bioihbjkbjnl/mcl2 huggingface dataset:
Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast
Condition: Acute Ankle Sprain; Ankle Ligament Rupture; Ankle Injuries
MeSH terms: Rupture; Sprains and Strains; Ankle Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study we compare two treatment options for ankle sprains. 100 patients were
      randomised between a flexible cast treatment and a removable and adjustable brace made out of
      the same materials.

      Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures
      were patient satisfaction scores with treatment as well as treatment result.
    


Intervention name(s): Functional treatment for ankle sprain using ankle cast; Ankle sprain treated with removable ankle support
Intervention type(s): Other; Other
Intervention description(s): Functional treatment for ankle sprain using ankle cast; Ankle sprain functionally treated with removable and adjustable ankle support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ankle Sprain; Ankle Distortion; Functional treatment; Brace treatment
Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect of JTT-302 on the increase of High
      Density Lipoprotein-Cholesterol (HDL-C) levels when administered daily for four weeks in
      subjects with low HDL-C levels.
    


Intervention name(s): JTT-302; JTT-302; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal; JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal; Matching placebo tablets, oral, 30 minutes after the start of the morning meal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Profile of Marketing Professional Audiologist Who Works in the Area of Audiology Clinic
Condition: Audiologist; Fortaleza
Study type: Observational

Summary: 
      the audiology has achieved a great advance, where currently speech pathologists act in
      private clinics and in public services, in addition to schools, colleges and universities. To
      observe the development of the area of Audiology in Brazil, we note that there is a growing
      number of new audiology procedures. In 1980 the practice of audiology was limited in
      hospitals, offices and private clinics, and in 1988 due to a new constitution that devoted
      attention to protection of health of workers, opened-if more than one field of work, the
      audiology occupational, because of the hearing losses induced by noise
    

Detailed description: 
      The area of audiology referred-if the science of hearing, auditory processing and corporal
      balance. The speech pathologist, Especialista em Audiologia, identifies, assesses and
      rehabilitation, empowering people with disabilities peripheral or central auditory,
      influencing the emergence of human communication disorders, as well as the balance disorders
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        replied to the questionnaire speech pathologists, of both sexes, active in the area of
        audiology clinic, of the city of Fortaleza, Ceará.
      
Biospecimen description: 
      no biospecimens are to be retained.
    
Keywords: speech and language; phonoaudiology; marketing
Level of Burn Out of Surgical Residents Working in Government Hospitals of Lahore
Condition: Burn Out Syndrome
MeSH terms: Burns; Burnout, Psychological
Study type: Observational

Summary: 
      The term burnout was coined by psychologist Herbert Freudenberger in 1974 in an article
      entitled "Staff Burnout" in which he discussed job dissatisfaction precipitated by
      work-related stress. A broadly applicable description defines burnout as a state of mental
      and physical exhaustion related to work or care giving activities. A long-standing conceptual
      and operational definition characterized burnout as a triad of emotional exhaustion
      (emotional over extension and exhaustion), depersonalization (negative, callous, and detached
      responses to others), and reduced personal accomplishment (feelings of competence and
      achievement in one's work) In the World Health Organization International Classification of
      Diseases, 10th revision, burnout is defined as a "state of vital exhaustion." Although no
      specific diagnosis of burnout is mentioned in the Diagnostic and Statistical Manual of Mental
      Disorders, burnout is a clear syndrome with significant consequences.

      Burnout in health care professionals has gained significant attention over the last several
      years. Given the intense emotional demands of the work environment, clinicians are
      particularly susceptible to developing burnout above and beyond usual workplace stress.
      Residency training, in particular, can cause a significant degree of burnout, leading to
      interference with individuals' ability to establish rapport, sort through diagnostic
      dilemmas, and work though complex treatment decision making. Overall, burnout is associated
      with a variety of negative consequences including depression, risk of medical errors, and
      negative effects on patient safety. The goal of this review is to provide medical educators
      and leaders with an overview of the existing factors that contribute to burnout, the impact
      of burnout, inter specialty variation, and suggestions for interventions to decrease burnout.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        General surgical residents of All the government Hospitals Of Lahore
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated
      non-squamous NSCLC Chinese patients will be investigated in this clinical trial.
    


Intervention name(s): Sintilimab; IBI305; Pemetrexed; Cisplatin; Placebo1; Placebo2
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200mg IV Q3W; 15mg/kg IV Q3W; 500mg/m2 IV Q3W; 75mg/m2 IV Q3W; Placebo1 IV Q3W; Placebo2 IV Q3W
Other intervention name(s): IBI308
Intervention MeSH terms: Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment Development of Triheptanoin (G1D)
Condition: Epilepsy; GLUT1DS1; Glut1 Deficiency Syndrome 1, Autosomal Recessive; Glucose Metabolism Disorders; Glucose Transport Defect; Glucose Transporter Type 1 Deficiency Syndrome; Glucose Transporter Protein Type 1 Deficiency Syndrome
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the maximum tolerated dose (MTD), as a percentage of calories consumed, of
      triheptanoin (C7 oil; C7) in a pediatric and adult patient population genetically diagnosed
      with glucose transporter type 1 deficiency disorder (G1D).
    

Detailed description: 
      The trial will use an open-label, standard 3+3 phase I design for determining the MTD of
      orally-administered C7 in G1D.

      Triheptanoin: a triglyceride oil containing three odd-carbon chain-length fatty acids (i.e.,
      a triglyceride of 7-carbon heptanoic acid). Triheptanoin will be taken 4 times per day
      (approximately every 6 hours) by mouth. it is dosed 4 times per day, divided evenly, and the
      total C7 daily dose will re-place 40% or 45% (depending on group) of the daily caloric intake
      from fat in the usual diet, based on current protocol guidelines. The oil should be taken
      approximately one hour before meals, and will be mixed with fat-free, sugar-free yogurt or
      pudding for administration.

      Up to thirty-six subjects will be enrolled in a 10-day maximum tolerable dose trial of C7.
      Initiation of C7 dosing will be conducted in the Children's Medical Center Dallas ambulatory
      Care Pavilion neurology Clinic. Subjects will be provided with C7 oil to take over the 7 days
      of administration.

      Subjects will not be required to stop other medications. Subjects will be directed to
      maintain their usual medications, including rescue seizure medications, as necessary for the
      course of the study. Subjects may have any clinical medical records transferred back to their
      referring physician at completion of the study.
    

Intervention name(s): Triheptanoin
Intervention type(s): Drug
Intervention description(s): Triheptanoin will be administered for 7 days 4 times daily.
Other intervention name(s): C7
Intervention model: Single Group Assignment
Intervention model description: The trial will use an open-label, standard 3+3 phase 1 design for determining the MTD of orally administered C7 in G1D.
Masking: None (Open Label)
Primary purpose: Treatment
Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional

Summary: 
      Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid
      Acoustic Pulse (RAP) device for the treatment of cellulite
    

Detailed description: 
      To assess the safety and tolerability of Soliton's RAP Nov Heavy for the treatment of
      cellulite. To assess the efficacy of Soliton's RAP Nov Heavy device for the temporary
      improvement in appearance of cellulite in terms of mean change in cellulite severity score
      (CSS).
    

Intervention name(s): Soliton Rapid Acoustic Pulse (RAP)
Intervention type(s): Device
Intervention description(s): Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.
Other intervention name(s): RAP
Intervention model: Single Group Assignment
Intervention model description: Single Group
Masking: None (Open Label)
Primary purpose: Device Feasibility
Chronic Rhinosinusitis in a Danish Population: Evaluation of Causes of Disease, Progress and Treatment
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Study type: Observational

Summary: 
      Introduction: Chronic Rhinosinusitis (CRS) is defined as inflammation of the nose and the
      paranasal sinuses. It is a very common disorder increasing in both incidence and prevalence
      with significant impact on quality of life and substantial health care costs. In this study
      we evaluate the prevalence of CRS in Denmark and there is a need for consensus about
      diagnosing this disease. Different questionnaires and different tests used for examination
      are evaluated together with the patients compliance and days lost through illness.

      Methods: As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on
      CRS was posted to 5000 residents on Funen. From the completed and returned questionnaires
      self reported CRS was evaluated. Respondents were invited for clinical examination including
      spirometry, skin prick test, bloodsample and an ENT examination including nasal endoscopy,
      acoustic rhinometry, peak nasal inspiratory flow and smell test. Questionnaire on quality of
      life (EQ-5D) and symptom severity (SNOT-22) was completed. Medical diagnosed CRS was
      diagnosed according to the definition on CRS stated by EPOS (European Position Paper on
      Rhinosinusitis and Nasal Polyps 2007). CRS is defined as inflammation in the nose and
      paranasal sinus and should be characterized by two or more symptoms one of which should be
      either nasal blockage/obstruction/congestion or nasal discharge, +/- facial pain/pressure,
      +/- reduction or loss of smell. Endoscopic signs should be present and symptoms must have
      been present > 12 weeks. Patients diagnosed with CRS were invited for a 1 year and 2 year
      follow up where examination and questionnaires were repeated and treatment compliance and
      days lost through illness were evaluated.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on CRS was
        posted to 5000 residents on Funen. From the completed and returned questionnaires self
        reported CRS was evaluated. Respondents were invited for clinical examination. Patients
        diagnosed with CRS were invited for a 1 year and 2 year follow up.
      
Biospecimen description: 
      Blodsamples.
    
Keywords: Chronic rhinosinusitis, SNOT 22, Quality of life
A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This open, randomized pilot feasibility trial is to evaluate the feasibility and effect of
      neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil, epirubicin plus
      cyclophosphamide (FEC) in treating postmenopausal women with ER-positive, HER2-negative
      breast cancer. Forty postmenopausal stage M0, ER-positive, HER2-negative invasive breast
      cancer women who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by
      imaging were randomly (1:1) enrolled to receive neoadjuvant everolimus plus letrozole for 18
      weeks or neoadjuvant FEC for 6 cycles before surgery. The primary objective is to determine
      the feasibility of neoadjuvant everolimus plus letrozole in postmenopausal patients with
      ER-positive, HER2-negative breast cancer. Secondary aims are to compare the ultrasound
      response rate, pathological complete response (pCR) rate, breast-conserving surgery rate,
      toxicities, and changes in the percentages or counts of peripheral blood CD4+ T cells, CD8+ T
      cells, tumor-specific CTLs, T helper cells (Th), regulatory T cells (Treg), and NK cells and
      changes in tumor Ki67 index (pre- versus post- neoadjuvant therapy).
    


Intervention name(s): Everolimus; Letrozole; Fluorouracil; Epirubicin; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Neoadjuvant endocrine therapy; Neoadjuvant endocrine therapy; Neoadjuvant chemotherapy; Neoadjuvant chemotherapy; Neoadjuvant chemotherapy
Other intervention name(s): RAD001; Femara; 5-Fu; EPB; CTX
Intervention MeSH terms: Cyclophosphamide; Fluorouracil; Everolimus; Letrozole; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Articaine 4% Versus Lidocaine 2% for Local Anesthesia of MIH-affected Maxillary Molars
Condition: Molar Incisor Hypomineralisation
MeSH terms: Molar Hypomineralization
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Comparison of injection pain with lidocaine and articaine. Comparison of the efficacy of
      lidocaine and articaine during treatment of MIH- maxillary molars.

      Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty
      six cooperative children, aged 6-12years old
    

Detailed description: 
      Background and Aims: Some dentists have difficulty obtaining effective anesthesia when
      treating MIH molars.

      There are no studies comparing the effectiveness of lidocaine and articaine in MIH-maxillary
      molars.

      Design: A randomized, controlled, crossover, Triple-blinding clinical study including twenty
      six cooperative children , aged 6-12 years old. Each child was randomly assigned to either
      articaine 4% or lidocaine 2% in their first session with the second solution being used at
      the second session.
    

Intervention name(s): Lidocaine 2%; Articaine 4%
Intervention type(s): Drug; Drug
Intervention description(s): The child will be injected with lidocaine 2%,after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and pain after injection and treatment will be evaluated using the Wong-Baker faces pain rating scale; The child will be injected with 4% Articaine, after that the treatment will be completed , Pain during injection and treatment will be assessed using the FLACC scale and Wong-Baker faces pain rating scale
Other intervention name(s): A; B
Intervention MeSH terms: Lidocaine; Carticaine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, controlled, crossover, Triple-blinding clinical study, Comparison of articaine 4% and lidocaine 2%
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: local anesthesia; Lidocaine 2%; Articaine 4%; molars
Immediate Effect of Irradiation With Low-level Laser Therapy on the Electromyographic Activity of the Upper Trapezius Muscles and the Level of Pain Among Patients With Non-specific Neck Pain
Condition: Neck Pain Treatment
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the present study is to assess the immediate effect of irradiation with low level
      laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the
      amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients
      with non-specific neck pain will be enrolled in a randomized, single-blind, crossover study.
      Each subject will receive two forms of treatment in random order: a single session of LLLT
      and placebo LLLT. In order to eliminate carry-over treatment effects, a one-week wash-out
      period will be respected between sessions. Surface electromyography will be used to determine
      nerve conduction velocity and activity in the upper trapezius muscles before and after
      treatment. The outcome measures will be determined by a numerical pain rating scale.
      Comparisons before and after irradiation with LLLT will determine the activity of the upper
      trapezius muscles and the level of pain. The data will be submitted to statistical tests
      considering a p-value of p < 0.05.
    


Intervention name(s): low level laser therapy; Placebo low level laser therapy
Intervention type(s): Device; Device
Intervention description(s): Will be performed irradiation with low-intensity laser in upper trapezius muscle; Will be not performed irradiation with low-intensity laser in upper trapezius muscle
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low-Level Laser Therapy; trapezius muscle; neck pain
Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Patient reported outcomes (PRO) have become an important endpoint assessed in clinical
      trials. It is important to understand the relationship between medication and patients'
      symptomatology, quality of life and well-being. We predict levodopa/carbidopa intestinal gel
      (LCIG; Duodopa) will significantly improve quality of life and emotional well-being compared
      to baseline in patients with advance Parkinson disease (APD) not well controlled with
      conventional treatment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Advanced Parkinson's Disease patients
      
Keywords: Duodopa; Advanced Parkinson's Disease; Levodopa/Carbidopa intestinal gel
A Study to Assess Retention Rate, Persistence and Adherence in Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated With Adalimumab in Routine Clinical Settings in Russian Federation
Condition: Spondylarthritis; Psoriatic Arthritis; Ankylosing Spondylitis (AS)
MeSH terms: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      The objective of this study is to access retention rate, persistence and adherence in
      population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis
      (PsA)) participants treated with adalimumab in routine clinical settings in the Russian
      Federation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) participants treated with
        adalimumab in routine clinical settings in the Russian Federation.
      
Keywords: Adalimumab; Ankylosing spondylitis; Psoriatic arthritis; Spondylarthritis; Humira®
The Representation of the Sensibility of the Breast on the Somatosensory Cortex
Condition: Healthy
Study type: Interventional

Summary: 
      Rationale: The representation of the breast on the somatosensory cortex has not been
      precisely located. Therefore, a pilot study with healthy subjects is needed to localize the
      sensibility of the breast on the somatosensory cortex with the use of a 7 Tesla fMRI.

      Objective: To determine the exact localization of the representation of the sensibility of
      the breast and nipple-areola complex on the somatosensory cortex. Secondly, to assess whether
      there are differences in representation between individuals of the same sex and between both
      sexes.

      Study design: A single center pilot study carried out in the Maastricht University Medical
      Center, the Netherlands.

      Study population: A total of 10 female and 10 male healthy individuals will be recruited.

      Intervention: Every subject will undergo a functional MRI scan with stimulators applied to
      the bare breast in a fixed pattern. These stimulate the skin and sensory nerves of the breast
      and nipple-areola complex in a random sequence.

      Main study parameters: The hemodynamic response after stimulation of the skin of the breast
      and nipple-areola complex, representing neuronal activity in that region, is measured. Within
      the somatosensory cortex (S1 and S2), the temporo-spatial brain activity patterns after the
      various stimulation conditions are assessed, and the representation of the breast on the
      somatosensory cortex is mapped.
    


Intervention name(s): Functional MRI scan
Intervention type(s): Device
Intervention description(s): 7.0 Tesla functional MRI scan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other