Kornimate/medical-research-clean huggingface dataset:
periodontal disease and colorectal cancer

Conditions: Periodontal Diseases; Colorectal Carcinoma

Summary: the aim of this interventional study is to determine the impact of periodontal disease and periodontal treatment on patients with colorectal cancer. the main questions were: 1. does periodontal treatment affect the levels of c-reactive protein in the blood of patients undergoing cancer treatment? 2. can the investigators isolate periodontal pathogenic bacteria fusobacterium nucleatum and porphyromonas gingivalis from the mucosa of cancerous colon tissue using the method of quantitative culture? the investigators will compare the levels of c-reactive protein in the blood of patients undergoing treatment for colorectal cancer who have received periodontal treatment with patients who have not received periodontal treatment. crp levels will be measured during the first examination with the oncological surgeon, on the first and second day after the surgical procedure, and during the first follow-up with the oncological surgeon. additionally, the investigators collected samples of cancerous colon mucosa from 10 participants for the attempt to isolate f. nucleatum and p. gingivalis using the quantitative culture method.


Eligibility criteria:
inclusion criteria: * colorectal cancer, scheduled for surgical treatment * consent to participate additional inclusion criteria fot the control group: * fiilled questionnaire * recorded crp results at the first examination, after surgery, and at the first follow-up examination. exclusion criteria: * under 18 years old * periodontal treatment in the past 12 months * antibiotic therapy in the last 3 months * edentulism * advanced stage cancer, scheduled for palliative care * chemotherapy or radiotherapy prior to surgical procedure
immunogenicity and safety of dtp-hb-hib using new hepatitis b bulk (bio farma)

Conditions: Diphtheria Vaccine Adverse Reaction; Tetanus Vaccine Adverse Reaction; Pertussis Vaccine Adverse Reaction; Haemophilus Influenzae Type B Vaccine Adverse Reaction; Hepatitis B Vaccine Adverse Reaction

Summary: this bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. the primary objective of this study is to evaluate protectivity of dtp-hb-hib vaccine (bio farma) using new hepatitis b bulk (bio farma).

this bridging study is a randomized, double blind, two arms parallel groups, prospective intervention study. total 220 infants, 0-3 days old will be involved in this study. the subject will be divided into 2 groups, 110 subjects are the investigational group and 110 subjects are the active comparator group. the objective of this study is to evaluate protectivity of dtp-hb-hib vaccine (bio farma) using new hepatitis b bulk (bio farma) and to asses the safety of dtp-hb-hib vaccine (bio farma) and recombinant hepatitis b vaccine using new hepatitis b bulk (bio farma).

Eligibility criteria:
inclusion criteria: 1. healthy, full term, newborns infants. 2. infant born after 37-42 weeks of pregnancy. 3. infant weighing 2500 gram or more at birth. 4. father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. 5. parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial. exclusion criteria: 1. child concomitantly enrolled or scheduled to be enrolled in another trial. 2. child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on day 0). 3. child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis. 4. child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis 5. newborn suspected of congenital or acquired immunodeficiency, based on anamnesis 6. child received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)). 7. child received other vaccination with the exception of bcg and poliomyelitis. 8. child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. 9. mother with hbsag and hiv positive (by rapid test within 30 days prior subject's birth) 10. mother suspected of immunodeficiency disease based on anamnesis

Keywords: dtp-hb-hib vaccine hepatitis b vaccine
the angioma's treatment evaluation with laser doppler imaging (ldi)

Conditions: Port-wine Stains (PWS)

Summary: based on the doppler effect, laser doppler imaging (ldi) uses the interaction of light with moving erythrocytes to visualize perfusion in the microcirculatory system. the new device to be used in this study have been adapted specifically for the application, facilitating its use in clinic. it has been designed to take a standard white light image of the area under inspection simultaneously with the perfusion image to facilitate clinical assessment. port-wine stain (pws) birthmarks are congenital, low-flow vascular malformations of the skin found in approximately 0.3% of children. they are commonly found on the face and neck and may cause serious psychological consequences. lasers are the modality of choice for the treatment of pws birthmarks. the use of pdl is very effective in pws in closing the blood vessels and diminishing therefore the redness of the skin. repeated laser treatment is necessary to achieve the desired clinical outcome. actually, the efficacy of the treatment of pws by the laser is obtained by clinical inspection and digital photography. by measuring the activity and intensity of the microcirculation present in and under the skin, the laser-doppler (ldi) will be capable of measuring the effect of pulsed dye laser (pdl) treatment for port-wine stains.


Eligibility criteria:
inclusion criteria: * children aged 12 months to 6 years old * port-wine stains (pws) * phototype's skin i, ii or iii exclusion criteria: * phototype's skin iv, v or vi * prior treatment with laser * contraindication of general anesthesia * refusal from the parents
denosumab and teriparatide study (data-hd and data-ex)

Conditions: Postmenopausal Osteoporosis

Summary: the aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide. the study extension will evaluate the effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.


Eligibility criteria:
inclusion criteria: * women aged 45+ * postmenopausal * osteoporotic with high risk of fracture exclusion criteria: * no significant previous use of bone health modifying treatments
effects of different treatment modalities for obstructive sleep apnea on temporomandibular joint

Conditions: Obstructive Sleep Apnea

Summary: this study aims to evaluate the subjective symptoms, clinical and radiographic signs of temporomandibular disorders related to the use of cpap, mad and physical therapy in the treatment of patients with obstructive sleep apnea.

the study will be conducted on thirty-nine patients with osa attending to sleep disorders breathing unit, chest department at mansoura university hospital confirmed by polysomnography in the period between july and september 2022. the patients will be divided equally into three therapy groups each compromise 13 patients: group i: patients will be treated with cpap. group ii: patients will be treated with digitally fabricated mad. group ii: patients will be treated with physical therapy.

Eligibility criteria:
inclusion criteria: * • all adult patients, diagnosed as having osa after full night polysomnography. exclusion criteria: * • pregnant patients

Keywords: obstructive sleep apnea tempromandibular joint
prospective randomized on-x versus sjm evaluation trial

Conditions: Heart Valve Disease

Summary: the study hypothesizes that rate of thromboembolic complications of the on-x prosthesis is reduced as compared to the sjm prosthesis.

the study is a multi-centre, randomized trial that will sequentially enroll up to 500 eligible patients in each group from up to 10 participating study centres internationally to test the hypothesis.

Eligibility criteria:
inclusion criteria: 1. the patient requires an isolated mitral or isolated aortic valve replacement. (patients undergoing coronary artery bypass and / or concomitant repair of mitral or tricuspid valves are eligible.) 2. the patient is a candidate for receipt of a mechanical heart valve. 3. the patient (or legal guardian) has signed a study-specific informed consent form agreeing to the randomization, data collection and follow-up requirements. 4. the patient can be having a re-operative procedure, so long as the previous prosthetic valve is explanted and the patient does not become a double valve implantation patient. exclusion criteria: 1. the patient is not a candidate to receive a mechanical heart valve. 2. the patient already has a prosthetic valve other than the valve(s) being replaced at this time. 3. the patient requires a tricuspid valve replacement. 4. the patient is enrolled in another investigative study or trial.

Keywords: thromboembolism mechanical heart valves randomized
point-of-care-ultrasound for sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: patients with obstructive sleep apnea (osa) are at risk for respiratory dysfunction in the perioperative environment. the study is designed to evaluate if point-of-care-ultrasound (pocus) measurements of upper airway anatomy may identify patients with osa and their severity.

obstructive sleep apnea (osa) is characterized by recurrent collapse of the pharyngeal airway during sleep, resulting in substantially reduced (hypopnea) or complete cessation (apnea) of airflow despite ongoing breathing efforts. osa has long been recognized as a heterogeneous disorder with potentially multiple contributing pathophysiological causes but with significant impact to perioperative morbidity. various osa phenotypes exist but, the predominant feature is a narrow and collapsible upper airway anatomy and is an interplay between pharyngeal soft tissue, genioglossus muscle tone and the bony anatomy and accounts for up to two-thirds of the variation in the ahi. identification of moderate-severe osa is crucial to prevent potential life-threatening cardiopulmonary complications perioperatively.(1) however, a large proportion of patients with osa remain undiagnosed at the time of surgery.(2) current screening tools are mainly questionnaire based and are largely sensitive but not specific (3) resulting in many false positives, unnecessary increased resource utilization, cost burden, and legal implications. gold standard laboratory polysomnography(psg) study is expensive and not widely available. point-of-care ultrasound (pocus) is a readily available, portable, noninvasive tool that has been used for airway evaluation and may be useful for osa screening.(4-8) study investigators want to evaluate the various pocus measures of osa in the perioperative population and correlate these measurements with the psg based severity of osa (based on apnea-hypopnea index -ahi) to find out the best measure or a combination of measures to diagnose the incidence and severity of osa.

Eligibility criteria:
inclusion criteria: * patients of either gender * age 18 through 85 * history of previous sleep study polysomnography (psg) exclusion criteria: * no prior sleep study * history of central sleep apnea * craniofacial/oropharyngeal malformations * oropharyngeal surgery since the last sleep study * ear/nose/throat tumor * history of ear/nose/throat surgery * inability to consent * non-english speaking
beta cell function and related pharmacodynamics of hms5552 in t2dm patients

Conditions: Type 2 Diabetes

Summary: this study evaluates the beta cell function, pharmacodynamics, pharmacokinetics, safety and tolerability after 4 weeks treatment of 75mgbid or 75mgqd of hms5552.


Eligibility criteria:
inclusion criteria: * male and female,age 18-65 years * has type 2 diabetes mellitus * bmi 20 to 29kg/m2 * willingness to adhere to the protocol requirement exclusion criteria: * patients with type1 diabetes mellitus * received any antidiabetic drug within run-in or during screening * hepatic diseases * kidney diseases * clinical abnormal finding in evg,labs and physical exams * women of child-bearing potential
use of muac as basic criterion for admission, follow-up and exit from the ambulatory nutrition program

Conditions: Malnutrition

Summary: the aim of this study is to provide comprehensive documentation of the relevant results and operational implications of this new model using mid-upper arm circumference (muac) as the single anthropometric criterion for admission, monitoring and exit of non- complicated in niger.

this is a first operational experiment using mid-upper arm circumference (muac) as the single anthropometric criterion for the admission, monitoring and exit of the management of uncomplicated sam (severe acute malnutrition) in niger, specific data as well as data from routine program will be collected to allow comprehensive documentation of all relevant results and operational implications of this new model. the experiment based on the use of the single anthropometric threshold for admission of a mid-upper arm circumference (muac)\<120 mm, which includes both children currently classified as having sam (currently with pb \<115 mm) and acute malnutrition moderate (mam, currently with a mid-upper arm circumference (muac)\<125 mm), as well as a follow-up of children with a mid-upper arm circumference (muac)≥ 120 mm, will identify how children respond to treatment and benefit of the spectrum of acute malnutrition.

Eligibility criteria:
inclusion criteria: * all children admitted for non-complicated sam (severe acute malnutrition) treatment exclusion criteria: * children between the ages of 6 and 59 months who were recently excluded from treatment by admission criteria based on muac (sabon guida site) but were previously eligible for treatment (ie muac ≥ 120 and z score \<-3).
exercise and nutrition intervention for frail older patients

Conditions: Frailty

Summary: the objective of this study is to evaluate the effect of a person-centered training and nutrition intervention six month after discharge in acutely admitted frail old medical patients on physical function. secondly, to evaluate the effect on frailty, quality of life, health literacy, nutrition, readmissions, death and consumption of home care costs.

evidence on how to improve physical function and avoid unnecessary readmissions for frail hospitalized older medical patients is not established as yet. in denmark, the few studies performed have not succeeded in showing a significant difference in physical function or quality of life, due to sector barriers, low compliance and uni-dimensional interventions and none of the studies addressed readmissions and or described a patient-centered approach. this research project will address this serious individual and societal challenge by testing and evaluating a person-centered complex intervention with emphasis on the patients´ own focus and goals. to increase the probability of developing a successful intervention with the patient in focus we have completed two qualitative studies with patients and health professionals. the primary results from these studies indicate that the pedagogical approach of the involved healthcare professional is important for establishing a good relation. patients had a desire of being more active, but after four week only a minority had their own expectations fulfilled. furthermore, the patients expressed that social relations had the potential of increasing adherence to training sessions. furthermore, a citizen's panel has been established, and possible elements important for the intervention were discussed on behalf of their own experiences with the healthcare system. the results of these qualitative studies and the latest evidence contributed to the development of the current intervention study.

Eligibility criteria:
inclusion criteria: * 65+ years old * acutely admitted with a medical focus at aalborg university hospital, south. * living in aalborg municipality (except 9230 svenstrup, 9240 nibe, 9293 kongerslev, 9381 sulsted, and 9382 tylstrup) * able to walk (assistance is ok) before admission. * speak and understand danish. exclusion criteria: * discharged with rehabilitatinplan for physiotherapy within the last 30 days. * dementia or other cognitive impairments. * terminal ill.

Keywords: older frailty strength training nutrition
amyloid beta-peptide 1-40 and alzheimer's disease

Conditions: Alzheimer Disease

Summary: the combined measurement of ab42 and tau protein (total and phosphorylated) in the spinal fluid has been shown to be promising in the diagnosis of alzheimer's disease (ad), and has justified its inclusion new diagnostic criteria. however, it can sometimes yield discordant results that are not discriminant (isolated variation in ab42 or p-181 tau). to answer this challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40 (aβ40). this marker reflects the patient's total amyloid deposits and is used to calculate the aβ42/aβ40 ratio. this ratio measures the relative variation of aβ42 as compared to the total amyloid burden. literature data on this topic are sparse and to date, no report has been published evaluating the utility of this marker in the diagnostic strategy for ad.


Eligibility criteria:
inclusion criteria: * patients attending the memory clinic of champagne-ardennes for memory disorders, and * whose diagnostic work-up requires assessment of biomarkers present in the cerebrospinal fluid are considered eligible for inclusion in this study. exclusion criteria: * patients who do not have any social security coverage will not be included.

Keywords: dementia biomarkers cerebrospinal fluid
local infiltration analgesia or intrathecal morphine in total knee arthroplasty

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine whether local infiltration analgesia is more effective than intrathecal morphine in reducing postoperative pain in total knee arthroplasty.

postoperative pain is often severe following total knee arthroplasty. spinal anesthesia is a common method in total knee arthroplasty. adding morphine to the local anesthetic injected intrathecally prolongs the analgetic effect, but may give the usual opioid side effects. the local infiltration analgesia (lia) technique has proven effective in reducing postoperative pain in total knee arthroplasty. in the lia technique a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively. the aim of this study is to evaluate if spinal anesthesia together with the lia technique provide better postoperative pain relief and mobilization than spinal anesthesia with addition of morphine to the local anesthetic intrathecally. primary end-point is morphine consumption the first 48 postoperative hours. secondary end-points are pain intensity, knee function, time to home readiness, hospital stay, side effects and patient satisfaction. patients are followed up to 3 months after surgery.

Eligibility criteria:
inclusion criteria: * patients scheduled for total knee arthroplasty under spinal anesthesia. * aged 40-85 yrs. * asa physical status i-iii and mobility indicating normal postoperative mobilization. exclusion criteria: * known allergy or intolerance to one of the study drugs. * serious liver-, heart- or renal decease. * rheumatoid arthritis. * chronic pain or bleeding disorder.

Keywords: postoperative pain local infiltration analgesia knee arthroplasty
identifying biological markers for severe depression

Conditions: Major Depressive Disorder

Summary: the primary objective of this study is to investigate the biological components of major depression. the investigators are particularity interested in genetic variation and how it contributes to cortisol (because cortisol is higher in severe depression than mild depression or healthy controls) and how it contributes to clinical symptoms, especially suicidal ideation/behavior and psychosis.


Eligibility criteria:
inclusion criteria for depressed patients: 1. diagnostic and statistical manual of mental disorders 4th edition (dsm-iv) diagnosis of unipolar major depressive disorder with or without psychotic features. 2. 21-item hamilton depression rating scale (hdrs) score greater than or equal to 21. 3. thase core endogenomorphic scale score greater than or equal to 8 on the items included in the 21-item hdrs. 4. between 18 - 70 years of age. 5. if currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least one-week prior to entering the study. 6. pre-existing (current) primary treating psychiatrist for subjects with psychotic features. 7. any secondary diagnoses from the anxiety disorder spectrum is acceptable. primary pre-existing chronic obsessive-compulsive disorder (ocd) will be an exclusion criteria. inclusion criteria for healthy controls: 1. between 18 - 70 years of age. 2. have a ham-d score of less than or equal to 5. exclusion criteria for depressed patients: 1. electroconvulsive therapy (ect) in the 6 months prior to the study. 2. abuse of drugs or alcohol in the 6 months prior to study. 3. unstable or untreated hypertension or cardiovascular disease. 4. use of additional prescription medications, street drugs, or alcohol during the week before the study. 5. any axis ii diagnosis or traits which would make participation in the study difficult. 6. current pregnancy or lactation. 7. post-partum depression 8. diagnosis of obsessive-compulsive disorder 9. history of significant cognitive decline exclusion criteria for healthy controls: 1. personal history of axis i or axis ii disorders. 2. active unstable medical problems. 3. abuse of drugs or alcohol in the 6 months prior to study. 4. use of additional prescription medications, street drugs, or alcohol during the week before the study. 5. currently pregnant or lactating. 6. history of significant cognitive decline