Kornimate/medical-research-clean huggingface dataset:
dyspnea and psychosocial effects of hand fan application in copd patients

Conditions: COPD; Dyspnea; Illness Perception; Anxiety; Depression

Summary: this randomized controlled trial aims to evaluate the effects of hand fan application on dyspnea, illness perception, anxiety, and depression in copd patients. a total of 56 voluntary copd patients (28 experimental, 28 control) will be recruited from ardahan state hospital chest diseases clinic. patients will be randomly assigned to the experimental or control group. the experimental group will receive a hand fan and use it for 10 minutes daily for six weeks, while the control group will receive standard care. dyspnea, illness perception, anxiety, and depression will be assessed using the visual dyspnea scale, illness perception questionnaire, and hospital anxiety and depression scale at baseline and after six weeks. data will be analyzed using statistical software. this study is expected to contribute to the literature by evaluating a non-pharmacological intervention for copd-related dyspnea and psychological outcomes.


Eligibility criteria:
inclusion criteria: * orientation and cooperation * no communication problems exclusion criteria: * having a copd exacerbation in the last 4 weeks
methodology and clinical value of rit in intestinal obstructive diseases mediated by colonic tet

Conditions: Fecal Microbiota Transplantation; Bowel Obstruction

Summary: the etiology of bowel obstruction is usually diagnosed by imaging techniques such as mscte,mre, et al, which have some disadvantages. for example, in order to obtain better image quality, mscte（multi-slices spiral computed tomography enterography） and mre（ magnetic resonance enterography）require patients to take a large amount of intestinal contrast solution orally, while for patients with intestinal obstruction, which may further aggravate the disease. our study team had confirmed the mid-gut tet could serve as the delivery way of contrast solution for mre bowel preparation with better accuracy of lesion detection and lower reduction of pain in cd（crohn's disease） patients. in this study, contrast solution will be delivered by colonic tet placed by lower gi-endoscopy, then we will evaluate the methodology and clinical value of this kind retrograde imaging technique in patients with intestinal obstructive diseases.


Eligibility criteria:
inclusion criteria: * symptoms of intestinal obstruction such as abdominal pain, abdominal distension, nausea, vomiting, cessation of anal exhaust and defecation； * abdominal x-ray or plain ct showed signs of intestinal obstruction; * participants suspected with intestinal stricture according to the recent lower gi endoscopy； * voluntarily sign written informed consent. exclusion criteria: * signs of peritonitis, perforation or massive hemorrhage of digestive tract; * accompanied with severe heart, brain, lung and kidney dysfunction, unable to take lower gi endoscopy; * allergic to laxatives or iodine contrast agents; * pregnant women; * confirmed or suspected claustrophobia; * inability to understand or provide informed consent

Keywords: washed microbiota transplantation fecal microbiota transplantation transendoscopic enteral tubing
prevention of respiratory infections and management among children (primakid)

Conditions: Recurrent Upper and Lower Respiratory Tract Infections (RTIs)

Summary: the primakid trial is a general practice based double-blind randomized placebo-controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections. a target number of 660 children aged 18-72 months with a history of two or more general practitioner attended episodes of rti, are included. exclusion criteria are diseases accompanied by a high risk of recurrent rti and conditions chronically treated with corticosteroids. over a period of 7 to 22 months follow-up, the number of febrile rti-episodes as primary outcome is assessed, and as secondary outcomes the severity and length of febrile rti-episodes, medical visits / interventions, health-related quality of life and productivity loss of parents.


Eligibility criteria:
inclusion criteria: * age between 18-72 months * a history of two or more episodes of general practitioner attended rtis exclusion criteria: * no intention to move within 12 months to another region * provision of informed consent * good mastering of the dutch language * absence of chronic diseases such as asthma treated with corticosteroids or high-risk disease (such as palatoschisis, down syndrome, cystic fibrosis, etc.) * no previous influenza vaccination or pneumococcal vaccination or hepatitis b vaccination * no hypersensitivity to eggs and/or antibiotics, and/or serious history of serious adverse events through vaccination
the effectiveness of nivolumab monotherapy as first-line therapy in adults with advanced melanoma in germany

Conditions: Melanoma

Summary: a retrospective, observational study based on chart reviews for patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between june 2015 and june 2016, conducted in a representative sample of sites in germany.


Eligibility criteria:
inclusion criteria: * adult patients with a primary diagnosis of advanced melanoma (histologically confirmed stage iii \[unresectable\] or stage iv skin, ocular, or mucosal melanoma) * newly initiated with nivolumab monotherapy as their first-line therapy for previously untreated advanced melanoma between june 2015 and june 2016 * at least 18 years of age at time of treatment decision exclusion criteria: * patients with a current primary diagnosis of a cancer other than advanced melanoma ie, a cancer other than melanoma that requires systemic or other treatment * patients currently included in an interventional clinical trial for his/her locally advanced or metastatic melanoma. patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. in case of a blinded study, the treatment arm (ie, type of administered treatment) needs to be known. * patients \< 18 years of age at time of treatment initiation other protocol defined inclusion/exclusion criteria could apply
patient preferences for barrett's esophagus and esophageal cancer screening tests

Conditions: Gastro Esophageal Reflux Disease; Barrett Esophagus

Summary: this study plans to learn more about what patients think about screening for esophageal cancer (eac) and barrett's esophagus (be); a pre-cancerous condition associated with esophageal cancer. the plan is to use this information to modify screening practices in the united states with the goal to decrease the number of people who die from esophageal cancer.

to achieve this goal, patient preferences for be/eac screening tests will be evaluated through a prospective multicenter discrete choice-based conjoint survey. patients will choose between a series of hypothetical options and rank their priorities and what they value according to differences in benefit of detection (sensitivity), convenience (time, setting), screening related physical harms (procedural discomfort), and financial harms. by evaluating relative importance of test characteristics and patient prioritization the study will (1) define patient preferences and barriers for attributes of be/eac screening modalities to elicit the overall preferred test as well as differences in each attribute that informed that choice and (2) characterize differences in be/eac test preferences by patient sociodemographic characteristics (age, sex, race, ethnicity) and by the presence or absence of gastroesophageal reflux disease (gerd).

Eligibility criteria:
inclusion criteria: * provision to sign and date the consent form. * stated willingness to comply with all study procedures and be available for the duration of the study. * individual has 3 or more established risk factors for be (age \> 50 years, chronic gerd, male, white race, smoking, obesity, family history of be/eac). exclusion criteria: * unable to consent. * prior diagnosis of be/eac. * life limiting comorbidity/ disability. * active dementia/ cognitive impairment. * incarcerated.

Keywords: gastroesophageal reflux disease barrett's esophagus barrett's esophagus screening be gerd
endurant stent graft system post approval study (engage pas)

Conditions: Aortic Aneurysm, Abdominal

Summary: the purpose of the study is to demonstrate the long term safety and effectiveness of the endurant stent graft system for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol. the clinical objective of the study is to evaluate the long term safety and effectiveness of the endurant stent graft system assessed at 5 years through freedom from aneurysm-related mortality (arm).


Eligibility criteria:
inclusion criteria: * age ≥18 years * indication for elective surgical repair of abdominal aortic aneurysm (aaa) with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the instructions for use of the endurant stent graft system * signed consent form. the subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information * intention to electively implant the endurant stent graft system * ability and willingness to comply with the clinical investigational plan (cip). exclusion criteria: * high probability of non-adherence to physician's follow-up requirements * current participation in a concurrent trial which may confound study results * female of childbearing potential in whom pregnancy cannot be excluded or who is lactating.

Keywords: aaa abdominal aortic aneurysm evar endovascular aneurysm repair
clinical study of the sonablate® 500 to treat localized (t1c/t2a) prostate cancer

Conditions: Prostate Cancer

Summary: this study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.

the proposed study is a prospective, non-randomized concurrently controlled study. the active treatment arm uses the hifu procedure with the sonablate device. the control arm uses the brachytherapy procedure. the safety and effectiveness of the sonablate arm will be compared with the brachytherapy arm. the control arm of the study will be conducted at clinical sites different from the sonablate arm.

Eligibility criteria:
inclusion criteria: * t1c or t2a carcinoma of the prostate confirmed by biopsy; * life expectancy of 5(five) years or more; * prostate biopsy with 10(ten) or more core biopsies; * gleason score of 6(six) or less; * serum prostate specific antigen (psa) of 10(ten)ng/ml or less; * prostate volume of less than 40(forty)cc; * distance from the anterior capsule surface to the posterior capsule surface (ap diameter) of 40(forty)cm or less; * informed consent for the treatment study through 24 months post-treatment follow-up exclusion criteria: * men who have had previous definitive treatment for prostate cancer; * evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years; * prior hormonal therapy for prostate cancer (including bilateral orchiectomy); * inability to tolerate a transrectal ultrasound; * active urinary tract infection; * functional bladder problems; * prior significant rectal surgery; * intra-prostatic calcifications greater than 1(one)cm in diameter; * interest in future fertility; * prostatic surgery/procedure (except biopsy) within 1(one) year; * large median lobe of the prostate; * use of medications that can affect psa within 2(two) months (e.g. finasteride, saw palmetto); * current bladder cancer, urethral stricture, or bladder neck contracture; * urinary tract and/or rectal fistula; * rectal fibrosis/stenosis; * anomaly of the rectal anatomy or mucus membrane; * prostate seroma/abcess; * prostatitis; * compromised renal function or upper urinary tract disease secondary to urinary obstruction; * bleeding disorders/coagulopathy based on measures of pt and ptt; * implant in the prostate or within 1(one)cm of the prostate; * zip code of the primary residence of the subject is greater than 200(two hundred) miles from the clinical site or transportation that would hinder the completion of the study

Keywords: primary prostate cancer primary t1c/t2a organ confined prostate cancer organ-confined
deep brain stimulation on dual-task gait performance in pd

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is the second most common neurodegenerative disease after alzheimer's disease. motor symptoms include rigidity, bradykinesia, tremor, and postural instability, these motor symptoms can cause gait dysfunction. non-motor symptoms include depression, dysarthria, cognitive disability, and sleep disturbance. although these symptoms can be improved through drug treatment, when the course of pd reaches the middle to late stage, it will still face the situation of weakened drug efficacy and the drug side effects increased. when medication can no longer adequately control the motor symptoms of pd, deep brain stimulation (dbs) becomes a powerful option. dbs is a surgical treatment that involves implanting one or more electrodes into specific areas of the brain, which deliver electrical stimulation to regulate or destroy abnormal neural signal patterns in the target area. the effect of dbs has been proven whether it is in improving motor-related symptoms or non-motor-related symptoms, but there are still some areas that have not been compared before and after the surgery, such as: gait variability, executive functions and dual-task walking. in addition, the parameters of electrical stimulation for dbs will also affect the clinical characteristics of patients. due to the large difference between individual cases, the recommendation of the electrical stimulation frequency still not be established. therefore, the influence of dbs and its parameters on the symptoms of pd is a topic worthy of discussion. purposes: (1) to investigate the long-term effects of dbs on the symptoms of pd. (2) to investigate the effects of dbs stimulation frequencies on walking performance and executive function in individuals with pd.


Eligibility criteria:
inclusion criteria: * idiopathic pd * age: 50\~80 yrs old * hoehn and yahr stage ≤ iv after dbs operation * implanted dbs system for at least 6 months * mmse ≥24 exclusion criteria: * other neurological disorders * any major systemic, psychiatric, visual, and musculoskeletal disturbances or other causes of walking inability

Keywords: deep brain stimulation dual-task walking executive function
effect of strength training and protein ingestion in old versus very-old

Conditions: Sarcopenia; Muscle Loss

Summary: from 3 interventiongroups in the project with clinicaltrials.gov id nct02034760, namely: hrtw: heavy strength training x3/week \& 20g whey protein twice daily. litw: light intensity training x3-5/week \& 20g whey protein twice daily. whey: 20g whey protein twice daily. 15 subjects from each group will be recruited and tested after 3 months of intervention. tests will include muscle cross sectional area (mri), muscle biopsies (fiber types, size, cell- and capillary count), functional- and strength measurements, plasma lipids, hba1c. tests are to be compared with project id nct01997320.

in- and exclusion criteria are listed in nct02034760. subjects will be randomized to interventions as described, and 15 subjects from each of the three groups will be tested after 12 weeks of intervention. 15 subjects are included in each group to account for an expected drop-out rate of 20%, and so 12 subjects are expected to complete each intervention. with this n an increase of around 11% in mri-evaluated muscle size can be detected with a powerlevel of 80% and an alpha of 0.05 and use of reported sd. primary outcome is muscle size (mri), and secondary outcomes are overall body composition (dxa), muscle strength, rate of force development, power, 30s chair stand, 400m gait speed, grip strength. tertiary outcomes are habitual activitylevel (accelerometry), blood samples (hba1c, cholesterols, creatinine), blood pressure, weight, bmi, wast- and hip circumference. results are to be compared with nct01997320 and so a population of 65+ can be compared with a population of 83+. both studies uses the same heavy strength training regimen.

Eligibility criteria:
inclusion criteria: * healthy, independently living * age at least 65 years exclusion criteria: * subjects dependent on help/nursing etc. * chronic medical diseases: diabetes mellitus, clinical knee or hip osteoarthritis, other types of arthritis or connective tissue disorders, active cancer, renal diseases, severe chronic obstructive pulmonary disease, cardiac arrhythmias or known decreased left ventricular ejection fraction, lactose or gluten intolerance, chronic inflammatory bowel diseases, non-treated hyper/hypothyroidism, dementia. * surgical diseases: bone, muscle, tendon or joint injuries compromising participation in exercise regimens. * implanted magnetic devices incompatible with mri-scanning. * weekly alcohol consumption \> 21 units (1 unit equals 4g of ethanol) for men and \> 14 for women. * medicine except acetylsalicylic acid, paracetamol, thyroid function hormones, statins in doses above 40mg/day or if combined with subjective myalgia, ace-inhibitors, angiotensin ii blockers, beta-blockers, calciumantagonists, proton-pump inhibitors, thiazides, potassium-sparing diuretics and loop diuretics. * \>1 hour of exercise weekly, except light activities such as stretching/gymnastics and bike-riding/walking as transportation.

Keywords: frailty ageing protein supplementation protein quality exercise training sarcopenia
fecal microbiota transplantation in pediatric ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: this study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (pen) in refractory pediatric uc where conventional therapy has failed, and the other was to explore the efficacy and safety of fmt plus pen as first-line therapy for pediatric active uc

recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of uc, and that fmt could be a useful treatment. in the refractory ulcerative colitis group, our study is aims to explore fmt plus pen in the treatment of refractory pediatric uc. in the induction stage of uc, standard therapy remained unchanged, fmt and pen treatment are added, and the investigators hope the withdrawal of conventional drug therapy was gradually reduced. refractory uc is defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-tnf agents). as a first-line treatment group for uc, our study is aims to explore fmt plus pen as a first-line treatment for active uc in children. participants treated with fmt coupled with pen are defined as the fmt group, and those treated with pen coupled with mesalazine served as the pen group. fmt treatment is given for at least one course of fmt treatment. if repeated fmts are received, it is usually at a 2 month interval. all the participants received pen (80% of total calories as a polymeric diet, peptamen, nestle, vevey, and switzerland) intervention to help induce and maintain clinical remission.

Eligibility criteria:
inclusion criteria: age of older than 2 years and younger than 16 years with no genetic diseases; as a first-line treatment group for uc, newly diagnosed with mild-to-moderate uc (defined by the pucai of \>10 and≤64); in the refractory ulcerative colitis group, all refractory pediatric with mild-to-moderate uc (defined by the pucai of \>10 and≤64) defined by children who failed conventional treatment (hormone, immunosuppressant, biologics); agree to received regularly colonoscopy exclusion criteria: children who were treated by pen (80%) less than 8 weeks; as a first-line treatment group for uc, patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-tnf agents as their first-line treatment; known contraindication to all fmt infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (ogd), enteroscopy, colonoscopy, enema and fecal capsule; unwilling to give informed consent/ assent

Keywords: fecal microbiota transplantation, ulcerative colitis
mri in prostate cancer diagnosis with prior risk assessment

Conditions: Prostate Cancer

Summary: to evaluate the diagnostic performance and cost-effectiveness of the mri-driven diagnostic pathway of prostate cancer, with upfront individual multivariate risk stratification.

screening for prostate cancer (pca) remains one of the most controversial issues in urological practice. although robust data from the european randomised study of screening for prostate cancer (erspc) suggest a disease specific survival benefit in favor of prostate-specific antigen (psa)-based pca screening, the coinciding unfavorable harm-benefit precludes that pca screening can be adopted as a public health policy. the diagnostic pathway needs to be optimized to reduce unnecessary testing and to avoid diagnosing those cancers that will never harm a patient if not detected through screening. some men may thus benefit from pca screening, but with the currently used diagnostics (i.e. the psa test and systematic trus (transrectal ultrasound )-guided prostate biopsy) many more men are harmed by unnecessary testing and the cascade of diagnostic and treatment related events that follow. further refinements to screening strategies, focusing on detecting only those pca that are potentially life threatening (clinically significant) are needed to become acceptable to the general population and health care providers. the investigators propose such a refinement within this protocol, with upfront individual risk prediction and in addition a mri-driven diagnostic pathway in only those men that are considered to be at intermediate/high-risk of having a potentially life threatening pca (in general defined as gleason sum score (gs) =7).

Eligibility criteria:
inclusion criteria: * men ≥ 50 years, * no prior prostate biopsies, * suspected of having prostate cancer based on psa blood test (≥ 3 ng/ml) and/or dre( digital rectal examination) and/or family history of prostate cancer, * fit to undergo all protocol procedures, * signed informed consent. exclusion criteria: * contra-indications to mri or trus biopsy procedures, * any medical condition precluding procedures described in the protocol

Keywords: prostate cancer multivariate risk assessment mri biopsy screening multicenter
cell free dna in mature b-cell lymphoma

Conditions: Mature B-Cell Lymphoma

Summary: the purpose of this study is to assess whether plasma cell free dna is an accurate tool that can early and dynamically inform on treatment outcome and an accessible source of tumor dna to track tumor clonal evolution.


Eligibility criteria:
inclusion criteria: * documented diagnosis of mature b-cell tumor according to who 2008 criteria * 18 years or older exclusion criteria: * chemotherapy before * other tumors