Kornimate/medical-research-clean huggingface dataset:
alteplase for blood flow restoration in hemodialysis catheters

Conditions: Thrombosis

Summary: we are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve the clot and restore blood flow through the catheter. we have developed a new way to administer alteplase by advancing it to the tip of the catheter at regular 10 minute intervals. we hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.

central venous catheters are commonly used for vascular access in the hemodialysis population. a common complication is low / no blood flow through the catheter due to clots. these are serious situations because patients may miss dialysis sessions and suffer significant morbidity. in an attempt to dissolve the clots and restore blood flow, thrombolytics are frequently instilled into the catheters between dialysis sessions . however, we have developed and new "push" protocol that advances fresh thrombolytic (alteplase) to the tip of the catheter in order to facilitate more effective and faster removal of the clot. we hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.

Eligibility criteria:
inclusion criteria: 1. adults \> 18 yrs old 2. hemodialysis patients 3. vascular access with a permanent catheter 4. no prior rt-pa use in the catheter over the previous 21 days 5. one rt-pa instillation per catheter (i.e. we will only document the results of 1 rt-pa instillation per catheter. numerous rt-pa instillations in the same catheter will not be considered new events, and not entered into the study) exclusion criteria: 1. critically ill patients in the icu setting. 2. contraindications / cautions with alteplase use including: known hypersensitivity to alteplase or its components (l-arginine, phosphoric acid, polysorbate 80), patients with known conditions associated with bleeding events (e.g.intracranial bleed in last 4 weeks, major hemorrhage in last 4 weeks (hgb drop of 20 g/l)), recent surgery (\<48 hours), recent biopsy (\<48 hours), hemostatic defects including severe hepatic disease, or current intracranial / intraspinal neoplasm. 3. hemodialysis catheter has been in the patient less than 14 days.

Keywords: catheter hemodialysis dysfunction thrombolytic alteplase
analgesia and wound healing assessment following topical morphine applied to patients with cutaneous cancer related pain

Conditions: Ulcer; Wounds and Injuries

Summary: cutaneous cancer-related pain is difficult to treat. these patients are often prescribed high systemic dosages of opioids. yet, many patients continue to report pain while experiencing dose-limiting side effects. an alternative approach to systemic administration is to apply topical medications. the advantage of topical application is the potential of achieving good analgesia using low dosages with few, if any, systemic side effects. current clinical data indicates, that topically applied morphine has an analgesic effect in patients with severe pain and that it may even improve wound healing. the clinical reports so far have been either case studies or double blind randomly controlled trials with a very small sample size of patients. there is still a great deal of information which is lacking about this modality of treatment regarding on the one hand, the mechanism of action and on the other, clinical issues. for example, is the mechanism of the effect actually peripheral? what is the adequate dose of analgesic medication for different types of skin conditions? wound healing has not been quantified. we will apply morphine topically to skin wounds of cancer and evaluate the effect of the treatment on pain, side effects, quantify wound healing, quantify morphine and its metabolites in blood and urine. should well controlled studies, demonstrate all or any of the peripheral effects of topical morphine, clinical application of this treatment modality would be possible. this could contribute towards better treatment of these patients, who have pain which is difficult to treat and can, at times, be intractable.


Eligibility criteria:
inclusion criteria: * moderate to severe resting pain (scores above 5/10). * stable analgesic regimen. * no surgical interventions planned during the study period. * able to self-assess pain and report it. * hospitalized or receiving home care for stage i; out-patients or receiving home care for stage ii. * wound not infected or covered with necrotic tissue. exclusion criteria: * true sensitivity to opioids

Keywords: skin ulcers topical morphine chronic pain cancer
extension study to compare long-term efficacy and safety of ranibizumab intravitreal injections versus dexamethasone intravitreal implant in patients with rvo

Conditions: Retinal Vein Occlusion

Summary: the study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with lucentis in comparison with ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies crfb002ede17 (nct01396057) and crfb002ede18 (nct01396083).


Eligibility criteria:
inclusion criteria: * patients must have completed the core study assessments at month 6 of study crfb002ede17 or crfb002ede18, respectively exclusion criteria: * patients who experienced an uncontrollable rise in iop during the core study crfb002ede17 respectively crfb002ede18, i.e. iop could not be decreased to a stable level of \< 25mmhg. * use of other investigational drugs * current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve * history of hypersensitivity to ranibizumab or ozurdex or any component of the ranibizumab respectively ozurdey formulation * any type of advanced, severe or unstable disease or its treatment, that could interfere with evaluations or put the patient at special risk * women * who were pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\>5 miu/ml) * who were menstruating and capable of becoming pregnant\* and not practicing a medically approved method of contraception (pearl index \<1\*\*)\*\*\* during and up to at least 4 weeks after the end of treatment. a negative pregnancy test (serum) for all women and for girls entering menarche was required with sufficient lead time before randomization * definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum fsh levels \>40 miu/ml or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy * examples of particularly reliable methods with pearl index (pi) \<1, according to guidelines of "deutsche gesellschaft für gynäkologie und geburtshilfe": * combination pill with estrogen and gestagen (no mini-pill, pi=0.1-0.9) * vaginal ring (nuvaring®, pi=0.65 uncorr.; 0.4 corr.) * contraceptive patch (evra®, pi= 0.72 uncorr.; 0.9 corr.) * estrogen-free ovulation inhibitors (cerazette®, pi=0.14) * progestin-containing contraceptives (implanon®, pi=0-0.08) * injectable 3-month depot progestins (pi=0.3-1.4; 0.88 corr.) * intra-uterine progestin device (mirena®, pi=0.16)

Keywords: macular degeneration macular edema retinal vein occlusion choroidal neovascularization signs and symptoms retinal degeneration retinal diseases eye diseases venous thrombosis sensation disorders dexamethasone acetate dexamethasone dexamethasone 21-phosphate bb 1101 anti-inflammatory agents therapeutic uses vision, low signs vision disorders
positron emission tomography - computed tomography (pet-ct) cetuximab project

Conditions: Metastatic Colorectal Cancer

Summary: molecular imaging with positron emission tomography (pet) using \[18f\] fluorodeoxyglucose (fdg) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. recently, fdg-pet has shown to be highly sensitive in detecting early response in other tumours. in this study, the investigators will prospectively investigate the role of early fdg-pet (at day 7 and week 6) in outcome prediction.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven colorectal cancer * unresectable stage iv disease * k-ras wild type tumour * patients scheduled to undergo chemotherapy with irinotecan and cetuximab exclusion criteria: * prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study * poorly controlled diabetes * concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection * symptomatic brain metastases * pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception
analgesia nociception index (ani) after unilateral radical mastectomy as an evaluation of paravertebral block failure

Conditions: Breast Cancer

Summary: paravertebral block (pvb) combined with general anesthesia (ga) is a conventional pain treatment for breast surgery but sometimes failures can occurs. the efficacy of this block has to be evaluated. also, for the intra-operative analgesic evaluation of this block, it is necessary to measure intra-operative analgesia index. a monitor of nociception for patients under ga, the physiodoloristm device, offers an index for measuring nociceptive inputs during surgery in anesthetized patients : the ani index (based on the single r-r interval analysis). the purpose of this observational and prospective study is to assess the variations of this ani index during breast surgery with or without axillary node dissection with a pvb. this will allow us to quantify the analgesic effect of a pvb during ga for unilateral radical breast surgery with or without axillary node dissection.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists score (asa) i or ii * woman * patients aged over 18 years * bmi between 17 and 30 kg/m2 * radical mastectomy with or without axillary node dissection. exclusion criteria: * preoperative consumption of opioid * local anesthesia allergy * local skin inflammation at the puncture area * inability to respond to pain assessment using a numerical rating score (nrs) * any contra-indication or patient's refusal for regional anesthesia b blocker medication * pace maker * inability to perform the pvb (at the appreciation of the anesthesiologist) * change of surgical procedure other modified radical mastectomy with or without axillary node dissection. * patient with a severe side effect or who cannot be controlled by additional therapy will be removed from the trial

Keywords: general anesthesia paravertebral block analgesia nociception index
alcohol-focused support of survivors in sororities training (assist) - pilot

Conditions: Alcohol Drinking in College

Summary: the goal of this clinical trial is to conduct a preliminary evaluation of the assist (alcohol-focused support of survivors in sororities training) intervention in sorority chapters. assist is a newly developed web-based intervention to increase peer support of sexual assault survivors and reduce encouragement of drinking to cope within social networks of sororities. to test whether the intervention is feasible and shows preliminary signs of working, a pilot cluster randomized trial will be conducted. sorority chapters will be recruited and randomly assigned to an intervention condition or an assessment-only condition. individuals within each sorority will be recruited and complete a norm documentation survey. one month later, participants will complete a baseline survey, and if assigned to the intervention condition, will then receive the web-based assist intervention, which will include normative feedback on values and drinking, psychoeducation about sexual assault recovery and the role of alcohol, and skills training in behaviors that can be used to support survivors without or while moderating heavy drinking. all participants will complete online follow-up surveys at 1-, 3-, and 6-months post-intervention.


Eligibility criteria:
chapter-level inclusion criteria: * greek organization of undergraduate women recognized by the office of fraternity \& sorority life with a physical house for chapter members * at least 80 active members individual-level inclusion criteria: * aged 18 years or older * current student * active member in a participating sorority chapter exclusion criteria: * \[none\]
investigating auditory processing in the users of auditory brainstem and cochlear implants

Conditions: Deafness

Summary: this is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (abi) devices. the study will evaluate different aspects of hearing and auditory processing in the users of implantable auditory devices.


Eligibility criteria:
inclusion criteria: * hearing impaired adult and or child (above 2 years old) who uses abis or cochlear implants. * no diagnosis of any other communicative or cognitive disorder other than hearing impairment. the individual must be able to visit the lab in order to participate in behavioral and electrophysiological experiments. * patients' implant device must have useable electrodes that do not result in uncomfortable or unpleasant non-auditory sensation. exclusion criteria: * diagnosed cognitive or communicative disorders (other than hearing impairment) * severe neurological disorders * no useable electrodes in their implants
comparison of misight 1-day and acuvue oasys for presbyopia in myopic children

Conditions: Myopia Progressing

Summary: this study will compare the effects on myopia progression over the course of one year for eyes wearing misight 1 day contact lenses compared to acuvue oasys for presbyopia contact lenses.


Eligibility criteria:
inclusion criteria: 1. aged 6-12 years (inclusive) 2. is willing to wear soft contact lenses daily 3. spherical equivalent myopic refractive error between -0.50 to -5.00 d in each eye and astigmatism \< 1.00 d 4. best corrected logmar visual acuity of 0.1 or better in both eyes 5. good ocular and general health 6. no previous use of myopia control interventions for more than 1 month or within the last 30 days 7. competent enough in english to be able to fully understand the participant information and consent form exclusion criteria: 1. strabismus at distance or near, amblyopia or significant anisometropia (\>1d) 2. systemic or ocular conditions that may affect contact lens use (e.g., allergy) or that may affect refractive development (e.g., ptosis) 3. previous history of ocular surgery, trauma, or chronic ocular disease 4. contraindications to contact lens use 5. ocular or systemic medication use which may interfere or interact with contact lens wear or ocular development 6. plans to migrate or move during the study 7. child, parents or guardians not willing to comply with treatment and/or follow-up schedule
musculo-scrawny manifestation associated with the endometriosis

Conditions: Endometriosis

Summary: the endometriosis is defined by the presence of endometriosic tissue outside of the womb and the prevalence is estimated to be 10% of women.here is a project aimed to compare musculo-scrawny pains between patients with endometriosis and whose don't suffer of this pathology;


Eligibility criteria:
inclusion criteria: * age between 18 and 45 * consulting in service of gynecology * first trimester of pregnancy or for pap smears exclusion criteria: * endometriosis diagnostic already done * rhumalogic disease known * age \ 50 * menopause
pelvic floor displacement in women with sui and healthy women: an ultrasound study (stress urinary incontinence)

Conditions: Healthy; Stress Urinary Incontinence

Summary: pelvic floor main role is to maintain continence. pelvic floor malfunction could lead to urinary incontinence (ui). the known prevalence of ui among women is 25%-72%, in about 25%-50% it is stress urinary incontinence (sui), sui prevalence changes with age and obstetric history. sui is the complaint of involuntary leakage on activities which involves inter abdominal pressure rase, such as effort or exertion, or sneezing or coughing. pelvic floor movement is coordinated with the diaphragm, it moves caudally while inhaling and cranially while exhaling. it was shown that cranial sagittal displacement of the pelvic floor is correlated to pelvic floor normal and efficient function. in order to maintain continence while internal abdominal pressure rises the pelvic floor as to work in a precise trajectory, timing and force. observing the urinary bladder by trans abdominal ultra sound (taus) was found as a valid and reliable way to estimate pelvic floor sagittal displacement and function.

50 women between the age 25-50 with a history of one vaginal delivery will be recruited for the study. 25 women who complain about stress urinary incontinence (research group) and 25 healthy women (control group). all research participants will sign first a participant consent form. all participants will be interviewed about their own delivery, measured for weight and height and follow a trans abdominal ultra sound (taus) examination. the research group participants will be asked to fill a quality of life questionaire concerning their sui complaint. at the taus examination the participant will be asked to perform: 1. 3 times quiet breathing. 2. 3 times forced exhalation. 3. 3 times cough. while doing so an ultra sound image of the urinary bladder will be saved for displacement measurements.

Eligibility criteria:
inclusion criteria: * women after one vaginal delivery on term. * women aged 25-50 * members of 'macabi medical services' exclusion criteria: * pregnancy * nulliparous women * women who had c section delivery * known neurologic disease * previous history of pelvic or back surgery * previous history of pelvic fracture * known pulmonary disease * active urinary tract infection

Keywords: taus breathing protocols and cough pelvic floor displacement women sui
36-months clinical evaluation of preheated and room temperature resin composite

Conditions: Dental Leakage

Summary: summary the aim of this study was to evaluate the effect of preheating resin composite (rc) on clinical performance of class i restorations in a period of 3-years using a split-mouth double-blinded randomized design.

the description of the experimental design followed the consolidated standards of reporting trials (consort) statement. the present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the split mouth design. thirty-five adult patients seeking dental treatment in operative department clinic at faculty of dentistry, university of mansoura were enrolled in the current study with a total of 70 class i restorations. no advertisement was made for participant recruitment, forming a sample of convenience. each patient much sign a consent form before participating in the current study. the study was conducted from october 2017 to june 2020 as a part of doctoral dissertation. mansoura university institution's ethics committee approved the form and protocol before conducting the study. the sample size was calculated based on the clinical success rate (100% retention rate at 3 years) of posterior class i restorations restored with nanofilled composite observed in a previous study.28 according to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. upon these data, a sample size of 30 subjects was appropriate. allowing for a 20% drop-out, sample size was set totalizing 35 subjects.

Eligibility criteria:
inclusion criteria: * patients with primary caries involving occlusal surface only with icdas 2 and 3 * patients with cavities no more than one-third of the intercuspal distance * patients must have a good oral hygiene; * patients with tooth gives positive response to testing with an electric pulp tester * patients with normal and full occlusion, * patients with opposing teeth should be natural with no restorations. exclusion criteria: * high caries risk patients with extremely poor oral hygiene, * patients involved in orthodontic treatment or periodontal surgery, * patients with periodontally involved teeth (chronic periodontitis) * patients with abutments should be excluded. * patients with heavy bruxism habits and clenching

Keywords: resin composite pain randomized clinical trial operative dentistry preheating
effect of omega 3 fatty acids on oxidative stress in hiv seropositive patients

Conditions: HIV/AIDS

Summary: introduction: highly active antiretroviral therapy (haart) has showed its effectiveness in the prevention of complications in seropositive for hiv patients. however, they develop some manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing cardiovascular risk. clinical trials in general population and in patients on hemodialysis have demonstrated a significant reduction in cardiovascular events using fish oil. omega-3 fatty acids are believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially triglycerides. also in general populations it has been described a benefit effect of omega 3 acids on oxidative stress. objective: to know the effect of omega 3 acids on different markers of oxidative stress in seropositive hiv patients. methods: we will perform a randomized parallel controlled clinical trial in seropositive hiv patients from 20 to 55 years old on clinical score a1, a2, b1 or b2 who received haart. they will be randomly assigned to receive omega 3 fatty acids 2.4 g (zonelabs, marblehead ma) or placebo for 6 months. at baseline anthropometric measurements, lipid profile, glucose and stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid peroxidation products) will be evaluated. sample size was calculated according to different variables. we selected the biggest one calculated for a difference in nitric oxide of 25% after treatment between groups and a standard deviation (sd) value of 10µmol/l. whit this information we obtained a sample size of 31 patients per group for an 80% statistical power with α= 0.05. assuming a 15% patient lost, a sample size of 35 per group was considered.


Eligibility criteria:
inclusion criteria: * seropositive hiv patients from 20 to 55 years old * on clinical score a1, a2, b1 or b2 * patients who received highly active antiretroviral therapy for at least 3 months. exclusion criteria: * patients diagnosed with diabetes mellitus * patients diagnosed with hypertension * patients using hypolipidemic agents or diagnosed with dyslipidemia before receiving haart therapy. * patients using protease inhibitors

Keywords: seropositive hiv omega 3 fatty acids oxidative stress