Kornimate/medical-research-clean huggingface dataset:
effectiveness of dental caries arrest treatment in primary teeth using agno3 followed by naf varnish

Conditions: Early Childhood Caries

Summary: * aim: this randomised controlled trial will systematically compare the efficacy of a 25% agno3 solution followed by 5% naf varnish with that of a 38% sdf solution in arresting caries teeth among preschool children when applied at half-yearly intervals over a 30-month period. * method: the extension of the consolidated standards of reporting trials 2010 statement will be followed for this 30-month, randomised, double-blinded, non-inferiority clinical trial. approximately 2,400 kindergarten children will be screened and at least 826 children with caries will be recruited. this sample size is sufficient for an appropriate statistical analysis (power at 90% \[β=0.10\] with a 2-sided type-i error of α=0.05), allowing for a 18% drop-out rate. the children will be randomly allocated into 2 groups to treat their caries over a 30-month period: group a - biannual application of a 25% agno3 solution followed by a 5% naf varnish, and group b - biannual application of a 38% sdf solution followed by a placebo varnish.clinical examinations will be conducted at 6-month intervals to assess whether the caries are arrested. information on confounding factors such as oral hygiene habits will be collected through a parental questionnaire. * possible results and implications: as the first of its kind, this study would help to determine whether agno3 followed by naf is at least as effective as sdf in arresting childhood caries. if so, because 25% agno3 and 5% naf contain less silver and fluoride, respectively, than 38% sdf, their use would be more favourable than sdf in young children.


Eligibility criteria:
inclusion criteria: * kindergarteners who have joined our outreach dental service will be invited to join this study. preschool children aged 3-4 years who have tooth decay and are attending the first year of kindergarten will be invited to join this study. exclusion criteria: * children who are uncooperative and difficult to manage, have major systemic diseases, or are on long-term medication will be excluded.

Keywords: silver nitrate sodium fluoride silver diamine fluoride caries non-inferiority trial
evaluation of the positioning of the dynacup cup "one c" versus "standard dynacup"

Conditions: Hip; Arthropathy

Summary: the ceramic-ceramic friction pair is widely used today in total hip arthroplasty, including fourth-generation ceramics which show the lowest wear rate. these have considerably reduced the risk of head fracture compared to previous generations; however, the risk of insert rupture persists with rates similar to those of third generation ceramics. these ceramic fractures require complex revision surgery, which brings complications, exposing patients to the risk of third-body wear and tear related to persistent post-surgical debris. they are frequently due to an incorrect assembly of the ceramic causing intraoperative or early postoperative rupture. to fix this, manufacturers have developed pre-assembled cups in the factory. the dynacup one c cup developed by corin® corresponds to the pre-assembled version of the dynacup cup, making it possible to eliminate the risk of anomaly during intraoperative assembly linked to the human factor and to offer patients with very small cups an adapted ceramic implant. a single study with a small sample compared the two implants (pre-assembled version \[vs\] modular version) clinically, radiologically and functionally without showing any significant difference. the lack of data in the literature comparing these two implants motivated us to conduct a randomized comparative study on a large sample of patients.

patients eligible for a total hip arthroplasty with a ceramic-ceramic friction couple and scheduled for surgery will be included in this study after information and collection of written consent. after randomization, a preoperative radiograph with a calibration ball will be taken to plan the prosthesis and identify the characteristics of the operated hip. an x-ray of the pelvis with a 28 mm ball will be carried out the day after the intervention according to the same preoperative procedures in order to measure the postoperative radiographic parameters.

Eligibility criteria:
inclusion criteria: * adult man and woman \> 18 years old * indication for hip arthroplasty with a dynacup one c or standard dynacup cup * patient informed of the study and signed a consent form exclusion criteria: * refusal to participate in the study * indication of a friction couple other than ceramic-ceramic * contraindication or the technical impossibility of implanting an impacted acetabular component * pregnant or breastfeeding women. * minor patients aged \< 18 years * subjects not affiliated to the national health insurance or to an equivalent insurance

Keywords: one-c stadard dynacup
percutaneous temporary placement of a phrenic nerve stimulator for diaphragm pacing, a first in human trial

Conditions: Ventilator Induced Lung Injury

Summary: study conducted to confirm phrenic nerve stimulation using the lungpacer live catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.

this study is being conducted to determine if in an anaesthetized (sedated, intubated and mechanically ventilated) subject the live catheter can be inserted percutaneously and activated via the electrical stimulator to stimulate the left and right phrenic nerves causing the diaphragm to contract in synchrony with mechanical ventilator breaths via phrenic nerve stimulation from a transvenously delivered electrical current.

Eligibility criteria:
inclusion criteria: * able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent. * able to undergo general anaesthesia (sedation, intubation and mechanical ventilation) * susceptible indication for atrial septal defect closure exclusion criteria: * subject has an ef of \< 30% * subject has a co-morbid illness or life expectancy \< 2 years * subject has experienced an ami within 72 hours prior to this procedure * subject is contraindicated for or unwilling to take aspirin or anticoagulants * subject is in cardiogenic shock * subject has other cardiovascular disease requiring open heart surgery * subject is known to have a demonstrated intra cardiac thrombus on echocardiography * subject has been treated with paralytic medications within 72 hours prior to procedure * subject has significant thoracic abnormalities such that placement of a left subclavian line would be difficult * inability to cannulate the left subclavian vein (post-consent exclusion) * subject has a known or suspected phrenic nerve paralysis * subject has co-existing temporary or implanted cardiac electrical devices such as a pacemaker or defibrillator * subject has an active systemic infection or local infection at or around the insertion site * subject is known or suspected to be pregnant or is lactating * subject will be unavailable for, or is unwilling to comply with, follow up requirements of the protocol * subject is currently enrolled in any other study of an investigational drug or device who has received treatment under that protocol with the investigational product during the 30 days prior to screening.
acupuncture for migraine prophylaxis

Conditions: Migraine Without Aura; Unilateral Headache

Summary: hypothesis: acupuncture obtains an abiding effect on migraine prophylaxis design: a open-label randomized controlled trial. 249 participants will be included. three arms: acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.

aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis design: a open-label randomized controlled trial will be performed in chengdu, hunan and chongqing province. two hundred and forty-three participants will be randomly assign to acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. after all the treatments was accomplished, there will be 5 times follow-ups in the impending every 4 weeks. the primary outcome is frequency of migraine attacks 16 weeks after inclusion. secondary outcomes include frequency of migraine attacks at the 4th and 24th week, headache severity, msq(migraine specific quality of life questionnaire msq version2.1), etc.

Eligibility criteria:
inclusion criteria: * age of a subject is between 18 and 65 years old(initially occured beneath the age of 50), male or female; * in accordance with diagnosis of migraine without aura in international classification of headache disorders, ichd-2, by ihs; * 2 to 8 times attack per month in recent 3 months, with each period beyond 15 days; * with migraine history for over 1 year; * be able and willing to finish the headache diary in baseline ; * informed consent form must be signed by patient or lineal relative; exclusion criteria： * patients who are unconscious, psychotic. * patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding. * with serious primary illness or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on. * pregnant women or women in lactation.

Keywords: acupuncture migraine prophylaxis
pet/ct: role in detecting unknown primary head and neck cancer

Conditions: Head and Neck Cancer

Summary: historically metastatic squamous cell carcinoma in a cervical lymph node from an occult primary malignancy of the head and neck was evaluated with panendoscopy and biopsies of high risk areas, such as the base of tongue, nasopharynx, and tonsils. this diagnostic protocol identifies the primary malignancy in about 50% of cases. in recent years, the availability of ct has slightly increased the detection rate to 65% when used as an adjunct to the traditional work-up. studies using pet as an adjunct are conflicting with detection rates ranging up to 75%. currently, no prospective study has analyzed the role of the pet-ct fusion in the work-up of an occult primary malignancy of the head and neck. this study will compare the detection rate of the traditional work-up to a new protocol involving a pre-operative diagnostic pet-ct.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * biopsy proven scc in a cervical lymph node * unknown primary cancer after: history, physical exam, and office endoscopy by otolaryngologist * negative chest x-ray for malignancy * patient consent signed to undergo investigative protocol exclusion criteria: * un-fit for general anesthesia * unable to lie flat for 45 minutes * unable to fast for \> 6 hours * unable to perform pet-ct (obesity \> 150kg) * pregnant * prior head and neck cancer * any invasive cancer (non-head and neck) within the last 2 years

Keywords: unknown primary, head and neck cancer, squamous cell carcinoma unknown primary head and neck cancer
evaluation of plasma non-coding rnas as biomarkers in coronary heart disease

Conditions: Coronary Disease

Summary: the purpose of this study is to determine whether the expression level of mir-320a are effective as biomarker in evaluating the diagnosis, prognosis and treatment effects of coronary heart disease.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older; 2. the most recent symptoms of coronary heart disease within 7 days; 3. meet one of the following conditions: a. clinical history of typical ischemic chest pain (more than 5 minutes of persistent chest pain); b. serum cardiac biomarkers positive (tnt/i or creatine kinase peak greater than 99% of url); c. electrocardiogram changes of myocardial ischemia. exclusion criteria: 1. pregnant women or plan to; 2. participate in any drug clinical trials within 3 months; 3. patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years; 4. serious neurological disease (alzheimer's disease, parkinson syndrome, progressive lower limbs or deaf patients); 5. previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix); 6. patients refused to comply with the requirements of this study to complete the research work; 7. according to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons).
computerized olfactory test - alzheimer disease mild stage

Conditions: Alzheimer Disease; Olfaction Disorders

Summary: this study evaluates the effectiveness of the smell tests that are used in early diagnosis of mild dementia.

for twenty years research has shown a strong link between olfactory disorders and alzheimer's disease. the focus is on the very early alteration of the olfaction which acts as a harbinger of the disease since it is detectable in its asymptomatic phase. in addition, olfactory involvement is a precursor to the transformation of mild cognitive impairment into ma. indeed the anatomical structures the first lesions are located in the transentorhinal region of the temporal lobe and entorhinal phase, before progressing towards the limbic system, which will mark the clinical appearance of the first signs of ad. in literature, it has been shown that there was no olfactory test that is recognized as a gold standard in the scientific community due to a lack of homogeneity of the tools used, their availability and their validity depending on the culture. moreover, of all the tests currently available, none are specific to neurodegenerative diseases. very recent studies show that there is also a strong preference for imaging tools or biomarkers in the detection of ad, but it appears that the olfactory disorders are well before these markers. it has been shown that an identification test is comparable in predictive accuracy to neuroimaging and cerebrospinal fluid sampling. this study will therefore focus on the calibration and validation of a computerized olfactory test for the diagnosis of alzheimer's disease and based the recommendations of professionals so as to promote the effective use of this test in clinical practice.

Eligibility criteria:
inclusion criteria: * being 60 years old and over * the participants enrolled in the control group must have a score of the mini-mental state exam test greater than or equal to 28. * the participants enrolled in the intervention group must have a diagnosis of alzheimer's disease, and the score of the mini-mental state exam test should be between 20 and 27 exclusion criteria: * presenting an unstable, acute or current psychiatric or physical condition that is severe enough to prevent the participant from participating in the study, as determined by the investigator. * having an uncorrected major visual or hearing impairment or anosmia (total olfaction loss).
suicide risk scale and distress intervention for the patients with chronic medical illness or physical disabilities

Conditions: Chronic Illnesses; Physical Disability

Summary: the aims of this study are developments of distress intervention and a suicidal risk scale for the patients with chronic medical illness or physical disabilities. to do these things, four times of interview \& completion of self-report scale will be done, and newly developed distress intervention will be simulated to subject group and control group.

the aims of this study are developments of distress intervention and a suicidal risk scale for the patients with chronic medical illness or physical disabilities. to achieve the aims, multidisciplinary team is organized such as doctors of internal medicine, rehabilitative medicine, psychiatrist specialized in psychosomatics, psychologist, nurse, social worker and researchers. before developing the intervention and scale, review of literature about intervention, suicide, management system of chronic illness, several scales and others are done. also, qualitative interview and self report scale with those patients are done to figure out what bothers them most, how they feel, and what kind of help they need. based on collected data, means of intervention is carefully selected and further review of literature is proceeded. also, questions which describe patients' feeling, discomfort, and need are made. moreover, modified management system of chronic illness is planned to develop to link between those who need help among patients and multidisciplinary team members. once, the intervention is developed, subject group and control group are recruited in stroke patients, and the intervention is simulated. the change of distress is measured before and after the intervention, and 1 month later the intervention is finished with several tools such as whoqol-bref, perceived stress scale, rosenberg self-esteem scale, acceptance of disability scale, participation scale, pain belief \& perception inventory, insomnia severity index, facit-fatigue, hospital anxiety and depression scale, digit span, trail making test, stroop test, verbal fluency test. also, newly developed questions and other scales are performed among patients to determine whether the newly developed questions are appropriate and how well they reflect their difficulties and feelings. after selecting the appropriate questions, the revised version will be tested by the patients twice in a different time frame. if the revised version is appraised appropriate, it will be distributed as a cell phone application.

Eligibility criteria:
inclusion criteria: * patients with chronic illness or physical disabilities (heart failure, chronic kidney disease, stroke patients) exclusion criteria: * patients who have other severe illness such as cancer, severe memory impairment or intellectual disabilities and others
epidural calcitonin in lower limb amputation

Conditions: Amputation Stumps

Summary: a prospective randomized double-blind clinical trial design will be used in a cohort of sixty patients of both genders, physical status american society of anaesthesiologist (asa) i and ii who will undergo lower limb amputation, will be enrolled into the present study. patients will divided randomly into two equal groups: epidural bupivacain-calcitonin and fentanyl (bc) group and bupivacain- fentanyl (bf) group, comprising of 30 patients each.

a cohort of sixty patients of both genders, physical status american society of anaesthesiologist (asa) i and ii who will undergo lower limb amputation, will be enrolled into the present study. patients will divided randomly into two equal groups: epidural bupivacain-calcitonin and fentanyl (bc) group and bupivacain- fentanyl (bf) group, comprising of 30 patients each.

Eligibility criteria:
inclusion criteria: * prospective randomized double-blind clinical trial design will be used in a cohort of sixty patients of both genders * physical status american society of anaesthesiologist (asa) i and ii * will undergo lower limb amputation exclusion criteria: * history of pituitary gland dysfunction * cardiac disease * chronic obstructive respiratory disease * contraindications to performing an epidural block such as: * coagulation abnormalities * spinal deformities, and * patients allergic to local anesthetics and or calcitonin will be excluded from the study

Keywords: epidural calcitonin amputation postoperative pain later complication
glycemic efficacy and renal safety study of dapagliflozin in subjects with type 2 diabetes mellitus and moderate renal impairment

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

all eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. all arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial

Eligibility criteria:
inclusion criteria: * males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control * clinical diagnosis of moderate renal impairment exclusion criteria: * ast and /or alt \> 3.0 times the upper limit of normal * serum total bilirubin \> 1.5 times uln * symptoms of severely uncontrolled diabetes * currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
selective use of antibiotics in neonates born to mothers with suspected chorioamnionitis

Conditions: Chorioamnionitis

Summary: retrospective chart review to determine the selective use of antibiotics in neonates born to mothers with suspected chorioamnionitis

to determine the incidence and types of adverse outcomes in infants born to mothers with signs of chorioamnionitis when these infants are asymptomatic and are not treated with antibiotics empirically.

Eligibility criteria:
inclusion criteria: • mother/baby dyads in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever (as diagnosed by obstetrician) exclusion criteria: none