bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients
Condition: End Stage Renal Disease (ESRD)
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H
      and to compare its performance characteristics and hemocompatibility with those of the
      commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe.

      10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood
      samples for several parameters will be collected during hemodialysis to assess the
      performance and hemocompatibility of the dialyzers under study. Data thus collected will be
      analyzed for comparison by standard statistical analysis.
    

Detailed description: 
      Current patients receiving dialysis treatment for end stage renal disease and who meet the
      inclusion/exclusion criteria will be entered into the study. These patients will continue on
      their standard dialysis regimen as stated in the clinics Standard Operating Procedures. Each
      patient will be studied for three weeks with each week starting with a dialyzer of a
      different manufacture but of comparable characteristics. Solute clearances and removal will
      be determined at each of the three dialysis sessions during the week. During session 2 of
      each week additional specimens will be taken to analyze for hemocompatibility. At the end of
      the study all clearances and the hemocompatibility markers for each dialyzer will be compared
      to one another as well as to the manufactures stated characteristics. Blood for the clearance
      and removal calculations will be taken at time 0, 60 minutes and 240 minutes. Blood for the
      hemocompatibility determinations will be taken at time 0, 15, 30, 60 and 240 minutes. Flow
      rates, anticoagulant therapy, erythropoietin therapy, venous and arterial pressures will also
      be recorded.
    

Intervention name(s): ELISIO-15H; Revaclear; Optiflux
Intervention type(s): Device; Device; Device
Intervention description(s): Each patient to undergo 3 successive hemodialysis/week with this dialyzer.; Each patient to undergo 3 successive hemodialysis/week with this dialyzer.; Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
Other intervention name(s): dialyzer; Dialyzer; Dialyzer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Gender-related Differences in Chinese Patients With AAD
Condition: Aneurysm Dissecting
MeSH terms: Aneurysm
Study type: Observational

Summary: 
      Few data exist on gender-related differences in clinical features, management, and outcomes
      of acute aortic dissection (AAD) in China. Accordingly, we enrolled 2015 patients with AAD
      from 15 hospitals in China to access differences in clinical features, management and
      outcomes between men and women. in this study, our results provided new insights into
      gender-related differences in clinical features, management and outcomes in the Chinese
      patients with AAD. Important implications may be helpful to improve diagnostic and
      therapeutic outcomes.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Chinese pupolation and foreign citizen of Chinese origin from 15 major hospitals in China
      
Keywords: aortic dissection; Chinese patients; gender differences
Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer
Condition: Extragonadal Germ Cell Tumor; Ovarian Cancer; Testicular Germ Cell Tumor; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation
      may help the body kill more tumor cells.

      PURPOSE: Phase II trial to study the effects of high doses of carboplatin, etoposide, and
      cyclophosphamide followed by autologous bone marrow transplantation in patients with relapsed
      or refractory germ cell cancer and other chemotherapy-sensitive solid tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Investigate the response rate, duration of response, survival, time to marrow
           reconstitution, and toxicity of two successive cycles of high dose carboplatin,
           etoposide, and cyclophosphamide chemotherapy and ABMT in patients with relapsed and
           refractory germ cell cancer or other chemotherapy-sensitive solid tumors.

        -  Further define the pretransplant characteristics of patients and their disease that
           might influence the outcome of this therapy.

      OUTLINE: Patients receive carboplatin and etoposide for 5 days and cyclophosphamide for 2
      days prior to ABMT.

      At day 60 following ABMT, if the patient has a complete response (CR) or partial response
      (PR) and nonhematologic toxicity is no greater than grade 2, a second ABMT course is given
      when hematologic parameters and other criteria are acceptable. If there is no CR or PR and/or
      nonhematologic toxicity exceeds grade 2, a second ABMT is not given.

      After ABMT patients are followed until disease progression or death.

      PROJECTED ACCRUAL: Ten patients will be accrued for this pilot study.
    

Intervention name(s): carboplatin; cyclophosphamide; etoposide; autologous bone marrow transplantation
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Etoposide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III malignant testicular germ cell tumor; recurrent malignant testicular germ cell tumor; unspecified adult solid tumor, protocol specific; stage III ovarian germ cell tumor; stage IV ovarian germ cell tumor; recurrent ovarian germ cell tumor; extragonadal germ cell tumor
Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum
Condition: Sun-induced Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      this study was proposed to provide more scientific and objective data on the clinical and
      aesthetic effects of these two toxins (Dysport and Xeomin).
    

Detailed description: 
      Subjects will perform 6 (six) visits during the study:

      Screening visit, performed 30 to 1 day before the visit 1, when eligible subjects will be
      recruited and first evaluations will be performed; visit 1, which is the baseline and when
      the injections will be performed; visit 2, 30 +/- 3 days after the injections, when
      evaluations will be performed; visit 3, 90 +/- 3 days after the injections, when evaluations
      will be performed; 4, 120 +/- 3 days after the injections, when evaluations will be
      performed; visit 5, 150 +/- 3 days after the injections, when evaluations will be performed.

      Assessment of percentage (%) of responders, after 5 months of injection, to the effects of
      two BT-A preparations, Dysport® and Xeomin®, by measuring frontalis m. wrinkle intensity at
      maximum contraction, as measured by visual Wrinkles Severity Scale (WSS).
    

Intervention name(s): Dysport; Xeomin
Intervention type(s): Drug; Drug
Intervention description(s): Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.; Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead
Other intervention name(s): botulinum toxin type A; botulinum toxin type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: botulinum toxin,; wrinkles
Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
Condition: Primary Immune Deficiency Disorders (PIDD)
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if NABI-IGIV (10%) [Immune Globulin Intravenous
      (Human), 10%] is safe and effective in preventing serious bacterial infections (SBIs) in the
      treatment of patients with primary immune deficiency disorders (PIDD) when compared to
      historical control data.
    


Intervention name(s): Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Intervention type(s): Biological
Intervention description(s): Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] is a clear or slightly opalescent, colorless to pale yellow sterile solution of 10% protein concentration of immunoglobulin G (100mg/mL). It is packaged as 5g in 50mL solution and 10g in 100mL solution. Dosing will be 300-800 mg/kg based on subject's prior dosing history. Infusions will be every 3 or 4 weeks.
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunodeficiency; humoral immunity; antibody deficiency; PID; PIDD
Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
Condition: Obesity
MeSH terms: Hyperphagia
Study type: Interventional

Summary: 
      There is a need for effective weight control methods for obese children. Environmental
      strategies such as reducing the size of dishware and serving utensils, storing food out of
      view and reducing food consumption while watching television may reduce food intake without
      requiring conscious, cognitive self-control. The investigators propose to test these methods
      when added to a current state-of-the-art behavioral program.
    

Detailed description: 
      Single blind study with outcome assessors (data collectors)and investigators masked (blinded)
      to intervention assignment. Analysis is intention-to-treat.
    

Intervention name(s): Standard Packard Pediatric Weight Control Program; Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six-month, family-based, group, behavioral weight control program; Six-month, family-based, group, behavioral weight control program plus Home-based Environmental strategies intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)
Condition: Osteoporosis; Bone Loss; Spinal Cord Injury
MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Individuals with spinal cord injury sustain significant loss of bone mass in their lower
      extremities (20-40% or more). This study evaluates the ability of PTH and weight-bearing, two
      interventions that build bone, to increase bone mass in this population.
    

Detailed description: 
      This pilot project aims to evaluate PTH with weight-bearing in a group of individuals with
      chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 12
      people with SCI will be enrolled into a 6 month study assessing the effects of a
      weight-bearing regime plus daily PTH (Forteo 20ug sc) on BMD and bone markers. Subjects will
      be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as
      well as bone markers of formation and resorption. An optional extension to 12 months will be
      offered to all subjects.
    

Intervention name(s): teriparatide; weight-bearing
Intervention type(s): Drug; Other
Intervention description(s): teriparatide 20ug daily sc for 6 months; device assisted walking
Other intervention name(s): Forteo; exercise
Intervention MeSH terms: Teriparatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial Comparing Best Supportive Care to Aloe Vera Gel
Condition: Radiation Dermatitis
MeSH terms: Dermatitis; Radiodermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Radiation therapy (RT) has been a component of breast cancer treatment for almost 100 years.
      Although initially used for the treatment of chest wall recurrences after mastectomy and for
      advanced inoperable disease, RT has evolved into a critical component of early therapy for
      women with an intact breast following lumpectomy and for mastectomized women who are at high
      risk for local failure. Currently breast cancer patients need a multidisciplinary management
      including surgery, chemotherapy and radiotherapy, radiotherapy has a significant role in loco
      regional control of the disease. It is estimated that 87% of these women will develop some
      degree of radiation-induced dermatitis, varying from mild to brisk erythema or even moist
      desquamation.

      Topical agents, such as corticosteroid creams and other products including Aquaphor
      (Beirsdorf Inc, Wilton, CT), and trolamine (Biafine; Genmedix Ltd, France), are commonly
      prescribed at the onset of radiation dermatitis or, in some institutions, at the beginning of
      radiotherapy.

      The aim of this randomized phase III study was to assess the effectiveness of aloe vera cream
      for the prevention of acute radiation-induced dermatitis of grade 2 or higher during
      postoperative radiotherapy for breast cancer, compared to best supportive care. The secondary
      objectives were to assess pain, treatment interruption as a result of skin reactions, and the
      quantity of life during the treatment.
    


Intervention name(s): Aloe vera gel
Intervention type(s): Drug
Intervention description(s): The aloe vera gel which was commercially available, contained water, aloe vera, D-panthenol, triethanolamine, carbomer 934P, hyaluronic acid, potassium sorbate, diazolidinyl urea, methylparaben, and propylparaben.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Radiation dermatitis; best supportive care; Aloe vera gel; phase III study was to assess the effectiveness of aloe vera and vitamin E.
Meniscal Lesions in Return to Sport After Anterior Cruciate Ligament Reconstruction
Condition: ACL Injury; Meniscus Lesion; Sport Injury
MeSH terms: Wounds and Injuries; Athletic Injuries; Anterior Cruciate Ligament Injuries
Study type: Observational

Summary: 
      Most athletes who undergo Anterior Cruciate Ligament Reconstruction (ACLR) plan to return to
      some level of sporting (RTS) activity. However, rates of return to pre-injury sport are often
      less than might be expected and many factors influence whether individuals return to sport
      after this surgery. This study aims to better understand the role of meniscal lesions in RTS
      and to assess the advantage of the integrated evaluation with clinical, biomechanical and
      psychological tests to decide the correct RTS timing in non-professional athletes undergoing
      ACLR.
    

Detailed description: 
      Twenty non-professional athletes with acute ACL injury were recruited in the Orthopaedic and
      Trauma Unit of University Hospital of Bari. All the patients underwent an all-inside
      semitendinosus (ST) tendon autograft ACLR with Arthrex TightRope cortical fixation.

      The clinical outcomes (modified Cincinnati Rating System Questionnaire (mCRSQ), Tegner
      Activity Level Score (TALS), Tegner Lysholm Knee Scoring Scale (TLKSS)), the self-reported
      psychological scores (Tampa Scale of Kinesiophobia (TSK) and the ACL Return to Sport after
      Injury (ACL-RSI) score) and biomechanical outcomes (stability, jump, coordination and fatigue
      tests) were assessed postoperatively at 18 months.
    

Intervention name(s): Clinical, self-reported psychological and biomechanical assessments
Intervention type(s): Other
Intervention description(s): medical check up
active and passive Range Of Motion (ROM)
anterior drawer test
knee's alignment
modified cincinnati rating system questionnaire (mCRSQ)
tegner lysholm knee scoring scale (TLKS)
Tegner Activity Level Score (TALS)
self-reported psychological questionnaires
Tampa Scale of Kinesiophobia (TSK)
ACL Return to Sport after Injury (ACL-RSI) score
biomechanical tests
Stability test: to balance on one/two legs on a free to move disc for 30s
Jump test: i) a maximize jump with both legs; ii) a maximize jump with only one leg; three consecutive jumps; iv) jump coordination path where the patient had to perform a forward-backward-forward jump and a sideway jump on one leg
Coordination test: a square hurdle was used for the quick test, where the patient had to step in and out with both feet for a total of 15-rep as quickly as possible
fatigue test: to rise and sit from a chair for 30-rep as quickly and safely as possible
Other intervention name(s): CLIMB Battery
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All the patients has been enrolled according to the eligible criteria in Orthopaedic and
        Trauma Unit of University Hospital of Bari
      
Keywords: Return to Sport; ACL reconstruction; Knee; Athletes
Immune Modulation From Trichuris Suis
Condition: Crohn Disease; Ulcerative Colitis; Intestinal Helminthiasis
MeSH terms: Helminthiasis; Crohn Disease
Study type: Observational

Summary: 
      Mucosal immunology during helminth infection
    

Detailed description: 
      The present study investigates the effects of Trichuris suis on human mucosal and systemic
      immunity in a single self-infected individual.
    

Intervention name(s): Trichuris suis eggs
Intervention type(s): Biological
Intervention description(s): Live eggs from swine whipworm, Trichuris suis
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A single healthy volunteer
      
Biospecimen description: 
      Blood cell and intestinal biopsies
Hypofractionated IMRT With Temozolomide for HGG
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional

Summary: 
      To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy,
      concomitant and adjuvant, in patients with newly diagnosed HGGs after surgery.

      Primary endpoint: progression free survival (PFS), Overall Survival (OS) and Toxicity.

      Secondary endpoint: to evaluate Quality of life (QoL) of patients after surgery, concomitant
      chemoradiotherapy and adjuvant chemotherapy through neuropsychological examination.
    

Detailed description: 
      We designed a study of a hypofractionated intensity modulated radiation therapy (IMRT), using
      VMAT RapidArc approach. The potential advantage of this approach is to deliver a more
      selective irradiation to tumor's target with reducing dose to normal brain and to allow to
      deliver a higher dose, optimizing the therapeutic window
    

Intervention name(s): Hypofractionated IMRT
Intervention type(s): Radiation
Intervention description(s): Hypofractionated IMRT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of a Vaccine Against Enterotoxigenic Escherichia Coli (ETEC) to Prevent Moderate to Severe Diarrhea
Condition: Diarrhea
MeSH terms: Escherichia coli Infections; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study about an experimental (investigational) vaccine called ACE527.
      ACE527 is a vaccine that is being made to prevent disease from a germ called enterotoxigenic
      Escherichia coli (ETEC). This germ causes diarrhea, largely in children living in developing
      countries and in travelers to those countries. One purpose of this study is to see if the
      vaccine is safe and develops an immune response. Another purpose is to see if it prevents
      people from getting sick when exposed to the ETEC germ. This ETEC germ is also experimental
      (investigational).
    

Detailed description: 
      This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge
      study designed to assess the protective efficacy of the ACE 527 vaccine, as well as collect
      expanded safety and immunogenicity data. The study will be carried out in two phases. In the
      initial vaccination phase, up to 72 subjects will be randomized 1:1 to receive either ACE527
      or placebo on an outpatient basis. Vaccine and placebo preparations will be given orally.
      Following vaccination, subjects will be followed as out-patients for safety using diary card
      surveillance, for vaccine shedding by qualitative stool culture (i.e. presence or absence)
      and for the development of local and systemic antibody responses to the ACE527 vaccine
      strains. In the subsequent inpatient challenge phase, up to 56 vaccinated subjects will be
      admitted as inpatients and challenged with the ETEC strain, H10407. The challenge dose will
      be administered orally.After challenge, subjects will be monitored for diarrhea and other
      signs/symptoms of enteric illness by daily medical checks, vital sign determinations, grading
      and weighing of all stools. Monitoring for fecal shedding of the challenge ETEC strain H10407
      will occur daily, after challenge, while in-patient. Local and systemic antibody responses to
      the challenge ETEC strain H10407 will also be assessed. All subjects will be treated with
      Abx.
    

Intervention name(s): ACE527; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): ACE527 comprises a mixture of three live, attenuated ETEC strains; ACAM2025 (CFA/I+ and LTB+), ACAM2022 (CS5+, CS6+ and LTB+), and ACAM2027 (CS1+, CS2+, CS3+ and LTB+). The vaccine is administered orally as a two-dose regimen, at 9x1010 cfu, on Days 0 and 21, in 200 ml CeraVacx buffer. The required volume of each vaccine strain, supplied as a frozen suspension, is mixed into the buffer solution prior to dosing.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vaccination; Challenge; Diarrhea; ETEC illness; Travelers diarrhea; ETEC; Enterotoxigenic E.coli