Kornimate/medical-research-clean huggingface dataset:
the impact of manual versus mechanical intestinal suturing on the incidence of postoperative complications following cystectomy with ileal conduit

Conditions: Bladder Cancer; Anastomosis; Complications; Ileus Paralytic

Summary: impact of manual versus mechanical intestinal suturing on the incidence and management of postoperative complications in patients undergoing radical cystectomy with ileal conduit.

currently, no specific trial compares hand-sewn intestinal anastomosis with mechanical stapled anastomosis in patients undergoing radical cystectomy with ileal conduit. at fundació puigvert, approximately one hundred radical cystectomies with ileal conduit are performed annually. due to the lack of evidence regarding the superiority of either intestinal anastomosis technique, the decision to use hand-sewn versus stapled anastomosis depends on the surgeon's expertise, without considering the potential impact of each technique on postoperative complication rates, surgical time, or functional outcomes. currently, no well-designed surgical trials demonstrate differences between hand-sewn and mechanical stapled anastomosis in radical cystectomy regarding intraoperative and postoperative complications. for this reason, the investigators will conduct a trial to assess the impact of each anastomosis technique

Eligibility criteria:
inclusion criteria: * patient who consents to participate and signs the informed consent. * patient candidate for radical open cystectomy and ileal conduit. exclusion criteria: * patient who is unable to complete the study questionnaires. * patient who has a life expectancy of less than 1 year. * candidate patients for other urinary diversions other than ileal conduit as a first option * candidate patients for laparoscopic or robotic cystectomy..

Keywords: bladder cancer cystectomy hand sewn anastamosis stapled anastamosis intestinal complications
brain lesion and visuospatial impairment in cp child

Conditions: Children with Cerebral Palsy

Summary: children with cerebral palsy (cp) show varying degrees of motor impairment and movement disorders whose perceptive-visual contribution has yet to be established. the literature reports that children with cp have more frequent neuro-visual disorders. the link between the location and size of the brain lesion and neurovisual symptomatology has yet to be explored. in this retrospective clinical data study, we will investigate in children with pc whether there is an anatomo-clinical correlation between visuo-spatial disorders is the brain injury of interest to the dorsal visual pathway. we will explore the volume of grey and white matter parietal involvement. to test visuo-spatial disorders, we will use the pvse (visuo-spatial elementary perception) test which does not require motor skills or language and is therefore suitable for children with a pc. this test will make it possible to better identify the deficit or deficits in order to adapt an early remediation. it could serve as a reference for comparing several pathologies/etiologies.


Eligibility criteria:
inclusion criteria: * male or female aged 4 to 18 yo * with a cp diagnosis * with pvse test completion during his/her regular follow-up * with a cerebral mri scan during his/her regular follow-up exclusion criteria: - with an incomplete pvse test or whose interpretation was deemed unreliable by the rater

Keywords: cerebral palsy, child, visuo-spatial disorder, brain lesion
champ: study of nvk-002 in children with myopia

Conditions: Myopia

Summary: stage 1: to evaluate the safety and efficacy of 2 concentrations of nvk-002 compared to vehicle (placebo) for slowing the progression of myopia in children over a 3 year treatment period. stage 2: to observe safety and efficacy in subjects re-randomized to one (1) year of treatment with nvk-002 or vehicle following 3 years of treatment in children with progressive myopia.

this will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages. stage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications. stage 2 is a randomized follow-up phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications, with subjects initially randomized to vehicle only eligible for randomization to low or high-dose nvk-002. treatment arms are: * nvk-002 low dose concentration * nvk-002 high dose concentration * vehicle (placebo)

Eligibility criteria:
inclusion criteria: 1. children aged 3 to ≤ 17.0 years. 2. myopia ser of at least -0.50 d and no worse than -6.00 d myopia in each eye as measured by cycloplegic autorefraction. exclusion criteria: 1. if present, astigmatism more than -1.50 d in either eye. 2. current or history of amblyopia or strabismus. 3. history of any disease or syndrome that predisposes the subject to severe myopia (e.g., marfan syndrome, stickler syndrome, retinopathy of prematurity). 4. history in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia). 5. serious systemic illness that, in the investigator's opinion, would render the subject ineligible. 6. chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over the-counter) other than the assigned study medication.

Keywords: child, myopia, nearsightedness
the chocolate study 2.0

Conditions: Normal Weight

Summary: the purpose of this study is to test how the brain responds when enjoyable foods such as chocolate are consumed. the investigators know that eating certain types of foods can make an individual want to keep eating even when he or she is full. the chemical in the brain that causes this is called dopamine. the investigators can measure this response by looking at changes to how an individual's eye responds to light.

the overall objective of this study is to determine dopamine (da) neuromodulation (changes in b-wave amplitude as measured by electroretinography (erg)) in response to consuming a highly reinforcing food (chocolate). the investigators hypothesize that orosensory stimulation with chocolates with increasing sugar content will increase the beta wave (b-wave) amplitude and the increase in the b-wave amplitude will correlate with score changes on the psychophysical effects questionnaire (peq). this will be accomplished by testing different chocolates (extreme dark (90% cocoa), dark (70% cocoa), milk (38% cocoa), and white (0% cocoa)) on different days using 1.0 cd∙s/m2 flash luminance energy.

Eligibility criteria:
inclusion criteria: * bmi 20-24.9 kg/m2 * ability to understand and sign the consent form * availability of transportation (i.e., participants must be able to provide their own transportation to the grand forks human nutrition research center) * be free of any major illness/disease exclusion criteria: * food allergies * participation in a weight loss diet/exercise program * pregnancy * lactation * metabolic illness/disease (diabetes, renal failure, thyroid illness, hypertension) * eye illness/disease (narrow angle glaucoma, macular degeneration, retinal detachment, cataracts) * psychiatric, neurological or eating disorders (schizophrenia, depression, parkinson's disease, huntington's disease, cerebral palsy, stroke, epilepsy, anorexia nervosa or bulimia nervosa) * taking any type of prescription medication with the exception of oral contraceptives and antihyperlipidemia agents
the psychiatric and cognitive phenotypes in velocardiofacial syndrome

Conditions: Velocardiofacial Syndrome; Williams Syndrome; Fragile X Syndrome

Summary: the purpose of this study is to investigate the psychiatric and cognitive phenotypes in velocardiofacial syndrome (vcfs), williams syndrome (ws)and fragile x syndrome characterization, treatment and examining the connection to developmental and molecular factors


Eligibility criteria:
inclusion criteria: * chromosomal deletion proven by fish examination exclusion criteria:

Keywords: velocardiofacial syndrome williams syndrome fragile x syndrome cognitive phenotype psychiatric phenotype
electronic pillbox-enabled sat versus dot for tb medication adherence and treatment outcomes

Conditions: Tuberculosis

Summary: to address the multifaceted challenges associated with tuberculosis (tb) in-person directly observed therapy (dot), the world health organization recently recommended countries maximize the use of digital adherence technologies. sub-saharan africa needs to investigate the effectiveness of such technologies in local contexts and proactively contribute to global decisions around patient-centered tb care. this study aims to evaluate the effectiveness of pillbox-enabled self-administered therapy (sat) compared to standard dot on adherence to tb medication and treatment outcomes in ethiopia. it also aims to assess the usability, acceptability, and cost-effectiveness (health-related quality of life and catastrophic costs) of the intervention from the patient and provider perspectives. it is designed as a multicenter, randomized, controlled, open-label, non-inferiority, effectiveness-implementation hybrid, mixed-methods, two-arm trial.


Eligibility criteria:
inclusion criteria: * patients with new or previously treated bacteriologically confirmed drug-sensitive pulmonary tb * eligible to start the standard 6-month first-line anti-tb medication * outpatient * men or women age 18 years and above * able and willing to provide informed consent exclusion criteria: * patients with known drug-resistant tb * any condition that causes cognitive impairment such as severe acute illness or injury, developmental retardation, or severe psychiatric illness and thus precludes informed consent or safely participating in the study procedures * inpatients * concurrent extrapulmonary tb * contraindicated medications * active liver disease that requires a tb regimen other than hrez

Keywords: tuberculosis medication event reminder monitor self-administered therapy directly observed therapy (dot) adherence treatement outcome digital health ethiopia
management of gastrointestinal and urogenital (gi/gu) bleedings in atrial fibrillation patients using pradaxa

Conditions: Atrial Fibrillation

Summary: this study is being conducted to collect data on the management of gastrointestinal and urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.

purpose:

Eligibility criteria:
inclusion criteria: * \>=18 years of age; * confirmed diagnosis of atrial fibrillation (af); * documentation that the patient had an acute gi and/or gu bleeding event and having taken at least one dose of dabigatran prior to the event. exclusion criteria: * confirmed diagnosis of valvular af (vaf); * documentation that the patient was taking dabigatran with other oral anticoagulant; * documentation of the patient receiving thrombolytic therapy prior to the event; * documentation that the patient was enrolled in an investigational clinical trial at the time of the event; * medical record was not available.
validation of a quality of life assessment tool in adult generalized dystonodyskinetic syndromes treated by continuous electrical neuromodulation

Conditions: Dystono-dyskinetic Syndromes

Summary: in spite of a growing interest in the evaluation of health-related quality of life in movement's disorders management, there is no tool specifically dedicated to dystonia and related syndromes that measures both the objective severity of the handicap and the patient's feelings about the surgical treatment in terms of subjective improvement. we have been working for several years at the bedside of patients operated on in the " pathologies cérébrales résistantes " unit on the development of a related questionnaire to assess both the motor severity and the patients' feelings about the evolution of their disease under deep brain stimulation (dbs). the self-questionnaire designed would allow to a certain extent to get away from the two gold standards currently used in the field, i.e. the burke, fahn \& marsden dystonia rating scale (bfmdrs) and the sf-36, thus facilitating the evaluation and allowing a homogenization of the practices for the different implanting centers on the french territory.

the construction of the tool in its particular design, including various targeted modules, stems from an experience of more than ten years acquired with patients treated by deep brain stimulation in the unit. the self-questionnaire thus obtained will be sent to 146 patients with generalized dystonodyskinetic syndrome, operated and followed in the unit, and submitted to various statistical analyses. the scores of the identified dimensions will be compared with the etiology of the abnormal movements (primary vs. secondary) as well as with the results obtained with the two scales currently used to evaluate abnormal movements (bfmdrs) and/or quality of life (sf-36) and finally with the patients' mood during their follow-up (bdi, stai). tolerance to surgery will also be measured.

Eligibility criteria:
inclusion criteria: * adulte between 18 an 80 years * patient with a generalized dystono-dyskinetic syndrome treated by electrical neuromodulation continue and follow-up in the unit * subject affiliated to the french social security system exclusion criteria: * non-french speaker * patients who are physically unable to answer the questionnaire and who have no trusted person to help * severe cognitive impairment (moca \<10, mdrs \<123, pm-38 \<70) * lack of informed consent
direct-safe: a randomized controlled trial of direct endovascular clot retrieval versus standard bridging thrombolysis with endovascular clot retrieval

Conditions: Ischemic Stroke

Summary: the study will be a multicentre, prospective, randomized, open label, blinded endpoint (probe) phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients within 4.5 hours of stroke onset. randomised patients will be stratified for site of baseline arterial occlusion into one of three groups: 1. internal carotid artery (ica) 2. middle cerebral artery (mca) 3. basilar artery (ba). patients will be randomised to either bridging intravenous thrombolysis with endovascular clot retrieval (ecr), or direct endovascular clot retrieval.

the direct-safe trial will include patients with acute ischemic stroke, who are ≥18 years of age and are eligible for standard intravenous tpa therapy within 4.5 hours of stroke onset. patients will be assessed for large vessel occlusion to determine their eligibility for randomization into the trial. eligible vessel occlusions include the internal carotid artery, basilar artery or middle cerebral artery (m1 or m2). patients will be consented after large vessel occlusion is confirmed based on standard care multimodal imaging. patients will be recruited in australia, new zealand, china, taiwan, vietnam, singapore and europe. randomisation either direct to ecr or standard thrombolytic therapy and ecr shall be in a 1:1 ratio. all patients will have a multimodal mr (or ct/ctp at investigator's discretion if mri not possible) at 18 to 30 hours post treatment to assess reperfusion, recanalization, ischemic core growth and hemorrhagic transformation. final follow up will occur at day 90.

Eligibility criteria:
inclusion criteria: 1. patients presenting with acute ischemic stroke eligible using standard criteria to receive iv thrombolysis within 4.5 hours of stroke onset 2. patient's age is ≥18 years 3. intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours of stroke onset. 4. arterial occlusion on cta or mra of the ica, m1, m2 or basilar artery exclusion criteria: 1. intracranial hemorrhage (ich) identified by ct or mri 2. rapidly improving symptoms at the discretion of the investigator 3. pre-stroke mrs score of ≥ 4 (indicating previous disability) 4. hypodensity in \>1/3 mca territory on non-contrast ct 5. contra indication to imaging with contrast agents 6. any terminal illness such that patient would not be expected to survive more than 1 year 7. any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. 8. pregnant women

Keywords: stroke ischemia cerebral infarction cerebrovascular disorders brain diseases central nervous system diseases nervous system diseases vascular diseases cardiovascular diseases pathologic processes brain infarction brain ischemia tissue plasminogen activator plasminogen fibrinolytic agents fibrin modulating agents molecular mechanisms of pharmacological action
a pilot study of smoking cessation treatment including varenicline in patients scheduled for planned surgery

Conditions: Smoking Cessation

Summary: it is possible to offer smoking cessation treatment including varenicline to patients scheduled for elective surgery. this study will evaluate whether or not this will enable some patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may lead to reductions in post-operative complication such as wound infections.

recruitment to this study was terminated (on february 23, 2010) earlier than originally planned because recruitment was much slower than expected and therefore the study has already achieved its main objective of assessing the feasibility of conducting a larger study of similar design to investigate the efficacy of smoking cessation therapy in a pre-surgical setting. the decision to end recruitment to the trial was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * smokers motivated to stop smoking scheduled for elective surgery exclusion criteria: * current or recent depression * current or recent suicidal ideation * uncontrolled or unstable clinically significant medical condition

Keywords: smoking cessation varenicline elective surgery wound infections post-operative complications
regulation of coagulation in orthopedic surgery to prevent dvt and pe, a controlled, double-blind, randomized study of bay 59-7939 in the extended prevention of vte in patients undergoing elective total hip replacement

Conditions: Prevention; Venous Thromboembolism

Summary: the purpose of this study is to assess if 10 mg bay 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.


Eligibility criteria:
inclusion criteria: * male and female patients aged 18 years or above * patients scheduled for elective total hip replacement exclusion criteria: * planned, staged total bilateral hip replacement * active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin * contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin * conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
reduction of masticatory muscle activity by restoring canine guidance

Conditions: Bruxism; Myopathy; Muscular Activity

Summary: in this study it is to be evaluated wether a restoration with composite resin fillings to reestablish a canine guidance will reduce masticatory muscle activity in patients with bruxism.

30 patients showing clinical symptoms of bruxism receive treatment within this clinical trial. typical symptoms like pain or tenseness of the masticatory muscles, headache or abrasions are mandatory preconditions. exclusion criteria are a present treatment with a biteguard or a sufficient canine guidance. in the first session a detailed history, a dental status and a clinical functional status are recorded. the baseline situation is documented by taking impressions with alginate of the maxilla and mandible for diagnostic study models. following this procedure a first measurement of the muscular activity is conducted for seven days with the grindcare device. after four weeks without any intervention a second measurement is conducted again for seven days. in the next session the canine cusps are restored with composite fillings. finally a sufficient canine guidance should be present. in the same session a second impression of the maxilla is taken. a third measurement is conducted, again followed by four weeks without any intervention. at last another impression of the maxilla is obtained and a final measurement for seven days is conducted. at the first examination and after the third measurement of the masticatory muscle activity the patients fill out the questionnaire of the oral health impact profile in order to allow for the assessment of possible functional restraints and mental interferences.

Eligibility criteria:
inclusion criteria: * patients show signs of bruxism * no canine guidance is present * no prosthodontic restorations of the canine are present exclusion criteria: * a sufficient canine guidance is present

Keywords: bruxism
effect of probiotic supplementation on immune function in healthy infants

Conditions: Inflammation

Summary: the purpose of this study is to understand how a probiotic might change the immune response of healthy infants.

problem of interest: lactic acid bacteria known as probiotics have been given to children and adults to prevent and treat gastrointestinal infections and to maintain intestinal health. this pilot study will collect information (biomarkers) of inflammation and immune response from healthy infants. how the problem will be studied: the investigators will give an active lactobacillus-containing probiotic or an inactive placebo without lactobacillus to 38 healthy infants in the metropolitan atlanta area from 2 weeks before until 2 weeks after they complete their rotavirus vaccine series. half will be assigned to receive the active probiotic, half to receive the placebo. neither the investigators nor the parent/ guardian of the study subject will know whether their infant is receiving the probiotic or placebo. a teaspoon of blood and a stool sample will be collected from each infant before they start taking the active probiotic or placebo and 2 weeks after they complete their rotavirus vaccine series. each infant will receive the probiotic or placebo product for 2 weeks before starting their rotavirus vaccine series until 2 weeks after they complete their rotavirus vaccine series. the blood and stool samples will be examined for levels of inflammatory markers and measures of immune response. the stool samples may be stored for the later study of probiotic bacteria as well as for other bacteria and viruses. these results will help to determine if this lactobacillus containing probiotic has an effect on immune response and inflammation in healthy infants. how research will advance scientific knowledge and human health: this study will provide new information about the impact of giving a lactobacillus-containing probiotic supplement to healthy infants. current standard of care: the current standard of care is for infants to receive a probiotic at the discretion of their caregiver. by studying probiotic administration in a controlled way with a fixed dose schedule and a well categorized probiotic, and measuring blood and stool markers, the investigators hope to better understand the impact of a probiotic on immune response and inflammation.

Eligibility criteria:
inclusion criteria: * healthy infant * eligible for rotavirus immunization series * no recognized immunodeficiency * ability to comply with study procedures exclusion criteria: * ineligible for rotavirus immunization series * recognized immunodeficiency * inability to comply with study procedures

Keywords: probiotic lactobacillus reuteri dsm 17938 healthy infants