Kornimate/medical-research-clean huggingface dataset:
tetram 2. treatment with erythropoetin in patients with spinal trauma with neurological deficit, maximum tolerated dose study

Conditions: Spinal Trauma With Neurological Deficit

Summary: the social, psychological, economic burden of spinal trauma with deficit is great, and there is no curative treatment. erythropoetin (epo) is promising, due to its neuroprotective effects demonstrated in vitro, in vivo in animal models and in a preliminary study including patients with stroke. the study primary end point is to find out the maximum tolerated dose of epo. this is based on the occurrence of pulmonary embolism during a 14 day delay following epo injection. secondary end points include comparisons of epo kinetics in blood and cerebrospinal fluid (csf), study of epo effects on several inflammatory and apoptotic bio markers and blood cell counts. the experimental design is a dose scale study (600 to 2400 ui/kg), using a single dose of rhuepo, (eprex®). the epo dose is defined using a bayesian continuous reassessment method (crm). the sample size is expected for less than 20 patients. eligible patients are patients aged 15 to 65 years, able to receive the epo injection within 12 hours of a spinal trauma, without vital blood loss or associated diseases. the follow-up lasts 6 months.


Eligibility criteria:
inclusion criteria: * patient, male or female, aged 15 to 65 years, covered by a social insurance system, having given an informed consent (or attested by a third person if unable to sign, or parents consent in minors), within 12 hours of a spinal trauma, without vital organ deficiency from a non spinal origin exclusion criteria: * impaired consciousness, * treatment not given within 12 hours, * cervical arthritis, * respiratory failure requiring artificial ventilation, * patient requiring blood transfusion superior to 2 units, * uncontrolled severe hypertension, * unstable hemodynamics, * patient suffering from epilepsy, * recent or uncontrolled angina pectoris, * having received high doses of glucorticoïds, * pregnant or breasting, * with more than 15 g/ml of haemoglobin, * with previous thrombo embolism disease, * with allergy to low molecular weight heparin, or * participating in another interventional study

Keywords: spinal trauma erythropoietin dose escalation study
emergency medical technician treat-and-leave patients receiving telemedicine consultation with emergency medical dispatch physician - a controlled before and after pilot-study

Conditions: Acutely Ill; Acutely Injured

Summary: a large part of acutely ill patient's access to the health care system starts by calling the emergency number 1-1-2 and thereby getting in touch with the emergency medical dispatch center (emdc). in most cases an ambulance is dispatched and the patient is brought to the hospital. these patients are not referred by a physician (eg. a gp) and represent an unselected subpopulation of the acutely ill patients. at present, all non-critically ill patients not evaluated by a pre-hospital physician are normally be transported to hospital as category 2 (without activated emergency lightning and sirens).a part of this patient population, however, is not critically ill and a proportion of these may not need hospital admittance . emergency medical technicians (em) are not allowed to treat - and- leave patients without a physician's involvement. if the emt had 24/7 online access to medical control i.e. in form of a physician present in the emdc , the number of patients transported to hospital for assessment may be reduced as well as response times for patients actually needing ambulance transportation. this could potentially reduce the workload on the whole healthcare system involved in the management of these patients - thereby potentially reducing costs. the objective of this study is to evaluate if a systematic telemedical assessment by an emdc-physician of all patients who receive an ambulance but are not critically ill and would have a category 2 transport to hospital can reduce the number of the patients that are transported to hospital and save costs and time.


Eligibility criteria:
inclusion criteria: * patients receiving an emergency ambulance after calling the emdc patients who are going to be admitted to a hospital in the central denmark region. * patients who are going to be transported as category 2 patients (non-critical illness, not requiring transport with activated lightning and sirens. exclusion criteria: * critically ill patients (patients who are going to be transported as category 1 patients (critical-illness, requiring immediate transport with activated sirens and warning lights ) * patients who are not supposed to be admitted to a hospital in the central denmark region

Keywords: emergency medical dispatch telemedicine emergency medical services pre-hospital
knowledge on preventive measures of hypertension

Conditions: Hypertension

Summary: hypertension among children and adolescents is on the rise in both developed and developing countries. childhood and adolescent obesity, a key factor for hypertension in this population results largely from unhealthy dietary and physical inactivity behaviours. adequate knowledge, a component for behavior change, has been found to be crucial to improving one's confidence to tackle these improper behaviours. despite this, there are gaps in knowledge on hypertension and its risks factors in ghanaian adolescents. using an educational intervention (health talk), the study therefore sought to improve knowledge on preventive measures of hypertension among senior high school students in ghana.

a pre-post interventional study using health talks was carried out among 345 adolescents aged 13 to 20 years. participants included both male and female students aged 13 to 20 years. owing to the large number, the students were divided into two groups. the pre-test was then administered. following this, two health education sessions were delivered by two registered nurses for each session. a week after these health talks, the research team went back to the school to collect data for the post-intervention. questionnaires used for both pre and post assessment collected data on demographic factors and knowledge on dietary and physical activity behaviours linked to hypertension.

Eligibility criteria:
inclusion criteria: * participants who gave consent * minors with parental or guardian assent exclusion criteria: * participants already living with hypertension
targeted genomic analysis of blood and tissue samples from patients with cancer

Conditions: Malignant Neoplasm

Summary: this research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. it may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.

primary objectives: i. to obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies. ii. to collect clinical outcomes of patients with actionable mutations for which sequencing has been performed. iii. to obtain tumor genome data for data storage and future computational analysis and correlation with clinical data. iv. to obtain tumor tissue for development of future in vitro and in vivo cancer models. outline: previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. patients may also undergo collection of blood samples for analysis of circulating cell-free deoxyribonucleic acid (dna) and circulating tumor cells. after completion of study, patients are followed up every 3 months for 2 years and then every 6 months for 15 years.

Eligibility criteria:
inclusion criteria: * karnofsky/lansky performance score \>= 30 * a signed written informed consent * evaluation in surgical/medical/radiation oncology/radiology clinic, with a history of biopsy-confirmed diagnosis of cancer of rare histology and/or poor prognosis with standard therapy; priority will be given to rare cancers with poor prognosis and lack of effective standard therapy; study principal investigator (pi) or designee will review and approve each case before enrollment * paraffin blocks of the patient's tumor tissue are available and accessible for analysis exclusion criteria: * karnofsky/lansky performance score \< 30 * life expectancy \< 3 months
study of ace-536 in healthy postmenopausal women

Conditions: Anemia

Summary: the purpose of this study is to find out whether ace-536 can be safely given to patients. this study will also look to see if ace-536 increases red blood cells, the cells that carry oxygen in the body.


Eligibility criteria:
key inclusion criteria: * postmenopausal women * body mass index (bmi) of 20 - 32 kg/m2. key exclusion criteria: * history of hypertension * subject has received any erythropoiesis stimulating agents (e.g., epogen, procrit, aranesp, etc.) within 6 months prior to day 1 * history of clinically significant cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other disease * surgery within 3 months (other than minor cosmetic surgery or minor dental procedures) * subject has received treatment with another investigational drug, or approved therapy for investigational use within 1 month prior to day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to day 1, whichever is longer
microfracture with/without collagen augmentation in patients undergoing high tibial osteotomy

Conditions: Collagen Augmentation

Summary: the quality of cartilage regeneration after marrow stimulation is well documented to be unpredictable, because they do not regenerate consistent amount of cartilage. to overcome the shortcomings of the microfracture technique, various augmentation techniques using synthetic collagen matrix, scaffolds or plug devices have been developed. however, their efficacy remains unclear. the purpose of this prospective randomized controlled study is to evaluate whether the microfracture in combination with collagen gel augmentation could improve the quality of cartilage regeneration in patients undergoing medial open wedge high tibial osteotomy (hto) for the treatment of medial unicompartmental knee osteoarthritis (oa).

cartifill™ (atelocollagen, sewon cellontech, seoul, korea) was developed to to provide a matrix stability and to maintain the blood clot in the defect site, which promoted the cartilage regeneration by mesenchymal stem cell . it was a atelocollagen, highly purified porcine derived type collagen і that has been modified to virtually eliminate the risk of rejection by removal of telopeptide. the investigators randomized patients undergoing hto in combination with microfracture to receive either microfracture alone (control group, n = 5) or microfracture with collagen augmentation (experimental group, n=6). at postoperative one year, the clinical outcome in terms of visual analogue scale of pain level (vas), knee injury and osteoarthritis outcome score (koos), international knee documentation committee (ikdc) score, and tegner scores were evaluated. in addition, second look arthroscopic examination and biopsy of regenerated cartilage were carried out when the hto plate was removed at postoperative one year. biopsy specimens were graded by international cartilage repair society visual assessment scale (icrs ii scores). finally, radiologic outcome in terms of magnetic resonance observation of cartilage repair tissue (mocart) scores was assessed using follow up mri undertaken at postoperative one year.

Eligibility criteria:
inclusion criteria: * aged below 65 years with isolated medial compartment osteoarthritis * good range of motion * no ligament instability * having medicare insurance exclusion criteria: * diagnosis of severe tricompartment osteoarthritis indicated for total knee arthroplasty * inflammatory arthritis(rheumatoid arthritis), osteonecrosis * flexion contracture ≥ 15° * knee range of motion \< 120° * joint instability * a history of knee joint infection and who refused to participate
breast cancer risk after diagnostic gene sequencing

Conditions: Genetic Predisposition to Disease

Summary: study of the psychological impact of breast cancer risk communication in cancer genetics based on the personalized estimation of the boadicea v5/plus model ("breast and ovarian analysis of disease incidence and carrier estimation algorithm-version 5 or plus").

the new bc gene testing and risk estimation using boadicea v5/plus model imply an increased complexity of communication during the cancer genetic consultation. it will be proposed to women referred to genetic counselling in the participating cancer genetic clinics . new qualitative (moderate risks, secondary results) and quantitative results (variation in the degree of cancer risk identified for the counselee and family members) and thus a personalized breast cancer risk may be obtained. how this complexity affects counselees' psychological reactions is not known. it is primarily aimed at comparing psychosocial needs and distress in healthy women (unaffected with bc) at high risk of breast or ovarian cancer undergoing genetic testing based on an enriched gene panel (index case gene panel plus prs) at curie institute in france and at the university hospital in cologne, germany.

Eligibility criteria:
inclusion criteria: 1. healthy woman, relative of a family member first tested (index case) who received a positive genetic test result (presence of a brca1 or brca2 deleterious variant or a moderate-penetrance bc gene deleterious variant) ; a. at cologne university hospital (germany), these healthy women may also be relatives of women (index case) who received a negative non-informative test result; 2. who accept bridges gene panel testing and the breast cancer risk prs; 3. aged 18 years or over with no upper limit; 4. able to give informed written consent in accordance with national/local regulations and procedures; 5. able to understand the questionnaire language of the participating genetic clinic. exclusion criteria: 1. woman affected with bc, with recurrent bc, with metastatic bc, with an ovarian cancer (oc) or cancer of any other site; 2. aged under 18 years old; 3. unable to give informed written consent; 4. unable to understand the questionnaire language of the participating clinic; 5. unable to answer the questionnaire due to physical or cognitive disturbance

Keywords: related women to index case risk estimation breast cancer ovarian cancer
wasting in chronic kidney disease

Conditions: Chronic Kidney Hospitalized

Summary: protein energy wasting is an independent factor associated with morbi-mortality in chronic kidney disease. wasting is particularly common in chronic diseases of organs such as kidney disease with a major impact at the stage of dialysis. it covers 20 to 70% of patients diagnosed with chronic kidney disease according to the degree of evolution of the disease and the diagnostic method. mechanisms of pew are based mainly on anorexia and metabolic abnormalities caused by kidney disease. nutritional treatment differs depending on the stage of the kidney disease acute or chronic treated whether or not by dialysis. nutritional monitoring should be regular, individualized and collaborative to detect a risk of pew or treat installed pew. refeeding techniques should allow all the nutritional needs. their indications depend on the clinic, biochemical assessment and nutrient intake.


Eligibility criteria:
inclusion criteria: * patients with kidney disease * patients hospitalized in a university hospital renal ward exclusion criteria: - hospitalization less than two weeks

Keywords: chronic kidney disease enteral nutrition oral nutritional supplements parenteral nutrition refeeding wasting
baclofen in managing acute alcohol withdrawal

Conditions: Alcohol Use Disorder; Alcohol Withdrawal

Summary: the study goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. the investigators will compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized controlled trial including patients receiving symptom triggered diazepam.

the conducted study will be randomized and single-blind (patients). after signing informed consent, the participants will be randomized in one of three groups: - placebo - baclofen 30 mg/day - baclofen 60 mg/day. the participants will be given a first administration after which the participant can receive clinical institute withdrawal assessment (ciwa-ar) score triggered diazepam, frequently assessed for at least 7 days. the primary outcome measure is the number of participants who received additional diazepam during these 7 days. the secondary outcome measure is the amount of diazepam received per group.

Eligibility criteria:
inclusion criteria: * be an inpatient at the psychiatry unit at uzbrussel at time of study enrollment. * be able to sign informed consent. * be male/female aged 18-60 * primary diagnosis of alcohol use disorder. exclusion criteria: * pregnancy and breastfeeding. * benzodiazepine use of more than the equivalent of diazepam 25 mg /day. * psychosis, confusion and acute mania. * parkinson's disease. * use of tricyclic antidepressants. * use of opioids. * known baclofen or benzodiazepine sensitivity or allergy. * unable to take oral medication. * epidermal growth factor receptor (egfr) \< 60 (blood samples are routinely performed at intake). * prior diagnosis of epilepsy. * lactose intolerance.
mechanisms underlying the sleep promoting effect of cherry juice standardized to its proanthocyanidin content

Conditions: Insomnia; Sleep Problem

Summary: this study is designed to demonstrate that cherry juice is effective in treating insomnia, and to show that it works by inhibiting an enzyme that will be measured in the blood.

this study will consist of 4 visits - 1 screening visit and 3 treatment visits. screening visit will consist of a fasting chemistry panel, a health questionnaire, an insomnia severity index, the epworth sleepiness scale, the pittsburgh sleep quality index, the beck depression inventory, the state-trait anxiety inventory, and the fatigue severity scale. ten subjects passing screening will take for 2 weeks between dinner and bedtime in a blinded and balanced order: 1. eight ounces of cherry juice standardized to its proanthocyanidin content in the morning and 8 ounces of cherry juice standardized to its procyanidin content 1-2 hours before bedtime for 14 days; 2. a similar amount of placebo juice with the same timing for the cross-over. there will be a 2-week washout between each of the treatment periods. subjects will be scheduled for two overnight psgs, one at the end of each two-week treatment period. on the morning following each test the insomnia severity index and other questionnaires will be repeated. the order of the placebo juice and cherry juice will be random and balanced.

Eligibility criteria:
inclusion criteria: * healthy male or female with a usual bedtime between 9 pm and midnight. * 65 years of age or older. * sleep problem \>3 nights per week, meeting the international classification of sleep disorders (icsd-2\*) diagnostic criteria of insomnia for at least 6 months. * an insomnia severity index ≥ 10 and a minimum of 30 minutes of either sleep-onset latency (sl) or wake after sleep onset (waso). \*icsd-2 general criteria for insomnia: * a complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early, or sleep that is chronically non-restorative or poor in quality. * the above sleep difficulty occurs despite adequate opportunity and circumstances for sleep. * at least one of the following forms of daytime impairment related to the nighttime sleep difficulty is reported by the patient: * fatigue or malaise. * attention, concentration, or memory impairment. * social or vocational dysfunction or poor school performance. * mood disturbance or irritability. * daytime sleepiness. * motivation, energy, or initiative reduction. * proneness for errors or accidents at work or while driving. * tension, headaches, or gastrointestinal symptoms in response to sleep loss. * concerns or worries about sleep. exclusion criteria: * diabetes. * sedating or hypnotic medications. * any chronic medication that has not had a stable dose for 1 month or longer.

Keywords: cherry juice pilot
aortic valve replacement above the aortic annulus (sa-avr) with the carpentier-edwards magna-ease bioprosthesis

Conditions: Aortic Valve Disease; Prosthesis; Cardiac, Heart, Functional Disturbance as Result

Summary: surgical valve replacement is commonly performed in patients with severe aortic valve disease. in small aortic annulus, implantation of bioprosthetic valves can be associated with limited functional capacity. to avoid this condition, we changed our surgical technique to implant a larger bioprosthesis. briefly, the prosthesis is sutured to the aortic annulus along the left and right coronary sinuses, and in a supraannular position along the noncoronary sinus, therefore allowing us to insert a prosthetic valve with a one-size larger diameter than the native aortic annulus.

surgical aortic valve replacement (avr) is recommended for severe aortic valve disease. bioprosthesis remains the substitute of choice for elderly patients. however, it may be associated with patient-prosthesis mismatch particularly for patients with small aortic annulus. moreover, "valve-in-valve" transcatheter aortic valve replacement (tavr) has become a suitable therapeutic option for bioprosthesis structural degeneration, especially in patients with high surgical risk. it is therefore of great importance to implant the widest bioprosthesis as possible at the first avr. the investigators report a surgical technique allowing the implantation of a larger bioprosthesis in patients with small aortic annulus: the supra-annular aortic valve replacement (sa-avr) above the aortic annulus. the investigators analyzed the postoperative outcomes of the sa-avr technique using the perimount magna ease (carpentier-edwards, irvine, california) bioprosthesis.

Eligibility criteria:
inclusion criteria: * patients older than 18 years who underwent a suprannular implantation of the carpentier edwards magna ease bioprosthetic valve between january 2010 and december 2017 in our institution, whatever the aetiology of the aortic valve disease. exclusion criteria: * patients younger than 18 years, patients who received a different bioprosthesis valve in the aortic position, patients who were lost of follow-up.

Keywords: bioprosthesis surgery supra-annular