bioihbjkbjnl/mcl2 huggingface dataset:
Photodynamic Therapy (PDT) for Oral Disinfection
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Photodynamic therapy (PDT) is a technique used for the oral disinfection. In dentistry, PDT
      for microbial inactivation may reduces both dental plaque and risk of developing caries as
      well as contributes to treat gingivitis, periodontitis, peri-implantitis and endodontic
      diseases. The investigators hypothesis was that PDT with blue light and curcumin promotes
      oral disinfection during 2 hours after treatment.
    

Detailed description: 
      PDT uses a non-toxic drug that is activated by exposure to light in the presence of oxygen.
      The excited state this drug transfers energy or electrons to ground state molecular oxygen
      producing cytotoxic effects on cell. There are productions of reactive oxygen species (ROS)
      and disrupts several of the cell's functions. This results in bacterial disinfection. In
      order to perform the PDT on the oral cavity, a device based on blue LED with transparent
      acrylic diffuser tip and cylindrical shape was developed.
    

Intervention name(s): mouthwash with curcumin; blue LED illumination
Intervention type(s): Drug; Device
Intervention description(s): Mouthwash with 20 ml of curcumin solution for 5 minutes; Oral cavity was illuminated with blue light for 5 minutes
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blue-LED; Curcumin; PDT; Oral disinfection
CEP249 Pediatric Accuracy Study
Condition: Insulin Requiring Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the Enlite Sensor™ and Enlite 3 Sensor performance
      in pediatric patients with insulin requiring diabetes at the beginning, middle and end of
      sensor wear.
    

Detailed description: 
      This study is a prospective, single arm, multi-center, in-clinic study.. There will be two
      consecutive phases of the study:

      A total of up to 260 subjects (2-18 years old) will be enrolled at up to 15 investigational
      centers

      Subjects will come for clinic visit for YSI reference glucose testing and for Enlite Sensor™
      and Enlite 3 Sensor™ testing. SMBG (Self-Monitoring of Blood Glucose) reference measurement
      is for subjects 2-6 years of age and cannot tolerate YSI.

      Study has a run-in period and a study period with a total of 10 visits
    

Intervention name(s): Enlite sensors
Intervention type(s): Device
Intervention description(s): Subject wears enlite sensor first and followed by enlite 3 sensor.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin requiring diabetes; Children; Sensor; Accuracy
Vasospasm in Pediatric Traumatic Brain Injury
Condition: Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and
      brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic
      brain injury (TBI) patients who have experienced a mild to severe head injury.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients who have been admitted for a traumatic brain injury to Duke University
        Hospital.
      
Keywords: traumatic brain injury; brain injury; head injury; vasospasm
Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair
Condition: Postoperative Pain; Hypospadias
MeSH terms: Hypospadias; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to determine if intravenous Dexamethasone combined with a pudendal nerve
      block is able to prolong postoperative analgesia in children undergoing hypospadias repair.
    

Detailed description: 
      It was a prospective study, randomized, double blind study, conducted at the Tunis Children's
      Hospital (January 2017-December 2018). After agreement with parents and the local ethics
      committee, the investigators included children aged 1 to 18 years, ASA 1-2, proposed for a
      hypospadias repair. Patients were randomized to: Group D receiving 0. 15mg/kg of
      Dexamethasone IV after induction and group P receiving the same volume of saline. The
      pudendal block was performed by neurostimulation after induction with Sevoflurane and 3
      gamma/kg Fentanyl IV. The success of the block was tested at 10 and 15 minutes, it was
      declared successful when the systolic blood pressure and heart rate did not increase by more
      than 20% compared to the baseline values at the time of the incision. No analgesics were
      administered at the end of the surgery. The pain was assessed by the CHEOPS score the first
      24 hours. The X2 test was used for qualitative variables and the student test for
      quantitative variables with P<0. 05 as the significance threshold. The number of patients
      required for the study was calculated (alpha=5% beta=90%) and was 62.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Intravenous Dexamethasone; Pudendal nerve block; Analgesia; Postoperative pain; Children; Hypospadias
Simple Changes Weight Loss Intervention
Condition: Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The investigators examined feasibility and acceptability of a non-restrictive diet focused on
      increasing dietary fiber and lean protein for weight loss. Fifteen obese adults enrolled in a
      12-week assessment which included 6 bi-weekly individual dietary counseling sessions to
      attain a daily goal of higher fiber (>35 g/day) and lean protein (0.8 g per kilogram/day of
      individual's ideal body weight).
    

Detailed description: 
      Participants were instructed to increase both their dietary fiber intake to 35 g/day and
      protein intake to 0.8 g per kilogram/day of their ideal body weight. Loss of 5% of their body
      weight are considered to achieve the weight-loss goal. The intervention included 6 bi-weekly,
      30-minute individual dietary counseling sessions over 12-weeks. Behavioral strategies
      including self-monitoring, problem solving, goal setting, stimulus control, food
      substitution, and relapse prevention were taught to assist participants in meeting their
      fiber and protein goals.
    

Intervention name(s): Dietary Intervention
Intervention type(s): Behavioral
Intervention description(s): Participants were instructed to increase both their dietary fiber intake to 35 g/day and protein intake to 0.8 g per kilogram/day of their ideal body weight. Patients in both conditions will receive intensive dietary instruction for 6 weeks, followed by a 6 weeks maintenance phase. Participants received dietary instructions via individual and group sessions led by registered dietitians.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fiber; lean protein; loss weight
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the safety of USL255 as adjunctive therapy in
      patients with refractory partial onset-seizures.
    


Intervention name(s): USL255
Intervention type(s): Drug
Other intervention name(s): Topiramate extended-release
Intervention MeSH terms: Topiramate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; partial onset seizure; adjunctive therapy
Increasing Physical Activity Levels in Low-Income Women
Condition: Healthy
Study type: Interventional

Summary: 
      Regular physical activity is important for good health. Women, particularly women with low
      incomes, have many personal barriers to regular physical activity. The purpose of this study
      is to reduce environmental barriers to physical activity for women in two specific low-income
      neighborhoods (in Louisville, KY) by providing opportunities for safe physical activity and
      addressing barriers such as lack of child care. Two groups of women will have pretest
      information (cholesterol, blood sugar, blood pressure, percent body fat, height, weight,
      waist and hip measurements) collected and the same information 6 months later at post-test.
      One group will have access to multiple physical activity opportunities in their neighborhood
      and at the neighborhood community center. An advanced registered nurse practitioner will
      facilitate the activity opportunities. The groups will be compared on their pretest and
      post-test information to see if the group with the physical activity opportunities has
      increased physical activity as measured by pedometer and self-report questionnaire, and to
      see if there are changes in the measures tested at pre and post (measures that may be
      improved by regular physical activity).
    


Intervention name(s): Physical activity opportunities for low-income women
Intervention type(s): Behavioral
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Prevention
Online Cognitive Behavioral Intervention Program for Hong Kong University Students
Condition: Psychological Distress
Study type: Interventional

Summary: 
      Brief summary:

      The objective of this study is to develop an internet-based cognitive behavioral intervention
      program (including an online platform and a smartphone application) for Chinese university
      students in Hong Kong, and examine its effectiveness in reducing psychological distress,
      anxiety/depression symptoms, and improving emotions and automatic thoughts. The 3-month
      maintenance effect will also be tested.
    

Detailed description: 
      Previous research has provided evidence for the effectiveness of internet-based cognitive
      behavioral intervention in improving mental health, but most studies were done in Western
      countries. This study is intended to design a culturally appropriate online program
      especially for Chinese university students in Hong Kong. The program will include 8 weekly
      sessions and one face-to-face session and one telephone follow-up with a with certified CBT
      therapist. The effects on psychological distress, anxiety/depression, emotions, and automatic
      thoughts will be tested.
    

Intervention name(s): REST Online（Reduce Stress Tour Online）
Intervention type(s): Other
Intervention description(s): Different cognitive behavioral skills are introduced and practiced in a 8 weekly online program, which includes animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, online assessment and reminder. One face-to-face session and one telephone follow-up provided by an experienced CBT therapist are also provided to clients.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Online Cognitive Behavioral Therapy
Masking: None (Open Label)
Primary purpose: Treatment
A Study of BMS-562086 in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and
      colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome
      (D-IBS)
    


Intervention name(s): Placebo; BMS-562086
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, once daily, 2 weeks; Tablets, Oral, once daily, 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Diarrhea-predominant irritable bowel syndrome
Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution
Condition: Parkinson's Disease - Autonomic Dysregulation
MeSH terms: Parkinson Disease; Autonomic Nervous System Diseases; Primary Dysautonomias
Study type: Observational

Summary: 
      Symptoms of blood pressure dysregulation, impaired swallowing and digestion are common
      amongst parkinson patients. The overall aim of this study is to examine blood pressure
      regulation and esophageal motility and gastric emptying in Parkinson's disease (PD) patients.

      The investigators hypothesize that - compared to age-matched controls - PD patients display
      an altered regulation of blood pressure, altered gastroesophageal motility, and delayed
      gastric emptying. These symptoms occur already early in the disease process, but aggravate
      with progression of the disease.

      The investigators will perform a 7-day blood pressure measurement, measurement of central
      blood pressure and pulse wave velocity, assessment of pulse variability, Schellong tests to
      assess orthostatic function, high resolution manometry assessments during swallowing acts,
      and a 13C-sodium octanoate breath test to assess gastric emptying, in 18 PD patients (9 each
      Hoehn&Yahr stages 1,2) and 12 age- and gender-matched healthy controls. Results will be
      interpreted in relation to the severity of PD motor symptoms.

      The investigators anticipate that blood pressure dysregulation and gastroesophageal motility
      disturbances will be present only in PD subjects, but not in matched controls without
      neurological disorders and without any extrapyramidal motor signs. Furthermore, the
      investigators expect to find an association between motor impairment and the severity of
      these autonomic symptoms, however, that according to the Braak staging, subtle disturbances
      must already be present in the early stages of PD.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects included in this trial must fulfil the he following criteria:

          -  informed, written & formal consent for participation

          -  male / female subjects, aged 50-70 years

             18 PD patients

          -  9 subjects Hoehn & Yahr stage 1, disease duration <4 years

          -  9 subjects Hoehn & Yahr stage 2; disease duration 4-8 years

             12 healthy control subjects

          -  age- and gender-matched

          -  without signs or history of neurological disorders

          -  without significant systemic comorbidities (malignant / cardiovascular)
Role of Subsequent Atrial Tachycardia in Mechanisms of Persistent AF
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Tachycardia
Study type: Observational

Summary: 
      In this study, the investigators aim to examine the prognostic role of subsequent Atrial
      Tachycardias (ATs) in the mechanisms of atrial fibrillation (AF). Therefore, the
      investigators compare patients who were randomly assigned to either undergo cardioversion
      after AF has been terminated to AT or further ablation until the achievement of sinus rhythm.
    


Intervention name(s): Catheter ablation of subsequent atrial tachycardia
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with persistent AF
      
Keywords: atrial fibrillation; catheter ablation; subsequent atrial tachycardia; mechanisms
Validation of Stenosis Assessment by Coronary Artery Computed Tomography Against Invasive Measurements of Fractional Flow Reserve in Patients With Significant Coronary Artery Stenoses
Condition: Coronary Artery Stenosis
MeSH terms: Coronary Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of CorCTA by comparing the results of the test
      with another imaging method called Fractional Flow Reserve (FFR), which is done as a part of
      the cardiac catheterization.
    

Detailed description: 
      Invasive X-ray coronary angiography remains the "reference standard" for the evaluation of
      coronary artery stenoses. Recently, coronary artery computed tomography angiography (CorCTA)
      has been introduced as a non-invasive method for the evaluation of coronary artery stenoses
      and has been shown to be highly accurate in stenosis detection when compared to invasive
      X-ray angiography. While invasive X-ray angiography and CorCTA evaluate morphological
      features of coronary arterial plaques, fractional flow reserve is an invasive measure of the
      hemodynamic significance of a stenosis obtained in the catheterization laboratory by
      measuring changes in intracoronary arterial pressure before and after maximal vasodilation
      induced by intracoronary adenosine. An FFR value less than 0.75 has been shown to predict
      ischemia in vascular beds distal to the stenosis by radionuclide perfusion modalities and has
      been shown to be associated with worse outcomes. Therefore, FFR is considered to be an
      invasive hemodynamic "reference standard" for the evaluation of the hemodynamic significance
      of coronary arterial stenoses. While intravascular ultrasound (IVUS) can provide additional
      morphological information in intermediate stenoses, it can not provide further functional
      information and cannot be used in more significant stenoses as the IVUS probe cannot be
      advanced through stenotic lesions.

      We are currently conducting investigation in the validation of CorCTA against FFR in
      intermediate coronary artery stenoses (40-70%) (see below under "Preliminary Data"). However,
      CorCTA has not been validated against invasive hemodynamic measurements of fractional flow
      reserve in patients with stenoses >70% by invasive X-ray angiography. We hypothesize that
      CorCTA-derived measurements are accurate in the diagnosis of hemodynamically significant
      coronary artery stenoses, using FFR as the reference standard in patients with coronary
      artery stenoses>70%.
    

Intervention name(s): FFR, IVUS, VH, or combination of the three
Intervention type(s): Procedure
Intervention description(s): Fractional Flow Reserve (FFR), Intravascular Ultrasound (IVUS), Virtual Histology (VH) or some combination of these three procedures will be completed during the cardiac catheterization procedure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: coronary artery stenoses
Home Pregnancy Test Evaluation, Lay User Study
Condition: Pregnancy Related
Study type: Observational

Summary: 
      This study is a performance evaluation study to assess the performance of a home pregnancy
      test (HPT) in the hands of lay users by comparing their results, when used according to the
      Instructions for Use (IFU), to (a) the lay user confirmed pregnancy status, as determined by
      a CE marked product, and (b) to trained technicians testing the same urine samples.

      The study will also assess the lay user's ability to correctly read results from randomised
      standards, in addition to leaflet comprehension and product ease of use.
    

Detailed description: 
      This is an observational study, designed to assess the performance of a home pregnancy test.

      The study aims to recruit at total 120 volunteers, being approximately equal numbers of
      'pregnant' and not-pregnant' women. Volunteers will be recruited either via direct invitation
      or advertisement and will attend the study site for one visit lasting 30-40 minutes

      Written informed consent will be obtained from all volunteers prior to starting the study.

      All volunteers will be issues a unique study number on admission to the study. All data and
      samples collected will be anonymised throughout the study.

      Volunteers will be provided with one investigational home pregnancy test and instructions for
      use. They will be asked to conduct the test, following the product instructions to obtain a
      test result which will be recorded on the result sheet. Volunteers will be instructed the
      product is investigational and the results should not be relied upon to determine their
      pregnancy status.

      Study volunteers will then be interviewed by the study technician, with regards to their
      understanding of the product instructions and complete an ease of use questionnaire. The
      comprehension interview may be recorded.

      The study technician will then perform 2 further investigational home pregnancy tests on
      randomised urine standards and the volunteer will read the results.

      Finally, the study technician will test the volunteer's urine sample with a marketed
      pregnancy test and record these results on the results sheet. The results of this test will
      be used to provide the volunteer with her pregnancy status at the end of the study.

      Urine samples provided by the volunteers will be tested with the investigational HPT by an
      independent technician and also measured for hCG by quantitative immunoassay. Samples may
      also be measured for other hormones related to pregnancy and fertility.

      With participant permission, the samples may be retained frozen within the SPD BioBank and
      used for future product evaluation or research purposes.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Female volunteers representative of home pregnancy test users.
      
Biospecimen description: 
      Urine sample