Kornimate/medical-research-clean huggingface dataset:
factors influencing the covid-19 vaccine immune response according to age and presence or not of a past history of covid-19

Conditions: Covid19

Summary: age is the main risk factor associated with the severity of covid-19. from the beginning of the vaccination campaign, elderly subjects are part of the priority population. however, immunosenescence appears to play a role in the natural post-covid-19 immunity of convalescent elderly subjects and also in the post-vaccination response. however, vaccination recommendations for both naïve (2 doses of vaccine) and convalescent subjects (1 dose of vaccine) do not differ according to age. to date, there is little data to suggest that the response to the vaccine in naïve or convalescent subjects may vary according to age in terms of qualitative and quantitative response and duration.

in addition, the reactogenicity following the vaccine, remains important with covid-19 vaccines, whether using an messenger ribonucleic acid (mrna) technique or an adenovirus vector technique. a better understanding of the parameters of early inflammatory response explaining this reactogenicity would allow to optimize the formulation of future vaccines. there are still several unknowns concerning the post-vaccination immune response (immunogenicity and reactogenicity) in older subjects,depending on their history of covid-19 and the type of vaccine administered. a better understanding of this immune response is necessary in order to propose the best vaccine strategies and regimens in this high-risk covid-19 population. thus, in partnership with sanofi pasteur and bioaster, the group on mucosal immunity and pathogens (gimap) and circulating immune complexes (cic) vaccinology team proposes to conduct a study comparing the humoral, cellular, mucosal and reactogenic post-vaccination immune response in subjects with a history of covid-19 \>3 months ago (convalescent, 1 dose of vaccine) versus subjects with no history of covid-19 (naive, 1 or 2 doses of vaccine depending on the type of vaccine used) according to age.

Eligibility criteria:
inclusion criteria: * for the group with a past history of covid-19 (convalescents)= subject within ≥ 3 months after infection * for the no past history of covid-19 (naives), subject with no known history of covid-19 * patient affiliated or entitled to a social security plan * patients who have received informed information about the study and who have co-signed a consent to participate in the study with the investigator exclusion criteria: * immunocompromised or under immunosuppressive treatment * subject with a history of covid hospitalized in intensive care * subject allergic to one of the components of the vaccines used in the study * subject vaccinated for covid-19 * subject with persistent symptoms of covid-19 (long covid) * subjects with unstable chronic pathology * persons deprived of liberty, hospitalized without consent * pregnant or breastfeeding woman

Keywords: immunogenicity reactogenicity mrna covid-19 vaccine covid-19 natural immunity age
post market clinical follow-up study on the performance and safety of lyoplant®

Conditions: Tumor, Cerebral Ventricle; Tumor, Cerebellar; Aneurysm Cerebral; Trauma, Brain

Summary: retrospective, single center, single arm pmcf study on the performance and safety of lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * use of investigational device according to instructions for use (ifu) exclusion criteria: * none

Keywords: lyoplant retrospective study decompressive craniectomy cerebral dura defect cerebellar dura defect spinal dura defects
harnessing alternative resources to aid kenyans with acute illness

Conditions: Cardiorespiratory Failure

Summary: kenya does not have enough experts to perform heart scans in patients who are very sick and in need of urgent intervention. the purpose of this research is to find out whether training kenyan nurses to perform basic heart scans would shorten the time it takes to know whether the heart and lungs are working normally in very sick patients, to guide treatment. patients will be placed into one of two groups: one group will have a quick scan of the heart and lungs carried out by trained nurses to see how well these organs are working, in addition to receiving the normal care offered at the hospital. the other group will receive the normal care offered in the hospital only and will not have a scan performed by these nurses. the time it takes to make a diagnosis between the two groups will then be compared. should the group that has heart scans by nurses be found to spend less time waiting for a diagnosis to be made, more nurses in kenya will be trained to provide this service, to minimise delays in our emergency departments.

echocardiography is a useful, non-invasive diagnostic tool in time-critical emergencies. a national shortage of cardiologists and of doctors in kenya however further compounds the problem of insufficient staff for emergency care and of any capacity building efforts. to achieve the goals of sustainable development goal number 3 (sdg-3) and realise the government's vision of universal healthcare for all, alternatives to the human resource challenge are key. modifying the scope of practice of kenyan nurses is one possible solution. task-shifting traditionally cardiologist roles such as focused cardiac ultrasound (focus) could shorten the time it takes to make a diagnosis in patients with cardiorespiratory failure of likely cardiac origin, making prolonged turnaround times in our public facilities a thing of the past. our overarching aim is to harness the power of nurses doing focus. the central hypothesis of this work is that in patients with cardiorespiratory failure, a nurse-led focus-guided service would shorten time to diagnosis, supporting interventions and improving outcomes among the critically ill. insight into potential barriers and enablers for the implementation of a nurse-performed focus service in kenya is crucial for the success of such a service redesign.

Eligibility criteria:
inclusion criteria: any one of: * systolic blood pressure \<90 millimetres of mercury (mmhg) * mean arterial pressure (map)\<65 millimetres of mercury (mmhg) * shock index \>1 (heart rate/systolic blood pressure) * respiratory rate \> 30 breaths/minute * oxygen saturations \<94% * arterial oxygen partial pressure (pao2) \<60 millimetres of mercury (mmhg) * arterial carbon dioxide partial pressure (paco2) \>50 millimetres of mercury(mmhg) exclusion criteria: * trauma * pregnancy * patients requiring immediate life-saving interventions eg cardiopulmonary resuscitation (cpr) or defibrillation
comparison of three antibiotic protocols in prevention of infection in dental implant surgery

Conditions: Dental Implant Failed

Summary: subjects who underwent a dental implant surgery were studied.subjects randomly were aligned into three groups:in group 1, subjects received prophylactic antibiotic orally (amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (amoxicillin 500 mg , q8h for five days). the sign and symptom of infection were studied and the incidence of infection in each group was determined.

subjects eligible for study inclusion had an edentulous area in the mandible or maxilla and underwent a dental implant surgery. subjects were excluded from study enrollment if they had systemic diseases which affect bone metabolism, history of allergy to amoxicillin, refused study enrollment or failed to return for follow-up. subjects were randomly divided into three groups : in group 1, subjects received prophylactic antibiotic orally (amoxicillin 2mg ,1 hour before surgery) and post-surgical antibiotic (amoxicillin 500 mg , q8h for five days), subjects received only prophylactic antibiotic (amoxicillin 2mg ,1 hour before surgery) in group 2 ,and in group 3, subjects received post-surgical antibiotic (amoxicillin 500 mg , q8h for five days) . an independent researcher made random allocation cards using computer-generated random. then, allocated cases were placed in a sealed envelope. all subjects used 0.2% chlorhexidine mouthwash in the treatment period. all implants were placed with a two-stage protocol. all subjects were followed up for 3 months to assess any infection signs and symptoms. infection was diagnosed based on clinical findings such as pain, redness of the area, and discharge around the fixture.an independent dentist who was blind the study groups, evaluated all subjects.

Eligibility criteria:
inclusion criteria: * have an edentulous area in the mandible or maxilla * underwent a dental implant surgery exclusion criteria: * systemic diseases which affect bone metabolism * history of allergy to amoxicillin * refused study enrollment * failed to return for follow-up.

Keywords: dental implant osseointegration infection
length of post operative dressing after carpal tunnel release

Conditions: Carpal Tunnel Syndrome

Summary: the purpose of the study is to prospectively compare the functional, satisfaction, and wound outcomes of patients treated with one of two accepted methods of postoperative dressing following carpal tunnel release. hypothesis: there will be no difference between the short term (approximately 2 - 3 days)and longer term (9 to 14 days)bulky dressing groups in terms of outcomes.


Eligibility criteria:
inclusion criteria: * adults * carpal tunnel syndrome exclusion criteria: * previous surgery for carpal tunnel syndrome * ipsilateral hand, arm, shoulder surgery with continued symptoms

Keywords: orthopedics, carpal tunnel syndrome, postoperative care
preference study between novofine® autocover™ and a novofine® 8 mm needle

Conditions: Diabetes; Healthcare Professionals; Delivery Systems

Summary: this trial is conducted in europe. the aim of this clinical trial is to assess the preference of 2 different needles used by nurses and health assistants. the trial consists of a handling test followed by a 12 week cross-over study.


Eligibility criteria:
inclusion criteria: * the participant must have been either a diabetes nurse or a diabetes health assistant with competence in subcutaneous injections of insulin for at least 4 weeks * participants must demonstrate proficiency with the injection device in the handling test prior to testing the novofine® autocover™ needle in patients
preoperative hypnosis in gynecology

Conditions: Pelvic Gynecological Cancer

Summary: the research hypotheses that preoperative formal hypnosis session reduces perioperative anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. the key objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among this population

anxiety is present preoperatively in 40% of patients. the operated subjects are on average 20% more anxious than the general population, according to a study of 2013. cancer as well as surgery modifying the body pattern and impairing femininity are risk factors for preoperative anxiety. recent work in both children and adults has shown that significant levels of preoperative anxiety increase the risk of postoperative complications and the occurrence of postoperative emotional and behavioral disorders. the consequences of hysterectomy increase patients' anxiety, for fear of affecting femininity, and the modification of the body regimen. the prevention of preoperative anxiety in such population is therefore a major issue.

Eligibility criteria:
inclusion criteria: * ≥ 18yrs with pelvic gynecological cancer (endometrium, cervix, ovary), * at any stage of the disease; * patient coming for anesthesia consultation before hysterectomy, * informed signed consent, * patient affiliated to or beneficiary of social security. exclusion criteria: * patient \<18yrs, * patient with a pelvic gynecological cancer that does not require hysterectomy; * patient with psychiatric history or a depressive syndrome; * deaf patient (deafness makes the hypnosis session impossible), * patient under legal protection.

Keywords: hypnosis preoperative anxiety hysterectomy hospitalisation
effect of an intervention to prevent acute kidney injury versus standard care in high-risk patients after major surgery

Conditions: Acute Kidney Injury (Nontraumatic)

Summary: there is no specific therapy for acute kidney injury. it is presumed that supportive measures improve the care and outcome of patients with acute kidney injury. to investigate whether an implementation of a supportive extended care "bundle" in high-risk patients for persistent acute kidney injury (aki) can reduce the occurrence of persistent surgical aki. in order to investigate whether the extended kdigo bundle can prevent persistent aki in patients with high chemokine ligand 14 (ccl14) as well as in patients with low ccl14, patients will be randomized with stratification by the ccl-value.

all patients will receive standard of care therapy according to the standards of our center. after identifying surgical patients with a moderate or severe (stage 2 or 3) aki patients will be randomly allocated to the control or intervention group according to the ccl14 results which will be measured as part of the study. according to the literature, patients with a ccl14 \<1.3ng/ml are at low risk of progression and patients with a ccl14≥1.3ng/ml are at high risk of aki progression. in order to have both patient groups included, we will have two groups (patients at low and at high risk of aki progression) and these will be randomized to receive either standard of care or an extended kdigo bundle (in total 4 groups). control intervention / reference test: patients in the control groups will be treated according to the standard of care. the only two hemodynamic targets in this group are the mean arterial pressure (mean arterial pressure (map)\>65mmhg) and passive leg raising test (plrt) (increase of cardiac output (co) \<10%). in the intervention groups, an extended kdigo guideline bundle will be implemented (discontinuation of all nephrotoxic agents when possible, optimization of volume status and perfusion pressure, consideration of a functional hemodynamic monitoring, close monitoring of serum creatinine and urine output, avoidance of hyperglycemia, consideration of alternatives to radio contrast agents, non-invasive or invasive diagnostic workup, nephrology consultation)

Eligibility criteria:
inclusion criteria: 1. adult patients (age ≥18 years) 2. moderate or severe aki ((defined by the 2012 kdigo criteria, kdigo stage 2 and 3), determined by either serum creatinine or urine output) within 72h after a surgical procedure 3. written informed consent exclusion criteria: 1. dialysis-dependent chronic kidney disease 2. prior kidney transplant 3. infections with human immunodeficiency virus or hepatitis 4. hepatorenal syndrome 5. pregnancy or breast-feeding 6. participation in another interventional trial that investigates a drug that affects the kidney function within the last 3 months 7. persons held in an institution by legal or official order 8. persons with any kind of dependency on the investigator or employed by the responsible institution or investigator

Keywords: surgery biomarker ccl14 protein
trial for application of laparoscopic total gastrectomy with lymph node dissection for gastric cancer (klass-06)

Conditions: Gastric Cancer

Summary: although laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in d2 lymph node dissection and anastomoses. some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. however, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with d2 lymph node dissection with open conventional surgery. therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with d2(d2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.


Eligibility criteria:
inclusion criteria: * patients who are over 20 and below 80 years old * patients who have performance status of ecog 0 or 1 * patients with american society of anesthesiology score of class i to iii * patients who are diagnosed with gastric adenocarcinoma not involving z-line by endoscopy with biopsy * patients with tumors which can be curatively resected by total gastrectomy with lymph node dissection based on preoperative study * patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (ct2 \~ ct4a) * patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (cn0 \~ cn2) * patients who agree with participating in the clinical study with informed consents * patients who can be followed for at least 3 years after study enrollment exclusion criteria: * patients who have possibility of distant metastasis in preoperative studies * patients who have history of gastric resection with any cause * patients who have complications (bleeding or obstruction) of gastric cancer * patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer * patients who are diagnosed and treated with other malignancies within 5 years * vulnerable patients * patients who participating or participated in other clinical trial within 6 months
buccal midazolam versus intranasal dexmedetomidine plus oral chloral hydrate in inguinal hernia repair

Conditions: Inguinal Hernia Repair

Summary: inguinal hernia surgery is one of the most common surgical procedures in early infancy. preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients

inguinal hernia surgery is one of the most common surgical procedures in early infancy. preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients. the administration of sedatives to a child before entering a surgical room is the most common way of reducing the child's distress and allows the child to undergo smooth anesthesia induction. chloral hydrate is a widely used sedative for young children undergoing imaging studies, with a high success rate. dexmedetomidine is a highly selective alpha-2 agonist for paediatric sedation. it produces sedation like natural non-rapid eye movement sleep and has respiratory-sparing effect.

Eligibility criteria:
inclusion criteria: * aged 2 to 7 * american society of anaesthesiology (asa) і and п scheduled for inguinal hernia repair exclusion criteria: * sensitivity to dexmedetomidine or midazolam, * infection of the upper respiratory tract, * severe liver or kidney disease, organ dysfunction, * cardiac arrhythmia or congenital heart disease

Keywords: midazolam dexmedetomidine chloral hydrate
prognosis of low-grade endometrial stromal sarcoma

Conditions: Low Grade Endometrial Stromal Sarcoma of Uterus (Diagnosis); Fertility-sparing Surgery; Survival Outcomes; Fertility Outcomes; Recurrence; Hormone Therapy; Adjuvant Therapy

Summary: this study is to investigate the survival outcomes and fertility outcomes in patients with uterine low-grade endometrial stromal sarcoma (lgess) treated in peking union medical college hospital. all primary and recurrent lgess patients will be enrolled. the study will collect retrospectively data consisting of epidemiological characteristics, surgical, medical treatment and adjuvant therapy. details about recurrence, mortality, pregnancy and obstetrical outcomes are also followed as primary endpoints. fertility-sparing procedures, including uterine-sparing and ovary-sparing surgeries will be recorded specifically.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * confirmed of lgess * acceptance of surgical treatment for lgess * with detailed follow-up outcomes exclusion criteria: - not meeting all of the inclusion criteria
a study to evaluate safety and effects of sotagliflozin 400 and 200 mg on glucose control in participants with type 2 diabetes, severe impairment of kidney function and inadequate blood sugar control

Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease Stage 4

Summary: primary objective: to demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin a1c (hba1c) reduction at week 26 in participants with type 2 diabetes who have inadequate glycemic control and severe renal impairment secondary objectives: * to assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in hba1c * to assess the effects of sotagloflozin 400 mg and 200 mg versus placebo * to evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

the study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment and a visit 4 weeks after completion of the randomized treatment period.

Eligibility criteria:
inclusion criteria : * participants with type 2 diabetes (drug-naïve or on antidiabetic therapy) and documented severe renal insufficiency - ckd4 - defined by an estimated glomerular filtration rate (egfr) equation (based on the 4 variable modification of diet in renal disease (mdrd) equation) of ≥15 and \<30 milliliter per minute (ml/min)/1.73 per meter square (m\^2). * signed written informed consent to participate in the study in accordance with local regulations. exclusion criteria: * at the time of screening, age \<18 years. * hemoglobin a1c (hba1c) \ 11%. * type 1 diabetes. * women of childbearing potential (wocbp) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study. * treatment with an sodium-glucose cotransporter type 2 (sglt2) inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months. * uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the investigator believes with result in a short life expectancy, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult. * lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the screening period, and still requiring treatment at randomization. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.