Kornimate/medical-research-clean huggingface dataset:
very low carbohydrate diet effects to gps, serum lactate and tnf alpha on colorectal cancer

Conditions: Diet Modification; Colorectal Adenocarcinoma; Systemic Inflammation; TNF Alpha; Lactate

Summary: this study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by glasgow prognostic score), serum lactate and tnf alpha levels

this study examine the effects of very low carbohydrate diet (in which the calories requirements are mostly from fat) to the level of systemic inflammation (measured by glasgow prognostic score), serum lactate and tnf alpha levels. the subjects are colorectal adenocarcinoma patients who were decided by experts to be managed by best supportive care. these patients are not deemed to be suitable for surgical intervention , chemotherapy or radiotherapy anymore. the main treatment is supportive. we would like to examined the effect of very low carbohydrate diet on these patients, in which theoretically tumtor cells of the colorectal adenocarcinoma needed glucose to replicate and increases the systemic inflammation response.

Eligibility criteria:
inclusion criteria: * diagnosed as colorectal adenocarcinoma pathologically * decided by a digestive surgery consultant to be managed with best supportive care * more than 17 years old and capable of making informed consent * karnofsky score \> 50% or ecog performance status \<=2 * no clinical signs of infection, with one or more of these criteria : fever, leukocytosis, local sign of infection (eg.abscess,ulcer) * ast \< 2 times normal limit * alt \< 2 times normal limit * serum creatinine \< 1,5 times normal limit * not pregnant (for women) * able to understand and willing participate and to sign informed consent form * no diabetes mellitus * no fat intolerance * no severe malnutrition or cancer cachexia exclusion criteria: * patient is still on other therapy for the tumour * patient with coexisting diseases which prohibits the patient to follow the study protocols

Keywords: very low carbohydrate diet colorectal adenocarcinoma
clinical implication of retinitis pigmentosa molecular diagnostic using high throughput sequencing.

Conditions: Retinitis Pigmentosa

Summary: the retinitis pigmentosa (rp) are genetic conditions that cause retinal degeneration leading to severe low vision and is the leading cause of consultation in reference centers dedicated to the ophthalmic genetics. these rare diseases are characterized by a triple heterogeneity (clinical, genetic and molecular), which made them unreachable by traditional molecular diagnostic sequencing technology by the large number of genes to be tested (\> 190). the advent of high-throughput sequencing (ngs) and targeted capture has opened unexpected possibilities of investigation and ultimately to improve the care of patients. this project aims to study the genetic and molecular epidemiology of an interregional french (grand est) cohort of patients. patients receive a detailed retinal phenotype (visual acuity, visual field, photographs of the fundus and erg). their dna will be analyzed by ngs targets the 190 known genes (https://sph.uth.edu/retnet/). this research will provide a molecular epidemiological cohort study compared to prior publications on the frequency of genes involved. the benefit for patients is important to: establish a mode of transmission of the disease and optimize genetic counseling (currently very empirical); establish phenotype-genotype correlations in the french population (very few studies to date) and from the data of international literature; identify patients likely to be included in future therapeutic protocols of research; identify patients with significant potential for future projects to identify new genes. the primary purpose of the protocol is to use high throughput sequencing to identify pathogenic variants in genes involved in rp. the secondary purposes will be the following: * determining the diagnostic yield * study the genotype-phenotype correlation. the secondary purposes will be the following: * determining the diagnostic yield * study the genotype-phenotype correlation


Eligibility criteria:
inclusion criteria: * subject of both sex, aged at least 2 years, being diagnosed with an rp, and/or having a family history of rp * informed about the results of the preliminary medical visit, or which (s) holder (s) parental authority or the guardian / curator has (have) was (been) informed * informed consent signed * affiliation to the french health system exclusion criteria: * the patient does not want to participate to the protocol * intercurrent diseases do not allow the practice of tests provided for this protocol * phenocopy * subject excluded or being excluded by another protocol * subject in emergency case * subject under judicial protection

Keywords: retinitis pigmentosa:
anti-restenosis after ami by erythropoietin

Conditions: Acute Myocardial Infarction

Summary: the epoc-ami study is to assess the safety and the efficacy of systemic administration of erythropoietin for inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction

stents coated with sirolimus or paclitaxel have been shown to significantly reduce restenosis in selected coronary lesions. however, the potential risk of late stent thrombosis forces prolonged treatment of dual anti-platelet regimen to all the patients after implantation of drug eluting stents. patients with acute myocardial infarction may have uncertain clinical characteristics, such as occult bleeding focus or further need for surgical procedures. thus, bare metal stent is considerably alternative for primary pci after ami and there remain an appreciable number of patients at risk for restenosis. use of systemic pharmacological therapy to inhibit coronary stent restenosis of bare metal stent has been largely unsuccessful. we have reported that erythropoietin could enhance reendothelialization leading to inhibition of in-stent restenosis by directly protecting endothelial apoptosis and mobilizing endothelial progenitors. the epoc-ami study is designed to assess the safety and the efficacy of systemic administration of erythropoietin aiming inhibition of neointimal hyperplasia after stent implantation in the patients with acute myocardial infarction.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute myocardial infarction within 12hrs of symptom onset. * succeeded reperfusion due to primary pci accomplished bare metal stent exclusion criteria: * patients with cardiogenic shock (e.g. systolic bp\<80mmhg,use of catecholamine, use of iabp) * patients with anemia required transfusion * patients who are unwilling or unable to comply with the trial protocol

Keywords: acute myocardial infarction restenosis erythropoietin epoc-ami
evaluation of the videodrama therapeutic device for children with autism spectrum disorders

Conditions: Autism Spectrum Disorder (ASD)

Summary: autism spectrum disorder (asd) is a neurodevelopmental disorder (valerie, sperenza, 2009) that begins early in development, characterized by persistent deficits in communication and social interactions across various contexts and restricted, repetitive patterns of behavior, interests, or activities. these symptoms significantly impact social, school/professional functioning, or other important areas and are not better explained by intellectual disability or global developmental delay (american psychiatric association, 2013).

currently, managing children with asd emphasizes compensating for communication and social interaction disabilities. communication tools like pecs or makaton and social skills groups have shown effectiveness but have limitations, particularly not addressing sensory atypicalities seen in children with asd. these sensory atypicalities are evident when children watch videos on screens. the idea is to use video to understand the sensory experiences of children with asd and help them move away from an isolated relationship with screens. new technologies can further isolate children with asd in their autistic sphere. the hypothesis is that observing these children with screens will provide better understanding of their sensory experiences and improve therapeutic support towards play and interaction with others

Eligibility criteria:
inclusion criteria: * children aged 3 to 15 years. * clinically confirmed asd by a psychiatrist. * parental or legal guardian consent for participation. * child showing a strong interest in screens and/or video content. * ability to tolerate the presence of other children. * minimum of 18 video drama sessions. * not having benefited from disease care in the past. * affiliation to a social security system exclusion criteria: * no asd diagnosis. * younger than 3 or older than 15 at the study start. * no interest in screens or video content. * parental or legal guardian refusal for participation. * dropping out before completing 18 sessions. * patient having benefited a disease care in the past

Keywords: autism videodrama
benefit of dual-chamber pacing with closed loop stimulation (cls) in tilt-induced cardioinhibitory reflex syncope

Conditions: Syncope

Summary: the purpose of this study is to assess whether the closed loop stimulation (cls) in addition to the ddd pacing is effective in reducing syncopal recurrences. the study hypothesis is that ddd pacing with cls stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.


Eligibility criteria:
inclusion criteria: patients affected by clinical diagnosis of reflex syncope who meet all the following criteria: * age \>=40 years * significant limitation of social and working life due to unpredictable or frequent syncope recurrences, ≥2 within the last year. * type 2b cardio-inhibitory response to tt (according to the vasis classification). * alternative therapies have failed or were not feasible. * exclusion of other possible competitive causes of syncope. exclusion criteria: - any other indication to ipg, implantable defibrillator (icd), cardiac resynchronization therapy (crt), according to current guidelines any cardiac dysfunctions possibly leading to loss of consciousness: * overt heart failure; * ejection fraction (lvef) \<40% (echo-assessed within 3-month prior to study participation); * myocardial infarction; * diagnosis of hypertrophic or dilated cardiomyopathy; * clinically significant valvular disease; * sinus bradycardia \<50 bpm or sinoatrial block; * mobitz i second-degree atrioventricular block; * mobitz ii second or third-degree atrioventricular block; * bundle-branch block; * rapid paroxysmal supraventricular tachycardia or ventricular tachycardia; * preexcited qrs complexes; * prolonged qt interval; * brugada syndrome; * arrhythmogenic right ventricular cardiomyopathy * symptomatic orthostatic hypotension diagnosed by standing bp measurement; * nonsyncopal loss of consciousness (eg, epilepsy, psychiatric, metabolic, drop-attack, cerebral transient ischemic attack, intoxication, cataplexy). * symptomatic cardioinhibitory carotid sinus hypersensitivity.

Keywords: syncope closed loop stimulation cls
randomized comparison of vaginal self sampling for human papillomavirus (hpv) testing by standard versus dry vaginal swabs

Conditions: Human Papillomavirus Infection

Summary: human papillomavirus (hpv) assays are likely to be used in cervical cancer screening. our objective is to simplify the method of collection of female genital tract specimens by determining if vaginal dry swabs are as accurate as the standard transport medium for hpv diagnosis.

high-risk human papillomavirus (hr-hpv) infections in women are clinically important because they have been associated with nearly all cases of preinvasive and invasive cervical neoplasia1. genital hr-hpv related infection is common, affecting approximately 10-25% of women, depending on the population and age-groups studied2-4. with the advance in our understanding of hpv biology and the development of technologies for hpv detection together with the poor sensitivity of a single pap test, there has been now a growing interest concerning the potential use of hpv dna testing as a screening tool for cervical cancer5. currently, there is no consensus on which sampling method is the most effective for hpv dna testing. these last years, studies have reported that samples provided by women themselves were suitable for dna testing and support the feasibility of self-collection for hpv dna testing6-8. data from these studies support that it is acceptable for the women and demonstrated that a fairly high concordance rate between the self- and physicians testing method has been achieved. potential advantage of self-collection is that it could improve access to health care, reduce healthcare costs and save time for patients and providers. available data have been reported with the use of specimen transport medium (stm), but the use of dry vaginal swab may potentially offer similar reliability than standard stm. small studies suggest that hpv test (pcr) sampled by physicians using dry vaginal swab seems to be as accurate as those performed in a standard medium for hpv detection9,10. dry vaginal swab offers potential advantages in terms of being more convenient for collection and is less expensive than a vaginal swab placed in a transport medium. the aim of our study is to assess the performance of self-obtained v-dry versus "standard" v-stm and its acceptability.

Eligibility criteria:
inclusion criteria: * 20 years or older, * first consultation in our colposcopy unit, * understands study procedures and accepts voluntarily to participate by signing the informed consent form (icf). exclusion criteria: * previous hysterectomy, * pregnant, * virgin, * not able to comply with the protocol study.

Keywords: self-collected vaginal samples hpv hpv self-obtained sample hpv specimen transport medium
smart box with ot equator attachment in retaining implant-assisted overdenture for the atrophic maxilla.

Conditions: Atrophic Maxilla; Edentulous Jaw

Summary: the aim of the present study is to clinically and radiographically evaluate the effect of the use of recently developed smart box accompanied with ot equator attachment in retaining of the inclined implant assisted overdenture for atrophic maxilla and to compare the vertical bone changes around axial implants with ot equator attachment and inclined implants with smart box attachment radiographically using cbct


Eligibility criteria:
inclusion criteria: * male patients with comparable age (30- 65 years). * all patients should have retruded, posteriorly atrophic completely edentulous maxilla with sinus pneumatization leaving less than 7mm bone height posteriorly and a sufficient amount of bone in the inter bicuspids region. * opposing mandibular dentate arch including bilateral posterior teeth. * all patients should have an adequate zone of keratinized mucosa. * all patients should be free from any intra-oral or systemic diseases that would otherwise affect the osseointegration of dental implants. * all patients should be well motivated, cooperative, and with adequate manual dexterity necessary to place and remove removable implant prosthesis to provide adequate oral hygiene around the endosseous implants. exclusion criteria: * patients with flabby maxillary ridges. * patients who are unwilling to accept implant overdentures as a treatment modality. * patients with temporomandibular and neuromuscular disorders.
observational registry for iltamiocel compared to placebo for urinary sphincter repair in post-surgical female stress incontinence

Conditions: Stress Urinary Incontinence

Summary: the main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the clbt clinical study.


Eligibility criteria:
inclusion criteria: * has completed participation within 15 months in the clbt clinical study for females with persistent or recurrent sui following surgical treatment (i.e., either subject has completed all follow-up visits or has been officially exited from the study). * has received at least one dose of iltamiocel as part of the clbt study. * must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures. * has access to a phone or electronic device to allow completion of electronic documents exclusion criteria: * has only received placebo as part of the clbt study. * unable or unwilling to provide informed consent.
pharmacokinetics of ampicillin in neonates with moderate to severe hypoxic-ischemic encephalopathy

Conditions: Hypothermia

Summary: controlled hypothermia has become the standard of care for neonates with moderate to severe hie. ampicillin and aminoglycosides are drugs that are universally used for the treatment of suspected neonatal sepsis, which may or may not be responsible for the etiology of hie. currently, medication dosage regimens are not altered in the setting of ch. a better understanding of the effects of our interventions on this unique population may help us tailor our therapy to the specific circumstances of the patient

hypoxic-ischemic encephalopathy (hie) affects approximately 1 to 2 per 1000 live births and remains a cause of significant morbidity and mortality in the neonatal period. in response to an anoxic insult, perfusion to vital organs is preserved; however, when this injury is profound concomitant injury to nonvital organs is observed. controlled hypothermia (ch) has been accepted as a neuroprotective therapeutic modality for neonates with moderate to severe hie because of its role in attenuating secondary brain injury. neonates exhibit varying degrees of multiorgan dysfunction after a hypoxic-ischemic insult, although the added beneficial and potential adverse effects that ch has in these babies have not been completely delineated or understood. ch has been shown to alter normal physiologic functioning of several organ systems. specific physiologic changes as a consequence of ch have been demonstrated in both animal and human models. the observed reduction in cardiac output and reflexive increase in systemic vascular resistance in response to ch alter renal perfusion and subsequently reduce glomerular filtration . drugs that are renally cleared may develop a prolonged half-life in this setting. finally, drug metabolism may further be affected by altered hepatic blood flow and temperature-dependent effects on hepatic enzyme activity . collectively, the potential effects of ch on drug metabolism and clearance are significant warranting further investigation. the investigator aims to evaluate the combined effects of hypoxia and hypothermia on ampicillin clearance and excretion

Eligibility criteria:
inclusion criteria: * gestational age \> 36 weeks * birth weight \> 1800 grams * age \< 6 hours old at the time of admission to the nicu * cord gas or abg/vbg with ph \ 16 within the first hour of life * presence of seizures or evidence of moderate to severe encephalopathy * presence of central line for lab draws exclusion criteria: • infants admitted for ch without central intravascular access.

Keywords: ampicillin
effect of bioskin ten-7 vs. standard treatment on patient reported outcomes and cytokine.

Conditions: Osteoarthritis of the Knee

Summary: the objectives of the study are 1.) to evaluate pain relief following the application of the bioskin ten-7 knee brace and 2.) to determine if use of the bioskin ten-7 knee brace is more effective at reducing inflammation than standard of care alone using synovial fluid cytokine analysis and validated outcome measures.

once consented, the patient is assigned to either group a or group b. group a patients will receive standard treatment only and will not be prescribed a knee brace. group b patients will receive standard treatment and the bioskin ten-7 knee brace. on day 0, the patient will be assigned to one of the 2 groups using a 1:1 assignment. vas, womac, oxford knee score, koos questionnaires will be administered and a sample of the patient's synovial fluid will be sent to labs for cytokine and cell count analysis. all patients will record use of nsaids and for group b, the start and end time of brace use will be recorded. all patients will return in 8 weeks to assess efficacy of treatment. all patients will return their diaries, complete the same validated outcome measures as day 0 and undergo a repeat synovial fluid analysis.

Eligibility criteria:
inclusion criteria: * male or female 18 years and older with primary diagnosis of knee oa with no other knee diagnosis. * must have telephone access. exclusion criteria: -
spi-2012 vs pegfilgrastim in the management of neutropenia in participants with breast cancer with docetaxel and cyclophosphamide (advance)

Conditions: Neutropenia; Breast Cancer

Summary: the purpose of this study was to compare the efficacy of a single dose of spi-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (tc), as measured by the duration of severe neutropenia (dsn) in cycle 1.

this was a phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of spi-2012 vs pegfilgrastim in participants with breast cancer treated with tc chemotherapy. each cycle was 21 days. four cycles were evaluated in this study. on day 1 of each cycle, participants received tc chemotherapy. on day 2 of each cycle, participants received study drug (spi-2012 or pegfilgrastim).

Eligibility criteria:
key inclusion criteria: * new diagnosis of histologically confirmed early-stage breast cancer (esbc), defined as operable stage i to stage iiia breast cancer * candidate for adjuvant or neoadjuvant tc chemotherapy * eastern cooperative oncology group (ecog) performance score ≤ 2 * absolute neutrophil count (anc) ≥ 1.5×10\^9/l * platelet count ≥ 100×10\^9/l * hemoglobin \> 9 g/dl * creatinine clearance \> 50 ml/min * total bilirubin ≤ 1.5 mg/dl * aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (ast/sgot) and alanine aminotransferase per serum glutamic-pyruvic transaminase (alt/sgpt) ≤ 2.5× upper limit of normal (uln). * alkaline phosphatase ≤ 2.0×uln key exclusion criteria: * active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease * locally recurrent or metastatic breast cancer * known sensitivity to e. coli -derived products or to any products to be administered during dosing * concurrent adjuvant cancer therapy * previous exposure to filgrastim, pegfilgrastim, or other g-csf products in clinical development within 12 months prior to the administration of study drug * active infection, receiving anti-infectives, or any serious underlying medical condition that would impair ability to receive protocol treatment * prior bone marrow or stem cell transplant * use of any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study * radiation therapy within 30 days prior to enrollment * major surgery within 30 days prior to enrollment

Keywords: neutropenia breast cancer long-acting myeloid growth factor early stage breast cancer docetaxel + cyclophosphamide (tc) chemotherapy