Kornimate/medical-research-clean huggingface dataset:
silicone vs pirfenidone in the treatment of hypertrophic scars and keloids

Conditions: Scars; Keloids; Hypertrophic Scar

Summary: justification: keloid scars are a major medical and cosmetic problem, especially in darker skin types that predominate in mexico. it is estimated that hypertrophic scars affecting from 1.5 to 4.5% of the general population. however, the exact prevalence is unknown but studies show that going from 32 to 67%. and there are studies documenting that this prevalence is higher in hispanic and black individuals and in the pediatric population. keloid scars can become highly symptomatic disfiguring and which affects the quality of life of patients and their self-esteem.problem statement: is silicone gel solutions superoxidation with equal or better than the gel 8% pirfenidone to treat keloids and hypertrophic scars? goal: to evaluate the efficacy of a silicone gel-oxidation with solutions compared to a gel containing 8% pirfenidone. hypothesis: if the silicone gel solutions superoxidation is equal or better than gel 8% pirfenidone to treat keloids and hypertrophic scars, then the reduction in the ecv and the eva will be similar in the first group than the second. design: comparative, observer blind, experimental and prospective study.

this is a comparative, non-inferiority, experimental, prospective, longitudinal pilot study with blind evaluator, in patients with keloid or hypertrophic scars. twenty patients per group randomly assigned to receive identical tubes of either a silicone-based gel with superoxidized water, or an 8% pirfenidone gel. follow-up was scheduled at 2, 4, 8, 12, and 16 weeks recording the location, mechanism of the scar, time of evolution, skin phototype, accompanying symptoms, dermatology life quality index, and validated scar assessment tools (patient and observer scar assessment scale, vancouver scar scale, and the analog visual scale for keloids).

Eligibility criteria:
inclusion criteria: * keloid or hypetrophic scar exclusion criteria: * collagen diseases pregnancy previous treatment for 3 months

Keywords: scars keloids hyperthrophic pirfenidone
transcutaneous posterior tibial nerve stimulation in patients with multiple sclerosis related urge incontinence

Conditions: Multiple Sclerosis

Summary: recently, several studies have investigated the safety and efficacy of the stoller afferent nerve stimulation (sans) treatment in multiple sclerosis (ms) patients. however, because of the differences among the published protocols (percutaneous versus transcutaneous stimulation, stimulation site, total number of sessions), and the absence of data on the duration of the effect, this treatment is not yet currently included in the rehabilitation programs. the present study aims at evaluating the efficacy of a protocol of sans in the short- and medium-term follow-up. the efficacy of the proposed stimulation protocol on the physiological parameters of bladder function will be also investigated.

the primary outcome will be the variation of urinary urgency and incontinence. it will be evaluated by self-reported measuring scales, such as the overactive bladder questionnaire (oab-q) and the international consultation on incontinence questionnaire-urinary incontinence short form (iciq-ui sf) in their italian forms. the expected outcome is that the treatment of posterior tibial nerve stimulation will reduce the frequency and the urgency of urination, and urinary incontinence. moreover, results from the follow-up will allow estimating the duration of the expected outcome.

Eligibility criteria:
inclusion criteria: * ms diagnosis according to the revised mcdonalds criteria. relapsing-remitting, primary and secondary progressive ms forms are allowed; * expanded disability status scale (edss) between 2 and 6.5 included; * minimental state examination ≥ cut off 24/84 by sex/age exclusion criteria: * any of the following in the month before enrolment: an ms relapse; current corticosteroids therapy because of ms; change in medicines prescribed against fatigue; attending an intensive physical therapy program; * new or active lesions on a brain or spinal cord mri scan in the 12 months before the study enrolment; * any musculoskeletal disease or any additional neurological disorder * urinary infections or surgery in perineal regions * skin lesions or carcinoma in situ * pregnancy * expanded disability status scale (edss) ≥ 7;

Keywords: incontinence perineum stoller's afferent nerve stimulation posterior tibial nerve stimulation
sensory recovery of reconstructed breast with breast reconstructive options

Conditions: Breast Cancer

Summary: over the past 10 years, there have been substantial improvements in breast reconstruction by plastic surgeons, and much has been achieved in aesthetic restoration after mastectomy. advances in both microsurgery and implants have allowed for a wider variety of surgical methods, and procedural skills that minimize donor site complications have been developed. with such satisfactory aesthetic results, interest has recently increased not only in breast reconstruction but also in sensory recovery. due to the growing expectation of patients, sensory discomfort may decrease overall patient satisfaction with breast reconstruction despite good aesthetic results. hence, for qualitative improvement of breast reconstruction surgery, efforts must be made to restore sensation in the reconstructed breast. there has been little research on the mechanism of sensory recovery despite its clinical importance. this study aimed to compare the degree of sensory recovery in the reconstructed breast using various reconstruction methods as well as to evaluate the status of neural regeneration with harvesting the tissues when nipple reconstruction is performed.


Eligibility criteria:
inclusion criteria: * female adults over 20 years of age * patients who have undergone or plan to undergo total mastectomy and immediate breast reconstruction after the diagnosis of breast cancer (including carcinoma in situ) * written consent to study participation exclusion criteria: * presence of neuropathy that may hinder accurate assessment of sensation * presence of dermatological condition that may hinder accurate assessment of sensation * inability to provide written consent * decided by the research team to be unsuitable for this study
use of antioxidant in endometriotic women to improve intracytoplasmic sperm injection (icsi)

Conditions: Endometriosis

Summary: ros plays an essential role in the pathogenesis of many reproductive processes. high follicular fluid ros levels are associated with negative ivf outcomes. is plasma level of reactive oxygen species is affected by antioxidant treatment in endometriotic women?

study design, size, duration: : prospective randomized controlled clinical trial 50 patients with endometriosis diagnosed by us prepared for icsi were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . randomization was done by closed envelop single blind for patient participants/materials, setting, methods: was done in the egyptian centre for ivf from march 2013 to october 2013 . 50 patients with endometriosis diagnosed by us prepared for icsi were enrolled in the study after consent. they were randomized into 2 groups 25 received antioxidants before starting the protocol , 25 did not receive . all patients were subjected to plasma sample before start long protocol for induction and second on day of ovum pick up . embryo transfer was done according to embryo grading .

Eligibility criteria:
inclusion criteria: * patients with endometriosis exclusion criteria: patients with no endometriosis , not suitable for icsi-

Keywords: icsi antioxidants ros endometriosis
in the prediction of recurrence and progression of nmibc; eortc or cueto or both?

Conditions: Bladder Cancer; Disease Progression; Recurrent Bladder Cancer

Summary: investigators aimed to evaluate the performance of the european organization for research and treatment of cancer(eortc) and the spanish urology association for oncological treatment(cueto) risk tables on all non-muscle invasive bladder cancer patients(nmibc), and those not treated with bcg and treated with bcg separately.

risk tables can be used for the prediction of recurrence and especially progression of nonmuscle invasive bladder cancer .the european organization for research and treatment of cancer(eortc) developed a risk table,which provides a scoring system for recurrence and progression risk.the eortc risk table includes these factors: number of tumors,tumor size,prior recurrence rate,t stage,presence of carcinoma in situ(cis),and grade for nmibc patients not treated by maintenance bacillus calmette-guerin(bcg) instillation therapy.the spanish urology association for oncological treatment(cueto)later proposed a modified model to be used for patients only treated with bcg instillation.this risk table includes these factors:age,gender,recurrent tumor,number of tumors,t stage,cis,and grade. there is no risk table that can be used for nmibc patients treated or not treated with bcg.should we use the eortc risk table for patients not treated with bcg and the cueto table only for those treated with bcg or is one of them sufficient to predict recurrence and progression in all patients?the main aim of this study was to compare the utility of the eortc and cueto risk tables in all patients, and separately in patients not treated with bcg and treated with bcg.

Eligibility criteria:
inclusion criteria: * primary or recurrent bladder cancer * non-muscle invasive bladder cancer * at least 60 months follow-up period if progression was not determined. exclusion criteria: * primary cis, * muscle-invasive disease after second look tur-bt * non-urothelial carcinoma of the bladder, * concomitant upper urinary tract tumor, * not able to contacted for whatever reason

Keywords: eortc cueto bladder neoplasm disease progression recurrence
subtle myocardial deformation abnormalities in asymptomatic nf-1 patients

Conditions: Neurofibromatosis Type 1

Summary: subtle myocardial deformation abnormalities in asymptomatic nf-1 patients: is cardiac screening needed?


Eligibility criteria:
inclusion criteria: * asymptomatic nf1 patients * aged 0-17y and 11 months exclusion criteria: * clinical heart failure, * history of cardiovascular disease * chronic renal insufficiency
mystar-5-year: long-term follow-up of patients with ischemic heart disease treated with cell therapy

Conditions: Acute Myocardial Infarction

Summary: the mystar-5-year study controls the patients 5 years after treatment with combined (intramyocardial and intracoronary) delivery of autologous bm-mncs. the clinical endpoint of this prospective non-randomized observational study is the macce, defined as major adverse cardiac and cerebrovascular events. patients will be investigated by echocardiography, spect and mri. 2d (noga-guided spect) and 3d (noga-guided mri) imaging will refine the evaluation with more exact analysis of the intramyocardial injected areas (roi).

background: based on the available long-term results of cardiac stem cell therapies, it seems, that it offers short-term moderate benefits, but the long-term outcome is still matter of debate. in 2008, the austrian arm of the mystar study (a prospective multi-center single-blind trial) including patients with recent ami and treated with combined (intramyocardial and intracoronary) delivery of autologous bm-mncs has been completed with 1-year fup. the mystar results showed moderate but significant improvement in infarct size and lv function similar to other trials, and confirmed safety, feasibility and efficacy of bmc treatment in ami patients. the patients enrolled in the study reach the 5 to 8 years fup at 2011, raising the question whether the combined delivery of autologous bm-mncs results in a long-term benefit for these patients. aim of the study: to investigate the long-term, 5 years clinical outcome of patients enrolled into the mystar study. study design: prospective non-randomized single-center austrian long-term fup registry. study patients: a total of 60 patients with previous cardiac stem cell therapy (participated in the mystar study) will be included in the present study primary endpoint: occurrence of macce (major adverse cardiac and cerebrovascular events, including all-cause death, re-ami, revascularization and stroke) during the mean 5 years follow-up. secondary endpoints: improvements of clinical symptoms, expressed as ccs and nyha scores, change in global lv ef, measured by echocardiography, size of infarction determined by stress-rest spect, lv and rv volumes, function and cardiac output measured by cardiac mri.

Eligibility criteria:
inclusion criteria: * previous participation in the mystar study, inclusion either in the early or late groups * signed informed consent exclusion criteria: * non-willingness of participation in the present fup study

Keywords: cell-based cardiac regenerative therapy intramyocardial injections noga procedure acute myocardial infarction
telmisartan/hydrochlorothiazide (hctz) fixed dose combination compared to its monocomponents in healthy subjects

Conditions: Healthy

Summary: study to demonstrate the bioequivalence of telmisartan and hctz administered as fixed dose combination in comparison to the single unit formulations


Eligibility criteria:
inclusion criteria: * healthy subjects as determined by results of screening * signed written informed consent in accordance with gcp (good clinical practice) and local legislation * age ≥ 18 and ≤ 45 years * broca ≥ - 20% and ≤ + 20% exclusion criteria: * any findings of the medical examination (including blood pressure, pulse rate and ecg and laboratory value) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * surgery of the gastro-intestinal tract (except appendectomy) * diseases of the central nervous system (such as epilepsy) or psychiatric disorders * supine blood pressure at screening of systolic ≤ 110 mmhg and diastolic ≤ 60 mmhg * history of orthostatic hypotension, fainting spells or blackouts * hypersensitivity to telmisartan and/or hctz and/or related classes of drugs * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial) * participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial) * smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day) * inability to refrain from smoking on study days * known alcohol abuse * known drug abuse * blood donation (≤ 1 month prior to administration) * excessive physical activities (≤ 5 days prior to administration) * for female subjects: * pregnancy * positive pregnancy test * no adequate contraception * inability to maintain this adequate contraception during the whole study period * lactation period
transient perivascular inflammation of the carotid artery (tipic) syndrome: clinical and radiological follow-up

Conditions: Cervical Pain; Vasculitis

Summary: tipic syndrome (previously called carotidynia) is a rare entity of unknown cause, where the patient has a temporary cervical pain associated with a suggestive inflammation around the carotid artery. usually considered as a unique and benign episode, some patients have recurrences and the follow-up is usually short. in this study the investigators aim to evaluate patients who presented a tipic episode at least 3 months before, clinically and with a cervical doppler ultrasound


Eligibility criteria:
inclusion criteria: - patients with at least one episode of tipic syndrome for more than 12 months
randomized clinical trial of skin closure with staples versus suture

Conditions: Wound Infection; Wound Complication

Summary: women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. skin closure with either staples or suture is considered standard of care. traditionally, most wounds have been closed with staples given their ease of use and quick application. in this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.

the investigators propose a randomized controlled trial to evaluate for a difference in wound complication rate between closure with sutures that are placed just below the skin level to hold the skin together and metal staples in obese women (bmi\>=30) undergoing gynecologic or gynecologic oncology via a midline skin incision for benign or cancer indications under the supervision of one of the full-time faculty members of the division of gynecologic oncology at washington university school of medicine.

Eligibility criteria:
inclusion criteria: * all women, \>=18 and \<= 85 years of age, undergoing surgery, via a midline laparotomy. * body mass index \>=30 * benign or oncologic indications for surgery. * women of childbearing age will be required to have a negative human chorionic gonadotropin (hcg) test within seven days of surgery. * surgery will be supervised by one of the gynecologic oncology attendings at washington university school of medicine. * ability to understand and willingness to sign an irb approved written informed consent document. exclusion criteria: * women who are pregnant or breastfeeding * pfannenstiel or transverse abdominal incision * concomitant panniculectomy or plastic surgery * women \<18 years of age * history of prior abdominal or pelvic radiation * inability to sign an informed consent form prior to registration on study * inability to understand spoken or written english * prisoner * mental incapacity * a history of allergic reactions attributed to either monocryl suture or stainless steel staples.

Keywords: wound infection wound separation skin staples subcuticular suture
light vs heavy weighted mesh repair in primary abdominal hernia in terms of surgical site infection

Conditions: Abdominal Hernia

Summary: this study compares the incidence of surgical site infections (ssi) in patients undergoing abdominal hernia repair using either light or heavy-weighted polypropylene mesh. the study aims to determine which mesh type results in fewer ssis, thereby guiding future surgical approaches to abdominal hernia repair.

hernias, a protrusion of abdominal contents through the abdominal wall, are often treated surgically using synthetic polypropylene mesh. two varieties of polypropylene mesh exist: light and heavy weighted. the lighter mesh is softer, less allergenic, and potentially leads to fewer post-surgical complications, including ssis. in contrast, heavier mesh, which has been traditionally used, consists of thicker threads with narrower gaps and has a higher chance of eliciting an immune response. this trial aims to assess the effectiveness of light mesh over heavy mesh in reducing ssis in abdominal hernia repairs, thereby providing data to support best practices in surgical care.

Eligibility criteria:
inclusion criteria: * patients aged 15 and above. * patients undergoing primary abdominal hernia repair using light or heavy mesh. exclusion criteria: * patients with incisional hernias. * patients with diabetes mellitus, chronic cough, steroid use, cancer, or immune-compromised status.

Keywords: abdominal hernia surgical site infection light weighted mesh heavy weighted mesh randomized controlled trial
adults habitual patellar dislocation:a multiple-center clinical investigation regarding diagnosis and therapeutic strategy

Conditions: Habitual Patellar Dislocation

Summary: adult habitual dislocation of the patella is a common dislocation of the patella. the range of lesions is wide and the severity is high. clinical diagnosis and treatment are difficult. in clinical work, misdiagnosis and treatment are not targeted at pathological mechanisms. this leads to irregular diagnosis and treatment, high failure rate and revision rate, and patients undergoing multiple operations. the project team developed a "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement" in the preliminary research, which overcomes the disadvantages of traditional knee extension surgery and is suitable for adults. early research shows safe and effective clinical efficacy. the purpose of this application project is to take independent innovation of core surgical technology as the lead, adopt a two-way cohort study method, compare the clinical efficacy of the new "four-in-one" technology and traditional soft tissue surgery in the treatment of adult habitual patellar dislocation, and analyze and formulate adult habituation comprehensive and systematic solutions for patella dislocation, relying on this scientific research project to conduct multi-center and large-sample clinical case studies, and evaluate the effectiveness and safety of independent innovative technologies through standardized medical research methods to improve the surgical treatment of adult habitual patella dislocation success rate, reduce recurrence rate and failure rate, improve the level of clinical treatment of the disease, and finally put forward a special clinical diagnosis and treatment system for the disease in the international academic community.


Eligibility criteria:
inclusion criteria: * patients with habitual dislocation of the patella over 14 years old * agree to participate in the study exclusion criteria: * combined with other knee ligament injuries * recurrent patellar dislocation * skin and soft tissue conditions do not allow surgery
overview of the mental health of adolescents in therapeutci, educational and pedagogical facilities in france

Conditions: Mental Health Disorder

Summary: assess the prevalence of various psychiatric disorders in adolescents aged 12 to 16 receiving support from therapeutic, educational and pedagogical institutes.


Eligibility criteria:
inclusion criteria: * adolescent aged 12 to 16 * in a ditep for at least 15 days * minor who has been informed and has not objected to the research (according to his/her capacity) * at least one person exercising parental authority who has read and understood the information note and has not objected to the research or * for a minor under guardianship: legal representative who has read and understood the information note and has not objected to the research. exclusion criteria: * minor and/or person(s) exercising parental authority who do not understand french * holder of parental authority opposed to the search * minor opposed to search