Kornimate/medical-research-clean huggingface dataset:
jump_start - optimization of care for young cancer patients with gastrointestinal tumors

Conditions: Gastrointestinal Cancer

Summary: jump_start aims to assess the needs of individuals aged ≤ 50 years with gastrointestinal (gi) tumors and implement a tailored support and counseling program at the university hospital heidelberg and the national center for tumor diseases (nct). in phase 1a, 12-15 individuals aged ≤ 50 years with gi tumors will be interviewed via telephone using semi-structured interviews to obstain a detailed understanding of the life situation, the burdens, and the care situation within the structures of the nct heidelberg. in phase 1b, the care networks of young patients with gi tumors beyond the nct, including the analysis of changes and important access routes/possible gatekeepers, will be explored using so-called ego-centered network analyses, in comparison with patients who received a gi tumor diagnosis after the age of 50. in response to the results of phase 1a and 1b, the care services for young patients with gi tumors will be optimized, and tailored counseling programs will be developed in phase 2. these project phases will be accompanied by quality of life assessments using european organisation for research and treatment of cancer (eortc) questionnaires. all patients with gi tumors (regardless of potential inclusion in phase 1a or 1b) will receive the eortc questionnaires once. in phase 2, quality of life will be assessed every 6 months.


Eligibility criteria:
inclusion criteria: * individuals aged ≥ 18 and ≤ 50 years receiving treatment for a gi tumor at the heidelberg university hospital * sufficient knowledge of the german language * capable of providing informed consent * additional recruitment for phase 1b and quality of life assessments: patients with gi tumor aged ≥ 51 years exclusion criteria: * individuals with a gi tumor diagnosis after the age of 50 (except in phase 1b and for quality of life assessments) * individuals with a gi tumor diagnosis under the age of 18 * lack of capacity to consent and/or absence of informed consent * insufficient knowledge of the german language * severe cognitive impairments

Keywords: quality of life gastrointestinal tumors
therapy by led (light emission diode) in cutaneous lesion: in vivo

Conditions: Burn Injury

Summary: light emitting diode (led) therapy has been investigated in burns and skin ulcers, as it has a bactericidal effect and promotes tissue repair. this study aims to evaluate led therapy at different wavelengths in the healing process of graft donor area in adult burn victims.

it is a blinded and controlled clinical trial in which burned adult patients will be selected, who will be irradiated with red (630 nm) and infrared (940 nm) leds at 4j / cm2 fluency, in the donor area of until complete reepithelialization. patients included will be the donor scalp area, with withdrawal of 0.2 mm. for application of the leds, the device will be calibrated for wavelength parameters, beam divergence, nominal power and fluency in the photobiophysical laboratory of the university of ribeirão preto - sp. three groups will be divided: gs = sham group (will not receive led irradiation), will only receive routine hospital care, gt-v = treatment group with red led, and gt-iv = treatment group with infrared led. patients will be randomized for group distribution. the donor areas will be evaluated by infrared thermography, computerized bioimpedance, infrared plethysmography, and vancouver healing scale at two times, the first within a period of up to 24 hours after graft surgery, and the second after release of the primary dressing. the evaluations will be carried out by an expert evaluator, blind to the groups. for the analysis of the results will be applied statistical tests intra and intergroup (p \<0.05). this research aims to contribute with a new therapeutic method in the control of infections commonly found in cutaneous lesions, as well as in the healing process of the skin.

Eligibility criteria:
inclusion criteria: patients admitted to the burn unit of the hcfmrp-usp - emergency unit, who agree to participate in the study and are over 18 years of age, guided and without diagnosis of psychiatric diseases, who have undergone graft surgery for a maximum of 24 hours, with a body mass index greater than 16 kg / m² and without infection (sepsis), and that do not present any factor that could interfere in healing such as diabetes or the use of corticosteroids. exclusion criteria: patients who develop infection, are not adherent to treatment or are willing to not continue to participate in the research are excluded.

Keywords: burn injury, phototherapy, wound healing
comparison of learning curves for two different techniques in vaginal hysterectomy

Conditions: Pelvic Organ Prolapse; Gynecologic Disorders; Surgery

Summary: randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures.

this is a prospective, randomized, spontaneous monocentric interventional study on a procedure in which 60 female patients will be enrolled with a diagnosis of pelvic organs prolapse which are eligible for vaginal hysterectomy. the data relating to the intervention will be collected, analyzed and compared through a descriptive statistics. patients will be randomized 1:1 in two groups: 1. study group: bipolar coagulation technique 2. comparison group: reabsorbable stitches the primary outcome of the study is to compare the learning curves for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women. secondary outcomes are to evaluate the effectiveness of the two different procedures through the evaluation of short-term outcomes for both procedures under consideration. the planned duration of recruitment will be 7 months. in this period of time it is planned to enrol a total of 60 patients. once the learning curve plateau has been reached for both procedures, the study will be considered finished. the number of samples was chosen on the basis of the feasibility of recruitment and the possibility of evaluating the learning curve of the operators.

Eligibility criteria:
inclusion criteria: * women aged \>18 years * genital prolapse \> ii degree in accordance with the "pop-q system" eligible for vaginal hysterectomy * understanding and signing of informed consent for surgical procedure exclusion criteria: * need for simultaneous bilateral adnexectomy * previous cesarian section * patients with abdominal laparoscopic or laparotomy history * patients with malignant pathology and/or adnexal pathology * confirmed or presumed pregnancy

Keywords: pelvic organ prolapse urogynecologic surgery learning curve bipolar vessels sealing
non-invasive prediction of necrotizing enterocolitis in preterm neonates with feeding intolerance using fecal lipocalin-2 and electrical cardiometry

Conditions: Feeding Intolerance in Preterm; NEC; Electrical Cardiometry; PreTerm Neonate

Summary: prospective observational study to evaluate the efficiency of using electrical cardiometry in combination with fecal lipocalin-2 for prediction of nec in preterm neonates with feeding intolerance

necrotizing enterocolitis is one of the most life-threatening conditions for premature infants in neonatal intensive care units (nicu) and is associated with severe intestinal inflammation and necrosis, which occurs in 5-16% of very low birth weight (vlbw) infants with a mortality rate of 20-50% and various long-term clinical sequelae for the survivors. although preterm intestinal epithelium is suggested to be predisposed to an exaggerated inflammatory response to the present microbiome, impaired mesenteric perfusion inducing bowel hypoxia and ischemia is suggested to be one of the factors playing a major role in the development of nec. pathogenesis of nec is multifactorial; however, one of the major factors is the disturbance in the end-organ blood ﬂow with early hypoperfusion and hypotension, predisposing for developing nec in preterm neonates. electrical cardiometry (ec) is an impedance-based method that has been introduced for continuous noninvasive hemodynamic monitoring for cardiac output (co) and do2 in both term and preterm infants. clinical studies have shown that abnormal perfusion in the splanchnic circulation, particularly in the superior mesenteric artery (sma), may have a role in the development of nec in newborns so can be used for early diagnosis and evaluation of nec progression. fecal lipocalin-2 (lcn2), also known as neutrophil gelatinase-associated lipocalin, is an anti-microbial molecule that was identified as a new robust biomarker for predicting nec development in very low birth weight infants. lcn2 can predict half of the cases who will develop nec in low birth weight preterms.

Eligibility criteria:
inclusion criteria: preterm neonates with gestational age ≤ 35 weeks, admitted to nicu, started enteral feeding and diagnosed as having feeding intolerance defined as stage ia and ib by modified bell's staging exclusion criteria: 1. chromosomal anomaly or multiple congenital malformations. 2. patient with surgical malformation of the intestinal tract (i.e. omphalocele, gastroschisis, malrotation, intestinal atresia) 3. patient diagnosed as hypoxic ischemic encephalopathy.

Keywords: preterm nec electrical cardiometry sma flow feeding intolerance in preterm fecal lipocalin-2
azithromycin plus chloroquine versus mefloquine in the treatment of uncomplicated p. falciparum malaria.

Conditions: Malaria

Summary: to compare azithromycin plus chloroquine versus mefloquine to treat uncomplicated plasmodium falciparum malaria.


Eligibility criteria:
inclusion criteria: * females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following: * blood smears positive for plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites * documented fever (38.5 c/101.3 f rectal or tympanic; 37.5 c/99.5 f axillary or 38 c/100.4 f oral) or history of fever (as reported by subject) within the prior 24 hours. exclusion criteria: * severe or complicated malaria. * pregnant or breast-feeding women.
optimisation of antipsychotic drug use in older people

Conditions: Alzheimer's Disease; Schizophrenia

Summary: drugs such as amisulpride, known as antipsychotic drugs, are used to treat troublesome and distressing symptoms in older people. although these drugs can be beneficial, they are associated with side effects, particularly in patients with dementia and schizophrenia- like illness. there is an urgent clinical need to understand why this is the case, to guide treatment strategies. this study aims to utilise brain imaging techniques that measure the action of antipsychotic drugs in the brain to explore the causes of this susceptibility in older people with dementia and schizophrenia-like illness, and translate these findings into direct patient benefit. the aim of the study is to investigate and compare the relationship between the action of amisulpride at brain sites during the first 10 weeks of amisulpride treatment in two patient groups - alzheimer's disease and schizophrenia-like illness. imaging data will be combined with data on drug dosage, levels of drug in the bloodstream and clinical response (symptom reduction and motor side effects) during dose titration.dose-response modelling will be carried out in both groups to establish the minimum clinically effective dose of amisulpride, optimum dose range and impact of variability and covariates on exposure-response relationships


Eligibility criteria:
inclusion criteria treatment and control (antipsychotic free) group schizophrenia * meet diagnostic criteria for schizophrenia-like illness * aged between 60 and 95 years of age * score \<6 on the geriatric depression scale alzheimer's * meet diagnostic criteria for ad * score \<=4 on the modified hachinski ischaemia scale * score \< 8 on a modified version of the updrs * aged between 60 and 95 years of age * score \<6 on the geriatric depression scale exclusion criteria treatment group schizophrenia * current or past history of addiction, traumatic brain injury or epilepsy * prescribed any drug that interferes with brain dopamine in past 2 weeks (6 weeks if depot antipsychotic medication). * medical conditions that might affect ability to tolerate a brain scan * unable to give informed consent alzheimer's * current or past history of psychiatric illness, traumatic brain injury or epilepsy * prescribed an antipsychotic or other oral drug that interferes with brain dopamine function within the past 2 weeks (6 weeks if depot antipsychotic medication). * medical conditions that might affect a person's ability to tolerate a brain scan control (antipsychotic free) group schizophrenia * prescribed psychotropic medication * unable to give informed consent alzheimer's • prescribed psychotropic medication

Keywords: amisulpride receptor occupancy antipsychotic sensitivity
ebv-specific cytotoxic t-lymphocytes (ctls) for refractory ebv infection

Conditions: Epstein-Barr Virus Infections; Primary Immune Deficiency Disorder

Summary: related donor epstein-barr virus (ebv) specific cytotoxic t cells (ctls) manufactured with the miltenyi clinimacs prodigy cytokine capture system will be administered in children, adolescents and young adults with refractory ebv infection post allogeneic hematopoietic stem cell transplantation (allohsct), with primary immunodeficiencies (pid) or post solid organ transplant. funding source: fda oopd


Eligibility criteria:
1. patients with epstein-barr virus infections post allogeneic hsct, primary immunodeficiencies or post solid organ transplant with: * increasing or persistent quantitative ebv rt-pcr dna copies despite two weeks of appropriate anti-viral therapy and/or * progressive clinical symptoms attributable to ebv, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly and/or * medical intolerance to anti-viral therapies including: * intolerance to rituximab consent: written informed consent given (by patient or legal representative) prior to any study-related procedures. performance status \> 30% (lansky \ 16 yrs) age: 0.1 to 79.99 years females of childbearing potential with a negative urine pregnancy test 2 donor eligibility 5.2.1 related donor available with a t-cell response to the ebv macs® gmp peptivator antigen(s) causing the therapy-refractory ebv infection. a. third party related allogeneic donor: if original donor is not available or does not have a t-cell response: third party related allogeneic donor (family donor \> 1 hla a, b, dr match to recipient) with igg positive to ebv and/or a t-cell response at least to the viral macs® gmp peptivator ebv select (containing among other antigens, na-1, lmp2a and bzlf-1). and allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (appendix 1). and obtained informed consents by donor or donor legally authorized representative prior to donor collection. 3 patient exclusion criteria: a patient meeting any of the following criteria is not eligible for the present study: patient with acute gvhd \> grade 2 or extensive chronic gvhd at the time of ctl infusion patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of ctl infusion patient treated with donor lymphocyte infusion (dli) within 4 weeks prior to ctl infusion patient with poor performance status determined by karnofsky (patients \>16 years) or lansky (patients ≤16 years) score ≤30% concomitant enrollment in another experimental clinical trial investigating the treatment of refractory ebv infection any medical condition which could compromise participation in the study according to the investigator's assessment known hiv infection female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment. known hypersensitivity to iron dextran patients unwilling or unable to comply with the protocol or unable to give informed consent. known human anti-mouse antibodies
clinical and genetic examination of usher syndrome patients' cohort in europe

Conditions: Usher Syndrome

Summary: this study aims to characterize usher patients in order to correlate this data with genetic information. tasks: * standardization and improvement of usher syndrome diagnosis: refine and elaborate special tests of visual and otological function in association with genotype that enable to determine the most significant markers for usher disease progression and therapeutic effect. * perform genotype and phenotype correlations in usher syndrome patients * develop and maintain database for phenotypically and genotypically well-characterized patient cohorts, suitable for future therapeutic trials


Eligibility criteria:
inclusion criteria : * clinical characteristics for ush1, ush2 and ush3 as defined by the usher syndrome consortium; * informed consent and agreement to participate in the study; * distance best corrected visual acuity ≥ 0.1. exclusion criteria: * systemic pathologies or severe ocular pathologies, systemic or topical medication usage, and/or other otolaryngology pathologies which could contaminate the results; * unwillingness to provide a blood sample ; * unwilling and/or unable to undergo the study procedures.

Keywords: retinitis pigmentosa syndromic congenital deafness usher syndrome retinitis pigmentosa and deafness progressive hearing loss retinitis pigmentosa
a study comparing shr-3167 and insulin degludec in type 2 diabetic subjects treated with basal insulin with or without oral antidiabetic drugs

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the glycemic control and safety of shr-3167 and insulin degludec in type 2 diabetic participants treated with basal insulin with or without oral antidiabetic drugs.


Eligibility criteria:
inclusion criteria: 1. males and females, 18 - 65 years old at the time of signing informed consent. 2. diagnosed with type 2 diabetes mellitus (t2dm) for at least 6 months prior to the day of screening. 3. treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to the day of screening. 4. 6.5% ≤ hba1c ≤ 10.0% at screening. exclusion criteria: 1. uncontrollable hypertension (with or without antihypertensive treatment) : systolic blood pressure ≥ 160 mmhg or diastolic blood pressure ≥ 100 mmhg at screening. 2. diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (lada), other special types of diabetes or secondary diabetes. 3. known or suspected allergy or intolerance to the test drug or excipient. 4. there was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months. 5. there is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease. 6. there is hyperthyroidism or hypothyroidism requiring treatment. 7. malignancy within 5 years prior to screening or high risk of recurrence. 8. those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening. 9. participated in clinical trials of any drug or medical device within 3 months prior to screening.
mixed-method evaluation of a parental psychoeducation programme in a suicide risk prevention group

Conditions: Suicide Prevention

Summary: the number of emergency consultations for children and adolescents for suicidal ideation and suicide attempts has been rising steadily since 2010, and even more so since 2020. in addition, 30% of children and adolescents who have committed a suicidal act reoffend within the year. psycho-education programmes for patients have been shown to be effective in a large number of psychiatric pathologies. the programs of psychoeducation for the caregivers of these patients have them also shown their effectiveness, however to date there is no parental psychoeducation program group, for the prevention of the suicidal risk of children and adolescents, which is validated. the service of child psychiatry at the robert debré hospital built a program for this purpose, according to current data from the science and has been offering it for 6 months to parents of patients who consulted for suicidal ideation. rate this program through the description of its implementation would allow it to be validated, this in a dissemination objective. this validation through a mixed method would also allow us to describe the experience participants in this program and to understand improvements track.

implementation study: non-randomized, single-center, quasi-experimental study before - after for the evaluation criteria of intermediate effectiveness (effectiveness). study mixed qualitative-quantitative method for the evaluation of several judgment criteria. the main objectives is to evaluate the implementation of a parental psychoeducation program in a group of suicide prevention through parental support for the entire program. the secondary objectives are to evaluate: * reaching the target population (reach) * the intermediate effectiveness of the program * the adoption of the program by health professionals * the implementation on other dimensions * the sustainability of the program

Eligibility criteria:
inclusion criteria: * parent committing to participate in the 4 sessions of the parental psychoeducation prevention program suicide risk (pepps program) * parents of children under 15 years and 6 months * parents fluent in french exclusion criteria: * lack of affiliation with a social security scheme or cmu (universal health coverage) * parents under guardianship or curatorship
melatonin for circadian sleep disorders in the blind

Conditions: Insomnia; Blindness; Daytime Sleepiness

Summary: this research project consists of a three part study with five embedded sub studies. the first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject (including sub-study 1). the second study phase identifies the optimum dose and timing of melatonin for regulating each individual's 24-hour sleep/waking cycle (including sub-study 2). the third study phase introduces a new independent variable, light (including sub-studies 3 and 4). sub-study 5 is an optional longitudinal study. sub-study 1 looks at how keeping a regular sleep schedule affects the body's natural rhythm. sub-study 2 looks at how individuals metabolize melatonin. sub-study 3 tests how individuals' endogenous melatonin production responds to bright outdoor light and sub-study 4 tests a previous finding that artificial bright light exposed daily behind the knee can regulate the body clock. sub-study 5 is an optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.


Eligibility criteria:
inclusion criteria: * blindness for at least one year, verified by an ophthalmologic exam * ability to comply with the requirements of the experimental protocol * competency to sign informed consent exclusion criteria (as determined by medical history and/or physical examination): * abnormal heart, liver or kidney function * a current axis i psychiatric or substance abuse disorder according to the dsm-iv manual * possibly external demands that limit the ability to maintain a regular schedule (e.g., night shift work) * sexually active female subjects of child-bearing potential will be asked to avoid pregnancy using accepted methods and will be notified that the effects of melatonin on a fetus are not known (we will ask subjects monthly if they are pregnant or trying to become pregnant) * if a subject reports she is pregnant or is trying to become pregnant anytime during her study participation, any study medications (melatonin or placebo) will be immediately withdrawn and the subject will be excluded from the study

Keywords: melatonin sleep blindness blind individuals