Kornimate/medical-research-clean huggingface dataset:
blood flow, muscle regeneration and sarcopenia

Conditions: Sarcopenia

Summary: due to the rapid aging of the population, sarcopenia is among the greatest challenges facing the health care system over the next quarter century. this age-related loss of skeletal muscle mass and strength directly contributes to the incidence of functional disability, thereby reducing independence and quality of life for the elderly. despite increasing efforts to combat sarcopenia, its etiology remains incompletely described. subsequently, limited progress has been made in developing comprehensive preventative and therapeutic strategies to combat the problem. a decreased ability to regenerate skeletal muscle fibers through the donation of skeletal muscle stem cells (satellite cells) is thought to contribute to sarcopenia. however, the upstream physiological mediators that regulate this impairment are poorly delineated. reduced muscle blood flow in advanced age appears to be a significant factor in reducing skeletal muscle regenerative capacity, but few data exist to confirm this hypothesis. thus to test this hypothesis we aim to conduct a translational pilot trial which examines regeneration in both young and old adults. furthermore, we aim to determine if muscle blood flow and satellite cell number are associated with muscle function. the central hypothesis of this proposal is that age-related declines in skeletal muscle angiogenesis and perfusion are significant causal factors in age-related losses of skeletal muscle mass. the specific aims and hypotheses of the project are as follows:


Eligibility criteria:
inclusion criteria: * men and women aged 18-30 years * men and women aged \> 70 years * body mass index \< 35 * willing and able to participate in all aspects of the study * sedentary to moderately active lifestyle \ 120 min/week * non-smoking exclusion criteria: * active treatment for cancer, stroke (\< 6 mo), peripheral vascular disease, coronary artery disease (myocardial infarction \<6 mo), state iii, iv congestive heart failure, valvular heart disease, major psychiatric disease, severe anemia, liver or renal disease, diabetes, severe osteoarthritis, blindness or deafness, fracture in upper or lower extremity within the last 6 months, upper or lower extremity amputation, anticoagulant therapy (aspirin use is permitted), parkinsons disease * failure to give consent * anabolic medications (growth hormone or testosterone) * high amounts of physical activity (i.e. running, bicycling etc \> 120 min/week). * dementing illness * smoking * pregnant * significant cognitive impairment; mini-mental state (mmse) exam \< 24 * statin usage * excessive alcohol use (\>2 drinks per day) * resting heart rate \> 120 bpm * systolic blood pressure \> 180 mmhg * diastolic blood pressure \> 110 mmhg * history of significant head injury * anticholinesterase inhibitor (such as aricept) * contraindications to mri (e.g. cardiac pacemaker, implanted cardiac defibrillator, aneurysm clip, claustrophobia, etc.) * current use of antidepressant medications
echocardiography in patients with covid-19

Conditions: COVID; ARDS, Human

Summary: prospective observational study of patients treated due to covid-19 disease. observation and analysis of echocardiographic studies performed in the intensive care setting.


Eligibility criteria:
inclusion criteria: * age above 18 years * covid-19 disease * invasive ventilation exclusion criteria: * none
dna diagnostics for minimizing metabolic side-effects of antipsychotics

Conditions: Psychoses

Summary: the purpose of this study is to assess patients treated with the antipsychotics aripiprazole (abilify®), olanzapine (zyprexa®), quetiapine (seroquel®), risperidone (risperdal®), or ziprasidone (geodon®) and to identify genetic variations more commonly found in individuals who develop diabetic metabolic signs and symptoms, which include changes in blood lipids, blood glucose, blood pressure, and body weight.

as many as 30% of psychiatric patients experience weight gain, central deposition of fat, dyslipidemia, increased blood glucose and hypertension--diabetic metabolic symptoms--upon treatment with atypical antipsychotic medication. as a result, cardiovascular disease risk is significantly increased. the long-term goal of this collaborative study is to identify, for each individual atypical antipsychotic (aap) medication, the gene variations associated with elevated risk of diabetic metabolic symptoms (dims). if such genes are identified, in the future genetic testing may help mental health care professionals choose treatment while minimizing the risk of undesirable side effects of antipsychotics. we propose to develop a novel product termed "physiotype" to deliver personalized information for each patient on the drug specific risks among aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone. the physiotype consists of a multi-gene ensemble of single nucleotide polymorphisms (snps) that, interpreted with a biomathematical algorithm, may explain most of the inter-individual differences in dims among the 5 aaps. if this study does identify related genes, genetic tests will be developed to provide patients and health care professionals with tools to identify those patients who are at risk of developing adverse metabolic side effects to antipsychotics.

Eligibility criteria:
inclusion criteria: * receiving atypical antipsychotic therapy (olanzapine, aripiprazole, quetiapine, risperidone, or ziprasidone) for 3 months * who have taken \>50% of the prescribed dose for the last month. exclusion criteria: * none

Keywords: single nucleotide polymorphism, snp, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, metabolic syndrome
a pilot study to evaluate a method for plaque when comparing stannous fluoride toothpaste to a regular dentifrice

Conditions: Plaque; Gingivitis

Summary: this study will evaluate the sensitivity of an assay and its ability to split a marketed stannous fluoride toothpaste versus a negative control.


Eligibility criteria:
inclusion criteria: in order to be included in the study, each subject must: * provide written informed consent to participate in the study; * be 18 years of age or older; * agree not to participate in any other oral/dental product studies during the course of this study; * agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed; * agree to maintain their current oral hygiene routine between the screening and baseline visit and not to add/change their oral care products during this time; * agree to refrain from any form of non-specified oral hygiene during the treatment periods (after the baseline visit), including but not limited to the use of products such as floss or whitening products; * agree to return for all scheduled visits and follow study procedures; * must have at least 16 natural teeth; * be in good general health, as determined by the investigator/designee based on a review of the health history/update for participation in the study; * agree to refrain from all oral hygiene for at least 12 hours prior to each visit; * agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit; * have at least 20 bleeding sites (sites with a score of 1 or 2 on the gbi index); * have minimum 3 sampling sites with bleeding and pocket depth ≥3mm but not deeper than 4mm; * have minimum 3 sampling sites without bleeding and with pocket depth ≤2mm. exclusion criteria: subjects are excluded from study participation where there is evidence of: * have had a dental prophylaxis within 2 weeks of plaque sampling visits; * have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or listerine within 2 weeks of plaque sampling visits; * have rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment; * need an antibiotic prophylaxis prior to dental visits; * a history of hypersensitivity to oral care products containing hydrogen peroxide; * a history of hypersensitivity to dyes (from products containing food dyes); * present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or * are pregnant (self-reported) or lactating.
positive expiratory pressure for the treatment of acute asthma in children

Conditions: Asthma

Summary: asthma is a leading cause of emergency department (ed) visits for children. a novel way of treating asthma is the use of positive expiratory pressure (pep). positive expiratory pressure works by creating pressure in the lungs to keep airways open and to clear mucus from the lungs. pep is already used in the treatment of asthma at the investigators institution, but studies evaluating the efficacy of pep therapy in asthma exacerbations do not exist. this study plans to learn more about the use of pep therapy in the treatment of asthma exacerbations in children in the emergency department. specifically, the study aims to evaluate if pep therapy reduces the severity of asthma exacerbations in children and if it reduces the need for additional therapies and admission to the hospital. this study will be a randomized control trial comparing children who receive standard therapy to those who receive standard therapy plus pep therapy in the treatment of asthma exacerbations. children age 2 to 18 years presenting to the ed with moderate to severe asthma exacerbations will be included in the study. reduction in clinical asthma severity will be measured by change in the pulmonary asthma score (the respiratory severity score used at the investigators institution). the need for additional therapies and hospitalization will also be evaluated.


Eligibility criteria:
inclusion criteria: * age \>= 2 and \< 18 years of age * established diagnosis of asthma, defined as at least two prior episodes of treatment with bronchodilators in their lifetime * initial ed presentation with a moderate to severe asthma exacerbation, as defined by a pulmonary asthma score (pas) \>7 * pas score \>7 and \<12 after completion of first line therapies (three doses albuterol/ipratropium bromide and oral corticosteroids) exclusion criteria: * do not receive complete first line therapies * immediately receive a disposition (admission or discharge) as determined by the treating clinician after completion of first line therapies * receive prednisone or more than two doses of inhaled bronchodilators prior to main ed evaluation (e.g. during ems transport or primary care visit) * co-morbid illnesses interfering with or contraindicated to usual asthma therapy (e.g. facial or airway abnormalities, pneumonia, chronic lung disease, congenital heart disease, cystic fibrosis, or pneumothorax) * critically ill at presentation * pregnant women (women known to be pregnant at the time of enrollment)
analytical validation of the abioscope device with the ivd capsule psp test: comparison of psp values measured with venous whole blood and those measured with arterial whole blood.

Conditions: Sepsis; Sepsis Bacterial

Summary: abionic has developed a targeted, rapid test for pancreatic stone protein (psp) in human k2-edta venous whole blood using the abioscope instrument. currently no psp study comparaison has been done between venous and arterial whole blood. abionic would like to confirm the equivalence of the psp between venous whole blood and arterial whole blood.


Eligibility criteria:
inclusion criteria: 1. provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis; 2. male or female, 18 years of age or older; 3. patient admitted to hospital 4. need for venous and arterial blood samples as part of standard of care 5. covered by a social security scheme. exclusion criteria: 1. subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure; 2. subject under juridical protection.

Keywords: abionic pancreatic stone protein point-of-care device immunoassay ivd
a study to assess the effectiveness of an investigational drug in elderly subjects with low vitamin d levels (0822a-009)

Conditions: Vitamin D Deficiency

Summary: this study will assess the effectiveness of an investigational drug in elderly subjects with low vitamin d levels.


Eligibility criteria:
inclusion criteria: * man or a woman 70 years old or older in general good health exclusion criteria: * having any form of neurological impairments that may impair motor function.
impact of qolibri medical device on the consequences of chronic pain: a randomized controlled trial

Conditions: Chronic Pain

Summary: a superiority study evaluating the impact of the qolibri software as medical device on functional and psychological consequences of chronic pain in primary care patients. a prospective, cluster-randomized, wait list, controlled multicentre study whose main objective is to evaluate the effectiveness of the qolibri digital therapy on quality of life improvement in patients living with chronic pain.


Eligibility criteria:
inclusion criteria: * patient experiencing at least moderate pain (on the categorical pain scale) for more than 3 months * patient with a bpi interference score ≥ 3 in at least 3 out of 7 dimensions * patient with a smartphone and an internet connection at the place of use * patient affiliated with a social security system or benefiting from such a system exclusion criteria: * patient opposing participation in the study * patient with severe anxiety and/or depressive disorders (especially a suicidal risk) * patient presenting one or more barriers to the initiation of cognitive-behavioral therapy (significant social difficulties, low adherence to current care, insufficient memory or cognitive abilities, lack of time, lack of motivation...), * adult patient under legal protection measures (guardianship, legal safeguard, psychiatric care, or deprived of liberty by judicial or administrative decision)

Keywords: pain, quality of life, functional impact, psychological impact, digital therapy
observational study to evaluate safety and performance of the total ankle prosthesis, easymove®

Conditions: Ankle Injuries and Disorders

Summary: this study is a post-market clinical follow-up conducted in order to collect long-term data on safety and performance of the easymove prosthesis, which is intended to be implanted in case of total ankle replacement, when used in real life conditions according to the instructions for use.

the primary objective is to evaluate the safety of the total ankle prosthesis, easymove, up to five years of follow-up. the secondary objectives are to evaluate both the safety and the performance of the total ankle prosthesis, easymove, up to five years of follow-up.

Eligibility criteria:
inclusion criteria: * patient implanted with the studied device according to the instructions for use, for primary surgery in patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis * adult patient (≥18 years old) * patient who received an information form and is willing to participate in the study exclusion criteria: * contraindications listed in the instructions for use * patient who is not able to express his/her non opposition
scrambler therapy for the reduction of chemotherapy-induced neuropathic pain

Conditions: Chemotherapy-Induced Peripheral Neuropathy; Malignant Neoplasm

Summary: this trial studies how well scrambler therapy works in reducing chemotherapy-induced neuropathic pain in patients with cancer. scrambler therapy is a type of treatment that uses electrodes placed on the skin. electricity is carried from the electrodes through the skin and blocks the pain.

primary objectives: i. to evaluate the efficacy of mc5-a scrambler therapy (scrambler therapy \[st\]) in reducing chemotherapy-induced painful peripheral neuropathy (cippn). ii. evaluate the change in pain score before and after 2 weeks (monday-friday) of the final st treatment. iii. assess for changes in other symptom burden (i.e insomnia, feeling of well-being, depression and anxiety) after 2 weeks (monday-friday) st treatment. secondary objectives: i. to evaluate the following with the treatment of st: ia. assess for changes in therapy induced neuropathy assessment scale (tnas). ib. assess for changes in using pain medications. ic. assess for changes in daily physical activities/functional status. id. assess for changes in quality of life using european organization of research and treatment of cancer (eortc) quality of life questionnaire (qlq) (chemotherapy induced peripheral neuropathy) chemotherapy-induced neuropathic pain (cipn) 20 questionnaire. ie. assess overall satisfaction with the st treatment using global impression of change questionnaire. tertiary (exploratory) objective: i. determine the change in sensation after 2 weeks (monday-friday) of the final st treatment. outline: patients undergo scrambler therapy over 30-45 minutes once daily (qd) monday-friday for 2 weeks. patients also undergo a quantitative sensory test and a gait assessment test using a fitbit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy. after completion of study, patients are followed up weekly for 3 weeks and at 4 weeks after the last day of scrambler therapy treatment.

Eligibility criteria:
inclusion criteria: * have a diagnosis of cancer and suffer from cipn for at least 3 months after the end of their last cancer chemotherapy * have average pain intensity of at least 4/10 * be in stable clinical situation (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled) in the month following the enrollment) * can give a written informed consent exclusion criteria: * pre-existence or history of seizure * pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy (i.e. idiopathic peripheral neuropathy, diabetic neuropathy * pregnancy * present with pacemaker or implantable defibrillators * present or past psychotropic substances and alcohol dependence * inability to understand patients' information and informed consent * skin lesion at the electrode placement site
gastric feeding versus transpyloric feeding in infants with severe bronchopulmonary dysplasia, a crossover study

Conditions: Bronchopulmonary Dysplasia; Feeding Intolerance

Summary: hospitalized infants with severe bronchopulmonary dysplasia (bpd) and feeding intolerance will be randomized to 2 weeks of continuous gastric feeding or continuous transpyoloric feeding. subjects will crossover after 2 weeks and receive 4 weeks of each feeding mode. respiratory status will be assessed to determine the optimal feeding mode for each infant.


Eligibility criteria:
inclusion criteria: * patients born \<32 weeks' gestation * currently admitted to the le bonheur nicu * grad 2 or 3 bpd (positive pressure or intubated at 36 weeks pma) * signs of gastroesophageal reflux, chronic aspiration, or other feeding intolerance. exclusion criteria: * known gastrointestinal anomalies * unable to tolerate ≥100ml/kg/day enteral feeding * congenital anomalies likely to alter feeding techniques * surgical feeding tube in place or expected within the next 8 weeks * expected to remain hospitalized \<8 weeks

Keywords: bpd
multicentre non-interventional study for efficacy,safety evaluation of breztri in pts with copd in russia

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a retrospective-prospective, non-interventional, multi-centre study that will be conducted in routine clinical settings in russia. eligible patients with moderate to severe copd routinely treated with breztri will be observed according to routine clinical practice for up to 24 weeks.

chronic obstructive pulmonary disease (copd) is a disease characterized by persistent airflow limitation that is usually progresses and is a consequence of a chronic inflammatory response of the respiratory pathways and lung tissue to the effects of inhaled harmful particles or gases. exacerbations and comorbid conditions are an integral part of the disease and contribute significantly to the clinical picture and prognosis \[1\]. patient-reported outcomes (both symptom-based and health-related quality of life-specific) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment response in copd patients \[12\]. there is a need to evaluate the patient-reported outcomes during a triple therapy with budesonide + glycopyrronium bromide + formoterol (breztri) in a real-life clinical practice. the aim of the study is to evaluate clinical and patient-reported outcomes of treatment with breztri through effectiveness measures assessed pre- and post-treatment initiation and safety monitoring. the study results will be interpreted in the context of an open label, single arm study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect.

Eligibility criteria:
inclusion criteria: 1. physician-diagnosed copd no less than 12 months before breztri treatment start; 2. patients who have not achieved adequate disease control when treated with a combination of ics and laba or a combination of laba and lama 3. initiated treatment with breztri ≤12 weeks before inclusion as prescribed according to the label; 4. cat score not more than 1 week before breztri start is available; 5. patients must be able and willing to read, comprehend and follow written instructions, and to comprehend and complete the questionnaires required by the protocol 6. have signed a written informed consent form (icf). exclusion criteria: 1. documented copd due to α-1 antitrypsin deficiency; 2. previous treatment with triple fixed-dose combination in 12 months prior to inclusion; 3. pregnancy or lactation period; 4. concomitant uncontrolled disease; 5. a diagnosis of bronchiectasis, sarcoidosis, interstitial lung disease, or idiopathic pulmonary fibrosis; 6. participation in other non-interventional observational trials that might, in the investigator's opinion, influence the assessment for the current study, or participation in any observational or clinical trial in the last 30 days prior to inclusion.

Keywords: chronic obstructive pulmonary disease copd breztri