Kornimate/medical-research-clean huggingface dataset:
association between low dose acetylsalicylic acid (asa) and proton pump inhibitors and risk of acute myocardial infarction or coronary heart disease death

Conditions: Nonfatal Myocardial Infarction; Coronary Death

Summary: the purpose of this study is to estimate the risk of myocardial infarction (mi)/coronary death associated with use of monotherapy low dose asa (single antiplatelet) as well as concomitant use of monotherapy low dose asa and proton pump inhibitors (ppis) in patients with serious coronary heart disease using two uk primary care databases.

number of anticipated subjects: in case-control analysis: 10.000-15.000 participants

Eligibility criteria:
inclusion criteria: * as above ( study population description). * all individuals aged 50-84 years with at least one year of enrolment with the primary care physician (pcp) and a computerized prescription history of at least one year before the start of the study. exclusion criteria: * recorded diagnosis of cancer prior to study start. * patients aged ≥ 70 years with a follow-up longer than one year if having fewer than two recorded consultations with a primary care physician (pcp) during their entire follow-up (proxy for incomplete and invalid data recording

Keywords: mi low dose aspirin ppi epidemiology nonfatal mi and coronary death
effects of etanercept on the heart, veins and thickness of certain major arteries in ankylosing spondylitis patients

Conditions: Ankylosing Spondylitis

Summary: study to assess whether etanercept therapy is able to increase flow-mediated vasodilatation in as, and whether etanercept can modify the intima-media thickness (imt) in these patients


Eligibility criteria:
inclusion criteria: 1. diagnosis of as, as defined by modified new york criteria for ankylosing spondylitis. 2. as with active disease as defined by bath ankylosing spondylitis disease activity index (basdai, see attachment 4) \>= 4 at screening visit. 3. patients capable, in the opinion of the investigator, of complying with the treatment schedule and doses throughout the 52 weeks 4. agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study. 5. ability to self-inject drug or have a designee who can do so. 6. ability to store injectable test article at 2ºc to 8ºc. exclusion criteria: 1. pregnancy confirmed by test taken at screening in all women except those who were surgically sterile or at least 1 year postmenopausal. sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception that needs to be continued for 15 days following discontinuation of the test article.

Keywords: imt evaluation in as patients treated with etanercept
determinants of early cystic fibrosis lung disease

Conditions: Cystic Fibrosis in Children

Summary: the overall objective of this study is to determine the impact early nutritional and respiratory indices have on early cf lung disease. this knowledge will guide clinical management of infants with cf, who are now primarily diagnosed through newborn screening.

the overall objective of this study is to determine the impact early nutritional and respiratory indices have on early cf lung disease. this knowledge will guide clinical management of infants with cf, who are now primarily diagnosed through newborn screening. we hypothesize that respiratory and nutritional indices during the first year of life are critical determinants of lung function in infants and preschoolers with cf. aim #1 - to examine the relationship between nutritional status (weight-for-age (wfa) and weight-for-length (wfl)) at 6 months of age and lung function at 1-2 years of age in infants with cf. hypothesis: infants with cf with poor nutritional status at 6 months of age will have worse lung function, as assessed through the raised volume rapid thoracoabdominal compression technique and plethysmography, compared to those with better nutritional indices, defined as improved weight-for-age and weight-for-length. aim #2 - to examine the relationship between nutritional status (wfa and wfl) in infants with cf at 12 months of age and the lung clearance index (lci) at 3-5 years of age. hypothesis: infants with cf with poor nutritional indices at 12 months of age will have a higher (worse) lci at 3-5 years of age compared to those with better nutritional status. aim #3 - to delineate the relationship between passive tidal breathing lung function testing in infants with cf at 4-8 weeks of age and subsequent lung function at 6-12 months of age. hypothesis: abnormalities in passive tidal breathing lung function testing will be associated with abnormal infant pulmonary function testing obtained via the raised volume rapid thoracoabdominal compression technique and plethysmography at 6-12 months of age.

Eligibility criteria:
inclusion criteria: * informed consent by a parent or legal guardian * a confirmed diagnosis of cf by newborn screening and either a documented sweat chloride of at least 60 meq/l by quantitative pilocarpine iontophoresis or a genotype with two cf-causing mutations * one month to five years of age. exclusion criteria: * chronic lung disease not due to cf * contraindications to sedation, including structural abnormalities of the upper airway or chest wall and severe gastroesophageal reflux * gestational age \< 36 weeks

Keywords: nutritional status infant pulmonary function testing lung clearance index multiple breath washout
a clinical study evaluating the safety and efficacy of idp-115 in patients with rosacea

Conditions: Rosacea

Summary: the purpose of this study is to assess the safety and effectiveness of idp-115 in treating patients with rosacea.


Eligibility criteria:
inclusion criteria: * presence of facial rosacea * presence of inflammatory lesions exclusion criteria: * dermatological conditions of the face that could interfere with clinical evaluations * known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption) * female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
exclusion of intra-atrial thrombus before catheter ablation

Conditions: Atrial Fibrillation; Thrombi

Summary: atrial fibrillation is the most frequent heart rhythm disorder. its symptomatic forms, resistant to drug therapy, require invasive management (catheter ablation), which exposes to potentially serious complications including thromboembolic complications. despite anticoagulant treatment, intra-atrial thrombus, which is a contraindication to catheter ablation, is detected in nearly 2 % of cases. its diagnosis requires prior transoesophageal echocardiography, an unpleasant examination. a previous study (nct02199080) showed that a zero ate score, defined by no heart failure, no hypertension, no history of stroke, d-dimer \< 270 ng/ml, has a negative predictive value of 100 % for the exclusion of intra-atrial thrombus. the objective of the study is to confirm the negative predictive value, sensitivity and specificity of the ate score for the exclusion of intra-atrial thrombus.


Eligibility criteria:
inclusion criteria: * adult patients, * patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia, * have signed or orally given an informed consent exclusion criteria: * contraindication to transoesophageal echocardiography, * transoesophageal echocardiography made in another centre than the centre of ablation, * pregnant women, parturient mothers and nursing mothers, * lives in an institution on court or authority order, * severely altered psychological health, * persons leaving in health or social establishment, * minors, * under guardianship, * persons unable to give their consent, * refusal to participate in the study.
fluciclovine and psma pet/ct for the classification and improved staging of invasive lobular breast cancer

Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Invasive Breast Lobular Carcinoma; Metastatic Breast Lobular Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8

Summary: this phase i trial studies how well fluciclovine positron emission tomography (pet)/computed tomography (ct) and psma pet/ct work in helping doctors understand and classify invasive lobular breast cancer in patients with invasive lobular breast cancer that is suspicious for or has spread to other places in the body (metastasized). fluciclovine and psma are radiotracers used in pet/ct imaging scans that emit radiation. the pet/ct scan than picks up the radiation being released to create a picture from within the body. information learned from this study may help researchers learn how to better identify metastatic disease in invasive lobular breast cancer patients which will impact appropriate staging.

primary objectives: i. improve detection of metastasis with fluciclovine f18 (fluciclovine) and gallium ga 68-labeled psma-11 (psma) pet versus best standard of care conventional imaging, as confirmed with histology. ii. determine concordance and discordance of invasive lobular breast cancer (ilc) detection with psma versus fluciclovine pet, as confirmed with histology. exploratory objective: i. establish the role of circulating tumor deoxyribonucleic acid (dna) (ctdna) directed to esr1 and pi3k dna in characterizing the degree of tumor burden as identified by metabolic amino acid transport and tumor neovasculature receptor imaging. outline: patients receive gallium ga 68-labeled psma-11 intravenously (iv) and undergo a pet/computed tomography (ct) scan over 30 minutes. on a separate day, patients receive fluciclovine f18 iv and undergo a pet/ct scan over 30 minutes. after completion of study, patients are followed up in 5-10 business days, and then up to 5 years.

Eligibility criteria:
inclusion criteria: * treatment naive biopsy proven ilc patients with ilc * either: a) clinical or imaging suspicion of metastatic disease; or b) proven metastatic disease but in whom there is suspicion of an even greater tumor burden that could change therapy approach * ability and willingness to undergo biopsy if needed per standard of care for possible metastasis which could change therapy approach exclusion criteria: * pregnancy. qualitative or quantitative serum or urine pregnancy test will be done in women of childbearing potential within 24 hours before pet * a female of childbearing potential (fcbp) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (if age \> 55 years); if the female subject is \ 1 year her reproductive status has to be verified by additional lab tests (\ 40 in women not on estrogen replacement therapy)
the effect of relaxation exerci̇se on comfort and anxiety in herniated lumbar disc surgery

Conditions: Lumbar Disc Herniation

Summary: this study aimed to investigate the effect of progressive relaxation exercises on the comfort and anxiety levels of patients undergoing lumbar disc herniation surgery in the neurosurgery clinic.

this study aimed to investigate the effect of progressive relaxation exercises on the comfort and anxiety levels of patients undergoing lumbar disc herniation surgery in the neurosurgery clinic.the study's data was conducted as experimental study on patients who will undergo surgery in the neurosurgery clinic of the ministry of health muammer ağım gemlik state hospital between march 2023 and july 2023. the sociodemographic characteristics questionnaire, immobilisation comfort scale and state anxiety scale were used for data collection. the shapiro-wilk normality test, the t-test for the same and different groups mean and standard deviation, pearson correlation analysis were used to evaluate the data.

Eligibility criteria:
inclusion criteria: * over 18 years of age, elective surgery, * undergoing ldh surgery for the first time, * undergoing lumbarmicrodiscectomy surgery, * asa 1 and 2 classification, * receiving only general anaesthesia under endotracheal intubation, * without cognitive impairment, hearing and vision problems, * volunteered to participate in the study, * patients who did not develop any complications that would affect comfort and anxiety exclusion criteria: * 18 years of age or younger, * with psychiatric disorders,

Keywords: anxiety comfort level nursing lumbar disc herniation progressive relaxation exercises
motor imagery ability after stroke

Conditions: Stroke

Summary: individuals with stroke may experience sensory-motor deficit and/or neglect, with possible reduction in motor imagery ability (mi). to our knowledge, no study completely investigated mi ability in one individual whereas mi practice can be performed using visual or kinesthetic modalities (respectively visualizing with mind's eyes or imagining movement using sensation) and internal or external perspectives (performing action as spectator or as actor). this study aims to investigate mi ability in patients with stroke as compared to aged-matched healthy individuals. the investigators will assess explicit mi ability using 3 questionnaires (movement imagery questionnaire-rs - miq-rs, kinesthetic and visual imagery questionnaire-20 - kviq-20, vividness of movement imagery questionnaire-2 - vmiq-2) and 2 tests (imagined time up and go - itug, imagined box and block test - ibbt). outcome parameters will be i) the composite score of vividness measured for all tests using likert scales, ii) the temporal equivalence between mi and physical practice (pp - where mi/pp ratio equal to 1 indicate good mi ability and respect of temporal equivalence between mi and pp) and iii) the amplitude of electrodermal activity. the investigators will also study implicit mi ability using a hand laterality judgment task. outcomes parameters will be response time (i.e. the duration to identify the hand laterality) and the percentage of correct responses.


Eligibility criteria:
inclusion criteria: for both groups: * be more than 18 years old * be less than 75 years old * benefit from social security for experimental group: * patient admitted in henry gabrielle hospital for rehabilitation * patient with one single episode of stroke exclusion criteria: for patients: * sign of cognitive decline (mmse score under 27/30) * evolutionary pathology associated for healthy subjects: - neurological or orthopaedical history
evaluation of the previsea device for predicting gastrointestinal impairment

Conditions: Gastrointestinal Complication

Summary: previsea is a noninvasive, disposable device that uses audio spectral analysis of sounds produced by the gastrointestinal tract to predict gastrointestinal impairment (gii). gii is most commonly associated with postoperative ileus (poi), but could be the result of other causes, such as early postoperative bowel obstruction. gii is defined as failure of successful early oral re-feeding in a subject undergoing major abdominal surgery. for subjects who are allowed to resume a diet during the first 24 hours after surgery, a failure to successfully orally re-feed a subject is defined as presentation with emesis, requiring a reversal of diet, or the placement of a nasogastric tube on first postoperative day or later. the device is considered non-significant risk (nsr). the device does not inform medical decisions in this study. researchers will be blinded to results of the device during this study.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 90 years 2. patient undergoing elective intestinal resection surgery including open, laparoscopic, robotic, or hand-assist technique for: 1. segmental ileocolic resection with or without diversion 2. segmental colon resection with or without diversion 3. segmental coloproctectomy with or without diversion 4. low anterior resection with or without diversion 5. abdominoperineal resection 6. total abdominal colectomy with or without diversion 7. proctocolectomy with or without end ileostomy or diversion 8. closure of end colostomy (hartmann's reversal) exclusion criteria: 1. allergies to any of the device components (i.e., adhesive) 2. inability to have prototype device applied to their abdominal wall due to disease conditions or surgical alterations(e.g., fistulas, stomas, drains, etc.) 3. patients undergoing: 1. small bowel resection without colonic resection 2. transanal proctectomy without transabdominal approach 3. perineal proctosigmoidectomy 4. closure of loop colostomy or ileostomy 4. patients with preoperative evidence of an anastomotic leak, deep wound infection, organ space infection, or urinary tract infection

Keywords: postoperative ileus postoperative bowel obstruction emesis reversal of diet nasogastric tube abdominal sounds gastrointestinal impairment elective intestinal resection
comparison of the berlin questionnaire to the portland sleep quiz

Conditions: Sleep Apnea

Summary: this trial is enrolling patients who are already being seen at ohsu sleep disorder center or have been referred for clinical reasons by their physician to the ohsu sleep disorder center and are going to have a sleep study that would be paid for by their insurance company for clinical reasons. the purpose of this study is to determine whether the portland sleep apnea quiz has a higher specificity and negative predictive value then the berlin sleep questionnaire in a patient population with a high predisposition to sleep apnea presenting to a sleep center.

this trial is enrolling patients who are already being seen at ohsu sleep disorder center or have been referred for clinical reasons by their physician to the ohsu sleep disorder center and are going to have a sleep study that would be paid for by their insurance company for clinical reasons. 400 consecutive adult subjects who have been referred by their doctor to the sleep disorder center and are undergoing a diagnostic sleep study at the ohsu sleep disorders center will be requested to fill out both a berlin questionnaire and portland sleep quiz on the night of the initial diagnostic polysomnography. the questionnaires will be collected and scored in a confidential manner. the predictive value of the questionnaires will be compared with the results of overnight polysomnography (apnea hypopnea index).

Eligibility criteria:
inclusion criteria: * adults more than 18 years old exclusion criteria: * subjects unwilling to complete the questionnaire

Keywords: obstructive sleep apnea
prospective evaluation of efficacy and safety of fondaparinux in surgical cancer patients, risk factors for thromboembolism

Conditions: Cancer; Cancer Diagnosis; Thromboembolism

Summary: non interventional multi-centric study that will aim in evaluating the efficacy and safety of fondaparinux in surgical cancer patients, identifying in parallel the most relevant and critical risk factors for thromboembolism.

non interventional multi-centric study that will aim in evaluating the efficacy and safety of fondaparinux in surgical cancer patients, identifying in parallel the most relevant and critical risk factors for thromboembolism. it is a cohort study, recruiting cancer patients over 18 years of age, who have been diagnosed with cancer for over a period of one year. exclusion criteria apply as well while all patients can withdraw their participation at any time point.

Eligibility criteria:
inclusion criteria: upcoming surgery for newly diagnosed or potential cancer or relapse / metastasis of cancer that has been treated and diagnosed ≥ 1 year exclusion criteria: * recent (\<6 months) episode of venous thromboembolic disease (deep vein thrombosis and / or pulmonary embolism and / or thrombosis in a rare location such as visceral or cerebral venous thrombosis) * pregnancy or pregnancy * patients on long-term anticoagulation for any reason (mkh, hmb or abk, doacs) at prophylactic or therapeutic dose, prior to enrollment in the study. * active haemorrhage, diagnosed hemorrhagic disorder, thrombocytopenia * ulcers or vasodilatations of the gastrointestinal tract * hemorrhagic stroke or surgery in the brain, spine or eye of the last trimester * bacterial endocarditis or other contraindication to the use of anticoagulant treatment * creatinine clearance \<20ml / min * thrombolytic treatment or administration of dextran in the 2 days preceding administration of fondaparinux

Keywords: cancer cancer diagnosis thromboembolism
efficacy and safety of saturno iib association on the control of ocular inflammation post-phacoemulsification

Conditions: Ocular Inflammation; Cataract

Summary: the purpose of this study is to evaluate the efficacy of saturno ii association on the control of ocular inflammation post-phacoemulsification


Eligibility criteria:
inclusion criteria: * participants of both sexes, aged 18 years or more; * participants presenting the diagnosis of cataract with indication for surgery by the phacoemulsification procedure; * participants who undergo surgery in only 1 eye at a time; * participants with intraocular pressure (iop) ≤ 20 mmhg; * signed consent. exclusion criteria: * used non-steroidal anti-inflammatory drugs or topical steroids or systemic inhalers within 21 days prior to randomization of the clinical trial; * performing the surgery for the second time, to correct the previous procedure or to change the lens; * decompensated glaucoma or ocular hypertension with iop above 21 mmhg; * active ocular infectious diseases; * history hypersensitivity to the active ingredients used in the study; * pregnancy or risk of pregnancy and lactating patients; * history alcohol abuse or illicit drug use; * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * participation in clinical trial in the year prior to this study.
closure of oroantral fistula (oaf) using platelet rich fibrin with middle meatal antrostomy

Conditions: Oroantral Fistula

Summary: the study evaluated the one stage endoscopic middle meatal antrostomy (emma) technique with the application of a platelet rich fibrin membrane (prf) for oroantral fistula (oaf) closure and relief of maxillary sinusitis.

this study was conducted on nine eligible patients who complained of oaf with odontogenic sinusitis. oral fistulectomy was done with proper curettage. then, emma was performed with simultaneous closure of the oaf by application of prf membrane and covering it with an acrylic splint. patients were clinically evaluated for closure of the oaf after 14th days postoperatively, relief of the symptoms, and assessment of the pain level. also, measurement of the size of the bone defect with the aid of computed tomography (ct) preoperatively and 24th weeks postoperatively.

Eligibility criteria:
inclusion criteria: 1 - adult patients between the ages of 20-60 years. 2- patients who were suffering from chronic fistula that occurred after the extraction of upper posterior teeth exclusion criteria: 1. patients who have any systemic disease that contraindicates any intervention under general anesthesia (e.g., coronary artery disease). 2. oaf that occurred as a result of other causes (e.g., cyst,and trauma)