bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia
Condition: Hyperferritinemia; Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia; Hyperferritinemia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of iron depletion with phlebotomies on
      blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload,
      compared with a dietary intervention alone.

      All subjects in this study will follow dietary and lifestyle counseling in a period of 3
      months.

      A randomized group will receive phlebotomies every 3 weeks in this period.
    


Intervention name(s): Phlebotomy; Dietary and lifestyle counseling.
Intervention type(s): Procedure; Behavioral
Intervention description(s): Volume of 400 mL every 3 weeks, 3 times.; Dietary and lifestyle counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of Glucose Flux on Fat Synthesis in a Whole Body Calorimeter
Condition: Type 2 Diabetes, Obesity, Prediabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The study is carried out to find out the inclusion of high and low glycaemic index foods to
      daily meals and how they impact 24 hour blood glucose fluctuations and energy regulation.
    

Detailed description: 
      The GI is a method of classifying foods based on the food's ability to raise the blood
      glucose level. Low GI foods are recommended as they have a lower impact on blood glucose
      concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose
      profiles and energy regulation in Asians. Healthy, normal-weight, Chinese males will be
      recruited. There will be two sessions (consisting of four days for each session) where they
      will consume either a high or low GI breakfast, lunch, snack (in the whole body calorimeter),
      and a high or low glycaemic index dinner at home. They will take part in two test sessions
      (each spanning over 3 days) with at least five days in between the two sessions. Their
      glycaemic response will be measured using a Continuous Glucose Monitoring System (CGMS)
      throughout the period, while substrate oxidation will be measured over 10 hours in the
      calorimeter (from breakfast, lunch and snack). This study specifically attempts to see how
      having high and low GI meals impact on blood glucose levels and energy regulation in Asians.
      The study is important in that it will be the first of its kind in the whole body calorimeter
      and enable us to compute the rate of fat synthesis and how it is modulated when subjects are
      fed a high GI diet (increased glucose excursions) and a low GI diet ( blunted glucose) over
      24 hours in healthy Asians. Obesity and diabetes rates are increasing exponentially in Asian
      populations and Singapore is no exception. Devising ways and means to staunch the escalation
      is therefore a priority. The findings of the research will contribute towards the long-term
      objectives of developing Asian specific dietary guidelines for weight and glycaemic control.
      The study data will also be important for the provision of practical food-based advocacy for
      better weight and glycaemic control in Singaporeans.
    

Intervention name(s): Breakfast, lunch, snack and dinner
Intervention type(s): Other
Intervention description(s): These meals (cereal, rice and bread meals) will be tested in subjects for their glycaemic response (CGMS) and substrate utilization (calorimeter)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the effect of ASP1707 twice daily on the
      pharmacokinetics of once weekly oral methotrexate (MTX).

      This study will also evaluate the effect of MTX on multiple-dose pharmacokinetics of ASP1707,
      as well as safety and tolerability of coadministration of ASP1707 and MTX in patients with
      rheumatoid arthritis (RA).
    

Detailed description: 
      Patients will check into the clinic on Day -1 and remain in the clinic until all exit
      procedures have been performed on the morning of Day 10.
    

Intervention name(s): ASP1707; methotrexate (MTX)
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Intervention MeSH terms: Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: methotrexate (MTX); Pharmacokinetics; ASP1707; Rheumatoid Arthritis (RA)
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Non Erosive Reflux Disease
Condition: Non-erosive Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the superiority of efficacy of CJ-12420, once
      daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4
    

Detailed description: 
      This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be
      randomly assigned to one of the three treatment groups (CJ-12420 50 mg or 100 mg or placebo).

      All subjects will be asked to take two tablets at the same time each day throughout the
      study, and also all subjects will be asked to record daily symptom in a subject diary on a
      daily basis.
    

Intervention name(s): CJ-12420 50mg; CJ-12420 100mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks; CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks; Placebo, tablet, once daily, oral administration for up to 4 weeks
Other intervention name(s): Not yet decided; Not yet decided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pegintron Induction Therapy in HCV Non-Responders
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the sustained virological response rate at 24 weeks
      after the end of experimental treatment (induction and 72 weeks) to that of standard 48 weeks
      treatment with PEG-inteferon alfa-2b and ribavirin in patients with chronic hepatitis C
      previous unresponsive to interferon alfa monotherapy or interferon alfa/ribavirin combination
      therapy.
    


Intervention name(s): Peginterferon alfa-2b; Ribavirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anal Motor Function in Fecal Incontinence
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Observational

Summary: 
      Traditionnal measurment of anorectal function is perfomed with manometric device using 2 to 3
      pressure sensors. The investigators aim to evaluate the usefulness of high resolution
      manometry to measure anorectal motility
    

Detailed description: 
      Measurment of anorectal function is traditionnaly made using manometric device composed of
      perfused or ballon catheters. This allows the recording of anorectal pressure on 2-3 sites.
      Recently, high resolution manometryu devices using > 36 pressure channels have been
      developped. The investigators therefore aim to evaluate the usefullness of the high
      resolution manometry in patient with fecal incontinence in terms of feasability and diagnosis
      accuracy
    

Intervention name(s): High resolution manometry
Intervention type(s): Device
Intervention description(s): Anorectal High resoltion manometry using electronic sensors
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Heathy controls Patient with Fecal Incontience
      
Keywords: Fecal incontinence, ano-rectal manometry
Reproducibility of Malaria Challenge in Healthy Volunteers
Condition: Healthy
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, single arm, single intervention safety and immunogenicity study in 6
      healthy, malaria-naive adults, conducted to demonstrate the successful implementation of the
      well-established malaria challenge model at the Seattle Biomedical Research Institute
      (Seattle BioMed).
    

Detailed description: 
      This study is designed to demonstrate the ability to inoculate malaria naive human volunteers
      with the Plasmodium falciparum strain of malaria sporozoites by the bite of infected
      mosquitoes under controlled conditions. Subjects are monitored closely for development of
      malaria and treated with standard doses of anti-malarial medications which the Plasmodium
      falciparum strain of malaria is known to be sensitive.

      Study participants will undergo malaria sporozoite challenge with wild-type NF54 strain of
      Plasmodium falciparum sporozoites administered via the bite of five infected Anopheles
      stephensi mosquitoes under controlled containment conditions.

      Participants will be closely monitored for acute reactogenicity and signs and/or symptoms of
      malaria infection, and from day five post-challenge, will have daily blood films examined for
      the presence of malaria parasites. Participants who develop malaria infection will be treated
      with a standard oral regimen of chloroquine, or other FDA-approved anti-malarial drugs, under
      direct observation. Participants will be treated upon first evidence of microscopic
      parasitemia or at day 18 if they remain negative. Participants will be housed with study
      staff in a local hotel for close observation from day 9 post-challenge, until three
      consecutive blood smears are negative and all symptoms have resolved, then followed weekly
      for a total of 8 weeks.

      Follow-up for safety will be conducted at 4- and 6- months post-challenge.
    

Intervention name(s): Malaria challenge (wild-type NF54 strain Plasmodium falciparum sporozoites)
Intervention type(s): Biological
Intervention description(s): Malaria sporozoite challenge with the wild-type NF54 strain of Plasmodium falciparum delivered by the bite of five infected Anopheles stephensi mosquitoes.
Masking: None (Open Label)
Keywords: Experimental malaria challenge
Very Long Term VHI Voice Outcome After MTIS
Condition: Laryngeal Paralysis
MeSH terms: Vocal Cord Paralysis; Paralysis
Study type: Interventional

Summary: 
      Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of
      operated patients using the voice handicap index scale
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): evaluating the voice outcome by the fullfilment of the voice handicap index
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Prevention of the Procedural Pain in the Newborn
Condition: Prevention of the Procedural Pain in the Newborn
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The aim of this study is to compare the impact of two non-medicinal strategies: the
      breast-feeding and saccharose to measure effects in cerebral cortex during pain using near
      infrared spectroscopy (NIRS)
    

Detailed description: 
      Many studies of non-medicinal treatments(saccharose and breast-feeding)show a decrease of
      expression of pain in newborn. However Slater and al questioned these practices due to the
      absence of modification of the cerebral answer measured by evoked potential.
    

Intervention name(s): saccharose versus breast-feeding
Intervention type(s): Procedure
Intervention description(s): saccharose versus breast-feeding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast-feeding; Saccharose; Breast-feeding newborn; cortical pain responses; near infrared spectroscopy (NIRS); Salivary rate cortisol; heel lance
Usefulness of Rehabilitation in Patients With Cervical Imbalance
Condition: Rehabilitation; Cervical Vertigo
MeSH terms: Vertigo
Study type: Interventional

Summary: 
      Using the data obtained in a study carried out at the Hospital of Alcañiz (Teruel, Spain)
      between February and July 2019, with a stabilometric platform and with movement sensors, the
      investigators want to demonstrate that the rehabilitation works in those patients with
      vertigo or dizziness of cervical origin. For this, the data obtained from that sample, which
      was of 67 patients, will be analyzed in a pre-post rehabilitation treatment study,
      objectifying whether the patients improved or not, both in terms of imbalance and cervical
      pain, if any.
    

Detailed description: 
      Using the data obtained in a study carried out at the Hospital of Alcañiz (Teruel, Spain)
      between February and July 2019, with a stabilometric platform and with movement sensors, the
      investigators want to demonstrate that the rehabilitation works in those patients with
      vertigo or dizziness of cervical origin. For this, the data obtained from that sample, which
      was of 67 patients, will be analyzed in a pre-post rehabilitation treatment study,
      objectifying whether the patients improved or not, both in terms of imbalance and cervical
      pain, if any. The 67 patients attended the rehabilitation consultation where, after taking
      the anamnesis, they began to perform balance tests with a stabilometric platform and those
      patients with associated neck pain, with cervical motion sensors. Treatment with conventional
      physiotherapy, electrotherapy or exercises at home was prescribed as appropriate to each one.
      3 months later, the patients were examined again in consultation, using a new anamnesis, the
      platform and the sensors. With the data obtained in said field work, carried out in 2019, the
      present study aims to analyze the usefulness of rehabilitation treatment in vertigo.
    

Intervention name(s): Rehabilitation Treatment: Physiotherapy, Electrotherapy or Exercises at home
Intervention type(s): Procedure
Intervention description(s): The 67 patients attended the rehabilitation consultation where, after taking the anamnesis, they began to perform balance tests with a stabilometric platform and those patients with associated neck pain, with cervical motion sensors. Treatment with conventional physiotherapy, electrotherapy or exercises at home was prescribed as appropriate to each one. 3 months later, the patients were examined again in consultation, using a new anamnesis, the platform and the sensors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients
Condition: Acute Lung Injury; ARDS
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      The investigators aim to study the specific elastance in ALI/ARDS patients during invasive
      mechanical ventilation.
    

Detailed description: 
      In sedated and paralyzed ALI/ARDS patients, we studied the specific elastance and also, we
      compared the specific elastance to healthy subjects during invasive mechanical ventilation.
    

Intervention name(s): mechanical ventilation
Intervention type(s): Behavioral
Intervention description(s): measurement of specific lung elastance during mechanical ventilation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gas exchange; respiratory mechanics
Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the combined effects of fosamprenavir 700mg BID + ritonavir 100mg BID +
      standardized dose of methadone, on plasma total and unbound methadone enantiomer
      pharmacokinetics (PK), opiate pharmacodynamic (PD) measures, and safety. The effect of
      methadone on plasma amprenavir PK will also be assessed by comparison to historical control
      data.
    


Intervention name(s): fosamprenavir + ritonavir + methadone
Intervention type(s): Drug
Intervention MeSH terms: Ritonavir; Fosamprenavir; Methadone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PK; PD; FPV; RTV; APV; ritonavir; fosamprenavir; amprenavir; methadone; pharmacokinetics; pharmacodynamics
Bioequivalence Study of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: Bayer Healthcare, Germany)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, two-way crossover bioequivalence study to determine
      the bioequivalence of Rivaroxaban from Repatoxaban 10 mg Tablets (Horus for Pharmaceutical
      Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed from: Bayer
      Healthcare, Germany)
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Repatoxaban; Xarelto
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 10 mg rivaroxaban; 1 tablet contains 10 mg rivaroxaban
Other intervention name(s): Xarelto
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
AZD0837 Extended Release (ER) Japan Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.
    


Intervention name(s): AZD0837; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablet, oral, once daily, 1+5 days; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Phase I; Healthy volunteers
Early Lung Cancer Detection Using Computed Tomography
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      Early detection of lung cancer may improve treatment outcomes. Risk factors have been
      identified, suggesting a population which might benefit from regular screening. Lung cancer
      screening using low-dose computed tomography (LDCT) has experienced a recent renaissance with
      reported sensitivity for detection of lung cancer of 2.7% in high-risk populations. The
      purpose of this study is to evaluate the utility of LCDT for the early diagnosis of lung
      cancer in Ontario.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        high risk current and former smokers
      
Keywords: Lung Cancer; Eary Diagnosis; Screening
T2Bacteria Panel Pivotal Study
Condition: Bacteremia
MeSH terms: Bacteremia
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria
      Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of
      the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status
      of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole
      blood "clinical samples".
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Candidates participating in the prospective arm of the study will come from the hospital
        population who have had a blood culture ordered per routine standard of care. The contrived
        arm of the study is open to any participants that meet the study enrollment criteria. The
        study population for both arms is defined as all subjects who meet the study eligibility
        criteria, provide informed consent, and provide the clinical specimens under this protocol.
Evaluation of Visual - Motor Development in Children With Retinopathy of Prematurity
Condition: Premature Retinopathy; Visual Impairment; Motor Delay
MeSH terms: Vision Disorders; Vision, Low; Retinal Diseases; Retinopathy of Prematurity
Study type: Observational

Summary: 
      The aim of this study was to investigate the eye structure, visual impairment, visual motor
      development and motor coordination of children between 2-6 ages that had applied to diod
      laser photocoagulation and intravitreal anti - vascular endothelial growth factor treatment.
    

Detailed description: 
      There are three different groups in this study. Children between 2-6 ages that had applied to
      diod laser photocoagulation and intravitreal anti - vascular endothelial growth factor
      treatment will have evaluated with Snellen Test, Titmus Fly Test, Optical Kohlerans
      Tomography, Beery-Buktenica Developmental Test of Visual Motor Integration, Peabody
      Developmental Motor Scales-II, World Health Organization Quality of Life - BREF and State -
      Trait Anxiety Inventory.
    

Intervention name(s): Snellen Test; Autorefractometer; Titmus Stereo Fly Test; Optical Kohlerans Tomography; Investigation of Visual Motor Integration; Peabody Developmental Motor Scales - II; World Health Organization Quality of Life - BREF; State - Trait Anxiety Inventory
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Visual acuity measurement; Refraction measurement; Stereopsis measurement; Retinal development measurement; Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.; Evaluation of motor development; Assesment of quality of life; Assesment of anxiety
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants who were followed up and treated in the outpatient clinic of Zeynep Kamil
        Women and Children Diseases Training and Research Hospital, Ophthalmology Clinic with the
        diagnosis of Prematurity Retinopathy between the years 2012-2015 were included in the
        study.