bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Uremic Pruritus With PA101B
Condition: Uremic Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double blind, placebo-controlled, parallel-arm, multi-center, Phase 2,
      proof-of-concept efficacy and safety study in patients with end-stage renal disease requiring
      hemodialysis.

      The purpose of the study is to determine the efficacy and safety profile of PA101B delivered
      via eFlow high efficiency nebulizer in patients with uremic pruritus who are symptomatic
      despite using standard treatments.
    

Detailed description: 
      The symptom score for determining eligibility will be established during the Screening Period
      (up to 4 weeks) and eligible patients will be randomly allocated in a 2:1 ratio between the
      active and placebo arms at the baseline visit (Week 0). During the Treatment Period, clinic
      visits will occur at the end of Weeks 1, 3, 5 and 7. Following completion of the Treatment
      Period, patients will enter a 2-week Washout Period in both treatment arms.

      Routine hemodialysis treatment will continue according to the dialysis unit's standard
      practice in all patients.

      Patients will be allowed to continue to use the same daily doses of pre-randomization H1
      antihistamines as well as the same daily doses of any other allowed medications throughout
      the study.

      Blood samples will be collected for various biomarkers. In a subset of patients, additional
      blood samples will be collected for pharmacokinetic assessments. Clinical safety assessments
      will be performed at each clinic visit.
    

Intervention name(s): PA101B; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg PA101B administered via inhalation twice daily for 7 weeks; Matching placebo administered via inhalation twice daily for 7 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uremic pruritus; Pruritus; Chronic itch; Itch; Hemodialysis; End-stage renal disease
Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.
Condition: Larynx; Oxygen; Intubation
Study type: Observational

Summary: 
      Specific and objective guidelines for choosing endobronchial tube size for main-stem
      intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size
      for OLV are likely to increase the safety and success. The primary aims of this study were to
      define the relationship between cricoid and mainstem bronchi (right and left) in children of
      various ages and to determine the effects of age, height and weight.
    

Detailed description: 
      Understanding the relationship between cricoid and mainstem bronchi can provide to be a
      useful adjunct for lung isolation in children. The relationship between cricoid dimensions
      and the dimensions of main-stem bronchi (right and left) have been studied using 2
      dimensional CT images and video-bronchoscopic images. The present study defines the
      volume-based relationship between the right main-stem bronchus (RMSB), left main-stem
      bronchus (LMSB) and the cricoid ring based on 3 dimensional CT derived images.

      Methods: The three dimensional CT images of 35 children, younger than 8 years, undergoing
      radiological evaluation unrelated to airway symptomatology were examined. The children were
      evaluated during spontaneous ventilation without airway devices either during natural sleep
      or with sedation. The 3-dimensional images of the airway column were evaluated at the level
      of cricoid, right mainstem bronchus and left main-stem bronchus, volumes were calculated and
      comparisons made between these levels. Univariate and multivariate regression analysis was
      used to determine whether one or more of the variables (age, gender, height, weight and
      cricoid) had a predictable relationship to the RMSB and the LMSB diameter.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The present study evaluated CT images of the chest of children less than 8 years of age.
        The database search of the electronic medical records identified 110 patients of which 40
        patients qualified for the study.
Presence of Nanoparticles in the Amniotic Fluid
Condition: Intrauterine Disorder
Study type: Observational

Summary: 
      The nanoparticles (NP) are defined as particles whose size is no greater than 100 nanometers.
      However, their impact on health remains little evaluated.

      Placental transfer of NP has been proven in many studies in vitro and in vivo in animals, and
      toxicity in the fetus has been studied in many animals. The investigators seem interesting at
      first to establish the mineralogical load in the amniotic fluid in humans.

      The first objective of this study is to determine the mineralogical NP load, quantity and
      composition, in the amniotic fluid in pregnant women.
    

Detailed description: 
      The analysis will be done on 100 amniotic fluid samples and 100 blood samples. Particle size
      analysis will be performed by a technique of dynamic light scattering, which permits the
      distribution by volume or by number of NP according to their size. Parallel to the different
      chemical species present in the sample must be measured by atomic emission spectrometry with
      inductively coupled plasma.

      The results of this study will be useful for further studies on the fetal toxicity of NP in
      humans.
    

Intervention name(s): Nanoparticles load
Intervention type(s): Procedure
Intervention description(s): Pregnant women will have a sampling of amniotic fluid to measure load and composition of nanoparticles.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women who receive an amniocentesis for medical reasons other than study
      
Biospecimen description: 
      amniotic fluid
    
Keywords: pregnant women; nanoparticles; amniotic fluid
A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects.
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch
      in healthy male subjects
    


Intervention name(s): Donepezil; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients Not Controlled by Amlodipine
Condition: Hypertension; Diabetes Mellitus
MeSH terms: Hypertension; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare losartan and benazepril in diabetic patients whose
      high blood pressure is not controlled by amlodipine and its relationship to statin current
      use.
    

Detailed description: 
      Hypertension and diabetes mellitus are important risk factors for cardiovascular morbidity
      and mortality. Endothelial dysfunction and vascular rigidity are two pathophysiological
      mechanisms that may explain this relationship. Recent publications showed that both ACEi
      (angiotensin-converting enzyme inhibitor-induced) and ARB (angiotensin receptor blocker) were
      capable of improving vascular stiffness and endothelial function, and that these effects
      occurred despite blood pressure reduction.

      This study main objective is to assess if ARB (losartan) effects are different from ACEi
      (benazepril) in endothelial function in patients with diabetes mellitus type 2 and blood
      pressure not controlled by amlodipine and its relationship to statin current use.

      Secondary analysis of vascular stiffness will be measured by pulse wave velocity and
      augmentation index. Echocardiographic parameters, such as indexes of diastolic function, will
      also be measured.
    

Intervention name(s): Benazepril; Losartan
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.; Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
Other intervention name(s): Lotensin; 0078-0447-05; Cozaar; 0006-0951-54
Intervention MeSH terms: Losartan; Benazepril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Diabetes Mellitus; Vascular stiffness; Endothelial function
Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
Condition: BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular
Study type: Interventional

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use
      of soy isoflavones supplements may prevent or treat early stage breast cancer. PURPOSE: This
      clinical trial studies soy isoflavones supplementation in treating women at high risk for or
      with breast cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES: I. To assess whether magnetic resonance imaging (MRI) volume (equivalent
      to 3-dimensional mammographic density) is reduced in high-risk women or those with invasive
      breast cancer or DCIS who are supplemented daily with soy (5p mg total isoflavones as
      aglycone) compared to placebo (microcrystalline cellulose) tablets for 1 year.II. To assess
      whether cell proliferation and apoptosis, as measured by Ki67 and caspase 3 staining,
      respectively, of breast epithelial cells is altered with soy treatment.SECONDARY OBJECTIVES:
      I. To assess whether other intermediate molecular markers including estrogen receptor alpha
      (ER alpha) and ER beta differ between women supplemented with soy vs placebo. OUTLINE:
      Patients are randomized to 1 of 2 treatment arms.ARM I: Patients receive oral soy isoflavones
      supplement once daily for12 months in the absence of disease progression.ARM II: Patients
      receive oral placebo once daily for 12 months in the absence of disease progression.
    

Intervention name(s): soy isoflavones; placebo; questionnaire administration; magnetic resonance imaging; biopsy; immunohistochemistry staining method; laboratory biomarker analysis; mammography
Intervention type(s): Dietary Supplement; Other; Other; Procedure; Procedure; Other; Other; Procedure
Intervention description(s): Given orally; Given orally; Ancillary studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies
Other intervention name(s): NovaSoy; soy phytoestrogens; PLCB; MRI; NMR imaging; NMRI; nuclear magnetic resonance imaging; biopsies; immunohistochemistry
Intervention MeSH terms: Phytoestrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Pre-Op Window Study Evaluating Anti-Proliferative Effects of Atorvastatin on the Endometrium
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese
      women who are to undergo surgical staging for endometrial cancer.
    

Detailed description: 
      This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese
      women who are to undergo surgical staging for endometrial cancer. After recruitment is
      completed, 24 paired endometrial biopsies and hysterectomy specimens from endometrial cancer
      patients treated at University of North Carolina at Chapel Hill will be retrospectively
      obtained from the Department of Pathology to serve as controls. These cases will be matched
      for stage and grade to the endometrial cancers of those women enrolled on this phase 0
      clinical trial and will undergo the same immunohistochemical analysis. Two previous phase 0
      window studies of metformin in endometrial cancer have found no difference in Ki-67
      expression between preoperative endometrial biopsy and hysterectomy specimen in control
      patients, although a difference was seen in metformin treated patients. However, the
      investigators plan to include a control group to ensure that changes found between pre- and
      post-atorvastatin treated patients are due to the effects of this drug versus differences in
      the type of specimen examined (i.e. endometrial biopsy specimen obtained in clinic versus
      hysterectomy specimen obtained at the time of surgery). In addition, enrolled patients will
      undergo repeat endometrial biopsy post- atorvastatin treatment at the time of their surgical
      staging. Thus, study investigators plan to compare pre-treatment endometrial biopsies to both
      post-treatment endometrial biopsies and hysterectomy specimens as well as have a historical
      control group.
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): Once enrolled on this pre-operative window study, patients with endometrial cancer will be treated with the standard clinical dose of atorvastatin (80 mg once daily orally) for an average of 2-4 weeks prior to surgical staging. Patients will need to be able to undergo atorvastatin treatment for a minimum of 2 weeks but no more than a maximum of 4 weeks prior to surgical staging.
Other intervention name(s): Ezetimibe
Intervention MeSH terms: Atorvastatin; Ezetimibe
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atorvastatin; endometrium; endometrial cancer
Safety, Tolerability, and Sustained Weight Loss of Endoscopic Sleeve Gastroplasty With Diet Modification and Exercise
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of endoscopic sleeve gastroplasty (ESG)
      with diet and exercise, to diet and exercise alone, to see which is better in weight loss
      reduction. Investigators will also compare the effects of ESG to diet and exercise
      comorbidities such as diabetes, sleep apnea and high cholesterol as well as the various
      obesity related hormones.
    

Detailed description: 
      This is a single center, prospective randomized case control study with an additional non
      randomized case arm. This study includes two research interventional groups. Groups A: ESG
      with diet and exercise modules. Group B: Diet and exercise modules only. Investigators
      propose to compare ESG to behavioral modification including diet and exercise for patients
      who have a BMI greater than or equal to 40 kg/m2 or greater than or equal to 30 kg/m2 with 1
      or more obesity related co-morbidity and who cannot undergo conventional bariatric surgery(or
      decline the surgical option). Investigators will also compare the effects of ESG to diet and
      exercise on comorbidities such as diabetes, sleep apnea and high cholesterol as well as the
      various obesity related hormones.
    

Intervention name(s): Endoscopic Sleeve Gastroplasty; Diet and Exercise
Intervention type(s): Procedure; Behavioral
Intervention description(s): endoscopic, rather than surgical approach, to perform sleeve gastroplasty; nutritional/exercise counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cultural Meal and Postprandial Oxidative Stress
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      This one-year randomized crossover study is proposed to compare the changes of postprandial
      oxidative stress (POS) after consumption of meals from different cultures in healthy Chinese
      adults, using a 'real-life, cultural meal' approach. It is hypothesized that the changes of
      POS differ with meals from different cultures. Four cultural meals are chosen, namely
      Southern Chinese, Northern Chinese, American, and South Indian, based on the known prevalence
      of chronic diseases between Caucasians, Chinese and Indians, and within the Southern and
      Northern Chinese population.
    


Intervention name(s): Southern Chinese meal; Northern Chinese meal; American meal; South Indian meal
Intervention type(s): Other; Other; Other; Other
Intervention description(s): White rice (1 bowl), stir fried choi sum (0.5 bowl) and stir fried lean pork (0.5 bowl) cooked with maize oil; Noodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil; Hamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil and Coca-cola classic (21 fluid ounces); Basmati rice (1 bowl), chicken curry dish (0.5 bowl), dry vegetable dish (i.e. green beans mixed with herbs) (0.5 bowl), yogurt made with milk powder mainly (0.5 bowl), pickle made with lemon, salt, chilli powder, Asafoetida and vegetable based oil (1 tablespoon)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Meal; Postprandial oxidative stress
Comparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of two care models on ADHD
      outcomes: one, a model of basic care management and structured communication with
      specialists, consistent with conventional descriptions of a patient-centered Medical Home;
      and another, which combines the Medical Home with theory-based care management strategies to
      address common reasons for ADHD treatment failure.
    


Intervention name(s): Collaborative Care Plus; Traditional Collaborative Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Traditional collaborative care + systematic addressing of ADHD comorbidities, parental mental health issues, and adherence to treatment plans; Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Bioavailability Study of Folic Acid in Healthy Women
Condition: Healthy; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the bioavailability of orally administered folic
      acid compared with the i.v. administered folic acid, and to use the samples collected to
      validate the analytical methods for estimation of folic acid in plasma and red blood cells
      (RBCs).
    

Detailed description: 
      Few formal pharmacokinetic studies have been conducted with folic acid to determine its
      absolute bioavailability, pharmacokinetic profile, or intra- and intersubject variability.
      Moreover, most analytical work has been completed in academic settings, and no Good
      Laboratory Practice (GLP)-validated assay method has been developed. This was a randomized
      (study drug assigned by chance), open-label, 3-way crossover, single-center trial, consisting
      of a prerandomization phase, an open-label treatment phase (3 single doses separated by
      washouts of 7 days each), and a posttreatment phase. Healthy volunteers were randomly
      assigned to 1 of 6 treatment sequences (2 healthy volunteers per sequence). All healthy
      volunteers received a single dose of folic acid in each treatment period (400-mcg oral
      solution, 400-mcg i.v. infusion, and a 1-mg oral tablet). Blood samples for pharmacokinetic
      analysis were collected at specified times following each dose. Blood samples for measurement
      of red cell folate were collected before dosing on Day 1 of Period 1. For each period,
      healthy volunteers were confined to the study unit from the evening before Day 1 through the
      completion of the Day 2 assessments (24-hour pharmacokinetic blood sample collection).
      End-of-study assessments took place on Day 17 or at the time of early withdrawal. Safety was
      evaluated based on the monitoring of adverse events, vital sign measurements, physical
      examinations, and clinical laboratory tests. Heart rate and blood pressure were measured at
      screening, on the first day of each treatment period (Days 1, 8, and 15), and at study
      completion (Day 17) or early withdrawal; body temperature was measured at screening only. A
      physical examination was performed at screening and at study completion (Day 17) or early
      withdrawal. Blood samples for serum chemistry and hematology and a random urine sample for
      urinalysis were taken at the start of the study, Days -21 to -2, and at the end of the study
      (Day 17 or early termination).

      All subjects received a single dose of folic acid in each treatment period (400-mcg oral
      solution, 400-mcg i.v. infusion, and a 1-mg oral tablet), separated by washouts of 7 days
      each.
    

Intervention name(s): Folic acid
Intervention type(s): Drug
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Folic Acid; Chemistry, Analytical; Administration, Oral; Infusions, Intravenous; Biological Availability; Safety