Kornimate/medical-research-clean huggingface dataset:
parathyroid hormone levels in relation to the phosphorus content of meals

Conditions: Renal Failure

Summary: patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the blood and a secondary increase in the ipth level. this chronic elevation in ipth can have adverse consequences, thus a variety of phosphate binders are given in an attempt to decrease the absorption of phosphorus present in the normal diet. some preliminary studies have indicated that the ipth level may change based on the amount of phosphorus present in a meal prior to any significant absorption of phosphorus. if this is true in hemodialysis patients, then the timing of the administration of phosphate binders in relation to the ingestion of meals needs to be considered

drugs used will include three phosphate binders already approved and commonly used. calcium acetate, aluminum hydroxide, and sevelamer (renagel) will be given on separate occasions in conjunction with a high phosphorus meal. they will be given in standard doses used in the treatment of high phosphorus levels in hemodialysis patients. the population targeted will included hemodialysis patients with elevated ipth and phosphorus levels. the patients will receive up to five separate meals. four of these will be high phosphorus content meals and one will be a low phosphorus content meal. on up to three occasions with the high phosphorus content meals the patients will ingest one of the three phosphate binders. the meals will be ingested after a twelve-hour overnight fast. labs will be drawn prior to meal ingestion and then at 15, 30, 60, 120 and 240-minute intervals. the labs will consist of ipth, phosphorus, calcium, and glucose. a serum albumin level will be obtained with the initial specimen only. the patients will have an ipth level of at least 200pg/ml and a serum phosphorus level of at least 4.0 mg/dl. the primary outcome will be the change in the ipth level in relation to the phosphorus content of the meals. secondary outcomes will include the change in ipth level in relation to the various phosphate binders being used.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * receiving treatment with hemodialysis for at least 90 days * serum ipth levels greater than 200pg/ml * serum phosphorus levels greater than 4.0mg/dl

Keywords: high ipth levels
improving asthma outcomes through spirometry distance learning

Conditions: Asthma

Summary: spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, yet few providers report its routine use for children with asthma. misclassification of asthma severity occurs when assessment is based on symptoms alone. this misclassification can lead to inadequate treatment, increased morbidity, and increased healthcare utilization/cost. the goal of this study is to test the effectiveness of a distance learning quality improvement program called spirometry 360 developed by the interactive medical training resources (imtr) group at the university of washington child health institute. the spirometry 360 program aims to improve care for children with asthma by enhancing provider knowledge and self-efficacy related to the use and interpretation of office-based spirometry.

the spirometry 360 program includes: 1. "spirometry fundamentals™: a basic guide to lung function testing," a computer-based training program that teaches primary care providers how to coach patients to produce high-quality spirometry tests and accurately interpret spirometric data; 2. spirometry learning lab: case-based teaching of spirometry in practice guides test administrators and interpreters through clinical examples in an interactive virtual classroom setting. these sessions are led by expert clinical faculty and are archived for future reference and review; 3. spirometry feedback: tailored analysis of providers' spirometry testing sessions offers monthly individualized feedback reports by clinical experts on spirometry tests performed in the clinic. this is a cluster randomized controlled trial to test the effectiveness of the spirometry 360 program. the spirometry 360 program will be provided to 25 primary care pediatric practices from two practice-based research networks. a separate group of 25 matched control practices recruited from these same networks will receive standard training from the equipment vendor during the study and the spirometry 360 training program at the end of the study.

Eligibility criteria:
inclusion criteria (parent): * parents must have a child who has had at least one visit for asthma with a participating provider during the 12 months before the study start date * must have monthly access to email and the internet * must have child aged 5-16 years inclusion criteria (child): * aged 5-16 years * must have access to email and the internet exclusion criteria (parents): * parents with children who are outside our target age range of 5-16 years old * parents with children who haven't had a clinic visit for asthma care in the last year * parents without monthly access to the internet exclusion criteria (child): * children who are outside our target age range of 5-16 years * children without monthly access to email and the internet

Keywords: asthma spirometry pediatric primary health care education, distance
a multiple ascending dose study of pegozafermin in participants with biopsy confirmed nonalcoholic steatohepatitis (nash) or nonalcoholic fatty liver disease (nafld) and at high risk of nash

Conditions: NASH

Summary: part 1: this is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with nash and nafld at high risk of nash, including a pre-defined number of participants with biopsy confirmed nash and fibrosis stages f1-f3 to be enrolled. part 2: this is a multi-center, open label evaluation of pegozafermin at 27 mg administered weekly for 20 weeks in participants with biopsy-proven nash (nas ≥4, fibrosis stage f2 or f3).


Eligibility criteria:
key inclusion criteria: * participants must be 21 to 75 years of age inclusive, at the time of signing the informed consent form (icf). * evidence of steatosis by fibroscan and magnetic resonance imaging based proton density fat fraction (mri-pdff) * nash or nafld at high risk for nash as reflected by at least one of the following: * diagnosis of nash with fibrosis (stages f1, f2 or f3), without cirrhosis, by percutaneous liver biopsy within 24 months prior to screening * central obesity with type 2 diabetes mellitus (t2dm) * central obesity with either increased alanine transaminase (alt) and/or fibroscan vibration-controlled transient elastography (vcte) score ≥7 kpa. * part 2 only: biopsy-proven nash in a liver biopsy obtained within 24 weeks of baseline with fibrosis stage f2 or f3 and nas ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. a small number of high risk f1 allowed. key exclusion criteria: * clinically significant disorder or a history of any illness that, in the opinion of the investigator, might confound the results of the study, or pose additional risk to the participant by participation in the study. * history of type 1 diabetes. * weight loss of more than 5% within 3 months prior to day -1 or more than 10% within 6 months prior to day -1 or planning to try to lose weight during conduct of study. * history of a liver disorder other than nash or clinical suspicion of a liver disorder other than nash * history of cirrhosis or evidence of cirrhosis

Keywords: nash, nafld liver diseases fatty liver metabolic diseases
home hemodialysis assisted by a nurse for arterio-venous fistula cannulation

Conditions: Hemolysis; Cannulation; Arteriovenous Fistula; Nurse's Role

Summary: home hd (hhd) is associated with better outcome in end-stage renal disease patients compared to in-center hd, in particular in terms of quality of life. however fear of avf cannulation is a known barrier for patient's choice and adoption of a hhd program. providing nurse assistance for the cannulation can help developing hhd programs. the aim of this study is to evaluate the feasibility of assisted home hemodialysis, with the intervention of a nurse at home for arterio-venous fistula cannulation.

* monocentric prospective interventional study. * intervention is assisted hhd, defined as: rope-ladder cannulation at the patient's home provided by a trained private nurse at each dialysis session, and connection to the nxstage system one * pilot study, with main objective defined as feasibility of the investigator's assisted hhd program. pilot study usually concerns a small population, allowing us to develop thereafter a bigger study if the results are encouraging. * primary end-point criteria defined as definitive cessation of hhd with transfer to an other dialysis modality.

Eligibility criteria:
inclusion criteria: * the patient must be aged more than 18, able to read and write, and have a person with him at home during hd session, according to the french law. exclusion criteria: * medical contra-indication for hhd
effects of fes-rowing in neurological disorders (fes-row)

Conditions: Spinal Cord Injuries

Summary: the main objective of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with traumatic paraplegia.

beyond the inability to walk, chronic paraplegic patients show an increase in their mortality from cardiovascular pathologies, compared to the same age groups of the general population. it is the hypoactivity induced by neurological impairment that is implicated in the first place in the pathogenesis of these abnormalities. the search for training methods adapted to these patients is justified to limit cardiovascular morbidity and mortality. the aim of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with stabilized paraplegia (non-walkers), of traumatic origin. study is divided in two 3-month phases. the first consists on a training on a rowing machine with solicitation of the electrostimulated lower limbs only for a period of 3 months at the rate of 3 sessions of 30 minutes per week. the second consists on a training on a rowing machine with solicitation of the electrostimulated lower limbs and upper for a period of 3 months at the rate of 3 sessions of 30 minutes per week. the evaluations are composed of the measurement of maximum oxygen consumption, muscle and neurological parameters

Eligibility criteria:
inclusion criteria: * paraplegia with traumatic origin * spinal cord injury ais (asia impairment scale) score a and b at least 12 months old * patient having given written consent * patient with social security scheme * ability to obtain a leg extension with a 30-minute electrostimulation program exclusion criteria: * protected adults (person in guardianship, curators or legal protection) * presence of contraindication criteria to carrying out a stress test or sustained physical activity decided by the doctor following the person with spinal cord injury. * drug treatment with cardiovascular or antidepressant effect * pressure sore * other associated neurological pathologies (stroke, peripheral neuropathy, myopathy, head trauma, ...) * affection of the shoulders of any etiology that could compromise the ability to use the rower. * spasticity of the lower limbs: modified ashworth scale (mas) greater than or equal to 2/4 (specifically quadriceps / hamstrings) * participation in another study

Keywords: spinal cord injury functional electrical stimulation cardiovascular prevention neuroplasticity rehabilitation
telerehabilitation for anterior cruciate ligament reconstruction - tar program in adolescents

Conditions: Telerehabilitation; Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament

Summary: anterior cruciate ligament (acl) injuries are common in adolescents and its prevalence has increased over the years, especially with more adolescents engaging in physical activities and competitive sports. standard of care for these injuries would be an acl reconstruction (aclr) to allow return to function and sports and reduce the risk of post-traumatic arthritis and recurrent knee injuries. rehabilitation post-aclr is crucial to optimise surgical outcomes and prevent re-rupture of acl. however, good compliance to rehabilitation is often a challenge for patients and healthcare providers. telerehabilitation for this group of patients may help to augment rehabilitation by improving patient compliance and overcome barriers to behavioural change often observed in traditional in-person physiotherapy. it can also allow remote monitoring and provide feedback to patients during exercises. in addition, it is a useful tool during pandemic when in-person visits are not possible. currently, very few studies have evaluated the use of telerehabilitation with remote monitoring for aclr, especially in adolescents. the use of home-based telerehabilitation post aclr may be key to improving patient motivation and exercise compliance in adolescents. for this pilot study, the intervention group will undergo the tar program in addition to standard care, which involves self-administered exercises in initial 12 weeks post aclr using a mobile application. the mobile application will detect key landmarks on the body for human pose estimation. participants will be able to perform their exercises with real-time feedback given, allowing for proper execution of the exercises. exercise adherence, range of motion and pain scores will be tracked via the application and therapists are able to monitor via the online dashboard. the control group will undergo standard in-person physiotherapy. primary aim of this study is to examine exercise adherence in tar program versus standard care post aclr in adolescents. secondary aims of this study are to examine the effects of tar program on knee strength, range, function, quality of life, treatment satisfaction, self-determination and number of face-to-face rehabilitation sessions required after aclr.


Eligibility criteria:
inclusion criteria: * participants age 12 to 20 years old * participants undergoing aclr surgery * participants willing to be included in either the intervention group (utilizing the mobile application) or control group exclusion criteria: * participants with complications after aclr surgery * participants with significant neurological or other lower limb impairments or conditions affecting mobility and function * participants with previous acl surgeries of the same affected lower limb * participants with previous surgeries or trauma to the unaffected lower limb

Keywords: telerehabilitation anterior cruciate ligament injuries anterior cruciate ligament reconstruction mobile application adolescent
study to assess the pharmacokinetics and pharmacodynamics of gsk461364 in subjects with non-hodgkins lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: this is a first time in human study that is being done to determine the maximum tolerated dose and initial pharmacokinetic parameters of gsk461364, given by iv, in adult subjects with solid tumors and non-hodgkins lymphoma.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of advanced solid tumor or non-hodgkins lymphoma (excluding hiv-associated lymphoma) that has relapsed or is refractory to standard therapies * at least 18 years of age * female who are of non-childbearing potential or who have a negative pregnancy test who uses approved contraception * male with a female partner of childbearing potential must have had a vasectomy or both are using approved contraception * lab values that are within range as described in the protocol * paraffin-embedded archival tumor tissue available for testing * signed written informed consent exclusion criteria: * undergone major surgery or received anti-cancer therapy * history of hemolytic anemia * clinical lab tests that are out of range as described in the protocol * females who are pregnant or lactating * significant heart problems * serious or unstable pre-existing medical or psychiatric condition * are not able to comply with the study protocol * use of prohibited medications * have low blood pressure * evidence of symptomatic or untreated central nervous system involvement and require corticosteroids or anti-epileptic meds

Keywords: non-hodgkins lymphoma cancer first time in human plk1 inhibitor advanced solid tumor gsk461364
enavogliflozin vs. pioglitazone on glucose and atherosclerosis

Conditions: Type 2 Diabetes

Summary: the current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (sglt2) inhibitor regarding various clinical issues including atherosclerosis. enavogliflozin is compared to pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose hba1c levels are not controlled by metformin with or without dpp-4 inhibitors. additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (hdlc), uric acid, blood pressure, and inflammatory markers, between the two drugs.


Eligibility criteria:
inclusion criteria: * type 2 diabetes patients with a glycated hemoglobin (hba1c) level of 7.0 - 10.5% at screening * males or females aged 20-80 years * individuals who have been taking metformin (≥ 500mg) with or without a dpp-4 inhibitor (such as sitagliptin, vildagliptin, saxagliptin, linagliptin, gemigliptin, alogliptin, teneligliptin, anagliptin, evogliptin) for at least the past 3 months * body mass index ≥ 23 kg/m² * estimated glomerular filtration ratio (egfr) ≥ 60 ml/min/1.73m² exclusion criteria: * patients with type 1 diabetes, gestational diabetes, or secondary diabetes due to other causes * patients with a history of acute cardiovascular disease within the last 3 months prior to the screening visit * pregnant or breastfeeding patients, or patients not using contraception. patients with chronic hepatitis b or c (excluding healthy carriers of hepatitis b), or liver disease (aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \> 3 times the upper limit of normal) * patients with heart failure or a history of heart failure * individuals with a history of cancer within the past 5 years (excluding those adequately treated for squamous cell carcinoma or thyroid cancer) * patients who have participated in another clinical study within the last 30 days * alcohol addiction * patients for whom the use of enavogliflozin or pioglitazone is contraindicated * patients taking other oral hypoglycemic agents or insulin or other investigational drugs * patients deemed unsuitable for the study based on the investigator's judgment
safety and efficacy of cryoballoon pulmonary vein isolation : a single center registry

Conditions: Atrial Fibrillation

Summary: the aim of this study was to assess the long-term success rates of pulmonary vein isolation using first and second generation cryoballoons in patients with paroxysmal and persistent atrial fibrillation.

the success of ablation is determined by the absence of recurrence of atrial fibrillation in the short term beyond 3 months, medium and long term on regular clinical follow-up and ecg holters. the patient cohort followed since 2007 allows a very long-term follow-up of patients who have benefited from atrial fibrillation cryoablation. isolation of the pulmonary veins by cryoballoon (ivp) has emerged as an alternative to radiofrequency in the treatment of drug resistant atrial fibrillation (af). (1) the potential benefits of cryoablation include shorter procedure times, decreased fluoroscopy time, shorter hospital duration, a different rate and type of complications compared to radio frequency offers potential benefits, including including shorter procedure times, a decrease in the length of hospital stay 1 and a reduction in fluoroscopic time. (2) effectiveness on a one year follow-up in cryoablation for af is comparable to that of radiofrequency ablation in a prospective, randomized study with a lower major complication rate (3,4). the number of subjects is limited and most retrospective studies on cryoablation have a limited number of patients or an average follow-up not exceeding one year. study of the data and results of the procedures of ablation of af by cryoablation and long-term follow-up of the patients of the chu of grenoble. regular monocentric cohort study based on collected data to identify the success rate of cryoablation ablation in paroxysmal and persistent af

Eligibility criteria:
inclusion criteria: * patients with an indication for ablation of atrial fibrillation at the chu of grenoble since the use of this technique (november 2007) until november 2016: * paroxysmal atrial fibrillation resistant to antiarrhythmic treatment. * persistent atrial fibrillation. * patients ≥18 years * patients with discernment who signed consent for information on the ablation procedure before surgery. exclusion criteria: * patient less than 18 years old * patient who refused to sign informed consent for the procedure of ablation

Keywords: atrial fibrillation; cryoballoon; ablation;
microvesicle production after acute trauma and its clinical impact on venothromboembolism

Conditions: Venothromboembolism

Summary: the purpose of this research study is to look at how trauma affects the ability of blood to clot. the blood of people who suffer a traumatic injury can under-clot or over-clot, and this research study will look at blood drawn from people after they suffer a traumatic injury to see how well their blood clots.


Eligibility criteria:
inclusion criteria: * male and female patients 18 years of age or older * blunt trauma patients including those with closed head injury * penetrating trauma patients exclusion criteria: * are on therapeutic anticoagulation * have preexisting coagulopathy * patients greater than 12 hours from time of injury * have history of malignancy or preexisting diagnosis of sepsis or renal failure * patients with burn injuries * male and female patients younger than 18 years of age * pregnant patients
study of the prevalence of iron deficiency in patients with heart failure

Conditions: Heart Failure

Summary: despite its known prevalence in heart failure, a recent study conducted by prof. cacoub (unpublished) on the french national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity. in chronic diseases including heart failure, transferrin saturation factor is only performed in about 10% of cases while it is recommended for patients with heart failure (french health high authority 2011). the purpose of this study is to obtain current data on the prevalence of iron deficiency in france in patients with heart failure, applying the recommendations of european society of cardiology and french health high authority (determination of ferritinemia and transferrin saturation factor).


Eligibility criteria:
inclusion criteria: * patient, male or female, over 18 years of age * patient present at the hospital on the day of the study * diagnosis of heart failure (acute or chronic) regardless of left ventricular ejection fraction (lvef) * patient with signed consent exclusion criteria: * protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision * pregnant or breastfeeding woman