Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of inhaled oligog cf-5/20 for the treatment cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a disease caused by a mutation in the gene that makes the cystic fibrosis transmembrane regulator protein. as a result mucus stagnation, obstruction and plugging take place in the respiratory and gastrointestinal tract, the biliary and pancreatic duct, and in the reproductive system. the objective of this study is to determine the safety and tolerability of 3 days of daily dosing of oligog cf-5/20 versus placebo in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy, male subjects aged 18 to 65 years inclusive * normal pulmonary function; i.e. fev1 ≥ 80% of predicted (for age, sex, height and race) and fev1/fvc ratio ≥ 0.7 * subject's pre -study physical examination, vital signs and electrocardiogram (ecg) are normal or do not show any clinically significant abnormalities as determined by the investigator * subject's pre - study laboratory screen are normal or, if outside of the laboratory reference range, not considered clinically significant exclusion criteria: * history of any clinically relevant chronic respiratory disorder, including asthma * current smoker or smoked within the last 12 months * history of significant drug or alcohol abuse (defined by the investigator). subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study. * subject who has inhaled any drug in the last 30 days prior to day 1 * subject who has received one or more days of systemic pharmacological treatment in the 14 days immediately prior to day 1 * participation in a new chemical entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks * subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, haematological or metabolic disorder

Keywords: digestive system diseases genetic diseases inborn respiratory tract diseases cystic fibrosis lung disease pancreatic diseases
non-pharmacologic patient centered pain control adjuncts during first trimester abortion

Conditions: Pregnancy Termination; Pain Management

Summary: this study will examine the use of non-pharmacologic pain control techniques and pain-management counseling as an additional tool for reducing pain during first trimester aspiration abortion.


Eligibility criteria:
inclusion criteria: * english speaking, able to read and understand consent form * age 18 + (minors eligible with parental consent) * seeking in-office aspiration termination of pregnancy * gestational age less than 14 weeks exclusion criteria: * not able to read or understand english * unable to understand consent * minors without parental consent * requesting narcotic or sedative analgesics * currently incarcerated * gestational age greater than 14 weeks * seeking medication abortion
prospective observational registry for obstructive sleep apnea in patients with acute myocardial infarction

Conditions: Obstructive Sleep Apnea; Acute Myocardial Infarction

Summary: obstructive sleep apnea (osa) has been known as a risk factor for coronary artery disease, heart failure, cerebrovascular accident and atrial fibrillation. one study reported that patients with osa have more atherosclerotic plaque burden in intravascular ultrasonography examination. among patients who admitted with acute myocardial infarction (ami), 65.7% (69 of 105) patients were diagnosed with osa. other long-term follow-up study revealed that 45.4% of patients (594 of 1311) who performed percutaneous coronary intervention (pci) were diagnosed with osa. moreover, the osa group was a significant independent predictor of major adverse cardiac and cerebrovascular events (macces). polysomnography (psg) is the gold standard for the diagnosis of osa. but, psg is expensive, time-consuming and difficult to perform immediately. recently, a portable device named watch-pat (itamar ltd, israel) was developed for the diagnosis of osa. validation study demonstrated a high correlation between watch-pat and psg in apnea-hypopnea index, lowest oxygen saturation and sleep time. this result suggested watch-pat can be performed as an alternative or supportive device of psg. watch-pat. the portable device also can be useful to detect osa in bus drivers who can be the reason for public traffic accidents. moreover, watch-pat can be applied to assess postoperative improvement of osa. although osa is known as one of the risk factors for cardiovascular disease, there is a lack of evidence to recommend of the evaluation of sleep disorder in patient with coronary artery disease. awareness and compliance for osa are very low in both patients and cardiologists. active diagnosis and treatment are definitely needed. therefore, the primary endpoint of this study is to evaluate the prevalence of osa in ami patients who treated pci. the secondary endpoint is to evaluate the 1-year incidence rate of macces according to the presence or absence of osa.


Eligibility criteria:
inclusion criteria: 1. age \> 20 years 2. successful pci in at least one major epicedial coronary artery exclusion criteria: 1. iabp or other hemodynamic support device 2. known osa on cpap treatment 3. intubation for mechanical ventilation 4. sedation given before watch-pat study 5. cardiogenic shock (sbp\<90mmhg) 6. heart failure requiring oxygen supplement 7. high risk of malignant ventricular arrhythmia 8. pregnancy 9. history of malignancy 10. expected life span \<12 months 11. inability to provide informed consent
genetic and environmental characteristics of primary pulmonary hypertension

Conditions: Lung Diseases; Hypertension, Pulmonary

Summary: the goal of this study is to identify the modifying genes and environmental features that regulate the clinical expression of mutations in bone morphogenetic protein receptor 2 (bmpr2); to develop the understanding of how bmpr2 mutations result in disease; and to identify the undiscovered genetic mutations that cause primary pulmonary hypertension (pph).

background: pph is a progressive disease that causes obstruction of the smallest arteries in the lungs, which often leads to heart failure. it threatens the lives of thousands of individuals. pph affects both genders at any age, although females are affected twice as often as males. in a recent important advance, mutations in bmpr2 were associated with both familial and sporadic pph. because only 20% of people with a bmpr2 mutation ever develop pph, other genes or modifying biologic events must contribute to the clinical development of the disease. pph was recently renamed idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension. design narrative: this study will utilize a database and specimen bank developed from 100 families affected by pph across the united states. in families with genetic mutations not yet identified, changes in the bmpr2 gene will be studied, including in the promoter and intronic regions, and chance recombination events that could confirm another locus near 2q33 will be examined. new methods will look for modifier genes in large families with known mutations; examine kindreds for mitochondrial dna haplotypes; and test candidate genes, including nos-1, nos-3, and the serotonin transporter. this study will determine the functional mechanisms by which variations found in the bmpr2 alleles alter bmp signal transduction by defining the biochemical effects of the mutant proteins on signaling pathways. in addition, the study will examine the perceived risks and benefits of clinical genetic testing and counseling in individuals from families at high risk for pph and will determine how this new information might be most helpful to these individuals and their families.

Eligibility criteria:
inclusion criteria: * diagnosis of pph, or family members of individuals diagnosed with pph, for inclusion in the database and specimen bank
radiation therapy to relieve symptoms in patients with advanced non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: this study will test the safety of quad shot radiation therapy using 2 different treatment schedules to find out what effects, if any, this treatment has on people with advanced nsclc who are receiving systemic therapy for their cancer. the quad shot treatment schedule reduces the number of days needed to deliver the radiation treatments, which may be less disruptive to systemic therapy schedules.


Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer with metastatic disease detected on cross-sectional imaging with a plan for one of the following systemic therapies: * carboplatin/paclitaxel * carboplatin/paclitaxel/pembrolizumab * carboplatin/pemetrexed * carboplatin/pemetrexed/pembrolizumab * pembrolizumab (single agent or in combination with other regimens in this list) * cisplatin/pemetrexed * cisplatin/pemetrexed/pembrolizumab * pemetrexed/pembrolizumab * pemetrexed * nivolumab (single agent or in combination with other regimens in this list) * ipilimumab/nivolumab * carboplatin/etoposide * carboplatin/etoposide/atezolizumab * cisplatin/etoposide * cisplatin/etoposide/atezolizumab * durvalumab (single agent or in combination with other regimens in this list) * atezolizumab (single agent or in combination with other regimens in this list) * patients eligible for the systemic therapy regimens notes * patients with stage iv nsclc who have symptomatic (defined by patient-reported cough, dyspnea, or hemoptysis) or near-symptomatic (determined radiographically to be threatening the airway, esophagus or vasculature) centrally located. * kps ≥ 60 * age ≥ 18 years. * able to provide informed consent. * patients at reproductive potential must agree to practice an effective contraceptive method. exclusion criteria: * previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. * serious medical co-morbidities precluding radiotherapy. * pregnant or breast-feeding women.

Keywords: cyclical hypofractionated palliative radiation (quad shot 20-148
effects of passive smoking on children during gastrointestinal endoscopy

Conditions: Gastro-Intestinal Disorders

Summary: to evaluate the effect of passive smoking in children during gastrointestinal endoscopy.

when the patients and their parents are arrived in the endoscopy unıt about 1 h before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment. then the parents smoking habits are documented about to detect the magnitude of passive smoking. endoscopist and anesthesiologist are blinded to the patients passive smoking history. then the sedation is applied and esophagogastroduodenoscopy procedures performed. side effects (e.g laryngospasm, coughing) during the study are recorded.

Eligibility criteria:
inclusion criteria: * asa ( american society of anesthesiologists) i- asa ii patients * aged 1- 18 year old patients exclusion criteria: * smoker patients

Keywords: esophagogastroduodenoscopy laryngospasm passive smoking sedation
factors for impairment of renal graft function in intensive care

Conditions: Graft Failure; Dialysis; Chronic Kidney Failure

Summary: hypothesis = hospitalization in the intensive care unit (icu) has an impact on the outcome of the renal graft, due to the therapeutic and exploratory procedures performed. the aim is to identify risk factors for renal graft degradation in the icu up to 2 years after hospitalization. optimization of renal graft management in the icu and management by nephrologists after the icu


Eligibility criteria:
inclusion criteria: * kidney graft * \> 18 years * first hospitalization in icu exclusion criteria: * chronic hemodialysis before icu * transfer to intensive care immediately after transplant within 24 hours
phase ii study of cholesterol- and cholestanol-free diet, lovastatin, and chenodeoxycholic acid for cerebrotendinous xanthomatosis

Conditions: Cerebrotendinous Xanthomatosis

Summary: objectives: i. assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in patients with cerebrotendinous xanthomatosis before and after a cholesterol- and cholestanol-free diet. ii. assess the biosynthesis of cholesterol and cholestanol, and measure the turnover of individual sterols and bile acids in these patients before and after lovastatin and chenodeoxycholic acid.

protocol outline: following a 2-week baseline assessment, patients participate in a feeding study for up to 3 weeks. the diet is free of cholesterol and cholestanol. for the next 4 weeks, patients return to their typical diet and are medicated with daily lovastatin and chenodeoxycholic acid. the feeding study is repeated for an additional 3 weeks, with the patient taking either lovastatin or chenodeoxycholic acid.

Eligibility criteria:
protocol entry criteria: cerebrotendinous xanthomatosis

Keywords: cerebrotendinous xanthomatosis inborn errors of metabolism rare disease
acute bronchiolitis and severity markers: interest in protein cc16

Conditions: Acute Bronchiolitis

Summary: acute bronchiolitis is a common viral infection in infants mainly due to rsv and rhinovirus. biomarkers can be useful for predicting its severity. the serum cc16 is a marker of epithelial aggression. its rate increase during rsv bronchiolitis in infants less than 7 months. it could be an early predictive biomarker of the severity of acute bronchiolitis, and secondarily for the development of asthma. two other markers of airway aggression seem to increase during acute bronchiolitis: serum sp-d protein and serum soluble receptor srage.

prospective, monocentric, case-control and study primary end-point: correlation between serum cc16 level and severity of the bronchiolitis, evaluated by a clinical scoring system established at the time of the admission in paediatric emergency unit. secondary end-points: correlation with urinary cc16; correlation with risk factors for bronchial epithelial aggression, viruses, immediate morbidity and mortality. study of serum sp-d and srage levels.

Eligibility criteria:
inclusion criteria: * infants under 1 year old hospitalized for acute bronchiolitis exclusion criteria: * broncho dysplasia * preterm under 34 weeks * cystic fibrosis * immune deficiency * suspicion of primary ciliary dyskinesia * congenital heart disease * acute renal failure

Keywords: acute bronchiolitis rsv cc16 sp-d srage severity biomarkers
pancreatectomy for net: external evaluation of who 2017 grading system

Conditions: Pancreatic Surgery

Summary: aim: the aim of this study was to investigate the clinicopathological factors and to evaluate the prognostic accuracy of the new world health organization (who) 2017 grading system in pancreatic neuroendocrine tumor (pannet) patients. methods: data collected between 1997 and december 2017 were analyzed. histological grading and staging was based on the who 2017 grading system. outcome after surgery and predictors of overall survival (os) and disease free survival (dfs) were evaluated.


Eligibility criteria:
inclusion criteria: - patients with histologically proven neuroendocrine tumor located in pancreas who underwent pancreatic resection (by open, laparoscopic or robotic approach) even in case of distant metastasis at time of surgery, with no previous or concurrent malignancy. exclusion criteria: - patients with tumors diagnosed as adenocarcinoma with scattered neuroendocrine cells or with focal neuroendocrine component were excluded of this study.

Keywords: neuroendocrine tumor survival who 2017 grading system pancreatectomy laparoscopy postoperative outcomes
intraoperative simultaneous pressure guided revascularization study

Conditions: Peripheral Vascular Diseases; Blood Pressure; Monitoring, Intraoperative; Clinical Decision-Making; Endovascular Procedures

Summary: this study aims to determine whether intraoperative physiologic measurements of blood flow to the leg during endovascular treatment of peripheral arterial disease (pad) can predict future clinical outcomes.

lower extremity peripheral arterial disease (pad) caused by atherosclerosis can cause cause leg pain, gangrene, and limb loss. pad is a result of poor blood flow to the extremity, and the emerging most common initial method of interventional treatment is endovascular therapy, for example angioplasty or stenting. the poor blood flow to the extremity can be inferred by the hemodynamic pressure of blood in the leg. these toe or ankle pressure measurements are typically performed before surgery to diagnose pad, and after surgery as surveillance. however, endovascular treatment has a high failure rate often exceeding 20% within a year. there is evidence that physiologic measurements prior to treatment and after treatment are closely related to clinical outcomes. this study introduces these physiologic measurements to the operating room, to determine if physiologic improvement can be detected instantaneously during endovascular revascularization. patients will be followed for a year following surgery to detect hemodynamic and clinical outcomes. the rationale of these intraoperative measurements would be to potentially guide future surgery, by providing real-time hemodynamic feedback to the operator.

Eligibility criteria:
inclusion criteria: * patients undergoing elective or semi-urgent endovascular procedures on lesions of the aorta, iliac, femoral, popliteal, or tibial arteries * symptomatic, atherosclerotic peripheral vascular disease. these symptoms include any rutherford's classification. exclusion criteria: * concurrent hybrid open procedure during endovascular revascularization requiring vascular clamping for any period of time, such as endarterectomy * prior open vascular surgery performed on the affected leg * emergent intervention for acute limb ischemia, defined as symptoms lasting less than 14 days * non-femoral vascular access

Keywords: intraoperative decision making revascularization physiologic monitoring feedback
personal electronic health records in improving screening rates for colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: use of a web-based risk assessment tool may help improve screening rates for colorectal cancer. purpose: this randomized clinical trial is studying personal electronic health records to see how well they work in improving screening rates for colorectal cancer.

objectives: * to assess whether screening rates for colorectal cancer (crc) can be substantially increased among adults in primary care through the use of a personal electronic health record that provides a link to a validated web-based tool to estimate an individual's risk of crc and electronic scheduling of crc screening exams. outline: this is a multicenter study. participants are stratified according to participating harvard vanguard medical associates (hvma) center. participants are randomized to 1 of 2 arms. * intervention arm: participants receive an electronic message within their myhealth account on behalf of their primary care physician providing a link to a web-based tool to allow them to assess their personal risk of colorectal cancer (crc). the tool provides an estimate of an individual's personal risk of developing different types of cancer over the next 10 years relative to others of the same age and sex. the tool also recommends steps that individuals can take to reduce their risk. the tool includes questions about family history; prior screening tests; dietary habits (red meat, fruits, and vegetables); weight and height; and use of folate, aspirin, estrogen therapy, alcohol, and tobacco. in addition, the electronic message provides information regarding options for crc screening, emphasizing colonoscopy every 10 years per the current hvma guidelines, followed by the secondary recommendation of annual fecal occult blood testing. detailed information is provided in the form of a link to online educational materials. participants may request either colonoscopy or fecal occult blood testing by responding to the electronic message and indicating their preference. participants who request colonoscopy are contacted by the gastroenterology department to proceed with crc screening; participants who request fecal occult blood testing will receive a stool card test kit in the mail from their primary care physician. * control arm: participants receive no intervention.

Eligibility criteria:
disease characteristics: * overdue for colorectal cancer screening (identified using automated extracts from the electronic medical record), as defined by the following criteria: * no fecal occult blood test within the past 12 months * no flexible sigmoidoscopy within the past 5 years * no colonoscopy within the past 10 years * receiving primary care at a harvard vanguard medical associates (hvma) center * registered to use the hvma patient portal (myhealth) and has an active myhealth account patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: colon cancer rectal cancer
the role and mechanism of vimentin in sepsis patients

Conditions: Sepsis

Summary: sepsis is the most common cause of death in the clinical critically ill patients. we have successfully screened the sepsis biomarkers by clinical proteomics approach and found that vimentin (vim) played an important role in the occurrence and development of sepsis. however, the exact mechanism is remaining unclear. in this study, the relationship between the changes of peripheral circulation vim expression and different stages of sepsis development will be further verified in lager clinical trials, as well as the relationship between vim expression and apoptosis of immune cells (e.g lymphocytes) will also be clarified. this may indicate that the role of vim in the cell-mediated immunity apoptosis and inflammation-related pathways. through the implementation of this study, we can clarify the clinical value of vim and the mechanism of vim-mediated immune cell apoptosis during the sepsis development from the molecular level, and determine whether the vim as a new target for sepsis diagnosis and treatment.


Eligibility criteria:
inclusion criteria: sepsis 3.0 was adopted to selected participants exclusion criteria: participants were excluded if they were younger than 18 years of age; contracted acquired immunodeficiency syndrome; had reduced polymorphonuclear granulocyte counts (\<500 μl-1); died within 24 h after admission to the icu; refused to participate in the study; or declined treatment during the period of observation.

Keywords: vimentin sepsis immune cells apoptosis