Kornimate/medical-research-clean huggingface dataset:
comparison of the osho protocol to a standard arm protocol of the german aml intergroup in patients with aml<60a

Conditions: Acute Myeloid Leukaemia

Summary: this protocol is part of the german aml intergroup trial, where the osho study arm is compared to the common german standard arm after randomization in a 9:1 ratio. the hypothesis involves primarily dosing and application of arac for induction. it is expected that cr rates and as a consequence also lfs are higher in protocols using higher arac compared to lower doses and that lfs might be superior in the study specific arm compared to the golden standard published several years ago. in the standard arm, arac 100mg/m2/day is given as continuous infusion over 7 days. daunorubicin is given as 60 mg/m2/day over a two hours infusion on days 3, 4 und 5. on day 22 a second induction course is applied. after reaching cr, three cycles of arac 3 g/m2 over three hours bid are infused on day 1, 3 und 5. in contrast the osho arm consists of induction therapy with ida 12 mg/m\*2 over 20-30-min-iv on day 1 - 3 and arac 2 x 1 g/m\*2 bid over 3-h-iv on days 1+3+5+7. a previous phase ii study of the osho has shown high cr in patients with relapsed aml using mitoflag. in this study we asked the question if mitoflag is superior to idaarac in newly diagnosed aml patients without cr after the first induction chemotherapy. therefore patients are randomized to receive either mitoflag or idaarac and the difference in cr rates evaluated. it is still unclear if two consolidation therapies are needed before allogeneic or autologous stem cell transplantation. this question is being addressed in the second part of the osho study, where patients are randomized to receive either one or two consolidation therapies. in this study all patients with aml and an age of 18-60 years except m3 are entered


Eligibility criteria:
inclusion criteria: adult patients \< or = 60 years acute myelogenous leukemia (aml) aml t(8;21)(q22;q22), aml1 (cbfa)/eto, aml(inv(16)(p13q22)) und variants (cbfb/myh11), aml 11q23, mll-anomalies, aml with normal karyotyp myelodysplastic syndrome (mds)raebt with 20-30% blasts. de novo aml secundary aml after mds secundary aml after chemotherapy with alkylantien sekundäre aml after chemotherapy with epipodophyllotoxin informed consent exclusion criteria: aml m3 patients included in another clinical trial contraindications for high dose cytotoxic therapy such as renal insufficiency liver insufficiency cardiac insufficiency nyha iii + iv, acute myocardial infarction uncontroled infection like pneumonia with hypoxemia or septic schock pregnancy karnofski-index of 10 and less second maligancy severe, decompensated metabolism disorders

Keywords: aml acute myeloid leukaemia low vs intermediate dose arac cr rate patients <60 years
hemolysis in blood samples in the er

Conditions: Hemolysis; Emergency Service, Hospital; Emergencies; Blood Specimen Collection

Summary: in this study, we aim to identify risk factors for hemolysis in blood samples drawn in the ed.


Eligibility criteria:
inclusion criteria: * \> 16 years exclusion criteria: * in vivo hemolysis
follow-up of inflammatory responses and multiorgan outcomes following neonatal brain injury

Conditions: Neonatal Encephalopathy

Summary: babies who have brain injury also frequently have involvement of their kidneys, lung and heart. although clinical care in the neonatal period is well defined there are few guidelines and evidence for developmental, heart and kidney followup in childhood. the investigators aim to develop and implement guidelines for health care workers and families on followup after neonatal brain injury. inflammation is an important factor in brain injury of newborns and also affects their heart lungs and other parts of their body. the investigators will use tests from the newborn period to predict outcome and help parents with planning health needs for their baby rather than waiting until any issues arise later on. by understanding inflammation the investigators can find methods to decrease the negative effects and improve outcomes in the future for babies and families.

neonatal brain injury is an important cause of neonatal death and disability such as cerebral palsy. perinatal global hypoxic ischemic associated with neonatal encephalopathy (ne) results in multi-organ dysfunction which may persist in later childhood. in addition perinatal inflammation has been associated with neonatal brain injury and implicated in adult neuropsychiatric conditions. the investigators aim to examine multi-organ dysfunction in early childhood in children who had ne by examining detailed cardiac, renal, neurological, haematological and neurodevelopmental outcomes. the investigators have previously defined detailed multi organ dysfunction (mod) in this cohort in the neonatal period in infants with ne including organ outcomes as well as serum, urine and cerebrospinal fluid (csf) biomarkers. they are now age-appropriate for detailed neurocognitive assessment and correlation with these biomarkers and the investigators plan to compare with age- matched controls. immunological markers such as the inflammasome and micrornas are altered in the neonatal period and may persist in early childhood. the investigators will modify negative inflammatory responses in vitro with specific antagonists as well as correlating these immune biomarkers with outcomes. quantifying multiorgan dysfunction in the neonatal period to ensure appropriate follow-up of all organs is merited. this would help in advanced clinical planning and long term follow up. in addition, understanding, the immune response in these children with ne and exploring systemic inflammation holds promise for future development of immunomodulatory adjunctive therapies and biomarkers to predict outcomes.

Eligibility criteria:
inclusion criteria: * children at 2-3 years * with diagnosis of neonatal encephalopathy * required therapeutic hypothermia exclusion criteria: -

Keywords: brain injuries multiple organ failure infant inflammation neutrophils
retrospective-prospective pns study

Conditions: Chronic Pain

Summary: this is a retrospective-prospective study in which 40 patients have received a permanent freedom pns system. subjects presented with chronic, intractable pain of peripheral nerve origin refractory to standard medical and/or surgical treatment. a retrospective chart review will be conducted to assess baseline and follow-up parameters in patients who have received a permanent implant with the freedom pns system for at least 12 months. missing data might be collected after informed consent.


Eligibility criteria:
inclusion criteria: a. subject is ≥ 18 years of age at time permanent implant; b. subject has been implanted with the freedom pns system; c. subject is willing to attend visit as scheduled, and comply with the study requirements (if prospective); d. patient is capable of giving informed consent. exclusion criteria: a. subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study (if prospective); b. any additional active implanted devices for the treatment of chronic pain in addition to the freedom pns system.

Keywords: chronic pain, pns, retrospective, prospective
study of mental care in spain

Conditions: Schizophrenia

Summary: non-interventional, multicenter, cross-sectional study to evaluate the mental care received by schizophrenic patients and their caregivers in spain irrespective of the drug prescribed.


Eligibility criteria:
inclusion criteria: * schizophrenia (dsm-iv criteria) * attended to the mental care units for the first time in 2006 exclusion criteria: * participation in another clinical trial * other criteria that according to the medical criteria make difficult the normal development of the study

Keywords: schizophrenia medical mental care caregiver sapin
polycystic ovarian syndrome (pcos) biomarker evaluation study

Conditions: Polycystic Ovarian Syndrome (PCOS)

Summary: the purpose of the study is to validate recently identified biomarkers for the identification of pcos in adolecent and young adult women.

the purpose of the study is to validate potential biomarkers for the aid in the diagnosis of pcos in adolescent and young adult women in the age range of 15-25 years. female subjects included in this study will have one visit where clinical data for assessing pcos will be collected and a blood draw will be performed to collect serum for measurement of parameters relevant to pcos will be performed. study subjects that receive a pcos diagnosis will have two follow up visits for follow up on treatment where additional serum and clinical data will be collected. the first visit will be 3 months after receiving the diagnosis and the second visit 6-12 months after the initial visit.

Eligibility criteria:
inclusion criteria: * female subjects age 15-25 years * signed written informed consent exclusion criteria: * less than 1 years from onset of menarche * use of hormonal contraceptives * documented ongoing pregnancy * major ovarian abnormalities, including subject with only one ovary, cysts and solid masses \> 2 cm as detected by transvaginal ultrasound * malignancy ( documented malignancy, documentation of current radiation therapy or chemotherapy in medical record)

Keywords: pcos biomarker adolescents
a very early standing study in elderly stroke

Conditions: Stroke

Summary: functional recovery is one of the main issues in the management of stroke and there are various ways in rehabilitation to promote this recovery. verticalization is a technique whose benefits have been widely demonstrated, particularly in neurology. although commonly used in the rehabilitation of stroke, evidence is still lacking as to its impact in this specific care. verticalization is underutilized in two situations: in the hyper acute phase as well as in elderly and very deficient patients. it has, however, been shown that the precocity of the treatment allows a better functional recovery. similarly, the re-education of the elderly is also debated since it has long been mentioned that age was a factor of poor prognosis, the objectives are sometimes underestimated. however, several studies have shown that with the same rehabilitation, elderly patients recover as much as younger patients. the differences found are at least in part due to "less rehabilitation" of older stroke patients. the different existing data lead us to the hypothesis that the verticalization of the elderly hemiplegic patient in acute phase would allow a better functional recovery.


Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke * age \> 70 * modified rankin scale (mrs) pre stroke : 0 or 1 * admission in the neuro vascular unit less than 48 hours after the onset of symptoms * nihss item 6 for lower extremity motor skills: 3 or 4 * modified functional ambulation classification : 0 * affiliated to a social security scheme exclusion criteria: * history of stroke with motor sequencing limiting walking * arterial stenosis limiting the sunrise before d4 (identified by doppler) * symptomatic orthostatic hypotension known or present in the acute phase * coma * patients who will be referred to a structure (unv or other) outside the department * fracture, orthopedic disorder or any other complication preventing verticalization * refusal of the patient to participate in the study or to be verticalized * patients under guardianship * patients deprived of their liberty by an administrative decision
a prediction model of hematological recovery after high-dose chemotherapy in pediatric solid tumor

Conditions: Pediatric Solid Tumor

Summary: this study aims to compare and evaluate the predicted values of the participants, and the algorithm predicted values of anc level reduction periods after high-capacity chemotherapy in pediatric solid tumor patients. the participants are pediatricians who voluntarily participate in this study and consent to this study.

n pediatric patients with solid tumors, chemotherapy for radical treatment is generally based on monitoring white blood cells, red blood cells, and platelets with repeated blood tests during treatment due to bone marrow depression. early blood culture and experiential intravenous antibiotics are required to prevent progression to sepsis if fever or other infection signs are accompanied by a decrease in absolute neutrophil count (anc) below 500/mm3. in addition, repeated blood transfusions are needed to keep the appropriate levels constant depending on clinical symptoms in platelet reduction or anemia. in particular, in the case of high-dose chemotherapy conducted on high-risk tumors, anticancer drugs are given over the dose expected to recover natural bone marrow function to improve the treatment performance of tumors responding to chemotherapy. moreover, it is challenging to recover naturally after high-dose chemotherapy so that the collected in advanced hematopoietic stem cells are implanted into the patient to support anc level recovery. however, despite the transplantation of these self-hematopoietic stem cells, some patients need long-term continuous blood transfusions due to delayed hematological recovery and may need long-term hospitalization to treat accompanying infections and complications. the researcher developed a model that can predict the suppression and hematological recovery of bone marrow after high-capacity anticancer drugs by analyzing blood tests and blood transfusions repeatedly from the diagnosis of pediatric solid tumors after high-capacity chemotherapy collected from 2000-2018.

Eligibility criteria:
inclusion criteria: * physician who is working at samsung medical center as a pediatric doctor * a person who voluntarily agrees to participate in the study exclusion criteria: * those who disagree with the study

Keywords: oncology prediction model hematological recovery
black cohosh extract in postmenopausal breast health

Conditions: Menopause; Hot Flashes

Summary: the purpose of the study is to determine if black cohosh extract (bce) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, ps2, fsh, lh, and psa levels in nipple aspirate fluid.

as in brief summary

Eligibility criteria:
* postmenopausal females * 20 months since any breastfeeding * active postmenopausal symptoms, i.e., hot flashes * at least 6 months since last menstrual period or have had a hysterectomy with both ovaries removed * able to make 4 visits during the trial to the study clinic in columbia, missouri

Keywords: estrogen stimulation relief of hot flashes nipple aspirate fluid body fluid levels of black cohosh
prophylactic antibiotic use in hernioplasty

Conditions: Inguinal Hernia

Summary: the purpose of this study is to determine whether prophylactic antibiotic use in inguinal hernioplasty are effective in prevention of infectious complication.


Eligibility criteria:
inclusion criteria: * primary inguinal hernia * elective surgery * must be older than 20 years of age * must not have any serious complication exclusion criteria: * incarceration * recurrence * drug allergy * diabetes mellitus * malignant diseases * serious heart diseases * psychological diseases * pregnancy * have been medicated with corticosteroids

Keywords: prophylactic antibiotic infection primary case
prevalence of temporomandibular joint disorders in wind musicians

Conditions: Temporomandibular Disorders (TMD)

Summary: this study aims to analyze the prevalence of temporomandibular joint disorders (tmd) in wind musicians, differentiating the impact by instrument type (woodwind vs. brass) and identifying potential risk factors (embouchure, posture, practice time). a cross-sectional observational design will be used, including professional and student musicians from orchestras and conservatories.

this observational cross-sectional study aims to assess the prevalence of temporomandibular joint disorders (tmd) in wind musicians and analyze the impact of instrument type (woodwind vs. brass) on tmd prevalence. additionally, the study will explore potential risk factors such as embouchure, posture, and practice time. the study will recruit professional and student wind musicians from orchestras and conservatories. participants will complete a validated questionnaire (dc/tmd) and undergo a clinical assessment to evaluate mandibular mobility, the presence of joint sounds (clicking, crepitus), and symptoms related to tmd. the data collection will take place in a single session per participant, estimated between march 1, 2025, and april 15, 2025. the collected data will be analyzed to compare tmd prevalence between different instrument groups and assess correlations with practice habits and postural factors. all data will be anonymized and stored securely according to applicable data protection regulations (lopd 3/2018, gdpr 2016/679). participation in the study is voluntary, and written informed consent will be obtained from all participants, or from their legal guardians in the case of minors.

Eligibility criteria:
inclusion criteria: * wind musicians (professional or student). * any age (if under 18, parental/legal guardian consent is required). * signed informed consent. exclusion criteria: * history of maxillofacial surgery. * presence of neurological disorders affecting mandibular function. * recent treatment for tmd. * severe bruxism diagnosis.

Keywords: temporomandibular disorders tmd orofacial pain embouchure disorders bruxism mandibular mobility jaw diseases
(lars) score validation of turkish language

Conditions: LARS - Low Anterior Resection Syndrome

Summary: long-term bowel dysfunction after resection for rectal cancer, known as low anterior resection syndrome (lars), is observed in many patients. the lars score was developed to measure this syndrome and its impact on quality of life in danish patients. recently, english and many other language versions have been validated. the aim of this study was to validate the turkish translation of the lars score in turkish patients who have undergone treatment for rectal cancer.

a total of 326 patients were reviewed and contacted for the study, and 222 (68%) were eligible for the analyses. the association between the lars score and quality of life and the test-retest reliability were studied. the intraclass correlation coefficient (icc) was calculated to understand the degree of reliability.

Eligibility criteria:
inclusion criteria:the inclusion criteria were * rectal adenocarcinoma within 15 cm from the anal verge * lar with either pme or tme. * bowel continuity restored for at least 18 months when invited for the study. exclusion criteria:exclusion criteria included * failed r0 surgery, * recurrence or dissemination, * having intestinal stoma, * previous cancer (except minor skin cancers) * dementia and inability to speak turkish (i.e., the need for a translator during treatment).

Keywords: turkish lars
continence pessary versus disposable intravaginal device trial

Conditions: Female Stress Incontinence

Summary: this is a multi-centered randomized controlled trial of women with stress urinary incontinence or stress predominant mixed urinary incontinence who desire non-surgical therapy.

in this randomized trial, eligible patients who provide written consent for participation will be enrolled. at enrollment we will collect baseline demographic data and ask participants to complete questionnaires and a 3-day bladder diary. subjects will be randomized in a 1:1 ratio to continence pessary or disposable intravaginal device.

Eligibility criteria:
inclusion criteria: * age 21 years or older (based on disposable intravaginal device manufacturing recommendations). * sui or sui-predominant mixed incontinence * english-speaking exclusion criteria: * pregnancy * current symptomatic urinary tract infection (uti). * postmenopausal bleeding of unknown etiology * neurogenic bladder * urinary retention (pvr \>150ml obtained via bladder scan or catheterization) * pelvic organ prolapse past the hymen as assessed by pop-q examination * inability to complete questionnaires in english or comply with study protocol * contraindication to pessary or disposable intravaginal device use or prior treatment or experience with either intervention. * prior surgery for stress urinary incontinence
livq-box® parameters in the diagnosis of liver inflammation

Conditions: Liver Inflammation; Fatty Liver Disease

Summary: to evaluate the correlation between livq-box® parameters carried by ilivtouch and liver inflammation in patients with nafld, as well as the diagnostic value of liver inflammation of different severity levels.

this study is a multi-center study that retrospectively analyzed and prospectively included 240 nafld patients in total who met the inclusion criteria. the laboratory, ilivtouch, and liver biopsy results were collected to evaluate the correlation between livq-box® parameters carried by ilivtouch and liver inflammation in patients with nafld, as well as the diagnostic value of liver inflammation of different severity levels. in the end, cut-off values for different stages of inflammation were obtained.

Eligibility criteria:
inclusion criteria: * patients diagnosed with nafld according to the diagnosis and management of nonalcoholic fatty liver disease: practice guidance from the american association for the study of liver diseases; * age over 18 years old, gender not limited; * not combined with liver diseases (such as viral hepatitis, drug-induced liver injury, autoimmune liver disease); * perform ilivtouch examination within ± 14 days of liver pathology examination; * no history of excessive alcohol consumption (converted to ethanol:\<140g/week for males,\<70g/week for females);
a study of continuous infusions of hno (nitroxyl) donor in patients with heart failure and impaired systolic function

Conditions: Heart Failure; Cardiac Failure; Reduced Ventricular Ejection Fraction

Summary: the purpose of this study is to evaluate the effects of bms-986231 on systolic and diastolic parameters in patients with heart failure and low ejection fraction.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * heart failure with reduced ejection fraction (lvef on echocardiogram of 40% or less) * stable guideline directed therapy for heart failure including oral diuretics, acei, arbs, arni, mras, and β blockers as tolerated, with no dose changes of these medications in the past 2 weeks * have screening values of nt pro-bnp ≥ 125 pg/ml (15 pmol/l) or bnp ≥ 35 pg/ml (10 pmol/l) exclusion criteria: * systolic blood pressure (sbp) \< 110 mm hg at screening or pre-randomization * heart rate \ 90 bpm at screening or pre-randomization * permanent atrial fibrillation, atrial flutter or having atrial fibrillation, atrial flutter * estimated glomerular filtration rate (egfr) \< 15 ml/min/1.73 m2 * ventricular assist device or prior heart transplant * prior solid organ transplant * body weight \< 45 kg or ≥ 140 kg * low quality echocardiographic visualization windows and image acquisition * permanent paced rhythm (vvi, ddd or biv pacing) other protocol defined inclusion/exclusion criteria could apply