Kornimate/medical-research-clean huggingface dataset:
a clinical trial to evaluate long-term efficacy and safety of lozenges containing lactobacilli reuteri (prodentis™) on gingivitis

Conditions: Gingivitis

Summary: the purpose of this study is to evaluate the long-term efficacy and safety of lozenges containing probiotics in reducing gingivitis. the primary purpose of this study is to support claims from u.s. instructions for use (ifu) for gum® periobalance®.


Eligibility criteria:
inclusion criteria: * willing and able to read, understand and sign an informed consent form. * good general health as evidenced by the medical history. * between 18 and 65 years of age. * male or female. * minimum of 20 teeth, excluding crowns and third molar teeth. * mean whole mouth modified gingival index of greater-than or equal to 2.0 at baseline. * willing to abstain from all oral hygiene procedures for 12-18 hours prior to clinical visits. * willing to abstain from eating and drinking in the morning of visits, only drinking water is allowed. * willing to abstain from interdental cleaning, chewing gums, oral whitening, mouth rinse and tobacco products for the study duration. * able to understand and follow study directions. * no known history of allergy to dairy products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study. exclusion criteria * presence of orthodontic appliances. * intra-oral soft tissue lesions due to pathology or trauma * patients with aggressive periodontitis, acute necrotizing ulcerative gingivitis, or gross decay at discretion of pi. * more than two sites with pocket depth \>5mm and concomitant attachment loss of \>2mm. * pregnant or lactating females or females of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence). * use of antibiotics within 3 months of enrollment * history of drug use that is associated with gum overgrowth (i.e., dilantin, nifedipine, etc) * chronic use of medication such as steroids, nsaids (more than 2-3 days/week), anti-coagulant medications, immunosuppressant medications or any other medications that in the opinion of the investigator would interfere with the evaluation or confound interpretation of the study results. use of low dose of acetylsalicylic acid (81 mg) is permitted. * unwilling to sign a confidentiality statement and/or return the test products. * medical condition which requires pre-medication prior to dental visits/procedures. * immune compromised individuals (hiv, aids, immunosuppressive drug therapy). * current use of probiotics or probiotic containing food (i.e., yogurt)
evaluation of a new predictive test of preterm birth in case of threatened preterm labor

Conditions: Threatened Preterm Labor; Preterm Delivery

Summary: threatened preterm labor (tpl) is defined by cervical changes and regular and painful uterine contractions occurring between 24 and 36 + 6 weeks of gestation that may or may not lead to premature labor and delivery. there is no reliable way to predict preterm delivery. the study's hypothesis is that the premaquick® test can improve the prediction of preterm delivery. the investigators also want to compare this test with the partosure® (placental alpha microglobulin-1) test.


Eligibility criteria:
inclusion criteria: * patient aged \> 18 years (with no upper age limit) * patient affiliated to a social security health regime * between 24 and 33 + 6 weeks of gestation (amenorrhea) * singleton pregnancy * patient with a tpl: uterine contractions during the last 24 hours felt by the patient, painful or not, and cervix less than or equal to 25 mm on endovaginal ultrasound * having signed an informed consent form exclusion criteria: * twin pregnancy * sexual intercourse less than 24 hours from inclusion * cervical cerclage * abundant metrorrhagia * premature rupture of membranes * pre-eclampsia * congenital malformation * presence of a placenta previa * pelvic examination in the previous 24 hours (compared to inclusion) * patient under guardianship, curatorship or safeguard of justice * persons deprived of their liberty by judicial or administrative decision * persons under psychiatric care under duress

Keywords: threatened preterm labor preterm delivery preterm birth igfbp-1
comparison of hypoglycaemic regimens during ramadan fasting in type 2 diabetes

Conditions: Diabetes, Type 2

Summary: type 2 diabetic patients who fast during ramadan experience swings in glycaemic control between hypoglycaemic troughs and hyperglycaemic spikes. hence, the dual challenge in fasting diabetics is to identify which treatment modality leads to the most stable blood glucose levels during a fast and how to smooth out these excursions and reduce risks of fast to a minimum.

study objectives: * to compare changes in clinical and metabolic parameters from baseline to the end of four weeks fasting in ramadan between four treatment arms: * diet and lifestyle measures alone. * metformin monotherapy. * combination therapy with metformin + sulfonylurea. * combination therapy with metformin + sitagliptin. * to compare the 24 hour cgms profile during ramadan fasting in type 2 diabetic patients before and after addition of acarbose to these pre-existing sub-maximal hypoglycaemic regimens.

Eligibility criteria:
inclusion criteria: * hba1c 6.5-9.5%. * type 2 diabetics on two or less oral hypoglycaemic agents. exclusion criteria: * any contraindications either to fasting or to any of the trial medication. * pregnancy. * serum creatinine \> 1.4 mg/dl. * serum alt \> twice upper limit normal. * history of pancreatitis, serum amylase \> twice upper limit normal. * history of intolerance to acarbose.
a study of an investigational zoster vaccine in subjects with a history of varicella (chickenpox) given concomitantly with another vaccine (v211-011)

Conditions: Herpes Zoster

Summary: the purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.


Eligibility criteria:
inclusion criteria: * adults 50 years of age or older exclusion criteria: * prior history of herpes zoster (shingles) * prior receipt of varicella or zoster vaccine * immunosuppressed

Keywords: prevention of herpes zoster
long-term cohort study of mesorectal excision for rectal cancer

Conditions: Rectum; Cancer

Summary: the aim of this cohort study is to record, evaluate and compare the surgical, oncological as well as the functional outcome and quality of life after mesorectal excision for rectal cancer

outcomes of mesorectal excision patients will be analysed. medical records will be reviewed and perioperative outcomes retrieved, incl. long-term oncological and functional/quality of life data. a retrospective cohort over 10 years (2007-2016) will serve as a control to a prospective cohort over 10 further years (2017-2026) as to investigate trends in perioperative and oncological outcomes (min. follow-up of 5 years + adequate cohort size). prospective data on bowel function, urogenital function and quality of life will measured at time of diagnosis and further. variations in neoadjuvant/adjuvant treatment and surgical approaches will be assessed for their effect on the outcomes of interest.

Eligibility criteria:
inclusion criteria: * men and women \>18 years * patients with rectal cancer * underwent mesorectal excision * agreed to fill in a validated questionnaires before surgery and after stoma reversal * informed consent exclusion criteria: * age \< 18 * no informed consent (no general consent, no consent to use personal data for research purpose)

Keywords: tme (total mesorectal excision) transanal tme laparoscopic tme robotic tme open tme quality of life
clinical markers of dysphagia in cardiac surgical patients

Conditions: Cardiovascular Diseases; Dysphagia

Summary: although dysphagia is a known complication of cardiac surgery, risk factors and sensitive bedside clinical markers of dysphagia have not yet been identified. this longitudinal study will enroll 380 cardiac surgical patients and identify contributing risk factors of incident cases of dysphagia and identify sensitive bedside markers of dysphagia. statistical modeling will produce two pragmatic clinical tools - a risk prediction model and a beside screening tool to improve care models.

swallowing impairment and vfmi are common, yet often overlooked, complications of cardiovascular surgical procedures. the true incidence of both dysphagia and vfmi in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patients undergoing cardiovascular surgery. the study is therefore aimed to determine the incidence of dysphagia and vfmi in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. in addition, the study is also aimed to assess the relative impact of vfmi and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status. the study will identify risk factors for postoperative dysphagia and vfmi in cardiovascular patients to build a practical electronic risk-stratification tool. the study will also aim to identify sensitive bedside clinical markers of dysphagia in postoperative cardiovascular patients to develop a bedside screening tool. all participants with planned surgeries will undergo two research visits (one preoperatively and one postoperatively) where they will undergo an instrumental swallowing test and complete several patient report outcomes and clinical tests. if they are found to have dysphagia after surgery, they will be offered no-cost follow-up swallow tests at months 1 and 6. for those without planned surgeries, the same course of tests with the exception of the preoperative research visit will be completed. finally, health-related outcomes will be indexed in enrolled participants to determine the impact of dysphagia.

Eligibility criteria:
inclusion criteria: * individuals 18-90 years of age * undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy at the university of florida heart and vascular hospital * not pregnant * willing to participate in research exams. exclusion criteria: * pregnant women * those unwilling to participate in research exams.

Keywords: cardiac surgery dysphagia extubation vocal fold mobility impairment peak cough flow (pcf)
oral cholecalciferol in prevention of type 2 diabetes mellitus

Conditions: Prediabetes; Vitamin D Deficiency

Summary: type 2 diabetes mellitus (t2dm) is a major public health problem .prevalence of vitamin d deficiency is also high i.e. 78-96% in different groups of population in north india. observational studies find association between low vitamin d status and type 2 diabetes mellitus. prediabetes is a condition that progress to diabetes at a rate of 6-10% per year .there is mechanistic support that vitamin d may influence both insulin secretion and insulin sensitivity and subsequently t2dm incidence. in general, cross-sectional and prospective studies support the role of vitamin d in the prevention of t2dm. this study will be a single blind randomized placebo controlled trial to study the effect of oral cholecalciferol in insulin sensitivity and secretion in adults with prediabetes who are also vitamin d insufficient.


Eligibility criteria:
inclusion criteria: * adults \> 20 years * impaired fasting glucose (ifg) - fpg 100-125 mg/dl * impaired glucose tolerance((igt)- 2hr ppg 140-199mg/dl or * both ( ifg +igt) * with or without hb a1c -5.7-6.4 % with * asymptomatic vitamin d deficiency(\< 20ng/ml) or vitamin d in sufficiency(\< 32ng/ml) exclusion criteria: * diabetes mellitus, * base line 25(oh)d3 \> 32 ng/ml, * symptomatic vitamin d deficiency, * any medication within last month that could affect insulin secretion, insulin sensitivity , vitamin d and calcium metabolism * chronic renal , hepatic ,malignant, intestinal or endocrine diseases * febrile illness or infective morbidity in last 2 weeks, * grossly deranged liver and kidney function

Keywords: prediabetes oral cholecalciferol
the biomarker analysis in locally advanced cervical cancer

Conditions: Uterine Cervical Neoplasms

Summary: sonic hedgehog (shh) signaling, including gli1, is critical to treatment resistance. for optimizing cervical cancer treatment, the pathological prognostic factors determine whether to administer adjuvant therapy. however, the majority of clinical results was from squamous cell carcinoma, rendering conclusions for adenocarcinoma less convincing. we aimed to examine the role of shh signaling in long-term clinical outcomes of cervical adenocarcinoma after receiving major surgery.

surgery, radiotherapy, and chemotherapy could achieve favorable locoregional control in cervical cancer. although good local control results, distant failure plays a major role in patients with treatment failure. we were interested in the potential biomarkers for recurrence after primary treatment for the following reasons. we wanted to identify patients at a high risk of recurrence. such patients must be intensively monitored. we required baseline data, such as the actuarial relapse rate, for evaluation in an additional randomized study. hence, we retrospectively analyzed the potential biomarkers for recurrence in cervical cancer. statistical analysis of the data was done using the chi-square test. disease free survival curves were constructed using the kaplan-meier method. comparisons between curves were performed using the log-rank test. multivariate analyses of factors associated with local and distant failure were made by logistic regression analysis. from 1987 to 2002, 62 patients with cervical adenocarcinoma that received major surgery were enrolled for analysis of shh signaling with a median follow-up period for 172.6 months (iqr 33.0-226.2 months). external beam radiotherapy with 50-60 gy followed by brachytherapy with 30 gy was delivered with or without concurrent weekly cisplatin 40 mg/m2. clinical outcomes in terms of local recurrence, progression free survival (pfs) and overall survival (os) will be analyzed. the expressions of shh, ptch-1, smo and gli1 were assessed by immunohistochemistry. statistics will be performed using international business machines (ibm) statistical package for the social science (spss) v22.

Eligibility criteria:
inclusion criteria: * cervical cancer patients * performance status eastern cooperative oncology group 0-1 (ecog 0-1) exclusion criteria: * non-other cancer previously

Keywords: cervical cancer biomarker recurrence
pediatric acute-onset neuropsychiatric syndrome (pans): clinical characterization and prospective course

Conditions: PANS; PANDAS

Summary: this study is a brief (3 month) longitudinal study following children between the ages of 4-16 years old who have been diagnosed with pediatric acute-onset neuropsychiatric syndrome (pans). parents and children (who are at a 2nd grade reading level) will complete questionnaires online or in person weekly for 3 months. additionally, parents will track their child's symptoms 3 times/week using a mobile application for 3 months. the investigators are hoping to begin to characterize the longitudinal trajectory of neuropsychiatric symptoms in children with pans. additionally, the study will seek to identify baseline demographic and clinical characteristics (e.g., gender, recent onset versus chronic course, gas versus other triggers) that predict severity of baseline neuropsychiatric symptoms and predict change in symptoms over time.


Eligibility criteria:
inclusion criteria: * english-speaking boys and girls ages 4-16 years * abrupt onset of ocd or severely restricted food intake * at least 2 equally abrupt-onset concurrent neuropsychiatric symptoms from the following 7 categories: anxiety, emotional lability/depression, irritability/aggression/severely oppositional behaviors, behavioral/developmental regression, deterioration in school performance, sensory or motor abnormalities (e.g. tics), somatic symptoms (e.g., urinary, sleep) * neuropsychiatric symptoms are not better explained by a known neurological or medical disorder. exclusion criteria: - too unstable psychiatrically or medically to participate safely in the protocol, per clinical judgment of the principal investigator or co-investigator
effects of a multi-intervention programme for the elderly

Conditions: Sarcopenia; Sarcopenic Obesity; Dementia

Summary: 1. to develop a multiactivity training programme. 2. to explore the effect of this programme on sarcopenia, sarcopenic obesity, cognitive impairment and parkinson's disease. 3. to compare the effects of the experimental and control treatments on the muscle strength, body composition, physical function performance and quality of life of the elderly.


Eligibility criteria:
inclusion criteria: (1) over 60 years old, (2) able to communicate and follow instructions; (3) stable condition with sufficient physical strength: able to maintain a seated position in a wheelchair or on the edge of a bed for at least one hour. (4) sarcopenia, sarcopenic obesity, cognitive impairment and parkinson's disease. exclusion criteria: (1) difficulty in standing or walking and obvious musculoskeletal disease, (2) unsuitable for diagnosis by a physician those engaged in sports activities, (3) serious diseases/unstable states, such as severe heart, lung, liver and kidney diseases, severe malignant tumors, severe nutrition poor, severe dementia, (4) more than 180 minutes of exercise per week in the past month, (5) no willingness to participate.
a single ascending dose study of r1671 in patients with mild intermittent asymptomatic asthma.

Conditions: Asthma

Summary: this 8 arm study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of r1671 or placebo in patients with mild, intermittent, asymptomatic asthma. patients will be randomized to receive placebo or r1671, at a starting dose of 0.0015mg, by intravenous infusion; this dose will be escalated in subsequent groups of patients after a satisfactory assessment of the data from the previous dose. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-50 years of age; * mild, intermittent, asymptomatic asthma; * history of asthma for \>=6 months; * non-smokers. exclusion criteria: * females of childbearing potential, or lactating; * history of immunologically medicated disease; * systemic antineoplastic or immunomodulatory treatment in past 6 months.
a trial of rehabilitation in obesity hypoventilation syndrome (ohs)

Conditions: Obesity Hypoventilation Syndrome

Summary: obesity is an escalating problem in the uk and a proportion of these patients have a condition known as obesity hypoventilation syndrome (ohs). this syndrome is associated with symptoms of breathlessness, reduction in exercise capacity, fatigue and headaches. previous research has shown that patients with this condition tend to use healthcare services more frequently and are often at risk of other diseases such as diabetes mellitus and high blood pressure. currently, the mainstay of treatment is noninvasive ventilation (niv), this is a mask ventilator that patients use overnight to improve oxygen levels and remove carbon dioxide (the waste gas of breathing), however this does not fully treat the underlying problem. the research group has shown that niv helps improve activity and contributes to weight loss in this group of patients. the aim of this research will be to investigate the effect of an exercise and nutrition programme in addition to niv on weight loss and activity levels compared to niv alone.


Eligibility criteria:
inclusion criteria: * diagnosis of ohs * age \>18 * bmi \> 30 kg/m2 * chronic hypercapnia , daytime paco2 \>6kpa * fev1/fvc ≥70% * evidence of sleep disordered breathing on overnight studies * tolerated niv \> 4hrs on 1st night during initiation of niv exclusion criteria: * hypercapnic respiratory failure secondary to an identifiable cause other than ohs. * age \<18 * respiratory acidosis (ph \<7.35) * wheelchair/bedbound patients * cognitive impairment which would prevent the subject from complying with trial protocol * unstable coronary artery syndrome * patients postintubation or decannulation following treatment requiring acute hypercapnic respiratory failure * patients undergoing renal replacement therapy * critical peripheral vascular disease * disabling locomotor disability preventing participation in exercises involved in the rehabilitation programme * pregnancy * bariatric surgery planned within 3 months
holistic approaches to depression

Conditions: Depression

Summary: the purpose of the study is to investigate whether yoga or a health education group alleviate depressive symptoms for an individual with a partial response to antidepressant medication.


Eligibility criteria:
inclusion criteria: 1. meets criteria for major depressive disorder (mdd) within the past two years; no history of bipolar disorder, schizophrenia, or psychotic symptoms in one's lifetime. 2. no current hazardous drug/ alcohol use. 3. depression symptom severity. participants must have a quick inventory of depressive symptoms (qids) score greater than or equal to 8 and less than or equal to 17. 4. benefit from current treatment. participants must report at least some benefit from their current antidepressant. 5. no significant suicidality, defined by a qids item #12 score \< 2 or pi judgement. 6. currently taking an antidepressant for depression, at a minimally therapeutic dose. participant has been taking an antidepressant for at least 8 weeks. 7. antidepressant dose has not changed in the 4 weeks prior to study entry; not planning to change antidepressant dosage in next 10 weeks. 8. (if in psychotherapy). therapist and therapy frequency has not changed in the past 6 weeks and not planning to change it in the next 3 months. 9. medically cleared for moderate exercise, documented by a note from their primary care provider. 10. not pregnant or planning on becoming pregnant in the next year. 11. naïve to study interventions. participants cannot have had \> 4 single sessions (or \> 8 total hours class time) of yoga, other classes in "mindful exercise," (e.g., qigong, tai chi), mindfulness based stress reduction, or health education in the past year or \>8 single classes of yoga within the past 2 years of the same. participants can not have practiced yoga at least once per week for 8 weeks in a row in the past 5 years. 12. does not practice meditation at home weekly or more often. 13. understands english sufficiently well to complete study assessment. 14. biomarker exclusions. participants who are taking oral steroids, insulin or oral hypoglycemic agents, or oral antibiotics, or who refuse blood draws, will not participate in the biomarker component of the study; however, they may participate in the rest of the study.

Keywords: depression yoga health education antidepressant