bioihbjkbjnl/mcl2 huggingface dataset:
A First-in-Human Study of LY3009385 in Healthy Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the safety of LY3009385 in healthy
      participants. The study drug is given as a single dose, by injections under the skin. Side
      effects will be documented. This study is approximately 28 days not including screening.
      Screening is required within 28 days prior to the start of the study.
    

Detailed description: 
      This is a single ascending dose study that examines the safety and tolerability,
      pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385
      administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3,
      9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive
      either LY3009385 or Placebo.

      Adjustments to the dose levels were permitted after review of emerging safety, PK, and
      glycemic data.

      The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.
    

Intervention name(s): LY3009385; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Kinesio Taping in Sit to Stand Movement fo Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Children with Cerebral Palsy (CP) present limited performance of functional activities and
      activities of daily life. Kinesio taping has been definied as a promising technique for
      children with CP ans has been extensively used in clinical practice. However, several studies
      have found a low level of evidence of its effectiveness in healthy individuals. We aim to
      evaluate the effects of the immediate application of Kinesio taping on the activation of the
      rectus femoris and anterior tibialis muscles and on the duration of sit-to-stand movement in
      children with CP.
    


Intervention name(s): Kinesio taping; Without taping
Intervention type(s): Other; Other
Intervention description(s): An experienced physiotherapist placed the base of the Kinesio taping strip, over rectus femoris muscle, 3cm bellow the anterior iliac spine, without tension. From this point, the Kinesio taping was placed up to the upper edge of the patella and stretched to 100% tension. It was, then, bi-sectioned, circled the patella and ended in the tuberosity of the femur, without tension. In order to avoid interference in the electromyography signals, a section was held at Kinesio taping at the point where the electrode was placed.; Children performed functional activities without tape
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: intervention; children
Evaluation of a Web-based Intervention to Promote Physical Activity in Patients With Heart Disease.
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Heart Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit)
      against usual care in increasing physical activity levels in patients with Coronary Artery
      Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a)
      have increased physical activity levels, b) will have a higher health-related quality of life
      at measurement dates and, c) will have greater improvements in psychosocial predictors.
    

Detailed description: 
      Most existing cardiac rehabilitation programs have little ability to expand participation
      using traditional delivery models that emphasize supervised, facility-based programs.
      Futhermore, facility based programs to promote physical activity behavior in patients with
      coronary artery disease (CAD) are limited in their impact because most patients are unwilling
      to travel more than 30-40 minutes to participate in a program. CardioFit is an off-site, 26
      week web-based physical activity coaching service for people with heart disease. Within the
      CardioFit program, patients will be assigned to an on-line "coach" and receive customized
      exercise programs based on their medical history, personal goals and preferences. A
      randomized control trial (RCT) is planned to evaluate the effectiveness of the web-based
      intervention at increasing physical activity levels against usual care in patients with CAD.

      This study is in the third phase of a three-phase research program to examine interventions
      to promote physical activity for the secondary prevention of Cardiovascular disease.
    

Intervention name(s): CardioFit
Intervention type(s): Behavioral
Intervention description(s): CardioFit is a 26-week tailored web-based physical activity coaching service for individuals with Coronary Artery Disease (CAD). It has been designed to help patients develop personalized exercise programs based on their medical history, personal goals and preferences. Access to Cardio-fit is through a secured website. The cardio-fit website contains physical activity advice and heart health educational information. Each patient is assigned an on-line coach, whose role is to assist in creating safe an effective physical activity program, and to answer any questions that patients may have throughout the program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Randomized Control Trial; Exercise Intervention; Prevention; Rehabilitation
SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY
Condition: Celiac Disease; Dental Caries
MeSH terms: Celiac Disease; Dental Caries
Study type: Observational

Summary: 
      The main aim of the study is to currently define the prevalence of celiac disease (CD) in
      children aged 5-10 years in 2 Italian cities (Ancona and Verona). The screening protocol is
      based on a 1st line genetic test (searche of HLA DQ2/DQ8 genotypes) followed by a serological
      diagnosis (IgA TTG and IgG DGP).
    

Detailed description: 
      All scholar children aged 5-10 years living in the cities of Ancona and Verona will be
      invited to partecipate. Children enrolled will be investigated as follows:

        1. HLA DQ2/DQ8 genotyping (by a rapid test)

        2. In children genetically predisposed to CD serological investigations will be performed
           (both IgA TTG and IgG DGP antibodies)

        3. The overall population will be evaluated for the prevalence and severity of dental
           caries (by using the DMFT/dmft index)
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 5-10 years
      
Biospecimen description: 
      Blood
    
Keywords: celiac disease; children; caries; HLA DQ2; HLA DQ8; screening
Sleep Disordered Breathing and Gestational Hypertension
Condition: Sleep Disordered Breathing; Obstructive Sleep Apnea; Gestational Hypertension; Preeclampsia
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional

Summary: 
      Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative
      estimates, 4% of the adult female population has SDB. SDB is a recognized cause of
      hypertension and treating SDB can improve blood pressure control in people with hypertension.
      More recently, research efforts have looked at SDB as a possible cause of pregnancy induced
      hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best
      way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This
      is inconvenient and for pregnant women often impossible to arrange, considering the short
      time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at
      the University of Saskatchewan are now looking at whether an adequate sleep assessment can be
      performed at the bedside - either in a patient's home or on the hospital ward. The
      researchers will also look at different treatment options for sleep apnea, to see if these
      can improve blood pressure control in this patient population, and delay the need for early
      delivery. The information from this study may result in a detailed sleep assessment becoming
      part of the complete assessment of women with PIH. There is an association between sleep
      disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may
      represent an effective addition to the management of the cardiovascular and metabolic
      perturbations of GHTN We plan to assess women whether treating SDB with one of two methods
      will improve the management of GHTN. We will also assess if one method is more effective than
      the other.
    


Intervention name(s): CPAP; Oral Appliance
Intervention type(s): Device; Device
Intervention description(s): One half of the subjects will be randomly assigned to wear continuous a positive airway pressure device on the second night of the study. Portable polysomnography will be repeated for this night and morning bloodwork for inflammatory markers will be repeated.; Half of the subjects will be assigned to wear an oral appliance and nasal strip on the second night of the study. Repeat portable polysomnography will be performed and morning bloodwork will again be drawn for inflammatory markers.
Other intervention name(s): Respironics M Series Autoset CPAP; Somnoguard AP oral apliance; Breathe Right Nasal Srip; Somnoguard AP; Breathe Right nasal strip
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Disordered Breathing; Obstructive Sleep Apnea; Gestational Hypertension; Preeclampsia
Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes
Condition: Dental Caries; Dental Fluorosis
MeSH terms: Dental Caries; Fluorosis, Dental; Fluoride Poisoning
Study type: Interventional
Phase: Phase 1

Summary: 
      Fluoride toothpaste has been associated not only with declining dental caries prevalence but
      also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride
      toothpaste use, the purpose of this study is to evaluate the availability of fluoride
      concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries
      effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from
      ingested toothpastes (with potential to cause dental fluorosis), in a sample of young
      Brazilian children using toothpaste formulations representative of those available and most
      used by this age-group.
    


Intervention name(s): Toothpaste
Intervention type(s): Drug
Intervention description(s): The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: toothpastes; bioavailability; sodium fluoride; monofluorphosphate; low-fluoride
Dose Ranging and Dose Frequency of LIPO-102
Condition: Subcutaneous Adipose Tissue Reduction
Study type: Interventional
Phase: Phase 2

Summary: 
      Dose Ranging and Dose Frequency of LIPO-102
    


Intervention name(s): LIPO-102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous Injection; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
pMDT in Thoracic Surgery--The Process Implementation Stage
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary
      postoperative pain management strategy is the best way to control postoperative pain in
      thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the
      thoracic surgery department of Peking University People's Hospital, the investigators have
      summarized the experience in multidisciplinary pain management and promoted this study in
      multi-centers across the country, hoping that this study can improve the current situation of
      acute pain management in patients after thoracic surgery, and at the same time, the
      deficiencies of this clinical protocol can be found out and improved.
    

Detailed description: 
      The postoperative acute pain refers to the acute pain (usually lasting less than 7 days) that
      occurs immediately after surgery, and its nature is traumatic pain. It may develop into a
      chronic pain, such as a neuropathic pain or a mixed pain, if it is not fully controlled at
      the initial state. It will seriously impact the physiology and psychology of a patient.
      According to the study, the postoperative acute pain is one of the risks for postoperative
      complications, and it may result in the death of a patient. However, the alleviation of a
      postoperative acute pain can shorten the duration of stay in hospital, and reduce the overall
      cost for treatment of a patient.

      The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary
      postoperative pain management strategy is the best way to control postoperative pain in
      thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the
      thoracic surgery department of Peking University People's Hospital, the investigators have
      summarized the experience in multidisciplinary pain management and promoted this study in
      multi-centers across the country, hoping that this study can improve the current situation of
      acute pain management in patients after thoracic surgery, and at the same time, the
      deficiencies of this clinical protocol can be found out and improved.
    

Intervention name(s): pMDT(Process Implementation)
Intervention type(s): Combination Product
Intervention description(s): The pMDT(Baseline Investigation) takes multi-model analgesia as the main technical means. Multimodal perioperative analgesia refers to the combination of analgesics, adjuvant drugs and analgesic techniques with different effects throughout the perioperative period to achieve the best curative effect of reducing postoperative acute and chronic pain.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing thoracic surgery in Peking University People's Hospital and other
        multi-centers.
      
Keywords: pMDT; Pain; Thoracic surgery
French Language Validation of the 5-minutes Montreal Cognitive Assessment (MoCA)
Condition: Cognitive Symptom; Evaluations, Diagnostic Self
MeSH terms: Neurobehavioral Manifestations
Study type: Interventional

Summary: 
      The aim of the study is to validate a french version of the 5 minutes version of the Montreal
      Cognitive Assessment as compared to the french full version of this test.
    

Detailed description: 
      The Montreal Cognitive Assessment (MOCA) is a test used to detect cognitive impairments. This
      test is available in different languages including french. A short version (the 5 minutes
      MOCA) has also been validated through a phone call use that allows to develop some
      epidemiological approaches. Nevertheless, this short version has not been validated in
      french.

      The main aim of the study is to validate the french translation of the short version of the
      MOCA as compared the the full french version of the test.

      To validate the short version, several groups of subjects will be included : healthy
      subjects, Alzheimer disease patients, Parkinson or Huntington diseases patients as well as
      diabetic patients.

      The inclusion of both healthy subjects and patients with different types of cognitive
      impairments will allow to validate the short version of the test.

      All subjects and patients will first be submitted to the full version of the MOCA during a
      face to face procedure. Thirty to forty days later, they will be submitted to the short
      version of the test through a phone call performed by an independent rater.

      Subgroups of healthy subjects and patients will also be used to determine the test-retest and
      inter-rater reliability of the short version of the MOCA.
    

Intervention name(s): Full version of the Montreal Cognitive Assessment; 5 minutes version of the Montreal Cognitive Assessment
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Patients or subjects will be submitted to the full version of the MOCA; The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Different populations including subjects with or without cognitive impairment will be used to determine the accuracy of a short version of the MOCA as compared to the full version of this scale.
Masking: None (Open Label)
Primary purpose: Diagnostic
Implementing Learning 2 BREATHE in Campus Connections
Condition: Mindfulness
Study type: Interventional

Summary: 
      The overall objective of this study is to investigate a mindfulness-based intervention's
      feasibility/acceptability and effectiveness for improving eating behaviors and depression
      symptoms among adolescents (9-18y; 63% living on low-income), referred to a community-based
      mentoring program for being "at-risk for not reaching their full potential" (e.g., Department
      of Human Services involvement, behavioral/emotion problems). As a part of this study, we will
      also characterize the real-time relationships among life stressors, untrained state
      mindfulness, and emotion regulation difficulties in adolescents' daily lives and determine to
      what extent an MBI helps adolescents to maintain mindfulness and emotion regulation in
      moments when they experience a stressor.
    


Intervention name(s): Learning to Breathe; Campus Connections
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Learning to Breathe is an evidence-based mindfulness curriculum for adolescents; Campus Connections is a mentoring program for at-risk adolescents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adolescents; mindfulness; ecological momentary assessment
Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
Condition: Patients With Gastroparesis Who Have Failed Standard Therapy
MeSH terms: Gastroparesis; Nausea; Vomiting
Study type: Interventional

Summary: 
      To provide oral domperidone to patients between the ages of 18 and 60 years of age, according
      to the investigator's judgment, a prokinetic effect is needed for the relief of severe
      gastroparesis. We have defined severe gastroparesis as 1) positive gastric emptying
      scintigraphy (more than 10% residue at 4 hours), 2) nausea, 3) early satiety, 4) abdominal
      pain. We will recruit patients for two years and the patients will be given domperidone for
      up to two years.
    


Intervention name(s): Domperidone
Intervention type(s): Drug
Intervention description(s): oral tablet; dose is 10mg per tablet given up to 3 times daily.
Intervention MeSH terms: Domperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastroparesis; domperidone; nausea; vomiting
Mobile Education for Emergency Ultrasound
Condition: Educational Problems
MeSH terms: Emergencies
Study type: Observational

Summary: 
      The investigators aim to investigate the feasibility of using mobile application platform for
      sonographic education.

      Junior physicians at the National Taiwan University Hospital will be enrolled in this study.
      To design and develop a secure mobile application platform (consisting of mobile device and a
      cloud-based server) for interactive teaching, remote social-based consultation and
      discussion. The information exchange through the platform carries images and simulated cases.

      This pioneer study can provide experience of mobile sonographic education and contribute to
      current medical education. Moreover, it can improve decision-making process and quality of
      care, and could lessen crowdedness at emergency departments. Furthermore, the integrated
      platform can be used in other educational programs in the future.
    

Detailed description: 
      As usual, it takes time for junior emergency physicians to have good diagnostic accuracy
      through traditional sonographic education. Applying the technology built in this project,
      junior emergency physicians will be provided with intelligent learning programs anywhere and
      anytime.

      Junior physicians at the National Taiwan University Hospital will be enrolled in this study.
    

Intervention name(s): educational platform
Intervention type(s): Other
Intervention description(s): The platform would be opened before they entered the study.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The junior physicians of the department of emergency medicine of the National Taiwan
        University Hospital.
      
Keywords: emergency medicine ,emergency ultrasound