Kornimate/medical-research-clean huggingface dataset:
treatment of dysphagia by using a synchronized electrical stimulation device

Conditions: Deglutition Disorders

Summary: the purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.

* design: prospective study * inclusion criteria of the patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(n=10) * inclusion criteria of the control group: who does not have any dysphagia symptoms, and does not have any underlying disease(n=10) * setting: hospital rehabilitation department * intervention: participants are applied electrical stimulation by a "synchronized electrical stimulation device(sesd)"

Eligibility criteria:
inclusion criteria: * who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study exclusion criteria: * who reject the checkup their deglutition function by high resolution manometry * who reject apply "synchronized electrical stimulator"
tobramycin inhalation powder (tip) administered once daily continuously versus tip administered bid in 28 day on / 28 day off cycles

Conditions: Cystic Fibrosis

Summary: to provide efficacy and safety data comparing two dosing schedules of tobramycin inhalation powder (tip) for the treatment of pulmonary pseudomonas aeruginosa in patients with cystic fibrosis.


Eligibility criteria:
inclusion criteria: 1. provide written informed consent, hippa (health insurance portability and accountability act) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure. 2. confirmed diagnosis of cf 3. fev1 at screening (visit 1) ≥25% and ≤ 80% of normal predicted values for age, sex, and height 4. p. aeruginosa must be present within 6 months prior to screening and at screening 5. able to comply with all protocol requirements 6. clinically stable in the opinion of the investigator exclusion criteria: 1. history of burkholderia cenocepacia (bcc) complex within 2 years prior to screening and/or bcc complex at screening 2. hemoptysis more than 60 cc at any time within 30 days prior to study drug administration 3. history of hearing loss or chronic tinnitus deemed clinically significant by the investigator 4. serum creatinine 2 mg/dl or greater, bun 40 mg/dl or greater, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening 5. known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics 6. patients who are unable to discontinue previously received inhaled antibiotic regimen(s) (inhaled antibiotics are not allowed other than study drug) 7. use of inhaled aminoglycosides within 28 days prior to study drug administration (visit 2) 8. use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration 9. use of loop diuretics within 7 days prior to study drug administration 10. administration of any investigational drug within 30 days prior to enrollment or 5 half-lives, whichever is longer 11. signs and symptoms of acute pulmonary disease, e.g , pneumonia, pneumothorax 12. hospitalization during the baseline visit 13. history of malignancy 14. patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening 15. patients with other clinically significant conditions (not associated with the study indication) which might interfere with the assessment of this study 16. patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable 17. pregnant or nursing (lactating) women 18. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are using two birth control methods. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cystic fibrosis cf
dry eye disease in the vitamin d and omega-3 trial (vital)

Conditions: Dry Eye Disease

Summary: the vitamin d and omega-3 trial (vital; nct 01169259) is a randomized clinical trial in 25,875 u.s. men and women investigating whether taking daily dietary supplements of vitamin d3 (2000 iu) or omega-3 fatty acids (omacor fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. this ancillary study is being conducted among participants in vital and will examine whether omega-3 fatty acids or vitamin d3, compared to placebo, reduce the incidence and/or progression of dry eye disease.

this ancillary study to vital will examine the efficacy of omega-3 fatty acids and vitamin d3 in prevention of dry eye disease. the primary aims are to test whether omega-3 fatty acid supplementation (1) reduces the incidence of dry eye disease, and (2) improves the natural history of dry eye disease by relieving symptoms and other impacts on quality of life. secondary aims are to estimate the incidence of dry eye disease in the us, prospectively examine the natural history of dry disease, explore factors that could modify or influence the impact of omega-3 fatty acid supplementation, evaluate the interrelationship of dry eye disease and depression, and test for possible independent or joint effects of vitamin d3 supplementation in the incidence and natural history of dry eye disease.

Eligibility criteria:
inclusion criteria: * all participants in vital (nct 01169259) are eligible to participate in this ancillary study. exclusion criteria: * none

Keywords: dry eye disease incidence progression
stapler versus conventional pharyngeal repair after total larygectomy

Conditions: Malignant Tumor of the Larynx

Summary: this study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.


Eligibility criteria:
inclusion criteria: * all consecutive patients undergoing total laryngectomy for advanced laryngeal carcinoma in the study duration . exclusion criteria: * infiltration of the safety margins proved by postoperative histopathology . * patients with tumor extension to the tongue base, or the hypopharynx . * patients who are unfit for surgery . * patients refusal to surgical treatment
heart and ischemic stroke relationship study

Conditions: Brain Ischemia; Acute Stroke; Heart Diseases

Summary: although cardio-embolic etiology of ischemic stroke (is) is largely respected, there is still no clear recommendation for routine complex cardiological examination in all is patients. using complex cardiological examination the investigators expect: 1. more accurate detection of patients with concomitant heart disease (cardiac rhythm disorder, valve disorders, acute coronary syndrome, cardiac thrombus and myxoma, atrial and ventricle septum defects) 2. higher number of etiologically determinated is, which is crucial for accurate secondary prevention.

the investigators expect significant changes of biochemical parameters (nt pro b-type of natriuretic peptide, pro-atrial natriuretic peptide, creatinkinase mb, troponin t), inflammatory markers (interleukine 6, procalcitonin, high sensitive c-reactive protein), and coagulation parameters in patients with ce is compared to other causes of is. assessing the glomerular filtration of cystatin c, glycated haemoglobin and serum lipids and its correlation with prior medicament use will allow to evaluate the long-term compensation of arterial hypertension, diabetes mellitus and dyslipidemia in is patients. in addition to the above mentioned comprehensive cardiological examinations, 1- and 3-week ecg-holter will be performed in subpopulation of patients old up to 50 years and with cryptogenic ischemic stroke in the period from 1st may 2013 to 31st december 2015. these patients will also fill in a special epidemiologic questionnaire. anticipated enrollment in this substudy of history study is 40 - 80 patients. in selected young cryptogenic stroke patients, a subcutaneous cardiac monitor was implanted for the detection of paroxysmal atrial fibrillation in the period from 1st january 2014 to 31st december 2015. from 2016 in young ischemic stroke (is) patients under 50 years, a standard perfusion/ventilation scintigraphy of lungs will be performed to exclude acute pulmonary embolization (coincidental) in case of elevated serum d-dimers after admission. in all enrolled young is patients, a bp holter will be performed after the discharge home to exclude possible arterial hypertension, which did not presented during hospitalization.

Eligibility criteria:
inclusion criteria: * ischemic stroke admitted within 12 hours from stroke onset at stroke center exclusion criteria: * none

Keywords: ischemia brain infarction acute stroke heart diseases myocardial infarction
pay-it-forward gonorrhea and chlamydia testing among men in china

Conditions: Gonorrhea

Summary: pioneer is a three-arm, programmatic cluster randomized controlled trial (rct) to compare effectiveness of three implementation strategies, followed by a mixed-methods implementation evaluation study

the study will be implemented at 12 clinics in guangdong, china, which will be randomly assigned to one of the intervention arms for delivering gonorrhea testing: a standard pay-it-forward implementation strategy with minimal encouragement to get tested, a community-engaged pay-it-forward strategy, and a control arm in which men pay for their own sexually transmitted disease (std) test. data sources will include survey data on acceptability of intervention, intervention appropriateness, feelings and attitudes towards interventions among participants, administrative data about test uptake, treatment rate, and donations, as well as qualitative data to gain insights about men's perceptions and attitudes towards the pay-it-forward interventions strategies, mechanisms driving uptake and donating behaviors. both survey and qualitative interviews with implementers and organizers about fidelity and adherence to protocol, intention to continue and maintain a pay-it-forward intervention, and barriers and facilitators of implementing the intervention will be conducted.

Eligibility criteria:
inclusion criteria: * at least 18 years old * have had sex over the past year * have not been tested for gonorrhea and chlamydia in the past year * reside in the city in the past three months * speak mandarin chinese or cantonese * mentally capable of providing informed consent to test for gonorrhea and chlamydia * own a mobile phone exclusion criteria: * \< 18 years of age

Keywords: gonorrhea sexually transmitted infection (sti) gonorrhea testing among men who have sex with men
il-2 "select" tissue collection protocol in patients with advanced melanoma

Conditions: Malignant Melanoma

Summary: the purpose of this study is to determine which participants with melanoma have a better response to il-2 and to identify markers that may predict response to il-2 by collecting participant information (for example; cancer diagnosis and history, prior treatments for cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after treatment.

original tumor slides will be collected to identify tumor markers that may predict responses to treatment. blood samples will be obtained prior to treatment with il-2.

Eligibility criteria:
inclusion criteria: * malignant melanoma that is metastatic or unresectable * eligible to receive high-dose il-2 * tissue block available with adequate tumor to perform rna extraction and dasl analysis exclusion criteria: * prior immunotherapy for unresectable or metastatic disease * untreated brain metastases, leptomeningeal disease, or seizure disorder

Keywords: melanoma il-2 aldesleukin
anti-oxidative influence from pomegranate tablets on male sperm quality in couples undergo infertility treatments due to male infertility.

Conditions: Male Infertility With Severe Oligo-terato-asteno-spermia

Summary: some animal studies revealed that the pomegranate juice may improve sperm quality in terms of concentration, motility and morphology, as well as in fertilization rate. minor data is available regarding the influence on male sperm.

pomegranate contains a high concentration of vitamins ( c, b1, b2, b3, b5), potassium, magnesium , zinc and is a good source for polyphenols .polyphenols molecules have been found to possess antioxidant properties and may effects the expression of different genes . recent studies indicate that among foods that contain polyphenols, juice extracted from the pomegranate has the highest concentration of measurable polyphenols . pomegranates have shown inhibitory effect on nf-κb and the map kinases jnk and erk, which are critical steps in the cascade of events leading to inflammatory response. the nf- κb pathway is activated in response to bacterial infection and initiates the inflammatory cascade, which may explain the protective effect of pomegranates on bacterial infections.

Eligibility criteria:
inclusion criteria: * tmc of less than 5 million spermatogonia in native sperm and morphology less than 4% by kruger criteria. exclusion criteria: * sensitivity to pomegranate

Keywords: pomegranate pills, male infertility, pregnancy rate, semen analysis, ros, oxidative stress
vvax001 cancer vaccine in (pre) malignant cervical lesions

Conditions: CIN 2/3; Cervical Cancer

Summary: immune modulating effects and safety of vvax001; different dosages will be tested in patients with a history of (pre) malignant cervical lesions.

vvax001 is a therapeutic cancer vaccine consisting of a replication-incompetent semliki forest virus (sfv) vector encoding hpv-derived tumor antigens. patients will receive three consecutive doses, with an interval of 3 weeks.

Eligibility criteria:
inclusion criteria: * a history of cin ii and iii or cervical cancer * minimally 12 weeks after completion of treatment * age of 18 years and older * baseline laboratory findings; adequate hepatic, renal ,and bone marrow function, hiv- and hbv-negative * patients of child-bearing potential should test negative using a serum pregnancy test and agree to utilize effective contraception during the entire treatment and follow-up period of the study * written informed consent according to local guidelines exclusion criteria: * prior treatment with immunotherapeutic agents against hpv * history of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or current or prior use (4 weeks before start of the study) of high dose immunosuppressive therapy. * history of a second malignancy except curatively treated low-stage tumors with a histology that can be differentiated from the cervical cancer type * participation in a study with another investigational drug within 30 days prior to the enrolment in this study * any condition that in the opinion of the investigator could interfere with the conduct of the study

Keywords: therapeutic vaccination
image and model based analysis of lung disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this research study is to develop ct scanning and image analysis techniques to help define and measure several key properties of the pulmonary system that cannot be obtained by other tests or exams.

specifically, the investigators are interested in understanding the difference between the normal aging process and the events that lead to emphysema. additionally, the investigators are interested in understanding the earliest signs (lung inflammation) of the disease process leading to three lung diseases, which include emphysema, fibrosis and sarcoidosis; all of which are described as "inflammatory lung diseases." the investigators will be using the data from this study to help define the normal values for the measured properties as well as deviation from normal values in smokers without defined lung disease and patients with inflammatory lung disease. the investigators believe that the analysis and scanning techniques being developed as part of this research will provide new and previously unavailable information on normal and diseased lungs so that ultimately the investigators can detect specific changes in the lungs due to a disease and measure any improvements in the anatomy and/or function of the pulmonary system after a patient has undergone treatment. this study involves research using x-ray computed tomography (ct) scanner, which is similar to previous ct scanners but operates much faster and provides finer image detail.

Eligibility criteria:
inclusion criteria: * non smokers, age 20-29, 40-49, 60-69, 80-89, cannot have smoked more than 20 cigarettes in their lifetime * smokers, age 20-29, 40-49, 60-69, 80-89, currently smoking a minimum of 1 pack (20 cigarettes) per day, normal smokers and mild to moderate chronic obstructive pulmonary disease (copd) exclusion criteria: * allergies - no allergies to shellfish, eggs, iodine * medications - no medications (except for birth control) for in the 'normal' category * no asthma - as self reported * bmi (body mass index) - must not exceed 32 or 100kg of weight * no other radiology studies in the last 12 months * no metal in lung field - no metal from larynx to stomach * no known heart disease * no known kidney disease or diabetes * must not be pregnant - subjects of childbearing potential with be given a urine pregnancy test
health education for women with suspeced infertility waiting for specialized care

Conditions: Infertility; Health Education; Telemedicine; Telehealth

Summary: introduction: infertility is defined as a couple's inability to achieve pregnancy after 12 months or more of regular unprotected intercourse. in brazil, it affects around eight million people. while health services provide resources for contraception, little attention is given to supporting conception and preserving fertility. objective: to evaluate the effectiveness of a remote educational and counseling intervention on infertility. method: open-label randomized clinical trial. couples referred for infertility will be identified in the electronic referral system. for inclusion, the woman of the couple must be 34 years old or less, no previous in-vitro fertilization attempts, and have access to telephone or internet. the control group will follow standard care, awaiting in-person consultation. the intervention group will also wait for in-person evaluation but receive additional education and counseling via video call. the primary outcome is the proportion of correct referrals according to local protocols. a total of 206 participants will be included to detect a difference between success rates of 50% and 30%, with 80% power and a 5% significance level.


Eligibility criteria:
inclusion criteria: * individuals referred to specialized infertility care in porto alegre. * age up to 33 years and 11 months. exclusion criteria: * lack of access to the internet or telephone. * prior specialized infertility treatment in the private healthcare system.
augmented reality navigation versus traditional ct guidance for preoperative localization of pulmonary nodules

Conditions: Pulmonary Nodule

Summary: this study aims to conduct a large-sample randomized controlled clinical trial, using traditional ct-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of intelligent ar glasses in assisting preoperative localizing of small pulmonary nodules.

this study is an open-label prospective single-center non-inferiority randomized controlled clinical trial. patients in the pulmonary hospital affiliated to tongji university who are scheduled to undergo percutaneous puncture localization of small pulmonary nodules are used as the research subjects. according to the entry and exit criteria patients were included in the clinical trial, and the enrolled patients were randomly divided into the ar glasses-assisted puncture localizing group (experimental group) and the ct-guided conventional pulmonary nodule puncture localizing group (control group), aiming to evaluate the puncture of pulmonary nodules guided by intelligent ar glasses. non-inferiority of localization compared with conventional ct-guided pulmonary nodule puncture localization.

Eligibility criteria:
inclusion criteria: 1. age 18-80, no gender limit; 2. chest ct shows that the nodule involves the outer third of the lung and can be removed by wedge resection; 3. chest ct (lung window mode), the maximum diameter of the nodule is ≤2 cm; 4. physical condition score ecog 0-2 points; 5. if you plan to undergo percutaneous puncture and localization of small pulmonary nodules, the puncture needle path will be determined by the attending physician; 6. patients voluntarily participate and sign informed consent. exclusion criteria: 1. the lesion is located in front of the scapula, and the needle path is blocked; 2. the distance between the center of the lesion and the top of the diaphragm is \< 3 cm; 3. the lesion is adjacent to the hilus or large blood vessels; 4. pleural adhesions caused by a history of thoracotomy or pleural infection; 5. the patient voluntarily withdraws midway.
assessing the effect of abstinence period on semen parameters

Conditions: Infertility, Male

Summary: the goal of this study is to learn about the impact of abstinence periods on sperm quality in healthy males 20-45 years of age with no significant comorbidities who are able to produce a semen sample via masturbation. the main question it aims to answer is: • do shorter abstinence periods result in improved semen quality? participants will provide semen samples for analysis following abstinence periods of 7 days, 5 days, 2 days, 1 day, and 3 hours.

participant duration: total length of time on study per subject is 14 days (including 5 days of visit required for sample production). subjects do not need to complete the visits in order but need to document abstinence period prior to sample production. no follow up will be needed after the study. primary objective: the primary objective is to examine the differences in semen analysis parameters after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours). secondary objectives: the secondary objective(s) is to assess changes in sperm dna fragmentation after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).

Eligibility criteria:
inclusion criteria: * males, aged 20-45 years * healthy, no significant comorbidities * able to produce a semen sample by masturbation * total sperm count ≥ 1 million sperm * abnormal sperm dna fragmentation (tunel assay value ≥ 20%) exclusion criteria: * age \ 45 years * significant comorbidities, including significant cardiac, pulmonary, gastrointestinal, hematologic, or neurologic disease * total sperm count \< 1 million sperm * aspermia (semen volume = 0) * normal sperm dna fragmentation (tunel assay value \< 20%)
midurethral sling with autologus rectus sheath

Conditions: Stress Urinary Incontinence

Summary: assessment of the safety and efficacy surgeon tailored rectus sheath midurethral sling

the rectus sheath is harvested in 5 cm length and 2 cm width , a 2cm width 8 cm length polypropolyine mesh is attached to the harvest rectus sheet sling on both side the procedure is carried with a similar technique to the outside in tot.

Eligibility criteria:
inclusion criteria: * stress incontinence exclusion criteria: * overactive bladder