Kornimate/medical-research-clean huggingface dataset:
pathway of dyspneic patient in emergency in france

Conditions: Acute Dyspnea

Summary: this observational retrospective multi-center study focuses on patients treated for acute dyspnea by emergency medical teams. the primary objective is to identify factors associated with the risk of mortality and rehospitalization in these patients. this evaluation will be conducted both overall and within specific subgroups of interest, including gender (men/women), age categories, mode of admission, and comorbidities.


Eligibility criteria:
inclusion criteria: * man or women aged 18 years and older. * patients with acute dyspnea managed by a medical emergency team at the investigator centers between 2010 and 2021. exclusion criteria: - cardiorespiratory arrest before emergency department management.
micrornas as biomarkers of pain intensity in patients with chronic fatigue syndrome (cfs)

Conditions: Chronic Fatigue Syndrome (CFS)

Summary: micrornas were shown to play an important role in regulating pain-processing in a wide range of experimental models and clinical pain disorders. thus, the aim of the present study is to evaluate a set of micro-rnas as diagnostic biomarkers of pain intensity in adolescents with chronic fatigue syndrome (cfs) and to correlate with inflammatory markers and pain related comorbidities.

the present study was performed to evaluate a set of micro-rnas as diagnostic biomarkers of pain intensity in adolescents with chronic fatigue syndrome (cfs) and to correlate with inflammatory markers and pain related comorbidities. thus, a total of 150 adolescents aged (12-18 years) were invited to participate in this study. they are classified into two groups; adolescents with cfs (n=100) and healthy control (n=50). rt-pcr and immunoassay analysis were used to estimate mirnas (mir-558, mir-146a, mir-150, mir-124, and mir-143) and immune-inflammatory markers (il-6, tnf-α, cox-2) respectively.

Eligibility criteria:
inclusion criteria: * participants with cfs who had constant or persisting fatigue lasting 3 months with the severe functional disability to such extent that prevents normal school attendance and also had no drug prescriptions (including hormone contraceptives), any medical or psychiatric disorder that might explain the fatigue were included in this study. exclusion criteria: * participants who had drug prescriptions (including hormone contraceptives), any medical or psychiatric disorder that might explain the fatigue were excluded from this study.

Keywords: micrornas chronic fatigue syndrome pain intensity
effect of azithromycin in women at risk of preterm labour

Conditions: Preterm Labor

Summary: the aim of this study is to evaluate the benefit of the addition of azithromycin to standard treatments to prolong pregnancy in women having intact membranes and is at risk of or in preterm labour.

study design: comparative controlled study. study site : the study will be conducted at the department of obstetrics and gynecology at beni-suef university hospital. study period: the study will be conducted from 15th september 2022 till reaching the target number. study population the control group will include pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy. the test group will involve pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus prophylactic azithromycin.:500 mg po once for 5 days every month. sample size: the sample size was determined using g\*power version 3.1.9.2 \[computer software\] (franz faul, kiel, germany),power analysis for a chi-square test was conducted in g-power to determine a sufficient sample size using an alpha error of probability of 0.05, power of 0.95, a medium effect size (w = 0.3) and 1 degree of freedom. based on the aforementioned assumptions, the desired sample size is 145. by calculating 25% drop out, so the least total sample size in both groups will be 200 patients (95 patients in each group). each patient will be subjected to: thorough history taking and examination. investigations: complete blood picture (cbc), bleeding profile , kidney function tests and liver function tests will be done. ultrasound: 2d ultrasound assessing : it will be carried out in gynecology and obstetrics department in beni-suef university hospital, ultrasonography criteria: ultrasound biometry of the fetus is now the gold standard for assessing fetal growth. the measurements most commonly used are the biparietal diameter, head circumference, abdominal circumference and femur length

Eligibility criteria:
inclusion criteria: * 24 \< pregnancy \<37 weeks of gestation. * threat or history of preterm labour. * preterm labour itself (non established) exclusion criteria: * antibiotics use within 14 days (except for pericerclage prophylaxis, or streptococcus b prophylaxis); * pprom; and fetal extraction required \<37 weeks. * current or past history of medical diseases (diabetes milletus, hypertension, systemic lupus erythematosus, cardiac diseases, etc ). * adverse perinatal outcome due to abdominal trauma. * structural fetal anomalies detected during anomaly scan. * allergy to azithromycin.

Keywords: preterm delivery azithromycin
study of patient preferences in relation to the fitting of a personalized and connected joint prosthesis.

Conditions: Prosthesis User; Orthopedic Disorder

Summary: the goal of this observational study is to learn about patients' preference toward the use of customized and connected prosthesis. the main questions it aims to answer are: * what is the acceptability of new customization and connectivity technologies by patients? * are they all at the same level of acceptability? participants will have to answer to a questionnaire of choice.


Eligibility criteria:
inclusion criteria: * more than 18 * non opposition expressed * should have a hip, knee or shoulder joint replacement exclusion criteria: * opposition expressed * having already a hip, knee or shoulder joint prosthesis
folfox6m plus sir-spheres microspheres vs folfox6m alone in patients with liver mets from primary colorectal cancer

Conditions: Colorectal Cancer Metastatic

Summary: this study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (sirt) using sir-spheres microspheres plus a standard chemotherapy regimen of folfox6m versus folfox6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma. treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the investigator.


Eligibility criteria:
inclusion criteria: * age 18 years or older * willing and able to provide written informed consent * unequivocal and measurable ct evidence of liver metastases which are not treatable by surgical resection or local ablation * limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (lung: 5 lesions total, \< 1 cm, or 1 single lesion of up to 1.7 cm; lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, \< 2 cm) * all imaging evidence used as part of the screening process must be within 28 days * suitable for either treatment regimen * who performance status 0-1 * adequate hematological, renal and hepatic function * life expectancy of at least 3 months without any active treatment exclusion criteria: * evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement or thrombosis as determined by clinical or radiologic assessment * previous radiotherapy delivered to the liver * non-malignant disease that would render the patient unsuitable for treatment according to the protocol * peripheral neuropathy \> grade 2 (nci-ctc) * dose-limiting toxicity associated with previous adjuvant 5-fu or oxaliplatin chemotherapy * prior non-adjuvant chemotherapy for any malignancy. adjuvant chemotherapy for colorectal cancer is permitted provided that it was completed more than 6 months before entry into the study * pregnant or breast feeding * concurrent or prior history of cancer other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix * allergy to contrast media that would preclude angiography of the hepatic arteries

Keywords: colon rectum metastatic colorectal cancer liver metastases
fetal alcohol syndrome/arnd research consortion

Conditions: Fetal Alcohol Syndrome

Summary: children will receive comprehensive evaluations through the uohsc abc program the assessment for the child will include: medical issues (including medication), dysmorphic examination, intellectual assessment, academic achievement, language, and motor skills. this program will provide appropriate non-study services and referrals. eligible families will be randomly assigned to treatment group or control group. treatment group will receive parent child interaction therapy (pcit). the control group will receive standard referrals and services through the abc program and the parent education/advocacy component of the project.

pcit has been adapted by the applicant for group administration. the intervention will consist of 90-minute sessions of pcit once a week for 14 weeks. during pcit sessions parents and children will participate in activities that promote interactions. a behavior specialist who will be observing through a two-way mirror assists parents in development of appropriate behaviors and interaction techniques. parents will be prompted by use of in-ear devices (i.e., bug in the ear). this intervention has been shown to be effective in other populations. for each family, individualized goals for parent-child interactions will be set and reviewed each session. homework assignments also will be given. parent component: three 90-minute sessions conducted in a group format. topics will include: fas/arnd education, impact of fas/arnd on families, specific development of a child with fas/arnd, and fas/arnd social skills and deficits. evaluation plan: treatment and control groups will be compared using pre- and post-tests measures. post-tests will be at the conclusion of the intervention and at a 6, 12, and 18-month follow-ups. process (e.g., parent satisfaction, compliance, etc) and outcome (e.g., behavior, family functioning, etc) measures will be evaluated.

Eligibility criteria:
inclusion criteria: * children ages 3 to 7 years

Keywords: treatment control
a prospective clinical study aimed to assess the technical feasibility of rr2 wearable home care neuromodulation system

Conditions: Atrial Fibrillation Recurrence

Summary: rr2 is a medical, home-care, digital therapeutic, wearable device. its main purpose is to deliver prescheduled, non-invasive, peripheral neuromodulation therapy, in conjunction with standard medical care, to relieve af symptoms, recurrence and overall burden.


Eligibility criteria:
inclusion criteria: 1. men and women aged ≥18 with ecg documented and symptomatic recent onset atrial fibrillation (af), lasting less than 48 hours 2. symptoms related to af with high probability 3. recent conversion or cardioversion to normal sinus rhythm (nsr) as evident by a documented electrocardiograms (ecg) 4. participants are able and willing to provide a signed informed consent 5. participants are able and willing to use rr2 homecare device and wear an ecg patch or a holter monitor for 24 hours. exclusion criteria: 1. hemodynamic instability (systolic blood pressure \ 170 bmp) 2. an active myocardial infarction evident from ecg signs 3. presence of pre-excitation syndrome 4. history of sick sinus syndrome 5. history of persistent af with documented episodes of \>7 days 6. heart failure, acute or chronic 7. participants currently enrolled in another study 8. recurrent vaso-vagal syncopal episodes 9. pregnancy or breast feeding 10. pacemaker or cardiac resynchronization therapy defibrillator (crt-d) or any implantable electrical stimulating device 11. history of epilepsy or seizures 12. peripheral neuropathy affecting the tested upper extremity 13. participants unsuitable for participating in the study according to attending physician 14. know allergy to .. (all materials that are in contact with patient's skin)
cryotherapy and body slimming

Conditions: Obesity; Cryotherapy Effect; Weight Loss

Summary: the purpose of this study is to evaluate the efficacy of cryotherapy on the slimming of subcutaneous fat mass in the abdomen and saddlebags. cryotherapy is a completely non-invasive method that induces a selective reduction of fat cells by localized and controlled cooling in areas such as the abdomen, flanks, inner knees, inner thighs, back and arms. adipose tissue is composed of two types of tissue: white and brown adipose tissue. studies have shown that exposure to cold induces an increase in the number of brown adipocytes (detected by pet/ct-scan) under the effect of the hormone irisin produced by the muscles. in addition, another study has shown that prolonged exposure to cold reduces the size of brown adipocytes leading to thermogenesis, suggesting that cold exposure may contribute to the control of obesity. the freezing technology of this cryotherapy unit allows the temperature of the subcutaneous adipose tissue to move almost instantaneously from -6°c to -10°c, gradually causing the reduction of subcutaneous adipose tissue.

prospective, monocentric pilot and comparative (before and after) study in simple blind (assessor different from the operator). * the effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the level of the saddlebags. * measurement of subcutaneous fat mass with idxa scanner on treated areas * metabolic parameters from a blood test: liver function (ast, alt, gamma gt), inflammatory markers, plasmatic fatty acids, glycerol, total cholesterol, triglycerides, lipids, blood sugar, insulin, lactate.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old and non-menopausal with a bmi between 20 and 30 (20≥imc≤30), with an overload of abdominal subcutaneous fat tissue and at the saddlebags exclusion criteria: * - \< 18 years old. * pregnancy * breastfeeding * cold allergy: 2-minute ice cube test positive * a waist/hip ratio indicative of a pathological fat distribution (\>0.8 for women, \>0.9 for men) * endocrine pathologies (cushing's disease, endocrine tumours, unbalanced frank or labile hypothyroidism, hirsutism and hyper-androgenism, insulin resistance and/or unbalanced type 2 diabetes...) * neoplasia * psychiatric pathologies with or without treatment (antidepressants, neuroleptics, anxiolytics...), well characterized anorexia-bulimia syndromes. * established alcoholism. daily alcohol consumption should not exceed 2 glasses of wine per day. * digestive pathologies (especially hepatic) and functional digestive disorders (chronic constipation, alternating constipation-diarrhoea, chronic abdominal pain). * weaknesses of the abdominal wall (umbilical, inguinal, crural hernias) * hiv in therapy * genetic deformities and diseases * vegetarian/vegetarian diet, macrobiotic diet * spasmophilia * surgery less than 3 months old * unbalanced coronary artery disease, untreated angina

Keywords: obesity cryotherapy weight loss saddlebags
long-term safety trial with nvdx3

Conditions: Distal Radius Fractures; Degenerative Lumbar Spondylolisthesis

Summary: an study evaluating the long-term safety of all patients previously treated with nvdx3.

an study evaluating the long-term safety of all patients previously treated with nvdx3 (referred to as the "core nvdx3 trial"). all patients having signed the icf enter the long term follow-up study.

Eligibility criteria:
inclusion criteria: 1. patient being implanted with nvdx3. 2. previously participated to one of the nvdx3 core clinical trials. 3. patient accepts to comply to a yearly follow-up safety visit for 10 additional years 4. patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent. exclusion criteria: no exclusion criteria are applicable.
a study to evaluate the efficacy and safety of dupilumab in adult patients with bullous pemphigoid

Conditions: Bullous Pemphigoid

Summary: the main purpose of this study is to investigate whether dupilumab is effective and safe for the treatment of bullous pemphigoid. dupilumab is a type of drug called a "monoclonal antibody". an antibody is a special kind of protein that the immune (defense) system normally makes to fight bacteria and viruses. bullous pemphigoid is an autoimmune subepidermal blistering disease, predominately affecting the elderly (typical onset after age 60). the study is looking at several other research questions, including: * side effects that may be experienced by people taking dupilumab * how dupilumab works in the body and affects the body * how dupilumab affects quality of life * how much dupilumab is present in the blood * to see if dupilumab works to wean the patient off oral corticosteroids


Eligibility criteria:
key inclusion criteria: * patients must have characteristic clinical features of bullous pemphigoid (bp) (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening and baseline visits. * study participants are required to have a confirmed diagnosis of bp based on histopathology, immunopathology, and serology at the baseline visit, as defined in the protocol. * bullous pemphigoid disease area index (bpdai) activity score ≥24 at baseline and screening visits. * baseline peak pruritus nrs score for maximum itch intensity ≥4 * karnofsky performance status score ≥50% at the screening visit. key exclusion criteria: * forms of pemphigoid other than classic bp (eg, brunsting-perry cicatricial pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita, or bp with concomitant pemphigus vulgaris) * patients who are receiving treatments known to cause or exacerbate bp (eg, angiotensin converting enzyme inhibitors, penicillamine, furosemide, phenacetin, dipeptidyl peptidase 4 inhibitor) who have not been on a stable dose of these medications for at least 4 weeks prior to the screening visit * have ever received treatment with an il-4 or il-13 antagonist such as dupilumab, tralokinumab, or lebrikizumab. * treatment with systemic corticosteroids within 7 days before the baseline visit * treatment with topical corticosteroids of medium potency or higher, topical calcineurin inhibitor, or topical crisaborole within 7 days before the baseline visit * treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit. * treatment with bp-directed biologics as follows: * any cell-depleting agents including but not limited to rituximab: within 12 months before the baseline visit, or until lymphocyte and cd 19+ lymphocyte count returns to normal, whichever is longer * other biologics (such as il-5 inhibitors benralizumab or mepolizumab): within 5 half-lives (if known) or 16 weeks prior to the baseline visit, whichever is longer * intravenous immunoglobulin within 16 weeks prior to the baseline visit note: other protocol defined inclusion/exclusion criteria apply
phase 3 study to evaluate the efficacy and safety of intravenous biib093 (glibenclamide) for severe cerebral edema following large hemispheric infarction

Conditions: Brain Edema; Stroke, Acute

Summary: the primary objective of part 1 of the study is to determine if biib093 improves functional outcome at day 90 as measured by the modified rankin scale (mrs) when compared with placebo in participants with large hemispheric infarction (lhi). the secondary objectives of part 1 of the study are to determine if biib093 improves overall survival at day 90 when compared with placebo, if biib093 improves functional outcome at day 90 on the mrs dichotomized 0-4 vs. 5-6 when compared with placebo, if biib093 reduces midline shift at 72 hours (or at time of decompressive craniectomy \[dc\] or comfort measures only \[cmo\], if earlier) when compared with placebo, and to evaluate the safety and tolerability of biib093 in participants with lhi. the objectives of part 2 of the study are to evaluate long-term disability following lhi, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of biib093 in subjects with lhi during the follow-up period.


Eligibility criteria:
inclusion criteria: 1. a clinical diagnosis of acute ischemic stroke in the middle cerebral artery (mca) territory. 2. a large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters cubed (cm\^3) on magnetic resonance imaging (mri) diffusion-weighted imaging (dwi), or computed tomography perfusion (ctp), or an alberta stroke program early ct score (aspects) of 1 to 5 with involvement of at least 2 defined cortical regions. 3. screening national institutes of health stroke scale (nihss) \>=10. 4. at the time of randomization, and in the investigator's judgement, it must be feasible for study drug treatment infusion to be initiated no later than 10 hours after time of symptom onset, if known, or the time last known normal. * participants who wake with stroke may be included if neurological and other exclusion criteria are satisfied. the time of stroke onset is to be taken as the midpoint between sleep onset (or last known to be normal) and time of waking. 5. for participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy mri-dwi. exclusion criteria: 1. participant is likely to have supportive care withdrawn on the first day. 2. commitment to decompressive craniectomy (dc) prior to enrollment. 3. evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: infarction cerebrovascular disorders brain diseases pathological processes necrosis central nervous system diseases vascular diseases cardiovascular diseases glyburide hypoglycemic agents physiological effects of drugs