bioihbjkbjnl/mcl2 huggingface dataset:
Can Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Rheumatoid patients have higher fall risk than normal population. Several fall risk factors
      were studied. No previous study investigated the role of musculoskeletal ultrasound as a
      predictor of fall risk in rheumatoid arthritis.
    

Detailed description: 
      Adults with rheumatoid arthritis are exposed to higher risk of fracture. Risk factors
      included joint tenderness, fatigue, muscle weakness, impaired balance and disease activity.

      Musculoskeletal ultrasound is a bed side radiographic tool that gained much attention in the
      last decade.It can detect stuctural chnges in the musculoskeletal system even before beeing
      detected by the x ray.

      Nowadays, musculoskeletal ultrasound is a very useful tool in examining rheumatoid patients.

      No previous study was done to investigate the role of musculoskeletal ultrasound as a
      predicting factor of fall risk in rheumatoid patients.

      Predicting the fall risk in such disease could help setting preventing measures to prevent
      falls with its sequels.
    

Intervention name(s): non
Intervention type(s): Other
Intervention description(s): non
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients with Rheumatoid arthritis .
      
Keywords: Rheumatoid arthritis; foot problems; Fall risk; predictors
Safety and Immunogenicity Study of Recombinant Modified Vaccinia Virus Ankara (MVA) Virus to Treat HIV Infection
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      At the end of 2004 there were more than 40 million people infected worldwide with HIV, with
      an estimated 16,000 new infections every day (Joint United Nations Programme on HIV/AIDS
      [UNAIDS], 2004). The HIV epidemic threatens whole societies particularly in Africa and Asia
      and rates of infections in the Western countries have also increased over the last few years.
      However, despite more than 15 years of research, an effective vaccine against HIV and
      acquired immunodeficiency syndrome (AIDS) has still not been developed.

      There is considerable evidence that cellular immune responses can effectively control HIV-1
      replication during acute and chronic infections thereby possibly protecting individuals from
      infection and preventing the spread of HIV. To be truly effective in the general population,
      a vaccine must induce responses specific to immunologically conserved regions. The
      epitope-based vaccine MVA-mBN32 represents a very logical approach to this problem because of
      its potential to elicit a polyfunctional immune response and to focus these responses to
      conserved epitopes.

      In this study the safety, tolerability, and immunogenicity of a recombinant MVA-BN® vaccine
      expressing cytotoxic T lymphocyte (CTL) and helper T lymphocyte (HTL) epitopes of HIV-1
      (MVA-mBN32) in 36 healthy volunteers will be examined. This will include a full analysis of
      CD4+ T helper cells and CD8+ CTL responses to these epitopes, to establish the potential of
      such a homologous prime-boost vaccine approach to induce a broad cell-mediated response to
      different HIV antigens.
    


Intervention name(s): MVA-mBN32; MVA-mBN32
Intervention type(s): Biological; Biological
Intervention description(s): 3 immunizations; first study group: 10E7_TCID50; 3 immunizations; second study group: 10E8_TCID50
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Safety; T-cell epitope; Acquired Immune Deficiency Syndrome Virus; HIV Preventive Vaccine
A Phase II Dose-escalation Study to Assess the Feasibility and Safety of Transendocardial Delivery of Three Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs)in Subjects With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability
      of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in
      subjects who have cardiomyopathy of both ischemic and idiopathic etiology.
    

Detailed description: 
      Heart failure subjects recruited will include those who have advanced heart failure NYHA (New
      York Heart Association) class II to IV and a depressed ejection fraction (EF < 40%). Baseline
      eligibility testing assessments will be completed within 28 days prior to cell delivery.
      Efficacy will be explored at 3, 6, and 12 months.

      This will be a single-blinded, dose-escalation, cohort study in 60 subjects allocated
      sequentially to 1 of 3 cohorts A, B, or C. Forty-five subjects will be randomized to receive
      transendocardial delivery of MPC treatment, and 15 subjects will be randomized to receive
      standard-of-care treatment without MPC administration. The fifteen subjects randomized to
      receive standard of care without needle injection will serve as the study's control
      population and will undergo mock mapping and verbal injection scripts.
    

Intervention name(s): Mesenchymal Precursor Cells (MPCs); Mesenchymal Precursor Cells (MPCs); Mesenchymal Precursor Cells (MPCs); standard-of-care treatment with mock mapping and injection procedures.; standard-of-care treatment with mock mapping and injection procedures.; standard-of-care treatment with mock mapping and injection procedures.
Intervention type(s): Biological; Biological; Biological; Procedure; Procedure; Procedure
Intervention description(s): 25 M allogeneic MPCs by transendocardial injection and mapping.; 75 M allogeneic MPCs by transendocardial injection and mapping.; 150 M allogeneic MPCs by transendocardial injection; Mock; Mock; Mock
Other intervention name(s): Revascor; Revascor; Revascor
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Heart Failure; Congestive Heart Failure
NMR Metabolomics Study of Follicular Fluid of Oncological Patients
Condition: Woman With Cancer Resorting Fertility Preservation
Study type: Observational

Summary: 
      Purpose: The purpose of this study was to evaluate the possible application of metabolomics
      to identify follicular fluid changes in cancer patients undergoing fertility preservation.
      Although metabolomics have been applied already in cancer studies, this is the first
      application on follicular fluid of cancer patients.

      Methods: The investigators selected for the study 10 patients with breast cancer and lymphoma
      who resorted to oocyte cryopreservation to preserve fertility and 10 healthy women undergoing
      in vitro fertilization treatments. Follicular fluid was collected at the time of oocytes
      retrieval. Metabolomic analysis of follicular fluids was performed by 1H NMR spectroscopy in
      combination with multivariate analysis to interpret the spectral data. Univariate statistical
      analysis was applied to find correlations between patients' features and metabolites
      identified by NMR.
    

Detailed description: 
      The purpose of this study was to evaluate the possible application of metabolomics to
      identify follicular fluid changes in cancer patients undergoing fertility preservation.
      Although metabolomics have been applied already in cancer studies, this is the first
      application on follicular fluid of cancer patients.

      Methods: The investigators selected for the study 10 patients with breast cancer and lymphoma
      who resorted to oocyte cryopreservation to preserve fertility and 10 healthy women undergoing
      in vitro fertilization treatments. Follicular fluid was collected at the time of oocytes
      retrieval. Metabolomic analysis of follicular fluids was performed by 1H NMR spectroscopy in
      combination with multivariate analysis to interpret the spectral data. Univariate statistical
      analysis was applied to find correlations between patients' features and metabolites
      identified by NMR.
    

Intervention name(s): oocytes retrieval
Intervention type(s): Procedure
Intervention description(s): The oocytes retrieval was performed after 34-36 hours from hCG administration . The collection of cumulus-oocyte complexes and FFs were performed via transvaginal ultrasound-guided aspiration with a needle of 18 gauge of diameter. The three major diameter follicles were identified by intraoperative ultrasound and FF of each follicle was collected in its own test tube.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        oncological patients with pathological diagnosis resorting fertility preservation
      
Biospecimen description: 
      follicular fluids
Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403
      milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis
      (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared
      with placebo in patients with idiopathic pulmonary fibrosis.
    

Detailed description: 
      This is a Phase 3, randomized, double-blind, placebo-controlled, safety and efficacy study of
      pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). Approximately 320 patients
      at approximately 50 centers will be randomly assigned (1:1) to receive pirfenidone 2403
      milligrams or placebo equivalent administered in divided doses three times per day (TID) with
      food. The primary outcome variable will be the absolute change in percent predicted Forced
      Vital Capacity from Baseline to Week 72. Patients will be randomized by geographic region.

      Patients will receive blinded study treatment from the time of randomization until the last
      patient randomized has been treated for 72 weeks. A Data Monitoring Committee (DMC) will
      periodically review safety and efficacy data to ensure patient safety.

      After week 72, patients who meet the Progression of Disease (POD) definition, which is a ≥
      10% absolute decrease in percent predicted Forced Vital Capacity or a ≥ 15% absolute decrease
      in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive
      permitted idiopathic pulmonary fibrosis therapies in addition to their blinded study drug.
      Permitted idiopathic pulmonary therapies include corticosteroids, azathioprine,
      cyclophosphamide and N-acetyl-cysteine (with restrictions).
    

Intervention name(s): Pirfenidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.; Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Idiopathic; Pulmonary; Fibrosis; Lung; Pirfenidone; InterMune
A Drug Interaction Study of Albiglutide and Digoxin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of
      digoxin when coadministered with albiglutide in healthy adult subjects.
    

Detailed description: 
      This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of
      digoxin when coadministered with albiglutide in healthy adult subjects. Subjects will receive
      a single dose of digoxin on Day 1 followed by 5 weekly subcutaneously injected doses of
      albiglutide and a second single dose of digoxin on Day 38. To determine the plasma
      pharmacokinetic parameters of digoxin after drug administration alone and after multiple
      doses of albiglutide, blood samples will be collected after each dose of digoxin.
    

Intervention name(s): digoxin plus albiglutide
Intervention type(s): Biological
Intervention description(s): A single dose of 0.5mg digoxin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide, followed by a single dose of 0.5mg digoxin on Day 38.
Intervention MeSH terms: Digoxin; rGLP-1 protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; albiglutide; Healthy volunteer; digoxin
The Effect of Mental Fatigue on Lower Limb Functional Performance Tests and Brain Activity in a Healthy Population
Condition: Mental Fatigue; Return to Sport; EEG; Brain Activity; Functional Performance
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      Objective of the study

      The main objectives of this project are:

        1. To assess the influence of mental fatigue on a return-to-play test battery in healthy
           population

        2. To assess the influence of mental fatigue on brain functioning during a balance and
           reaction time task in healthy population In a later stage, these experiments could be
           carried out in a clinical context (e.g. in an ankle sprain population).

      The researchers will use a randomized, placebo controlled, counter-balanced, cross-over
      design.

      Thirteen healthy subjects will visit the lab 3 times. On the first visit (familiarisation
      trial), the investigators will collect the participants' characteristics. The participants
      will also be familiarized to the procedures and materials of the experiment during this first
      visit. The second and third visit contain the experimental setup and will proceed as follows:
      first, the participants will fill in a mental fatigue scale (M-VAS) and motivation scale.
      Next, the subjects will carry out a functional test battery (hop test, vertical jump test,
      Y-balance test, and a balance reaction-time test). Session rate of perceived exertion (RPE)
      is measured to indicate how fatigued the participants feel because of the test battery; also,
      M-VAS is collected once more. Then, a short cognitive task (Flanker task) is followed by
      either a long intensive cognitive task (90 minutes Stroop task) or control task (90 minutes
      documentary). Afterwards, participants have to carry out the Flanker task, fill in M-VAS
      (2x), perform the same test battery, fill in session RPE and one final fatigue scale (Nasa
      TLX). Heart frequency and EEG will be measured continuously during the trials.
    


Intervention name(s): Mental Fatigue; Control
Intervention type(s): Other; Other
Intervention description(s): modified stroop task; documentary
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Functional Neuroanatomy and Regional Metabolism Before and After Treatment With Duloxetine
Condition: Depression
MeSH terms: Depression
Study type: Observational

Summary: 
      The findings may guide future investigations on novel therapeutic targets in depressive
      subjects. Based on the depicted link between personality traits and altered brain metabolism
      and function, the latter might be used as supporting objective measures and possible
      biomarkers for increased depression risk.
    

Detailed description: 
      Interoceptive awareness (IA) is the awareness of bodily signals and has been highlighted as
      important in many early theories of emotion. William James was one of the first to present a
      psychological theory linking viscero-afferent feedback to emotional experience. The
      processing of bodily and thus interoceptive stimuli may be a crucial component in yielding
      empathy, since affective states are often assumed to involve awareness of one´s own bodily
      state. The assumption of a close relationship between interceptive awareness and empathy is
      further supported when considering the regions recruited during both processes, like the
      insula and the anterior cingulate cortex. Although especially the affective component may
      implicate interoception and interoceptive awareness, the impact of interoception on empathy
      has never been evaluated behaviorally or neurophysiologically.

      Also associated with altered insula and anterior cingulate cortex (ACC) function is
      Alexithymia. Alexithymia, a personality trait, is marked by cognitive and affective features
      including difficulties in identifying and describing feelings as well as in distinguishing
      feelings from bodily sensations of emotional arousal. Recent studies found a negative
      correlation between prefrontal glutamate (Glu) and mental perspective taking as well as
      extraversion. Even though several functional imaging studies investigated the neuronal
      signatures of interoceptive awareness and the personality trait alexithymia, little is known
      about the functional relevance of neurotransmitter concentrations
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with an acute depressive episode (n = 20; 10 females; mean age ± SD age, 32.2 ±
        10.3 years; number of episodes 2.7 ± 1.9; age of onset 26.7 ± 9.1 years) were recruited
        from the inpatient department of psychiatry at the University of Zurich. All patients were
        either medication naïve or not on any psychotropic medication for at least 6 weeks prior to
        study enrollment. Participants were entered into the study after a full explanation of the
        purpose of the study and the study procedures and after written consent was obtained as
        approved by the University of Zurich's institutional review board.
      
Keywords: Empathy; Interoceptive Awareness; fMRI; MRS
Neuropsychological Development and Functional Outcome Sin Children With Hirschsprung Disease at School Age
Condition: Hirschsprung's Disease (HD)
MeSH terms: Hirschsprung Disease
Study type: Interventional

Summary: 
      Hirschsprung's disease (HD) is a rare congenital disease (1:5000) characterized by neonatal
      functional low bowel obstruction that is caused by aganglionosis of the distal bowel. HD
      treatment consists in surgery of colonic reduction in the early childhood, requiring
      afterward a long-term follow-up. In the long term complications (incontinence, constipation,
      enterocolitis, soiling)but also iterative anesthesia in childhood and repeated
      hospitalizations can have negative effects on child's development.

      The main aim of the study is to estimate neuropsychological development at school age (6-10
      years). Of children operated of HD Secondary aims are evaluation of the neuro-driving
      development and global health, comparison of quality of life levels to those of French
      population standards as well as to study the complex relations between on one hand the
      quality of life of these children and on the other hand the socio-demographic data, the
      initial clinical elements and the surgical coverage, as well as their health and current
      cognitive profile.

      This multicenter study included pediatric surgery departments of Marseille. All children born
      between 1/1/2005 and 31/12/2010 and presenting HD represent the population. All the families
      will be contacted resting on the networks of set up follow-up. A written agreement will be
      collected with the parents. For all the participating children, a consultation will be
      organized: quality of life data (reported by children and by their parents in validated
      standardized questionnaires), clinical examination of the child, cognitive profile of the
      child. The duration of inclusion is scheduled for 12 months.

      This is the first French study using auto-reported data on children's quality of life at
      school age affected by a HD. The results of this study will allow developing hypotheses on
      predictive risk factors for neuropsychological development disorders. Besides a better
      knowledge of the relation existing between these children quality of life and their
      functional results due to the disease could help clinicians in their medical reflections.
    


Intervention name(s): psychometric evaluation; neuropsychological evaluation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Wechsler type composite scales (WISC); Evaluation of child behavior by the Goodman questionnaire: Strengths and Difficulties Questionnaire
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Repeated Dose Phase I Study of FYU-981
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male
      adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each
      step. After follow-up examination in the step of lower dose, the next dose is administered.
    


Intervention name(s): FYU-981, (Oral daily dosing for 7 days); Placebo, (Oral daily dosing for 7 days)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomized to the FYU-981 arm receive active drug, FYU-981.; Subjects randomized to the placebo arm receive placebo.
Intervention MeSH terms: Dotinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Antiemetic Effect of the Addition of Ondansetron to the Morphine Solution in Patient-Controlled Analgesia (PCA)
Condition: Postoperative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      PCA morphine always introduces nausea and vomiting during the postoperative period.
      Ondansetron can reduce PONV (postoperative nausea vomiting). We, the researchers at Khon Kaen
      University, are trying to add ondansetron in PCA morphine. Patients receive a small dose of
      ondansetron when they request morphine.
    


Intervention name(s): ondansetron adding in PCA
Intervention type(s): Drug
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ondansetron; PCA