Kornimate/medical-research-clean huggingface dataset:
prevalence of blood pressure complications during cesarean section in pre-eclamptic patients (hope)

Conditions: Pre-eclampsia; Pre-Eclampsia, Severe

Summary: preeclampsia (pe) is an obstetric placental vascular pathology with a prevalence of 2 to 5% of pregnant women. it is defined by learned societies by the association of high blood pressure (bp≥140/90mmhg) and proteinuria \&gt; 0.3g/day. the last french maternal mortality report 2024 places cardiovascular complications among the main causes of maternal death. pe has an increasing number of deaths in 2016-2018 and significant preventability (66%). cesarean sections in pre-eclamptic patients are difficult procedures and, do not benefit from any specific recommendations. cesarean section is promptly performed under regional anesthesia by spinal anesthesia or spinal anesthesia with combined epidural, techniques that cause maternal arterial hypotension with consequences for the baby. these hypertensive patients, often on antihypertensives, challenge the anesthesiologist to manage the hemodynamic balance between the risk of arterial hypotension generated by the anesthesia corrected by vasoactive amines and the risk of major hypertension secondary to their management. the major risk in these patients with low platelet counts is hemorrhagic stroke. our study is an observational, bi-centric study between the maternity wards of the clermont ferrand and lille university hospitals. it consists of collecting data prospectively on all pre-eclamptic patients undergoing a non-urgent cesarean section. the objective is to observe the management of hemodynamics and calculate the prevalence of complications such as maternal hypotension and/or hypertension through the implementation of non-invasive monitoring (clearsight). patients meeting the inclusion and non-inclusion criteria may be included in the study by an investigator after having given a non-opposition agreement after having received clear and fair information about the study. in any case, the care of patients participating in the study will not be modified in any way compared to the usual practices of the services.


Eligibility criteria:
inclusion criteria: * pre-eclamptic patient according to the criteria defined by sfar 2020. * indication of organised or semi-urgent cesarean section (green or orange code). * adult patient, benefiting from a social security system. * oral non-opposition to participation in the study. exclusion criteria: * urgent cesarean (red code). * patient refusal. * patient does not understand french. * individual protection measures : guardianship, curatorship.

Keywords: cesarean section blood pressure complications pre-eclampsia hypertension hypotension
electronic registry of male patients with congenital adrenal hyperplasia 21-hydroxylase deficiency

Conditions: Congenital Adrenal Hyperplasia

Summary: observational, retrospective, prospective, single-center cohort study. participation in the registry will be offered consecutively to any patient with the disease, newly diagnosed or with documented diagnosis made at another center, at any stage of the disease. laboratory tests, imaging study for patient monitoring and care procedures all will be conducted in accordance with normal clinical practice.

observational, retrospective, prospective, single-center cohort study conducted at the uoc of endocrinology and diabetes prevention and treatment of irccs aou of bologna. participation in the registry will be offered consecutively to any patient with the disease, newly diagnosed or with documented diagnosis made at another center, at any stage of the disease. laboratory tests, imaging study for patient monitoring, and care procedures all will be conducted in accordance with normal clinical practice. for the retrospective phase, patients whose diagnosis of cah was made on or after 01/01/1960 will be enrolled, and observation related to this phase will be extended until this study is approved. the study population is partly from direct access at the u.o.c. of endocrinology and diabetes prevention and treatment, as the regional referral center for this rare disease (congenital adrenal hyperplasia). the potentially involved cohort is estimated to be about 30 patients at the time the registry was established. it is assumed that both retrospective and prospective phases can be completed in 15 subjects and retrospective alone in the remaining 15 subjects. the registry may become the reference for calculating incidence and prevalence in emilia romagna of the disease under study.

Eligibility criteria:
inclusion criteria: * male gender; * age 18 years or older; * newly or previously diagnosed patients with cah from 21-hydroxylase enzyme deficiency, in whom cyp21a2 gene analysis for determination of pathological mutations and genotype has already been performed; * obtaining informed consent. exclusion criteria: * patients with an unsure diagnosis of cah; * patients with cah caused by (or with the co-presence of) pathogenic molecular alterations other than mutations in the cyp21a2 gene.

Keywords: congenital adrenal hyperplasia
rbc transfusion in severe anemia with lactic acidosis

Conditions: Anemia

Summary: the hypothesis of this study is that prolonged-storage rbcs are not inferior to short-storage rbcs for the time required to clear elevated blood lactate levels in children with severe anemia.

this study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.

Eligibility criteria:
inclusion criteria: * age 6 mos to 5 years * hg \ 5 mm exclusion criteria: * receiving transfusion other than rbcs * children with known or suspected cardiac disease

Keywords: anemia transfusion rbc storage age tissue oxygenation malaria
sex-dependent effects of flavanols on vascular status

Conditions: Cardiovascular Diseases

Summary: epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. endothelial dysfunction is the key event in the development and progression of cardiovascular disease. the aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy post-menopausal femal subjects (\>50 years) * healthy male subjects (\>50 years) exclusion criteria: * acute inflammation * cardiac arrhythmia * renal failure * heart failure (nyha ii-iv) * diabetes mellitus * crp \> 1 mg/dl * malignant disease

Keywords: flavanols sex-related cardiovascular effects
investigating the safety and clinical performance of eight ivascular devices for endovascular intervention in renal, iliac or femoral arteries

Conditions: Artery Disease

Summary: the rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from ivascular.


Eligibility criteria:
inclusion criteria: * corresponding to the ce-mark indications/contra-indications and according to the ifu of the device. * patient is \>18 years old. * patient understands the nature of the procedure and provides written informed consent prior to enrollment in the study. * target lesion(s) is/are located in renal, iliac or femoral arteries. * patient is eligible for treatment with the oceanus 18 balloon dilatation catheter and/or the oceanus 35 balloon dilatation catheter and/or the luminor 18 drug coated balloon and/or the luminor 35 drug coated balloon and/or the restorer peripheral stent system and/or the ivolution pro peripheral self-expanding stent system and/or the icover covered peripheral stent system and/or the sergeant peripheral support catheter as described in ifu for each device. exclusion criteria: * anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following ifu of the investigational devices. * known contraindication and/or allergy to (a component of) an investigational device. * pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding. * life expectancy of less than 12 months. * any planned surgical intervention/procedure within 30 days after the study procedure. * any patient considered to be hemodynamically unstable at onset of the procedure.
awake bedside assessment of the airway and evaluation of tracheal intubation with cmac d-blade or video stylet in bariatric surgery

Conditions: Difficult Intubation in Obesity

Summary: patients undergoing bariatric surgery often present challenges during intubation due to limited neck mobility, increased soft tissue in the airway, and elevated body mass index (bmi). predicting difficult intubation in these patients is critical to ensuring safety. the simplified airway risk index (sari) by ganzouri is a validated tool for predicting difficult intubation. it considers factors like neck mobility, mallampati score, and body weight, which are highly relevant in difficult airway prediction in the bariatric population. the cmac video laryngoscope is widely used to manage difficult airways. two commonly used devices are the cmac d-blade, designed explicitly for difficult airways, and the cmac video stylet, which combines video guidance with a flexible tip. this study will compare the efficacy and safety of these two devices in bariatric patients with an anticipated difficult airway, as identified by the sari.

comparing the effectiveness and safety of the cmac d-blade versus the cmac video-style for awake bedside airway assessment and their performance during tracheal intubation in bariatric patients with expected difficult intubation as predicted by the simplified airway risk index (sari). standard monitoring will be attached and recorded. preoperative awake airway assessment: after airway topicalization, both devices will be used for airway assessment according to the group allocation, and the cormack and leane will be recorded. induction of anesthesia: a standardized protocol will be followed for all patients, including preoxygenation and administration of propofol, fentanyl, and muscle relaxants (e.g., rocuronium). intubation: the intubating anesthetist will use the assigned device. - rescue strategy: if intubation fails after three attempts or exceeds 120 seconds, the anesthetist will switch to an alternative device or follow the institutional difficult airway protocol.

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years) * bmi ≥ 35 kg/m² * sari score ≥ 4 * scheduled for elective bariatric surgery exclusion criteria: 1. sari score \< 4. 2. any known or suspected airway pathology (such as tumors, airway trauma, or history of airway surgery/tracheostomy). 3. emergency surgery. 4. coagulopathy. 5. seizures, pregnancy, 6. mouth opening ≤ 2 cm. 7. contraindications to general anesthesia or neuromuscular blockade and uncooperative patients.

Keywords: cmac d-blade cmac video-style bariatric patients simplified airway risk index (sari)
a study of lumacaftor in combination with ivacaftor in cystic fibrosis subjects aged 12 years and older who are homozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Summary: the primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at week 24 in participants aged 12 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation on the cf transmembrane conductance regulator (cftr) gene.

this was a phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter study of orally administered lumacaftor in combination with ivacaftor in participants aged 12 years and older with cf who are homozygous for the f508del-cftr mutation. the study included a screening period (day -28 through day -1), a treatment period (day 1 \[first dose of study drug\] to week 24 ± 5 days), and a safety follow-up visit (4 weeks ± 7 days after the week 24 visit).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf * homozygous for the f508del cftr mutation * forced expiratory volume in 1 second (fev1) greater than or equal to (\>=) 40 percent (%) and less than or equal to (=\<) 90% of predicted normal for age, sex, and height * willing to remain on a stable cf medication regimen through week 24 or, if applicable, the safety follow up visit exclusion criteria: * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose of study drug * history of solid organ or hematological transplantation * history of alcohol or drug abuse in the past year * ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening * use of strong inhibitors, moderate inducers or strong inducers of cytochrome p450 3a (cyp3a) within 14 days before day 1 of dosing
the clinical trial protocol for the influenza virus vaccine (split virion, inactivated) （children forms of drug）

Conditions: Influenza

Summary: the purpose of this study is to evaluate the safety and the immunogenicity of influenza virus vaccine (split virion, inactivated)(children forms of drug) that do not contains preservative.

influenza virus vaccine (split virion, inactivated) that do not contain preservative. ha contents 7.5μg/0.5ml per dose include h1n1、h3n2 and b. inactivated split influenza vaccine was manufactured by sanofi pasteur ha contents 7.5μg/0.5ml per dose include h1n1、h3n2 and b. this is a randomized, blind phase 3 clinical trial. total 1200 adults (ages from 6 months to 36 months ) were selected, randomized to two groups \[influenza virus vaccine (split virion, inactivated) and inactivated split influenza vaccine , each group n=600\], adults in each group will be vaccinated with two doses of either influenza virus vaccine (split virion, inactivated) or sanof ivv respectively,21 days apart.

Eligibility criteria:
inclusion criteria: * males and females, age from 6 months to 35 months ; * adults, parent(s) or guardians are able to understand and sign informed consent for participation; * participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; * infants no vaccinated with influenza or other preventive biologicals in recent 7 days; * axillary temperature ≤37℃. exclusion criteria: * have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy; * low platelet or bleeding disorder do not allow vaccination into the muscle; * have damaged or lower immunological function; * received blood, plasma or immunoglobulin treatment since birth; have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( down syndrome, diabetes, sickle cell anemia or neural guillain-barre syndrome ); * have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, hiv. exclusion criteria for doses 2 * have serious anaphylaxis or high fever, convulsion during first dose; * have any circus of exclusion criteria after eligible for study; * have serious adverse event which related to previous vaccination; * withdrawal and discontinuance criteria; * received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents; * vaccinated with any other vaccine（except dtp）; * stop observation determined by investigator owing to occurring serious adverse event.

Keywords: influenza virus vaccine (split virion, inactivated) influenza
national registry of irpf in china

Conditions: Idiopathic Retroperitoneal Fibrosis

Summary: the aim of this study is to establish a nation-wide cohort study of idiopathic retroperitoneal fibrosis (irpf) in china. methods: all the patients fulfilling diagnostic criteria of irpf would be enrolled from multi-centers around china. a online database system has been established. endpoints: the primary endpoint is to investigate the clinical manifestations of chinese irpf patients; the secondary endpoints including the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

this is a multicenter registry study of irpf patients. newly diagnosed irpf patients will be recruited from all over the china. inclusion criteria: patients with newly diagnosed irpf will be recruited. exclusion criteria: patients with secondary forms of retroperitoneal fibrosis or malignancy are excluded. the data will be uploaded through the platform of chinese rheumatology information platform. demographic data, initial symptoms, disease duration, history of allergy, and physical examination, organ involvements, laboratory findings, radiological and pathological results, as well as treatment, side effects will be recorded. this study was approved by the medical ethics committee of pumch (beijing, china). all patients will sign informed consent. statistical analysis: all parameters are described in the standard summary statistics, including mean, standard deviation, minimum, and maximum. all statistical analyses will be performed by spss. endpoints: the primary endpoint is to investigate the organ involvements of chinese irpf patients. the secondary endpoints include the demographic features,laboratory characteristics, immunological tests, imaging and pathological features, in addition, the treatment and prognosis of the disease.

Eligibility criteria:
inclusion criteria: * conforming to the diagnostic criteria of irpf;definite irpf must have the following characteristics: (1) the typical finding of imaging shows retroperitoneal mass, surrounding the abdominal aorta and iliac arteries, with encasement of ureters and/or organ dysfunction; (2) exclusion of disease progression after standard glucocorticoid treatment; and (3) histopathological findings shows a ﬁbrous tissue with signs of chronic inﬂammation. the inﬂammatory component is comprised of lymphocytes, plasma cells and macrophages. neutrophils and granulomas are rare ﬁndings. possible irpf required (1) and (2), but without histopathological examination. exclusion criteria: * none of them met the criteria for other autoimmune diseases. none had malignant disease. secondary forms of rpf related to drugs, infections, malignancies, erdheim-chester disease and igg4-rd, need to be excluded.

Keywords: registry; cohort-study; idiopathic retroperitoneal fibrosis；
treatment for young adults with anorexia nervosa

Conditions: Anorexia Nervosa

Summary: temple university is conducting a national institute of health funded research study designed to develop and refine a family-based treatment manual for young adults with anorexia nervosa as well as assess the feasibility of this out-patient psychotherapy.

anorexia nervosa (an) is a serious psychiatric illness that occurs in an estimated 0.5 to 3.7% of women. the illness severely affects physical, emotional, and social functioning. the mortality rates associated with this severely disabling condition are higher than those for any other psychiatric disorder and substantially higher than those expected in the general population. lower weight at presentation, longer illness duration, and alcohol abuse are associated with a higher risk of mortality. treatment-outcome for adult an is poor with a quarter of adults with an having poor outcome. in an, promising outcomes are seen in family-based treatment (fbt) for adolescent patients who present between the ages of 12 to 18 with a short duration of illness. a manualized version of fbt has now been tested in several studies and case series, showing that well over 80% of participants had good or intermediate outcome at post-treatment. despite its efficacy with adolescents, fbt has not been utilized with young adults. the purpose of this study is to develop and refine fbt to promote weight gain in young adults with anorexia nervosa.

Eligibility criteria:
inclusion criteria: * meet dsm-iv criteria for an (restricting/binge-purge type) (bmi 16.0-18.5) * medically stable for outpatient treatment * availability of at least one supportive adult of choice in study client's environment * stable dose of psychotropic medication (8 weeks) for co-morbid condition exclusion criteria: * associated physical illness that necessitates hospitalization * psychotic illness or other mental illness requiring hospitalization * current dependence on drugs or alcohol * physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight * previous family-based treatment for anorexia

Keywords: an
integrated smoking cessation and mood management for acs patients

Conditions: Acute Coronary Syndrome; Tobacco Use

Summary: quitting smoking following acute coronary syndrome can reduce mortality up to 50%. however, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. behavioral activation (ba) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. the investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing ba based mood management techniques for post-acs smokers; behavioral activation treatment for cardiac smokers (bat-cs). objective: for this r56 the investigators will conduct a vanguard trial to pilot all methods, materials, and systems for the later fully powered bat-cs vs. attention control trial. the investigators will enroll up to 36 smokers with acs and randomize them to 12 weeks of bat-cs or an attention control (health and wellness education). both groups will be offered the nicotine patch if medically safe.


Eligibility criteria:
inclusion criteria: 1. hospital inpatients with an acs diagnosis documented in medical record, 2. smoked 1 or more cigarettes per day before being hospitalized, 3. age of 18-75, 4. english fluency, 5. lives within a 1 hour drive of the admitting hospital and has no plans to move away from the area for 1 year, 6. willing to consider quitting smoking at discharge, 7. has telephone, and 8. willing to consent to all study procedures. exclusion criteria: 1. limited mental competency (i.e., mini mental status exam score ≤ 23); 2. presence of severe mental illness that would interfere with participation (e.g., schizophrenia) or suicidality; 3. expected discharge to hospice; and 4. currently attending counseling for depression or smoking cessation.

Keywords: smoking depression behavioral activation