Kornimate/medical-research-clean huggingface dataset:
efficacy of different toothbrushes and hygiene regimen

Conditions: Dental Plaque; Halitosis

Summary: to evaluate: 1) evaluate the efficacy of a regimen commercially available versus brush alone on established plaque and gingivitis on adolescents. the group 1 will use the following procedure: colgate ultrasoft toothbrush, colgate total 12 toothpaste and plax mouthwash, and the other group will use colgate ultrasoft toothbrush and colgate cavity protection toothpaste; 2) the level of halitosis. two calibrated and blinded examiners (cohen kappa 85%) will evaluate the gingival condition using the visible plaque indices, a simplified oral hygiene index - ihos and gingival bleeding index, with the aid of a who probe. for the evaluation of halitosis levels, all individuals will respond to a questionnaire regarding personal data, general and oral health, which includes hygiene habits and received previous guidelines for the procedures to be performed in the second moment. at the next consultation, subjects will be assessed clinically for halitosis using the portable breathalert™ sulfide monitor (tanita corporation, japan), in addition to the evaluation of the tongue flap index (isl), ph and salivary flow. the evaluations will be in the following periods: baseline, 1, 3 and 6 months of brushing. data will be submitted to descriptive statistical analysis to demonstrate the distributions frequency of biofilm indices and gingival bleeding. the differences in the criteria evaluated will be submitted to fisher's exact test (α = 0.05) and their performance at different times will be evaluated by the mann-whitney test (α = 0.05).


Eligibility criteria:
inclusion criteria: * good general health; * age 12 to 17; * absence of motor, comprehension and cognitive difficulties that impede adequate oral hygiene. exclusion criteria: * active dental caries with cavity exposing dentin (visible cavity) on teeth for which the simplified oral hygiene index will be used. if these teeth are not present, adjacent teeth may be considered; * teeth with formation defects and dental crowding; * periodontal disease (tooth mobility \> 2 mm, pocket \> 5 mm, gingivitis); * parafunctional habits (bruxism, nail biting), active clamps for removable partial dentures, use of orthodontic appliance; * volunteer or legal guardian who does not agree with the terms of the study or has difficulty appearing for the follow up appointments; * pregnant volunteers; * use of medications that alter gingival health, such as antibiotics, in the previous three months; * use of mouthwash or toothpaste containing products for the control of biofilm; * smokers; * systemic disease (diabetes).
a study to assess the effect of hepatic impairment on safinamide pharmacokinetics

Conditions: Hepatic Impairment

Summary: the primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with normal hepatic function.


Eligibility criteria:
inclusion criteria: * hepatically impaired subjects - subjects with liver cirrhosis and different degrees of impaired hepatic function: mild and moderate impaired hepatic function (grade a, or b according to child-pugh classification) * healthy subjects - subject is in good age-appropriate physical and mental health as established by medical history, physical examination, ecg and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to the dosing * all subject have given written informed consent before any study-related activities are carried out exclusion criteria: * any clinically relevant disease or condition, which in the investigator's opinion would exclude the subject from the study * diseases or surgeries of the gastrointestinal tract, which could influence the gastro-intestinal absorption and/or motility * hepatically impaired subjects - subjects with primary biliary liver cirrhosis, hepatic encephalopathy grade iii and iv, sepsis or spontaneous bacterial peritonitis, gastrointestinal bleeding within one month before the study, esophagus varices \> grade ii, acute hepatic failure of any aetiology, portosystemic shunt, renal impairment (creatinine clearance \< 50 ml/min calculated by use of cockroft gault formula) * healthy subjects - use of any medication, including multi-vitamin preparations, received within 21 days prior to the drug administration, or within six times the elimination half-life, whichever is longest, except combined oral contraceptives and occasional use of paracetamol or ibuprofen within 14 days before study drug administration

Keywords: hepatic impairment liver diseases pharmacokinetics to investigate pharmacokinetics of safinamide in subjects with mild and moderate hepatic impairment as compared to healthy subjects with normal hepatic function
use of allograft adipose matrix for small joint arthritis of the hand

Conditions: Osteoarthritis Hand

Summary: the purpose the research is to evaluate the safety and efficacy of injection of adipose allograft matrix (aam) to the small joints of the hand for treatment of early stage osteoarthritis. the hypothesis is that use of aam injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options with autologous fat transfer. as standard of care, routine strength, pain scale scores (vas) and range of motion will be recorded, a baseline disability survey (dash score) will also be administered. after these have all been recorded and administered in a separate visit the patient will undergo the lipofilling procedure. the subject population will include patients over the age of 18 who present with joint pain of the hand with radiographic evidence of osteoarthritis.

the investigators central hypothesis is that use of aam injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options. the overall aim of the project is to validate the clinical use of aam for the treatment of early-stage osteoarthritis of the hand in adult patients (\>18 years of age). the specific aims for this project are: 1. to determine the safety of use of leneva as a lipofilling alternative to autologous fat grafting for arthritis of the hand a. to determine safety, the investigators will evaluate for any adverse reactions to the injection at each of the follow up time-points 2. to determine the efficacy of the technique as measured by clinical outcomes in terms of pain, disability, range of motion and strength a. to determine efficacy, the investigators will measure visual analogue pain scale scores as measures by visual analogue scale, disability scores as measured with dash scores, and standardized range of motion and strengths scores as measured by the same study administrator at each of the follow up time points 3. to determine patient satisfaction with the procedure a. to determine patient satisfaction, the investigators will administer a survey at each of the follow up time points

Eligibility criteria:
inclusion criteria: * patients greater than 18 years, with presentation to the cedars sinai hand clinic for joint pain of the hand carpometacarpal, interphalangeal, proximal interphalangeal, and distal interphalangeal joints (cmc, ip, pip or dip joints). * radiographic evidence of osteoarthritis. exclusion criteria: * prior intervention for the presenting joint (either in the form of cortisone or hyaluronic acid injection or surgery). * rheumatoid or other inflammatory arthritis condition * collagen vascular disease * pregnancy or breast-feeding * congestive heart failure * chronic obstructive pulmonary disease * chronic renal failure * those who had medication or oral supplements for the previous 4 weeks that could prolong bleeding time (e.g.; aspirin, plavix).
wisconsin evaluation of emergency department care coordination

Conditions: Emergency Department Visit

Summary: the state of wisconsin is now expanding its investment in care coordination models as an effort to reduce inappropriate hospital emergency department (ed) use, improve health outcomes, and reduce medicaid expenditures. this effort begins with a pilot program to support emergency department care coordination in hospitals and health systems that apply and are selected to participate in the pilot program. the wisconsin medicaid program seeks to understand whether this program achieves its intended goals and, specifically, whether the medicaid payment for such care coordination services produces the intended program outcomes. hospitals will select members that will receive care coordination services. in a quasi-experimental approach, the study team will compare members that do vs. do not receive the services will be used examine the effects of care coordination and referrals on total ed visits, primary-care treatable ed visits, non-emergent ed visits, and health care costs, as well as the specific effects of referring patients to providers who offer low-cost and after-hours care. to assess the importance of targeting, study team will conduct stratified analyses of vulnerable groups such as people with disabilities and individuals with specific clinical needs.


Eligibility criteria:
inclusion criteria: * adults who are medicaid enrolled * have had 5+ emergency department visits in the past year exclusion criteria: * participants who are concurrently eligible for medicare * children (individuals age \<18 years).

Keywords: medicaid cares (wisconsin client assistance for re-employment and economic support)
study of diclofenac capsules to treat osteoarthritis pain

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine whether diclofenac \[test\] capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.


Eligibility criteria:
inclusion criteria: * primary diagnosis of functional class i-iii oa of the hip or knee with documented osteoarthritis flare at baseline * chronic user of nonsteroidal anti-inflammatory drugs (nsaids) and/or acetaminophen for oa pain * discontinued all analgesic therapy at screening * for women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control exclusion criteria: * history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nsaids, including diclofenac * requires continuous use of opioid or opioid combination products to control oa pain of the knee or hip * clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease * significant difficulties swallowing capsules or unable to tolerate oral medication * previous participation in another clinical study of diclofenac capsules or received any investigational drug or device or investigational therapy within 30 days before screening.
measurement of the strength of the posterior tibial muscle by hand-held dynamometer

Conditions: Valgus Foot Deformity

Summary: adult flat foot valgus is a degenerative pathology that causes damage to the ligaments of the hindfoot as well as dysfunction of the tendon of the posterior tibial muscle. currently, there is a lack of a tool allowing a standardized, reliable, reproducible and validated measurement of the strength of the tendon of the posterior tibial muscle in consultation of foot surgery. the hand-held dynamometer could be that tool. the study would consist in measuring the strength of the tendon of the posterior tibial muscle in healthy subjects with a hand-held dynamometer (microfet2) by two examiners and compared to isometric reference measurements (con-trex cmv multi-joint) to validate the reliability of the measurement and its reproducibility.


Eligibility criteria:
inclusion criteria: * patients from physical medicine and rehabilitation department hospitalized for pathologies other than neurological or osteo-articular pathologies affecting the lower limbs, * having no neurological or osteo-articular pathology affecting the lower limbs f one year, * no history of surgery on the rear foot and ankle, * written informed consent from person, * socially insured patient person, * person willing to comply with all study procedures and study duration. exclusion criteria: * neurological or osteo-articular pathologies affecting the lower limbs, * known pathologies of the tendon of the posterior tibialis muscle, * deformations of the foot (flat foot, hollow foot), * history of hindfoot or ankle surgery, * pregnant or breastfeeding woman, * inability to receive information, consent and participate in the whole study, * person under judicial protection or deprived of liberty, * person participating in another clinical trial, * no social insurance cover, * no written consent.

Keywords: posterior tibial hand-held dynamometer, isokinetics isokinetics, measurement validation
nosocomial bacteriuria in geriatric internal medicine services and follow-up care and geriatric rehabilitation of the strasbourg university hospitals

Conditions: Urinary Tract Infection

Summary: this thesis is a comparative study of the epidemiological characteristics of health-care associated bacteriuria in short and medium term of geriatrics wards in strasbourg's university hospital, between 2003 and 2017, in the follow-up of eric de pasquale's thesis in 2010. this comparative study will allow to see the evolution of urinary bacterial ecology, bacterial sensitivity to antibiotics, and the part of multi-resistant bacteria, during these 14 years in geriatric services in strasbourg.


Eligibility criteria:
inclusion criteria: * patient of age who has been hospitalized in geriatric wards (rehabilitation car service and internal medicine) of strasbourg's university hospital * date of hospital leaving after 1/1/17 and before 1/1/18 * patient who has a health-care urinary tract infection (occurred more than 48h after admission) * single bacteria in the cbeu * bacteriuria \> 105 cfu/ml regardless which clinical context or bacteria * if a patient has several bacteriuria, they can be included if they appear after a precedent episode well treated or if the bacteria is different from the precedent exclusion criteria: * participation refusal * leaving of hospital out of the inclusion period * urinary tract infection which occurred less than 48h after admission (communitarian infection) * bacteriuria \< 105 cfu/ml * multiple bacteria in the cbeu

Keywords: health care associated urinary tract infection bacteriuria elderly geriatrics antimicrobial resistance multi-resistant bacteria
exercise and diabetes - an observational study of exercise and blood glucose control

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: this proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes.

this proposal seeks to gather continuous blood glucose and physical activity data from individuals with and without diabetes who are physically active and exercising for health benefits. the investigators hypothesize that insulin requirements will be inversely related to intensity of activity and an algorithm will be able to detect physical activity and automatically adjust insulin doses. once such an algorithm has been determined for an individual, it can be applied to future similar situations, but ideally the algorithm will be dynamically refined based on closed-loop feedback information.

Eligibility criteria:
inclusion criteria: * inclusion criteria for subjects with diabetes * type 1 diabetes or insulin requiring type 2 diabetes for at least 1 year * use insulin to control diabetes * physically active (regularly work out, swim, run, walk, bike, etc.) * free of major micro- and macrovascular complications of diabetes * 18-75 years of age * a1c \< 9.0% inclusion criteria for subjects without diabetes * no evidence of diabetes and physically active exclusion criteria: * unwilling to perform repeated glucose checks or take insulin as instructed * abnormal thyroid function, kidney function, liver function * pregnancy
a post-marketing surveillance study to assess the safety of cervarix (glaxosmithkline [gsk] biologicals' human papillomavirus [hpv] -16/18 vaccine), when administered according to the approved prescribing information (pi) in korea

Conditions: Neoplasms, Rectal

Summary: the purpose of this post-marketing surveillance (pms) study is to collect safety information on the use of cervarix upon the expanded indication to anal cancer to both women and men (at least 600 korean women and men) within 30 days after each vaccination dose, when administered according to the approved prescribing information (pi) in korea in a real health care setting over a period of 4 years.


Eligibility criteria:
inclusion criteria: * subject or/and subjects whose parent(s)/legally acceptable representative(s) \[lar(s)\], in the opinion of the investigator, can and will comply with the requirements of the protocol. * korean male or female subjects aged 9-25 years who are eligible for the series of cervarix according to the locally approved pi. * written informed consent obtained from the subject/from the parent(s)/lar of the subject. exclusion criteria: * at the time of pms entry, the contraindications and precautions of use indicated in the locally approved pi. pi should be checked and the subject must not be included in the pms if there is any contraindication. any changes in the locally approved pi must be implemented immediately. * subjects who had previous administration of a hpv vaccine other than cervarix will not be enrolled into the study. * subjects who are not eligible for vaccination with cervarix according to the medical judgement of physician. * child in care.

Keywords: human papillomavirus vaccine adverse events after vaccination safety serious adverse events after vaccination
capnography library - data collection in the critical care environment stage 2

Conditions: Respiratory Insufficiency

Summary: capgnography is the monitoring of the concentration or partial pressure of carbon dioxide in the expired respiratory gases; as such, it is a non-invasive monitoring technique which allows fast and reliable insight into ventilation, circulation and metabolism. capnography has proven to be more effective than clinical judgement alone in the early detection of adverse respiratory events. the shape of a capnogram is identical in all humans with healthy lungs; any deviations in shape must be investigated to determine a physiological or a pathological cause of the abnormality. data from a previous pilot study yielded two major findings: 1. prediction of requirement for intubation, by the creation of an "integrated pulmonary index" (ipi) based on non-invasive physiological parameters 2. breathing patterns during weaning in order to identify specific patterns used to predict extubation success/failure the intent of the current study is to gather sufficient data to either prove or disprove the findings of the previous study

the patient's monitoring period will be as follows: non-intubated patients - initiation: as soon as possible after admission and/or extubation and no later than 24 hours after either. termination- either 2 hours after intubation or after 8 hours of monitoring overall. intubated patients - initiation: no later than 24 hours after a decision to begin weaning has been made . termination: upon icu (intensive care unit) discharge or for the duration of 10 days at most. data will be collected using three tools: 1. capnostream raw data (co2 (carbon dioxide) waveform, etco2 (end-tidal carbon dioxide), respiratory rate, spo2 (saturation of peripheral oxygen), pulse rate, ipi, alarms, events and any other messages generated by the monitor) will be transferred from the monitor to a laptop via a dedicated recording program. 2. ventilator data (settings and resultant patient parameters) will be transferred from the monitor to a laptop via a dedicated recording program. 3. patient monitoring parameters (heart rate, blood pressure, cvp (central venous pressure), temperature, spirometry values etc) shall be recorded from the multi parameter monitors already in use in the icu and transferred online to a laptop using dedicated recording software. all recorded parameters will be synchronized. data will be recorded from at least two of the tools, the capnostream and the ventilator.

Eligibility criteria:
inclusion criteria: * over the age of 18 * suffering from severe illness requiring admission to the icu * expected to be hospitalized in the icu for a minimum of 8 hours exclusion criteria: * under the age of 18 * the patient's refusal to participate in the study * any change in the patient's condition that may interfere with data collection
cdp-choline treatment in ats users

Conditions: Substance Use Disorders

Summary: this study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.

this study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline (cdp-choline) in amphetamine-type stimulants-using adolescents. multi-level assessments will be performed to determine whether cdp-choline administration with supportive psychotherapy, compared to placebo administration with supportive psychotherapy, will 1) repair ats-induced neural cell damage of the target brain regions, 2) improve cognitive deficits and normalize the relevant target neural circuits, and then 3) reduce ats-taking behaviors in ats-using adolescents.

Eligibility criteria:
inclusion criteria: * aged 14-40 years * amphetamine (or amphetamine-like) use disorder (dsm-iv-tr) * informed consent * seeking treatment exclusion criteria: * major medical or neurological illnesses * psychiatric illnesses requiring hospitalization, prescription of psychotropic medications, or emergency psychiatric interventions * current and past diagnosis of a psychotic disorder, bipolar disorder, conduct disorder, or attention-deficit hyperactivity disorder * occasional ats use (less than monthly use) * iq of 80 or lower * pregnancy or breastfeeding * clinically significant suicidal or homicidal ideation * substance use disorders (substances other than amphetamine or ma)

Keywords: amphetamine type stimulant adolescents
impact of netrin-1 in the pathophysiology of placenta accreta spectrum

Conditions: Pathophysiology of Placenta Accreta

Summary: the main goal of this study is to assess the role of netrin 1, neogenin and zeb1 in pas-associated invasion

* to evaluate the immunohistochemical expression of these proteins in pas specimens in comparison with the control placental tissues. * to correlate their expression with the demographic parameters. * to assess the correlation between their expression in pas specimens.

Eligibility criteria:
inclusion criteria * pas patients who underwent hysterectomy to allow proper pathologic grading of pas exclusion criteria * patients with fundal and middle anterior or posterior placenta, * pregnancy associated with morbid conditions such as hypertension, diabetes mellitus, autoimmune disease, cardiac disease, renal disease, history of anemia, blood transfusion, other blood diseases and endocrinal disease; fetal distress or intrauterine growth retardation. * uterine scar pregnancies were excluded

Keywords: netrin-1, neogenin,pas, zeb-1