bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Home Exercise Delivery on Compliance & Outcomes for Musculoskeletal Pain
Condition: Chronic Pain; Compliance, Patient; Chronic Low Back Pain; Knee Pain Chronic
MeSH terms: Musculoskeletal Pain; Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      Patients seeking care for chronic low back or knee pain will be recruited for enrollment, and
      randomized within two phases (retention and compliance). Patients will consent to a 2-step
      study design, with independent randomization for each. The initial step will assess retention
      based on 4 different exercise prescription strategies. This will be assessed short-term, and
      then the 2nd step will consist of a second independent randomization to receive different
      reminder strategies to determine their influence on exercise compliance at home.
    

Detailed description: 
      Patients seeking care for their chronic low back or knee pain will be recruited to
      participate in a trial investigating the value of different exercise and education
      prescription strategies as well as strategies to determine the influence of various exercise
      reminder strategies. On day 1 of enrollment, patients will be randomized and instructed in
      two different types and amounts of exercises, as well as two types of delivery strategies.
      The ability to recall and perform these exercises will be assessed 20 minutes after
      completion of the instructional period (retention). In phase 2, patients will be randomized
      to receive different reminder strategies (none, email, text, and/or video) and their
      compliance assessed over a 1 month period (compliance). Self-reported compliance over the
      first month, and health care utilization outcomes will be analyzed for the 1 year following
      completion of the 1 month period, in all groups.
    

Intervention name(s): Number of Exercises; Type of Instruction; Delivery Type; Mobile Reminder
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.; The type of instruction in phase 1 will be compared: Instruction by providing a handout only vs being instructed by a provider and practiced by the patient with provider feedback.; In phase 2 subjects will be provided 4 exercises using only a handout vs delivered to them electronically with the addition of a video.; A text-message based mobile reminder tool will be utilized to engage with subjects via texting on a daily basis to provide reminders and encouragement to perform their home exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric
      acceptability across three iterations of a novel spectacle lens design.
    

Detailed description: 
      This feasibility study was conducted to assess the performance of three experimental
      spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with
      myopia.
    

Intervention name(s): Spectacle lenses
Intervention type(s): Device
Intervention description(s): Spectacle lenses with clear central apertures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Device Feasibility
Combine TACE and Autologous Tcm Immunotherapy Versus TACE Alone for HCC With MVI After Radical Resection
Condition: Hepatocellular Carcinoma; Malignant Neoplasm
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of combining autologous Tcm
      immunotherapy and TACE in HCC patients with MVI after radical resection. Patients will be
      assigned either to the experimental arm to receive autologous Tcm immunotherapy and TACE or
      to the active comparator (TACE alone).
    

Detailed description: 
      Hepatocellular carcinoma (HCC) is one of the common cancer worldwide, which is the third
      cause of cancer related deaths. Radical hepatic resection remains the main treatment for
      hepatocellular carcinoma, the 5-year survival rate of HCC after surgery was 60-70%.
      Unfortunately, HCC is prone to postoperative recurrence that more than 50% of patients
      relapse within 2 years, which has become the key to restrict the therapeutic effect of
      hepatocellular carcinoma. Microvascular invasion (MVI) is one of the main risk factors for
      poor prognosis in HCC.

      Autologous cell immunotherapy is to collect patient's own immune cells and then given back to
      the patient after amplified in vitro that can improve the anti-tumor immune response. Tcm
      (central memory T cells) are effective anti-tumor immune cells that exhibit the long-term
      survival and self-renewal capacity in vivo. Autologous Tcm immunotherapy combining
      chemotherapy, surgery or radiotherapy would effectively prolong survival period, prevent
      tumor recurrence and metastasis, then improve quality of life in patients.
    

Intervention name(s): TACE plus autologous Tcm immunotherapy; TACE
Intervention type(s): Combination Product; Procedure
Intervention description(s): TACE:transcatheter arterial chemoembolization.
Autologous Tcm immunotherapy: to collect patient's own immune cells and then given back to the patient after amplified in vitro.; TACE:transcatheter arterial chemoembolization.
Intervention MeSH terms: Chlorotrianisene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
COVID-19 IN CHILDREN IN NIGER, 2020
Condition: to Contribute to a Better Control of COVID-19 in Children in Niger
MeSH terms: COVID-19
Study type: Observational

Summary: 
      On January 30, 2020, the WHO declared COVID-19 a global health emergency. Children were
      affected with less severe forms. Niger had implemented measures in a context where children
      are a source of contamination. The objective was to determine the factors associated with
      COVID-19 in children in Niger from February to August 2020 through an analysis of the
      national database.
    

Detailed description: 
      We conducted an analytical cross-sectional study including all COVID-19 suspects in the
      database. We used Excel and Epi Info 7.2.4. software for data extraction and analysis.
      Frequencies and proportions were calculated, we estimated in a logistic regression the OR of
      association with their 95% confidence interval, the factors associated with COVID-19 at the
      threshold of p<0.05.

      Results: Of 572 notified suspected COVID-19 cases in children aged 0-15 years, 11.36% were
      positive. The median age of infected children was 10 years [IQR: 5- 13 years]. The sex ratio
      of males to females was 2.1. Children aged 11-15 years were 49.2%, 61.5% resided in Niamey,
      4.6% had comorbidities. The notion of travel was 12.3% and 40% had a notion of contact, 24.4%
      had a fever, 23.2% had a cough, 18% were hospitalized and the case fatality was 1.5%. In
      etiological analysis, the factors associated with COVID-19 were sex ORa= 0.51 [0.28-0.93]
      p=0.028, the presence of symptoms ORa= 2.29 [1.23-4.25] p=0.008 and the notion of contact
      ORa= 0.32 [0.13-0.77] p=0.011.

      exposed children were sensitive to COVID-19, all age groups were affected with a male
      predominance. We recommend barrier measures adapted to young people, early detection and
      management of infected children.
    

Intervention name(s): cross-sectional study
Intervention type(s): Other
Intervention description(s): analytical cross-sectional study with retrospective collection of epidemiological surveillance data on COVID-19 in Niger.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This was an analytical cross-sectional study with retrospective collection of
        epidemiological surveillance data on COVID-19 in Niger. The study period spanned six (6)
        months from February 25 to August 28, 2020. Children aged 0-15 years suspected of having
        COVID-19 whose data were in the DSRE database were included. We used the data extraction
        form that served as a secondary database containing only our variables of interest.
      
Keywords: factors, COVID-19, children, database, Niger
Proellex® Pharmacokinetic Bridging Study II
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way
      crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.
    

Detailed description: 
      This is an open-label, randomized, single-center, outpatient, unblinded, single-dose,
      three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34
      years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state,
      formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B);
      successive dosing will be separated by at least one week intervals from the previous dosing.
      Blood will be collected prior to taking the dose, and following the dose for 24 hours
      post-dose. Subjects will be discharged from the study after the last blood sample is obtained
      after the third dose of Proellex®. Safety will be assessed throughout the study.
    

Intervention name(s): Proellex 25 mg formulation A; Proellex 25 mg formulation B
Intervention type(s): Drug; Drug
Intervention description(s): One Proellex 25 mg formulation A capsule; One 25 mg Proellex capsule formulation B administered both fed and fasted
Other intervention name(s): Telapristonee acetate; Telapristone acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PK; Pharmacokinetics
HIV Risk and Prevention in Women
Condition: HIV
Study type: Interventional

Summary: 
      This study gathers information about HIV testing utilization and influences on HIV testing
      decisions among young, general population Russian women at-risk of HIV exposure. The study
      compares HIV testing acceptance across two types of low-barrier testing strategies (opt-in
      vs. opt-out) and conducts one of the first randomized experimental comparisons of these
      strategies. The overarching goal is to gain knowledge that can be used to increase
      utilization of HIV testing among at-risk young women and offer gender-specific strategies for
      improving prevention.
    

Detailed description: 
      The study uses an adaptive design. That is, the procedures and phases of the study
      experienced by a participant depend to some extent on their responses to earlier phases.
      Ultimately, this design yields a number of practice relevant pathways and endpoints, each of
      which has a testing rate associated with it.

      Phase-I is initial screening for risk status, collecting background data, and ascertaining
      whether there has been recent independent HIV testing. If there has been independent testing,
      information about the independent testing is collected and the participant's involvement is
      complete.

      Those who are not independent testers enter Phase-II. Phase II will include: randomization to
      opt-in vs. opt-out conditions; a survey asking about reasons for acceptance or
      non-acceptance; participating in a focus group in which participants who have not accepted
      HIV testing (non-accepters) and those who accepted (accepters) will be asked to discuss their
      health beliefs related to HIV prevention, barriers and reasons for testing/not testing; then
      (5) after the focus group is complete, privately offer another testing opportunity to
      non-accepters, under the same opt-in or opt-out strategy to which they previously were
      randomized. The design was selected in order simultaneously answer a number of questions that
      we believe will be important for engineering a testing and prevention strategy suitable for
      testing in a subsequent study: (1) identify key attitudes, beliefs and knowledge (survey);
      (2) contrast opt-in and opt-out strategies (randomized trial); (3) generate qualitative data
      about reasons for decisions in the women's own words (focus group); and (4) identify any
      incremental benefit related to peer discussion.
    

Intervention name(s): Opt-in or Opt-out testing; Focus Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Study participants will be offered a health screening onsite.; Study participants will be invited to participate in a focus group discussion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: transmission; prevention; women; childbearing age; HIV testing; testing strategy
Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      The major goal of this project is to identify the role of the immune responses in the
      emergence of protease inhibitor mutants during therapy.
    

Detailed description: 
      Objective 1: Evaluate the role of the immune responses in determining the emergence of HCV
      NS3 resistance mutation during protease inhibitor therapy

      Hypothesis 1 (HT 1): Low HLA binding to peptides containing protease inhibitor resistance
      mutations is associated with the emergence of protease inhibitor mutants during therapy and
      failure of the treatment.

      Hypothesis 2 (HT 2): A hole in T cell repertoire may allow emergence of protease inhibitor
      mutants during protease inhibitor therapy which leads to loss of the immune responses to
      these mutants and failure of treatment.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Investigators plan to enroll 20 human subjects with chronic hepatitis C virus infection
        from the outpatient clinic at the University of Cincinnati College of Medicine.
      
Biospecimen description: 
      Blood lymphocytes from enrolled subjects will be retained until all investigations will be
      performed and publications are generated. After that remaining samples will be discarded
      properly according to the Biosafety instructions.
    
Keywords: Hepatitis C; HCV
Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome
Condition: Arthrodesis
Study type: Interventional

Summary: 
      Ultrasonic bone osteotome has been utilized in various surgical field, but the use in
      neurosurgery especially in spine surgery is not widely spread. In the present study, the
      investigators are going to compare bony fusion rate after cervical laminotomy either with
      ultrasonic osteotome or conventional drill.
    

Detailed description: 
      Ultrasonic bone osteotome has been utilized in various surgical field, but the use in
      neurosurgery especially in spine surgery is not widely spread. The tissue selectivity of
      ultrasonic osteotomy may enhance operative time and reduce tissue trauma. Moreover, bony
      fusion rate may be increased because of low thermal injury to the bone. In the present study,
      we are going to compare bony fusion rate after cervical laminotomy either with ultrasonic
      osteotome or conventional drill.
    

Intervention name(s): ultrasonic osteotome; drill
Intervention type(s): Device; Device
Intervention description(s): making gutter with ultrasonic osteotome; making gutter with drill
Other intervention name(s): misonix; electronic drill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arthrodesiss; cervical vertebra; laminoplasty
CHARITÉ™ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc
      compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at
      one level of the lumbar spine (either L4/L5 or L5/S1).
    

Detailed description: 
      Treatments for disc degeneration have historically included conservative modalities, such as
      rest, heat, electrotherapy, physical therapy, and analgesics to surgery. Currently, there are
      two main surgical techniques for treatment of disc degeneration: (1) nucleotomy or
      diskectomy, i.e., excision of part or all of the degenerated disc, which is typically
      performed for treatment of radicular syndrome in the case of disc herniation; and (2) spinal
      fusion, i.e., grafting bone between the vertebrae adjacent to the degenerated disc to
      eliminate articulation at the damaged segment, which is typically performed for treatment of
      degeneration together with instability and reduction of the intervertebral space. Rigid
      internal fixation may also be used to promote fusion.

      The CHARITÉ Artificial Disc is designed to provide a new therapeutic option for treatment of
      degenerative disc disease as an alternative to spinal fusion to preserve function in the
      lumbar vertebral region. Each institution participating in the study was to treat the first 5
      consecutive study participants with the CHARITE to as it involves a modification to the
      technique used for anterior fusion. Data will be collected on these "training" cases but will
      not be included in the comparison with the control (fusion) treatment.

      Comparison: Outcomes for patients treated with the CHARITÉ Artificial Disc will be compared
      to outcomes for patients treated with anterior lumbar interbody fusion.
    

Intervention name(s): CHARITÉ Artificial Disc; Anterior Interbody Fusion with BAK Cage
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arthroplasty; lumbar; spine
The Senstivity and Specificity of Using Salivary miRNAs in Detection of Malignant Transformation of Oral Lesions.
Condition: Oral Premalignant Lesions
MeSH terms: Precancerous Conditions
Study type: Observational

Summary: 
      Due to cancer is a leading cause of death world wide , we will coduct the study to evaluate
      the diagnostic accuracy of using salivary miRNAs (412,512) from the salivary extracellular
      vesicles (index test) in detection of the malignant transformation of the premalignant
      lesions using the qualitative real time polymerase chain reaction (qRT-PCR) analysis in
      comparison to taking biopsy .
    

Detailed description: 
      our study is a case control study,we will coduct our study to evaluate specificity and
      sensitivity of using salivary extracellular vesicles miRNAs (412,512) in detection of
      malignant transformation in potientially malignant oral lesions by using qRT-PCR analysis
      ,participants will be selected and arranged in 3 groups the control group, potentially
      malignant group and malignant group ,the salivary samples from the participants will be
      collected and then microRNA extraction steps will be done through the laboratory steps ,that
      include extracellular vesicles isolation, PCR Analysis for miRNA-412 and miRNA-512 expression
      ,also the histopathologic diagnosis and examination of all specimens were confirmed by
      pathologist.
    

Intervention name(s): using salivary miRNA (412,512)
Intervention type(s): Diagnostic Test
Intervention description(s): quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.
Other intervention name(s): biopsy sample for potientially maliganat and malignant group
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  Group of normal control subjects: 18 Healthy subjects presenting no clinically
             detectable oral lesions matched for age, gender, and risk factors .Group of subjects
             with potentially malignant lesions: 18 patient with innocuous lesions.

          -  Group of subjects with malignant lesions:18 patient with suspicious lesions
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
Condition: Scoliosis; Adolescent Idiopathic Scoliosis (AIS)
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Adolescent Idiopathic scoliosis affects 3-4% of the Canadian population, of which about 10%
      will need a brace treatment during pubertal growth spurt. The design is made relatively
      corsets empirically, hence the relative efficiency of this treatment. Our team has developed
      innovative methods for design, optimization and computer aided manufacturing-based numerical
      simulation models customized to each patient, and a system of evaluation and adjustment of
      corsets. In this project, the investigators will evaluate the effectiveness of this platform
      customized treatment and demonstrate its clinical application
    


Intervention name(s): Optimized brace versus conventional Boston brace
Intervention type(s): Other
Intervention description(s): Surface topography using Inspeck cameras allows production of a 3D reconstruction of the patient's trunk, this reconstruction will help to produce the optimized brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an EOS imaging system to allow 3D reconstructions. The SRS-22r will be collected at all clinical visits. Study questions will be aligned as much as possible with other prospective scoliosis protocols so as to minimize patient and surgeon response burden. The study protocol requires no additional visits or radiographs beyond standard of care. Ibuttons are installed in each brace and used to measure the compliance of the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Scoliosis; Spine deformity; Brace; 3D
Effects on the Airway Lumen of Talsaclidine in Combination With Propranolol in Comparison to the Effects of the Monosubstances in Healthy Elderly Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effects on airway lumen of talsaclidine in combination with propranolol
      and of talsaclidine and propranolol given as monosubstances
    


Intervention name(s): Propranolol; Talsaclidine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment