bioihbjkbjnl/mcl2 huggingface dataset:
Gasdermin-D and Pannexin-1 in Pregnancy
Condition: Pregnancy Complications; Maternal Obesity
MeSH terms: Pregnancy Complications; Obesity, Maternal; Obesity
Study type: Interventional

Summary: 
      One -third of fertile women around the world are overweight or obese. This means increasing
      risk for both the mother and the child. Fat tissue is a factor in gestational DM development
      and the increase in material inflammation and oxidative stress. According to new knowledge,
      it is an important need to examine molecules that are not handled in new and human research
      in these mechanisms in fat and placenta tissues in obesity. For this purpose, the examination
      of the expression of gasdermin-D and pannex-1 proteins, which are shown to be produced in the
      cells of both tissues, is worth investigating in human fat tissue and placenta. Gasdermins
      and pannexins are proteins intersecting by interacting in cellular functions.

      Gasdermins cause piroptosis, a type of litic proinflammatory cell death. Pannexin-1 plays in
      various cellular functions, including inflammation. These are examined in a small number of
      in vitro studies in material fat tissue and placenta, and the design of this study in people
      whose applications are applied is original in humans.

      The status of the expressions of the gasdermin-D and pannexin-1 proteins, which will be
      examined for the first time in obese pregnant women's fat and placental tissues, are the
      subject of this research with each other and their relationship with other maternal and
      neonatal data.
    


Intervention name(s): Biomarker measurement of pannexin-1 and gasdermin-D
Intervention type(s): Diagnostic Test
Intervention description(s): These biomarkers were measured in the placental and adipose tissues of the participants.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: gasdermin-D; pannexin-1; placenta; omental tissue; fat tissue; maternal obesity; inflammation; oxidative stress; biochemistry; ELISA
SES, Health Behaviors and CVD Among Vietnam-Era Twins
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To further characterize the nature of the association between socioeconomic status (SES),
      health behaviors and early cardiovascular disease in the Vietnam Era Twin (VET) Registry, a
      sample of over 4,000 twin pairs.
    

Detailed description: 
      BACKGROUND:

      Cardiovascular disease (CVD) affects approximately 60,800,000 Americans each year, claiming
      the lives of nearly one million of these people (American Heart Association, 2001). CVD is
      likely to be complex in etiology, reflecting the combined effect of both genes and
      environment, as well as gene x gene and gene x environment interaction. Examination of
      environmental factors thought to affect CVD risk in the context of a genetically informative
      design can help elucidate the relative contribution of genetic and environmental factors and
      potentially aid in identifying environmental factors that may interact with genetic
      vulnerability in predicting CVD. Cardiovascular morbidity and mortality are over-represented
      among individuals in lower socioeconomic strata, as are behaviors that increase the
      likelihood of cardiovascular events, including smoking, heavy alcohol consumption and
      physical inactivity (Adler et al., 1994; Anderson & Armstead, 1995). Thus, it is commonly
      assumed that socioeconomic status (SES) serves as an important environmental influence on
      health and health behaviors. Twin studies partition genetic and environmental variance and
      detect gene x environment interaction and provide a unique opportunity to study the
      association between SES and health.

      DESIGN NARRATIVE:

      The study will characterize the nature of the association between socioeconomic status (SES),
      health behaviors and cardiovascular disease (CVD) in the existing Vietnam Era Twin (VET)
      registry, a sample of over 4000 male twin pairs with a mean age of 51 in 1999. Specifically,
      the study will: 1) determine how strongly environmental factors contribute to individual
      differences in SES, health behaviors and CVD, relative to genetic factors; 2) examine whether
      measures of SES are associated with health behaviors and CVD mortality when controlling for
      concomitant genetic influences; and 3) investigate whether SES interacts with genetic
      vulnerabilities to predict health behaviors and CVD (gene x environment interaction). Using
      VETdatasets, the primary method of analysis will be twin structural equation modeling.
Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls
Condition: Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on
      kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus
      and healthy controls
    


Intervention name(s): Empagliflozin; BI 10773
Intervention type(s): Drug; Drug
Intervention description(s): open label
Intervention MeSH terms: Empagliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
International Study of Childhood Obesity, Lifestyle and the Environment
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Observational

Summary: 
      The primary aim of the International Study of Childhood Obesity, Lifestyle and the
      Environment (ISCOLE) is to determine the relationship between lifestyle characteristics and
      obesity in a large multi-national study of 10 year-old children, and to investigate the
      influence of behavioral settings and physical, social and policy environments on the observed
      relationships within each country.
    

Detailed description: 
      Data will be collected in 12 countries (500 children per site) from five major regions of the
      world (Eurasia & Africa, Europe, Latin America, North America, and the Pacific).
      Cross-sectional evaluations will be undertaken in each country. The physical characteristics
      of the children will be directly measured in order to classify their body weight and
      adiposity status, and physical activity and dietary patterns will be measured with the most
      objective techniques currently available. A concise set of environmental measures that are
      feasible, valid and meaningful across the international settings included in this research
      will also be employed. The results of this study will provide a robust examination of the
      correlates of obesity and weight gain in children, focusing on both sides of the energy
      balance equation. The results will also provide important new information that will inform
      the development of lifestyle interventions to address childhood obesity that can be
      culturally adapted for implementation around the world.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        boys and girls who are approximately 10 years
      
Keywords: International; Childhood; Obesity; ISCOLE; Pennington Biomedical Research Center; PBRC; longitudinal; multinational
The Different Effectiveness of Single Acupoint（PC6 or CV12) vs Matching Acupoints(PC6 and CV12) in Chemotherapy-induced Nausea and Vomiting
Condition: to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      The purpose of this study is to clarify whether the matching acupoints are more effective
      than a single point by electro-acupuncture in the management of chemotherapy-induced nausea
      and vomiting .
    


Intervention name(s): single point Neiguan(PC6) plus antiemetic drug; single point Zhongwan(CV12) plus antiemetic drug; matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug; only antiemetic drug
Intervention type(s): Other; Other; Other; Drug
Intervention MeSH terms: Antiemetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Condition: Falciparum Malaria
MeSH terms: Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is
      pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).
    


Intervention name(s): Artesunate (Test); Artesunate (Comparator)
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet, single dose, 1 x 100 mg; Oral tablet, single dose, 2 x 50 mg
Intervention MeSH terms: Artesunate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bio-equivalence, Healthy Volunteers
Docetaxel and Irinotecan in Gastric Cancer
Condition: Stomach Cancer; Gastric Cancer; Chemotherapy Effect
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the role of docetaxel and irinotecan combination in second line gastric cancer. The
      primary end point is response rate. Secondary end points are toxicity, PFS and OS.
    

Detailed description: 
      Gastric cancer is a major killer in oncology. The expected overall survival of metastatic
      patients is less than 2 years. Moreover, most of the patients develop cachexia and worsening
      of performance over time. As a result, many patients are not fit for second line treatment
      when eligible. There is currently no approved consensus for third line treatment regimen and
      in most of the patients it is usually best supportive care.

      Irinotecan and docetaxel were tested as single agents or in combination with other drugs
      (e.g. FOLFIRI) in second line setting. However, the combination of these two drugs together
      was not tested before. Both agents are active in second line setting which is considered the
      last chance of the patient in view of lack of evidence in third line setting.
    

Intervention name(s): Docetaxel; Irinotecan
Intervention type(s): Drug; Drug
Intervention description(s): patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival; patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival
Intervention MeSH terms: Docetaxel; Irinotecan
Intervention model: Single Group Assignment
Intervention model description: Patients from multiple oncology centers across Egypt are recruited for this study. Second line treatment of advanced gastric cancer will be tested with irinotecan and docetaxel combination
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric; stomach; docetaxel; irinotecan; chemotherapy; second line
I Change Adherence & Raise Expectations
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The iCARE study, a clustered-randomized controlled trial, is evaluating an adherence
      promotion intervention for adolescents that Cystic Fibrosis (CF) care teams will implement.
      Half the centers will receive the Comprehensive Adherence Program (CAP) for 2 years. CAP
      consists of training in the CF My Way program (a validated problem-solving adherence
      promotion intervention). The other half of the centers will receive CAP in year 2 of the
      study. Participants are patients age 11-20 years old who are diagnosed with CF and have been
      prescribed at least one of the following medications for at least 6 months prior to signing
      the informed consent: azithromycin, hypertonic saline, Pulmozyme®, TOBI®, or inhaled
      compounded tobramycin. Rate of refilling prescriptions is the primary outcome with lung
      function decline rates, exacerbation rates, and patient reported measures including health
      related quality of life and CF knowledge and skills, as secondary outcomes.

      A central goal of this study is to test the effectiveness of the comprehensive adherence
      program (CAP), described above, versus standard care (SC) for adolescents and young adults
      seen in outpatient CF clinics.
    


Intervention name(s): Comprehensive Adherence Program (CAP)
Intervention type(s): Behavioral
Intervention description(s): The Comprehensive Adherence Program (CAP) consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cystic Fibrosis; Adherence; Problem-Solving; Adolescents; Education; Skills Remediation
Mechanisms and Treatment of Intradialytic Hypertension - Sodium
Condition: Hemodialysis; End-stage Renal Disease; Hypertension; Intradialytic Hypertension
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to determine the role of dialysate exposure and fluid removal
      during hemodialysis in the pathophysiology of intradialytic hypertension.
    

Detailed description: 
      Specific Aim #1 To determine in a crossover study of 15 maintenance hemodialysis patients
      with intradialytic hypertension whether standard dialysis with ultrafiltration (dialysate Na
      of 140), dialysis without ultrafiltration (dialysate Na of 140), or ultrafiltration alone (no
      dialysate) is associated with the an increase in systolic blood pressure during hemodialysis

      Specific Aim #2 To determine in a crossover study of 15 maintenance hemodialysis with
      intradialytic hypertension whether standard dialysis with ultrafiltration, dialysis without
      ultrafiltration, or ultrafiltration alone is associated with change in either endothelin-1 or
      nitric oxide during hemodialysis

      SUBSTUDY AIMS

      Specific Aim #1 To determine in a randomized 3-week, 2 period crossover study of 15
      maintenance hemodialysis patients with intradialytic hypertension whether high vs low
      dialysate-to-serum Na gradients impairs release of NO, increases ET-1 or causes an acute
      intradialytic increase in systolic BP,.

      Specific Aim #2 TO determine in a randomized 16-week, 2-period crossover study of 30
      hemodialysis patients with intradialytic hypertension the effects of 8 weeks of high
      dialysate-to-plasma Na gradients to 8-weeks of low Na gradients on EC function (FMD and ADMA)
      and 44 hour ambulatory BP.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Our study population will include up to 45 ESRD patients whose BP increases during
        hemodialysis. Patients who dialyze at any of the 3 UT Southwestern-affiliated dialysis
        units will be screened for possible enrollment.
      
Biospecimen description: 
      Samples stored for nitric oxide and endothelin-1 measurements
    
Keywords: hemodialysis; end-stage renal disease; hypertension
Menstrual Differences in Airway Inflammation in Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Observational

Summary: 
      Asthma is a chronic inflammatory lung disease characterized by airway hyper-responsiveness
      and reversible airway obstruction. Over the last decade, the prevalence of asthma is on the
      rise and it disproportionately affects more women than men. As much as 40% of women with
      asthma are known to have worsening of asthma symptoms and lung function prior to
      menstruation. This syndrome is being increasingly recognized as premenstrual asthma (PMA).
      The pathologic differences in female asthmatics with and without this syndrome are not known.
      The evidence regarding the role of sex hormones has been contradicting. We propose an
      observational cohort study to examine the changes in airway inflammation in women with asthma
      in relation to their menstrual cycle and their association with sex hormone levels. In
      addition we will include women on oral contraceptives to determine their effect on airway
      inflammation and asthma symptoms.

      We hypothesis that:

        -  Women with premenstrual asthma will show increased indices of airway inflammation in
           various phases the monthly menstrual cycle.

        -  In women with premenstrual asthma, a change in serum estradiol/progesterone ratio during
           the late luteal phase is associated with worsening of airway inflammation, air flow
           limitation and asthma symptoms.

        -  The use of oral contraceptives is associated with suppression of the cyclical changes in
           airway inflammation due to lack of fluctuations in estradiol and progesterone levels.

      Recruited subjects will be asked to record asthma symptom scores, morning Peak Expiratory
      Flow Rate (m-PEFR) and rescue asthma medication (β2-agonist) used daily during the one month
      screening period to identify women with and without pre-menstrual asthma. Asthmatic women
      with regular menstrual cycles will be evaluated in their follicular phase (days 5-8) and
      luteal phase (days 21-24) and women on oral contraceptive pills (OCP) will be evaluated on
      days 9-12 of their OCP cycle and during the days 25-28, off of OCP consecutively for a
      2-month period.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females diagnosed with asthma, with either regular menstral cycles or on monophasic oral
        contraceptives, with or without pre-mentstual asthma symptoms
      
Biospecimen description: 
      Serum Eosinophil Cationic Protein (ECP) samples will be obtained. The 5ml blood samples for
      measuring ECP levels will be collected in silica gel-containing tubes. After centrifuging,
      the supernatant will be frozen and ECP levels will bemeasured using an ELISA kit
Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
Condition: TTR Cardiac Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional

Summary: 
      Researchers are gathering information to see if using an FDA approved implantable device can
      help with monitoring of your heart arrhythmias.
    


Intervention name(s): Biotronic 3 implant of device; Biotonic 3 explant of device
Intervention type(s): Device; Device
Intervention description(s): The Biotronic 3 device will be implanted by the research team physician.; The Biotronic 3 device will be removed from the patient by the research team physician.
Intervention model: Single Group Assignment
Intervention model description: 50 patients with TTR-wt cardiac amyloidosis will be monitored with an implantable loop recorder to determine frequency of atrial and ventricular arrhythmias. After 6 months the device will be explanted unless required for further clinical monitoring.
Masking: None (Open Label)
Primary purpose: Prevention
A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Using a 4-arm, cluster-randomized controlled trial, the investigators will test the
      effectiveness of different behavioral economic interventions in increasing statin use and
      reducing LDL cholesterol among patients with poor cholesterol control who are at very high
      risk for CVD. The investigators will test these approaches among primary care physicians and
      their patients at very high risk of CVD at Geisinger Health System and University of
      Pennsylvania outpatient clinics.
    

Detailed description: 
      Cardiovascular disease (CVD) is the leading cause of death in the United States. Despite
      strong evidence that reducing low-density lipoproteins (LDL) with statins successfully lowers
      CVD risk, physicians under-prescribe statins, physicians fail to intensify treatment when
      indicated, and more than 50% of patients stop taking statins within one year of first
      prescription, though such therapy typically should be life-long. In this study, we will test
      the effectiveness of different behavioral economic interventions in increasing statin use and
      reducing LDL cholesterol among patients with poor cholesterol control who are at very high
      risk for CVD. The application of conceptual approaches from behavioral economics offers
      considerable promise in advancing health and health care. Pay for performance initiatives
      represent one such potential application, but one in which incorporating the underlying
      psychology of decision makers has not generally been done, and experimental tests have not
      been conducted. We will test these approaches among primary care physicians and their
      patients at very high risk of CVD at Geisinger Health System and University of Pennsylvania
      outpatient clinics. Using a 4-arm, cluster-randomized controlled trial, we aim to answer
      these questions: [1] How does the provision of provider incentives compare to the provision
      of patient incentives, to a combination of patient and provider incentives, or to no
      incentives at all? [2] Are results sustained after incentives and other interventions are
      withdrawn? [3] How do these approaches compare in implementation, acceptability, cost, and
      cost-effectiveness?
    

Intervention name(s): Behavioral Economic Intervention
Intervention type(s): Behavioral
Intervention description(s): Various combinations of financial incentives to patients and providers.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular Disease