Kornimate/medical-research-clean huggingface dataset:
clinical performance of the atbfinder® test system for selection of antibiotic therapy in persons with cystic fibrosis

Conditions: Cystic Fibrosis; Lung Infection Bacterial

Summary: this prospective case-control study was planned to evaluate the efficacy of antibiotic therapy selected with the atbfinder® in persons with cystic fibrosis.

this pilot study entitled "clinical performance of the atbfinder® diagnostic test system for selection of antibiotic therapy in persons with cystic fibrosis " was designed to demonstrate the clinical performance of antibiotics selected with the atbfinder® for the treatment of lung infections in persons with cystic fibrosis.

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis based on sweat chloride levels = or \> 60, or genetic testing showing 2 pathogenic mutations. * ability to provide a clinical sample (expectorated sputum, throat culture or bronchoalveolar lavage) prior to the start of the antibiotic treatment. * prior treatment of a pulmonary exacerbation with systemic antibiotics in the preceding year. exclusion criteria: * inability to meet any of the above inclusion criteria. * systemic therapy with an antibiotic or corticosteroids in the 3 weeks preceding enrollment in the study, except those on chronic inhaled antibiotics. * primary or secondary (drug- or condition-induced) immune compromise. * creatinine \> 2 x upper limit of normal for age. * previous participation in this study in the prior 28 days.
comparison of anesthetic modalities on hemodynamic stability and postoperative pain in diabetic foot patients undergoing minor lower extremity amputation

Conditions: Diabetic Foot Ulcer; Lower Extremity Amputation

Summary: diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations (lea) associated with diabetes. traditionally general and spinal anesthesia were the preferred modality of anesthesia. the use of sciatic nerve block has recently gained popularity, however, without the supporting evidence of any benefits. this study was to evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative pain in diabetic foot patients undergoing minor lea.


Eligibility criteria:
inclusion criteria: * diabetic foot patients who underwent minor lea exclusion criteria: * emergency cases * patients who underwent major upper or lower extremity amputations * patients who received general anesthesia following fail regional or spinal anesthesia * patients who underwent lea within 1year, and patients who underwent other concomitant surgeries

Keywords: patients
reliability of multiple-repetition-maximum tests in patients with cardiovascular disease or risk factors

Conditions: Heart Failure; Coronary Heart Disease (CHD); Atrial Fibrillation (AF); Diabetes Mellitus; Arterial Hypertension

Summary: exercise training is a cornerstone in the prevention and rehabilitation of cardiovascular disease. while research has primarily focused on endurance training, resistance training becomes more and more important. the gold standard to prescribe resistance training intensity or monitor longitudinal changes is the 1-repetition-maximum (1-rm) test. however, particularly for unexperienced individuals, this test may not be recommendable due to the high load and an increased risk of injuries. alternatively, there are several published formulas to estimate the 1-rm based on a multiple-repetition-maximum (or repetition-to-failure) test. however, these formulas have been primarily tested in healthy individuals. moreover, the reliability of the 1-rm estimation based on two tests with different submaximal weight is unknown. therefore, the present study evaluates the agreement of the 1-rm estimation (based on different formulas) between two multiple-rm tests with different weight in 50 patients with cardiovascular disease (heart failure, coronary heart disease, atrial fibrillation) or cardiovascular risk factors (type 2 diabetes, arterial hypertension).


Eligibility criteria:
inclusion criteria: * age ≥ 50 years * at least one of the following cardiovascular diseases / risk factors: * heart failure * coronary heart disease * atrial fibrillation * arterial hypertension * type 2 diabetes mellitus * clinically stable for ≥ 4 weeks * medical clearance to perform resistance training / strength testing * signed written informed consent exclusion criteria: * pregnancy * acute infection * chronic joint inflammation * knee, hip, ankle, wrist, elbow or shoulder pain * known osteoporosis (t-value ≤ -2.5) * uncontrolled hypertension (≥160 mmhg systolic / ≥100 mmhg diastolic) * known cerebral or thoracic aneurysm

Keywords: resistance training cardiovascular disease cardiovascular risk factors muscle strength
cerebrospinal fluid congestion in spinal stenosis patients

Conditions: Spinal Stenosis

Summary: the investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal fluid congestion.


Eligibility criteria:
inclusion criteria: * neurogenic claudication more than 3months * relief neurogenic claudication by lumbar flexion * spinal stenosis symptom by physical exam. * who can walk more than 30 min. exclusion criteria: * vascular claudication by physical exam.( abi \<0.9) * structural change in vertebral ( tumor, congenital deformity) * operation history at spinal bone * metallic foreign body * peripheral polyneuropathy
cerebral autoregulation in patients with epilepsy

Conditions: Epilepsy

Summary: the purpose of this study is to determine whether patients with epilepsy exhibiting impaired dca, which may contribute to subsequent stroke.

the relationship between epileptic seizures and cerebrovascular disease is complex, ranging from mechanisms to clinical manifestation. stroke is one of the most common causes of epilepsy in adulthood. it was also reported that patients with epilepsy exhibited a higher risk of stroke. but its potential mechanism was never fully understood. dynamic cerebral autoregulation(dca), a mechanism to maintain the cerebral bold flow, has been proved to be critical for the occurrence ,development and prognosis of ischemic neurovascular disease. in this study, we hypothesis that impaired dca play a role in epilepsy and subsequent stroke.

Eligibility criteria:
inclusion criteria: * patients with epilepsy, as diagnosed by eeg exclusion criteria: * patients with status epilepticus * intracranial and/or extracranial major vascular stenosis/occlusion diagnosed by a transcranial doppler (ems-9pb, delica, china) and carotid ultrasound (iu22, phillips, andover, ma) * a prior symptomatic cerebral vascular disease * a history of hypertension, cardiovascular disease, diabetes, hyperlipemia, current arrhythmia, hyperthyroidism, anemia and unstable blood pressure, which may undermine hemodynamic stability, or inability to cooperate sufficiently to complete the cerebral auto regulation examination * insufficient bilateral temporal bone windows for insonation of the middle cerebral artery * intolerance to cerebral autoregulation measurements

Keywords: epilepsy, dynamic cerebral autoregulation
dietary supplements and aging muscle

Conditions: Sarcopenia

Summary: the purpose of this study is to determine whether older adults (ages 65-89) who consume the dietary supplement juven (abbott laboratories) versus placebo for 6 months will demonstrate increases in fat-free mass, muscle volume,and physical function.


Eligibility criteria:
inclusion criteria: * ages 65-89 * ambulatory exclusion criteria: * cognitive impairment * history of renal or hepatic disease * history of hypotension * history of peripheral artery disease * uncontrolled hypertension * uncontrolled diabetes * self-reported claustrophobia * current smoker * steroid or androgen use with the previous 3 months * individuals with pacemakers and defibrillators

Keywords: sarcopenia aging muscle dietary supplement hmb arginine glutamine
the use of faster acting aspart in type 1 diabetes patients

Conditions: Type 1 Diabetes; Insulin; Time in Range

Summary: data on switching from traditional mealtime insulins to fast-acting insulin aspart (fiasp) in routine clinical practice are sparse. the aim was to evaluate the efficacy and safety of switching from traditional mealtime insulin to fiasp in a "real-world" clinical practice setting in people with type 1 diabetes in belgium.

the primary endpoint was the evolution of time in range (tir, 70-180 mg/dl) at 6 and 12 months. secondary endpoints included change in hba1c, bmi, insulin doses, time below range (t\ 180 and t\>250 mg/dl). retrospective analysis two-center study

Eligibility criteria:
inclusion criteria: * type 1 diabetes patients * duration of diabetes \> 2 years * using cgm for \> 6 months exclusion criteria: * using smbg * pregnancy * using glucocorticoids or immunosuppressive agents * active oncological problem

Keywords: fast acting insulin glucometrics
effects of fermented milk product enriched with plant sterols and policosanols in mild hypercholesterolaemic adults

Conditions: Mildly Hypercholesterolemic Subjects

Summary: the objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on ldl-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of product consumption versus active control product.


Eligibility criteria:
inclusion criteria: * male and female aged 20-75 years; * bmi between 19 and 30 kg/m2 , * ldl-cholesterol plasma level between 130 mg/dl and 190 mg/dl (bounds included) stabilized for more than 3 months, * without statin monotherapy or other hypocholesterolaemic drug treatment, * accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (ncep-atp iii guidelines) exclusion criteria: * serum triglyceride (tg) levels ≥ 4 mmol/l (3.5 g/l), having experienced any cardiovascular event in the last 6 months, * receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters

Keywords: plant sterol - policosanols - hypercholesterolemia - dairy
a study for obstructive sleep apnea using a new at-home sleep test

Conditions: Obstructive Sleep Apnea

Summary: the purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

one treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. however, oral appliance therapy does not treat sleep apnea effectively in all individuals. in order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner. the device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.

Eligibility criteria:
inclusion criteria: 1. minimum 18 years of age 2. participant has been deemed suitable for oral appliance therapy 3. prescription for oral appliance 4. adequate range of motion 5. adequate dentition 6. ability to understand and provide informed consent 7. ability and willingness to meet the required schedule exclusion criteria: 1. loose teeth or advanced periodontal disease 2. full dentures

Keywords: oral appliance therapy
valé: a multidisciplinary childhood obesity treatment program for latino communities

Conditions: Pediatric Obesity

Summary: this proposal aims to test the initial feasibility and efficacy of a 10-week multidisciplinary pediatric weight management program among low-income latino children, aged 5 to 11 years, from the woodbridge, va area. the following specific aims will be tested:

specific aim 1: to test the acceptability of a multidisciplinary group intervention targeted towards low-income latino families with a child who is obese. specific aim 2: to test the effectiveness of the intervention by determining differences in behavioral changes (i.e. nutrition and physical activity habits), anthropometric (bmi-for-age, body fat) and clinical health outcomes (i.e. blood pressure, blood biomarkers) between children exposed to the intervention program vs. control children.

Eligibility criteria:
inclusion criteria: * pre-pubertal (girls must not have started menses) * of latino/hispanic descent (parent self-identified) * bmi for age \>85th percentile (based on cdc growth reference) * child between 5-11 years old * healthy (no known chronic diseases or regular medication) * parent/adult caregivers willing to participate in all study visits exclusion criteria: * not of latino/hispanic descent * \ 11 years old * bmi for age \<85th percentile * not pre-pubertal (girls have experienced their first menses) * child has learning deficits or acute/chronic medical condition * parent/guardian has no transportation or unable to participate in sessions
obesity assessment and education through the internet

Conditions: Obesity

Summary: the purpose of this study is to develop a web-based obesity risk assessment and counseling tool and examine its feasibility and effectiveness in improving the rate and quality of physician counseling about obesity, dietary change, and physical activity.

despite the high prevalence of obesity and its associated health risks, physicians do not address weight and behaviors that contribute to obesity because of lack of knowledge, training, and access to resources. to address these physician barriers to counseling, the investigator has developed a web-based tool that collects and integrates relevant patient clinical and behavioral information online and generates patient-specific recommendations and links to resources in the form of electronic patient and physician reports. in doing so, the tool provides physicians with a time saving device that identifies at risk patients who are motivated to make behavioral changes; at the same time, the tool provides tailored resources and recommendations that help physicians deliver more effective counseling. the pilot study described in this application randomizes overweight primary care patients to a control group and the web-based intervention. the aims of the study are to examine the feasibility of incorporating the web-based tool into primary care practice and to collect preliminary data on its potential effectiveness on improving the rate and quality of physician-patient discussions about weight and on improving several clinical and behavioral outcomes.

Eligibility criteria:
inclusion criteria: * received invitation from participating primary care practices * scheduled non-urgent appointment with their usual primary care provider * bmi \> 25 kg/m2 * willing and able to participate in a web-based computerized self-administered questionnaire * english-speaking exclusion criteria: * pregnancy * terminal illness * not competent to give consent

Keywords: obesity
robotic minimally invasive inguinal hernia repair with dexter

Conditions: Inguinal Hernia Repair

Summary: this study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the dexter robotic system, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.


Eligibility criteria:
inclusion criteria: * aged \> 18 years * patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed. * able to provide informed consent according to local regulation exclusion criteria: * morbidly obese patients (bmi \> 40) * any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments * need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery * bleeding diathesis * pregnancy * patients with pacemakers or internal defibrillators * any planned concomitant procedures * patient deprived of liberty by administrative or judicial decision or under legal guardianship * participation in another interventional clinical trial
povidone iodine vs avenova: a pre-injection disinfection study (pave study)

Conditions: Age-related Macular Degeneration; Diabetic Retinopathy; Diabetic Macular Edema

Summary: to compare the efficacy and comfort of two fda approved pre-injection antiseptics when used for intravitreal injections.

intravitreal injection of medicine has become the most common ocular procedure billed to medicare. one of the main problems with this procedure is the postoperative discomfort due to the need to disinfect the eye with povidone iodine (pi). this disinfectant lowers the risk of endophthalmitis, but is very rough on the corneal epithelium, producing a type of corneal abrasion in many patients that is very uncomfortable in the first few days after injection. many patients refuse the pi disinfection even though avoiding it increases the risk of endophthalmitis with the procedure. recently another disinfectant has been fda approved specifically for the eye to treat blepharitis and dry eye. avenova (av), a dilute solution of hypochlorous acid, is used several times a day for these conditions. some practices have begun using it for pi sensitive patients before an intravitreal injection as it is fda-approved for disinfecting peri-ocular structures. a recent in vitro study was published showing that it is superior to pi in kill times for bacteria cultured for endophthalmitis cases. some physicians say it is superior to pi with respect to patient comfort, however, to date, there is little literature about its use for intravitreal injection. the objective of this study is to assess comfort levels between the two fda-approved disinfection options and to compare disinfection rates between pi and av. the hypothesis is that av will be as effective or more effective in elimination ocular pathogens as pi and will be significantly more comfortable for patients.

Eligibility criteria:
inclusion criteria: * subjects must be receiving same day bilateral injections of an anti-vegf agent for any ophthalmic condition. * subject must be fluent in english. exclusion criteria: * under 18 years old. * subjects with an allergy or adverse reaction to povidone iodine or avenova.

Keywords: intravitreal injection disinfectant comfort povidone iodine avenova
comparisons of morphological measurement between coronary computed tomography and optical coherence tomography

Conditions: Coronary Artery Disease

Summary: the objective of this study is to evaluate the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (ccta) by current version of heartflow software and the impact on fractional flow reserve (ffrct) by using optical coherence tomography (oct) as reference standard.

analysis of ccta and oct was conducted under blind in independent organizations. after unblinding the ccta and oct case identification number, the oct image was co-registered to ccta data. after co-registration of ccta and oct lesion locations, the minimal lumen area (mla) was detected with both modalities. ffroct was calculated using oct-updated models in which ccta-based lumen geometry was replaced by oct-based lumen geometry. lesions were grouped according to their severity of calcification (using agatston score) and minimum lumen diameter.

Eligibility criteria:
inclusion criteria: - patients who underwent ccta prior to coronary angiography and oct within 6 months. exclusion criteria: 1. prior coronary artery bypass graft (cabg) surgery 2. contraindication to beta blocker agents or nitrates 3. tachycardia or significant arrhythmia 4. impaired chronic renal function (egfr \<30) 5. subjects with known anaphylactic allergy to iodinated contrast material 6. pregnancy or unknown pregnancy status in subject of childbearing potential 7. cases with poor oct or ccta image for analyzing
phase 2 safety and efficacy study of zilucoplan (ra101495) to treat pnh patients

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: the purpose of the study is to evaluate the safety and efficacy of zilucoplan (ra101495) in patients with paroxysmal nocturnal hemoglobinuria (pnh). there will be two groups of patients in the study: the first group will include patients who have never received eculizumab for treatment of pnh. the second group will include patients who have received treatment with eculizumab for at least 6 months prior to the study. patients will be treated with ra101495 for 12 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of pnh by flow cytometry * for treatment naive patients: subjects must not have received treatment with eculizumab prior to or during the screening period and must have a lactate dehydrogenase (ldh) level ≥2 times the upper limit of normal (xuln) during screening * for patients who previously received eculizumab: subjects must have received treatment with eculizumab for at least 6 months prior to screening exclusion criteria: * history of meningococcal disease * current systemic infection or suspicion of active bacterial infection

Keywords: pnh