Kornimate/medical-research-clean huggingface dataset:
aloe vera versus thyme honey mouthwash in management of xerostomia in type 2 diabetics

Conditions: Xerostomia

Summary: the objectives of the present study are to: 1. compare the clinical efficacy of (50%) aloe vera versus (20%) thyme honey mouthwash on management of xerostomia in diabetic patients by measuring the salivary flow rate as a primary objective. 2. asses the biochemical effect of aloe vera and thyme honey on the level of salivary nitric oxide, xerostomia grade as well as patient quality of life as a secondary objective. research question: which is better aloe vera or thyme honey in improving salivary flow rate in diabetic patients suffering from xerostomia? patient grouping and randomization: patients with xerostomia will be randomly distributed into three groups using a computer-generated randomization table. allocation concealment will be achieved by a sealed opaque envelope with a ratio of 1:1:1 group 1 (aloe vera group) include (15) patient suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash group 2 (thyme honey group): include (15) patient suffering from diabetes induced xerostomia that will receive thyme honey mouthwash group 3 (saline control group): include (15) patient suffering from diabetes induced xerostomia that will receive saline mouthwash

saliva is a complex mix from major as well as minor salivary glands and gingival crevicular fluids. it is a clear and slightly acidic diluted secretion with more than 99% water, electrolytes, immunoglobulins, enzymes, proteins, mucin and nitrogenous products. subjective feeling of a dry mouth is known as xerostomia, which may result from diminished saliva production, but some people reported feeling a dry mouth even though there was no decrease in saliva quantity.diabetes mellitus is considered one of the main causes of xerostomia there are different treatments modalities of xerostomia which include pharmacological and non-pharmacological treatments.recently different herbs were used in the treatment of xerostomia and showed promising results and great patient acceptance among which aloe vera and thyme honey are used.

Eligibility criteria:
inclusion criteria: 1. both gender, with type 2 diabetes mellitus only and suffering from xerostomia. 2. patients willing to follow all the instructions and attend all the study-associated visits. exclusion criteria: 1. patients who had received radiation therapy to the head and neck region. 2. patients with other systemic diseases known to cause xerostomia (sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, hepatitis c virus, tuberculosis, or sarcoidosis). 3. patients using any other medication for their dry mouth condition (pilocarpine, cevimeline) 7 days before entering into the study. 4. patients requiring hospitalization for any medical problem during the study. 5. known hypersensitivity to the active ingredient of the product that will be used as assessed by the medical history questionnaire. 6. vulnerable groups such as mentally or physically handicapped individuals, pregnant females, prisoners.

Keywords: xerostomia aloevera thyme honey type 2 diabetes
concomitant administration of the novavax vaccine and a 20-valent pneumococcal conjugate vaccine in adults aged ≥60 years

Conditions: COVID-19; Pneumococcal Infections

Summary: vaccination is a key strategy for preventing respiratory illnesses. pneumococcal vaccination is recommended for all adults aged over 60 or 65 years (depending local guidelines) who have never received a pneumococcal vaccine or whose previous vaccination history is unknown. given their wide application, co-administration of pneumococcal and covid-19 vaccines may support broad population-wide coverage. however, it is unclear whether the co-administration of the novavax (nvx) vaccine and a 20-valent pneumococcal conjugate vaccine (pcv20) results in lower immunogenicity than the administration of either alone. the investigators will thus conduct a 4-four arm study with the following treatments: nvx plus placebo (nvx arm), pcv20 plus placebo group (pcv20 arm), nvx plus pcv20 (combination arm), and placebo plus placebo group (placebo arm). vaccines and/or placebo will be administered as single doses, given as intramuscular injections on day 1 (one in each shoulder). subjects will be randomly assigned to one of the four arms. the outcome will be the antibody levels after 28 days.


Eligibility criteria:
inclusion criteria: * age: 60 years or older * males and females * able and willing (in the investigator's opinion) to comply with all study requirements. * participants, who already received three covid-19 vaccines, of which the third was a mrna vaccine (bnt162b2 or mrna-1273) and at least 16 weeks ago * only applicable for women: last menstrual bleeding more than one year ago exclusion criteria: * use of immunosuppressants * congenital or acquired immunodeficiency (eg, history of hiv infection, hematological disease, current malignancy, or others) * chronic condition that may significantly interfere with the immune response in the opinion of the investigator * history of covid-19 within 16 weeks before study vaccination * previous pneumococcal vaccination * contraindication against any ingredient of the nvx or the pcv20 vaccine
influence of a new polycationic disinfectant on clostridium difficile incidence and environmental colonisation

Conditions: Clostridium Difficile

Summary: the aim of this study is to 1) test the efficacy of phmg-based disinfectant against c. difficile spores, 2) test whether it reduces the incidence of c. difficile associated disease (cdad) and 3) evaluate cost.

environmental disinfection has been proved to be efficient when controlling epidemics caused by c. difficile. in recent years its epidemiology has changed leading to increased morbidity and mortality in many countries. c. difficile infections are often difficult to treat and reinfections frequently occur. the major concern is a new strain of c. difficile, o27, which produce many times more spores than other types and spreads easily in institutions. patients who have a c. difficile infection should be kept in contact isolation in hospitals and other institutions. c. difficile is a spore forming bacteria which is resistant to some normally used disinfectants like alcohol and quats. spores may remain viable for months in environment. disinfectants currently in use, like chloramines and glutaralde-hyde, are risk both for workers and to environment because of their corrosive and irritating nature. polyhexamethyleneguanidine(phmg) is a new disinfectant which is effective against microbes including bacteria and bacterial spores, viruses and fungi, safe to people handling it and friendly to environment and surfaces. it has been tested in the laboratory of helsinki university according to many en-standards to disinfectants. it can be used as a hand disinfectant, instrument disinfectant and surface disinfectant. phmg was introduced in three wards for hand hygiene and environmental disinfection in cdad patients' rooms. the rooms for showers and toilets were coated with biocide coating (phmg) as well as bed frames in investigational wards. three wards were control wards and continued using alcohol based hand disinfectants and routine environmental cleaning and disinfection with quats/chloramines. after 6 month's intervention period, the incidence of cdad cases were compared to that during the preceeding 10 months. surveillance for environmental and hcws´ hand contamination by c. difficile were performed by taking microbiological samples both from environmental sites and hands twice before intervention and then twice in month within intervention period.

Eligibility criteria:
inclusion criteria: ( classified as a hcf-onset, hcf-associated cdad ) * toxin or culture positive c difficile * symptom onset more than 72 hours after admission to hospital * symptom onset less than 4 weeks after discharge exclusion criteria: * recurrence of cdad within 8 weeks * symptom onset before admission to hospital or less than 72 hours after admission to hospital

Keywords: clostridium difficile disinfectant
preoperative hypnosis versus premedication in gynecological surgery

Conditions: Gynecologic Disease; Anxiety Disease

Summary: the aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by state-trait anxiety index (stai-y) self-administered questionnaire compared to premedication by alprazolam®.


Eligibility criteria:
inclusion criteria: * patient's age: over 18 years * patient care and follow-up at the regional maternity center of nancy (chru of nancy) * female patient for whom gynecological laparoscopic surgery is programmed and lasting longer than 1 hour (ovarian cyst, laparoscopy infertility, laparoscopic promontofixation, noncarcinogenic assisted laparoscopy hysterectomy, endometriosis, diagnostic laparoscopy, pyosalpinx, hydrosalpinx) * patient with physical status score (asa) score between 1 and 3 * with standardized anesthesia protocol * patient affiliated to a social security * patient has received complete information about the organization of the research and has signed her informed consent exclusion criteria: * pretreatment by benzodiazepines * known hypersensitivity to alprazolam® (including undocumented) * prohibition conditions to alprazolam®: severe respiratory insufficiency, sleep apnea syndrome, myasthenia, severe acute or chronic hepatic impairment * ongoing major depressive episode * chronic use (\> 1 month) of benzodiazepines or morphine or analgesics of level 2 * participation in a therapeutic trial 6 months before inclusion in this trial * patient referred to in articles l. 1121-5 to l. 1121-8 and l1122-2 of the public health code

Keywords: premedication/ hypnosis/ anxiety/surgery
hybrid ablation of persistent and long-standing persistent stand-alone atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study evaluates in detail efficacy and safety (including neurological safety) of hybrid ablation of stand-alone, persistent and long-standing persistent atrial fibrillation (af). an implantable ecg monitor will be implanted to all patients for rhythm monitoring. neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial doppler measurement.

hybrid ablation (i.e. surgical thoracoscopic ablation, followed by catheter endocardial ablation) represent a new treatment option for patients with atrial fibrillation. 60 patients will undergo a two-stage, hybrid ablation, all of them will have an ecg monitoring device implanted and will be followed for up to three years. neurological safety of both surgical and catheter procedures will be assessed by three examinations. magnetic resonance will be performed before surgery, 5 days after surgery and at the 180 days visit to search for (subclinical) cerebral ischemia. complex neuropsychological examination will be performed before surgery, afer 1 month after surgery and at 180 days visit to search for changes in cognitive functions, behavioral functions etc. transcranial doppler will be performed during surgical and catheter ablation to detect microembolic signals.

Eligibility criteria:
inclusion criteria: * patients age \> 18 years * patients with persistent/long-standing persistent af according to the standard ehra definition. * patients with symptomatic af that is refractory to at least one antiarrhythmic medication. * absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease) * ability to sign an informed consent exclusion criteria: * paroxysmal af * af secondary to a reversible cause (i.e., thyreopathy, etc.) * indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.) * severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the af is clearly of secondary etiology * known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)

Keywords: atrial fibrillation hybrid ablation
effect of transjugular intrahepatic portosystemic shunt on gut microbiota in cirrhotic patients

Conditions: Cirrhosis; Acquired Portal-systemic Shunt Due to Cirrhosis; Hepatic Encephalopathy

Summary: the purpose of this study is to determine the effect of transjugular intrahepatic portosystemic shunt on gut microbiota and associated inflammatory factors in cirrhotic patients.

cirrhosis is associated with qualitative and quantitative changes in the gut microbiota that can potentiate disease progression and complications such as hepatic encephalopathy (he) and infections. dysbiosis or altered gut microbiota, due to decreased autochthonous or commensal taxa, has been found in stool and colonic mucosa in cirrhotic patients, which is in turn linked with disease severity and systemic inflammation. tips can decompress the hypertensive portal vein,so that the intestinal congestion can be decrease too. hence we summarize that tips may have effect on gut microbiota and associated inflammatory factors in cirrhotic patients.

Eligibility criteria:
inclusion criteria: * cirrhotic patients who received tips; * treatment-naive to tips and major operation involving liver such as surgical shunt, hepatic resection and liver transplantation) exclusion criteria: * uncontrolled infection or sepsis; * hepatobiliary or pancreatic malignancy or biliary obstruction; * vital organ dysfunction; * administration of antibiotics (after tips and 2 weeks before tips); * cachexia; * pregnant or breeding women

Keywords: cirrhosis gut microbiota transjugular portosystemic shunt hepatic encephalopathy
early detection of aortic stenosis in the community during flu vaccination

Conditions: Aortic Stenosis

Summary: prospective cohort study to test the hypothesis that patients identified with severe aortic stenosis are under-diagnosed and under-treated. such patients shall be identified by auscultation or target echocardiography during flu vaccination. the hypothesis is that this will increase detection of aortic stenosis in the community.

the design plans for two study phases: 1. feasibility study: screening by auscultation and target echocardiography during flu vaccination in a single practice in birmingham; 2. screening study: multi-centre screening by auscultation or target echocardiography in geographically diverse general practices across the united kingdom. in each phase, the patient will be identified by auscultation and target echocardiography. management and onward referral will be at the clinical discretion of the gp. results of clinical review, investigation, follow-up and management will be recorded at 3 months from that date.

Eligibility criteria:
inclusion criteria: * adults aged over 65years attending for influenza vaccination. * written informed consent to data collection exclusion criteria: * known aortic stenosis * previous aortic valve repair/replacement

Keywords: aortic stenosis, auscultation, target echocardiography
study to obtain blood and voided urine samples to improve the diagnosis of melioidosis

Conditions: Melioidosis; Systemic Inflammatory Response Syndrome; Suspected or Confirmed Bloodstream Infections

Summary: clinical samples \[blood and voided urine (only for phase a)\] from patient recruited at sihanouk hospital centre of hope (shch) and hope community medical center (cmc) will be processed (decontamination) and shipped to sri international with the purpose of design and validation (proof of concept) and (case/control series) of in-vitro diagnostics for melioidosis.

study will be proposed to all patients at sihanouk hospital centre of hope (shch) and hope community medical center (cmc) presenting with systemic inflammatory response syndrome (sirs). blood samples will be collected upon admission for patients with blood culture request as part of routine patient care and agreement on informed consent. a second sample will be collected in patients with blood culture proven melioidosis or suspicion of melioidosis (only for phase b), at day 5 after initiation of appropriate antibiotic treatment. depending on the final diagnosis, a subset of patients will be assigned to 3 groups: 1. patients for whom blood cultures grew burkholderia pseudomallei 2. patients for whom blood cultures did not grow a pathogen, but have other body site grown with burkholderia pseudomallei, or are suspected of melioidosis 3. patients for whom blood cultures grew with another pathogen in phase a only, at least 20 ml of voided urine will be collected when a patient is hospitalized and identified as belonging to study group 1, 2 or 3. a second collection of voided urine will be collected for group 1 and 2 patients during routine further hospital stay or a routine follow-up visit. the clinical samples from these patients will be processed and shipped to sri international with the purpose of design (=phase a) and validation (=phase b) of in-vitro diagnostics for melioidosis. a coded database will be completed with basic demographic, clinical and microbiological data and final diagnosis. this coded information will be provided to sri international.

Eligibility criteria:
inclusion criteria: * adult (\>18 years old) * blood culture request by treating physician as part of standard care * willing to give informed consent exclusion criteria: * refusal to give informed consent

Keywords: blood infection, melioidosis, rapid diagnostic test
guard-aki: validation of aki-sapere in cardiac surgery patients

Conditions: Coronary Artery Disease

Summary: cardiac surgery associated acute kidney injury (csa-aki) has been recognized as the second most common cause of hospital acquired aki. the development of csa-aki is independently associated with an increased risk of in-hospital death. there are currently no biomarkers that could identify patients at higher risk for aki and current risk predictor scores that are based on clinical and demographic information are inadequate. therefore, a diagnostic test for predicting aki risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent csa-aki occurrence and improve patient outcomes. the primary purpose of this study is to validate a panel of biomarkers identified in the discovery study (referred to as aki-sapere prognostic) to identify patients at risk for all stages of csa-aki.


Eligibility criteria:
inclusion criteria: * adult patients (\>40 years) undergoing non-emergency (urgent or scheduled) cardiac surgery using cardiopulmonary bypass (cabg or combined cabg/valve). * patients must be able to understand english and be willing to sign informed consent. exclusion criteria: * emergency surgery * off-pump coronary bypass grafting * aortic aneurysm repair * congenital heart disease repair * heart transplant or left ventricular assist device patient * severe heart failure (left ventricular ejection fraction \<25%) * hemodynamic instability or requiring preoperative vasopressors or iabp * pre-existing kidney disease (egfr \<30 ml/min/1.73 m2) or renal transplantation. * presence of major active infection (chronic or acute, eg, sepsis, hiv, pneumonia) * chronic liver disease/cirrhosis * participation in an additional trial at the time of surgery or anytime within 30d of surgery where intervention could potentially alter renal health (unless in the control arm)
motherhood and microbiome

Conditions: Preterm Birth

Summary: this is a prospective cohort, enriched with women with a prior term birth, of singleton pregnancies who will be followed for the outcome of preterm birth. the main exposure of interest is the characterization of the cervico-vaginal microbiota. women will be recruited from a population seeking routine obstetrical care at obstetrical practices at penn. they will have three research visits during pregnancy to complete questionnaires and collect samples of cervico-vaginal fluid and cervical cells. outcome data will be collected about the prenatal events and timing of delivery.

patients will be recruited around the time of their routine obstetrical visits. they will be asked to participate in three visits total. visit one/enrollment occurs between 16 and 20 weeks of gestation, visit two at 20-24 weeks, and visit three at 24-28 weeks. at each visit, vaginal swabs will be collected. the patient will also be asked to fill out a series of surveys related to stress, anxiety,and depression in pregnancy. research coordinators will perform chart abstraction after delivery.

Eligibility criteria:
inclusion criteria: - pregnant women receiving care in university of pennsylvania health system exclusion criteria: * non-singleton pregnancy (twins, triplets, etc.) * known major fetal anomaly * known hiv positive status * history of organ transplant * chronic steroid use (greater than 20 mg per day for more than 30 days at the time of first study visit)

Keywords: cervicovaginal microbiome microbiome preterm birth cervical remodeling preterm delivery microbiota
bobath and vojta therapy for ds

Conditions: Down Syndrome; Motor Performance; Bobath Therapy; Vojta Technique

Summary: different physiotherapy approaches and education programs are applied to minimize motor and mental impairment in children with down syndrome (ds). the present study was conducted with the aim of comparing the effectiveness of two different physiotherapy approaches in babies with down syndrome in the early period. a total of 23 babies with ds aged between 0-24 months were included in the study. infants were randomly divided to two groups: bobath therapy (bt) group included 12 infants (6 girls and 6 boys) and vojta technique (vt) group included 11 infants (4 girls and 7 boys). the infants were applied a total of 12 sessions of physiotherapy (twice weekly during 6 weeks). alberta infant motor scale (aims) was used for comparison of motor development level before and after the therapy. emotional status of the mothers was evaluated with beck depression scale (bds) and quality of life was evaluated with nottigham health profile (nhp).


Eligibility criteria:
inclusion criteria: * being between 0 and 2 years * being diagnosed with ds exclusion criteria: * having an additional neuro-motor disease

Keywords: infant with down syndrome bobath therapy vojta technique