Kornimate/medical-research-clean huggingface dataset:
distal perfusion timing, early or conservative, to prevent limb ischemia during peripheral va-ecmo

Conditions: Extracorporeal Membrane Oxygenation Complication

Summary: peripheral va-ecmo is widely used in refractory cardiogenic shock patients as a salvage therapy. in most cases, the femoral artery and vein are used for the vascular approach. large cannulas are usually used for proper oxygenation, which may cause peripheral limb ischemia. distal perfusion catheterization (dpc) at the ipsilateral arterial cannula site is recommended to prevent distal limb ischemia. however, there is no consensus on the proper timing of dpc and additional invasive procedures may cause complications during va-ecmo support. in this analysis, the investigators compare the clinical outcomes of distal limb ischemia complications between the conventional dpc group (dpc at the time of limb ischemia sign) and the preemptive dpc group (dpc at the time of va-ecmo application).


Eligibility criteria:
inclusion criteria: * age ≥19 years old * refractory cardiogenic shock with peripheral va-ecmo * informed consent exclusion criteria: * unwilling or unable to obtain informed consent from the participant or substitute decision-maker * patients who are currently pregnant, postpartum period within 30 days or are breast-feeding * va-ecmo application for causes other than cardiogenic shock * severe coagulopathy * irreversible limb ischemia requiring interventional procedures or surgery at the time of va-ecmo (previously diagnosed aso(atherosclerosis obliterans) patients)

Keywords: extracorporeal membrane oxygenation limb ischemia cardiogenic shock
sis graft and traditional repair in vaginal wall prolapse

Conditions: Pelvic Organ Prolapse

Summary: the objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. this a randomized and prospective study. clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the pelvic organ prolapse questionnaire (p-qol), sexual function with fsfi and possible complications.

the objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. this a randomized and prospective study. clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the pelvic organ prolapse questionnaire (p-qol), sexual function with fsfi and possible complications

Eligibility criteria:
inclusion criteria: * anterior vaginal wall prolapse with poin ba at least at +1; * pre and postmenopausal patients exclusion criteria: * patients without surgical indication; * infection; * coagulopathy; * gynecologic cancer; * liver or kidney active diseases.

Keywords: pelvic organ prolapse surgical treatment
cognitive behavioral treatments for depression in chronic illness

Conditions: Major Depression

Summary: duke university medical center in collaboration with glendale adventist medical center propose a randomized clinical trial of conventional cognitive behavior therapy (ccbt) vs. religious cognitive behavior therapy (rcbt) for major depression in medical patients with chronic disabling illness. therapists will deliver the treatment in real time over the internet and/or by telephone to increase treatment access. this planning grant seeks support for a two-site study (north carolina and california) that consists of two phases. in phase i (rounsaville 1a) the investigators will conduct an open trial of 30 patients to assess subject recruitment, refine rcbt and ccbt manuals and protocol, assess compliance with treatment, acceptability of treatment and delivery system (online vs. telephone), and allow therapists gain experience with delivery system and rcbt. in phase ii (rounsaville 1b) the investigators will conduct a randomized proof of concept comparison of ccbt vs. rcbt that will demonstrate feasibility and confirm the expected clinically meaningful difference for a definitive r01 application. in phase ii, 70 religious patients ages 18-85 with a new episode of major depression (mini), scores of 16-35 on the beck depression inventory (bdi), and at least one chronic disabling medical illness will be randomized to either ccbt or rcbt. the trial will consist of ten 50 min sessions administered by master's level therapists and delivered over 12 weeks. the primary endpoint will be bdi score at baseline, 4, 8, 12, and 24-week follow-up. christian, jewish, hindu, buddhist, and muslim versions of the rcbt manual will be developed, and cbt experts in each of these traditions will supervise therapists delivering the intervention to patients from these faith traditions. the purpose of this study is to determine feasibility and effect sizes for a future, fully powered treatment study. the importance is that results will be relevant to therapists well beyond those who explicitly practice pastoral counseling, extending to many secular therapists as well. if 65% of americans indicate that religion is an important part of daily life and the vast majority of chronically ill medical patients wish to include it in their therapy, then all therapists (whether they have explicit training in pastoral counseling or not) are likely to encounter patients in which this approach would be applicable.


Eligibility criteria:
inclusion criteria: * chronic disabling medical illness * religion at least somewhat important to patient * major depressive disorder by mini neuropsychiatric interview * beck depression inventory scores of 16-28 (moderately severe depression) * live near durham, north carolina, or near glendale, in southern california exclusion criteria: * significant cognitive impairment * significant suicidal thoughts or risk * no access to telephone

Keywords: depression
optimal value increase of egg products

Conditions: Healthy; Inflammation; Aging

Summary: the aim of this project is to evaluate daily intake of eggshell membrane taken as supplement (capsule), will reduce markers of inflammation in older people.


Eligibility criteria:
inclusion criteria: the study will include home-dwelling men and women ≥ 70 years. all subjects have to be in a good enough condition to meet up at the department of nutrition, university of oslo at two occasions during the study period. exclusion criteria: * crp \>10 mg/l * egg allergy * use of medication affecting inflammation * unstable use of medication or supplements last 3 months * unwilling to keep the physical activity level, habitual dietary intake, tobacco use and weight stable during the study period * severe illness last 3 months * unwilling to perform physical tests * eligibility * diabetes type i or ii, hba1c ≥ 6.5 %

Keywords: eggshell membrane healthy volunteers old volunteers
evaluation of a non-invasive urinary collection technique for the adaptation of diuretic treatment in incontinent heart failure patient over 75 years of age in the acute phase

Conditions: Diuresis in Incontinent Patients

Summary: heart failure is a general disease affecting many organs and regulatory systems with a prevalence of 10% after 75 years of age, leading to significant hospitalization in the elderly. this generates a significant cost for our health system. the management of patients over 75 years of age in acute heart failure requires special monitoring of diuresis and weight. however, it is sometimes difficult to collect urine from incontinent elderly patients (not catheterized, habitually wearing protection) under intravenous diuretics. the evaluation of a non-invasive technique of urine collection for the adaptation of diuretic treatment in the incontinent patient with heart failure over 75 years of age in the acute phase seems to us to be interesting to conduct.


Eligibility criteria:
inclusion criteria: * patient over 75 years of age * geriatric short-stay inpatient, geriatric/cardio medicine unit geriatrics * incontinent patient with urinary protection * patient with acute heart failure according to the diagnosis made by the doctors of unity * patient treated with intravenous diuretic * patient benefiting from a social security scheme or benefiting from it by a third party * patient who gave their non-opposition to the study after clear information exclusion criteria: * patient hospitalized in another unit of the geriatric division * patient allergic to the protections provided * patient carrying a bladder probe upon entry into the unit * patient with a precarious non-perfusable venous capital
level of adherence of subjects receiving saizen® via easypod™ electromechanical device for growth hormone treatment

Conditions: Growth Disorders

Summary: this is a chinese, multicentre, observational study to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter longitudinal observational study. parents/subjects will provide their informed consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: * to assess the level of adherence of subjects receiving saizen® via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to identify adherence subject profiling * to asses the impact of adherence on insulin-like growth factor 1 (igf1) (i.e. above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * over the age of \>2 years * under \<18 years of age, or over 18 without fusion of growth plates * patients diagnosed with growth hormone deficiency * naïve to growth hormone treatment * parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. if the child is old enough (16 years old) to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country. exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the summary of product characteristics (smpc) * use of an investigational drug or participation in another interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
novatears® eye drops observational study

Conditions: Dry Eye Disease

Summary: this observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device novatears® eye drops for a duration of 5 to 7 weeks.


Eligibility criteria:
inclusion criteria: * according to novatears® instruction for use * ≥ 18 years * patients with mild to moderate disease and hyper-evaporative dry eye disease applying eye lid hygiene for at least 14 days * ability and willingness to provide written informed consent * ability and willingness to participate in all examinations * willingness and ability to return for follow up visit exclusion criteria: * patients with hypersensitivity to any of the components of novatears® * patients with contact lenses, pregnancies, or who are breast feeding * patients with non evaporate dry eye disease * patients taking lipid containing eye drops or requiring pharmacologic treatment of dry eye disease
efficacy of metformin in pcos: metabolic and hormonal factors

Conditions: Polycystic Ovary Syndrome

Summary: hypothesis: metformin treatment normalises hormone values and metabolic parameters in women with pcos. ovulation is restored and bleeding periods become regular. fifty women with pcos (rotterdam criteria) are randomised to either placebo or metformin for 6 months. after a wash-out period of 3 months, the opposite treatment is given for another 6 months. measurements are performed before ech treatment period, every second month during treatment and after completing treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of pcos * age 20 - 45 exclusion criteria:diabetes * diabetes * hormonal treatment * pregnancy, lactation * periclimacteric

Keywords: polycystic ovary syndrome metformin metabolic syndrome hyperandrogenism ovulation
efficacy and safety of aqx-1125 in unstable copd

Conditions: COPD

Summary: the primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of aqx-1125 compared to placebo in subjects following exacerbations of chronic obstructive pulmonary disease (copd) by targeting the ship1 (src homology 2-containing inositol-5'-phosphatase 1) pathway.

chronic obstructive pulmonary disease (copd) is a leading cause of morbidity and mortality worldwide. acute exacerbations of copd are usually treated with steroids and/or antibiotics. currently this conventional therapy has significant side effects including osteoporosis, cataracts and suppression of the immune system (from the steroids) and increasing bacterial resistance and other side effects from the use of antibiotics. during an acute exacerbation of copd, the inflammation in the airways increases. aqx-1125 represents a new type drug that based current data is thought decrease the inflammatory process and therefore may provide a therapeutic benefit in the treatment of copd.

Eligibility criteria:
inclusion criteria: 1. male or female aged ≥40 years at screening 2. history of copd for at least 18 months prior to screening, characterised by excessive sputum production 3. chronic productive cough for at least 3 months in each of the 2 years prior to screening (if other causes of productive cough have been excluded) and/or an exacerbation of copd with predominantly bronchitic symptoms at enrolment 4. at least 2 documented exacerbations during the last 18 months prior to screening. 5. presentation of a diagnosed acute exacerbation of copd, or have recently (within 3 days) been discharged from hospital due to an acute exacerbation of copd 6. ability to perform pulmonary function testing and with documented fixed airway obstruction determined by an fev1 /fvc \[forced vital capacity\] ratio (post-bronchodilator) of \<0.70 and a predicted fev1 value of 30%-80% of normal within the 6 months prior to visit 1. 7. former smoker or current smoker, both with a smoking history of at least 10 pack years exclusion criteria: 1. diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis \[cf\] or significant non-cf bronchiectasis) 2. known alpha-1-antitrypsin deficiency 3. treatment with roflumilast or theophylline within 1 month prior to screening 4. lobar pneumonia, with current positive chest x-ray (cxr) or within the 3 months prior to screening including the presence of any new radiological infiltrate on cxr within the previous two weeks 5. hospitalisation for more than 7 days for current acute exacerbation, or the requirement for intubation during hospitalisation 6. for outpatients, prior medical history indicating that previous exacerbations required \>3 weeks to stabilise

Keywords: exacerbation of copd unstable copd
efficacy and safety of oral semaglutide versus empagliflozin in subjects with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of this trial is to investigate efficacy and safety of oral semaglutide versus empagliflozin in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * male or female, age above or equal to 18 years at the time of signing informed consent * diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening * hba1c (glycosylated haemoglobin) of 7.0-10.5 % (53-91 mmol/mol) (both inclusive) * stable daily dose of metformin (at least 1500 mg or maximum tolerated dose as documented in the subject medical record) at least 90 days prior to the day of screening exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).for certain specific countries: additional specific requirements apply * any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * history of pancreatitis (acute or chronic) * history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) * any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening * subjects presently classified as being in new york heart association class iv * planned coronary, carotid or peripheral artery revascularisation known on the day of screening * subjects with alt (alanine aminotransferase) above 2.5 x upper normal limit * renal impairment defined as estimated glomerular filtration rate below 60 ml/min/1.73 m\^2 as per chronic kidney disease epidemiology collaboration formula (ckd-epi) * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. an exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days * proliferative retinopathy or maculopathy requiring acute treatment. verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation * history or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ) * history of diabetic ketoacidosis
predictors of postoperative delirium after transcatheter aortic valve implantation

Conditions: Postoperative Delirium

Summary: patients undergoing transcatheter aortic valve implantation (tavi) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. hemodynamic instability, cerebral embolism, sedation, general anesthesia and hospitalization in intensive care expose those patients to postprocedural delirium. acute neurocognitive dysfunctions are associated with adverse outcomes in these population. the objective of this study is to determine the incidence of delirium and neurocognitive disorders in elderly patients after tavi.


Eligibility criteria:
inclusion criteria: * age 65\>years * patients undergoing transcatheter aortic valve implantation * patients have given informed consent for participation at the study exclusion criteria: * patient suffering from delirium (cam diagnosis) at recruitment * inability to understand the national languages * emergency procedures

Keywords: delirium transcatheter aortic valve implantation elderly
training based on declarative memory cues improved gait in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: deficits in automatic motor control, characteristic of parkinson's disease (pd), contribute to progressive impairment in gait performance. the use of declarative memory cues in order to promote the engagement of attention and activation of the next movement in gait may minimize the consequences of lack of automatic control. the purpose of this study is to verify the long-term efficiency of a new strategy based on declarative memory cue to improve the gait performance and independence in daily life activities (dla) in patients with pd.

background: deficits in automatic motor control, characteristic of parkinson's disease (pd), contribute to progressive impairment in gait performance. the use of declarative memory cues in order to promote the engagement of attention and activation of the next movement in gait may minimize the consequences of lack of automatic control. objectives: to verify the long-term efficiency of a new strategy based on declarative memory cue to improve the gait performance and independence in daily life activities (dla) in patients with pd. design: parallel prospective, single blind, randomized clinical trial. setting: brazilian parkinson association. participants: forty-four patients with pd in stages 2-3 of disease evolution according to hoehn and yahr classification interventions: the experimental training (et) consisted of eight gait training sessions, twice a week, using the declarative memory cues strategy (dmcs). the control training (ct) consisted of a similar gait training without dmcs. primary outcome measure: gait performance in terms of speed and stride length. secondary outcome measure: independence in dla according to section ii of the unified parkinson's disease rating scale. randomization: participants were randomized into a control group (cg), which performed the ct, and an experimental group (eg), which performed the et, through blinded drawing of names. statistical analysis: the gait performance and adl independence before, 2 and 60 days after the end of training were compared for cg and eg using repeated-measures analysis of variance (rm-anova).

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease according to the uk brain bank criteria; * in stage 2-3 of the disease evolution according to the hoehn and yahr; * treated with levodopa or its synergists; * capable to ambulate independently indoors without aid; * referring 5 to 15 years of education; * good visual and auditory acuity. exclusion criteria: * presence of other neurological (excluding pd), orthopedic or cardiopulmonary problems; * visual and auditory deficiency; * dementia \[assessed by the mini mental state examination (mmse), cut-off 23\]; * depression \[according to the geriatric depression scale (gds-15), cut-off 6\] * participation in other physical therapy training.

Keywords: parkinson disease gait cues memory training