bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands
Condition: Albuminuria; Chronic Kidney Diseases; Diabetes; Hypertension
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Albuminuria
Study type: Interventional

Summary: 
      The purpose of this study was to collect additional performance and clinical data on the
      Minuteful - Kidney test device (previously "ACR | U.S. Urine Analysis Test System"),
      following the original data collection (NCT04626271).

      This method comparison and usability study was designed to evaluate the agreement levels of
      the Minuteful - Kidney Test with the comparator device (URiSCAN Optima) as well as the
      device's usability including the lay user's ability to understand and implement the device
      instructions. It also evaluates the ease of use of the device under actual use conditions in
      a simulated home environment.
    

Detailed description: 
      Eligible subjects meeting the inclusion criteria were recruited at the designated site by the
      study personnel. Following subject consent, the Minuteful - Kidney test kit, in its original
      packaging, along with the Minuteful - Kidney smartphone application were provided to the
      subject in a simulated home- use environment. All subjects were requested to follow the
      in-app instructions to complete the test, without any guidance from the study staff before,
      during or after testing. After each subject completed the test, the urine sample was tested
      by a professional user at the clinical site on the URiSCAN Optima device. Each urine sample
      was tested twice: once using the Minuteful - kidney test by the lay user and once using the
      comparator device (URiSCAN Optina) by the professional user.

      To evaluate the usability of the device, study staff on-site were asked to observe and
      document the user performance on key tasks in the study flow as well as information regarding
      the user behavior while performing the test. Subjects were also asked to answer a usability
      post-test questionnaire.
    

Intervention name(s): Minuteful - Kidney Urine Analysis Test System
Intervention type(s): Device
Intervention description(s): Urine samples were collected and tested by a lay user, using the Minuteful - Kidney test device. The lay user test results were compared to the results obtained by testing the same urine sample on the comparison device, the URiSCAN Optima.
Other intervention name(s): Minuteful - Kidney; Minuteful - Kidney Test Device; ACR | U.S. Urine Analysis Test System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method
Condition: Healthy
Study type: Observational

Summary: 
      The main goal of the study is to determine the physiological parameters of sublingual
      microcirculation in children in different age categories using Sidestream Dark-Field Imaging
      Method. No significant differences are expected to be found between measurements in healthy
      volunteers in different age categories.
    

Detailed description: 
      After recording the basic anthropometric parameters, pressure, pulse and O2 saturation, each
      volunteer who meets the inclusion criteria will have their microcirculation measured using a
      Sidestream Dark-Field (SDF) probe placed sublingually by one examiner using the SDF method.
      The measurement will be performed in supine position in a disease-free period, with normal
      diets, at least 2 hours after the last meal in the afternoon, for girls outside the menses
      period. Premedication or analgesia will not be used. A total of 3 video clips will be
      recorded from different parts of the sublingual area with a minimum length of 20 seconds in a
      row, unless the child needs a short break between measurements. The recorded videos will then
      be processed offline by one evaluator who is trained and experienced in microcirculation
      evaluation, three best and most stable parts of each video clip will be analysed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include 40 healthy volunteers. Of these, 10 pre-school children (3-5.9
        years), 10 younger school children (6-10.9 years), 10 children in puberty(11-14.9 years)
        and 10 post-puberty adolescents will be included (15-18.9 years).
      
Keywords: Microcirculation; Children
Effect of Cognitive Stimulating Interventions on Cognitive Self-Efficacy and Sense of Happiness Among Older Adults
Condition: Self- Efficacy
Study type: Interventional

Summary: 
      The present study aims to determine the effect of cognitive stimulation interventions on
      cognitive self-efficacy and sense of happiness among older adults.

      Research hypothesis:

      Older adults who receive the cognitive stimulation interventions exhibit higher cognitive
      self-efficacy and sense of happiness than those who do not receive it.
    

Detailed description: 
      A convenient sample of eighty (80) older adults will be used according Epi info V 7.0 program
      calculation based on the following statistical parameters ; Population size: 250, expected
      frequency: 50%, confidence coefficient: 95%, acceptable error: 10%, minimum sample size = 70.

      The study will include eighty (80) older adults aged 60 years and more and fulfilling the
      following criteria:

      Inclusion criteria

        1. Aged 60 years and old.

        2. Able to read and write.

        3. Have mild cognitive impairment: score of score of 18-23 based on the Mini Mental State
           Examination Scale (MMSE).

        4. Have no depression: score of 0 to 4 using the Geriatric Depression Scale Short Form
           (GDS_SF).

        5. Accept participation in the study. 6. Available at the selected setting during the time
           of data collection. 7. Have no pronounced impairment of their visual and auditory
           abilities could affect their participation in the group and make use of most of the
           materials in the sessions, as determined by the researchers.

      The selected study subjects (80) will be randomly assigned to two equal groups of 40 older
      adults each as flows; Group 1, study group: include older adults who will receive the
      proposed interventions, cognitive stimulation interventions.

      Group 2, control group: include older adults who will receive the routine activities of the
      elderly club.
    

Intervention name(s): Cognitive Stimulating Interventions
Intervention type(s): Behavioral
Intervention description(s): a quasi-experimental research design.The study subjects of group 1, the study group, will receive the proposed interventions, the cognitive stimulation interventions through small groups of study subjects receiving 12 sessions of group activities (2 sessions/week, approximately 45- 60 minutes/session). A group size of 6 to 8 will be conducted. The interventions group will be conducted in activity rooms within the elderly club.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Sense of Happiness; Cognitive Stimulating Interventions
A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, parallel-arm study will assess the safety and tolerability of
      RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive
      citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo
      in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.
    


Intervention name(s): RO4995819; citalopram; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): multiple oral doses, Days 10-16; multiple oral doses, Days 1-16; multiple oral doses, Days 10-16
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation
Condition: Bone Substitutes; Calcium Phosphates; Hydroxyapatite; Rhodophyta; Sinus Floor Augmentation
MeSH terms: Calcium Metabolism Disorders
Study type: Interventional

Summary: 
      Twenty patients scheduled for lateral-window sinus floor Elevation (SFE) are randomized into
      two groups: use of SYMBIOS® Biphasic Bone Graft Material (Group 1) or of Algipore® Bone
      Substitution Material (Group 2).

      Biopsies are taken 3 months after SFE and during implant surgery after 6 months. One ground
      section per biopsy (n=40) is stained, scanned, and histomorphometrically analyzed for new
      bone, old bone, soft tissue, graft, bone infiltration of graft, bone-to-graft contact, and
      penetration depth.
    


Intervention name(s): Use of Symbios Bone Graft Material; Algipore Bone Substitution Material
Intervention type(s): Device; Device
Intervention description(s): Patients will receive Symbios Bone Graft Material according to randomization Group.; Patients will receive Algipore Bone Substitution Material according to randomization Group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Twenty patients scheduled for lateral-window sinus floor Elevation SFE will be randomized to an HA and a β-TCP/HA Group.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Behavioral Maintenance Treatment for Smoking Cessation
Condition: Smoking
Study type: Interventional

Summary: 
      Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment
      strategy in promoting longer-term smoking abstinence. The investigators will also conduct
      secondary analyses of mediators and moderators of treatment response.
    

Detailed description: 
      400 adult smokers will be randomized. Our primary goal is to examine the effectiveness of a
      multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. All
      smokers will receive the same "Acute Phase Treatment" that combines nicotine patch, bupropion
      and intensive self-regulatory skills training. Nicotine patches will be provided for 8 weeks
      and bupropion and skills training will be provided for of 9 weeks. Participants will then
      enter a "Maintenance Treatment Phase" during which half (n=200) will receive three
      individualized relapse prevention training sessions spread over a 12 week period. They will
      also receive 12 weeks of self-administered RPT administered via written treatment modules.
      Finally, telephone counseling will be provided in conjunction with an Interactive Voice
      Response system (IVR) that will allow early detection of smoking "slips" and rapid response
      by treatment staff. The other half (n=200) will be assigned to a control condition that
      consists of three counselor-led sessions of "supportive therapy" spread over a 12 week
      period.
    

Intervention name(s): cognitive behavior therapy
Intervention type(s): Behavioral
Intervention description(s): At each clinic session, staff met with participants individually for 30 minutes to develop cognitive and behavioral skills to resist urges to smoke. Staff used self-efficacy questionnaires to assess participants' confidence in their abilities to resist urges to smoke in specific situations and behavioral worksheets to help participants articulate treatment plans to be used in managing their behavior in these situations without smoking. Those participants randomized to extended CBT continued to work with treatment staff individually on the development and use of cognitive and behavioral cessation and relapse prevention skills. Treatment sessions, lasting approximately 30 minutes, were conducted at the San Jose clinic site at weeks 8, 12, 16 and 20.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Effect of Inspiratory Muscle Training on Postural Stability, Posture Perception and Trunk Rotation in Children With Adolescent Idiopathic Scoliosis.
Condition: Adolescent Scoliosis
MeSH terms: Scoliosis; Respiratory Aspiration
Study type: Interventional

Summary: 
      Trunk rotation and distortion of the rib cage, which are common in patients with adolescent
      idiopathic scoliosis, result in abnormal configuration of the diaphragm and intercostal
      muscles. This reduces the capacity of the respiratory muscles to produce force, and results
      in respiratory muscle weakness. The diaphragm, which is the major respiratory muscle, is also
      a component of the core muscles responsible for postural stability. Therefore, diaphragm
      muscle weakness results in deterioration of postural stability. Our aim in this study is to
      investigate the effect of inspiratory muscle training added to the routine scoliosis exercise
      program on postural stability and posture perception.
    


Intervention name(s): Conventional Scoliosis Exercise Program; Inspiratory Muscle Training
Intervention type(s): Other; Other
Intervention description(s): Program will include breathing exercises, spinal stabilization and strengthening exercises, posture exercises and stretching execises.; Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: postural stability; posture perception; inspiratory muscle training; adolescent idiopathic scoliosis
Trial of Zinc and HIV Progression in Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool
      children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and
      improves growth.
    

Detailed description: 
      The purpose of this study is to examine whether daily oral zinc supplementation to
      HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays
      HIV disease progression, and improves growth.
    

Intervention name(s): Zinc
Intervention type(s): Dietary Supplement
Intervention description(s): zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children > 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Zinc; HIV; Infants; Children; Morbidity; Child health outcomes; treatment naive; treatment experienced
Glycemic and Insulinemic Impact of a Test Granola Versus a Control Granola
Condition: Glycemic; Insulinemic; Subjective Hunger Responses
Study type: Interventional

Summary: 
      The objectives of this study are to examine the blood glucose and serum insulin response
      elicited by servings of Test Granola and Control Granola containing equal amounts of
      available carbohydrate over a 3 h time period. In addition, the subjective hunger response to
      these foods will be measured over 3 h.
    


Intervention name(s): Test Granola; Control Granola
Intervention type(s): Other; Other
Intervention description(s): 50.5 Test Granola; 54.3 Control Granola
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Phototherapeutic Keratectomy (PTK) on Recurrent Corneal Erosions
Condition: Recurrent Corneal Erosions
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the ten-year visual results and outcome of excimer laser phototherapeutic
      keratectomy (PTK) for recurrent corneal erosions.
    

Detailed description: 
      A retrospective chart review of 26 eyes of 23 patients with recurrent corneal erosions
      treated by PTK from 1996 to 2000 was performed. All eyes had failed to respond to
      conventional therapy. Data regarding the preoperative and postoperative best-corrected visual
      acuity (BCVA), spherical equivalent (SE), symptomatic relief, incidence of recurrence, and
      complications arising from the laser treatment were analyzed. The mean duration of symptoms
      prior to PTK was 18 months (range, 8 to 36 months). The corneal epithelium was debrided, and
      laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using
      the Technolas 217C Plano Scan excimer laser. Mean postoperative follow-up was 12 years
      (range, 10 to 14 years).
    

Intervention name(s): Surgery
Intervention type(s): Procedure
Intervention description(s): The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Corneal erosions; PTK
Uroflowmetry in Children With Enuresis Nocturnal
Condition: Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Observational [Patient Registry]

Summary: 
      Background: Enuresis nocturna is an important social and psychological problem in children.
      Uroflowmetry is an important test used to investigate lower urinary tract symptoms..

      Objective:To evaluate the uroflowmetry (UFM) results of children with nocturnal enuresis
      (NE).

      Method:

      The uroflowmetry findings of healthy and visualized children without any urinary symptoms and
      who were prospectively admitted to the urology and pediatric surgery outpatient clinic with
      the complaint of Enuresis nocturna between January 2020 and July 2021 were compared.
      Information (anamnesis, physical examination, radiology results and laboratory tests) and
      uroflowmetry results of NE and healthy children included in the study were recorded.
    

Detailed description: 
      SMale and Female,
    

Intervention name(s): uroflowmetry
Intervention type(s): Device
Intervention description(s): Qmax(ml/s),Qav(ml/s),Volume (ml)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric,primary monosymptomatic enuresis nocturna, 6-16 years, without comorbidity
      
Keywords: enuresis nocturna; uroflowmetry; child
Study of Bacteroides Thetaiotaomicron in Young People Aged 16 to 18 Years With Stable Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and tolerability of Bacteroides
      thetaiotaomicron (Thetanix®)) capsules in young people aged 16 to 18 years with stable
      Crohn's disease.
    

Detailed description: 
      This study is a single (Part A) and multiple (Part B) dose study. Following informed consent
      and screening, 10 eligible subjects will receive a single dose of Thetanix or placebo in the
      clinic. A Safety Review Committee will review the safety data up to Day 7 from these first
      ten subjects and determine if it is appropriate to continue into Part B in which 10 subjects
      will receive 15 doses of Thetanix or placebo in a twice daily dosing regimen over 7.5 days.
      In both parts of the study, 8 of the 10 subjects will randomly receive Thetanix and 2
      subjects will randomly receive placebo. Each dose consists of three capsules. Subjects in
      Part B will receive the first and last dose in the clinic and will take 13 doses at home.
      While at home, subjects will be required to answer questions about their health, record their
      body temperature and when they take the capsules in an electronic diary. Subjects developing
      a fever will undergo further assessments, including blood cultures. Subjects will provide
      stool samples for analysis of microbiota and faecal calprotectin.
    

Intervention name(s): Thetanix; Placebo
Intervention type(s): Other; Other
Intervention description(s): Thetanix is an encapsulated lyophilised formulation of a pure culture of Bacteroides thetaiotaomicron with excipients.; Placebo is encapsulated microcrystalline cellulose without Bacteroides thetaiotaomicron.
Other intervention name(s): B. theta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate Safety and Immunogenicity of AERAS-402 Administered in HIV-negative, BCG-vaccinated, QFT (+) and (-) Adults Without Evidence of TB
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The available live tuberculosis vaccine Bacillus Calmette-Guérin (BCG) provides incomplete
      protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or
      "booster", while not toxic, does not provide much additional protection. AERAS-402 presents
      tuberculosis antigens in the setting of a new, live, replication deficient adenovirus vaccine
      that may increase T cell immunity and thus protection from tuberculosis. Since BCG-vaccinated
      individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be
      administered to individuals in Kenya who have already been vaccinated with BCG.
    

Detailed description: 
      This Phase I study will be conducted as a double-blind, randomized, placebo-controlled study
      in 20 healthy adult subjects. The study will enroll 10 subjects who are QFT-G positive at
      screening and 10 subjects who are QFT-G negative at screening. Within QFT-G group, subjects
      will be randomized to receive AERAS-402 or placebo in a ratio of 4:1. One dose level of
      AERAS-402 (3 x 10^10 vp) will be investigated in this study. All subjects will receive a
      single dose of study vaccine (AERAS-402 or placebo) on Study Day 0 and a second dose of study
      vaccine (AERAS-402 or placebo) on Study Day 56. All vaccinations will be administered by IM
      injection into the deltoid muscle.

      The sample size was selected as adequate for preliminary safety evaluations and initial
      immunogenicity reviews for this phase study, rather than for statistical reasons. If no
      serious adverse events are observed in 16 subjects who receive AERAS-402, the upper bound of
      the 95% confidence interval on the rate of serious adverse event occurrence is 17.1 percent.

      The selection of AERAS-402 dose level for evaluation in this study was derived from animal
      studies and based on the safety profile for the completed and ongoing clinical studies in the
      U.S. and South Africa.The total duration of follow-up is 182 days for each subject with a
      total of eleven follow-up clinic visits. The study is planned at a single site in Kisumu,
      Kenya.
    

Intervention name(s): Placebo; AERAS-402
Intervention type(s): Biological; Biological
Intervention description(s): This is the identical buffer solution in which AERAS-402 is formulated.; Given to 8 participants that were QFT-G(-) at screening and 8 participants that were GFT-G(+) at screening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention