bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RO4998452 in Type 2 Diabetes Patients With Varying Degrees of Renal Impairment
Condition: Diabetes Mellitus Type 2
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This 4 arm study will investigate the pharmacodynamics and pharmacokinetics of RO4998452 in
      type 2 diabetes patients with varying degrees of renal impairment. Eligible patients will be
      divided into 4 groups, with normal renal function, or mild, moderate or severe renal
      impairment. All patients will receive a single oral dose of RO4998452 in the fasted state.The
      anticipated time on study treatment is <3 months (single dose study)and the target sample
      size is <100 individuals.
    


Intervention name(s): RO4998452
Intervention type(s): Drug
Intervention description(s): 20mg po single dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
Condition: Anemia; Iron-deficiency; Iron Deficiency Anemia; Hiv
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Randomized, placebo-controlled trial of the effect of 84 days of daily iron supplementation
      on iron status, gut microbiome profile, infectious disease frequency, and HIV disease
      severity in moderately anemic [hemoglobin 9 - <11 g/dL (6-59 mo); hemoglobin 9 - < 11.5 g/dL
      (5 -12 years)], HIV-infected Ugandan children between the ages of 6 mos and 12 years.
    


Intervention name(s): Ferrous Sulfate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.; Placebo with identical appearance comparison intervention arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Epicardial Adipose Tissue Thickness in Polycystic Ovary Syndrome (PCOS)
Condition: Epicardial Adipose Tissue Pcos
MeSH terms: Polycystic Ovary Syndrome
Study type: Observational

Summary: 
      The aim of the present study was to search whether epicardial adipose tissue thickness, a
      predictor of increased cardiovascular risk, increases in PCOS patients or not and, if it
      does, to analyze the relationship of EATT with insulin resistance, adiponectin and
      biochemical and anthropometric parameters.
    

Detailed description: 
      Context: Polycystic ovary syndrome (PCOS) is characterized with chronic oligo/unovulations,
      hyperandrogenism and insulin resistance. Insulin resistance is mostly attributed to visceral
      adipose tissue. Epicardial adipose tissue thickness (EATT) is in close relation with
      atherosclerotic coronary heart disease and its importance in PCOS is not determined yet.
      Thus, we aimed to clarify EATT in patients with PCOS and compare with healthy matched
      controls. In addition we searched plasma adiponectin levels to clarify its relationship with
      EATT in patients with PCOS.

      Settings: EATT was determined by echocardiography. Insulin resistance is calculated as
      HOMA-IR and plasma adiponectin levels were determined with ELISA radioimmunoassay at Gülhane
      School of Medicine, Ankara, Turkey.

      Patients: Patients with PCOS and healthy controls who were similar in body mass index (BMI)
      and age (p=0.118, p=0.081, respectively) were enrolled in the study after having their
      written consents.

      Results: Mean EATT and HOMA-IR levels were significantly higher (p=0.001, p=0.001,
      respectively) while plasma adiponectin concentrations were significantly lower (p=0.0032) in
      patients with PCOS than controls. There was no correlation between plasma adiponectin levels
      and EATT in subjects (p=0.824). EATT levels were in positive correlation with HOMA-IR, plasma
      triglyceride concentrations and body mass index (BMI) (p=0.022, p=0.027, p=0.022,
      respectively). HOMA-IR, triglyceride levels, HDL-Cholesterol, LH/FSH ratio were most powerful
      determinants of EATT in logistic regression modeling (p=0.016, p=0.021, p=0.049, p=0.039,
      respectively).

      Conclusion: EATT is increased in patients with PCOS in concordance with HOMA-IR level and
      these findings may reflect the increased risk for atherosclerotic cardiovascular disease in
      this particular patient group.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        45 patients wit pcos and 45 control cases
      
Keywords: epicardial adipose pcos
Polymorphism of the Cytochrome P450-system in Renal Transplants
Condition: Function of Renal Transplant
Study type: Observational

Summary: 
      In this study the researchers want to investigate genetic polymorphisms of cytochrome 450
      enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for
      differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus,
      cyclosporine A).

      All patients who receive one of these drugs can be included and drug blood trough levels,
      dosing and genetics are compared.
    

Detailed description: 
      Primary endpoint is the

        1. serum creatinine in patients with and without polymorphysms

        2. rate of rejections in patients with and without polymorphysms
    

Intervention name(s): tacrolimus; sirolimus; everolimus; cyclosporin A
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): retrospective analyze of drug levels in comparison to polymorphism; retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism; retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism; retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism
Intervention MeSH terms: Cyclosporine; Sirolimus; Everolimus; Tacrolimus; Cyclosporins
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patinets after kidney transplantation
      
Biospecimen description: 
      DNA samples to analyze polymorphisms
    
Keywords: cyclosporin A; Tacrolimus; Everolimus; Sirolimus; Fluvastatin
NK Cells Treatment for COVID-19
Condition: Novel Coronavirus Pneumonia
MeSH terms: Pneumonia; Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV)
      emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus
      therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may
      serve as useful effectors against danger infection. The purpose of this clinical
      investigation is to evaluate the safety and efficiency of NK Cells in combination with
      standard therapy for pneumonia patients infected with 2019-nCoV.
    


Intervention name(s): NK Cells
Intervention type(s): Biological
Intervention description(s): twice a week of NK cells (0.1-2*10E7 cells/kg body weight)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Breathing Maneuvers on Peripheral Glucose Metabolism
Condition: Vagus Nerve Stimulation; Insulin Sensitivity; Deep Breathing Maneuver
MeSH terms: Respiratory Aspiration; Insulin Resistance
Study type: Interventional

Summary: 
      Two important mechanisms play a major role in the pathogenesis of type 2 diabetes: insulin
      resistance of the target tissues and the impaired insulin secretion from pancreatic β-cells.
      Postprandial factors (such as insulin) are perceived by the human brain and induce signals
      that regulate glucose metabolism via the parasympathetic nervous system.

      Deep breathing exercise can increase parasympathetic nerve activity. Heart rate variability
      (HRV) in healthy people can be significantly increased by deep breathing maneuvers,
      indicating a shift from sympathetic activity to parasympathetic activity.

      The hypothesis is that this postprandial shift results in a change in peripheral glucose
      metabolism. In turn, the increased parasympathetic activity could potentially result in a
      change in postprandial insulin sensitivity or secretion.

      To test this hypothesis, this study investigates the effect of deep breathing exercise versus
      normal breathing on insulin sensitivity, on insulin secretion, glucose tolerance, resting
      energy expenditure, and on parasympathetic tone (analysis of heart rate variability).
    


Intervention name(s): deep breathing
Intervention type(s): Other
Intervention description(s): Deep breathing maneuver to increase parasympathetic nerve activity
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask
Condition: Upper Airway Obstruction
MeSH terms: Airway Obstruction
Study type: Interventional

Summary: 
      Upper airway obstruction (UAO) is common complication during induction of general anesthesia.
      The mechanism of UAO during anesthesia has not been well understood. Posterior displacement
      of soft palate are believed to be the primary contributing factors. The mechanism of UAO
      during anesthesia share many similarities with obstructive sleep apnea (OSA). Since nasal
      continuous positive airway pressure (nCPAP) can maintain the airway patent in patients with
      OSA, the investigators hypothesize that nCPAP during induction of anesthesia will reduce the
      incidence and severity of UAO.
    


Intervention name(s): nasal mask
Intervention type(s): Procedure
Intervention description(s): nasal mask use instead of face mask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: continuous positive airway pressure; nasal mask; upper airway obstruction
Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1
Condition: Type 2 Diabetes
MeSH terms: Thrombosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to learn more about why patients with diabetes have increased
      heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood
      vessel. The proposed protocol will study the separate and combined effects of hyperglycemia
      and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2 DM. Our
      hypothesis is that hyperglycemia, rather than hyperinsulinemia, is responsible for the
      dysregulation of fibrinolytic balance in diabetics.
    

Detailed description: 
      This study will test the hypothesis that hyperglycemia will impair, while hyperinsulinemia
      will improve endothelial function and vascular fibrinolytic balance in type 2 DM. As
      discussed above, their roles in the increased prevalence of thrombotic events occurring in
      diabetics have not been defined. More recent data supports insulin as profibrinolytic and
      hyperglycemia to cause endothelial dysfunction. Conclusive studies are lacking in diabetic
      subjects. Furthermore, preliminary data from this lab indicates that in non-diabetic
      controls, hyperglycemia results in a prothrombotic state by increasing plasma PAI-1 and
      reducing tPA levels. The proposed protocol will study the separate and combined effects of
      hyperglycemia and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2
      DM.
    

Intervention name(s): Hyperinsulinemic Hyperglycemic Clamp
Intervention type(s): Other
Intervention description(s): Glucose Clamp
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Type 2 Diabetes; Endothelial Function; Fibrinolytic Balance
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
Condition: Osteoporosis, Postmenopausal; Osteoporosis; Osteoporosis Vertebral; Osteoporosis Risk; Osteoporosis Fracture; Osteoporosis Localized to Spine; Osteoporosis, Age-Related; Osteoporosis Senile; Osteoporosis of Vertebrae
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Osteoporotic Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to measure the early effects of abaloparatide on tissue-based
      bone formation using samples obtained by transiliac crest bone biopsy after quadruple
      fluorochrome labeling.
    

Detailed description: 
      This was an open-label, single-arm study of postmenopausal women with osteoporosis treated
      with 80 micrograms (μg) abaloparatide for 3 months. Transiliac bone biopsies were taken at 3
      months after quadruple fluorochrome labeling. The treatment duration of 3 months was
      determined to be the optimal time when biochemical markers of bone turnover peak and are
      predictive of subsequent changes in bone mineral density (BMD).

      The main study was conducted for a 3-month treatment period with a 1-month follow up. A
      sub-study was conducted at 1 site to collect peripheral quantitative computed tomography
      (pQCT) data. Study treatment for participants in the sub-study was extended for an additional
      3 months of study drug administration for a total of 6 months of treatment.
    

Intervention name(s): Abaloparatide
Intervention type(s): Drug
Intervention description(s): Abaloparatide is a novel, synthetic, 34 amino acid peptide designed to be a potent and selective activator of the PTH/PTH-related protein (PTHrP) type 1 receptor (PTHR1) signaling pathway with 41% homology to PTH[1-34] and 76% homology to human PTHrP[1-34].
Other intervention name(s): TYMLOS®; BA058
Intervention MeSH terms: Abaloparatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BA058; abaloparatide; TYMLOS®; Bone metabolism; Osteoporosis; Fracture; Bone loss
Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of rabeprazole extended release 50 mg
      (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in
      subjects with healed erosive gastroesophageal reflux disease (eGERD).
    

Detailed description: 
      This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects
      who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups,
      rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily).

      Please note that this study is not a duplicate of E3810-G000-305; this is a separate study
      being conducted along with -305.
    

Intervention name(s): Rabeprazole ER; Ranitidine
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg capsule, taken orally, once daily for 26 weeks.; 150 mg capsule, taken orally, twice daily for 26 weeks.
Other intervention name(s): Aciphex
Intervention MeSH terms: Rabeprazole; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal; Reflux; Disease; GERD
Aronia Berry Consumption on Blood Pressure
Condition: Prehypertension; Healthy
MeSH terms: Prehypertension
Study type: Interventional

Summary: 
      Aronia berries are a native North American berry with high naturally occurring anthocyanins
      among other polyphenols. Based on their polyphenol composition, there is growing interest in
      the potential for Aronia berries to elicit health promoting cardio-metabolic effects.
      Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may
      improve blood vessel function.

      Thus, the primary focus of this project is to evaluate the effects of Aronia berry
      polyphenols on blood pressure and other biomarkers of cardiovascular disease risk such as
      endothelial function, arterial stiffness and blood lipids.
    


Intervention name(s): Placebo; Aronia extract
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.; Powdered extract obtained from aronia berries (Aronia melanocarpa).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: (Poly)phenols; Aronia berry; Blood pressure; Vascular function
Soy Protein and Breast Cancer Risk Reduction
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian
      hormones and breast density are considered breast cancer risk markers. We propose to test the
      hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a
      corresponding reduction in breast density comparing to casein protein.
    

Detailed description: 
      The aims will be tested by conducting a randomized, double-blind study, with two arms and 100
      women in each arm. Premenopausal women will be recruited and randomly allocated to take one
      of two different dietary supplements daily for 2 years. The two test diets soy protein drink
      and caseinate protein drink. Multiple blood, urine, and breast fluid samples will be obtained
      before and during the dietary intervention period and analyzed for ovarian hormones. At
      baseline and after the intervention period, breast density, and bone density will be assessed
      by radiological techniques at baseline and 1 yr and 2 yr after protein drink supplementation.
      The efficacy of the dietary intervention will be determined by comparing mean changes of
      ovarian steroids, and density of the breast and bone tissues over the 2 year dietary
      intervention period in the two diet groups with adjustment for baseline values and individual
      patient characteristics of interest. We predict that 2 years of soya dietary supplements will
      reduce breast density, which will be explained by individual hormonal changes.
    

Intervention name(s): soy milk; cow's milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.; Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Other intervention name(s): Not applicable, research product; Not applicable, research product
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo controlled, 2 parallel groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: soy diet; breast cancer; ovarian hormones; breast density; prevention
Single Dose Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Doses of Zolpidem in Children
Condition: Insomnia; Sleep Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multicenter trial to evaluate the single-dose safety, tolerability and
      pharmacokinetics-pharmacodynamics of Zolpidem in a group of children with sleep disturbances
      stratified by age and dose.
    

Detailed description: 
      The consequences of sleep deprivation to the productivity of the individual and society are
      extensive. (Most clinicians and patients believe that insomnia becomes a clinical problem
      requiring therapy when excessive daytime sleepiness impairs cognition and mood, interfering
      with a patient's performance of functions that require alertness. Chronic sleep deprivation
      often leads to adverse personal, medical and psychiatric complications, underscoring the
      common request of patients for treatment by their physician.

      With an increasing focus on the problem of sleep deprivation in children of all ages, our
      appreciation of the scope of the problem is expanding. It is estimated that up to 40 % of
      infants experience difficulty in settling and frequent nighttime wakings with sleep
      disturbances including bedtime resistance, delayed onset of sleep, and disruptive night
      wakings occurring in 25 to 50 % of preschoolers. In school-aged children, parents reported an
      incidence of bedtime resistance in 15 % of their children.

      Very limited data exist describing the pharmacokinetics of zolpidem in pediatrics. Colle and
      colleagues reported the zolpidem clearance to be 3 times greater in children (n=6) compared
      to young adults (n=104) though Cmax and AUC values were similar despite a higher zolpidem
      dose (mg/Kg) in the children. Unfortunately these data raise more questions than they answer
      regarding zolpidem disposition relative to age and highlight the need to comprehensively
      determine zolpidem disposition characteristics across a broad age range of pediatric
      subjects.

      In summary, although researchers have been hesitant to include children in drug studies, the
      data indicate that pediatric sleep disturbance have a negative health impact on children and
      warrant pharmacologic intervention. Studies to identify the appropriate drug and dosage for
      children of all ages are essential in addressing this health problem that impacts the child
      and his/her family.
    

Intervention name(s): Zolpidem
Intervention type(s): Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Sleep Disorder; Sleep Deprivation