Kornimate/medical-research-clean huggingface dataset:
study to determine the effectiveness of pillar palatal implants to treat obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (osa) in the united states and europe. the implants are placed into the soft area in the roof of the mouth providing support to the soft palate. this research is being done to compare daytime sleepiness and sleep related quality of life after palatal implants.

patients will be enrolled into the study based on sleep study results, a physical exam and inclusion/exclusion criteria. once enrolled, patients are randomized into either the pillar palatal implant group or a placebo/sham group. in both cases, patients come into the office for placement of the implants. this is an outpatient procedure. patients are followed at one week, one month and 3 months. at each follow-up visit, patients will undergo a physical exam and complete questionnaires related to sleep and quality of life. patients will also undergo reaction time testing on hand-held device similar to a pocket video game. at the three month visit, patients will return to the sleep lab for another sleep study.

Eligibility criteria:
inclusion criteria: * 18 years or older * body mass index equal to 32 or less * apnea-hypopnea index greater than/equal to 10 and less than/equal to 30 * symptoms of daytime sleepiness exclusion criteria: * septal deviation or nasal obstruction * nasal polyps * severe seasonal allergies * soft palate length insufficient to accommodate implants * fujita modified mallampati class 3 * large tonsils * lingual tonsil hypertrophy * hypopharyngeal obstruction * previous pharyngeal surgery * previous upper respiratory tract cancer or radiation therapy * active respiratory tract infection * dysphagia or speech disorder * neurologic disorder * unstable psychiatric disorder * pregnant or breastfeeding * history of falling asleep driving or mva due to sleepiness * currently on cpap therapy or other device for osa * other sleep disorders

Keywords: obstructive sleep apnea daytime sleepiness pillar palatal implants
assessment of liver fibrosis and prognosis in chinese patients with chb infection using ste/stq elastography

Conditions: Cirrhosis

Summary: this national multicenter prospective study is aimed to study the diagnositic performance of ste/stq elastography in liver fibrosis and prognosis in patients with chronic hepatitis b infection.

ultrasound liver elasticity measurement and imaging has not only been proposed as an alternative to evaluate the severity of chronic liver fibrosis, but also as a mean to stratify patients with advanced fibrosis according to risks of occurrence of clinical complications of end-stage liver diseases. sound touch elastography (ste）and sound touch quantify (stq) developed by mindray resona 7 imaging system provide both two-dimensional and point shear-wave elastography of tissue elasticity with stronger penetration and easy operation. this analysis will study the diagnositic performance of ste/stq elastography for lver fibrosis and the prognostic value of ste/stq elastography for the prediction of clinical complications of chronic liver diseases.

Eligibility criteria:
inclusion criteria: * patients undergoing a liver ultrasound exam due to confirmed hepatitis b infection , * patients having reached the age of majority in china, * patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the ste/stq measurement date, and having the recommended quality criterion: minimal length of biopsy samples of 15 mm, stored in paraffin minimal number of portal tracts of 6 per biopsy samples * patients of chinese ethnic origin. exclusion criteria: any of the conditions below will exclude patients from the study: * any patient presenting with combined etiologies of chronic liver diseases:，including non hepatitis b viral infection（hepatitis a, c, d, e）, alcoholic chronic liver disease, hemochromatosis, autoimmune hepatitis，etc * any patient presenting with a co-infection of hiv * any patient presenting with combined liver tumor * any patient ever received liver transplantation * pregnant women * acute hepatitis
isosorbide mononitrate for anti-vascular endothelial growth factor (vegf) induced kidney injury

Conditions: Kidney Injury; Proteinuria; Hypertension

Summary: the purpose of this study is to test the hypothesis that isosorbide mononitrate prevents deterioration of renal function in patients receiving anti-angiogenic therapies that target vascular endothelial growth factor (vegf).


Eligibility criteria:
inclusion criteria: * patients on or enrolled for anti-vegf therapy * new-onset proteinuria, defined as a urine protein: creatinine ratio (upc) of \>500mg/g or hypertension (systolic bp ≥ 140 mm hg and/or diastolic bp ≥ 90 mm hg) or a decrease in egfr by ≥ 25% from baseline before starting therapy. exclusion criteria: * pregnant women * breast-feeding women.

Keywords: kidney injury proteinuria hypertension anti-vegf
a cost-effectiveness analysis of the single-implant mandibular overdenture treatment

Conditions: Mouth, Edentulous

Summary: the aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by a single implant. the study hypothesis is that simo is more effective but more costly than the conventional denture, though this incremental cost is relatively low for the offered effectiveness in terms of clinical and patient-reported outcomes.

this randomized clinical trial alongside a cost-effectiveness analysis will include twenty-eight edentulous individuals who meet eligibility criteria. new maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. then, participants will be randomized into one of the treatment groups: conventional complete denture group or single-implant mandibular overdenture group. each participant allocated to the overdenture group will then receive a straumann® standard plus slactive® regular neck implant (straumann 0.33.051s/052s/053s institute straumann ag, basel, switzerland) in the mandibular midline. a healing abutment will be connected and the implant will be allowed to heal for approximately 3 weeks. then, a 3.4mm retentive titanium anchor abutment (straumann 048.439, institute straumann ag, basel, switzerland) will be connected and tightened to 35 n.cm with a torque wrench. the matrix will be incorporated to the denture using self-curing acrylic resin and the patient will be instructed to keep the upper and lower dentures firmly occluded in the habitual position until the final polymerization of the resin. direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment and patient-reported outcomes will be assessed. incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. a markov decision tree will be constructed to set out the consequences of the competing alternatives. sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.

Eligibility criteria:
inclusion criteria: * no contraindications for implant surgery (mainly related to uncontrolled systemic diseases) * present enough bone volume in the mandibular midline area for implant placement without the need of bone augmentation procedures. * be able to understand and answer the questionnaires used in the study * agree to participate by providing a written informed consent. exclusion criteria: * noncompliant participants * individuals who do not agree to be randomly allocated to the treatment study group * presence of signs of untreated temporomandibular disorders, uncontrolled systemic or oral conditions that require additional treatments

Keywords: mandibular prosthesis implantation prostheses and implants denture, complete, lower
vitamin d supplementation in pediatrics. oral or parenteral! d2 or d3

Conditions: Vitamin D Deficiency

Summary: a study will be performed on vitamin d deficient/ insufficient egyptian children to compare the efficacy of oral and parenteral forms of ergocalciferol and cholecalciferol in raising serum 25(oh) d levels in these subjects


Eligibility criteria:
inclusion criteria: * laboratory evidence of vitamin d deficiency or insufficiency without clinical signs of rickets exclusion criteria: * vitamin d or calcium supplementation within the last 6 months before inclusion, patients with diabetes mellitus, chronic liver disease and kidney disease, congenital or rheumatic heart disease, malabsorption syndromes, thyroid disease, juvenile rheumatic diseases, or other bone disorders.

Keywords: vitamin d, ergochalciferol, cholecalciferol, oral, parenteral
predictive value of sflt-1/plgf ratio for the diagnosis of cardiovascular disorders in the puerperium: pilot study

Conditions: Cardiovascular Disorder; Puerperium; Disease

Summary: the goal of this clinical trial is to identify a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks postpartum) by making use of a panel of placental biochemical markers (sflt-1 and plgf: already used in pregnancy for prediction of preeclampsia), demographic, clinical and laboratory data. the goal is to create a score that allows the clinician to identify those expectant mothers who at discharge are at increased risk of developing cardiovascular/hypertensive disorders.

at the time of recruitment, patients will be adequately informed about the purpose and modality of the study and will sign an informed consent form for participation in the study. on the first postpartum day, on the occasion of the blood tests included in the normal care routine, the patients will undergo measurement of circulating levels of angiogenic factors (soluble fms-like tyrosine kinase, sflt-1; placental growth factor, plgf), already used in pregnancy for predicting the risk of early and late preeclampsia. marker assay kits will be provided free of charge by the company dasit. prior to collection, systolic and diastolic blood pressure will be measured by manual sphygmomanometer in supine position after at least 15 minutes of rest. anamnestic, clinical and laboratory data regarding pregnancy, childbirth and puerperium will be collected. a diary for recording blood pressure values in the puerperium will be provided on the same occasion. the patient will be instructed in home blood pressure monitoring which should take place twice a week for the next 6 weeks after delivery. return of the diary containing the pressure data will be done by e-mail. postpartum hypertension is defined according to acog criteria as a systolic blood pressure ≥ 140 mmhg and/or diastolic blood pressure ≥ 90 mmhg. if altered blood pressure values are found, the patient will be invited to go to the emergency department or to her primary care physician and treated according the usual clinical practice.

Eligibility criteria:
inclusion criteria: * age \> 18 years and \< 44 years * single pregnancy * understanding and obtaining informed consent exclusion criteria: * language misunderstanding * twin pregnancies * inability to comply with study arrangements (e.g., inability to home recording of blood pressure values)

Keywords: sflt-1/plgf ratio
covid-19 and obstetric transmission

Conditions: COVID; Pregnancy Complications

Summary: the aim of this study is to capture data, laboratory markers, and clinical outcomes of obstetric and neonatal outcomes in cases of covid-19 during pregnancy and of pregnancies exposed to a covid-19 vaccine in cuyahoga county.

a review of the 55 cases of obstetric covid-19 cases world-wide demonstrate the following fetal complications of covid-19: miscarriage (2%), intrauterine growth restriction (iugr; 10%), pre-eclampsia, and pre-term birth (39%). in wuhan, china, nine women who were covid-19 positive were surveilled for vertical transmission and overall obstetric and early neonatal outcomes. amniotic fluid, umbilical cord blood, and neonatal throat swabs were collected at the time of delivery, and breastmilk samples were collected after lactation commenced. there was no viral detection of covid-19 demonstrated.2 however, two neonates in the united kingdom have tested positively for covid-19 after delivery from an infected mother. most recently, antibodies were detected (igm and igg) in the serum of a neonate born via cesarean delivery to a known positive mother. therefore, vertical transmission has not been completely ruled out. additionally, infection at varying times of pregnancy has not been well delineated or correlated to neonatal or maternal outcomes at time of delivery. therefore, there is a need to continue surveying and documenting clinical findings in obstetric covid-19 cases. this study will follow pregnant women who are diagnosed during any point of their pregnancy with covid-19 and those who were vaccinated. during pregnancy. the aim will be to evaluate maternal and neonatal specimens for the presence of covid-19 virus, immune and cellular response.

Eligibility criteria:
inclusion criteria: * covid-19 infection at any time of the pregnancy, or presumed case by symptoms and direct contact with a positive case * pregnancy documented by ultrasound exclusion criteria: * covid-19 infection before or after pregnancy * person under investigation, but not a presumed or known positive case
physical activity assessment of patients with diabetic foot wounds

Conditions: Diabetic Foot

Summary: the study evaluates the compliance of patients who suffer from a diabetic foot wound to follow a physical activity program, adapted to their medical condition. this study will aslo evaluate the security of this program, and how it could improve or not the quality of life, the diabet's metabolical balance, and the wounds's cicatrization speed.

the study is a prospective monocentric study, leaded in the lille chru. this study is a physical activity program feasibility assessment for patients with diabetic foot wounds. the muscular mass stabilization and the physical activity is almost never used to heal diabetic feet wounds. with this study, we evaluate the compliance of patients to follow a physical activity program, which could lead to a further study, with more patients and multicentric, and it could measure the impact of this program on metabolical balance, wound size and quality of life. the study will last 6 months, the inclusion will last 3 months, and each patient will have a 3 months follow-up time. the patient have several medical appointments in the diabetic foot unit, where the compliance will be evaluated, wound size and security will also be evaluated. the activity program is a suite of exercises, 4 times in a week, it lasts 30 minutes? the first day, follow-up book is given to the patient. during the follow-up, the patient will still have his usual medical appointments, which will occur at the 30th, 60th and 90th days. phone-call appointments will also be possible at the 15th and 45th days.

Eligibility criteria:
inclusion criteria: * men and women * every patient over 18 years old * diabet whatever the type, with foot wound, whatever the size, or duration. exclusion criteria: * medical condition : sub-gonal amputation, which makes physical activity impossible. wound localization which would lead to a wound degradation, like the heel, the plantar face of toes. * administrative cause : impossibility to provide written informed consent, impossibility to be followed up during the needed duration, no medical insurance, rejection to sign the consent paper.

Keywords: diabetic foot physical activity muscular mass cicatrization offloading
efficacy and safety of anthrax vaccine, gc1109

Conditions: Anthrax

Summary: 1. background the newly developed anthrax vaccine gc1109 has been proven safe and effective in preclinical studies. 2. objective - to evaluate the immunogenicity and safety of the anthrax vaccine gc1109 in healthy male volunteers. 3. study design * single-blinded * randomized * placebo controlled * phase 1 study


Eligibility criteria:
inclusion criteria: 1. healthy male subjects between 18 and 45 years of age at the time of screening visit 2. 18.5kg/m2 ≤bmi \< 30kg/m2 at the time of screening visit 3. subjects without congenital or chronic disorder exclusion criteria: -

Keywords: anthrax vaccine bioterrorism efficacy safety
effects of exenatide in type 2 diabetic patients with congestive heart failure

Conditions: Type 2 Diabetes Mellitus; Congestive Heart Failure

Summary: the purpose of this study is to determine if exenatide will improve global cardiac function in patients with type 2 diabetes mellitus and congestive heart failure, by favorable effects on cardiac metabolism leading to improvement of cardiac efficiency.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * male and postmenopausal female * age 18 years an above * metformin therapy (stable, maximum tolerable dose for 2 months) * hba1c 6.5-10% * confirmed congestive heart failure (nhya functional class ii-iv) * ejection fraction \< 50% * patients should receive a stable standard therapy for their cardiac condition for 3 months prior entering the study exclusion criteria: * type 1 diabetes mellitus * serious renal or liver impairment * (receiving treatment for) malignant disease * cardiovascular event \< 3 months prior to inclusion * acute congestive heart failure * any reason for not being able to sustain the imaging studies * pacemaker/icd * contraindications for the use of exenatide/ insulin * use of insulin, thiazolidinediones, incretin-based therapies within 4 months of screening * chronic use of glucocorticoids, nsaids or centrally acting drugs (\> 2 weeks) within 2 weeks immediately prior to screening

Keywords: exenatide type 2 diabetes mellitus congestive heart failure incretin hormones glp-1 agonist cardiac metabolism insulin resistance cardiac mri
cancer screening smoking cessation and respiratory assessment

Conditions: Lung Cancer; Protection Against Malignant Lung Neoplasm (Diagnosis)

Summary: the cassandra project (cancer screening, smoking cessation, and respiratory assessment) is a project led by separ whose main coordinators are dr. luis seijo, a pulmonologist at the clínica universitaria de navarra, and dr. juan carlos trujillo-reyes, a thoracic surgeon at the hospital de la santa creu i sant pau and coordinator of the thoracic oncology area, in addition to the collaboration of a large number of professionals with expertise in lung cancer screening. despite its proven efficacy, spain does not yet have a unified lung cancer screening protocol. the aim of the cassandra project is to initiate a national screening program that can join forces with existing smoking cessation programs in spain, which have proven to be insufficient in reducing the number of people affected by lung cancer. cassandra aims to analyze the feasibility of implementing a lung cancer screening program in spain implemented in the public health system and carry out a cost-effectiveness analysis

cassandra aims to be the first lung cancer screening pilot project in spain. a project to assess the feasibility of implementation as well as to look for models that allow a better selection of the cases to be screened.

Eligibility criteria:
inclusion criteria: * age 50-75 years active smoker with cumulative dose of \>20 packets/year * age 50-75 years ex-smoker less than 15 years old with cumulative dose of \> 20 packets/year exclusion criteria: * pre-existing or new-onset comorbidities that, in the opinion of the coordinator, prevent surgical resection if lung cancer is found on low dose computed tomography (ldct) scan, for example, severe chronic obstructive pulmonary disease (copd) with forced expiratory volume at one second (fev1) \< 30%. * inability to sign the informed consent or collaborate with the ct scan. * performing a chest ct for any reason in the previous year or planned ct for any reason in the next 3 months. * subjects with a history of any cancer (except non-melanoma skin cancer) in the 5 years prior to inclusion in the screening program.

Keywords: lung cancer tobacco cessation respiratory assessment
study comparing the efficacy of two ibuprofen formulations

Conditions: Pain

Summary: this is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.


Eligibility criteria:
inclusion criteria : * outpatients with post-operative pain following surgical extraction of third molars, * examined by the attending dentist or physician and medically cleared to participate in the study, * in general good health and have no contraindications to the study or rescue medication. exclusions criteria: * any serious medical condition, * acute localized dental infection at the time of surgery , * females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.

Keywords: dental pain analgesia
lidocaine infusion in radical cystectomy

Conditions: Postoperative Ileus

Summary: radical cystectomy (rc) remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. nowadays, enhanced recovery pathway is used to decrease morbidity and improve acute rehabilitation after rc. postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy.

radical cystectomy remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. the high rates of morbidity and mortality reflect the fact that the majority of patients undergoing this procedure are elderly patients with multiple comorbidities. postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy. to reduce the risk of ileus, prokinetics such as metoclopramide should be used postoperatively. local anesthetics exert their actions as local anesthesia and antiarrhythmic through na channels blocking but still have many other important actions through other receptors (e.g., m1 muscarinic receptors) that occur at very low plasma levels compared to levels needed for na channels blocking, one of these actions is the anti-inflammatory effect against surgical stress response. several randomized studies found that i.v. lidocaine shortens duration of postoperative ileus and some of it reported decreased postoperative pain with i.v. lidocaine, so they recommended i.v. lidocaine as a safe, simple, and less invasive method for management of postoperative ileus and equal to postoperative epidural analgesia.

Eligibility criteria:
inclusion criteria: * 45-75 yr asa class i,ii, and iii elective radical cystectomy exclusion criteria: * allergy to the study medication, pre-existing chronic pain at any site requiring treatment, psychiatric disease, hepatic or renal impairment, seizure disorder requiring medication within the previous 2 years