bioihbjkbjnl/mcl2 huggingface dataset:
Association of Quantitative and Functional Imaging With Clinical Outcome After Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      The overall study aim is to provide additional magnetic resonance imaging parameters of the
      cervical spinal cord, brainstem and brain and a better understanding of changes after spinal
      cord injury (SCI) and to define new magnetic resonance (MR) biomarkers to correlate with
      sensomotoric functioning and clinical outcome.
    

Detailed description: 
      Injury of the spinal cord, for instance induced by trauma, is complex involving primary
      mechanisms caused by forces directly affecting the spinal cord and secondary mechanisms
      consisting of complex physiological processes after trauma.

      Conventional magnetic resonance imaging (MRI) is the current standard to assess morphologic
      changes of the spinal cord after injury. However, conventional MRI provides little
      information regarding the health and integrity of the brain and spinal cord tissue itself,
      due to the fact that signal intensity changes are non-specific and do not correspond directly
      with physiological processes. This is reflected in the poor correlation of conventional MRI
      data with neurological and functional impairment in various spinal cord pathologies (such as
      multiple sclerosis compression myelopathy) and failure to provide reliable prognostic
      information.

      By applying a combination of diffusion weighted imaging, functional MRI and magnetic
      resonance spectroscopy will give us a better understanding of the changes after injury of the
      cervical spinal cord, brainstem and brain. Correlating the imaging data with the neurological
      and clinical status of patients could improve the patient status prediction and therapy
      planning.

      This study is divided into three sub-projects:

      i) Reproducibility study of the MR measurements in healthy controls ii) Progression of MR
      biomarkers in subacute patients with SCI and comparison to chronic patients with SCI iii)
      Prediction of clinical outcome based on MR biomarkers
    

Intervention name(s): Healthy controls; Subacute SCI patients; Chronic SCI patients
Intervention type(s): Other; Other; Other
Intervention description(s): individuals without spinal cord injury; individuals with spinal cord injury ≥ 2 weeks; individuals with spinal cord injury ≥ 24 months
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  20 healthy controls

          -  35 patients with subacute spinal cord injury

          -  20 patients with chronic spinal injury
Bone Microarchitecture in Women Practicing Golf
Condition: Bone Microarchitecture
Study type: Observational

Summary: 
      After the age of 50, one in three women and one in eight men will experience at least one
      fragility fracture during the rest of their lives. It is currently recognized that physical
      activity has an osteogenic actions, especially when it includes the impact transmitted to the
      skeleton. In this context, the investigators propose a study to determine whether the regular
      practice of golf could be particularly beneficial for the skeleton, not only in the lower
      limbs, due to repeated impacts to the ground when it requires sustained walking, but also the
      upper limbs due to the impacts transmitted by the club at the time of striking the ball, as
      has been amply demonstrated with racquet sports.
    

Detailed description: 
      Each patient will have 1 blood samples and 1 measure of bone by 3D micro-tomography (3D CT
      Scan).These examinations and sampling will take place on 1 day.
    

Intervention name(s): 3D CT scan
Intervention type(s): Other
Intervention description(s): Measure of bone micro-architecture by 3D micro-tomography
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subject practicing foot walk or golf or sedentary
      
Biospecimen description: 
      Blood sample
    
Keywords: Bone microarchitecture; Playing golf; Walkers
Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of repeated
      doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an
      investigational drug that is currently being studied as a lipid lowering agent.
    


Intervention name(s): PF-04950615 (RN316); PF-04950615 (RN316); PF-04950615 (RN316); PF-04950615 (RN316); PF-04950615 (RN316)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Infusion every week; Infusion every week; Infusion every week; Infusion every week; Infusion every week
Intervention MeSH terms: Bococizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Dyslipidemia; LDL; High Cholesterol; Japanese Volunteers; PF-04950615; RN316
Study of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      ALV003-0812 is a study of the safety and tolerability of a study drug (ALV003) in healthy
      adult volunteers and in patients with well-controlled celiac disease, following a meal that
      contains gluten.
    

Detailed description: 
      ALV003-0812 (the FED study) is designed to evaluate the safety and tolerability of a single
      dose of the study drug, ALV003, administered at one of four different dose levels, and
      following a test meal containing a small amount (1 gram) of gluten. ALV003 has been
      demonstrated to proteolyze (assist with the digestion of) various forms of gluten (gluten
      flour, wheat bread) in laboratory studies and in animals. Celiac disease has been estimated
      to affect 1% of the population of the United States, is related to gluten, and has a wide
      range of clinical manifestations including chronic gastrointestinal symptoms, malabsorption,
      and bone disease.
    

Intervention name(s): ALV003; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Doses via intragastric tube at dosages of either 100 mg, 300 mg, 900 mg, or 1800 mg; Placebo to be administered via intragastric tube
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Celiac Disease
Efficacy of Pioglitazone on Microcirculation in Type 2 Diabetes Patients Treated With Insulin
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to measure microcirculation in type 2 diabetes patients with
      peripheral edema who are taking pioglitazone, once daily (QD).
    

Detailed description: 
      Pioglitazone is a thiazolidinedione compound with a mode of action as a peroxisome
      proliferator-activated receptor gamma agonist. Activation of this receptor causes increased
      transcriptional activity at a number of locations that are important to carbohydrate and
      lipid (fat) metabolism. Insulin resistance is reversed by enhancing the action of insulin,
      thereby promoting glucose utilization in peripheral tissues, suppressing gluconeogenesis in
      the liver, and reducing lipolysis at the adipocyte.

      In previous studies of pioglitazone, peripheral edema (swelling in the hands, feet, and legs)
      was reported as an adverse event more often in pioglitazone groups and appears to be a dose
      dependent phenomenon with pioglitazone. The incidence of peripheral edema in monotherapy
      studies was 3.2% in pioglitazone patients compared with 0.7% placebo patients and was
      reported more by females than males. This incidence was higher when pioglitazone was combined
      with sulphonylurea or insulin (5.9% and 15.6%, respectively). In comparison, the incidence of
      edema, when sulphonylurea or insulin was combined with placebo, was 2.1% and 7.5%,
      respectively.

      This study is designed to identify the mechanisms underlying peripheral edema formation with
      pioglitazone in patients with Type 2 diabetes.

      Individuals who participate in this study will provide written informed consent and will be
      required to commit to a screening visit and approximately 4 additional visits at the study
      center. Study participation is anticipated to be about 10 to 12 weeks (or approximately 3
      months). Multiple procedures will occur at each visit which may include fasting, blood
      collection, urine collection, physical examinations and electrocardiograms.
    

Intervention name(s): Pioglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone 15 mg to 30 mg, tablets, orally, once daily for up to 10 weeks; Pioglitazone placebo-matching tablets, orally, once daily for up to 10 weeks
Other intervention name(s): Actos; AD4833
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy
Efficacy Study of Pioglitazone and Ramipril Combination Therapy in Treating Non-diabetic Hypertensive Patients.
Condition: Inflammation; Hypertension
MeSH terms: Hypertension; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on
      low grade inflammation and vascular function in hypertensive patients.
    

Detailed description: 
      Patients with insulin resistance and an activated inflammation are prone for cardiovascular
      complications like myocardial infarction or stroke. Pharmacological interventions reducing
      vascular inflammation are thought to reduce cardiovascular risk in diabetic and in
      non-diabetic patients.

      Intervention with ACE inhibitors like ramipril is an established and widely used treatment
      for patients with high blood pressure, proven to reduce cardiovascular risk. Treatment of
      non-diabetic patients with pioglitazone has shown to improve the cardiovascular risk profile
      in non-diabetic patients beyond its effect on blood glucose levels.

      The purpose of this study is to evaluate effects on low grade inflammation and vascular
      function of pioglitazone in non-diabetic, hypertensive patients with pre treatment with
      angiotensin converting enzyme inhibitors (that will be replaced by the study medication at
      time of randomization).
    

Intervention name(s): Pioglitazone; Pioglitazone and ramipril; Ramipril
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pioglitazone 15 mg, tablets, orally, once daily and ramipril placebo-matching tablets, orally, once daily for two weeks; increased to:
Pioglitazone 30 mg, tablets, orally, once daily and ramipril placebo-matching tablets, orally, once daily for up to 10 weeks.; Pioglitazone 15 mg, tablets, orally, once daily and ramipril 2.5 mg, tablets, orally, once daily for two weeks; increased to:
Pioglitazone 30 mg, tablets, orally, once daily and ramipril 5 mg, tablets, orally, once daily for up to 10 weeks.; Pioglitazone placebo-matching tablets, orally, once daily and ramipril 2.5 mg, tablets, orally, once daily for two weeks; increased to:
Pioglitazone placebo-matching tablets, orally, once daily and ramipril 5 mg, tablets, orally, once daily for up to 10 weeks.
Other intervention name(s): ACTOS®; AD4833; ACTOS®; AD4833
Intervention MeSH terms: Pioglitazone; Ramipril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: drug effects; Hypertension; Vascular Resistance; Drug Therapy; physiopathology, vascular
Musculoskeletal Problems and Strategies Developed by Physiotherapists to Cope With Them
Condition: Occupational Diseases; Muscle Pain
MeSH terms: Myalgia; Occupational Diseases
Study type: Observational

Summary: 
      The aim of this study is to investigate whether there is a difference in areas such as
      occupational musculoskeletal injuries and strategies developed by physiotherapists working in
      different fields, burnout and occupational satisfaction.
    

Detailed description: 
      This study is a descriptive, cross-sectional online survey study. In this study, it is aimed
      to reach people who have graduated from the Physiotherapy and Rehabilitation Departments of
      the Faculties of Health Sciences or the Physical Therapy and Rehabilitation Schools of
      universities in Turkey, which provide education for 4 years and have the title of
      "physiotherapist". Physiotherapists will be divided into 5 groups according to the fields
      they work. Group 1 is only pediatric patients, Group 2 is orthopedics and sportsman, Group 3
      is neurology and intensive care, Group 4 is general group that receives patients in many
      fields, and Group 5 is physiotherapists working in the field of public health. planned to
      occur. Before starting the study, the participants will be asked to fill in the Volunteer and
      Consent Form that they voluntarily participated in, and then they will be asked to fill out
      the Personal Information Form, the Extended Nordic Musculoskeletal System Questionnaire, the
      Pain Coping Inventory, the Maslach Burnout Scale, and the Vocational Satisfaction Scale
      prepared by us. According to the results obtained, 5 different groups will be compared among
      themselves by the determined parameters. The surveys to be used will be uploaded to the
      Google Forms database. Then, the participants will be asked to participate in the study by
      being reached via online media such as e-mail, mobile phone applications , social media.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Extended Nordic Musculoskeletal Questionnaire Pain Management Inventory Maslach Burnout Scale Vocational Satisfaction Scale
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        physiotherapists who have been actively working for more than a year
      
Keywords: physiotherapist; burnout; professional satisfaction
Comparative Study of Specular Microscopes for Endothelial and Corneal Cell Measurements
Condition: Corneal Endothelial Cell Loss
MeSH terms: Corneal Endothelial Cell Loss
Study type: Observational

Summary: 
      The primary objective of this clinical study is to collect clinical data to support an FDA
      510(k) submission for the Topcon Specular Microscope SP-1P. The secondary objective is to
      evaluate any adverse events found during the clinical study.
    


Intervention name(s): Topcon Specular Microscope SP-1P; Konan Specular Microscope CELLCHEK XL
Intervention type(s): Device; Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ophthalmology Practice
A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety, reactogenicity, and humoral
      immunogenicity of mRNA-1020, mRNA-1030, and mRNA-1010 vaccines against vaccine-matched
      influenza A and B strains.
    


Intervention name(s): mRNA-1030; mRNA-1020; mRNA-1010; Active Comparator
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Sterile liquid for injection; Sterile liquid for injection; Sterile liquid for injection; Sterile liquid for injection
Other intervention name(s): Seasonal influenza vaccine; Seasonal influenza vaccine; Seasonal influenza vaccine; Seasonal influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza vaccine; mRNA-1020; mRNA-1030; Moderna
Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      The purpose of this study is to learn the effects of fasting on cancer cells while you get
      maintenance treatment.
    

Detailed description: 
      Cancer cells use an increased supply of glucose to make energy and do not have protection
      against fasting that normal cells do. Because of this, researchers would like to study how
      fasting may help chemotherapy target cancer cells instead of normal cells. Initial studies
      suggest that fasting may decrease the side effects of chemotherapy and increase the chances
      of your cancer responding to the chemotherapy. Patient populations will have non-small cell
      lung cancer in which chemo-immunotherapy with carboplatin/pemetrexed and pembrolizumab have
      been recommended to treat the cancer as part of standard care.

      Primary Objective 1. To determine the feasibility and compliance of administering a
      fasting-mimicking diet (FMD) in patients with advanced NSCLC receiving maintenance therapy

      Secondary Objectives

      1. To assess a patient's willingness to fast for second cycle

      Correlative Objectives

        1. To assess DNA damage via measurement of γ-Η2ΑΧ foci in PBMCs at baseline and following
           one cycle of FMD (day 21 or day 28)

        2. To assess spheroid formation from circulating tumor cells (CTCs) isolated from patients
           post FMD as compared to baseline (prior to fasting)

        3. To measure the changes in immune markers prior to and after administering the FMD
    

Intervention name(s): Fasting-Mimicking Diet
Intervention type(s): Other
Intervention description(s): Chemo-immunotherapy + FMD (fast-mimicking diet)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fasting; diet; chemo-immunotherapy; lung cancer; circulating tumor cells
Control of Asthma Patients Symptomatic on Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether IPL512,602 is safe and effective for the
      treatment of asthma symptoms in patients who remain symptomatic on a background therapy of
      inhaled corticosteroids.
    

Detailed description: 
      This multicenter, randomized, double-blind, placebo-controlled, parallel group study will
      include subjects with persistent moderate to severe asthma who require inhaled
      corticosteroids and inhaled short-acting β2-agonists (SABAs). Subjects who pass screening at
      Visit 1 will enter a 2-3 week baseline period to confirm stable asthma symptoms and collect
      baseline data. Subjects will continue with ongoing prescribed treatment during this period,
      or as modified by the investigator based on clinical judgment. Subjects will use the SABA
      prescribed for them to alleviate asthma symptoms on an as needed basis throughout the study.
      If eligible, at Visit 2 subjects will be randomized to treatment with either IPL512,602 (20
      mg) daily or placebo in a 1:1 ratio. Randomization in each treatment group will be stratified
      into two subgroups: those receiving low to medium doses of inhaled corticosteroids (≤500 µg
      per day fluticasone or equivalent) and those receiving high doses of inhaled corticosteroids
      (>500 µg per day fluticasone or equivalent). During the 8-week treatment period, subjects
      will return to the clinic after 1, 2, 4, 6, and 8 weeks of treatment (Visits 3-7). Adverse
      event data will be collected for 14 days following the last dose administration (Visit 8).
    

Intervention name(s): IPL512,602 20 mg once daily; IPL512,602 Matching Placebo once daily
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: 8-week treatment; oral tablets; persistent moderate to severe asthma; AQLQ; asthma control; quality of life
Effect of Child Preference for Parental Selection During Induction
Condition: Anxiety State; Child Behavior
Study type: Observational

Summary: 
      Induction of anesthesia can be distressing both for children and their parents.
      Nonpharmacological behavioral interventions can reduce the anxiety of children without
      significant adverse effects as seen with sedative drugs. has not been documented.

      The aim of this study will be to evaluate the effect of children's preference on parental
      selection during the induction of anesthesia on children and parental anxiety during the
      perioperative period.
    

Detailed description: 
      Anesthetic induction can be one of the most stressful experiences for the child during the
      perioperative period, with almost 50% of the children showing significant anxiety. . To
      minimize the effect of anxiety, several methods have been adopted, such as the introduction
      of day-case surgery, parental presence at the induction of anesthesia, distractions and the
      use of pharmacological agents like midazolam to reduce anxiety.

      Although the effect of parental presence on the anxiety of children and parents was studied
      in various studies. Whether the children's choice of parental selection affects anxiety is
      not studied yet. In this study, we will evaluate the anxiety of children by using mYPAS .
    

Intervention name(s): Selection of parent(mother or father) according to children preference; Selection of parent(mother or father) according to randomization
Intervention type(s): Procedure; Procedure
Intervention description(s): The parent who will accompany the child during the perioperative period will be determined by children preference; The parent who will accompany the child during the perioperative period will be determined by randomization.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        80 children of both sex, aged 4-8 years with ASA physical Status I-II will be enrolled
      
Keywords: day- case surgery; anxiety; children