Kornimate/medical-research-clean huggingface dataset:
maternal consumption of xylitol to reduce early childhood decay (maxed study)

Conditions: Dental Caries; Oral Microbial Colonization

Summary: the purpose of this study is to determine if the childsmile programme (www.child-smile.org) with the additional maternal use of xylitol is more effective at reducing dental decay in children than a childsmile program alone. the children will be compared in the two groups at age two, to determine how the interventions affected the early colonization of mutans streptococci, an important risk factor of tooth decay. at three and at five years the investigators will also examine the amount of tooth decay in these children. using midas (scotland's national health service dental data) records, the investigators will follow the oral health of the children until the age of 5 years. main hypothesis: the maternal consumption of xylitol reduces early childhood caries

xylitol has been shown to decrease mutans streptococci transmission between mother and child. such maternal consumption of xylitol studies have, however not been tested in a scottish population. sign 83, (www.sign.ac.uk/pdf/sign83.pdf) a scottish government publication states that carrying out research in this area is needed. childsmile (www.child-smile.org) is a scottish government programme that promotes oral health from birth, particularly amongst people living in priority areas. parents of newborn children who are assessed to be at risk of developing tooth decay are referred to the programme by their health visitor. parents are visited at home by a dental health support worker. the dental health support worker will give more information, advice and arrange regular visits for participants to their local dental practice. this research study will compare two groups; one group randomised into the childsmile preventative programme, the other group randomised into the childsmile preventative programme plus consuming 5 grams of xylitol per day. we will be testing the mutans streptococci of the mother, at start of the study, and testing the mutans streptococci of mother and child at (child) aged two, in both groups- we will then be testing the dental decay of children in both groups the research study will use existing nhs fife funding. nhs fife currently employs approximately 15 dental health support workers, of which part of their role will be to support this project recruiting of study is planned to start in january 2010.

Eligibility criteria:
inclusion criteria: * mother with high counts of ms (ms equal or higher than log 5) * child less than 3 months of age * has a close relationship with fife (e.g. lives or works in fife) * child seen by health visitor * mother who is the main carer of her children exclusion criteria: * mother with low or no ms * child older than 3 months of age * child not seen by health visitor * no close relationship with fife (e.g. doesn't live or work in fife) * mother who is not the main carer of her children

Keywords: xylitol mutans streptococci maternal consumption early childhood tooth decay early childhood caries childsmile
ultrasound guided pudendal block in transurethral prostatectomies

Conditions: Pain, Postoperative

Summary: the pudendal nerve conveys sensory, motor, sympathetic fibres to the perineum, bladder neck and proximal urethra. pain management during transurethral procedures is a major concern.patients who have been catheterized under anesthesia complained of urgency in the postoperative period because of catheter-related bladder irritation. we want to investigate that the effect of pudendal block to postoperative pain, bladder spasm and patient comfort in transurethral prostatectomies

outcome measures usg guided transperineal pudendal block success postoperative pain score (vas score) postoperative bladder spasm (severity of bladder discomfort will record as severe(behavioral responses such as strong vocal response, flailing limbs),moderate (not accompanied by any behavioral responses) and no bladder discomfort. postoperative patient's comfort (poor, sufficient, good)

Eligibility criteria:
inclusion criteria: * asa i,ii,iii status * who were scheduled to have elective transurethral resection of the prostate exclusion criteria: * chronic renal failure * coagulopathy * active anorectal disease * active urinary tract infection * uncontrolled diabetes

Keywords: pudendal nerve block postoperative pain bladder spasm
prospective study of celiac block injection: 1 vs. 2

Conditions: Chronic Pancreatitis; Pancreatic Cancer

Summary: the purpose of this prospective randomized study is to compare the clinical effectiveness of eus-guided cb performed with a single injection versus two injections of medication into the celiac ganglion region.


Eligibility criteria:
inclusion criteria: * patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer that are referred for eus-guided celiac block will be eligible to participate in this study. chronic pancreatitis and pancreatic cancer must be measured and documented by prior ct, ercp, or eus. * patients should not have significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (copd) that would limit survivability of the sedation given or the procedure. * age \> or = to 18 years * no evidence of significant active infection (ie. pneumonia, peritonitis, wound sepsis, etc) * no evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc) * no evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol. * patient must provide signed written informed consent. * patients that have had a previous celiac plexus block are eligible for this study exclusion criteria: * the patient's celiac trunk should be imaged clearly under endoscopic ultrasound. the patient's celiac plexus should be accessed easily with a needle for the medication injection. if this cannot be done safely due to the patient's anatomy (intervening blood vessel or tumor), the patient will not be eligible for the procedure or study.
adch63 me-trap and mva me-trap malaria vaccines evaluation in healthy adults and children in a malaria endemic area

Conditions: Malaria

Summary: the purpose of this trial is to assess the safety and immunogenicity of mva me-trap and adch63 me-trap candidate vaccines in healthy children and adult volunteers in a malaria endemic region. the regimen proposed here has protected non-immune volunteers in oxford against sporozoite challenge, and so may be protective against naturally acquired infection in the gambia.


Eligibility criteria:
inclusion criteria: * consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.with consenting parents. exclusion criteria: * clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. * severe malnutrition. * hypersensitivity to hdcrv. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, kathon, neomycin, betapropiolactone. * history of splenectomy haemoglobin less than 9.0 g/dl, where judged to be clinically significant in the opinion of the investigator * serum creatinine concentration greater than 70 mol/l, where judged to be clinically significant in the opinion of the investigator * serum alt concentration greater than 45 u/l, where judged to be clinically significant in the opinion of the investigator * blood transfusion within one month of enrolment. * history of vaccination with previous experimental malaria vaccines. * administration of any other vaccine or immunoglobulin within two weeks before vaccination. * current participation in another clinical trial, or within 12 weeks of this study. * any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial. * likelihood of travel away from the study area. * hiv positive. * positive malaria antigen test

Keywords: vaccine immune response
collections of blood and stool samples in patients with acute hepatitis

Conditions: Hepatitis

Summary: hepatitis is an inflammation of the liver. hepatitis can be caused by an infection with a virus, but poisonous (toxic) substances can also cause it. researchers have identified several of the viruses responsible for hepatitis, however some patients with hepatitis show no evidence of being infected with known hepatitis viruses. researchers call conditions like this, seronegative hepatitis. it means that a patient has hepatitis but he/she does not have evidence in their blood of a viral infection. seronegative hepatitis is often complicated by autoimmune disorders and associated severe disorders especially, fulminant hepatitis of childhood and post-hepatitis aplastic anemia. researchers have attempted to identify the cause of these conditions but have been unsuccessful. therefore, this study was developed to collect blood and stool samples from patients with seronegative hepatitis in order to help identify the virus responsible.

while several viruses have been identified as agents of liver inflammation, some proportion of cases of acute hepatitis are seronegative and show no evidence of prior infection with known hepatitis viruses a, b, c, or e. seronegative acute hepatitis is often complicated by autoimmune phenomena or late severe consequences, especially fulminant hepatitis of childhood and post-hepatitis aplastic anemia. efforts in the hematology branch to identify an infectious agent in these latter two syndromes have been unsuccessful, probably because they are immune-mediated and also accompanied by massive tissue destruction. we now propose systematic collection of blood and fecal samples from patients with seronegative acute hepatitis for purposes of virus identification research. samples will be collected from patients in united states army clinics; patient identifiers will be employed.

Eligibility criteria:
collection of blood samples.

Keywords: liver disease novel agents serum viruses non-a,g hepatitis seronegative acute hepatitis
earlier detection and optimization of treatment and prognosis for patients with early-onset colorectal cancer

Conditions: Early-onset Colorectal Cancer

Summary: the study aims to collect high quality clinical data on lifestyle and patient biomaterials prior to start or during / after treatment of early-onset colorectal cancer (eocrc) and to inform on treatment and survival outcomes of eocrc patients.

the current study will be complementary to compraya, a prospective cohort study focused on risk factors of impaired medical and psychosocial outcomes of adolescents and young adults with cancer (aya) and to genaya, focused on genetic testing of aya. the collected data and materials will be essential for an in-depth analysis of the epidemiology, exposomes and pathophysiology of eocrc and compare this with average-onset crc (aocrc) and healthy controls. these data will facilitate multiomics studies and the identification of high-risk profiles and blood- and/or stool-based biomarkers, which in turn will enable the development of prevention and early detection strategies to ultimately improve prognosis and the prevalence, risk factors and mechanisms of impaired health outcomes (short- and long-term medical and psychosocial effects and late effects) over time among eocrc patients wil be examined.

Eligibility criteria:
inclusion criteria: * patients with locoregional or metastatic colorectal cancer (crc) * histologically proven crc * age 18 - 49 years at time of first crc diagnosis * able to understand the informed consent form * provide written informed consent. exclusion criteria: * mentally incompetent patients based on the opinion of treating physician * inability to understand the dutch language
vibration training in epicondylitis

Conditions: Epicondylitis; Pain; Tendinopathy

Summary: a number of different therapeutic approaches to treat lateral epicondylitis have been tested partly in randomized trials, such as polidocanol sclerosing injections, botulinom toxin a injections, braces, surgery and topical no patches. one study indicates that patients with lateral epicondylitis (lateral elbow tendinopathy) have poorer elbow proprioception in contrast to healthy controls (juul-kristensen b, et al., j shoulder elbow surg 2008;17(1 suppl):72s-81s.) based on a suggested poorer elbow proprioception in lateral elbow tendinopathy, the investigators hypothesize that a dedicated proprioceptive intervention might be able to reduce pain and improve function. as such a rct is planned with two intervention arms with proprioceptive training using the flexi-bar vibration device (www.flexi-bar.co.uk) +/- the xco-trainer (www.xco-trainer.co.uk) over twelve weeks.

the investigators sought to evaluate the clinical effects of either a vibration training using the flexi-bar vibration device (www.flexi-bar.co.uk) +/- the xco-trainer (www.xco-trainer.co.uk) in a randomized trial among patients suffering lateral elbow tendinopathy (lateral epicondylitis). primary outcome measure of this clinical trial is pain on a visual analogue scale (vas 0-10) before and after 12 weeks of training. secondary outcome parameters involve dash score before and after, grip strength (jamar), vibration and two-point discrimination (mm).

Eligibility criteria:
inclusion criteria: * lateral elbow tendinopathy * informed consent * ability to run at least 40-60min per week with a xco-trainer device exclusion criteria: * other sources of lateral elbow pain (joint instabilities, fractures) * no consent * no ability to run at least 40-60min per week using a xco-trainer device

Keywords: epicondylitis pain tendon
the effect of high frequency jet ventilation (hfjv)during laparoscopic operations

Conditions: Cholecystolithiasis

Summary: investigators conducted a randomised perspective study to determine whether the use of hfjv instead of conventional mechanical ventilation will reduce the adverse cardiovascular effects of pneumoperitoneum during laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * healthy patients, undergoing laparoscopic surgery for symptomatic cholecystolithiasis. exclusion criteria: * asa 3 and 4

Keywords: pneumoperitoneum laparoscopy hfjv cardiovascular symptomatic
study of the efficacy and safety of npc-15 for sleep disorders of children with neurodevelopmental disorders

Conditions: Sleep Disorders; Neurodevelopmental Disorder

Summary: the purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of npc-15.

this study will be a multicenter and open label trial. the trial has three phases; the screening phase, treatment phase and post-treatment phase. the screening phase comprises a screening visit where subject's initial eligibility will be evaluated. during open label treatment phase, all patients will be administered npc-15 1 mg, 2 mg or 4 mg on the basis of their doctors' judgements.

Eligibility criteria:
inclusion criteria: * female or male patients aged 6 to 15 years. * patients with "neurodevelopmental disorder" diagnosed by using dsm-5. * patients with average of daily sleep latency persisted over 30 min and the condition is continuous over 3 months * patients who are out-patient, not hospitalized patient. * signed informed consent obtained from rearer(s)/parent(s)/guardian(s) of the patient, or signed ic or informed assent obtained from the patient themselves. exclusion criteria: * patients with at least severity in either conceptual area, or social area, or practical area of intellectual disability have judged more than " the most severe" by using dsm-5. * patients who took melatonin (including supplement) in history. * patients who had taken ramelteon within 4 weeks before clinical study starts.

Keywords: melatonin npc-15 sleep disorders neurodevelopmental disorder sleep latency dsm-5
a study to determine the effect of welchol tablets on cholesterol in patients who have been taking simvastatin for at least 4 weeks.

Conditions: Hypercholesterolemia

Summary: the primary objective is to determine the effect of welchol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.


Eligibility criteria:
inclusion criteria: * males or females * \> or = to 18 years of age * on a stable dose of simvastatin for 4 or more weeks * ldl-c \> or = to 115 mg/dl and \< or = to 250 mg/dl * tg \< 300 mg/dl * women are not pregnant or breast-feeding or planning to become pregnant * women had a hysterectomy or tubal ligation or are post menopausal or are practicing an acceptable method of contraception exclusion criteria: * bmi \> 40 * allergic to colesevelam hcl * history of swallowing disorder * history of gastrointestinal motility disorder * any disorder that might interfere with the study * history of drug or alcohol abuse
ses, health behaviors and cvd among vietnam-era twins

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to further characterize the nature of the association between socioeconomic status (ses), health behaviors and early cardiovascular disease in the vietnam era twin (vet) registry, a sample of over 4,000 twin pairs.

background: cardiovascular disease (cvd) affects approximately 60,800,000 americans each year, claiming the lives of nearly one million of these people (american heart association, 2001). cvd is likely to be complex in etiology, reflecting the combined effect of both genes and environment, as well as gene x gene and gene x environment interaction. examination of environmental factors thought to affect cvd risk in the context of a genetically informative design can help elucidate the relative contribution of genetic and environmental factors and potentially aid in identifying environmental factors that may interact with genetic vulnerability in predicting cvd. cardiovascular morbidity and mortality are over-represented among individuals in lower socioeconomic strata, as are behaviors that increase the likelihood of cardiovascular events, including smoking, heavy alcohol consumption and physical inactivity (adler et al., 1994; anderson \& armstead, 1995). thus, it is commonly assumed that socioeconomic status (ses) serves as an important environmental influence on health and health behaviors. twin studies partition genetic and environmental variance and detect gene x environment interaction and provide a unique opportunity to study the association between ses and health. design narrative: the study will characterize the nature of the association between socioeconomic status (ses), health behaviors and cardiovascular disease (cvd) in the existing vietnam era twin (vet) registry, a sample of over 4000 male twin pairs with a mean age of 51 in 1999. specifically, the study will: 1) determine how strongly environmental factors contribute to individual differences in ses, health behaviors and cvd, relative to genetic factors; 2) examine whether measures of ses are associated with health behaviors and cvd mortality when controlling for concomitant genetic influences; and 3) investigate whether ses interacts with genetic vulnerabilities to predict health behaviors and cvd (gene x environment interaction). using vetdatasets, the primary method of analysis will be twin structural equation modeling.

Eligibility criteria:
no eligibility criteria
comparison between rectal suppository acetaminophen and diclofenac sodium as analgesia for postpartum perineal tear

Conditions: Perineal Tear; Perineal Laceration (Obstetric)

Summary: to assess the prevalence of pain score for perineum pain following childbirth followed by phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal suppository in postpartum perineum pain secondary to perineal trauma.

studies has demonstrated that non-steroidal anti-inflammatory drugs (nsaids) rectal suppositories are associated with less pain up to 24 hours after birth, and less additional analgesia is required. therefore, in view of rectal route of analgesic administration is better in local action and systemic paracetamol also proven to be effective in controlling post-partum perineal pain with unknown effectiveness in its suppository form; the investigators would like to conduct this study to investigate the effectiveness of acetaminophen rectal suppository versus diclofenac rectal suppository in controlling postpartum perineal pain. this study will be conducted in 2 stages. stage 1 is a 3 months prospective observational study which aims to determine the prevalence and severity of perineal pain following childbirth in hospital sultanah aminah, johor bahru; while stage 2 is a single blinded, open-labelled, randomized control trial study design which will determine if acetaminophen rectal suppository is as equivalence as diclofenac rectal suppository in reducing postpartum perineal pain secondary to perineal trauma.

Eligibility criteria:
inclusion criteria: stage 1: a) all pregnant women who sustained perineal trauma (either 1st degree tear, 2nd degree tear or episiotomy) post vaginal delivery stage 2: 1. all pregnant women who have planned vaginal delivery in hsajb from 1st january 2016 till 30th june 2016. 2. all pregnant women who sustained 1st degree/ 2nd degree perineal tear or episiotomy tear post vaginal delivery. 3. all pregnant women who have consented to involve in the study. exclusion criteria: stage 1: 1. patient who sustained additional perineal tear (eg. labial tear or periurethral tear) following childbirth. 2. patient who developed post-partum complications. stage 2: 1. patient who is allergic to paracetamol or voltaren. 2. patient who is unable to or unwilling to give consent. 3. patient who is ended up with caesarean section. 4. patient who sustained additional perineal tear including labial tear or periurethral tear. 5. patient who developed postpartum complications (eg. retained placenta, uterine atony, postpartum haemorrhage, multiple vaginal wall tear etc. )
safety and efficacy of inactivated sars-cov-2 vaccine in immune-related myopathy (myasthenia gravis and inflammatory myopathy) patients ：a prospective observational study

Conditions: Covid19; Myopathy

Summary: this study is a prospective observational study. we aim to investigate the safety and efficacy of inactivated sars-cov-2 vaccine between immune-related myopathy (myasthenia gravis and inflammatory myopathy) patients and health controls. the main study factors include adverse events following immunization (aefi), serum specific antibody (acetylcholine receptor (achr) antibody, anti-musk (muscle-specific kinase) antibody, myositis antibody) and virus neutralizing antibody titers.


Eligibility criteria:
inclusion criteria: 1. complete behavioral ability 2. voluntary willingness to vaccinate 3. clinically confirmed immune-related myopathy (myasthenia gravis and inflammatory myopathy) and immune-related myopathy (myasthenia gravis and inflammatory myopathy)was stable 4. informed consent to the research exclusion criteria: 1. no independent behavior ability 2. vaccination is contraindicated 3. other diseases that significantly affect the immune function 4. other diseases that may significantly affect immune function are being treated 5. vaccination contraindication was found during the study observation period 6. other diseases that may significantly affect immune function were diagnosed during the study observation period 7. treatments for other diseases that may significantly affect immune function were initiated during the study observation period 8. refused regular follow-up