Kornimate/medical-research-clean huggingface dataset:
oral intradialytic amino acid supplementation to vitalize end-stage kidney disease patients on hemodialysis

Conditions: End Stage Renal Disease

Summary: the study will test and compare the efficacy of a single essential amino acid valine with a combination of essential amino acids (eaa) supplement on fatigue, frailty, and cognitive function in end-stage kidney disease (eskd) patients undergoing hemodialysis (hd) treatment.

this single center outpatient study will test and compare the efficacy of a single essential amino acid, valine with a combination of essential amino acids (eaa) supplementation on fatigue, fragility and cognitive function in end-stage kidney disease (eskd) patients aged 18-64 years undergoing hemodialysis (hd) treatment at least three times a week.

Eligibility criteria:
inclusion criteria: 1. male or female 2. age 18-64 years 3. receiving 3 x weekly in clinic hemodialysis for at least 6 months exclusion criteria: 1. hypersensitivity to amino acid(s) and/or any excipient 2. clinical documentation of covid-19 3. concomitant intake of amino acids supplements 4. current use or abuse of alcohol, marijuana, narcotic, or other substances 5. heart failure receiving active management 6. malignant cancer receiving anticancer therapy 7. diagnosis of major depressive disorder receiving antidepressants 8. diagnosis of chronic liver disease 9. cerebrovascular disease with sequelae 10. upper limb amputation, osteoarthritis, or degenerative diseases of fingers, carpel tunnel syndrome in the non-fistula or graft hand preventing completion of hand grip strength test.

Keywords: fatigue end-stage kidney disease hemodialysis
resistance training in lung cancer patients on chemotherapy

Conditions: Inflammation; Lung Cancer

Summary: the purpose of this study is to examine the effectiveness of a resistance training program on reducing systemic inflammation and improving chemotherapy completion in lung cancer patients being treated with curative intent chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically diagnosed with lung cancer * stage i, ii, or iii * eligible for chemotherapy with curative intent * 21 years of age or older * approval to participate in study by treating oncologist or family physician exclusion criteria: * unstable cardiac disease * untreated bone or brain metastases

Keywords: inflammation chemotherapy lung cancer
controlled study to evaluate the efficacy and safety of the treatment with growth hormone in tibia fractures

Conditions: Bone Fracture; Tibia Fractures

Summary: this trial is conducted in africa, europe and middle east. this trial investigates the efficacy and safety of three dose levels of norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. the trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. in the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.


Eligibility criteria:
inclusion criteria: * primary surgical treatment of tibia fracture using intramedullary nailing * closed fractures: tscherne type c1, c2 and c3 * open fractures: gustilo grade i, ii and iiia exclusion criteria: * open growth plate on x-rays * known chronic endocrine or metabolic disease including diabetes and severe obesity defined as body mass index (bmi)1 \> 32.0 * severe head injury defined as patients who are stuporous or comatose with pupillary enlargement or asymmetry * critically ill patients defined as patients in need of mechanical ventilation (except during surgical procedures) or circulatory support (defined as use of inotropic drugs)
impact of personalized interventions to raise teleconsultation awareness in ehpad

Conditions: Wound Healing Disorder

Summary: the cicat-occitanie network offers expertise for health professionals concerning wound care, in particular through teleconsultations. this study aimed to understand the obstacles reported by healthcare professionals in lozere's ehpad related to the use of this network. this cluster randomized controlled trial also sought to evaluate the effect of personalized intervention for each ehpad on the use of this network.


Eligibility criteria:
inclusion criteria: - be a resident in lozère's ehpad exclusion criteria: - patient who reject the study protocol

Keywords: telemedicine cluster randomised trial
exchange of azathioprine by mycophenolatmofetile and cyclosporine a dose reduction after heart transplantation

Conditions: Heart Transplantation

Summary: the purpose of this study is to improve or save renal function by optimizing the immunosuppressive regimen by reducing the cyclosporine a dose and the exchange of azathioprine by mycophenolatmofetile, which is an effective immunosuppressive agent and will minimize the risk of acute rejection episodes.

the decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects.long-term administration of calcineurin inhibitors is associated with chronic nephrotoxicity.

Eligibility criteria:
inclusion criteria: * current immunosuppressive regimen: cyclosporine a, azathioprine and corticosteroids for at least 12 month * heart transplantation above 3 years dated back * serum creatinine \< 3,5 mg/dl (310 µmol/l) and bun \< 150 mg/dl * cyclosporine a blood level between 50 and 250 ng/ml during the last 12 month exclusion criteria: * carcinoma within the last 3 years * acute rejection episodes during the last 6 month * infection requiring therapeutic intervention * hepatitis b, hepatitis c or hiv infection * wbc \< 3000/µl, haemoglobin \< 9g/dl, platelets \< 70.000/µl * florid gastrointestinal ulcer * haemodialysis within the last 4 weeks before study entry * pregnancy / lactation * administration of other immunosuppressive agents than prescribed * mycophenolatmofetile incompatibility

Keywords: cyclosporine renal insufficiency, chronic long-term care
liquid biopsy for the diagnosis of intestinal-type adenocarcinoma of the ethmoid (blade)

Conditions: Ethmoid Sinus Tumor; Adenocarcinoma; Circulating Tumor Cell

Summary: the role of this transversal study is to assess the specificity and sensitivity of liquid biopsy to detect circulating cells tumor of adenocarcinoma of the ethmoid. blood sample of participants will be collected at the moment of the surgical procedure or recurrence diagnosis; immediately after surgery; at day 8-10; at month 2-3 of postoperative follow-up. two comparison groups will be studied: one age and gender-matched group and one professional exposure-matched group to assess the sensitivity and specificity of liquid biopsy


Eligibility criteria:
inclusion criteria: * case group: diagnosis of adenocarcinoma of the ethmoid on biopsy or imaging recurence; age\>/= 18 years; patient consent ; * age and gender-matched control group: consulting patient in otolaryngology head and neck surgery department without adenocarcinoma of the ethmoid; no personal history of cancer; no familial history of colorectal adenocarcinoma; * exposition control group: professional exposition to wood dust, leaver or nickel for at least 12 months; consulting patient in otolaryngology head and neck surgery department without adenocarcinoma of the ethmoid; no personal history of cancer; no familial history of colorectal adenocarcinoma; exclusion criteria: * patient presenting with another malignant tumor * deprivation of liberty * patient under guardianship * other cancer diagnosed or under treatment * recurrent patient previously included in the study * refusal to accept the monitoring described and/or to provide the information required for the study * no affiliation or non-beneficiary of a social security system; * pregnant or breast-feeding women in accordance with article l1121-5 of the public health code (csp)
psychological sequelae after sudden cardiac death in the patient and his relatives

Conditions: Post Traumatic Stress Disorder; Resuscitated Sudden Cardiac Death

Summary: this study will evaluate and describe the occurrence of acute traumatic stress and persistence of post traumatic stress disorder (ptsd) after resuscitated sudden cardiac death (scd) in patient and relatives present during the event. the population will be composed of 40 patients: 20 with resuscitated scd and 20 relatives. two interviews will be performed by a psychologist within one week after resuscitated scd and at month 3. questionnaire stanford acute stress reaction questionnaire (sasrq), life events checklist for diagnostic and statistical manual of mental disorders (dsm-5) (lec-5) and posttraumatic stress disorder checklist for dsm-5 (pcl-5) will be filled during these interviews.

in spite of therapeutic advances, sudden cardiac death (scd) remains a frequent (60000/year in france) and often fatal disease (5% survival). because it is by definition unexpected, the psychological impact on resuscitated patients and on relatives may be important. however little studies have evaluated it. patients who later develop ptsd, generally have acute stress disorder. in patients with resuscitated sudden cardiac death, acute psychological distress is frequent and ptsd was identified in 40% of patients. concerning relatives, haywood (2018) call them the "forgotten patients" to emphasize the absence of recognition of his psychological trauma. ptsd was more frequent in people who were witness of the scd vs those who were not there. hofland et al (2018) showed that people present during resuscitation maneuvers had more acute stress than others. this study will evaluate acute stress disorder with sasrq scale in patients with resuscitated scd and their relative just after the event. at 3 months, presence of ptsd will be evaluated with pcl-5 and lec-5 in patients and their relatives.

Eligibility criteria:
inclusion criteria: * patients with resuscitated sudden cardiac death and/or their relative * patients who are fluent in french * patients who have given their 'no objection to participation to the research' * patients of both gender over 18 years * women with childbearing potential and effective contraception exclusion criteria: * people who are not able to give their 'no objection to participate to the research' * people with major cognitive disorders post sudden cardiac death * people with known psychiatric disorder * women who are known to be pregnant or lactating * person deprived of liberty by judicial or administrative decision * people under legal protection (under the protection of a conservator)

Keywords: sudden cardiac death
effect of the use of an add-on device connected to a smartphone app on difficult-to-treat asthmatic patient's adherence

Conditions: Asthma

Summary: the purpose of this study is to assess the effect of a smartphone application connected to an add-on device system fitted on pressured metered dose inhaler (pmdi) on adherence to take medications as prescribed and clinical outcomes in difficult-to-treat asthmatic patients.


Eligibility criteria:
inclusion criteria: * patient's written informed consent obtained prior to any study-related procedures * male or female patient aged 18 years and above * patient with established diagnosis of asthma for at least 6 months * patient on maintenance therapy (fixed dose combination ics/laba) with high dose of ics * patient with act score \<20 at screening and at randomization * non- or ex-smoker who smoked ≤ 10 pack-years prior to screening * patient must have their own android® or iphone operating system (ios) smartphone * ability to use the pmdi device correctly exclusion criteria: * patient with an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 to 3 month prior to screening * patient with a history of near-fatal asthma * clinically relevant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, psychiatric or any other disorder that would put the safety of the subject at risk through participation, or which would affect the analysis * patient not able to be compliant with the study requirements. * patient with a bmi \> 40 * patient working on night shifts * patient participating in the clinical phase of an interventional trial or have done so within the last 30 days prior to screening. * patient who has an already planned major surgery or hospitalization * female patient who is pregnant or lactating or who plans to become pregnant in the next 4 months. * patient with a history of hypersensitivity to any of the components of foster pmdi

Keywords: post-market study
multimodal ultrasound and hepatocellular response to local treatments

Conditions: Hepatocellular Carcinoma

Summary: consecutive patients with hcc who should undergo to locoregional treatments (ablation or trans-arterial chemoembolization) according to international guidelines will be enrolled. atients will undergo ceus and swe before and after 24 hours from the procedure as per clinical practice in our center. subsequently, the patients will continue the normal follow-up which includes control computed tomography/magnetic resonance one month after treatment and subsequently every three months.

primary objective: to evaluate the correlation between pre-treatment ultrasound parameters (d-ceus and elastography) and one-month response to therapy evaluated with contrast-enhanced computed tomography. secondary objective: to identify quantitative ultrasound parameters able to predict overall survival and disease-free survival. study design: prospective single-center study. methods: 50 consecutive patients with hcc who should undergo to locoregional treatments (ablation or trans-arterial chemoembolization) according to international guidelines will be enrolled in the unit of internal medicine and gastroenterology of the policlinico gemelli. after obtaining informed consent and identifying the target lesion in b-mode ultrasound, patients will undergo ceus and swe before and after 24 hours from the procedure as per clinical practice in our center. subsequently, the patients will continue the normal follow-up which includes control computed tomography/magnetic resonance one month after treatment and subsequently every three months. in addition, the personal, clinical and laboratory data necessary to determine the hepatological scores of disease severity such as meld and child-pugh will be collected. the study has an expected duration of one year.

Eligibility criteria:
inclusion criteria adult patients with single nodule hepatocellular carcinoma detectable with b-mode ultrasound and scheduled for locoregional treatment exclusion criteria: * liver failure * previous treatments fo hepatocellular carcinoma * chronic or acute heart failure * known ipersesitivity to ultrasound contrast agent * pregnancy and lactation
home use sensor study

Conditions: Diabetes Mellitus

Summary: the purpose of this clinical investigation is to evaluate the accuracy of the eversense continuous glucose monitoring system (eversense system) measurements when compared with a self-monitoring blood glucose (smbg) meter. the investigation will assess device performance in two insertion locations (abdomen and upper arm), evaluate safety of the eversense system usage, and assess the usability of the eversense system in the hands of user at home setting. changes in hba1c from baseline will also be evaluated.


Eligibility criteria:
inclusion criteria: 1. adult subjects, age ≥18 years 2. clinically confirmed diagnosis of diabetes mellitus for ≥1 year and using insulin by subcutaneous injection or insulin pump. 3. subject has signed an informed consent form and is willing to comply with protocol requirements exclusion criteria: 1. female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study 2. a condition preventing or complicating the placement, operation or removal of the sensor or wearing of transmitter, including upper extremity deformities or skin condition 3. symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke within 6 months; uncontrolled hypertension (systolic\>160 mm hg or diastolic \>100 mm hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign pacs and pvcs allowed). subjects with asymptomatic coronary artery disease (e.g., cabg, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from cardiologist documented. 4. history of hepatitis b, hepatitis c, or hiv 5. currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); glucocorticoids (excluding ophthalmic or nasal). this exclusion does include the use of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site only); antibiotics for chronic infection (e.g. osteomyelitis, endocarditis) 6. a condition requiring or likely to require magnetic resonance imaging (mri) 7. known topical or local anesthetic allergy 8. known allergy to glucocorticoids 9. any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. conditions include, but are not limited to, psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. investigator will supply rationale for exclusion 10. participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period 11. the presence of any other active implanted device\*
virtual reality during hemodialysis

Conditions: End Stage Renal Disease; Hemodialysis-Induced Symptom

Summary: the main objective of this investigation is to assess if an intradialysis virtual reality exercise-based program results in an improvement in physical function and if it results in high adherence rates to exercise. the secondary aim is to assess the effect of intradialysis vr in physical activity level, health related quality of life and in cognitive function.

participants will be randomized into one of two groups. the first group will start with 12 weeks of virtual reality exercise during hemodialysis and will carry on with a control period of 12 weeks. the second group will start with a control period of 12 weeks (no exercise) and will carry on with a virtual reality exercise period of 12 weeks. the virtual reality exercise will undertake up to 30 minutes of exercise. after warming up, participants will play to an adapted 'treasure hunt' game. their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. the aim of the game will be to achieve the higher possible score.they will move their legs to pick up coins and to avoid bombs. an adapted kinect technology will be used for the game development. the exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises.

Eligibility criteria:
inclusion criteria: * at least 3 months in hemodialysis treatment * clinically stable exclusion criteria: * recent cardiac events (less than 3 months) * unable to exercise

Keywords: exercise physical function health related quality of life
epidemiology and intervention of obstructive sleep apnea based on community

Conditions: Sleep Apnea, Obstructive; Hypertension; Obesity; Diabetes; Hyperdiploid; Fatigue Syndrome, Chronic; Insomnia Chronic; Quality of Life; Economic Problems; Compliance, Patient; Health Impairment

Summary: this observational study in a real-world community was designed to perform epidemiological investigation and assess effect of cpap intervention of obstructive sleep apnea.

patients with obstructive sleep apnea receiving cpap or not would be observed in years. primarily impact of cpap on health assessment andx control rate of hypertension would evaluated.

Eligibility criteria:
inclusion criteria: 1) ahi \>= 5 events/h exclusion criteria: 1. any condition which in the opinion of researched makes the eligible participants unsuitable for this study, such as severe copd, heart failure in nyha class iii to iv, and others 2. any condition potentially precluding follow-up visits, such as sereve insomnia, cognitive behavioral disorder, and others 3. patients receiving cpap treatment

Keywords: obstructive sleep apnea real world community
assessment of integration success of an implant system with a novel abutment attachment design in early loaded cases

Conditions: Partial Edentulism; Tooth Disease

Summary: integration success rates measured by resistance to countertorque testing will be higher for the experimental implant design than for the control implants.

in this study patients are randomized to receive either the experimental implant system or the control nanotite certain tapered (standard abutment connection) and assessed for integration success measured by countertorque testing and cumulative success rate in cases that are loaded early

Eligibility criteria:
inclusion criteria: * patients of either sex and older than 18 years of age * patients needing at least one dental implant to treat partial edentulism * patients physically able to tolerate surgical and restorative dental procedures * patients agreeing to all protocol visits exclusion criteria: * patients with infection or severe inflammation at the intended treatment sites * patients smoking greater than 10 cigarettes per day * patients with uncontrolled diabetes mellitus * patients with uncontrolled metabolic diseases * patients who received radiation treatment to the head in the past 12 months * patients needing bone grafting at the intended treatment sites * patients known to be pregnant at screening visit * patients with para-functional habits like bruxing and clenching

Keywords: edentulism dental implants clinical study nanotite certain tapered implant randomized crestal bone level early loading
th1, th2, th17 phenotype in urea cycle disorders

Conditions: Urea Cycle Disorder; Lysinuric Protein Intolerance

Summary: infection-related hyperammonemia in patients with urea cycle disorders is an important cause of morbidity and mortality. the relationship between immune system cells and the metabolic pathways used by these cells and inborn errors of metabolism is still under investigation. current studies are generally based on experiments in mice. the investigators' goal is to study specific t cell subsets to understand the effects of the urea cycle on t cells. the investigators collected blood samples from participants with lysinuric protein intolerance and urea cycle disorders for basic immunophenotyping, lymphocyte proliferation in response to phytohemagglutinin and cdmix, and cytokine analysis involving th1, th2, and th17 and compared them with age-matched healthy controls. they also examined amino acid profiles in sera and supernatants before and after stimulation with pma-ionomycin.

the investigators aim to compare cellular immune response of t cell phenotype and proliferative functions in addition to lymphocyte subset analysis between urea cycle disorders and healthy controls. complete blood counts, immunoglobuline levels, lymptocyte subset analysis and thelper cells will be analyzed. additionally, t helper cells will be measured regarding their cytokine profile as th1, th2 and th17. t cell proliferation response and aminoacid profiles in supernatants before and after stimulation will be measured.

Eligibility criteria:
inclusion criteria: * children without any chronic conditions and having normal immunoglobulins and lymphocyte subsets exclusion criteria: * for healthy control, children having any signs for primary immune deficiencies