Kornimate/medical-research-clean huggingface dataset:
the effectiveness and safety of intravesical gemcitabine instillation to prevent intravesical recurrence

Conditions: Urothelial Carcinoma

Summary: the aim of this study is to evaluate the effectiveness and safety of intravesical gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma.

study design: intervention model: single group assignment masking: open label primary outcome measures: two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. secondary outcome measures: time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. safety of intravesical 2000mg/52.6ml gemcitabine instillation.

Eligibility criteria:
inclusion criteria: * the subjects who will undergo nephroureterectomy due to ureter or renal pelvis urothelial carcinoma * male or female aged 18 or over 18 years and not more than 85 years who were diagnosed as upper urinary tract urothelial carcinoma * normal bone marrow function: hemoglobin \>10 g/dl, anc \>1,500/mm3, platelet count\>100,000/mm3 * normal bladder volume and function * normal liver function: * bilirubin ≤ 1.5 times of upper normal limit * ast/alt ≤ 1.8 times of upper normal limit * alkaline phosphatase ≤ 1.8 times of upper normal limit * subjects who voluntarily decided to participate and signed the written informed consent exclusion criteria: * concomitant bladder cancer * subjects who underwent any treatment due to bladder cancer within 3 years * prior hypersensitivity reaction history to gemcitabine * neurogenic bladder * subjects who underwent chemotherapy due to any cancer within 6 months * subjects who underwent neoadjuvant chemotherapy due to ureter or renal pelvis urothelial carcinoma * hypersensitivity to gemcitabine or component of gemcitabine * in case of co-administration of gemcitabine and cisplatin in severe renal failure patients * moderate to severe liver dysfunction or renal dysfunction (glomerular filtration rate \< 30 ml/min) * severe bone marrow suppression * severe infection * female who are pregnant or has a possibility of pregnancy * nursing female * interstitial pneumonia or pulmonary fibrosis which is evident on chest x-ray and symptomatic * subjects who are undergoing radiotherapy on chest
changes induced by breakfast cereals enriched with omega-3 in the lipidic profile

Conditions: Overweight

Summary: the inclusion of breakfast cereals enriched with omega-3 for female users of a pharmacy who had some lipidic profiles to the limit is highly conditioned by their nutritional acceptance. the main objective is to assess the effect of breakfast cereals intake with omega-3 on women lipid profile values to the limit, users of a pharmacy in elche and in this way reduce the small dyslipidemia.

the investigators performed an intervention including 133 women (age 25-70 years). participants were randomly and single-blind distributed into three groups: group 1 (n=38) consumed cereal with omega-3 (cw-3 + d), cereal (c) and diet (d), group 2 (n=38). volunteers consumed (c) + (d) and group 3 (n=37) consumed only diet. all groups followed a limit levels-cholesterol diet. circulating total cholesterol, hdl-cholesterol, ldl-cholesterol, triglycerides and glucose were determined at the beginning and end of a 30-day test. statistical analysis was carried out using statgraphics centurion xv software (statpoint technologies, inc. warrington, va, usa); likewise, significance was defined at p ≤ 0.05. data are reported as mean ± standard error of the mean (sem). intra-group statistical comparisons were performed using the following hypothesis tests, both parametric and non-parametric: t-test, sign test and signed rank test for paired samples. inter-group statistical comparisons were performed using the one-way analysis of variance and the kruskal-wallis hypothesis tests. also, fisher's least significant difference (lsd) multiple range test and tukey's honestly significant difference (hsd) were used in order to determine which means were significantly different from the others. in addition, generalized multiple regression was used to statistically analyze the relationships between the variations in the lipid profile and the different factors included in the study.

Eligibility criteria:
inclusion criteria: * voluntarily participation * ages between 25-70 years * undergoing dyslipidemia * with no pharmacological treatment * cholesterol (250-300 mg/dl) * triglycerides (160-175 mg/dl) exclusion criteria: * subjects undergoing any pharmacological treatment that may influence lipid metabolism * lipid levels outside the range of those specified in the inclusion criteria * subjects that were deemed to be unlikely to complete the treatment or to cooperate fully at the investigator´s discretion.

Keywords: breakfast cereal omega-3 cholesterol lipidic profile consumption acceptability
safety study of il-21/ipilimumab combination in the treatment of melanoma

Conditions: Melanoma

Summary: the purpose of this study is to determine whether the combination of interleukin-21 (il-21) and ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with ipilimumab alone

allocation: part 1 dose escalation phase: non-randomized; part 2 cohort expansion phase: randomized

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * unresectable stage iii or stage iv melanoma * part 1 dose escalation: prior melanoma treatment allowed except for the following: ipilimumab, bms-982470 (ril-21), anti-programmed death-1 (anti-pd-1), anti-programmed death-ligand 1 (anti-pd-l1), anti-pd-l2 or anti-cd137 * part 2 cohort expansion: prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted * eastern cooperative oncology group (ecog) performance status of 0 or 1 * measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) * normal liver function tests exclusion criteria: * part 1 dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed * part 2 cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded * autoimmune disease
the effect of cognitive rehabilitation on epileptic pateints under treatment

Conditions: Cognitive Dysfunction; Epilepsy

Summary: it is clear that studies on cognitive rehabilitation in epilepsy patients mostly focus on patients undergoing epilepsy surgery and are largely classified according to the type of epilepsy. the main purpose of this study is to determine whether cognitive impairments associated with antiepileptic drugs develop in epilepsy patients using neuropsychological tests and event-related potentials, and if such an impairment is present, to investigate whether cognitive rehabilitation is beneficial.

patients who were planned to start monotherapy were first included in the study by performing a face-to-face moca test. after the moca test, experienced neurologists measured event-related potentials, including p300 and n200 potentials and n2p3 amplitudes, in the electrophysiology laboratory. patients for each drug were randomly assigned to the no cognitive rehabilitation group (a) or the cognitive rehabilitation group (b). at the end of the second month, moca test and event-related potential measurements were performed again in both groups, and the results were analyzed statistically.

Eligibility criteria:
inclusion criteria: * newly diagnosis of epilepsy, - * before monotherapy had started exclusion criteria: * diagnosis of psychogenic non-epileptic seizures, * epileptic patients currently receiving antiepileptic drugs, * epileptic patients exhibiting cognitive dysfunction * epileptic patientswith dementia

Keywords: cognitive rehabillitation antiseizure medication moca p300, n200
allogeneic vs autologous prp for diabetic wounds in renal dysfunction: a randomized controlled trial

Conditions: Diabetic Wounds; Platelet Rich Plasma; Allogeneic Blood Transfusions; Renal Dysfunction

Summary: diabetic wounds are difficult to heal. autologous platelets in diabetic patients with renal insufficiency have poor function. allogeneic platelet plasma has a promising application prospect. comparing the efficacy and safety differences between allogeneic platelet plasma and autologous platelet plasma is of significant importance and value for the clinical application.

this study is a single-center, randomized, parallel control, superior trial. fifty-six renal dysfunction patients with diabetic-related wound after wound bed preparation will be randomly assigned to the autologous platelet plasma group and allogeneic platelet plasma group in a 1:1 ratio. the primary outcome is the wound healing rate at 4 weeks (stitches removal). the secondary outcomes include the wound healing rates at 3, 6, and 8 weeks, healing time, post-operative wound infection, 7-day, 2-, 3-, 4-, 6-, 8-week pain relief progression assessed by visual analog scale, incidence of mortality, reoperation, and adverse events during the follow-up period.

Eligibility criteria:
inclusion criteria: 1. the patient is aged 18-80 years old; 2. diagnosed as type 1 or type 2 diabetes according to the world health organization standard, blood sugar has been controlled before enrollment, and the level of glycated hemoglobin hba1c is less than 10%; 3. abnormal renal function defined as: * serum creatinine \>106 μmol/l (men) or \>97 μmol/l (women) * and egfr \<90 ml/min/1.73m² (ckd-epi) ； 4. the patient has diabetes wounds with poor healing or prolonged healing need standard wound treatment; 5. after preparing the wound bed, the condition for using platelet plasma to close the wound is met\*; 6. voluntarily sign an informed consent form; exclusion criteria: 1. blood glucose is out of control or not yet effectively controlled，; 2. severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet; 3. active bleeding inside the wound, and routine basic treatment plans cannot be implemented； 4. uncontrolled systemic or disseminated infections; 5. patients with advanced malignant tumors; 6. pregnant or lactating women； 7. the patient is unable to cooperate or has mental disorders; 8. according to the judgment of the researchers, the patient has a clear and irremovable cause that affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.

Keywords: diabetic wounds platelet rich plasma allogeneic blood renal dysfunction
episodic future thinking and compassion

Conditions: Compliant Behavior; Self-Control; Impulsive Behavior

Summary: during the covid-19 (coronavirus disease 2019) pandemic, public health departments have issued guidelines to limit viral transmission. in this environment, people will feel urges to engage in activities that violate these guidelines, but research on guideline adherence has been reliant on surveys asking people to self-report their typical behaviour, which may fail to capture these urges as they unfold. guideline adherence could be improved through behaviour change interventions, but considering the wide range of behaviours that covid-19 guidelines prescribe, there are few methods that allow observing changes of aggregate guideline adherence in the 'wild'. in order to administer interventions and to obtain contemporaneous data on a wide range of behaviours, the researchers use ecological momentary assessment. in this preregistered parallel randomised trial, 95 participants aged 18-65 from the united kingdom were assigned to three conditions using blinded block randomisation, and engage in episodic future thinking (n = 33), compassion exercises (n = 31), or a sham procedure (n = 31) and report regularly on the intensity of their occurrent urges (min. 1, max. 10) and their ability to control them. the researchers investigate whether state impulsivity and vaccine attitudes predict guideline adherence, while assessing through which mechanism these predictors affect behaviour.


Eligibility criteria:
inclusion criteria: * resides in the united kingdom * fluent in english * must pass attention check in eligibility survey exclusion criteria: * less than 50% compliance with ecological momentary assessment surveys

Keywords: episodic future thinking compassion impulsivity self-control pandemic public health
a study of pulmonary hypertension peripheral limitations

Conditions: Pulmonary Arterial Hypertension; Healthy

Summary: the investigators are doing this research study to compare whole body aerobic training with isolated leg training (with weights) and its impact on effectiveness in symptoms and quality of life in patients with pulmonary arterial hypertension (pah).


Eligibility criteria:
inclusion criteria: 1. pulmonary arterial hypertension (pah) subjects: 1. informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. nyha class ii-iv 3. lvef ≥ 40 % within the preceding year. 4. no hospitalizations due to heart failure in the preceding 30 days. 5. no recent initiation of pulmonary vasodilator in the last 60 days 6. pulmonary arterial hypertension by right heart catheterization (mean pa pressure ≥ 20 mmhg with pvr\>2 wood units) with no evidence of heart failure with preserved ejection fraction (exercise pcwp \<25 mm hg). 7. symptomatic pah patients with plan to undergo exercise rhc for reassessment of exertional symptoms 2. healthy controls: 1. informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. no known diagnosis of heart failure exclusion criteria: * myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening. * planned coronary, carotid, or peripheral artery revascularization. * any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease). * wheelchair bound or orthopedic inability to exercise * chronic hypoxemia with inability to exercise without oxygen supplementation (pah subjects) or need for oxygen supplementation (healthy controls) * skeletal muscle myopathy * history of rhabdomyolysis * participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening. * receipt of any investigational medicinal product within 30 days before screening * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. * major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator. * any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.

Keywords: muscle training
the effect of watching relaxing video during cystoscopy

Conditions: Pain; Anxiety; Urological Nursing; Lower Urinary Tract Symptoms

Summary: the cystoscopy procedure may cause pain and anxiety in patients. since cystoscopy causes more pain in men, studies on pain and anxiety during cystoscopy are more common in men than women. the aim of this study was to evaluate the effect of watching relaxing video during cystoscopy on the pain and anxiety levels of female patients.

cystoscopy is a safe procedure with low risk of morbidity commonly used to evaluate lower urinary tract symptoms such as hematuria, voiding disorders, irritant bladder symptoms, anatomical disorders. patients experience pain and anxiety when cystoscope is inserted into the bladder. the various methods (drug or non-drug) are used for pain and anxiety during the cystoscopy. although there are a lot of studies on male patients, there are limited studies evaluating pain severity in the female patients during urological procedures. in addition, there wasn't found any randomized controlled study for video use from non-drug methods to distract attention in these patients. based on the study results in the literature, investigators aimed to evaluate the effect of watching relaxing video on the pain and anxiety levels of female patients during rigid cystoscopy.

Eligibility criteria:
inclusion criteria: * age \> 18 years * female gender * rigid cystoscopy for the first time exclusion criteria: * presence of any contraindication for cystoscopy (such as lidocaine allergy, urinary tract infection, and urethra-related anatomical disorders) * any analgesic used 24 hours before cystoscopy * manipulations such as double-j stent placement or removal, and/or bladder biopsy.

Keywords: anxiety cystoscopy female nursing pain video
effect of bariatric surgery versus medical therapy on metabolic syndrome

Conditions: Metabolic Syndrome

Summary: bariatric surgery (bs) is known to improve the components of metabolic syndrome (ms) in obese patients. however, few studies have evaluated the impact of bariatric surgery versus medical therapy (mt) in patients with ms, especially in patients with low body mass index (bmi). this study aimed to assess the effect of bariatric surgery on ms in patients with low bmi by comparing bs (bmi\<35 kg/m2 and bmi≥35 kg/m2) with mt (bmi\<35 kg/m2). a retrospective study including patients with ms undergoing bariatric surgery and medical therapy at a single institution. we follow up the 5 years effect of bariatric surgery versus medical therapy on the remission of ms, its individual components, atherosclerotic cardiovascular disease (ascvd) risk, and medication used.

1. study design and patients this study aimed to compare bariatric surgery(bs) with medical therapy (mt) for the management of low bmi patients with ms, approved by the ethics committee and institutional review at our hospital. 100 patients underwent bariatric surgery and 100 patients receiving medical therapy for obesity and type 2 diabetes between 2010 and 2020 at our institution. all patients met the chinese guidelines developed by the chinese society for metabolic \& bariatric surgery (csmbs). all patients achieve diagnostic criteria for ms, defined by the presence of at least 3 of the 5 following criteria derived from the joint interim statement (jis) definition. 2. outcome and data collection all patients follow up the change of improvement in ms and its components following bariatric surgery and medical therapy, including waist circumference, hyperglycemia, hypertension, hyperlipidemia, long-term cvd risk, and medication use 3. treatments 3.1 bs group the bariatric surgical procedures performed included roux-en-y gastric bypass and sleeve gastrectomy. 3.2 mt group according to the guidelines in china, patients in the medical therapy group received glucose-lowering, lipid-lowering, and antihypertensive medications, with the following targets: glycosylated hemoglobin\ 1.3 mmol/l for female or 1.0 mmol/l for male.

Eligibility criteria:
1. inclusion criteria: * bmi\<35 kg/m\^2 * underwent bariatric surgery or medical therapy * patients met the diagnostic criteria for ms, defined criteria derived from the joint interim statement (jis) 2. exclusion criteria: * patients who failed to follow up * insulin dependent diabetes * congenital dementia * brain trauma * epileps * severe hypoglycemic coma * cerebrovascular disease * ischemic * heart disease * renal dysfunction * alcohol abuse * mental illness * psychoactive substance abuse * unwillingness to provide informed consent

Keywords: metabolic syndrome medical therapy bariatric surgery body mass index
this study will collect clinical and patient reported satisfaction data from males requiring urine output management overnight in the home setting.

Conditions: Urinary Incontinence

Summary: this post-market study will assess the performance of and user satisfaction with the purewick™ male external catheter in a home setting. the study will also observe safety of the study device and collect information from participants about their experience using the device.

approximately 15 men requiring the use of diapers or pads at night for urine management will take part in this prospective, open-label, crossover trial. participants will be 1:1 randomized to a treatment sequence using two devices: the purewick™ system (purewick™ male external catheter \& purewick™ urine collection system) and the ultraflex™ self-adhering male external catheter. participants will use each urine management device overnight while sleeping for a period of 7 days with a 2-day washout period in between. total duration of participation is approximately 16 days. the primary efficacy endpoint is the mean capture rate. the primary safety endpoint is the number of device-related aes requiring medical intervention. capture rates and adverse events are assessed daily throughout each 7-day treatment phase. sleep disturbance is assessed at baseline and every 7 days during treatment. end of study preference questionnaire is completed at the end of treatment. device adherence is assessed by the proportion of device wear nights that the study device became dislodged. tolerability is assessed by number of nights of actual device use.

Eligibility criteria:
inclusion criteria: 1. adult male participants ≥ 65 years of age at the time of signing the informed consent 2. male anatomy at the time of enrollment 3. currently use diapers, pads, or equivalent at night for urine output management 4. willing to comply with all study procedures in this protocol 5. provision of signed and dated informed consent form exclusion criteria: 1. has frequent episodes of bowel incontinence; or 2. has chronic urinogenital infections, active genital herpes; or 3. has urinary retention; or 4. has experience using study devices in the home setting within the last year; or 5. is agitated, combative, and/or uncooperative and may remove the external catheter; or 6. has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or 7. any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or 8. is considered a vulnerable population.

Keywords: purewick urine collection system male external catheter urinary incontinence urine management nocturia nocturnal enuresis