Kornimate/medical-research-clean huggingface dataset:
clinical trial of yyd701-2 for treatment of nasolabial folds

Conditions: Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds

Summary: a multicenter, active-controlled, randomized, evaluator and subject blinded, split-face, comparative, non-inferiority, medical device clinical trial. this study is randomized, evaluator and subject blinded, split-face medical device clinical trial. the subjects are injected investigational device(yyd701-2 or restylane perlane lidocaine) in right or left nasolabial folds.


Eligibility criteria:
inclusion criteria: * male and female aged between 30 and 75 years, inclusive * subjects who want improvement of nasolabial folds that are rated as grade 3 or 4 on wrinkle severity rating scale(wsrs) * subjects who have visually symmetrical bilateral nasolabial folds * subjects who consent to discontinue all dermatological treatment or cure including wrinkle correction in and around infraorbital region during this trial * subjects who voluntarily decide to participate in this trial and provide written consent in the informed consent form exclusion criteria: * subject who have bleeding disorder in the past or present * other criteria as identified in the protocol
a study to evaluate the efficacy and safety of mizoribine in the treatment of lupus nephritis

Conditions: Lupus Nephritis

Summary: to demonstrate that the treatment effect in lupus nephritis of mzr is non-inferior to that of standard therapy ctx through analyzing overall remission rate after treatment.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with sle according to american college of rheumatology (acr) criteria in 1997; * patient who has had a kidney biopsy within 365 days prior to screening which was confirmed as class iii, iii+v, iv, iv+v, or v according to the pathologic classification of international society of nephrology/renal pathology society (isn/rps) in 2003; * patient with 24hr-urine protein ≥ 1.0g; * sle-dai \> 8 ; * male or female patient between 18 and 70 years (inclusive) at informed consent obtained date; * patient with body weight between 40kg and 80kg (inclusive) at screening; * patients who sign the informed consent form; exclusion criteria: * patient who had history of allergy to any investigational product (mzr, ctx) or hormone; * patient who had received accumulated dosage of ctx \>3g within one year prior to screening. * patient who had received immunosuppressant or chinese traditional medicine with immunosuppressive effect within 30 days prior to screening; * patient who had received prednisone\>1.0mg/kg/day or equivalent dose of other oral glucocorticoid therapies within 30 days prior to screening; * patient who received other investigational drugs within 30 days prior to screening; * patient who have received plasma exchange therapy or immunoadsorption therapy within 30 days prior to screening; * patient who require pentostatin or live vaccine (not including flu vaccine); * patient who is undergoing renal replacement therapy; * patient who received kidney transplantation; * patient with malignancy; * patient with severe hypertension (sbp \> 160mmhg or dbp \> 100mmhg) which has not been effectively controlled; * patient with white blood cell count \<3×109/l /l(=3.0 gi/l); * patient with scr \> 176.8μmol/l; * patient who has a value that is \> 3 times of the upper limit of normal range for ast or alt; * patient with hepatitis b, hepatitis c or hiv infection; * patient with other serious infections; * patient who is unsuitable for participating in this study in the opinion of investigators ( e.g. uncontrolled diabetes, central nervous system lupus , lupus encephalopathy, active psychosis,osteonecrosis of the femoral head, fulminant hepatitis, peptic ulcer, etc.); * female patient who is pregnant, currently breast feeding or willing to become pregnant; * patient with any other diseases that would affect the evaluation of efficacy or safety.
mechanical thrombectomy and catheter directed thrombolysis utilization in patients with deep vein thrombosis

Conditions: Deep Vein Thrombosis

Summary: the goal of this observational study is to assess the utilization of mechanical thrombectomy and catheter-directed thrombolysis in patients with deep vein thrombosis in tertiary care. the main questions it aims to answer are: 1. how many patients with deep vein thrombosis are potentially eligible for mechanical thrombectomy and catheter-directed thrombolysis in a tertiary hospital? 2. what is the actual number of patients undergoing endovascular interventions for deep vein thrombosis? participants received endovascular treatment according to the clinical protocol of the treatment.

tertiary hospital database was analyzed. all the records of patients referred for deep vein thrombosis were extracted. the collected data included general patient information, medical history, results of physical examination, duplex ultrasound, laboratory analysis, etc. indications and contraindications for mechanical thrombectomy and catheter-directed thrombolysis were assessed, considering possible benefits and risks. patients who could be eligible for this technique were identified

Eligibility criteria:
inclusion criteria: * lower limb, pelvic, or inferior vena cava deep vein thrombosis exclusion criteria: -

Keywords: mechanical thrombectomy catheter directed thrombolysis iliofemoral deep vein thrombosis
financial toxicity in cancer patients

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study will seek to generate the early data needed to understand the relationship between constructs and measures of patients' coping resources and psychological response and measures of patients' financial toxicity. to collect this early descriptive data, the overall goal of this study is to identify social, behavioral, and knowledge factors associated with financial toxicity outcomes. identifying these factors will ultimately help elucidate targets for behavioral, psychosocial, and/or educational and coaching interventions.

primary objectives: 1. examine the associations between measures of self-efficacy, quality of social support, and financial literacy with the outcome measure of financial toxicity. 2. identify the feasibility of collecting these measures in a spanish-speaking cancer patient population. 3. describe the relationship between financial toxicity and clinical outcomes (survival and disease status). this is an exploratory aim. 4. a) describe the correlation between measures of self-efficacy, quality of social support, financial literacy and clinical and demographic patient characteristics with outcome measure of financial toxicity, by tumor type and age subgroups. b) describe response rate to the financial toxicity measure (\>50% completed items on the survey instrument), by tumor type and age subgroups. this is an exploratory aim. outline: participants will complete a survey packet that is estimated to take about 30 minutes. the survey packet will be collected at baseline and at 6 months.

Eligibility criteria:
inclusion criteria: * participant must be able to read and speak english or spanish * participant must have diagnosis of cancer within the past 365 days; all disease sites and all stages are eligible for enrollment exclusion criteria: * unable to give consent
hpv infections, cancer of the vulva and therapeutical success

Conditions: HPV; Human Papilloma Virus

Summary: hpv infections may be responsible for different types of cancer in females. primary goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.

hpv infections may be responsible for different types of cancer in females. primary goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions. after having retrospectively identified patients with vulvar cancer incl. their preinvasive lesions in the clinical registry the hpv status of the samples is prospectively analyzed using a new multiplex pcr array. two groups are build: patients with hpv associated vulvar cancer and patients with non-hpv associated vulvar cancer. then, the rate of patients who respond to radiotherapy within the groups is analyzed by building kaplan meier plots according to the patients survival and recurrence rate.

Eligibility criteria:
inclusion criteria: * pts. who suffer from vulvar cancer and their preinvasive lesions * positive informed consent * complete set of data * treatment in luebeck university exclusion criteria: * opposite of above

Keywords: hpv prevalence recurrence rate survival
peroral supplemental nutrition in end-stage renal disease with and without hiv comorbidity

Conditions: End-Stage Renal Disease

Summary: end-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic changes or both. human immunodeficiency virus-infection may exacerbate the state of malnutrition. in a pilot study, we recruit both hiv invected and non-infected patients on hemodialysis. non-hiv patients will be randomized to peroral supplemental nutrition or no peroral supplemental nutrition. all hiv patients will receive peroral supplemental nutrition. the nutritional state will be determined in magnet resonance tomography at the start and at the end of the study (muscle diameter of triceps m.) and with laboratory parameters (plasma albumin and others). the hypothesis is that supplemental peroral nutrition (a total 250 kcal per day) will stop loss of muscle mass in end-stage renal disease patients (compared to their counterparts without supplemental peroral nutrition) as well as in the high risk group of hiv patients. this pilot study may lead to larger randomized clinical trials and, may affect dietary recommendations.

in end-stage renal disease (esrd), cachexia is a common finding. metabolic changes, malnutrition, or both appear to be the underlying problems. in fact, lean body mass per body weight better predicts prognosis than creatinin based models (ndt, 2004.19:1182). in addition, comorbidity such as hiv infection may exacerbate cachexia found in esrd. whether or not daily supplemental, high-caloric nutrition in esrd corrects a catabolic state in esrd is unclear. hypothesis to be tested: daily supplemental high-caloric nutrition beneficially affects cytokine stimulation (tnf alpha, il 1beta, il 6, crp) and nutritional state (cross sectional area of triceps m. in mid-humerus position (mrt), plasma albumin) in in hiv-positive hemodialysis patients and in chronic hemodialysis patients compared to chronic hemodialysis patients without supplemental nutrition.

Eligibility criteria:
inclusion criteria: * patients on hemodialysis for more than 1 year, * group 1: hiv infection exclusion criteria: * patients on hemodialysis for less than 1 year, * group 2 and 3: hiv infection * no pre-/post dialysis weight differences of \> 3 kg after long hd free interval over last 10 hd sessions. * no current high-caloric nutrition supplements or planned high-caloric supplements for clinical reasons. * pregnancy * for women: no use of oral contraceptives or other at least equally effective contraception in women with childbearing potential * known neoplastic disease other than skin tumors (except melanoma) * mental disease or retardation with impaired judgement power

Keywords: end-stage renal disease chronic kidney disease
influence of core muscles activation using physical fitness on the performance of chest compression

Conditions: Heart Arrest

Summary: chest compression, a key component of cardiopulmonary resuscitation (cpr), has a major role for survival of cardiac arrest patients. according to 2015 american heart association (aha) guideline, rescuers provide high quality cpr to adult cardiac arrest patients including 5 to 6 cm depth and 100 to 120 beat per minute rate chest compression. however, in cpr situation, chest compression depth and rate vary according to provider's muscle strength. in other words, the individual difference of the degree of physical activity will make the different result for cpr. so, the investigators hypothesize that the core muscles activation using physical fitness improves the quality of chest compression and the quality of cpr, eventually.


Eligibility criteria:
inclusion criteria: * medical school students and interns had experienced in cardiopulmonary resuscitation (cpr) education exclusion criteria: * patients with musculoskeletal disease * patients with cardiovascular disease * patients with lung disease

Keywords: cardiopulmonary resuscitation manikins physical fitness
study on the quality of life among adolescents with attention deficit/hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: attention deficit hyperactivity disorder (adhd) with a overall prevalence of 5.3% is one of the most common neurobehavioral disorders in children. in the foreign literature, many studies bring to light in children and adolescents the negative impact of adhd on overall quality of life. some of these studies were able to identify the fact that the higher the age of adhd children or adolescents, the lower the quality of life. currently, to our knowledge, only a few european studies have demonstrated the negative impact of adhd on the quality of life of children and adolescents. in addition, these studies used only questionnaires intended for parents and not for children or adolescents. during a regular follow-up consultation with their referent child psychiatrist, adolescents accompanied by at least one of their parents will be informed of the modalities of our study. a newsletter will be delivered to parents and one to the adolescent. if neither the adolescent nor the parents is opposed to participate, the child psychiatrist will register the patient on the list of study participants. he will also fill out a medico-social information sheet about the adolescent as to summarize the data in the medical record. at the end of this consultation, in the waiting room, adolescents will answer questionnaires kidscreen-27 and mspss; their parents will complete the cbcl questionnaire. these questionnaires will be handed to the secretary who will put them back in the patient's record. the kidscreen-27, mspss and cbcl questionnaires as well as the medico-social information sheet will be source documents. the principal investigator or one of the associates investigators will complete the case report form from these source documents. for this purpose the data will be entered anonymously into a data entry software on a computer server secured by the centre psychothérapique de nancy (cpn). then, anonymous data from the software will be forwarded to dr. epstein of the clinical investigation center for statistical analysis. the study will begin when the favourable opinion of the ethical research comittees will be obtained and the study will last one year.

cross-sectional, descriptive epidemiological study based on single-centre trials

Eligibility criteria:
inclusion criteria: * adolescents aged 12 to 18 years * diagnosis of adhd (f 90.0) ascertained by a child psychiatry according to cim-10 criteria * seen by a child psychiatrist in consultation and accompanied by at least one of their parents * adolescents and at least one parent who has received enlightened information about the study * non-opposition to participate in the study gathered from at least one of their parents * patient affiliated or beneficiary of a social security scheme exclusion criteria: * illiteracy of the parents or the adolescents * difficulties to understand french for the parents or the adolescents
mothers' approach to clinical research amongst their preterm or healthy newborns

Conditions: Parents Approval to Research

Summary: parental approval to enroll their sick children in clinical research was studied. however, the motivation of parents to enroll healthy children and/or babies was not yet studied. the importance of clinical research among the healthy population is of extreme value. the aim of this study is to assess the motivation, medical trust and other factors influencing parents' decision to enroll their healthy baby in a clinical study.

mothers to either healthy full-term babies post delivery or preterms will be asked to anonymously answer a questionnaire. the questionnaire includes demographic data, questions regarding their approach to medical issues, factors that influence her to enroll her baby in a research trial (different research types, different benefits from the research and fears). finally, the mother will be asked if she will be willing to enroll her baby to on-going studies in the department.

Eligibility criteria:
inclusion criteria: * mothers to healthy newborns during hospital stay after delivery, and mothers of preterm infants during their hospitalization in nicu. exclusion criteria: * mothers of sick newborns (respiratory distress, receiving iv infusion, etc.) who are in the special care for newborns.

Keywords: parents newborn clinical trials
long-term follow-up after ventral hernia repair with strattice mesh

Conditions: Ventral Hernia

Summary: this study will assess long-term outcomes (greater than 12 months) following ventral hernia repair with strattice mesh reinforcement.

subjects will be retrospectively identified as having undergone operative repair of ventral hernia with strattice mesh reinforcement during the period january 1, 2013 - november 1, 2017. follow-up data will be collected either at a postoperative clinic visit or via telephone interview.

Eligibility criteria:
inclusion criteria: * hernia repair with strattice mesh * age 18 or older exclusion criteria: * under age 18 * no history of hernia repair
cardiopulmonary bypass-induced lymphocytopenia and the potential effects of protease inhibitor

Conditions: Cardiopulmonary Bypass

Summary: in previous studies, 90% of patients who underwent elective cardiopulmonary bypass procedure manifested cd4 counts of less than 500 cells/microliter in the immediate (day 1) post-operative period. this study will investigate whether or not nelfinavir increases those cd4 counts in the post-operative period.

see brief summary.

Eligibility criteria:
inclusion criteria: * any patient undergoing elective (non-emergency) cardiopulmonary bypass for coronary artery bypass grafting, cardiac valve replacement, or both. exclusion criteria: * a dozen different medical conditions and two dozen medical contraindications.
professional life after breast cancer: feasibility of a coaching program for an adapted return to work

Conditions: Breast Cancer

Summary: the diagnosis of breast cancer and the treatments implemented have a significant impact on the professional situation. maintaining employment and/or reintegration into working life are therefore major issues for cancer patients. this trial proposes to study the feasibility of a support/coaching program for a return to work in patients after breast cancer.

this study involves patients with breast cancer at the end of their adjuvant treatment. the aim of this study is to evaluate the feasibility of a support program for an adapted return to work of these patients. this back-to-work support program including an individual interview to identify patient needs and expectations, 7 coaching workshops (every 3 weeks +/- 15 days) and a final individual assessment post workshops. the evolution of quality of life, psychological distress and perceptions concerning work will also be evaluated through assessments and questionnaires before (inclusion) and after the support program \[1 month (+/- 7 days) and 6 months (+/- 1 month) after the final individual assessment\]. the study also aims to estimate the recruitment rate in the study and to assess the satisfaction of this support program. finally, the impact of this support program on the return to work will be described. this initial study will eventually lead to a larger research protocol on the effectiveness of the program, using a randomized controlled trial design.

Eligibility criteria:
inclusion criteria: * age ≥18 years * patients cared at the montpellier cancer institute (icm) for non-metastatic breast cancer who have received adjuvant treatment (radiotherapy and/or chemotherapy) * patient who has completed adjuvant treatment, except for hormonotherapy * patient practicing a profession at the time of diagnosis, looking for a job or in professional retraining at the time of diagnosis * patient expressing spontaneously or on request of the oncologist physical or psychological difficulties in the professional field * patient wishing to be accompanied for an adapted return to her current job or for a return to a new more adapted job * patient who signed the informed consent after informed information by her clinician exclusion criteria: * metastatic breast cancer or any other cancer within the last 5 years * patient who haven't completed herr adjuvant treatment (chemotherapy and/or radiotherapy) * psychological condition requiring therapeutic support (objectified by the mini international neuropsychiatric interview test (mini) by identifying a diagnostic and statistical manual (dsm)-iv axis i psychiatric disorder (american psychiatric association, 1994) sheehan et al., 1998) with the patient's refusal of adequate psychiatric treatment (medicated or not) at the time of inclusion in the study * severely impaired global cognitive functioning (objectified by an adjusted score of less than 20 on the montreal cognitive assessment (moca) test) * physical inability to answer questionnaires

Keywords: return to work
efficacy and safety of enzyme replacement therapy in patients with fabry disease

Conditions: Fabry Disease

Summary: the goal of this observational study is to learn how enzyme replacement therapy works in patients with fabry disease. the main question it aims to answer is: what medical problems do participants have? participants already on enzyme replacement therapy as part of their regular medical care for fabry disease will be observed as usual. their data will be collected by their doctor.

all patients on enzyme replacement therapy could be enrolled in the study. three medicines are currently available in russia (fabagal®, fabrazyme®, replagal®) so the patients form three cohorts. for all patients retrospective data are collected for 12 months prior enrollment. all patients are observed prospectively for 6 months. at the point of 6 months patients taking fabrazyme or replagal at the moment finish the study. patients on fabagal are observed for 12 more months (up to 18 months after enrollment).

Eligibility criteria:
inclusion criteria: * men and women with a confirmed diagnosis of fabry disease; * prescribed course of enzyme replacement therapy with any drug (fabagal, fabrazim, replagal); * age 8 - 65 years; * signed informed consent of the patient and/or his/her legal representative for participation in the study and processing of personal data. exclusion criteria: * renal replacement therapy or kidney transplantation; * critical illness unrelated to fabry disease; * pregnancy or breastfeeding; * refusal of the patient (or his/her legal representative) from further participation in the study or medical care.

Keywords: fabry ert enzyme replacement therapy