bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy
Condition: Patellar Tendinitis
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      In the sports field, patellar tendinopathy is, as a pathology, one of the main concerns for
      athletes, both because of its incidence and because of the difficulty involved in their
      recovery. At the ultrasound level, tendinopathies can be divided, depending on the presence
      or absence of an intratendon Doppler signal, into hypervascular or hypovascular tendinopathy.
      Its classification is, today and clinically speaking, merely qualitative through the
      observation of the explorer. The ultrasound evaluation is carried out through a probe that is
      placed on the patient's skin, the procedure to be followed to obtain a vascular image is
      merely operator-dependent, that is, the position of the probe, the pressure exerted on the
      skin or even ultrasound optimization parameters can drastically modify the results.

      Due to high pressure on the probe, the intratendon Doppler signal may be diminished in the
      quantitative variables of area, number of signals, pixel intensity, perimeter, solidity,
      perfusion index, circularity, major and minor diameter.

      From a certain pressure on the probe, the intratendon Doppler signal can be drastically
      altered.

      This study will try to evaluate the influence of the pressure exerted by the examiner with
      the probe on the quantitative variables of the intratendon Doppler signal in patellar
      tendinopathy.

      To carry out the study, a single group with patellar tendinopathy will be established.
      Ultrasound evaluations with Doppler mode will be performed on the tendon using different
      probe pressures, monitoring the applied force and recording the images obtained for later
      analysis.
    


Intervention name(s): Intratendon vascularization
Intervention type(s): Procedure
Intervention description(s): Ultrasonic exploration by power-Doppler of the intratratendon vascularization, making longitudinal cuts of the patellar tendon and with previously pre-established Doppler optimization parameters for all patients. The optimization parameters of the power-Doppler signal will be set at a Doppler frequency of 6.7 MHz, pulse repetition frequency (PRF) of 0.7 kHz. The lowest wall filter and a standardized gain just below the level that produces random noise will be applied. This examination will be repeated several times with different probe pressures, which will be quantitatively adjusted through the force sensor and maintained with the articulated arm. A 4-second static video will be recorded of the longitudinal section that presents a higher Doppler signal in each of the scans at different probe pressures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder
Condition: Menopause; Sexual Abstinence
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypoactive Sexual Desire Disorder ( HSDD ) is very common in postmenopausal women due to a
      reduction in circulating androgen levels. The aim of this study is to evaluate the effects of
      Tribulus Terrestris in premenopausal women with HSDD.
    

Detailed description: 
      Hypoactive Sexual Desire Disorder ( HSDD ) is the most prevalent female sexual dysfunction in
      society mainly in postmenopausal women, and is strongly linked to the quality of life of
      women . The androgen hormones decline over age in the premenopausal period, more sharply
      after menopause. Tribulus terrestris is a plant native to India , recommended in the
      treatment of infertility , low libido and impotence . Its main active ingredient is the
      protodioscin , which has been attributed to an increase in testosterone levels and improved
      sexual function . The aim of this study is to evaluate the effects of Tribulus Terrestris in
      premenopausal women with HSDD .
    

Intervention name(s): Tribulus Terrestris; Placebo
Intervention type(s): Drug; Other
Intervention description(s): patients will use 750 mg/day during 120 days; patients will use placebo pills with the same shape of the drug
Other intervention name(s): tribulus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: postmenopausal; hypoactive; sexual disorder; androgen
The Inner Garden and Care for Children With Moderate to Severe Agitation
Condition: Child Behavior Disorders
MeSH terms: Mental Disorders; Child Behavior Disorders
Study type: Interventional

Summary: 
      The objective is to compare the care including the solution of ambient sensory biofeedback
      "Inner Garden", compared to the care without this solution, on the regulation of behavioral
      disorders during a crisis requiring to take the child out of group care. The nursing support
      with the "Inner Garden" tool in three care units will be compared with the practice in six
      other units not equipped with this tool.
    

Detailed description: 
      Psychiatric illnesses affect more than one person in five each year. In France, the majority
      of disorders among minors under the care of child psychiatry in full or part-time
      hospitalization are disorders of psychological development (32%) and behavioural and
      emotional disorders (24.6%). Hospitalisation is reserved for the most complex acute crisis
      situations, as well as for children who need to be cared for by a multidisciplinary team
      several times a week to support their psychological development. In our study, the
      investigators focus on one of the clinical manifestations regularly present: the state of
      agitation when its intensity is moderate to severe. "The state of agitation is defined as a
      psychic, motor and relational behavioural disorder that leads to a reaction of intolerance on
      the part of people in the entourage". The care teams will then implement care actions that
      will be a graduated response adapted to the intensity of these states of agitation. In
      addition to the support provided by a caregiver, the investigators propose to use the "Inner
      Garden" system developed in 2014 at the laboratory of National Institute for Research in
      Digital Science and Technology in Bordeaux. It is an interactive Zen garden allowing to
      present feedback (topographical, physiological) under different sensory modalities.
    

Intervention name(s): Inner Garden
Intervention type(s): Device
Intervention description(s): Care actions adapted to the intensity of the states of agitation (The child can be removed from the group while remaining in the same room on a chair with a caregiver. If the problems are too serious, the child can be accompanied to a "soothing" room where the carer will take care of him/her individually. In units equipped with Inner Garden, the child can use it under semi- supervision of nurses.)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life,
      greater satisfaction, and fewer adverse events compared with using the standard needle.
    

Detailed description: 
      This study is a "N of one" trial where the patient is their own control. We will provide the
      quality of life questionnaire, the MOS-HIV questionnaire; ISR questionnaire and a
      satisfaction questionnaire to patients that have used a standard need to inject enfuvirtide
      for at least one month. As well, demographics and laboratory data will be collected. The same
      procedures will be given 1 month after the use of Biojector in a follow-up visit.
    

Intervention name(s): Biojector
Intervention type(s): Device
Intervention description(s): All patients received biojector to use with BID enfuvirtide doses
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Injection site reactions; enfuvirtide administration
A Study to Compare the Bioavailability and Pharmacokinetics of Cyclosporine After Intravenous Administration of NEUROSTAT®, a CREMOPHOR® EL-free Lipid Emulsion, and SANDIMMUNE® Injection (a Suspension of Cyclosporine in CREMOPHOR® EL) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bioavailability, pharmacokinetic profiles and the tolerability of two
      formulations of intravenous cyclosporine in healthy volunteers.
    

Detailed description: 
      Participants were randomized into two treatment sequences: the test product followed by the
      reference product or vice versa. There was a washout period set to 14-21 days between the
      first and second treatment period. Through an indwelling IV cannula, the subjects received
      either 5 mg/kg NeuroSTAT® (test) or 5 mg/kg Sandimmune® (reference), infused at a constant
      rate over 4 h with a syringe pump. A total of 22 blood samples for Cyclosporine analysis were
      obtained pre-dose and at pre specified time points with last sample 48 h after start of
      infusion.
    

Intervention name(s): Sandimmune® Injection; NeuroSTAT®
Intervention type(s): Drug; Drug
Other intervention name(s): CicloMulsion® (ready-to-use lipid emulsion of Cyclosporine A)
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: bioequivalence; pharmacokinetics; tolerability; safety; ciclosporin; cyclosporine; cyclosporine A; Sandimmune; Sandimmun; CicloMulsion; NeuroSTAT
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
Condition: Tuberculosis; Tuberculosis, Pulmonary; Early Gastric Cancer
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile
      of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB).
    

Detailed description: 
      Gastrectomy is a well-known risk factor for TB. Also, there were some reports about
      malabsorption of anti-TB drugs in the gastrectomized patients. However, pharmacokinetics of
      recently used first line anti-TB drugs in the gastrectomized patients have not been well
      evaluated simultaneously. Therefore, the investigators aim to evaluate the effect of
      gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with pulmonary
      TB through this study.
    

Intervention name(s): standard first line anti-TB drugs
Intervention type(s): Drug
Intervention description(s): We will perform pharmacokinetic study in gastrectomy and non-gastrectomy group, to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with TB
Other intervention name(s): Pharmacokinetics of Anti-tuberculosis Drugs
Intervention MeSH terms: Antitubercular Agents
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Among patients with pulmonary TB diagnosed in our hospital and treated with 4 first line
        anti-TB drug(isoniazid/rifampicin/ethambutol/pyrazinamide= HREZ), we recruit patients who
        underwent gastrectomy to Gastrectomy group. And then, we recruit age-sex matched patients
        who did not underwent gastrectomy to Non-gastrectomy group.(age ±3 years)
      
Keywords: tuberculosis; pharmacokinetics; first-line drugs; gastrectomy
A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of a single dose level of gefapixant
      (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA)
      of the knee compared with placebo after 4 weeks of treatment.

      The study will also assess the safety and tolerability, changes in physical function,
      stiffness, treatment response and health outcomes.
    

Detailed description: 
      Subjects who satisfy entry criteria at Screening will enter the Washout Phase, discontinuing
      their current nonsteroidal anti-inflammatory drug (NSAID) therapy.

      Up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to
      gefapixant or placebo.

      Subjects will complete Treatment Visits 1, 2, 3, and 4 weeks after starting study drug. At
      each Treatment Visit, subjects will undergo efficacy assessments and safety procedures.
      During the Washout and Treatment Phases subjects will complete the 'average pain' Numeric
      Pain Rating Scale (NPRS) and count of rescue medication used for the preceding 24 hours.

      Subjects will return 2 weeks after their last Treatment Visit (for a Follow-Up Visit).
    

Intervention name(s): Gefapixant; Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): BID; Placebo
Other intervention name(s): AF-219; MK-7264
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Efficacy and Tolerability of Black Cohosh Vs Tibolone in Patients With Menopausal Symptoms
Condition: Menopause
Study type: Interventional
Phase: Phase 3

Summary: 
      The benefit-risk-balance of the isopropanolic Cimicifuga racemosa extract (iCR) is compared
      with tibolone in menopausal symptoms treatment. Menopausal patients aged 40 - 60 years and
      with a Kupperman Menopause Index (KMI) equal or more than 15 participate and were assigned to
      either iCR corresponding to 40 mg crude drug/day (n=122) or tibolone 2,5 mg/day (n=122)
      orally. The primary endpoint is the benefit-risk balance at end of treatment.
    

Detailed description: 
      The benefit-risk-balance of the isopropanolic Cimicifuga racemosa extract (iCR) is compared
      with tibolone in menopausal symptoms treatment. The randomized, double-blind, controlled
      3-month study in 5 centres of 3 cities in China enrolled 244 menopausal patients aged 40 - 60
      years and with a Kupperman Menopause Index (KMI) equal or more than 15. The participants were
      assigned to either iCR corresponding to 40 mg crude drug/day (n=122) or tibolone 2,5 mg/day
      (n=122) orally. The primary endpoint is the combination of the Mann-Whitney values (MWV) of
      the KMI and the frequency of adverse events (benefit-risk balance) at end of treatment.
    

Intervention name(s): Black Cohosh (iCR) or tibolone
Intervention type(s): Drug
Intervention MeSH terms: Tibolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Climacteric symptoms; Black Cohosh; Efficacy; Safety
Randomized Study of Cognitive-Behavioral Therapy vs Imipramine and Their Combination for Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine which treatment is most effective for patients with panic disorder:
      cognitive-behavioral therapy (CBT) plus imipramine (IMI), CBT plus placebo, CBT alone, IMI
      alone, or placebo alone.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
      randomized to receive one of five treatments: cognitive-behavioral therapy (CBT) alone,
      imipramine plus medical management (IMI), CBT plus IMI, pill placebo plus medical management
      (PLA), or CBT plus PLA.

      Patients are seen by therapists for 11 sessions over 12 weeks (3 sessions during days 1-10
      followed by 6 weekly sessions and 2 biweekly sessions). Each CBT session lasts approximately
      1 hour, each IMI session lasts approximately 30 minutes, and patients in combined treatment
      see 2 therapists for a total of about 80 minutes. Oral IMI or placebo is taken daily.

      Patients not responding to placebo or IMI after the initial 12 weeks are offered alternative
      treatment for up to 3 months or given a referral; responders continue to be treated monthly
      for the next 6 months. This is followed by a washout period of 6 months, after which patients
      receive final assessment. All therapy and assessment sessions are video- or audiotaped.

      Patients are interviewed by an independent evaluator at the start of treatment and 3, 9, and
      15 months later, and must keep a set of weekly self-monitoring forms. In addition, patients
      complete rating forms and questionnaires, and undergo carbon dioxide measurement at the start
      of treatment and 3, 9, and 15 months later.

      At study conclusion, patients are told which medication they received and receive treatment
      recommendations.
    

Intervention name(s): imipramine; cognitive-behavioral therapy
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Imipramine
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: anxiety disorder; disease-related problem/condition; neurologic and psychiatric disorders; panic disorder; rare disease
Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine feasibility and efficacy of the Ubiquitous Spaced
      Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly
      individuals with mild cognitive impairment (MCI).
    

Detailed description: 
      The Spaced Retrieval-based Memory Advancement and Rehabilitation Training (SMART) which
      consisted of 24 one-hour face-to-face sessions (Lee, Park et al. 2009) was developed based on
      the spaced retrieval training (SRT), which was effective in improving memory retention span
      of very mild to mild Alzheimer's disease patients. The Ubiquitous SMART (U-SMART) by
      transforming the current SMART to a self-administered program using an application working on
      IPAD was developed, and was examined its feasibility and efficacy in the elderly individuals
      with mild cognitive impairment.
    

Intervention name(s): U-SMART
Intervention type(s): Device
Intervention description(s): 4-weeks' training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild cognitive impairment; Cognitive rehabilitation; Cognitive therapy; Spaced retrieval Training; Alzheimer's disease; Memory enhancement; U-healthcare
The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study
Condition: Kidney Disease
MeSH terms: Kidney Diseases
Study type: Interventional

Summary: 
      The Southeastern Kidney Transplant Coalition is an academic-community collaboration between
      partners in the kidney disease community who share the common goal of eliminating health
      disparities in access to kidney transplantation among African American End Stage Renal
      Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this
      community-based coalition include patients with kidney disease, dialysis facility staff and
      providers, transplant centers, quality improvement organizations, and patient advocacy
      organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of
      kidney transplantation is the lowest in the nation. Further, the investigators research
      suggests that racial disparities in access to kidney transplantation are concentrated in the
      Southeast, where African Americans are less likely to access each step in the transplant
      process. The long-term goal of the investigators Coalition is to use community- based
      participatory research approaches to develop, test, and disseminate sustainable, community
      interventions improve access to transplant for African American patients with kidney disease.
      The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community study
      proposes to use community-based participatory research methods to develop a multilevel
      intervention to reduce racial disparities in access to kidney transplantation. The long-term
      impact of this application will be to reduce racial disparities in the kidney disease
      community.
    


Intervention name(s): Behavioral Interventions for Dialysis Facilities
Intervention type(s): Behavioral
Intervention description(s): Educational seminars and monthly educational webinars
Peer-to-peer mentoring program
Bulletin boards about transplantation
Facility-specific feedback reports detailing transplant referral data for their center compared to state average
Formulate a facility-specific improvement plan to increase transplant referrals.
Requirement to form a Patient and Family Advisory Group to increase outreach about transplant education within the facility.
Monthly monitoring and reporting of patient referrals to ESRD Network
Conduct a patient and family education session about transplantation
Host a movie day to show Living ACTS (About Choices in Transplantation & Sharing) video
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Dialysis facilities; African Americans; Racial disparity; Kidney Transplantation; Community-based Participatory Research; Coalition; Georgia