Kornimate/medical-research-clean huggingface dataset:
treating stress urinary incontinence: laparoscopic obturator urethropexy vs burch urethropexy

Conditions: Stress Urinary Incontinence

Summary: stress urinary incontinence (sui) is a highly prevalent concern within the female population. although mid urethral slings (mus) have been the first line treatment for sui for almost twenty years, due to recent fda warnings and many countries banning the use of vaginal mesh, a significant portion of patients now request non-mesh anti-incontinence procedures. in such cases, burch colposuspension would be the next option discussed with patients. in the short term, the efficacy of burch colposuspension is comparable to mus. however, the noteworthy disadvantages of burch colposuspension include a high rate of urinary retention. this increased risk of urinary retention is due to the acute angle of the stitches, and is a problem that burch colposuspension shares with the retropubic sling, a type of acutely-angled mus. a variant of the retropubic sling, the transobturator tape (tot), has shown that a rounder angle of elevation significantly reduces the risk of urinary retention. as such, this study proposes a novel technique of laparoscopic obturator urethropexy (lou) as an alternative to the traditional burch colposuspension. in this new proposed technique, stitches are placed into the obturator internus fascia rather than cooper's ligament, reducing the angle of elevation of the bladder neck, aiming to lower the risk of post-operative urinary retention. the aim of our randomized control trial is to assess the effectiveness of lou compared to burch colposuspension in terms of urinary continence. our secondary aim is to report on perioperative and postoperative complications, functional outcomes including urinary retention, recurrent urinary tract infection, recurrent/persistent urgency, de novo urgency, recurrent sui, and sexual function, as well as overall quality of life.


Eligibility criteria:
inclusion criteria: * at least 18 years of age and be able to read and write english * women with symptomatic sui, stress predominant mixed urinary incontinence symptoms confirmed on urodynamic study (uds), or occult sui (i.e. demonstrable urinary leakage on preoperative urodynamics with prolapse reduction in a patient without overt urinary incontinence symptoms), including women undergoing concomitant pelvic organ prolapse (pop) surgery or mus sling removal exclusion criteria: * known or suspected disease that affects bladder function (e.g. multiple sclerosis, parkinson disease), including a known diagnosis of voiding dysfunction * pregnancy * desired fertility * urethral diverticulum * history of radical pelvic surgery or pelvic radiation therapy * current chemotherapy or radiation therapy for malignancy
short-term outcomes of eras protocol in rame for esophageal cancer

Conditions: Esophageal Cancer Patients

Summary: this single-center, retrospective cohort study aimed to evaluate the short-term outcomes of enhanced recovery after surgery (eras) protocol in perioperative robotic-assisted mckeown esophagectomy (rame) among esophageal cancer patients.


Eligibility criteria:
inclusion criteria: 1. first detected and endoscopically confirmed esophageal cancer; 2. preoperative evaluation showed no distant metastases and suitable for rame; 3. preoperative clinical stage of i to iii; exclusion criteria: 1. patients had a history of thoracic or abdominal surgery; 2. patients were iv to vi in the american society of anesthesiologists (asa) physical status classification system; 3. patients had other malignancies; 4. patients had missing clinical data
metagenomic evaluation of the gut microbiome in patients with lynch syndrome and other hereditary colonic polyposis syndromes

Conditions: Lynch Syndrome; Hereditary Colonic Polyposis Syndromes

Summary: the purpose of this study is to understand the role bacteria that normally live in the colon may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer. the investigators will collect stool specimens as well as additional colon biopsy specimens during the patient's scheduled colonoscopy procedure. the investigators will also collect a questionnaire about diet and lifestyle. the samples will be used to study the impact of diet on naturally-occurring oral and gut bacteria and their influences on human health including risk of cancer.


Eligibility criteria:
inclusion criteria: * male or female age 18 or older * hereditary colorectal cancer syndrome with one of the following: * lynch syndrome, as defined by the presence of a deleterious germline mutation in the mlh1, msh2, msh6, pms2 or epcam genes * other hereditary colonic polyposis syndromes, as defined by the presence of a deleterious germline mutation in any one of the following polyposis genes (apc, biallelic myh, stk11, smad4, bmpr1a, or other crc-risk associated genes at discretion of pi) exclusion criteria: * unable to provide informed consent for testing * unable to complete english language questionnaire * receiving active chemotherapy * having completed active chemotherapy less then 12 months prior to day of scheduled lower endoscopy * no infectious or drug induced colitis less then 12 months prior to day of scheduled lower endoscopy * no history of inflammatory colitis (crohn's disease or ulcerative colitis)

Keywords: gut microbiome 15-016
predictive value of 18f-faza in rectum cancer

Conditions: Locally Advanced Rectum Cancer

Summary: the primary purpose of the study is to investigate 18f-faza-pets role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer.


Eligibility criteria:
inclusion criteria: * histopatologically verified adenocarcinoma in the rectum * t4 tumor eller t3 tumor \< 10 cm from the anus and \< 5 mm from the mesorectal fascie measured by mr scan. at the distal part of the rectum the distance to the mesorectal fascie is \< 5 mm and therefore all t3 tumors are included in this area * suitable for preoperative radiation and chemotherapy * no distant metastases * age \>18 years * hematology anc ≥1.5x10\^9/l. thrombocytes ≥ 100x10\^9/l. * biochemistry bilirubin ≤ 3 x unl. alat ≤ 5 x unl * creatinine ≤ unl * contraception for fertile women * written and orally informed consent exclusion criteria: * other malignant disease within 5 years, excl. non-melanotic skin cancer * previous radiation treatment of the pelvis * pregnant or breastfeeding women * surgery within 6 weeks prior to enrollment * serious concurrent medical disease * enrollment in study "a prospective observational study of patients with rectum cancer after concomitant radiation and chemotherapy", where the patients are potientially not operated.

Keywords: rectum cancer faza 18f-faza-pet/ct radiotherapy chemoradiotherapy
validation of a newly developed liquid jet aesthesiometer

Conditions: Ocular Surface Disease

Summary: a new liquid jet aesthesiometer prototype was developed with the aim to measure ocular surface sensitivity by employing a liquid jet. this study aims to validate this new prototype by means of correlating its measurement with a previously validated air jet aesthesiometer, the non-contact aesthesiometer (ncca; by murphy et al. 1996) and by exploring the repeatability of ocular surface sensitivity measurement.

currently, no aesthesiometer is available that delivers reliable and repeatable measurement of ocular surface sensitivity in a routine clinical setup. the only commercially available cochet- bonnet aesthesiometer uses a tactile-mechanical stimulus (the tip of a nylon thread), which can cause a microerosion when applied to the corneal surface. additional disadvantages represent poor stimulus reproducibility, a limited stimulus bandwidth and the influence of humidity and age on the bending capibility of the nylon thread. for research purposes prototypes of non-contact air aesthesiometers (eg by murphy et al. and belmonte et al) are being used. this study aims to correlate ocular surface sensitivity measurements of a newly developed prototype, the liquid jet aesthesiometer, with the non-contact air jet aesthesiometer by murphy et al. 1996 and to explore its repeatability of measurement. in this repeated measures design 60 subjects participate in corneal sensitivity measurements during two appointments with each described aesthesiometer.

Eligibility criteria:
inclusion criteria: * ocular surface index score \< 13.0 exclusion criteria: * systemic disease such as diabetes, diseases, injuries and operations in the anterior segment of the eye * systemic medication and / or eyedrops / ointments that may have an influence of the tearfilm. * contact lens wear less than 48 hours before commencement of study measurements.

Keywords: ocular surface sensitivity
effects of three different mouth rinses on dental plaque in children

Conditions: Gingival Diseases

Summary: dental plaque is a major problem in the field of oral and dental health and its prevention is more important to avoid dental caries and gingival diseases. mouth washes are very useful in the reduction of microbial plaque and gingival inflammation. sodium fluoride mouth wash is one of the ways that prevent dental plaque. recently, using herbal products are efficient in decreasing dental plaque. pomegranate peels and guava leaves extracts are an essential medicinal plant with various pharmacological properties. aim of study: to evaluate and compare the efficiency of different mouth rinses (sodium fluoride mouth rinse, guava leaves aqueous extract and pomegranate aqueous extract) on dental plaque in children, clinically by measuring gingival and plaque indices scores and microbiologically by measuring of streptococcus mutans and lactobacillus. materials and methods: forty apparently healthy and cooperative children were selected from the outpatient dental clinic of pediatric dentistry department, faculty of dentistry, suez canal university. children were randomly divided into three groups as follows: group (i):10 children will rinse with sodium fluoride, group (ii): 10 children will rinse with guava leaves aqueous extract and group (iii):10 children will rinse with pomegranate peels aqueous extract. group (iv):10 children will rinse with water (control group). instructions for oral hygiene and using mouth wash will be demonstrated for every child. clinical and microbiological examinations will be done firstly at day one before using any type of examined mouthwashes (0-base line), then clinical and microbiological follow up will be done after 7 and 15 days of using different mouthwash for each group.


Eligibility criteria:
inclusion criteria: 1. children are apparently healthy. 2. their age's ranges from 6-12 years {mixed dentition}, first permanent molars were fully erupted. 3. children are not taking antibiotics, steroids and inflammatory therapy for two weeks before study or during this study. 4. children are caries free at time of the study. 5. children with no regular use of chewing xylitol gum. 6. children without orthodontic appliance. 7. children are not using fluoride tooth paste or any topical fluoride application at time of study. 8. children who have dental plaque. exclusion criteria: 1. uncooperative children. 2. children with history of allergy to dental products or their products 3. parents refusal.
mobile intervention to improve adherence of oral anti-cancer medications among acute myeloid leukemia patients, the txt4aml study

Conditions: Acute Myeloid Leukemia

Summary: this clinical trial studies how well a mobile intervention consisting of a text messaging program and an electronic "smart" pill bottle with medication reminders works to improve adherence to oral anti-cancer medications among patients with acute myeloid leukemia (aml). medication adherence is how well patients take medications as prescribed by their doctors, and good medical adherence is when patients take medications correctly. poor medication adherence has been shown to be a barrier to effective treatment. collecting feedback on patient experiences using the mobile intervention may help doctors design new methods and material for providing educational information to aml patients who are taking oral anti-cancer medications.

primary objective: i. to examine the feasibility, acceptability and preliminary efficacy of txt4aml in a pilot single arm study. secondary objective: i. to explore the association between overall treatment responses and real-time oral anti-cancer medication (oam) adherence. exploratory objective: i. to summarize and assess other patient-reported outcomes, collected either as patient chart review or through self-reported survey, as well as the patient post-intervention interviews. outline: patients receive interactive text messages to help with adherence to medications and a smart pill bottle with medication reminders on study.

Eligibility criteria:
inclusion criteria: * patients diagnosed with acute myeloid leukemia (aml) * patients will be or is taking venetoclax (or any other oral anticancer medication) as part of their first line therapy * has a phone with text capabilities * among patients aged 18 and older we will enroll participants regardless of race or ethnicity exclusion criteria: * individuals who are terminally ill (defined as having less than 2 months to live) * individuals for whom there is documentation of inability to provide consent in the medical record * do not speak/read english * this study will exclude pediatric patients (defined as individuals under age 18 years)
opioid free anesthesia: what about patient comfort?

Conditions: Anesthesia

Summary: 66 female patients undergoing breast cancer surgery were randomized in the jules bordet institute, the belgian oncology institute. one group received an opioid anesthesia, the other group an opioid free one. the hypothesis of this study was that opioid free anesthesia improves the postoperative quality of recovery of anesthesia.

opioids used as part of balanced anesthesia have known undesired side effects such as: respiratory depression, post-operative nausea and vomiting, pruritus, difficulty voiding and ileus. the purpose of this study was to determine whether opioid free anesthesia influences the quality of recovery. a multimodal approach combining ketamine, lidocaine and clonidine was used as an alternative for an opioid based anesthesia. the hypothesis of this study was that patient comfort and satisfaction level after an opioid free anesthesia would be higher compared to after a more traditional opioid anesthesia.

Eligibility criteria:
inclusion criteria: * oncological patients undergoing a total mastectomy or lumpectomy associated with a total axillary dissection were screened. * patients with an asa physical status of ii were included. * knowledge of either french, english or dutch was required. exclusion criteria were the following: * allergy or contraindications to one of the study drugs, renal failure, hepatic failure, hyperthyroidism, av block 2 or 3 or severe bradycardia, left ventricular failure, unstable blood pressure, epilepsy and psychiatric disturbance.

Keywords: pain patient comfort
epidemiological study to describe non small cell lung cancer (nsclc) clinical management patterns in central eastern europe and russia (lung-epiclin)

Conditions: Non Small Cell Lung Cancer

Summary: the overall aim of the study is: to provide accurate and reliable information regarding nsclc clinical management across central eastern european countries and russia in order to detect unmet medical needs of this disease in terms of: * patient and hospital characteristics. * diagnostic and treatment approaches: initial and subsequent. * follow-up patterns in clinical management. * outcomes: symptoms, death, functionality, quality of life. * use of resources and burden on patients and health care systems. addendum objective is to collect epidemiological data on egfr mutation status (m+, m-) in the russian population


Eligibility criteria:
inclusion criteria: * confirmed nsclc diagnosis (e.g.bronchoscopic biopsy or fnab), all stages, men and women, attending the responsible department of treating this type of patients for the first time between january 1st, 2010 and march 31st, 2010 * for patient reported outcome (pro) sub-sample: ability to read and write since they will be asked to participate in the pro part of the study. selection will not be based on the disease stage of each patient, in order to avoid a selection bias. * tumour tissue samples (in paraffin-embedded blocks) suitable for egfr mutation testing available. exclusion criteria: * mixed histology of small cell and non-small cell lung cancer.

Keywords: non small cell lung cancer egfr mutation nsclc
predictors of pulmonary hypertension in patients with hypersensitivity pneumonitis

Conditions: Pulmonary Hypertension; Hypersensitivity Pneumonitis

Summary: hypersensitivity pneumonitis (hp) is a complex immune mediated disorders caused by repeated inhalation of and sensitization to wide range of antigens including organic particles and chemical compounds, leading to exaggerated immuneresponse. hypersenstivity pneumonitis is a common form of diffuse parenchymal lung diseases in egypt .pulmonary hypertension has been found as a complication of a number of diseases affecting the lung interstitium, including hypersensitivity pneumonitis, with subsequent affection of the life expectancy rationale of the study: to find predictors for the development of pulmonary hypertension in patients with hypersensitivity pneumonitis

cross sectional study included 60 patients with established diagnosis of hp , work up includes history of exposure, clinical examination, hrct chest, abgs,6mwd, desaturation degree , spirometry, echocardiography and right heart catheter in patients with high echo probability of ph.

Eligibility criteria:
inclusion criteria: * all patients with confirmed diagnosis of hypersensitivity pneumonitis exclusion criteria: * other interstitial lung diseases
the utility of positive psychology in military tbi rehabilitation

Conditions: Traumatic Brain Injury

Summary: service members and veterans (smvs) report more persisting symptoms following traumatic brain injury (tbi) compared to civilian populations (ommaya, ommaya, dannenber, \& salazar, 1996). therefore, it is important to utilize interventions that reduce psychological impairments and increase resiliency during military tbi rehabilitation. unlike traditional behavioral health treatments that focus on reducing maladaptive behaviors and negative thoughts, positive psychological treatments focus on increasing positive emotions to increase well-being. there is substantial growing evidence demonstrating that cultivating positive emotions is preventative and improves resiliency and psychological (bolier et al., 2013; sin \& lyumbomirsky, 2009), cognitive (estrada, isen, \& young, 1997; ashby \& isen, 1999; isen \& daubman, 1984; isen, daubman, \& nowicki, 1987; fredrickson \& branigan, 2001), and health outcomes (pressman \& cohen, 2005). this study will examine the effectiveness of traditional behavioral health treatment versus behavioral health treatment with an added positive psychological group treatment in terms of psychological, cognitive, and health outcomes during tbi rehabilitation. the hypothesis is that smv's with tbi will experience improved outcomes with added positive psychological treatment compared to traditional behavioral health treatment alone. there will be about 100 people taking part in the study, randomly assigned to either a traditional behavioral health treatment group or an alternative behavioral health treatment group (therefore, up to 50 people will be enrolled in each) at the fort belvoir intrepid spirit center over a period of 30 months. study participants will be randomly assigned to groups, and over 3 months the study procedures include participating in group behavioral health treatment and/or individual behavioral health treatment and completing pre/post-treatment questionnaires focusing on psychological, cognitive, and health outcomes. the behavioral health intervention has not been well-studied; thus, the behavioral health intervention is considered experimental for the treatment of psychological symptoms. additionally, the impact on other areas of functioning (i.e., cognitive functioning and overall health) is currently unknown.


Eligibility criteria:
inclusion criteria: * documented mild tbi or moderate tbi. * individual is recommended to have a behavioral health provider at isc fort belvoir for general tbi-related psychological impairments. * individual has decision making capacity for informed consent based on medical provider clinical judgement and initial evaluation. * individual scored a 14 or lower on the patient health questionnaire-9, indicating no worse than moderate depressive symptoms. * individual is 18 years or older. * individual is defense enrollment eligibility reporting system-eligible. exclusion criteria: * individuals with severe depressive symptoms (phq-9 score above 14). * documented severe traumatic brain injury. * minors and pediatric populations.
nitazoxanide pharmacokinetic parameters in renal impaired subjects

Conditions: Renal Impairment; Renal Disease; Kidney Disease

Summary: this study is being conducted to evaluate the major nitazoxanide (ntz) active metabolite in adult participants with renal impairment and healthy adults.

this study is being conducted to assess the pharmacokinetics of the major nitazoxanide active metabolite as well as the safety and tolerability in renal impaired (mild, moderate and severe) and healthy matched control adults following repeated oral dose administration of ntz 500 mg twice a day for 7 days.

Eligibility criteria:
inclusion criteria: 1. males or females, between 18 and 80 years of age, inclusive 2. with a minimum body weight of ≥ 50.0 kg for males and ≥ 45.0 kg for females and within a bmi range of 18.0 to 40.0 kg/m\^2, inclusive 3. females participating in this study must be of non-childbearing potential or must be using highly effective contraception for the full duration of the study 4. matched to subjects with mild, moderate and/or severe renal impairment in age (± 15 years), bmi (± 20%) and sex 5. the diagnosis of renal impairment has been stable, without significant change in overall disease status in the last 3 months prior to screening other protocol-defined inclusion criteria may apply exclusion criteria: 1. positive serum pregnancy test at screening or positive urine pregnancy test 2. having taken ntz at any time prior to the first study drug administration 3. history of alcohol abuse within 1 year prior to screening 4. history of drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening 5. excessive consumption of xanthine-based drinks (\> 4 cups or glasses per day), food or beverages containing xanthine derivatives or xanthine-based compounds, 48 hours prior to the first dosing 6. donation of plasma within 7 days prior to dosing or donation or loss of 500 ml or more of whole blood within 8 weeks prior to the first dosing 7. strenuous exercise within 72 hours prior to check-in 8. history of a major surgical procedure within 30 days prior to screening 9. presence or history of malignancy within the prior 3 years, with the exception of treated basal cell or squamous cell carcinoma 10. poor peripheral venous access 11. subjects who are taking warfarin or other highly plasma protein-bound drugs with narrow therapeutic indices other protocol-defined exclusion criteria may apply

Keywords: pharmacokinetics healthy volunteer renal disease kidney disease renal impairment antiparasitic antiprotozoal