prior to the study.
    

Detailed description: 
      All products were used according to the manufacturer's instructions. KP24 and Banlice were
      applied twice separated by a one week interval. MOOV Head Lice Treatment was applied on Day
      0, Day 7 and Day 14. The cure rate (absence of live lice) one day after the first
      administration for all products was a secondary outcome measure. The cure rate at 7 days
      after the final administration (Day 14 for Banlice or KP24 and at Day 21 for MOOV Head Lice
      Treatment) was the primary outcome measure. Siblings were treated if these were found to be
      infected as an enrolment criteria.
    

Intervention name(s): 1) MOOV Head Lice Treatment (Ego Pharmaceutical).; Banlice Mousse Aerosol (Pfizer, Australia); 3) KP24 Medicated Foam (Nelson Laboratories)
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Pediculus; capitis; lice