bioihbjkbjnl/mcl2 huggingface dataset:
ViBone in Cervical and Lumbar Spine Fusion
Condition: Spondylosis; Cervical Spondylosis; Spondylolisthesis; Herniated Nucleus Pulposus; Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration; Spondylolisthesis; Spondylosis
Study type: Observational

Summary: 
      Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical
      discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
    

Detailed description: 
      This study is a prospective, multi-center study to evaluate the clinical and radiographic
      outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be
      gathered for up to 50 subjects undergoing ACDF surgery and up to 50 subjects undergoing
      lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100
      subjects. The purpose of this study is to assess clinical and radiographic outcomes in
      patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects
      will be followed for 12 months following surgery.
    

Intervention name(s): ViBone
Intervention type(s): Other
Intervention description(s): Viable Bone Allograft
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients, 18-80 years of age undergoing 1-3 level anterior cervical
        discectomy fusion (ACDF), or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using
        ViBone.
      
Keywords: Anterior Cervical Discectomy and Fusion (ACDF); Transforaminal Lumbar Interbody Fusion (TLIF); Posterior Lumbar Interbody Fusion (PLIF)
Search for Biomarkers in Human Glaucoma: Lymphocytes Alterations and Rate of Progression
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Observational

Summary: 
      The aim of this study was to evaluate the lymphocyte phenotype in primary open- angle
      glaucoma (POAG) patients compared to healthy subjects of the same age, in order to confirm
      the importance of immune responses in glaucoma and the possible correlation to the severity
      of the disease.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic in Parma (University hospital of Parma)
      
Keywords: glaucoma; immunology; immunophenotype
Pharmacokinetics of BF2.649 in Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open, parallel group study in subjects with normal renal function compared to
      those with renal dysfunction.
    

Detailed description: 
      The pharmacokinetic of BF2.649 (pitolisant) is already well established from several studies
      in healthy human, and a recent pharmacokinetic study gave data on 12 young healthy volunteers
      compared to 12 elderly subject receiving 20mg/day during 14 days.

      The aim of this study is to investigate effect of renal impairment on the pharmacokinetics of
      BF2.649 administrated on a single oral dose of 20 mg.

      The once daily dose of 20 mg BF2.649 (pitolisant) chosen for this study corresponds to the
      usual therapeutic dose.

      Twenty four subjects will be stratified according to renal function by using assessment of
      glomerular filtration rate (GFR) as defined by MDRD formula as follows:

        -  4 subjects from 18 to 75 years of age with mild impaired renal function defined by GFR
           between 60 and 89 ml/min (STAGE 2 according to the international classification of
           chronic kidney disease)

        -  4 subjects from 18 to 75 years of age with moderate impaired renal function defined by
           GFR between 30 and 59 ml/min (STAGE 3 according to the international classification of
           chronic kidney disease)

        -  4 subjects from 18 to 75 years of age with severe impaired renal function defined by GFR
           between 15 and 29 ml/min (STAGE 4 according to the international classification of
           chronic kidney disease)

        -  12 healthy subjects with normal renal function defined by GFR>90 ml/min with no
           proteinuria (<0.15g/L determined by urinalysis) matched with impaired renal function
           subjects on ethnic group, sex, age (+/- 5 years), and BMI (+/- 20%)
    

Intervention name(s): BF2.649
Intervention type(s): Drug
Intervention description(s): single dose 20 mg
Other intervention name(s): Pitolisant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal impairment
A Study to Assess the Safety and Tolerability of SOBI003 in Pediatric MPS IIIA Patients
Condition: Sanfilippo Syndrome Type A (MPS IIIA)
MeSH terms: Mucopolysaccharidosis III
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      MPS IIIA, also known as Sanfilippo A, is an inherited lysosomal storage disease (LSD). MPS
      IIIA is caused by a deficiency in sulfamidase, one of the enzymes involved in the lysosomal
      degradation of the glycosaminoglycan (GAG) heparan sulfate (HS). The natural course of MPS
      IIIA is characterized by devastating neurodegeneration with initially mild somatic
      involvement. The aims of the present study is to assess the dose related safety,
      tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SOBI003, a chemically
      modified recombinant human (rh) Sulfamidase developed as an enzyme replacement therapy (ERT).
    

Detailed description: 
      This is an open-label, non-controlled, parallel, sequential ascending multiple-dose,
      multicenter study to assess the dose related safety, tolerability, PK and PD of SOBI003 in
      pediatric MPS IIIA patients. Patients between 1 and 6 years of age who have not received
      previous treatment for MPS IIIA with an ERT, gene- or stem cell therapy will be eligible to
      participate in the study. The study is planned to consist of 3 dose cohorts, each comprising
      3 patients. Treatment initiations will be staggered within each cohort in order to be able to
      observe, interpret and treat possible adverse reactions. SOBI003 is administered as weekly
      i.v. infusions over a period of 24 weeks. Upon completion of the 24-week treatment period
      with satisfactory tolerability, the patient is offered to receive continued SOBI003 treatment
      by participation in an extension study.
    

Intervention name(s): SOBI003
Intervention type(s): Drug
Intervention description(s): Weekly i.v.infusion
Other intervention name(s): Modified recombinant human sulphamidase
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was designed to include three arms, up to 20 mg/kg. After a company decision to end the development of the compound it was decided to not start a third cohort, but if stated safe the dose could increase up to 20 mg/kg in cohort 1 and 2.
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Adjuvant TACE Treatment in CK18 Positive Patients
Condition: Postoperative Adjuvant TACE; Hepatocellular Carcinoma.
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      To evaluate and analyse the clinical effect and application value of postoperative adjuvant
      TACE treatment in patients with different expression levels of CK18 using randomized
      controlled study and provide evidence for the necessity of postoperative adjuvant TACE.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        320 patients with HCC
      
Biospecimen description: 
      tumor tissue
    
Keywords: Cell keratin 18
Phase II Dose-Finding Study of SK-0403 With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in
      patients with Type2 Diabetes Mellitus
    


Intervention name(s): SK-0403
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Investigating the Benefits of a 3D Camera for Recording Healing Wound Dimensions
Condition: Chronic and Non-healing Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The study will explore whether a 3D camera data can provide a more accurate baseline
      measurement (compared to 2D images with manual measurement) to support better clinical
      decision making in referrals to tissue viability.
    

Detailed description: 
      Chronic and non-healing wounds are a significant problem to manage in community and represent
      a significant workload in community nursing. The current management for non-healing wounds
      includes referral to the tissue viability service, using a 2 D photographic image with
      assessment information. This study will pilot the use of a 3 D camera and associated software
      that introduces measurement and monitoring of wounds as a specific intervention. The
      introduction of 3 D measurement and monitoring of wounds will be compared with usual care.
      With a target recruitment of 30 patients via tissue viability, the pilot will report on the
      feasibility of using this outcome measure and the effectiveness of monitoring on wound
      closure or improvement.
    

Intervention name(s): 3d camera
Intervention type(s): Other
Intervention description(s): 3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Functional Dyspepsia Microbiome Study
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Observational

Summary: 
      Recurrent abdominal pain has long been acknowledged to be the most common chronic pain
      entities in children. The purpose of this study is to describe the microbiome in children
      with FD and to explore relationships between the microbiome and postprandial distress
      syndrome, anxiety scores, and mucosal biomarkers or anxiety. The specific goals of this study
      are to: 1) Determine the frequencies and relative proportions for specific bacteria or
      bacteria phyla in children with FD in both duodenal mucosal specimens and stool samples. 2)
      Determine if the frequencies or proportions of specific bacteria or bacteria phyla differ
      between children with and without PDS. 3) Determine bi-variate correlations between
      bacteria/phyla frequency, bacteria/phyla proportions, anxiety scores, and mucosal biomarkers,
      respectively.
    

Detailed description: 
      The purpose of the current study is to describe the microbiome in children with FD and to
      explore relationships between the microbiome and postprandial distress syndrome, anxiety
      scores, and mucosal biomarkers or anxiety.

      SPECIFIC AIMS

        1. To determine the frequencies and relative proportions for specific bacteria or bacteria
           phyla in children with FD in both duodenal mucosal specimens and stool samples.

        2. To determine if the frequencies or proportions of specific bacteria or bacteria phyla
           differ between children with and without PDS.

        3. To determine bi-variate correlations between bacteria/phyla frequency, bacteria/ phyla
           proportion, anxiety scores, and mucosal biomarkers, respectively.
    

Intervention name(s): EGD; Collection of Stool Specimens
Intervention type(s): Procedure; Other
Intervention description(s): In this study patients are being scoped(EGD) as standard of care and being asked to allow .5 aggregate of tissue biopsy to be taken for research purposes.; We will be collecting stool samples from each participant for research purposes. Within two weeks after EGD tissue collection.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolecents ages 8 to 17 inclusive that have been diagonsed with functional
        dyspepsia and are scheduled to have a EGD with biopsy.
      
Biospecimen description: 
      Collection of .5 aggregate of doudenal tissue. Collection of stool samples.
Neo-adjuvant Erbitux-based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer
Condition: Locally Advanced Malignant Neoplasm; Oral Cancer; Oropharyngeal Carcinoma
MeSH terms: Neoplasms; Mouth Neoplasms; Oropharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Epidermal growth factor receptor（EGFR） is a potential target for new anticancer therapy in
      head and neck squamous cell carcinoma, because blocking the EGFR by a monoclonal antibody
      results in inhibition of the stimulation of the receptor, therefore, in inhibition of cell
      proliferation, enhanced apoptosis, and reduced angiogenesis, invasiveness and metastases. The
      study hypothesis is that neo-adjuvant Erbitux-based chemotherapy followed by surgery and
      radiotherapy for locally advanced oral/oropharyngeal cancer could benefit the patients on
      prognosis. The endpoints of this study are the pathological complete response after
      neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy, the survival
      rate, and the safety.
    

Detailed description: 
      The primary endpoint of this study is the pathological complete response after neo-adjuvant
      Erbitux-based chemotherapy followed by surgery and radiotherapy. The second endpoint of this
      study is the disease free survival rates (1, 2, 3, 5 years), locoregional control rates (1,
      3, 5 years), overall survival rate (3, 5 years), and the safety.
    

Intervention name(s): Neo-adjuvant Erbitux-based chemotherapy
Intervention type(s): Drug
Intervention description(s): Name/Substance: Erbitux Formulation: 2 mg/ml or 5 mg/ml Dose: 400 mg/m^2 initial, and then 250 mg/m^2 weekly Route: Intravenous infusion Frequency & treatment mode: Weekly Duration: 6 weeks
Name/Substance: Docetaxel Formulation: Liquid (20 mg/2 ml) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)
Name/Substance: Cisplatin Formulation: Powder (30 mg) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)
Arms: Neo-adjuvant Erbitux-based chemotherapy
Other intervention name(s): Followed by surgery and radiotherapy
Intervention MeSH terms: Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral cancer; Oropharyngeal cancer; Induction chemotherapy; Targeted chemotherapy; Surgery; Radiotherapy; Effects of Chemotherapy
Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy
Condition: Shoulder Dysfunction; Breast Cancer; Modified Radical Mastectomy
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Patients who underwent modified radical mastectomy were enrolled in the study. 200 subjects
      were randomly divided into 4 groups: 7 days postoperative shoulder isotonic training + 4
      weeks postoperative progressive resistance training group, postoperative 7 Isometric training
      for the shoulder joint + progressive resistance training for 3 weeks after surgery group, 3
      days postoperative isotope training + 4 weeks postoperative progressive resistance training
      group, 3 days postoperative shoulder isotonic training + postoperative 3 Weekly progressive
      resistance training group. The effects of interventional rehabilitation at different time
      points on the recovery of shoulder function after breast cancer operation were observed. The
      results of the study will provide evidence-based evidence for the time point of intervention
      in early functional exercise after modified radical mastectomy for breast cancer.
    


Intervention name(s): 7 days SIE plus 4 weeks PRE; 7 days SIE plus 3 weeks PRE; 3 days SIE plus 4 weeks PRE; 3 days SIE plus 3 weeks PRE
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.; Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.; Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.; Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: breast cancer modified radical mastectomy; shoulder dysfunction; Rehabilitation Training
Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
Condition: Vaginal Prolapse
MeSH terms: Uterine Prolapse; Prolapse
Study type: Observational

Summary: 
      The main objective of the study is to assess the effectiveness of the sheathed speculum in
      providing adequate visualization and access to the cervix in patients with excessive vaginal
      tissue.

      The secondary objective is to rate the patient's comfort evaluation during the sheathed
      speculum examination.
    

Detailed description: 
      This is a descriptive clinical trial designed to assess the efficacy of a sheathed speculum
      in providing adequate visualization and access to the cervix in women with excessive vaginal
      tissue. Eligible, consented subjects who fail their initial speculum examination (because
      their cervix is not visualized due to the collapse of loose lateral vaginal walls) will have
      a sheathed speculum examination instead of the standard-of-care exam whereby the clinician
      fabricates a solution at the bedside (condom with tip cut placed on speculum, concomitantly
      using an additional instrument like a lateral-wall retractor, glove with tip of thumb placed
      over the speculum, using the largest speculum available)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        excessive vaginal tissue
PS128 May Improve Off Duration on Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the short term effects (12 Weeks) of
      Lactobacillus plantarum PS128 (PS128) on Parkinson's disease (PD) symptoms.
    

Detailed description: 
      This study is designed to examine the extent to which L. plantarum PS128 can improve symptoms
      in PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in
      specific brain regions. Patients with PD will receive PS128 treatment for 12 weeks. Symptoms
      of PD will be clinically evaluated before and after the treatment, and the results will be
      compared.
    

Intervention name(s): daily ingestion of Lactobacillus plantarum PS128
Intervention type(s): Dietary Supplement
Intervention description(s): daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      MOA-728, an investigational drug, is currently being studied for the relief of constipation
      associated with postoperative ileus and treatment of opioid induced constipation in patients
      receiving palliative care. This study will further investigate the IV formulation of MOA-728
      comparing PK/PD time points for a 20-minute versus a 4-hour infusion.
    


Intervention name(s): MOA-728
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: opioids; chronic pain
Reconstruction of the Medial Patellofemoral Ligament - A Randomised Controlled Trial Comparing Two Surgery Technics
Condition: Knee Stability; Patella Luxation
MeSH terms: Joint Dislocations
Study type: Interventional

Summary: 
      The purpose of this present study is to determine which surgery technic provides the best
      clinical outcome after medial patellofemoral ligament reconstruction comparing suture anchors
      and screw fixation in medial femoral condyle.
    


Intervention name(s): Anchor fixation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Intravenous Interferon During Liver Transplant
Condition: Hepatitis C; Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Fibrosis
Study type: Interventional

Summary: 
      The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in
      hepatitis C positive patients undergoing liver transplantation. The hypothesis is that
      patients who receive ribavirin immediately before transplant and intravenous interferon alfa
      2b during the anhepatic phase(while the liver is removed)will have sustained virologic
      response post liver transplant.
    

Detailed description: 
      The study is evaluating intravenous interferon given during the anhepatic phase of lvier
      transplant. Ribavirin was given as well. Serial measurements for HCV RNA were determined 12,
      24 72, 96 hrs and 4 weeks after liver transplant.
    

Intervention name(s): IV interferon
Intervention type(s): Drug
Intervention description(s): IV interferon 5MU during anhepatic phase
Intervention MeSH terms: Interferons
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cirrhosis; hepatitis C