Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of the ability of spyglass cholangioscopy to facilitate radiation free ercp

Conditions: Choledocholithiasis; Biliary Obstruction

Summary: prospective evaluation of the ability of spyglass cholangioscopy to facilitate radiation free ercp for non-complex bile duct stone disease.


Eligibility criteria:
inclusion criteria: 1. age 18 and above 2. non-complex biliary stone disease involving stones in the common bile or common hepatic duct. 3. patient has undergone non-invasive imaging (abdo us, mrcp etc) which clearly delineates bile duct diameter and suggests non complex biliary stone disease. 4. willing and able to comply with the study procedures and provide written informed consent to participate in the study. exclusion criteria: 1. age \<18 2. potentially vulnerable subjects including, homeless people, pregnant females, employees and students. 3. participation in another related investigational study that could affect the results of this study within the previous 30 days 4. complex biliary stone disease cases with unusual location of the stones (intra hepatic, cystic duct, stone proximal to bile duct stricture) 5. known bile duct infection (cholangitis defined as ongoing fevers on the day of the ercp procedure or purulence evident at the ampulla or bile duct on cannulation/sphincterotomy. if clear bile is aspirated during the study procedure, we will proceed according to study procedures. if purulence is detected upon aspiration of bile during the procedure, patient will be excluded from the study and undergo standard radiation-based ercp rather than cholangioscopy.) 5) complex post-surgical anatomy e.g. billroth type ii anatomy, roux-en-y-gastrojejunostomy

Keywords: ercp, choledocholithiasis, cholangioscopy
toripalimab plus radiotherapy for elderly esophageal cancer patients treated with non-chemotherapy strategy

Conditions: Esophageal Cancer; Radiation Therapy; Immunotherapy; Chemotherapy

Summary: the goal of this clinical trial is to explore the therapeutic efficacy of immune checkpoint inhibitors combined with radical radiotherapy in elderly patients with esophageal cancer.

older patients with esophageal cancer are universally intolerant to chemotherapy. this study is performed to explore a non-chemotherapy strategy for elderly esophageal cancer patients. participants will be treated with toripalimab monoclonal antibody maintenance versus s-1 combined with radiotherapy, intended to explore the efficacy and safety of non-chemotherapy strategy for elderly esophageal cancer patients.

Eligibility criteria:
inclusion criteria: carcinoma of the esophagus confirmed histologically or cytologically. lesions that can be measured according to the recist standard. ajcc/uicc staging of esophageal carcinoma (sixth edition) clinical staging ⅱa to ⅲ. age ≥ 70 years ≤ 85 years old. the ecog physical state score is 0 to 1. no esophageal perforation, active esophageal bleeding, or significant invasion of trachea or thoracic aorta. patients with not previously received chest radiation and speech therapy, immunotherapy, or biological therapy. hemoglobin ≥ 100g/l, platelets ≥ 100 \* 10\^9/l, absolute neutrophil count ≥ 1.5 \* 10\^9/l。 serum creatinine ≤ 1.25 times unl or creatinine clearance ≥ 60 ml/min. serum bilirubin ≤ 1.5 times unl, ast (sgot) and alt (sgpt) ≤ 2.5 times unl, and alkaline phosphatase ≤ 5 times unl. no history of interstitial pneumonia or previous interstitial pneumonia. fev1\>0.8l。 the patient signs a formal informed consent form. exclusion criteria: patients with chest radiation, chemotherapy, or surgical resection of esophageal cancer before the start of this trial patients with multifocal esophageal cancer, and the lower boundary of the primary lesion of the esophagus is less than 3cm from the esophageal gastric junction. patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a previous history of interstitial pneumonia. patients with obvious esophageal ulcer, moderate or above pain in chest and back, and symptoms of esophageal perforation. patients who cannot understand or may not comply with the test requirements. patients with other malignant lesions, except for curable skin cancer (non melanoma), cervical carcinoma in situ or malignant disease that has been cured for ≥ 5 years. researchers believe that some obvious diseases should be excluded from this study.
effect of lactose in patients with chronic liver disease and minimal hepatic encephalopathy

Conditions: Hepatic Encephalopathy; Liver Cirrhosis

Summary: two groups of patients with minimal hepatic encephalopathy will be studied. the treatment group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive "lactose-free" milk (3.5 g of lactose) two times a day for 21 days. clinical history, nutritional assessment, biochemical studies, psychometric tests, critical flicker frequency and a quality of life questionnaire will be performed. the patient will be assessed weekly 21 days. an external monitor will control the randomization process in order to allocate the patients into both study group and will not share the assignation codes with anyone until the end of the study.

mortality due to chronic liver disease is among the first five causes of mortality related to digestive tract and liver diseases in patients on productive age. one of the most frequent complications of chronic liver insufficiency is minimal hepatic encephalopathy (mhe), which affects the quality of life and predisposes to the development of clinical hepatic encephalopathy. there are few evidences on the therapeutic alternatives for minimal hepatic encephalopathy. the administration of non-absorbable disaccharides has been proven to ameliorate mhe. lactose maldigestion may justify the use of lactose in patients with chronic liver disease as a non-absorbable disaccharide for the treatment of mhe. the aim of our study is to evaluate the efficacy of lactose administration in patients with minimal hepatic encephalopathy.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic liver disease of whichever etiology * minimal hepatic encephalopathy * lactose maldigestion exclusion criteria: * patients with clinical manifestations of hepatic encephalopathy * recent use of antibiotics or psychotropic drugs * recent use of alcohol abuse * gastrointestinal bleeding * others neurological disorders that affect the psychometric test * chronic renal failure * congestive heart failure * chronic obstructive pulmonary disease * severe symptoms of lactose intolerance

Keywords: hepatic encephalopathy liver cirrhosis disaccharides lactose quality of life
effects of egg ingestion on endothelial function in adults with coronary artery disease

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine the effects of daily consumption of eggs or egg substitute for 6 weeks on endothelial function and on cholesterol and lipoprotein levels in participants with clinically established coronary heart disease (chd).

restriction of dietary cholesterol, and thus the avoidance or restriction of egg intake, is routinely recommended to patients with coronary disease. however, the relative importance of dietary cholesterol to serum lipids has become a subject of active debate. eggs provide a complete array of amino acids and an array of micronutrients, and are low in total fat. epidemiological and clinical studies have showed that dietary intake of omega-3 fatty acids decreases the risk of coronary heart disease (chd). endothelial function testing represents a uniquely valuable means of assessing aggregated influences on cardiac risk by gauging physiologic responses of the vascular endothelium. in prior studies the investigators have shown that daily egg ingestion for 6 weeks did not adversely affect endothelial function in healthy adults or in hyperlipidemic adults. the investigators now propose a prospective, randomized, single-blind crossover study to assess the effects of eggs, egg substitute and high-carbohydrate american breakfast on endothelial responses and serum lipids in participants with clinically established chd.

Eligibility criteria:
inclusion criteria: 1. males age greater than 35 years; 2. post-menopausal females not currently on hormone replacement therapy; 3. non-smokers; 4. cvd as defined by the presence of at least one coronary stenosis \>50% determined angiographically or a documented history of myocardial infarction. exclusion criteria: 1. failure to meet inclusion criteria; 2. anticipated inability to complete study protocol for any reason; 3. current eating disorder; 4. use of lipid-lowering or antihypertensive medications unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to ef scanning; 5. regular use of high doses of vitamin e or c; 6. use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutraceuticals; 7. regular use of fiber supplements; 8. diabetes; 9. sleep apnea; 10. restricted diets by choice (i.e., vegetarian, vegan); 11. coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin.

Keywords: coronary artery disease egg consumption endothelial function
information improvement for surgical patients through portable video media

Conditions: Prostatic Hyperplasia; Bladder Cancer

Summary: the aim of this study is to evaluate the comprehension of the informed consent with the standard verbal communication (svc) versus portable video media (pvm).

the informed consent (ic) is a fully ethical and legal consolidated requirement. ic is the voluntary authorization by a patient for surgical treatment (mesh). the ic has to include: 1. what is and for what is it, 2. how is it made, 3. what effect will produce, 4. which patients will benefit, 5. alternatives, 6. risks and special situations. the standard ic is based in written and verbal information, but the information provided is insufficient, leading to misunderstanding and even litigation. technology plays an important role in the improvement of ic: the portable video media, tablet, with the application (app) iuro assists the procedure through videos and illustrations. to evaluate and measure the comprehension of the information that patients received, we elaborated and validated a "questionnaire to evaluate the comprehension of ic" (the process was mounted as "questionnaire for urology ic validation" in the poster session at the 17th international european association of urology nurses (eaun) meeting, munich-germany). the patients undergoing to bladder or prostate transurethral resection were selected. afterwards they were randomized previous the interview, into two groups: patients informed by pvm with the app iuro (experimental group) versus patients with an svc (control group). the questionnaire was used to compare the comprehension of the surgery immediately and 15 days after the surgery. the items regarding questionnaire were: information, utility of the intervention, side effects, complications, comorbidity, usefulness of information, anxiety and risks.

Eligibility criteria:
inclusion criteria: * patients who are going to receive transurethral resection of bladder or prostate * patients, women and men, older than 18 years without any mental disability exclusion criteria: * patients who refuse to participate in the study * patients who have inability to communicate in spanish. * several visual problems that limit the ability to read written material

Keywords: informed consent patient education mobile applications
covid-19 - multicentre study on nosocomial transmission of sars-cov-2 virus: an ancillary study (noso-cor immuno)

Conditions: Infection Viral

Summary: there are still uncertainties about the existence of protective immunity and the duration of protective antibodies in patients infected with sars-cov-2. serological testing is an appropriate tool for epidemiological investigations to assess the persistence of antibodies over time. the nature of the immune response induced by this virus is also poorly understood. this ancillary study aims at assessing the immunological characteristics of patients that participated in the noso-cor study at hospices civils de lyon six and twelve months after the initial infectious episode. two visits will be scheduled at 6 and 12 months (± 1 month) after the initial sars-cov-2 infectious episode, blood, saliva and nasopharyngeal samples will be collected for seroprevalence and immunological investigation.


Eligibility criteria:
inclusion criteria: sars-cov-2 confirmed by rt-pcr * adults \> 18 years * signed consent form * affiliated to the french health system exclusion criteria: * pregnant women * hospitalized patients * individuals subject to legal protection * imprisoned individuals * individuals who have expressed an opposition to participate, or who do not wish to donate blood samples
capsaicin cream as an adjunctive therapy for nausea and vomiting of pregnancy

Conditions: Hyperemesis Gravidarum; Nausea Gravidarum; Vomiting of Pregnancy

Summary: between fifty and eighty percent of pregnant women experience nausea and vomiting in pregnancy making it one of the most common medical complications of pregnancy. hyperemesis gravidarum is an extreme form of nausea and vomiting of pregnancy and results in evidence of acute starvation (i.e. large ketonuria), and weight loss (\>5% of a woman's pre-pregnancy weight). hyperemesis gravidarum is also surprisingly common. in fact, it is the second leading cause of preterm hospitalization during pregnancy, second only preterm labor. hospitalization is often required because hyperemesis is frequently refractory to common anti-nausea medications. however, capsaicin cream, a potent trpv1 agonist, commonly used to relieve muscular and neuropathic pain, may be able to reduce the symptoms of nausea and emesis in patients with nausea and vomiting of pregnancy. smaller studies have demonstrated capsaicin to be both safe and effective when used to treat intraoperative nausea during cesarean delivery. to begin to address whether capsaicin cream could be used to reduce preterm admissions and shorten emergency room visits for hyperemesis, this study will randomize women presenting to the emergency room for nausea and vomiting to treatment with capsaicin cream as an adjunctive medication or routine care. the project will investigate the impact of capsaicin cream on hospital length of stay as well as representation for additional treatment. if effective, capsaicin cream has the potential not only to reduce emergency room visits, hospital admissions and overall health care costs, but also to drastically improve patient quality of life.


Eligibility criteria:
inclusion criteria: * pregnant women in the first trimester (0-14 weeks gestation) * presenting to the emergency room at women \& infants hospital in rhode island with a chief complaint of nausea and vomiting * english or spanish speaking * have not taken an anti-emetic such as reglan or zofran within the 6 hours prior to presentation exclusion criteria: * allergy to reglan, capsaicin or zofran * another identifiable source for nausea and vomiting (i.e. gastritis, covid, diabetic ketoacidosis) * molar pregnancies, * patients with a history of gastroparesis * patients with a history of preexisting diabetes mellitus

Keywords: capsaicin nausea vomiting pregnancy hyperemesis gravidarum
inflammatory profiling in chronic lung disease

Conditions: Pulmonary Hypertension

Summary: the aim of this study is to investigate the underlying inflammatory profile in patients with chronic lung disease and determine the association pulmonary hypertension.

chronic lung diseases (cld), such as chronic obstructive pulmonary disease (copd) and idiopathic pulmonary fibrosis (ipf) are often complicated by the presence of pulmonary hypertension (ph), where even a mild elevation of blood pressure in the pulmonary arteries is associated with an even poorer prognosis. in this study, we will investigate whether similarities exist in the inflammatory profile that could potentially underlie all forms of pulmonary hypertension. inflammatory data will be generated using flow cytometry, expression profiling and histological analysis and compared to the associated clinical data.

Eligibility criteria:
inclusion criteria: * patients undergoing lung transplant with copd or ipf, with associated ph * signed informed consent exclusion criteria: * patients without written informed consent * signs of any infection such as pneumonia, pulmonary tuberculosis or infections with pleural effusions.

Keywords: vascular diseases lung diseases respiratory tract diseases
skin and blood research samples from healthy volunteers and patients with hematologic diseases

Conditions: Anemia, Sickle Cell

Summary: the investigators plan to obtain skin and blood samples from healthy volunteers and patients with a benign, inherited hematologic disease to use for research to use homologous recombination to correct β-globin gene mutations in therapeutically useful cells, like autologous induced pluripotent stem cells from sickle cell anemia patients.

* to obtain skin biopsy samples from normal healthy volunteers and patients with a benign, inherited hematologic disease, such as sickle cell anemia, to create induced pluripotent stem cells. pluripotency will be confirmed by injecting potential ips cell lines into immunodeficient mice, assessing the ability of each line to cause cystic teratomas in recipient mice. * to define the efficiency of homologous recombination in induced pluripotent stem cells derived from skin biopsy samples. * to define the efficiency of homologous recombination in human embryonic stem cells using nih-approved cell lines. * to establish the genetic consequences of the derivation of human induced pluripotent cells in normal controls or patients with benign, inherited, hematologic diseases, by genomic analysis, including whole genome sequencing. * to establish the genetic consequences of homologous recombination in human induced pluripotent stem cells and embryonic stem cells by genomic analysis, including whole genome sequencing. * to obtain blood samples to confirm genetic mutations in patients with an inherited hematologic disease (and to confirm no mutations in healthy volunteers).

Eligibility criteria:
inclusion criteria: * age ≥ 18. * no active systemic skin infection at biopsy site. * no allergy to lidocaine or other local anesthetics exclusion criteria: all patients * history of a bleeding disorder, easy bleeding, or bruising. * inability or unwillingness to provide informed consent. sickle cell patients * platelets ≤ 50,000 * inr ≥ 1.5 * currently bing given intravenous heparin

Keywords: stem cells
a study to assess changes in clinical management after datscan imaging of subjects with clinically uncertain parkinsonism or an illness with similar symptoms

Conditions: Parkinsonian Syndromes

Summary: patients come to their doctor showing possible symptoms of a movement disorder. it is possible that these symptoms may get worse over time. there is more than one disease that can cause such symptoms. the most common movement disorder illnesses are parkinson´s disease and essential tremor. sometimes it is difficult for doctors to make the right diagnosis because the symptoms caused by these illnesses are almost the same. on the other hand the correct treatment for parkinson´s disease is different from the correct treatment for essential tremor. this study aims to see whether having pictures of the brain taken with datscan can affect the way the doctor treats these patients and whether it can affect their quality of life directly.


Eligibility criteria:
inclusion criteria: * subjects with clinically uncertain parkinsonian syndromes or monosymptomatic, atypical or incomplete presentation of tremor, rigidity, bradykinesia or postural instability. * onset of clinical manifestations within the last 5 years exclusion criteria: * differential diagnosis between parkinsons´s disease and progressive supranuclear palsy or between parkinson´s disease and multiple system atrophy * subjects with an established/certain movement disorder clinical diagnosis * presence of known causes of tremor

Keywords: parkinsonian syndromes, parkinsonism, datscan, spect, clinical management, quality of life, movement disorder clinically uncertain parkinsonian syndromes
safety and efficacy study of ciprofloxacin for inhalation in patients with non-cystic fibrosis bronchiectasis "orbit-1"

Conditions: Non-Cystic Fibrosis Bronchiectasis

Summary: the purpose of this study is to evaluate the safety and efficacy of ciprofloxacin for inhalation in the treatment of patients with non-cystic fibrosis (cf) bronchiectasis.


Eligibility criteria:
inclusion criteria: 1. are willing and able to provide written informed consent. 2. are males or females 18 to 80 year of age, inclusive. 3. have had a confirmed diagnosis of non-cf bronchiectasis per high resolution computed tomography (hrct) for at least 4 years. 4. confirmation of infection with p. aeruginosa at screening exclusion criteria: 1. have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics. 2. have an exacerbation during the screening phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug. 3. have a diagnosis of cystic fibrosis.. 4. have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to visit 1: * azithromycin * hypertonic saline * bronchodilator medications * oral corticosteroid. 5. have received an investigational drug or device within 28 days prior to visit 1. 6. have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients' treatment, assessment, or compliance with the protocol.

Keywords: pseudomonas aeruginosa antimicrobial inhalation ciprofloxacin non-cystic fibrosis bronchiectasis