bioihbjkbjnl/mcl2 huggingface dataset:
Inertial Sensors Used to Learn Manipulation
Condition: Medical Education
Study type: Interventional

Summary: 
      -  Background Context: no studies have been identified to analyse the effect of real time
           feedback (using inertial sensors) on physiotherapy students learning the art of
           posterior-anterior thoracic manipulation (PATM).

        -  Purpose: to study the effect caused by real-time feedback on the learning process for
           PATM, comparing two undergraduate physiotherapy student groups. Hypothesis: significant
           differences will exist in the execution parameters of manipulation among students
           receiving real-time feedback versus those who do not.

        -  Study Design/Setting: longitudinal, pre-post intervention.

        -  Patient Sample: Sixty-one undergraduate physiotherapy students were divided randomly
           into two groups, G1 (n = 31) (group without feedback in real time) and G2 (n = 30)
           (group with real-time feedback).

        -  Outcome Measures: time, displacement and velocity and improvement (only between groups)
           to reach maximum peak, to reach minimum peak from maximum peak, total manipulation time.

        -  Methods: two groups of physiotherapy students learned PATM, one using a traditional
           method and the other using real-time feedback (inertial sensor). Measures were obtained
           pre- and post-intervention. Intragroup pre- and post-intervention and intergroup
           post-intervention scores were calculated. An analysis of the measures' stability was
           developed through an ICC (1,2).

        -  Results: the values of ICC ranged from 0.881 to 0.997. Statistically significant
           differences were found in all variables analysed (intra- and inter-group) in favour of
           G2.

        -  Conclusions: the learning process for posterior-anterior thoracic manipulation is
           facilitated when the student receives real-time feedback.
    


Intervention name(s): Real Time Feedback; Traditional Learning Method
Intervention type(s): Device; Device
Intervention description(s): Before beginning practice, one of the teachers performed the manipulation and explained the graph parameters as real-time feedback to consider when interpreting the graph, leaving the graphic as the benchmark execution; Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: Spinal Manipulation; Teaching; Thoracic Vertebrae; Feedback
Hormonal Birth Control and the Risk of Acquiring HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether hormonal birth control increases, decreases,
      or does not change the risk of women becoming infected with HIV.

      Sexual intercourse between men and women is the main way HIV is transmitted. About 90 percent
      of HIV infections in women are caused by sexual intercourse. Also, hormonal birth controls
      are widely used. This study hopes to find out whether hormonal birth control changes the risk
      of women becoming infected with HIV.
    

Detailed description: 
      Heterosexual intercourse is the primary mode of HIV transmission worldwide and accounts for
      about 90% of HIV infections in women. Hormonal contraceptives including COCs and injectables
      are among the most widely used contraceptives in the world. Understanding the impact of
      hormonal contraception on HIV transmission is a critical unanswered public health question.
      Because of the critical nature of this issue to women of reproductive age worldwide, a
      methodologically sound study must be undertaken. It must be determined if hormonal
      contraceptive use increases the risk of HIV infection and the magnitude of the association,
      if it exists.

      This study takes place in Thailand, Uganda, and Zimbabwe. HIV-seronegative women continue
      using their current birth control method (low dose COC, DMPA injections, or non-hormonal
      contraceptive methods [condoms, sterilization, or no modern contraception method]) for the
      duration of the study. They are followed every 12 weeks for a minimum of 15 months and a
      maximum of 24 months, or until seroconversion. Pelvic exams, including Pap smears, are done,
      blood samples are drawn, and vaginal and cervical specimens are tested for any sexually
      transmitted diseases (STDs). Women are provided with free treatment for any STDs that are
      diagnosed. They complete a questionnaire on sexual behavior and contraceptive history;
      counseling on contraceptive use and reducing HIV risk is provided.
    

Intervention name(s): Ethinyl estradiol/levonorgestrel; Medroxyprogesterone acetate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Medroxyprogesterone Acetate; Levonorgestrel; Ethinyl Estradiol; Medroxyprogesterone; Ethinyl estradiol, levonorgestrel drug combination; Estradiol
Primary purpose: Treatment
Keywords: HIV Seronegativity; Delayed-Action Preparations; Risk Factors; Prevalence; Contraceptive Agents, Female; Contraceptives, Oral, Combined; Medroxyprogesterone 17-Acetate
Non-invasive Mapping Using Ultra-high Frequency Electrocardiography
Condition: Left Bundle-Branch Block; Right Bundle-Branch Block; Non-Specific Intraventricular Conduction Defect
MeSH terms: Bundle-Branch Block; Heart Block; Cardiac Conduction System Disease
Study type: Interventional

Summary: 
      Cardiac electrical mapping is an important tool that allows doctors to study the electrical
      activity of the heart in detail. Electrical mapping systems used in clinical practice are
      time consuming, invasive and very costly. Ultra-high frequency electrocardiography is a novel
      non-invasive cardiac mapping system. Ultra-high frequency electrocardiography (UHF-ECG) can
      be performed in 10-15 minutes without any risk or discomfort to patients.

      The aim of this study is to refine this mapping system, verify it against invasive mapping
      and develop software to bring this novel system into routine clinical use including
      predicting which patients will respond to cardiac resynchronisation therapy.
    

Detailed description: 
      This is a single centre laboratory study aiming to utilise ultra-high frequency
      electrocardiography to construct cardiac electrical activation maps.

      All participants will attend for an UHF-ECG. This involves placing standard
      electrocardiography electrodes (up to 48) followed by electrocardiography recording using the
      UHF-ECG machine for 10-15 minutes.

      Participants undergoing a clinically indicated VT ablation procedure will their UHF-ECG done
      before the procedure at a separate time. The ablation procedure itself will proceed as
      standard with no alternation whatsoever in study participants and no invasive measurements
      will be undertaken during the procedure. After the procedure is complete the 3D electrical
      maps collected to guide VT ablation will be analyzed and used for the study. The invasive
      maps will be compared with the non-invasive maps obtained using UHF-EGC.
    

Intervention name(s): Ultra-high frequency electrocardiography
Intervention type(s): Diagnostic Test
Intervention description(s): Patients will have an ultra-high frequency electrocardiography performed.
Intervention model: Single Group Assignment
Intervention model description: Patients will have an ultra-high frequency electrocardiogram done.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ultra-high frequency electrocardiography; Left bundle branch block; Cardiac resynchronization Therapy; His Bundle Pacing
Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects
Condition: Seasonal Influenza; Influenza; Influenza Due to Unspecified Influenza Virus; Human Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and
      hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit
      influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated
      children aged 6 to <36 months.
    


Intervention name(s): MF59C.1-adjuvanted subunit influenza vaccine; Sub unit, Inactivated, Influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm; 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Cell mediated immunity; cell mediated immune response; Children; adjuvanted
A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer
Condition: Renal Cell Cancer; Metastatic Renal Cell Cancer
MeSH terms: Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      -  Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1
           and Flt3. Phase I study has shown that the toxicity is manageable.

        -  The purpose of this study is to compare the efficacy and safety profile between
           Famitinib and Sunitinib in patients with metastatic renal cell carcinoma.
    


Intervention name(s): Famitinib; Sunitinib
Intervention type(s): Drug; Drug
Intervention description(s): Famitinib 25 mg p.o. qd; Sunitinib 50 mg p.o. qd
Intervention MeSH terms: Sunitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MRCC; Metastatic Renal Cell Cancer; Famitinib; Sunitinib
Pharmacokinetics of Different CoQ10 Formulations
Condition: Coenzyme Q10 Pharmacokinetics
Study type: Interventional

Summary: 
      The objective of this trial is to compare the bioavailability (AUC, Tmax, and Cmax) of
      different Coenzyme Q10 preparations in healthy adults. Pharmacokinetic parameters of orally
      ingested CoQ10 such as AUC, Cmax and Tmax, as well as the ratio of reduced CoQ10 levels to
      total CoQ10 plasma levels (using the AUC) after administration are compared.
    


Intervention name(s): CoQ10
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will be randomly and blindly assigned to receive a single dose (200 mg) of one of the preparations (treatments).
Fasting blood samples are taken at baseline (t=0) or pre-dose for CoQ10 baseline determination.
Participants receive treatment at time zero with a glass of water (~ 125 mL), along with a standardized breakfast-provided immediately after the dose.
Capsules are administered as a single oral dose, with a wash-out period of at least 3-4 weeks between the two Coenzyme Q10 test products.
Capillary blood samples are collected at time points 0, 0.5, 1, 2, 3, 4,5, 6, 8, 10, 12, 24, 48- and 72-hours post-dose. A standardized lunch is provided after the 4hr blood sample, as well as a standardized dinner after the 8-h sample. Identical meals are served to all participants on each test day.
Intervention MeSH terms: Coenzyme Q10
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bioavailability; CoQ10; Ubiquinol; delivery system; pharmacokinetics
Practices Made by Patients to Avoid Insulin Injection Pain
Condition: Diabetes Mellitus
Study type: Observational [Patient Registry]

Summary: 
      Abstract Objective: This study was conducted to determine the knowledge levels of DM patients
      about the disease and insulin use, and their practices to avoid insulin injection pain.

      Methods: Data were collected from 399 patients who administered insulin injections in the
      study. Patient identification form, disease and treatment compliance form, Morisky-8
      Treatment Adherence Scale (MMAS-8), and Visual Analog Scale were used for data collection.
      The data were collected by the same researcher by face-to-face interview technique.
    

Detailed description: 
      The face-to-face interview technique was applied to all patients who met the inclusion
      criteria and accepted to participate in the study, in the waiting area of the internal
      medicine outpatient clinic. Data were collected by the same researcher. Questionnaire forms
      were filled in the form of questions and answers in 10-15 minutes.
    

Intervention name(s): filling out a survey
Intervention type(s): Other
Intervention description(s): This research is a descriptive study
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals with diabetes between the ages of 18-65
      
Keywords: Insuline injection pain; lipohypertrophy; nursing care
Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of
      the lesions are in the fissures of the first permanent molars. This study aims to investigate
      the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese
      children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride
      solution. The cost-effectiveness of these methods will also be compared. About 400 children,
      aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted
      in school using portable dental lights and instruments to identify teeth that need caries
      prevention. The children will be randomly allocated to one of the three test or the control
      groups. Treatments will be provided in the study primary schools according to standard
      clinical protocols. Follow-up examinations will be carried out every six months for 30 months
      to assess whether the preventive methods are successful, i.e. no dental caries develops in
      the treated teeth. The findings of this study will be of great value to dentists and public
      health authorities in deciding on the most appropriate dental caries prevention programme for
      school children in China and other developing countries.
    


Intervention name(s): placement of fissure sealant; fluoride varnish; silver fluoride; placebo control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): placement of resin-based fissure sealant at baseline without replacement; topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months; topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year; application of water onto tooth surface every year
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: tooth decay; fluoride; sealant; prevention
Exploratory Study Comparing ClearSight System 2D Map to Post Surgery Histopathological Analysis in Lumpectomy
Condition: Breast Cancer
Study type: Observational

Summary: 
      Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study
      comparing ClearSight system to histopathological to determine negative-margins in breast
      conserving surgery.
    

Detailed description: 
      This study is a multicenter, non-randomized, cross-sectional comparative exploratory study
      comparing the ClearSight System 2D map results to post surgery histopathological analysis of
      excised mass in lumpectomy surgery. The Efficacy Objective is to assess the ability of the
      ClearSight™ System to detect malignant tissue less than or equal to 1 mm of margins of
      excised breast specimen in breast conserving surgery using histopathological assessment as
      reference. The Safety Objective is that all adverse events, serious adverse events (SAE) will
      be reported according to local regulations. The actual reporting is discussed in section 0.
      No device-related adverse events are expected. For more information please refer to the
      Investigator Brochure.
    

Intervention name(s): ClearSight™ System
Intervention type(s): Device
Intervention description(s): comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with primary breast cancer
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
Condition: Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immune response of Novartis Meningococcal ACWY
      conjugate vaccine in healthy adolescents and adults.
    


Intervention name(s): Meningococcal ACWY Polysaccharide Vaccine; MenACWY CRM (19 to 55 years); Meningococcal ACWY Conjugate Vaccine; Novartis MenACWY Vaccine (56 to 65 Years)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.; One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.; One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.; One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Meningococcal; meningitis; vaccine; adolescents; adults
Food Effect Study With BMS-955176
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the impact of a light meal, a standard meal, and a
      high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted
      conditions.
    

Detailed description: 
      Primary Purpose

      Other: This study will assess the impact of a light meal, a standard meal, and a high fat
      meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose
      of 180 mg relative to fasted conditions.
    

Intervention name(s): BMS-955176
Intervention type(s): Drug
Intervention description(s): Single dose by mouth for each treatment specified
Intervention MeSH terms: BMS-955176
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
Condition: Abortion, First Trimester
Study type: Interventional

Summary: 
      This study examined the acceptability and feasibility of using a simplified regimen of
      medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone
      and misoprostol, and buccal administration of misoprostol, would be both acceptable to women
      and efficacious.
    


Intervention name(s): Home administration of 200 mg mifepristone
Intervention type(s): Drug
Intervention description(s): Home administration of 200 mg mifepristone
Intervention MeSH terms: Mifepristone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Adenoma Miss Rate With Water Exchange vs Carbon Dioxide Colonoscopy
Condition: Colonic Adenoma; Water Exchange Colonoscopy
MeSH terms: Adenoma
Study type: Observational

Summary: 
      This was an observational study comparing consecutive group of WE and CO2 insufflation in
      terms of right and proximal colon AMR by tandem colonoscopy.
    

Detailed description: 
      This was a prospective observational study to assess how WE colonoscopy would fit into
      clinical and research practices. We first observed whether optimal WE colonoscopy decreased
      the AMR in the right and proximal colon in a tandem approach. If WE did lower the AMR as
      compared with data in the literature, a randomized RCT deserves to be studied. For the
      calculation of sample size in the upcoming RCT, the AMR in the CO2 group would be collected.
      The differences of the AMRs in the right and proximal colon determined by tandem colonoscopy
      using WE or CO2 insufflation would then be compared.
    

Intervention name(s): Water exchange colonoscopy; CO2 insufflation colonoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): During back-to-back colonoscopy, the first examination was completed with water exchange during insertion and CO2 insufflation during withdrawal. The second examination was completed with CO2 insufflation during both the insertion and withdrawal.; During back-to-back colonoscopy, the first examination was completed with CO2 insufflation during both the insertion and withdrawal. The second examination was also completed with CO2 insufflation during both the insertion and withdrawal.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        86 eligible patients completed first-pass colonoscopy with WE insertion and CO2 withdrawal,
        followed by back-to-back second-pass colonoscopy with CO2 insertion and CO2 withdrawal
        during July 9 to Oct 12, 2018; Another 86 eligible patient completed first-pass colonoscopy
        with CO2 insertion and CO2 withdrawal, followed by back-to-back second-pass colonoscopy
        with CO2 insertion and CO2 withdrawal during Oct 15 to Nov 21, 2018.
      
Keywords: Adenoma miss rate; Adenoma detection rate