Kornimate/medical-research-clean huggingface dataset:
early diagnosis of oral cancer by detecting p16 hydroxymethylation

Conditions: Oral Epithelial Dysplasia

Summary: the purpose of this study is to verify the function of p16 hydroxymethylation diagnostic reagents in early diagnosis of oral cancer.

background:oral epithelial dysplasia (oed) is one of the common precancerous lesions among chinese adults. to investigate the clinical predictive value of p16 hydroxymethylation diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the prospective multi-center double-blind cohort study. methods:265 patients with histologically confirmed mild or moderate oed were included in the present study. after the bisulfite modification and tet assistant bisulfite modification, methylight and methylation-specific pcr (msp) assays were used to analyze p16 methylation and status in these patients. building three follow-up queue by p16-methylated, p16-hydroxymethylation and p16-unmethylated. the statistical analysis used spss16.0. all p-values were two-sided. p\<0.05 was considered to test for statistical significance difference.

Eligibility criteria:
inclusion criteria: * histopathological diagnosis of oral lesions meet the epithelial diagnostic criteria for mild to moderate grade oed; * no local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips; * without the treatment history by laser , radiation or chemical; * be able to sign the informed consent; exclusion criteria: * histopathological diagnosis of oral lesions do not meet the epithelium of mild to moderate dysplasia diagnostic criteria; histological diagnosis of severe grade oed or malignant disease; * pregnancy or breast-feeding women; * serious heart, lung, liver , kidney and other systemic diseases local area stimulate by residual root and crown, sharp cusp, poor restoration and biting cheek or lips; * oed treatment history by laser, radiotherapy, or chemotherapy; * tumor and psychiatric patients; * patients are unable to cooperate;
nirs predict low cardiac output state in neonates and infants in cardiac surgery

Conditions: Congenital Heart Disease

Summary: neonates and infants that have cardiac surgery with cardiopulmonary bypass (cpb) for congenital heart disease are at great risk for experiencing life-threatening low cardiac output syndrome (lcos) in the first 24 hours after surgery. the poor perfusion and inadequate oxygen delivery that occurs may result in multiple organ failure and death. it is lcos that is responsible for the majority of early postoperative deaths in this population of neonates and infants. improved pediatric probes placed in peripheral locations using near infrared spectroscopy (nirs) may permit continuous monitoring of venous saturations reflecting overall perfusion and oxygen balance in the tissues. following parental or guardian consent, 30 neonates and infants scheduled to undergo surgery for congenital heart disease will be enrolled. at the end of surgery, four equanox advance 8004cb probes will be placed on the flank, lower extremities and the forehead. continuous nirs saturations will be monitored and stored for analysis. point of care (poc) lactates will be obtained after admission to the intensive care unit (icu) every 2 hours for the first 24 hours postoperatively, then once at 48 hours. the association between nirs oxygen saturation and poc lactate values will be assessed using mixed linear models taking into account the repeated measures design. exploratory analyses will be performed to assess whether nirs oxygen saturation is associated with outcomes such as days in icu, adverse events and mortality. the ability to use noninvasive, continuous monitoring for overall perfusion and cardiac output will allow better and earlier therapy for neonates and infants following cardiac surgery.


Eligibility criteria:
inclusion: * pediatric patients 0-3 years of age * scheduled to undergo cardiopulmonary bypass surgery (cpb) for repair of congenital heart defects exclusion: * weight \ 20 kg * greater than 3 years of age * thrombosed femoral arteries * prior fasciotomies * currently on extracorporeal membrane oxygenation (ecmo)

Keywords: near infrared spectroscopy (nirs) equanox advance 8004cb probes cerebral vascular circulation peripheral perfusion
performance evaluation of blood glucose monitoring systems

Conditions: Diabetes Mellitus

Summary: the goal of this single-center, comparative, open label, in-vitro diagnostic device performance evaluation was to investigate the performance of two sanofi-aventis bgmss (bgstar® and ibgstar®) with regard to system accuracy (polaris), precision and hct influence (helios).

the main study (polaris) investigated blood glucose measuring accuracy and intra-assay precision while the substudy (helios) investigated potential haematocrit interference of sanofi-aventis bgmss bgstar® and ibgstar® and partly of competitor bgmss according to iso 15197 \[1\] and tno 2001 quality guideline \[2\], respectively. the primary objective of the system accuracy evaluation is to identify the number of blood glucose readings of both sanofi-aventis devices within the iso 15197 area of acceptable accuracy of ± 20% \[dev%\] for blood samples with glucose concentration \> 75 mg/dl (4.2 mmol/l) and within the iso 15197 area of acceptable accuracy of ± 15 mg/dl (± 0.83 mmol/l) for blood samples with glucose concentration \< 75 mg/dl (4.2 mmol/l) as compared to the statstrip® connectivity reference method. the primary objective of the haematocrit interference evaluation is to demonstrate that the bgstar® and ibgstar® devices meet the hct interference requirements according to tno 2001 quality guideline when used to measure bg of venous whole blood as compared to a venous plasma reference method (ysi 2300 stat plus™) at hct levels between 35 - 55% in terms of:(1) a mean deviation not exceeding ± 10% \[dev%\] for hyperglycaemic glucose concentrations (150 - 180, 250 - 280, 320 - 350 mg/dl) and (2)a mean deviation not exceeding ± 18 mg/dl (1.0 mmol/l) \[devtotal\] for hypo- and normoglycaemic glucose values (50 - 60, 100 - 120 mg/dl) compared to the reference method at hct levels between 35 - 55%.

Eligibility criteria:
inclusion criteria: * healthy subjects or patients with type 1 or type 2 diabetes * screening glucose levels fall into required glucose ranges * screening hematocrit values between 36 % to 55 % exclusion criteria: * history of hypotension during blood draws * intake of drugs known to interfere with blood glucose readings * biochemical safety parameters outside of reference ranges * hb \< 11 g/dl * lack of compliance * history of frequent hypoglycemia

Keywords: diabetes mellitus blood glucose self-assessment accuracy intra-assay precision hematocrit interference
sleep behavior and rest-activity circadian rhythm (rar) in hip/knee prosthesis

Conditions: Sleep; Pain; Hospitalization; Arthroplasty Complications; RAR

Summary: the consequences of chronically insufficient sleep are both behavioral and medical. . patients who undergo total knee or hip arthroplasty commonly complain of sleep fragmentation after hospitalization the aim of the present study is to evaluate the changes inrest-activity circadian rhythm (rar) and objective and subjective sleep quality and perceived pain, untill the 10th hospitalization day, in patients who underwent total knee or hip arthroplasty.

the national health and nutrition examination survey found that 22% of the us population reported 6 h of sleep or less and another 15% registered 5 h of sleep or less per 24 h (1). the consequences of chronically insufficient sleep are both behavioral and medical. quantity and quality of sleep represent important factors for the quality of life, which can have positive or negative influence on individual health (2-4). patients who undergo total knee or hip arthroplasty commonly complain of sleep fragmentation after hospitalization (5,6) such patients experience acute postsurgical pain and discomfort, including restriction of their leg movement to prevent dislocation of the hip implant in the acute stage. the results of previous post-surgery studies have shown that rem sleep was severely reduced and awake time increased on the first postoperative night compared with the preoperative night (7,8).it is necessary for patients to secure the appropriate amount and quality of sleep to facilitate recuperation after surgery. sleep disturbance is also related to the presence of delirium. the aim of the present study is to evaluate the changes in objective and subjective sleep quality and perceived pain, untill the 10th hospitalization day, in patients who underwent total knee or hip arthroplasty.

Eligibility criteria:
inclusion criteria: * male of female subjects aged between 50 and 80 years old. * knee or hip arthroplasty at irccs galeazzi orthopedic institute. * cognitively intact * inclusion in the rehabilitation program within the orthopedic specialist rehabilitation unit of irccs galeazzi orthopedic institute. * informed signed consent. exclusion criteria: * cancer history. * body mass index \ 40.0. * melaton consumption. * previous clinical sleep disorders.

Keywords: sleep actigraphy pain patients hospitalization hip replacement knee replacement arthroplasty rar
phase iii clinical trial of dp-r206 and bonvia in postmenopausal women with osteoporosis

Conditions: Postmenopausal Women With Osteoporosis

Summary: a multicenter, randomized, double-blind, active-controlled, phase iii clinical trial to evaluate the efficacy and safety of dp-r206 and bonviva for 16 weeks once a month on the improvement of vitamin d in postmenopausal women with osteoporosis.


Eligibility criteria:
inclusion criteria: * female more than 40 years old in postmenopausal exclusion criteria: * subject who has a history of malignant cancer
evaluation of compliance with treatment by genvoya in hiv post-exposure prophylaxis

Conditions: HIV Risk

Summary: this study measures the proportion of enrolled patients taking the uninterrupted hiv post-exposure prophylaxis genvoya for four weeks

this study measures the proportion of enrolled patients taking the uninterrupted hiv post-exposure prophylaxis elvitegravir/cobicistat/ftc/tenofovir alafenamide (e/c/f/taf) for four weeks. elvitegravir is an hiv-1 integrase strand transfer inhibitor (insti). cobicistat is a selective, mechanism-based inhibitor of cytochrome p450 (cyp) enzymes of the cyp3a subfamily. emtricitabine is a nucleoside reverse transcriptase inhibitor (nrti) and nucleoside analogue àf 2'-dexicytidine. tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (ntrti) and phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).

Eligibility criteria:
inclusion criteria: * an age above 18 years * consultation within 48 hours following a risk of hiv transmission (blood or sexual contact) * indication for hiv post-exposure prophylaxis (according to french guidelines) * person able to understand the nature of the study * person who signed his consent form to participate in the study exclusion criteria: * person exposed to hiv risk from person infected by hiv, whose therapeutic history justifies the prescription of another combination of antiretroviral drugs * contraindications to the prescription of genvoy * other medical contraindications * person infected by hepatitis b virus * pregnant or lactating woman
trial of iw-1973, a stimulator of soluble guanylate cyclase (sgc) in patients with stable type 2 diabetes and hypertension

Conditions: Diabetes Mellitus, Type 2; Hypertension

Summary: to compare the safety, tolerability, pharmacokinetic (pk) profile, and pharmacodynamic (pd) effects of 2 treatment regimens of iw-1973 tablet (40 mg per day) administered orally for 2 weeks to patients with stable type 2 diabetes mellitus and hypertension.


Eligibility criteria:
inclusion criteria: * patient is ambulatory male or female * patient's body mass index score is \> 20 and \< 40 kg/m\^2 at the screening visit * women of childbearing potential must have a negative pregnancy test at the time of screening and check-in and must agree to use protocol-specified contraception throughout the duration of the study * patient's health is stable with no clinically significant findings on physical examination * patient has type 2 (ie, adult onset) diabetes mellitus diagnosed by a physician or nurse practitioner \> 6 months before the screening visit, is on a stable glycemic control medication, and protocol specified hemoglobin (hb)a1c values at the screening visit * patient has hypertension diagnosed by a physician or nurse practitioner \> 6 months before the screening visit, and blood pressure (bp) within the protocol's acceptable range * patients must be on a stable regimen for hypertension control that includes an angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb), stable for 28 days * other inclusion criteria per protocol exclusion criteria: * patient has a clinically significant active or unstable medical condition that, in the opinion of the investigator, would preclude trial participation * patient is on medication(s) that, when co-administered with a sgc stimulator, could increase the risk of hypotension * patient has evidence of severe or active end-organ damage * patient is an active smoker or has used any nicotine-containing products (cigarettes, e-cigarettes, vape pens, cigars, chewing tobacco, gum, patches) during the 6 months before check-in. use of nicotine is excluded during the study until after the end of trial visit. * other exclusion criteria per protocol
study to evaluate oral ubrogepant in the acute treatment of migraine during the prodrome in adult participants

Conditions: Migraine

Summary: study to evaluate the efficacy, safety, and tolerability of oral ubrogepant in the acute treatment of migraine when administered during the prodrome


Eligibility criteria:
inclusion criteria: * at least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ichd-3 (international classification of headache disorders 3rd edition) * migraine onset before age 50 years * by history, the participant's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom * history of 2 to 8 migraine attacks per month with moderate to severe headache in each of the 3 months prior to the screening visit exclusion criteria: * difficulty distinguishing migraine headache from tension-type or other headaches * participants who overuse medication for migraine defined as use of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, nonsteroidal anti-inflammatory drugs (nsaids), acetaminophen) ≥ 15 days/month in the 3 months prior to visit 1 per investigator's judgment * has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ichd-3 * a current diagnosis of chronic migraine as defined by ichd-3 or a history of 15 or more headache days per month on average in the 6 months prior to visit 1 in the investigator's judgment. a headache day is defined as a day in which there was any occurrence of a headache of a minimum duration of 2 hours or a headache of any duration for which acute medication was taken * has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ichd-3 * required hospital treatment of a migraine attack 3 or more times in the 6 months prior to visit 1 * history of malignancy in the 5 years prior to visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer * history of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that, per investigator judgment, may affect the absorption or metabolism of the study intervention; participants with prior gastric bariatric interventions (eg, lap band) which have been reversed are not excluded

Keywords: migraine
cardiorespiratory fitness in children and adolescents after cancer treatment.

Conditions: All Types of Pediatric Cancer

Summary: the power-study is a two-arm exercise intervention study for pediatric patients following acute cancer treatment. this clinical trial will investigate the effects of a 12-week moderate to high-intensity exercise program on cardiorespiratory fitness in children and adolescents beginning 6 weeks after completion of acute cancer treatment.

the main objective of the power study is to investigate the effects of a 12-week moderate to high-intensity, partially supervised exercise program on cardiorespiratory fitness (vo2peak) in children and adolescents who have completed acute cancer treatment. this randomized controlled trial will include n=56 patients. patients will be randomly assigned to the intervention or the control group. patients in the intervention group will perform two supervised exercise sessions per week, one personal training session and one group-based training session. during an initial consultation, both groups receive recommendations for individual physical activity goals and a brochure with exercise recommendations as well as a fitness tracker to monitor their daily physical activity. only the intervention group will receive daily activity targets, which will be adjusted on a regular basis. the study starts 6 weeks after completion of the patient's acute cancer treatment. secondary aims of this interventional study are to evaluate additional performance markers, including muscle strength, functional mobility, balance, body composition and patient-reported outcomes including qol, fatigue, and cognitive function as well as blood markers to evaluate changes in metabolic, immune, and heart health.

Eligibility criteria:
inclusion criteria: * children and adolescents between 7 and 23 years of age * completion of acute cancer treatment and receiving follow-up care in krefeld (helios hospital krefeld) * 6 weeks post cancer-treatment * signed informed consent (parents and patient) exclusion criteria: * \ 23 years of age * medical condition that limits participation in one of the study arms * inability to follow the training-protocol * inability to carry out the spiroergometry on a cycle ergometer

Keywords: exercise cardiorespiratory fitness pediatric oncology child health physical activity immune function
baduanjin program effect on geriatric functional dyspepsia

Conditions: Functional Dyspepsia

Summary: functional dyspepsia is very common between geriatric population

forty egyptian geriatrics with functional dyspepsia, after randomization, will be divided to 2 groups; the first 20-geriatric group will receive 5-session per-week 40-minute baduinjuin for 8 weeks plus the daily dose of pantoprazole (40 mg orally administered tablet drug. in the other 20-geriatric group, the daily dose of drug will be administered only for 8 weeks .

Eligibility criteria:
inclusion criteria: * functional dyspepsia complaints * geriatric population exclusion criteria: * cardiac complaints * respiratory complaints * articular complaints
a study of raltitrexed plus docetaxel versus docetaxel as second-line chemotherapy in subjects with gastric cancer

Conditions: Gastric Cancer

Summary: a study of raltitrexed plus docetaxel versus docetaxel as second-line chemotherapy in subjects with gastric cancer.the purpose of this study is to compare the activity of raltitrexed plus docetaxel versus docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (pfs) in each treatment arm.


Eligibility criteria:
inclusion criteria: 1. signed informed consent form 2. performance status- eastern cooperative oncology group (ecog) 0-2; 3. histologically or cytologically confirmed gastric cancer; 4. the first-line chemotherapy failure (required containing 5-fluorouracil) 5. at least have one measurable disease(according to recist, response evaluation criteria in solid tumors ) 6. life expectancy of at least 3 months; exclusion criteria: 1. received any prior treatment including raltitrexed; 2. active or uncontrolled infection; 3. concurrent treatment with an investigational agent or participation in another therapeutic clinical trial; 4. pregnant or lactating women.

Keywords: second-line chemotherapy raltitrexed
safety and immunogenicity of a group b streptococcus vaccine in non pregnant and pregnant women 18-40 years of age

Conditions: Streptococcal Infections

Summary: this study will evaluate the safety and immunogenicity of a group b streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.


Eligibility criteria:
inclusion criteria: * group 1 (non pregnant women): healthy females 18-40 years of age inclusive. * group 2 (healthy pregnant women): healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation) exclusion criteria: * group 1 (non pregnant women): pregnant or nursing; history of severe allergy to previous vaccines; known hiv positive * group 2 (healthy pregnant women): history of severe allergy to previous vaccines; known hiv positive

Keywords: group b streptococcus gbs vaccine prevention of group b streptococcus infection
tailored therapy for helicobacter pylori rescue treatment

Conditions: Helicobacter Pylori Infection

Summary: with increasing antibiotic resistance and unsatisfactory results of empiric eradication regimens, tailored therapy may be the best choice to achieve high efficacy for rescue treatment. this study aimed to evaluate the eradication rates, safety, and compliance of antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with helicobacter pylori infection.


Eligibility criteria:
inclusion criteria: * participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease * previous failures of h. pylori eradication therapy and need rescue therapy * ability and willingness to participate in the study and to sign and give informed consent * confirmed h. pylori infection exclusion criteria: * less than 18 years old * with previous gastric surgery * major systemic diseases * pregnancy or lactation * allergy to any of the study drugs * administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Keywords: helicobacter pylori rescue therapy tailored therapy antimicrobial susceptibility testing
improving vision and quality of life in the nursing home

Conditions: Refractive Error; Cataract

Summary: the primary purpose of this study is to evaluate whether interventions to improve vision in nursing home residents have an impact on residents' health-related quality of life. the interventions being evaluated are correction of refractive error (near-sightedness, far-sightedness, presbyopia) and cataract surgery.

the purpose of this project is two-fold: 1.) to establish the psychometric properties of the nursing home vision-specific health-related quality of life (hrqol) instrument, and; 2.) to evaluate the responsiveness of this instrument. responsiveness will be assessed in two independent preliminary prospective intervention evaluations. the first responsiveness evaluation will involve a new spectacle intervention and the second will involve first eye cataract surgery. in addition, we will examine the association between the responsiveness of this instrument, and changes in visual functioning measures and other demographic variables.

Eligibility criteria:
inclusion criteria: * at least 60 years of age or older * expected to stay in facility foe at least 8 months * stable medical condition * moderately cognitively impaired or better exclusion criteria: * those not meeting inclusion criteria