bioihbjkbjnl/mcl2 huggingface dataset:
ToleroMune Grass Follow on Study
Condition: Rhinoconjunctivitis; Grass Allergy
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Grass pollen allergens are recognised as a major cause of allergic diseases in humans and
      animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen
      allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass
      pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising
      vaccine, currently being developed for the treatment of grass allergy.

      The purpose of this optional observational follow-on study is to further evaluate
      rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all
      dosing visits in study TG002 approximately two years after the start of treatment.
    

Detailed description: 
      This is a follow-up study to a multi-centre, randomised, double-blind, placebo controlled,
      parallel group clinical study (TG002) which evaluated the efficacy, safety and tolerability
      of three doses of ToleroMune Grass versus placebo in grass allergic subjects. Subjects who
      completed TG002 in calendar year 2012 will undergo a further single exposure to grass
      allergens in an EEU.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subject previously randomised in study TG002 and completed all dosing visits and the PTC
      
Keywords: Grass Allergy; Rhinoconjunctivitis; Environmental Exposure Unit; Immunotherapy; ToleroMune Grass
Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?
Condition: Needlestick Injuries
MeSH terms: Needlestick Injuries
Study type: Interventional

Summary: 
      This study will investigate the influence of adjusting the pH of lidocaine on pain during
      subcutaneous injection. Each participant will receive two injections on the abdomen with
      different pH. After each injection, the subject will be asked to evaluate the pain on a
      Visual analog scale (0-100 mm). It is anticipated that the pain decreases with increasing pH.
      The aim of the study is to find a simple method for pain reduction that can be used in
      clinical practice.
    


Intervention name(s): Lidocaine injection with bicarbonate; lidocaine injection
Intervention type(s): Procedure; Procedure
Intervention description(s): bicarbonate added to change pH; Lidocaine injection with pH unchanged
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Injections; Lidocaine; Healthy volunteers
Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomised Clinical Trial
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The recent introduction of robotic surgical system has revolutionized the field of minimally
      invasive surgery. The investigators hypothesized that adoption of a robotic surgical system
      for patients with right-side colon cancer seems appealing because This system provides
      high-definition three-dimensional vision, eliminates physiologic tremor, and better
      ergonomics. This randomized controlled trial was designed to determine the safety and
      efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.
    


Intervention name(s): robot-assisted surgery; laparoscopic right-hemicolectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA); Conventional laparoscopic procedures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: colon cancer; robot; laparoscopy; primary, right-side colon cancer; robot-assisted surgery
Validation of a Pharmacokinetic Pharmacodynamic Model to Administer Propofol in Obese Patients
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to validate an integrated pharmacokinetic-pharmacodynamic model
      to administer propofol in obese patients.

      Our hypothesis is that pharmacokinetic and pharmacodynamic changes occur with increasing
      weight and that mathematical models to administer drugs in obese patients can be developed to
      accurately predict dose schemes in this population.
    

Detailed description: 
      Propofol is the most frequently used IV anesthetic today. Propofol TCI is commonly used for
      induction and maintenance of general anaesthesia in obese and non obese patients. However,
      current propofol PK models, used in TCI devices, were derived from studies that did not
      include obese patients. A controversial issue for propofol dose adjustment in this population
      has been the selection of an adequate size descriptor to scale PK parameters, as drug
      administration based on total body weight can result in overdose, and conversely,
      administration based on ideal body weight can result in a sub-therapeutic dose. In a previous
      study from our group, we developed a PK model capable of characterizing the influence of
      obesity on propofol disposition. The purpose of this study is to validate this model to
      administer propofol in obese patients.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): General anesthesia will be induced administering propofol by effect site TCI system using our previously derived model, the target plasma concentration initially will be set at 4 mcg/ml. After loss of consciousness, rocuronium 0.6mg/kg, and remifentanil 0.2mcg/kg/min will be given to facilitate tracheal intubation. After intubation propofol target will be decreased to 3 for 10 minutes and then adapted to the needs of each patient to maintain stable BIS values between 40 and 50. At the end of surgery propofol infusion will be stopped, and patients will be transferred to the recovery unit extubated. Samples of 2.5 ml of arterial blood will be taken at 2, 5 and 10 min after every new target is set. Thereafter samples will be taken at 2, 5, 10, 15, 30, 60, 120 min after stopping drug infusion. Blood samples will be immediately centrifuged and then stored until analysis.
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: anaesthetics iv; propofol; pharmacokinetics; pharmacodynamic
Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)
Condition: Nicotine Dependence; Smoking Cessation
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The study's major aim is to investigate the ability of a commercial Electronic Nicotine
      Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling
      to quit. Secondary aims are to monitor adverse events and measure participants' perception
      and acceptance of the product.

      This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and
      adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette -
      "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a
      safe device that allows smoking reduction or abstinence in smokers.
    

Detailed description: 
      Cigarette smoking continues to be a very difficult addiction to break. Therefore, improved
      approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette), a
      battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette, may help
      smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. The
      efficacy of these devices in smoking cessation and/or smoking reduction studies has never
      been investigated.

      In this prospective proof-of-concept study we monitored possible modifications in smoking
      habits of 40 smokers (unwilling to quit) experimenting the 'Categoria' e-Cigarette focusing
      on smoking reduction and smoking abstinence. Study participants were invited to attend four
      study visits: at baseline, week-4, week-8, and week-12. Product use, number of cigarettes
      smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking
      reduction and abstinence rates were calculated. Adverse events and product preferences were
      also reviewed.
    

Intervention name(s): E-Cigarette 7.2 mg nicotine
Intervention type(s): Device
Intervention description(s): Participants were given a free e-Cigarette kit containing two rechargeable batteries, a charger, and two atomizers and instructed on how to charge, activate and use the e-Cigarette. Key troubleshooting were addressed and phone numbers were supplied for both technical and medical assistance. A full 4-weeks supply of 7.2 mg nicotine cartridges ("Original" cartridges; Arbi Group Srl, Milano, Italy) was also provided and participants were trained on how to load them onto the e-Cigarette's atomizer
Other intervention name(s): E-Cigarette with nicotine cartridges
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: electronic cigarette; ENDD; nicotine; smoking cessation; smoking reduction
Rapid HIV Testing for Emergency Department Patients
Condition: HIV Infections
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to test data collection options in emergency departments (EDs)
      and to enhance ED patient awareness of the risk of HIV infection.
    

Detailed description: 
      Rapid HIV testing is a new technology that speeds receipt of HIV test results. Its use in EDs
      has been demonstrated, but patient acceptance of rapid testing in the ED has not been
      optimal. It is likely that the low acceptance is partially due to ED patients not realizing
      the risk of acquiring an HIV infection or the importance of knowing their HIV status. The
      purpose of this study is to test data collection options in EDs and to enhance ED patient
      awareness of the risk for HIV infection.

      This three phase study will take place at the Rhode Island Hospital Emergency Department.
      Each participant will be followed for the duration of their ED visit.

      In Phase I, the proportion of participants who are willing to undergo rapid HIV testing in
      the ED will be measured. Additionally, the HIV testing history of these participants, their
      reasons for undergoing testing or for never having been tested for HIV, and factors
      associated with acceptance or decline of testing and history of HIV testing will be
      determined. An educational video will be developed and used to investigate its effectiveness
      in convincing participants to have the rapid HIV test. All participants agreeing to undergo a
      rapid HIV test will receive a survey to complete.

      In Phase II, a questionnaire and feedback tool to make participants aware of their risk for
      an HIV infection through injection drug use and sex will be developed and investigated.

      In Phase III, the questionnaire and feedback tool developed in Phase II will be used to
      determine whether or not making participants aware of their risk for an HIV infection
      increases their acceptance of being tested for HIV in the ED. Participants in Arm 1 will
      receive the questionnaire and feedback tool while participants in Arm 2 will not.
    

Intervention name(s): HIV risk education
Intervention type(s): Behavioral
Intervention description(s): Education for Phase III participants about potential risk of HIV infection before being asked to take a rapid HIV test in the ED
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Patient Education; Emergency Medicine; HIV Prevention; HIV Seronegativity
Effectiveness of Pragmatic Shoulder Technique VS Traditional Physical Therapy
Condition: Shoulder Pain; Shoulder Impingement; Shoulder Injuries; Frozen Shoulder; Shoulder Capsulitis
MeSH terms: Shoulder Pain; Bursitis; Shoulder Impingement Syndrome; Shoulder Injuries
Study type: Interventional

Summary: 
      Isolated and combined effectiveness of pragmatic protocols on shoulder range of motion had
      been investigated and found effective in healthy participants. To our knowledge, there was
      insufficient literature to support the comparison between pragmatic and traditional protocols
      in the treatment of shoulder pathologies.
    

Detailed description: 
      Different physical therapy treatments are being used for shoulder pathologies which include
      modalities (hot pack, TENS), ROM exercises, stretching, strengthening, soft tissue
      mobilization and set of pragmatic manual techniques.The set of pragmatic manual therapies are
      novel techniques (comprises of acromioclavicular mobilization, serratus anterior stretch,
      thoracic manipulation, RC facilitation, and PCS) and its isolated effectiveness on ROM in
      healthy subjects has been investigated and found effective. These studies recommended the use
      of a pragmatic protocol for the prevention and rehabilitation of shoulder injuries and
      pathologies (unpublished data).As per our knowledge there is insufficient literature to
      support the comparison of the effectiveness of a set of pragmatic protocols with traditional
      interventions. Our research is proposed to compare the efficacy of pragmatic interventions
      with that of traditional interventions in patients with shoulder pathology and their effect
      on the quality of life.
    

Intervention name(s): set of pragmatic shoulder technique; traditional physical therapy
Intervention type(s): Other; Other
Intervention description(s): Group A received pragmatic intervention which includes Pectoralis major and minor stretch, AC joint mobilization, rotator cuff facilitation for subscapularis and infraspinatus, serratus anterior stretch, thoracic manipulation and posterior capsular stretch.; Group B received traditional interventions which includes modalities such as TENS and hot pack, soft tissue mobilization, joint mobilization, stretching and strengthening etc. other than pragmatic intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: quasi-experimental
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pragmatic intervention,; shoulder pathologies,; shoulder pain,; shoulder range of motion; pragmatic shoulder intervention,
Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of BIBV 308 SE, Versus a Solution of BIBV 308 SE in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative pharmacokinetics and tolerability of two experimental extended release
      formulations and a standard formulation of BIBV 308 SE following multiple doses.
    


Intervention name(s): BIBV 308 SE solution; BIBV 308 SE capsule L; BIBV 308 SE capsule S
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effects of GW679769 on Sleep and Cognitive Function in Subjects With Primary Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects
      participate in a clinical screening visit and a two-night PSG recording session in the sleep
      laboratory. Eligible subjects then participate in three separate two-night PSG sessions in
      which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior
      to bedtime, one treatment for each session in a balanced order. Each treatment session is
      separated by a two-week drug-free period and occur on the same day of the week. A safety
      follow-up visit occurs 2 weeks after the last treatment session.
    


Intervention name(s): GW679769; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): GW679769
Intervention MeSH terms: Casopitant
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Diagnostic
Keywords: sleep,; polysomnography.; GW679769,; primary insomnia,; cognitive function,
Respiratory Muscle Strength and Function in Healthy Kids
Condition: Respiratory Muscle Strength
Study type: Observational

Summary: 
      Respiratory muscle strength training (RMST) is a potential treatment option that has been
      shown to increase strength and ventilatory function in critically ill patients, patients on
      ventilators and patients with mild neuromuscular weakness. Currently researchers are
      examining the role of inspiratory muscle strength training (IMST) in pressure performance of
      ventilator dependent children with Pompe disease. However, normal pressure-flow-timing
      responses of lung function are not well-characterized in healthy children. The purpose of
      this study is to measure RMST-induced changes in respiratory function in healthy children.
      Children will undergo one session of lung function and strength testing. By studying healthy
      children's respiratory function, this study will also help to develop more efficient
      respiratory muscle training exercise prescriptions for children with neuromuscular weakness
      and impaired respiratory function.
    

Detailed description: 
      The goals of this study are to collect and evaluate respiratory muscle strength training
      (RMST) induced changes in ventilatory function in healthy children. Children will undergo one
      session of pulmonary function and strength testing to quantify rate of inspiratory and
      expiratory pressure development and to determine whether inspiratory and expiratory pressure
      correlate to maximal respiratory pressures and forced pulmonary function tests. Currently
      normal pressure-flow-timing responses are not well-characterized in healthy children. The
      purpose of this study is to help develop more efficient RMST exercise prescriptions for ill
      children on ventilators and with neuromuscular weakness.

      Participants in the study will refrain from caffeine products and exercise on the day of
      respiratory testing. In conjunction with respiratory testing, baseline and exertional blood
      pressure, heart and respiratory rate, and pulse oximetry will be monitored. Participants will
      complete tidal flow-volume assessments and forced expiratory maneuvers according to the
      AMerican Thoracic Society guidelines. Participants will undergo 5 sets of 10 maximal-effort
      breaths against standardized resistances (one set each at 0, 5, 10, 15, and 20 cm H20).
      Following each set, subjects will rate the load magnitude and their feelings of breathing
      discomfort using a 0-10 visual analog scale. Participants will also perform maximal
      inspiratory and expiratory pressure maneuvers. All tests will be separated by at least 2-3
      minutes of rest.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy Children
      
Keywords: Healthy Kids; Respiratory; Volunteers
Population-based Estimates of Medical Comorbidities in Women With Lower Urinary Tract Symptoms or Pelvic Organ Prolapse
Condition: Lower Urinary Tract Symptoms; Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse; Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      The purpose of this study is to investigate the comorbidities of lower urinary tract symptoms
      or pelvic organ prolapse in a nationwide population-based data in Taiwan during the study
      period of 2001-2010, a total of 10 years.
    


Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with low urinary tract symptoms
      
Keywords: women
Terminal Latency Index, Residual Latency and Median Ulnar F Latency Difference in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Observational

Summary: 
      Terminal latency index, residual latency and median ulnar F latency difference in carpal
      tunnel syndrome are specific parameters for the diagnosis
    

Detailed description: 
      Carpal tunnel syndrome is the most common compression neuropathy. This study was performed to
      determine the value of terminal latency index, residual latency and median ulnar F latency
      difference to investigate their sensitivity and specificity in the diagnosis of this
      syndrome.

      We retrospectively determined the 160 patients. We evaluated the nerve conduction studies of
      patient and healthy arms. We recorded all nerve conduction study values.
    

Intervention name(s): nerve conduction study
Intervention type(s): Other
Intervention description(s): nerve conduction study
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who had gone to electrodiagnostic study and diagnosed as carpal tunnel syndrome