bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Group Patient Education on Glycemic Control Among People Living With Type 2 Diabetes in Vietnam
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study measures the effect of a 3-month patient education and self-management
      intervention in a low-resource setting, on diabetes knowledge and levels of blood glucose
      control.
    

Detailed description: 
      In Vietnam, there is a low level of diabetes knowledge among the general population, and
      significantly lower awareness in rural areas compared with urban areas. This highlights the
      urgent need for communication and education to improve the knowledge of the Vietnamese
      population of patients with type 2 diabetes on risk factors, complications, prevention and
      treatment. The main goal of this study is to evaluate the effects of a patient education and
      self-management intervention as add-on to usual diabetes care in a low-resource setting on
      diabetes knowledge and blood glucose control parameters in Vietnamese patients with type 2
      diabetes.

      This is a single-center, randomized, controlled study among adult out-patients with type 2
      diabetes. Patients meeting the inclusion criteria are randomly assigned to a community
      intervention or to usual diabetes care alone (control group) for a period of 3 months. The
      intervention consists of group education on type 2 diabetes, including, in addition to usual
      diabetes care: information on diet, exercise, drug therapy, and adherence. Each patient
      should attend the group education monthly over 3 consecutive months. Usual diabetes care is
      consistent with the ADA guidelines and comprises standard dietary and exercise advice in
      addition to antidiabetes treatment. Diabetes knowledge is measured with a modified Michigan
      University Diabetes Knowledge Test (MDKT). Other study outcomes includes change in mean
      HbA1c, fasting blood glucose, and systolic blood pressure.
    

Intervention name(s): patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control; Usual diabetes care alone
Intervention type(s): Other; Other
Intervention description(s): The intervention consisted group education on type 2 diabetes, including, in addition to usual diabetes care: information on diet, exercise, drug therapy, and adherence; Usual diabetes care was consistent with the ADA guidelines (15) and comprised standard dietary and exercise advice in addition to antidiabetes treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 2 diabetes; education; glycemic
Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis
Condition: Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Observational

Summary: 
      This is a 3-week, non-interventional, observational study of patients undergoing chemotherapy
      (sutent) designed as a three-arm parallel study. In this study, the efficacy of Ectoin
      containing mouthwash given prophylactically for the prevention of mucositis in patients
      before radio- and/or chemotherapy; as well as during radio- and/or chemotherapy for patients
      with mucositis compared to standard treatment should be investigated. The study doesn't
      intervene with routine treatment strategy.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with radio- and/or chemotherapy-induced mucositis
      
Keywords: Non interventional study; Ectoin; Mouth wash; Mucositis; Chemotherapy; Radiotherapy
Lifestyle Intervention Trial in Obese Elderly
Condition: Obesity
Study type: Interventional

Summary: 
      Obesity causes frailty in obese older adults by exacerbating the age-related decline in
      physical function. However, appropriate management of obesity in older adults is
      controversial. Weight loss without exercise could worsen frailty by accelerating the usual
      age-related decline in muscle and bone mass that leads to sarcopenia and osteopenia,
      respectively. Because of the important problem of frailty in obese older adults, it is
      important to determine the most efficacious approach in reducing, or even reversing frailty
      in this population. The primary objective of this proposal is to evaluate which distinct type
      of physical exercise (resistance, aerobic, or combined resistance + aerobic) is most
      efficacious in preventing the weight-loss-induced reduction in muscle and bone mass and
      reversing frailty in obese older adults.
    


Intervention name(s): Diet + Resistance Training; Diet + Aerobic Training; Diet + Resistance/Aerobic Exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and resistance exercise training 3-days/week for 24 weeks.; Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and aerobic exercise training 3-days/week for 24 weeks; Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and combined resistance/aerobic exercise training 3-days/week for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Mild Traumatic Brain Injury Registry
Condition: Brain Injury, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of the study is to gather information about patients with mild traumatic brain
      injury in order to develop guidelines for evaluation and treatment.
    

Detailed description: 
      The Mild Traumatic Brain Injury Registry is a prospective study which includes patients who
      have been seen in the CMC ED with a diagnosis of mild brain injury or concussion and a
      negative CT scan. The investigators will be collecting blood samples, and administering
      cognitive and balance tests. The investigators will also be following symptoms and cognition
      throughout the first year to help define typical recovery, and guide prognosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are seen in the CMC emergency department who have a clearly defined history of
        traumatic brain injury that produced at least transient alteration in consciousness, or
        change in mood, together with one or more persistent symptom lasting longer than one hour
        after impact. Symptoms can include head pain, nausea, dizziness, disequilibrium, confusion,
        amnesia, or irritability. All patients must be awake and alert (GCS 13 to 15), and must be
        enrolled within 72 hours of the injury.
      
Biospecimen description: 
      Blood samples will be obtained in the emergency room and processed for future analysis.
      Depending on the blood volume obtained, up to two citrate, two EDTA, and one Paxgene tube
      will be collected.
    
Keywords: brain concussion
Switchability Study Between Brand and Generic Topiramate
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The purpose of the study is to prove the bioequivalence of brand and generic topiramate.
    

Detailed description: 
      Generic antiepileptic drugs (AED) achieve blood concentration similar to the brand AED.
      However, controversies exist about efficacy and safety of substituting generic AEDs. Because
      even minor absorption and kinetic differences can elicit a breakthrough seizure in patients
      who are changed to a generic AED from brand AED. Therefore, more ideal evaluation of
      interchangeability from the brand AEDs to generic formulation of the same drug is three-way
      or four-way crossover study, which can evaluate within-subject variability in pharmacokinetic
      and pharmacodynamic. Investigator designed four-way crossover study aimed to assess
      bioequivalence of brand and generic topiramate, to measure trough serum level , and to
      evaluate efficacy, tolerability and side effect of generic topiramate.
    

Intervention name(s): Pharmacokinetic study
Intervention type(s): Procedure
Intervention description(s): Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy; anticonvulsants; generic drugs
Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of a primary prevention program for anxiety
      disorders.

      This study was completed between 2000 and 2002, with the final report transmitted to the
      Quebec ministry of health in 2003.
    

Detailed description: 
      This study reports the results of a study evaluating a book-supported prevention program
      "Dominique's Handy Tricks" for anxiety disorders in children aged 9 to 12 years of age. This
      cognitive-behavioural program is delivered using a combination of story-based books and
      workshop sessions. The originality of the program comes from the use of story books that were
      not developed for anxiety management specifically. Every session is based on a story
      describing characters facing common stressors in childhood and how they managed to cope with
      their daily problems. In our randomized control trial with 46 children, participation in the
      program lead to a significant improvement in coping skills, self-efficacy, anxiety
      sensitivity, signs of anxiety and phobic avoidance. The theoretical and practical elements
      underlying the delivery of this primary prevention programs are described. It is suggested
      that such an approach, without any labelling specific to anxiety disorders, can be useful in
      universal primary prevention programs.
    

Intervention name(s): Dominique's Handy Tricks
Intervention type(s): Behavioral
Intervention description(s): Children assisted to 10 workshops where they learned exercises to control their stress and anxiety.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: No condition; Primary prevention; Anxiety
Use of ROTEM for Multi-level Spine Surgery
Condition: Coagulation
Study type: Observational

Summary: 
      The purpose of this study is to obtain coagulation profiles of patients undergoing
      multi-level spine surgeries with ROTEM® and routine coagulation tests. The investigators will
      compare the data from ROTEM® and routine coagulation tests with each other and with blood
      loss and transfusion therapies used.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Large metropolitan hospital.
      
Biospecimen description: 
      a small sample of blood will be obtained from a pre-existing arterial line.
    
Keywords: To determine the efficacy of ROTEM on assessing coagulation profiles.
Effects of Feedback on Learning of a Motor Sequence Task
Condition: Adult
Study type: Interventional

Summary: 
      Feedback delivered during motor practice can help promote motor skill learning and promote
      confidence. However, the optimal way to provide feedback to promote learning and confidence
      is unknown. This project will study how the feedback that is provided during practice of a
      movement skill can help people learn and build confidence. The investigators will measure
      motor skill performance and confidence before and after a session of motor practice.
    

Detailed description: 
      Feedback may be a useful tool to optimize motor learning during practice. For example,
      feedback during practice that indicates the learner is performing above average (i.e.
      positive social comparative feedback) enhances motor skill learning and self-efficacy in
      healthy adults. While this type of feedback is hypothesized to promote learning in some
      tasks, no studies have examined whether positive social comparative feedback during practice
      promotes motor learning in a traditional motor sequence task. Therefore, the aim of the
      proposed project is to investigate the effect of positive social comparative feedback on the
      learning of a joystick-based motor sequence task in healthy adults. The study aims to recruit
      60 participants who will be randomized into 1 of 3 feedback groups (control group,
      performance feedback, and performance plus positive feedback). Participants will practice a
      motor sequence task on a single day and then return for retention performance testing about
      24 hours later. Changes in performance (response time to complete a sequence) and
      self-efficacy will be measured from baseline to 24 hours later at retention.
    

Intervention name(s): Motor Sequence Task
Intervention type(s): Behavioral
Intervention description(s): Participants will be seated at a laptop with the right hand on a standard joystick. The movement of the joystick will move a cursor on the computer screen. Targets will appear on the laptop screen as a circle in one of twelve spatially distinct locations. The learner must move the joystick "cursor" to inside the target before the next target will appear.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Motor learning; Feedback
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
Condition: Chronic Insomnia; Adults; Elderly
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled,
      parallel-group, Bayesian adaptive, dose response study in subjects with chronic insomnia.
      Subjects will be randomized to 1 of 6 doses of E2006 (1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25
      mg) or placebo.
    

Detailed description: 
      The study will have 2 phases, Prerandomization and Randomization. The Prerandomization Phase
      will last up to 21 days and will consist of a Screening Period (Days -21 to -2) and a
      Baseline Period (Day -1). Following the Baseline Period, all eligible subjects will be
      randomized, in a double-blind manner, to receive E2006 or placebo for 15 nights during the
      Treatment Period (Days 1 to 15), then all subjects will receive placebo, in a single-blind
      manner, for 2 nights (Days 16 to 17) during the Rebound Insomnia Assessment Period (Days 16
      to 18). Subjects will not receive any treatment during the Follow-up Period (Days 19 to 29).
      All subjects will come to the clinic for screening procedures. During the Screening Period,
      subjects will complete the Sleep Diary each day. Polysomnographic sleep will be measured
      during the Screening Period on 2 consecutive nights between Day -9 and Day -3. These 8-hour
      polysomnograms (PSGs) will start at the median habitual bedtime calculated from responses on
      the Sleep Diary completed 7 days immediately prior to the first PSG night. Subjects may leave
      the clinic between the screening/baseline PSG nights.
    

Intervention name(s): E2006; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): E2006 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg, in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights; E2006-matched placebo in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Insomnia; Adults; Elderly
Effectiveness of a Functional Literacy Program for Formerly Homeless Adults
Condition: Literacy
Study type: Interventional

Summary: 
      The purpose of this study is to assess a functional literacy program for formerly homeless
      adults now residing in supported housing who have difficulty performing daily life skills
      requiring functional literacy (e.g., bill paying, medication management, community
      transportation) needed to maintain housing placements. The hypothesis is that intervention
      group participants will improve in functional literacy compared to the control group that
      does not receive the intervention.
    

Detailed description: 
      Sixty-five percent of homeless adults are reported to be illiterate or marginally literate.
      The lack of literacy in a high technological society negatively impacts this population's
      ability to participate in daily life activities including finding and maintaining employment,
      renting and maintaining an apartment, seeking health care, using public transportation, and
      managing finances. Poor literacy marginalizes this population from societal participation and
      maintains this group in a state of lack and deficiency.

      A literacy program will be delivered to participants who are formerly homeless and now
      residing in supported shelter. Participants will be randomly assigned to an intervention
      (n=20) or control (n=20) group. The intervention group will receive the functional literacy
      intervention over 8 weeks, twice weekly. Intervention sessions will allow participants to
      learn literacy skills within the context of real-life daily activities like grocery shopping,
      preparing a meal, and purchasing subway cards. Control group participants will not receive
      intervention.
    

Intervention name(s): Functional Literacy Program; Usual Care Management Services
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will be provided twice weekly in 2-hour sessions, over 8 weeks. The 16 intervention sessions will provide the opportunity for participants to learn functional literacy skills to (1) manage an apartment, (2) access community resources, (3) manage finances, (4) access free recreational activities. All sessions will address literacy skills needed to complete basic daily life activities in the home and community environments. Literacy skills will first be learned and practiced within the supported shelter, and then extended to the community.; The control group will receive the usual housing services without additional intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately 10 participants will be randomly assigned to an intervention group; another 10 will be randomly assigned to a control group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: functional literacy; homelessness; daily life activities
Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be
      given once a day to patients with COPD in order for the effect to last for 24 hours.
    


Intervention name(s): carmoterol (CHF 4226); carmoterol (CHF 4226); placebo; salmeterol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): carmoterol (CHF 4226) 2 μg once a day, in the morning
(1 puff of carmoterol 2 μg + 1 puff of placebo pMDI); carmoterol (CHF 4226) 4 μg once a day, in the morning
(1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg); placebo once a day, in the morning
(1 puff of placebo pMDI + 1 puff of placebo pMDI); Salmeterol 50 μg twice daily, in the morning and in the evening
(1 blister of Serevent Diskus BID)
Other intervention name(s): CHF 4226; TA2005; CHF 4226; TA2005; Serevent Diskus/Accuhaler
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Laryngeal Reflex Study Under Propofol Anesthesia: Effect of Intravenous Lidocaine
Condition: Laryngospasm
MeSH terms: Laryngismus
Study type: Interventional
Phase: Phase 3

Summary: 
      To describe respiratory and laryngeal responses to laryngeal stimulation during propofol
      anesthesia in children. To determine whether the co-administration of lidocaine blunts these
      reflex responses. The outcome of primary interest is the reflex laryngospasm.

      Hypotheses:

      I: The severity of laryngospasm evoked by laryngeal stimulation is reduced 2 min. after iv.
      administration on 2mg/kg lidocaine in pediatric patients anesthetized with propofol
      (3mcg/ml).

      II:The incidence of laryngospasm elicited by controlled stimulation 10min. after iv.
      administration of lidocaine is equivalent to the response before the administration of
      lidocaine.
    

Detailed description: 
      Based on our previous work assessing the laryngeal reflex responses in children, the use of
      propofol appears to be promising regarding a low incidence of laryngospasm. Compared with a
      sevoflurane-based anesthesia, the incidence was found to be significantly lower, but there is
      a high incidence of other reflex responses, such as coughing and expiration reflexes. The use
      of lidocaine has been advocated to reduce the incidence of laryngospasm in anesthetized
      children. However, based on clinical studies its effectiveness in the prevention or
      attenuation of laryngospasm is controversial.

      In a previous work using a established stimulation model (stimulating the laryngeal mucosa
      with a small amount of distilled water under direct fiberbronchoscopic observation), we
      observed a risk reduction of 60% of laryngospasm 2min. after the application of 2mg/kg bolus
      of lidocaine. This effect had already diminished after 10 min.

      The laryngeal reflex responses differ largely in children anesthetized with either
      inhalational anesthetics or with propofol. The impact iv administered lidocaine on laryngeal
      and respiratory reflex responses in children anesthetized with propofol has not been
      assessed, although this combination might result in a profound suppression of laryngeal
      reflex responses.
    

Intervention name(s): NaCl 0,9%
Intervention type(s): Drug
Intervention description(s): Propofol 3micrgr/ml (TCI plasma concentration) and NaCl 0,9% 2min. and 10min. application
Other intervention name(s): Propofol; Disoprivan; Recofol; Natriumchlorid
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anesthesia; Children; Larynx