bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant
Condition: Myeloma Multiple; Lymphoma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant
      using generic pegfilgrastim vs brand-name pegfilgrastim.
    

Detailed description: 
      Thirty consecutive adults with lymphoma or myeloma receiving autologous peripheral blood stem
      cell transplant will be included in this phase 2 clinical trial. Patients will be allocated
      1:1 in two groups: one subcutaneous 6 mg dose of generic pegfilgrastim (control group) or one
      6mg dose of brand-name pegfilgrastim (intervention group) both at day +1 after the
      autotransplant. Daily complete blood counts were collected and time to neutrophil
      (>0.5x10^3/microL) and platelet recovery (>20x10^3/microL) will be obtained. The
      investigators will describe the proportion of adverse events and median time to neutrophil
      and platelet recoveries. Median or mean time to neutrophil recovery and time to platelet
      recovery will be calculated and compared with Mann-Whitney-Wilcoxon test or student T.
    

Intervention name(s): Pegfilgrastim
Intervention type(s): Drug
Intervention description(s): Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
Other intervention name(s): Neulasta; Linkix
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Autotransplant; Neutrophil recovery; Pegfilgrastim
The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study
Condition: Vaccination
Study type: Observational

Summary: 
      The purpose of this study is to determine if women would find it acceptable to receive the
      HPV vaccine postpartum at the pediatrician's office at the time of their child's two-month
      well- child visit when offered during the third trimester of pregnancy.
    

Detailed description: 
      There are a large number of young adult women who have not received any doses of HPV vaccine
      or are incompletely vaccinated. Recommendation for HPV vaccine could occur during pregnancy
      with the administration of the vaccine postpartum. Finding a way to make it easy for women to
      present for vaccination is imperative as this is currently a 3-vaccine series. The
      investigators are interested in understanding if women would find it acceptable if the
      investigators discussed and encouraged the vaccine while pregnant with receipt of the vaccine
      through their child's pediatrician at well-child visits in the postpartum period. The
      investigators will survey women in the third trimester of pregnancy to determine if they
      would find this acceptable and follow-up with them after their child's two month pediatric
      visit to reevaluate their opinion. No doses of the vaccine will be given.

      The investigators are also interested in understanding other factors that could affect
      whether or not women would be interested in receiving the HPV vaccine postpartum. This
      includes rates of attendance at postpartum visits as well as behavioral, knowledge and
      demographic characteristics that may be associated with acceptability of receiving the
      vaccine.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women will be recruited from the hospital based UNC Obstetric and Gynecology (UOG) Clinic
        including the resident clinic, faculty clinics and maternal fetal medicine clinics. The UOG
        Clinic cares for a diverse population of women from the immediate geographical area as well
        as referrals from 14 surrounding funded health centers.
      
Keywords: Human Papillomavirus; HPV; Postpartum
Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region
Condition: Lax Skin
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects
      undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue
      in the neck and submental region.
    

Detailed description: 
      This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects
      undergoing a procedure to improve the appearance of lax tissue in the neck and submental
      region. All study subjects will be treated with the Renuvion APR Device.

      Phase I (n=17) of this study will be conducted primarily to provide safety data, however,
      effectiveness data will also be collected at the above stated timepoints through 6 months
      post-procedure.

      Phase II (n=65) of this study is the expansion of the study to a pivotal study.
    

Intervention name(s): Renuvion APR Device
Intervention type(s): Device
Intervention description(s): The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Submental, Neck
Overlapping Neural Circuits in Pediatric OCD
Condition: Obsessive Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to examine the brain functioning of children and adolescent with
      OCD before and after treatment with Exposure and Response Prevention (EXRP) therapy.
    

Detailed description: 
      The capacity to coordinate thoughts and actions to execute goal-directed behaviors (cognitive
      control) and the capacity to anticipate, respond to, and learn from reward (reward
      processing) are key processes for human behavior. Dysfunction in these processes has been
      hypothesized to contribute to repetitive thoughts and behaviors in many disorders, including
      obsessive-compulsive disorder (OCD), Tourette Syndrome (TS), and eating disorders. The
      investigators will use multimodal imaging to investigate neural circuits that support
      cognitive control and reward processing, using pediatric OCD as a model system. The
      short-term goal is to clarify how circuit-based abnormalities contribute to repetitive
      thoughts/behaviors; these data will inform future trans-diagnostic studies. The long-term
      goal is to identify control and reward circuit-abnormalities as targets for new
      trans-diagnostic treatments.
    

Intervention name(s): CBT treatment for OCD based on Exposure & Response Prevention (EX/RP) and when indicated medication treatment
Intervention type(s): Behavioral
Intervention description(s): CBT treatment consisted of 12-16 hour-long sessions. For exceptional cases not showing clinical improvement after six CBT treatment sessions, complementary pharmacological treatment (SSRI) was offered as part of our treatment protocol. CBT for OCD involves gradually exposing patients to anxiety provoking stimuli while having patients refrain from engaging in compulsive rituals and/or avoidance behaviors. There are three major components of CBT treatment for OCD, specifically: (1) exposure to anxiety provoking stimuli, (2) response prevention, and (3) cognitive techniques intended to decrease anxiety during the exposure and response prevention processes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: OCD; Functional Magnetic Resonance Imaging (fMRI); Magnetic Resonance Imaging (MRI)
DxH520 Pediatric Reference Interval Verification
Condition: Healthy Subjects
Study type: Observational

Summary: 
      Results from this study will be used to verify that the published pediatric reference
      intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.
    

Detailed description: 
      Pediatric specimens from each age range will be tested from apparently healthy children. Ten
      male and Ten female are required for each age range. The values will be assessed against
      published reference ranges to verify that the values obtained fall within the expected
      reference interval for the age ranges listed below:

        1. Neonate: 0 to 30 days

        2. Infant: > 30 days to 2 years

        3. Child: 3 years to 12 years

        4. Adolescent: 13 years to 21 years
    

Intervention name(s): CBC/Diff Reference Interval
Intervention type(s): Diagnostic Test
Intervention description(s): Results will not be used to manage patients
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pediatric specimens from apparently healthy children
Study of Granisetron Hydrochloride Nasal Spray (GNS) in Healthy Volunteers
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the pharmacokinetics (PK), safety and tolerability of
      3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays (GNS)
      as compared to Granisetron IV Injection and Granisetron Tablet in healthy Volunteers.
    


Intervention name(s): GNS Spray 0.5mg; GNS Spray 1.0mg; GNS Spray 2.0mg; Kytril 1mg (IV injection); Kytril 1mg (Tablet)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Granisetron Nasal Spray; Granisetron Nasal Spray; Granisetron Nasal Spray; Granisetron; Granisetron
Intervention MeSH terms: Granisetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nausea; Vomiting; Chemotherapy; Radiation therapy
Open-label Study to Evaluate the Effect of MBP-80 on Bone Remodelling
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      This study will determine if daily oral intake of 200g of a marketed yogurt with fortified
      calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in
      postmenopausal women. The efficacy of the product is measured by examining the variation of
      biochemical markers of bone turnover. MBP 80 is a particular protein contained in milk; it
      has been added to the yogurt provided for this study. The effects of MBP 80 on the quality of
      bone tissue have not yet been proven.
    

Detailed description: 
      The morbidity and mortality associated with osteoporotic related fractures is devastating in
      terms of disability to an individual and cost to the global economy. As the world's
      population ages, this will present a major public health issue since a larger proportion of
      women remain undiagnosed and untreated even with the availability of therapies and calcium
      and vitamin D supplements. Consequently, it remains important to evaluate dairy products
      (milk, cheese, and yogurt) that can be safely provided as a supplement for bone health in
      addition to the current pharmacological treatments.

      The rationale of this study is to assess the beneficial effect of a daily dietary supplement
      of MBP 80 mg in a yogurt matrix with fortified calcium content on bone remodelling in healthy
      early postmenopausal women with neither osteoporosis nor estrogens/progestin therapy.
    

Intervention name(s): 200 g yogurt with fortified calcium content and MBP 80 mg
Intervention type(s): Dietary Supplement
Intervention description(s): Intake of one container of vanilla or strawberry yogurt in the morning on a daily basis during 12 weeks.
Other intervention name(s): Yoplait Asana TM
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: osteoporosis; postmenopausal women; bone remodelling; bone turnover markers
TEAS-induced Analgesia: Dual vs Single Acupoints
Condition: Postoperative; Acute Pain; Chronic Pain
MeSH terms: Chronic Pain; Acute Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of transcutaneous electric acupoint
      stimulation(TEAS) at single acupoint or dual acupoints on opioid consumption and
      postoperative pain in patients undergoing radical mastectomy
    


Intervention name(s): transcutaneous electric acupoint stimulation; electrode attached but no stimulation
Intervention type(s): Other; Other
Intervention description(s): electrodes are attached o the skin and electric stimulation is given; electrodes are attached o the skin but no stimulation is given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: mastectomy; transcutaneous electrical acupoint stimulation; acute pain; chronic pain
Prevalence of Glaucoma in Belgium: a Multicenter National Trial
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      To screen for the presence of glaucoma in a Belgian population over 40 years old using an AI
      algorithm developed for the detection of glaucoma based on fundus pictures.
    

Detailed description: 
      In this study, we aim to detect individuals with glaucoma and refer them for further
      evaluation and treatment when necessary. In so doing, we want to get an estimation of the
      prevalence of glaucoma in the Belgian population of 40+ years.

      A fundus picture will be acquired without pupil dilation. This examination will be followed
      by an intra-ocular pressure measurement. The results will be discussed with the participating
      subject by the present physician. For each subject, both eyes will be evaluated. In case of
      suspected glaucoma, the subject will be referred to an ophthalmologist for further
      evaluation.
    

Intervention name(s): AI algorithm for the detection of glaucoma
Intervention type(s): Device
Intervention description(s): The investigational device that will be used during this study is an AI algorithm embedded into an API for the detection of glaucoma developed by MONA.health
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Effect of Diet Composition on Liver Fat and Glucose Metabolism
Condition: Fatty Liver
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      This study is designed to determine if the amount of fat and saturated fat in the diet
      contributes to the development of a condition called fatty liver disease in the absence of
      changes in weight.
    

Detailed description: 
      A condition called non-alcoholic steatohepatitis is characterized by fat accumulation in the
      liver and associated inflammation. This condition is strongly associated with obesity,
      insulin resistance and type 2 diabetes. Diets high in saturated fat result in fatty liver,
      insulin resistance and liver injury in animal models. Dietary composition may contribute not
      only to hepatic fat accumulation and insulin resistance but may also promote inflammation
      leading to chronic liver disease in humans. This study will test the hypothesis that a diet
      high in fat and saturated fat contributes to liver fat accumulation, insulin resistance and
      inflammation by comparing the effects of a four-week, weight stable high fat/high saturated
      fat diet (55% calories from fat/25% saturated fat) with a four-week, weight stable low
      fat/low saturated fat diet (20% fat/8% saturated fat) in overweight and obese subjects.
    

Intervention name(s): high fat/high saturated fat diet; low fat/low saturated fat diet
Intervention type(s): Other; Other
Intervention description(s): 4 weeks 55% fat/25% saturated fat isocaloric diet; 4 weeks 20% fat/8% saturated fat isocaloric diet
Other intervention name(s): Diet; Diet
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: fatty liver; insulin resistance; diet; inflammation; oxidative stress
Second Forward View Examination of Proximal Colon on Adenoma Detection Rate
Condition: Colon Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      This clinical trial is being conducted to assess whether second forward view examination of
      proximal colon could increase adenoma detection rate of right colon.
    


Intervention name(s): Second Examination
Intervention type(s): Procedure
Intervention description(s): The colonoscopy is passed to the cecum and then withdrawn to hepatic flexure. Then, the scopy is inserted to the cecum and withdrawn to hepatic flexure again for second foreard view examination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide and filgrastim in
      treating patients with stage IV, relapsed, or refractory low-grade follicular non-Hodgkin's
      lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the feasibility of high-dose cyclophosphamide and filgrastim (G-CSF)
      in patients with stage IV, relapsed, or progressive low-grade follicular non-Hodgkin's
      lymphoma. II. Determine the toxic effects of this regimen in these patients, including those
      with marrow involvement. III. Determine the rates of complete remission (CR) and partial
      remission and time to failure in previously treated and untreated patients. IV. Determine the
      effectiveness of this regimen in eradicating bcl-2 rearrangements, as determined by
      polymerase chain reaction (PCR), in previously untreated patients. V. Correlate the duration
      of CR to PCR results in responding patients.

      OUTLINE: Patients are stratified according to prior treatment (yes vs no). Patients receive
      cyclophosphamide IV over 90 minutes on day 1 and filgrastim (G-CSF) subcutaneously beginning
      on day 3 and continuing until blood counts recover. Treatment continues every 2 weeks for 4
      courses in the absence of disease progression or stable disease. Patients who achieve
      complete remission (CR) after completion of course 4 receive 2 additional courses. Patients
      who achieve partial remission (PR) after completion of course 4 receive 2 additional courses,
      and those who achieve CR after completion of course 6 receive 2 additional courses. Patients
      are followed every 2 months for 6 months, every 6 months for 2 years, and then annually
      thereafter.
    

Intervention name(s): filgrastim; cyclophosphamide
Intervention type(s): Biological; Drug
Intervention MeSH terms: Cyclophosphamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma
Changes of Dendritic Cells in Acute Lung Injury
Condition: Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury; Wounds and Injuries
Study type: Observational

Summary: 
      To observe changes of circulating and tissue dendritic cells in acute lung injury,including
      invasive aspergillosis pneumonia
    

Detailed description: 
      Change of circulating and tissular dendritic cells of patients with acute lung injury was
      still unclear, we used a flow cytometry-based assay to quantify circulating and tissular DCs
      and their HLA-DR surface expression at the time of diagnosis and during the first week of
      evolution in patients with acute lung injury, and healthy people as controls.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Sepsis induced-ALI patients with mechanical ventilation including invasive aspergillosis
      
Keywords: dendritic cell
Progression of Sub-Clinical Atherosclerosis
Condition: Atherosclerosis; Cardiovascular Diseases; Heart Diseases; Carotid Artery Diseases
MeSH terms: Carotid Artery Diseases; Cardiovascular Diseases; Heart Diseases; Atherosclerosis
Study type: Observational

Summary: 
      To determine the rate of progression of sub-clinical cardiovascular disease as measured in
      carotid intimal medial thickness over a period of 8 to 10 years.
    

Detailed description: 
      BACKGROUND:

      Strong associations exist between cardiovascular events and increased carotid artery wall
      intima-media thickness (IMT) as measured non-invasively by carotid ultrasound. Carotid IMT is
      accepted as a surrogate marker of sub-clinical cardiovascular disease.The study will
      determine the rate of progression of sub-clinical cardiovascular disease (change in IMT) over
      a period of 8 to 10 years.

      DESIGN NARRATIVE:

      The study will determine the rate of progression of sub-clinical cardiovascular disease
      (change in intimal medial thickness {IMT}) over a period of 8 to 10 years. Imaging and IMT
      measurements of approximately 2800 to 3000 members of the Framingham Offspring cohort having
      had baseline IMT measurements at their 1995-98 clinic visit will be repeated in 2005-2007.
      The principal aims of the project are to study the primary hypotheses that: 1. Interim
      exposure to traditional cardiovascular risk factors measured over 50 years is positively
      associated with the progression rate of carotid IMT. 2. Baseline carotid IMT and cumulative
      exposure to cardiovascular risk factors 20 years before the baseline visit are a better
      predictor of progression of sub-clinical disease after 8 to 10 years than the interim
      exposure to risk factors. 3. Novel risk factors such as C-reactive protein and homocysteine
      affect progression of carotid atherosclerosis more than traditional risk factors. This study
      will add a phenotypic marker of site-specific change in sub-clinical cardiovascular disease
      to the Framingham Study database. This complements ongoing research on the progression of
      sub-clinical cardiovascular disease and its associations with family history of premature
      cardiovascular events and genomic markers
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community based in Framingham MA