Kornimate/medical-research-clean huggingface dataset:
combination statin, acetylsalicylic acid and dutasteride use in prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess whether there is any interaction between statins, acetylsalicylic acid (asa) and dutasteride on protection from prostate cancer, the development of high grade prostate cancer, or lower urinary tract symptoms.

a review of data collected from reduce (reduction by dutasteride of prostate cancer events) study participants will be performed. data required for the analysis includes: ethnicity, prostate specific antigen (psa) levels, prostate volumes, presence of diabetes, concomitant medication use (for statin and asa), prostate biopsy results at 2 and 4 years, body mass index (bmi), digital rectal exam (dre) results, family history of prostate cancer and benign prostatic hyperplasia (bph) outcomes: urinary retention, international prostate symptom score (ipss), urinary tract infections (uti)s. the association of drug interactions with prostate cancer will be explored by using a multivariate logistic regression model including all possible interaction terms between dutasteride, asa and statins (i.e. statin+asa+dutasteride, statin+asa, dutasteride+statin, dutasteride+asa). any interaction term found to be insignificant ( i.e. p\>0.05) will be removed from the model. if a statistically significant interaction term is identified, the study cohort will be stratified by drug use, and the relative risk (rr)of prostate cancer among the different drug users will be reported. to control for potential confounders, a multivariate regression model will be constructed adjusting for age, family history of prostate cancer, dre results and bmi.

Eligibility criteria:
inclusion criteria: * participants who received dutasteride or placebo and had at least one post-baseline prostate biopsy exclusion criteria: * participants not taking concomitant statins or asa

Keywords: statins acetylsalicylic acid dutasteride prostate cancer lower urinary tract symptoms prevention drug interactions
safety, efficacy and dose titration of sodium oligo-mannurarate capsule on mild to moderate alzheimer's disease

Conditions: Alzheimer Disease; Cognitive Impairment

Summary: the primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best therapeutic dose of sodium oligo-mannurarate capsule.

alzheimer's disease is known for placing a great burden on caregivers which includes social, psychological, physical or economic aspects. research indicates that the disease is associated with plaques and tangles in the brain. currently used treatments offer a small symptomatic benefit. no treatments to delay or halt the progression of the disease are, as of yet, available. the investigators suppose sodium oligo-mannurarate capsule to be effective to halt the progression of the disease.

Eligibility criteria:
inclusion criteria: * at least primarily educated. * accord with probable alzheimer disease of national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association(nincds-adrda)'s criteria. * 10 points ≤ minimum mean-square error(mmse) ≤ 24 points. * hachinski ischemia scale \<4 points. * hamilton depression scale ≤10 points. * should have stable accompanying person, or at least contact 2 hours per day, 4 days per week with accompanying person. the accompanying person should help the patient throughout the trial. * signed the information consent form. exclusion criteria: * have been in other clinical trials within 30 days before this trial' start. * women during pregnancy or lactation. * dementia caused by other diseases. * previous nervous system diseases. * abnormal laboratory results. * uncontrolled hypertension. * unstable or serious diseases of heart, lung, liver, kidney and blood. * visual or auditory handicap. * significant focal lesions revealed by electronic computer x-ray tomography(ct) or magnetic resonance imaging(mri) in one year before enrollment. * alcohol abuse or drug abuse. * psychotic, including patients with serious depression. * patients being in drug therapy of alzheimer disease which cannot be stopped. * in treatment of heparin, polysaccharide sulfate, mannose ester 3 weeks before the recruitment. * investigator consider the patient cannot finish this trial for any reason. * relatives or employees of the investigators, staff of the investigate centers, contract research organization and sponsor.
comparing the sleep strip otc™ accuracy in screening for sleep apnea syndrome against the reference method, an in-lab full night polysomnographic (psg)

Conditions: Sleep Apnea Syndrome

Summary: the primary purpose of this study is to demonstrate the equivalence of the new sleep strip otc(tm) compared to the reference method of an in-lab, attended full-night polysomnographic (psg) study.

a prospective, single center two phase study to evaluate the validity and the predictability of the sleepstrip otctm in screening for sas, as compared to the reference method, an in-lab, full night, attended polysomnographic (psg) study. the study will consist of two phases: i: optimization phase:will be performed at the clinic; 20 participants will be enrolled. each participant will be connected simultaneously to the sleepstrip otc(tm) and to the standard lab sensors and recorder. this phase is intended to allow slp to optimize the analysis parameters for optimal performance and will be considered as a pilot phase. ii: equivalence phase: at least 180 participants will be enrolled. all participants will receive the sleepstrip otc(tm) for a night test at home, before or after undergoing an independent psg test at the sleep lab. out of 180 participants, at least 26 participants will receive two sleepstrip otc(tm) devices for two consecutive night tests at home. the remaining participants will receive one sleepstrip otc(tm) for one night test.

Eligibility criteria:
inclusion criteria: * male or female participants, 18 years of age or older at time of enrollment. * participants who present at the technion sleep disorder center for a psg test, and who are willing comply with study procedures. * participants who are willing to sign a written. exclusion criteria: * participant has a clinically significant untreated chronic disease which may unable him/ her to participate in the study. * participant has facial hair or any other skin problem that may hinder proper application of the device on destined facial area. * participant is suffering from a respiratory-track infection or a runny nose at enrollment. * participant is unable to comprehend the purpose of the study as stated in the participant consent form. * participant is unable to comply with the technical requirements of the study.

Keywords: sleep apnea syndrome sas sleepstrip otc
pain using reduced fluence parameters in photocoagulation for diabetic retinopathy.

Conditions: Proliferative Diabetic Retinopathy

Summary: the used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters.


Eligibility criteria:
inclusion criteria: * patients 18 years or older, that signed informed consent * proliferative diabetic retinopathy with indication for panretinal photocoagulation exclusion criteria: * previous retinal photocoagulation * previous ocular surgical procedures * ocular media opacities * history of trigeminal neuralgia * chronic ocular pain * depression under conductual or medical treatment

Keywords: proliferative diabetic retinopathy laser photocoagulation pain
multidisciplinary and coordinated follow-up based on a telemonitoring web platform for improving cpap compliance in low cardiovascular risk sleep apnea patients : optisas 1 study

Conditions: Sleep Apnea Syndrome; Low Cardiovascular Risk

Summary: targeted population: sleep apnea patients at low cardiovascular risk newly treated by cpap hypothesis: six months cpap compliance might be greater in the telemonitoring arm compared to usual cpap care. main goal: to compare 6-months cpap compliance when sleep apnea patients at low cardiovascular risk are randomly allocated to usual cpap care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.

study procedures: the telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of oximetry, cpap compliance, side effects and residual events. secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. automatic algorithms have been built-up for early adjustment of cpap treatment in case of side effects, leaks and persistent residual events. an interim analysis will be performed when 200 patients will be included.

Eligibility criteria:
inclusion criteria: * age between 18 to 78 years * men and women * ahi \> 30 / hour * patient with low cardiovascular score (\<5% defined by european score) * patient affiliated to the national health insurance * willingness to use a telemonitoring system exclusion criteria: * known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease) * central sleep apnea syndrome * previous cpap treatment with respiratory support for sleep respiratory trouble * cardiac failure * hypercapnic chronic respiratory failure (daytime paco2 \> 50 mmhg) * terminal disease

Keywords: obstructive sleep apnea syndrome telemedicine patient compliance
short- and long-term hemodynamic effects of carotid endarterectomy and carotid artery stenting

Conditions: Stroke

Summary: carotid artery stenting(cas) and endarterectomy(cea) are both important treatment strategy for patients with ica (internal carotid artery) stenosis. three dimensional pseudo-continuous arterial spin labeling (pcasl) is a noninvasive perfusion imaging modality to detect reperfusion for recanalization therapy. and it provides information about absolute cbf (ml 100 g-1 tissue min-1) at the brain tissue level. the aim of the present study was to evaluate the series hemodynamic changes in patients who had conducted cas or cea by using 3d pseudo-continuous arterial spin labeling (pcasl) to explore the potential pattern of cbf alternation and thus to improve the prevention strategy for hyperperfusion syndrome.

patients: patients with unilateral severe internal carotid artery (ica) stenosis of stroke eligible were enrolled who underwent cas vs cea.all patients underwent previous scan in 7 days before cas and cea and consecutive scan once per 24 hours after cas and cea. baseline characteristics of patients were recorded including age,gender, hypertension, hypercholesterolemia, diabetes melitus, smoking, obesity, qualifying stroke event. protocols: mri scan protocols t2 weighted image,t1 weighted image,diffusion weighted image(dwi),fluid-attenuated inversion recovery (flair),arterial spin labeling(asl) with post labeling delay (pld) of 2.0s,territory asl(tasl)(pld=2.0s),3-dimensional fast spoiled gradient echo(3d-fspgr). imaging evaluation： 1. pseudo-continuous arterial spin labeling (pcasl) with post labeling delay (pld) of 2.0s evaluation of cerebral blood flow in target downstream territory. 2. flair hyperintensity vascular sign. 3. collateral pattern assessment by territorial asl(tasl) (pld=2.0s). treatment strategy: patients were randomly treated by cea(carotid endarterectomy) or cas(carotid artery stenting). follow up: patients were followed up every 24 hours after treatment procedure, and would have a repeat mri scan after 3 months, 6 months and 1 year.

Eligibility criteria:
inclusion criteria: * informed patient's consent for ica stenting or endarterectomy * lack of contraindications to mri * symptomatic, unilateral ica stenosis 70-99%;irrelevant stenosis \<50% of contralateral ica * tia or stroke - within 360 days exclusion criteria: * intracranial hemorrhage * informed consent not obtained * common exclusion for mri such as patients with claustrophobia * patients with poor imaging quality（poor imaging quality mainly defined as the image cannot be applied to future analysis on account of severe motion artifacts appeared in conventional mri and mistakes in the mri process by accident factors which cannot to be applied to future analysis） * bilateral internal carotid artery occlusion

Keywords: arterial spin labeling mri perfusion carotid artery stenting carotid endarterectomy
"syringe free" long-axis in-plane vs. short-axis out-of-plane approach for central venous catheter placement

Conditions: Catheter Complications; Critical Illness

Summary: internal jugular, subclavian, or femoral veins are often used for central venous catheter (cvc) placement. regardless of which vein is preferred, the "seldinger" technique is used most frequently. the most commonly used method with ultrasound is the short-axis out-of-plane approach. the main problem in this method is that the correct needle tip is missed, and it causes some complications by causing posterior wall punctures. the "syringe-free" technique is first reported by matias et al. in adults; it is a technique that allows full real-time monitoring of the guidewire insertion into the vein without blood aspiration. it is a great advantage in cvc placement, especially with the long-axis in-plane approach. when the literature is reviewed, no study other than a 12 case study in which brachiocephalic vein catheterization related to cvc placement was performed using this technique in children was found. there is no randomized study comparing the "syringe-free" long-axis in-plane technique with the classic short-axis out-of-plane technique in pediatric patients. this study compares these two techniques' efficacy and complication rates in critically ill children requiring cvc placement.


Eligibility criteria:
inclusion criteria: * patients older than 3 months, younger than 15 years old * critical illness pediatrics exclusion criteria: * patients younger than 3 months and older than 15 years, * body weight less than 5000 gr, * anatomical malformation in the neck, * infection at the intervention site, * thrombosis

Keywords: ultrasound catheter long axis short axis pediatrics syringe free
cipropal (ciprofloxacin prophylaxis in acute leukaemia)

Conditions: Acute Lymphoblastic Leukaemia - Category

Summary: cipropal is a randomised trial comparing daily ciprofloxacin with local standard care during the induction phase of paediatric all treatment, and aims: 1. to assess the efficacy of ciprofloxacin prophylaxis in the reduction of infection during the induction phase of treatment for paediatric acute lymphoblastic leukaemia within the alltogether-1 trial. 2. to evaluate the impact of ciprofloxacin prophylaxis on antimicrobial resistance, both of invasive infections and colonising organisms.

this is a multi-centre randomised trial of prophylactic ciprofloxacin (10mg/kg bd, enteral/iv) versus standard of care during the neutropenic period of induction (with an internal pilot study) in patients aged 1-17 years with de-novo all treated on alltogether-1. exclusion criteria include: patients with down syndrome (who already receive ciprofloxacin prophylaxis), contraindication to fluoroquinolones, non-consent to alltogether-1 or cipropal. amr of colonising organisms will be assessed with stool or peri-rectal swab cultures performed at five timepoints within the first year. longer term invasive infection amr monitoring will include sensitivity testing of all organisms isolated in confirmed infection for the duration of alltogether-1. the primary outcome is the rate of sterile site bacterial infections during induction, evaluated by intention to treat analysis. secondary outcomes include rates of febrile episodes, febrile neutropenia, severe infection and infection-related death; rates of amr; antibiotic exposure; secondary infections; and quinolone side effects. a model-based health economic analysis will be undertaken. using a conservative effect estimate of 40% reduction in bacteraemia (i.e. a reduction from 15% to 9%) 1052 patients randomised 1:1 gives 85% power with a 5% 2-sided alpha.

Eligibility criteria:
inclusion criteria: * paediatric patients (1-17 years inclusive) with de-novo acute lymphoblastic leukaemia treated on alltogether-1 in the uk in the first 5 days of therapy, up to 14 days is acceptable. * written informed consent exclusion criteria: * non-participants of the alltogether-1 trial * patients with down syndrome who already receive ciprofloxacin prophylaxis * chronic active arthritis * other contraindication to fluoroquinolones

Keywords: antibiotic prophylaxis
continuous glucose monitor application after hospital discharge for the improvement of outcomes in patients with poorly controlled type 2 diabetes and active cancer

Conditions: Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm; Type 2 Diabetes Mellitus

Summary: this clinical trial studies the effect of a continuous glucose monitor application in improving outcomes in patients with poorly controlled type 2 diabetes and active cancer. patient satisfaction with type 2 diabetes management influences medication-taking behavior as well as health outcomes. adding continuous glucose monitor application to diabetes treatment plan after hospital discharge plan may improve patient satisfaction and reduce diabetes distress.

primary objective: i. evaluate if addition of continuous glucose monitor (cgm) to diabetes treatment plan following inpatient hospitalization is associated with improved patient satisfaction with dm management in patients with cancer and poorly controlled type 2 diabetes mellitus. secondary objectives: i. evaluate feasibility of cgm initiation upon hospital discharge. ii. evaluate effect of cgm on recognition of post-hospitalization hypoglycemia. iii. evaluate patient reported outcome of cgm incorporation into patient diabetes care burden. iv. evaluate effect of cgm on depression score before and after cgm use. outline: prior to hospital discharge, patients receive cgm application and education on how to apply the cgm, and how to use the sensor and its associated smart phone application (app). patients also receive basic diabetes mellitus education. after hospital discharge, patients use cgm for up to 28 days.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * insulin use \> 10 units per day * hemoglobin a1c \> 8.5% * smart phone compatible with libreview app exclusion criteria: * type 1 diabetes mellitus (dm) * inability to consent * pregnancy * prisoners * discharge to skilled nursing facility
glioma and exercising

Conditions: High Grade Glioma

Summary: to investigate the influence of two physical activity and exercising (pae) interventions, namely resistance training and endurance training in relation to quality of life, depression, fatigue, sleep, anxiety, stress and coping, body image, and social interactions (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion, inflammatory markers, and objective sleep (physiological dimensions), along with cancer-related dimensions

patients with high grade glioma (who iii° and iv°) and undergoing radiotherapy, chemotherapy, or both radio- and chemotherapy suffer from decreased quality of life (qol). this study is to analyse the influence of two adjuvant interventions of physical activity and exercising (pae) (namely resistance training and endurance training) in relation to quality of life, depression, fatigue, sleep, anxiety, stress and coping, body image, and social interactions (psychological dimensions); cardiorespiratory fitness, morning cortisol secretion, inflammatory markers, and objective sleep (physiological dimensions).

Eligibility criteria:
inclusion criteria: * patients with high grade glioma (who iii° and iv°), and undergoing radiotherapy, chemotherapy, or both * willing and able to follow the study intervention * signed written informed consent exclusion criteria: * severe psychiatric (psychosis, suicidal behavior, substance use disorder) and somatic comorbidities (severe cardiovascular disease, severe diabetes, impairments of the musculo-skeletal system) * patients not willing or able anymore to follow the study protocol.

Keywords: interventions of physical activity and exercising (pae) resistance training endurance training
sport and self esteem in patients living with hiv

Conditions: HIV Seropositivity

Summary: adapted athletic activity has shown benefits in patients with certain chronic diseases, including improving fatigue and pain in patients with cancer, and improving the symptoms of severe depression. among patients living with human immunodeficiency virus (plhiv), sport appears to be less common than for people who do not live with hiv. in fact, 44% of plhiv in a swiss cohort (10,500 patients) were inactive in 2014, whereas this percentage was 26% in the general population in switzerland. we did not find any french data on the prevalence of sports activity among plhiv. the benefits of sport in plhiv are numerous: meta-analyzes on interventional studies of aerobic and resistance exercises show a significant improvement in maximum oxygen consumption, muscle strength, percentage of body fat, quality of life and symptoms of depression. an improvement in cognitive function was noted in a randomized study. an iranian randomized study of 2017 showed an improvement in the cd4 count, after 8 weeks of resistive exercise, but two meta-analyzes of 2016 and 2017 did not find a significant change in cd4 or viral load with physical exercise. on the other hand, several studies have shown that sports practice improves self-esteem. in addition, an australian randomized study in 2006 showed an improvement in self-efficacy in plhivs after a six-month exercise (aerobic and resistance) program. furthermore, self-esteem (defined as positive self-esteem) is a factor facilitating adherence to antiretroviral therapy. the objective of this descriptive study is to evaluate the prevalence of sports activity in a french adult population infected with hiv and to seek an association with self-esteem. in addition, the investigators will look for an association between sport and fatigue, pain, sleep, lymphocyte t cd4 cell levels, viral load.


Eligibility criteria:
inclusion criteria: * patient with hiv * aged over 18 * patient followed by a physician in one of the participating centers of the regional coordination of the fight against hiv infection (corevih) pays de la loire exclusion criteria: * refusal or unability to answer the self-questionnaire. * patient under guardianship

Keywords: sport hiv self esteem
safety and efficacy of single port laparoscopic surgery in colon cancer

Conditions: Colon Cancer

Summary: this randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * pathologic proven colon cancer exclusion criteria: * tumor located in distal transverse colon, splenic flexure, and descending colon * distant metastasis * acute obstruction and/or perforation * associated with fap or hnpcc * synchronous malignancy * asa score 3 or 4 * pregnancy * no consent