Kornimate/medical-research-clean huggingface dataset:
study to assess the efficacy and safety of sk-ms10 in subjects with acute and chronic gastritis

Conditions: Erosive Gastritis

Summary: the purpose of this study is to assess the efficacy and safety of sk-ms10 in subjects with acute and chronic gastritis.


Eligibility criteria:
inclusion criteria: 1. have been diagnosed as erosive gastritis by endoscopy within 1 weeks before enrollment. 2. patients who voluntarily signed written informed consent may participate in the study. exclusion criteria: 1. pregnant or lactating female. 2. patients have gastric ulcer, duodenal ulcer and gerd. 3. use of any proton pump inhibitor, h2-receptor antagonist, muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study drug therapy 4. patients requiring corticosteroid therapy 5. severe neurological or psychological disease 6. history of allergic reaction to the medications used in this study 7. use of other investigational drugs within 30 days prior to the study. 8. patients that investigators consider ineligible for this study
laparoscopic iieocecus-sparing right hemicolectomy for cancer of the hepatic flexure and proximal transverse colon

Conditions: Hepatic Flexure Colon Cancer; Proximal Transverse Colon Cancer

Summary: to investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe

our study is a single arm, single center clinical trial. the enrolled patients will accept laparoscopic ileocecus-sparing right hemicolectomy. the primary endpoint: postoperative complications, 1-year local recurrence. the second endpoint: conversion to conventional right hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year disease free survival, r0 resection, specimen morphometry

Eligibility criteria:
inclusion criteria: 1. patients suitable for curative surgery 18-75years old 2. asa grade i-iii 3. qualitative diagnosis: a pathological diagnosis of adenocarcinoma; 4. localization diagnosis: the tumor located at hepatic flexure and proximal transverse colon(proximal to the right branch of middle colic artery); 5. enhanced ct scan of chest, abdominal and pelvic cavity: assessment of tumor stage is t1-t4n0 or tanyn+; there is no distant metastasis. 6. intraoperative measurement: the distance between colic branch of ileocolic artery and proximal edge of the tumor should be longer than 5cm. 7. informed consent exclusion criteria: 1. simultaneous or metachronous multiple primary colorectal cancer; 2. history of familial adenomatous polyposis, ulcerative colitis or crohn's disease. 3. preoperative imaging examination results show: fused lymph node at the root of ileocolic artery. 4. distant metastasis. 5. history of any other malignant tumor in recent 5 years. 6. patients need emergency operation. 7. not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc). 8. informed consent refusal

Keywords: hepatic flexure colon cancer proximal transverse colon cancer ileocecus-sparing laparoscopic right hemicolectomy
power exercise for stroke recovery: the power feasibility trial

Conditions: Stroke

Summary: post-stroke deficits are highly common and functional impairment persists throughout life after stroke. skeletal muscle mass and strength are fundamental contributors to mobility throughout the adult life course. stroke-related muscle atrophy contributes to loss of strength, and declines in lower extremity function, cardiorespiratory fitness, and walking independence and post-stroke sarcopenia. improving the quantity and function of skeletal muscle needs to be an important therapeutic target after stroke. resistance exercise training (ret) has been shown to increase skeletal muscle mass, strength and power, reduce oxidative stress, improve cardiac function, and better regulate lipids after stroke. however, the feasibility and the effects of a power focused ret program for individuals with stroke need to be examined.

this study is a single-group, open label trial examining the feasibility and preliminary effect estimates of a 10-week power-focused exercise training program in people living with stroke. fifteen participants with chronic stroke will participate in the exercise program 3 times per week for 10 weeks at a progressive intensity. the program will take place at a community exercise gym built for older adults and people with physical disabilities. feasibility outcomes will be assessed throughout the trial. effectiveness outcomes will be assessed at baseline and immediately post-intervention.

Eligibility criteria:
inclusion criteria: * ≥18 years old * ≥6 months post-stroke * able to walk \>10 meters with or without the use of an assistive device * living in the community * mild to moderate stroke severity (modified rankin scale ≤3) exclusion criteria: * any contraindications to exercise for people with cardiovascular disease, such as unstable angina, uncontrolled hypertension, orthostatic blood pressure with exercise, or uncontrolled arrhythmias * significant cognitive impairment that would preclude safe exercise participation (montreal cognitive assessment score \<26) * actively engaged in stroke rehabilitation services

Keywords: stroke resistance training power training feasibility study skeletal muscle
protocolized post-extubation respiratory support study

Conditions: Mechanical Ventilation Complication; Acute Respiratory Failure; Intubation Complication

Summary: invasive mechanical ventilation is common in the medical intensive care unit, and the period of time following extubation remains high risk as 11 to 15% of patients require reintubation after their first extubation. reintubation is associated with increased rates of nosocomial infection and is an independent predictor of mortality. non-invasive ventilation and high flow nasal cannula are the only therapies that have been shown to reduce the rate of reintubation. recent clinical trials suggest that all patients might benefit from some form of post-extubation respiratory support, but use of these therapies in usual care remains low. proper is a cluster-randomized, multiple-crossover trial comparing a respiratory therapist driven protocol to provide post-extubation respiratory support to all patients, compared to usual care. the trial will enroll patients undergoing extubation in the medical icu at vanderbilt from october 2017 until march 2019. the primary outcome will be reintubation within 96 hours.

proper is a prospective, pragmatic, cluster-randomized, multiple-crossover trial comparing a respiratory therapist driven protocol for post-extubation respiratory support to usual care. the primary outcome will be reintubation by 96 hours. all adults (age 18 or older) who receive at least 12 hours of mechanical ventilation and are extubated in the vanderbilt medical icu will be enrolled in the trial. the icu will be divided into 2 clusters, based on the geographic areas covered by the two respiratory therapist dedicated to that icu. the study will occur in three month blocks. one cluster will be randomized to receive protocolized post-extubation respiratory support (as prescribed by a protocol and delivered by a respiratory therapist), while the other cluster receives usual care, which can include post-extubation respiratory support when requested by the clinical team. at the end of three months, the clusters will cross-over, such that each cluster will spend half of the study receiving protocolized post-extubation respiratory and half of the study receiving usual care. it is anticipated that approximately 630 patients will be enrolled from the medical icu during the 18 month study period.

Eligibility criteria:
inclusion criteria: 1. patient is located in a participating unit 2. patient undergoing extubation from mechanical ventilation 3. patient has been receiving mechanical ventilation for at least 12 hours 4. age ≥ 18 years old exclusion criteria: 1. patient is receiving ventilation via a tracheostomy 2. patient is being extubated to comfort measures or has "do not reintubate" order in place at the time of extubation 3. patient has required reintubation after a prior attempt at extubation during this hospitalization 4. unplanned or self-extubation, where immediate reintubation is deemed necessary by the clinical team
covid-19 and va-lrti: second versus first wave of the pandemic

Conditions: Severe COVID-19

Summary: multicenter observational retrospective cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between covid-19 patients from the first and the second wave of the pandemic.

covapid2 is a multicenter retrospective observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between covid-19 patients from the first and the second wave of the pandemic. patients with confirmed sars-cov-2 community-acquired pneumonia and receiving invasive mechanical ventilation for more than 48h in the participating icus from the start of covid pandemic are eligible for this study. consecutive patients will be included from the beginning of the first wave (starting on 01-01-2020, data already collected in the covapid1 study) and the second wave (starting on 10-01-2020). 10-20 patients per wave will be included in each center. vat and vap are defined using clinical, radiological and quantitative microbiological criteria.

Eligibility criteria:
inclusion criteria: * major (18 years and older) * admitted to the icu * intubated and mechanically ventilated for more than 48 hours * with a confirmed community-acquired sars-cov2 pneumonia exclusion criteria: * refusal to participate * lack of social security coverage

Keywords: sars-cov-2 ventilator-associated tracheobronchitis ventilator-associated pneumonia bacterial co-infection covid-associated pulmonary aspergillosis
healthy directions after lung surgery pilot

Conditions: Carcinoma, Non Small Cell Lung

Summary: the objective of this proposal is to test the feasibility and acceptability of a lifestyle risk reduction intervention for patients with lung cancer receiving surgical treatment. this study will provide the preliminary data needed to conduct a larger randomized controlled trial that tests an innovative, multidisciplinary intervention that has the potential to transform the standard of care for patients receiving surgical treatment for lung cancer.


Eligibility criteria:
patient inclusion criteria: * \> 21 years of age * english speaking * md approval to participate in study * meets one of the inclusions below: * 1. a histological diagnosis of nsclc undergoing potentially curative treatment * 2. or those undergoing surgical procedures for lung cancer (includes patients undergoing diagnostic testing or those presenting with lung nodules * 3.or patients who have had a surgical procedure for lung cancer within the last six months. * may invite a buddy to join study with them defined as a friend, partner, adult child or sibling buddy inclusion criteria: * ≥ 21 years of age, * english speaking, who is invited by the subject to join as a support person (e.g., friend, partner, adult child or sibling)

Keywords: non-small cell lung cancer (nsclc) multiple risk factor lifestyle intervention health behavior lifestyle risk reduction health related quality of life
studies of pancreatic islet mass by positron emission tomography (pet)

Conditions: Type 1 Diabetes

Summary: this study investigates the hypothesis that differences in beta-cell mass in patients with diabetes and healthy individuals can be monitored by the positron emission tomography (pet) tracer \[11c\]5-hydroxytryptophane.


Eligibility criteria:
inclusion criteria: * adult patients with type 1 diabetes * adult, healthy controls exclusion criteria: * pregnancy * impaired renal function
alpha1 antitrypsin aerosol therapy in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the hypothesis being tested is that inhibition of the enzyme known as elastase in the airways of patients with cystic fibrosis will help decrease the number of bacteria. alpha1 antitrypsin, an elastase inhibitor, will be given to patients with cystic fibrosis by aerosol therapy twice in 1 day and sputum will be collected to measure the density of bacteria

cystic fibrosis is usually characterized by chronic bacterial infections of the airways. neutrophils release the enzyme elastase in the airways and this enzyme can prevent the ingestion and killing of bacteria by the airway phagocytic cells. the hypothesis being tested is that inhibition of elastase in the airways will help neutrophils decrease the number of bacteria. each subject with cystic fibrosis will first undergo aerosol therapy with a sterile saline solution and sputum will be collected 2, 4 and 6 hours after the aerosol therapy to measure the density of bacteria. subsequently, alpha1 antitrypsin, an elastase inhibitor, will be given to the same patients by aerosol therapy twice in 1 day and sputum will be collected at 2, 4 and 6 hours after treatment to measure the density of bacteria. the results will be compared to those obtained after after aerosol therapy with saline solution. study phase ii study type interventional study design purpose - treatment allocation - nonrandomized trial masking - open control - active assignment - cross-over endpoint - efficacy primary outcome measure bacterial density in sputum as determined by colony forming units at 2, 4 and 6 hours after prolastin therapy.

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis * age 14 years and older * women must have a negative pregnancy test and used effective contraception * must be able to produce sputum * sputum culture positive for pseudomonas aeruginosa exclusion criteria: -
fecal microbiome transplantation (fmt) for type 1 diabetes

Conditions: Type 1 Diabetes

Summary: this study intends to reconstruct intestinal micro-ecology through fecal microbiome transplantation (fmt) technology, to treat patients with type 1 diabetes, and combine intestinal metagenomics and 16s rrna sequencing technology to study the relevant mechanism of intestinal micro-ecology for the treatment of type 1 diabetes.

type 1 diabetes is an organ-specific autoimmune disease based on islet beta cell-specific destruction and absolute insulin deficiency. studies on the pathogenesis of intestinal flora and type 1 diabetes have shown that as an "endocrine organ", intestinal microbes play an important role in regulating the secretion of the body. bacteria in the intestine can not only directly synthesize hormones or hormone-like compounds, but also regulate the synthesis and secretion of corresponding hormones in the widely distributed intestinal endocrine cells, thereby participating in the regulation of various biological functions in the human body. this study uses fecal microbiome transplantation (fmt) to explore another potential treatment for type 1 diabetes.

Eligibility criteria:
inclusion criteria: * (1) type 1 diabetes patients. * (2) age between 18 and 65 years old, regardless of gender. * (3) no serious comorbidities. * (4) accept and suitable for endoscopic catheterization (tet) and fecal transplantation (fmt). * (5) can receive follow-up and follow-up examinations on time. (6) subjects need to sign an informed consent form. exclusion criteria: * (1) systematic application of glucocorticoids, other immunosuppressive drugs or biological immune modulators, antibiotics, probiotics, and other microecological agents to alter intestinal motility within 6 months prior to enrollment. * (2) an infection that is active. * (3) combined with irritable bowel syndrome, inflammatory bowel disease, celiac disease, and other chronic gastrointestinal diseases, the condition has not been controlled. * (4) chronic diseases such as cerebrovascular disease, cardiovascular disease, and diabetic autonomic neuropathy. * (5) pregnancy or with a pregnancy plan * (6) severe organ dysfunction (including decompensated cirrhosis, malignant tumors, etc.)

Keywords: fecal microbiome transplantation (fmt)
sarpogrelate drug interaction

Conditions: Hypertension; Peripheral Artery Disease

Summary: this is a randomized, open-label, single \& multiple-dose, three-sequence, three-period crossover study to investigate the effect of sarpogrelate hydrochloride on the disposition of metoprolol tartrate in healthy male volunteers

eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ecg) and clinical laboratory tests within 4 weeks before study drug administration. subjects suitable for this study will be admitted to the clinical trial center of ajou university medical center on the day before dosing (day -1). on day 1, subjects will be dosed study drug (metoprolol tartrate 100 mg once a day only, or metoprolol tartrate 100 mg once a day with sarpogrelate hydrochloride 100 mg three times a day, sarpogrelate hydrochloride 100 mg three times a day pretreatment for three days and metoprolol tartrate 100 mg once a day with sarpogrelate hydrochloride 100 mg three times a day). pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing. after one week of washout period (day 8), subjects will be dosed study drug by crossover manner, and pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing. after one week of washout period (day 15), subjects will be dosed study drug by crossover manner, and pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing.

Eligibility criteria:
inclusion criteria: * healthy male subjects aged 20 - 45 years * with in 20% of ideal body weight, {ideal body weight=\[height(cm)-100\]\*0.9} * agreement with written informed consent exclusion criteria: * clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (past history or present) * inadequate result of laboratory test (especially, ast/alt \> 1.25 x unl, total bilirubin \> 1.5 x unl) * positive reaction in the hbs ag, anti-hcv ab, anti-hiv ab, vdrl test * taking otc(over the counter)medicine including oriental medicine within 7 days * clinically significant allergic disease (except for mild allergic rhinitis and dermatitis seems to be not need for medication) * subject with known for hypersensitivity reaction to metoprolol or sarpogrelate * previous whole blood donation within 60 days or component blood donation within 30 days * previous participation of other trial within 90 days * continued taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day) * an impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Keywords: drug-drug interaction pharmacokinetics pharmacodynamics
the role of the gut metagenome on the development of age related macular degeneration (amd)

Conditions: Age Related Macular Degeneration

Summary: the primary objective of this study is to assess whether compositional and functional alterations of the gut metagenome may be related to amd. the primary variable for this assessment is the composition of the gut metagenome which will be analyzed by shotgun sequencing to characterize the faecal metagenome. the secondary endpoint is to assess whether single nucleotide polymorphisms in cfh, arms2, c3, plekha1, htra-1, vegf-a, vegf-b, vegfr and apoe genes which have been shown to be risk factors for the development of amd and other macular diseases correlate with alterations in the gut metagenome .

age-related macular degeneration (amd) is the most frequent cause of blindness in the elderly. despite major research efforts in the last decades the etiology of amd remains largely undefined and therefore treatment options are only very limited. however, there is evidence that nutrition and inflammation play a role in the pathogenesis of amd . the latter is also corroborated by the finding that single nucleotide polymorphism in the gene encoding complement factor h is associated with amd . in addition to chf other genes such as arms2, c3, plekha1, htra-1, vegf-a, vegf-b, vegfr and apoe have been associated with development of amd. recent findings have implicated the gut microbiota as a contributor of metabolic diseases through the modulation of host metabolism and inflammation . gut bacteria use mostly fermentation to generate energy, converting sugars, in part, to short-chain fatty acid, that are used by the host as energy source. beyond short-chain fatty acids gut bacteria can provide some amino acids and contribute certain vitamins such as biotin to the host . the investigators propose to investigate whether compositional and functional alterations of the gut microbiota are a risk factor for developing amd.

Eligibility criteria:
inclusion criteria: * subject must be willing to give written informed consent and willing to provide blood and stool probes * patients with clinically confirmed amd 18 years of age or greater * probands with no signs of amd 18 years of age or greater exclusion criteria: * smoking * chronic inflammatory disease (autoimmune diseases such as rheumatoid arthritis, lupus erythematodes, chronic inflammatory bowel disease) * diabetes as defined by the world health organization (who) criteria * treated hyperlipidemia * obesity with a body mass index (bmi) greater than or equal to 30 * recent (3 month) history of use of systemic antibiotics * opacities of ocular media excluding detailed observation of the retina