bioihbjkbjnl/mcl2 huggingface dataset:
Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)
Condition: Carotid Stenoses
MeSH terms: Carotid Stenosis
Study type: Interventional

Summary: 
      The odontological radiology method Panorama is known to be able to spot calcifications in the
      area of the carotid arteries. The calcifications could be carotid stenoses which is
      affiliated with an increased risk of stroke. The study aims to investigate if panorama
      examinations can be used as a starting point for further investigation of the carotid
      arteries.
    

Detailed description: 
      We intend to examinate 100 consecutive persons that have calcifications in the area of the
      carotid arteries with carotid duplex-ultrasound. The prevalence of carotid stenoses > 50%
      (According to the NASCET criteria) in this group is the primary result of interest, answering
      the most fundamental question - should persons with calcifications in the area of the carotid
      arteries seen on panorama be screened with ultrasound in order to find asymptomatic carotid
      stenoses? Since the publication of the ACST and the ACAS studies it is clear that some of
      these patients might have indications for surgery.

      A second part of the study aims to more fully understand what it is that the panorama
      examination reveals. In this part will 100 patients that are going to undergo surgery to
      remove their carotid stenoses will be examined with panorama. The carotid plaque that is
      removed during the surgery will be examined radiologically.

      Primary endpoint:

        -  Subpopulation prevalence of carotid stenoses > 50% in persons with calcifications in the
           area of the carotid arteries seen in a panoramic examination.

      Secondary endpoints:

        -  Statistical data (sensitivity, specificity, accuracy, likelihood ratio and predictive
           values) for panorama to find carotid stenoses with ultrasound as gold standard.

        -  Qualitative description of the relationship between panoramic calcification images and
           the removed carotid plaques.

      AMENDMENT JUNE 2011: The different arms of the study will be published seperately.
    

Intervention name(s): Carotid ultrasound examination; Panorama examination
Intervention type(s): Other; Other
Intervention description(s): Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.; Examination with the odontological radiological method "Panorama", including a frontal verification image
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Panorama; Carotid stenoses
Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants
Condition: Heart Decompensation, Acute
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      An intravenous infusion in healthy subjects to obtain information about the absorption,
      metabolism, and excretion (AME) of BMS-986231
    


Intervention name(s): BMS-986231
Intervention type(s): Drug
Intervention description(s): BMS-986231
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Interventional

Summary: 
      This aim of this study to quantify the subjective ocular awareness of different eyelid
      cleansing wipes available for the management of Demodex folliculorum.
    


Intervention name(s): Sensitive Eyes® Plus Saline Solution; Oust™ Demodex® Wipes™; I-LID N LASH PLUS® Eyelid Cleanser; Blephadex Lid Wipes; Eye Cleanse Lid Wipes; Blephademodex
Intervention type(s): Drug; Other; Other; Other; Other; Other
Intervention description(s): Sensitive Eyes® Plus Saline Solution; Oust™ Demodex® Wipes™; I-LID N LASH PLUS® Eyelid Cleanser; Blephadex Lid Wipes; Eye Cleanse Lid Wipes; Blephademodex
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant receives 6 different interventions in random order
Masking: None (Open Label)
Primary purpose: Treatment
The Gentle Cardiac Rehabilitation Study
Condition: Secondary Prevention of Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to develop a tai-chi based exercise program designed for
      patients who recently had a heart attack and do not wish, or are unable, to attend
      traditional cardiac rehabilitation.
    

Detailed description: 
      We will estimate the feasibility, acceptability and safety of two different doses of the Tai
      Chi intervention (primary outcome). 60 patients (30 per dose arm) will be randomly assigned
      to a standard dose of Tai Chi (the dose used by our group in large studies of heart failure
      patients) or to a high dose matching the recommended frequency and duration of exercise
      classes in current CRs. Acceptability assessments will include surveys and focus groups to
      formally assess the impact of Tai Chi on facilitators and barriers to CRs in this population.
      We will also obtain estimates of effect sizes of each dose on accelerometry measured physical
      activity and on the proportion of patients achieving the current American Heart Association
      (AHA) recommendation for physical activity (secondary outcome). Additional outcomes will be
      cardiac fitness, quality of life, body weight, and sleep. In addition, we will gather
      exploratory information on possible mechanisms by which Tai Chi training may affect physical
      activity. We will collect information on possible mediators such as exercise self-efficacy,
      perceived social support, and depression. In addition, since Tai Chi training is associated
      with meditative practices aimed at increasing present-moment awareness, we will gather
      information on mindfulness levels. Measurements will be conducted at baseline, 3-, 6-, and 9
      months after enrollment.
    

Intervention name(s): PLUS; LITE
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 1 hour tai chi session 3 times a week (weeks 1-12), to twice a week (week 13-16), and every other week (week 17-26) for a total of 24 weeks; 1 hour tai chi session 3 times a week (weeks 1-12)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: physical activity; coronary heart disease; exercise; affect; mind/body therapies; stress, psychological
Effects of Allergic Rhinitis on the Nasal/Sinus Microbiome
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      The purpose of this study is to find out if the bacteria present in the nose or sinuses of
      people with seasonal allergies changes during their allergy season. Another purpose of this
      study is to see if the bacteria present in the nose and sinuses of non-allergic people are
      the same as allergic people before the allergy season and if it changes during the season.
      Many bacteria are difficult to grow in the laboratory so the investigators are using analysis
      of DNA (the genetic material in cells) of the bacteria in the nose and sinus to find them.
      The investigators will be testing DNA of the bacteria only and not of the human subjects
      taking part in this study. This research is being done to help us understand how allergy
      affects bacteria in the nose and sinuses.
    


Intervention name(s): Swab of vestibule and middle meatus of nose
Intervention type(s): Other
Intervention description(s): Swabs of vestibule and middle meatus of nose will be taken prior to and during the grass/tree allergy season
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with seasonal allergies and healthy controls from the community.
Cognitive Function in Adults With Cardiac Disease
Condition: Cognitive Impairment; Cardiac Disease
MeSH terms: Heart Diseases; Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to identify cardiac patients' degree of unappreciated mild
      impairment in cognitive function patterns of cognitive function, and influencing factors
      related to cognitive functioning during hospitalization. The results from the study will
      contribute to tailoring the delivery of patient education to optimize patient understanding
      of information in future clinical practice.

      It is hypothesized that the study will demonstrate the following:

        1. The degree of cognitive function for patients hospitalized in a CICU will be below the
           scores for normal functioning adults.

        2. Patients with acute cardiovascular conditions will score differently in cognitive
           functioning at various times throughout their hospitalization.

        3. Relationships between cognitive function and following variables:

             -  Patients with greater sleep deprivation or fatigue will exhibit lower cognitive
                functioning.

             -  Patients with greater hunger will exhibit lower cognitive functioning.

             -  Patients who are experiencing greater anxiety will exhibit lower cognitive
                functioning.

             -  Patients who are experiencing depression will exhibit lower cognitive functioning.

             -  Patients who have undergone or will undergo shortly treatment or procedures will
                exhibit lower cognitive functioning.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients hospitalized in the University Hospitals' (Cleveland, OH) coronary intensive
        unit (CICU) being treated for acute cardiovascular conditions
      
Keywords: Cognitive Function; Cognitive Impairment; Hospitalization; Cardiac Disease
Postoperative Bladder Testing After Total Laparoscopic Hysterectomy
Condition: Laparoscopic Hysterectomy; Enhanced Recovery After Surgery
Study type: Interventional

Summary: 
      The objective of this study is to determine if backfilling the bladder immediately
      post-operatively, prior to removal of the foley catheter, in patients undergoing same-day
      total laparoscopic hysterectomy will hasten time to first spontaneous void and time to
      discharge
    

Detailed description: 
      In recent years, a paradigm shift from traditional perioperative care models to "Enhanced
      Recovery After Surgery (ERAS)" has taken place across a wide range of surgical subspecialties
      including minimally-invasive gynecologic surgery. Many gynecologic procedures that once
      required hospital admission are now being performed as outpatient procedures. To optimize
      same-day discharge through the ERAS pathways, protocols call for early removal of urinary
      catheters following gynecologic surgery. Studies in urogynecologic literature have shown that
      a backfill-assisted voiding trial is superior to a spontaneous voiding trial in patients
      undergoing transvaginal surgery. However, there are limited studies published in literature
      focusing on minimally invasive gynecologic procedures, specifically laparoscopic
      hysterectomies. A successful spontaneous voiding trial is usually a postoperative criteria
      prior to discharge after same-day total laparoscopic hysterectomy. Through this randomized
      controlled trial, the investigators aim to compare two techniques of postoperative bladder
      testing for patients undergoing same-day total laparoscopic hysterectomy. This study would
      provide valuable data on improved measures for predicting voiding efficiency, time to first
      void, and time to discharge for patients undergoing same-day total laparoscopic
      hysterectomies. Ultimately, the investigators predict that backfilling the bladder
      immediately postoperatively, prior to removal of the foley catheter, will hasten time to
      first spontaneous void and reduce the amount of time spent in the recovery room.
    

Intervention name(s): InstilIing normal saline into bladder; Removal of foley catheter
Intervention type(s): Procedure; Procedure
Intervention description(s): Backfilling the bladder with 200 mL of normal saline immediately postoperatively, prior to foley catheter removal, after same-day total laparoscopic hysterectomy can potentially increase time to first spontaneous void and time to discharge.; Removal of the foley catheter is routinely performed after same-day laparoscopic hysterectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing for patients undergoing same-day total laparoscopic hysterectomy
Masking: Single (Participant)
Primary purpose: Other
Keywords: minimally invasive gynecologic surgery; same-day discharge; bladder testing
Lipid Lowering Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester
Condition: Hypercholesterolemia; Hyperlipidemias; Dyslipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal
      based snack bar with added plant stanol ester when used between meals as part of a habitual
      diet by subjects with mild to moderate hypercholesterolemia.
    


Intervention name(s): Plant stanol ester; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Different Education Methods Before Invasive Urodynamics
Condition: Urologic Diseases; Urodynamics
MeSH terms: Urologic Diseases
Study type: Interventional

Summary: 
      Aim: This study was carried out to compare the effects of different education methods
      utilized before a urodynamic testing procedure on patients' pain, anxiety, readiness for the
      procedure, and satisfaction.

      Background: Urodynamic testing is an invasive procedure that causes pain and anxiety. Patient
      education is an evidence-based nursing intervention that relieves pain and anxiety and
      increases patient satisfaction.

      Design: The study is a single-center, randomized controlled clinical trial. Method:
      Participants (n=80) were randomly assigned to four groups. While patients in the control
      group were provided with routine clinical information, patients in the intervention group
      were given education with brochures, videos, and brochure-supported videos. The research data
      were collected by using a Data Collection Form with items about participants' descriptive
      characteristics, the State Anxiety Inventory, and the Visual Analog Scale.
    


Intervention name(s): Patients in the Brochure Education Group; Patients in the Video Education Group; Patients in the Brochure-Supported Video Education Group; Control Group
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Patients in the Brochure Education Group were given information about urodynamics in a room reserved for education, and the education brochure was introduced. Patients reviewed the brochure and at the end of the education, it was given to them.; Patients in the Video Education Group were informed about urodynamics in a room reserved for education. Patients watched the educational video on a computer. The urodynamics patient education video was shown to patients once during the session. They did not request to watch it again.; Patients in the Brochure-Supported Video Education Group were given information about urodynamics in a room reserved for education, and the education brochure was introduced. They examined the brochure and watched the educational video on a computer.; Patients in this group were given routine clinical information by the healthcare professional that would perform the urodynamics procedure. After patients were given verbal information, a written text containing the necessary preparations for urodynamics was given to them. The routine patient information text included adjustment to the appointment day and time, nutrition, mechanical bowel preparation, and medications necessary for the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Clinical Trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain; anxiety; satisfaction; readiness; patient education; nursing; urodynamics
Does Zumba Improve Cognition in Healthy APOE e4 Carriers and Noncarriers
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The main purpose of this study is to compare the effects on attention and memory functioning
      to participating in an aerobic and dance exercise called Zumba to educational program on
      exercise that encourages regular stretching and walking.
    


Intervention name(s): Zumba exercise
Intervention type(s): Other
Intervention description(s): Subjects with do Zumba exercise for approximately 60 minutes twice a week for 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Zumba exercise; ApoE
Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction
Condition: Wrinkle Reduction
Study type: Interventional

Summary: 
      The purpose of this pivotal investigation is to evaluate the safety and efficacy of the
      Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction.
    

Detailed description: 
      This is an Open-label, Prospective, Multicenter Pivotal Study of approximately 40 male or
      female subjects, age 25 to 65 years who desire RF treatment for wrinkle reduction and
      improvement in skin quality. Subjects will receive RF treatments with the Cutera truSculpt™
      radiofrequency (RF) device. Subjects will return to the site after study treatments have been
      delivered 12 weeks post-final treatment.
    

Intervention name(s): truSculpt RF
Intervention type(s): Device
Intervention description(s): Subjects will receive RF treatments
Other intervention name(s): Device: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study in Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of GT20029
Condition: Androgenetic Alopecia; Acne Vulgaris
MeSH terms: Alopecia; Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled, parallel group, dose escalation study to
      evaluate the safety, tolerability and pharmacokinetics (PK) of GT20029 following topical
      single ascending dose in healthy subjects and multiple ascending dose administration in
      subjects with androgenetic alopecia(AGA) or acne
    


Intervention name(s): GT20029 Gel; GT20029 Gel Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Stage 1: One single dose Stage 2: One single dose per day (QD) or twice a day (BID) treatment over 14-day period; Stage 1: One single dose Stage 2: One single dose per day (QD) or twice a day (BID) treatment over 14-day period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer
Condition: Locally Advanced Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to investigate the feasibility, safety and efficacy of triplet regimen of
      neoadjuvant chemotherapy in patients with locally advanced rectal cancer
    

Detailed description: 
      In this pilot phase II study, the investigators enrolled Chinese adults(age 18 to 70 years)
      with locally advanced stage II/III rectal cancer. The neuadjuvant chemotherapy regimen is :
      oxaliplatin 85 mg/m2 and irinotecan 150 mg/m2, combined with 5FU 2,400 mg/m2 by 46 h
      infusion, repeated at 2week intervals for 5 cycles. Total mesorectal excision was scheduled
      4-5 weeks after completion of neoadjuvant treatment and followed by a further 7 cycles of
      mFOLFOX or 4 cycles of XELOX. Primary outcome measures of this phase II trial were
      feasibility, safety, tolerance and efficacy of neoadjuvant treatment.
    

Intervention name(s): FOLFOXIRI
Intervention type(s): Drug
Intervention description(s): oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 5-Fluorouracil; rectal cancer; irinotecan; oxaliplatin; neoadjuvant chemotherapy
Effectiveness of Ottobock Helmet Therapy in Infants With Plagiocephaly, Brachycephaly or Combination of Both
Condition: Plagiocephaly, Positional; Plagiocephaly, Nonsynostotic; Brachycephaly
MeSH terms: Plagiocephaly; Craniosynostoses; Plagiocephaly, Nonsynostotic
Study type: Observational

Summary: 
      The objective of the research is to measure the effectiveness of the Ottobock helmet, an
      innovative 3D-printed cranial orthosis used to correct infant cranial positional deformation:
      plagiocephaly, brachycephaly or combination of both.

      This research is a retrospective multi-centric study composed of a collection of clinical
      data from orthotists database and a survey for patient's parents.
    

Detailed description: 
      The Ottobock helmet is a cranial orthosis used to correct infant cranial positional
      deformation: plagiocephaly, brachycephaly or combination of both. This medical device is a
      3D-printed helmet, with an elastic closing system which allow the head growth, maintain a
      constant pressure in the helmet and ensure a good adjustment.

      Even though there is an effectiveness observed, there are no existing clinical evidences on
      this type of helmet so far, and there is a need to conduct a research on a large number of
      patients to measure the effectiveness and describe the population treated. This study will
      give more information to health professionals (doctors, orthopedic technicians, etc.) and
      health authorities, about the benefits of the orthopedic treatment of the positional cranial
      deformations in infants.

      The study is composed of an electronic case report form (eCRF) to be fulfilled by the
      orthotists and an electronic questionnaire (ePRO) to be fulfilled by the patient's parents.
      The electronic questionnaires, data treatment and analysis are handled by a Contract Research
      Organization (CRO).
    

Intervention name(s): Ottobock helmet
Intervention type(s): Device
Intervention description(s): Patients treated in current practice
Other intervention name(s): MyCRO Band
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study population is composed of infants who have been fitted with an Ottobock helmet to
        treat their positional cranial deformation: plagiocephaly, brachycephaly or a combination
        of these two deformations.
      
Keywords: Cranial orthosis; Helmet treatment