bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's Disease
Condition: Crohn Disease; Enteral Nutrition; Gastrointestinal Microbiome
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      Inflammatory bowel diseases (IBD) are chronic inflammatory diseases. It is believed that the
      inflammation results from sustained abnormal immune response towards altered or pathogenic
      microbiota in genetically susceptible hosts. Malnutrition is common in IBD, especially in
      pediatric Crohn's disease(CD). Exclusive enteral nutrion(EEN) has been shown to improve
      nutritional status and inflammatory markers in pediatric CD. But there is limited data about
      the effect of EEN on Chinese children with CD. In this study, investigators focused on
      disease process,nutritional status and gut microbiome of Chinese children with
      newly-diagnosed CD after EEN treatment.
    


Intervention name(s): Exclusive Enteral Nutrition
Intervention type(s): Dietary Supplement
Intervention description(s): a complete liquid diet of formula for 8 weeks were adminstered in Crohn's Diseas patients ,Nutritional intake was based on the child's estimated energy requirements, no regular table food during 8 weeks treament.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exclusive enteral nutrition
Metric Properties of de Morton Mobility Index
Condition: Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      Metric properties (convergent validity, predict validity, known-groups validity,
      responsiveness, floor and ceiling effects, minimal clinically important difference) of the de
      Morton Mobility Index (DEMMI) in patients with musculoskeletal impairments undergoing
      impatient rehabilitation will be investigated.
    

Detailed description: 
      Convergent validity of DEMMI will be assessed in terms of correlations with the other outcome
      measures. Known-groups validity will be demonstrated by differences in DEMMI scores between
      patients who were not able to walk and those who were able to walk with or without walking
      aid. Predictive validity of DEMMI at admission for functional independence at discharge from
      rehabilitation will be estimated. The minimal clinically important difference of DEMMI,
      responsiveness and floor or ceiling effects will also be estimated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with musculoskeletal impairments with or without impairments of peripheral nerves
      
Keywords: DEMMI; outcome measurement; physiotherapy; clinimetric properties
Optical Coherence Tomography (OCT) Normative Data Collection Study
Condition: Healthy
Study type: Observational

Summary: 
      This study is being initiated to create a normal database including measures of optic nerve
      head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg
      Spectralis OCT device.
    

Detailed description: 
      This multi-center, prospective, observational (non-interventional) study is the third in a
      series to measure structural parameters of the optic nerve head, the peripapillary retinal
      nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is
      conducted in normal volunteers of various non-Caucasian ethnic group, and data will be
      combined with Caucasian subjects to be representative of the US population: (1) Hispanic
      Descent, (2) Black or African American Descent, (3) Asian Descent, (4) American Indian or
      Alaskan Native Descent. This study will complement the previous study S-2012-1 NORM-cc, in
      which normal data from Caucasian individuals were collected.

      The main goal of the study is to provide the range of these structural parameters in normal
      eyes. The study will include at least 87 (enrollment target: 135) normal volunteers; each
      study site will recruit at least 29 (target: 45) subjects with an age range of 18 to 90 years
      and an approximately equal number of females and males. All subjects will undergo Spectralis
      OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field
      testing in one single visit. All examinations performed on the subjects are non-significant
      risk procedures because the medical devices are cleared for marketing in Europe and in the
      U.S. Total study duration including IRB approval is anticipated to not exceed 4 months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Recruitment will be from persons who respond to recruitment initiatives at the individual
        centers or have signed a release saying that they are willing to be approached for
        participation in research.

        At least 87 subjects (enrollment target: 135 subjects) will be selected from qualifying
        normal volunteers. Age range will be from ≥18 to 90 years. The age of the subjects will be
        defined by their month of birth versus the month of giving consent to participate in this
        study. A subject who is 40 years and 11 months old will be counted as being in the age
        group "31 to 40 years". Each site will attempt to recruit subjects in about equal numbers
        in each age group. The distribution in the age groups should be fairly equal among subjects
        in each ethnic group alone.
      
Keywords: Normal subjects
Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess efficacy, safety and tolerability of treatment with
      zibotentan and dapagliflozin in combination and dapagliflozin 10 mg as monotherapy in
      participants with chronic kidney disease (CKD) with estimated glomerular filtration rate
      (eGFR) ≥ 20 mL/min/1.73 m^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and ≤
      5000 mg/g.
    

Detailed description: 
      The study will be conducted in approximately 220 sites in North America, South America,
      Africa, Asia/Pacific, and European countries.

      Participants will be randomized to 12 weeks of treatment plus 2 weeks follow-up.

      After screening, eligible participants will be stratified by diabetes (diabetic kidney
      disease [DKD] versus non-diabetes mellitus [non-DM] CKD) and baseline eGFR (below or equal
      versus above 45 mL/min/1.73m^2).

      A total of 495 participants will be randomised into this study, including participants
      randomised under the earlier study design. Four hundred and fifteen (415) participants will
      be randomised to have 166 participants in zibotentan Dose A/dapagliflozin 10 mg combination
      arm and dapagliflozin 10 mg monotherapy arm, and 83 participants in the zibotentan Dose
      B/dapagliflozin 10 mg combination arm.

        -  Zibotentan Dose A + Dapagliflozin 10 mg once daily.

        -  Zibotentan Dose B + Dapagliflozin 10 mg once daily.

        -  Placebo + Dapagliflozin 10 mg once daily

      Participants who were previously randomised cannot be re-randomised.
    

Intervention name(s): Zibotentan; Dapagliflozin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive zibotentan as per the arms they are randomized.; Participants will receive 10 mg dapagliflozin as per the arms they are randomized.; Participants will receive placebo as per the arms they are randomized to.
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Zibotentan; Nephrology; Dapagliflozin; Sodium-glucose co-transporter 2; sodium-glucose co-transporter 2 inhibitor; Kidney diseases; Endothelin antagonist
Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models
Condition: Gastrostomy Tube Rupture; Gastrostomy Tube Durability; Gastrostomy Tube Convenience
MeSH terms: Rupture
Study type: Observational

Summary: 
      Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in
      the market, however durability is variable. In a prospective randomized study, five
      commercial devices available in the market will be tested in 20 consecutive patients each.
      Tube performance will be observed during 6 months and durability will be assessed by
      Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design
      and material will influence outcome.
    

Detailed description: 
      Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in
      the market, however durability is variable. In a prospective randomized study, five
      commercial devices available in the market will be tested in 20 consecutive patients each,in
      patients submitted to long-term outpatient nutritional support. Tube performance will be
      observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as
      Cox regression analysis.It is hypothesized that tube design and material will influence
      outcome.This study is important because tube dysfunction and unscheduled changes are
      expensive troubles that disrupt the nutritional protocol and are responsible for multiple
      inconveniences to the patient and the caretaker.
    

Intervention name(s): Tube assessment visits
Intervention type(s): Other
Intervention description(s): Patients will return every 2 months for clinical questionnaire about leaks, obstructions or other dysfunctions of the tube. Objective tube examination for cracks, rupture, obstruction or dislodgement, along with replacement if necessary, will be carried out (total of 3 visits/6 months)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults on long-term nutritional care requiring prolonged gastrostomy feeding via
        percutaneous endoscopic gastrostomy
      
Keywords: gastrostomy; tube; endoscopic; replacement; tube rupture; durability; tube loss; balloon rupture
Influence of Dogs on Learning in Children
Condition: Learning; Human-animal Interaction
Study type: Interventional

Summary: 
      In a randomised controlled cross-over study, the influence of interacting with a dog on
      children's learning performance is investigated.
    


Intervention name(s): Human-dog interaction; Stuffed toy dog
Intervention type(s): Other; Other
Intervention description(s): The tests are completed in the presence of a dog. Further, before starting the tests, the children have 15 minutes to interact with the present dog.; The tests are completed in the presence of a stuffed toy dog. Further, before starting the tests, the children have 15 minutes to play with the stuffed toy dog.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Jowl Improvement With Injectable Fillers
Condition: Jowls
Study type: Interventional

Summary: 
      This is a prospective clinical study to demonstrate a reduction in jowling and laxity of the
      jawline that can be achieved following facial volume enhancement using JUVÉDERM VOLUMA™ XC
      (0.3% w/w lidocaine). The secondary measure will be if this can be achieved with Jawline
      injection only, or if a superior result can be obtained with both cheek and jowl injection.
    

Detailed description: 
      This study is proposed to evaluate the best protocol for achieving improvement in the sagging
      jawline.

      JUVÉDERM VOLUMA™ XC will be injected in each of 16 women with sagging of grades 1-3 using a
      published jawline evaluation scale.

      Patients will be randomized into 1:1 into 2 groups:

      Patient Group 1: JUVÉDERM VOLUMA™ XC 1-2 syringes (each syringe is 1 cc) will be injected
      bilaterally into the lateral jawline and inferior cheek area (preauricular area) (the latter
      area will be added if necessary to achieve visual improvement in jowl attenuation). Total
      syringes used per person will have a range of 1-2)

      Patient Group 2: JUVÉDERM VOLUMA™ XC 1-3 syringes (each syringe is 1 cc) will be injected
      bilaterally into the lateral cheek (zygomatic) area plus JUVÉDERM VOLUMA™ XC 1-2 syringes
      (each syringe is 1 cc) will be injected into the lateral jawline and inferior cheek area
      (preauricular area) (the latter area will be added if necessary to achieve visual improvement
      in jowl attenuation). Total syringes used per person will have a range of 2-5)

      High-resolution photographs from multiple angles will be taken in identical lighting and
      position with the VISIA CR (clinical research) and with the Fotofinder at baseline, 2 weeks,
      4 weeks, 8 weeks, and 12 or 16 weeks. Additional real-time video telemedicine visits will
      take place at 6 months and 12 months. In addition, a 72-hour safety phone call will be
      completed with the subject after each injection session. All visit timing will be based on
      the last injection session. One blinded dermatologist and one unblinded dermatologist will
      rate the patient's severity of jowling based on the Jawline Rating Scale (JRS) (1) at the
      4-week, 8-week, and either 12 or 16-week visits. The patient will also rate their jowling
      based on the JRS as well as their satisfaction with the procedure.
    

Intervention name(s): JUVÉDERM VOLUMA™ XC
Intervention type(s): Device
Intervention description(s): Injectable gel
Other intervention name(s): non-animal hyaluronic acid
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Jowls; Lower Face Laxity; Filler; JUVÉDERM VOLUMA™ XC.; Melolabial Folds; Wrinkles
Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      In addition to the motor and sensory functions, sexual function changes after spinal cord
      injury and is considered one of the most common problems, ranging from a decrease in sexual
      desire to disturbances of erection, orgasm and ejaculation.

      Objective: To assess the impact of the complexity of traumatic spinal cord injury in male
      sexual function.
    

Detailed description: 
      Methods: Observational study (CEAC 41221414.5.0000.5208) conducted with 45 men, mean age 34
      (CI 31.5 to 37.1), with spinal cord injury and active sex life. Sexual function was assessed
      by the International Index of Erectile Function (IIEF) and level and degree of injury were
      determined following the guidelines of the International Standards for Neurological and
      Functional Examination Classification of Spinal Cord Injury. Data were collected after at
      least six months of injury in referral hospitals. Descriptive statistics and bivariate
      analysis were applied to observe the association between sexual function and complexity of
      the lesion, with a 0.05 significance level.
    

Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): Sexual function was assessed by the International Index of Erectile Function (IIEF) and level and degree of injury were determined following the guidelines of the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury.
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Observational study, conducted between March 2015 and ending in January 2016, with males,
        aged between 18 and 60 years; clinical diagnosis of traumatic spinal cord injury, injury
        time equal to or greater than six months, heterosexual and sexually active.
      
Keywords: Sexuality; Spinal cord injuries; Penile erection; erectile dysfunction
Cognitive Correlates of Antidepressant Treatment Response in Elders
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      Major depression is a very common health problem affecting older persons. The present
      standard of treatment is with medications called "antidepressants". Antidepressants have been
      studied extensively in older persons with normal brain function and have been shown to be
      effective. However, certain types of brain dysfunction called "executive impairment"
      (inability to do higher order thinking) may lead to poor treatment outcomes. This study will
      compare how older depressed people with different levels of executive impairment respond
      differently to standard antidepressant treatment. Knowing this information will lead to more
      rational targeting of available treatments, leading to improved treatment outcomes.
    


Intervention name(s): Zoloft (antidepressant)
Intervention type(s): Drug
Intervention description(s): Zoloft 50-200 mg po od x 12 weeks
Other intervention name(s): Sertraline
Intervention MeSH terms: Sertraline; Antidepressive Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antidepressants; depression; zoloft; psychiatry; psychology
Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap
Condition: Complex Digital Injuries
Study type: Interventional

Summary: 
      Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging
      problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap
      including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous
      defect of the proximal phalanx.
    


Intervention name(s): Composite Flap
Intervention type(s): Procedure
Intervention description(s): nerve transfer with the dorsal branch of the digital nerve
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Soft tissue loss; nerve defect; dorsal branch of the proper digital nerve; heterodigital arterialized nerve pedicle flap; Composite Flap; nerve flap; nerve transfer
Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years
Condition: Pertussis; Whooping Cough; Tetanus; Lockjaw; Diphtheria
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and efficacy of 9 different vaccines containing aP
      (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy
      subjects 18 to 40 years of age.
    


Intervention name(s): Acellular pertussis vaccine; Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed); Licensed TdaP booster vaccine; Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany); Saline solution
Intervention type(s): Biological; Biological; Biological; Biological; Other
Intervention description(s): Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.; Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.; Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm.; To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine.; Subjects received one injection of saline solution at one month after vaccination.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: pertussis; booster vaccine; tetanus; diphtheria in adults
Multicenter Clinical Trial for the Evaluation of Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.
Condition: Graft Versus Host Disease; Chronic and Expanded Graft Versus Host Disease; Immune System Diseases
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease; Immune System Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main purpose of this trial is to assess the safety and feasibility of treatment with
      two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro
      in patients undergoing haematopoietic stem cell transplantation (HSCT, who have developed
      chronic and extensive graft versus host disease (GVHD).

      Mesenchymal stem cells (MSCs) express low levels of HLA class I molecules, and do not express
      class II molecules neither CD40, CD80 and CD86, being unable to induce proliferation of
      allogeneic lymphocytes. In addition, MSCs inhibit lymphocyte proliferation by inhibiting cell
      division and maintaining these cells in a quiescent state. This supports the hypothesis that
      MSCs are universal suppressors.
    


Intervention name(s): Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.; Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.
Intervention type(s): Other; Other
Intervention description(s): Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. Low dose: 1 x10e6 / Kg.
Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin.; Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. High dose: 3 x10e6/Kg.
Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Graft versus host disease; Mesenchymal stem cell; Allogeneic mesenchymal stem cell; Adipose tissue; Allotransplant; Allogenic; Mesenchymal Stem Cells; Immune System Diseases; Chronic; Expanded