bioihbjkbjnl/mcl2 huggingface dataset:
In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty
Condition: Knee Prosthesis
Study type: Observational

Summary: 
      This study will compare the kinematics data collected from patients with implants created by
      different manufacturers to see which of these implants provides a more normal-like kinematic
      pattern compared to the normal knee.
    

Detailed description: 
      A better understanding of knee joint kinematics is important to explain premature
      polyethylene wear failures within knee implants and to help design a prosthesis that most
      closely approximates the normal knee. Therefore, the objectives for this study are to compare
      the in vivo kinematic patterns for subjects implanted with either a Stryker Triathlon
      Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) or Zimmer NexGen PCR TKA
      design to determine if there are any kinematic differences between these TKA designs. Each
      subject will be asked to undergo a fluoroscopic evaluation while performing weight-bearing
      activities under surveillance using the University of Tennessee's new mobile tracking
      fluoroscopic unit while performing deep knee bend and ramp up and ramp down activities. The
      mobile fluoroscopy unit is approved for use by the State of Tennessee on a study-by-study
      basis after IRB approval is obtained for each study.
    

Intervention name(s): Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA); Zimmer PCR TKA
Intervention type(s): Device; Device
Intervention description(s): The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.; The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.
Other intervention name(s): Triathlon PCR TKA; Zimmer NexGen PCR TKA
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be patients of Dr. Harold E. Cates of Tennessee Orthopaedic Clinics and
        must have been implanted with either a Stryker Triathlon CR TKA or Zimmer PCR TKA
      
Keywords: Knee Prosthesis; Total Knee Arthroplasty; Cruciate Retaining; Posterior Cruciate Retaining
French Adaptation of the AIDA (Assessment of Identity Development in Adolescence) and LoPF-Q (Levels of Personality Functioning Questionnaire) Scales.
Condition: Personality Disorders; Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Observational

Summary: 
      The main objective of this study is to develop the French version of the two questionnaires
      AIDA and LoPF-Q. The secondary objective is to investigate the links between disrupted
      development of identity and adolescent psychopathology.

      To participate in the study, patients will have to complete online or paper versions of the
      questionnaires AIDA-LoPF and other assessments of personality and general psychopathology
      (BB5, SDQ). Parents will have to answer complete the parent version of the SDQ questionnaire.
      The BPFSC-11, which is a clinician-rated assessment, will be completed in a subgroup of
      patients, by the same healthcare professional, in order to assess the concurrent validity.
      The investigators will also add the clinical diagnoses according to ICD-10 found in the
      medical record.
    

Detailed description: 
      A personality disorder is a lasting mode of behavior and lived experience that deviates
      significantly from what is expected in the culture of the individual is invasive and rigid,
      appears in early adolescence or adulthood, is stable over time and is a source of distress or
      impaired functioning.

      Most of the tools for assessing high-risk personality disorders and traits have been
      developed in adults.Yet it is important to have effective tools to distinguish personality
      disorders from other mental disorders as early as possible. The identification of young
      people at high risk of personality disorders allows their rapid referral to appropriate
      psychotherapies.

      The AIDA and LoPF-Q, screening questionnaires, were recently developed to include an
      assessment of personality functioning in the process of diagnosing emotional and behavioral
      disorders in adolescence. They have been tested in several countries such as Germany, USA,
      Mexico, Croatia… The results of the studies show that AIDA and LoPF questionnaires are
      reliable and valid instruments for assessing normal and disturbed identity in adolescents and
      distinguishes well between patients with psychiatric illnesses and healthy controls.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population studied includes adolescents followed in psychiatry, whether they are
        hospitalized (UCAP or full hospitalization at MPEA Saint-Eloi in Montpellier) or followed
        on an outpatient basis (MPEAs Peyre Plantade and Saint-Eloi in Montpellier).
      
Biospecimen description: 
      NC
    
Keywords: Adolescents; Questionnaires
Titanium Elastic Nails in the Treatment of Pediatric Femur Fractures
Condition: Femur Fracture
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Interventional
Phase: Phase 1

Summary: 
      Titanium elastic nails in the pediatric femoral fractures: A prospective randomized clinical
      trial of eliminating nail protrusion to decrease soft tissue complications
    

Detailed description: 
      This study will be conducted as a prospective cohort study of children and adolescents
      treated with TEN for a femoral shaft fracture. All children and adolescents presenting to the
      Emergency department of a participating center with a femur fracture will be approached for
      inclusion in the study. The primary outcome for this study will be functional recovery, as
      measured using a pediatric specific generic QOL measurement tool. The clinical outcome
      measure which will be used will be the performance version of the ASK (ASK-p) which has been
      previously tested and shown to be valid, reliable, and responsive in children and adolescents
      with acute and chronic Orthopaedic disorders. The first time point for data collection will
      be at four months. Clinical data which will be obtained over the course of follow-up will
      include clinical evaluation of hip and knee range of motion, limb rotation, clinical
      measurement of limb length, fracture union, and the presence of complications, including the
      need for nail removal in the group in which it was not planned. The second time point for
      data collection will be at one year. Again, the ASK-p will be mailed to all subjects in
      advance to allow completion at the desired time. The return of questionnaires and process for
      reminder notifications will proceed in a similar fashion to the four month time point.
      Clinical and radiographic data will be collected in a similar fashion to the four month time
      point. No subjects will be excluded on the basis of failure to return questionnaires at the
      one year time point since this represents a secondary outcome.
    

Intervention name(s): Elimination of titanium elastic nail prominence at the insertion site and leaving the nails in situ
Intervention type(s): Procedure
Intervention description(s): See Detailed Description.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Femur fracture; titanium elastic nails
Total Knee Replacement With the ROCC Knee
Condition: Osteoarthritis; Rheumatoid Arthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study was to assess the results of a Total Knee prosthesis specifically
      intended to enhance functional performance , especially in terms of physical and sports
      activity.
    

Detailed description: 
      Clinical and radiographic results , complications, early post-operative and late functional
      outcome and survivorship were studied in a continuous prospective series of 500 patients (
      602 knees) managed using the ROCC knee ( BIOMET INC - Warsaw- IND, USA).

      A minimum follow-up of 5 years was required.
    

Intervention name(s): Total knee replacement with the ROCC® knee prosthesis
Intervention type(s): Device
Intervention description(s): replacement of an osteoarthritic knee with a total knee prosthesis operation may be for a single knee ( unilateral) or both knees of a patient ( bilateral)
Other intervention name(s): Total knee arthroplasty; Total knee prosthesis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee prosthesis; total knee replacement; total knee arthroplasty; prospective study; Therapeutic level IV
Community and Systems-level HIV Prevention in Peru
Condition: HIV
Study type: Interventional

Summary: 
      This project involves adapting 3 new intervention components, and then testing them, in
      combination with a multi-level, community-based intervention, to promote HIV prevention and
      sexual health among men who have sex with men and transgender women in Lima, Peru. The total
      intervention has a community-based intervention and a systems-level intervention at the
      hospital where people living with HIV get care and medications.
    

Detailed description: 
      Mpowerment (MP) is an evidence-based community-level, structural, social and behavioral
      intervention for HIV prevention for young men who have sex with men (MSM). MP targets
      individual and community empowerment and community mobilization, self-affirmation, sexual
      self-knowledge and creation of a supportive and affirming social environment. MP has been
      widely used in the U.S. but not in Peru, with the exception of earlier pilot research. In the
      earlier research, MP was adapted for the sociocultural issues facing MSM and transgender
      (trans) women in Peru, and only focused risk reduction and increasing HIV testing. In
      addition to the MP (which is called the community-based intervention), a health systems
      component has been added. The health systems includes (1) sensitization of hospital staff
      (where people living with HIV obtain their medication) to the issues facing transgender women
      and MSM; (2) the use of Navigators, who help MSM and trans women at the hospital navigate the
      system of care and remain in care; and (3) a focus on "positive prevention", in which
      providers talk about the positive aspects of maintaining in care and being virally suppressed
      instead of only talking about "avoiding death." There is a 2.5 year implementation of the
      intervention, called "Projecto Orgullo Plus" or Project Pride Plus, which involves a
      longitudinal cohort of MSM/trans in two large districts of Lima, Peru. Primary outcomes will
      be unprotected anal sex and HIV testing. Secondary outcomes will be self-reported visits to
      hospital for care and adherence to medications.
    

Intervention name(s): Generacion Actual
Intervention type(s): Behavioral
Intervention description(s): See description in arm description.
Other intervention name(s): Mpowerment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two different districts are being used, one in which the intervention is implemented and the other is a no-intervention comparison site.
Masking: None (Open Label)
Primary purpose: Prevention
Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?
Condition: Human Immunodeficiency Virus; Herpes Simplex
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Herpes Simplex; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the levels of immune and inflammatory markers among
      HIV-1, HSV-2 co-infected adults achieving plasma HIV RNA suppression to <50 copies/mL,
      between those randomized to valacyclovir and placebo, over a twelve-week intervention period.
    

Detailed description: 
      Highly active antiretroviral therapy (HAART) has dramatically reduced HIV-1 infection (herein
      referred to as 'HIV') related morbidity and mortality, transforming an invariably fatal
      disease into a manageable, chronic condition. Yet even HAART-treated HIV infection is
      characterized by chronic systemic inflammation and immune activation. This systemic
      inflammatory response is composed of multiple components, and can be quantified by measuring
      markers of immune activation, inflammatory cytokines, acute phase reactants, endothelial
      activation markers, and markers of microbial translocation. This inflammation is clinically
      relevant, as it may contribute directly to HIV disease progression and non-AIDS related
      morbidity and mortality in HIV-infected patients. Because this inflammation persists even in
      the context of suppressive HAART, albeit at modestly decreased levels, adjunctive therapeutic
      strategies to attenuate this persistent inflammatory response are therefore needed. Herpes
      simplex virus type 2 is a common, clinically important co-infection seen in individuals
      living with HIV infection, and may contribute to this ongoing inflammation. This pilot trial
      will investigate whether short-term valacyclovir for HSV-2 suppression can decrease systemic
      inflammation in HAART-treated, HIV-1, HSV-2 co-infected individuals.
    

Intervention name(s): Valacyclovir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Valacyclovir will be used at two different dosages (1g po BID and 500mg po BID) to be used for 12 weeks. Supplied as 500mg caplets.; Placebo, supplied as caplets identical in appearance, odour and taste to valacyclovir 500mg caplets.
Other intervention name(s): Apo-Valacycyclovir; Valtrex
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation
Condition: Pacemaker DDD; Cardiopulmonary Endurance
Study type: Interventional

Summary: 
      The purpose of this study is to observe the changes of cardiopulmonary endurance in patients
      with pacemaker implantation after long-term exercise, to explore the significance of exercise
      on patients with pacemaker implantation, and to analyze the difference of the effect of
      exercise on cardiopulmonary endurance in patients with normal LVEF of different pacing ratios
    


Intervention name(s): Supervise and guide regular exercise
Intervention type(s): Other
Intervention description(s): Aerobic exercise, evaluated by cardiopulmonary exercise test, 3-5 times a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Preliminary Efficacy of SBRT in Patients With Metastatic RCC Treated With Targeted or IO Therapy
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional

Summary: 
      Aim of this phase 1b study is to evaluate safety and preliminary efficacy of stereotactic
      body radiation therapy in patients with metastatic renal cell carcinoma treated with VEGFR,
      mTOR or immune checkpoint inhibitors.
    

Detailed description: 
      This is prospective phase 1b study.

      Patients with metastatic RCC receiving targeted or IO therapy (VEGFR inhibitor or mTOR
      inhibitor or checkpoint inhibitors in approved treatment lines and in standard therapeutic
      regimens) with stable diseaseor durable partial response for at least 4 months, are enrolled
      in the study.

      The initial examination includes CT with contrast, where the selected measured 2 metastatic
      sites, stable for at least 4 months but no more than 6 months of targeted therapy (increase
      or decrease in size in the course of targeted therapy should not exceed 10%). Metastases have
      to be located in one organ. Allowed location of metastases: lungs, liver, lymph nodes,
      contralateral kidney, adrenal gland.

      Size of selected metastases should not be less than 5 mm and not more than 4 cm.
    

Intervention name(s): SBRT
Intervention type(s): Radiation
Intervention description(s): Dose and schedule will be depended on metastases location.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal cell carcinoma; metastasis; stereotactic body radiation therapy; targted therapy; immune checkpoint inhibitors
Study to Evaluate the Safety and Microbiology of C16G2 in Adolescent and Adult Dental Subjects
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the clinical study is to evaluate the safety and bacterial impact of study
      drug (C16G2) administered in multiple oral gel doses to adolescent and adult dental subjects.
    

Detailed description: 
      The purpose of the clinical study is to evaluate the safety and microbiology of C16G2
      administered in multiple oral gel doses to adolescent and adult dental subjects. Subjects
      will be assigned to three study cohorts and receive 2 different volumes of C16G2 Gel or
      Placebo. Prior to commencing enrollment of subjects 12-17 years of age, a safety only cohort
      of 4-8 adolescent subjects will receive 4 study drug administrations on Day 0. A safety data
      review will be performed by the Medical Monitor on Days 1 and 5. If no safety concerns are
      identified, enrollment of adolescent subjects receiving 7 days of study drug administration
      will be initiated in Study Arms 1 & 2. Enrollment of adult subjects in Study Arms 1 & 2 may
      start before the Adolescent Safety Only Cohort is initiated. Before dosing of study drug,
      eligible subjects will undergo professional dental prophylaxis on Day 0. Microbiology will be
      assessed by measuring S. mutans and total bacteria counts.
    

Intervention name(s): C16G2; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Antimicrobial peptide; Placebo
Other intervention name(s): Antimicrobial peptide
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of SI-6603 in Patients With Lumbar Disc Herniation
Condition: Intervertebral Disc Disease; Lumbar Disc Disease
MeSH terms: Spinal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in
      patients with lumbar disc herniation.
    


Intervention name(s): Condoliase; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.25U, intradiscal injection, one time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Message Framing on Blood Donation-Study 1
Condition: Rh Negative Blood Donor
Study type: Interventional

Summary: 
      Rh negative blood group is a rare blood group in China, as it only accounts for 0.3-0.4
      percent of the Han population. Therefore, low inventory is often found in blood collection
      and supply agencies in many regions in China. On July 18, 2018 blood stockpile of O-negative
      and B-negative in Guangzhou Blood Center reached the warning line, and we took measures for
      emergency recruitment. O-negative and B-negative blood donors whose last donation dates were
      between January 1, 2015 and December 31, 2017 were identified and randomly assigned to three
      groups. Three different recruitment text messages were send to these groups respectively. At
      the same time, A-negative and AB-negative blood donors were marked as control group. We
      observed the re-donation rates among four groups within three months.
    


Intervention name(s): Gain-frame SMS; Loss-frame SMS; Control SMS
Intervention type(s): Other; Other; Other
Intervention description(s): Emergency recruitment cell phone short messages that emphasizing donating blood can save patients' lives were sent to donors in this group.; Emergency recruitment cell phone short messages emphasizing that donating blood can prevent patients from death were sent to donors in this group.; Emergency recruitment cell phone short messages that only mentioning the low Rh-negative blood stockpile were sent to donors in this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study to Evaluate the Effect of Verapamil on the Pharmacokinetics of ASP015K in Healthy Adult Subjects
Condition: Healthy Subjects; Pharmacokinetics of ASP015K
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of verapamil, a P-glycoprotein (P-gp)
      inhibitor, on the pharmacokinetics of ASP015K. This study will also assess the safety and
      tolerability of ASP015K administered alone and also and in combination with verapamil.
    

Detailed description: 
      Eligible subjects will be admitted to the clinical unit on day -1 and remain confined until
      day 15.
    

Intervention name(s): ASP015K; verapamil
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): CALAN®
Intervention MeSH terms: Verapamil; Peficitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ASP015K; Pharmacokinetics; Healthy Subjects