bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Condition: Immune Thrombocytopenic Purpura (ITP)
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR
      (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic
      idiopathic thrombocytopenic purpura.
    


Intervention name(s): Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution
Intervention type(s): Drug
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic idiopathic thrombocytopenic purpura
Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease
Condition: Chronic Renal Failure; Polycystic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Polycystic Kidney Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs)
      therapy in chronic renal failure due to autosomal dominant polycystic kidney disease (ADPKD).
    

Detailed description: 
      The investigators will assess the 18-month safety and potential efficacy of autologous MSCs
      as therapy for ADPKD. A total of 6 patients with ADPKD IV injection of high doses 2×106 of
      autologous mesenchymal stem cells / kg their weight, which will be derived from biopsies of
      their bone marrow. Assessments will be made at 1, 3, 6, 12 and 18 months after cell
      injection. Changes in GFR rate were evaluated by scan isotope.
    

Intervention name(s): Intravenous injection autologous mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Intravenous injection of mesenchymal stem cell in patients with PKD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous mesenchymal stem cells; polycystic kidney disease; intravenous injection; CRF
Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Observational

Summary: 
      Work requirements for medical trainees result in substantial sleep loss. Sleep loss has been
      associated with increased levels of certain inflammatory hormones that could have negative
      impact on blood vessel function. The purpose of this study is to determine the effects of
      sleep loss on blood hormone levels and blood vessel function in medical trainees.
    

Detailed description: 
      Context: Sleep loss is associated with increased blood levels of interleukin-6 (IL-6) and
      C-reactive protein (CRP). Medical residents are often deprived of normal sleep during
      extended work shifts, but the effects of work-related sleep loss on biomarkers of vascular
      inflammation and function are unknown.

      Objective: We sought to test the hypothesis that sleep loss during extended work shifts
      during medical training is associated with increased circulating levels of pro-inflammatory
      biomarkers and evidence of vascular dysfunction.

      Design: Outcome measures were assessed after extended 30-hour work shifts and non-extended
      6-hour work shifts in a single-blind, randomized crossover design.

      Setting: University hospital medical intensive care unit

      Patients or Other Participants: Twenty-two healthy medical residents were studied during a
      medical intensive care unit rotation.

      Main Outcome Measure(s): Sleep related cytokines (interleukin-6 and tumor necrosis factor),
      serum markers of vascular inflammation (C-reactive protein), and flow-mediated dilation in
      the brachial artery.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: Inflammation Mediators [D23.469]; Cardiovascular Physiologic Phenomena [G09.330.553]
Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones
Condition: Endourology
MeSH terms: Ureteral Calculi; Ureterolithiasis
Study type: Interventional

Summary: 
      a prospective comparative study designed to compare the outcomes of transperitoneal
      Laparoscopic ureterolithotomy (T-LUL), mini-percutaneous antegrade ureteroscopy (A-URS) and
      retrograde ureteroscopy (R-URS) in treating patients with LPUS (15-20 mm). the following
      parameters were assessed and compared (demographic data and stones characteristics, Stone
      free rate and complications)
    

Detailed description: 
      we aimed in the current study to comprehensively evaluate and to compare the outcome of
      transperitoneal laparoscopic ureterolithtomy, retrograde ureteroscopy and mini-percutaneous
      antegrade ureteroscopy for management of large proximal ureteric stone (15 -20 mm) with
      regards to; operative time, stone free rate, success rate, hospital stay and complications.

      A total of 105 participants were enrolled in the trial between April 2021 and June 2023 to
      accomplish this. Inclusion criteria for this study included patients who had a single
      proximal Ureteral stone (between the pelvi ureteric junction and the upper border of the
      sacroiliac joint) measuring 15-20 mm in diameter.

      Patients were randomly allocated to receive either TPLU, RURS, or Minin-perc Antegrade URS,
      with a 1:1:1 allocation ratio. After providing informed permission, the patients were
      randomly assigned to one of three groups: Group I (35 patients treated with TPLU), Group II
      (35 patients treated with RURS), and Group III (35 patients not treated with either TPLU or
      RURS) (Included 35 patients who were treated by Mini-perc Antegrade URS)
    

Intervention name(s): transperitoneal laparoscopic ureterolithotomy (T-LUL)/ retrograde flexible ureteroscopy (R-URS) /Antegrade mini-percutaneous flexible ureteroscopy (A-URS)
Intervention type(s): Procedure
Intervention description(s): extraction or fragmentation of large proximal ureteral stones via different minimally invasive procedures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Expansion of a Dengue-1 Live Virus Human Challenge
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to
      develop an appropriate challenge model. This study supports the expansion of the data set of
      the current Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) model to produce uncomplicated
      dengue-like illness.
    

Detailed description: 
      This is an expansion of a previous study conducted under NCT02372175. In this study up to
      nine healthy subjects between 18 and 45 years old will be inoculated with Dengue 1 Live Virus
      Human Challenge (DENV-1-LVHC) at a dose used in the previous study. Subjects will be closely
      monitored for the first 28 days with continued follow up through 6 months. Clinical and
      laboratory parameters, viremia and antibody levels will be assess. The goal is to expand the
      data set of symptoms produced by uncomplicated dengue-like illness.
    

Intervention name(s): Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)
Intervention type(s): Biological
Intervention description(s): Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dengue; Flavivirus Infections; Virus Diseases
Generic vs. Name-Brand Levothyroxine
Condition: Congenital Hypothyroidism; Hypothyroidism
MeSH terms: Congenital Hypothyroidism; Hypothyroidism
Study type: Interventional

Summary: 
      This study compares two different brands of thyroxine (thyroid hormone). Currently,
      pharmacists may be substituting generic formulations of thyroid hormone without your doctor
      knowing about this. Although a small difference in thyroid function is not significant in
      most healthy children, adolescents and adults, in infants and toddlers even a small
      difference in thyroid function can have important harmful consequences on brain development.
      The purpose of the present study is to learn whether the difference between brands of thyroid
      hormone that are currently being substituted is sufficient to cause a difference in thyroid
      function.
    

Detailed description: 
      This study is an unblinded, randomized controlled cross-over study, which involves taking 2
      different forms of levothyroxine sequentially over a 16 week period. Subjects will have a
      total of 3 visits over this time period. At the first visit, subjects are randomized to
      receive either generic (Sandoz) levothyroxine or Synthroid (Abbott) brand of levothyroxine.
      Blood is drawn for baseline thyroid function studies and other markers which are influenced
      by thyroid hormone at each visit. The second visit is the cross-over visit, and the final
      visit is a close-out visit, after which each subject will resume taking their previous
      formulation of levothyroxine.
    

Intervention name(s): Brand Name Levothyroxine (Synthroid); Generic formulation of Levothyroxine
Intervention type(s): Drug; Drug
Intervention description(s): Randomized crossover study using 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott), then 8 weeks of the generic formulation of levothyroxine (manufactured by Sandoz). The dose of medication does not change throughout the duration of the study.; Randomized crossover study using 8 weeks of the generic formulation of levothyroxine (manufactured by Abbott, then 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott). The dose of medication does not change throughout the duration of the study.
Other intervention name(s): Levothyroxine; No other names
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Indoxyl Sulfate Have a Role in Uremic Pruritus?
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      Itching is a widespread and disturbing complain from patients with chronic kidney disease
      (CKD); epidemiologic data have suggested that approximately 40% of patients with end-stage
      renal disease experience moderate to severe itching. The pathogenesis of renal pruritus is
      multifactorial. Triggering factors may include uremia-related abnormalities, accumulation of
      uremic toxins, systemic inflammation and cutaneous xerosis. Indoxyl sulfate (IS) is a
      protein-bound uremic toxin resulting from the metabolism of dietary tryptophan accumulating
      in patients with end-stage renal disease.
    

Detailed description: 
      Patients with end-stage renal disease undergoing hemodialysis complaining of itching not
      related to other cause than renal failure will take activated charcoal with foods and serum
      level of indoxyl sulphate will be studied
    

Intervention name(s): Uremic pateints with itching
Intervention type(s): Dietary Supplement
Intervention description(s): Activated charcoal
Intervention model: Single Group Assignment
Intervention model description: Patients will take activated charcoal for two months
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Depression Following Multiple Brain Tests
Condition: Major Depression; Dysthymia
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to correlate brain testing with treatment outcome.
    

Detailed description: 
      40 medication-free Depressed Patients will receive a battery of neuropsychologic tests,
      standard dichotic listening tests, EEG, ERP and an f-MRI while performing a neuropsychologic
      test, the Simon. Once testing is completed, patients will be treated in an open treatment
      trial of SSRI. Non-responders will then receive Bupropion followed by Tricyclic
      Antidepressant if still depressed. While our main purpose is to correlate imaging testing
      with other measures of brain functioning, we also intend to see whether f-MRI findings
      demonstrate specific brain areas which differ between responders and non-responders. At the
      end of SSRI treatment, patients will have a second f-MRI scan to investigate any changes
      treatment and/or response may have caused.
    

Intervention name(s): Escitalopram; Bupropion; Imipramine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 8 weeks: up to 40 mg/day; 8 weeks: up to 450 mg/day (for patients without history of seizures or risk for developing seizures.; 8 weeks: up to 300mg/day
*if patient does not have contraindication.
Other intervention name(s): Lexapro; Wellbutrin; Tofranil, Pressamine
Intervention MeSH terms: Bupropion; Imipramine; Escitalopram
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depression; Dysthymia; f-MRI; Escitalopram; Bupropion; Imipramine; Neuropsychologic test; Dichotic listening; EEG; ERP
A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
Condition: Malignant Salivary Gland Tumors
MeSH terms: Salivary Gland Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized Phase II study of Adjuvant Concurrent Radiation and Chemotherapy versus
      Radiation alone in Resected High-Risk Malignant Salivary Gland Tumors
    


Intervention name(s): Cisplatin: 40 mg/m2 weekly during radiation; Radiation: 60-66 Gy in 2 Gy daily fractions
Intervention type(s): Drug; Radiation
Intervention description(s): Cisplatin: 40 mg/m2 weekly during radiation for 7 doses; Radiation: 60-66 Gy in 2 Gy daily fractions
Intervention MeSH terms: Cisplatin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Virtual Reality Exercises on Balance in Children With Brain Tumors
Condition: Postural Balance
MeSH terms: Brain Neoplasms
Study type: Interventional

Summary: 
      30 patients with brain tumor will be included in the study between the ages of 6 and 18 who
      have undergone surgery. Patients included in the study will be randomly assigned to two
      groups. The study group will be included in the Nintendo Wii Fit Plus Balance Game exercise
      program under the supervision of a physiotherapist for 2 days per week for 8 weeks. The
      control group will be taken to the conventional exercise program under the supervision of a
      physiotherapist for 2 days a week, 1 hour a day. The assessments will be made before the
      exercise program begins and at the end of the 8th week. Patients' physical measurements were
      assessed by anthropometric evaluations, muscle strength measurement, pain Visual Analogue
      Scale, walking Observational Walking Analysis, Balanced Pediatric Functional Range Test,
      Timed Up and Go (TUG) and one foot standing test and Nintendo Wii Fit Plus Balance
      Assessment, Functional capacity 2 min. With Walking Test, fatigue with PedsQL
      Multidimensional Fatigue Scale, daily life activities will be evaluated with WeeFIM.
    

Detailed description: 
      In our pediatric rehabilitation policlinic we have seen that these children has problems in
      balance and coordination from cause muscle weakness and cerebral-sensory-proprioceptive
      problems. We have evaluated with all parameters belong the physiotherapy and rehabilitation
      measurements and then planning this study with study protocol.
    

Intervention name(s): exercises
Intervention type(s): Other
Intervention description(s): exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: balance; brain tumor; virtual reality
Antineoplaston Therapy in Treating Children With Primitive Neuroectodermal Tumors
Condition: Childhood CNS Primitive Neuroectodermal Tumor
MeSH terms: Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for children with primitive neuroectodermal tumors that have not
      responded to standard therapy provide very limited benefit to the patient. The anti-cancer
      properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of
      children with primitive neuroectodermal tumors that have not responded to standard therapy.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on children (> 6 months of age) with primitive neuroectodermal
      tumors that has not responded to standard therapy.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in children with primitive
           neuroectodermal tumors that has not responded to standard therapy, as measured by an
           objective response to therapy (complete response, partial response or stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in children with a brain
           tumor.

      OVERVIEW: This is a single arm, open-label study in which children with primitive
      neuroectodermal tumors that have not responded to standard therapy receive gradually
      escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the
      maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence
      of disease progression or unacceptable toxicity. After 12 months, patients with a complete or
      partial response or with stable disease may continue treatment.

      To determine objective response, tumor size is measured utilizing MRI scans, which are
      performed every 8 weeks for the first two years, every 3 months for the third and fourth
      years, every 6 months for the 5th and sixth years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent primitive neuroectodermal tumor
The Prevention of Thromboembolic Complications Associated With Coil Embolization
Condition: Thromboembolic Stroke; Aspirin; Clopidogrel; Coil Embolization; Prevention
Study type: Observational

Summary: 
      Clopidogrel has been to be reported to be superior to aspirin for the prevention of
      thromboembolic complications associated with coil embolization in patients with ruptured
      aneurysms.
    


Intervention name(s): Aspir-Low Pill
Intervention type(s): Drug
Intervention description(s): patients were prescribed 75 mg/day of either aspirin
Intervention MeSH terms: Aspirin
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with ruptured cerebral hemorrhage
Effects of Whole Grain on Weight Maintenance
Condition: Abdominal Fat; Body Weight
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      Epidemiological studies suggest that whole grain consumption affects measures of obesity
      including BMI, body fat tissue, and body weight. Most cross-sectional studies demonstrate
      rather consistently an inverse association between BMI and whole grain consumption.
      Furthermore, prospective cohort studies suggest that people with high whole grain consumption
      have less risk for body weight gain compared with low whole grain consumption.

      The purpose of this study is to assess the effects of inclusion of whole grain in the diet on
      anthropometric measures, particularly abdominal fat regain after a weight loss diet.

      It is anticipated that the short-term regain of abdominal fat after a weight loss diet is
      lower in volunteers consuming whole grain than in volunteers consuming refined grain.
    


Intervention name(s): Diet rich in whole grain; Refined grain
Intervention type(s): Other; Other
Intervention description(s): Ready-to-eat breakfast cereals and other cereal products, rich in whole grain; Ready-to-eat breakfast cereals and other cereal products, low in whole grain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: weight maintenance