Kornimate/medical-research-clean huggingface dataset:
effect of a locally delivered probiotic in periodontitis

Conditions: Chronic Periodontitis

Summary: saccharomyces boulardii is commonly employed as a live non-pathogenic probiotic microbial feed or food supplement. s. boulardii reduces the secretion of key pro inflammatory cytokines and promotes the production of anti-inflammatory cytokines such as il-10, which is pertinent in the context of pathogenic mechanisms in periodontitis.

one method of altering the subgingival environment is by using probiotics. probiotics are live microorganisms, which when administered in adequate amounts, confer a health benefit on the host by passively occupying a niche that may otherwise be colonized by pathogens. this tends to limit a pathogen's ability to bind to tissue surfaces and to produce virulence factors.8 in the past few years, probiotics have been investigated for periodontal health. studies have shown that certain gut bacteria can exert beneficial effects in the oral cavity by inhibiting pathogenic species. teughels et al., in a study showed that application of beneficial oral bacteria subgingivally after scaling and root planing led to a more host compatible subgingival microbiota which may also effect the promotion of a beneficial host response.10 studies have revealed that probiotic lactobacillus strains (l. reuteri, l salivarius, l. casei, l. acidophilus) were useful in reducing gingival inflammation and the number of black-pigmented rods, including porphyromonas gingivalis, in the saliva and subgingival plaque. streptococcus sanguinis \& s. uberis were found to inhibit the growth of periodontopathogens \& a strong negative between aggregatibacter actinomycetemcomitans and s. sanguinis. weissella cibaria isolates in the form of probiotic rinse possess the ability to inhibit biofilm formation, both in vitro and in vivo.

Eligibility criteria:
inclusion criteria: * subjects having at least one pocket ≥5 mm in each quadrant were included in the study. exclusion criteria: * medically compromised patients and patients having received any form of surgical or non-surgical therapy in the 6 month period leading to the study were not included.
development and evaluation of rehabilitation consult for survivors of head and neck cancer

Conditions: Head and Neck Neoplasms

Summary: although evidence exists to support cancer rehabilitation, services are fragmented and rehabilitation professionals are consulted infrequently and often long after treatment ends, when chronicity of problems limits the impact of intervention. therefore, the objective of this project is to develop, implement, and conduct a pilot evaluation of the rehabilitation consult (rc). the rc program goals are to increase knowledge about rehabilitation needs and resources to meet those needs; to establish individualized rehabilitation goals for hnc survivors and personalized action plans to meet those goals; and to provide support to hnc survivors for the implementation and evaluation of action plans. this project consisted of intervention development and pilot evaluation; this trial registration describes the pilot evaluation phase only.

a rc for survivors of head and neck cancer (hnc) was developed in collaboration with an advisory panel that includes survivors, family members, health care professionals, and health system representatives. this phase of the study aims to conduct a pilot evaluation of the rc using a mixed method, single group study with a convenience sample of approximately 35 survivors of hnc post primary cancer treatment, recruited from the princess margaret cancer center hnc clinics. in addition to the rc intervention, participants will be required to attend 3 research assessments (pre intervention, post intervention, and 1 month follow-up) that are a combination of face-to-face visits and telephone calls. quantitative data analysis will be exploratory and descriptive, and effect sizes will be calculated for all outcomes to help plan for a future, controlled trial. means, standard deviations, and cohen's d effect size will be calculated for normally distributed data. for non-normally distributed data, medians, ranges, and a nonparametric effect size r will be calculated. for qualitative analysis, all interviews will be audio recorded, transcribed verbatim, and analyzed using a two-phased, hybrid approach that is both deductive and inductive. findings will be summarized and reported to the advisory panel, who will then make recommendations regarding any additional modifications to the rc. the research team will make final decisions about rc modifications and will finalize a version for future evaluation.

Eligibility criteria:
inclusion criteria: * adult survivors of hnc who have completed active treatment (surgery, radiation, chemotherapy or any combination thereof) within 1-18 months. exclusion criteria: * lack of english fluency, * cognitive impairment, or concurrent major degenerative conditions likely to cause functional deterioration, and * known active cancer.

Keywords: rehabilitation head and neck cancer quality of life self-efficacy
improving the frequency of colonoscopy in patients with a previous colorectal polyp

Conditions: Colorectal Cancer; Precancerous Condition

Summary: rationale: receiving a reminder letter from their doctor may increase the frequency of colonoscopy in patients who have had a colorectal polyp removed. purpose: this randomized clinical trial is studying how well a reminder letter from their doctor improves the frequency of colonoscopy in patients who have had a colorectal polyp removed.

objectives: * determine whether rates of surveillance colonoscopy can be substantially increased by linking computerized data on endoscopic screening procedures to computerized pathology data to identify patients with prior adenomatous polyps who are due for repeat colonoscopy. * evaluate whether the impact of the intervention varies by patient characteristics, including age, sex, or site of primary care. outline: this is a randomized, controlled, crossover study. patients are stratified according to age (≤ 65 years of age vs \> 65 years of age), gender, time elapsed since last colonoscopy, and primary care physician's (pcp) membership in harvard vanguard medical associates (yes vs no). patients are randomized to 1 of 2 arms. * arm i: pcps are mailed response forms (regarding the disposition of their eligible patients \[e.g. patient letter mailed, patient called, scheduled for colonoscopy, colonoscopy completed elsewhere, patient refused procedure, clinical contraindication, patient deceased\]) and letters reminding them that their patients are due for a follow-up colonoscopy. pcps who do not return response forms within 4 weeks are sent a second set of reminders and patient letters. * arm ii: six months after the beginning of the study, pcps are mailed response forms and patient letters once. a second set of reminders and patient letters are not sent. projected accrual: a total of 800 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * prior diagnosis of adenomatous polyp * underwent prior colonoscopy with polypectomy at brigham and women's hospital * due for repeat colonoscopy according to current national guidelines of the american gastroenterology association (no colonoscopy within the past 5 years) patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: colon cancer rectal cancer precancerous condition
feasibility study: histological characterization after treatment with the ulthera® system

Conditions: Skin Laxity

Summary: up to 6 subjects will be enrolled. subjects who have already chosen to have a surgical facelift procedure will be enrolled. subjects will receive selective ulthera® ultrasound exposures in the pre-auricular regions. subject will return for a follow-up visit up to 48 hours post-treatment, on the day of their rhytidectomy. study images will be obtained pretreatment, immediately post-treatment, and at the follow-up visit.

this study is a prospective, single-center clinical trial. subjects will be enrolled at the investigator's discretion if they meet inclusion/ exclusion criteria and provide written informed consent. enrolled subjects will be treated with an assigned transducer based on their order of enrollment. at the study follow-up visit, subjects will undergo resection of the treated tissue for histological analysis prior to their planned rhytidectomy procedure.

Eligibility criteria:
inclusion criteria: * male or female, age 30 to 65 years scheduled for rhytidectomy. * subject in good health. * understands and accepts the obligation not to undergo any other procedures in the areas to be treated. * willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. * subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at visit 1 and be willing and able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, iud, surgical sterilization, abstinence) during the study. women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) postmenopausal for at least 12 months prior to study; b) without a uterus and/or both ovaries; or c) a bilateral tubal ligation at least six months prior to study enrollment. exclusion criteria: * presence of an active systemic or local skin disease that may affect wound healing. * severe solar elastosis. * significant scarring in areas to be treated. * open wounds or lesions in the area to be treated. * severe or cystic acne on the area to be treated. * presence of a metal stent or implant in the facial area to be treated. * inability to understand the protocol or to give informed consent.

Keywords: ulthera® system ultherapy™ treatment ulthera, inc. ultrasound treatment for skin tightening
assessment of hemodynamic response in cardiopulmonary bypass graft after cardiopulmonary bypass using transesophegeal echocardiography

Conditions: Cardiopulmonary Bypass Graft

Summary: this is a double blind randomization study, assessing hemodynamic response in patients who underwent a cardiopulmonary bypass graft (cabg) with cardiopulmonary bypass (cpb) using intraoperative trasnesophageal echocardiography (tee) to know what inotropic drug will be batter to improve the heart function. epinephrine, milrinone, dobutamine and levosimendan will be assessment.


Eligibility criteria:
inclusion criteria: * sinusal ritmus * ef \> 35% * elective cabg surgery exclusion criteria: * no accept * severe valvular regurgitation or stenoses * chest pain * cardiogenic shock

Keywords: cabg echocardiography heart failure heart function
physiological and sensory responses to prolonged fasting in humans

Conditions: Fasting; Metabolic Disturbance; Energy Supply; Deficiency; Adiposity

Summary: this study aims to establish the metabolic/molecular response in both adipose tissue and skeletal muscle as well as sensory experiences (pain, fatigue, drive) to prolonged fasting of 3 days duration. participants will undergo sequential meal assessment before and after a 3 day fast with measures taken throughout each fasting day.

this study will employ a single-arm, non-randomised design in which participants will act as their own control prior to undergoing 3 days of fasting. the control phase includes 3 days of habitual energy balance assessment before coming into the laboratory for baseline meal testing with blood, muscle, and adipose samples as well as anthropometric assessment. participants will then be provided with a standardised lunch to be consumed around midday and a standardised dinner to be consumed at 2000 h. participants will then be asked to refrain from caloric intake for 3 days until they return to the laboratory for follow up measures. participants will be provided with monitoring equipment throughout the 3 days of fasting and will be asked to provide a blood sample at 0800 h each day alongside self recording of blood pressure, weight, and urinary ketones each day. on the middle day (day 2) participants will also be asked to come into the lab to provide a blood sample at 2000 h. the follow up visit will be identical to that performed before the fast, including meal testing, blood, muscle, and adipose samples.

Eligibility criteria:
inclusion criteria: * • body mass index 20.0-29.9 kg∙m-2 * age 18-45 years * willing to abstain from food intake for just over 3 days (\~82 hours) * able and willing to provide informed consent and safely comply with study procedures * females to maintain record of regular menstrual cycle phase or contraceptive use * no anticipated changes in lifestyle during the study (e.g. holidays or exercise programmes) exclusion criteria: * • any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias * any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes) * any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment * pregnancy * breastfeeding * lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker) * history of eating disorders (e.g. anorexia) * any reported recent (\<6 months) change in body mass (± 3%) * uncontrolled hyperthyroidism * advanced cerebrovascular insufficiency or dementia * advanced liver or kidney insufficiency * history of migraine and or headache * psychotic disorders * unstable or severe coronary artery disease * retinal detachment * duodenal or stomach ulcer * cancer and malignant disease * regular use of non-steroidal anti-inflammatory drugs (nsaids) * use of systemic corticoids * use of antihypertensives (especially beta-blockers and diuretics) * use of antidiabetics * use of anti-coagulants * use of psychotropics (especially neuroleptics and lithium) * use of anticonvulsants.
study of a non-invasive glucose measuring device

Conditions: Diabetes Mellitus

Summary: this explorative clinical investigation has been launched to collect spectral raman data paired with validated glucose reference values in persons with diabetes.


Eligibility criteria:
inclusion criteria: 1. male or female subject ≥18 years. 2. subject with type 2 diabetes. 3. signed informed consent form (icf). exclusion criteria: 1. individual treated with intensified insulin treatment. 2. sodium, potassium. creatinine, egfr, and alat (more than three times the upper limit of normal range). 3. clinically relevant anaemia or thrombocytopenia. 4. infection with hepatitis b, c or hiv (if subject participates in subprotocol 1). 5. intake of anticoagulant medication (with the exception of acetylsalicylic acid, ass 100). 6. for female subjects: pregnancy or breastfeeding or lack of a negative pregnancy test (except in case of menopause, sterilization, or hysterectomy). 7. subjects not able to understand and read local language. 8. cognitive impairment, or in investigator's opinion, subject is not able to follow instructions provided and as specified in the clinical investigation plan (cip). 9. subject not able to hold hand/arm steady (including tremors and parkinson's disease). 10. skin changes, tattoos, or diseases on right thenar (measurement site). 11. reduced circulation in right hand evaluated by allen's test. 12. known allergy to medical grade alcohol. 13. haemodialysis. 14. topical administration of glucocorticoids at the right hand for the past 7 days or during the study period. 15. any disorder, which in the investigator's opinion, might jeopardise subject's safety or compliance with the cip. 16. any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g., mental, or visual incapacity, language barriers, alcohol or drug abuse. 17. dependency from the sponsor or the clinical investigator (e.g., co-workers of the sponsor, the study site, and/ or their families). 18. subjects currently participating in another study.

Keywords: non-invasive blood sugar raman spectroscopy
assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction

Conditions: Asthma; Pulmonary Disease, Chronic Obstructive

Summary: assessment of the inhalation profiles of four dry powder inhalers in patients with variable degrees of lung obstruction

randomized to device sequence

Eligibility criteria:
inclusion criteria: * subjects with a physician documented history or diagnosis of asthma for at least 6 months * reversibility, defined as an increase in fev1 at the screening visit of greater than or equal to 12% and 200 ml * subjects with a physician documented history or diagnosis of mild or severe chronic obstructive pulmonary disease exclusion criteria: * female subjects who are pregnant * subjects who have a history of life-threatening asthma/copd or who have experienced two or more exacerbations requiring hospitalization in the 12 months prior to screening * evidence of lower respiratory tract infection * subjects diagnosed with pulmonary fibrosis, bronchiectasis, pneumoconiosis, sarcoidosis or tuberculosis

Keywords: inhalation profiles asthma copd
quest for tumour evolution of non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: to study and comprehend the evolutionary and genomic landscape between primary and metastatic sites and the dynamics of intratumour and intertumour heterogeneity over time with reference to the treatment modalities for each chinese patient with non-small cell lung cancer.

the importance of intratumour and intertumour heterogeneity in non-small cell lung cancer has been extensively interrogated recently. however there is a lack of similar data associated with treatment and survival outcomes in chinese population. unicorn-quest, a prospective observational study of chinese patients with either primary or metastatic non-small cell lung cancer, aims to identify the evolutionary changes from the primary tumour, regional nodes and distant metastases of the same patients and among different patients, through multiregion and longitudinal tumour and nodal collection with next-generation sequencing. by following non-small cell lung cancer from early stage to relapse or distant metastasis, identifying the changes of genomic landscape with correlation with treatment and survival outcomes, this study may help identify unique cancer trajectories and novel therapeutic targets for non-small cell lung cancer in chinese population.

Eligibility criteria:
inclusion criteria: * written informed consent * patients ≥18 years of age, with histologically confirmed non-squamous non-small cell lung cancer who plan to receive active anti-cancer treatment for their non-small cell lung cancer. * sufficient tissues with a minimum of two tumour or nodal regions are available for the study based on pre-operative imaging and post-operative pathological findings. exclusion criteria: * any other\* malignancy diagnosed or relapsed at any time, which is currently being treated (including by hormonal therapy). any other\* current malignancy or malignancy diagnosed or relapsed within the past 3 years\*\*. \*exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer \*\*an exception will be made for malignancies diagnosed or relapsed more than 2, but less than 3, years ago only if a pre-operative biopsy of the lung lesion has confirmed a diagnosis of nsclc. * psychological condition that would preclude informed consent

Keywords: next generation sequencing
assessment of neural signals for the control of assistive devices

Conditions: Spinal Cord Injury (SCI), Initial Encounter

Summary: the study will investigate the use of motor intention-based cortical signals to trigger epidural spinal cord stimulation (escs) with individuals with sci. motor intention of ul tasks will be decoded using brain-computer interface (bci) system based on cortical signals recorded using an electroencephalographic (eeg) system or using their intracranially implanted devices electrocorticographic (ecog).


Eligibility criteria:
inclusion criteria: * patients age 18 and older * able to sign informed consent * not participating in other studies that limit participation * chronic (\>6 month) traumatic spinal cord injury (sci) (c4-t1 neurological injury with american spinal injury association impairment scale (ais a-d) with some residual function. exclusion criteria: * patients that are pregnant * patients under the age of 18 * patients unable to provide informed consent

Keywords: brain computer interface epidural spinal cord stimulation
single patient room versus open bay in nicu

Conditions: Neurodevelopmental Outcomes

Summary: the nicu at the iwk health center in halifax, nova scotia is embarking on a redevelopment project that will see its current open bay design converted to a single room care environment. there will be a period during the redevelopment when new single room care unit will coexist with one open bay unit. this provides a unique opportunity to explore the effect of the two different environmental designs on both short and long-term outcomes. preterm infants (under 31 weeks gestational age) and very low birth weight infants (under 1500 grams) will be randomized to either the open bay unit or the single patient room unit, at 36 months corrected age neurodevelopmental outcomes will be assessed.

do very preterm infants (\< 31 weeks gestational age) and very low birth weight infants (\< 1500 grams) admitted to a single patient room in the nicu have improved long-term neurodevelopmental outcomes when compared to very preterm infants admitted to an open bay in the nicu? babies who will be admitted to nicu will be randomized to either the open-bay unit or single room care. the randomization will be achieved through the use of the wannnt (winnipeg assessment of neonatal nurses need tool) and current patient census; this involves taking 1/3 of the fraction of the patient census on each team and adding it to 2/3 of the fraction of the wannnt. this methodology was reviewed by several iwk committees including ethics, family leadership council, neonatal care committee and the family centered care committee. this randomization is designed to ensure fairness and an equitable workload between the two units. eligible study infants are also enrolled in the perinatal follow-up program (pfu) as a standard of care at the iwk health center. the baby's legal guardian signs a consent to be enrolled in the pfu program and to allow collection and use of data for their child as long as their child cannot be identified from the use of the data. all families of infants admitted to nicu, whether or not they have been enrolled in the pfu program will receive an information package explaining the single patient room nicu compared with the open bay nicu. at three years of corrected gestational age, all eligible infants will have the bayley scales of infant and toddler development - version 3 assessment completed which evaluates cognitive, language and motor skills. these infants will also be examined for the presence or absence of cerebral palsy.

Eligibility criteria:
inclusion criteria: * all very preterm infants born less than 31 weeks gestational age or birth weight less than or equal to 1500 grams * age less than 14 days * multiples will be randomized to the same arm. exclusion criteria: * babies with major anomalies * babies admitted for palliative care only

Keywords: developmental disabilities follow-up studies infant, premature intensive care units, neonatal randomized controlled trial