Kornimate/medical-research-clean huggingface dataset:
interoception-based yoga for chronic pain

Conditions: Chronic Pain

Summary: the purpose of this research is to examine the feasibility and acceptability of an interoception-based yoga program for chronic pain. interoception involves your ability to feel sensations in your body (such as your heartbeat or muscle tension) as well as how you think about and interpret those sensations. interoception may be an important component of chronic pain and the research team is studying whether yoga can change how you feel, think about, and interpret sensations in your body.


Eligibility criteria:
inclusion criteria: * self-reported chronic pain lasting ≥ 3 months (such as widespread musculoskeletal pain, fibromyalgia, migraine etc.) * in the past week, has pain interfered with your day-to-day activities? yes * self-reported ambulatory ability without an assistive device * self-reported ability to get on and off the floor without assistance. * no ongoing mind-body practice (\<1x/week over the past 6 months). * physical activity readiness questionnaire screen pass or physician consent * english-speaking * able and willing to provide consent * no plans to move or travel outside the area in the next 2 months exclusion criteria: * ages \<18 or ≥ 65 at time of screening * pain lasting \< 3 months * in the past week, has pain interfered with your day-to-day activities? no * use of any assistive device (e.g. cane, walker, wheelchair). * inability to get on and off the floor without assistance. * a consistent ongoing mind-body practice (mindfulness, yoga, meditation, tai chi, qigong), at least 1x/week over the past 6 months * physical activity readiness questionnaire screen fail or non-consent of physician * non-english speaking * non-consent * plans to move or significant travel outside the area in the next 2 months * known pregnancy * recent surgery or acute bone, joint or nerve injury (within the past 6 months) * severe or progressive neurological conditions such as parkinson's disease, dementia, multiple sclerosis, or acquired brain injury * separate pain-related diagnoses: cancer-related pain, complex regional pain syndrome, postural orthostatic tachycardia syndrome, functional neurological/ movement disorders * active or planned worker's compensation or personal injury claim * concurrent participation in another interventional study (e.g. physical activity, mind-body or drug trials)
a study of pharmacokinetics, pharmacodynamics and safety of adding etc-1002 to atorvastatin 80 mg

Conditions: Hyperlipidemia

Summary: the purpose of this research study is to measure the amount of atorvastatin and etc-1002 in the blood, to determine how etc-1002 affects the level of ldl-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine, and to see how etc-1002 is tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background therapy in statin-treated patients.


Eligibility criteria:
inclusion criteria: * taking daily stable statin doses for at least 4 weeks prior to screening visit. * ldl-c between 100-220 mg/dl for patients taking daily high-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit; or, * ldl-c between 115-220 mg/dl for patients taking moderate- or low-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit. * must be willing to discontinue other lipid-regulating therapies during the study exclusion criteria: * history of acute significant cardiovascular disease. * current clinically significant cardiovascular disease. * history of inability to tolerate any statin at any dose due to muscle-related pain or weakness.

Keywords: ldl-cholesterol hypercholesterolemia etc-1002 adenosine triphosphate citrate lyase atorvastatin
epidemiologic study of the distribution of vaccine-type streptococcus pneumoniae serotypes in adults in the us with community-acquired pneumonia

Conditions: Pneumonia, Pneumococcal; Vaccines, Pneumococcal

Summary: the main purpose of this study is to use an investigational urine assay to estimate the proportion of pneumonia in adults 50 years or older in different areas throughout the us that is caused by certain types of the bacteria streptococcus pneumoniae (also called pneumococcus).


Eligibility criteria:
inclusion criteria: * age 50 years and older. * presents to a study site with clinically suspected pneumonia. * has a radiographic finding that is consistent with pneumonia. * able and willing to provide urine. exclusion criteria: * transfer to a study hospital after already being hospitalized for 48 hours or more at any other inpatient facility (such as community hospital). * hospital-acquired pneumonia (ie, pneumonia developing 48 hours after hospital admission). * previous enrollment in this study within the past 30 days.

Keywords: pneumococcal pneumonia community-acquired pneumonia
optimizing iron suppletion after roux-en-y gastric bypass

Conditions: Iron Deficiency

Summary: multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after roux-en-y gastric bypass.

morbid obesity is worldwide a still growing problem. the number of bariatric procedures are still increasing with 9000 bariatric operations in 2009. the golden standard is the roux-en-y gastric bypass (rygb). the rygb ensures an excess weight loss of 60-70% in our hospital. unfortunately vitamin and mineral deficiencies are a consequence from rygb. iron deficiency occurs in 14-66% in the first two years after surgery. worldwide there are three most used options of treatment for this: treatment with ferrous fumarate, ferrous gluconate and intravenous injection of ferinject. our goal is to determine which treatment is the most effective to normalize ferritin values in the blood and which treatment is the most cost-effective one after a rygb.

Eligibility criteria:
inclusion criteria: * all women who underwent a roux-en-y gastric bypass and developed an iron deficiency postoperatively (ferritin\<20microgram/l) exclusion criteria: * iron deficiency peroperative, blood transfusions during study period, iron containing nutritional supplements except the standard multivitamins after bariatric surgery, decreased renal failure, excessive blood loss due to menstruation, anemia not caused by iron deficiency, accumulation of iron, hypersensitivity for noe of the medicinal products, psychiatric illness, pregnancy
evaluation of inhaled antibiotics on bacterial diversity and richness in the cystic fibrosis lung

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to characterize bacterial diversity and richness in the sputum of cystic fibrosis patients treated with every-other-month tobi™ podhaler™ and continuous alternating therapy with tobi™ podhaler and colistimethate (colistin).


Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis confirmed by mutation analysis of the cystic fibrosis transmembrane conductance regulator gene * sputum or throat swab culture positive for pseudomonas aeruginosa at or within 6 months of enrollment * age ≥12 years * forced expiratory volume in one second (fev1) 25-90 percent-predicted exclusion criteria: * age \<18 years * inability to routinely expectorate sputum without induction by hypertonic saline * inability to provide or withdrawal of written informed consent * history of aminoglycoside sensitivity or adverse reaction to inhaled antibiotics * serum creatinine ≥ 2.0 mg/dl * serum blood urea nitrogen (bun) ≥40 mg/dl * pregnancy or lactating at screening * history of systemic intravenous anti-pseudomonal antibiotics within 28 days of enrollment

Keywords: cystic fibrosis microbiome sputum tobramycin colistimethate
observational prospective pmcf study to confirm performance and safety of intelect® devices in real world

Conditions: Musculoskeletal Disorders; Skeletal Disorder; Muscle Disorder

Summary: djo uk ltd (enovis) is conducting this study to confirm the performance and safety of the chattanooga intelect® devices in real world use. this study will record post market clinical data on the use of a number of mdr-ce marked devices that are part of the chattanooga intelect® device family to ensure the continued acceptability of the benefit-risk ratio, and to identify possible systematic misuse or off-label use of the devices (intelect® mobile 2 combo, intelect® mobile 2 ultrasound, intelect® mobile 2 electrotherapy (stim), intelect® transport 2 combo and intelect® transport 2 ultrasound).

this clinical investigation is a post-market, real word, international, multi center, prospective, observational study to confirm the safety and performance of the chattanooga intelect® when used in accordance with their approved intended use, to comply with medical device regulation (eu) 2017/745 (mdr) article 61 and part b of annex xi.

Eligibility criteria:
inclusion criteria: 1. patients with musculoskeletal and skeletal muscle deficit disorders assigned to be treated with any of the intelect® devices according to the current clinical practice at the selected sites and based on the opinion of the investigator. 2. patient male or female with age ≥18 years old. 3. patient able to provide written informed consent. for france only: to be affiliated to the social security system or to be beneficiary of such system exclusion criteria: 1. patients participating in another clinical study or who have completed a clinical study less than 30 days prior to enrollment. 2. patients who for any reason e.g. significant co-morbidities or other reasons, are considered by the investigator unsuitable for study participation.

Keywords: tens nmes ultrasound pain rom
prevalence of brca in patients with ovarian cancer

Conditions: BRCA Status; Ovarian Cancer

Summary: the aim of this prospective registration and translational research study is to evaluate the praevalence of brca regarding germline and somatic mutations.

explorative analysis will be performed.

Eligibility criteria:
inclusion criteria: * female ovarian cancer patients aged \>= 18 years. * women with first diagnosis of epithelial ovarian cancer or women diagnosed with platinum-sensitive recurrent ovarian cancer. * multiple platinum based prior therapies are allowed. exclusion criteria: * non-epithelial ovarian malignancy. * platinum-resistant or refractory disease. * paraffin embedded tumor samples not available.
factors affecting the prognosis of early ovarian cancer

Conditions: Ovarian Cancer

Summary: to elucidate factors affecting survival of early stage ovarian cancer

to analyze factors affecting survival of early ovarian cancer, such as cell type, cell grade, intraoperative rupture, and laparoscopy vs. laparotomy, etc.

Eligibility criteria:
inclusion criteria: * early stage ovarian cancer exclusion criteria: * nil.
an extension to the b1451027 protocol to evaluate the long term safety and tolerability of dimebon in patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of dimebon in patients with alzheimer's disease.

this study was terminated on may 7, 2010 as part of modification of the dimebon development plan following lack of demonstration of efficacy in the completed dim14 (connection) study. the study was not terminated due to any safety findings. dimebon has been well -tolerated in clinical trials. demonstration of efficacy for dimebon in alzheimer's disease is pending completion of the ongoing dim18 (concert) study.

Eligibility criteria:
inclusion criteria: * completion of previous phase 3 dimebon study (b1451027). exclusion criteria: * have any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
mre as a screening tool for axspa in ibd

Conditions: Axial Spondyloarthritis; Crohn Disease

Summary: this study aims to assess the effectiveness (specificity and sensitivity) of using magnetic resonance enterography (mre) as a screening tool for axial spondyloarthritis (axspa) in patients with crohns disease. patients with evidence of axspa on mre imaging will be assessed clinically for axspa (including a dedicated axial magnetic resonance imaging scan of the spine and sacroiliac joints) and will be compared to a group of age and sex-matched control participants with crohn's disease but with no evidence of axspa on mre imaging.

spondyloarthritis (spa) is a term that encompasses psoriatic arthritis with axial disease, ankylosing spondylitis and non-radiological axial spondyloarthritis. the prevalence of spa in the general population is estimated to be between 0.01%-2.5%. spa patients have a high burden of inflammatory bowel disease (ibd), which primarily includes crohn's disease (cd) and ulcerative colitis (uc), with an estimated prevalence of 10%-12%. however, few studies have investigated the converse; the presence of ibd cases with undiagnosed spa. untreated spa may lead to a significant impact on general health and quality of life; therefore early diagnosis and treatment is crucial. most cd patients will have had a mre assessment for their cd, which also captures the axial skeleton and can therefore be used to screen for evidence of axial spa (axspa). in this study, mre images from consenting cd subjects will be reviewed for evidence of axspa. cd patients with evidence of axspa will then be reviewed in a rheumatology clinic to assess more specifically for spa. this will include completion of patient reported outcome measures, clinical examination, routine blood tests, human leucocyte antigen (hla)-b27 genotyping and a dedicated axial magnetic resonance imaging (mri) scan. the patients will also be consented to participate in the second part of the study which will be to compare these 'cases' statistically to a 'control' group of age- and sex-matched cd subjects without mre evidence of axspa. this study aims to: (i) determine the validity, sensitivity and specificity of mre as a screening tool for axspa in cd patients using dedicated axial mri scans with clinical assessment as the gold standard; (ii) devise an algorithm of clinical indices that can be used as a screening tool for axspa in cd cases.

Eligibility criteria:
inclusion criteria: 1. subjects who are willing and able to give informed consent for participation in the study. 2. male and female subjects aged 18 years or above. 3. diagnosed by the gastroenterology team with crohn's disease. 4. mre imaging since 2015 for their crohn's disease. exclusion criteria: 1. subjects unwilling or unable to give informed consent.
study to compare the pharmacokinetics profiles of four racecadotril products

Conditions: Diarrhea

Summary: this study is designed to compare the pharmacokinetics of four products used for treatment of acute diarrhea.

the study will be a single dose, randomized, four -way, four-sequence crossover study in 24 healthy subjects, with equal numbers of males and females (minimum of 10 of either gender). subjects who drop out will not be replaced. the four doses of medication given in the study (a single dose in each of the four study periods) will be separated by a washout period of at least 7 calendar days. in each study period, 17 blood samples for pharmacokinetic analysis will be taken over 12 hours. blood samples will be centrifuged and concentrations of thiorphan (the active metabolite) in plasma will be measured using a validated chromatographic assay. pharmacokinetic parameters will be calculated from plasma concentration data.

Eligibility criteria:
inclusion criteria: * male or female subjects (equal numbers of males and females) * volunteers aged of at least 18 years but not older than 55 years * subjects will have a body mass index (bmi) within protocol-specified parameters. * non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study. * clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance * have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study * willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures exclusion criteria: * seated pulse rate and blood pressure within protocol-specified parameters. * relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or johnson \& johnson subsidiaries; and the families of each) * females who are pregnant or are lactating * females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study * history of significant hypersensitivity to racecadotril or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs * use of certain drugs/medications within protocol-specified timeframes * medical history or condition that may, per protocol or in the opinion of the investigator, adversely affect the safety of the study subject or compromise study results.

Keywords: antidiarrheals
sedation to electroencephalography with dexmedetomidine or chloral hydrate

Conditions: Other Conditions of Brain

Summary: this study evaluates the use of dexmedetomidine or chloral hydrate for sedation during electroencephalography in patients with neurological disorders. the hypothesis is that this drugs provides similar changes in eeg pattern.

patients with chronic neurological disorders such as cerebral palsy or autism need to be sedated during electroencephalography (eeg). however, various sedatives and hypnotics affect the outcome of the review and is not shown. chloral hydrate (ch) is widely used in children, but in this patients it is less effective.recently, dexmedetomidine (dex) has been tested because preliminary data suggests that this drug does not affect the eeg. the aim of the present work was to compare the electroencephalogram (eeg) pattern during ch or dex sedation, to test the hypothesis that both drugs exert similar effects in eeg.seventeen patients were evaluated during sedation with dex or ch on separate occasions.the eeg was subjected to qualitative and quantitative analysis. clinical variables were also compared.

Eligibility criteria:
inclusion criteria: * neurological disorder * behavior disorder * epilepsy exclusion criteria: * cardiac disease * respiratory disease

Keywords: sedation electroencephalography dexmedetomidine chloral hydrate
combining nutrition supplementation with an exercise program in elderly malnourished frail patients after hospital stay

Conditions: Frailty; Sarcopenia; Malnutrition; Protein

Summary: the objective of this study is to investigate the feasibility of a combined nutritional and home-based exercise intervention in elderly, malnourished, frail patients after hospital discharge. adherence to exercise program, adherence to oral nutrition supplement, potential inhibiting factors to follow exercise program, changes in nutritional status, muscle mass and function, quality of life are outcome factors. the intervention consists of 12 weeks with a physical exercise program (vivifrail) and oral nutritional supplementation (moltein plus). the investigators hypothesize that 12 weeks of a combined nutritional and home-based multicomponent exercise program is feasible for frail elderly patients after hospital discharge, meaning that ≥70% of the exercise sessions will be completed and oral supplements will be consumed by the participants.


Eligibility criteria:
inclusion criteria: * age ≥ 65 * malnutrition: nutrition risk screening ≥3 * frail/pre-frail status according fried frailty phenotype: 1-2 criteria present = pre frail, \> 2 criteria present = frail * frailty status according to sppb: a: 0-3 points = disabled, b (b+): 4-6 points = frail (at risk of falls), c (c+): 7-10 points = pre-frail (at risk of falls), d: 10-12 points = robust. * ability to sit * consent to participate in the study * ability to follow the instructions of the vivifrail program * prescription for use of an ons exclusion criteria: * severe acute cardiovascular issues: eg. unstable angina pectoris, uncontrolled arrhythmia, uncontrolled arterial hypertension or unstable cardiovascular disease or other unstable medical condition. * persisting oedema and/or ascites * contraindication for the protein-rich ons (e.g. cow's milk allergy, end stage renal disease without renal replacement therapy) or dysphagia for liquids * non-removable plasters or bandages at feet or hands aggravating body impedance analysis (bia), implanted defibrillation device * parenteral/tube feeding * no access to telephone or severe hearing loss * terminal illness * hospitalized due to pulmonary thromboembolism * considerable cognitive impairment: mini-mental score \< 18 or advice of healthcare professionals against inclusion due to cognitive or psychological reasons.

Keywords: elderly exercise program oral nutrition supplementation
detection of fabry disease in chronic renal failure patients in area provence - alpes - côte d'azur

Conditions: Fabry Disease

Summary: fabry disease is a rare genetic disease characterized by an enzyme deficiency, called alpha-galactosidase a, which normally breaks down a lipid, is missing or does not function properly. as a result, the lipid accumulates in the body, this leads to multisystem impairment, including progressive renal failure. several studies have focused on the detection of this disease in end-stage renal failure patients, transplant or hemodialysis. this study aims to diagnose the fabry patients earlier, among men aged 18-60 years with a glomerular filtration rate estimated by mdrd between 60 and 15 ml/min/1, 73m2, or between 90 and 60 ml/min/1, 73m2 in association with proteinuria greater than 0.3 g / g or creatinine level greater than 0,5 g/l. this screening will be conducted by a blood test to measure the level of alpha-galactosidase a activity by micromethod from samples taken from blood spots on filter paper. if this assay was positive, confirmation of diagnosis of fabry disease will done the standard method: macrodosage of leukocytic alpha-galactosidase a activity. this multicenter prospective study, openly contacted in medical practice, with patient follow-up corresponding to the management of renal insufficiency, will be offered to all departments of nephrology and dialysis for adults in the provence - alpes - côte d'azur. the objective of this study is to assess the prevalence of fabry disease in the target population and to identify previously undiagnosed patients, enabling them to benefit from appropriate management of their disease, including whether need enzyme replacement therapy.


Eligibility criteria:
inclusion criteria: * men aged 18 to 60 years * glomerular filtration rate estimated by mdrd between 60 and 15 ml/min/1, 73m2, or between 90 and 60 ml/min/1,73m2 in association with proteinuria greater than 0.3 g/g creatinine or 0.5 g/l * patient able to understand the benefits and risks of the study * written consent, informed, signed * patients insured under social security, exclusion criteria: * patients with a confirmed diagnosis of fabry disease * patients belonging to a family in which a diagnosis of fabry disease was confirmed * patients protected by law (under guardianship).