Kornimate/medical-research-clean huggingface dataset:
evaluation of variable pressure support ventilation in the therapy of acute lung injury

Conditions: Acute Lung Injury

Summary: variable pressure support during assisted spontaneous breathing (noisy psv) has been shown to improve the respiratory function in experimental acute lung injury (ali). we aimed at comparing the effects of noisy psv with traditional psv on the respiratory function of patients suffering from ali.


Eligibility criteria:
inclusion criteria: * age 18 to 75 yrs * 150 mmhg \< pao2/fio2 \< 300 mmhg * mechanical ventilation with psv or bipap * less than 15 days of mechanical ventilation * at least 20% of minute ventilation originated from spontaneous breathing exclusion criteria: * bmi \> 35 * esophageal disease * neuromuscular disease * instable thorax * pneumothorax * head trauma * brain injury * increased intracranial pressure * agitation * increased need for vasoactive drugs * chronic lung disease * acute coronary disease * participation in another clinical trial within the last 4 weeks at enrollment interruption criteria: * acute change of mental status * sao2 \< 92% * pha \< 7.30 * respiratory rate \> 30 or \< 6 /min * dyspnea * diaphragm/thorax antagonism * diaphoresis * abnormal use of respiratory muscles * increase of the heart rate above 120% of baseline or absolute value \ 130 /min * mean arterial pressure above 120% of baseline or absolute value \ 110 mmhg
prognostic factors of disabling low back pain in patients with chronic low back pain

Conditions: Chronic Low Back Pain; Mechanical Low Back Pain

Summary: the aim of the present study is to quantify the relative contribution of variables obtained during a physical fitness evaluation and a short screening questionnaire in determining the short-term and long term risk of persistent disabling low back pain in patients with chronic low back pain. it has been hypothesized that patients with higher physical fitness will present a lower risk of persistent disabling low back pain and so, a lower score on the questionnaire.


Eligibility criteria:
inclusion criteria: * adults between 18 and 60 years old * nonspecific low back pain : pain located between the twelfth rib and the inferior gluteal fold for which no specific source of pain could be identified * chronic low back pain : pain present for 12 weeks or more, and included both constant and recurrent patterns of pain * able to read and understand french exclusion criteria: * history of surgery or major trauma to the spine * current use of medication known to impair physical effort and pain perception * lumbar scoliosis of more than 20° * collagenosis, severe osteoporosis * neuromuscular disease * malignant tumor * non-controlled hypertension * infection * radiculopathy * progressive neurologic defect * myelopathy * lumbar disc hernia * pregnancy * active lower body injury and/or severe and disabling pain limiting the capacity to undergo the evaluation.

Keywords: chronic low back pain prognostic factors disabling low back pain lumbar muscle activity start back screening tool physical evaluation
assessment of candidate protein expression in breast cancer specimens

Conditions: Breast Cancer

Summary: rationale: studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. purpose: this research study is looking at tumor tissue samples from patients who have undergone surgery for breast cancer.

objectives: * to determine if candidate genes display differential expression between normal and cancer breast tissues. outline: previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Eligibility criteria:
inclusion criteria: disease characteristics: * diagnosis of breast cancer * tissue samples available * samples are selected based on presence or absence of tumor receptors, (i.e.; estrogen, progesterone, and her2 receptors) and grouped into following 4 categories: * estrogen receptor (er)-positive/progesterone receptor (pr)-positive/her2-negative * er-positive/pr-positive/ her2-positive by fish * er-negative/pr-negative/her2-positive * er-negative/pr-negative/her2-negative(triple negative or basal-type cancers) patient characteristics: * menopausal status not specified prior concurrent therapy: * not specified exclusion criteria: * there are no exclusion criteria in this protocol

Keywords: breast cancer estrogen receptor-negative breast cancer estrogen receptor-positive breast cancer progesterone receptor-negative breast cancer progesterone receptor-positive breast cancer triple-negative breast cancer her2-negative breast cancer her2-positive breast cancer
clinical evaluation of dailies total 1® performance in a japanese population

Conditions: Refractive Error

Summary: the purpose of this study is to compare dailies total1® (dt1) to 1-day acuvue® trueye® (te) for investigator-rated successful lens centration in japanese population.


Eligibility criteria:
inclusion criteria: * must sign an informed consent form; * habitual current daily disposable soft contact lenses wearer; * symptoms of contact lens discomfort as defined by the symptomatology (eligibility) questionnaire; * lenses within the power range specified in the protocol; * vision correctable to 20/25 or 0.1 logmar (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at visit1; * acceptable lens fit with both study contact lenses; * willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits; * other protocol-specified inclusion criteria may apply. exclusion criteria: * currently wearing dt1 or te sphere lenses; * ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator; * eye injury or surgery within 12 weeks immediately prior to enrollment; * history of herpetic keratitis, ocular surgery or irregular cornea; * prior refractive surgery; * monocular (only 1 eye with functional vision) or fit with only 1 lens; * participation in any clinical trial within 30 days of the enrollment visit; * other protocol-specified exclusion criteria may apply.
micro plug set - post market clinical follow-up (pmcf) plan

Conditions: Trauma Injury; Bleeding

Summary: this is an observational, post market clinical follow-up (pmcf) intended to evaluate the residual risks of the micro plug set which is intended for use during arterial embolization of the peripheral vasculature. this pmcf will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.


Eligibility criteria:
inclusion criteria: * subject is scheduled for arterial embolization in the peripheral vasculature. * subject is greater than 18 years of age exclusion criteria: * subject is unable to give informed consent * subject is pregnant or breastfeeding * subject has allergy to nickel * patient requires neurologic or cardiac use of an occlusion device, contrary to the micro plug set instructions for use.
an investigation of the past 10 yrs health care for primary care patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to describe copd health care and to assess demographics, concurrent diseases and mortality and the use of pharmaceuticals for a chronic obstructive pulmonary disease (copd) population in real life in primary care during the last ten years.


Eligibility criteria:
inclusion criteria: * copd diagnosis according to medical records. * use of drugs prescribed for obstructive lung diseases

Keywords: epidemiological copd health care treatment in primary care
efficacy of omaveloxolone treatment for dysphagia in french patients with friedreich's ataxia

Conditions: Friedreich Ataxia

Summary: friedreich's ataxia (fa) is a rare, inherited neurodegenerative disease that typically begins in children and young people. it primarily affects the spinal cord, peripheral nerves and cerebellum of the brain. clinical manifestations include progressive gait and limb ataxia, auditory and optic neuropathy, cardiomyopathy, scoliosis, dysarthria, and dysphagia. in advanced stages, individuals may become wheelchair-dependent, leading to a severe loss of autonomy and reduced life expectancy. to date, there are no effective treatments known to reverse or halt disease progression. heart disease remains the leading cause of death in individuals with fa. in january 2024, omaveloxolone was approved for early access in france to treat fa in patients aged 16 years and older. dysphagia is a central manifestation in fa, and may lead to severe complications such as malnutrition, dehydration, and aspiration-related pneumonia, as well as reduced self-esteem and social isolation. despite its clinical relevance, dysphagia remains underexplored in clinical trials, including in major omaveloxolone studies where no specific tool for measuring dysphagia has been incorporated. this study aimed to comprehensively evaluate the effect of omaveloxolone on dysphagia after six months of treatment, in a cohort of french patients with friedreich's ataxia who benefited from early access to treatment between february 2024 and may 2025. the severity of dysphagia will be assessed using the sydney swallow questionnaire (ssq), completed by patients at baseline and after six months of omaveloxolone treatment.


Eligibility criteria:
inclusion criteria: * aged ≥ 16 years * confirmed diagnosis of friedreich's ataxia, genetically verified. * omaveloxolone therapy between february 2024 and may 2025, having receive treatment for at least 6 months. exclusion criteria: * participants who interrupted treatment permanently before 6 months. * participants who did not complete the ssq (sydney swallow questionnaire) at baseline and after 6 months of treatment.
effect of laparoscopic sleeve gastrectomy in the morbidly obese, kidney transplant candidate

Conditions: Obesity, Morbid; Transplant; Failure, Kidney

Summary: a prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the potential renal transplant candidate who is denied acceptance due mainly to the morbid obesity.

the remaining factor in determining the effectiveness of bariatric surgery in the transplant population will be to study the effect on the pharmacokinetics of immunosuppressive medication, height, weight, bmi, abdominal circumference, blood pressure, hba1c , average daily insulin requirements, lipid profile, tsh, 24h urine creatinine clearance and the sf-36 quality of life questionnaire.

Eligibility criteria:
inclusion criteria: * adult (\>18 years) * stage iv and v chronic renal disease (glomerular filtration rate \< 30 ml/min, * body mass index (bmi) of greater than 40 kg/m2 or \> 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes exclusion criteria: * medically unfit for surgical intervention * previous gastric or intestinal surgery * active gastric disease * pregnancy or lactation * known intolerance to tacrolimus or mycophenolic acid * awaiting potential multi-organ transplantation * active infection
imaging characteristics of chronic lumbar disc herniation from the perspective of core muscles and subcutaneous fat tissue thickness

Conditions: Lumbar Disc Herniation

Summary: fat infiltration and atrophy of lumbar muscles are related to spinal degenerative conditions, which can be seen reliably on mri scans of lumbar disc herniation (ldh) patients. the aim of this study was to investigate the relationship between the degeneration of core muscles, obesity and chronic ldh. fifty-five healthy volunteers and fifty-five chronic ldh patients (the course of the disease is more than six months) were enrolled. core muscle percent fat and subcutaneous fat tissue thickness(sftt) were used as the outcome measure, and logistic regression and independent samples t-test as the analytical methods to compare the relationship of the following five independent variables (erector spinae, rectus abdominis, \[transversus abdominal, internal abdominal oblique, and external abdominal oblique muscle\], lumbar multifidus, and psoas major muscles) and sftt with ldh.


Eligibility criteria:
inclusion criteria: * patients in good physical health; ②patients aged 20 to 55 years, including 20 and 55 years, male or female; ③patients who agree to participate in the study and sign the informed consent. exclusion criteria: * patients who performed lumbar and abdominal muscles exercises in the past; ②patients unable to tolerate magnetic resonance imaging or claustrophobia; * patients who are deemed unsuitable for the clinical trial. removing criteria: * patients who decline participation of various reasons; * patients unable to comprehend questions asked by the researchers; ③patients intolerant to necessary examinations.
airway inflammation, symptoms and lung function in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a chronic inflammatory disease with high prevalence worldwide and with relevant impact on patient-related quality of life, morbidity and mortality. there is evidence that airway inflammation correlates with the severity of the disease and that airway inflammation is further enhanced during exacerbation. however, it is unknown whether daily fluctuation of symptoms or changes in lung function is paralleled by changes in airway inflammation.

patients will undergo a visit every 7 days during one month (5 visits in total). at each visit airway inflammation (exhaled no, sputum inflammatory cell count) and lung function will be performed. at home patients will be asked to fill a daily diary for symptom assessment.

Eligibility criteria:
inclusion criteria: * post-bronchodilator fev1/fvc ratio \< 70% * post-bronchodilator fev1 \< 80% * smokers or ex-smoker with pack/years \> 15 exclusion criteria: * atopy * asthma * concomitant lung diseases (e.g. lung cancer) * acute infections of the respiratory tree in the previous 2 months including copd exacerbation.

Keywords: copd airway inflammation symptoms lung function correlation
laser therapy for vulvovaginal symptoms in breast cancer patients

Conditions: Vulvovaginal Atrophy; Genitourinary Symptoms and Ill-Defined Conditions

Summary: to determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (vva) or genitourinary syndrome of menopause (gsm) in women with breast cancer.

laava 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive "sham" laser treatment (setting of close to zero) participants will receive the 3 treatments approximately 4 weeks apart. participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. at the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received "sham" treatment will be allowed to crossover to "active" treatment if they wish.

Eligibility criteria:
inclusion criteria: * women with a history of early breast cancer \>18 years of age * at baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm vas scale. symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia. * three groups of patients will qualify: * treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for \>6 months * premenopausal women on gnrh (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor * postmenopausal women on tamoxifen or an aromatase inhibitor * willingness to give written informed consent and willingness to comply with the study * up to date pap test / hpv (human papillomavirus) testing exclusion criteria: * medical contraindication to the use of fractional ablative co2 laser * use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment * use of vaginal lubricants or moisturisers 14 days prior to the study treatment * active or recent genitourinary infections (\<30 days) * genital prolapse (grade iii) * active or symptomatic vulvo-vaginal dermatological conditions (lichen sclerosus, lichen planus, vulval psoriasis, chron's disease, hidradenitis suppurativa, vulval dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial neoplasia, genital warts) * inability to tolerate the use of fractional ablative co2 laser (eg vaginismus)

Keywords: genitourinary symptoms of menopause co2 fractional ablative laser early breast cancer vulvovaginal atrophy vaginal dryness dyspareunia vaginal itch dysuria
acute effects of action observation on neck pain

Conditions: Neck Pain

Summary: this study aims to assess the immediate effects of action observation therapy on the cervical muscles' strength, pain intensity, tactile acuity and pain pressure threshold in individuals with chronic nonspecific neck pain.

this study is a randomized controlled trial with two arms: action observation group vs control group. the action observation group will be asked to watch videos of neck exercises with full attention and concentration and not perform any motion or execute any movement during the observation time. the control group will be asked to watch videos of a landscape. participants will be assessed at baseline and at post-intervention for muscle strength, pain intensity, pressure pain threshold and tactile acuity.

Eligibility criteria:
inclusion criteria: * have nonspecific chronic neck pain, defined as a recurrent or persistent pain that lasts more than 3 months, with no trauma or etiology/diagnosis associated. exclusion criteria: * visual and hearing dysfunction not corrected by eyeglasses/contact lenses or a hearing aid; * infectious diseases; * cervical myelopathy; * cervical surgery; * cervical fracture or/and subluxation; * vestibular pathology; * neurological disorder/deficits; * rheumatic autoimmune diseases; * history of cancer; * severe cervical trauma.
efficacy of let's know! first grade

Conditions: Developmental Language Disorder and Language Impairment

Summary: oral language skills are vital for reading comprehension. some children, however, are at increased risk for reading comprehension difficulties due to underlying oral language deficits. school-based interventions that target children's abilities to understand and produce spoken language have shown positive effects for improving language and reading comprehension of children with typical development and those at-risk for language disorders, so it is likely that they will benefit children with low oral language skills. the purpose of this study is to examine the efficacy of a small-group intervention for improve language skills in first grade students with low oral language skills.

oral language skills, which consist of both lower-level (vocabulary and grammar) and higher-level skills (inferencing, comprehension monitoring, and text structure knowledge) are crucial for reading comprehension. children with low oral language skills are at increased risk for negative academic outcomes due to their deficits in understanding and producing language. multi-component interventions have shown positive effects for improving language comprehension and reading comprehension outcomes of children with typical development and at-risk for language and literacy disorders, and thus may benefit children with low oral language skills. the purpose of this study is to examine the efficacy of let's know!, a small group multi-component intervention, for improving language comprehension skills in first-grade students with low oral language skills. a randomized controlled trial will be employed to compare the language comprehension outcomes for a treatment group compared to a business-as-usual control group.

Eligibility criteria:
inclusion criteria: * enrolled in first-grade; * receive a score of below than 5 on two items on the student language scale (nelson et al., 2018) or be receiving school speech-language services for language impairment; * be proficient in english, per caregiver report; * have no other neurological impairments (e.g., intellectual disability, autism) per parent report; * have corrected vision; * no hearing impairment. exclusion criteria: * cannot be enrolled in english-language learner services in the school.

Keywords: developmental language disorder language intervention
salt loading and thiazide intervention study

Conditions: Hypertension

Summary: the investigators of this study propose to examine the relationships between stk39 (serine threonine kinase 39) genotypes and responses to salt loading and to thiazide diuretics, hydrochlorothiazide. the investigators hypothesize that stk39 genotypes will be associated with the outcome of both interventions and can contribute to personalized care for hypertension.

although hypertension can be easily diagnosed and there are many medications available to treat hypertension, this condition is poorly managed in many patients and is a leading cause of morbidity and mortality worldwide. because a newly identified hypertension susceptibility gene, stk39 (serine threonine kinase 39), plays a central role in kidney sodium transport, the investigators propose a pharmacogenetics study to examine the relationships between stk39 genotypes and blood pressure responses to salt loading and to thiazide diuretics, hydrochlorothiazide. in addition, stk39 genotypes may also predict those hypertension patients more likely to develop thiazide-induced hyperglycemia. the investigators hypothesize that stk39 genotypes of those single nucleotide polymorphisms (snps) that are associated with baseline systolic blood pressure (sbp), diastolic blood pressure (dbp), and hypertension status, will be associated with the outcome of both interventions. therefore these snps can act as markers and contribute to personalized care for hypertension by identifying patients most likely to effectively control their blood pressure by adopting salt-reducing diet versus patients most likely to effectively and safely control their blood pressure by taking thiazide diuretics.

Eligibility criteria:
inclusion criteria: * old order amish * age 18 to 65 * have systolic blood pressure between 120 and 160 and diastolic blood pressure between 80 and 100 exclusion criteria: * history of myocardial infarction, stroke, congestive heart failure, liver disease * known cause of secondary hypertension * diabetes or fasting glucose \> 100 mg/dl * women who are pregnant, on oral contraceptives, or menstruating * used hydrochlorothiazide (hctz) in the last 8 weeks or known allergy to hctz * taking non-steroidal anti-inflammatory drugs * estimated glomerular filtration rate \< 80 ml/m * intention to alter dietary habit during the study * abuse of alcohol or drug

Keywords: hypertension hydrochlorothiazide hctz salt sensitivity hydrochlorothiazide induced hyperglycemia