bioihbjkbjnl/mcl2 huggingface dataset:
Energy Transfer Therapy in Treatment of Medial Gastrocnemius
Condition: Strain of Gastrocnemius Muscle (Diagnosis); Diathermy Plate Burn; Thermography; Sports Physical Therapy
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      This study develops the effects of Capacitive and Resistive Energy Transfer Therapy (TECAR)
      on medial gastrocnemius using thermographic cameras, algometry and lunge tests, in a pre-post
      study with basketball players using a control group to which placebo is applied. (simulated
      technique) and an intervention group to which the technique is performed. The main objective
      of the study is to establish whether the TECAR produces physiological and mechanical changes
      in the subjects that improve muscle recovery.
    


Intervention name(s): TECAR Therapy; Placebo
Intervention type(s): Procedure; Other
Intervention description(s): The intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current.; simulated TECAR Therapy (machine off)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Correlation of Laparoscopic Experience and Functional Brain Activation: A PET Scan Study
Condition: Brain Function
Study type: Interventional

Summary: 
      The purpose of the research is to determine how practicing laparoscopic motor tasks affects
      the functional anatomy of the brain, and to investigate whether there is a correlation
      between surgical experience and functional brain activition. Additionaly, the investigators
      plan to use eye-tracking technology to see if the use of this technology can distinguish
      surgeons of various skill levels. The investigators hope that this study leads to new and
      effective methods of training surgical residents. All of the data will be collected at The
      Feinstein Institute for Medical Research, and may be used in future studies, which may or may
      not be related to urological diseases.
    


Intervention name(s): observational
Intervention type(s): Other
Intervention description(s): PET Scan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Comparison of experienced and novice laparoscopic surgeons
The Application of the Self Care Deficit Nursing Theory in Adolescents With Cystic Fibrosis
Condition: Cystic Fibrosis; Adolescence; Self-care
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The present study evaluates the effect of nursing care based on the Self-Care Deficit Nursing
      Theory on the knowledge and skills related to self-care among adolescents with Cystic
      Fibrosis.
    

Detailed description: 
      This study included 30 adolescents who were equally divided into the intervention and control
      groups. The data were collected by using the Sociodemographic Data Form and the Self-Care
      Knowledge and Skills Evaluation Forms for Adolescents with Cystic Fibrosis. A total of seven
      home visits were conducted with the adolescents in the intervention group, during which
      individualized care plans were applied based on the Self-Care Deficit Nursing Theory. The
      self-care needs of the adolescents in the control group were identified based on data
      collected during two home visits conducted at the onset of the study and after 4.5 months.

      As a result of the application of nursing interventions based on the Self-Care Deficit
      Nursing Theory, a statistically significant increase was noted in the self-care knowledge and
      skills of the adolescents in the intervention group (p<0.05). Additionally, nursing
      interventions and nursing diagnosis decreased significantly over time in all adolescents in
      the intervention group (p<0.05).

      Orem's Self-Care Deficit Nursing Theory was useful in enhancing the self-care knowledge and
      skills of adolescents with Cystic Fibrosis.
    

Intervention name(s): Supportive-Educative Nursing Care
Intervention type(s): Other
Intervention description(s): Adolescents in the intervention group were received Supportive-Educative Nursing Care based on Orem's Self Care Deficit Nursing Theory
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 2 group in the study. Intervention Group and Control Group. The control group received no intervention by principal researcher.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cystic Fibrosis; Adolescence; Self-care
Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years
Condition: Fracture; Abuse Physical
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      When a child less than 2 years old attends the Emergency Department (ED) with an injury,
      carers should offer an explanation. When there is no explanation or if the explanation is
      inconsistent & because the child cannot say what happened, the doctor will need to consider
      all possible causes including child abuse. To help exclude abuse, the doctor will request
      x-rays of all the child's bones to make sure there are no other unexplained fractures. This
      requires up to 20 x-rays, which are called a skeletal survey. Even if there are no fractures,
      some or all of the x-rays will be repeated in the following 7-21 days, because by that time
      any fractures will have started to heal and so are easier to see than on the first skeletal
      survey. It means that if a doctor is worried about abuse, the child may need to have up to 40
      x-rays, which amounts to a significant radiation dose (more than 6 months of natural UK
      background radiation) & increases the child's lifetime risk of getting cancer. 79 to 97 out
      of 100 skeletal surveys performed are normal. While it is of paramount importance to identify
      if a child is being abused, it is also important to minimise radiation dose. A camera which
      detects light and heat given off by the body has shown promise in some areas of medical
      practice. We plan to compare the results from the camera to those of the skeletal survey in
      40 children below 2 years of age attending our hospital over a 6-month period. We hope to
      demonstrate that this technology can be used to further select children who should have a
      skeletal survey, reducing radiation dose in children without missing those who are being
      abused and sending them home to be abused again.
    


Intervention name(s): Thermal Imaging Camera
Intervention type(s): Device
Intervention description(s): To develop a non-ionising radiation-based method of excluding fractures in children with suspected physical abuse
Intervention model: Single Group Assignment
Intervention model description: Thermal Imaging
Masking: None (Open Label)
Primary purpose: Diagnostic
Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
Condition: Mumps; Rubella; Measles; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Study type: Interventional
Phase: Phase 2

Summary: 
      Since measles-mumps-rubella (MMR) and varicella vaccinations are established as routine
      childhood practice and often co-administered during the second year of life, a combined
      measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine is fully justified. Such a combined
      vaccine was developed and extensively studied in susceptible children. In countries where
      varicella mass-vaccination is already implemented, a transition period is necessary as
      children who started with separate first-dose vaccinations of MMR and varicella will receive
      a single shot of the combined vaccine as the second dose. To account for those situations,
      this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine
      given in place of separate MMR and varicella vaccines as a second dose.
    


Intervention name(s): MeMuRu-OKA (study vac); MMR, Varicella vacc (control)
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Chronic Pain in Spinal Cord Injury
Condition: Spinal Cord Injuries; Pain
MeSH terms: Spinal Cord Injuries; Chronic Pain; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic
      pain in adults that have had a spinal cord injury.
    

Detailed description: 
      This double masked placebo-controlled trial will randomize patients (n=100) with a greater
      than 6 month history spinal cord injury and a greater than 3 month history of associated pain
      to a daily dose of amitriptyline or placebo for 6 weeks. Patients will be examined before
      randomization by a study physician or nurse masked to their treatment assignment. They will
      be assessed by telephone interview before, during treatment, at the end of treatment and 4
      months later to assess pain, pain interference with activities, physical and mental health,
      and number of health care visits for pain.
    

Intervention name(s): Amitriptyline
Intervention type(s): Drug
Intervention MeSH terms: Amitriptyline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Spinal Cord injury (SCI); Chronic Pain; Amitriptyline
A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The primary objective of the study was to measure the change in bladder function as measured
      by Urogenital Distress Inventory (UDI)-6 compared to baseline over 6 months of Tysabri
      treatment. Secondary objectives were to (i) measure change from baseline over 6 months of
      Tysabri treatment in the number of urinary incontinence episodes per participant per week,
      (ii) measure change from baseline over 6 months of Tysabri treatment in the number of
      micturitions per participant per day, (iii) measure change in The North American Research
      Committee on Multiple Sclerosis (NARCOMS) bladder/bowel subscale (PSB) scores from baseline
      over 6 months of Tysabri treatment and (iv) measure change in Incontinence Impact
      Questionnaire (IIQ)-7 scores from baseline over 6 months of Tysabri treatment.
    


Intervention name(s): BG0002 (natalizumab)
Intervention type(s): Drug
Intervention description(s): Participants who are newly prescribed TYSABRI, but have not received their first infusion, will be invited to participate.
Other intervention name(s): TYSABRI
Intervention MeSH terms: Natalizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women 18 years or older with relapsing remitting multiple sclerosis who have never
        received an infusion of TYSABRI.
      
Keywords: RRMS; Relapsing Remitting; MS
Safety and Immunogenicity of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans
Condition: Safety, Immunogenicity
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of freeze-dried rabies
      vaccine (MRC-5 cells)in different age health human populations, according to the traditional
      Essen methods (1-1-1-1-1) vaccination.
    


Intervention name(s): 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old; 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old; 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old; 2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old; 2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old; 2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval; freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval; freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval; freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval; freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval; freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Diet and the Aging Brain
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      We investigate whether a change in diet could provide positive effects on general brain
      functions in healthy elderly people.
    

Detailed description: 
      The age-related degradation of cognitive functions even to the point of neurodegenerative
      disorders such as alzheimer's disease are a growing public-health concern with potentially
      devastating effects.

      Refering to animal data and empirical studies, a healthy diet rich in unsaturated fatty acids
      and low in calories should improve cognitive functions such as learning and memory. To test
      this hypothesis, we study general brain functions in healthy elderly subjects (50-80 years
      old) during a short term diet.
    

Intervention name(s): diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diet; elderly; age-related diseases; prevention; cognitive decline; Clinical study
Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The study was an observational, retrospective cohort design, using US administrative
      insurance claims data, to better understand Healthcare resource utilization (HRU) and
      healthcare costs among women with mBC initiated on a CDK4/6 inhibitor.
    

Detailed description: 
      This study used an observational, retrospective cohort design, using US administrative
      insurance claims data, previously employed in an existing project, to better understand HRU
      and healthcare costs among women with mBC initiated on a CDK4/6 inhibitor.

      Adult women with HR+/HER2- mBC initiated on a CDK4/6 inhibitor were included in the study and
      were stratified into cohorts based on the first CDK4/6 inhibitor they received (i.e.,
      abemaciclib, palbociclib, or ribociclib), regardless of the line of therapy and menopausal
      status.

      The initiation of the first CDK4/6 inhibitor was defined as the index date. The index
      treatment was defined as the CDK4/6 inhibitor initiated on the index date (i.e., abemaciclib,
      palbociclib, or ribociclib).

      The 6-month period preceding the index date was considered as the baseline period, and was
      used to measure patient characteristics.

      Outcomes were measured between the index date and 1) the end of the study period
      (persistence, switch, HRU, costs) OR 2) the end of the index treatment (adherence, dose
      modification, frequency of monitoring), as relevant. The end of the study period was defined
      as the earliest occurrence between the end of continuous enrollment and the end of data
      availability.
    

Intervention name(s): Ribociclib; Palbociclib; Abemaciclib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants who initiated CDK4/6i therapy; Participants who initiated CDK4/6i therapy; Participants who initiated CDK4/6i therapy
Intervention MeSH terms: Palbociclib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study analyses were conducted among HR+/HER2- women with at least one claim for treatment
        with CDK4/6 inhibitor for mBC
      
Keywords: Metastatic breast cancer,; CDK4/6,; health resource utilization,; healthcare costs,; treatment patterns
Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This clinical study has been launched to collect spectral Raman data and reference
      measurements to establish and validate a calibration model for the device during daily
      glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic
      range. The study is a combined home-based and in-clinic study where subjects will attend the
      clinic two times.
    


Intervention name(s): P0.3
Intervention type(s): Device
Intervention description(s): Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Non-invasive glucose monitoring; Raman spectroscopy
The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance
Condition: Oral Glucose Tolerance
Study type: Interventional

Summary: 
      Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.
    

Detailed description: 
      Participants will be randomly assigned to one of three parallel arms: 0% (water), 5 mg, 15mg
      aspartame. Participants will have an oral glucose tolerance test at the beginning and end of
      a 12 week intervention. . Participants will report to the lab weekly for 12 weeks to pick up
      their next week's intervention products and measurements for body weight, waist
      circumference, blood pressure and heart rate. They will consume their intervention products
      daily for 12 weeks. They will record appetite sensations and collect a 24 hour urine sample
      at weeks 0, 4, 8, and 12.
    

Intervention name(s): aspartame; water
Intervention type(s): Other; Other
Intervention description(s): will be given 5mg aspartame or 15 mg aspartame; control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Tolerability and Clinical Activity of ASM-024 in Stable Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and clinical activity of
      ASM-024 in stable moderate asthma.
    


Intervention name(s): ASM-024; ASM-024 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Target dose of 10 mg ASM-024 administered once by inhalation; Target dose of 100 mg ASM-024 administered once by inhalation; Placebo administered once by inhalation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stable moderate asthma
Observational Registry on Acute Coronary Syndromes in Campania
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      This registry aims to collect data related to management of patients affected by acute
      coronary syndromes and hospitalized in the Campania Region of Italy
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patints hospitalized for Acute Coronary Syndromes
Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to help answer the following research question:

        -  Whether administration of an aprepitant containing regimen, an olanzapine containing
           regimen or regimen containing both will prevent nausea and vomiting better for patients
           undergoing an autologous stem cell transplant with melphalan chemotherapy. Both of these
           medications are approved by the United States Food and Drug Administration (FDA) for
           nausea and vomiting.

        -  Participants will be randomly assigned to one of the 3 treatment groups:

             -  Arm A: aprepitant containing anti-emetic therapy

             -  Arm B: olanzapine containing anti-emetic therapy

             -  Arm C: Aprepitant plus olanzapine containing anti-emetic therapy
    

Detailed description: 
      This is a multi-center, randomized, non-inferiority phase 3 study conducted to determine an
      appropriate anti-emetic regimen for patients receiving melphalan for an autologous stem cell
      transplant (SCT). Candidates for this trial will include patients aged 18-80 years with
      hematologic malignancies receiving high dose melphalan as part of a conditioning regimen for
      an autologous stem cell transplant. Patients will be enrolled in 3 arms. Patients in Arm A
      will receive an aprepitant containing anti-emetic regimen. Patients in Arm B will receive an
      olanzapine containing anti-emetic regimen. Patients in Arm C will receive an aprepitant plus
      olanzapine containing anti-emetic regimen. Patients must be able to tolerate oral
      medications.

      Patients will be carefully monitored for rates of emesis, nausea, and mucositis. Any adverse
      events will be recorded. Impact on quality of life will also be assessed. A total of 184
      patients will be accrued to each arm. It is anticipated that the accrual period will last
      approximately 2-3 years. The primary endpoint of this study is a complete response, defined
      as no emesis and no rescue therapy within 120 hours of melphalan administration.
    

Intervention name(s): o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1; Olanzapine10 mg orally daily on Days -1,0,+1 and +2; Aprepitant plus Olanzapine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Add aprepitant to anti-emetic regimen; add olanzapine to anti-emetic regimen; add aprepitant and olanzapine to anti-emetic regimen
Other intervention name(s): Emend; Zyprexa; Emend; Zyprexa
Intervention MeSH terms: Olanzapine; Aprepitant; Fosaprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: autologous; myeloma; transplant