Kornimate/medical-research-clean huggingface dataset:
association between periodontitis and the level of anti-citrullinated protein antibodies in rheumatoid arthritis

Conditions: Periodontal Diseases; Rheumatoid Arthritis

Summary: the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics. the aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (acpas) in gingival crevicular fluid before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (ra) patients

the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics. the aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (acpas) in gingival crevicular fluid before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (ra) patients materials and methods: a total of 40 participants suffering from periodontitis and rheumatoid arthritis will be referred from the badr hospital (faculty of medicine, helwan university) to misr international university's dental clinic complex. gingival crevicular fluid (gcf) samples will be collected from the patients before performing periodontal therapy (baseline). assessment of acpas will be quantified using enzyme-linked immunoassay (elisa) as the primary outcome at baseline and after 3 months. assessment of 2ry outcomes includes clinical periodontal and ra parameters at baseline and after 3 months.

Eligibility criteria:
inclusion criteria: * rheumatoid patients fulfilling the acr criteria for the classification of ra * 18 years * both genders * presence of at least 8 teeth exclusion criteria: * smoking * diabetes mellitus * pregnant females * patients who had undergone periodontal treatment within last 3 months * antibiotic therapy during last 3 months * other autoimmune diseases

Keywords: periodontitis rheumatoid arthritis anti citrullinated protein antibodies peptidyl arginine deminase enzyme gingival crevicular fluid (gcf)
improving older adults' decision making for osat

Conditions: Obstructive Sleep Apnea

Summary: this study evaluates the feasibility of conducting a randomized controlled trial that tests a patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed obstructive sleep apnea treated in an outpatient sleep clinic. half of the participants will use a patient decision aid, while the other half will receive general information about sleep.

patient decision aids are one strategy for helping older adults make informed decisions about treatments. patient decision aids improve patients' knowledge about therapies and encourage them to actively weigh the risks and benefits of each therapy.

Eligibility criteria:
inclusion criteria: 1. age \>= 60 years 2. diagnosed with obstructive sleep apnea on a sleep study 3. able to read english-language newspaper text (if needed, using contact lens/glasses) 4. able to write words in a paper booklet 5. scheduled for a sleep clinic appointment with a ucla sleep provider 6. able to attend a sleep educational session prior to sleep clinic appointment exclusion criteria: 1. unable to provide informed consent 2. dementia 3. mild cognitive impairment diagnosis or mini-cog score \< 3 4. treated for obstructive sleep apnea for \> 30 days prior to scheduled sleep education intervention 5. severe physical or mental illness (e.g., hospitalized within past 7 days prior to scheduled sleep education intervention, substance abuse within 90 days of sleep education intervention)
device accuracy of non-invasive glucose measurements in ethnic skin

Conditions: Diabetes Mellitus

Summary: this clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

the subjects enrolled in this protocol will dedicate 30 days of home-based measurement, scheduled within a 40 days' time frame. for reference measurements, subjects will be equipped with a blood glucose meter (contour next one, ascenia). optical measurements are collected with the investigational medical device. each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a blood glucose meter and two investigational medical device measurements.

Eligibility criteria:
inclusion criteria: * between 18 and 40 years of age. * have a diagnosis of diabetes mellitus. * distribution of skin phototype: 50-70 % of enrolled subjects phototype iv, 20-40 % of enrolled subjects phototype iii, 5-15 % of enrolled subjects phototype ii, 5-15 % of enrolled subjects phototype i. * be willing to perform a minimum of 8 finger sticks per day during the study. * be willing to perform a minimum of 8 optical measurements per day during the study. * be willing to provide written signed and dated informed consent. exclusion criteria: * breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control during the study execution (applicable to female subjects only). * subjects not able to understand and read english. * inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator. * subject is not able to hold hand/arm steadily (including tremors and parkinson's disease). * diagnosed with cardiovascular diseases. * reduced circulation in right hand evaluated by allen's test. * subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity. * radiotherapy for the past six months. * extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements. * known allergy to medical grade alcohol used to clean the skin. * systemic or topical administration of glucocorticoids for the past 7 days and under investigation. * subjects undergoing dialysis treatment. * concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff. * medical history or any condition that may, in the opinion of the investigator, compromise subject's ability to participate. * subjects currently enrolled in another study.

Keywords: non-invasive glucose monitoring
refining the interpretation of the tinel's sign for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: this is an observational study to investigate the electromyographic (emg) activity and nerve conduction velocity (ncv) of healthy individuals during the tinel's sign performed at different wrist positions. the study aims to identify the wrist position that best isolates median nerve activity during the tinel's sign.

the study will be conducted in a controlled laboratory setting, equipped with an electromyography (emg) machine and a nerve conduction velocity (ncv) measurement device. we will recruit 30 healthy adults, aged 18-45 years, with no history of hand or wrist pain, neurological or muscular disorders. participants will be excluded if they have any contraindications to emg or ncv measurement. the independent variable will be the wrist position during the tinel's sign, and the dependent variables will be the emg activity of the thenar and hypothenar muscles and the ncv of the median and ulnar nerves. emg activity will be measured using surface electrodes placed on the thenar and hypothenar muscles. ncv will be measured using a standard ncv measurement device. to minimize bias, the same trained examiner will perform all tests and measurements, and the examiner will be blinded to the emg and ncv data during the tests. differences in emg activity and ncv across different wrist positions will be analyzed using repeated measures anova. post-hoc pairwise comparisons will be performed using bonferroni correction. the study protocol will be submitted to the local ethics committee for approval, and all participants will provide informed consent.

Eligibility criteria:
inclusion criteria: * healthy individuals aged 18-45 years * no history of hand or wrist pain, neurological or muscular disorders exclusion criteria: * any contraindications to emg or ncv measurement
effects of acute grape seed extract supplementation on muscle metaboreflex in healthy young individuals

Conditions: Dietary Supplementation

Summary: the aim of this study was to determine whether grape seed extract (gse) supplementation could reduce the blood pressure (bp) in response to static exercise and post exercise muscular ischemia (pemi) in normotensive young adults. in 12 healthy subjects (7 male and 5 female, 24.6±3.4 yr), we compared acute effect of both gse (600 mg) and placebo (pl: 600 mg) on changes from rest in systolic bp (sbp), diastolic bp (dbp), mean arterial pressure (map), heart rate (hr), stroke volume (sv), cardiac output (co), and total peripheral resistance (tpr) during static exercise (se) and pemi. subjects completed 2 min of se at 30% of maximal voluntary contraction (mvc) followed by 2 min of pemi.


Eligibility criteria:
inclusion criteria: * healthy volunteers (sbp \< 120 mmhg, dbp \< 80 mmhg) exclusion criteria: * cardiovascular and/or pulmonary disease, * musculoskeletal disorders * medications that prevent the safe completion of the exercise protocol
cord blood nesfatin-1 and irisin in the intrauterine growth restricted fetuses

Conditions: Nesfatin-1; Irisin; Intrauterine Growth Restriction

Summary: : the aim of this study is to investigate cord blood irisin and nesfatin-1 levels in pregnancies with intrauterine growth retardation and to determine whether they are associated with abnormal fetal doppler findings or not.

this study was conducted at yüzüncü yıl university medical faculty obstetrics and gynecology clinic. the study group included 34 pregnant women ranged from 18 to 45 years old who have intrauterine growth retardation and underwent ceseraen section. 32 pregnant women who had no abnormality on prenatal follow-up and underwent elective ceserean seciton served as control group. the maternal age, height, weight, body mass index (bmi), systolic and diastolic blood pressures were recorded in both groups of patients. maternal serum total blood count and biochemical parameters were obtained from the laboratory parameters. gestational week at birth, birth weight, sex, 1st and 5th minute apgar scores were recorded. blood samples were collected from all the cases during the cesarean section for measurmenet of nesfatin-1 and irisin by doubly clamped umbilical cord. blood samples were immediately centrifuged in sterile tubes and maintained at -80 ° c until assessed.

Eligibility criteria:
inclusion criteria: * pregnant women with intrauterine grwoth rectricted fetuses. * healthy pregnancies exclusion criteria: * pregnant women with chronic medical conditions * multiple pregnancies * fetuses with fetal malfomations or genetic syndromes * pregnant women older than 45 years old
shockwave therapy for acute low back pain

Conditions: Acute Low Back Pain (Low Back Pain for Less Than 3 Months)

Summary: the purpose of this study is to determine whether shockwave therapy is more effective in the treatment of unspecific acute low back pain than sham therapy. 60 patients with acute low back pain will be recruited to a single-blinded, randomized, placebo-controlled trial. they are randomized to receive either shockwave therapy or sham treatment by a identically looking device for 4 weeks, twice a week. additionally patients receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if necessary for even 4 weeks. the primary outcome variable will be measured at day 0, every week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. the clinical outcome will be primarily measured by pain intensity using a visual analogue scale. secondary outcome measures are oswestry disability index, beck's pain depression scale, roland morris disability questionnaire and the eq-5d. data will be analysed for the difference in change of scores between groups using one-way t-test.


Eligibility criteria:
inclusion criteria: low back pain for less than 3 months exclusion criteria: * patients with relevant leg pain * patients with spine operations in the past * neurologic symptoms * scoliosis with cobb angle \> 10° * patients experienced in shock wave therapy * patientes with ongoing therapy with blood diluting drugs such as phenprocumon * patients with osteoporosis * patients with back pain after trauma * patients with infective diseases or tumor diseases * patients with relevant psychological diseases
heart transplant registry of városmajor

Conditions: Disorder Related to Cardiac Transplantation

Summary: the purpose of this registry is to determine the long term outcomes of heart transplantations performed at the semmelweis university heart and vascular center. all eventual interventional and non-interventional procedures will be accounted for and summarized.


Eligibility criteria:
inclusion criteria: * heart transplant recipient * \>18 years old * signed informed consent * cared for at the semmelweis university heart and vascular center exclusion criteria: * denies consent to registry

Keywords: heart transplant cardiac allograft vasculopathy chronic rejection immunosuppressant therapy
the effect of nutrition education on glycemic control in patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the study aims to elucidate whether patients with t1d initiating sensor monitoring experience greater improvement in glycemic control (hba1c) when provided with structured nutrition education compared to those initiating sensor monitoring without such education.

education on carbohydrate counting and flexible insulin dosing improves glycemic control, which is also enhanced by glucose sensor usage. however, the combined effect of structured education and the initiation of sensor monitoring remains unclear.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * type 1 diabetes duration for at least 12 months prior to sensor initiation * glucose sensor monitoring initiated at the diabetes centre of the general university hospital in prague exclusion criteria: * uncertain diabetes type * pregnancy * change or suspension of glucose sensor monitoring during the study period * unavailability of sensor data * automated insulin delivery treatment

Keywords: carbohydrate counting flexible insulin dosing structured education glycemic control glucose monitoring
a multicenter trial on the utility and impact of computed tomography and serum ca-125 in the management of newly diagnosed ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of the research is to determine if blood tests and a ct scan done before surgery can predict how successful the surgery will be. in patients who have cancer of the ovary that has spread, it is hoped that the ct scan will be able to identify the various places where the cancer has spread so that additional surgeons can be available to help with the surgical procedure. if you have confirmed stage 3 or 4 ovarian, fallopian tube, or primary peritoneal cancer, you may undergo a ct scan of the abdomen and pelvis after the surgery to compare how much cancer the surgeon thought was left after surgery to what is seen on ct scan. a ct scan of the chest will be done if your physician thinks it is necessary.

this study is designed to assess the utility and impact of computed tomography (ct)scanning of the abdomen and pelvis and preoperative serum ca-125 levels in the management of patients undergoing surgery for presumed ovarian cancer.

Eligibility criteria:
inclusion criteria: * all patients \> 18 years of age undergoing surgery for presumed ovarian, fallopian tube, or primary peritoneal cancer. * patients must be medically and physically able to undergo general anesthesia and possible tumor debulking. * patients must read and sign informed consent form after the nature of the study has been fully explained. exclusion criteria: * presence of clinically significant disease, allergy, or other disorder precluding the ability to safely perform ct scan of the abdomen and pelvis with oral and intravenous contrast. * vulnerable patients (minors, mentally retarded patients, prisoners, etc.)

Keywords: newly diagnosed ca 125 ct scan 01-048
a clinical study to assess the safety and effectiveness of the omni® surgical system

Conditions: Glaucoma, Open-Angle

Summary: the purpose of this study is to evaluate the long-term safety and effectiveness of the omni® surgical system in subjects who were treated under protocol #06213


Eligibility criteria:
inclusion criteria: • participated in, received treatment, and completed protocol #06213 exclusion criteria: * systemic disease that, in the opinion of the investigator, would put the subject's health at risk and/or prevent completion of required study visits * ocular pathology which, in the investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (amd), corneal edema, fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to screening visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits)
templates as cognitive aids in emergency airway equipment preparation: the template airway trial

Conditions: Airway Management

Summary: comparison of preparation times (in seconds) for emergency airway management (equipment only) with and without a template.

comparison of time (in seconds) needed to prepare all necessary equipment for one form of emergency airway management with and without a template. participants will be randomized to "preparation with template (a)" and "preparation without template (b)" and all participants will be measured twice for both arms a and b, however, evaluation will take place on two separate days. methods of airway management evaluated will be endotracheal intubation, supraglottic airway device and oral fiberoptic intubation, with a total of three measurements per participant per study day and two study days per participant. participants will be nurses in the intensive care unit and, as a control group, anesthesia nurses will also be evaluated in order to factor in the effects of experience. the study will take place in the usual work environment of participants and with the standard equipment.

Eligibility criteria:
inclusion criteria: * age 18 years and older * written informed consent * qualification as a nurse (icu or anesthesia) * employed with university medical centre of johannes gutenberg university (jgu) mainz exclusion criteria: * none
a multicenter, retrospective observational study to evaluate the effectiveness and safety of polatuzumab vedotin

Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)

Summary: to assess the clinical outcomes following treatment with pola in combination with bendamustine, rituximab (br) or rituximab (r) in patients with r/r dlbcl who are not eligible for transplantation in the real-world setting.

this study is a multi-center retrospective observational study. it aims to evaluate the effectiveness and safety of polatuzumab vedotin treatment in patients with hematopoietic stem cell transplantation ineligible relapsed/refractory diffuse large b-cell lymphoma (r/r dlbcl), who met the criteria to access pola through the compassionate use program (cup). based on the medical records of patients in the four participating hospitals, the study database will be established by using the unified case report form (crf) to search extract information the data of target population from the hospital database, that is, the variables without personal identification information.

Eligibility criteria:
inclusion criteria: hospitalized patients patients who enrolled in the pola cup program and met the following criteria: * histologically confirmed dlbcl, patients have exhausted all therapeutic options for dlbcl and have been treated with at least two prior lines of therapy including r-chop (or similar regimen for 1l dlbcl) * not considered to be eligible for bone marrow transplantation (bmt) (both allogenic or autologous) * have documented recent progression following or during last treatment, or became intolerant to the last treatment * does not have ≥ grade 2 peripheral neuropathy(pn) prior to receiving pola * patients treated with pola-br or pola-r regimens exclusion criteria: * patients participating in other clinical studies of pola.

Keywords: diffuse large b-cell lymphoma (dlbcl) polatuzumab vedotin
extension study of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease

Summary: study rin-pf-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.

study rin-pf-302 is a phase 3, multicenter, open-label extension (ole) study for eligible subjects who completed study rin-pf-301 or study rin-pf-303 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (ipf). following ole entry, subjects will return at week 4, week 12, and every 12 weeks thereafter for up to 6 years or until the subject prematurely discontinues study treatment due an adverse event (ae)/serious adverse event (sae) or other reason, inhaled treprostinil becomes commercially available for ipf, or the study is discontinued by the sponsor (whichever is sooner). efficacy assessments will include spirometry (forced expiratory volume in 1 second \[fev1\] and forced vital capacity \[fvc\]), time to clinical worsening, time to first acute exacerbation of ipf, overall survival, king's brief interstitial lung disease (k-bild) questionnaire, plasma n-terminal pro-brain natriuretic peptide (nt-probnp) concentration, supplemental oxygen use, and diffusion capacity of lungs for carbon monoxide (dlco). safety assessments will include monitoring for the development of aes/saes, vital signs, clinical laboratory parameters, and electrocardiogram (ecg) parameters. in addition, up to 24 eligible subjects may participate in a pk substudy to evaluate the systemic exposure of treprostinil after inhaled administration.

Eligibility criteria:
inclusion criteria: 1. subject gives voluntary informed consent to participate in the study. 2. the subject participated in study rin-pf-301 or study rin-pf-303 and remained on study drug and completed all scheduled study visits or was enrolled in study rin-pf-301 or study rin-pf-303 at the time that the study or study subject was discontinued by the sponsor. 3. women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at ole entry visit and baseline) and non-lactating, and will abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug. 4. males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug. 5. in the opinion of the investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits. exclusion criteria: 1. subject is pregnant or lactating. 2. in the opinion of the investigator, enrollment in study rin-pf-302 would represent a risk to the subject's overall health.

Keywords: treprostinil ipf ild