bioihbjkbjnl/mcl2 huggingface dataset:
Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Condition: Burns
MeSH terms: Burns
Study type: Observational

Summary: 
      PURPOSE:

      Is to test the feasibility and the reliability of the Arabic version of wee functional
      independence measure (weeFIM) in children with healed burns.

      BACKGROUND:

      Since kids are the most influenced casualty of burn and they may have lasting disabilities
      because of this harm, consequently they should have care in evaluation and treatment
      procedure in exploration.

      There are two main instruments that can be utilized to evaluate the function of young kid's
      which are the Functional independence measure for kids (WeeFIM) instrument and the Pediatric
      evaluation of disability inventory (PEDI) instrument.

      Therefore, the aim of this study was to investigate the reliability and feasibility of the
      Arabic version of the WeeFIM instrument in kids from 3 years to 16 years of age with healed
      burn.

      HYPOTHESES:

      Arabic version of WeeFIM questionnaire will not be feasible and reliable to measure and
      report the functional outcome of kids with healed burns.

      RESEARCH QUESTION:

      Is the Arabic version of weeFIM instrument feasible and reliable enough to measure and report
      the functional outcome of children with healed burns?
    

Detailed description: 
      1. First the weeFIM will undergo forward Arabic translation followed by English backward
           translation.

        2. Second the instrument will be adapted to Egyptian accent.

        3. Third the process of filling of questionnaire will be applied. It will be either parent
           filled or child filled. And will be performed by interview for illiterate patients.

        4. Last, statistical analysis for feasibility and reliability will be performed.
    

Intervention name(s): WeeFIM instrument
Intervention type(s): Other
Intervention description(s): In a formative setting, the WeeFIM tool examines functional independence in kids aged 6 months to 7 years old. It can also be used with children over the age of 7 who show functional ability. The instrument may be controlled by observational data or a meeting, and it takes 15 to 20 minutes to create [10].
Observational model: Case-Crossover
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Enrollment of participants was done for all children who meet the inclusion criteria. The
        demographic details about each parent and child were noted, and screening was done for
        adherence to inclusion and exclusion criteria. The tool was given to all children aged 3
        years to 16 years who were hospitalized in one of the two places for more than two weeks
        after the burn.
      
Keywords: WeeFIM instrument; functional independence; pediatric burns
Beach Tennis And Hypertension Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of the present study was to evaluate the effect of a beach tennis session on
      24-hour ambulatory blood pressure in adults with hypertension. The main hypothesis is that a
      single session of beach tennis would decrease ambulatory blood pressure compared with a
      non-exercise control session.
    

Detailed description: 
      In this randomized crossover trial, participants performed randomly assigned two experimental
      sessions: a beach tennis session and a non-exercise control session. The beach tennis session
      started with a standardized 5-minute warm-up consisting of basic techniques, followed by
      three 12-minute beach tennis matches with 2-minute intervals between them. Heart rate and
      rating of perceived exertion were continuously recorded during the beach tennis session, and
      enjoyment was measured after the beach tennis session. The control session was performed in
      seated rest. Both experimental sessions lasted 45 minutes. Ambulatory blood pressure was
      measured continuously for 24-hour after sessions.
    

Intervention name(s): Beach Tennis session
Intervention type(s): Behavioral
Intervention description(s): The Beach Tennis training session will be composed by a warm up of 5 min of BT in which technical exercises (i.e., serve, volley, forehand and backhand) will be performed After that, 3 BT small games of 12 min with a 2 minute interval between games using the conventional rules of sport will be performed. Before the session and after each small game, data regarding heart rate, blood pressure and rate perceived exertion will be recorded.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Beach Tennis; Sport training; Post exercise hypotension; Ambulatory blood pressure monitoring
Transcranial Direct Current Stimulation for Attention Deficit
Condition: Infantile Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      Infantile hemiplegia due to brain injury is associated with poor attention. Left-sided
      infantile hemiplegia affects the learning and acquisition of new skills. This study is aiming
      to improve the Selective visual attention (SVA) through transcranial direct current
      stimulation (tDCS) in children with Left-sided infantile hemiplegia .
    

Detailed description: 
      Infantile hemiplegia (IH) refers to brain injuries that occur before or at birth and lead to
      hemiplegia/ total paralysis of one side of the body, including the face, arm and leg. The IH
      is quit rare condition and occurs in 1 in 1000 live births. however, the condition is
      reported to cause functional and cognitive disability. Children with IH suffer from poor
      attention particularly visual attention, that is essential to be understand the written
      language. A focused reading is essential in learning and children with IH possess moderate
      intelligence and attend school.

      Transcranial direct current stimulation(tTCS) is a novel intervention that use small
      amplitude electrical currents to stimulate the essential areas of the brain through surface
      electrodes placed on the corresponding areas of the brain.

      The eligible children were divided into two groups. one group received tDCS with visual
      attention activities and the second group received sham tDCS with similar activities. The
      effect will be assessed before and after with Strops-color testing and a academic reading
      test.

      The experiment intends to explore the affect of tTCS on visual attention span among children
      with Left-sided infantile hemiplegia.
    

Intervention name(s): transcranial direct current stimulation; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): The tDCS stimulator (ActivaDose II tDCS Device; IOMED Inc., Salt Lake City, USA) is a standardized instrument used and tested in children. Two tDCS electrodes of dimensions 3" x 3" were used for the brain stimulation. The electrodes were inserted into a wet saline sponge.; Five children with LSIH were randomly allocated to this group. All participants received sham tDCS for 3 weeks on alternate days and completed 10 treatment sessions. The sham tDCS followed preparatory procedures similar to that used for the experimental group, except that the device was disconnected after the initial increase of the current. Children usually started the activity without noticing that the device was disconnected. The children were assessed at baseline, during the 5th and 10th sessions, and during a follow-up that was scheduled for 4 months later.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Laser Ablation Study for trEatment of atRial Fibrillation (LASER)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      This protocol aims at assessing the efficacy of performing catheter ablation for atrial
      fibrillation (AF) with laser catheters versus performing it with radiofrequency (RF)
      catheters. In order to study laser catheter ablation efficacy, MRI analysis of the lesions 3
      months after the procedure will be performed in both groups. MRI analysis will detect
      ablation gaps in the lesions encircling pulmonary veins. The primary endpoint will compare
      the number of gaps in the laser catheter and the RF group. The secondary endpoint of the
      study is recurrence of AF after 12 months. The target population of the study is patients
      with paroxysmal or persistent AF undergoing AF ablation.
    


Intervention name(s): Laser ablation; RF ablation
Intervention type(s): Device; Device
Intervention description(s): Pulmonary vein isolation using the laser ablation catheter; Pulmonary vein isolation using the RF ablation catheter
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Catheter Ablation; Radiofrequency; Laser; Atrial Fibrillation
Dose Response of Neural Mobilization on Hamstring Flexibility in Low Back Pain
Condition: Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study will be a randomized control trial and will be conducted in Riphah International
      Hospital, National orthopedic and specialist hospital, Riphah international hospital and
      Chambeli institute of physiotherapy. A sample of 34 participants will be taken. Participants
      will be randomized into Group A and Group B through lottery method. Group A will receive High
      Dose Neural Mobilization Technique, Hot pack for 15 minutes, strengthening exercises with
      10rep/8sets , strengthening exercises for quadriceps and static stretching exercise for
      hamstring with 10 rep/8sets, While Group B will receive Low Dose Neural Mobilization
      Technique with minimal intensity, hot pack: 15 minutes, strengthening exercises with
      10rep/4sets. Both groups will be given session of 40 min/day, 2 days/week for 4 weeks,
      assessment will be done at baseline, at the end of 1st week, 2nd week, 3rd week & at the end
      of 4th week. The outcome measure will be Numeric Pain Rating Scale (NPRS), Oswestry
      Disability Index (ODI), Active Knee Extension test (AKE) and Lumbar flexion by Schober
      method. Data will be analyzed be SPSS 22.
    


Intervention name(s): High Dose Neural Mobilization Technique; Low Dose Neural Mobilization Technique
Intervention type(s): Other; Other
Intervention description(s): Patients in This Group will receive the high dose neural mobilization along with hot pack, strengthening exercises, Neural mobilization technique (slump, sciatic). Participants in the NMG will be asked to actively perform knee extension, ankle dorsiflexion, and head extension in a slumped posture (body and neck semi flexion) followed by simultaneous ankle plantar flexion together with knee and head flexion, Hot pack for 15 minutes, Strengthening exercises of muscles with 10 /8sets. Strengthening exercises of quadriceps with10 rep/8sets, Static stretching exercise for hamstring muscle with 10 rep/8sets, Group A will be given session of 40 min/day, 2 days/week for 4 weeks.; Patients in this Group will receive the same treatment as group A but with less intensity and low dosage. Hot pack: 15 minutes, Strengthening exercises of muscles with 10 rep/4sets, Static stretching exercise for hamstring muscle with 10 rep/4sets. Group B will be given session of 40min/day, 2 days/week for 4weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neural Mobilization Technique; Oswestry Disability Index; Active Knee Extension Test; Numeric Pain Rating Scale; Lumbar flexion by Schober method
Therapy for Undergraduate College Students Who Binge Drink and Are Depressed
Condition: Depression; Alcohol Abuse
MeSH terms: Alcoholism; Depression
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effectiveness of 2 different therapy courses
      for undergraduate college students who binge drink and experience depressive symptoms.
    

Detailed description: 
      After a screening visit (2 ½ hrs) to confirm eligibility for the study, all participants will
      receive 8 weekly, 1-hour, individual sessions therapy with a counselor. Participants will be
      randomly assigned, by chance, like the flip of a coin, to the therapy course they will
      attend. In one of the therapy courses, students are asked questions about their drinking and
      receive personalized feedback about it, and are taught coping skills for their depressive
      symptoms. In the second course, students are also taught coping skills for their depressive
      symptoms but they may or may not talk about alcohol consumption depending on the students'
      preference. So, both courses teach the same coping skills for depressive symptoms but include
      different levels of focus on alcohol.

      Participants will also complete 2 follow-up visits, at the end of the 8 sessions and then
      again 4 weeks after completing treatment. These will involve filling out some questionnaires
      and completing a few neuropsychological tests (these questionnaires and neuropsychological
      tests will also be completed during the screening visit).
    

Intervention name(s): Combined Motivational Interviewing and Cognitive Behavioral Therapy; Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 sessions with study clinician, which focus on depressive symptom treatment and alcohol use Both courses teach coping skills for depression (CBT). However, one course focuses only on treatment for depression whereas the other provides also information tailored to the students' level of drinking and experience with regard to alcohol use.
In one course students are asked questions about their drinking, receive personalized feedback about it and are taught coping skills for their depressive symptoms; Cognitive behavioral therapy is a type of therapy in which students will be taught coping skills for their depressive symptoms but they may or may not talk about alcohol consumption depending on the students' preference.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Moisturizer on Malaysian Women Facial Skin
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the effect of Product X on facial skin of
      middle-aged women in Malaysia. The main questions it aims to answer are:

        1. The effect of Product X on skin hydration of middle-aged women in Malaysia.

        2. The effect of Product X on skin elasticity of middle-aged women in Malaysia.

        3. The effect of Product X on skin wrinkle of middle-aged women in Malaysia.

        4. To observe any adverse effect occurrence with the use of Product X.

      Participants will used Product X for 8 week and the skin assessment will be carried out at
      baseline, week 2, 4 and week 8.
    


Intervention name(s): Other: Product X moisturizer
Intervention type(s): Other
Intervention description(s): Product X moisturizer containing Hyaluronic Acid and Rosa Damascena Flower Water
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Middle-aged women, moisturizer
Evaluation of Peripheral Nerve Stimulation for Acute Treatment of Migraine Pain
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Clinical study to determine the responder rate of the TheraNova Migraine Treatment System to
      that of a sham control treatment.
    


Intervention name(s): Sham Treatment Location; Verum Treatment Location
Intervention type(s): Device; Device
Intervention description(s): The device applies transcutaneous electrical nerve stimulation to the bicep; The device applies transcutaneous electrical nerve stimulation to the hand
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the safety and immunogenicity of a recombinant
      hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at
      3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA
      formulation.
    

Detailed description: 
      All currently licensed influenza vaccines in the United States are produced in embryonated
      hen's eggs. There are several well-recognized disadvantages to the use of eggs as the
      substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could
      be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is
      usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process
      that can be time consuming, is not always successful, and can select receptor variants that
      may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken
      flocks, and that might be an important issue in a pandemic due to an avian influenza virus
      strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore,
      development of alternative substrates for influenza vaccine production has been identified as
      a high-priority objective.

      One potential alternative method for production of influenza vaccine is expression of the
      influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids
      dependence on eggs and is very efficient because of the high levels of protein expression
      under the control of the baculovirus polyhedrin promoter.
    

Intervention name(s): PanBlok; rHA adjuvant
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection
Other intervention name(s): rHA; recombinant hemagglutinin; SE
Intervention MeSH terms: Hemagglutinins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza
Relative Bioavailability Study for GSK1838262 (Gabapentin Enacarbil)
Condition: Pharmacokinetics; Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative drug concentrations achieved with
      different formulations of GSK1838262 in healthy volunteers.
    

Detailed description: 
      This is an open-label, randomized, single-dose, five-period, crossover study to evaluate the
      relative drug concentrations with different formulations of GSK1838262 in healthy volunteers.
      Four new formulations will be tested against the current formulation to identify the most
      promising new formulations for further development. Each subject will participate in five
      dosing periods and each period will be separated by at least seven days. Blood and urine
      samples will be collected over the 36 hour period following each dose administration to
      measure the drug concentrations.
    

Intervention name(s): open label
Intervention type(s): Drug
Intervention description(s): This is an open-label, randomized, single-dose, five-period, crossover study. All subjects will receive GSK1838262.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: healthy volunteer; formulations; bioavailability; pharmacokinetics
Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the
      treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in
      naive patients with type 2 diabetes.

      The objective of this study is to evaluate the safety, tolerability and pK profile of
      Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single
      dose, in step A. In step A will be included 25 volunteers.

      In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin
      Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be
      included 24 volunteers.
    


Intervention name(s): Step A: metformin glycinate 620 mg single dose; Step A: metformin glycinate 1240 mg single dose; Step A: metformin glycinate 2480 mg single dose; Step A: metformin hydrochloride 1000 mg single dose; Step A: metformin glycinate 1240 mg,food intake; Step B: metformin glycinate 620 mg BID; Step B: metformin hydrochloride 500 mg BID
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): metformin glycinate 620 mg single dose; metformin glycinate 1240 mg single dose; metformin glycinate 2480 mg single dose; metformin Chlorhydrate 1000 mg single dose; metformin glycinate 1240 mg, intake of food; metformin glycinate 620 mg BID, 8 days; metformin Chlorhydrate 500 mg BID, 8 days
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metformin glycinate; pharmacokinetics; pharmacodynamics