Kornimate/medical-research-clean huggingface dataset:
clinical trial of safety and immunogenicity of recombinant sars-cov-2 s-trimer vaccine (cho cells) as booster vaccination in populations aged 18 to 59 years

Conditions: COVID-19

Summary: increased immune escape of emerging sars-cov-2 variants and waning neutralizing antibody levels over time indicate the importance of covid-19 vaccine booster dose. preclinical findings have shown that the recombinant sars-cov-2 s-trimer vaccine exhibited favorable safety and immunogenicity. herein, we conducted a randomized, open-label, positive control trial to assess the safety and immunogenicity of the booster shot in healthy subjects aged 18-59 years who have completed two-dose primary series of inactivated vaccine for 6-15 months. a total of 63 eligible participants were enrolled to receive the recombinant sars-cov-2 s-trimer vaccine or inactivated vaccine, and only one participant in 30 μg recombinant sars-cov-2 s-trimer vaccine cohort withdrew owing to personal work reasons on september 26, 2022. subjects in each dose group (5 μg, 10 μg, 30 μg recombinant sars-cov-2 s-trimer vaccine) was randomly assigned to receive the experimental vaccine or inactivated vaccine in a 2:1 ratio.


Eligibility criteria:
inclusion criteria: * eligible participants were those who completed the two-dose primary series of icv for 6-15 months * voluntarily consented to participate in this trial * agreed to take effective contraceptive measures (women of childbearing potential) from signing the informed consent form to 12 months after booster vaccination. exclusion criteria: * history of allergy to any vaccine or its excipients; * presence of severe, uncontrollable or hospitalized diseases; * history of major surgery within 3 months prior to enrollment; * history of severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers) or covid-19; * congenital or acquired immunodeficiency or autoimmune disease; * any acute diseases or acute attacks of chronic diseases within 7 days prior to enrollment; * receipt of any covid-19 prophylactic medication other than primary series of icv; * long-term receipt (\>14 consecutive days) of glucocorticoids or other immunosuppressive agents within the past 6 months; * receipt of biological agents, immunopotentiators or immunosuppressants within the past 6 months; * receipt of blood or blood-related products within 3 months prior to vaccination; * administration of antipyretics, painkillers or antiallergics within 24 hours prior to vaccination; * participating or planning to participate in other clinical trials during the study period; * pregnant or lactating females, women of childbearing age of pregnancy test positive; * presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.
influence of prematurity and its respiratory sequel on exercise testing in childhood

Conditions: The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study

Summary: prospective study comparing hemodynamic and respiratory changes and exercise capacity during cardio-pulmonary-exercise-testing (cpet) in 4 groups of infants; three different groups of premature infants and term controls

the study population included 4 groups of infants; preterm infants born \< 300 weeks' gestation with bpd (i.e. oxygen dependence for at least 28 postnatal days 5), preterm infants born \< 300 weeks' gestation without bpd, late preterm infants (born at 340-366 weeks' gestation) and term controls. pulmonary function testing and spirometry were measured participants performed cpet on an electronically braked cycle ergometer. during the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. the peak oxygen consumption (vo2max) was measured and served as the primary endpoint of the study.

Eligibility criteria:
inclusion criteria: * 7-10 years of age * the ability to ride stationary bicycles as assessed by the parents. exclusion criteria: * immobility * an acute febrile or upper respiratory illness in the last 2 weeks * the use systemic or inhaled steroids or antiepileptic drugs in the previous month * inhaled bronchodilator use in the previous 24 hours * a chronic lung illness (with the exception of bpd and asthma) * congenital cardiac defect (with the exception of atrial septal defect and patent foramen ovale).
vitamin d supplementation during pregnancy for prevention of asthma in childhood

Conditions: Asthma

Summary: the aim of this study is to prevent asthma symptoms (recurrent wheeze) in childhood by supplementation with high dose vitamin d to the mother during pregnancy. participants are mothers and children of the abc (asthma begins in childhood) cohort. mothers are recruited during pregnancy and receive daily supplement with 2400 iu of vitamin d3 or placebo from week 24 og gestation to 1 week after delivery. in addition all mothers are advised to take the recommended dose of 400 iu vitamin d daily. the mothers in abc also participate in an interventional trial with fish oil supplementation, and the vitamin d randomization is stratified by fish oil treatment group. the child is followed with acute and planned vits at the research unit, and wheeze is diagnosed according to predefined algorithms.


Eligibility criteria:
inclusion criteria: mother: * pregnant in week 22-26 of gestation * participating in the abc-cohort * living in sealand, denmark * fluent in danish * willing to let the child participate in the study exclusion criteria: mother: * intake of more than 400 iu of vitamin d during the last 6 months * endocrinological disease such as calcium metabolic disorder, parathyroid disorder, thyroid disorder or diabetes type 1 * tuberculosis * sarcoidosis * in need of diuretics or heart medication including calcium channel blockers

Keywords: wheeze infections allergy eczema vitamin d
the validity of core sensor in heat training for male and female endurance athletes

Conditions: Temperature Change, Body

Summary: this study is investigating the efficacy of core™ devices in calculating core body temperature in athletes under varying environmental conditions.

as athletes exercise, their core body temperature rises, which can affect their performance. additionally, repeated mild to moderate heat stress, heat acclimation, can be used to improve exercise tolerance and performance. thus, an athlete can gain performance benefits through monitoring their heat loading while training. the aim of this study is to compare the core™ body temperatures recorded during exercise in two different environmental conditions in which the investigators will get a separation of core temperature and skin temperature. the investigators will accomplish this by recruiting trained and elite athletes, ages 18-59, to participate in two exercise sessions in the heat at low (10-20%) and high (80-100%) relative humidity. the investigators will compare the core™ temperature estimates against an fda approved ingestible temperature monitoring device to assess the accuracy of the core™ devices.

Eligibility criteria:
inclusion criteria: * highly trained or elite athlete * nonsmokers * able to read and speak english * no underlying cardiovascular limitations exclusion criteria: * currently or previously a habitual smoker (nicotine/cannabis) * pregnant, breast feeding, trying to conceive, undergoing treatment to increase sperm count * those taking medications that affect cardiovascular function, with the exception of oral contraceptives * history of stroke, clotting disorders or venous thrombosis * a history of heat illness or heat injury * history of obstructive diseases of the gastrointestinal tract including diverticulosis, diverticulitis, inflammatory bowel disease, peptic ulcer disease, chron's disease, ulcerative colitis, or previous gi surgery

Keywords: exercise heat acclimation core temperature heat loading heat stress thermoregulation
the use of dhea in women with premature ovarian failure

Conditions: Premature Ovarian Failure

Summary: dhea supplementation has been used in women with infertility and diminished ovarian reserve. there is a small report in 5 women with pof that benefited from the use of dhea over several months. the investigators aim to evaluate further the use of dhea in women with premature ovarian failure (pof).


Eligibility criteria:
inclusion criteria: * women with pof exclusion criteria: * women without ovaries
evaluation for the effect of smartphone based training on chronic ankle instability subjects

Conditions: Chronic Ankle Instability

Summary: this study aims to verify the training effect of smartphone-based training for chronic ankle instability(cai) subjects. by randomizing subjects to app training group, clinical training group and control group, the training effect will be compared among groups.

postural control ability may be damaged after ankle sprains. poor postural control ability is the risk factors of the ankle sprain, forming a vicious circle of recurrent sprains. proper and early assessment is the key to breaking down the circle. smartphones have been utilized in the medical field. with built-in sensors, utilizing smartphones as assessment tools can provide quantitative data of postural control performance. this study aims to verify the training effect of smartphone-based training for cai subjects. cai subjects were recruited and randomly assigned to app training group, home training group and control group, receiving 6 weeks of intervention. pre-test was conducted before the intervention, and the post-test was conducted after the 6-week intervention. the follow up assessment was conducted 4 weeks after the post-test.

Eligibility criteria:
inclusion criteria: * at least one ankle sprain history * at least 2 times of sprain and feeling unstable * diagnosed as functional ankle instability * full recovered from injury * cumberland ankle instability tool\<24 * ankle instability instrument \>5 yes * identification of functional ankle instability \>11 exclusion criteria: * diagnosis as mechanical instability * neurological deficits * lower extremity injury within the past 6 wk * history of lower-extremity surgery * other conditions known to affect balance

Keywords: chronic ankle instability smartphone
antiemetic efficacy and safety of dexamethasone in obstetric surgical patients

Conditions: Postoperative Nausea and Vomiting

Summary: this is a randomised controlled double blinded clinical trial to determine the antiemetic efficacy and safety of either 8 mg of dexamethasone or normal saline (placebo) given 1 hour before induction of either spinal or general anaesthesia in 2 arms (of 150 each).


Eligibility criteria:
inclusion criteria: * all woman above 18 years old presenting for obstetric surgery and have consented to study. exclusion criteria: * refusal/unable to consent, * younger than 18 years old, * hypertensive, * diabetic, * preeclamptic, * sepsis, * asaiiie plus.

Keywords: ponv
population pharmacokinetics, effectiveness and safety of cefuroxime in neonates

Conditions: Infectious Disease

Summary: cefuroxime is a time-dependent antibiotic that is used to treat bacterial infections. however, population pharmacokinetic，effectiveness and safety data for cefuroxime in neonates are lacking. the aim of this study was to assess the population pharmacokinetics, effectiveness, and safety of cefuroxime in neonates.


Eligibility criteria:
inclusion criteria: * age: postnatal age ≤28 days; * cefuroxime used as part of antimicrobial treatment; * parental written consent. exclusion criteria: * expected survival time less than the treatment cycle; * receiving other systemic trial drug therapy; * other factors that the researcher considers unsuitable for inclusion.
study of factors favoring the onset of novo atrial fibrillation in the immediate aftermath of coronary artery bypass surgery

Conditions: Coronary Artery Bypass Graft With or Without ECC

Summary: before la surgery: transthoracic cardiac echography will be done systematically, to measure among other things the size of the left atrium. during surgery: surgery under extracorporeal circulation: tissue samples will be harvested from the right atrium (one before clamping of the aorta (t0= pre-ischemia sample), immediately before declamping of the aorta (t1= post-ischemia sample). surgery without extracorporeal circulation: tissue samples from the right atrium before cabg (t0) and a second sample after cabg (t1). in parallel with the harvesting of cardiac tissue, blood samples will be taken at different times (h0, h3, h24) to correlate tissue data with systemic data. these will be taken by the anesthetists. after the surgery: holter ecg will be set up for 7 days of continuous recording. each patient will fill in an observation notebook. the biological samples will be analysed immediately and the biological data obtained will be recorded in the observation notebook.


Eligibility criteria:
inclusion criteria: * patients who have provided written informed consent * patients covered by the national health insurance scheme * heart surgery (cabg) with and without extracorporeal circulation * elective or deferred emergency surgery * consecutive patients aged less than 80 years exclusion criteria: * patients less than 18, under guardianship * patients over 18, under guardianship * patients who do not understand the study data * patients undergoing emergency surgery who therefore cannot be given or understand the explanations for the study (patients in shock, intubated patients with mechanical ventilation) * history of heart surgery * history of af * treatment with cordarone.
standing, stepping and voluntary movement spinal cord epidural stimulation

Conditions: Spinal Cord Injuries

Summary: this study will determine the level of functional gain, below the injury for voluntary control of movements, and recovery standing and stepping function as a result of activation of spinal circuits with sces in humans with severe paralysis. training will consist of practicing stepping, standing and voluntary movements in the presence of specific sces configurations designed specific for stepping (step-sces), specific for standing (stand-sces) and for the voluntary movements of the legs and trunk (vol-sces). ability to step, stand, move voluntarily, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury.


Eligibility criteria:
inclusion criteria: * non-progressive sci * at least 2 years post injury * stable medical condition * inability to walk independently overground * unable to voluntarily move all individual joints of the legs exclusion criteria: * ventilator dependent * untreated painful musculoskeletal dysfunction, fracture or pressure sore * untreated psychiatric disorder or ongoing drug abuse * cardiovascular, respiratory, bladder, or renal disease unrelated to sci * pregnant at the time of enrollment or planning to become pregnant during the time course of the study

Keywords: epidural stimulation
24-hour ambulatory blood pressure monitoring in patients with blood pressure above thresholds in general practice

Conditions: Hypertension; Blood Pressure Monitoring, Ambulatory; Primary Health Care

Summary: high blood pressure (hbp) is a major modifiable cardiovascular risk factor which prevalence is gradually increasing. reducing blood pressure (bp) significantly decreases cardiovascular morbi-mortality. nevertheless, bp control remains insufficient: only 51% of french patients using antihypertensive drugs achieve the bp control targets. hbp is mostly diagnosed and managed in primary care. nevertheless, office bp measurements are unreliable for bp control and poorer predict target organ damage. ambulatory bp measurements are recommended for hbp diagnosis and follow-up. 24-hour ambulatory blood pressure monitoring (abpm) is the most cost-effective strategy. its superiority has been demonstrated for hbp diagnosis and cardiovascular prognosis. in france, abpm is poorly available and little studied in primary care. therefore, the investigators conducted a regional prospective study to analyze the feasibility and benefits of abpm among primary care hypertensive patients in daily practice.


Eligibility criteria:
inclusion criteria: * patients aged over 18 years * with an office inclusion consultation systolic/diastolic bp≥ 140/90 mmhg * able to understand french language and to consent to participate in the study exclusion criteria: * patients aged \< 18 years * with conditions preventing technically adequate abpm (chronic atrial fibrillation) * with contraindications to abpm (musculotendinous disease of the upper limb, past history of phlebitis of the upper limb or phlebitis in progress, past history of olecranon bursitis or bursitis in progress) * with previous abpm in the 12 months prior to the inclusion consultation * pregnant or lactating women
retrovir capsules in the treatment of hiv-infected patients in renal failure

Conditions: HIV Infections; Kidney Failure, Chronic

Summary: to evaluate the safety, tolerance, and pharmacokinetics of retrovir (azt) administration in hiv-infected patients in renal failure receiving maintenance hemodialysis.


Eligibility criteria:
inclusion criteria patients must have: * a positive hiv antibody test (elisa confirmed by western blot). * chronic renal failure managed by a stable hemodialysis regimen. * acceptable hepatic function defined by specified lab values. * life expectancy \> 6 months. * enrollment is limited to 9 chronic hemodialysis patients and 9 continuous ambulatory peritoneal dialysis (capd) patients. these patients must be stable in their esrd treatment regimen before entry. exclusion criteria co-existing condition: patients with the following are excluded: * active, serious opportunistic infections at the time of study entry. * fever \> 100 degrees f at study entry. * severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss). patients with the following are excluded: * active, serious opportunistic infections at the time of study entry. * fever \> 100 degrees f at study entry. * severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss). prior medication: excluded within 2 weeks of study entry: - any other experimental therapy. drugs which cause significant bone marrow suppression. rifampin or rifampin derivatives. cytolytic chemotherapy. drugs which cause significant hepatotoxicity. excluded within 4 weeks of study entry: - immunomodulating agents, including steroids, interferon, isoprinosine, and interleukin 2. excluded within 8 weeks of study entry: - other antiretroviral agents (e.g., zidovudine \[azt\], suramin, ribavirin, hpa-23, foscarnet, dextran sulfate, disulfiram, dda/ddc, or dideoxycytidine). active drug or alcohol abuse.

Keywords: kidney failure, chronic acquired immunodeficiency syndrome aids-related complex zidovudine renal dialysis
effect of vitamin d on everolimus trough concentrations among heart transplanted patients

Conditions: Vitamin D Deficiency

Summary: vitamin d is part of the regular treatment regimen among patients after heart transplantation. due to potential drug-drug interaction between vitamin d and everolmus, these patients are in increased risk for increased everolimus metabolism, potentially leading to under- immunosupression.

post heart transplantation patients treated with everolimus will be screened for vitamin d levels. patients defined as deficient will be treated with vitamin d with close and intensive monitoring everolimus levels, adjusting oral daily dose to maintain therapeutic levels.

Eligibility criteria:
inclusion criteria: heart transplanted patients treated with everolimus exclusion criteria: -
whether proton pump inhibitors, administered prior to or after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or liquids,following anterior cervical surgery

Conditions: Dysphagia; GERD; Degenerative Joint Disease

Summary: the researchers wish to investigate whether proton pump inhibitors, administered prior to or after surgery, can reduce the incidence and/or severity of difficulty swallowing foods and/or liquids,following anterior cervical surgery.

over half of patients who underwent anterior cervical surgery may experience dysphagia in the month following the operation. dysphagia, characterized as difficulty swallowing foods and/or liquids, is a debilitating condition that not only reduces the quality of life for our patients but also results in poor nutritional intake, which may lead to delays in healing and recovery after surgery. current understanding of dysphagia following cervical surgery is very rudimentary. many published reports were retrospective studies where the incidence of dysphagia was later found to be greatly underreported. furthermore, many studies utilized small sample sizes producing varying data regarding the incidence and severity of postoperative dysphagia. most importantly, a review of the medical literature failed to find any consistently proven recommendations or therapies that can reduce the incidence or severity of postoperative dysphagia. a recently published study shows that gastroesophageal reflux disease (gerd) is also a common complaint following anterior cervical surgery. the study also shows a positive correlation between the severity of postoperative gerd and severity of postoperative dysphagia. other studies also showed that patients suffering from gerd-associated dysphagia may be successfully treated with proton pump inhibitors. based on these studies, along with anecdotal reports, the investigators hypothesize that proton pump inhibitors may reduce the incidence and/or severity of dysphagia following anterior cervical surgery.

Eligibility criteria:
inclusion criteria: * must be at least 18 years of age. * scheduled to undergo anterior cervical surgery for degenerative joint disease. exclusion criteria: * patients undergoing revision procedures, multi-level procedures, or procedures treating conditions other than degenerative joint disease. * patients with preoperative dysphagia. * patients currently taking any acid suppressing medications (proton pump inhibitors, h2 blockers, antacids, etc). * patients who are pregnant or nursing. * patients who, due to drug allergies, hypersensitivities/anaphylactic reactions to esomeprazole or contraindications (hypersensitivity to benzimidazoles, osteoporosis), are unable to take esomeprazole. * patients unable to attend follow-up visits or answer the dysphagia questionnaires. eligibility criteria: * scheduled to undergo anterior cervical surgery for degenerative joint disease.

Keywords: esomeprazole magnesium postoperative dysphagia gastroesophageal reflux disease anterior cervical surgery proton pump inhibitor
the effect of oxytocin on gastric emptying

Conditions: Dyspepsia; Lack of Satiety

Summary: the investigators have seen that oxytocin lowers satiety in healthy subjects. patients with dyspepsia suffers from decreased accommodation and increased satiety postprandially. the investigators now want to examine whether oxytocin may diminish symptoms in these patients.

patients will come twice for a slow satiety drinking test. once they will get saline infusion and once oxytocin 40 mu/min. at the same time they register satiety on a vas scale.

Eligibility criteria:
inclusion criteria: * dyspepsia exclusion criteria: * age \> 65 years * cardiac disease

Keywords: oxytocin satiety dyspepsia