bioihbjkbjnl/mcl2 huggingface dataset:
Combined Use of Coronary MDCTA, Coronary Doppler Ultrasonography and PET Perfusion in Diagnosing Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Multislice CT angiography is a novel but already established and widely used in diagnosing
      coronary artery disease (CAD). It is very reliable in ruling out hemodynamically significant
      narrowings in coronary arteries (Negative predictive value). However, it may overestimate the
      severity of the stenoses in up to 30% of the coronary artery lesions (positive predictive
      value 70%). However, when coupled with a functional or flow-sensitive diagnostic test, such
      as PET perfusion or coronary doppler ultrasonography, one can assume that even the PPV may be
      as high as 95 %. Despite this assumption, there's no scientific evidence to support use of
      such hybrid multi-modality tests at present.

      The investigators hypothesis is that improving the diagnostic accuracy of non-invasive
      diagnosis of coronary artery disease will decrease the proportion of patients that need
      catheter angiographies. The avoidance of these unnecessary invasive procedures will improve
      patients´ quality of life and may even redirect health care resources in a more efficient
      way.
    

Detailed description: 
      Coronary MDCTA (multi-detector CT angiography) is a novel but already established and
      widespread diagnostic method to diagnose coronary artery disease. When performed with a
      64-detector (slice) CT, its strength is an excellent negative predictive value, NPV (98%).
      Specificity (86%) is good but the positive predictive value (PPV) is only moderate (70%).
      This is due to the ability of MDCTA to detect even minor vessel wall changes before they are
      functionally significant, and the tendency of CT to overestimate the volume of dense
      calcifications. However, when coupled with a functional or flow-sensitive diagnostic test,
      such as PET perfusion or coronary doppler ultrasonography, one can assume that even the PPV
      may be as high as 95 %. Despite this assumption, there's no scientific evidence to support
      use of such hybrid multi-modality tests at present.

      Our hypothesis is that improving the diagnostic accuracy of non-invasive diagnosis of
      coronary artery disease will decrease the proportion of patients that need catheter
      angiographies. The avoidance of these unnecessary invasive procedures will improve patients´
      quality of life and may even redirect health care resources in a more efficient way.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with chest pain
      
Biospecimen description: 
      serum
    
Keywords: Coronary artery disease; MDCT; Positron emission tomography; Ultrasound
Impact of Two Methods of Listening to Music During Exercise on Perceived Exertion and Overall Physical Activity
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      The purpose of the study is to compare two different methods of listening to music while
      performing aerobic exercise: synchronous music listening vs. asynchronous music listening.
      Synchronous music listening while exercising is a learned activity where the participant
      moves his or her body in synchrony with the beat of the music, similar to dancing or to
      participating in a group exercise (aerobics) class. Our hypothesis is that synchronous music
      listening reduces the level of perceived exertion to the exercise and motivates the subject
      to exercise more often. This study randomly assigns 46 subjects, age 20-55 years old to
      either a control group of listening to their own favorite music in an asynchronous fashion or
      to an intervention group of listening to prepared music in a synchronous fashion over a six
      week period.
    


Intervention name(s): Active teaching in synchronous listening to music while exercising
Intervention type(s): Behavioral
Intervention description(s): Subjects will be instructed to exercise while listening to four audio tutorials that are stored on their MP-3 player. These tutorials guide the subject on how to synchronize his or her body movements to the beat of the music.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: synchronous; exercise; music; heartbeat; tunes
Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the present study is to further establish in a randomized controlled
      trial, the safety and efficacy of weekly Grafix® administration versus control in patients
      with chronic diabetic foot ulcers. The primary endpoint is complete wound closure of the
      index wound, defined as 100% re-epithelialization as determined by the Investigator.

      Grafix® is a product regulated for use in the US by the FDA as a Human Cellular and Tissue
      Based Product (HCT/P) under Title 21 CFR Part 1271.
    

Detailed description: 
      The treatment indication is for chronic, diabetic foot ulcers (DFUs) between 1cm2 and 15cm2
      located below the malleoli on the plantar or dorsal surface of the foot. Patients must have
      confirmed Type I or Type II Diabetes.

      Patients will receive treatment every week for 12 weeks duration in the Single-Blind
      Treatment phase of the trial.

      Patients who receive Grafix® or control will be evaluated for primary efficacy up to 84 days,
      and for safety and wound re-occurrence for 84 days after wound closure. Patients in the
      control group whose wounds are not closed at the end of treatment may be offered Grafix® in
      an Open-Label Treatment phase. The Open-Label Treatment phase can last up to an additional 84
      days.
    

Intervention name(s): Tissue; Control
Intervention type(s): Other; Other
Intervention description(s): Allograft Tissue Cellular Repair Matrix; Non-adherent Dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic DFUs; Diabetic Foot Ulcers
Safety Study of Intranasal Oxytocin in Frontotemporal Dementia
Condition: Frontotemporal Dementia
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Interventional
Phase: Phase 1

Summary: 
      Oxytocin is a hormone produced by the brain that appears to have important roles in social
      cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin
      on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia
      were investigated. The results from the pilot study suggested that oxytocin may be associated
      with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal
      Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the
      present study will examine the safety and tolerability of three different doses of intranasal
      oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.
    


Intervention name(s): oxytocin; Saline Nasal Mist
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomized to receive intranasal oxytocin or placebo in a dose escalation paradigm with three dose cohorts: 24IU, 48IU and 72IU of intranasal oxytocin twice daily for 1 week; Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Frontotemporal Dementia; oxytocin; Pick's disease
Effects of Virtual Reality in TKA Patients
Condition: Knee Arthropathy
MeSH terms: Joint Diseases; Kinesiophobia
Study type: Interventional

Summary: 
      The goal of this clinical trial] is to investigate the effects of virtual reality (VR) in
      patients undergoing total knee arthroplasty (TKA). The main questions it aims to answer are:

        -  Does VR have effects on pain, kinesiophobia, and function during the early
           rehabilitation period of patients who have undergone TKA

        -  Does VR contribute to the success of exercise treatment after TKA

      All the patients included in the study were informed about the disease, the goals of
      post-surgical rehabilitation, the conditions to be considered after TKA and exercises.
      Sitting on the side of the bed and mobilization in or out of the room with a walker were
      provided with the postoperative 1st day exercises. The patients were discharged 2.5 days
      after surgery. The patients in both groups were taught an exercise program for home practice.

      In addition to the exercise program, the virtual reality application was applied before the
      exercises to the VR group. The second evaluation was made 3 days after the end of the
      treatment in both patient groups.

      Researchers compared VR and exercise to see if pain, kinesiophobia, pain catastrophizing,
      knee range of motion, function, and quality of life had changed.
    


Intervention name(s): virtual reality application; exercise
Intervention type(s): Device; Other
Intervention description(s): VR was used for 10 minutes a day in the sitting position for three weeks, twice a week, by watching a walking video before beginning the exercises. Patients were instructed to imagine themselves walking while concentrating on walking and watching the video. The patients were asked to stop watching video by removing their VR glass if they experienced discomfort such as dizziness and nausea during the VR application. They were told to continue watching the video when the discomfort was gone. In cases where similar discomforts recurred, the treatment was terminated.; activities included sitting on the side of the bed and mobilizing in and out of the room using a walker. Patients were provided an exercise program for at-home practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee arthroplasty; VR; Exercise; Pain; Kinesiophobia; Catastrophization; Function
Energy Drinks & Driving Ability
Condition: Driver Sleepiness
MeSH terms: Sleepiness
Study type: Interventional

Summary: 
      Rationale: Sleepiness behind the wheel is the cause of many traffic accidents. It is claimed
      that a 15-minute break and consuming an energy drink such as Red Bull® Energy Drink
      counteracts driver sleepiness.

      Objective: The objective of this study is to compare driving simulator performance after (1)
      a 15-minute break with placebo, (2) a 15-minute break with Red Bull® Energy Drink, and (3)
      continued driving.

      Study design: A double-blind, placebo-controlled crossover study. Study population: Healthy
      human volunteers, 21-35 years old.

      Intervention: Each subject performs 3 test days:

        1. 4 hours continued driving

        2. 2 hours driving, a 15-minute break + Red Bull® Energy Drink, followed by 2 hours driving

        3. 2 hours driving, a 15-minute break + placebo, followed by 2 hours driving Main study
           parameters/endpoints: Standard Deviation of Lateral Position (SDLP), i.e. the weaving of
           the car.
    


Intervention name(s): Red Bull Energy drink
Intervention type(s): Other
Intervention description(s): During a 15 minute break, subjects consume 250 ml of Red Bull® Energy Drink or placebo. Before and after the break, a 2 hour driving test is scheduled.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: sleepiness; driving
Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      The main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin
      treatment on HOMA-index improvement in two different groups of women, belonging to the
      Mexican and Italian population, both affected by Polycystic Ovary Syndrome.
    

Detailed description: 
      This is an open-label clinical trial aimed at evaluating and comparing the effect of
      myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different
      groups of PCOS patients from the Mexican and Italian population. The addition of
      alpha-lactalbumin helps to increase the intestinal absorption of myo-inositol and
      consequently improve its effect. The scientific evidence so far available shows that these
      two groups of PCOS women have a different genetic, nutritional, and behavioural profile.
      Important factors are body mass index and insulin resistance, both increased in the Mexican
      women, although among them PCOS prevalence is not higher compared to many other populations.
      Therefore, the focus of this study is to check the effects of the combined administration of
      myo-inositol and alpha-lactalbumin for six months (with a control at three months) e to
      compare these effects between the two groups of patients, monitoring several hormonal
      parameters connected to the menstrual cycle regularization.
    

Intervention name(s): myo-inositol, alpha-lactalbumin, folic acid
Intervention type(s): Dietary Supplement
Intervention description(s): Evaluating the improvement vs the baseline after three and six months of treatment
Intervention MeSH terms: Folic Acid; Inositol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myo-inositol; alpha-lactalbumin; HOMA-index; ovulation; hyperandrogenism
The Effect of Using Interactive Mobile Application for the Management of Chemotherapy- Induced Nausea and Vomiting in Children
Condition: Oncology; Nausea and Vomiting Chemotherapy-Induced; Pediatric Cancer; Mobile Application
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      The aim of this study was to develop an interactive mobile application and to investigate the
      effect of this application on the management of nausea and vomiting symptoms by using it
      during chemotherapy treatment.
    

Detailed description: 
      Intensive chemotherapy protocols are the most commonly used treatments in childhood cancers.
      While these protocols increase recovery rates, they may also cause some undesirable side
      effects. Nausea and vomiting are one of the most common toxic side effects associated with
      chemotherapy. The aim of this study was to develop an interactive mobile application and to
      investigate the effect of this application on the management of nausea and vomiting symptoms
      by using it during chemotherapy treatment.

      The study will be conducted with 61 children between 8-18 years of age who received
      chemotherapy in the Pediatric Hematology-Oncology Clinic at Trakya University Health Research
      and Application Center. The study was planned as a randomized controlled study. Data will be
      collected with the "Information Form" and "Rhodes Adapted Rhodes Nausea and Vomiting Scale
      for Children". The interactive mobile application will be downloaded to the phones of the
      experimental group and this device will be used from the first chemotherapy day to the
      seventh day. While the experimental group evaluates their nausea and vomiting via mobile
      application twice a day, every 12 hours for one week, the control group will record their
      nausea and vomiting experiences in the "Nausea and Vomiting Diary". While the experimental
      group will be able to use the mobile application which consists of diverting attention,
      routine control will be applied to the control group.
    

Intervention name(s): 5inD
Intervention type(s): Device
Intervention description(s): Interactive Mobile Application which is includes five different game (mandala, puzzle, tetris, music, breath exercise)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the necessary cause
      of cervical cancer. This study is designed to evaluate the long-term immunogenicity and
      safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the
      first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals
      with objectives & outcome measures of the extension phase from Year 5 to Year 10. The
      objectives & outcome measures of the primary phase and extension phase up to year 4 are
      presented in a separate protocol posting (NCT00196937).
    

Detailed description: 
      Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No
      vaccine was administered in this extension study.

      Results on outcome measures describing analyses on other studies are not reported in this
      record. Please refer to the records mentioned in the respective outcome measure titles.
    

Intervention name(s): Blood sampling; Cervico-vaginal secretion (CVS) samples
Intervention type(s): Procedure; Procedure
Intervention description(s): Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.; CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cervical cancer; HPV vaccine
A Blinded, Placebo-Controlled Study of the Safety and Pharmacokinetics of Single Doses of Intravenous Deferiprone in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Single center, randomized, double-blind, placebo-controlled, adaptive sequential
      ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of
      single doses of deferiprone administered by intravenous infusion to healthy males and
      females. A bioavailability comparison will be included.
    


Intervention name(s): Deferiprone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Deferiprone for infusion, 10mg/mL for intravenous infusion.
Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2); Placebo: normal saline solution.
Other intervention name(s): Ferriprox; DFP; L1; Saline solution.
Intervention MeSH terms: Deferiprone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Healthy; Deferiprone; DFP; L1
Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study
Condition: Schizophrenia and Disorders With Psychotic Features; Affective Disorders, Psychotic; Self Concept
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Affective Disorders, Psychotic
Study type: Observational

Summary: 
      The objective of this study is to explore the longitudinal course of self-disturbances (SD)
      in schizophrenia. The main aim of the study is to investigate, in a 6-7-year follow-up of a
      representative sample of patients with first-episode schizophrenia, bipolar disorder and
      other psychoses. The overall aim is to expand our knowledge about the role of SDs in
      psychotic disorders. Increased knowledge here will aid diagnosis and treatment. The current
      study is a seven year follow-up of this representative cohort, with baseline measures of SDs
      and a comprehensive clinical and neurocognitive assessment battery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients reffered to their first adequate treatment for broadly defines psychotic disorders
        (inkluding both schizophrenia - and bipolar Spectrum disorders) in Oppland and Hedmark
        counties in Norway, in 2008 - 2009 participated the base-line part of the study(E. Haug,
        2012).
      
Biospecimen description: 
      Blood tests including cardiovascular risk factors and immunological parameters (cytokines).
To Assess the Safety, Tolerability and Pharmacokinetics of AZD2820 After Single Ascending Doses
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, single-blind, placebo-controlled Phase I study to investigate the
      safety, tolerability and pharmacokinetics after administration of single doses of AZD2820 to
      healthy male subjects.
    


Intervention name(s): AZD2820; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous Injection in abdomen or Thigh; Subcutaneous Injection in abdomen or Thigh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Phase 1; healthy male volunteers; dose escalation; pharmacokinetics; Single Ascending Dose; AZD2820 Cmax; tmax; t1/2λz
A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood
      glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2
      diabetes.
    


Intervention name(s): insulin degludec
Intervention type(s): Drug
Intervention description(s): Insulin degludec (IDeg) injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject was randomly allocated to 2 out of 4 treatments.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment